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MS2_fixed_5_shot_test

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MS2_fixed_5_shot200

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Objectives To evaluate the effect of association of tamsulosin/tadalafil taken daily compared with tamsulosin/placebo in the lower urinary tract with urodynamic study ( UDS ) . Methods All patients underwent baseline UDS before r and omization to tamsulosin 0.4 mg/tadalafil 5 mg ( Group 1 ; n = 20 ) or tamsulosin 0.4 mg/placebo ( Group 2 ; n = 20 ) once daily for 30 days . End-of- study UDS were performed on completion of the treatment period . The primary end point was to demonstrate changes in urodynamic variables in the voiding phase , detrusor pressure at maximum flow ( PdetQmax ) , and maximum flow rate ( Qmax ) , from baseline to week four . Results The primary outcome measure of this clinical trial , PdetQmax , showed a significant reduction in tamsulosin/tadalafil group ( 13 ± 17.0 ) compared to tamsulosin/placebo ( −1.2 ± 14.35 ) group ( P = 0.03 ) . Qmax increased in both groups , tamsulosin/tadalafil ( 1.0 ± 2.4 ) and tamsulosin/placebo ( 1.4 ± 2.4 ) , but the difference was not significant between treatment groups ( P = 0.65 ) . Total IPSS , storage , and voiding sub-score improved significantly in tamsulosin/tadalafil compared with tamsulosin/placebo group . Conclusions The association of tamsulosin/tadalafil reduces detrusor pressure at maximum flow without changing the maximum flow rate during micturition and significantly improves lower urinary tract symptoms compared with the isolated use of tamsulosin This prospect i ve study evaluated the safety of tadalafil 5 mg taken once a day in terms of hypotensive side effects and whether it improves lower urinary tract symptoms ( LUTS ) and restores sexual function in patients with erectile dysfunction who are receiving concomitant α-blocker ( AB ) therapy for benign prostatic hyperplasia ( BPH ) . A total of 158 LUTS/BPH patients receiving AB therapy for ≥3 months were given tadalafil 5 mg once a day . Before treatment with tadalafil ( V1 ) , and 4 weeks ( V2 ) and 12 weeks ( V3 ) after starting tadalafil , blood pressure , heart rate , International Prostate Symptom Score ( IPSS ) , maximal urine flow rate ( Qmax ) , postvoiding residual urine volume , and International Index of Erectile Function ( IIEF-5 ) score were measured . Of the 158 LUTS/BPH patients , a total of 119 completed the trial . Blood pressure ( systolic and diastolic ) and heart rate did not change . IPSS and IIEF-5 scores improved significantly , but Qmax and postvoiding residual urine volume did not ; however , in the 39 men with a low baseline Qmax ( ≤10 mL/s ) , Qmax rose significantly from 7.97 ± 1.44 mL/s ( baseline ) to 8.91 ± 1.60 mL/s ( V3 ; P = .012 ) . The remaining patients ( baseline Qmax > 10 mL/s ) did not change . At V2 and V3 , adverse side effects were observed in 10 men ( 7.30 % ) and 6 men ( 5.04 % ) , respectively . Facial flushing was the most common adverse side effect ( 6 men at V2 and 4 men at V3 ) , followed by headache ( 2 men each at V2 and V3 ) and dizziness ( 2 men at V2 ) . Two patients dropped out of the study because of adverse side effects . In conclusion , tadalafil 5 mg once a day in combination with AB appeared to have few adverse effects on hypotensive events and can improve LUTS and restore sexual function Summary Aims / objectives : In the BESIDE study , combination therapy ( antimuscarinic [ solifenacin ] and β3‐adrenoceptor agonist [ mirabegron ] ) improved efficacy over solifenacin monotherapy without exacerbating anticholinergic side effects in overactive bladder ( OAB ) patients ; however , a potential synergistic effect on the cardiovascular ( CV ) system requires investigation . Methods OAB patients remaining incontinent despite daily solifenacin 5 mg during 4‐week single‐blind run‐in , were r and omised 1:1:1 to double‐blind daily combination ( solifenacin 5 mg/mirabegron 25 mg , increasing to 50 mg after week 4 ) , solifenacin 5 or 10 mg for 12 weeks . CV safety assessment s included frequency of CV‐related treatment‐emergent adverse events ( TEAEs ) , change from baseline in vital signs ( systolic blood pressure [ SBP ] , diastolic blood pressure [ DBP ] , pulse rate ) and electrocardiogram ( ECG ) parameters . Results The frequency of hypertension , tachycardia and ECG QT prolongation , respectively , was low and comparable across combination ( 1.1 % , 0.3 % , 0.1 % ) , solifenacin 5 mg ( 0.7 % , 0.1 % , 0.1 % ) , and solifenacin 10 mg groups ( 0.8 % , 0 % , 0.1 % ) . Adjusted mean ( SE ) change from baseline to end of treatment ( EoT ) in SBP , DBP , and pulse rate with combination ( 0.07 mm Hg [ 0.38 ] , −0.35 mm Hg [ 0.26 ] , 0.47 bpm [ 0.28 ] ) , solifenacin 5 mg ( −0.93 mm Hg [ 0.38 ] , −0.45 mm Hg [ 0.26 ] , 0.43 bpm [ 0.28 ] ) and solifenacin 10 mg ( −1.28 mm Hg [ 0.38 ] , −0.48 mm Hg [ 0.26 ] , 0.27 bpm [ 0.28 ] ) was generally comparable , with the exception of a mean treatment difference of ~1 mm Hg in SBP between combination and solifenacin monotherapy ; SBP was unchanged with combination and decreased with solifenacin monotherapy . Mean changes from baseline to EoT in ECG parameters were generally similar across treatment groups , except for QT interval corrected using Fridericia 's formula , which was higher with solifenacin 10 mg ( 3.30 mseconds ) vs. combination ( 0.49 mseconds ) and solifenacin 5 mg ( 0.77 mseconds ) . Conclusion The comparable frequency of CV‐related TEAEs , changes in vital signs and ECG parameters indicates no synergistic effect on CV safety outcomes when mirabegron and solifenacin are combined PURPOSE We examined the effects of doxazosin , finasteride and combination therapy among men with benign prostatic hyperplasia on quality of life assessed with MOS-SF-36 ( Medical Outcomes Study Short-Form 36 ) and 2 disease specific instruments ( BII , benign prostatic hyperplasia Impact Index and I-PSS-QoL , International Prostate Symptom Score-QoL ) during 4 years . MATERIAL S AND METHODS The MTOPS ( Medical Therapy of Prostatic Symptoms ) study was a multicenter , r and omized , double-blind , placebo controlled clinical trial with a primary outcome of time to benign prostatic hyperplasia progression . Change in quality of life was a secondary outcome . A total of 2,872 men enrolled in the MTOPS study who had 3 baseline quality of life measures and at least 1 followup measure by any of the quality of life instruments were analyzed . RESULTS Compared with men assigned to placebo , men assigned to doxazosin and combination experienced a statistically significant improvement in the BII at year 4 . Men assigned to each of the drug groups also experienced a significant improvement in the I-PSS-QoL compared with those assigned to placebo . Considering longitudinal changes during 4 years , a significant improvement in BII and I-PSS-QoL scores was observed in men assigned to the drug groups compared with those assigned to placebo . However , there were no significant differences for the MOS-SF-36 subscales and summary scores when drug groups were compared with the placebo group . CONCLUSIONS The quality of life of men treated with doxazosin , finasteride , and the drugs combined generally improved when assessed with the BII and the I-PSS-QoL compared with those treated with placebo . Quality of life did not show improvement when measured by the MOS-SF-36 BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) Objectives The aim of this study was to compare outcomes using two preference-based measures of health status ( EQ-5D-5L and OAB-5D ) in patients with overactive bladder ( OAB ) treated with solifenacin plus mirabegron or solifenacin monotherapy in the BESIDE trial . Methods Patients with OAB who remained incontinent after 4 weeks ’ treatment with solifenacin 5 mg were r and omized 1:1:1 to combination treatment ( solifenacin 5 mg plus mirabegron [ 25 mg for the first 4 weeks/50 mg for the last 8 weeks ] ) , solifenacin 5 mg , or solifenacin 10 mg . EQ-5D-5L and OAB-q were administered at baseline , weeks 4 , 8 , 12 , and end of treatment ( EoT ) . OAB-5D scores were derived from OAB-q results . Responder analysis was carried out using several definitions of minimally important difference . Results A total of 2054 patients received one or more doses of study treatment ( combination , n = 694 ; solifenacin 5 mg , n = 684 ; solifenacin 10 mg , n = 676 ) . EQ-5D-5L Index mean score changes ( from baseline to EoT ) were greater with combination ( 0.059 ) than with solifenacin 5 mg ( 0.040 ) and 10 mg ( 0.044 ) monotherapy , but the differences were not statistically significant . A significantly greater improvement was observed for combination on OAB-5D ( 0.107 vs 0.085 for 5 mg , and 0.087 for 10 mg ; p ≤ 0.01 ) . The dimensions most improved overall were anxiety/depression , pain/discomfort , and usual activities on EQ-5D-5L , and urge , urine loss , and coping on OAB-5D . The proportion of responders was significantly greater with combination compared with monotherapy using OAB-5D only . Conclusions Improvements were observed in all study arms on both the EQ-5D-5L and OAB-5D , although only the OAB-5D showed a statistically significant benefit for combination versus solifenacin monotherapy . Combining generic and condition-specific preference-based health status measures allowed for assessment of dimensions that were particularly relevant to this patient population , while permitting comparison with outcomes from other studies , treatments , and population s via EQ-5D Twenty-nine postmenopausal women with OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination . This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression . Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy . The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron . This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events . The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful . For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy . This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient . PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women

MS2_fixed_5_shot201

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND AND OBJECTIVES : Little is known about chronic neuromotor disability ( CND ) including cerebral palsy and motor impairments after acquired brain injury in children surviving early complex cardiac surgery ( CCS ) . We sought to determine the frequency and presentation of CND in this population while exploring potentially modifiable acute care predictors . METHODS : This prospect i ve follow-up study included 549 children after CCS requiring cardiopulmonary bypass at ≤6 weeks of age . Groups included those with only 1 CCS , mostly biventricular CHD , and those with > 1 CCS , predominantly single ventricle defects . At 4.5 years of age , 420 ( 94.6 % ) children received multidisciplinary assessment . Frequency of CND is given as percentage of assessed survivors . Predictors of CND were analyzed using multiple logistic regression analysis . RESULTS : CND occurred in 6 % ( 95 % confidence interval [ CI ] 3.7%–8.2 % ) of 4.5-year survivors ; for 1 CCS , 4.2 % ( CI 2.3%–6.1 % ) and > 1 , 9.8 % ( CI 7%–12.6 % ) . CND presentation showed : hemiparesis , 72 % ; spasticity , 80 % ; ambulation , 72 % ; intellectual disability , 44 % ; autism , 16 % ; epilepsy , 12 % ; permanent vision and hearing impairment , 12 % and 8 % , respectively . Overall , 32 % of presumed causative events happened before first CCS . Independent odds ratio for CND are age ( days ) at first CCS , 1.08 ( CI 1.04–1.12 ; P < .001 ) ; highest plasma lactate before first CCS ( mmol/L ) , 1.13 ( CI 1.03–1.23 ; P = 0.008 ) ; and > 1 CCS , 3.57 ( CI 1.48–8.9 ; P = .005 ) . CONCLUSIONS : CND is not uncommon among CCS survivors . The frequency of associated disabilities characterized in this study informs pediatricians caring for this vulnerable population . Shortening the waiting period and reducing preoperative plasma lactate levels at first CCS may assist in reducing the frequency of CND BACKGROUND It is not known whether developmental and neurological outcomes in the preschool period differ depending on whether the predominant vital organ support strategy used in infant heart surgery was total circulatory arrest ( CA ) or low-flow cardiopulmonary bypass . METHODS AND RESULTS Infants with D-transposition of the great arteries who underwent an arterial-switch operation were r and omly assigned to a support method consisting predominantly of CA or low-flow cardiopulmonary bypass . Developmental and neurological status were evaluated blindly at 4 years of age in 158 of 163 eligible children ( 97 % ) . Neither IQ scores nor overall neurological status were significantly associated with either treatment group or duration of CA . The CA group scored lower on tests of motor function ( gross motor , P=0.01 ; fine motor , P=0.03 ) and had more severe speech abnormalities ( oromotor apraxia , P=0.007 ) . Seizures in the perioperative period , detected either clinical ly or by continuous electroencephalographic monitoring , were associated with lower mean IQ scores ( 12.6 and 7.7 points , respectively ) and increased risk of neurological abnormalities ( odds ratios , 8.4 and 5.6 , respectively ) . The performance of the full cohort was below expectations in several domains , including IQ , expressive language , visual-motor integration , motor function , and oromotor control . CONCLUSIONS Use of CA to support vital organs during open heart surgery in infancy is associated , at the age of 4 years , with worse motor coordination and planning but not with lower IQ or with worse overall neurological status Background : It is unknown whether intraoperative hyperglycemia in infants is associated with worse neurodevelopmental outcomes after low-flow cardiopulmonary bypass ( LF ) , deep hypothermic circulatory arrest ( CA ) , or both . Methods : In a data base review of a prospect i ve trial of 171 infants undergoing arterial switch for D-transposition of the great arteries who were r and omly assigned to predominately LF or CA , glucose was measured after induction ( T1 ) , 5 min after cardiopulmonary bypass onset ( T2 ) , at the onset of CA or LF ( T3 ) , 5 min after CPB resumption ( T4 ) , at rewarming to 32 ° C ( T5 ) , 10 min after cardiopulmonary bypass weaning ( T6 ) , and 90 min after CA or LF ( T7 ) . Outcomes included seizures , electroencephalographic findings , and neurodevelopmental evaluation at 1 , 4 , and 8 yr . Results : Glucose concentrations were affected by support strategy and age at surgery . Lower glucose in the entire group at T6–T7 tended to predict electroencephalographic seizures ( P = 0.06 and P = 0.007 ) but was not related to clinical seizures . Within the predominantly CA group , higher glucose did not correlate with worse outcomes . Rather , it was associated with more rapid electroencephalographic normalization of “ close burst ” and “ relative continuous ” activity at all times except T2 ( P ≤ 0.03 ) , a finding more pronounced in infants aged 7 days old or younger . Intraoperative serum glucose concentrations were unrelated to neurodevelopmental outcomes at ages 1 , 4 , and 8 yr . Conclusions : Low glucose after cardiopulmonary bypass tended to relate to electroencephalographic seizures and slower electroencephalogram recovery , independent of CA duration . High glucose concentrations were not associated with worse neurodevelopmental outcomes . Avoiding hypoglycemia may be preferable to restricting glucose in infants undergoing heart surgery Objective . Studies of developmental outcomes in children with congenital heart disease ( CHD ) frequently use assessment s conducted in infancy as primary endpoints . Whether test scores of CHD patients in infancy are predictive of status at school age has not been evaluated , however . Methods . In the Boston Circulatory Arrest Study , 135 children with D-transposition of the great arteries repaired by arterial switch operation were administered the Bayley Scales of Infant Development and the Fagan Test of Infant Intelligence at 1 year of age and the Wechsler Intelligence Scale for Children , Third Edition and the Wechsler Individual Achievement Test at 8 years . Results . Although most 1-year test scores were significantly associated with 8-year test scores , the amounts of shared variance were modest ( < 10 % ) . All 1-year test scores had poor sensitivity ( 16%–32 % ) and poor positive predictive value ( 35%–42 % ) but good specificity ( 80%–93 % ) and negative predictive value ( 78%–79 % ) . More than half of the children with low scores at 8 years ( ≤85 ) had had scores > 84 at 1 year . Conclusion . This pattern suggests that although test scores at 1 year are modestly associated with test scores at 8 years , many children who are at risk for poor late outcomes will not be identified on the basis of 1-year test scores . Long-term follow-up of children with CHD is necessary to draw inferences about the developmental sequelae of preoperative , intraoperative , and postoperative factors BACKGROUND Deep hypothermia with either total circulatory arrest or low-flow cardiopulmonary bypass is used to support vital organs during heart surgery in infants . We compared the developmental and neurologic sequelae of these two strategies one year after surgery . METHODS Infants with D-transposition of the great arteries who underwent an arterial-switch operation were r and omly assigned to a method of support consisting predominantly of circulatory arrest or a method consisting predominantly of low-flow bypass . Developmental and neurologic evaluations and magnetic resonance imaging ( MRI ) were performed at one year of age . RESULTS Of the 171 patients enrolled in the study , 155 were evaluated . After adjustment for the presence or absence of a ventricular septal defect , the infants assigned to circulatory arrest , as compared with those assigned to low-flow bypass , had a lower mean score on the Psychomotor Development Index of the Bayley Scales of Infant Development ( a 6.5-point deficit , P = 0.01 ) and a higher proportion had scores < or = 80 ( i.e. , 2 SD or more below the population mean ) ( 27 percent vs. 12 percent , P = 0.02 ) . The score on the Psychomotor Development Index was inversely related to the duration of circulatory arrest ( P = 0.02 ) . The risk of neurologic abnormalities increased with the duration of circulatory arrest ( P = 0.04 ) . The method of support was not associated with the prevalence of abnormalities on MRI scans of the brain , scores on the Mental Development Index of the Bayley Scale , or scores on a test of visual-recognition memory . Perioperative electroencephalographic seizure activity was associated with lower scores on the Psychomotor Development Index ( P = 0.002 ) and an increased likelihood of abnormalities on MRI scans of the brain ( P < 0.001 ) . CONCLUSIONS Heart surgery performed with circulatory arrest as the predominant support strategy is associated with a higher risk of delayed motor development and neurologic abnormalities at the age of one year than is surgery with low-flow bypass as the predominant support strategy BACKGROUND Truncus arteriosus ( TA ) is an uncommon congenital cardiac lesion that portends an exceedingly poor prognosis if not repaired . The objective of this study was to assess the clinical and developmental outcomes in a prospect i ve cohort of patients who underwent TA repair . METHODS All patients who underwent a TA repair between 1996 and 2012 were included . Follow-up clinical , neurologic , and developmental data were obtained from the Western Canadian Complex Pediatric Therapies Follow-up Program data base . Functional developmental outcomes were assessed at 21.1 ± 2.5 months of age with the Adaptive Behavior Assessment System-II , General Adaptive Composite ( GAC ) score . Survival and outcomes were compared between those with and without chromosomal abnormalities ( CA ) . Survival and freedom from reintervention were assessed by Kaplan-Meier analysis . RESULTS The study comprised 36 infants ( 19 male ) . CA was identified in 13 , with 22q11.2 deletion in 10 patients . Patients underwent TA repair at a median age of 10 days ; 5 patients underwent concomitant interrupted arch repair . There were 8 deaths , 2 of which occurred in the hospital . The 5-year survival was 79.4 % . Survival was similar between those with and without CA . At 5 years , freedom from reoperation was 77.2 % . The mean GAC was higher in the patients without CA ( 93.6 ± 12.8 vs 76.1 ± 13.1 , p = 0.0016 ) . CONCLUSIONS Patients with surgically repaired TA continue to have significant postoperative mortality . Reoperation and cardiac catheterization are eventualities for a quarter of patients in the first 5 years of life . Functional developmental outcome in patients without CA is good , although it is significantly impaired in those with CA Objectives Neonates with single ventricle congenital heart disease are at risk for structural cerebral abnormalities . Little is known about the further evolution of cerebral abnormalities until Fontan procedure . Methods Between August 2012 and July 2015 , we conducted a prospect i ve cross-sectional two centre study using cerebral magnetic resonance imaging ( MRI ) and neuro-developmental outcome assessed by the Bayley-III . Forty-seven children ( 31 male ) were evaluated at a mean age of 25.9 ± 3.4 months with hypoplastic left heart syndrome ( 25 ) or other single ventricle ( 22 ) . Results Cerebral MRI was abnormal in 17 patients ( 36.2 % ) including liquor space enlargements ( 10 ) , small grey ( 9 ) and minimal white ( 5 ) matter injuries . Eight of 17 individuals had combined lesions . Median ( range ) cognitive composite score ( CCS ) ( 100 , 65 - 120 ) and motor composite score ( MCS ) ( 97 , 55 - 124 ) were comparable to the reference data , while language composite score ( LCS ) ( 97 , 68 - 124 ) was significantly lower ( P = 0.040 ) . Liquor space enlargement was associated with poorer performance on all Bayley-III subscores ( CCS : P = 0.02 ; LCS : P = 0.002 ; MCS : P = 0.013 ) . The number of re-operations [ odds ratio ( OR ) 2.2 , 95 % confidence interval ( CI ) 1.1 - 4.3 ] ( P = 0.03 ) and re- interventions ( OR 2.1 , 95 % CI 1.1 - 3.8 ) ( P = 0.03 ) was associated with a higher rate of overall MRI abnormalities . Conclusions Cerebral MRI abnormalities occur in more than one third of children with single ventricle , while the neuro-developmental status is less severely affected before Fontan procedure . Liquor space OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Perioperative risk factors were inconsistently associated with developmental outcomes . INTERPRETATION The literature on children undergoing surgery in early infancy suggests that infants with a single ventricle are at highest risk of adverse developmental outcomes . WHAT THIS PAPER ADDS Children with complex congenital heart disease ( CHD ) are at increased risk of impaired developmental outcome . Children with single-ventricle CHD have worse outcomes than children with two-ventricle CHD . Children with two-ventricle CHD gradually grow out of their initial developmental impairment . Perioperative factors are inconsistently associated with outcome

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder ( ADHD ) in several , mostly uncontrolled studies . This pilot study is design ed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD . Fourteen children ( 8–15 years ) with ADHD defined according to the DSM-IV-TR criteria were r and omly allocated to 30 sessions of EEG-neurofeedback ( n = 8) or placebo feedback ( n = 6 ) . Safety measures ( adverse events and sleep problems ) , ADHD symptoms and global improvement were monitored . With respect to feasibility , all children completed the study and attended all study visits and training sessions . No significant adverse effects or sleep problems were reported . Regarding the expectancy , 75 % of children and their parent(s ) in the active neurofeedback group and 50 % of children and their parent(s ) in the placebo feedback group thought they received placebo feedback training . Analyses revealed significant improvements of ADHD symptoms over time , but changes were similar for both groups . This pilot study shows that it is feasible to conduct a rigorous placebo-controlled trial to investigate the efficacy of neurofeedback training in children with ADHD . However , a double-blind design may not be feasible since using automatic adjusted reward thresholds may not work as effective as manually adjusted reward thresholds . Additionally , implementation of active learning strategies may be an important factor for the efficacy of EEG-neurofeedback training . Based on the results of this pilot study , changes are made in the design of the ongoing study The efficacy of group parent training was assessed in improving compliance and time on task in preschoolers with attention-deficit disorder with hyperactivity . Positive effects were obtained on measures of child compliance , but not on measures of attention . Parental compliance-management skills and overall style of interaction were also positively affected . The use of parent training for early intervention with ADDH children is discussed This study evaluates the effectiveness of cognitive behavioral therapy ( CBT ) in improving the home behavior of children with attention deficit hyperactivity disorder ( ADHD ) . Twenty-five boys ( age 7 to 13 ) with a diagnosis of ADHD were r and omized to a CBT or supportive therapy control group . Outcome measures included parent and teacher ratings of the child on the Behavior Problem Checklist-Attention Problem Subscale ( BPC-AP ) , and the Self-Control Rating Scale ( SCRS ) , parent ratings on the Modified Werry Weiss Activity Scale , and child ratings on the Piers Harris Self-Concept Scale and Matching Familiar Figures Task . Data were analyzed using a two-way analysis of variance for main effects . A significant improvement favoring CBT was found on the Werry Weiss Scale , which measures the parent 's perception of the child 's hyperactivity in the home , and the child 's rating of his/her self-esteem on the Piers Harris Self-Concept Scale . Other outcome measures did not demonstrate statistical differences . This research provides support for the use of CBT in children with ADHD . CBT was found to improve the parent 's perception of the child 's hyperactivity in the home as well as the child 's self-esteem Methods : Various developmental problems including attention-deficit/hyperactivity disorder ( ADHD ) have been linked to biological deficiencies in polyunsaturated fatty acids ( PUFAs ) . Additionally , there is evidence that symptoms may be reduced with PUFA supplementation . This study investigated effects of supplementation with PUFAs on symptoms typically associated with ADHD . Because nutrients work synergistically , additional effects of micronutrient supplementation were also investigated . A total of 132 Australian children aged 7 to 12 years with scores ≥2 SD above the population average on the Conners ADHD Index participated in a r and omized , placebo-controlled , double-blind intervention over 15 weeks , taking PUFAs alone , PUFAs + micronutrients , or placebo . Due to unreturned question naires , data were only available for 104 children . Results : Significant medium to strong positive treatment effects were found on parent ratings of core ADHD symptoms , inattention , hyperactivity/impulsivity , on the Conners Parent Rating Scale ( CPRS ) in both PUFA treatment groups compared with the placebo group ; no additional effects were found with the micronutrients . After a one-way crossover to active supplements in all groups for a further 15 weeks , these results were replicated in the placebo group , and the treatment groups continued to show significant improvements on CPRS core symptoms . No significant effects were found on Conners Teacher Rating Scales . Conclusion : These results add to preliminary findings that ADHD-related problems with inattention , hyperactivity , and impulsivity might respond to treatment with PUFAs and that improvements may continue with supplementation extending to 30 weeks Neurofeedback treatment has been demonstrated to reduce inattention , impulsivity and hyperactivity in children with attention deficit/hyperactivity disorder ( ADHD ) . However , previous studies did not adequately control confounding variables or did not employ a r and omized reinforcer-controlled design . This study addresses those method ological shortcomings by comparing the effects of the following two matched biofeedback training variants on the primary symptoms of ADHD : EEG neurofeedback ( NF ) aim ing at theta/beta ratio reduction and EMG biofeedback ( BF ) aim ing at forehead muscle relaxation . Thirty-five children with ADHD ( 26 boys , 9 girls ; 6–14 years old ) were r and omly assigned to either the therapy group ( NF ; n = 18 ) or the control group ( BF ; n = 17 ) . Treatment for both groups consisted of 30 sessions . Pre- and post-treatment assessment consisted of psychophysiological measures , behavioural rating scales completed by parents and teachers , as well as psychometric measures . Training effectively reduced theta/beta ratios and EMG levels in the NF and BF groups , respectively . Parents reported significant reductions in primary ADHD symptoms , and inattention improvements in the NF group were higher compared to the control intervention ( BF , dcorr = −.94 ) . NF training also improved attention and reaction times on the psychometric measures . The results indicate that NF effectively reduced inattention symptoms on parent rating scales and reaction time in neuropsychological tests . However , regarding hyperactivity and impulsivity symptoms , the results imply that non-specific factors , such as behavioural contingencies , self-efficacy , structured learning environment and feed-forward processes , may also contribute to the positive behavioural effects induced by neurofeedback training This pilot study evaluated the effects of supplementation with PUFA on blood FA composition and behavior in children with Attention-Deficit/Hyperactivity Disorder (AD/HD)-like symptoms also reporting thirst and skin problems . Fifty children were r and omized to treatment groups receiving either a PUFA supplement providing a daily dose of 480 mg DHA , 80 mg EPA , 40 mg arachidonic acid ( AA ) , 96 mg GLA , and 24 mg α-tocopheryl acetate , or an olive oil placebo for 4 mon of doubleblind parallel treatment . Supplementation with the PUFA led to a substantial increase in the proportions of EPA , DHA , and α-tocopherol in the plasma phospholipids and red blood cell ( RBC ) total lipids , but an increase was noted in the plasma phospholipid proportions of 18∶3n-3 with olive oil as well . Significant improvements in multiple but outcomes ( as rated by parents ) were noted in both groups , but a clear benefit from PUFA supplementation for all behaviors characteristic of AD/HD was not observed . For most outcomes , improvement of the PUFA group was consistently nominally better than that of the olive oil group ; but the treatment difference was significantly , by secondary intent-to-treat analysis on only 2 out of 16 outcome measures : conduct problems rated by parents ( −42.7 vs. −9.9 % , n=47 , P=0.05 ) , and attention symptoms rated by teachers ( −14.8 vs. + 3.4 % , n=47 , P=0.03 ) . PUFA supplementation led to a greater number of participants showing improvement in oppositional defiant behavior from a clinical to a non clinical range compared with olive oil supplementation ( 8 out of 12 vs. 3 out of 11 , n=33 , P=0.02 ) . Also , significant correlations were observed when comparing the magnitude of change between increasing proportions of EPA in the RBC and decreasing disruptive behavior as assessed by the Abbreviated Symptom Question naire ( ASQ ) for parents ( r=−0.38 , n=31 , P<0.05 ) , and for EPA and DHA in the RBC and the teachers ' Disruptive Behavior Disorders ( DBD ) Rating Scale for Attention ( r=−0.49 , n=24 , P<0.05 ) . Interestingly , significant correlations were observed between the magnitude of increase in α-tocopherol concentrations in the RBC and a decrease in scores for all four subscales of the teacher 's DBD ( Hyperactivity , r=−0.45 ; Attention , r=−0.60 ; Conduct , r=−0.41 ; Oppositional/Defiant Disorder , r=−0.54 ; n=24 , P<0.05 ) as well as the ASQ for teachers ( r=−0.51 , n=24 , P<0.05 ) . Thus , the results of this pilot study suggest the need for further research with both n−3 FA and vitamin E in children with behavioral disorders Thirty-one children , selected for marked inattention and overactivity , were studied in a double-blind , placebo-controlled crossover study of essential fatty acid ( EFA ) supplementation . Subjects received the active treatment and placebo conditions for 4 weeks each and were assessed on a variety of cognitive , motor , and st and ardized rating scale measures . EFA supplementation ( evening primrose oil ; Efamol ® ) result ed in significantly lower levels of palmitoleic acid ( a nonessential fatty acid ) and higher concentrations of dihomogammalinolenic acid , an EFA previously found to be deficient in some hyperactive children . Supplementation was also associated with significant changes on two performance tasks and with significant improvement to parent ratings on the subscales design ated as Attention Problem and Motor Excess of the Revised Behavior Problem Checklist . However , a variety of eight other psychomotor performance tests and two st and ardized teacher rating scales failed to indicate treatment effects . When the experimentwise probability level was set at.05 , only 2 of 42 variables showed treatment effects . Baseline EFA concentrations appeared to be unrelated to treatment response . It was concluded that EFA supplementation , as employed here , produces minimal or no improvements in hyperactive children selected without regard to baseline EFA concentrations Utilizing a double-blind , placebo design , the effects of a high ( 0.8 mg/kg ) and a low ( 0.4 mg/kg ) dose of methylpheni date alone and in combination with behavioral parent training plus child self-control instruction were evaluated with 96 attention deficit hyperactivity disorder children . No evidence of the superiority of the combined conditions relative to medication alone was found . Some limited support was found for the hypothesis that the effects of a high dose of psychostimulant medication could be achieved by combining the low dose with a behavioral intervention . The importance of the latter finding is highlighted by the fact that both the benefits and untoward effects of the psychostimulants appear to increase with the dose Few studies have examined whether attention can be improved with training , even though attention difficulties adversely affect academic achievement . The present study was a r and omized-controlled trial evaluating the impact of Computerized Attention Training ( CAT ) and Computer Assisted Instruction ( CAI ) on attention and academic performance in 77 inattentive first grade rs . Students receiving either intervention were more likely than controls to show a moderate decline in teacher rated attention problems in first grade . Students receiving CAI also showed gains in reading fluency and in teacher ratings of academic performance . Intervention effects for attention were absent by second grade largely because attention problems declined in all groups . However , post hoc analyses indicated potential longer-term benefits for children with 6 or more inattentive symptoms at baseline . Persistent attention problems were associated with poorer academic performance in multiple domains . Results provide initial evidence that CAT and CAI can improve children ’s attention in the classroom - and support additional studies to determine whether more clinical ly significant benefits are attainable Nine hyperactive male subjects , selected on the basis of showing a favorable " response " to the Feingold diet in an earlier study , were maintained on a strict elimination ( Feingold ) diet for 11 weeks , and were given multiple trials of placebo and challenge food material s. Parental and teacher ratings , classroom behavior observations , and neuropsychological test scores obtained during baseline , placebo , and challenge conditions , in general , were not found to be adversely affected by the artificial color challenge material s. As expected , comparable data gathered on a matched control group showed them to receive substantially better ratings than the hyperactive subjects on the majority of the comparison measures employed . Possible explanations for the discrepancy between the dramatic clinical -anecdotal reports that have been given and the much more equivocal findings from formal experimental projects are presented OBJECTIVE To evaluate two different parent-based therapies for preschool attention-deficit/hyperactivity disorder ( ADHD ) in a community sample . METHOD Three-year-old children displaying a preschool equivalent of ADHD ( n = 78 ) were r and omly assigned to either a parent training ( PT ; n = 30 ) , a parent counseling and support ( PCO&S ; n = 28 ) , or a waiting-list control group ( n = 20 ) . The PT group received coaching in child management techniques . The PC&S group received nondirective support and counseling . Measures of child symptoms and mothers ' well-being were taken before and after intervention and at OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Free fatty acid supplementation produced small but significant reductions in ADHD symptoms even with probably blinded assessment s , although the clinical significance of these effects remains to be determined . Artificial food color exclusion produced larger effects but often in individuals selected for food sensitivities .

MS2_fixed_5_shot203

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Objectives This study aim ed to test the hypothesis that there is no difference in the survival rates of molars treated according to the conventional restorative treatment ( CRT ) using amalgam , atraumatic restorative treatment ( ART ) using high-viscosity glass ionomer , and ultraconservative treatment ( UCT ) protocol after 3.5 years . Material s and methods Cavitated primary molars were treated according to CRT , ART , and UCT ( small cavities were restored with ART and medium/large cavities were daily cleaned with toothpaste/toothbrush under supervision ) . Molar extraction s result ing from toothache , sepsis , or pulp exposure were failures . The Kaplan – Meier method was used to estimate the survival curves . Results The numbers of treated teeth , among the 302 6–7-year-old children , were 341 ( CRT ) , 244 ( ART ) , and 281 ( for UCT group : 109 small ART , 166 open cavities , and 6 combinations ) . Protocol groups were similar at baseline regarding gender and mean decayed missing filled tooth score , but not regarding age and type of surface . The numbers of molars extracted were 22 ( CRT ) , 16 ( ART ) , and 26 ( UCT ) . Fistulae were most often recorded . After 3.5 years , the cumulative survival rate ± st and ard error for all molars treated was 90.9 ± 2.0 % with CRT , 90.4 ± 2.4 % with ART , and 88.6 ± 1.9 % with UCT ( p = 0.13 ) . Only a type of surface effect was observed over the 3.5-year period : survival rates for molars were higher for single- than for multiple-surface cavities . Conclusion There was no difference in the cumulative survival rates of primary molars treated according to the CRT , ART , and UCT protocol s over a 3.5-year period . Clinical relevance Keeping cavities in primary molars biofilm-free might be another treatment option alongside restoring such cavities through conventional and ART protocol OBJECTIVES To assess and compare the cumulative survival rate of amalgam and atraumatic restorative treatment ( ART ) restorations in primary molars over 3 years . METHODS 280 children aged 6 - 7 years old were enrolled in a cluster r and omized controlled clinical trial using a parallel group design covering two treatment groups : conventional restorative treatment with amalgam ( CRT ) and atraumatic restorative treatment ( ART ) using a high-viscosity glass-ionomer ( HVGIC ) Ketac Molar Easymix . Three pedodontists placed 750 restorations ( 364 amalgam and 386 ART in 126 and 154 children , respectively ) which were evaluated at 0.5 , 1 , 2 and 3 years . The proportional hazard rate regression model with frailty correction , ANOVA and Wald tests , and the Jackknife procedure were applied in analysing the data . RESULTS The cumulative survival rates over 3 years for all , single- and multiple-surface CRT/amalgam restorations ( 72.6 % , 93.4 % , 64.7 % , respectively ) were no different from those of comparable ART/HVGIC restorations ( 66.8 % ; 90.1 % and 56.4 % , respectively ) ( p=0.10 ) . Single-surface restorations had higher survival rates than multiple-surface restorations for the both treatment procedures ( p<0.0001 ) . A higher proportion of restorations failed because of mechanical reasons ( 94.8 % ) than of secondary caries ( 5.2 % ) . No difference in reasons for restoration failures between all types of amalgam and ART/HVGIC restorations were observed ( p=0.24 ) . SIGNIFICANCE The high-viscosity glass-ionomer used in this study in conjunction with the ART is a viable option for restoring carious dentin lesions in single surfaces in vital primary molars The aim of the present clinical study was an in vivo evaluation of an improved conventional glass ionomer cement Ketac Molar ( ESPE ) , compared to a polyacid modified composite resin , Dyract ( Dentsply/De Trey ) , used in primary molars . Fifty-three Ketac Molar and fifty-two Dyract restorations were placed in box-only preparations in primary molars . The application time for the chemically cured Ketac Molar , was longer compared to the light-cured Dyract . In comparing the material s , no differences were found , comparing both material s regarding secondary caries , marginal adaptation , wear and fracture toughness . One case of recurrent caries adjacent to a Ketac Molar restoration and two cases in the Dyract group were reported . Two Ketac Molar restorations and one Dyract showed bulk fracture at the time of evaluation . At the twelve-month evaluation , no difference between the investigated material s was registered , which indicates that Ketac Molar can be used as a proximal restoration in the primary dentition . It should be emphasized , however , that one-year data should not be extrapolated to indicate the long-term success of restorations BACKGROUND As the world population ages , the requirement for cost-effective methods of treating chronic disease conditions increases . In terms of oral health , there is a rapidly increasing number of dentate elderly with a high burden of maintenance . Population surveys indicate that older individuals are keeping their teeth for longer and are a higher caries risk group . Atraumatic Restorative Treatment ( ART ) could be suitable for patients in nursing homes or house-bound elderly , but very little research has been done on its use in adults . OBJECTIVES To compare the cost-effectiveness of ART and a conventional technique ( CT ) for restoring carious lesions as part of a preventive and restorative programme for older adults . METHODS In this r and omized clinical trial , 82 patients with carious lesions were r and omly allocated to receive either ART or conventional restorations . Treatment costs were measured based on treatment time , material s and labour . For the ART group , the cost of care provided by a dentist was also compared to the cost of having a hygienist to provide treatment . Effectiveness was measured using percentage of restorations that survived after a year . RESULTS Eighty-two patients received 260 restorations , that is , 128 ART and 132 conventional restorations . 91.1 % of the restorations were on one surface only . After a year , 252 restorations were assessed in 80 patients . The average cost for ART and conventional restorations was € 16.86 and € 28.71 respectively ; the restoration survival percentages were 91.1 % and 97.7 % , respectively . This result ed in a cost-effectiveness ratio of 0.18 ( ART ) and 0.29 ( CT ) . When the cost of a hygienist to provide ART was inserted in the analysis , the result ing ratio was 0.14 . CONCLUSIONS Atraumatic restorative treatment was found to be a more cost-effective alternative to treat older adults after 1 year , compared to conventional restorations , especially in out of surgery facilities and using alternative workforce such as hygienists . Atraumatic restorative treatment can be a useful tool to provide dental care for frail and fearful individuals who might not access dental treatment routinely BACKGROUND Laboratory studies show diverse behaviour of different br and s of glass-ionomer cements ( GIC ) . AIM This study investigated the clinical performance [ survival rate ( SR ) ] of three GIC br and s applied to proximal atraumatic restorative treatment ( ART ) restorations . Additionally , the SR of the tooth was evaluated . DESIGN Proximal cavities of 262 primary molars were restored . The patients had been r and omly allocated to two operators and three GIC br and s : Fuji IX , Hi-Dense , and Maxxion R. Restorations were evaluated after 1 , 6 , 12 , 18 , 24 , 30 , and 36 months . Failed restorations were , if possible , repaired or replaced . Linear regression analyses were used to evaluate the effect of GIC br and , operator , and surface of restoration . Kaplan-Meier survival analysis and log-rank test were performed for both restoration survival and tooth survival ( α = 5 % ) . RESULTS After 3 years , 82.4 % of the restorations were evaluated . The SR of the restorations was 24.4 % , and there was no difference among GIC br and s ( log-rank test , P = 0.6 ) . In the first 18 months , a significant operator effect and significantly higher failures in distal surfaces were found . The SR of the tooth was 81.7 % . CONCLUSIONS The SR of proximal ART restorations was relatively low when compared with the SR of the tooth . There are no differences in the performance among the GIC br and s used in the study This study compared the survival of restorations produced through the atraumatic restorative treatment ( ART ) approach using glass-ionomer with those produced through the traditional approach using amalgam ( MTA ) in deciduous dentitions over a period of 3 years . Using a parallel group design , 835 grade 1 children , aged 6–7 years , participated . A total of 482 children were treated through the ART and 353 children through the MTA approach . Eight dentists produced a total of 1,891 single- and multiple-surface restorations . After 3 years , 22.1 % of the restorations were lost for evaluation . There was a statistically significant difference in the combined survival of all single- and multiple-surface restorations between the two approaches in favour of the ART approach ( p = 0.04 ) . The study revealed a 3-year cumulative survival percentage of single-surface ART and MTA restorations of 86.1 and 79.6 % , respectively . The difference was statistically significant ( p = 0.03 ) . The main reasons for both single-surface ART and MTA restorations to fail was ‘ restoration missing ’ followed by ‘ gross marginal defect ’ . The 3-year cumulative survival percentages of multiple-surface ART and MTA restorations were 48.7 and 42.9 % , respectively . The difference was not statistically significant ( p > 0.05 ) . The 3-year survival percentages of single- and multiple- surface ART and MTA restorations varied widely amongst the 8 operators with an operator effect ( p = 0.001 ) for multiple-surface MTA restorations . It can be concluded that the ART approach using glass-ionomer yielded better results in treating dentinal lesions in deciduous teeth than did the traditional approach using amalgam after 3 years . It is recommended to select the ART approach to complement the other activities of the school oral health programme BACKGROUND The authors evaluated the 24-month performance of a packable resin-based composite/dentin bonding system and a high-viscosity glass ionomer cement ( GIC ) in restorations placed in primary molars with the atraumatic restorative treatment ( ART ) approach . METHODS Three dentists placed 419 restorations in 219 children aged 6 through 10 years who had bilateral matched pairs of carious posterior Class I and II primary teeth . They used a split-mouth design to place the two material s , which were assigned r and omly to contralateral sides . The authors evaluated the restorations according to U.S. Public Health Service Ryge criteria . RESULTS After 24 months , 96.7 percent of the Class I GIC restorations and 91 percent of the resin-based composite restorations survived , while the success rates for the Class II restorations were 76.1 percent and 82 percent for the GIC and resin-based composite restorations , respectively . The survival rate of the Class II resin-based composite restorations was 5.9 percent higher than that of the GIC restorations at the 24-month evaluation , but this difference was not statistically significant . However , the study results showed a statistically significant difference in survival rates between Class I and II restorations for both material s. CONCLUSION AND CLINICAL IMPLICATION S The two-year clinical performance of both material s was satisfactory for the restoration of Class I and II primary molars using the ART approach OBJECTIVES The aims of this study are to assess the feasibility of the Atraumatic Restorative Treatment ( ART ) approach in primary teeth and to compare the ART approach with traditional amalgam restorations in primary molars . METHODS This study was conducted in a paediatric dentistry clinic in Kuwait between April 1999 and December 2001 . The ART and amalgam restorations were placed r and omly on comparable pairs of primary molars , if available . In addition , the ART approach was used for other primary teeth that had no pulpal involvement and no perceived pain before treatment . The restorations were assessed by both the ART evaluation criteria and USPHS criteria in August-September 2000 and in August-December 2001 . The mean follow-up period for the restorations was 8.3 months in the first assessment ( 2000 ) and 22 months in the second assessment ( 2001 ) . The assessment was possible for 35 children ( mean age = 5.7 years ) , 18 of whom had comparable pairs ( n = 35 pairs ) of restorations in their primary molars . In addition , 48 other ART restorations were assessed in 2000 and 42 in 2001 . RESULTS In a 2-year follow-up , 89.6 % of all ART restorations were considered successful . The failure rate of the comparable pairs of ART and amalgam restorations was 5.7 % . There was no significant difference in success rate between ART and amalgam techniques . CONCLUSIONS Based on a 2-year follow-up evaluation , the class I ART restor OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

CONCLUSION ART restorations have similar survival rate compared to conventional treatment and can be considered an option to restore occlusoproximal cavities in primary molars

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE We evaluated the association between mothers ' use of multivitamin supplements and their infants ' risk for omphalocele , a congenital anomaly of the abdominal wall . Omphalocele can occur in certain multiple congenital anomaly patterns with neural tube defects , for which a protective effect of multivitamins with folic acid has been demonstrated . METHODS We used data from a population -based case-control study of infants born from 1968 - 1980 to mothers residing in metropolitan Atlanta . Case-infants with nonsyndromic omphalocele ( n = 72 ) were actively ascertained from multiple sources . Control-infants ( n = 3029 ) , without birth defects , were selected from birth certificates by stratified r and om sampling . RESULTS Compared with no use in the periconceptional period , periconceptional use of multivitamin supplements ( regular use from 3 months before pregnancy through the first trimester of pregnancy ) was associated with an odds ratio for nonsyndromic omphalocele of 0.4 ( 95 % confidence interval [ CI ] : 0.2 - 1.0 ) . For the subset comprising omphalocele alone or with selected midline defects ( neural tube defects , hypospadias , and bladder/cloacal exstrophy ) , the odds ratio was 0.3 ( 95 % CI : 0.1 - 0.9 ) . These estimates were similar when the reference group also included women who began using multivitamins late in pregnancy ( during the second or third month of pregnancy ) . The small number of participants limited the precision of subgroup analyses and translated into wide confidence intervals that included unity . CONCLUSIONS Periconceptional multivitamin use was associated with a 60 % reduction in the risk for nonsyndromic omphalocele . These findings await replication from additional studies to confirm the findings , generate more precise estimates , and detail possible mechanisms of actions The hypothesis was tested that the additional dietary uptake of n-3 fatty acids , in particular of DHA and 5-methyltetrahydrofolate ( 5-MTHF ) , during the second half of pregnancy would influence proliferation and apoptosis in the full-term human placenta . The diets of pregnant women from Spain ( n 55 ) were supplemented with modified fish oil and /or 5-MTHF or placebo , and assigned in a r and om , double-blind manner to one of the four groups . Immunohistochemistry and immunoblotting were used to detect placental proliferation and apoptosis with monoclonal antibodies for key proteins that reflected the extent of both processes : proliferation cell nuclear antigen ( PCNA ) , p53 , cytokeratin 18 neoepitope . The PCNA level in the fish oil/5-MTHF-treated group was higher by 66 % ( P < 0.05 ) than that of the placebo group , whereas the levels of p53 and cytokeratin 18 neoepitope were unaffected by treatment . PCNA expression was altered only in the trophoblast compartment ( placebo 11.1 ( se 0.5 ) % v. combination 21.5 ( se 1.2 ) % ; P < 0.05 ) , whereas the proportion of nuclei stained in endothelial and other stromal cells was similar in the placebo and combined treatment groups . No correlation was found between fish oil or 5-MTHF supplementation and the levels of the proteins . The present data suggest that supplementation with fish oil and /or 5-MTHF had no effect on the parameters reflecting placental proliferation and apoptosis . A defined combination of DHA and 5-MTHF may , however , affect placental proliferation One third of the Indian babies are of low birth weight ( < 2.5 kg ) , and this is attributed to maternal undernutrition . We therefore examined the relationship between maternal nutrition and birth size in a prospect i ve study of 797 rural Indian women , focusing on macronutrient intakes , dietary quality and micronutrient status . Maternal intakes ( 24-h recall and food frequency question naire ) and erythrocyte folate , serum ferritin and vitamin C concentrations were measured at 18 + /- 2 and 28 + /- 2 wk gestation . Mothers were short ( 151.9 + /- 5.1 cm ) and underweight ( 41.7 + /- 5.1 kg ) and had low energy and protein intakes at 18 wk ( 7.4 + /- 2.1 MJ and 45.4 + /- 14.1 g ) and 28 wk ( 7.0 + /- 2.0 MJ and 43.5 + /- 13.5 g ) of gestation . Mean birth weight and length of term babies were also low ( 2665 + /- 358 g and 47.8 + /- 2.0 cm , respectively ) . Energy and protein intakes were not associated with birth size , but higher fat intake at wk 18 was associated with neonatal length ( P < 0.001 ) , birth weight ( P < 0.05 ) and triceps skinfold thickness ( P < 0.05 ) when adjusted for sex , parity and gestation . However , birth size was strongly associated with the consumption of milk at wk 18 ( P < 0.05 ) and of green leafy vegetables ( P < 0.001 ) and fruits ( P < 0.01 ) at wk 28 of gestation even after adjustment for potentially confounding variables . Erythrocyte folate at 28 wk gestation was positively associated with birth weight ( P < 0.001 ) . The lack of association between size at birth and maternal energy and protein intake but strong associations with folate status and with intakes of foods rich in micronutrients suggest that micronutrients may be important limiting factors for fetal growth in this undernourished community Higher folate needs are present during pregnancy , which may lead to tissular deficiency in the mother and to depleted newborn folate reserves . The aim of this work was to assess the prevalence of folate deficiency and to establish the rates of serum and red cell folate in two groups of mothers and newborn infants , one receiving only iron and the other iron and folate during pregnancy . The rates of serum and red cell folate found at the end of pregnancy were significantly higher in the group which received folate ; however , the percentage of cases with tissular folate deficiency was low in both groups , with no significant difference ( 3.8 % and 1.3 % , respectively ) . These findings , along with the lack of effect of supplemental folate on erythropoiesis , pose some questions on the usefulness of supplemental folate during pregnancy in our country BACKGROUND The risk of recurrent neural-tube defects is decreased in women who take folic acid or multivitamins containing such during the periconceptional period . The extent to which folic acid supplementation can reduce the first occurrence of defects is not known . METHODS We conducted a r and omized , controlled trial of periconceptional multivitamin supplementation to test the efficacy of this treatment in reducing the incidence of a first occurrence of neural-tube defects . Women planning a pregnancy ( in most cases their first ) were r and omly assigned to receive a single tablet of a vitamin supplement ( containing 12 vitamins , including 0.8 mg of folic acid ; 4 minerals ; and 3 trace elements ) or a trace-element supplement ( containing copper , manganese , zinc , and a very low dose of vitamin C ) daily for at least one month before conception and until the date of the second missed menstrual period or later . RESULTS Pregnancy was confirmed in 4753 women . The outcome of the pregnancy ( whether the fetus or infant had a neural-tube defect or congenital malformation ) was known in 2104 women who received the vitamin supplement and in 2052 who received the trace-element supplement . Congenital malformations were significantly more prevalent in the group receiving the trace-element supplement than in the vitamin-supplement group ( 22.9 per 1000 vs. 13.3 per 1000 , P = 0.02 ) . There were six cases of neural-tube defects in the group receiving the trace-element supplement , as compared with none in the vitamin-supplement group ( P = 0.029 ) . The prevalence of cleft lip with or without cleft palate was not reduced by periconceptional vitamin supplementation . CONCLUSIONS Periconceptional vitamin use decreases the incidence of a first occurrence of neural-tube defects A r and omised double-blind prevention trial with a factorial design was conducted at 33 centres in seven countries to determine whether supplementation with folic acid ( one of the vitamins in the B group ) or a mixture of seven other vitamins ( A , D , B1,B2,B6,C and nicotinamide ) around the time of conception can prevent neural tube defects ( anencephaly , spina bifida , encephalocele ) . A total of 1817 women at high risk of having a pregnancy with a neural tube defect , because of a previous affected pregnancy , were allocated at r and om to one of four groups -- namely , folic acid , other vitamins , both , or neither . 1195 had a completed pregnancy in which the fetus or infant was known to have or not have a neural tube defect ; 27 of these had a known neural tube defect , 6 in the folic acid groups and 21 in the two other groups , a 72 % protective effect ( relative risk 0.28 , 95 % confidence interval 0.12 - 0.71 ) . The other vitamins showed no significant protective effect ( relative risk 0.80 , 95 % Cl 0.32 - 1.72 ) . There was no demonstrable harm from the folic acid supplementation , though the ability of the study to detect rare or slight adverse effects was limited . Folic acid supplementation starting before pregnancy can now be firmly recommended for all women who have had an affected pregnancy , and public health measures should be taken to ensure that the diet of all women who may bear children contains an adequate amount of folic acid BACKGROUND Zinc and folate are important for fetal growth . However , the relationship between the dietary intake of these nutrients and pregnancy outcome is not settled . METHODS A prospect i ve study was conducted to ascertain the relationship between maternal dietary zinc and folate intake ( n = 1398 ) , serum zinc and folate levels ( n = 289 ) , and infant birthweight . Twenty-four hour recalls were used to measure energy , zinc , folate and other nutrient intakes at 18 and 30 weeks of gestation . Subjects in the study were offered daily folic acid ( 1.0 mg ) and iron ( 60 mg as ferrous sulfate ) at enrollment . RESULTS Maternal zinc nutriture as assessed by serum and dietary intake was not associated with birthweight or length of gestation . There was a small but significant positive association between maternal folate intake and adjusted infant birthweight ( beta = 0.05 , p = 0.03 ) . The indirect measures of maternal nutritional status including maternal pre-pregnancy weight ( beta = 8.0 , p = 0.0001 ) and weight gain during pregnancy ( beta = 18.1 , p = 0.0001 ) were stronger predictors of adjusted infant birthweight as compared to energy intake and intake of zinc and folate . An increase of 320 , 290 , and 48 g in infant birthweight was associated with the 90th-10th percentile difference for pre-pregnancy weight , weight gain during pregnancy , and folate intake respectively . CONCLUSION These results indicate that pre-pregnancy weight and weight gain during pregnancy are both strong predictors of infant birthweight . Folate intake , although significantly associated with birthweight , was a weak predictor while maternal intake of zinc and other nutrients was not associated with birthweight BACKGROUND Adolescents are more likely than adults to consume energy-dense , micronutrient-poor diets and to experience adverse pregnancy outcomes . OBJECTIVES The objectives were to assess micronutrient intake and blood biomarkers prospect ively in pregnant adolescents recruited to the About Teenage Eating ( ATE ) Study and to determine associations with pregnancy outcome . DESIGN Pregnant adolescents ( n = 500 ) were recruited from 2 UK inner city population s. Dietary intake was assessed with three 24-h dietary recalls , and micronutrient status was assessed by measurement of third trimester blood biomarkers . Pregnancy outcomes included small-for-gestational age ( SGA ) birth and preterm delivery . RESULTS Median iron and folate intakes were lower than UK and US recommended amounts . Folate and vitamin B-12 status were lower in smokers , despite no differences in dietary intake . Serum folate was < 7.0 nmol/L in 12 % of subjects , and serum total homocysteine ( tHcy ) was elevated ( > 10 micromol/L ) in 20 % of subjects . Fifty-two percent of the subjects had iron deficiency anemia , and 30 % had serum 25-hydroxyvitamin D concentrations < 25 nmol/L. The incidence of SGA birth was higher in subjects with poorer folate status ( red blood cell folate , P = 0.003 ; serum folate , P = 0.02 ; tHcy OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

In contrast , we did not find any beneficial effect of folate supplementation on placental weight or on length of gestation . There is a paucity of well-conducted RCTs investigating the effect of folate supplementation on health outcomes in pregnancy .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Supplementation with n-3 polyunsaturated fatty acids ( PUFA ) for 6 weeks did not alter plasma leptin concentrations in male smokers . Changes in dietary intake of saturated fatty acids ( FA ) correlated positively , whereas changes in the intake of PUFA correlated negatively to changes in plasma leptin levels . A 3-week n-3 PUFA-enriched diet , as compared with a 3-week lard-enriched diet , induced lower plasma leptin concentration and reduced leptin mRNA expression in rat epididymal adipose tissue . In the human trophoblast cell line ( BeWo ) , n-3 PUFA had a dose- and time-dependent effect on leptin expression . One mM of eicosapentaenoic acid or docosahexaenoic acid ( DHA ) reduced leptin expression by 71 % and 78 % , respectively , as compared with control , after 72 h. There was no effect on expression of the signal transducing form of the leptin receptor . In BeWo cells transfected with the human leptin promoter , we found that n-3 PUFA reduced leptin promoter activity ; in contrast saturated and monounsaturated FA had no effect on leptin promoter activity . The transcription factors peroxysomal proliferator activated receptor gamma and sterol regulatory element binding protein-1 mRNAs were reduced after incubation with n-3 PUFA , whereas the expression of CCAAT/enhancer binding protein alpha was unchanged . DHA-reduced leptin expression was abolished in BeWo cells grown in cholesterol-free medium . In conclusion , n-3 FA decreased leptin gene expression both in vivo and in vitro . The direct effects of PUFA on leptin promoter activity indicate a specific regulatory action of FA on leptin expression BACKGROUND Information is lacking on the potential effect of n-3 polyunsaturated fatty acids ( PUFAs ) on the adipose tissue of patients with type 2 diabetes . OBJECTIVE We evaluated whether n-3 PUFAs have additional effects on adiposity , insulin sensitivity , adipose tissue function ( production of adipokines and inflammatory and atherogenic factors ) , and gene expression in type 2 diabetes . DESIGN Twenty-seven women with type 2 diabetes without hypertriglyceridemia were r and omly allocated in a double-blind parallel design to 2 mo of 3 g/d of either fish oil ( 1.8 g n-3 PUFAs ) or placebo ( paraffin oil ) . RESULTS Although body weight and energy intake measured by use of a food diary were unchanged , total fat mass ( P < 0.019 ) and subcutaneous adipocyte diameter ( P < 0.0018 ) were lower in the fish oil group than in the placebo group . Insulin sensitivity was not significantly different between the 2 groups ( measured by homeostasis model assessment in all patients and by euglycemic-hyperinsulinemic clamp in a subgroup of 5 patients per group ) . By contrast , atherogenic risk factors , including plasma triacylglycerol ( P < 0.03 ) , the ratio of triacylglycerol to HDL cholesterol ( atherogenic index , P < 0.03 ) , and plasma plasminogen activator inhibitor-1 ( P < 0.01 ) , were lower in the fish oil group than in the placebo group . In addition , a subset of inflammation-related genes was reduced in subcutaneous adipose tissue after the fish oil , but not the placebo , treatment . CONCLUSIONS A moderate dose of n-3 PUFAs for 2 mo reduced adiposity and atherogenic markers without deterioration of insulin sensitivity in subjects with type 2 diabetes . Some adipose tissue inflammation-related genes were also reduced . These beneficial effects could be linked to morphologic and inflammatory changes in adipose tissue . This trial was registered at clinical trials.gov as NCT0037 The study was design ed to evaluate the chronic regulation of plasma leptin by dietary ( n-3 ) polyunsaturated fatty acids ( PUFA ) in insulin-resistant , sucrose-fed rats . Male Sprague-Dawley rats were r and omly assigned to consume for 3 or 6 wk a diet containing 57.5 % ( g/100 g ) sucrose and 14 % lipids as either fish oil ( SF ) or control oils ( SC ) . After 3 and 6 wk of consuming the SF diet , plasma leptin was 70 % ( P < 0.001 ) and 75 % ( P < 0.05 ) greater , respectively , than in rats fed the SC diet . The same result was found when plasma leptin was adjusted by total fat mass , as measured by dual-energy X-ray absorptiometry . Despite high leptin levels , food intake of rats fed the SF diet was greater than in SC-fed rats without any difference in body weight or total fat mass . After 3 wk , accumulated leptin in epididymal and retroperitoneal adipose tissue was higher in the SF-fed rats than in the SC-fed rats . However , after 6 wk , tissue leptin in the SF-fed rats did not differ from that of the SC-fed rats . The SF diet increased adipose tissue glucose transporter-4 protein quantity and prevented the sucrose-induced elevations in plasma triglycerides and free fatty acids . When all SC- and SF-fed rats ( both diets and feeding duration s ) were considered , plasma leptin levels were positively correlated with body weight ( r = 0.5 , P < 0.0001 ) and with total fat mass ( r = 0.5 , P < 0.0005 ) . These results suggest that plasma leptin at a given time could be inappropriately high for a given fat mass in insulin-sensitive rats fed ( n-3 ) PUFA Introduction There is evidence that n-3 polyunsaturated fatty acids ( n-3 PUFAs ) exert beneficial effects to improve type 2 diabetes mellitus ( T2DM ) , but its complications remain poorly understood . Hypoadiponectinemia is one of the important mechanisms responsible for T2DM which necessitates developing novel therapeutic strategies . We aim ed to determine the effect of n-3 PUFA supplementation on circulating adiponectin and mRNA expression of adiponectin receptors ( AdipoR1 , AdipoR2 ) and Sirt-1 in T2DM patients . Material and methods A r and omized , double-blind , placebo-controlled trial of 10-week follow-up of n-3 PUFAs ( 2.7 g/day ) vs. placebo in T2DM patients ( n = 88 ) was conducted . In detail , T2DM patients ( n = 44 ) were treated with n-3 PUFAs and the remainder received placebo . Anthropometric and metabolic characteristics were assessed in all participants . Circulating level of adiponectin and mRNA expression of AdipoR1 , AdipoR2 and Sirt-1 were measured in peripheral blood mononuclear cells ( P BMC ) using real-time polymerase chain reaction before and after the intervention . Results It was found that n-3 PUFAs increased AdipoR1 gene expression ( fold change = 1.321 in n-3 PUFAs vs. 1.037 in placebo ) and AdipoR2 mRNA ( fold change = 1.338 in n-3 PUFAs vs. 1.034 in placebo ) . No significant changes were observed for Sirt-1 expression . The serum level of adiponectin significantly ( p = 0.035 ) increased in n-3 PUFAs ( 5.09 to 5.58 μg/ml ) but remained unchanged in the placebo group . Conclusions Daily supplementation with n-3 PUFAs ( 2.7 g ) was effective to significantly improve gene expression of AdipoR1 and AdipoR2 and the serum level of adiponectin in T2DM patients . Therefore , n-3 PUFAs might emerge as an adjuvant for current antidiabetic therapies . However , confirmatory long-term studies are required BACKGROUND : Visfatin is an adipocytokine which is secreted from adipose tissue and can affect on the diabetes inflammatory reaction and also serum lipids level . On the other h and , Omega-3 can also prevent formation of insulin resistance . In the present study , the effect of Omega-3 on the serum visfatin concentration was evaluated . METHODS : 71 women with type II diabetes were r and omly assigned to the group that took Omega-3 capsules or control group with placebo capsules . In the first step , study subjects filled a question naire collecting their age , height , weight , waist circumference , and hip circumference . Also their blood sample s were taken for blood tests . In the second step , the intervention was done for 8 weeks and in the third step the aforementioned were collected again . In the blood sample s visfatin and lipid profiles ( low density lipoprotein [ LDL ] , high density lipoprotein [ HDL ] , triglyceride [ TG ] , and cholesterol ) , glucose and HbA1c were measured . RESULTS : There was no significant difference in serum visfatin level between Omega-3 and placebo groups before the intervention ( p = 0.14 ) , while after the intervention , the mean serum visfatin level in the Omega-3 group was significantly higher ( p < 0.001 ) . In addition , the mean difference between the serum visfatin level before and after the intervention in both groups was significant ( p < 0.001 ) . CONCLUSIONS : This study showed an increase in visfatin level following consuming Omega-3 fats but according to controversial issues on insulin-like function of visfatin , the effects of Omega-3 on diabetes should be studied more in further studies Objectives —Fish oil rich in n-3 polyunsaturated fatty acids ( PUFAs ) or n-3 PUFAs have been shown to reduce the incidence of coronary heart disease . Here we investigated the effect of highly purified eicosapentaenoic acid ( EPA ) on production of adiponectin , the only established antiatherogenic and antiinflammatory adipocytokine , in rodent models of obesity and human obese subjects . Methods and Results —We demonstrated that EPA increases adiponectin secretion in genetically obese ob/ob mice and high-fat diet – induced obese mice . In the in vitro coculture of adipocytes and macrophages , EPA reversed the coculture-induced decrease in adiponectin secretion at least in part through downregulation of tumor necrosis factor-&agr ; in macrophages . We also showed significant increase in plasma adiponectin concentrations in human obese subjects after a 3-month treatment with EPA ( 1.8 g daily ) . Multivariate regression analysis revealed that EPA treatment is the only independent determinant of plasma adiponectin concentrations . Conclusion —This study demonstrates that EPA increases adiponectin secretion in rodent models of obesity and human obese subjects , possibly through the improvement of the inflammatory changes in obese adipose tissue . Because EPA has reduced the risk of major coronary events in a large-scale , prospect i ve , r and omized clinical trial , this study provides important insight into its therapeutic implication in obesity-related metabolic sequelae Recent evidence suggests that omega-3 polyunsaturated fatty acids [ n-3 PUFAs : eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) ] , improve insulin sensitivity in humans . In a double-blind , placebo-controlled , r and omized , crossover study , we investigated the effects of EPA/DHA on paraoxonase-1 activity as well as fasting and postpr and ial levels of circulating adiponectin and leptin in 34 subjects with type 2 diabetes mellitus who received daily for 6 weeks either 2 g purified EPA/DHA or olive oil ( placebo ) , separated by a 6 weeks washout . At the end of each treatment , measurements were performed in fasting state and 2 , 4 , and 6 h following a st and ardized high-fat meal ( 600 kcal ) . No significant differences in fasting and postpr and ial circulating adiponectin , leptin , and paraoxonase-1 activity were seen between n-3 PUFAs and placebo . Our data do not support an insulin sensitizing effect of n-3 PUFAs by means of influencing circulating adipocytokines in this population . Clinical Trial Register Number : NCT00328536 Background Energy restriction affects circulating leptin and ghrelin concentrations . The aim of this study To investigate whether seafood consumption affects fasting leptin and ghrelin concentrations in addition to weight loss . Methods In this 8-week dietary intervention , subjects ( 324 Icel and ic , Spanish and Irish subjects , 20–40 years , BMI 27.5–32.5 kg/m2 ) were r and omized to energy-restricted diets ( −30 % ) of identical macronutrient composition but different amount of seafood : control ( no seafood ) ; lean fish ( 150 g cod , three times per week ) ; fatty fish ( 150 g salmon , three times per week ) ; EPA&DHA [ daily docosahexaenoic (DHA)/eicosapentaenoic acid ( EPA ) capsules ] . Anthropometric data , ghrelin , leptin , and insul OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusion Plant and marine sources of n-3 PUFAs can modify serum leptin and adiponectin levels by increasing adiponectin and decreasing leptin levels in patients with type 2 diabetes . Due to some limitations in this study , further studies are needed to reach a definitive conclusion about the effect of n-3 PUFAs on the levels of leptin and adiponectin in T2DM

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background — MRI-detected brain lesions are common after left atrial catheter ablation for symptomatic atrial fibrillation . The clinical relevance of these acute ischemic lesions is not fully understood , but ablation-related cerebral injury could contribute to cognitive dysfunction . Methods and Results — In the prospect i ve Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation ( MACPAF ) study , serial 3-T brain MRIs and neuropsychological assessment were performed to analyze the rate of ablation-related brain lesions and their effect on cognitive function . Thirty-seven patients with paroxysmal atrial fibrillation ( median age , 63.0 [ interquartile range , 57–68 ] years ; 41 % female ; median CHA2DS2VASc score 2 [ interquartile range , 1–3 ] ) underwent 41 ablation procedures according to study criteria . None of these patients had overt neurological deficits after ablation . High-resolution diffusion-weighted imaging , performed within 48 hours after ablation , showed that new brain lesions ( range , 1–17 ) were present in 16 ( 43.2 % ) patients after 18 ( 43.9 % ) left atrial catheter ablation procedures . Follow-up MRI at 6 months ( median , 6.5 ; interquartile range , 6–7 ) revealed that 7 ( 12.5 % ) of the 56 total acute brain lesions after ablation formed a persistent glial scar in 5 ( 31.3 % ) patients . Large diffusion-weighted imaging lesions and a corresponding fluid-attenuated inversion recovery lesion 48 hours after ablation predicted lesion persistence on 6-month follow-up . Neither persistent brain lesions nor the ablation procedure itself had a significant effect on attention or executive functions , short-term memory , or verbal and nonverbal learning after 6 months . Conclusions — Ablation-related acute ischemic brain lesions persist to some extent but do not cause cognitive impairment 6 months after the ablation procedure . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01061931 BACKGROUND Asymptomatic cerebral lesions ( ACL ) may occur during atrial fibrillation ( AF ) ablation . We sought to compare the ACL incidence between 3 contemporary technologies : ( 1 ) irrigated radiofrequency current ( RFC ) , ( 2 ) the single big cryoballoon ( CB ) , and ( 3 ) the endoscopic laser-balloon ( LB ) in a prospect i ve r and omized pilot study . METHODS AND RESULTS Ninety-nine patients were treated in 3 groups . Diffusion weighted MRI was acquired pre- ( n = 20 ) and 24 - 48 h postablation ( n = 99 ) . After ablation , new ACL were detected in 22 % of patients without significant differences between groups ( RFC 8/33 ; CB 6/33 ; LB 8/33 ; P = 0.8 ) . The presence of hypertension was identified as the only independent predictor of ACL by univariate regression analysis . During LB ablation , more ablation lesions ( 140 ± 19 vs 119 ± 18 ; P = 0.007 ) were applied during longer procedures ( 166 ± 36 vs 143 ± 32 min ; P = 0.05 ) in patients with ACL . Univariate analysis revealed that a higher number of ablation lesions predicted ACL ( P = 0.02 ) . CONCLUSION In this prospect i ve , r and omized , single-center pilot study , ablation technology did not influence the occurrence of ACL during AF ablation INTRODUCTION There are limited comparative data on catheter ablation of atrial fibrillation ( CAAF ) using the second-generation cryoballoon ( CB-2 ) versus point-by-point radiofrequency ( RF ) . This study examines the acute/long-term CAAF outcomes using these 2 strategies . METHODS AND RESULTS In this multicenter , retrospective , nonr and omized analysis , procedural and clinical outcomes of 1,196 patients ( 76 % with paroxysmal AF ) undergoing CAAF using CB-2 ( n = 773 ) and open-irrigated , non-force sensing RF ( n = 423 ) were evaluated . Pulmonary vein isolation was achieved in 98 % with CB-2 and 99 % with RF ( P = 0.168 ) . CB-2 was associated with shorter ablation time ( 40 ± 14 min vs. 66 ± 26 min ; P < 0.001 ) and procedure time ( 145 ± 49 minutes vs. 188 ± 42 minutes ; P < 0.001 ) , but greater fluoroscopic utilization ( 29 ± 13 minutes vs. 23 ± 14 minutes ; P < 0.001 ) . While transient ( 7.6 % vs. 0 % ; P < 0.001 ) and persistent ( 1.2 % vs. 0 % ; P = 0.026 ) phrenic nerve palsy occurred exclusively with CB-2 , other adverse event rates were similar between CB-2 ( 1.6 % ) and RF ( 2.6 % ) ; P = 0.207 . However , freedom from AF/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with CB-2 ( 76.6 % ) versus RF ( 60.4 % ) ; P < 0.001 . While this difference was evident in patients with paroxysmal AF ( P < 0.001 ) , it did not reach significance in those with persistent AF ( P = 0.089 ) . Additionally , CB-2 was associated with reduced long-term need for antiarrhythmic therapy ( 16.7 % vs. 22.0 % ; P = 0.024 ) and repeat ablations ( 14.6 % vs. 24.1 % ; P < 0.001 ) . CONCLUSION In this multicenter , retrospective , nonr and omized study , CAAF using CB-2 coupled with RF as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated , non-force sensing RF , alone BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P < .001 ) . The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P < .001 ) , and 22 ± 63 seconds and 9 ± 20 seconds ( P = NS ) , respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P < .001 ) . During 6-month follow-up , 84.2 % of patients in the non-CF group and 94.7 % in the CF group were free from any atrial tachyarrhythmias ( P = .34 ) . CONCLUSION CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome Background — There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency ( RF ) and cryoballoon catheter ( CB ) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation . Methods and Results — In a prospect i ve , noninferiority study , 315 patients were r and omly assigned to RF ( n=159 ) or CB ( n=156 ) ablation . The primary end point was freedom from atrial arrhythmia with absence of persistent complications . Patients were largely comparable between groups with more vascular disease in the RF group ( 8.2 % versus 2.6 % for CB ; P=0.028 ) . The primary end point at 12 months was achieved by 70.7 % with RF and 73.6 % with CB ( multiple procedure success ) , including 31 redo procedures in each group ( 19.5 % of RF versus 19.9 % of CB ; P=0.933 ) . For the intention-to-treat population , noninferiority of CB was revealed for the predefined inferiority margin ( risk difference , 0.029 ; 95 % confidence interval , −0.074 to 0.132 ; P<0.001 ) . Rates at 6 months were 63.1 % and 64.1 % for the RF and CB groups ( single procedure success ) , and noninferiority was confirmed ( risk difference , 0.010 ; 95 % confidence interval , −0.097 to 0.116 ; P=0.002 ) . Periprocedural complications for the index procedure were more frequent in the CB group ( 5.0 % RF , 12.2 % CB ; P=0.022 ) with a significant difference in phrenic nerve palsies ( 0 % RF , 5.8 % CB ; P=0.002 ) . Conclusion — This large , prospect i ve , r and omized , controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00774566 AIMS Catheter ablation of the pulmonary veins ( PVs ) is a promising therapeutic approach for symptomatic atrial fibrillation ( AF ) . The prospect i ve r and omized single-centre study ' Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation ' ( MACPAF ; clinical trials.gov NCT01061931 ) compared the efficacy and safety of two balloon-based PV ablation systems . METHODS AND RESULTS Thirty-two patients underwent PV ablation for symptomatic paroxysmal AF using the A rct ic Front ® or the HD Mesh Ablator ® catheter according to study protocol . The primary endpoint was complete PV isolation ( PVI ) at the end of the ablation procedure , determined by exit block after achieving entrance block . Long-term follow-up data are not included in this publication . Patients ' mean age was 61.7 ± 8.9 years , 43.2 % were female , and median CHA₂DS₂-VASc score was 2.0 . In the intention-to-treat analysis , the rate of the primary endpoint was 56.5 % in patients r and omized to the A rct ic Front ® and 9.5 % in patients r and omized to the HD Mesh Ablator ® catheter ( P = 0.001 ) . In the per- protocol analysis , complete PVI was achieved in 13 ( 76.5 % ) of 17 A rct ic Front ® patients but in none of the 15 HD Mesh Ablator ® patients ( P < 0.0001 ) . There were one major and two minor complications in each study arm but no clinical ly evident stroke . Post-procedural AF recurrence was detected within hospital stay in two ( 11.8 % ) A rct ic Front ® patients and in seven ( 46.7 % ) HD Mesh Ablator ® patients ( P = 0.049 ) . CONCLUSION The MACPAF study revealed a superiority of the A rct ic Front ® catheter concerning complete PVI . Owing to the insufficient efficacy of the HD Mesh Ablator ® catheter , the safety board decided to stop MACPAF prematurely BACKGROUND Catheter ablation is an established treatment for atrial fibrillation ( AF ) . Cryoballoon ablation ( CBA ) has emerged as an alternative to radiofrequency ablation ( RFA ) . However , there are few data comparing these modalities for treatment of paroxysmal AF ( pAF ) in the U.S. POPULATION The purpose of this study was to OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Pool analyses indicated that CB ablation was more beneficial in terms of procedural time [ st and ard mean difference = −0.58 ; 95 % confidence interval ( CI ) , −0.85 to −0.30 ] , complications without phrenic nerve injury ( PNI ) [ odds ratio ( OR ) = 0.79 ; 95 % CI , 0.67–0.93 ; I2 = 16 % ] , and recrudescence ( OR = 0.83 ; 95 % CI , 0.70–0.97 ; I2 = 63 % ) for PAF ; however , the total complications of CB was higher than RF . The subgroup analysis found that , compared with non-contact force radiofrequency ( non-CF-RF ) , both first-generation cryoballoon ( CB1 ) and second-generation cryoballoon ( CB2 ) ablation could reduce complications with PNI , procedural time , and recrudescence . However , the safety and efficacy of CB2 was similar to those of CF-RF . Conclusion Available overall and subgroup data suggested that both CB1 and CB2 were more beneficial than RF ablation , and the main advantages were reflected in comparing them with non-CF-RF . However , CF-RF and CB2 showed similar clinical benefits

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: CONTEXT Recent guidelines for treatment of overweight and obesity include recommendations for risk stratification by disease conditions and cardiovascular disease ( CVD ) risk factors , but the role of physical inactivity is not prominent in these recommendations . OBJECTIVE To quantify the influence of low cardiorespiratory fitness , an objective marker of physical inactivity , on CVD and all-cause mortality in normal-weight , overweight , and obese men and compare low fitness with other mortality predictors . DESIGN Prospect i ve observational data from the Aerobics Center Longitudinal Study . SETTING Preventive medicine clinic in Dallas , Tex . PARTICIPANTS A total of 25714 adult men ( average age , 43.8 years [ SD , 10.1 years ] ) who received a medical examination during 1970 to 1993 , with mortality follow-up to December 31 , 1994 . MAIN OUTCOME MEASURES Cardiovascular disease and all-cause mortality based on mortality predictors ( baseline CVD , type 2 diabetes mellitus , high serum cholesterol level , hypertension , current cigarette smoking , and low cardiorespiratory fitness ) stratified by body mass index . RESULTS During the study period , there were 1025 deaths ( 439 due to CVD ) during 258781 man-years of follow-up . Overweight and obese men with baseline CVD or CVD risk factors were at higher risk for all-cause and CVD mortality compared with normal-weight men without these predictors . Using normal-weight men without CVD as the referent , the strongest predictor of CVD death in obese men was baseline CVD ( age- and examination year-adjusted relative risk [ RR ] , 14.0 ; 95 % confidence interval [ CI ] , 9.4 - 20.8 ) ; RRs for obese men with diabetes mellitus , high cholesterol , hypertension , smoking , and low fitness were similar and ranged from 4.4 ( 95 % CI , 2.7 - 7.1 ) for smoking to 5.0 ( 95 % CI , 3.6 - 7.0 ) for low fitness . Relative risks for all-cause mortality in obese men ranged from 2.3 ( 95 % CI , 1.7 - 2.9 ) for men with hypertension to 4.7 ( 95 % CI , 3.6 - 6.1 ) for those with CVD at baseline . Relative risk for all-cause mortality in obese men with low fitness was 3.1 ( 95 % CI , 2.5 - 3.8 ) and in obese men with diabetes mellitus 3.1 ( 95 % CI , 2.3 - 4.2 ) and as slightly higher than the RRs for obese men who smoked or had high cholesterol levels . Low fitness was an independent predictor of mortality in all body mass index groups after adjustment for other mortality predictors . Approximately 50 % ( n = 1674 ) of obese men had low fitness , which led to a population -attributable risk of 39 % for CVD mortality and 44 % for all-cause mortality . Baseline CVD had population attributable risks of 51 % and 27 % for CVD and all-cause mortality , respectively . CONCLUSIONS In this analysis , low cardiorespiratory fitness was a strong and independent predictor of CVD and all-cause mortality and of comparable importance with that of diabetes mellitus and other CVD risk factors BACKGROUND The proportion of overweight adolescents has increased , but the behavioral risk factors for overweight youth are not well understood . OBJECTIVE To examine how diet , physical activity , and sedentary behaviors relate to overweight status in adolescents . DESIGN AND SETTING Baseline data from the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition Project , a r and omized controlled trial of adolescents to determine the effects of a clinic-based intervention on physical activity and dietary behaviors . PARTICIPANTS A total of 878 adolescents aged 11 to 15 years , 42 % of whom were from minority background s. MAIN OUTCOME MEASURE Centers for Disease Control and Prevention body mass index-for-age percentiles divided into 2 categories : normal weight ( < 85th percentile ) and at risk for overweight plus overweight ( AR + O ) ( > or=85th percentile ) . RESULTS Overall , 45.7 % of the sample was classified as AR + O with a body mass index for age at the 85th percentile or higher . More girls from minority background s ( 54.8 % ) were AR + O compared with non-Hispanic white girls ( 42 % ) ( chi(2)(1 ) = 7.6 ; P = .006 ) . Bivariate analyses indicated that girls and boys in the AR + O group did fewer minutes per day of vigorous physical activity , consumed fewer total kilojoules per day , and had fewer total grams of fiber per day than those in the normal-weight group . Boys in the AR + O group also did fewer minutes per day of moderate physical activity and watched more minutes per day of television on nonschool days than normal-weight boys . Final multivariate models indicated that independent of socioeconomic status ( as assessed by household education level ) , girls had a greater risk of being AR + O if they were Hispanic or from another minority background ( odds ratio [ OR ] = 1.65 ; 95 % confidence interval [ CI ] , 1.09 - 2.49 ) and a reduced risk of being AR + O as minutes per day of vigorous physical activity increased ( OR = 0.93 ; 95 % CI , 0.89 - 0.97 ) . A low level of vigorous physical activity was the only significant risk factor for boys being AR + O ( OR = 0.92 ; 95 % CI , 0.89 - 0.95 ) . Analyses based on meeting behavioral guidelines supported these findings and showed that failing to meet the 60 min/d moderate to vigorous physical activity guideline was associated with overweight status for both girls and boys . In addition , boys who failed to meet sedentary behavior and dietary fiber guidelines were more likely to be overweight . CONCLUSIONS Of the 7 dietary and physical activity variables examined in this cross-sectional study , insufficient vigorous physical activity was the only risk factor for higher body mass index for adolescent boys and girls . Prospect i ve studies are needed to clarify the relative importance of dietary and physical activity behaviors on overweight in adolescence BACKGROUND It is unclear how moderate and vigorous intensities of physical activity ( PA ) are associated with cardiovascular fitness ( CVF ) and percentage of body fat ( % BF ) in adolescents . OBJECTIVE We tested the hypothesis that vigorous PA , to a greater degree than moderate PA , would be associated with better CVF and lower % BF . DESIGN This was a cross-sectional study of 421 black and white high school students ( x age : 16 y ) . PA was measured with 5 d of accelerometry and expressed in min/d of moderate or vigorous PA . CVF was measured with a multistage treadmill test and was expressed as the oxygen consumption at a heart rate of 170 bpm . % BF was measured with dual-energy X-ray absorptiometry . Multiple regressions were used to determine the degree to which variance in CVF and % BF was explained by PA , after control for age , sex , race , and the sex x race interaction . RESULTS A higher index for CVF was associated with higher amounts of moderate and vigorous PA ; more variance was explained by vigorous than by moderate PA . Lower % BF was associated with higher amounts of vigorous PA but not with the amount of moderate PA . CONCLUSION Black and white adolescents who engaged in relatively large amounts of free-living vigorous exercise were likely to be relatively fit and lean Type 2 diabetes is a common disease in industrialized countries . It is a major cause of cardiovascular disease and all-cause mortality ( 1 - 6 ) , and its prevalence has increased continuously over the past few decades ( 1 ) . The American Diabetes Association currently defines impaired fasting glucose as a fasting plasma glucose level from 6.1 to 6.9 mmol/L ( 110 to 125 mg/dL ) and type 2 diabetes as a fasting plasma glucose level of 7.0 mmol/L ( 126 mg/dL ) or more ( 1 ) . Data from several prospect i ve studies show an inverse association between physical activity and diabetes ( 7 - 13 ) . However , these studies are limited by the use of self-reporting of physical activity and presence of type 2 diabetes ( 7 - 12 ) . Self-reporting of physical activity tends to be imprecise , and type 2 diabetes is undiagnosed in about 50 % of the prevalent cases ( 14 ) . This leads to misclassification on both exposure and outcome measures ( 15 ) . These limitations may result in underestimation of the true association between sedentary habits and risk for type 2 diabetes . Impaired fasting glucose is a strong predictor of type 2 diabetes , cardiovascular disease , and other diabetic complications ( 6 , 16 - 18 ) . The underlying cause of impaired fasting glucose is unknown , and no prospect i ve study of the association between physical activity and impaired fasting glucose has been published . We examined the relation of cardiorespiratory fitness , objective ly determined by a maximal exercise test on a treadmill , to the incidence of impaired fasting glucose and type 2 diabetes . Cases of impaired fasting glucose and diabetes at baseline and follow-up were determined by using the American Diabetes Association 's current guidelines ( 1 ) . Methods Patients In our population -based prospect i ve study , we included 8633 men 30 to 79 years of age at baseline ( mean , 43.5 years ) who completed at least two medical evaluations at the Cooper Clinic in Dallas , Texas , from 1970 to 1995 . Patients come to the Cooper Clinic for preventive medical examinations and health promotion counseling . Many are sent by their employers for these services , some are referred by their personal physicians , and others are self-referred . More than 97 % of the patients are white , and most are employed in executive or professional occupations . More than 75 % are college graduates . Although study participants came from middle and upper socioeconomic strata , they were similar to other well-characterized population -based cohorts in terms of blood pressure , cholesterol level , body weight , and cardiorespiratory fitness ( 19 ) . The study was review ed and approved annually by the institutional review board at the Cooper Institute for Aerobics Research . Additional details of the study methods and population characteristics of the cohort have been published elsewhere ( 20 , 21 ) . Because clinical or sub clinical heart disease and other conditions associated with type 2 diabetes may alter the level of physical activity and thus cardiorespiratory fitness , we excluded men with an abnormal resting or exercise electrocardiogram or a history of heart attack , stroke , or cancer at the baseline clinical examination ( n=2350 ) . The baseline evaluation was performed after participants gave written informed consent for the initial medical examination and registration in the follow-up study . Examinations were done after patients had fasted for at least 12 hours and included personal and family health histories , a question naire on demographic characteristics and health habits , a physical examination , an exercise test , anthropometric measurement , electrocardiography , blood chemistry analyses , and blood pressure measurement . Technicians who followed a st and ard manual of operations administered all procedures . Impaired fasting glucose and type 2 diabetes were diagnosed according to American Diabetes Association criteria that define impaired fasting glucose as a fasting plasma glucose level of 6.1 to 6.9 mmol/L ( 110 mg/dL to 125 mg/dL ) and diabetes as a fasting plasma glucose level of 7.0 mmol/L ( 126 mg/dL ) or more ( 1 ) . Patients who did not meet these criteria but who reported a history of diabetes or current therapy with oral antidiabetic agents or insulin were also considered to have diabetes . We excluded patients who had diabetes at baseline according to any of these criteria ( n=377 ) . Cardiorespiratory fitness was assessed with a maximal exercise test that followed a modified Balke protocol ( 22 ) . Details of treadmill speed and elevation have been described elsewhere ( 20 , 21 ) . Briefly , the test began with the patient walking on a horizontal treadmill at 88 m/min . After the first minute , the elevation increased to 2 % ; the elevation then increased 1 % each minute up to 25 minutes . For the few patients who were still able to continue , the elevation was held constant after 25 minutes and the speed was increased by 5.4 m/min until the patient reached volitional fatigue . Use of this protocol for the exercise test correlates highly ( r=0.92 ) with measured maximal oxygen uptake ( 23 ) . All patients in our study achieved at least 85 % of their age-predicted maximal heart rate ; average maximal heart rates ( SD ) in each age group were 186 11 beats/min for patients 30 to 39 years of age , 179 12 beats/min for those 40 to 49 years of age , 172 13 beats/min for those 50 to 59 years of age , and 162 17 beats/min for those 60 years of age or older . Average maximal heart rates in each age group exceeded the age-predicted rate ( OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

VPA was more strongly associated with reduced body fat and central adiposity compared with MPA and /or MVPA . Additionally , VPA was more strongly associated with increased CRF when compared with lower intensities . Findings were inconclusive between all PA intensity levels and CM biomarkers , and several significant relationships observed for VPA were attenuated when controlling for CRF . A potential VPA dose is identified as yielding favorable health benefits in adiposity and fitness . While CM biomarkers were not consistently associated with PA intensity level , the literature suggests VPA may yield health benefits above those received from MPA for reduced adiposity and improved CRF .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE The authors examined the efficacy of intramuscular flunitrazepam compared with intramuscular haloperidol for the immediate control of agitated or aggressive behavior in acutely psychotic patients . METHOD Twenty-eight actively psychotic in patients , aged 20 - 60 years , who were under treatment with neuroleptic agents were selected for the study . Each was r and omly assigned on a double-blind basis to receive either 5 mg i.m . of haloperidol ( N=13 ) or 1 mg i.m . of flunitrazepam ( N=15 ) during an aggressive event . Verbal and physical aggression was measured over time with the Overt Aggression Scale . Patients were also rated with the Brief Psychiatric Rating Scale and the Clinical Global Impression scale . RESULTS Both flunitrazepam and haloperidol exhibited acute antiaggressive activity . This beneficial effect , as assessed by the Overt Aggression Scale , was obtained within 30 minutes . CONCLUSIONS Intramuscular flunitrazepam may serve as a convenient , rapid , safe , and effective adjunct to neuroleptics in reducing aggressive behavior in emergency psychiatric setting Although paramedics and emergency department ( ED ) personnel are routinely required to assess the mental states of patients they are attempting to treat , no structured and easily administered tool has been vali date d for their use . The objective of this study was to determine whether a quantitative Brief Mental Status Examination ( BMSE ) can serve as such a tool . The six-item BMSE was administered to 100 ED patients for whom an assessment of mental status was warranted . The st and ard assessment of mental status ( normal , mildly impaired , or severely impaired ) and competence to refuse emergency care were provided by the attending physician . The usefulness and ease of administration of the BMSE were rated by the physicians and nurses administering it . We found that BMSE scores correlated significantly with physicians ' assessment s of patients ' mental status and competence to refuse care . Using physician assessment as a st and ard , the BMSE had a sensitivity of 72 % and a specificity of 95 % in identifying severely impaired individuals . Examiners ' ratings of ease of administration were closely related to the degree of impairment found . Finally , examiners rated the BMSE as useful in 98 % of cases . We conclude from these preliminary results that the BMSE , upon further testing , may prove to be a valid and useful tool for assessing the mental states of emergency patients in both prehospital and ED setting Abstract Background Kraepelin ’s partial interpretation of agitated depression as a mixed state of “ manic-depressive insanity ” ( including the current concept of bipolar disorder ) has recently been the focus of much research . This paper tested whether , how , and to what extent both psychomotor symptoms , agitation and retardation in depression are related to bipolarity and anxiety . Method The prospect i ve Zurich Study assessed psychiatric and somatic syndromes in a community sample of young adults ( N = 591 ) ( aged 20 at first interview ) by six interviews over 20 years ( 1979–1999 ) . Psychomotor symptoms of agitation and retardation were assessed by professional interviewers from age 22 to 40 ( five interviews ) on the basis of the observed and reported behaviour within the interview section on depression . Psychiatric diagnoses were strictly operationalised and , in the case of bipolar-II disorder , were broader than proposed by DSM-IV-TR and ICD-10 . As indicators of bipolarity , the association with bipolar disorder , a family history of mania/hypomania/cyclothymia , together with hypomanic and cyclothymic temperament as assessed by the general behavior inventory ( GBI ) [ 15 ] , and mood lability ( an element of cyclothymic temperament ) were used . Results Agitated and retarded depressive states were equally associated with the indicators of bipolarity and with anxiety . Longitudinally , agitation and retardation were significantly associated with each other ( OR = 1.8 , 95 % CI = 1.0–3.2 ) , and this combined group of major depressives showed stronger associations with bipolarity , with both hypomanic/cyclothymic and depressive temperamental traits , and with anxiety . Among agitated , non-retarded depressives , unipolar mood disorder was even twice as common as bipolar mood disorder . Conclusion Combined agitated and retarded major depressive states are more often bipolar than unipolar , but , in general , agitated depression ( with or without retardation ) is not more frequently bipolar than retarded depression ( with or without agitation ) , and pure agitated depression is even much less frequently bipolar than unipolar . The findings do not support the hypothesis that agitated depressive syndromes are mixed states . Limitations The results are limited to a population up to the age of 40 ; bipolar-I disorders could not be analysed ( small N ) Objective Published research on agitation is limited by the difficulty in generalizing findings from trials using moderately agitated , carefully selected patients treated with single agents . More specifically , there are few comparative studies examining common intramuscular ( IM ) regimens ( ie , haloperidol with or without benzodiazepines ) with IM atypical antipsychotics . Therefore , we conducted a retrospective chart review to compare IM olanzapine and haloperidol in a “ real-world ” population with agitation . Method We performed a retrospective evaluation of charts from 146 consecutive emergency department patients who received either IM haloperidol or IM olanzapine for agitation . We used a clinical ly oriented proxy marker of efficacy — the necessity for additional medication intervention for agitation (AMI)—as our primary outcome measure . Results Additional medication intervention for agitation was required by 43 % ( 13/30 ) patients when haloperidol was given alone and by 18 % ( 13/72 ) when haloperidol was given with a benzodiazepine . In the case of olanzapine , AMI was required by 29 % ( 6/21 ) of patients receiving olanzapine alone and by 18 % ( 2/11 ) of patients given olanzapine plus a benzodiazepine . A significant percentage of patients had clinical characteristics ( nonpsychiatric triage complaint , drug/alcohol use , severe agitation ) that differ from more selective sample s. Conclusions Overall , these finding suggest that in a naturalistic emergency department setting , haloperidol monotherapy is less effective — at least in requiring AMI — than olanzapine with or without a benzodiazepine or haloperidol plus a benzodiazepine . Moreover , these later 3 regimens seemed comparable . Prospect i ve studies examining the treatment of real-world agitation , including head-to-head comparisons of the haloperidol-benzodiazepine combination with newer IM antipsychotics , are needed Abstract : Quetiapine ( QTP ) combined with lithium ( Li ) or divalproex ( DVP ) for the treatment of mania was evaluated in 2 double-blind , placebo-controlled studies . Patients were r and omized to 3 or 6 weeks of treatment with QTP plus Li/DVP or placebo ( PBO ) plus Li/DVP . Quetiapine was dosed up to 800 mg/d ; Li was dosed to achieve serum concentrations of 0.7 - 1.0 mEq/L and DVP to 50 - 100 μg/mL. A total of 402 patients were r and omized : 197 to QTP + Li/DVP and 205 to PBO + Li/DVP . The mean quetiapine dose in responders was 492 ( ±204 ) mg/d . Improvement in the Young Mania Rating Scale ( YMRS ) at day 21 in the QTP + Li/DVP group ( −15.29 ) was statistically superior to the PBO + Li/DVP group ( −12.19 ) ( P < 0.05 ) . A statistically significant difference in favor of quetiapine was observed within the first week ( P < 0.05 ) . Significantly more QTP + Li/DVP patients achieved a response ( ≥50 % decrease in the YMRS ) at day 21 ( QTP + Li/DVP , 55.7 % ; PBO + Li/DVP , 41.6%;P < 0.01 ) . Improvements in Clinical Global Impression-Bipolar Severity of Illness scores by day 21 were also significantly greater in QTP + Li/DVP-treated patients ( −1.59 ) versus PBO + Li/DVP ( −1.19 ) ( P < 0.01 ) . Common adverse events ( ≥5 % and twice that in the PBO + Li/DVP group ) in the QTP + Li/DVP group were somnolence , dry mouth , and asthenia . Quetiapine combined with Li/DVP was not associated with extrapyramidal symptoms ( including akathisia ) or emergent depression . More QTP + Li/DVP-treated patients completed the trial , and there was no difference in discontinuation rates due to adverse events between the two groups . Quetiapine , in combination with lithium or divalproex , is well tolerated and has superior efficacy to lithium or divalproex alone in the treatment of bipolar mania Background Conventional antipsychotics augmented with benzodiazepines have been the st and ard acute treatment for psychiatric emergencies for more than 50 years . The inability of patients to give informed consent limits r and omised , controlled studies . This observational study on immediate therapy for aggression and impulse control in acutely agitated patients ( IMPULSE ) evaluated the short-term effectiveness and tolerability of atypical and typical antipsychotic medications ( AP ) in a non-interventional setting . Methods This was a comparative , non-r and omised , prospect i ve , open-label , observational study . Treatment over the first 5 days was classified according to whether any olanzapine , risperidone , or haloperidol was included or not . Documentations ( PANSS-excited component , CGI-aggression , CGI-suicidality , tranquilisation score ) were at baseline ( day 1 ) and days 2–6 after start of AP . Results During the short treatment-period , PANSS-EC and CGI-aggression scores improved in all cohorts . 68.7 % of patients treated with olanzapine , 72.2 % of patients treated with risperidone , and 83.3 % of patients treated with haloperidol received concomitant benzodiazepines ( haloperidol vs. non-haloperidol : p < 0.001 ) . More patients treated with olanzapine ( 73.8 % ) were fully alert according to a tranquilisation score and active at day 2 than patients treated with risperidone ( 57.1 % ) or haloperidol ( 58.0 % ) . Conclusion Current medication practice s for immediate aggression control are effective with positive results present within a few days . In this study , concomitant benzodiazepine use was significantly more frequent in patients receiving haloperidol OBJECTIVE Aggressive patients are not uncommon in acute inpatient behavioral health units of general hospitals . Prior research identifies various predictors associated with aggressive inpatient behavior . This prospect i ve observational study examines the demographic and clinical characteristics of aggressive in patients and the routine medications these patients were receiving at discharge . METHOD Thirty-six adults diagnosed with a DSM-IV mental disorder who met 2 of 6 established inclusion criteria for high violence risk and a Clinical Global Impressions-Severity of Illness ( CGI-S ) scale score ≥ 4 were observed for a maximum of 28 days on the 23-bed case mix acute behavioral health unit of St Luke 's University Hospital , Bethlehem , Pennsylvania , from January 2012 to May 2013 . Primary outcome measures were the Modified Overt Aggression Scale ( MOAS ) and CGI-S ; secondary measures were symptom outcome measures and demographic and clinical characteristics data . Analysis was conducted using repeated measures methodology . RESULTS Younger males with a history of previous violence , psychiatric admissions , and symptoms of severe agitation were more at risk for aggressive behavior . Positive psychotic symptoms , a diagnosis of bipolar disorder , substance use , and comorbid personality disorders also increased risk . Significant improvements from baseline to last visit were observed for the CGI-S and MOAS ( P < .001 for both ) , with a significant correlation between the MOAS and CGI-S at last visit ( P < .001 ) . Only the symptom of agitation was significantly correlated to MOAS scores at both baseline and last visit ( P < .001 ) . CONCLUSION Patients significantly improved over time in both severity of illness and level of aggression This r and omized , parallel-group , open study investigated the efficacy and safety of risperidone oral solution ( RIS-OS ) in combination with clonazepam and intramuscular haloperidol for the treatment of acute agitation in patients with schizophrenia , and the study explored the possibility of decreasing the efficacy of an acute 6-week treatment by switching intramuscular haloperidol injection to RIS-OS . Two hundred and five agitation-exhibiting schizophrenic in patients at six hospitals were originally included in the study . The 47-day trial consisted of 5 days ( session I ) of receiving either oral treatment ( RIS-OS plus clonazepam ) or intramuscular treatment ( intramuscular haloperidol ) and a 42-day ( session II ) period of either withdrawing from clonazepam or shifting from intramuscular haloperidol to a RIS-OS period . The primary efficacy outcome was measured as the change in the Positive and Negative Sy OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

For its management , experts agreed in considering verbal de-escalation and environmental modification techniques as first choice , considering physical restraint as a last resort strategy .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Study Design From a r and om population sample , those experiencing frequent headaches were identified . They were examined to determine how many fulfilled the 1990 international Headache Society classification criteria for cervicogenic headache . Objective To estimate the prevalence of cervicogenic headache in the general population and in the group experiencing frequent headaches . Summary of Background Data Only with the publication of the 1990 headache classification criteria did a generally accepted clinical definition of cervicogenic headache emerge . The prevaience of this form of headache has been estimated only in two highly selected in-clinic patient population s. No data exist regading the prevalence in representative unselected population s. Methods . A short question naire on headaches was mailed to 826 r and omly selected residents of a midsized Danish town . A group of 57 individuale in the age range 20–59 years who reported having headache episodes on 5 or more days in the previous month were identified . Forty-five of the 57 were eventually interviewed and examined with respect to the IHS criteria for cervicogenic headache ( the radiological criteria were omitted on ethical grounds ) . Results Of the 45 persons examined , eight fulfilled the diagnostic criteria for cervicogenic headache , equivalent to a prevalence in the headache group of 17.8 % ( 95 % confidence interval = 8%-32 % ) . Conclusions Cervicogenic headache appears to be a relatively common form of headache , similar to migraine in prevaience OBJECTIVE This article evaluates reliability and diagnostic validity of the cervical flexion-rotation test ( FRT ) to discriminate subjects with headache because of C1/2 dysfunction . In addition , this study evaluates agreement between experienced and inexperienced examiners . METHODS These were 2 single blind comparative measurement study design s. In study 1 , 2 experienced blinded examiners evaluated the FRT in 10 asymptomatic controls , 20 subjects with cervicogenic headache ( CeH ) where C1/2 was the primary dysfunctional level , and 10 subjects with CeH but without C1/2 as the primary dysfunctional level . In study 2 , 2 inexperienced and 1 experienced blinded examiners evaluated the FRT in 12 subjects with CeH and 12 asymptomatic controls . Examiners were required to state whether the FRT was positive and also to determine range of rotation using a goniometer . An analysis of variance with planned orthogonal comparison , single measure intraclass correlation coefficient ( 2,1 ) , and Bl and -Altman plot were used to analyze FRT range of rotation between the examiners . Sensitivity , specificity , and examiner agreement for test interpretation were analyzed using cross tabulation and kappa . RESULTS In study 1 , sensitivity and specificity of the FRT was 90 % and 88 % with 92 % agreement for experienced examiners ( P < .001 ) . Overall diagnostic accuracy was 89 % ( P < .001 ) and kappa = 0.85 . In study 2 , for inexperienced examiners , FRT mobility was significantly greater than for experienced examiners , but sensitivity , specificity , agreement , and kappa values were all within clinical ly acceptable levels . CONCLUSIONS The FRT can be used accurately and reliably by inexperienced examiners and may be a useful aid in CeH evaluation A single blind , age and gender matched , comparative measurement study was design ed to assess active range of cervical motion and passive range of rotation in cervical flexion in asymptomatic and cervicogenic headache subjects . Both procedures are commonly used in clinical practice to evaluate patients with cervicogenic headache . We studied 20 women and eight men with side dominant cervicogenic headache ( mean age 43.3 years ) matched with 28 asymptomatic subjects . Two experienced manipulative therapists , who were blind to each other 's measurement , noted active ranges of cervical motion and passive cervical rotation performed in the flexion-rotation test using the Cervical Range of Motion Device . Headache severity was assessed by a question naire . Additionally , one therapist prior to neck motion assessment determined the dominant symptomatic cervical motion segment . Active cervical motion in each direction was identical between the cervicogenic and control groups . In contrast , average rotation in flexion was 44 degrees to each side in the asymptomatic group and 28 degrees towards the headache side in the symptomatic group . C1 - 2 was deemed to be the dominant segmental level of headache origin in 24 of 28 subjects . In those 24 subjects range of rotation during the flexion-rotation test was inversely correlated to headache severity Persistent intermittent headache is a common disorder and is often accompanied by neck aching or stiffness , which could infer a cervical contribution to headache . However , the incidence of cervicogenic headache is estimated to be 14 - 18 % of all chronic headaches , highlighting the need for clear criterion of cervical musculoskeletal impairment to identify cervicogenic headache sufferers who may benefit from treatments such as manual therapy . This study examined the presence of cervical musculoskeletal impairment in 77 subjects , 27 with cervicogenic headache , 25 with migraine with aura and 25 control subjects . Assessment s included a photographic measure of posture , range of movement , cervical manual examination , pressure pain thresholds , muscle length , performance in the cranio-cervical flexion test and cervical kinaesthetic sense . The results indicated that when compared to the migraine with aura and control groups who scored similarly in the tests , the cervicogenic headache group had less range of cervical flexion/extension ( P=0.048 ) and significantly higher incidences of painful upper cervical joint dysfunction assessed by manual examination ( all P<0.05 ) and muscle tightness ( P<0.05 ) . Sternocleidomastoid normalized EMG values were higher in the latter three stages of the cranio-cervical flexion test although they failed to reach significance . There were no between group differences for other measures . A discriminant analysis revealed that manual examination could discriminate the cervicogenic headache group from the other subjects ( migraine with aura and control subjects combined ) with an 80 % sensitivity Purpose : Dysfunction of cervical and shoulder girdle muscles as reason of cervicogenic headache ( CEH ) was reinvestigated with clinical and neurophysiological studies . Methods : Forty office workers were r and omized into two groups to verify efficiency of supervised kinesiotherapy ( N = 20 ) aim ed with improvement of muscle ’s activity and headache symptoms releasing . Headache intensity was evaluated with visual analog scale ( VAS ) , range of cervical movement ( ROM ) with goniometer , trigger points ( TrPs ) incidence with palpation and muscle ’s strength with Lovett ’s scale . Reaction of patients for muscle ’s elongation was also evaluated . Surface electromyographical recordings were bilaterally analyzed at rest ( rEMG ) and during maximal contraction ( mcEMG ) . Results : Deficits of cervical flexion and muscles strength were found in all patients . TrPs occurred predominantly in painful trapezius muscle . Incidence of trigger points coexisted with intensity of CEH . Results indicated on muscles dysfunction which improved only after supervised therapy . Positive correlations between increase in rEMG amplitudes and high VAS scores , high-amplitude rEMG recordings incidence and increased number of TrPs were found . Negative correlation was detected between amplitude in mcEMG and amplitude of rEMG recordings . Conclusions : Dysfunction of trapezius muscle was most responsible for CEH etiology . Proposed algorithm of kinesiotherapy was effective as complementary method of the CEH patients treatment OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusions : Despite low levels of evidence , manual examination of the cervical spine appears to aid the diagnostic process related to CGH and can be implemented by both experienced and inexperienced examiners

MS2_fixed_5_shot210

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) are common in aging males and frequently occur together . Tadalafil has demonstrated efficacy in treating both conditions . AIM The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men . We also assessed relationships of baseline disease severity and prostate specific antigen ( PSA ) to outcomes . METHODS Data were pooled from four multinational , r and omized studies of men ≥45 years with LUTS/BPH , with analyses restricted to sexually active men with ED . R and omization ( baseline ) followed a 4-week placebo run-in ; changes from baseline were assessed vs. placebo using analysis of covariance . MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS subscores , Quality -of-Life Index ( IPSS-QoL ) , BPH Impact Index ( BII ) , and International Index of Erectile Function-Erectile Function ( IIEF-EF ) Domain score were used in this study . RESULTS Tadalafil ( N = 505 ) significantly improved total IPSS vs. placebo ( N = 521 ) ; mean changes from baseline were -6.0 and -3.6 , respectively ( P < 0.001 ) . Improvements in IIEF-EF Domain score ( tadalafil , 6.4 ; placebo , 1.4 ) were also significant vs. placebo , as were the IPSS storage and voiding subscores , IPSS-QoL , and BII ( all P < 0.001 ) . No significant impact of baseline ED severity or PSA category on IPSS response was observed ( interaction P values , 0.463 and 0.149 , respectively ) . Similarly , improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category ( interaction P values , 0.926 and 0.230 , respectively ) . Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated ( r = -0.229 ) . Treatment-emergent adverse events were consistent with previous reports . CONCLUSIONS Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions . Improvements in both conditions were significant regardless of baseline severity . Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated PURPOSE We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment . MATERIAL S AND METHODS We performed a single center , r and omized , double-blind , placebo controlled trial in 25 patients with spinal cord injury who had erectile dysfunction and micturition disorders . A baseline urodynamic test was performed as well as a second urodynamic test 1 to 3 hours after the administration of 20 mg vardenafil and placebo in 15 and 10 cases , respectively . In all patients st and ard oral oxybutynin administration was not discontinued . Statistical assessment included the 3 urodynamic parameters maximum detrusor pressure during voiding , maximum cystometric capacity and detrusor overactivity volume . RESULTS Placebo administration did not affect urodynamic parameters . After vardenafil administration maximum detrusor pressure was significantly decreased ( 59.3 vs 52.1 cm H(2)O , p < 0.001 ) and maximum cystometric capacity considerably improved ( 233.5 vs 272 ml , p < 0.001 ) . The most dramatic variations were observed for detrusor overactivity volume ( 174 vs 218 ml , p < 0.0001 ) . In 7 patients with American Spinal Injury Association classification A and spinal cord injury above T6 we observed the most significant improvement in the evaluated urodynamic items , including maximum detrusor pressure 57 vs 52 cm H(2)O ( p = 0.039 ) , maximum cystometric capacity 253 vs 296 ml ( p = 0.004 ) and detrusor overactivity volume 177 vs 229 ml ( p = 0.003 ) . CONCLUSIONS This trial demonstrates that in spinal cord injured patients a single 20 mg vardenafil administration achieved a significant decrease in maximum detrusor pressure , an improvement in maximum cystometric capacity and a remarkable increase in detrusor overactivity volume value INTRODUCTION Lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) and erectile dysfunction are common disorders of advancing age . AIM To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH . METHODS In this prospect i ve r and omized study , 133 men complaining of LUTS due to BPH were included . Forty-five patients received tamsulosin 0.4 mg/day alone ( Group A ) , 44 patients received tadalafil 10 mg/day ( Group B ) , and combination therapy ( tamsulosin and tadalafil both ) was instituted in 44 patients ( Group C ) . After a 2-week medication free run-in period , they were evaluated for International Prostatic Symptom Score ( IPSS ) , International Index of Erectile Function score ( IIEF5 ) , quality of life ( IPSS QoL ) , maximum urinary flow rate ( Qmax ) , post-void residual urine ( PVR ) volume , and safety parameters before and at 3 months of treatment . MAIN OUTCOME MEASURES There were primary ( IPSS , IPSS QoL index , Qmax , and PVR ) and secondary ( erectile function [ EF ] domain scores from IIEF5 ) efficacy end points . Safety assessment included laboratory tests and patient 's reporting of adverse event . RESULTS A significant improvement in IPSS score was observed in all the 3 groups A , B , and C ( -50.90 % , P < 0.05 ; -33.50 % , P < 0.05 ; and -53.90 % , P < 0.05 , respectively ) . IIEF5 score increased significantly in these three groups ( + 39.28 % , P < 0.05 ; + 45.96 % , P < 0.05 ; and + 60.23 % , P < 0.05 , respectively ) . A significant increase in Qmax and decrease in PVR were also observed ( 33.99 % , P < 0.05 ; 29.78 % , P < 0.05 ; and 37.04 % , P < 0.05 ) and ( -60.90 % , P < 0.05 ; -49.45 % , P < 0.05 ; and -62.97 % , P < 0.05 , respectively ) . The QoL scores improved significantly ( -73.35 % , P < 0.05 ; -70.26 % , P < 0.05 ; and -79.65 % , P < 0.05 , respectively ) . Side effects were dyspepsia , heartburn , headache , flushing , myalgia , and backache . Adverse effect dropout was 3.7 % . No participant experienced any severe or serious adverse events . CONCLUSIONS In patients with LUTS due to BPH , tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS . Their EF also improves with these medications . The improvement is better with combination therapy compared with single agent alone PURPOSE Tadalafil significantly improves lower urinary tract symptoms suggestive of benign prostatic hyperplasia . We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international , placebo controlled studies of tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia . MATERIAL S AND METHODS After a 4-week placebo lead-in period 1,500 men were r and omized to tadalafil 5 mg or placebo for 12 weeks . Data were analyzed using ANCOVA . Maximum urinary flow rate values were rank transformed for analysis . RESULTS Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197 . Tadalafil 5 mg significantly increased maximum urinary flow vs placebo ( median 1.1 vs 0.4 ml per second , p = 0.003 ) . At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second ( p = 0.142 ) in 731 patients , at a baseline of 250 to 450 ml the change was -0.3 and 0.7 ml per second ( p = 0.011 ) in 428 , and at a baseline of greater than 450 ml the change was -0.2 and 2.0 ml per second ( p = 0.186 ) in 38 for placebo and tadalafil , respectively . The difference was 0.3 , 1.0 and 2.2 ml per second , respectively . At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was -2.1 and -0.8 ml per second ( p = 0.246 ) , at a maximum of 10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second ( p = 0.044 ) , and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second ( p = 0.189 ) for placebo and tadalafil , respectively . Tadalafil improved I-PSS ( International Prostate Symptom Score ) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups ( each p < 0.001 ) . CONCLUSIONS This integrated analysis revealed a small but statistically significant median maximum urinary flow rate improvement for tadalafil vs placebo . The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume PURPOSE Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction . We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction . MATERIAL S AND METHODS Four separate analyses used integrated data from 4 r and omized , double-blind , placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS ( International Prostate Symptom Score ) improvement was due to improvement in IIEF-EF ( International Index of Erectile Function-Erectile Function domain score ) . Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms . RESULTS A total of 1,496 men , of whom 77 % had erectile dysfunction , received at least 1 dose of tadalafil 5 mg once daily or placebo . The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 ( p < 0.0001 ) in total I-PSS vs -2.2 ( p = 0.0007 ) for men without erectile dysfunction . The correlation between change from baseline in total I-PSS and IIEF-EF was weak ( r(2 ) = 0.08 , p < 0.0001 ) . The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement ( 2.25 ) was derived from a direct treatment effect of 1.57 ( 70 % , p < 0.001 ) and an indirect treatment effect of 0.67 ( 30 % via IIEF-EF improvement , p < 0.001 ) . Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct ( 92.5 % , p < 0.001 ) vs indirect ( 7.5 % , p = 0.32 ) treatment effects via IIEF-EF improvement . CONCLUSIONS Regardless of the analytical approach , self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia , supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction BACKGROUND Metabolic syndrome ( MetS ) and benign prostate hyperplasia (BPH)/low urinary tract symptoms ( LUTS ) are often comorbid . Chronic inflammation is one of the putative links between these diseases . Phosphodiesterase type 5 inhibitors ( PDE5i ) are recognized as an effective treatment of BPH-related LUTS . One proposed mechanism of action of PDE5 is the inhibition of intraprostatic inflammation . In this study we investigate whether PDE5i could blunt inflammation in the human prostate . METHODS Evaluation of the effect of tadalafil and vardenafil on secretion of interleukin 8 ( IL-8 , a surrogate marker of prostate inflammation ) by human myofibroblast prostatic cells ( hBPH ) exposed to different inflammatory stimuli . We preliminary evaluate histological features of prostatic inflammatory infiltrates in BPH OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Pooled data analyses revealed that tadalafil 5 mg once daily allows the clinical ly-meaningful improvement of LUTS and nocturnal voiding frequency independent of both erectile dysfunction severity and improvement . PDE5-Is are safe and effective in improving both LUTS and erectile function in appropriately selected men with LUTS/BPE . We found evidence to confirm that phosphodiesterase type 5 inhibitors are a valid treatment option for men affected by bothersome urinary symptoms with or without erectile dysfunction

MS2_fixed_5_shot211

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: CONTEXT Despite evidence of efficacy of antihypertensive agents in treating hypertensive patients , safety and efficacy of antihypertensive agents for coronary artery disease ( CAD ) have been discerned only from subgroup analyses in large trials . OBJECTIVE To compare mortality and morbidity outcomes in patients with hypertension and CAD treated with a calcium antagonist strategy ( CAS ) or a non-calcium antagonist strategy ( NCAS ) . DESIGN , SETTING , AND PARTICIPANTS R and omized , open label , blinded end point study of 22 576 hypertensive CAD patients aged 50 years or older , which was conducted September 1997 to February 2003 at 862 sites in 14 countries . INTERVENTIONS Patients were r and omly assigned to either CAS ( verapamil sustained release ) or NCAS ( atenolol ) . Strategies specified dose and additional drug regimens . Tr and olapril and /or hydrochlorothiazide was administered to achieve blood pressure goals according to guidelines from the sixth report of the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) of less than 140 mm Hg ( systolic ) and less than 90 mm Hg ( diastolic ) ; and less than 130 mm Hg ( systolic ) and less than 85 mm Hg ( diastolic ) if diabetes or renal impairment was present . Tr and olapril was also recommended for patients with heart failure , diabetes , or renal impairment . MAIN OUTCOME MEASURES Primary : first occurrence of death ( all cause ) , nonfatal myocardial infa rct ion , or nonfatal stroke ; other : cardiovascular death , angina , adverse experiences , hospitalizations , and blood pressure control at 24 months . RESULTS At 24 months , in the CAS group , 6391 patients ( 81.5 % ) were taking verapamil sustained release ; 4934 ( 62.9 % ) were taking tr and olapril ; and 3430 ( 43.7 % ) were taking hydrochlorothiazide . In the NCAS group , 6083 patients ( 77.5 % ) were taking atenolol ; 4733 ( 60.3 % ) were taking hydrochlorothiazide ; and 4113 ( 52.4 % ) were taking tr and olapril . After a follow-up of 61 835 patient-years ( mean , 2.7 years per patient ) , 2269 patients had a primary outcome event with no statistically significant difference between treatment strategies ( 9.93 % in CAS and 10.17 % in NCAS ; relative risk [ RR ] , 0.98 ; 95 % confidence interval [ CI ] , 0.90 - 1.06 ) . Two-year blood pressure control was similar between groups . The JNC VI blood pressure goals were achieved by 65.0 % ( systolic ) and 88.5 % ( diastolic ) of CAS and 64.0 % ( systolic ) and 88.1 % ( diastolic ) of NCAS patients . A total of 71.7 % of CAS and 70.7 % of NCAS patients achieved a systolic blood pressure of less than 140 mm Hg and diastolic blood pressure of less than 90 mm Hg . CONCLUSION The verapamil-tr and olapril-based strategy was as clinical ly effective as the atenolol-hydrochlorothiazide-based strategy in hypertensive CAD patients Aims Whereas product labels of beta blockers list peripheral arterial disease ( PAD ) as a contraindication , current PAD guidelines state otherwise . We aim ed to evaluate the clinical efficacy and safety of the ß1 selective blocker nebivolol in hypertensive patients with PAD . Methods and results This multicentre , prospect i ve , double-blind , active controlled , parallel-group study compared once-daily treatment with nebivolol ( Neb ) 5 mg vs. hydrochlorothiazide ( HCTZ ) 25 mg , in hypertensive patients with Fontaine stage II ( intermittent claudication ) . The primary endpoint was the initial claudication distance ( ICD ) during treadmill exercise after 24-week treatment in the per protocol population , using a noninferiority statistical approach . A total of 177 patients ( mean age was 66.3 ± 9.2 years , 76.7 % men ) were r and omized to study treatment and 127 completed the study ; the intent-to-treat ( ITT ) analysis was performed on 163 patients , the per protocol analysis on 127 patients . Both drugs lowered blood pressure significantly . After 24-week treatment , ICD increased in the Neb group in the ITT population by 28.3 % ( 95 % CI 15.6–41.0 ) vs. in the HCTZ group by 26.5 % ( 14.4–38.5 ) , and in the per protocol population in the Neb group by 26.4 % ( 13.4–39.4 ) vs. in the HCTZ group by 32.1 % ( 18.4–45.7 ) . Thus , noninferiority of Neb could neither be confirmed nor rejected . An increase of absolute claudication distance ( ACD , mean percentage increase after 24 weeks on Neb 15.8 ± 33.2 vs. on HCTZ 20.2 ± 46.6 ) was observed without statistical differences between groups . Ankle-brachial index ( ABI ) increased slightly in both groups . Generally , both treatments were well tolerated . Conclusion The increases in ICD , ACD and ABI with nebivolol suggest that this medication does not have negative effects on hypertensive patients with symptomatic PAD , and can be used for treatment of hypertension in these patients at high cardiovascular risk without reducing the walking ability In a six month placebo-controlled cross-over trial twenty patients with hypertension and peripheral arterial disease were r and omised to captopril 25 mg twice daily , atenolol 100 mg once daily , labetalol 200 mg twice daily , or pindolol 10 mg twice daily for one month . Although all treatments were equally effective at lowering blood pressure , pain-free and maximum walking distances on a treadmill were decreased by atenolol , labetalol , and pindolol , but not by captopril . Post-exercise calf blood flow availability was impaired by atenolol , labetalol , and pindolol , but not by captopril . Despite ancillary characteristics of cardioselectivity , intrinsic sympathomimetic activity , or combination with alpha-blockade , beta-blockers seem to impair the lower limb circulation in such patients , whereas captopril seems to preserve it , possibly by maintaining the collateral blood supply BACKGROUND Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results . This r and omised controlled trial , done in 190 hospitals in 23 countries , was design ed to investigate the effects of perioperative beta blockers . METHODS We r and omly assigned 8351 patients with , or at risk of , atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate ( n=4174 ) or placebo ( n=4177 ) , by a computerised r and omisation phone service . Study treatment was started 2 - 4 h before surgery and continued for 30 days . Patients , health-care providers , data collectors , and outcome adjudicators were masked to treatment allocation . The primary endpoint was a composite of cardiovascular death , non-fatal myocardial infa rct ion , and non-fatal cardiac arrest . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00182039 . FINDINGS All 8351 patients were included in analyses ; 8331 ( 99.8 % ) patients completed the 30-day follow-up . Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint ( 244 [ 5.8 % ] patients in the metoprolol group vs 290 [ 6.9 % ] in the placebo group ; hazard ratio 0.84 , 95 % CI 0.70 - 0.99 ; p=0.0399 ) . Fewer patients in the metoprolol group than in the placebo group had a myocardial infa rct ion ( 176 [ 4.2 % ] vs 239 [ 5.7 % ] patients ; 0.73 , 0.60 - 0.89 ; p=0.0017 ) . However , there were more deaths in the metoprolol group than in the placebo group ( 129 [ 3.1 % ] vs 97 [ 2.3 % ] patients ; 1.33 , 1.03 - 1.74 ; p=0.0317 ) . More patients in the metoprolol group than in the placebo group had a stroke ( 41 [ 1.0 % ] vs 19 [ 0.5 % ] patients ; 2.17 , 1.26 - 3.74 ; p=0.0053 ) . INTERPRETATION Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm , and the importance and need for large r and omised trials in the perioperative setting . Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol Twenty four male hypertensive patients suffering also from peripheral obstructive arterial disease were r and omly subdivided in two groups and after a period of farmacological wash-out of one month Group I was treated with Captopril ( C 50 mg bid ) or Ticlopidine ( T 250 mg bid ) for three months and then with the association C plus T for three months again . After placebo administration for one month , patients were further treated with C plus T at low doses ( 25 mg bid and respectively 250 mg daily ) . In the first part of the study , patients of Group II received an inverse sequence of the drugs ( before Ticlopidine 250 mg bid and then Captopril 50 bid ) . In both groups of patients C induced a significant decrease of blood pressure and an increase of PFWD , TWD , and WI . T did not modify blood pressure but slightly increased PFWD , TWD , and WI . The improvement was more evident during administration of C plus T , whereas placebo administration induced a trend toward baseline values . Finally , the chronic administration of C plus T for twelve months induced a further improvement of all considered parameters . In conclusion , chronic administration of C plus T may be useful in the treatment of hypertensive patients suffering from intermittent claudication , improving significantly PFWD and TWD Context Few therapies substantially reduce symptoms and improve exercise performance in patients with peripheral arterial disease ( PAD ) . Contribution In this double-blind trial , investigators r and omly assigned 40 older adults without diabetes and with symptomatic PAD to receive either ramipril or placebo , 10 mg once daily for 24 weeks . Compared with placebo , ramipril increased maximum and pain-free walking time and walking speed and distance . Caution s The trial was small and involved selected patients with limited mobility and exercise tolerance . Implication s Ramipril may improve symptoms in some patients with PAD . The Editors This article has been retracted . See Notice of Retraction . Peripheral arterial disease ( PAD ) is a common disorder , with 12 % of adults older than 50 years of age having an anklebrachial index ( ABI ) that is diagnostic of PAD ( < 0.9 ) ( 1 ) . Approximately one third of these patients experience intermittent claudication during walking , limiting normal activities . Medical treatments to improve walking distance are limited . The angiotensin-converting enzyme ( ACE ) inhibitor ramipril reduced cardiovascular morbidity and mortality compared with placebo in patients with established atherosclerotic disease , including PAD , in the Heart Outcomes Prevention Evaluation ( HOPE ) study ( 2 ) . This effect seemed to be independent of blood pressure reduction ( 3 ) and may relate to the known benefits of ACE inhibitors on both coronary and brachial endothelial function ( 4 ) . No previous controlled studies have investigated the effect of ACE inhibitors on symptoms of intermittent claudication . Given the positive effects of ramipril in the HOPE trial and its convenient once-daily dosing formulation , we hypothesized that therapy with ramipril would improve intermittent claudication symptoms . We aim ed to examine the effect of 6-month ramipril therapy on walking distance and claudication pain in a defined group of patients with claudication due to infrainguinal PAD by using a double-blind , r and omized , placebo-controlled design . Methods This article has been retracted . See Notice of Retraction . We screened 152 patients with PAD from general practice clinics in the Melbourne , Australia , metropolitan area ( Figure 1 ) . Of them , 40 patients ( mean age , 66 years [ SD , 4 ] ) were recruited and completed the trial . All patients gave written informed consent to participate in the study . The Ethics Committee of the Alfred Hospital , Melbourne , Australia , approved the study , and we performed the study in accordance with the Declaration of Helsinki 2000 . All participants had an ABI less than 0.9 at rest in at least 1 leg ; had a history of intermittent claudication ( unilateral or bilateral ) , which was stable for 6 months ; had evidence of superficial femoral artery stenosis or occlusion on duplex ultrasonography ; had blood pressure of 160 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

However , lack of data specifically examining outcomes in PAD patients should not detract from the overwhelming evidence on the benefit of treating hypertension and lowering blood pressure

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: AIMS AND OBJECTIVES To compare drug adherence to lipid-lowering therapy among out patients with coronary artery disease who received information via short message service , via short message service and Micro Letter , or via phone only . BACKGROUND Messaging applications and short message service are commonly used internationally . However , little is known about how coronary artery disease out patients in China may benefit from receiving health education through these technologies . DESIGN R and om sampling method . METHODS Data were collected from March-December 2013 . Subjects from Chengdu City , China , were r and omised to three groups : short message service , short message service + Micro Letter , and phone ( control ) . Appointment reminders and health information were delivered to patients in accordance with design ations . After six months , adherence to statin prescriptions was compared among the groups by using the Morisky Medication Adherence Scale . Logistic regression analysis was applied to determine those independent variables that were related to adherence . RESULTS The short message service and short message service + Micro Letter groups had better cumulative adherence ( lower Morisky Medication Adherence Scale scores ) after six months than phone group , and the short message service + Micro Letter group had better cumulative adherence ( lower Morisky Medication Adherence Scale scores ) than the short message service group . Female sex , older age and marriage show positive associations with adherence . CONCLUSIONS Short message service and messaging applications , such as Micro Letter , are effective means of providing discharged patients with reminders and coronary artery disease-related health information . Implementation of a short message service + Micro Letter program can improve outpatient adherence to medication . RELEVANCE TO CLINICAL PRACTICE This research offers useful information to help medical staff design effective interventions to improve medication compliance among coronary artery disease patients Background Effective use of proven treatments for high blood pressure , a preventable health risk , is challenging for many patients . Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment , though more research is needed on impact and patient perceptions of such support interventions , especially in low-re source setting s. Method An individually-r and omised controlled trial in a primary care clinic in Cape Town ( 2012–14 ) , tested the effect of an adherence support intervention delivered via SMS-texts , on blood pressure control and adherence to medication , for hypertensive patients . ( Trial registration : Clinical Trials.gov NCT02019823 ) . We report on a qualitative evaluation that explored the trial participants ’ experiences and responses to the SMS-text messages , and identified barriers and facilitators to delivering adherence support via patients ’ own mobile phones . Two focus groups and fifteen individual interviews were conducted . We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three research ers . Results Most participants were comfortable with the technology of using SMS-text messages . Messages were experienced as acceptable , relevant and useful to a broad range of participants . The SMS-content , the respectful tone and the delivery ( timing of reminders and frequency ) and the relational aspect of trial participation ( feeling cared for ) were all highly valued . A subgroup who benefitted the most , were those who had been struggling with adherence due to high levels of personal stress . The intervention appeared to coincide with their readiness for change , and provided practical and emotional support for improving adherence behaviour . Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility . Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours . Conclusion Adherence support for treatment of raised blood pressure , delivered via SMS-text message on the patient ’s own phone , was found to be acceptable , relevant and helpful , even for those who already had their own reminder systems in place . Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-re source operational setting , issues that future research should explore in greater depth Background Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities ( eg , hypertension , diabetes ) . These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients ’ physiological data . This technology is also relatively inexpensive , has an intuitive interface , and provides the capability for real-time personalized feedback to help motivate patient self-efficacy . Automated summary reports of patients ’ adherence and blood pressure can easily be uploaded to providers ’ networks helping reduce clinical inertia by reducing regimen alteration time . Objective The aim of this study was to assess the feasibility , acceptability , and preliminary outcomes of a prototype mobile health ( mHealth ) medication and blood pressure ( BP ) self-management system for kidney transplant patients with uncontrolled hypertension . Methods A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design . The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback . A 3-month proof-of-concept r and omized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray . Participants r and omized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging . Controls received st and ard of care and their adherence continued to be monitored with the medication tray reminders turned off . Providers received weekly summary reports of patient medication adherence and BP readings . Results Participation and retention rates were 41/55 ( 75 % ) and 31/34 ( 91 % ) , respectively . The prototype system appears to be safe , highly acceptable , and useful to patients and providers . Compared to the st and ard care control group ( SC ) , the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations . Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the st and ard care group ( 7 adjustments in 5 patients versus 3 adjustments in 3 patients ) during the 3-month trial based on the information provided in the weekly reports . Conclusions These data support the acceptability and feasibility of the prototype mHealth system . Further trials with larger sample sizes and additional biomarkers ( eg , whole blood medication levels ) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods . Trial Registration Clinical trials.gov NCT01859273 ; http:// clinical trials.gov/ct2/show/NCT01859273 ( Archived by WebCite at http://www.webcitation.org/6IqfCa3A3 ) Background The effectiveness of mobile technology to improve medication adherence via customized Short Messaging Service ( SMS ) reminders for stroke has not been tested in re source poor areas . We design ed a r and omized controlled trial to test the effectiveness of SMS on improving medication adherence in stroke survivors in Pakistan . Methods This was a parallel group , assessor-blinded , r and omized , controlled , superiority trial . Participants were central ly r and omized in fixed block sizes . Adult participants on multiple medications with access to a cell phone and stroke at least 4 weeks from onset ( Onset as defined by last seen normal ) were eligible . The intervention group , in addition to usual care , received reminder SMS for 2 months that contained a ) Personalized , prescription tailored daily medication reminder(s ) b ) Twice weekly health information SMS . The Health Belief Model and Social Cognitive theory were used to design the language and content of messages . Frontline SMS software was used for SMS delivery . Medication adherence was self-reported and measured on the vali date d Urdu version of Morisky Medication Adherence Question naire . Multiple linear regression was used to model the outcome against intervention and other covariates . Analysis was conducted by intention-to-treat principle . Results Two hundred participants were enrolled . 38 participants were lost to follow-up . After 2 months , the mean medication score was 7.4 ( 95 % CI : 7.2–7.6 ) in the intervention group while 6.7 ( 95 % CI : 6.4–7.02 ) in the control group . The adjusted mean difference ( Δ ) was 0.54 ( 95 % CI : 0.22–0.85 ) . The mean diastolic blood pressure in the intervention group was 2.6 mmHg ( 95 % CI ; −5.5 to 0.15 ) lower compared to the usual care group . Conclusion A short intervention of customized SMS can improve medication adherence and effect stroke risk factors like diastolic blood pressure in stroke survivors with complex medication regimens living in re source poor areas .Trial registration Clinical trials.gov NCT01986023 last accessed at https:// clinical Background : Medication non-adherence leads to a vast range of negative outcomes in patients with coronary artery disease . An automated web-based system managing short message service ( SMS ) reminders is a telemedicine approach to optimise adherence among patients who frequently forget to take their medications or miss the timing . Aim : This paper sought to investigate the effect of automated SMS-based reminders on medication adherence in patients after hospital discharge following acute coronary syndrome ( ACS ) . Methods : An interventional study was conducted at a tertiary teaching hospital in Malaysia . A total of 62 patients with ACS were equally r and omised to receive either automated SMS reminders before every intake of cardiac medications or only usual care within eight weeks after discharge . The primary outcome was adherence to cardiac medications . Secondary outcomes were the heart functional status , and ACS-related hospital readmission and death rates . Results : There was a higher medication adherence level in the intervention group rather than the usual care group , ( χ2 (2)=18.614 , p<0.001 ) . The risk of being low adherent among the control group was 4.09 times greater than the intervention group ( relative risk = 4.09 , 95 % confidence interval ( CI ) 1.82–9.18 ) . A meaningful difference was found in heart functional status between the two study groups with better results among patients who received SMS reminders , ( χ2 ( 1 ) = 16.957 , p<0.001 ) . Conclusion : An automated SMS-based reminder system can potentially enhance medication adherence in ACS patients during the early post-discharge period Patient adherence to immunosuppressive medications adherence is crucial to survival of the patient and a transplanted kidney , yet adherence is variable . Using a prospect i ve , descriptive design , immunosuppressive medication adherence of 44 renal transplant recipients was followed for 6 months at a Midwestern transplant center using electronic monitoring . Four medication adherence patterns emerged from a hierarchical cluster analysis : those who took medications on time , those who took medications on time with late/missed doses , those who rarely took medications on time and who were late with morning and /or evening doses , and those who missed doses . This study is a step toward developing and implementing interventions targeted to specific patterns of poor adherence OBJECTIVES Evaluate the utility of 2 electronic medical record (EMR)-linked , automated phone reminder interventions for improving adherence to cardiovascular disease medications . STUDY DESIGN A 1-year , parallel arm , pragmatic clinical trial in which 21,752 adults were r and omized to receive either usual care ( UC ) or 1 of 2 interventions in the form of interactive voice recognition calls-regular ( IVR ) or enhanced ( IVR+ ) . The interventions used automated phone reminders to increase adherence to cardiovascular disease medications . The primary outcome was medication adherence ; blood pressure and lipid levels were secondary outcomes . METHODS The study took place in 3 large health maintenance organizations . We enrolled participants who were 40 years or older , had diabetes mellitus or atherosclerotic cardiovascular disease , and were suboptimally adherent . IVR participants received automated phone calls when they were due or overdue for a refill . IVR+ participants received these phone calls , plus personalized reminder letters , live outreach calls , EMR-based feedback to their primary care providers , and additional mailed material s. RESULTS Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) compared with UC ( 1.6 to 3.7 percentage points ) . Adherence to ACEIs/ARBs was also significantly higher for IVR+ relative to IVR participants . These differences persisted across subgroups . Among statin users , IVR+ participants had significantly lower low-density lipoprotein ( LDL ) levels at follow-up compared with UC ( Δ = -1.5 ; 95 % CI , -2.7 to -0.2 mg/dL ) ; this effect was seen mainly in those with baseline LDL levels ≥ 100 mg/dL ( Δ = -3.6 ; 95 % CI , -5.9 to -1.3 mg/dL ) . CONCLUSIONS Technology-based tools , in conjunction with an EMR , can improve adherence to chronic disease medications and measured cardiovascular disease risk factors OBJECTIVE To evaluate medication adherence and treatment outcomes in elderly out patients using daily-dose blister packaging ( Pill Calendar ) compared with medications packaged in bottles of loose tablets . DESIGN R and omized controlled trial . SETTING Ambulatory care clinics at Ohio State OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Limitations of trials included small sample sizes , short duration of follow-up , self-reported outcomes , and insufficient assessment of unintended harms and financial implication s. Current evidence suggests that mHealth tools can improve medication adherence in patients with cardiovascular diseases .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Major Depression with Psychotic Features ( psychotic depression ) is a common , debilitating psychiatric disease . We hypothesized that mifepristone , a cortisol receptor ( GRII ) antagonist , would significantly reduce psychotic symptoms in psychotic depression . Two hundred fifty-eight patients with psychotic depression enrolled at 29 sites were r and omized to mifepristone or placebo for 7 days . The primary outcome was rapid and sustained response , defined as a 50 % or greater decrease in Brief Psychiatric Rating Scale - Positive Symptom Subscale scores at the end of treatment ( day7 ) and 49 days later ( day 56 ) . Cochran-Mantel-Haenszel compared proportions of responders to mifepristone versus placebo adjusting for site . Exploratory analyses compared response of patients with mifepristone plasma concentrations of > or = 1800 ng/ml to placebo . The primary endpoint was not statistically significant . However , the Breslow-Day test indicated a statistically significant site-by-treatment interaction . Mifepristone produced significantly higher response among the twenty sites who participated from the trial onset ( p<.05 ) , whereas no difference was observed at the nine sites added late in the trial . Patients with mifepristone plasma levels > or = 1800 ng/ml were significantly more likely to respond than placebo patients ( Intent-to-Treat : OR=2.4 , p=.03 ; Initial 20 sites : OR=4.1 , p=.002 ) . The results of this trial are instructive in two respects . First , while statistical adjustments for [ corrected ] site are common in multisite clinical trials , this study reminds trialists to formally evaluate the interaction of site by treatment . Second , the association between increased mifepristone plasma concentration levels and greater clinical response , detected despite the site-by-treatment interaction , suggests that higher plasma levels may be needed for maximizing the probability of a positive response Objective To compare the efficacy of imipramine and fluvoxamine in in patients from two centers suffering from a depressive disorder according to DSM IV criteria . Methods The study included 141 patients with a depressive disorder according to DSM IV criteria . After a drug-free and placebo run-in period of 1 week , patients were r and omized to imipramine or fluvoxamine ; doses of both drugs were adjusted to a predefined target blood level . Efficacy was evaluated 4 weeks after attaining predefined adequate plasma level . Results The mean age of the study group ( 47 males , 94 females ) was 51.8 ( range 19–65 ) years . Of these 141 patients , 56 had episode duration longer than 1 year , 48 had mood congruent psychotic features , and 138 patients received medication . Seven patients did not complete the medication trial . The total number of patients using concurrent medication was 12/138 ( 8.6 % ) . On the primary outcome criteria patients on imipramine improved significantly better on the change of illness severity score of the CGI ( χ2 exact trend test=4.089 , df=1 , P=0.048 ) . There was no significant difference in 50 % or more reduction on the HRSD , the other primary outcome criterion . On the secondary outcome criteria the mean reduction of the HRSD scores was significantly larger in the imipramine group than in the fluvoxamine group ( mean difference=3.1 , st and ard error (SE)=1.4 , t=2.15 , df=136 , P=0.033 ) . There was no significant difference in the number of patients with an HRSD ≤7 at the final evaluation . Conclusions In depressed in patients imipramine is more efficacious than fluvoxamine . Both drugs were well tolerated by all patients This article reports on the evidence for the validity of psychotic major depression as a distinct subtype based on cross-sectional and 1-year prospect i ve data from the Epidemiologic Catchment Area study . Consistent with findings from previous clinical studies , only about 14 % of major depressions were accompanied by psychotic features . Psychotic as compared with nonpsychotic depression had a more severe course , as reflected in increased risk of relapse , persistence over 1 year , suicide attempts , hospitalization , comorbidity , and financial dependency . These differences could not be explained by differences in demographic characteristics or by symptom severity , as assessed by symptom profile or number of symptoms . The boundary problem with schizophrenia and bipolar affective disorder that is seen in clinical studies was also found in this sample . To our knowledge , this is the first study to examine the validity of psychotic depression in a community sample ; the findings are consistent with those from clinical sample s. They support the clinical significance of psychotic depression and the continuation of its inclusion as a distinct subtype in DSM-IV The rationale for treating psychotic major depression with glucocorticoid receptor ( GR ) antagonists is review ed . Five patients with psychotic major depression were given 600 mg of mifepristone in a 4-day , double-blind , placebo-controlled crossover study . All the patients completed the protocol and adverse effects were not observed or reported . All of the five patients showed substantial improvements in their Hamilton Rating Scale for Depression scores while they were receiving mifepristone , and four of the five patients showed substantial improvement in their Brief Psychiatric Rating Scale scores . Little , if any , improvement was seen with placebo . These preliminary results suggest that short-term use of GR antagonists may be effective in the treatment of psychotic major depression and that additional study , perhaps using higher doses or more treatment days , seems warranted Patients with psychotic depression respond well when treated with a combination of an antidepressant and antipsychotic medication . We previously reported that they will respond in a similar fashion when treated with amoxapine monotherapy . There are few prospect i ve studies on the pharmacologic treatment response of psychotic depression subtypes . We treated 37 in patients , 21 with mood congruent ( MC ) psychotic depression and 16 with mood incongruent ( MI ) psychotic depression , in a r and omized double-blind fashion with either the combination of amitriptyline and perphenazine or with amoxapine for 4 weeks . Depression and psychosis ratings improved in a similar manner in both the MC or MI patients irrespective of medication treatment group . Global response rates were similar in the MI patients and MC patients . The data suggest that classifying psychotic depression into MC versus MI subtypes may have limited acute prognostic value in pharmacotherapy response rates High rates of attrition have been reported in r and omized controlled trials of patients with severe psychiatric illness , including psychotic depression ( MDpsy ) . The purpose of this study is to examine factors associated with overall attrition and with subtypes of attrition in the Study of the Pharmacotherapy of Psychotic Depression ( STOP-PD ) . Secondary analysis of data collected in a multi-site , r and omized , placebo-controlled trial . Clinical services of academic hospitals . Participants comprised 259 persons with MDpsy , aged 18 - 93 years . The intervention consisted of the r and om allocation to 12 weeks of treatment of either olanzapine plus sertraline or olanzapine plus placebo . Demographic and clinical variables associated with overall non-completion and sub-types of non-completion of r and omized treatment . One hundred and seventeen ( 45.2 % ) subjects did not complete 12 weeks of r and omized treatment . In a logistic regression analysis , inpatient entry status , olanzapine monotherapy , and higher cumulative medical burden were statistically significant independent predictors of overall non-completion . In a multinomial logistic regression model that examined predictors of subtypes of non-completion , subjects who entered the study as an inpatient were less likely to complete because of inadequate efficacy as determined by the investigator , and older subjects were less likely to complete because of poorer tolerability . Subjects who were assigned to olanzapine monotherapy , younger subjects , and subjects who entered the study as in patients were less likely to complete because of reasons other than efficacy or tolerability . Underst and ing factors that contribute to premature discontinuation in studies of MDpsy , and to the specific reasons for attrition , has the potential to improve the management of this disorder , as well as improve the design of future clinical trials of MDpsy Abstract : This prospect i ve study assessed the influence of resistance to antidepressant pharmacotherapy on the short-term response to subsequent electroconvulsive therapy ( ECT ) . Previous research has shown that patients with medication resistance were less likely to respond to ECT . This finding may be applicable to the population of depressed in patients in The Netherl and s , where ECT is often preceded by several medication trials . Eighty-five patients ( 61 female and 24 male patients ) with DSM-IV criteria for depressive disorder , both with and without mood congruent psychotic features , were included for analysis . Medication resistance was rated with the Antidepressant Treatment History Form . Medication resistance was predefined in accordance with the previous research in this field . When a reduction of at least 50 % on the 17-item version of the Hamilton Rating Scale for Depression ( HRSD ) between pre- and post-ECT is used as response criterion , medication-resistant patients were equally likely to respond to subsequent ECT ( 30/48 = 82.5 % ) than patients without medication resistance ( 30/37 = 81.1 % ) . Even when post-ECT HRSD score ≤7 was used ( full remission ) , there was no significant difference between medication-resistant patients ( 21/48 = 43.8 % ) and patients without medication resistance ( 15/37 = 40.5 % ) . When potential confounding variables were taken into account , these differences remain nonsignificant . In contrast to earlier research , medication resistance does not influence short-term response to subsequent ECT and it can still be of considerable efficacy Psychotic major depression ( PMD ) is found to be a relatively common psychiatric condition that affects up to nearly 20 % of patients with major depression . Previous studies by our group have shown rapid reversal of psychotic symptoms in some PMD patients treated with mifepristone , in addition to restoring a more normal afternoon cortisol release . The rationale for treating patients with PMD with a glucocorticosteroid receptor antagonist is further discussed . In total , 30 patients with PMD were treated with either 600 mg/day mifepristone or placebo for 8 days in a r and omized double-blind manner . The Hamilton Depression Rating Scale ( HDRS ) and the Brief Psychiatric Rating Scale ( BPRS ) were administered at baseline and again after 8 days of treatment . Cortisol and ACTH were measured hourly from 1800 to 0900 at baseline and after 8 days of treatment . Significantly , more patients in the mifepristone group ( seven of 15 ) showed a 50 % or greater decline on the BPRS positive symptom subscale , an index of psychotic symptoms , as compared to the placebo group ( two of 15 ) . Patients who received mifepristone had lower HDRS and BPRS scores at study completion compared to those who received placebo , but these differences were not statistically significant . In addition , mifepristone significantly elevated cortisol and ACTH levels and steepened ascending slopes from 1800 to 0100 and from 0100 to 0900 as compared to placebo . Clinical and biological effects of mifepristone were comparable among males and females . Age was found to significantly and positively correlate with changes in cortisol and ACTH . These results suggest that short-term use of mifepristone may be effective in the treatment of PMD and may re-regulate the HPA axis . Additional blinded studies are warranted The authors investigated the pharmacological treatment of delusional depression by assigning patients on a r and om double-blind basis to amitriptyline alone , perphenazine alone , or a combination of the two . Fourteen ( 78 % ) of the 18 patients assigned to amitriptyline plus perphenazine were responders , compared with seven ( 41 % ) of 17 patients treated with amitriptyline alone and three ( 19 % ) of the 16 patients treated with perphenazine alone . The combination of amitriptyline and perphenazine was clearly superior ( p less than .01 ) Preliminary open trials performed by the authors and others with Moclobemide , a new MAO-A inhibitor , indicated that the drug has a satisfactory antidepressant activity . In the present double-blind study Moclobemide has been compared to placebo in a group of 34 unipolar psychotic or neurotic depressed patients . The mean daily dose of Moclobemide was 297 mg and treatment lasted from two to four weeks . Drug effectiveness was measured by improvements in the Hamilton Rating Scale for Depression ( HRSD ) , Clinical Global Impression ( CGI ) and 100 mm Visual Analogue Scale ( VAS ) . The results have shown that the active drug was markedly superior to placebo . The mean total score of HRSD was reduced from 41.7 to 16.5 in 18 pts . treated with Moclobemide and from 36.3 to 29.1 in 16 pts . who received placebo . Self- assessment with VAS showed a mean reduction from 82.7 mm to 42.2 mm and from 84.3 to 70.6 mm respectively . Moderate to marked improvement was observed by the CGI in 15 cases treated with Moclobemide and mild to moderate in 5 cases who received placebo . The treatment was well tolerated Open-label studies and r and omized clinical trials have suggested that mifepristone may be effective for the treatment of major depression with psychotic features ( psychotic depression ) . A recent study reported a correlation between mifepristone plasma concentration and clinical response . The current study aim ed to evaluate the safety and OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Some evidence indicates that combination therapy with an antidepressant plus an antipsychotic is more effective than either treatment alone or placebo . Evidence is limited for treatment with an antidepressant alone or with an antipsychotic alone

MS2_fixed_5_shot214

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Depression is common and the efficacy of antidepressants is suboptimal . High plasma homocysteine has been consistently associated with depression , and treatment with certain B vitamins demonstrably reduces its concentration . AIMS To determine whether vitamins B6 , B12 and folic acid enhance response to antidepressant treatment over 52 weeks . METHOD R and omised , double-blind , placebo-controlled trial of citalopram ( 20 - 40 g ) together with 0.5 mg of vitamin B12 , 2 mg of folic acid and 25 mg of vitamin B6 for 52 weeks ( Australian and New Zeal and Clinical Trials Registry : 12609000256279 ) . Participants were community-dwelling adults aged 50 years or over with DSM-IV-TR major depression . We measured severity of symptoms with the Montgomery-Åsberg Depression Rating Scale ( MADRS ) . The primary outcome was remission of the depressive episode after 12 , 26 and 52 weeks . Secondary outcomes included reduction of MADRS scores over time and relapse of major depression after recovery by week 12 . Results In total , 153 people were r and omised ( 76 placebo , 77 vitamins ) . Remission of symptoms was achieved by 78.1 and 79.4 % of participants treated with placebo and vitamins by week 12 ( P = 0.840 ) , by 76.5 and 85.3 % at week 26 and 75.8 and 85.5 % at week 52 ( effect of intervention over 52 weeks : odds ratio ( OR ) = 2.49 , 95 % CI 1.12 - 5.51 ) . Group differences in MADRS scores over time were not significant ( P = 0.739 ) . The risk of subsequent relapse among those who had achieved remission of symptoms at week 12 was lower in the vitamins than placebo group ( OR = 0.33 , 95 % CI 0.12 - 0.94 ) . CONCLUSIONS B vitamins did not increase the 12-week efficacy of antidepressant treatment , but enhanced and sustained antidepressant response over 1 year . Replication of these findings would m and ate that treatment guidelines adopt the adjunctive use of B vitamins as a safe and inexpensive strategy to manage major depression in middle-aged and older adults Objective Major depression is a mood disorder that causes changes in physical activity , appetite , sleep and weight . Regarding the role of zinc in the pathology of depression , the present study was aim ed to investigate the effects of zinc supplementation in the treatment of this disease . Methods This study was a double-blind r and omized clinical trial . Forty four patients with major depression were r and omly assigned to groups receiving zinc supplementation and placebo . Patients in Zinc group received daily supplementation with 25 mg zinc adjunct to antidepressant ; Selective Serotonin Reuptake Inhibitors ( SSRIs ) , while the patients in placebo group received placebo with antidepressants ( SSRIs ) for twelve weeks . Severity of depression was measured using the Beck Depression Inventory at baseline and was repeated at the sixth and twelfth weeks . ANOVA with repeated measure was used to compare and track the changes during the study . Results The mean score of Beck test decreased significantly in the zinc supplement group at the end of week 6 ( P < 0.01 ) and 12 ( P < 0.001 ) compared to the baseline . The mean score of Beck Depression Inventory reduced significantly compared to the placebo group at the end of 12th week ( P < 0.05 ) Conclusion The results of the present study indicate that zinc supplementation together with SSRIs antidepressant drug improves major depressive disorders more effectively in patients with placebo plus antidepressants ( SSRIs ) BACKGROUND Epidemiological evidence supports a relationship between vitamin D and mental well-being , although evidence from large-scale placebo-controlled intervention trials is lacking . AIMS To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women ; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms ; and if there is an association between serum 25-hydroxyvitamin D levels and mental health . METHOD A double-blind , r and omised , placebo-controlled trial of women aged 70 or older ( the Vital D Study : IS RCT N83409867 and ACTR12605000658617 ) . Participants were r and omly assigned to receive 500 000 IU vitamin D(3 ) ( cholecalciferol ) orally or placebo every autumn/winter for 3 - 5 consecutive years . The tools utilised at various time points were the General Health Question naire , the 12-item Short Form Health Survey , the Patient Global Impression-Improvement scale and the WHO Well-Being Index . Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants . RESULTS In this non- clinical population , no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health . Serum 25-hydroxyvitamin D levels in the vitamin D group were 41 % higher than the placebo group 12 months following their annual dose . Despite this difference , scores from the question naires did not differ . Furthermore , there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups . CONCLUSIONS The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D(3 ) is a practical intervention to prevent depressive symptoms in older community-dwelling women Patients with depression have been extensively reported to be associated with the abnormality of omega-3 polyunsaturated fatty acids ( PUFAs ) , including significantly low eicosapentaenoic acid and docosahexaenoic acid in cell tissue contents ( red blood cell membrane , plasma , etc . ) and dietary intake . However , more evidence is needed to support its relation . In this study , we conducted an 8-week , double-blind , placebo-controlled trial , comparing omega-3 PUFAs ( 6.6 g/day ) [ corrected ] with placebo , on the top of the usual treatment , in 28 patients with major depressive disorder . Patients in the omega-3 PUFA group had a significantly decreased score on the 21-item Hamilton Rating Scale for Depression than those in the placebo group ( P < 0.001 ) . From the preliminary findings in this study , omega-3 PUFAs could improve the short-term course of illness and were well tolerated in patients with major depressive disorder The efficacy of a deficit oriented add-on therapy with free amino acids in depressive patients treated with the antidepressant Remeron ® was evaluated . About 40 in- patients were investigated by a r and omised double-blind placebo-controlled study during 4 weeks . Plasma levels of 20 amino acids and measures of depression , suicidal behaviour and aggression were surveyed on admission and after a 4 weeks ’ therapy with Remeron ® plus an individualized amino acid mixture or placebo . The preparation of the amino acid mixture was based on an aminogram and consisted of essential amino acids plus vitamins and trace elements as co-factors for the amino acid metabolism . Patients of the experimental group showed a significantly better improvement of depression and a higher responder rate than those of the placebo group . The results suggest that oral application of a deficit oriented amino acid mixture can improve the therapeutic outcome of an antidepressant . Furthermore , lacking side effects of the amino acids result ing also in a better patient compliance may improve the benefit/risk ratio Controversy exists as to whether eicosapentaenoic acid ( EPA ) or docosahexaenoic acid ( DHA ) or both are responsible for the efficacy of n-3 polyunsaturated fatty acids in depression . We conducted a single-center , r and omized , double-blind , placebo-controlled , multi-arm , parallel-group trial , comparing the efficacy of EPA versus DHA as adjuvants to maintenance medication treatments for mild-to-moderate depression . Eighty-one mild-to-moderately depressed out patients were r and omly assigned to receive either 1g/d of EPA or DHA or placebo ( coconut oil ) for 12 weeks . The primary outcome measure was the 17-item Hamilton Depression Rating Scale ( HDRS ) final score in the modified intention-to-treat population , which comprised of all r and omized patients with at least 1 post-r and omization observation ( n=62 ; 61.3 % female ; mean age 35.1 ± 1.2 years ) . Allocated treatments were well tolerated . Although there was no significant difference between groups at baseline , patients in the EPA group showed a significantly lower mean HDRS score at study endpoint compared with those in the DHA ( p<0.001 ) or placebo ( p=0.002 ) groups . Furthermore , response to treatment ( defined as a ≥ 50 % decrease from the baseline HDRS score ) was only observed in 6 patients receiving EPA , while no one in any of DHA or placebo groups responded to treatment . Overall , these data suggest greater efficacy of EPA compared to DHA or placebo as an adjunctive treatment in mild-to-moderate depression . However , further , r and omized controlled trials are needed to support these findings One hundred and fifteen patients from 5 general practice s participated in a 12-week , double-blind study comparing L-tryptophan , amitriptyline , L-tryptophan-amitriptyline combination and placebo in the treatment of depression . Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo . Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups . Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active treatment groups , but this difference was not significant . Plasma amitriptyline and nortriptyline levels were similar in the amitriptyline and combined treatment groups . St and ard haematological and biochemical profiles did not alter significantly in any group , but mean heart rate was significantly increased in patients receiving amitriptyline . There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms CONTEXT Studies of depressed psychiatric patients have shown that antidepressant efficacy can be increased by augmentation with omega-3 fatty acids . OBJECTIVE To determine whether omega-3 improves the response to sertraline in patients with major depression and coronary heart disease ( CHD ) . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial . Between May 2005 and December 2008 , 122 patients in St Louis , Missouri , with major depression and CHD were r and omized . INTERVENTIONS After a 2-week run-in period , all patients were given 50 mg/d of sertraline and r and omized in double-blind fashion to receive 2 g/d of omega-3 acid ethyl esters ( 930 mg of eicosapentaenoic acid [ EPA ] and 750 mg of docosahexaenoic acid [ DHA ] ) ( n=62 ) or to corn oil placebo capsules ( n=60 ) for 10 weeks . MAIN OUTCOME MEASURES Scores on the Beck Depression Inventory ( BDI-II ) and the Hamilton Rating Scale for Depression ( HAM-D ) . RESULTS Adherence to the medication regimen was 97 % or more in both groups for both medications . There were no differences in weekly BDI-II scores ( treatment x time interaction = 0.02 ; 95 % confidence interval [ CI ] , -0.33 to 0.36 ; t(112 ) = 0.11 ; P = .91 ) , pre-post BDI-II scores ( placebo , 14.8 vs omega-3 , 16.1 ; 95 % difference-in-means CI , -4.5 to 2.0 ; t(116 ) = -0.77 ; P = .44 ) , or HAM-D scores ( placebo , 9.4 vs omega-3 , 9.3 ; 95 % difference-in-means CI , -2.2 to 2.4 ; t(115 ) = 0.12 ; P = .90 ) . The groups did not differ on predefined indicators of depression remission ( BDI-II < or = 8 : placebo , 27.4 % vs omega-3 , 28.3 % ; odds ratio [ OR ] , 0.96 ; 95 % CI , 0.43 - 2.15 ; t(113 ) = -0.11 ; P = .91 ) or response ( > 50 % reduction in BDI-II from baseline : placebo , 49.0 % vs omega-3 , 47.7 % ; OR , 1.06 ; 95 % CI , 0.51 - 2.19 ; t(112 ) = 0.15 ; P = .88 ) . CONCLUSIONS Treatment of patients with CHD and major depression with sertraline and omega-3 fatty acids did not result in superior depression outcomes at 10 weeks , compared with sertraline and placebo . Whether higher doses of omega-3 or sertraline , a different ratio of EPA to DHA , longer treatment , or omega-3 monotherapy can improve OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Mixed results were found for zinc , folic acid , vitamin C , and tryptophan , with nonsignificant results for inositol . No major adverse effects were noted in the studies ( aside from minor digestive disturbance ) . A meta- analysis of adjunctive omega-3 versus placebo revealed a significant and moderate to strong effect in favor of omega-3 . Conversely , a meta- analysis of folic acid revealed a nonsignificant difference from placebo . Current evidence supports adjunctive use of SAMe , methylfolate , omega-3 , and vitamin D with antidepressants to reduce depressive symptoms

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE To evaluate the effectiveness of a program to increase walking to and from school . DESIGN A cluster r and omised controlled trial . SETTING 24 primary public schools in inner west Sydney , Australia . PARTICIPANTS 1996 students aged 10 - 12 years and their parents . INTERVENTION A two-year multi-component program included classroom activities , development of school Travel Access Guides , parent newsletters and improving environments with local councils . MEASURES Two measures were used : a survey completed by students on how they travelled to and from school over five days , and a survey completed by their parents on how their child travelled to and from school in a usual week . RESULTS The percentage of students who walked to and from school increased in both the intervention and control schools . Data from parent surveys found that 28.8 % of students in the intervention group increased their walking , compared with 19 % in the control group ( a net increase of 9.8 % , p=0.05 ) . However this effect was not evident in the student data . CONCLUSION The study produced a mixed result , with a high variation in travel patterns from school to school . Intervention research should address the complexity of multiple factors influencing student travel to school with a focus on changing local environments and parents ' travel to work BACKGROUND The aim of this study was to determine the impact of pedometer use and self-regulation strategies on adolescents ' daily physical activity . METHODS Junior high school students ( n=113 ) enrolled in seventh- and eighth- grade physical education classes ( 52 girls , 61 boys ) volunteered to participate in a 5-week study to assess daily step counts . Ten physical education classes were r and omly assigned to 1 of 3 groups : ( a ) self-regulation , ( b ) open , and ( c ) control . RESULTS A repeated- measures , mixed-model analysis of variance revealed a significant 3x4 ( Group by Time ) interaction effect , F6,290=2.64 , P<.02 . Follow-up analyses indicated participants in the self-regulation group took 2071 to 4141 more steps/d than the control . No other significant differences emerged among groups on step counts . CONCLUSIONS It appears that having access to and charting daily step counts ( ie , self-regulatory strategies ) positively influenced young adolescents to attain a higher number of steps/d Background Levels of physical activity ( PA ) in UK children are much lower than recommended and novel approaches to its promotion are needed . The Children , Parents and Pets Exercising Together ( CPET ) study is the first exploratory r and omised controlled trial ( RCT ) to develop and evaluate an intervention aim ed at dog-based PA promotion in families . CPET aim ed to assess the feasibility , acceptability and potential efficacy of a theory-driven , family-based , dog walking intervention for 9–11 year olds . Methods Twenty-eight families were allocated r and omly to either receive a 10-week dog based PA intervention or to a control group . Families in the intervention group were motivated and supported to increase the frequency , intensity and duration of dog walking using a number of behaviour change techniques . Parents in the intervention group were asked to complete a short study exit question naire . In addition , focus groups with parents and children in the intervention group , and with key stakeholders were undertaken . The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute ( cpm ) . Intervention and control groups were compared using analysis of covariance . Analysis was performed on an intention to treat basis . Results Twenty five families were retained at follow up ( 89 % ) and 97 % of all outcome data were collected at baseline and follow up . Thirteen of 14 ( 93 % ) intervention group parents available at follow up completed the study exit question naire and noted that study outcome measures were acceptable . There was a mean difference in child total volume of PA of 27 cpm ( 95 % CI -70 , 123 ) and -3 cpm ( 95 % CI -60 , 54 ) for intervention and control group children , respectively . This was not statistically significant . Approximately 21 % of dog walking time for parents and 39 % of dog walking time for children was moderate-vigorous PA . Conclusions The acceptability of the CPET intervention and outcome measures was high . Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable , but did not result in a significant increase in child PA in this exploratory trial . Trial registration IS RCT Objective To describe levels of physical activity , sedentary time and adherence to Chief Medical Officers ( CMO ) physical activity guidelines among primary school-aged children across the UK using objective accelerometer-based measurements . Design Nationally representative prospect i ve cohort study . Setting Children born across the UK , between 2000 and 2002 . Participants 6497 7-year-old to 8-year-old singleton children for whom reliable accelerometer data were available for at least 10 h a day for at least 2 days . Main outcome measures Physical activity in counts per minute ( cpm ) ; time spent in sedentary and moderate-to-vigorous intensity physical activity ( MVPA ) ; proportion of children meeting CMO guidelines ( ≥60 min/day MVPA ) ; average daily steps . Explanatory measures Gender , ethnicity , maternal current/most recent occupation , lone parenthood status , number of children in the household and country/region of residence . Results The median daily physical activity level was 595 cpm ( IQR 507 , 697 ) . Children spent a median of 60 min ( IQR 47–76 ) in MVPA/day and were sedentary for a median of 6.4 h/day ( IQR 6–7 ) . Only 51 % met CMO guidelines , with girls ( 38 % ) less active than boys ( 63 % ) . Children took an average of 10 229 ( 95 % CI ( 8777 to 11 775 ) ) steps each day . Children of Indian ethnicity were significantly less active overall than all other ethnic groups . Children of Bangladeshi origin and those living in Northern Irel and were least likely to meet CMO guidelines . Conclusions Only half of 7-year-old children in the UK achieve recommended levels of physical activity , with significant gender , ethnic and geographic variations . Longitudinal studies are needed to better underst and the relevance of these (in)activity patterns for long-term health and well-being . In the meantime population -wide efforts to boost physical activity among young people are needed which are likely to require a broad range of policy interventions Background To evaluate the impact of a walking school bus ( WSB ) program on student transport in a low-income , urban neighborhood . Methods The design was a controlled , quasi-experimental trial with consecutive cross-sectional assessment s. The setting was three urban , socioeconomically disadvantaged , public elementary schools ( 1 intervention vs. 2 controls ) in Seattle , Washington , USA . Participants were ethnically diverse students in kindergarten-5th grade ( aged 5–11 years ) . The intervention was a WSB program consisting of a part-time WSB coordinator and parent volunteers . Students ' method of transportation to school was assessed by a classroom survey at baseline and one-year follow-up . The Pearson Chi-squared test compared students transported to school at the intervention versus control schools at each time point . Due to multiple testing , we calculated adjusted p-values using the Ryan-Holm stepdown Bonferroni procedure . McNemar 's test was used to examine the change from baseline to 12-month follow-up for walking versus all other forms of school transport at the intervention or control schools . Results At baseline , the proportions of students ( n = 653 ) walking to the intervention ( 20 % + /- 2 % ) or control schools ( 15 % + /- 2 % ) did not differ ( p = 0.39 ) . At 12-month follow up , higher proportions of students ( n = 643 , p = 0.001 ) ) walked to the intervention ( 25 % + /- 2 % ) versus the control schools ( 7 % + /- 1 % ) . No significant changes were noted in the proportion of students riding in a car or taking the school bus at baseline or 12-month follow up ( all p > 0.05 ) . Comparing baseline to 12-month follow up , the numbers of students who walked to the intervention school increased while the numbers of students who used the other forms of transport did not change ( p < 0.0001 ) . In contrast , the numbers of students who walked to the control schools decreased while the numbers of students who used the other forms of transport did not change ( p < 0.0001 ) . Conclusion A WSB program is a promising intervention among urban , low-income elementary school students that may promote favorable changes toward active transport to school . Trial Registration Clinical Trials.gov PURPOSE This intervention compares the effectiveness of daily step count targets with time-based prescription for increasing the health-related physical activity of low-active adolescent girls . METHODS We assigned participants ( N = 85 , mean age 15.8 + /- 0.8 yr ) depending on school attended to a control ( CON ) , pedometer ( PED ) , or minutes ( MIN ) group . The intervention groups were involved in a 12-wk physical activity self-monitoring and educative program . The only difference between the intervention groups was that the PED group set daily step count targets whereas the MIN group set daily time-based goals for physical activity involvement . Pre- , mid- , and postintervention changes in physical activity ( 4-d blinded step count and 3-d physical activity recall ) and body mass index ( BMI ) were assessed using a series of 3 ( group assignment ) x 3 ( time ) ANOVA . Where significant interactions were found , separate follow-up simple main effects tests were used . RESULTS At postintervention , only the PED group had significantly increased their total activity as measured by a 4-d step count , when compared with the control ( P = 0.03 , ES = 0.13 ) . The group , time , and interaction effects for 4-d step count were significant , indicating that although both the participants in the PED and the MIN groups significantly increased their step count across the 12-wk intervention ( P = 0.00 - 0.01 ) , the participants in the PED group had a greater increase at the midintervention time point ( P = 0.04 , ES = 0.10 ) . No pre- , mid- , or postintervention changes were reported in any group for BMI ( F = 1.18 , P = 0.32 ) . CONCLUSION The use of pedometers and daily step count targets with low-active adolescent girls may result in short-term ( 6 wk ) enhanced physical activity related outcomes when compared with traditional time-based physical activity prescriptions . However , both interventions appear to result in similar improvements in physical activity when duration of the observation is extended to 12 wk PURPOSE To compare the effects of different patterns of regular brisk walking on fitness , risk factors for cardiovascular disease , and psychological well-being in previously sedentary adults . METHODS Twenty-one subjects ( 14 women ) , aged 44.5 + /- 6.1 yr ( mean + /- SD ) were r and omly assigned to two different , 6-wk programs of brisk walking in a cross-over design , with an interval of 2 wk . One program comprised one 30-min walk per day , 5 d.wk(-1 ) ( long bout ) and the other three 10-min walks per day , also 5 d.wk(-1 ) ( short bouts ) . All walking was at 70 - 80 % of predicted maximal heart rate . Maximal oxygen uptake ( (.)VO(2max ) ) , body composition , resting arterial blood pressure , fasting plasma lipoprotein variables , and psychological parameters were assessed before and after each program . RESULTS Overall , subjects completed 88.2 + /- 1.1 % and 91.3 + /- 4.1 % of prescribed total walking time in the short- and long-bout programs , respectively . Both programs increased plasma concentrations of high-density lipoprotein cholesterol , and decreased concentrations of triacylglycerol and total cholesterol ( all < 0.05 ) . There were no changes in body mass , but the sum of four skinfolds , waist circumference , and hip circumference were decreased after both walking programs ( all P<0.05 ) . Predicted (.)VO(2max ) increased with both programs ( P<0.05 ) , but this increase was greater with the program based on short bouts ( P<0.05 ) . Both walking patterns result ed in similar decreases in tension/anxiety ( P<0.05 ) . CONCLUSION These findings suggest that three short bouts ( 10 min ) of brisk walking accumulated throughout the day are at least as effective as one continuous bout of equal total duration in reducing cardiovascular risk and improving aspects of mood in previously sedentary individuals PURPOSE To derive a regression equation that estimates metabolic equivalent ( MET ) from accelerometer counts , and to define thresholds of accelerometer counts that can be used to delineate sedentary , light , moderate , and vigorous activity in adolescent girls . METHODS Seventy-four healthy 8th grade girls , age 13 - 14 yr , were recruited from urban areas of Baltimore , MD , Minneapolis/St . Paul , MN , and Columbia , SC , to participate in the study . Accelerometer and oxygen consumption (.-)VO(2 ) ) data for 10 activities that varied in intensity from sedentary ( e.g. , TV watching ) to vigorous ( e.g. , running ) were collected . While performing these activities , the girls wore two accelerometers , a heart rate monitor and a Cosmed K4b2 portable metabolic unit for measurement of (.-)VO(2 ) . A r and om-coefficients model was used to estimate the relationship between accelerometer counts and (.-)VO(2 ) . Activity thresholds were defined by minimizing the false positive and false negative classifications . RESULTS The activities provided a wide range OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Commonly employed behaviour change techniques within successful interventions included goals and planning , feedback and monitoring , social support and repetition and substitution . Conclusions Walking interventions , particularly those conducted in the school environment , have the potential to increase PA in children and adolescents . Conclusions on which interventions most effectively increased walking behaviours in this population were hindered by the limited number of identified interventions and the short duration of interventions evaluated .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Implantable cardioverter defibrillator ( ICD ) implantation is a common approach in patients at high risk of sudden cardiac death . To check for normal function , it is necessary to test the ICD . For this purpose , repetitive induction and termination of ventricular fibrillation by direct current shocks is required . This may lead to minor myocardial damage . Cardiac troponin T ( cTnT ) and I ( cTnI ) are specific markers for the detection of myocardial injury . Because these proteins usually are undetectable in healthy individuals , they are excellent markers for detecting minimal myocardial damage . The objective of this study was to evaluate the effect of defibrillation of induced ventricular fibrillation on markers of myocardial damage . METHODS This study included 14 patients who underwent ICD implantation and intraoperative testing . We measured cTnT , cTnI , creatine kinase MB ( CK-MB ) mass , CK activity , and myoglobin before and at definite times after intraoperative shock application . RESULTS Depending on the effectiveness of shocks and the energy applied , the cardiac-specific markers cTnT and cTnI , as well as CK-MB mass , showed a significant increase compared with the baseline value before testing and peaked for the most part 4 h after shock application . In contrast , the increases in CK activity and myoglobin were predominantly detectable in patients who received additional external shocks . CONCLUSIONS ICD implantation and testing leads to a short release of cardiac markers into the circulation . This release seems to be of cytoplasmic origin and depends on the number and effectiveness of the shocks applied BACKGROUND The implantable cardioverter-defibrillator ( ICD ) is highly effective in reducing mortality among patients at risk for fatal arrhythmias , but inappropriate ICD activations are frequent , with potential adverse effects . METHODS We r and omly assigned 1500 patients with a primary -prevention indication to receive an ICD with one of three programming configurations . The primary objective was to determine whether programmed high-rate therapy ( with a 2.5-second delay before the initiation of therapy at a heart rate of ≥200 beats per minute ) or delayed therapy ( with a 60-second delay at 170 to 199 beats per minute , a 12-second delay at 200 to 249 beats per minute , and a 2.5-second delay at ≥250 beats per minute ) was associated with a decrease in the number of patients with a first occurrence of inappropriate antitachycardia pacing or shocks , as compared with conventional programming ( with a 2.5-second delay at 170 to 199 beats per minute and a 1.0-second delay at ≥200 beats per minute ) . RESULTS During an average follow-up of 1.4 years , high-rate therapy and delayed ICD therapy , as compared with conventional device programming , were associated with reductions in a first occurrence of inappropriate therapy ( hazard ratio with high-rate therapy vs. conventional therapy , 0.21 ; 95 % confidence interval [ CI ] , 0.13 to 0.34 ; P<0.001 ; hazard ratio with delayed therapy vs. conventional therapy , 0.24 ; 95 % CI , 0.15 to 0.40 ; P<0.001 ) and reductions in all-cause mortality ( hazard ratio with high-rate therapy vs. conventional therapy , 0.45 ; 95 % CI , 0.24 to 0.85 ; P=0.01 ; hazard ratio with delayed therapy vs. conventional therapy , 0.56 ; 95 % CI , 0.30 to 1.02 ; P=0.06 ) . There were no significant differences in procedure-related adverse events among the three treatment groups . CONCLUSIONS Programming of ICD therapies for tachyarrhythmias of 200 beats per minute or higher or with a prolonged delay in therapy at 170 beats per minute or higher , as compared with conventional programming , was associated with reductions in inappropriate therapy and all-cause mortality during long-term follow-up . ( Funded by Boston Scientific ; MADIT-RIT Clinical Trials.gov number , NCT00947310 . ) OBJECTIVES The purpose of this study was to prospect ively examine the role of clinical , laboratory , echocardiographic , and electrophysiological variables as predictors of appropriate initial implantable cardioverter-defibrillator ( ICD ) therapy for ventricular tachycardia ( VT ) or ventricular fibrillation ( VF ) or death in the Multicenter Automatic Defibrillator Implantation Trial II ( MADIT-II ) population . BACKGROUND There is limited information regarding the determinants of appropriate ICD therapy in patients with reduced ventricular function after a myocardial infa rct ion . METHODS We used secondary analysis in one arm of a multicenter r and omized clinical trial in patients with a previous myocardial infa rct ion and reduced left ventricular function . RESULTS We analyzed baseline and follow-up data on 719 patients enrolled in the ICD arm of the MADIT-II study . Appropriate ICD therapy was observed in 169 subjects . Clinical , laboratory , echocardiographic , and electrophysiological variables , along with measures of clinical instability such as interim hospitalization for congestive heart failure ( IH-CHF ) and interim hospitalization for coronary events ( IH-CE ) , were examined with proportional hazards models and Kaplan-Meier time-to-event curves before and after first interim hospitalization . Interim hospitalization-CHF , IH-CE , no beta-blockers , digitalis use , blood urea nitrogen ( BUN ) > 25 , body mass index ( BMI ) > or = 30 kg/m2 , and New York Heart Association functional class > II were associated with increased risk for appropriate ICD therapy for VT , VF , or death . In a multivariate ( stepwise selection ) analysis , IH-CHF was associated with an increased risk for the end point of either VT or VF ( hazard ratio [ HR ] 2.52 , 95 % confidence interval [ CI ] 1.69 to 3.74 , p < 0.001 ) and for the combined end point of VT , VF , or death ( HR 2.97 , 95 % CI 2.15 to 4.09 , p < 0.001 ) . Interim hospitalization-CE was associated with an increased risk for VT , VF , or death ( HR 1.66 , 95 % CI 1.09 to 2.52 , p = 0.02 ) . CONCLUSIONS These results provide important mechanistic information , suggesting that worsening clinical condition and cardiac instability , as reflected by an IH-CHF or IH-CE , are subsequently associated with a significant increase in the risk for appropriate ICD therapy ( for VT/VF ) and death AIMS AND OBJECTIVE Outcome data of patients with implantable cardioverter defibrillators ( ICD ) and atrial fibrillation ( AF ) are conflicting . The German DEVICE registry aims to add further information on this particular cohort . METHODS AND RESULTS The German DEVICE registry is a nationwide prospect i ve multicenter data base of ICD implantations . 3261 patients are included ( 81 % males , 2701 ( 82.8 % ) first ICD implantations , 560 ( 17.2 % ) ICD replacements ) . Cardiac resynchronization therapy ( CRT-D ) was performed in 882 patients ( 27.0 % ) . Sinus rhythm ( SR ) was present in 2654 ( 81.4 % ) and atrial fibrillation ( AF ) in 607 ( 18.6 % ) . Left ventricular ejection fraction ( LVEF ) did not differ between groups ( SR 32.3 % , AF 30.4 % ; p = 0.09 ) . AF patients were older ( AF 70.9 versus SR 63.9 years ; p < 0.0001 ) , presented with more co-morbidities ( diabetes , hypertension , chronic kidney disease ; all p < 0.001 ) . In-hospital complications were not significantly different between groups ( p = 0.58 ) . Follow-up information after one year was available in 2967 patients ( 91 % ) . One-year overall mortality after first ICD implantation was 4.9 % for SR and 11.2 % for AF patients ( p < 0.0001 ) ; mortality one year after ICD replacement was 8.4 % for SR and 12.0 % for AF ( p = 0.34 ) . No statistically significant difference between SR and AF patients receiving a CRT device was observed ( SR 6.9 % , AF 10.7 % , p = 0.16 ) in terms of one-year mortality . CONCLUSION The German DEVICE registry demonstrates that patients with AF who receive ICD devices are older , have more co-morbidity and more severe heart failure . AF carries an independent 1.39 fold risk ( 95 % CI 1.02 - 1.89 ) of death after one year in patients only with first ICD implantation A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Atrial fibrillation history is statistically significantly associated with adverse major clinical outcomes in ICD-implanted HF patients . Patients with AF have a higher risk of all-cause mortality , appropriate , and inappropriate ICD interventions compared with patients with no AF history .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: PURPOSE Major primary care reforms have been introduced in recent years in the United Kingdom , including financial incentives to improve clinical quality and provide more rapid access to care . Little is known about the impact of these changes on patient experience . We examine patient reports of quality of care between 2003 and 2007 , including r and om sample s of patients on practice lists and patients with long-term conditions . METHODS We conducted a cross-sectional design study of family practice s in which question naires were sent to serial sample s of patients in 42 representative general practice s in Engl and . Question naires sent to sample s of patients with chronic disease ( asthma , angina , and diabetes ) and r and om sample s of adult patients ( excluding patients who reported any long-term condition ) in 2003 , 2005 , and 2007 addressed issues of access , communication , continuity of care , coordination , nursing care , and overall satisfaction . RESULTS There were no significant changes in quality of care reported by either group of patients between 2003 and 2007 for communication , nursing care , coordination , and overall satisfaction . Some aspects of access improved significantly for patients with chronic disease , but not for the r and om sample s of patients . Patients in both sample s reported seeing their usual physician less often and gave lower satisfaction ratings for continuity of care . Most scores were significantly higher for the chronic illness sample s than for the r and om sample s of patients in 2003 , even after adjusting for age . CONCLUSIONS There was a modest improvement in access to care for patients with chronic illness , but all patients now find it somewhat harder to obtain continuity of care . This outcome may be related to the incentives to provide rapid appointments or to the increased number of specialized clinics in primary care . The possibility of unintended effects needs to be considered when introducing pay for performance schemes Abstract Objectives : To assess variation in the quality of care in general practice and identify factors associated with high quality care . Design : Observational study . Setting : Stratified r and om sample of 60 general practice s in six areas of Engl and . Outcome measures : Quality of management of chronic disease ( angina , asthma in adults , and type 2 diabetes ) and preventive care ( rates of uptake for immunisation and cervical smear ) , access to care , continuity of care , and interpersonal care ( general practice assessment survey ) . Multiple logistic regression with multilevel modelling was used to relate each of the outcome variables to practice size , routine booking interval for consultations , socioeconomic deprivation , and team climate . Results : Quality of clinical care varied substantially , and access to care , continuity of care , and interpersonal care varied moderately . Scores for asthma , diabetes , and angina were 67 % , 21 % , and 17 % higher in practice s with 10 minute booking intervals for consultations compared with practice s with five minute booking intervals . Diabetes care was better in larger practice s and in practice s where staff reported better team climate . Access to care was better in small practice s. Preventive care was worse in practice s located in socioeconomically deprived areas . Scores for satisfaction , continuity of care , and access to care were higher in practice s where staff reported better team climate . Conclusions : Longer consultation times are essential for providing high quality clinical care . Good teamworking is a key part of providing high quality care across a range of areas and may need specific support if quality of care is to be improved . Additional support is needed to provide preventive care to deprived population s. No single type of practice has a monopoly on high quality care : different types of practice may have different strengths . What is already known on this topic Quality of care varies in virtually all aspects of medicine that have been studied Most studies look at quality of care from a single perspective or for a single condition What this study adds Quality of care varies for both clinical care and assessment s by patients of access and interpersonal care Practice s with longer booking intervals provide better management of chronic disease ; preventive care is less good in practice s in deprived areas No single type of practice has a monopoly on high quality care — small practice s provide better access but poorer diabetes care Good team climate reported by staff is associated with a range of aspects of high quality BACKGROUND Evidence from cost-effective smoking cessation programs is scarce . This study determined the cost-effectiveness of 3 smoking cessation strategies as provided by general practitioners ( GPs ) in Germany . METHODS In a cluster-r and omized smoking cessation trial , rates and intervention costs for 577 smoking patients of 82 GPs were followed up for 12 months . Three smoking cessation treatments were tested : ( 1 ) GP training plus GP remuneration for each abstinent patient , ( 2 ) GP training plus cost-free nicotine replacement medication and /or bupropion hydrochloride for the patient , and ( 3 ) a combination of both strategies . Smoking abstinence at 12 months was the primary outcome used to calculate incremental cost-effectiveness ratios and net monetary benefits . RESULTS Intervention 1 was not effective compared with treatment as usual ( TAU ) . Interventions 2 and 3 each proved to be cost-effective compared separately with TAU . When applying a 95 % level of certainty of cost-effectiveness against TAU , euro 9.80 or euro 6.96 , respectively , had to be paid for each additional 1 % of patients abstinent at 12 months ( maximum willingness to pay ) . That means that in intervention 2 , euro 92.12 per patient in the program must be invested to gain 1 additional quitter ( as opposed to euro 39.10 paid per patient during the trial ) . In intervention 2 , the cost was euro 82.82 , as opposed to euro 50.04 . Neither of these 2 cost-effective treatments proved to be superior to the other . The cost-effectiveness of both treatments was stable against TAU in sensitivity analyses . ( The exchange rate from October 1 , 2003 , was used ; euro1 = $ 1.17 . ) CONCLUSIONS Both treatments have a high potential to reduce smoking-related morbidity at a low cost . It is highly recommended that they be implemented as a routine service offered by GPs because in many countries , health insurance plans currently do not fund nicotine replacement therapy BACKGROUND Tobacco quitlines offer clinicians a means to connect their patients with evidence -based treatments . Innovative methods are needed to increase clinician referral . METHODS This is a clinic r and omized trial that compared usual care ( n = 25 clinics ) vs a pay-for-performance program ( intervention ) offering $ 5000 for 50 quitline referrals ( n = 24 clinics ) . Pay-for-performance clinics also received monthly up date s on their referral numbers . Patients were eligible for referral if they visited a participating clinic , were 18 years or older , currently smoked cigarettes , and intended to quit within the next 30 days . The primary outcome was the clinic 's rate of quitline referral ( ie , number of referrals vs number of smokers seen in clinic ) . RESULTS Pay-for-performance clinics referred 11.4 % of smokers ( 95 % confidence interval [ CI ] , 8.0%-14.9 % ; total referrals , 1483 ) compared with 4.2 % ( 95 % CI , 1.5%-6.9 % ; total referrals , 441 ) for usual care clinics ( P = .001 ) . Rates of referral were similar in intervention vs usual care clinics ( n = 9 ) with a history of being very engaged with quality improvement activities ( 14.1 % vs 15.1 % , respectively ; P = .85 ) . Rates were substantially higher in intervention vs usual care clinics with a history of being engaged ( n = 22 clinics ; 10.1 % vs 3.0 % ; P = .001 ) or less engaged ( n = 18 clinics ; 10.1 % vs 1.1 % ; P = .02 ) with quality improvement . The rate of patient contact after referral was 60.2 % ( 95 % CI , 49.7%-70.7 % ) . Among those contacted , 49.4 % ( 95 % CI , 42.8%-55.9 % ) enrolled , representing 27.0 % ( 95 % CI , 21.3%-32.8 % ) of all referrals . The marginal cost per additional quitline enrollee was $ 300 . CONCLUSION A pay-for-performance program increases referral to tobacco quitline services , particularly among clinics with a history of less engagement in quality improvement activities OBJECTIVE This study determined the effect of 2 financial incentives --- bonus and enhanced fee-for-service --- on documented immunization rates during a second period of observation . METHODS Incentives were given to 57 r and omly selected inner-city physicians 4 times at 4-month intervals based on the performance of 50 r and omly selected children . Coverage from linked records from all sources was determined for a sub sample of children within physician offices . RESULTS Up-to- date coverage rates documented in the charts increased significantly for children in the bonus group ( 49.7 % to 55.6 % ; P < .05 ) and the enhanced fee-for-service group ( 50.8 % to 58.2 % ; P < .01 ) compared with the control group . The number of immunizations given by these physicians did not change significantly , although the number of immunizations given by others and documented by physicians in the bonus group did increase ( P < .05 ) . Up-to- date coverage for all groups increased from 20 to 40 percentage points when immunizations from physician charts were combined with other sources . CONCLUSIONS Both financial incentives produced a significant increase in coverage levels . Increases were primarily due to better documentation not to better immunizing practice s. The financial incentives appeared to provide motivation to physicians but were not sufficient to overcome entrenched behavior patterns . However , true immunization coverage was substantially higher than that documented in the charts BACKGROUND This study tested the effects of two organizational support processes , the provision of financial incentives for superior clinical performance and the availability of a patient ( smoker ) registry and proactive telephone support system for smoking cessation , on provider adherence to accepted practice guidelines and associated patient outcomes . METHODS Forty clinics of a large multispecialty medical group practice providing primary care services were r and omly allocated to study conditions . Fifteen clinics each were assigned to the experimental conditions " control " ( distribution of printed versions of smoking cessation guidelines ) and " incentive " ( financial incentive pay-out for reaching preset clinical performance targets ) . Ten clinics were r and omized to receive financial incentives combined with access to a central ized patient registry and intervention system ( " registry " ) . Main outcome measures were adherence to smoking cessation clinical practice guidelines and patients ' smoking cessation behaviors . RESULTS Patients ' tobacco use status was statistically significant ( P < 0.01 ) more frequently identified in clinics with the opportunity for incentives and access to a registry than in clinics in the control condition . Patients visiting registry clinics accessed counseling programs statistically significantly more often ( P < 0.001 ) than patients receiving care in the control condition . Other endpoints did not statistically significantly differ between the experimental conditions . CONCLUSIONS The impact of financial incentives and a patient registry/intervention system in improving smoking cessation clinical practice s and patient behaviors was mixed . Additional research is needed to identify conditions under which such organizational support processes result in significant health care quality improvement and warrant the investment The study aim was to evaluate the impact of the experimental introduction of salaried contracts in Engl and on general practitioner ( GP ) behaviour and the quality of care . A controlled before- and -after design was implemented involving ten practice s of st and ard contract GPs , paid largely by capitation and fee-for-service , and ten salaried GP practice s. Diaries and routinely available data were used to assess GP workload , and patient assessment s of the quality of care were obtained by postal question naire . GPs in salaried practice s spent less time on practice administration but more working out-of-hours and in direct patient care , allowing more patients to be seen . Total list sizes were smaller in salaried compared with st and ard contract practice s , but lists per GP were higher because of staffing policies . Salaried GPs tended to provide shorter consultations compared with st and ard contract GPs , prescribe in fewer consultations , but referral rates were similar . Quality was rated as higher for seven out of thirteen aspects of care examined in salaried practice s and two in st and ard contract practice s. However , none of these differences were statistically significant . To conclude , salaried contracts did not adversely affect GP productivity and had little impact on other aspects of GP behaviour or the quality of care provided Objective : To evaluate new strategies to enhance the promotion of smoking cessation in general practice . Design : Cluster r and omised trial , 2 × 2 factorial design . Setting : 82 medical practice s in Germany , including 94 general practitioners . Participants : 577 patients who smoked at least 10 cigarettes per day ( irrespective of their intention to stop smoking ) and were aged 36–75 years . Interventions : Provision of a 2-h physician group training in smoking cessation methods and direct physician payments for every participant not smoking 12 months after recruitment ( TI , training+incentive ) ; provision of the same training and direct participant reimbursements for pharmacy costs associated with nicotine replacement therapy or bupropion treatment ( TM , training+medication ) . Main outcome measure : Self-reported smoking abstinence obtained at 12 months follow-up and vali date d by serum cotinine . Results : In intention-to-treat analysis , smoking abstinence at 12 months follow-up was 3 % ( 2/74 ) , 3 % ( 5/144 ) , 12 % ( 17/140 ) and 15 % OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Six of the seven studies showed positive but modest effects on quality of care for some primary outcome measures , but not all . The use of financial incentives to reward PCPs for improving the quality of primary healthcare services is growing . However , there is insufficient evidence to support or not support the use of financial incentives to improve the quality of primary health care .

MS2_fixed_5_shot218

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE To assess the serum level of 25 hydroxyvitamin D 25OHD among healthy Saudi Arabian women living in the eastern province . METHODS A cross-sectional r and omized study was conducted between February 1st 2008 and May 31st 2008 at the King Fahd University Hospital , Al-Khobar , Kingdom of Saudi Arabia in 200 Saudi women between 25 - 35 years group 1 and women of > or = 50 years group 2 . Clinical examination , laboratory tests , a complete blood picture , serum calcium , phosphorous , alkaline phosphatase , parathormone , and the serum levels of 25OHD levels were carried out . Data on lifestyle , dietary , and demographic question naires were collected . Vitamin D was defined as deficient with serum level < 50 nmol/L , insufficient between 52 - 72 nmol/L , and normal as 75nmol/L. RESULTS In group 1 , 70 % of women had normal 25OHD , and in women of group 2 , 45 % had normal levels of 25OHD . Alkaline phosphatase and parathormone levels were significantly higher in women with low vitamin D levels . Sun exposure and consumption of dairy products were minimal . CONCLUSION Vitamin D deficiency among healthy young Saudi women of 25 - 35 years was 30 % and 55 % in women of > or = 50 years . This study indicates that hypovitaminosis D is common in young and postmenopausal women . Efforts are require to augment and encouraged women for adequate exposure to sunlight and increased intake of fortified vitamin D products to maintain skeletal health Background : Calcium absorption is generally considered to be impaired under conditions of vitamin D deficiency , but the vitamin D status that fully normalizes absorption is not known for humans . Objective : To quantify calcium absorption at two levels of vitamin D repletion , using pharmacokinetic methods and commercially marketed calcium supplements . Design : Two experiments performed in the spring of the year , one year apart . In the first , in which participants were pretreated with 25-hydroxyvitamin D ( 25OHD ) , mean serum 25OHD concentration was 86.5 nmol/L ; and in the other , with no pretreatment , mean serum concentration was 50.2 nmol/L. Participants received 500 mg oral calcium loads as a part of a st and ard low calcium breakfast . A low calcium lunch was provided at mid-day . Blood was obtained fasting and at frequent intervals for 10 to 12 hours thereafter . Methods : Relative calcium absorption at the two 25OHD concentrations was estimated from the area under the curve ( AUC ) for the load-induced increment in serum total calcium . Results : AUC9 ( ± SEM ) , was 3.63 mg hr/dL ± 0.234 in participants pretreated with 25OHD and 2.20 ± 0.240 in those not pretreated ( P < 0.001 ) . In brief , absorption was 65 % higher at serum 25OHD levels averaging 86.5 nmol/L than at levels averaging 50 nmol/L ( both values within the nominal reference range for this analyte ) . Conclusions : Despite the fact that the mean serum 25OHD level in the experiment without supplementation was within the current reference ranges , calcium absorptive performance at 50 nmol/L was significantly reduced relative to that at a mean 25OHD level of 86 nmol/L. Thus , individuals with serum 25-hydroxyvitamin D levels at the low end of the current reference ranges may not be getting the full benefit from their calcium intake . We conclude that the lower end of the current reference range is set too low Summary This study aim ed to compare the vitamin D status in healthy Moroccan men and women aged 50 years and older . A total of 186 Moroccan women and 68 men , who had no previous diagnosis of osteoporosis , were recruited prospect ively . We found in this study a high prevalence of hypovitaminosis D with no difference between men and women . Purpose The main purpose of this study was to describe and compare the vitamin D status , parathormone , calcium , and phosphate of healthy Moroccan men and women aged 50 years and older . Methods We conducted two cross-sectional studies , in postmenopausal women from October 2008 to November 2009 and in men over 50 years old , from December 2009 to August 2010 . A total of 186 Moroccan women and 68 men , who had no previous diagnosis of osteoporosis , were recruited prospect ively . For the definition of hypovitaminosis D , the preferred level for 25-hydroxyvitamin D ( 25(OH)D ) insufficiency , which is now recommended by many experts , is 30 ng/mL ( 75 nmol/L ) , and the levels below 10 ng/ml ( 25 nmol/L ) indicate deficiency . Results The prevalence of vitamin D deficiency in men and women was 4.4 and 8.6 % , respectively , and the prevalence of vitamin D(25(OH ) D ) insufficiency in men and women were 85.2 and 77.4 % , respectively . In men and women , no correlations were found between intact parathormone ( PTHi ) and 25(OH ) D ( r = 0.056 ) . Conclusions Despite a sunny environment , we found in this study a high prevalence of hypovitaminosis D ( insufficiency + deficiency ) in Moroccan men over 50 years old and postmenopausal women INTRODUCTION Vitamin D status is considered as an important determinant of bone health but supplementation trials with vitamin D(3 ) have yielded conflicting results . The aim of this study was to investigate the associations between serum 25-hydroxyvitamin D ( 25-OH D ) , bone turnover markers , bone mineral density ( BMD ) , radius bone loss and incidence of fracture in postmenopausal women . METHODS 669 postmenopausal women ( mean age : 62.2 years ) belonging to a population -based cohort were followed prospect ively for a median of 11.2 years . At baseline , 25-OH D levels , BMD , bone turnover markers and clinical risk factors of osteoporosis were assessed . BMD loss at the radius was estimated by annual measurements of BMD and all incident fractures which occurred in 134 women were confirmed by radiographs . RESULTS 73 % and 35 % of women had serum 25-OH D levels below 75 and 50 nmol/l which correspond respectively to the median and lowest optimal values recently proposed for fracture prevention . 11 % of women had levels below 30 nmol/l . Serum 25-OH D correlated modestly with intact PTH ( r(2)=0.023 , p<0.0001 ) , but not with bone turnover markers or BMD at the hip and radius after adjustment for age . When levels of 25-OH D were considered as a continuous variable , there was no significant association between 25-OH D levels and radius BMD loss or fracture risk . After adjustment for age , there was no significant difference in incidence of fracture , BMD , radius BMD loss , bone turnover markers , grip strength and the percentage of fallers in the previous year between women with 25-OH D levels below or above 75 , 50 or 30 nmol/l . CONCLUSIONS In a population of home-dwelling healthy postmenopausal women with few of them with severe vitamin D deficiency , vitamin D status may not be an important determinant of bone health Objective : The aim of this study was to evaluate serum N-aminoterminal propeptide of type I collagen ( P1NP ) , C-terminal telopeptide of type I collagen ( & bgr;-CTX ) , and vitamin D status in healthy Chinese postmenopausal women . The study was also design ed to investigate their possible relationships with osteoporosis phenotypes . Methods : A community-based population of 1,724 postmenopausal women in Beijing was r and omly selected . Serum bone turnover markers and 25-hydroxyvitamin D [ 25(OH)D ] were tested by an automated Roche electrochemiluminescence system . Dual-energy x-ray absorptiometry was used to measure bone mineral density ( BMD ) . Results : The mean ( SD ) values of serum & bgr;-CTX and P1NP were 0.439 ( 0.210 ) and 56.7 ( 27.9 ) ng/mL , respectively . The 25(OH)D level of postmenopausal women in Beijing was remarkably low ( 13.2 ± 5.4 ng/mL ) . Serum & bgr;-CTX and P1NP levels were negatively correlated with BMDs of lumbar spine , femoral neck , and total hip ( all P < 0.01 ) . The cubic regression model better fitted the relationships of BMD and bone turnover markers . Serum & bgr;-CTX levels were significantly higher in women with sustained osteoporotic fracture or vertebral fracture ( P = 0.006 and 0.012 , respectively ) . No association between P1NP and fracture or vertebral fracture was detected . The same situation applied to 25(OH)D. 25(OH)D was negatively correlated with & bgr;-CTX and P1NP ( r = −0.073 and −0.088 , P = 0.002 and < 0.001 , respectively ) . Conclusions : Serum & bgr;-CTX and P1NP levels were negatively correlated with BMD . & bgr;-CTX was significantly higher in postmenopausal women with sustained fracture or vertebral fracture . Vitamin D deficiency was highly prevalent in postmenopausal women in Beijing There is an increase in the incidence of falls with aging and about 10 % of falls lead to fractures . Nearly all hip fractures are due to falls and hip fractures are the most severe of the osteoporotic fractures because they lead to a 20 % mortality rate and a loss of independent living in 50 % of cases . Although there are multiple factors associated with falls , our interest is the role that vitamin D metabolism plays in the pathogenesis of falls . Recent clinical trials show that both vitamin D and the metabolite calcitriol reduce the number of falls by 30 - 40 % in elderly subjects . This should also reduce the number of fractures . In European studies , the decrease in falls could be attributed to an improvement in the muscle weakness that often accompanies vitamin D deficiency . However , in the studies using calcitriol there was no vitamin D deficiency , so the mechanism of its efficacy is less clear . It could be due to increased muscle strength , an improvement in the neurological control of balance or both . Underst and ing these mechanisms would allow us to search for analogs of vitamin D that act more selectively on muscle and on the central nervous system Throughout evolution , exposure to sunlight and the photo synthesis of vitamin D(3 ) in the skin has been critically important for the evolution of l and vertebrates . During exposure to sunlight , the solar UVB photons with energies 290 - 315 nm are absorbed by 7-dehydrocholesterol in the skin and converted to previtamin D(3 ) . Previtamin D(3 ) undergoes a rapid transformation within the plasma membrane to vitamin D(3 ) . Excessive exposure to sunlight will not result in vitamin D intoxication because both previtamin D(3 ) and vitamin D(3 ) are photolyzed to several noncalcemic photoproducts . During the winter at latitudes above approximately 35 degrees , there is minimal , if any , previtamin D(3 ) production in the skin . Altitude also has a significant effect on vitamin D(3 ) production . At 27 degrees N in November , very little ( approximately 0.5 % ) previtamin D(3 ) synthesis was detected in Agra ( 169 m ) and Katm and u ( 1400 m ) . There was an approximately 2- and 4-fold increase in previtamin D(3 ) production at approximately 3400 m and at Everest base camp ( 5300 m ) , respectively . Increased skin pigmentation , application of a sunscreen , aging , and clothing have a dramatic effect on previtamin D(3 ) production in the skin . It is estimated that exposure in a bathing suit to 1 minimal erythemal dose ( MED ) is equivalent to ingesting between 10,000 and 25,000 IU of vitamin D(2 ) . The importance of sunlight for providing most humans with their vitamin D requirement is well documented by the seasonal variation in circulating levels of 25-hydroxyvitamin D [ 25(OH)D ] . Vitamin D deficiency [ i.e. , 25(OH)D < 20 ng/ml ] is common in both children and adults worldwide . Exposure to lamps that produce UVB radiation is an excellent source for producing vitamin D(3 ) in the skin and is especially efficacious in patients with fat malabsorption syndromes . The major cause of vitamin D deficiency globally is an underappreciation of sunlight 's role in providing humans with their vitamin D(3 ) requirement . Very few foods naturally contain vitamin D , and those that do have OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Neither latitude , region of the world , nor laboratory methodology were found to be associated with the prevalence of hypovitaminosis

MS2_fixed_5_shot219

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The effect of bone cement viscosity and cement mantle thickness on the migration of the Exeter total hip prosthesis was studied in a prospect i ve , r and omized , double-blind clinical Roentgen Stereophotogrammetric Analysis study . Forty-one cemented total hip arthroplasty in 39 patients were included and r and omized into a low/medium Simplex P cement group and a high-viscosity Simplex AF cement group . At time of stem introduction , 5 minutes after mixing , the Simplex AF was more viscous than Simplex P. No statistical difference existed between the 2 cement groups , for neither translation nor rotation migration data . Subsidence of the stem at 2-year follow-up was 1.1 + /- 0.56 mm for Simplex AF cement and 1.5 + /- 1.00 mm for Simplex P cement . The mean rotation of the acetabular components about the sagittal axis was 1.7 degrees + /- 3.8 degrees in the Simplex AF group and 0.7 degrees + /- 2.1 degrees for the Simplex P group . No effect of cement mantle thickness on migration of neither the acetabular cups nor the femoral stems was found . Although there were no differences in migration data for the cups and the stems , 2 acetabular cups in the Simplex AF group ( almost 10 % ) were revised because of mechanical loosening . Because of these findings , we suggest caution before using this new high-viscosity bone cement for fixation of acetabular components Background In uncemented total hip arthroplasty with hydroxyapatite coating , early weight bearing is frequently practice d but there is still not much evidence to support this recommendation . Method In a prospect i ve r and omized study we evaluated the effect of partial and full weight bearing after cementless total hip arthroplasty ( ABG ; Stryker-Howmedica ) using radiostereometric analysis ( RSA ) . Between February 1996 and February 2000 , 43 consecutive patients ( mean age 53 ( 41–63 ) years , 23 women ) with hip osteoarthrosis received an uncemented and hydroxyapatite-coated prosthesis with an anteverted stem . All patients were operated in a st and ardized way by three experienced surgeons and they were r and omized to partial ( P ) or full ( F ) weight bearing during the first 6 weeks after surgery . The patients in the partial weight bearing group were equipped with a pressuresensitive insole signaling when their load exceeded the prescribed weight limit . Results At 3-month follow-up , the mean proximal (+)/ distal ( - ) migration of the stem was -0.14 mm ( -1.93– 0.11 ) in group P and -0.31 mm ( -4.30–0.16 ) in group F ( p = 0.6 ) . At 1-year follow-up , the mean migration was –0.17 mm ( -2.18–0.21 ) and -0.28 mm ( -4.31–0.11 ) , respectively ( p = 0.9 ) . There was no significant difference in stem rotations either ( p < 0.2 ) . The cup translations , rotations , and femoral head penetration were similar in the two groups ( p < 0.1 ) . There were no re-operations during the first year . Interpretation We did not find any adverse effect of full weight bearing immediately after operation , which justifies use of this regimen after uncemented total hip arthroplasty of the ABG type One hundred consecutive ABG ( Anatomique Benoist Giraud , Howmedica ) hydroxyapatite-coated hip arthroplasties in 97 patients were evaluated prospect ively with a follow-up time of 4 to 10 years ( mean , 6 years ) . Clinical results were excellent with an improvement in the Merle d'Aubigne score from 9 preoperatively to 17.4 at 5 years . Thigh pain was persistent in only 3 % ; it was mild in nature and controlled with simple analgesics . Kaplan-Meyer survivorship analysis was 100 % for the femoral stem and 95 % for the acetabular cup at 6 years . Of concern was the high polyethylene wear measured with an average of 0.24 mm/y ( range , 0.05 - 0.76 mm/y ) 155 patients ( 171 hips ) with a mean age of 50 years ( 24 - 64 ) were r and omized to uncemented PCA ( 84 hips ) or Harris-Galante type I ( 87 hips ) total hip arthroplasty . Clinical and radiographic evaluations were done regularly . The improvements in the Harris hip and pain scores did not differ . Osteolysis developed in 5 PCA and 17 Harris-Galante hips . 13 hips in the PCA and 16 in the Harris-Galante ( HG ) group were revised because of mechanical failures and 1 hip ( HG ) because of infection after a mean follow-up of 9 years . Decreased 10-year survival rate , based on revision as end-point , was noted for the PCA ( 85 % ) , compared with the Harris-Galante cup ( 99 % ) . The corresponding survival rate of the PCA stem ( 96 % ) was higher than that observed for the Harris-Galante design ( 86 % ) . When radiographic failures were included , the survival rates of the 4 different components dropped to between 73 % and 94 % . These findings indicate that further revisions will be necessary and continuous radiographic follow-up is indicated to enable revision before severe bone destruction has occurred . Although the PCA and the Harris-Galante design s differed as regards the survival of the individual components , the overall clinical and radiographic survival rates of these cementless total hip arthroplasties were poor Surgery and other invasive therapies are complex interventions , the assessment of which is challenged by factors that depend on operator , team , and setting , such as learning curves , quality variations , and perception of equipoise . We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process . We also encourage the widespread use of prospect i ve data bases and registries . Reports of new techniques should be registered as a professional duty , anonymously if necessary when outcomes are adverse . Case series studies should be replaced by prospect i ve development studies for early technical modifications and by prospect i ve research data bases for later pre-trial evaluation . Protocol s for these studies should be registered publicly . Statistical process control techniques can be useful in both early and late assessment . R and omised trials should be used whenever possible to investigate efficacy , but adequate pre-trial data are essential to allow power calculations , clarify the definition and indications of the intervention , and develop quality measures . Difficulties in doing r and omised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems . Alternative prospect i ve design s , such as interrupted time series studies , should be used when r and omised trials are not feasible . Established procedures should be monitored with prospect i ve data bases to analyse outcome variations and to identify late and rare events . Achievement of improved design , conduct , and reporting of surgical research will need concerted action by editors , funders of health care and research , regulatory bodies , and professional societies In a prospect i ve study of 100 consecutive Wagner resurfacing hip arthroplasties in ninety-three patients , the outcomes for all hips were determined for an eight to ten-year follow-up period . By survivorship analysis , the rate of survival of the arthroplasty was calculated to be 70 per cent at five years , but only 40 per cent at eight years . The major cause of failure was aseptic loosening of the acetabular or femoral component , or both . Fracture of the neck of the femur occurred in three hips . Although the medium-term results ( at fifty-six to eighty-three months ) were better than those in most comparable studies of resurfacing arthroplasty , the poor long-term results ( at ninety-one to 118 months ) show that meaningful studies of new prosthetic design s must continue for at least eight years , and , if at all possible , must include 100 per cent follow-up . The survival curve for the resurfacing arthroplasties in this study can serve as the basis for comparison of the early , medium , and long-term results of future design s of resurfacing hip prostheses We report an independent prospect i ve review of the first 230 Birmingham hip resurfacings in 212 patients at a mean follow-up of five years ( 4 to 6 ) . Two patients , one with a loose acetabular component and the other with suspected avascular necrosis of the femoral head , underwent revision . There were two deaths from unrelated causes and one patient was lost to follow-up . The survivorship with the worst-case scenario was 97.8 % ( 95 % confidence interval 95.8 to 99.5 ) . The mean Harris hip score improved significantly ( paired t-test , p < 0.05 ) from 62.54 ( 8 to 92 ) pre-operatively to 97.7 ( 61 to 100 ) at a mean of three years ( 2.1 to 4.3 ) , then deteriorated slightly to a mean of 95.2 ( 47 to 100 ) at a mean of five years . The mean flexion improved from 91.5 degrees ( 25 degrees to 140 degrees ) to 110.4 degrees ( 80 degrees to 145 degrees ) at a mean of three years with no further improvement at five years ( 111.2 degrees ; 70 degrees to 160 degrees ) . On radiological review at five years , one patient had a progressive lucent line around the acetabular component and six had progressive lucent lines around the femoral component . A total of 18 femoral components ( 8 % ) had migrated into varus and those with lucent lines present migrated a mean of 3.8 degrees ( 1.02 degrees to 6.54 degrees ) more than the rest . Superolateral notching of the femoral neck and reactive sclerosis at the tip of the peg of the femoral component were associated with the presence of lucent lines ( chi-squared test , p < 0.05 ) , but not with migration of the femoral component , and are of unknown significance . Our results with the Birmingham hip resurfacing continue to be satisfactory at a mean follow-up of five years We evaluated the clinical and radiographic outcomes of 100 consecutive primary total hip arthroplasties in which a proximally coated anatomically design ed femoral component was fixed without cement for the treatment of primary osteoarthritis . The minimum duration of follow-up was six years ( average , 7.1 years ) . The eighty-eight patients who had the arthroplasties were followed prospect ively with a st and ard clinical evaluation that involved use of the Harris hip score and a radiographic evaluation based on the criteria of the Hip Society . Bone ingrowth was evaluated with the method of Engh et al. The average age of the patients at the time of the operation was 62.6 years ( range , thirty-nine to eighty-four years ) . Fifty-one patients were men and thirty-seven were women . The average preoperative Harris hip score was 48 points , with an average pain score of 15 points and an average function score of 26 points . Nonmechanical complications that necessitated a revision operation included one deep hematogenous infection , one late periprosthetic fracture , and a 0.5-inch ( 1.27-centimeter ) limb-length discrepancy . At the time of the most recent follow-up , the average Harris hip score was 96 points , with an average pain score of 42 points and an average function score of 45 points . The prevalence of pain in the anterior part of the thigh was 5 percent ( five hips ) . One patient had a revision of the femoral component because of aseptic loosening , and one had a revision of the acetabular component because of recurrent dislocations . Radiographic assessment revealed consistent evidence of proximal bone ingrowth . No complete radiolucent line was identified , except around the stem that had loosened . Twenty-seven femoral components were associated with slight pedestal formation . No osteolytic lesion of the femur was identified . Nonprogressive pelvic osteolysis was identified in four hips , but none of the lesions were more than two millimeters in diameter . None of the acetabular components migrated , and no radiolucent line of more than two millimeters in thickness was seen around any acetabular cup . The data from this study , in which the minimum duration of follow-up was six years , indicate that the anatomically design ed prosthesis can provide good results , with low prevalences of pain in the thigh and loosening of the component , in younger , active patients Two series of 100 consecutive primary total hip arthroplasties , each using a single design of noncemented or cemented femoral component ( all 28 mm heads ) , were compared . One cemented and two noncemented stems underwent revision for aseptic loosening . Of unrevised hips , outcome data statistically favored cemented , rather than noncemented , stems . The data for cemented and noncemented stems , respectively , were : An excellent to good result in 97 % versus 88 % ; thigh pain in 3 % versus 40 % ; subsidence in 0 % versus 22 % ; and endosteal cavitation in 6 % versus 12 % . For patients with 25 unrevised matched pairs , selected by gender , age , diagnosis , and weight , outcome data also statistically favored cemented over noncemented stems , respectively : an excellent or good result in 25 versus 20 hips ; thigh pain in two versus eight hips ; and subsidence in none versus six hips . Midterm followup data for these concurrent total hip arthroplasty series of a mid1980s design revealed prevalence of mechanical failure of 1 % for cemented stems OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

INTERPRETATION There was a clinical ly relevant association between early migration of acetabular cups and late revision due to loosening .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background The prevalent raise of type 2 diabetes ( T2D ) around the globe , are creating higher risk for cardiovascular diseases ( CVDs ) and increasing strain on each country ’s health care budget in the world . Microalbuminuria has appeared as a key parameter in diabetic patients . Microalbuminuria is also related to increased cardiovascular morbidity in people who are non-obese diabetic . Some studies have suggested that consumption of symbiotic foods might help improve the metabolic profile , inflammatory factors and biomarkers of oxidative stress . The aim of trial was to determine the effect of symbiotic supplementation on glycemic control , lipid profiles and microalbuminuria in non-obese T2D . Methods In this r and omized , double-blind , clinical ly controlled trial , 70 patients with T2D ( 28 females , 42 males ) were r and omly divided into two groups ( n = 35 for each group ) . The symbiotic group ( SG ) consumed 500 mg/d of symbiotic supplementations containing probiotics ( Lactobacillus family , Bifidobacterium family , Streptococus thermophilus ) , Prebiotics ( Fructo oligosaccharide ) and B group vitamins ( 1 mg ) , lactose ( 0.5 mg ) , malt-dextrin , magnesium saturate and the placebo group ( PG ) consumed capsules filled with row starch and also B group vitamins ( 1 mg ) , lactose ( 0.5 mg ) , malt-dextrin , magnesium saturate for 9 weeks . Fasting blood glucose ( FBG ) , hemoglobin A1c ( HbA1c ) , blood lipid profiles , 24-h dietary recalls , and anthropometric measurements were measured at the baseline and at the end of trial . SPSS software , version 16 was used to test the data and the results were expressed as mean ± st and ard deviation . Paired sample s T-Test were used to compare continuous variables within groups . Comparison between different groups was performed through two independent sample s T-Test . In the absence of normal distribution , the comparison between the groups was made using non-parametric Wilcoxon on signed ranks and Mann – Whitney tests . P values < 0.05 was considered significant . Results Symbiotic supplementation decreased significantly , FBG ( P = 0.05 ) and HbA1c ( P < 0.01 ) . There were no significant differences in lipid profiles within and between the groups at the end of study ( P > 0.05 ) . Microalbuminuria ( P < 0.05 ) and HbA1c ( P < 0.05 ) are increased significantly in PG at the end of the study . Furthermore , the mean changes of microalbuminuria and HbA1c experienced significant between the two groups . There was significant reduction in urea between two groups from baseline ( P = 0.051 ) . No significant changes in baseline were shown in creatinine among the two groups or within either groups ( P > 0.05 ) . Conclusion The consumption of 500 mg/d symbiotic supplementation for 9 weeks could improve the HbA1c , BMI and Microalbuminuria in T2D . Although , No effect has been indicated on FBS , lipid profiles , urea and creatinine . Trial Registration The trial has been registered in the Iranian Registry of Clinical Trials I RCT 2015072223284N1 , identifier . Registered 21 May 2016 “ retrospectively registered ” Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P < 0.05 ) , LDL cholesterol −0.84 versus −0.18 mmol/L ( P < 0.001 ) , CRP −2.9 versus −0.7 mg/L ( P < 0.05 ) , TNF-α −0.45 versus −0.12 ng/mL ( P < 0.001 ) , HOMA-IR −1.1 versus −0.6 ( P < 0.001 ) , serum endotoxin −45.2 versus −30.6 pg/mL ( P < 0.001 ) , steatosis ( P < 0.05 ) , and the NASH activity index ( P < 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index To our knowledge , no reports are available indicating the favorable effects of synbiotic bread consumption on blood lipid profiles among patients with type 2 diabetes mellitus ( T2DM ) . This study was conducted to evaluate the effects of the daily consumption of synbiotic bread on blood lipid profiles of patients with T2DM . This r and omized double-blinded controlled clinical trial was performed with 78 diabetic patients , aged 35–70 years . After a 2-week run-in period , subjects were r and omly assigned to consume either synbiotic ( n = 26 ) , probiotic ( n = 26 ) or control bread ( n = 26 ) for 8 weeks . The synbiotic bread contained viable and heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin ( HPX ) as prebiotic per 1 g. The probiotic bread contained L. sporogenes ( 1 × 108 CFU ) per 1 g. Patients were asked to consume the synbiotic , probiotic and control breads three times a day in a 40 g package for a total of 120 g/day . Biochemical measurements including blood lipid profiles were conducted before and after 8 weeks of intervention . Consumption of the synbiotic bread , compared to the probiotic and control breads , led to a significant decrease in serum TAG ( P = 0.005 ) , VLDL-C ( P = 0.005 ) , TC/HDL-C ( P = 0.002 ) and a significant increase in serum HDL-C levels ( P = 0.01 ) . No significant effect of synbiotic bread consumption on FPG , TC , LDL-C and non-HDL-C levels was seen compared to the probiotic and control breads ( P > 0.05 ) . Trial registry code : http://www.i rct .ir I RCT 201311215623N13 Background The consumption of foods containing probiotic and prebiotic ingredients is growing consistently every year , and in view of the limited number of studies investigating their effect in the elderly . Objective The objective of this study was to evaluate the effect of the consumption of a symbiotic shake containing Lactobacillus acidophilus , Bifidobacterium bifidum and fructooligosaccharides on glycemia and cholesterol levels in elderly people . Methods A r and omized , double-blind , placebo-controlled study was conducted on twenty volunteers ( ten for placebo group and ten for symbiotic group ) , aged 50 to 60 years . The criteria for inclusion in the study were : total cholesterol > 200 mg/dL ; triglycerides > 200 mg/dL and glycemia > 110 mg/dL. Over a total test period of 30 days , 10 individuals ( the symbiotic group ) consumed a daily dose of 200 mL of a symbiotic shake containing 108 UFC/mL Lactobacillus acidophilus , 108 UFC/mL Bifidobacterium bifidum and 2 g oligofructose , while 10 other volunteers ( the placebo group ) drank daily the same amount of a shake that did not contain any symbiotic bacteria . Blood sample s were collected 15 days prior to the start of the experiment and at 10-day intervals after the beginning of the shake intake . The st and ard lipid profile ( total cholesterol , triglycerides and HDL cholesterol ) and glycemia , or blood sugar levels , were evaluated by an enzyme colorimetric assay . Results The results of the symbiotic group showed a non-significant reduction ( P > 0.05 ) in total cholesterol and triglycerides , a significant increase ( P < 0.05 ) in HDL cholesterol and a significant reduction ( P < 0.05 ) in fasting glycemia . No significant changes were observed in the placebo group . Conclusion The consumption of symbiotic shake result ed in a significant increase in HDL and a significant decrease of glycemia . Trial Registration Clinical Trials.gov : Nonalcoholic fatty liver disease is the most prevalent chronic liver disease in Western countries ; it can progress to nonalcoholic steatohepatitis ( NASH ) , cirrhosis and hepatocarcinoma . The importance of gut-liver-adipose tissue axis has become evident and treatments targeting gut microbiota may improve inflammatory and metabolic parameters in NASH patients . In a r and omized , controlled clinical trial , involving 50 biopsy-proven NASH patients , we investigated the effects of synbiotic supplementation on metabolic parameters , hepatic steatosis , intestinal permeability , small intestinal bacterial overgrowth ( SIBO ) and lipopolysaccharide ( LPS ) serum levels . Patients were separated into two groups receiving Lactobacillus reuteri with guar gum and inulin for three months and healthy balanced nutritional counseling versus nutritional counseling alone . Before and after the intervention we assessed steatosis by magnetic resonance imaging , intestinal permeability by lactulose/mannitol urinary excretion and SIBO by glucose breath testing . NASH patients presented high gut permeability , but low prevalence of SIBO . After the intervention , only the synbiotic group presented a reduction in steatosis , lost weight , diminished BMI and waist circumference measurement . Synbiotic did not improve intestinal permeability or LPS levels . We concluded that synbiotic supplementation associated with nutritional counseling seems superior to nutritional counseling alone for NASH treatment as it attenuates steatosis and may help to achieve weight loss Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background : Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Oral administration of symbiotic and Vitamin E has been proposed as an effective treatment in NAFLD patients . This study was carried out to assess the effects of symbiotic and /or Vitamin E supplementation on liver enzymes , leptin , lipid profile , and some parameters of insulin resistance ( IR ) in NAFLD patients . Material s and Methods : We r and omly assigned sixty NAFLD adult patients to receive ( 1 ) symbiotic twice daily + Vitamin E-like placebo capsule ; ( 2 ) 400 IU/d Vitamin E + symbiotic-like placebo ; ( 3 ) symbiotic twice daily + 400 IU/d Vitamin E ; and ( 4 ) symbiotic-like placebo + Vitamin E-like placebo for 8 weeks . Results : Symbiotic plus Vitamin E supplementation led to a significant decrease in concentrations of liver transaminase ( P ≤ 0.05 ) . Mean difference of apolipoprotein A-1 was more significant in symbiotic group compared to control . However , mean difference of apolipoprotein B100/A-1 was only significant in symbiotic group compared to control . At the end of the study , significant differences in total cholesterol ( TC ) and low-density lipoprotein cholesterol ( LDL-C ) were seen between the symbiotic plus Vitamin E and control groups ( P < 0.001 ) . Furthermore , intake of symbiotic plus Vitamin E supplements led to a significant decrease in concentrations of triglycerides ( TG ) after the OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The effects are more pronounced when synbiotics supplements are consumed for > 8 weeks . Synbiotic supplements may be beneficial to improve lipid profile , especially when they are consumed for > 8 weeks

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Extraction socket remodeling and ridge preservation strategies have been extensively explored . PURPOSE To evaluate the efficacy of applying a micro-titanium stent as a pressure bearing device on extraction socket remodeling of maxillary anterior tooth . MATERIAL S AND METHODS Twenty-four patients with a extraction socket of maxillary incisor were treated with spontaneous healing ( control group ) or by applying a micro-titanium stent as a facial pressure bearing device over the facial bone wall ( test group ) . Two virtual models obtained from cone beam computed tomography data before extraction and 4 months after healing were 3-dimenionally superimposed . Facial bone wall resorption , extraction socket remodeling features and ridge width preservation rate were determined and compared between the groups . RESULTS Thin facial bone wall result ed in marked resorption in both groups . The greatest palatal shifting distance of facial bone located at the coronal level in the control group , but middle level in the test group . Compared with the original extraction socket , 87.61 ± 5.88 % ridge width was preserved in the test group and 55.09 ± 14.46 % in the control group . CONCLUSIONS Due to the facial pressure bearing property , the rigid micro-titanium stent might preserve the ridge width and alter the resorption features of extraction socket BACKGROUND Tooth extraction typically leads to loss of ridge width and height . The primary aim of this 6-month r and omized , controlled , blinded , clinical study was to determine whether ridge preservation would prevent post- extraction resorptive changes as assessed by clinical and histologic parameters . METHODS Twenty-four patients , 10 males and 14 females , aged 28 to 76 ( mean 51.5 + /- 13.6 ) , requiring a non-molar extraction and delayed implant placement were r and omly selected to receive either extraction alone ( EXT ) or ridge preservation ( RP ) using tetracycline hydrated freeze-dried bone allograft ( FDBA ) and a collagen membrane . A replaced flap , which did not completely cover the sockets , was used . Following extraction , horizontal and vertical ridge dimensions were determined using a modified digital caliper and an acrylic stent , respectively . Prior to implant placement , a 2.7 x 6.0 mm trephine core was obtained and preserved in formalin for histologic analysis . RESULTS The width of the RP group decreased from 9.2 + /- 1.2 mm to 8.0 + /- 1.4 mm ( P<0.05 ) , while the width of the EXT group decreased from 9.1 + /- 1.0 mm to 6.4 + /- 2.2 mm ( P<0.05 ) , a difference of 1.6 mm . Both the EXT and RP groups lost ridge width , although an improved result was obtained in the RP group . Most of the resorption occurred from the buccal ; maxillary sites lost more width than m and ibular sites . The vertical change for the RP group was a gain of 1.3 + /- 2.0 mm versus a loss of 0.9 + /- 1.6 mm for the EXT group ( P<0.05 ) , a height difference of 2.2 mm . Histologic analysis revealed more bone in the RP group : about 65 + /- 10 % versus 54 + /- 12 % in the EXT group . The RP group included both vital bone ( 28 % ) and non-vital ( 37 % ) FDBA fragments . CONCLUSIONS Ridge preservation using FDBA and a collagen membrane improved ridge height and width dimensions when compared to extraction alone . These dimensions may be more suitable for implant placement , especially in areas where loss of ridge height would compromise the esthetic result . The quantity of bone observed on histologic analysis was slightly greater in preservation sites , although these sites included both vital and non-vital bone . The most predictable maintenance of ridge width , height , and position was achieved when a ridge preservation procedure was employed OBJECTIVE This systematic review aims to evaluate the scientific evidence on the efficacy in the surgical protocol s design ed for preserving the alveolar ridge after tooth extraction and to evaluate how these techniques affect the placement of dental implants and the final implant supported restoration . MATERIAL AND METHODS A thorough search in MEDLINE - PubMed , Embase and the Cochrane Central Register of controlled trials ( CENTRAL ) was conducted up to February 2011 . R and omized clinical trials and prospect i ve cohort studies with a follow-up of at least 3 months reporting changes on both the hard and soft tissues ( height and /or width ) of the alveolar process ( mm or % ) after tooth extraction were considered for inclusion . RESULTS The screening of titles and abstract s result ed in 14 publications meeting the eligibility criteria . Data from nine of these 14 studies could be grouped in the meta-analyses . Results from the meta-analyses showed a statistically significant greater ridge reduction in bone height for control groups as compared to test groups ( weighted mean differences , WMD = -1.47 mm ; 95 % CI [ -1.982 , -0.953 ] ; P < 0.001 ; heterogeneity : I(2 ) = 13.1 % ; χ(2 ) P-value = 0.314 ) and a significant greater reduction in bone width for control groups compared to the test groups ( WMD = -1.830 mm ; 95 % CI [ -2.947 , -0.732 ] ; P = 0.001 ; heterogeneity : I(2 ) = 0 % ; χ(2 ) P-value = 0.837 ) . Subgroup analysis was based on the surgical protocol used for the socket preservation ( flapless/flapped , barrier membrane/no membrane , primary intention healing/no primary healing ) and on the measurement method utilized to evaluate morphological changes . Meta-regression analyses demonstrated a statistically significant difference favoring the flapped subgroup in terms of bone width ( meta-regression ; slope = 2.26 ; 95 % IC [ 1.01 ; 3.51 ] ; P = 0.003 ) . CONCLUSIONS The potential benefit of socket preservation therapies was demonstrated result ing in significantly less vertical and horizontal contraction of the alveolar bone crest . The scientific evidence does not provide clear guidelines in regards to the type of bio material , or surgical procedure , although a significant positive effect of the flapped surgery was observed . There are no data available to draw conclusions on the consequences of such benefits on the long-term outcomes of implant therapy OBJECTIVE To evaluate dimensional alterations of the alveolar ridge that occurred following tooth extraction at sites grafted with Bio-Oss ( ® ) Collagen . MATERIAL AND METHODS Twenty-eight subjects with maxillary incisors , canines , and premolars scheduled for extraction were included . The tooth was carefully removed . The patients were r and omly assigned to a test or a control group . In the test group patients , Bio-Oss ( ® ) Collagen was placed in the fresh extraction socket while in the controls no grafting was performed . Radiographic examination ( cone beam computed tomograms , CBCT ) was performed immediately after tooth extraction and socket treatment . Four months later , a new CBCT was obtained . In the radiographs , ( i ) the distance ( mm ) between base of the alveolar process ( apex ) and the buccal and palatal crests was determined , ( ii ) the outer profile of alveolar process of the experimental sites was outlined , and the cross section of the area ( mm(2 ) ) determined . RESULTS After 4 months of healing , the buccal and to a less extent also the palatal bone plate had become markedly reduced in height . The placement of a bio material in the socket failed to prevent resorption of the buccal and palatal bone walls . The cross-sectional area of the control ridge was reduced about 25 % and of the test ridge with 3 % . CONCLUSION The placement of a xenograft in fresh extraction sockets markedly counteracted the reduction in the hard tissue component of the edentulous sites OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The use of DBB/CF reduced the magnitude of vertical bone resorption , yet the study showed high risk of bias . Implication s of Key Findings Within the limitations of this systematic review , L-PRF reduced the magnitude of vertical and horizontal bone resorption , which places L-PRF as a potential material of choice for ridge preservation procedures . Conclusions Within the limitations and weaknesses of both studies , the use of DBB/CF prevented the vertical crestal bone resorption while the L-PRF prevented both the horizontal and vertical crestal bone resorption .

MS2_fixed_5_shot222

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The two senior authors ( PMP , RP ) independently began using an identical enhanced posterior soft tissue repair after total hip replacement through a posterior approach . In the first author 's experience , a dislocation rate of 4 % in 395 patients before using the enhanced closure was reduced to 0 % in 395 patients in whom the enhanced closure was performed . In the second author 's experience , 160 total hip replacements had a dislocation rate of 6.2 % before the enhanced closure whereas 124 total hip replacements had a dislocation rate of 0.8 % after the enhanced closure . These results are highly statistically significant Benefits of a direct anterior approach ( DAA ) versus a posterior-lateral ( PA ) approach to THA were assessed in a single-surgeon , IRB-approved , prospect i ve , r and omized clinical study . Subjects ( 43 DAA and 44 PA ) were evaluated at 6 weeks , and 3 , 6 and 12 months . The primary end point was ability to climb stairs normally and walk unlimited at each time point . Secondary end points included assessment by several outcome instruments . DAA subjects performed better during the immediate post-operative period ; they had lower VAS pain scores on the first post-operative day , more subjects climbing stairs normally and walking unlimited at 6 weeks , and higher HOOS Symptoms scores at 3 months . There were no significant differences between groups at later time points . Findings confirm previous reports of benefits of DAA versus PA in early post-operative phases Minimally invasive total hip arthroplasty ( MIS THA ) aims at minimizing damage to muscles and tendons to accelerate postoperative recovery . Computer navigation allows a precise prosthesis alignment without complete visualization of the bony l and marks during MIS THA . A r and omized controlled trial ( RCT ) was conducted to determine the effectiveness of a computer-navigated MIS anterior approach for THA compared to a conventional posterolateral THA technique on the restoration of physical functioning during recovery following surgery . Thirty-five patients underwent computer-navigated MIS THA via the anterior approach , and 40 patients underwent conventional THA using the conventional posterolateral approach . Gait analysis was performed preoperatively , 6 weeks , and 3 and 6 months postoperatively using a body-fixed-sensor based gait analysis system . Walking speed , step length , cadence , and frontal plane angular movements of the pelvis and thorax were assessed . The same data were obtained from 30 healthy subjects . No differences were found in the recovery of spatiotemporal parameters or in angular movements of the pelvis and thorax following the computer-navigated MIS anterior approach or the conventional posterolateral approach . Although gait improved after surgery , small differences in several spatiotemporal parameters and angular movements of the trunk remained at 6 months postoperatively between both patient groups and healthy subjects The goal of the current study was to investigate whether preoperative rehabilitation advice reinforced by a patient information booklet can aid recovery after total hip arthroplasty in terms of pain , function , satisfaction , and quality of life . Thirty-five patients awaiting primary total hip arthroplasty were recruited into this study and r and omly allocated before admission to receive either the st and ard pathway of care or the rehabilitation program and booklet . All patients showed increases in function and psychological variables with time . The preoperative class and booklet , however , seemed to have the greatest impact on length of hospital stay , reducing the hospital stay by 3 days , and therapy input required , significantly influencing the cost of the procedure ( the rehabilitation class led to a cost saving of 587 British pounds ; approximately 810 dollars , per patient ) . In addition , patients attending the class reported higher levels of satisfaction ( 99 % satisfied in the preoperative rehabilitation class compared with 80 % in the control group 3 months postoperatively ) and had more realistic expectations of surgery Objective : To evaluate the outcome after spinal surgery when adding prehabilitation to the early rehabilitation . Design : A r and omized clinical study . Setting : Orthopaedic surgery department . Subject : Sixty patients scheduled for surgery followed by inpatient rehabilitation for degenerative lumbar disease . Interventions : The patients were computer r and omized to prehabilitation and early rehabilitation ( 28 patients ) or to st and ard care exclusively ( 32 patients ) . The intervention began two months prior to the operation . The prehabilitation included an intensive exercise programme and optimization of the analgesic treatment . Protein drinks were given the day before surgery . The early postoperative rehabilitation included balanced pain therapy with self-administered epidural analgesia , doubled intensified mobilization and protein supplements . Main measures : The outcome measurements were postoperative stay , complications , functionality , pain and satisfaction . Results : At operation the intervention group had improved function , assessed by Rol and Morris Question naire ( P = 0.001 ) . After surgery the intervention group reached the recovery milestones faster than the control group ( 1—6 days versus 3—13 , P = 0.001 ) , and left hospital earlier ( 5 ( 3—9 ) versus 7 ( 5—15 ) days , P = 0.007 ) . There was no difference in postoperative complications , adverse events , low back pain and radiating pain , timed up and go , sit-to-st and or in life quality . Patient satisfaction was significantly higher in the intervention group compared with the control group . Conclusion : The integrated programme of prehabilitation and early rehabilitation improved the outcome and shortened the hospital stay — without more complications , pain or dissatisfaction BACKGROUND It is currently unknown whether functional restrictions following total hip arthroplasty can reduce the prevalence of early postoperative dislocation . Our hypothesis was that dislocation was more likely to occur in patients who were not placed on these restrictions . METHODS We performed a prospect i ve , r and omized study to evaluate the role of postoperative functional restrictions on the prevalence of dislocation following uncemented total hip arthroplasty through an anterolateral approach . Of the 630 eligible consecutive patients , 265 patients ( 303 hips ) consented to be r and omized into one of two groups ( the " restricted " group or the " unrestricted " group ) . The patients in both groups were asked to limit the range of motion of the hip to < 90 degrees of flexion and 45 degrees of external and internal rotation and to avoid adduction for the first six weeks after the procedure . The patients in the restricted group were instructed to comply with additional hip pre caution s during the first six weeks postoperatively . Specifically , these patients were managed with the placement of an abduction pillow in the operating room before bed transfer and used pillows to maintain abduction while in bed ; used elevated toilet seats and elevated chairs in the hospital , in the rehabilitation facility , and at home ; and were prevented from sleeping on the side , from driving , and from being a passenger in an automobile . All patients were followed for a minimum of six months postoperatively . RESULTS There was one dislocation in the entire cohort ( prevalence , 0.33 % ) . This dislocation occurred in a patient in the restricted group during transfer from the operating table to a bed with an abduction pillow in place . Patients in the unrestricted group were found to return to side-sleeping sooner ( p < 0.001 ) , to ride in automobiles more often ( p < 0.026 ) , to drive automobiles more often ( p < 0.001 ) , to return to work sooner ( p < 0.001 ) , and to have a higher level of satisfaction with the pace of their recovery ( p < 0.001 ) than those in the restricted group . There was an additional expenditure of approximately $ 655 per patient in the restricted group . CONCLUSIONS Total hip arthroplasty through an anterolateral approach is likely to be associated with a low dislocation rate . Removal of several restrictions did not increase the prevalence of dislocation following primary hip arthroplasty at our institution . However , it did promote substantially lower costs and was associated with a higher level of patient satisfaction as patients achieved a faster return to daily functions in the early postoperative period BACKGROUND Improvements in surgical techniques and increase of femoral head size might have changed the rationale for movement restrictions after total hip replacement ( THR ) . AIM To evaluate the influence of movement restrictions and assistive devices on rehabilitation after fast track THR . DESIGN Non-r and omized , controlled study . SETTING Inpatient . POPULATION 365 consecutively included THR patients . METHODS Patients included the 3 initial month of the study underwent rehabilitation with restrictions in hip movement and a st and ard package of assistive devices ( restricted group ) . This group was compared to patients included the following 3 months with less restricted hip movement and use of assistive devices according to individual needs ( unrestricted group ) . Question naires on function , pain , quality of life ( HOOS ) , anxiety ( HADS ) , working status and patient satisfaction were completed before THR , 3 and 6 weeks after . RESULTS The HOOS function score at the 3 measurement times was ( mean ± SD ) ; unrestricted group : 46 ± 17 - 76 ± 9 - 83 ± 14 compared to restricted group : 43 ± 16 - 81 ± 14 - 83 ± 13 . Changes over time was significantly higher in the restricted group ( P=0.004 ) . Return to work 6 weeks after THR for the unrestricted group compared to restricted group was : 53 % versus 32 % ( P=0.045 ) . No significant differences between groups in pain , symptoms , quality of life , anxiety/depression , hip dislocations and patient satisfaction . CONCLUSION This study showed slightly slower recovery in patient-reported function after reduction in movement restrictions and use of assistive devices , but the difference was eliminated after 6 weeks . Reduced movement restrictions did not affect the other patient-reported outcomes and led to earlier return to work . CLINICAL REHABILITATION IMPACT It is possible to reduce movement restrictions and use of assistive devices considerably . More research on safety issues is needed to eluci date the effect of unrestricted rehabilitation on hip dislocation Currently , many rehabilitation protocol s for total hip replacements ( THRs ) include activity restrictions to prevent postoperative dislocation . There is increasing dem and for more efficient and safe rehabilitation protocol s. This r and omized prospect i ve study evaluates the need for hip restrictions following a modified anterolateral procedure . From 2004 to 2008 , 81 patients seeking elective THRs were r and omly assigned into a st and ard rehabilitation group or an early rehabilitation group . The st and ard group included restrictions to avoid hip flexion > 90 degrees and avoidance of riding in a car for the first postoperative month . The early group had no flexion or car riding restrictions . Forty-three patients were in the st and ard group and 38 patients were in the early group . There were no significant demographic differences between the 2 groups . All patients completed the Short Form 12- question Health Survey and Harris Hip Score preoperatively and at 4 weeks , 1 month , 3 months , and 1 year postoperatively . The time-points at which the patient first drove and ambulated with a cane , without a cane , and without a limp were also collected . No incidents of dislocation occurred . Patients in the early group were faster to ambulate with only a cane ( P=.03 ) , without a cane ( P<.001 ) , and without a limp ( P=.003 ) . They also drove earlier ( P=.02 ) . Pace of recovery was the only significant difference between the 2 groups . The early rehabilitation protocol increases the pace of recovery compared to a pathway with hip pre caution s without increasing complications OBJECTIVE Dislocation is a well-known complication after total hip arthroplasty ( THA ) , and is the second-highest cause of revision surgery . Our objective was to assess the effect of preoperative patient education on the occurrence of hip dislocation within 6 months after primary THA . METHODS Between 1998 and 2007 , we conducted a prospect i ve cohort study at the Geneva University Hospital Department of Orthopaedic Surgery , including all primary THAs performed via an anterolateral transgluteal approach with the use of a 28-mm diameter head . The preoperative education session was introduced in June 2002 and included advice on muscle strengthening exercises and postoperative restrictions of range of motion as a means of preventing dislocation . The main outcome was the incidence of dislocation within 6 months of surgery . RESULTS A total of 597 patients who underwent 656 THAs between June 2002 and June 2007 participated in the education session , whereas 1,641 patients who underwent 1,945 procedures did not . Forty-six dislocations occurred over the study period , 5 ( 0.8 % ) in participants and 41 ( 2.1 % ) in non participants ( absolute risk reduction 1.3 % ; 95 % confidence interval [ 95 % CI ] 0.4 , 2.3 ) , with the time interval between surgery and dislocation being significantly shorter among participants ( 0.2 versus 1.2 months ) . Non participants had a 2.8 times higher risk of dislocation than participants ( unadjusted odds ratio [ OR ] 2.80 ; 95 % CI 1.10 , 7.13 ) . Adjustment for age , sex , comorbidities , and prior surgery did not change the results ( adjusted OR 2.79 ; 95 % CI 1.09 , 7.15 ) . CONCLUSION Our findings suggest that participation in a preoperative patient education session may reduce the risk of dislocation within 6 months after THA OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Patients in the unrestricted group resumed activities significantly faster and were more satisfied with their pace of recovery . Conclusion : A more liberal lifestyle restrictions and pre caution s protocol will not lead to worse dislocation rates after total hip arthroplasty , but will lead to earlier and better resumption of activities and higher patient satisfaction . These results appear to hold up for various surgical approaches

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Calcium and vitamin D are essential nutrients for bone health . Periods of activity with repetitive mechanical loading , such as military training , may result in increases in parathyroid hormone ( PTH ) , a key regulator of Ca metabolism , and may be linked to the development of stress fractures . Previous studies indicate that consumption of a Ca and vitamin D supplement may reduce stress fracture risk in female military personnel during initial military training , but circulating markers of Ca and bone metabolism and measures of bone density and strength have not been determined . This r and omized , double-blind , placebo-controlled trial sought to determine the effects of providing supplemental Ca and vitamin D ( Ca+Vit D , 2000 mg and 1000IU/d , respectively ) , delivered as 2 snack bars per day throughout 9weeks of Army initial military training ( or basic combat training , BCT ) on PTH , vitamin D status , and measures of bone density and strength in personnel undergoing BCT , as well as independent effects of BCT on bone parameters . A total of 156 men and 87 women enrolled in Army BCT ( Fort Sill , OK ; 34.7 ° N latitude ) volunteered for this study . Anthropometric , biochemical , and dietary intake data were collected pre- and post-BCT . In addition , peripheral quantitative computed tomography was utilized to assess tibia bone density and strength in a subset of volunteers ( n=46 ) . Consumption of supplemental Ca+Vit D increased circulating ionized Ca ( group-by-time , P=0.022 ) , maintained PTH ( group-by-time , P=0.032 ) , and increased the osteoprotegerin : RANKL ratio ( group-by-time , P=0.006 ) . Consistent with the biochemical markers , Ca+Vit D improved vBMD ( group-by-time , P=0.024 ) at the 4 % site and cortical BMC ( group-by-time , P=0.028 ) and thickness ( group-by-time , P=0.013 ) at the 14 % site compared to placebo . These data demonstrate the benefit of supplemental Ca and vitamin D for maintaining bone health during periods of elevated bone turnover , such as initial military training . This trial was registered with ClincialTrials.gov , NCT01617109 It is hypothesized that vitamin D insufficiency in athletes might negatively affect sport performance . The objective of this study was to examine the effect of vitamin D3 supplementation on physical performance of adolescent swimmers with vitamin D insufficiency . Fifty-three adolescent competitive swimmers with vitamin D insufficiency ( serum 25-hydroxyvitamin-D concentrations ( 25(OH)D ) < 30 ng/ml , mean 24.2 ± 4.8 ng/ml ) were r and omized to receive 2,000 IU/day of vitamin D3 or placebo for 12 weeks . Swimming performance at several speeds , arm-grip strength , and one-legged balance , were measured before and after supplementation . The age-adjusted changes in performance variables during the study were compared between groups . 25(OH ) D concentrations at study end were significantly higher in the vitamin group compared with the placebo group ( 29.6 ± 6.5 ng/ml vs. 20.3 ± 4.2 ng/ml , p < .001 ) , yet only 48 % of the vitamin group became vitamin D sufficient with this dosing . No between-group differences were found in the changes of the performance variables tested . No significant differences in performance were found between participants that became vitamin D sufficient , and those who did not . No significant correlation was found between the change in serum 25(OH)D and age-adjusted balance , strength or swimming performance at study end . Vitamin D3 supplementation that raised serum 25(OH)D concentrations by a mean of 9.3 ng/ml above placebo in adolescent swimmers with vitamin D insufficiency , did not improve physical performance more than placebo Young male jockeys compromise bone health by engaging in caloric restriction and high volumes of physical activity during periods of musculoskeletal growth and development . The aim of this r and omised , double-blinded , placebo-controlled trial was to establish whether calcium and vitamin D supplementation would improve bone properties of young male jockeys . We conducted a 6-month trial with two groups of weight- , height- and age-matched apprentice male jockeys ( age=20.2 ± 3.2 yrs ) . Participants were supplemented with 800 mg of calcium and 400 IU of vitamin D ( S , n=8 ) or a placebo ( cellulose ) ( P , n=9 ) daily for 6-months . Baseline calcium intake was ( 669.7 ± 274.3 ( S ) vs 790.4 ± 423.9 ( P ) and vitamin D 64.6 ± 19.5 ( S ) vs 81.2 ± 24.4 ( P ) with no statistical differences . Peripheral quantitative computed tomography ( pQCT ) measured ultra-distal ( 4 % ) and proximal ( 66 % ) tibial bone properties at baseline and 6 months . Blood-borne markers of bone turnover , P1NP and CTX and vitamin D concentration were assessed . After co-varying for height , weight and baseline bone measurements , the supplemented group displayed greater post-intervention bone properties at the 66 % proximal site with cortical content ( mgmm ) 6.6 % greater ( p<0.001 ) , cortical area ( mm(2 ) ) 5.9 % larger ( p<0.001 ) , cortical density ( mgcm(2 ) ) 1.3 % greater ( p=0.001 ) , and total area ( mm(2 ) ) 4 % larger ( p=0.003 ) . No other between group differences in bone variables were observed . Blood analysis indicated higher vitamin D levels ( 18.1 % , p=0.014 ) and lower CTx ( ng/L ) ( -24.8 % , p=0.011 ) in the supplemented group with no differences observed in P1NP . This is the first r and omised controlled trial to examine the efficacy of calcium and vitamin D supplementation in improving bone properties in a highly vulnerable , young athletic , weight-restricted population . Results using pQCT indicate beneficial effects of supplementation on bone properties in as little as six months . Although the study size is small , this intervention appears promising as a strategy for improving bone health in young athletes in weight-restricted sports Purpose Vitamin D inadequacy is a global health concern in athletes as well as the general population . Whilst the role of vitamin D in skeletal health is well defined , there remains uncertainty over whether vitamin D supplementation has an added benefit beyond bone health . Methods This r and omised placebo-controlled trial in healthy male and female Gaelic footballers ( n = 42 ) investigated the effect of vitamin D3 supplementation [ 3000 IU ( 75 µg ) daily for 12 weeks , via an oral spray solution ] on VO2 max which was the primary outcome measure . Secondary outcomes included skeletal muscle and lung function . Results Supplementation significantly increased total 25-hydroxyvitamin D concentrations compared to the placebo group ( mean ± SD change from baseline , 36.31 ± 32.34 vs. 6.11 ± 23.93 nmol/L , respectively ; P = 0.006 ) . At baseline , 50 and 22 % of footballers presented with vitamin D insufficiency ( 31–49 nmol/L ) and deficiency ( < 30 nmol/L ) , respectively . Total 25-hydroxyvitamin D concentration did not significantly correlate with any measure of physical performance . Analysis of covariance ( ANCOVA ) models demonstrated that vitamin D supplementation over 12 weeks had no significant effect on VO2 max ( P = 0.375 ) , vertical jump height ( P = 0.797 ) , left and right h and grip strength ( P = 0.146 and P = 0.266 , respectively ) , forced vital capacity ( P = 0.573 ) or forced expiratory volume at 1 s ( P = 0.665 ) , after adjusting for confounders . The high prevalence of vitamin D inadequacy observed in this cohort of collegiate Gaelic footballers supports the need for vitamin D supplementation during wintertime to avoid being at risk of poor bone health . Conclusions Twelve-week daily supplementation with 3000 IU ( 75 µg ) vitamin D3 successfully resolved deficiency but did not have any significant effect on VO2 max , skeletal muscle or lung function This study determined if 6-weeks vitamin D2 supplementation ( vitD2 , 3800 IU/day ) had an influence on muscle function , eccentric exercise-induced muscle damage ( EIMD ) , and delayed onset of muscle soreness ( DOMS ) in National Association for Stock Car Auto Racing ( NASCAR ) NASCAR pit crew athletes . Subjects were r and omized to vitD2 ( n = 13 ) and placebo ( n = 15 ) , and ingested supplements ( double-blind ) for six weeks . Blood sample s were collected and muscle function tests conducted pre- and post- study ( leg-back and h and grip dynamometer strength tests , body weight bench press to exhaustion , vertical jump , 30-s Wingate test ) . Post- study , subjects engaged in 90 min eccentric-based exercise , with blood sample s and DOMS ratings obtained immediately after and 1- and 2-days post-exercise . Six weeks vitD2 increased serum 25(OH)D2 456 % and decreased 25(OH)D3 21 % versus placebo ( p < 0.001 , p = 0.036 , respectively ) , with no influence on muscle function test scores . The post- study eccentric exercise bout induced EIMD and DOMS , with higher muscle damage biomarkers measured in vitD2 compared to placebo ( myoglobin 252 % , 122 % increase , respectively , p = 0.001 ; creatine phosphokinase 24 h post-exercise , 169 % , 32 % , p < 0.001 ) , with no differences for DOMS . In summary , 6-weeks vitD2 ( 3800 IU/day ) significantly increased 25(OH)D2 and decreased 25(OH)D3 , had no effect on muscle function tests , and amplified muscle damage markers in NASCAR pit crew athletes following eccentric exercise Summary The aim of this study was to investigate vitamin D status and stress fracture risk during Royal Marine military training . Poor vitamin D status was associated with an increased risk of stress fracture . Vitamin D supplementation may help to reduce stress fracture risk in male military recruits with low vitamin D status . Introduction Stress fracture is a common overuse injury in military recruits , including Royal Marine ( RM ) training in the UK . RM training is recognised as one of the most arduous basic training programmes in the world . Associations have been reported between serum 25-hydroxyvitamin D ( 25(OH)D ) and risk of stress fracture , but the threshold of 25(OH)D for this effect remains unclear . We aim ed to determine if serum 25(OH)D concentrations were associated with stress fracture risk during RM training . Methods We prospect ively followed 1082 RM recruits ( males aged 16–32 years ) through the 32-week RM training programme . Troops started training between September and July . Height , body weight and aerobic fitness were assessed at week 1 . Venous blood sample s were drawn at weeks 1 , 15 and 32 . Serum sample s were analysed for 25(OH)D and parathyroid hormone ( PTH ) . Results Seventy-eight recruits ( 7.2 % ) suffered a total of 92 stress fractures . Recruits with a baseline serum 25(OH)D concentration below 50 nmol L−1 had a higher incidence of stress fracture than recruits with 25(OH)D concentration above this threshold ( χ2(1 ) = 3.564 , p = 0.042 ; odds ratio 1.6 ( 95 % confidence interval ( CI ) 1.0–2.6 ) ) . Baseline serum 25(OH)D varied from 47.0 ± 23.7 nmol L−1 in February , to 97.3 ± 24.6 nmol L−1 in July ( overall mean 69.2 ± 29.2 nmol L−1 , n = 1016 ) . There were weak inverse correlations between serum 25(OH)D and PTH concentrations at week 15 ( r = −0.209 , p < 0.001 ) and week 32 ( r = −0.214 , p < 0.001 ) , but not at baseline . Conclusion Baseline serum 25(OH)D concentration below 50 nmol L−1 was associated with an increased risk of stress fracture . Further studies into the effects of vitamin D supplementation on stress fracture risk are certainly warranted Abstract : The first part of this study consisted of an 18 month follow-up of the vitamin D status and parathyroid function in a group of 54 French male adolescents , aged from 13 to 16 years old and all pupils of a jockey training school . During the 18 month period four samplings were made , one every 6 months . The first was during September of the first year , the second and third during March and OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Both doses led to sufficiency concentrations during winter months . Among athletes with baseline vitamin D suggesting sufficiency , serum 25(OH)D sufficiency was maintained from different doses at both latitudes . Conclusion Despite achieving sufficiency in vitamin D concentrations from ≥3000 IU supplementation , physical performance did not significantly improve .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND AND AIMS Cardiovascular diseases are the major cause of mortality among diabetic patients . The concentration of malondialdehyde ( MDA ) and homocysteine is believed to play a role in cardiovascular diseases . Omega-3 fatty acid supplementation could be effective in some diabetes complications and in the control of the glycemic index . However , it may increase lipid peroxidation . The objective of this study was to determine the effect of omega-3 fatty acids on the concentration of homocysteine and MDA in diabetic patients . METHODS AND RESULTS A r and omized double-blind , placebo-controlled clinical trial was conducted on 81 patients with type 2 diabetes . The patients were r and omly assigned to either the treatment or control groups . Each subject received three capsules of omega-3 fatty acids or a placebo every day for a period of 2months . The two groups were similar in terms of body mass index and food intake . At the beginning of the study and after 2months of supplementation their levels of HbA(1)c , homocysteine , MDA , C-reactive protein ( CRP ) , total cholesterol , LDL-cholesterol and fasting blood sugar ( FBS ) were determined . Due to omega-3 fatty acid supplementation , homocysteine was changed significantly in both treatment and control groups up to -3.10mumol/L and 0.10mumol/L respectively , and HbA(1)c decreased by 0.75 % in the treatment group and increased by 0.26 % in the control group . However , the changes in fasting blood sugar ( FBS ) , malondialdehyde ( MDA ) , C-reactive protein ( CRP ) , total cholesterol and LDL-cholesterol levels were not significant . CONCLUSION The consumption of omega-3 fatty acid supplements ( 3g/day ) for 2months decreases the levels of homocysteine in diabetic patients with no change in FBS , MDA and CRP levels The aim of this study was to examine the effect of Max EPA ( a commercially available fish oil preparation ) on serum cholesterol lipoproteins and apolipoproteins in insulin-dependent diabetic ( IDDM ) men with dosages that were likely to be acceptable to patients . Twenty-two male IDDM patients aged 20–41 yr , 6 of whom had retinopathy , were recruited from the Royal Perth Hospital diabetic clinic . After screening , subjects were divided into three groups . Six of the subjects without retinopathy were r and omly selected and allocated to a control group . The remaining 16 patients ( 10 without and 6 with retinopathy ) received a fish oil supplement . All subjects were advised to maintain their usual dietary patterns . Sixteen patients , including the 6 with retinopathy , were instructed to take 15 Max EPA fish oil capsules/day with meals . Patients in the control group did not take Max EPA . Three weeks of Max EPA supplementation without other dietary modification led to a significant rise in total cholesterol ( P < 0.01 ) , which could be accounted for by increases in low-density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) cholesterol . The increase in HDL cholesterol was explained by a 33 % rise ( P < 0.001 ) in its HDL2 subclass . Changes in apolipoproteins were examined and showed that the level of apolipoprotein A-l increased after ingestion of fish oil and correlated significantly ( P < 0.05 ) with the rise in HDL cholesterol . Apolipoprotein A-ll showed a significant fall at the end of Max EPA intake in a subgroup of patients with retinopathy , and this correlated significantly ( P < 0.05 ) with the fall in HDL3 cholesterol observed at this time . A significant rise in apolipoprotein B ( P < 0.05 ) was correlated with the rise in LDL cholesterol . Possible adverse effects of the increase in both total and LDL cholesterol after 15 g/day Max EPA may be compensated for by a rise in the protective HDL2 subclass . However , in view of this hypercholesterolemic effect and evidence that suggests that LDL apolipoprotein B may be a risk factor for coronary heart disease , these findings raise questions regarding the safety of fish oils in patients with IDDM BACKGROUND Information is lacking on the potential effect of n-3 polyunsaturated fatty acids ( PUFAs ) on the adipose tissue of patients with type 2 diabetes . OBJECTIVE We evaluated whether n-3 PUFAs have additional effects on adiposity , insulin sensitivity , adipose tissue function ( production of adipokines and inflammatory and atherogenic factors ) , and gene expression in type 2 diabetes . DESIGN Twenty-seven women with type 2 diabetes without hypertriglyceridemia were r and omly allocated in a double-blind parallel design to 2 mo of 3 g/d of either fish oil ( 1.8 g n-3 PUFAs ) or placebo ( paraffin oil ) . RESULTS Although body weight and energy intake measured by use of a food diary were unchanged , total fat mass ( P < 0.019 ) and subcutaneous adipocyte diameter ( P < 0.0018 ) were lower in the fish oil group than in the placebo group . Insulin sensitivity was not significantly different between the 2 groups ( measured by homeostasis model assessment in all patients and by euglycemic-hyperinsulinemic clamp in a subgroup of 5 patients per group ) . By contrast , atherogenic risk factors , including plasma triacylglycerol ( P < 0.03 ) , the ratio of triacylglycerol to HDL cholesterol ( atherogenic index , P < 0.03 ) , and plasma plasminogen activator inhibitor-1 ( P < 0.01 ) , were lower in the fish oil group than in the placebo group . In addition , a subset of inflammation-related genes was reduced in subcutaneous adipose tissue after the fish oil , but not the placebo , treatment . CONCLUSIONS A moderate dose of n-3 PUFAs for 2 mo reduced adiposity and atherogenic markers without deterioration of insulin sensitivity in subjects with type 2 diabetes . Some adipose tissue inflammation-related genes were also reduced . These beneficial effects could be linked to morphologic and inflammatory changes in adipose tissue . This trial was registered at clinical trials.gov as NCT0037 The effects of ( n-3 ) fatty acids on the postpr and ial state were investigated by monitoring the alimentary responses to identical test meals fed to adults [ n = 11 ; fasting triacylglycerol ( TG ) 2.55 + /- 0.24 mmol/L ; mean + /- SEM ] after a self-selected diet baseline period ( BLP ) and then after a 6-wk ( n-3 ) fatty acid period ( FOP ) [ approximately 5.2 g ( n-3 ) fatty acids ] and a 6-wk control oil period ( COP ) administered in r and om order . Sample s were drawn immediately prior to the test meal ( time 0 ) and then hourly from 2 to 6 h postmeal . Postpr and ial plasma triacylglycerol ( TG ) and TG-rich lipoprotein ( TRL ) TG apo B48 , and B100 absolute concentrations were significantly lower after FOP than after COP or BLP , while plasma cholesterol was unchanged . Normalizing the results as increments over time 0 eliminated the diet effect on all but plasma TG . Time remained a significant effect for plasma TG , TRL TG , and TRL TC . Finally , only absolute TRL B48 and absolute and incremental plasma TG concentrations displayed significant time-diet interactions . These results suggest that postpr and ial TRL apo B reductions are likely caused by ( n-3 ) fatty acid suppression of both hepatic and intestinal apoB secretion/ synthesis . Altered TRL metabolism , i.e. changes in postpr and ial TG , cholesterol , apo B48 , and increase in LDL particle size , may represent an additional mechanism for the reduced heart disease risk associated with fish [ ( n-3 ) fatty acid ] consumption BACKGROUND Plasma lipoproteins may be classified by their apolipoprotein composition . The lipoprotein subclass containing apolipoproteins B and C ( LpB : C ) is considered the most atherogenic . OBJECTIVE We evaluated the acute effects of individual fatty acids on apolipoprotein B ( apo B)-containing lipoproteins in adults with type 2 diabetes ( n = 15 ) . DESIGN We administered 3 meals in a r and omized , double-blind , crossover design . Treatments contained skim milk and 50 g fat from high-oleic acid safflower and canola oils ( monounsaturated fatty acid ; MUFA ) , MUFA + 3.5 g alpha-linolenic acid ( ALA ; MUFA + ALA ) from high-ALA canola oil , or MUFA + 4.0 g both eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ; MUFA + EPA/DHA ) from sardine oil . Apo B , LpB , LpB : C , LpB : E + LpB : C : E , and LpA-II : B : C : D : E were measured at baseline and 2 and 4 h after the meal . Flow-mediated dilation was measured at baseline and 4 h after the meal . RESULTS The treatments significantly increased apo B and LpB postpr and ially ( P < 0.03 for both ) , but the magnitude of the changes did not differ significantly between the treatments . The postpr and ial change in LpB : C was 23 % lower after MUFA + EPA/DHA than after MUFA ( treatment x time interaction , P < 0.0001 ) . MUFA + ALA attenuated the increase in LpA-II : B : C : D : E in those with high triacylglycerols ( > /=1.69 mmol/L ) but was the only treatment to significantly increase this particle in those with low triacylglycerols ( treatment x group interaction , P < 0.0001 ) . Examination of change scores did not reveal the source of the interaction of treatment and time ( P < 0.007 ) for LpB : E + LpB : C : E. Furthermore , the subjects with the largest increases in LpB : C exhibited the largest impairment in endothelial function . CONCLUSIONS The results suggest that unsaturated fatty acids differentially affect concentrations of apo B-containing lipoprotein subclasses . A rise in LpB : C adversely affects endothelial function . Meals containing MUFA + EPA/DHA attenuated the postpr and ial rise in LpB : C and the impairment of endothelial function OBJECTIVE Dietary interventions can improve pregnancy outcomes in women with gestational diabetes mellitus ( GDM ) . We compared the effect of a low – glycemic index ( GI ) versus a conventional high-fiber ( HF ) diet on pregnancy outcomes , birth weight z score , and maternal metabolic profile in women at high risk of GDM . RESEARCH DESIGN AND METHODS One hundred thirty-nine women [ mean ( SD ) age 34.7 ( 0.4 ) years and prepregnancy BMI 25.2 ( 0.5 ) kg/m2 ] were r and omly assigned to a low-GI ( LGI ) diet ( n = 72 ; target GI ∼50 ) or a high-fiber , moderate-GI ( HF ) diet ( n = 67 ; target GI ∼60 ) at 14–20 weeks ’ gestation . Diet was assessed by 3-day food records and infant body composition by air-displacement plethysmography , and pregnancy outcomes were assessed from medical records . RESULTS The LGI group achieved a lower GI than the HF group [ mean ( SD ) 50 ( 5 ) vs. 58 ( 5 ) ; P < 0.001 ] . There were no differences in glycosylated hemoglobin , fructosamine , or lipids at 36 weeks or differences in birth weight [ LGI 3.4 ( 0.4 ) kg vs. HF 3.4 ( 0.5 ) kg ; P = 0.514 ] , birth weight z score [ LGI 0.31 ( 0.90 ) vs. HF 0.24 ( 1.07 ) ; P = 0.697 ] , ponderal index [ LGI 2.71 ( 0.22 ) vs. HF 2.69 ( 0.23 ) kg/m3 ; P = 0.672 ] , birth weight centile [ LGI 46.2 ( 25.4 ) vs. HF 41.8 ( 25.6 ) ; P = 0.330 ] , % fat mass [ LGI 10 ( 4 ) vs. HF 10 ( 4 ) ; P = 0.789 ] , or incidence of GDM . CONCLUSIONS In intensively monitored women at risk for GDM , a low-GI diet and a healthy diet produce similar pregnancy outcomes Background Omega–3 fatty acids prevent cardiovascular disease ( CVD ) events in patients with myocardial infa rct ion or heart failure . Benefits in patients without overt CVD have not been demonstrated , though most studies did not use treatment doses ( OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

We conclude that omega-3 fatty acids may be associated with lower inflammatory biomarkers among diabetic and cardiovascular patients .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Purpose . To compare erectile function ( EF ) recovery of patients treated by early penile rehabilitation therapy ( PRT ) with sildenafil and with control group . Method . Forty men treated by bilateral nerve sparing radical prostatectomy ( NSRP ) and with a normal pre-operative EF were enrolled . Fourteen days after surgery , they were r and omised to a flexible-dose sildenafil group and to a control group . The International Index of Erectile Function ( IIEF ) question naire was completed before surgery and at 3 , 6 , 12 and 24 weeks after NSRP . Results . In the group treated , the mean IIEF score before surgery was 26.2 and 14.1 , 16.2 , 22.5 and 25.2 at 3 , 6 , 12 and 24 weeks after NSRP , respectively . In the control group , the respective scores were 26.5 and 12.4 , 15.8 , 15.3 and 17.4 . There was a significant difference in IIEF mean score ( 25 ± 6 vs. 17 ± 9 , p < 0.05 ) and in the potency rate ( 87 % vs. 56 % ) between the groups at 24 weeks after NSRP . The percentage of patients who were capable of having medication-unassisted intercourse was 54 % vs. 21 % ; 34 % vs. 18 % of patients had a normal EF with 72 % vs. 32 % of responders to sildenafil . Conclusions . PRT with PDE-5 inhibitors should be offered early after RP to allow the recovery of EF Four weeks after bilateral nerve-sparing radical retropubic prostatectomy , men with normal erectile function before surgery were r and omized to double-blind sildenafil ( 50 or 100 mg ) or placebo nightly for 36 weeks , followed by an 8-week drug-free period before assessment of erectile function . Enrollment was prematurely ceased and only 76 men completed because , assuming a placebo response rate similar to the published literature ( for example , 34 % in meta- analysis ) , the 25 % response at blinded interim review suggested a lack of treatment effect . On the contrary , spontaneous erectile function ( a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘ Were erections good enough for satisfactory sexual activity ? ’ ) occurred in only 4 % of the placebo group ( n=1 of 25 ) versus 27 % ( n=14 of 51 , P=0.0156 , Fisher 's exact test ) of the sildenafil group . Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections BACKGROUND The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors ( PDE5-Is ) on penile function after nerve-sparing radical prostatectomy ( NSRP ) remains unclear . OBJECTIVE The primary objective was to compare the efficacy of tadalafil 5 mg once daily and tadalafil 20 mg on dem and versus placebo taken over 9 mo in improving unassisted erectile function ( EF ) following NSRP , as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain ( IIEF-EF ) score ≥ 22 after 6-wk drug-free washout ( DFW ) . Secondary measures included IIEF-EF , Sexual Encounter Profile question 3 ( SEP-3 ) , and penile length . DESIGN , SETTING , AND PARTICIPANTS R and omised , double-blind , double-dummy , placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate ( Gleason ≤ 7 ) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada . INTERVENTIONS 1:1:1 r and omisation to 9 mo of treatment with tadalafil 5 mg once daily , tadalafil 20 mg on dem and , or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily ( all patients ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Logistic regression , mixed-effects model for repeated measures , and analysis of covariance , adjusting for treatment , age , and country , were applied to IIEF-EF scores ≥ 22 , SEP-3 , and penile length . RESULTS AND LIMITATIONS Four hundred twenty-three patients were r and omised to tadalafil once daily ( n=139 ) , on dem and ( n=143 ) , and placebo ( n=141 ) . The mean age was 57.9 yr of age ( st and ard deviation : 5.58 yr ) ; 20.9 % , 16.9 % , and 19.1 % of patients in the tadalafil once daily , on dem and , and placebo groups , respectively , achieved IIEF EF scores ≥ 22 after DFW ; odds ratios for tadalafil once daily and on dem and versus placebo were 1.1 ( 95 % confidence interval [ CI ] , 0.6 - 2.1 ; p=0.675 ) and 0.9 ( 95 % CI , 0.5 - 1.7 ; p=0.704 ) . At the end of double-blind treatment ( EDT ) , least squares ( LS ) mean IIEF-EF score improvement significantly exceeded the minimally clinical ly important difference ( MCID : ΔIIEF-EF ≥ 4 ) in both tadalafil groups ; for SEP-3 ( MCID ≥ 23 % ) , this was the case for tadalafil once daily only . Treatment effects versus placebo were significant for tadalafil once daily only ( IIEF-EF : p=0.016 ; SEP-3 : p=0.019 ) . In all groups , IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment . At month 9 ( EDT ) , penile length loss was significantly reduced versus placebo in the tadalafil once daily group only ( LS mean difference 4.1 mm ; 95 % CI , 0.4 - 7.8 ; p=0.032 ) . CONCLUSIONS Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP , and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes . Unassisted EF was not improved after cessation of active therapy for 9 mo . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01026818 PURPOSE We evaluated the safety and efficacy of 100 and 200 mg avanafil for the treatment of adult males with erectile dysfunction after bilateral nerve sparing radical prostatectomy . MATERIAL S AND METHODS This was a double-blind , placebo controlled , parallel group , phase 3 study in males age 18 to 70 years with a history of erectile dysfunction of 6 months or more after bilateral nerve sparing radical prostatectomy . Patients were r and omized to 100 or 200 mg avanafil or placebo ( taken 30 minutes before sexual activity ) for 12 weeks . Primary end points included successful vaginal insertion ( Sexual Encounter Profile [ SEP ] question 2 ) , successful intercourse ( SEP3 ) and change in score on the erectile function domain of the International Index of Erectile Function ( IIEF-EF ) question naire . RESULTS A total of 298 patients were r and omized and 84.6 % completed the study . At baseline 16.1 % were age 65 years or older and 71.5 % had severe erectile dysfunction ( mean overall IIEF-EF domain score 9.2 ) . After 12 weeks there were significantly greater increases in SEP2 and SEP3 and change in mean IIEF-EF domain score with 100 and 200 mg avanafil vs placebo ( p < 0.01 ) . Following dosing with avanafil 36.4 % ( 28 of 77 ) of sexual attempts ( SEP3 ) at 15 minutes or less were successful vs 4.5 % ( 2 of 44 ) for placebo ( p < 0.01 ) . Avanafil was generally well tolerated . No serious adverse events were reported and fewer than 2 % of patients discontinued the study due to an adverse event . CONCLUSIONS Avanafil in 100 and 200 mg doses was effective and well tolerated in improving erectile function after prostatectomy . Results suggest a rapid onset of action and sustained duration of effect , with all 3 primary end points being achieved at both dose levels PURPOSE We evaluated the efficacy and safety of tadalafil 20 mg , taken on dem and , in men with erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy ( BNSRRP ) . MATERIAL S AND METHODS This r and omized , double-blind , placebo controlled multicenter study consisted of a 4-week treatment-free run-in period ( baseline ) followed by 12 weeks of treatment . A total of 303 men ( mean age 60 years ) with preoperative normal erectile function who had undergone a BNSRRP 12 to 48 months before study were r and omized ( 2:1 ) to tadalafil ( 201 ) or placebo ( 102 ) . The 3 co- primary end points were changes from baseline in the International Index of Erectile Function erectile function domain score , and the percentage of positive responses to Sexual Encounter Profile questions 2 ( successful penetration ) and 3 ( successful intercourse ) . The Global Assessment Question and the Erectile Dysfunction Inventory of Treatment Satisfaction question naire were secondary end points . We defined a priori a subgroup of 201 patients reporting evidence of postoperative tumescence , defined as 50 % or greater " yes " responses to Sexual Encounter Profile question 1 ( ability to achieve at least some erection ) during baseline intercourse attempts and stratified r and omization based on this criterion . RESULTS Patients receiving tadalafil reported greater improvement on all primary and secondary end points ( p < 0.001 ) compared to placebo . For all r and omized patients and for the subgroup with evidence of postoperative tumescence , the mean International Index of Erectile Function erectile function domain score increased for patients receiving tadalafil ( mean + /- SEM 5.3 + /- 0.5 and 5.9 + /- 0.7 , respectively , p < 0.001 vs placebo for both ) . For all r and omized patients who received tadalafil , the mean percentage of successful penetration attempts was 54 % and the mean percentage of successful intercourse attempts was 41 % . For the subgroup with evidence of postoperative tumescence these values were 69 % and 52 % , respectively . Of all patients r and omized to tadalafil 62 % and of the subgroup patients r and omized to tadalafil 71 % reported improved erections . Patients receiving tadalafil reported greater treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction than those receiving placebo . Headache ( 21 % ) , dyspepsia ( 13 % ) and myalgia ( 7 % ) were the most commonly reported adverse events . CONCLUSIONS Tadalafil 20 mg , taken on-dem and , was an efficacious and well tolerated treatment for erectile dysfunction following BNSRRP OBJECTIVE To evaluate the change in penile size r bilateral nerve sparing retropubic radical prostatectomy ( BNSRRP ) and possible effect of Tadalafil . MATERIAL S AND METHODS A total of 65 patients underwent BNSRRP and they were evaluated prospect ively for a whole year of follow-up . The patients were r and omized to control without rehabilitation ( Group 1 ) or Tadalafil rehabilitation group ( Group 2 ) . The patients were evaluated at months 3 , 6 and 12 postoperatively for erectile function , penile measurements ( flaccid penile length , penile length at maximum erection , penile circumference at flaccid status , and penile circumference at maximum erection ) , penile abnormalities and general health status . Statistical analysis was performed by Chi-Square test and significance was defined as p value < 0.05 . RESULTS In Group 1 there was significant decrease in penile measurements at month 3 compared to preoperative measurements . There was decrease in all parameters at month 6 compared to month 3 but only the decrease in penile length at maximum erection was significant . There were no significant differences between postoperative months 6 and 12 for all measurements . In Group 2 there was a tendency to decrease in all measurements at month 3 compared to baseline . There was no significant difference for penile measurements between postoperative 3rd and 6th months and between 6th month and the first year . CONCLUSION Although further large sample d trials are needed to describe the possible positive effect of tadalafil or other PDE5-I 's on penile size after BNSRRP , tadalafil rehabilitation is effective in preserving penile size especially in the early postoperative period after BNSRRP OBJECTIVE To examine the preference for 2 dosing regimens ( on dem and or 3 times/week ) for tadalafil , a phosphodiesterase 5 inhibitor with a duration of effectiveness up to 36 hours in men with erectile dysfunction ( ED ) . DESIGN AND METHODS SURE is a 14 European country , multicenter , crossover , and open-label study OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

By network meta- analysis , sildenafil seems to be the most efficiency with a slightly higher rate of treatment-emergent adverse events ( TEATs ) , whereas tadalafil had the lowest TEATs . Compared with placebo , PDE5-Is manifested significantly improved treatment outcomes . Overall , regular regimen demonstrated statistically pronounced better potency than on-dem and .

MS2_fixed_5_shot226

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose CONTEXT Obstructive sleep apnea ( OSA ) is strongly related to obesity . Weight loss is recommended as part of the overall management plan for obese patients diagnosed with OSA . OBJECTIVE To determine whether surgically induced weight loss is more effective than conventional weight loss therapy in the management of OSA . DESIGN , SETTING , AND PATIENTS A r and omized controlled trial of 60 obese patients ( body mass index : > 35 and < 55 ) with recently diagnosed ( < 6 months ) OSA and an apnea-hypopnea index ( AHI ) of 20 events/hour or more . These patients had been prescribed continuous positive airway pressure ( CPAP ) therapy to manage OSA and were identified via accredited community sleep clinics . The trial was conducted between September 2006 and March 2009 by university- and teaching hospital-based clinical research ers in Melbourne , Australia . Patients with obesity hypoventilation syndrome , previous bariatric surgery , contraindications to bariatric surgery , or significant cardiopulmonary , neurological , vascular , gastrointestinal , or neoplastic disease were excluded . INTERVENTIONS Patients were r and omized to a conventional weight loss program that included regular consultations with a dietitian and physician , and the use of very low-calorie diets as necessary ( n = 30 ) or to bariatric surgery ( laparoscopic adjustable gastric b and ing ; n = 30 ) . MAIN OUTCOME MEASURES The primary outcome was baseline to 2-year change in AHI on diagnostic polysomnography scored by staff blinded to r and omization . Secondary outcomes were changes in weight , CPAP adherence , and functional status . RESULTS Patients lost a mean of 5.1 kg ( 95 % CI , 0.8 to 9.3 kg ) in the conventional weight loss program compared with 27.8 kg ( 95 % CI , 20.9 to 34.7 kg ) in the bariatric surgery group ( P < .001 ) . The AHI decreased by 14.0 events/hour ( 95 % CI , 3.3 to 24.6 events/hour ) in the conventional weight loss group and by 25.5 events/hour ( 95 % CI , 14.2 to 36.7 events/hour ) in the bariatric surgery group . The between-group difference was -11.5 events/hour ( 95 % CI , -28.3 to 5.3 events/hour ; P = .18 ) . CPAP adherence did not differ between the groups . The bariatric surgery group had greater improvement in the Short Form 36 physical component summary score ( mean , 9.3 [ 95 % CI , 0.5 to 18.0 ] ; P = .04 ) . CONCLUSION Among a group of obese patients with OSA , the use of bariatric surgery compared with conventional weight loss therapy did not result in a statistically greater reduction in AHI despite major differences in weight loss . TRIAL REGISTRATION anzctr.org Identifier : 12605000161628 CONTEXT Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes . OBJECTIVE To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control . DESIGN , SETTING , AND PARTICIPANTS Unblinded r and omized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia , with general community recruitment to established treatment programs . Participants were 60 obese patients ( BMI > 30 and < 40 ) with recently diagnosed ( < 2 years ) type 2 diabetes . INTERVENTIONS Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric b and ing with conventional diabetes care . MAIN OUTCOME MEASURES Remission of type 2 diabetes ( fasting glucose level < 126 mg/dL [ 7.0 mmol/L ] and glycated hemoglobin [ HbA1c ] value < 6.2 % while taking no glycemic therapy ) . Secondary measures included weight and components of the metabolic syndrome . Analysis was by intention-to-treat . RESULTS Of the 60 patients enrolled , 55 ( 92 % ) completed the 2-year follow-up . Remission of type 2 diabetes was achieved by 22 ( 73 % ) in the surgical group and 4 ( 13 % ) in the conventional-therapy group . Relative risk of remission for the surgical group was 5.5 ( 95 % confidence interval , 2.2 - 14.0 ) . Surgical and conventional-therapy groups lost a mean ( SD ) of 20.7 % ( 8.6 % ) and 1.7 % ( 5.2 % ) of weight , respectively , at 2 years ( P < .001 ) . Remission of type 2 diabetes was related to weight loss ( R2 = 0.46 , P < .001 ) and lower baseline HbA1c levels ( combined R2 = 0.52 , P < .001 ) . There were no serious complications in either group . CONCLUSIONS Participants r and omized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss . These results need to be confirmed in a larger , more diverse population and have long-term efficacy assessed . TRIAL REGISTRATION actr.org Identifier : ACTRN012605000159651 IMPORTANCE Controlling glycemia , blood pressure , and cholesterol is important for patients with diabetes . How best to achieve this goal is unknown . OBJECTIVE To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 2-group unblinded r and omized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c ( HbA1c ) level of 8.0 % or higher , body mass index ( BMI ) between 30.0 and 39.9 , C peptide level of more than 1.0 ng/mL , and type 2 diabetes for at least 6 months . The study began in April 2008 . INTERVENTIONS Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery . Medications for hyperglycemia , hypertension , and dyslipidemia were prescribed according to protocol and surgical techniques that were st and ardized . MAIN OUTCOMES AND MEASURES Composite goal of HbA1c less than 7.0 % , low-density lipoprotein cholesterol less than 100 mg/dL , and systolic blood pressure less than 130 mm Hg . RESULTS All 120 patients received the intensive lifestyle-medical management protocol and 60 were r and omly assigned to undergo Roux-en-Y gastric bypass . After 12-months , 28 participants ( 49 % ; 95 % CI , 36%-63 % ) in the gastric bypass group and 11 ( 19 % ; 95 % CI , 10%-32 % ) in the lifestyle-medical management group achieved the primary end points ( odds ratio [ OR ] , 4.8 ; 95 % CI , 1.9 - 11.7 ) . Participants in the gastric bypass group required 3.0 fewer medications ( mean , 1.7 vs 4.8 ; 95 % CI for the difference , 2.3 - 3.6 ) and lost 26.1 % vs 7.9 % of their initial body weigh compared with the lifestyle-medical management group ( difference , 17.5 % ; 95 % CI , 14.2%-20.7 % ) . Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss . There were 22 serious adverse events in the gastric bypass group , including 1 cardiovascular event , and 15 in the lifestyle-medical management group . There were 4 perioperative complications and 6 late postoperative complications . The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group . CONCLUSIONS AND RELEVANCE In mild to moderately obese patients with type 2 diabetes , adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal . Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00641251 BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Context Observational studies have shown sustained weight loss after surgery for extreme obesity . No r OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Compared with non-surgical treatment of obesity , bariatric surgery leads to greater body weight loss and higher remission rates of type 2 diabetes and metabolic syndrome .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background Neurocognitive testing has been endorsed as a “ cornerstone ’ of concussion management by recent Vienna and Prague meetings of the Concussion in Sport Group . Neurocognitive testing is important given the potential unreliability of athlete self-report after injury . Relying only on athletes'ormalities after injury . Study Design Case control study ; Level of evidence , 3 . Methods High school and college athletes with a diagnosed concussion were tested 2 days after injury . Postinjury neurocognitive performance ( Immediate Postconcussion Assessment and Cognitive Testing ) and symptom ( postconcussion symptom ) scores were compared with preinjury ( baseline ) scores and with those of an agex and education-matched noninjured athlete control group . “ Abnormal ” test performance was determined statistically with Reliable Change Index scores . Results Sixty-four percent of concussed athletes reported a significant increase in symptoms , as judged by postconcussion symptom scores , compared with preinjury baseline at 2 days after injury . Eighty-three percent of the concussed sample demonstrated significantly poorer neurocognitive test results relative to their own baseline performance . The addition of neurocognitive testing result ed in a net increase in sensitivity of 19 % . Ninety-three percent of the sample had either abnormal neurocognitive test results or a significant increase in symptoms , relative to their own baseline ; 30 % of a control group demonstrated either abnormalities in neurocognitive testing or elevated symptoms , as judged by postconcussion symptom scores . For the concussed group , use of symptom and neurocognitive test results result ed in an increased yield of 29 % overreliance on symptoms alone . In contrast , 0 % of the control group had both symptoms and abnormal neurocognitive testing . Conclusion Reliance on patients ’ self-reported symptoms after concussion is likely to result in underdiagnosis of concussion and may result in premature return to play . Neurocognitive testing increases diagnostic accuracy when used in conjunction with self-reported symptoms OBJECT The aim of this study was to develop a decision rule for physicians in developing countries to identify patients with minor head injury who will benefit from emergency brain CT scanning . METHODS Three hundred eighteen patients with a history of blunt head trauma and a Glasgow Coma Scale ( GCS ) score > or= 13 who had presented within 12 hours of trauma underwent nonenhanced brain CT and were included in this prospect i ve study . Computed tomography findings that necessitated neurosurgical care ( either observation or intervention ) were considered as positive findings . Logistic regression was used to develop the decision rule . RESULTS Computed tomography scans were always normal in patients < 65 years old who did not have an obvious head wound , a raccoon sign , vomiting , memory deficit , or a decrease in their GCS score . Patients with 1 major criterion ( GCS score < 14 , raccoon sign , failure to remember the impact , age > 65 years , or vomiting ) or 2 minor criteria ( wound at the scalp or GCS score < 15 ) had an abnormal CT scan in 13 % of the cases . CONCLUSIONS The decision rule developed by the authors appears to be 100 % sensitive and 46 % specific for positive findings on brain CT and will , in developing countries , help clarify the decision to obtain scans OBJECTIVE : The purpose of this study was to compare concussion rates and recovery times for athletes wearing newer helmet technology compared to traditional helmet design . METHODS : This was a three-year , prospect i ve , naturalistic , cohort study . Participants were 2,141 high school athletes from Western Pennsylvania . Approximately half of the sample wore the Revolution helmet manufactured by Riddell , Inc. ( n = 1,173 ) and the remainder of the sample used st and ard helmets ( n = 968 ) . Athletes underwent computerized neurocognitive testing through the use of ImPACT at the beginning of the study . Following a concussion , players were reevaluated at various time intervals until recovery was complete . RESULTS : In the total sample , the concussion rate in athletes wearing the Revolution was 5.3 % and in athletes wearing st and ard helmets was 7.6 % [ & khgr;2 ( 1 , 2 , 141 ) = 4.96 , P < 0.027 ] . The relative risk estimate was 0.69 ( 95 % confidence interval = 0.499– 0.958 ) . Wearing the Revolution helmet was associated with approximately a 31 % decreased relative risk and 2.3 % decreased absolute risk for sustaining a concussion in this cohort study . The athletes wearing the Revolution did not differ from athletes wearing st and ard helmets on the mechanism of injury ( e.g. , head-to-head strike ) , on-field concussion markers ( e.g. , amnesia or loss of consciousness ) , or on-field presentation of symptoms ( e.g. , headaches , dizziness , or balance problems ) . CONCLUSION : Recent sophisticated laboratory research has better eluci date d injury biomechanics associated with concussion in professional football players . This data has led to changes in helmet design and new helmet technology , which appears to have beneficial effects in reducing the incidence of cerebral concussion in high school football players OBJECTIVE Our purpose was to determine whether sex differences exist with respect to post-concussion symptoms and neurocognitive function in concussed collegiate athletes . METHODS A prospect i ve dependent- sample cohort design was used to compare baseline and post-concussion neuropsychological test scores and endorsed symptoms as functions of serial post-concussion assessment with respect to time and sex . The Immediate Post-concussion Assessment and Cognitive Testing ( ImPACT ) battery was administered to a multicenter analysis group of 79 concussed athletes . This computerized neuropsychological test was given to the athletes during the preseason and , on average , 2 and 8 days postinjury . RESULTS Multivariate analyses revealed no significant between-group differences on baseline test performance with respect to sex on any of the ImPACT composite scores or on the total symptom score . Multivariate analyses of post-concussion data revealed a significant main effect of time on ImPACT scores , but no main effect of sex was identified , and no time-by-sex interaction existed . Post hoc analysis revealed that concussed female athletes performed significantly worse than concussed male athletes on visual memory tasks ( P = 0.001 ) , and analysis of endorsed post-concussion symptoms revealed that concussed men were significantly more likely than concussed women to report post-concussion symptoms of vomiting ( P = 0.001 ) and sadness ( P = 0.017 ) . Athletes ' scores were examined individually using the reliable-change methodology . At 2 days post-injury , 58 % of concussed athletes had one or more reliable incidents of performance decline or increases in symptom reporting . At 8 days post-concussion , 30 % of concussed athletes were still showing one or more reliable change from preseason values . CONCLUSIONS College athletes exhibit differences on visual memory composite scores and symptoms post-concussion as a function of sex . These data support the importance of evaluating neuropsychological status and post-concussion symptoms in concussed athletes . In addition , these data illustrate the importance of analyzing an individual athlete 's recovery pattern , because individual differences in recovery trajectories may be overshadowed by global norm-group comparisons The purpose of the current study was to explore potential differences in pre- and post-concussion performance on a computerized neurocognitive concussion test between African American and White high-school and collegiate student-athletes . A prospect i ve case-control design was used to compare baseline and 2- and 7-day post-concussion computerized neurocognitive performance and symptoms between 48 White and 48 African American athletes matched for age , gender , and concussion history . The Immediate Post-Concussion Assessment Cognitive Test ( ImPACT ) version 2.0 ( NeuroHealth System , LLC , Pittsburgh , PA , USA ) computer software program was used to assess neurocognitive function ( i.e. , verbal and visual memory , motor processing speed , and reaction time ) and concussion symptoms . Regardless of race/ethnicity , there were significant decrements in computerized neurocognitive performance and increased symptoms following a concussion for the entire sample . African Americans and Whites did not differ significantly on baseline or post-concussion verbal memory , visual memory , reaction time , and total reported symptoms . However , African American participants were 2.4 × more likely to have at least one clinical ly significant cognitive decline on ImPACT at 7 days post-concussion and scored lower at 7 days post-concussion compared with baseline on processing speed than White participants . The authors concluded that the baseline ImPACT test was culturally equivalent and construct valid for use with these two racial/ethnic groups . However , in contrast , the findings support deleterious performance for the African American athletes compared with the White athletes on the ImPACT post-concussion evaluation that is of critical clinical relevance and warrants further research OBJECTIVE The relationship between athlete reports of symptoms , neurophysiological activation , and neuropsychological functioning is investigated in a sample of high school athletes . METHODS All athletes were evaluated using functional magnetic resonance imaging ( fMRI ) , a computer-based battery of neurocognitive tests , and a subjective symptom scale . Athletes were evaluated within approximately 1 week of injury and again after clinical recovery using all assessment modalities . RESULTS This study found that abnormal fMRI results during the first week of recovery predicted clinical recovery . As a group , athletes who demonstrated hyperactivation on fMRI scans at the time of their first fMRI scan demonstrated a more prolonged clinical recovery than athletes who did not demonstrate hyperactivation at the time of their first fMRI scan . CONCLUSION These results demonstrate the relationship between neurophysiological , neuropsychological , and subjective symptom data in a relatively large sample composed primarily of concussed high school athletes . fMRI represents an important evolving technology for the underst and ing of brain recovery after concussion and may help shape return-to-play guidelines in the future BACKGROUND : This study compared early serum levels of ubiquitin C-terminal hydrolase ( UCH-L1 ) from patients with mild and moderate traumatic brain injury ( TBI ) with uninjured and injured controls and examined their association with traumatic intracranial lesions on computed tomography ( CT ) scan ( CT positive ) and the need for neurosurgical intervention ( NSI ) . METHODS : This prospect i ve cohort study enrolled adult patients presenting to three tertiary care Level I trauma centers after blunt head trauma with loss of consciousness , amnesia , or disorientation and a Glasgow Coma Scale ( GCS ) score 9 to 15 . Control groups included normal uninjured controls and nonhead injured trauma controls presenting to the emergency department with orthopedic injuries or motor vehicle crash without TBI . Blood sample s were obtained in all trauma patients within 4 hours of injury and measured by enzyme-linked immunosorbent assay for UCH-L1 ( ng/mL ± st and ard error of the mean ) . RESULTS : There were 295 patients enrolled , 96 TBI patients ( 86 with GCS score 13–15 and 10 with GCS score 9–12 ) , and 199 controls ( 176 uninjured , 16 motor vehicle crash controls , and 7 orthopedic controls ) . The AUC for distinguishing TBI from uninjured controls was 0.87 ( 95 % confidence interval [ CI ] , 0.82–0.92 ) and for distinguishing those TBIs with GCS score 15 from controls was AUC 0.87 ( 95 % CI , 0.81–0.93 ) . Mean UCH-L1 levels in patients with CT negative versus CT positive were 0.620 ( ±0.254 ) and 1.618 ( ±0.474 ) , respectively ( p < 0.001 ) , and the AUC was 0.73 ( 95 % CI , 0.62–0.84 ) . For patients without and with NSI , levels were 0.627 ( 0.218 ) versus 2.568 ( 0.854 ; p < 0.001 ) , and the AUC was 0.85 ( 95 % CI , 0.76–0.94 ) . CONCLUSION : UCH-L1 is detectable in serum within an hour of injury and is associated with measures of injury severity including the GCS score , CT lesions , and NSI . Further study is required to vali date these findings before clinical application . LEVEL OF EVIDENCE : II , prognostic study Previous studies have presented conflicting results regarding the predictive value of various clinical symptoms and signs for performing computed tomography ( CT ) scan in minor head injury . Moreover , despite the presence in the literature of several similar publications regarding whether or not CT should be employed at the time of presentation of minor head injured patients , data regarding delayed CT are limited . The objective of this study was to determine whether high-risk criteria represent a significant indication for initial CT scan in patients with minor head trauma , and whether or not analysis using delayed CT scan is necessary in patients with high-risk criteria before being discharged . Patients presenting to the Emergency Department with minor head trauma between September 1 , 2003 and September 1 , 2004 were evaluated prospect ively . After being divided into two main groups , low- and high-risk , four separate sub-groups based on age were established . Initial spiral CT examination was done within 3 h of trauma on all patients in addition to a delayed control CT scan in those with high-risk criteria between 16 and 24 h after trauma . The difference between the high- and low-risk groups in terms of abnormal CT findings was statistically significant ( p < 0.0005 ) . Among high-risk patients there was a significant OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

: The results of this systematic review identify the consistent and prevalent indicators of concussion and their associations , derived from the strongest evidence in the published literature .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE The authors examined the efficacy of intramuscular flunitrazepam compared with intramuscular haloperidol for the immediate control of agitated or aggressive behavior in acutely psychotic patients . METHOD Twenty-eight actively psychotic in patients , aged 20 - 60 years , who were under treatment with neuroleptic agents were selected for the study . Each was r and omly assigned on a double-blind basis to receive either 5 mg i.m . of haloperidol ( N=13 ) or 1 mg i.m . of flunitrazepam ( N=15 ) during an aggressive event . Verbal and physical aggression was measured over time with the Overt Aggression Scale . Patients were also rated with the Brief Psychiatric Rating Scale and the Clinical Global Impression scale . RESULTS Both flunitrazepam and haloperidol exhibited acute antiaggressive activity . This beneficial effect , as assessed by the Overt Aggression Scale , was obtained within 30 minutes . CONCLUSIONS Intramuscular flunitrazepam may serve as a convenient , rapid , safe , and effective adjunct to neuroleptics in reducing aggressive behavior in emergency psychiatric setting BACKGROUND Acute psychotic illness , especially when associated with agitated or violent behaviour , can require urgent pharmacological tranquillisation or sedation . In several countries , clinicians often use benzodiazepines ( either alone or in combination with antipsychotics ) for this outcome . OBJECTIVES To estimate the effects of benzodiazepines , alone or in combination with antipsychotics , when compared with placebo or antipsychotics , alone or in combination with antihistamines , to control disturbed behaviour and reduce psychotic symptoms . SEARCH METHODS We search ed the Cochrane Schizophrenia Group 's register ( January 2012 ) , inspected reference lists of included and excluded studies and contacted authors of relevant studies . SELECTION CRITERIA We included all r and omised clinical trials ( RCTs ) comparing benzodiazepines alone or in combination with any antipsychotics , versus antipsychotics alone or in combination with any other antipsychotics , benzodiazepines or antihistamines , for people with acute psychotic illnesses . DATA COLLECTION AND ANALYSIS We reliably selected studies , quality assessed them and extracted data . For binary outcomes , we calculated st and ard estimates of relative risk ( RR ) and their 95 % confidence intervals ( CI ) using a fixed-effect model . For continuous outcomes , we calculated the mean difference ( MD ) between groups . If heterogeneity was identified , this was explored using a r and om-effects model . MAIN RESULTS We included 21 trials with a total of n = 1968 participants . There was no significant difference for most outcomes in the one trial that compared benzodiazepines with placebo , although there was a higher risk of no improvement in people receiving placebo in the medium term ( one to 48 hours ) ( n = 102 , 1 RCT , RR 0.62 , 95 % CI 0.40 to 0.97 , very low quality evidence ) . There was no difference in the number of participants who had not improved in the medium term when benzodiazepines were compared with antipsychotics ( n = 308 , 5 RCTs , RR 1.10 , 95 % CI 0.85 to 1.42 , low quality evidence ) ; however , people receiving benzodiazepines were less likely to experience extrapyramidal effects ( EPS ) in the medium term ( n = 536 , 8 RCTs , RR 0.15 , 95 % CI 0.06 to 0.39 , moderate quality of evidence ) . Data comparing combined benzodiazepines and antipsychotics versus benzodiazepines alone did not yield any significant results . When comparing combined benzodiazepines/antipsychotics ( all studies compared haloperidol ) with the same antipsychotics alone ( haloperidol ) , there was no difference between groups in improvement in the medium term ( n = 155 , 3 RCTs , RR 1.27 , 95 % CI 0.94 to 1.70 , very low quality evidence ) but sedation was more likely in people who received the combination therapy ( n = 172 , 3 RCTs , RR 1.75 , 95 % CI 1.14 to 2.67 , very low quality evidence ) . However , more participants receiving combined benzodiazepines and haloperidol had not improved by medium term when compared to participants receiving olanzapine ( n = 60,1 RCT , RR 25.00 , 95 % CI 1.55 to 403.99 , very low quality evidence ) or ziprasidone ( n = 60 , 1 RCT , RR 4.00 , 95 % CI 1.25 to 12.75very low quality evidence ) . When haloperidol and midazolam were compared with olanzapine , there was some evidence the combination was superior in terms of improvement , sedation and behaviour . AUTHORS ' CONCLUSIONS The evidence from trials for the use of benzodiazepines alone is not good . There were relatively little good data and most trials are too small to highlight differences in either positive or negative effects . Adding a benzodiazepine to other drugs does not seem to confer clear advantage and has potential for adding unnecessary adverse effects . Sole use of older antipsychotics unaccompanied by anticholinergic drugs seems difficult to justify . Much more high quality research is needed in this area Rapid tranquilization is a routinely practice d method of calming agitated psychotic patients by use of neuroleptics , benzodiazepines , or both in combination . Although several studies have examined the efficacy of the three approaches , none have compared these treatments in a prospect i ve , r and omized , double-blind , multicenter trial . Ninety-eight psychotic , agitated , and aggressive patients ( 73 men and 25 women ) were prospect ively enrolled during an 18-month period in emergency departments in five university or general hospitals . Patients were r and omly assigned to receive intramuscular injections of lorazepam ( 2 mg ) , haloperidol ( 5 mg ) , or both in combination . Patients in each treatment group received 1 to 6 injections of the same study drug within 12 hours , based on clinical need . They were evaluated hourly after the first injection until at least 12 hours after the last . Efficacy was assessed on the Agitated Behavior Scale ( ABS ) , a modified Brief Psychiatric Rating Scale ( MBPRS ) , Clinical Global impressions ( CGI ) scale , and an Alertness Scale . Effective symptom reduction was achieved in each treatment group with significant ( P < .01 ) mean decreases from baseline at every hourly ABS evaluation . Significant ( P < .05 ) mean differences on the ABS ( hour 1 ) and MBPRS ( hours 2 and 3 ) suggest that tranquilization was most rapid in patients receiving the combination treatment . Study event incidence ( side effects ) did not differ significantly between treatment groups , although patients receiving haloperidol alone tended to have more extrapyramidal system symptoms . The superior results produced by the combination treatment support the use of lorazepam plus haloperidol as the treatment of choice for acute psychotic agitation OBJECTIVE To compare the effectiveness of intramuscular olanzapine , ziprasidone , haloperidol plus promethazine , haloperidol plus midazolam and haloperidol alone as the first medication(s ) used to treat patients with agitation and aggressive behavior . METHOD One hundred fifty patients with agitation caused by psychotic or bipolar disorder were r and omly assigned under double-blind conditions to receive olanzapine , ziprasidone , haloperidol plus midazolam , haloperidol plus promethazine or haloperidol alone . The Overt Agitation Severity Scale , Overt Aggression Scale and Ramsay Sedation Scale were applied within 12 hours after the first dosage . RESULTS All medications produced a calming effect within one hour of administration , but only olanzapine and haloperidol reduced agitation by less than 10 points , and only olanzapine reduced aggression by less than four points in the first hour . After twelve hours , only patients treated with haloperidol plus midazolam had high levels of agitation and aggression and also more side effects . Ziprasidone , olanzapine and haloperidol alone had more stable results for agitation control , while ziprasidone , haloperidol plus promethazine and olanzapine had stable results for aggression control . CONCLUSION Olanzapine , ziprasidone , haloperidol plus promethazine , haloperidol plus midazolam and haloperidol were effective in controlling agitation and aggression caused by mental illness over 12 hours . Although all the drugs had advantages and disadvantages , haloperidol plus midazolam was associated with the worst results in all the observed parameters Sixteen healthy volunteers were administered midazolam followed by placebo or the benzodiazepine antagonist , flumazenil , in a double-blind , cross-over study . Flumazenil reversed midazolam-induced sedation on the subjective , psychophysiological and motor indices used . In contrast , there was little evidence of any reversal of amnesic effects , which were assessed using both direct ( explicit ) and indirect ( implicit ) measures of memory . Results are discussed in terms of dissociating the sedative and amnesic effects of benzodiazepines The combination of haloperidol , 5 mg , and lorazepam , 4 mg , was both effective and safe for managing agitated behavior in an open trial with acutely psychotic patients . The combination also appeared to be superior to its individual components when studied in a r and omized , nonblind trial . The principle of the combined use of antipsychotics and sedative-hypnotics was further tested by comparing two new combinations : thiothixene , 5 mg , and lorazepam , 4 mg , versus haloperidol , 5 mg , and phenobarbital sodium , 130 mg . These combinations had comparable efficacy and safety , and the level of transquilization approached that produced by the haloperidol-lorazepam combination in the preceding studies Objective To determine whether haloperidol alone results in swifter and safer tranquillisation and sedation than haloperidol plus promethazine . Design Pragmatic r and omised open trial ( January-July 2004 ) . Setting Psychiatric emergency room , Rio de Janeiro , Brazil . Participants 316 patients who needed urgent intramuscular sedation because of agitation , dangerous behaviour , or both . Interventions Open treatment with intramuscular haloperidol 5 - 10 mg or intramuscular haloperidol 5 - 10 mg plus intramuscular promethazine up to 50 mg ; doses were at the discretion of the prescribing clinician . Main outcome measures The primary outcome was proportion tranquil or asleep by 20 minutes . Secondary outcomes were asleep by 20 minutes ; tranquil or asleep by 40 , 60 , and 120 minutes ; physically restrained or given additional drugs within 2 hours ; severe adverse events ; another episode of agitation or aggression ; additional visit from the doctor during the subsequent 24 hours ; overall antipsychotic load in the first 24 hours ; and still in hospital after 2 weeks . Results Primary outcome data were available for 311 ( 98.4 % ) people , 77 % of whom were thought to have a psychotic illness . Patients allocated haloperidol plus promethazine were more likely to be tranquil or asleep by 20 minutes than those who received intramuscular haloperidol alone ( relative risk 1.30 , 95 % confidence interval 1.10 to 1.55 ; number needed to treat 6 , 95 % confidence interval 4 to 16 ; P=0.002 ) . No differences were found after 20 minutes . However , 10 cases of acute dystonia occurred , all in the haloperidol alone group . Conclusions Haloperidol plus promethazine is a better option than haloperidol alone in terms of speed of onset of action and safety . Enough data are now available to change guidelines that continue to recommend treatments that leave people exposed to longer periods of aggression than necessary and patients vulnerable to distressing and unsafe adverse effects . Trial registration Current Controlled Trials IS RCT N83261243 A comparison of loxapine and haloperidol parenterally in acute psychotic , agitated patients was carried out as a r and omized double‐blind trial . The trial covered 15 patients in each group , and the diagnoses were psychogenic psychosis ( 18 cases ) and acute schizophrenia ( 12 cases ) . The patients received 25–50 mg loxapine or 2.5–5 mg haloperidol combined with biperiden 2.5–5 mg every 6–12 hours over a 72‐hour period . The average daily dose was 130 mg loxapine or 12 mg haloperidol In a double-blind , prospect i ve study , 2 mg of intramuscular lorazepam and 5 mg of intramuscular haloperidol were equally effective in controlling aggression , agitation , and assaultive behavior . Although lorazepam and haloperidol produced an equivalent mean decrease in aggression , significantly more subjects who received lorazepam had a greater decrease in aggression ratings than haloperidol recipients ; this effect was independent of sedation . Lorazepam produced significantly fewer extrapyramidal symptoms . These data support the current clinical practice of using lorazepam ( alone , or in combination with a neuroleptic ) for control of acute aggressive and assaultive behavior Abstract Objective To compare two widely used drug treatments for people with aggression or agitation due to mental illness . OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The association of haloperidol with promethazine ( H + P ) promoted tranquilization and presented better safety profile , with moderate quality evidence . Olanzapine demonstrated benefit towards tranquilization and good safety profile , but needed additional administration to keep tranquilization . There was no benefit in the use of haloperidol alone or associated to another psychotropic to most outcomes evaluated .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE The purpose of this prospect i ve study was to determine whether the timing of prophylactic antibiotics at cesarean delivery influences maternal/neonatal infectious morbidity . STUDY DESIGN In this double-blind placebo-controlled trial , cefazolin was given at skin incision ( group A ) or at cord clamping ( group B ) . Patients were eligible for the trial if they had labored and required a cesarean delivery . RESULTS Over a 30-month period 303 patients with singleton pregnancies entered the trial ; 153-group A , 149-group B. Demographics , indication for cesarean delivery ( P = .54 ) , and operative time ( P = .999 ) , as well as rates of endometritis ( RR 0.67 , 95 % CI 0.42 - 1.07 ) , wound infection ( RR 0.84 , 95 % CI 0.45 - 1.55 ) , neonatal sepis ( RR 1.28 , 95 % CI 0.91 - 1.79 ) , and NICU admissions ( RR 1.28 , 95 % CI 0.91 - 1.79 ) were similar between the 2 groups . CONCLUSION There was no difference in maternal infectious morbidity whether antibiotics were given before skin incision or at cord clamping In an ongoing prospect i ve study at 2 hospitals , 114 cesarean section patients were studied to determine whether giving ampicillin after umbilical cord clamping is as effective as perioperative ampicillin in reducing maternal postoperative morbidity . The same patients have also been studied to determine the effect of prophylactic cesarean section ampicillin on the newborn . Results have shown that prophylactic ampicillin initiated after cord clamping is as effective in reducing maternal morbidity as ampicillin initiated prior to the surgery . There is also no evidence from our study that the transplacental passage of prophylactic ampicillin increases immediate or delayed neonatal infections Eighteen vaginally delivered women who developed late postpartum endometritis seven to 42 days after delivery were prospect ively studied . Multiple microorganisms were recovered from the endometrium , including Chl aim ydia trachomatis , genital mycoplasmas , and a wide variety of bacteria . Erythromycin therapy was successful in ten of the 13 women who were followed OBJECTIVES To assess prospect ively the efficiency and safety of two extended spectrum cephalosporins used as pre-operative prophylaxis in nonelective cesarean sections , and compare the results to those of a third group of patients that received cefamezine post cord clamping . METHODS Two hundred and forty one patients undergoing a nonscheduled cesarean section were assigned to receive either cefonicid or ceftriaxone prior to skin incision . These patients were followed prospect ively for infectious and fetal complications . The outcome of these patients was also compared with another group of 194 patients that received cefamezine prophylaxis post cord clamping , and whose data were collected retrospectively . Chi-square analysis of variance were performed with P < 0.05 considered significant . RESULTS There were no significant differences in the febrile complications among the two groups of patients that received pre-operative prophylaxis . However , these patients had significantly less wound infections ( P = 0.008 ) and a significantly shorter hospital stay ( P < 0.001 ) than the patients who received their prophylactic antibiotics post cord clamping . CONCLUSIONS Extended-spectrum cephalosporins , when given pre-operatively , are both effective and safe , and may have an advantage over intra-operative first generation cephalosporins in the reduction of post cesarean section infectious morbidity OBJECTIVE : To describe the effect of an extended-spectrum prophylactic antibiotic regimen on postcesarean endometritis . METHODS : This is a cohort study of trends in postcesarean endometritis using data both from prospect i ve surveillance by the infection control unit and from query of our obstetric computerized data base to compare three periods of antibiotic prophylaxis : st and ard narrow-spectrum with intravenous first- or second-generation cephalosporin ( 1992–1996 ) , clinical trial of extended-spectrum with addition of intravenous doxycycline and oral azithromycin ( 1997–1999 ) , and routine use of extended-spectrum with addition of intravenous azithromycin ( 2001–2006 ) to st and ard cephalosporin prophylaxis . RESULTS : A total of 48,913 deliveries at 24 weeks or more of gestation occurred from 1992 to 2006 , of which 10,966 ( 22.4 % ) were cesarean deliveries . Annual cesarean rates increased from 16 % to 27.5 % . Trends in the incidence of postcesarean endometritis revealed a biphasic decrease consistent with the phased introduction of extended-spectrum prophylaxis . Incidence ( 95 % confidence interval [ CI ] ) of endometritis by prospect i ve surveillance dropped from 19.9 % ( 95 % CI 18.6–21.3 % ) to 15.4 % ( 95 % CI 13.2–17.9 % ) during the clinical trial period : relative risk ( RR ) 0.77 ( 95 % CI 0.66–0.91 ) , P=.002 ; and then to 6.3 % ( 95 % CI 5.0–7.9 % ) during routine use of extended-spectrum prophylaxis : RR 0.41 ( 95 % CI 0.31–0.54 ) , P<.001 . Corresponding incidence by data base query dropped from 23 % ( 95 % CI 21.5–24.4 % ) to 16 % ( 95 % CI 14.4–17.9 % ) : RR 0.69 ( 95 % CI 0.61–0.79 ) , P<.001 ; and then to 2.1 % ( 95 % CI 1.8–2.6 % ) : RR 0.13 ( 95 % CI 0.11–0.16 ) , P<.001 . These findings were unchanged after adjusting for potential confounders . CONCLUSION : Extended-spectrum antibiotic prophylaxis involving the addition of azithromycin to st and ard narrow-spectrum prophylaxis was associated with a significant reduction in postcesarean endometritis . LEVEL OF EVIDENCE : OBJECTIVE To determine if extended spectrum prophylactic antibiotic treatment ( with efficacy against Ureaplasma urealyticum ) reduces post – cesarean delivery clinical endometritis . METHODS After cord clamping at cesarean delivery , subjects received prophylaxis with cefotetan . Subjects were then simultaneously r and omized ( double blind ) to receive doxycyline plus azithromycin versus placebo . Post – cesarean delivery endometritis was defined clinical ly as fever of 100.4F or higher with one or more supporting clinical signs or a physician diagnosis of endometritis plus the absence of a nonpelvic source of fever . RESULTS A total of 597 women were enrolled , 301 in the doxycycline/azithromycin group and 296 in the placebo group . The study population was 56 % black , 25.5 ± 6.2 years of age , and 43 % nulliparous . The groups were similar ( P > .05 ) for black race , parity , maternal age , and most risk factors for post – cesarean delivery endometritis . The frequency of post – cesarean delivery endometritis ( 16.9 % versus 24.7 % , P = .020 ) , wound infections ( 0.8 % versus 3.6 % , P = .030 ) , and a combination of these two outcomes ( 19.0 % versus 27.8 % , P = .019 ) were significantly lower in the doxycycline/azithromycin group compared with the placebo-treated group . The doxycycline/azithromycin versus placebo groups were dissimilar for maternal leukocytosis ( 24.9 % versus 12.5 % , P = .042 ) and frequency of classic uterine incision ( 7.6 % versus 12.5 % , P = .048 ) . Adjusting for these factors did not alter the risk ratio for post – cesarean delivery endometritis in the active versus placebo-treated group ( relative risk 0.65 , 95 % confidence interval 0.43 , 0.98 ) . Length of stay was longer in the placebo group overall ( 104 ± 56 versus 95 ± 32 hours , P = .016 ) and among women with endometritis ( 146 ± 52 versus 127 ± 46 hours , P = .047 ) . CONCLUSION Extended spectrum prophylactic antibiotic treatment ( with presumed efficacy against U urealyticum ) given to women undergoing cesarean delivery at term shortens hospital stay and reduces the frequency of post – cesarean delivery endometritis and wound infections A protected , triple-lumen transcervical culture method was used to recover organisms from the endometrium . At least one facultative or one anaerobic species of bacteria was recovered from 82 % of the patients , and genital mycoplasmas were recovered from 76 % of the women with endometritis . Bacteria together with genital mycoplasmas were present in 61 % of the women , bacteria alone were present in 20 % , genital mycoplasmas alone were present in 16 % , and Chlamydia trachomatis was isolated from 2 % of the patients . The most common organisms included Gardnerella vaginalis , Peptococcus spp . , Bacteroides spp . , Staphylococcus epidermidis , group B Streptococcus , and Ureaplasma urealyticum . A r and omized , double-blind regimen of either piperacillin or cefoxitin was equally successful in treating the postpartum endometritis The objective of this study was to test the hypothesis that 1 g of cefazolin administered preoperatively is no more effective than the same dose administered after cord clamping in preventing postcesarean infectious morbidity . Ninety consecutive laboring subjects undergoing cesarean delivery at > or = 37 weeks gestation were r and omized by computer to receive 1 g of cefazolin intravenously preoperatively or after cord clamping in a double-blinded , placebo-controlled study . The 2 groups were compared for differences in maternal and neonatal demographics , and intrapartum and operative characteristics associated with postcesarean infection . Primary maternal outcome variables were endometritis or wound infection . Secondary outcomes included intra-abdominal abscess formation , septic pelvic thrombophlebitis , pneumonia , or urinary tract infection . Neonatal outcomes included sepsis screens , sepsis , pneumonia , and meningitis . Subjects were followed 6 weeks postoperatively for late complications . Subjects receiving cefazolin preoperatively or after cord clamping had similar maternal and neonatal demographics , and intrapartum and operative characteristics . One patient in the former group experienced both endometritis and wound infection . In the latter group , 2 wound infections and 1 case of endometritis occurred ( P = 0.35 ) . There were no secondary maternal infections . Two infants treated for pneumonia and 2 other infants readmitted with febrile illnesses were born to mothers receiving cefazolin preoperatively . Overall , 8 neonates were evaluated for suspected sepsis and all had negative studies . Six of these infants ' mothers received cefazolin preoperatively ( P = 0.28 ) . In conclusion , 1 gram of cefazolin preoperatively is no more effective than the same dose administered after cord clamping in preventing postcesarean infectious morbidity , but is associated with a trend toward increased suspected sepsis in the newborn . However , this trend may be related to differences between the study groups ' risk factors for infection OBJECTIVE The purpose of this study was to characterize the pharmacokinetics of orally administered azithromycin in the term gravid woman . STUDY DESIGN Twenty women who were scheduled for elective cesarean delivery were enrolled prospect ively and received 1 g of oral azithromycin at either 6 , 12 , 24 , 72 , or 168 hours before the operation . All women received spinal anesthesia , at which time a sample of cerebrospinal fluid was obtained for analysis . Maternal serum and urine were obtained immediately before the operation . Intraoperatively , sample s of myometrium , maternal adipose tissue , placenta , amniotic fluid , and umbilical arterial and venous cord blood were obtained . Azithromycin levels were determined quantitatively with high-pressure liquid chromatography with electrochemical detection . RESULTS All participants tolerated the preoperative azithromycin without significant adverse reactions . Peak maternal serum azithromycin levels occurred within 6 hours of drug administration . Although high serum levels of azithromycin were reached early , a rapid decline in drug concentration was noted over the initial 24 hours after the drug administration ( 6-hour : 311 ng/mL ; 24-hour : OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Although current guidelines for antibiotic prophylaxis recommend the administration of narrow-spectrum antibiotics ( cefazolin ) after clamping of the umbilical cord , the data suggest that antibiotic administration before surgical incision or the use of extended-spectrum regimens ( involving azithromycin or metronidazole ) after cord clamp may reduce postcesarean maternal infection by up to 50 % . : The use of either cefazolin alone before surgical incision or an extended-spectrum regimen after cord clamp seems to be associated with a reduction in postcesarean maternal infection .

MS2_fixed_5_shot230

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Aim : To investigate the acceptability and feasibility of adapted group therapy for anxiety in children with autism spectrum disorder in a pilot r and omised controlled trial . Method : A total of 32 children aged 9–13 years were r and omised to immediate or delayed therapy using the ‘ Exploring Feelings ’ manual ( Attwood , 2004 ) . Child and parent groups were run in parallel , for seven weekly sessions , under the supervision of experienced psychologists . The primary blinded outcome measures addressed change in overall functioning and in severity of the primary anxiety diagnosis after 3 months . Results : Children met diagnostic criteria for 1–6 anxiety disorders ( median 3 ) . At end point , both parents and children in the immediate therapy group were more likely to report a reduction in anxiety symptoms . Fidelity of delivery of the group therapy was high , and attendance was 91 % . Conclusions : This pilot trial established that children and families were willing to be recruited and r and omised , the outcome measures were acceptable , the format and content of the groups were feasible within UK child and adolescent mental health services , the intervention was appreciated by families and attrition was very small BACKGROUND Children with high-functioning autism spectrum disorders ( ASD ) are at high risk for developing significant anxiety . Anxiety can adversely impact functioning across school , home and community environments . Cognitive behavioral therapies ( CBT ) are frequently used with success for children with anxiety symptoms . Modified CBT interventions for anxiety in children with ASD have also yielded promising results . METHODS Fifty children with high-functioning ASD and anxiety were r and omizedto group CBT or treatment-as-usual ( TAU ) for 12 weeks . Independent clinical evaluators , blind to condition , completed structured interviews ( Anxiety Disorders Interview Schedule – Parent Version;ADIS-P ) pre- and post-intervention condition . RESULTS Forty-seven children completed either the CBT or TAU condition . Results indicated markedly better outcomes for the CBT group . Significant differences by group were noted in Clinician Severity Ratings , diagnostic status , and clinician ratings of global improvement . In the intent-to-treat sample , 10 of 20 children ( 50 % ) in the CBT group had a clinical ly meaningful positive treatment response , compared to 2 of 23 children ( 8.7 % ) in the TAU group . CONCLUSIONS Initial results from this r and omized , design ed treatment study suggest that agroup CBT intervention specifically developed for children with ASD may be effective in decreasing anxiety . Limitations of this study include small sample size , lack of an attention control group , and use of outcome measures normed with typically developing Data from a r and omized clinical trial comparing the relative efficacy of individual cognitive-behavioral therapy ( ICBT ) , family CBT ( FCBT ) , and a family-based education/support/attention control ( FESA ) condition were used to examine associations between in-session therapeutic techniques related to parent training ( PT ) and treatment outcomes . This study explored the extent to which therapists ' use of PT techniques , specifically ( a ) parental anxiety management , ( b ) transfer of control from therapist to parent to child over child 's coping , ( c ) communication skills training , and ( d ) contingency management training , contributed to treatment outcome in family-based CBT . Children ( N = 53 ; 31 males ; 7.8 - 13.8 years of age ; M = 10.1 years , SD = 2.3 ; 85 % Caucasian , 9 % African American , 4 % Asian , 2 % " other " background ) with a principal anxiety disorder completed 16 sessions of CBT with their parents . The relative contributions of PT components on treatment outcome were evaluated . As hypothesized , both transfer-of-control and parental anxiety management techniques significantly contributed to improvement on clinician and parent ratings of child global functioning within FCBT . PT did not significantly contribute to improvement on measures of child anxiety . These preliminary findings suggest that when FCBT is conducted for child anxiety , PT ( i.e. , transfer-of-control and parental anxiety management techniques ) may contribute to improvements in the child 's global functioning Anxiety is common among adolescents with autism spectrum disorders ( ASD ) and may amplify the core social disability , thus necessitating combined treatment approaches . This pilot , r and omized controlled trial evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention ( MASSI ) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity . The treatment was acceptable to families , subject adherence was high , and therapist fidelity was high . A 16 % improvement in ASD social impairment ( within-group effect size = 1.18 ) was observed on a parent-reported scale . Although anxiety symptoms declined by 26 % , the change was not statistically significant . These findings suggest MASSI is a feasible treatment program and further evaluation is warranted OBJECTIVE To examine the efficacy of a modular cognitive-behavioral therapy ( CBT ) protocol relative to treatment as usual ( TAU ) among children with high-functioning autism spectrum disorders ( ASD ) and clinical ly significant anxiety . METHOD A total of 45 children ( 7 - 11 years of age ) with high-functioning ASD and clinical ly significant anxiety were r and omized to receive 16 sessions of weekly CBT or TAU for an equivalent duration . After screening , assessment s were conducted at baseline , post-treatment , and 3-month follow-up . Raters were blind to treatment condition . RESULTS Youth receiving CBT showed substantial improvement relative to TAU on primary anxiety outcomes . Of 24 children r and omized to the CBT arm , 18 ( 75 % ) were treatment responders , versus only 3 of 21 children ( 14 % ) in the TAU arm . Gains were generally maintained at 3-month follow-up for CBT responders . CONCLUSIONS Relative to usual care , CBT adapted for anxious youth with high-functioning ASD demonstrates large effects in reducing anxiety symptoms . This study contributes to the growing literature supporting adapted CBT approaches for treating anxiety in youth with ASD BACKGROUND High rates of anxiety disorders , particularly obsessive compulsive disorder ( OCD ) are reported in people with Autism spectrum disorders ( ASD ) . Group cognitive behavioral treatment ( CBT ) has been found effective for anxiety in young people with ASD but not been OCD specific . One uncontrolled pilot study of individual CBT for OCD for adults with ASD showed good treatment efficacy . METHODS Forty-six adolescents and adults ( mean age 26.9 years , 35 Males ) with ASD and comorbid OCD were r and omized to CBT for OCD or anxiety management ( AM ) , a plausible control treatment . Treatments were matched in duration ( mean of 17.4 sessions CBT ; 14.4 sessions AM ) , the Yale-Brown Obsessive Compulsive Severity Scale ( YBOCS ) as primary outcome measure and evaluations blind to treatment group . Treatment response was defined as > 25 % reduction in YBOCS total severity scores . RESULTS Both treatments produced a significant reduction in OCD symptoms , within-group effect sizes of 1.01 CBT group and 0.6 for the AM group . There were no statistically significant differences between the two groups at end of treatment , although more responders in the CBT group ( 45 versus 20 % ) . Effect sizes for self-rated improvement were small ( 0.33 CBT group ; -0.05 AM group ) . Mild symptom severity was associated with improvement in the AM but not the CBT group . Family/carer factors were important for both groups , in that increased family accommodation was associated with poorer outcome . CONCLUSIONS Evidence -based psychological interventions , both AM and CBT , were effective in treating comorbid OCD in young people and adults with ASD The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder ( ASD ) . Twenty-two children ( ages 8–14 ; IQ ≥ 70 ) with ASD and clinical ly significant anxiety were r and omly assigned to 16 sessions of the Coping Cat program ( cognitive-behavioral therapy ; CBT ) or a 16-week waitlist . Children in the CBT condition evidence d significantly larger reductions in anxiety than those in the waitlist . Treatment gains were largely maintained at two-month follow-up . Results provide preliminary evidence that a modified version of the Coping Cat program may be a feasible and effective program for reducing clinical ly significant levels of anxiety in children with high-functioning ASD This study aim ed to evaluate the Program for the Education and Enrichment of Relational Skills ( PEERS : Laugeson et al. in J Autism Dev Disord 39(4):596–606 , 2009 ) . PEERS focuses on improving friendship quality and social skills among adolescents with higher-functioning ASD . 58 participants aged 11–16 years-old were r and omly assigned to either an immediate treatment or waitlist comparison group . Results revealed , in comparison to the waitlist group , that the experimental treatment group significantly improved their knowledge of PEERS concepts and friendship skills , increased in their amount of get-togethers , and decreased in their levels of social anxiety , core autistic symptoms , and problem behaviors from pre-to post-PEERS . This study provides the first independent replication and extension of the empirically-supported PEERS social skills intervention for adolescents with ASD BACKGROUND Children with autism spectrum disorders often present with comorbid anxiety disorders that cause significant functional impairment . This study tested a modular cognitive behavioral therapy ( CBT ) program for children with this profile . A st and ard CBT program was augmented with multiple treatment components design ed to accommo date or remediate the social and adaptive skill deficits of children with ASD that could pose barriers to anxiety reduction . METHOD Forty children ( 7 - 11 years old ) were r and omly assigned to 16 sessions of CBT or a 3-month waitlist ( 36 completed treatment or waitlist ) . Therapists worked with individual families . The CBT model emphasized behavioral experimentation , parent-training , and school consultation . Independent evaluators blind to treatment condition conducted structured diagnostic interviews and parents and children completed anxiety symptom checklists at baseline and posttreatment/postwaitlist . RESULTS In intent-to-treat analyses , 78.5 % of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment , as compared to only 8.7 % of the waitlist group . CBT also outperformed the waitlist on diagnostic outcomes and parent reports of child anxiety , but not children 's self-reports . Treatment gains were maintained at 3-month follow-up . CONCLUSIONS The CBT manual employed in this study is one of the first adaptations of an evidence -based treatment for children with autism spectrum disorders . Remission of anxiety disorders appears to be an achievable goal among high-functioning children with autism BACKGROUND The aim of the study was to evaluate the effectiveness of a brief CBT intervention for anxiety with children diagnosed with Asperger syndrome ( AS ) . A second interest was to evaluate whether more intensive parent involvement would increase the child 's ability to manage anxiety outside of the clinic setting . METHODS Seventy-one children aged ten to twelve years were recruited to participate in the anxiety programme . All children were diagnosed with AS and the presence of anxiety symptoms was accepted on parent report via brief interview . Children were r and omly assigned to one of three conditions : intervention for child only , intervention for child and parent , wait-list control . RESULTS The two intervention groups demonstrated significant decreases in parent-reported anxiety symptoms at follow-up and a significant increase in the child 's ability to generate positive strategies in an anxiety-provoking situation . There were a number of significant differences between the two interventions to suggest parent involvement as beneficial . CONCLUSIONS The sample of children with AS in this study presented with a profile of anxiety similar to a sample of clinical ly diagnosed anxious children . The intervention was endorsed by parents as a useful programme for children diagnosed with Asperger syndrome and exhibiting anxiety symptoms , and active parent involvement enhanced the usefulness of the programme . Limitations of the study and future research are discussed We compared the effects of a 16-week Cognitive-Behavioral Therapy ( CBT ) program and a Social Recreational ( SR ) program on anxiety in children with Autism Spectrum Disorders ( ASD ) . Seventy children ( 9–16 years old ) were r and omly assigned to either of the programs ( nCBT = 36 ; nSR = 34 ) . Measures on child ’s anxiety using the Spence Child Anxiety Scale — Child ( SCAS-C ) and the Clinical Global Impression — Severity scale ( CGI-S ) were administered at pre- , post-treatment , and follow-ups ( 3- and 6-month ) . Children in both programs showed significantly lower levels of generalized anxiety and total anxiety symptoms at 6-month follow-up on SCAS-C. Clinician ratings on the CGI-S demonstrated an increase in the percentage of participants rated as “ Normal ” and “ Borderline ” for both programs . Findings from the present study suggest factors such as regular sessions in a structured setting , consistent therapists , social exposure and the use of autism-friendly strategies are important components of an effective framework in the management of anxiety in children and adolescents with ASD OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Clinician- and parent-reported outcome measures showed that psychosocial interventions were superior to waitlist and treatment-as-usual control conditions at post-treatment . However , the results of self-reported outcome measures failed to reach significance . The sensitivity analyses did not significantly change these results and the subgroup analysis indicated that individual treatment was more effective than group treatment .

MS2_fixed_5_shot231

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: PURPOSE OF THE STUDY Older adults ' gait is disturbed when a dem and ing secondary cognitive task is added . Gait training has been shown to improve older adults ' walking performance , but it is not clear how training affects their cognitive performance . This study examined the impact on gait , in terms of cost or benefit to cognitive performance , of training healthy older adults to walk to a rhythmic musical beat . DESIGN AND METHODS In a mixed model design , 45 healthy older adults aged more than 65 years ( M = 71.7 years ) were r and omly assigned to 3 groups . One group received a rhythmic musical training and their dual-task ( DT ) walking and cognitive performances were compared with a group who had music playing in the background but no training , and a third group who heard no music and received no training . Outcomes in single-task ( ST ) and DT conditions were step-time variability and velocity for gait and correct cognitive responses for the cognitive task . RESULTS The Musical Training group 's step-time variability improved in both the ST ( p < .05 ) and the DT ( p < .05 ) after training , without adversely affecting their cognitive performance . No change was seen in the control groups . IMPLICATION S Rhythmic musical training can improve gait steadiness in healthy older adults with no negative impact on concurrent cognitive functioning . This could potentially enhance " postural reserve " and reduce fall risk Background Home-based exercise programs can improve physical functioning and health status of elderly people . Successful implementation of exercise interventions for older people presents major challenges and supporting elderly people properly while doing their home-based exercises is essential for training success . We developed a tablet-based system — ActiveLifestyle — that offers older adults a home-based strength-balance training program with incorporated motivation strategies and support features . Objective The goal was to compare 3 different home-based training programs with respect to their effect on measures of gait quality and physical performance through planned comparisons between ( 1 ) tablet-based and brochure-based interventions , ( 2 ) individual and social motivation strategies , and ( 3 ) active and inactive participants . Methods A total of 44 autonomous-living elderly people ( mean 75 , SD 6 years ) were assigned to 3 training groups : social ( tablet guided , n=14 ) , individual ( tablet guided , n=13 ) , and brochure ( brochure guided , n=17 ) . All groups joined a 12-week progressive home-based strength-balance training program . Outcome measures were gait performance under single and dual task conditions , dual task costs of walking , falls efficacy , and physical performance as measured by the Short Physical Performance Battery ( SPPB ) . Furthermore , active ( ≥75 % program compliance ) and inactive ( < 75 % program compliance ) individuals were compared based on their characteristics and outcome measures . Results The tablet groups showed significant improvements in single and dual task walking , whereas there were no significant changes observable in the brochure group . Between-groups comparisons revealed significant differences for gait velocity ( U=138.5 ; P=.03 , r=.33 ) and cadence ( U=138.5 , P=.03 r=.34 ) during dual task walking at preferred speed in favor of the tablet groups . The brochure group had more inactive participants , but this did not reach statistical significance ( U=167 , P=.06 , r=.29 ) . The active participants outperformed the inactive participants in single and dual task walking , dual task costs of walking , and SPPB scores . Significant between-groups differences were seen between the tablet groups and the brochure group , in favor of the tablet groups . Conclusions A tablet-based strength-balance training program that allows monitoring and assisting autonomous-living older adults while training at home was more effective in improving gait and physical performance when compared to a brochure-based program . Social or individual motivation strategies were equally effective . The most prominent differences were observed between active and inactive participants . These findings suggest that in older adults a tablet-based intervention enhances training compliance ; hence , it is an effective way to improve gait Background Community ambulation is a highly complex skill requiring the ability to adapt to increased environmental complexity and perform multiple tasks simultaneously . After stroke , individuals demonstrate a diminished ability to perform dual-tasks . Current evidence suggests that conventional rehabilitation does not adequately address gait-related dual-task impairments after stroke , which may be contributing to low levels of participation and physical inactivity in community-dwelling stroke survivors . The objective of this study is to investigate the efficacy of dual-task gait training in community-dwelling adults within 1 year of stroke . Specifically , we will compare the effects of dual-task gait training and single-task gait training on cognitive-motor interference during walking at preferred speed and at fastest comfortable speed ( Aim 1 ) , locomotor control during obstacle negotiation ( Aim 2 ) , and spontaneous physical activity ( Aim 3 ) . Methods / Design This single-blind r and omized controlled trial will involve 44 individuals within 12 months of stroke . Following baseline evaluation , participants will be r and omly allocated to single- or dual-task gait training . Both groups will receive 12 , 30-minute sessions provided one-on-one over 4–6 weeks in an outpatient therapy setting . Single-task gait training involves practice of gait activities incorporating motor relearning principles . Dual-task gait training involves an identical gait training protocol ; the critical difference being that the dual-task gait training group will practice the gait activities while simultaneously performing a cognitive task for 75 % of the repetitions . Blinded assessors will measure outcomes at baseline , post-intervention , and 6 months after completion of the intervention . The primary outcome measure will be dual-task effects on gait speed and cognition during unobstructed walking . Secondary outcomes include spatiotemporal and kinetic gait parameters during unobstructed single- and dual-task walking at preferred and fastest comfortable walking speeds , gait parameters during high and low obstacle crossing , spontaneous physical activity , executive function , lower extremity motor function , Timed Up and Go , balance self-efficacy , number of falls , and stroke-related disability . Hypotheses for each aim will be tested using an intention-to-treat analysis with repeated measures ANOVA design . Discussion This trial will provide evidence to help clinicians make decisions about the types of activities to include in rehabilitation to improve dual-task walking after stroke . Trial registration Clinical Trials.gov This study examined transfer effects of fall training on fear of falling ( Falls Efficacy Scale-International [ FES-I ] ) , balance performance , and spatiotemporal gait characteristics in older adults . Eighteen community-dwelling older adults ( ages 65 - 85 ) were r and omly assigned to an intervention or control group . The intervention group completed 12 training sessions ( 60 min , 6 weeks ) . During pre- and posttesting , we measured FES-I , balance performance ( double limb , closed eyes ; single limb , open eyes ; double limb , open eyes with motor-interfered task ) , and gait parameters ( e.g. , velocity ; cadence ; stride time , stride width , and stride length ; variability of stride time and stride length ) under single- and motor-interfered tasks . Dual tasks were applied to appraise improvements of cognitive processing during balance and gait . FES-I ( p = .33 ) and postural sway did not significantly change ( 0.36 < p < .79 ) . Trends toward significant interaction effects were found for step width during normal walking and stride length variability during the motor dual task ( p = .05 , ηp 2 = .22 ) . Fall training did not sufficiently improve fear of falling , balance , or gait performance under single- or dual-task conditions in healthy older adults Objective : To evaluate the effects of a balance training program including dual- and multi-task exercises on fall-related self-efficacy , fear of falling , gait and balance performance , and physical function in older adults with osteoporosis with an increased risk of falling and to evaluate whether additional physical activity would further improve the effects . Design : R and omized controlled trial , including three groups : two intervention groups ( Training , or Training+Physical activity ) and one Control group , with a 12-week follow-up . Setting : Stockholm County , Sweden . Participants : Ninety-six older adults , aged 66 - 87 , with verified osteoporosis . Interventions : A specific and progressive balance training program including dual- and multi-task three times/week for 12 weeks , and physical activity for 30 minutes , three times/week . Main measures : Fall-related self-efficacy ( Falls Efficacy Scale-International ) , fear of falling ( single-item question – ‘ In general , are you afraid of falling ? ’ ) , gait speed with and without a cognitive dual-task at preferred pace and fast walking ( GAITRite ® ) , balance performance tests ( one-leg stance , and modified figure of eight ) , and physical function ( Late-Life Function and Disability Instrument ) . Results : Both intervention groups significantly improved their fall-related self-efficacy as compared to the controls ( p ≤ 0.034 , 4 points ) and improved their balance performance . Significant differences over time and between groups in favour of the intervention groups were found for walking speed with a dual-task ( p=0.003 ) , at fast walking speed ( p=0.008 ) , and for advanced lower extremity physical function ( p=0.034 ) . Conclusions : This balance training program , including dual- and multi-task , improves fall-related self-efficacy , gait speed , balance performance , and physical function in older adults with osteoporosis The purpose of this study was to compare the efficiency of three different balance training strategies in an effort to underst and the mechanisms underlying training-related changes in dual-task balance performance of older adults with balance impairment . Elderly individuals with balance impairment , age 65 and older , were r and omly assigned to one of three individualized training programs : single-task ( ST ) balance training ; dual-task training with fixed-priority ( FP ) instruction ; and dual-task training with variable-priority ( VP ) instruction . Balance control during gait , under practice d and novel conditions , was assessed by calculating the center of mass and ankle joint center inclination angles in the frontal plane . A smaller angle indicated better balance performance . Other outcomes included gait velocity , stride length , verbal reaction time , and rate of response . All measures were collected at baseline and the end of the 4-week training . Results indicated that all training strategies were equally effective ( P>.05 ) at improving balance performance ( smaller inclination angle ) under single-task context s. However , the VP training strategy was more effective ( P=.04 ) in improving both balance and cognitive performance under dual-task conditions than either the ST or the FP training strategies . Improved dual-task processing skills did not transfer to a novel dual-task condition . Results support Kramer et al. 's proposal that VP training improves both single-task automatization and the development of task-coordination skills Background Previous research has mainly targeted older people with high risk of falling . The effectiveness of exercise interventions in older people with mild levels of balance dysfunction remains unexplored . Objective This study evaluated the effectiveness of a home balance and strength exercise intervention in older people systematic ally screened as having mild balance dysfunction . Design This was a community-based , r and omized controlled trial with assessors blinded to group allocation . Participants Study participants were older people who reported concerns about their balance but remained community ambulant ( n=225 ) . After a comprehensive balance assessment , those classified as having mild balance dysfunction ( n=165 ) were r and omized into the trial . Intervention Participants in the intervention group ( n=83 ) received a 6-month physical therapist – prescribed balance and strength home exercise program , based on the Otago Exercise Program and the Visual Health Information Balance and Vestibular Exercise Kit . Participants in the control group ( n=82 ) continued with their usual activities . Outcome Measures Laboratory and clinical measures of balance , mobility , and strength were assessed at baseline and at a 6-month re assessment . Results After 6 months , the intervention group ( n=59 ) significantly improved relative to the control group ( n=62 ) for : the Functional Reach Test ( mean difference=2.95 cm , 95 % confidence interval [CI]=1.75 to 4.15 ) , the Step Test ( 2.10 steps/15 seconds , 95 % CI=1.17 to 3.02 ) , hip abductor strength ( 0.02 , 95 % CI=0.01 to 0.03 ) , and gait step width ( 2.17 cm , 95 % CI=1.23 to 3.11 ) . There were nonsignificant trends for improvement on most other measures . Fourteen participants in the intervention group ( 23.7 % ) achieved balance performance within the normative range following the exercise program , compared with 3 participants ( 4.8 % ) in the control group . Limitations Loss to follow-up ( 26.6 % ) was slightly higher than in some similar studies but was unlikely to have biased the results . Conclusions A physical therapist – prescribed home exercise program targeting balance and strength was effective in improving a number of balance and related outcomes in older people with mild balance impairment Background While many studies confirm the positive effect of cognitive and physical training on cognitive performance of older adults , only little is known about the effects of simultaneously performed cognitive and physical training . In the current study , older adults simultaneously performed a verbal working memory and a cardiovascular training to improve cognitive and motor-cognitive dual task performance . Twenty training sessions of 30 minutes each were conducted over a period of ten weeks , with a test session before , in the middle , and after the training . Training gains were tested in measures of selective attention , paired-associates learning , executive control , reasoning , memory span , information processing speed , and motor-cognitive dual task performance in the form of walking and simultaneously performing a working memory task . Results Sixty-three participants with a mean age of 71.8 ± 4.9 years ( range 65 to 84 ) either performed the simultaneous training ( N = 21 ) , performed a single working memory training ( N = 16 ) , or attended no training at all ( N OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Evidence from subgroup comparisons showed no difference in treatment-related changes between cognitive-motor and motor-motor dual tasks , or when interventions were compared to active or inactive controls . In summary , physical exercise interventions can improve dual-task walking in older adults primarily by increasing the speed at which individuals walk in dual-task conditions . Currently , evidence concerning whether physical exercise interventions reduce DTC or alter the self-selected dual-task strategy during unobstructed walking is greatly lacking , mainly due to the failure of studies to measure and report reciprocal dual-task effects on the non-gait task

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values < 0.01 . CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity Background R and omised controlled trials demonstrate a 60 % reduction in type 2 diabetes incidence through lifestyle modification programmes . The aim of this study is to determine whether such programmes are feasible in primary health care . Methods An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes . A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006 . Main outcome measures taken at baseline , three , and 12 months included weight , height , waist circumference , fasting plasma glucose and lipids , plasma glucose two hours after oral glucose challenge , blood pressure , measures of psychological distress and general health outcomes . To test differences between baseline and follow-up , paired t-tests and Wilcoxon rank sum tests were performed . Results At twelve months participants ' mean weight reduced by 2.52 kg ( 95 % confidence interval 1.85 to 3.19 ) and waist circumference by 4.17 cm ( 3.48 to 4.87 ) . Mean fasting glucose reduced by 0.14 mmol/l ( 0.07 to 0.20 ) , plasma glucose two hours after oral glucose challenge by 0.58 mmol/l ( 0.36 to 0.79 ) , total cholesterol by 0.29 mmol/l ( 0.18 to 0.40 ) , low density lipoprotein cholesterol by 0.25 mmol/l ( 0.16 to 0.34 ) , triglycerides by 0.15 mmol/l ( 0.05 to 0.24 ) and diastolic blood pressure by 2.14 mmHg ( 0.94 to 3.33 ) . Significant improvements were also found in most psychological measures . Conclusion This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care setting s , with reductions in risk factors approaching those observed in clinical trials . Trial NumberCurrent Controlled Trials IS RCT The purpose of the present study was to evaluate the impact of a lifestyle intervention programme , combined with a daily low-glycaemic index meal replacement , on body-weight and glycaemic control in subjects with impaired glucose regulation ( IGR ) . Subjects with IGR were r and omly assigned to an intervention group ( n 46 ) and a control group ( n 42 ) . Both groups received health counselling at baseline . The intervention group also received a daily meal replacement and intensive lifestyle intervention to promote healthy eating habits during the first 3 months of the study , and follow-up visits performed monthly until the end of the 1-year study . Outcome measurements included changes in plasma glucose , glycated Hb ( HbA1c ) , plasma lipids , body weight , blood pressure and body composition ( such as body fat mass and visceral fat area ) . The results showed that body-weight loss after 1 year was significant in the intervention group compared with the control group ( -1·8 ( SEM 0·35 ) v. -0·6 ( SEM 0·40 ) 2·5 kg , P<0·05 ) . The 2 h plasma glucose concentration decreased 1·24 mmol/l in the intervention group and increased 0·85 mmol/l in the control group ( P<0·05 ) compared with their baseline , respectively . A 5 kg body-weight loss at 1 year was associated with a decrease of 1·49 mmol/l in 2 h plasma glucose ( P<0·01 ) . The incidence of normal glucose regulation ( NGR ) in the two groups was significantly different ( P=0·001 ) . In conclusion , the combination of regular contact , lifestyle advice and meal replacement is beneficial in promoting IGR to NGR BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p<0.001 ; difference between groups ) . Intervention participants also had greater changes in total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p<0.001 ) . These differences were sustained after 12 months , and adjustment for differences in race and gender did not alter these findings . With only two matched YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention BACKGROUND Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus . The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care setting s. OBJECTIVE We investigated the effect of medical nutrition therapy ( MNT ) compared with usual care on fasting plasma glucose values , glycated hemoglobin ( HbA1c ) , serum lipid levels , and Diabetes Risk Score , from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes . DESIGN Prospect i ve , r and omized , parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7 % to 6.4 % , recruited between April 2010 and May 2011 who completed a 12-week intervention period . MAIN OUTCOME MEASURES The primary outcome measure was fasting plasma glucose . Secondary outcome measures were HbA1c , serum lipid levels , and Diabetes Risk Score . STATISTICAL ANALYSES A factorial repeated measures analysis of variance was used to make comparisons between the two groups ( the MNT and usual care groups ) and two measures of time ( baseline and 12 weeks postintervention ) . Data analysis was performed using the Statistical Package for the Social Sciences ( release 19.0 , 2010 , SPSS Inc ) . RESULTS There was a significant interaction for group assignment and HbA1c ( P=0.01 ) , with the MNT group experiencing significantly lower HbA1c levels than the usual care group ( 5.79 % vs 6.01 % ) after the 12-week intervention . There was a significant interaction for group assignment and Diabetes Risk Score ( P=0.001 ) . Diabetes Risk Score for the MNT group decreased from 17.54±3.69 to 15.31±3.79 compared with the usual care group score , which went from 17.23±4.69 to 16.83±4.73 . Regardless of group assignment , both groups experienced a reduction in total cholesterol ( P=0.01 ) and low-density lipoprotein cholesterol ( P=0.04 ) level . CONCLUSIONS The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes Purpose The objective was to take prevention from the clinic to the community by including a high-risk group and working with the community to tailor , enhance , deliver , and evaluate a community-based version of the Diabetes Prevention Program ’s ( DPP ) clinic-based lifestyle intervention . Methods This was a nonr and omized prospect i ve study using a single-group design . Study eligibility included a screening glucose value in the normal to prediabetes range with no current diagnosis of diabetes , overweight , not pregnant nor planning to become pregnant during study period , aged 18 to 65 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The cost of intervention per participant delivered by dietitians was lower than interventions delivered by non-dietitians , although few studies reported costs . Lifestyle interventions are effective in reducing body weight and glucose-related outcomes . Dietitian-delivered interventions , compared with those delivered by other personnel , achieved greater weight reduction . No consistent trend was identified across different delivery channels

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Low serum 25-hydroxyvitamin D ( 25-[OH]D ) levels have been associated with lower FEV(1 ) , impaired immunologic control , and increased airway inflammation . Because many patients with chronic obstructive pulmonary disease ( COPD ) have vitamin D deficiency , effects of vitamin D supplementation may extend beyond preventing osteoporosis . OBJECTIVE To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations . DESIGN R and omized , single-center , double-blind , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00666367 ) SETTING University Hospitals Leuven , Leuven , Belgium . PATIENTS 182 patients with moderate to very severe COPD and a history of recent exacerbations . INTERVENTION 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year . MEASUREMENTS The primary outcome was time to first exacerbation . Secondary outcomes were exacerbation rate , time to first hospitalization , time to second exacerbation , FEV(1 ) , quality of life , and death . RESULTS Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group ( mean between-group difference , 30 ng/mL [ 95 % CI , 27 to 33 ng/mL ] ; P < 0.001 ) . The median time to first exacerbation did not significantly differ between the groups ( hazard ratio , 1.1 [ CI , 0.82 to 1.56 ] ; P = 0.41 ) , nor did exacerbation rates , FEV(1 ) , hospitalization , quality of life , and death . However , a post hoc analysis in 30 participants with severe vitamin D deficiency ( serum 25-[OH]D levels < 10 ng/mL ) at baseline showed a significant reduction in exacerbations in the vitamin D group ( rate ratio , 0.57 [ CI , 0.33 to 0.98 ] ; P = 0.042 ) . LIMITATION This was a single-center study with a small sample size . CONCLUSION High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations . In participants with severe vitamin D deficiency at baseline , supplementation may reduce exacerbations . PRIMARY FUNDING SOURCE Applied Biomedical Research Program , Agency for Innovation by Science and Technology ( IWT-TBM ) RATIONALE Restoration of vitamin D sufficiency may reduce asthma exacerbations , events that are often associated with respiratory tract infections and cold symptoms . OBJECTIVES To determine whether vitamin D supplementation reduces cold symptom occurrence and severity in adults with mild to moderate asthma and vitamin D insufficiency . METHODS Colds were assessed in the AsthmaNet VIDA ( Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness ) trial , in which 408 adult patients were r and omized to receive placebo or cholecalciferol ( 100,000 IU load plus 4,000 IU/d ) for 28 weeks as add-on therapy . The primary outcome was cold symptom severity , which was assessed using daily scores on the 21-item Wisconsin Upper Respiratory Symptom Survey . MEASUREMENTS AND MAIN RESULTS A total of 203 participants experienced at least one cold . Despite achieving 25-hydroxyvitamin D levels of 41.9 ng/ml ( 95 % confidence interval [ CI ] , 40.1 - 43.7 ng/ml ) by 12 weeks , vitamin D supplementation had no effect on the primary outcome : the average peak WURSS-21 scores ( 62.0 [ 95 % CI , 55.1 - 68.9 ; placebo ] and 58.7 [ 95 % CI , 52.4 - 65.0 ; vitamin D ] ; P = 0.39 ) . The rate of colds did not differ between groups ( rate ratio [ RR ] , 1.2 ; 95 % CI , 0.9 - 1.5 ) ; however , among African Americans , those receiving vitamin D versus placebo had an increased rate of colds ( RR , 1.7 ; 95 % CI , 1.1 - 2.7 ; P = 0.02 ) . This was also observed in a responder analysis of all subjects achieving vitamin D sufficiency , regardless of treatment assignment ( RR , 1.4 ; 95 % CI , 1.1 - 1.7 ; P = 0.009 ) . CONCLUSIONS Our findings in patients with mild to moderate asthma undergoing an inhaled corticosteroid dose reduction do not support the use of vitamin D supplementation for the purpose of reducing cold severity or frequency Background Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing . We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study . Methods We r and omised 180 pregnant women at 27 weeks gestation to either no vitamin D , 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol , in an ethnically stratified , r and omised controlled trial . Supplementation improved but did not optimise vitamin D status . Research ers blind to allocation assessed offspring at 3 years . Primary outcome was any history of wheeze assessed by vali date d question naire . Secondary outcomes included atopy , respiratory infection , impulse oscillometry and exhaled nitric oxide . Primary analyses used logistic and linear regression . Results We evaluated 158 of 180 ( 88 % ) offspring at age 3 years for the primary outcome . Atopy was assessed by skin test for 95 children ( 53 % ) , serum IgE for 86 ( 48 % ) , exhaled nitric oxide for 62 ( 34 % ) and impulse oscillometry of acceptable quality for 51 ( 28 % ) . We found no difference between supplemented and control groups in risk of wheeze [ no vitamin D : 14/50 ( 28 % ) ; any vitamin D : 26/108 ( 24 % ) ( risk ratio 0.86 ; 95 % confidence interval 0.49 , 1.50 ; P = 0.69 ) ] . There was no significant difference in atopy , eczema risk , lung function or exhaled nitric oxide between supplemented groups and controls . Conclusion Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level , was not associated with decreased wheezing in offspring at age three years . Trial Registration Controlled-Trials.com IS RCT There is intense interest in the role of vitamin D in the development of asthma and allergies . However , studies differ on whether a higher vitamin D intake or status in pregnancy or at birth is protective against asthma and allergies . To address this uncertainty , the Vitamin D Antenatal Asthma Reduction Trial ( VDAART ) was developed . VDAART is a r and omized , double-blind , placebo-controlled trial of vitamin D supplementation in pregnant women to determine whether prenatal supplementation can prevent the development of asthma and allergies in women 's offspring . A secondary aim is to determine whether vitamin D supplementation can prevent the development of pregnancy complications , such as preeclampsia , preterm birth , and gestational diabetes . Women were r and omized to the treatment arm of 4000IU/day of vitamin D3 plus a daily multivitamin that contained 400IU of vitamin D3 or the placebo arm of placebo plus a multivitamin that contained 400IU daily of vitamin D3 . Women who were between the gestational ages of 10 and 18 weeks were r and omized from three clinical centers across the United States - Boston Medical Center , Washington University in St. Louis , and Kaiser Permanente Southern California Region ( San Diego , CA ) . Supplementation took place throughout pregnancy . Monthly monitoring of urinary calcium to creatinine ratio was performed in addition to medical record review for adverse events . Offspring are being evaluated quarterly through question naires and yearly during in-person visits until the 3rd birthday of the child . Ancillary studies will investigate neonatal T-regulatory cell function , maternal vaginal flora , and maternal and child intestinal flora Objective : The aim of this pilot study was to determine the combined effect of vitamin D and omega-3 polyunsaturated fatty acid ( PUFA ) supplementation on airway function and inflammation in recreational athletes with exercise-induced bronchoconstriction ( EIB ) . Methods : Ten recreational athletes with EIB participated in a single-blind , placebo-controlled trial over six consecutive weeks . All subjects attended the laboratory on three occasions . Each visit was separated by a period of 3 weeks : visit 1 ( usual diet ) , visit 2 ( placebo ) and visit 3 ( SMARTFISH ® NutriFriend 2000 ; 30 µg vitamin D3–3000 mg eicosapentaenoic acid , 3000 mg docosahexaenoic acid ) consumed once daily for a period of 3 weeks . Venous blood was collected at the beginning of each trial to determine vitamin D status . Spirometry was performed pre- and post-eucapnic voluntary hyperpnoea ( EVH ) . Results : The Maximum fall in FEV1 ( ΔFEV1max ) post-EVH was not different between visits ( usual diet : −15.9 ± 3.6 % , placebo : −16.1 ± 6.1 % , vitamin D + omega-3 PUFA : −17.8 ± 7.2 % ) . Serum vitamin D remained unchanged between visits . Conclusion : Vitamin D and omega-3 PUFA supplementation does not attenuate the reduction in lung function post-EVH . This finding should be viewed as preliminary until the results of r and omised controlled trials are made available BACKGROUND Asthma exacerbations , most often caused by respiratory tract infections , are the leading causes of asthma morbidity and comprise a significant proportion of asthma-related costs . Vitamin D status might play a role in preventing asthma exacerbations . OBJECTIVES We sought to assess the relationship between serum vitamin D levels and subsequent severe asthma exacerbations . METHODS We measured 25-hydroxyvitamin D levels in sera collected from 1024 children with mild-to-moderate persistent asthma at the time of enrollment in a multicenter clinical trial of children r and omized to receive budesonide , nedocromil , or placebo ( as-needed beta-agonists ) : the Childhood Asthma Management Program . Using multivariable modeling , we examined the relationship between baseline vitamin D levels and the odds of any hospitalization or emergency department visit over the 4 years of the trial . RESULTS Thirty-five percent of all subjects were vitamin D insufficient , as defined by a level of 30 ng/mL or less 25-hydroxyvitamin D. Mean vitamin D levels were lowest in African American subjects and highest in white subjects . After adjusting for age , sex , body mass index , income , and treatment group , insufficient vitamin D status was associated with a higher odds of any hospitalization or emergency department visit ( odds ratio , 1.5 ; 95 % CI , 1.1 - 1.9 ; P = .01 ) . CONCLUSION Vitamin D insufficiency is common in this population of North American children with mild-to-moderate persistent asthma and is associated with higher odds of severe exacerbation over a 4-year period BACKGROUND The cholecalciferol inputs required to achieve or maintain any given serum 25-hydroxycholecalciferol concentration are not known , particularly within ranges comparable to the probable physiologic supply of the vitamin . OBJECTIVES The objectives were to establish the quantitative relation between steady state cholecalciferol input and the result ing serum 25-hydroxycholecalciferol concentration and to estimate the proportion of the daily requirement during winter that is met by cholecalciferol reserves in body tissue stores . DESIGN Cholecalciferol was administered daily in controlled oral doses labeled at 0 , 25 , 125 , and 250 micro g cholecalciferol for approximately 20 wk during the winter to 67 men living in Omaha ( 41.2 degrees N latitude ) . The time course of serum 25-hydroxycholecalciferol concentration was measured at intervals over the course of treatment . RESULTS From a mean baseline value of 70.3 nmol/L , equilibrium concentrations of serum 25-hydroxycholecalciferol changed during the winter months in direct proportion to the dose , with a slope of approximately 0.70 nmol/L for each additional 1 micro g cholecalciferol input . The calculated oral input required to sustain the serum 25-hydroxycholecalciferol concentration present before the study ( ie , in the autumn ) was 12.5 micro g ( 500 IU)/d , whereas the total amount from all sources ( supplement , food , tissue stores ) needed to sustain the starting 25-hydroxycholecalciferol concentration was estimated at approximately 96 micro g ( approximately 3800 IU)/d . By difference , the tissue stores provided approximately 78 - 82 micro g/d . CONCLUSIONS Healthy men seem to use 3000 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Meta- analysis of a modest number of trials in people with predominantly mild to moderate asthma suggests that vitamin D is likely to reduce both the risk of severe asthma exacerbation and healthcare use . Children and people with frequent severe asthma exacerbations were under-represented ; additional primary trials are needed to establish whether vitamin D can reduce the risk of severe asthma exacerbation in these groups

MS2_fixed_5_shot234

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The purpose of the present study was to determine the reliability and validity of the Functional Rating Index ( FRI ) for athletes with low back pain ( LBP ) . In this cross-sectional and prospect i ve cohort study , the vali date d Persian FRI ( PFRI ) was tested in 100 athletes with LBP and 50 healthy athletes . From the athletes with LBP , data were recollected among 50 athletes with a 7-day interval to examine test-retest reliability . The content validity was excellent , and the athletes with LBP responded to all items with no floor or ceiling effects . The discriminative validity was supported by a statistically significant difference in PFRI total scores between the athletes with LBP and healthy athletes . The concurrent criterion validity was good ( rho = 0.72 ) . The construct , convergent validity was good ( r = 0.83 ) . The internal consistency reliability estimate was high ( Cronbach 's α = 0.90 ) . Factor analysis demonstrated a single-factor structure with an explained variance of 52.22 % . The test-retest reliability was excellent , indicated by an ICC(agreement ) of 0.97 , and the agreement observed in the Bl and and Altman plot demonstrated no systematic bias . It is concluded that the PFRI has excellent psychometric properties for assessing athletes with LBP Background The severity and course of spinal pain is poorly understood in adolescents . The study aim ed to determine the prevalence and two-year incidence , as well as the course , frequency , and intensity of pain in the neck , mid back , and low back ( spinal pain ) . Methods This study was a school-based prospect i ve cohort study . All 5th and 6th grade students ( 11–13 years ) at 14 schools in the Region of Southern Denmark were invited to participate ( N = 1,348 ) . Data were collected in 2010 and again two years later , using an e-survey completed during school time . Results The lifetime prevalence of spinal pain was 86 % and 89 % at baseline and follow-up , respectively . A group of 13.6 % ( 95 % CI : 11.8 , 15.6 ) at baseline and 19.5 % ( 95 % CI : 17.1 , 22.0 ) at follow-up reported that they had pain frequently . The frequency of pain was strongly associated with the intensity of pain , i.e. , the majority of the participants reported their pain as relatively infrequent and of low intensity , whereas the participants with frequent pain also experienced pain of higher intensity . The two-year incidence of spinal pain varied between 40 % and 60 % across the physical locations . Progression of pain from one to more locations and from infrequent to more frequent was common over the two-year period . Conclusions Spinal pain is common at the age of 11–15 years , but some have more pain than others . The pain is likely to progress , i.e. , to more locations , higher frequency , and higher pain intensity over a two-year period OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Our findings show strong positive evidence for structural validity and internal consistency in patients with SP and LBP . The current evidence shows that the FRI is comparable with both the Oswestry Disability Index and the Neck Disability Index in responsiveness .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background The increased prevalence of overweight and obesity warrants preventive actions , particularly among people in transitional stages associated with lifestyle changes , such as occupational retirement . The purpose is to investigate the effect of a one year low-intensity computer-tailored energy balance programme among recent retirees on waist circumference , body weight and body composition , blood pressure , physical activity and dietary intake . Methods A r and omised controlled trial was conducted among recent retirees ( N = 413 ; mean age 59.5 years ) . Outcome measures were assessed using anthropometry , bio-impedance , blood pressure measurement and question naires . Results Waist circumference , body weight and blood pressure decreased significantly in men of the intervention and control group , but no significant between-group-differences were observed at 12 or at 24-months follow-up . A significant effect of the programme was only observed on waist circumference ( -1.56 cm ( 95%CI : -2.91 to -0.21 ) ) at 12 month follow up among men with low education ( n = 85 ) . Physical activity and dietary behaviours improved in both the intervention and control group during the intervention period . Although , these behaviours changed more favourably in the intervention group , these between-group-differences were not statistically significant . Conclusions The multifaceted computer-tailored programme for recent retirees did not appear to be effective . Apparently the transition to occupational retirement and /or participation in the study had a greater impact than the intervention programme . Trial registration Clinical Trials NCT00122213 Objectives To examine the trajectories of physical activity from preretirement to postretirement and to further clarify whether the changes in physical activity are associated with changes in body weight . Design Prospect i ve . Setting French national gas and electricity company ( GAZEL cohort ) . Participants From the original sample of 20 625 employees , only those retiring between 2001 and 2008 on a statutory basis were selected for the analyses ( analysis 1 : n=2711 , 63 % men ; analysis 2 : n=3812 , 75 % men ) . Persons with data on at least one preretirement and postretirement measurement of the outcome were selected . Primary and secondary outcome measures All outcome data were gathered by question naires . In analysis 1 , the annual prevalence of higher physical activity ( walking ≥5 km/week ) 4 years before and after retirement was analysed . In analysis 2 , changes in leisure-time sport activities ( engagement , frequency and manner ) from preretirement to postretirement were analysed with simultaneous changes in body weight ( kilogram ) . Results In analysis 1 ( n=2711 ) , prevalence estimates for 4 years before and 4 years after retirement showed that higher leisure-time physical activity ( walking at least 5 km/week ) increased by 36 % in men and 61 % in women during the transition to retirement . This increase was also observed among people at a higher risk of physical inactivity , such as smokers and those with elevated depressive symptoms . In a separate sample ( analysis 2 , n=3812 ) , change in weight as a function of preretirement and postretirement physical activity was analysed . Weight gain preretirement to postretirement was 0.85 ( 95 % CI 0.48 to 1.21 ) to 1.35 ( 0.79 to 1.90 ) kg greater among physically inactive persons ( decrease in activity or inactive ) compared with those physically active ( p<0.001 ) . Conclusions Retirement transition may be associated with beneficial changes in lifestyle and may thus be a good starting point to preventive interventions in various groups of individuals in order to maintain long-term changes Background People in transitional life stages , such as occupational retirement , are likely to gain weight and accumulate abdominal fat mass caused by changes in physical activity and diet . Hence , retirees are an important target group for weight gain prevention programmes , as described in the present paper . Methods / Design A systematic and stepwise approach ( Intervention Mapping ) is used to develop a low-intensity energy balance intervention programme for recent retirees . This one-year , low-intensity multifaceted programme aims to prevent accumulation of abdominal fat mass and general weight gain by increasing awareness of energy balance and influencing related behaviours of participants ' preference . These behaviours are physical activity , fibre intake , portion size and fat consumption . The effectiveness of the intervention programme is tested in a cluster r and omised controlled trial . Measurements of anthropometry , physical activity , energy intake , and related psychosocial determinants are performed at baseline and repeated at 6 months for intermediate effect , at 12 months to evaluate short-term intervention effects and at 24 months to test the sustainability of the effects . Discussion This intervention programme is unique in its focus on retirees and energy balance . It aims at increasing awareness and takes into account personal preferences of the users by offering several options for behaviour change . Moreover , the intervention programme is evaluated at short-term and long-term and includes consecutive outcome measures ( determinants , behaviour and body composition ) OBJECTIVE To evaluate the efficacy at 6- , 12- , and 24-month follow-up of Keep Active Minnesota ( KAM ) , a telephone and mail-based intervention design ed to promote physical activity ( PA ) maintenance among currently active adults age 50 to 70 . METHOD Participants who reported having recently increased their MVPA to a minimum of 2d/wk , 30 min/bout , ( N=1049 ) were recruited in 2004 and 2005 from one large managed care organization in Minnesota , and r and omly assigned to either treatment ( KAM ; N=523 ) , or Usual Care ( UC ; N=526 ) with PA assessed using the CHAMPS question naire , and expressed as kcal/wk energy expenditure . RESULTS We find a sustained , significant benefit of the intervention at 6 , 12 and 24 months . kcal/wk expenditure in moderate or vigorous activities was higher at 6 ( p<.03 , Cohen 's d(6m)=.16 ) , 12 ( p<.04 , d(12 m)=.13 ) and 24 months ( p<.01 , d(24 m)=.16 ) for KAM participants , compared to UC participants . CONCLUSIONS The KAM telephone- and mail-based PA maintenance intervention was effective at maintaining PA in both the short-term ( 6 months ) and longer-term ( 12 and 24 months ) relative to usual care Background Computer tailoring and motivational interviewing show promise in promoting lifestyle change , despite few head-to-head comparative studies . Purpose Vitalum is a r and omized controlled trial in which the efficacy of these methods was compared in changing physical activity and fruit and vegetable consumption in middle-aged Dutch adults . Methods Participants ( n = 1,629 ) were recruited via 23 general practice s and r and omly received either four tailored print letters , four motivational telephone calls , two of each type of intervention , or no information . The primary outcomes were absolute change in self-reported physical activity and fruit and vegetable consumption . Results All three intervention groups ( i.e. , the tailored letters , the motivational calls , and the combined version ) were equally and significantly more effective than the control group in increasing physical activity ( hours/day ) , intake of fruit ( servings/day ) , and consumption of vegetables ( grams/day ) from baseline to the intermediate measurement ( week 25 ) , follow-up 1 ( week 47 ) and 2 ( week 73 ) . Effect sizes ( Cohen ’s d ) ranged from 0.15 to 0.18 . Participants rated the interventions positively ; interviews were more positively evaluated than letters . Conclusions Tailored print communication and telephone motivational interviewing or their combination are equally successful in changing multiple behaviors The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice Background Important health benefits can be derived when low-cost ( e.g. , computer-tailored ) physical activity interventions for older adults demonstrate sustained effects . Purpose The purpose of the study was to conduct in-depth analysis on the long-term efficacy of two tailored physical activity interventions for older adults . Methods A r and omized controlled trial ( n = 1,971 ) with two computer-tailored interventions and a no-intervention control group was conducted . The two tailored interventions consisted of three tailored letters , delivered during 4 months . The basic tailored intervention targeted psychosocial determinants alone , while the environmentally tailored intervention additionally targeted environmental determinants , by providing tailored environmental information . Self-reported behaviors ( i.e. , total physical activity , transport walking and cycling , leisure walking and cycling , and sports ) were measured at baseline and 12 months . Additionally , potential personal , health-related , and psychosocial moderators of the intervention effects were examined . Results The environmentally tailored intervention was effective in changing total physical activity , leisure cycling , and sports compared with the basic intervention and control group . No intervention effects were found for the basic intervention . Moderation analysis revealed that participants with a higher age , lower body mass index , and higher intention were unresponsive to the interventions . Conclusions Providing environmental information is an effective intervention strategy for increasing physical activity behaviors among older adults , especially among certain “ at-risk ” subgroups such as lower educated , overweight , or insufficiently active participants . Moderation analysis was perceived as a promising method for identifying meaningful subgroups that are unaffected by an intervention , which should receive special attention in future interventions Background : Evidence on the association between social support and leisure time physical activity ( LTPA ) is scarce and mostly based on cross-sectional data with different types of social support collapsed into a single index . The aim of this study was to investigate whether social support from the closest person was associated with LTPA . Methods : Prospect i ve cohort study of 5395 adults ( mean age 55.7 years , 3864 men ) participating in the British Whitehall II study . Confiding/emotional support and practical support were assessed at baseline in 1997–99 using the Close Persons Question naire . LTPA was assessed at baseline and follow-up in ( 2002–04 ) . Baseline covariates included socio-demographics , self-rated health , long-st and ing illnesses , physical functioning and common mental disorders . Results : Among participants who reported recommended levels of LTPA at baseline , those who experienced high confiding/emotional support were more likely to report recommended levels of LTPA at follow-up [ odds ratio ( OR ) : 1.39 , 95 % confidence interval ( CI ) : 1.12–1.70 in a model adjusted for baseline covariates ] . Among those participants who did not meet the recommended target of LTPA at baseline , high confiding/emotional support was not associated with improvement in activity levels . High practical support was associated with both maintaining ( OR : 1.34 , 95 % CI : 1.10–1.63 ) and improving ( OR : 1.25 , 95 % CI : 1.02–1.53 ) LTPA levels . Conclusion : These findings suggest that emotional and practical support from the closest person may help the individual to maintain the recommended level of LTPA . Practical support also predicted a change towards a more active lifestyle Aims /hypothesis . The aim of the Diabetes Prevention Study is to assess the efficacy of an intensive diet-exercise programme in preventing or delaying Type II ( non-insulin-dependent ) diabetes mellitus in subjects with impaired glucose tolerance , to evaluate the effects of the intervention programme on cardiovascular risk factors and to assess the determinants for the progression to diabetes in persons with impaired glucose tolerance . Methods . A total of 523 overweight subjects with impaired glucose tolerance ascertained by two oral glucose tolerance tests were r and omised to either a control or intervention group . The control subjects received general information at the start of the trial about the lifestyle changes necessary to prevent diabetes and about annual follow-up visits . The intervention subjects had seven sessions with a nutritionist during the first year and a visit every 3 months thereafter aim ed at reducing weight , the intake of saturated fat and increasing the intake of dietary fibre . Intervention subjects were also guided individually to increase their physical activity . Results . During the first year , weight loss in the first 212 study subjects was 4.7 ± 5.5 vs 0.9 ± 4.1 kg in the intervention and control group , respectively ( p < 0.001 ) . The plasma glucose concentrations ( fasting : 5.9 ± 0.7 vs 6.4 ± 0.8 mmol/l , p < 0.001 ; and 2-h 7.8 ± 1.8 vs 8.5 ± 2.3 mmol/l , p < 0.05 ) were significantly lower in the intervention group after the first year of intervention . Favourable changes were also found in blood OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

There was no evidence for a relationship between intervention effectiveness and mode of delivery or number of intervention contacts ; however , interventions which involved individually tailoring with personalized activity goals or provision of information about local opportunities in the environment may be more effective . Conclusions Interventions in adults aged 55 to 70 years led to long term improvements in physical activity at 12 months ; however , maintenance beyond this is unclear . Identified physical activity improvements are likely to have substantial health benefits in reducing the risk of age-related illnesses .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background — Catheter ablation of ventricular tachycardia ( VT ) is effective and particularly useful in patients with frequent defibrillator interventions . Various substrate modification techniques have been described for unmappable or hemodynamically intolerable VT . Noninducibility is the most frequently used end point but is associated with significant limitations , so the optimal end point remains unclear . We hypothesized that elimination of local abnormal ventricular activities ( LAVAs ) during sinus rhythm or ventricular pacing would be a useful and effective end point for substrate-based VT ablation . As an adjunct to this strategy , we used a new high-density mapping catheter and frequently used epicardial mapping . Methods and Results — Seventy patients ( age , 67±11 years ; 7 female ) with VT and structurally abnormal ventricle(s ) were prospect ively enrolled . Conventional mapping was performed in sinus rhythm in all , and a high-density Pentaray mapping catheter was used in the endocardium ( n=35 ) and epicardially . LAVAs were recorded in 67 patients ( 95.7 % ; 95 % confidence interval , 89.2–98.9 ) . Catheter ablation was performed targeting LAVA with an irrigated-tip catheter placed endocardially via a transseptal or retro grade aortic approach or epicardially via the subxiphoid approach . LAVAs were successfully abolished or dissociated in 47 of 67 patients ( 70.1 % ; 95 % confidence interval , 58.7–80.1 ) . In multivariate analysis , LAVA elimination was independently associated with a reduction in recurrent VT or death ( hazard ratio , 0.49 ; 95 % confidence interval , 0.26–0.95 ; P=0.035 ) during long-term follow-up ( median , 22 months ) . Conclusions — LAVAs can be identified in most patients with scar-related VT . Elimination of LAVAs is feasible and safe and is associated with superior survival free from recurrent VT BACKGROUND For patients who have a ventricular tachyarrhythmic event , implantable cardioverter-defibrillators ( ICDs ) are a mainstay of therapy to prevent sudden death . However , ICD shocks are painful , can result in clinical depression , and do not offer complete protection against death from arrhythmia . We design ed this r and omized trial to examine whether prophylactic radiofrequency catheter ablation of arrhythmogenic ventricular tissue would reduce the incidence of ICD therapy . METHODS Eligible patients with a history of a myocardial infa rct ion underwent defibrillator implantation for spontaneous ventricular tachycardia or fibrillation . The patients did not receive antiarrhythmic drugs . Patients were r and omly assigned to defibrillator implantation alone or defibrillator implantation with adjunctive catheter ablation ( 64 patients in each group ) . Ablation was performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm . The primary end point was survival free from any appropriate ICD therapy . RESULTS The mortality rate 30 days after ablation was zero , and there were no significant changes in ventricular function or functional class during the mean ( + /-SD ) follow-up period of 22.5+/-5.5 months . Twenty-one patients assigned to defibrillator implantation alone ( 33 % ) and eight patients assigned to defibrillator implantation plus ablation ( 12 % ) received appropriate ICD therapy ( antitachycardia pacing or shocks ) ( hazard ratio in the ablation group , 0.35 ; 95 % confidence interval , 0.15 to 0.78 , P=0.007 ) . Among these patients , 20 in the control group ( 31 % ) and 6 in the ablation group ( 9 % ) received shocks ( P=0.003 ) . Mortality was not increased in the group assigned to ablation as compared with the control group ( 9 % vs. 17 % , P=0.29 ) . CONCLUSIONS In this r and omized trial , prophylactic substrate-based catheter ablation reduced the incidence of ICD therapy in patients with a history of myocardial infa rct ion who received ICDs for the secondary prevention of sudden death . ( Current Controlled Trials number , IS RCT N62488166 [ controlled-trials.com ] . ) One hundred and one patients with sustained unimorphic ventricular tachycardia underwent programmed ventricular stimulation with one of two protocol s. Fifty patients underwent programmed stimulation with protocol A , which consisted of burst overdrive pacing , single , double , and triple extrastimuli at the right ventricular apex , right ventricular outflow tract , or septum , and then at the left ventricular apex . Fifty-one patients underwent programmed stimulation with protocol B , which consisted of burst overdrive pacing , single and double extrastimuli at the right ventricular apex , right ventricular outflow tract or septum , and at the left ventricular apex , followed by triple extrastimuli at these sites . The stimulation protocol was continued until sustained ventricular tachycardia or rapid , polymorphic ventricular tachycardia greater than 10 sec in duration was induced . With protocol A , clinical and non clinical ventricular tachycardia was induced in 76 % and 36 % of patients , respectively ; with protocol B , clinical and non clinical ventricular tachycardia was induced in 85 % and 38 % of patients , respectively . Direct-current countershock for sustained polymorphic ventricular tachycardia was required in 10 % of patients studied under protocol A , compared with in 2 % of patients studied under protocol B. With protocol A , near-maximal yield of induced clinical ( 72 % ) and non clinical ventricular tachycardia ( 30 % ) was attained after the use of triple extrastimuli at the first stimulation site . The yield of stimulation at a second right ventricular site and of left ventricular stimulation was only an additional 2 % each . With protocol B , triple extrastimuli increased the yield of induced clinical ventricular tachycardia from 61 % to 85 % . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Recurrent sustained ventricular tachycardia ( VT ) is not responsive to antiarrhythmic drugs in the majority of patients , who therefore need therapy with nonpharmacological methods . We evaluated prospect ively the feasibility , safety , and efficacy of transcatheter radiofrequency ( RF ) ablation of VT in 21 selected patients with ischemic heart disease and VT . METHODS AND RESULTS Twenty-one patients with ischemic heart disease and recurrent , drug-refractory VT documented by 12-lead ECG were selected who had sufficient hemodynamic tolerance of VT to undergo transcatheter mapping . Documented clinical VT was reproduced by programmed cardiac stimulation ( PCS ) , and the site of origin was localized by a combination of techniques , including pace mapping , activation-sequence mapping , recordings of middiastolic potentials , and application of re setting and entrainment principles . RF current at 55 V was applied ( 3.8 + /- 3.1 applications per patient ) for as long as 30 seconds at a time to target sites . Twenty-four distinct clinical VTs ( mean cycle length , 445 + /- 52 milliseconds ) were mapped and ablated in 21 patients . In 17 of 21 patients ( 81 % ) , the procedure was acutely successful , and the target clinical VT could no longer be induced by PCS after the procedure , whereas in 4 patients , clinical VT remained inducible . By contrast , VTs with shorter cycle length and different QRS morphology than the ablated VT could still be induced by PCS in 12 of 21 patients . One patient died in intractable congestive heart failure 10 days after the procedure , and the remaining 20 are alive at the end of the follow-up period . The majority of the patients continued to be treated with at least one additional mode of antiarrhythmic therapy ; 12 patients were still taking antiarrhythmic drugs , and 9 patients received an implantable cardioverter/defibrillator . During a mean follow-up period of 13.2 + /- 5.0 months , 9 of 20 patients ( 45 % ) had recurrent VT . In 4 patients , the recurrent VT was different than the previously ablated one . Clinical VT recurred in all 4 patients in whom RF ablation had been acutely unsuccessful . Four patients with recurrent VT underwent repeat RF ablation procedures that were acutely successful and had no further recurrence . CONCLUSION Transcatheter RF ablation is feasible but has only moderately high efficacy in a small , selected group of patients with ischemic heart disease and drug-refractory , highly frequent , hemodynamically tolerated , sustained VT . In the majority of the patients , this treatment technique is palliative rather than definitive , and many of the patients continue to require other methods of antiarrhythmic therapy BACKGROUND This study evaluated the cost-effectiveness of catheter ablation therapy versus amiodarone for treating ventricular tachycardia ( VT ) in patients with structural heart disease . The analysis used a societal perspective for a hypothetical cohort of VT patients with implantable cardioverter-defibrillators , who were experiencing frequent shocks . METHODS AND RESULTS We calculated incremental cost-effectiveness of ablation relative to amiodarone over 5 years after treatment initiation . Event probabilities were from the Chilli r and omized clinical trial ( Chilli Cooled Ablation System , Cardiac Pathways Corporation , Sunnyvale , Calif ) , the literature , and a consensus panel . Costs were from 1998 national Medicare reimbursement schedules . Quality -of-life weights ( utilities ) were estimated using an established preference measurement technique . In a hypothetical cohort of 10 000 patients , 5-year costs were higher for patients undergoing ablation compared with amiodarone therapy ( $ 21 795 versus $ 19 075 ) . Ablation also produced a greater increase in quality of life ( 2.78 versus 2.65 quality -adjusted life-years [ QALYs ] ) . This yielded a cost-effectiveness ratio of $ 20 923 per QALY gained for ablation compared with amiodarone . Results were relatively insensitive to assumptions about ablation success and durability . In less severe patients with good ejection fractions who suffer their first VT episode , the incremental cost-effectiveness ratio was $ 6028 per QALY gained . These cost-effectiveness ratios are within the range generally thought to warrant technology adoption . CONCLUSIONS This study demonstrates that , from a societal perspective , catheter ablation appears to be a cost-effective alternative to amiodarone for treating VT patients Reproduction of spontaneously occurring ventricular tachycardia ( VT ) and induction of previously undocumented VT were studied prospect ively in 98 patients : 48 with documented sustained VT or ventricular fibrillation , 25 with nonsustained or exercise-induced VT , and 25 with no documented VT . Patients received 1 to 4 ventricular extrastimuli and ventricular burst pacing at 2 right ventricular ( RV ) sites , first at twice late diastolic threshold , and then at 10 mA using a prospect i ve , t and em study design . Spontaneously occurring VT was reproduced in 37 of 48 patients ( 77 % ) at twice late diastolic threshold and in 1 other patient ( 2 % ) at 10 mA. VT was reproduced at both RV sites in 17 of 48 patients ( 35 % ) and at 1 site in 20 of 48 patients ( 42 % ) at twice late diastolic threshold . A previously undocumented VT was induced in 7 of 25 patients ( 28 % ) with no documented VT at twice diastolic threshold and 14 of 25 patients ( 56 % ) at 10 mA. A previously undocumented VT was induced in 33 of 73 patients ( 45 % ) with a history of sustained or nonsustained VT at twice late diastolic threshold and in 47 of 73 patients ( 64 % ) at 10 mA. In patients with documented sustained VT , the use of up to 4 ventricular extrastimuli at multiple RV sites increases the sensitivity of the test . In patients without documented VT , the induction of previously undocumented VT with more than 3 ventricular extrastimuli limits the specificity of the test . Increased current provides only a slight advantage over 4 ventricular extrastimuli at twice late diastolic threshold in terms of reproduction of spontaneously occurring VT , but leads to a marked increase in induction of previously undocumented VT Background — Electrical storm ( ES ) caused by recurrent episodes of ventricular tachycardia ( VT ) can cause sudden death in patients with implantable cardioverter-defibrillators and adversely affects prognosis in survivors . Catheter ablation has been proposed for treating ES , but its long-term effect in a large population has never been verified . Methods and Results — Ninety-five consecutive patients with coronary artery disease ( 72 patients ) , idiopathic dilated cardiomyopathy ( 10 patients ) , and arrhythmogenic right ventricular dysplasia/cardiomyopathy ( 13 patients ) undergoing catheter ablation for drug-refractory ES were prospect ively evaluated . Short-term efficacy OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Noninducibility of VT after VT ablation is associated with improved arrhythmia-free survival and all-cause mortality

MS2_fixed_5_shot237

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background —In patients with paroxysmal atrial fibrillation ( AF ) , catheter ablation maintains sinus rhythm more effectively than antiarrhythmic drugs ( AADs ) , but its effect on symptoms and quality of life ( QOL ) has not been fully characterized . Methods and Results —We evaluated symptoms and QOL in a multicenter , r and omized trial comparing catheter ablation with AADs as second-line treatment for patients with paroxysmal AF . The Short Form (SF)-36 health survey and the AF Symptom Checklist were administered at baseline and 3 , 6 , and 9 months after a blanking or dose-titration period . The primary between-group comparisons were conducted at 3 months because of permitted crossover from AAD to ablation beyond this time . Additional analyses based on subsequent follow-up were performed , including the construction of mixed linear regression models to assess the impact of multiple factors on follow-up QOL scores . At baseline in both the ablation ( n=103 ) and the AAD ( n=56 ) groups , 7 of 8 SF-36 scales were well below population norms , as were the physical ( PCS ) and mental ( MCS ) summary scores . At 3 months , the same 7 SF-36 scales were significantly ( P<0.01 ) higher in the ablation than in the AAD group , as were the PCS ( 52.0±7.8 versus 47.1±10.6 ; P<0.01 ) and MCS ( 52.4±8.1 versus 46.6±9.8 ; P<0.01 ) scores , whereas symptom frequency ( 9.3±9.2 versus 19.0±12.6 ; P<0.001 ) and symptom severity ( 7.7±7.2 versus 16.2±10.0 ; P<0.001 ) were significantly reduced . In multivariable analysis , ablation and recurrent arrhythmias most strongly correlated with QOL changes over time . Conclusions —For second-line therapy of paroxysmal AF , ablation is superior to AAD treatment at improving symptoms and QOL . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00116428 Background In contrast to surveys in cardiologist setting s , presentation and management of atrial fibrillation ( AF ) in primary care patients is less well studied . Methods and results The prospect i ve ATRIUM ( OutpatientRegistry Upon Morbidity of Atrial Fibrillation ) collected data from patients with AF seen by 730 physicians representing a r and om sample of all primary care physicians in Germany . ATRIUM enrolled 3,667 patients ( mean age , 72 ± 9 years ; 58 % male , mean CHADS2 score 2.2 ± 1.3 ) , 994 ( 27.1 % ) with paroxysmal , 944 ( 25.7 % ) with persistent or long-st and ing persistent and 1,525 ( 41.6 % ) with permanent AF ( no AF type was specified in 204 patients ) . Mean duration since initial diagnosis of AF was 61 ± 66 months ( median 42 , interquartile range 14–88 ) . Reported symptoms included palpitations ( 43 % ) , shortness of breath ( 49 % ) , fatigue ( 49 % ) , dizziness ( 37 % ) and angina ( 20 % ) . Most common concomitant conditions were hypertension ( 84 % ) , heart failure ( 43 % ) , coronary artery disease ( 345 % ) , diabetes ( 35 % ) and chronic kidney disease ( 20 % ) . Prior myocardial infa rct ion was present in 11 % of patients , prior stroke in 10 % and prior transient ischemic attack in 10 % . Antithrombotic medication was used by 93 % of the patients ( oral anticoagulants , 83 % ) . Rate control therapy was reported in 75 % and rhythm control therapy in 33 % , often added to rate control . Drugs for rhythm and rate control included ß-blockers ( 75 % ) , calcium antagonists ( 15 % ) , digitalis ( 29 % ) , sodium channel blockers of type IA ( quinidine , 1.0 % ) or IC ( flecainide or propafenone , 5 % ) , and potassium channel blockers including amiodarone ( 11 % ) . In the year prior to enrollment , 46 % of the patients had been cardioverted ( 23 % by drugs , 22 % electrically ) , catheter ablation had been performed in 5 % , and 10 % received a pacemaker or defibrillator . A high proportion ( 44 % ) of the patients were hospitalized in the year prior to enrollment . Conclusions Patients with AF managed in primary care often receive guideline -conforming therapy including antithrombotic therapy , rate control and rhythm control ( numbers given above ) . Despite this apparent adherence , almost half of the patients were hospitalized in the year prior to enrollment , suggesting that the therapies applied do not stabilize patients sufficiently to keep them out of hospital BACKGROUND Recent data have shown that the septum and anterior left atrial ( LA ) wall may contain " rotor " sites required for AF maintenance . However , whether adding ablation of such sites to st and ard ICE-guided PVAI improves outcome is not well known . OBJECTIVE To determine if adjuvant anterior LA ablation during PVAI improves the cure rate of paroxysmal and permanent AF . METHODS One hundred AF patients ( 60 paroxysmal , 40 persistent/permanent ) undergoing first-time PVAI were enrolled over three months to receive adjuvant anterior LA ablation ( Group I ) . These patients were compared with 100 r and omly selected , matched first-time PVAI controls from the preceding three months who did not receive adjuvant ablation ( Group II ) . All 200 patients underwent ICE-guided PVAI during which all four PV antra and SVC were isolated . In group I , a decapolar lasso catheter was used to map the septum and anterior LA wall during AF ( induced or spontaneous ) for continuous high-frequency , fractionated electrograms ( CFAE ) . Sites where CFAE were identified were ablated until the local EGM was eliminated . A complete anterior line of block was not a requisite endpoint . Patients were followed up for 12 months . Recurrence was assessed post-PVAI by symptoms , clinic visits , and Holter at 3 , 6 , and 12 months . Patients also wore rhythm transmitters for the first 3 months . Recurrence was any AF/AFL > 1 min occurring > 2 months post-PVAI . RESULTS Patients ( age 56 + /- 11 years , 37 % female , EF 53%+/- 11 % ) did not differ in baseline characteristics between group I and II by design . Group I patients had longer procedure time ( 188 + /- 45 min vs 162 + /- 37 min ) and RF duration ( 57 + /- 12 min vs 44 + /- 20 min ) than group II ( P < 0.05 for both ) . Overall recurrence occurred in 15/100 ( 15 % ) in group I and 20/100 ( 20 % ) in group II ( P = 0.054 ) . Success rates did not differ for paroxysmal patients between group I and II ( 87 % vs 85 % , respectively ) . However , for persistent/permanent patients , group I had a higher success rate compared with group II ( 82 % vs 72 % , P = 0.047 ) . CONCLUSIONS Adjuvant anterior LA ablation does not appear to impact procedural outcome in patients with paroxysmal AF but may offer benefit to patients with persistent/permanent AF BACKGROUND The aim of this prospect i ve study was to evaluate the recurrences of atrial fibrillation ( AF ) and flutter ( AFL ) after circumferential pulmonary vein ablation ( CPVA ) using repetitive long-term Holter recordings , and to evaluate the change in quality of life ( QoL ) , especially in patients with asymptomatic AF recurrences . METHODS A total of 149 patients with AF were followed up with 7-day Holter monitoring at 3 , 6 , and 12 months after CPVA . We calculated the burden of AF/AFL defined as the percentage of time in AF/AFL , and patients with documented arrhythmia were divided into isolated symptomatic episodes of arrhythmia , mixed symptomatic/asymptomatic arrhythmia , or isolated asymptomatic arrhythmia . The QoL was analyzed with SF-36 question naires in patients with sinus rhythm after CPVA , and in patients with recurrence of symptomatic and asymptomatic arrhythmia , respectively . RESULTS Asymptomatic arrhythmia was observed in 44 % of the patients with documented arrhythmia at 12 months of follow-up . In patients with persistent AF , 63 % of the documented arrhythmia at 12 months of follow-up was asymptomatic and often persistent . In the subgroup of patients with asymptomatic arrhythmia , the QoL improved significantly in the physical scores , in contrast to patients with symptomatic arrhythmia who had unchanged or worsened QoL scores . CONCLUSIONS Asymptomatic arrhythmia is very common after AF ablation . Our data indicate that these patients improve their physical component of the QoL significantly , which may be considered a palliative success of treatment . We suggest that patients with asymptomatic AF recurrences are carefully evaluated before considering reablation . Repetitive rhythm monitoring after AF ablation is very important considering the postablation management of anticoagulant therapy AIMS To investigate the effectiveness of additional substrate modification ( SM ) by left atrial ( LA ) linear lesions as compared with pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( AF ) in a prospect i ve r and omized study . Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF . The benefit of PVI alone and additional linear lesions has not been vali date d in a r and omized study so far . METHODS AND RESULTS Sixty-two patients with persistent AF ( median duration 7 , range 1 - 18 months ) were r and omly assigned to either PVI alone ( n = 30 ) or additional SM ( n = 32 ) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus . Procedures including SM were performed using a three-dimensional mapping system ( EnSite NavX , St Jude Medical , St Paul , MN , USA ) . Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups . Follow-up included daily trans-telephonic ECG transmitted irrespective of the patient 's symptoms . PVI was successful in 98 % of all targeted veins in both groups . Additional SM did not increase fluoroscopy time ( 72.1+/-18.7 vs. 72.9+/-17.3 min , P=0.92 ) because of the use of three-dimensional navigation in the PVI+SM group . AF recurrences within the first 4 weeks following ablation were more common after PVI alone ( 77 % ) than additional SM ( 44 % , P=0.002 ) . After a follow-up time of 487 ( 429 - 570 ) days , only 20 % of patients undergoing st and alone PVI remained in sinus rhythm when compared with 69 % following PVI combined with SM ( P=0.0001 ) . Two patients assigned to PVI+SM experienced procedure-related complications ( cardiac tamponade and minor stroke ) which resolved without sequelae . CONCLUSION PVI alone is insufficient in the treatment of persistent AF . However , additional left linear lesions increase the success rate significantly . Early AF-relapses are associated with a negative outcome after PVI alone but not following additional SM Background —The modification of atrial fibrillation cycle length ( AFCL ) during catheter ablation in humans has not been evaluated . Methods and Results —Seventy patients undergoing ablation of prolonged episodes of AF were r and omized to pulmonary vein ( PV ) isolation or additional ablation of the mitral isthmus . Mean AFCL was determined at a distance from the ablated area ( coronary sinus ) at the following intervals : before ablation , after 2- and 4-PV isolations , and after linear ablation . Inducibility of sustained AF ( ≥10 minutes ) was determined before and after ablation . Spontaneous sustained AF ( 715±845 minutes ) was present in 30 patients and induced in 26 ( AFCL , 186±19 ms ) . PV isolation terminated AF in 75 % , with the number of PVs requiring isolation before termination increasing with AF duration ( P = 0.018 ) . PV isolation result ed in progressive or abrupt AFCL prolongation to various extents , depending on the PV : to 214±24 ms ( P < 0.0001 ) when AF terminated and to 194±19 ms ( P < 0.002 ) when AF persisted . The increase in AFCL ( 30±17 versus 14±11 ms ; P = 0.005 ) and the decrease in fragmentation ( 30.0±26.8 % to 10.3±14.5 % ; P < 0.0001 ) were significantly greater in patients with AF termination . Linear ablation prolonged AFCL , with a greater prolongation in patients with AF termination ( 44±13 versus 22±23 ms ; P = 0.08 ) . Sustained AF was noninducible in 57 % after PV isolation and in 77 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

There is limited evidence to suggest which ablation method was the best . There is limited evidence to suggest that CA may be a better treatment option compared to medical therapies in the management of persistent AF . This review was also unable to recommend the best CA method

MS2_fixed_5_shot238

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE To study the effects of varicocele treatment on testicular function in adolescents . DESIGN A prospect i ve controlled study in 88 r and omly selected adolescents . SETTING All participants were referred to the fertility outpatient clinic of our university hospital . PARTICIPANTS All participants with a varicocele were r and omly assigned into two groups . Group 1 ( n = 33 ) was not treated , whereas group 2 ( n = 34 ) was treated . A similar group of healthy volunteers without a varicocele served as a control group ( group 3 , n = 21 ) . INTERVENTIONS Testes volumes were measured at intake and during follow-up using an orchiometer . Semen analysis was performed according to st and ard procedures both at intake and after 1 year of follow-up . Serum hormone levels were determined at intake using a radioimmunoassay . Treatment was performed by means of transcatheter embolization of the left testicular vein . MAIN OUTCOME MEASURES Testes volumes and semen quality at intake and after 1 year of follow-up were compared within and between the three groups . Hormonal parameters were determined at intake only . RESULTS Before treatment , the mean left testis volume in groups 1 ( n = 26 ) and 2 ( n = 27 ) ( 20.0 mL ; 95 % confidence interval [ CI ] : 18.2 to 21.8 and 21.6 mL ; 95 % CI : 19.4 to 23.8 , respectively ) were significantly smaller than those in the control group ( n = 19 ) ( 24.5 mL ; 95 % CI : 22.7 to 26.4 ) . During follow-up , left testis volumes of the treated group were comparable with those in the control group ( 24.2 mL ; 95 % CI : 22.2 to 26.1 and 24.8 mL ; 95 % CI : 23.0 to 26.7 respectively ) and significantly ( P < 0.001 ) different from the untreated group ( 20.3 mL ; 95 % CI : 18.8 to 21.8 ) . A significant increase in left ( P < 0.01 ) as well as right ( P < 0.05 ) testis volume was observed after treatment . Semen parameters before treatment were not significantly different between the three groups . Sperm concentration increased significantly ( P < 0.01 ) from 47.4 x 10(6)/mL ( 95 % CI : 42.5 to 53.3 ) to 68.9 x 10(6)/mL ( 95 % CI : 50.6 to 87.2 ) in the treated group , whereas semen quality in the untreated and control groups did not change . Although both testes volumes and sperm concentration improved in the treated group , these phenomena were not consistently correlated to each other . CONCLUSIONS Although not apparent in all adolescents , varicocele correction result ed in an increase in left testis volume and sperm concentration . At this moment , it is not clear if early preventive treatment of varicocele in adolescents , in time , will have a positive effect on testicular function INTRODUCTION Adolescent males with varicoceles present a dilemma for surveillance and treatment . Testicular volumetrics have not been shown to predict SA outcomes . Serial SAs are thus recommended in asymptomatic adolescent males with varicoceles and normal testicular development , but the natural history of semen parameters is unknown . OBJECTIVE To explore the natural history of semen parameters in adolescent boys with a left varicocele under active surveillance . STUDY DESIGN Adolescents with an asymptomatic unilateral left varicocele , Tanner V development , normal testicular volumes , and an initial SA were retrospectively review ed in a single-institution prospect ively followed cohort . Total motile count ( TMC ) was calculated . A cutoff of TMC Z 20 million was used to dichotomize SA results into " normal " or " poor . " Those with poor SA were offered repeat SA . Cumulative probabilities of normal TMC over successive rounds of SA were calculated . Bivariate models were used to explore associations of a second consecutive poor TMC with age and varicocele grade . RESULTS A total of 216 patients provided an initial SA between 1992 and 2015 . We excluded 17 for a history of cryptorchidism or incomplete SA data for a final cohort of 199 patients with median follow-up of 3.3 years ( interquartile range 1.5 - 5.6 years ) . The mean age at initial SA was 17.9 years ( range 14.8 - 21.8 years ) . One hundred and nine out of 199 had an initial normal TMC . Of the 90 out of 199 with an initially poor TMC , 51 had repeat SA and 24 of the 51 patients improved to normal TMC . Of the 27 patients with two consecutive poor TMCs , 15 had a third SA and five out of 15 improved to normal TMC . Thus , cumulatively , 55 % , 67 % , and 69 % of all patients had a normal TMC after an initial , second , and third SA , respectively . However , fewer patients in each round of SA normalized their TMC ( Figure ) . Neither age nor varicocele grade was associated with a second consecutive poor TMC . DISCUSSION Two-thirds of Tanner V boys with an uncorrected varicocele and normal testicular volumes achieve a normal TMC regardless of varicocele grade or age . Despite Tanner V development , 47 % with an initial " poor " SA will improve to normal status without surgery . However , a small subgroup of patients will have persistently poor TMC and thus should be targeted in future research for timely intervention . CONCLUSION Semen parameters improve over time . SA should be followed and repeated at least once in symptomatic Tanner V boys with varicoceles The aim of this prospect i ve study was to assess long-term functional results ( spermiograms ) in subjects who underwent laparoscopic varicocelectomy via either of 2 procedures ( ligation or preservation of testicular artery ) . A total of 122 patients underwent laparoscopic varicocelectomy performed via either of the 2 different procedures : complete ligation of the spermatic vessels or preservation of the spermatic artery . After surgery when patients achieved 18 years , they were asked to undergo semen analysis . Spermiogram results were divided into 2 subgroups : " normal " and " abnormal . " We analyzed volume , sperm count per mL , percentage of motile spermatozoa , percentage of normal spermatozoa , and percentage of vitality for each group . Both groups showed the same results in terms of " normal " and " abnormal " spermiograms ( World Health Organization criteria ) , but analysis showed higher sperm concentration per mL , sperm motility , volume , vitality , and rate of morphologically normal sperm for the group with arteries preserved and " normal " spermiograms ( P < .01 ) . Analysis of data from the spermiograms showed that preservation of the testicular artery was the best possible option in terms of semen quality . Therefore , we believe that surgical treatment of varicocele should be carried out using procedures involving artery preservation OBJECTIVE To compare the effect of transumbilical single-site single-port with that of transumbilical single-site double-port laparoscopic varicocelectomy in the treatment of varicocele in adolescents . METHODS We r and omly assigned 80 varicocele patients aged 10 - 16 years to two groups of equal number to receive transumbilical single-site single-port and single-site double-port laparoscopic varicocelectomy , respectively . We compared the operation time , postoperative hospital stay , incisional pain , complications and satisfaction with the abdominal cosmetic outcomes between the two groups . RESULTS All the operations were successfully performed . The double-port group showed a significantly higher score on the Visual Analogue Scale than the single-port group ( 4.8 + /- 1.4 vs 3.6 + /- 1.1 , t = -4.986 , P < 0.01 ) , but there were no significant differences between the two groups in the operation time ( [ 29.8 + /- 4.2 ] vs [ 31.2 + /- 4.6 ] min , t = 1.383 , P = 0.171 ) , postoperative hospital stay ( [ 1.95 + /- 0.7 ] vs [ 1.82 + /- 0.8 ] d , t = -0.784 , P = 0.436 ) , complications ( 0 vs 0 ) and scores on the satisfaction with abdominal cosmetic outcomes ( 4.6 + /- 0.6 vs 4.8 + /- 0.5 , t = 1.253 , P = 0.214 ) . No recurrence , umbilical hernia , hydrocele and orchiatrophy were found in the two groups of patients at 6 months after operation , and no visible scar was observed on the abdominal surface . CONCLUSION With strict surgical indications , single-site single-port and single-site double-port laparoscopic varicocelectomies have similar clinical effects in the treatment of varicocele , which leave no scar on the abdominal surface . Single-site double-port laparoscopy needs no special instruments and therefore is worthier of wide clinical application BACKGROUND / PURPOSE The purpose of this investigation was to evaluate the advantages and the shortcomings of laparoscopic varicocelectomy compared with open traditional treatment of varicoceles . METHODS A total of 654 patients were operated on for left-sided varicoceles over 5 years from 1995 to 2000 . To evaluate the clinical efficiency of the treatment , the patients were divided r and omly into 2 groups . Laparoscopic varicocelectomy ( LV ) was performed on 434 patients , and open varicocelectomy ( OV ) in 220 patients . Outcome data looked at relapse rate , presence of hydrocele , wound complications , and testicular or scrotal edema . Operating time , postoperative length of stay , and pain control also were compared . In both groups , the operations were performed by Palomo 's technique with preservation of lymphatics and mass ligation of the artery and veins in the retroperitoneum above the internal inguinal ring . RESULTS In LV versus OV , relapse rates were 1.84 % versus 1.36 ( P < 0.5 ) , hydrocele occurrence was 0.23 % versus 1.82 % ( P < 0.1 ) , wound complication was 0.23 % versus 7.73 % , and testicular or scrotal edema was 3.9 % versus 13.1 % . LV hospital stay was an average of 3 days versus 7 days for OV . Operating time was 15 minutes for LV versus 26 minutes in open . Postoperative analgesic use was almost cut in half with LV . CONCLUSION The clinical efficacy of LV is superior to traditional OV OBJECTIVE Hydrocele , the main complication of laparoscopic varicocelectomy , is thought to result from a disruption of gonadal lymphatics . The aim of this study was to evaluate the effectiveness of patent blue V dyeing to identify and preserve lymphatic vessels and to assess whether the lymphatic sparing technique avoids postoperative hydrocele in adolescent boys undergoing a laparoscopic procedure . MATERIAL S AND METHODS Fifty-two ( 52 ) boys affected by varicocele Grade III ( range , 12 - 16 years ) underwent a left-sided laparoscopic varicocelectomy . Twenty-six ( 26 ) boys were r and omly assigned to a lymphatic nonsparing ( LNS ) group , and the others to a lymphatic sparing ( LS ) group . Before surgery in the LS group , 2 mL of patent blue V was injected under the tunica dartos on the left side . RESULTS All varicocelectomies were performed laparoscopically . Lymphatic vessels were identified in 23 ( 88.5 % ) boys of the LS group . In the remaining three ( 11.5 % ) , the lymphatics could not be identified clearly . No adverse local or generalized reactions were noted . At a mean follow-up of 14 months , no recurrent varicocele or testicular volume reduction were detected . Hydrocele developed in 4 LNS patients and 1 was operated on . No patient from the LS group developed a hydrocele . CONCLUSIONS Staining gonadal lymph vessels with patent blue V is an effective and simple method of visualization of the lymphatic drainage from the testis . Blue-stained lymph vessels could be readily distinguished and preserved during a laparoscopic varicocelectomy , which results in a decrease of hydrocele development . To vali date an efficacy of vital staining of lymphatic vessels in avoiding hydrocele formation , a larger series and longer follow-up are necessary Because the treatment of a varicocele in adolescents remains controversial , we undertook a prospect i ve study in 51 male adolescents , aged 15 - 21 years , who were referred for a varicocele . Twenty-nine patients were treated with high retroperitoneal ligation of the left spermatic vein , and 22 were untreated . Eighteen healthy adolescent volunteers without a varicocele were also assessed . Testicular volume was measured using an orchiometer , and semen analyses were carried out at referral and after 1 year of follow-up . In addition , serum luteinizing hormone ( LH ) , follicle-stimulating hormone ( FSH ) and testosterone levels were estimated by radioimmunoassay . Both patient groups had significantly smaller testis volumes than the controls OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Based on current available r and omized controlled trials , there is low to moderate level of evidence that radiological or surgical treatment of adolescent varicocele is associated with improved testicular size/growth and sperm concentration .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background — Physical activity ( PA ) is well known to reduce the risk of cardiovascular disease . We hypothesized that regular PA , possibly acting through reductions in blood pressure and body mass index ( BMI ) , would reduce the risk of incident atrial fibrillation ( AF ) in women . Methods and Results — We prospect ively followed 34 759 women who reported their leisure-time PA levels for the occurrence of AF . We estimated energy expenditure in metabolic equivalent (MET)-h/wk and vali date d self-reported AF with medical records . The mean ( SD ) age of the 34 759 participants was 54.6 ( 7.0 ) years , the mean BMI was 26.0 ( 5.0 ) kg/m2 , 26.5 % had hypertension , and the median ( IQR ) PA was 8.4 ( 2.8 , 20.4 ) MET-h/wk . After a median of 14.4 years of observation , 968 women had development of AF . In age- , cholesterol- , smoking- , alcohol- , diabetes- , and race-adjusted models , increasing quintiles of PA were associated with reduced risks of AF ( hazard ratio for extreme quintiles , 0.82 ; 0.66 to 1.01 ; P trend=0.007 over quintiles ) . Although this association was not substantially different after adjusting for hypertension ( 0.87 ; 0.70 to 1.07 ; P trend 0.02 ) , it was attenuated after adjustment for BMI ( 0.99 ; 0.80 to 1.23 ; P trend=0.22 ) . Women who achieved the federal government 's recommendation of 7.5 MET-h/wk of PA were at reduced risk of AF compared with those who did not ( 0.86 ; 0.75 to 0.98 ; P=0.03 ) . This association was also attenuated by BMI ( 0.96 ; 0.84 to 1.10 ; P=0.57 ) . Conclusions — In middle-aged women , physical activity was associated with a modestly reduced risk of AF . However , this relationship was no longer significant after controlling for body mass index Background No previous studies have examined the interplay among socioeconomic status , sex , and race with the risk of atrial fibrillation ( AF ) . Methods and Results We prospect ively followed 14 352 persons ( 25 % black , 75 % white , 55 % women , mean age 54 years ) who were free of AF and participating in the Atherosclerosis Risk in Communities ( ARIC ) study . Socioeconomic status was assessed at baseline ( 1987–1989 ) through educational level and total family income . Incident AF through 2009 was ascertained from electrocardiograms , hospitalizations , and death certificates . Cox regression was used to estimate hazard ratios and 95 % CIs of AF for education and family income . Interactions were tested between socioeconomic status and age , race , or sex . Over a median follow‐up of 20.6 years , 1794 AF cases occurred . Lower family income was associated with higher AF risk ( hazard ratio 1.45 , 95 % CI 1.27 to 1.67 in those with income less than $ 25 000 per year compared with those with $ 50 000 or more per year ) . The association between education and AF risk varied by sex ( P=0.01 ) , with the lowest education group associated with higher AF risk in women ( hazard ratio 1.88 , 95 % CI 1.55 to 2.28 ) but not in men ( hazard ratio 1.15 , 95 % CI 0.97 to 1.36 ) compared with the highest education group . Adjustment for cardiovascular risk factors attenuated the associations . There were no interactions with race or age . Blacks had lower AF risk than whites in all income and education groups . Conclusions Lower family income was associated with a higher AF risk overall , whereas the impact of education on AF risk was present only in women . Differences in socioeconomic status do not explain the lower risk of AF in blacks compared with whites Background —Low-density lipoprotein ( LDL ) cholesterol is a strong risk factor for atherosclerosis but has an inverse association with atrial fibrillation ( AF ) . We aim ed to provide insight into the paradoxical association of LDL cholesterol with AF by evaluating the relationship of various lipoprotein measures and incident AF . Methods and Results —We prospect ively evaluated lipoprotein measures among 23 738 healthy middle-aged and older women ( median follow-up 16.4 years ; N=795 incident AF events ) . Baseline LDL cholesterol was directly measured , lipoprotein particle concentrations and size were measured by nuclear magnetic resonance spectroscopy , and apolipoproteins were measured by immunoassay . Cox regression models were adjusted for age , AF risk factors , inflammatory , and dysglycemic biomarkers . After multivariable adjustment , inverse associations with AF were observed ( hazard ratio , 95 % confidence interval for top versus bottom quintile , P value ) for LDL cholesterol ( 0.72 , 0.56–0.92 , P=0.009 ) , the total number of LDL particles ( 0.77 , 0.60–0.99 , P=0.045 ) , and very-low-density lipoprotein particles ( 0.78 , 0.61–0.99 , P=0.04 ) , which was driven by the number of cholesterol-poor small LDL ( 0.78 , 0.61–1.00 , P=0.05 ) and small very-low-density lipoprotein particles ( 0.78 , 0.62–0.99 , P=0.04 ) . By contrast , the larger cholesterol-rich LDL particles and all high-density lipoprotein measures were not associated with AF in multivariable models . Adjustment for inflammatory and dysglycemic biomarkers had minimal impact on these associations . Conclusions —In this prospect i ve study , the inverse association between LDL cholesterol and AF extended to several other atherogenic lipoproteins , and these associations are unlikely to be mediated by direct cholesterol effects . Clinical Trial Registration — Clinical Trials.gov ; Unique Identifier : NCT00000479 Summary Background The associations of blood pressure with the different manifestations of incident cardiovascular disease in a contemporary population have not been compared . In this study , we aim ed to analyse the associations of blood pressure with 12 different presentations of cardiovascular disease . Methods We used linked electronic health records from 1997 to 2010 in the CALIBER ( CArdiovascular research using LInked Bespoke studies and Electronic health Records ) programme to assemble a cohort of 1·25 million patients , 30 years of age or older and initially free from cardiovascular disease , a fifth of whom received blood pressure-lowering treatments . We studied the heterogeneity in the age-specific associations of clinical ly measured blood pressure with 12 acute and chronic cardiovascular diseases , and estimated the lifetime risks ( up to 95 years of age ) and cardiovascular disease-free life-years lost adjusted for other risk factors at index ages 30 , 60 , and 80 years . This study is registered at Clinical Trials.gov , number NCT01164371 . Findings During 5·2 years median follow-up , we recorded 83 098 initial cardiovascular disease presentations . In each age group , the lowest risk for cardiovascular disease was in people with systolic blood pressure of 90–114 mm Hg and diastolic blood pressure of 60–74 mm Hg , with no evidence of a J-shaped increased risk at lower blood pressures . The effect of high blood pressure varied by cardiovascular disease endpoint , from strongly positive to no effect . Associations with high systolic blood pressure were strongest for intracerebral haemorrhage ( hazard ratio 1·44 [ 95 % CI 1·32–1·58 ] ) , subarachnoid haemorrhage ( 1·43 [ 1·25–1·63 ] ) , and stable angina ( 1·41 [ 1·36–1·46 ] ) , and weakest for abdominal aortic aneurysm ( 1·08 [ 1·00–1·17 ] ) . Compared with diastolic blood pressure , raised systolic blood pressure had a greater effect on angina , myocardial infa rct ion , and peripheral arterial disease , whereas raised diastolic blood pressure had a greater effect on abdominal aortic aneurysm than did raised systolic pressure . Pulse pressure associations were inverse for abdominal aortic aneurysm ( HR per 10 mm Hg 0·91 [ 95 % CI 0·86–0·98 ] ) and strongest for peripheral arterial disease ( 1·23 [ 1·20–1·27 ] ) . People with hypertension ( blood pressure ≥140/90 mm Hg or those receiving blood pressure-lowering drugs ) had a lifetime risk of overall cardiovascular disease at 30 years of age of 63·3 % ( 95 % CI 62·9–63·8 ) compared with 46·1 % ( 45·5–46·8 ) for those with normal blood pressure , and developed cardiovascular disease 5·0 years earlier ( 95 % CI 4·8–5·2 ) . Stable and unstable angina accounted for most ( 43 % ) of the cardiovascular disease-free years of life lost associated with hypertension from index age 30 years , whereas heart failure and stable angina accounted for the largest proportion ( 19 % each ) of years of life lost from index age 80 years . Interpretation The widely held assumptions that blood pressure has strong associations with the occurrence of all cardiovascular diseases across a wide age range , and that diastolic and systolic associations are concordant , are not supported by the findings of this high-resolution study . Despite modern treatments , the lifetime burden of hypertension is substantial . These findings emphasise the need for new blood pressure-lowering strategies , and will help to inform the design of r and omised trials to assess them . Funding Medical Research Council , National Institute for Health Research , and Wellcome Trust Background Atrial fibrillation ( AF ) is the most common cardiac arrhythmia and is associated with increased risk of stroke and death . Obesity is an independent risk factor for AF , but modifiers of this risk are not well known . We studied the roles of obesity , physical activity , and their interaction in conferring risk of incident AF . Methods and Results The Women 's Health Initiative ( WHI ) Observational Study was a prospect i ve observational study of 93 676 postmenopausal women followed for an average of 11.5 years . Incident AF was identified using WHI‐ascertained hospitalization records and diagnostic codes from Medicare cl aims . A multivariate Cox 's hazard regression model adjusted for demographic and clinical risk factors was used to evaluate the interaction between obesity and physical activity and its association with incident AF . After exclusion of women with prevalent AF , incomplete data , or underweight body mass index ( BMI ) , 9792 of the remaining 81 317 women developed AF . Women were , on average , 63.4 years old , 7.8 % were African American , and 3.6 % were Hispanic . Increased BMI ( hazard ratio [ HR ] , 1.12 per 5‐kg/m2 increase ; 95 % confidence interval [ CI ] , 1.10 to 1.14 ) and reduced physical activity ( > 9 vs. 0 metabolic equivalent task hours per week ; HR , 0.90 ; 95 % CI , 0.85 to 0.96 ) were independently associated with higher rates of AF after multivariate adjustment . Higher levels of physical activity reduced the AF risk conferred by obesity ( interaction P=0.033 ) . Conclusions Greater physical activity is associated with lower rates of incident AF and modifies the association between obesity and incident AF Background — Vigorous exertion and endurance training have been reported to increase atrial fibrillation ( AF ) . Associations of habitual light or moderate activity with AF incidence have not been evaluated . Methods and Results — We prospect ively investigated associations of leisure-time activity , exercise intensity , and walking habits , assessed at baseline and up date d during follow-up visits , with incident AF , diagnosed by annual 12-lead ECGs and hospital discharge records , from 1989 to 2001 among 5446 adults ≥65 years of age in the Cardiovascular Health Study . During 47 280 person-years of follow-up , 1061 new AF cases occurred ( incidence 22.4/1000 person-years ) . In multivariable-adjusted analyses , leisure-time activity was associated with lower AF incidence in a grade d manner , with 25 % ( hazard ratio [ HR ] 0.75 , 95 % confidence interval [ CI ] 0.61 to 0.90 ) , 22 % ( HR 0.78 , 95 % CI 0.65 to 0.95 ) , and 36 % ( HR 0.64 , 95 % CI 0.52 to 0.79 ) lower risk in quintiles 3 , 4 , and 5 versus quintile 1 ( P for trend < 0.001 ) . Exercise OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

A systematic evaluation of the available evidence suggests similarities as well as important differences in the risk factors for incidence of AF as compared with other cardiovascular diseases , which has implication s for the primary prevention strategies for atrial fibrillation

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background : Exercise can be beneficial for cardiopulmonary , musculoskeletal or neurological systems , and other factors including mood , and may be beneficial in reducing fall risks , dementia and variables associated with quality of life ( QOL ) . Parkinson 's disease ( PD ) produces progressive motor and cognitive deterioration that may leave those inflicted unable to participate in st and ard exercise programs . Alternative forms of exercise such as yoga may be successful in improving physical function , QOL and physiological variables for overall well-being . Aim : This r and omized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD . Methods and Material s : Thirteen people with stage 1 - 2 PD were r and omized to either a yoga ( n = 8) or a control group ( n = 5 ) . The yoga group participated in twice-weekly yoga sessions for 12 weeks . Participants were tested at baseline , and at 6 and 12 weeks using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , clinical measures of health-related QOL and physiological measures . Results : Significant improvement in UPDRS scores ( P = .006 ) , diastolic blood pressure ( P = 0.036 ) and average forced vital capacity ( P = 0.03 ) was noted in the yoga group over time . Changes between groups were also noted in two SF-36 subscales . Positive trends of improvement were noted in depression scores ( P = 0.056 ) , body weight ( P = 0.056 ) and forced expiratory volume ( P = 0.059 ) . Yoga participants reported more positive symptom changes including immediate tremor reduction . Conclusions : The results suggest that yoga may improve aspects of QOL and physiological functions in stages 1 - 2 PD . Future larger studies are needed to confirm and extend our findings of the effects of yoga in PD Objectives : Published preliminary findings from a r and omized-controlled trial suggest that an 8-week Yoga of Awareness intervention may be effective for improving symptoms , functional deficits , and coping abilities in fibromyalgia . The primary aims of this study were to evaluate the same intervention ’s posttreatment effects in a wait-list group and to test the intervention ’s effects at 3-month follow-up in the immediate treatment group . Methods : Unpaired t tests were used to compare data from a per protocol sample of 21 women in the immediate treatment group who had completed treatment and 18 women in the wait-list group who had completed treatment . Within-group paired t tests were performed to compare posttreatment data with 3-month follow-up data in the immediate treatment group . The primary outcome measure was the Fibromyalgia Impact Question naire Revised ( FIQR ) . Multilevel r and om-effects models were also used to examine associations between yoga practice rates and outcomes . Results : Posttreatment results in the wait-list group largely mirrored results seen at posttreatment in the immediate treatment group , with the FIQR Total Score improving by 31.9 % across the 2 groups . Follow-up results showed that patients sustained most of their posttreatment gains , with the FIQR Total Score remaining 21.9 % improved at 3 months . Yoga practice rates were good , and more practice was associated with more benefit for a variety of outcomes . Discussion : These findings indicate that the benefits of Yoga of Awareness in fibromyalgia are replicable and can be maintained Fibromyalgia is a chronic syndrome characterized by widespread pain , sleep disturbance , stiffness , fatigue , headache , and mood disorders . Recent research has result ed in an improved underst and ing of fibromyalgia and its possible causes . This article highlights some of the current research , discusses a strategy for using yoga and meditation as a therapy for fibromyalgia sufferers , and presents the results of a preliminary 8-week study using yoga and meditation to help manage fibromyalgia symptoms . The study of 11 participants found significant improvement in the overall health status of the participants and in symptoms of stiffness , anxiety , and depression . Significant improvements were also seen in the reported number of days " felt good " and number of days " missed work " because of fibromyalgia . Nonsignificant improvements were seen in measures of pain , fatigue , and how one felt in the morning . Effect sizes were medium to large for most tested areas . This study supports the benefits of yoga and meditation for individuals with fibromyalgia and encourages further research to explore their use as st and ard therapies for fibromyalgia Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Background There is evidence for augmented processing of pain and impaired endogenous pain inhibition in Fibromyalgia syndrome ( FM ) . In order to fully underst and the mechanisms involved in FM pathology , there is a need for closer investigation of endogenous pain modulation . In the present study , we compared the functional connectivity of the descending pain inhibitory network in age-matched FM patients and healthy controls (HC).We performed functional magnetic resonance imaging ( fMRI ) in 42 subjects ; 14 healthy and 28 age-matched FM patients ( 2 patients per HC ) , during r and omly presented , subjectively calibrated pressure pain stimuli . A seed-based functional connectivity analysis of brain activity was performed . The seed coordinates were based on the findings from our previous study , comparing the fMRI signal during calibrated pressure pain in FM and HC : the rostral anterior cingulate cortex ( rACC ) and thalamus . Results FM patients required significantly less pressure ( kPa ) to reach calibrated pain at 50 mm on a 0–100 visual analogue scale ( p < .001 , two-tailed ) . During fMRI scanning , the rACC displayed significantly higher connectivity to the amygdala , hippocampus , and brainstem in healthy controls , compared to FM patients . There were no regions where FM patients showed higher rACC connectivity . Thalamus showed significantly higher connectivity to the orbitofrontal cortex in healthy controls but no regions showed higher thalamic connectivity in FM patients . Conclusion Patients with FM displayed less connectivity within the brain ’s pain inhibitory network during calibrated pressure pain , compared to healthy controls . The present study provides brain-imaging evidence on how brain regions involved in homeostatic control of pain are less connected in FM patients . It is possible that the dysfunction of the descending pain modulatory network plays an important role in maintenance of FM pain and our results may translate into clinical implication s by using the functional connectivity of the pain modulatory network as an objective measure of pain dysregulation & NA ; A mounting body of literature recommends that treatment for fibromyalgia ( FM ) encompass medications , exercise and improvement of coping skills . However , there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping . The aim of this r and omized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping . A sample of 53 female FM patients were r and omized to the 8‐week Yoga of Awareness program ( gentle poses , meditation , breathing exercises , yoga‐based coping instructions , group discussion s ) or to wait‐listed st and ard care . Data were analyzed by intention to treat . At post‐treatment , women assigned to the yoga program showed significantly greater improvements on st and ardized measures of FM symptoms and functioning , including pain , fatigue , and mood , and in pain catastrophizing , acceptance , and other coping strategies . This pilot study provides promising support for the potential benefits of a yoga program for women with FM OBJECTIVES This study aim ed to verify whether techniques of yoga with and without the addition of Tui Na might improve pain and the negative impact of fibromyalgia ( FMS ) on patients ' daily life . DESIGN Forty ( 40 ) FMS women were r and omized into two groups , Relaxing Yoga ( RY ) and Relaxing Yoga plus Touch ( RYT ) , for eight weekly sessions of stretching , breathing , and relaxing yogic techniques . RYT patients were further su bmi tted to manipulative techniques of Tui Na . OUTCOME MEASURE Outcome measures comprised the Fibromyalgia Impact Question naire ( FIQ ) , pain threshold at the 18 FMS tender points , and a verbal graduation of pain assessed before treatment and on the followup . The visual analog scale ( VAS ) for pain was assessed before and after each session and on the follow-up . RESULTS Seventeen ( 17 ) RYT and 16 RY patients completed the study . Both RY and RYT groups showed improvement in the FIQ and VAS scores , which decreased on all sessions . The RYT group showed lower VAS and verbal scores for pain on the eighth session , but this difference was not maintained on the follow-up . Conversely , RY VAS and verbal scores were significantly lower just on the follow-up . CONCLUSIONS These study results showed that yogic techniques are valid therapeutic methods for FMS . Touch addition yielded greater improvement during the treatment . Over time , however , RY patients reported less pain than RYT . These results suggest that a passive therapy may possibly decrease control over FMS symptoms OBJECTIVES Restorative yoga ( RY ) is a gentle type of yoga that may be beneficial for cancer patients and post-treatment survivors . Study goals were : to determine the feasibility of implementing a RY intervention for women with breast cancer ; and to examine group differences in self-reported emotional , health-related quality of life , and symptom outcomes . METHODS Women with breast cancer ( n=44 ; mean age 55.8 years ) enrolled in this study ; 34 % were actively undergoing cancer treatment . Study participants were r and omized to the intervention ( 10 weekly 75-minute RY classes ) or a waitlist control group . Participants completed question naires at Week 0 ( baseline ) and Week 10 ( immediately post-intervention for the yoga group ) . RESULTS Group differences favoring the yoga group were seen for mental health , depression , positive affect , and spirituality ( peace/meaning ) . Significant baseline*group interactions were observed for negative affect and emotional well-being . Women with higher negative affect and lower emotional well-being at baseline derived greater benefit from the yoga intervention compared to those with similar values at baseline in the control group . The yoga group demonstrated a significant within-group improvement in fatigue ; no significant difference was noted for the control group . CONCLUSIONS Although limited by sample size , these pilot data suggest potential benefit of RY on emotional outcomes and fatigue in cancer patients . This study demonstrates that a RY intervention is feasible for women with breast cancer ; implication s for study design and implementation are noted with an emphasis on program adoption and participant adherence OBJECTIVES To develop and vali date a new risk-of-bias tool for nonr and omized studies ( NRSs ) . STUDY DESIGN AND SETTING We developed the Risk of Bias Assessment Tool for Nonr and omized Studies ( RoBANS ) . A validation process with 39 NRSs examined the reliability ( interrater agreement ) , validity ( the degree of correlation between the overall assessment s of RoBANS and Method ological Index for Nonr and omized Studies [ MINORS ] , obtained by plotting the overall risk of bias relative to effect size and funding source ) , face validity with eight experts , and completion time for the RoBANS approach . RESULTS RoBANS contains six domains : the selection of participants , confounding variables , the measurement of exposure , the blinding of the outcome assessment s , incomplete outcome data , and selective outcome reporting . The interrater agreement of the RoBANS tool except the measurement of exposure and selective outcome reporting domains ranged from fair to substantial . There was a moderate correlation between the overall risks of bias determined using RoBANS and MINORS . The observed differences in effect sizes and funding sources among the assessed studies were not correlated with the overall risk of bias in these studies . The mean time required to complete RoBANS was approximately 10 min . The external experts who were interviewed evaluated RoBANS as a " fair " assessment tool . CONCLUSIONS RoBANS shows moderate reliability , promising feasibility , and validity . The further refinement of this tool and larger validation studies are required OBJECTIVES AND METHODS This study examined whether gentle Hatha yoga reduced fibromyalgia-related symptoms for a convenience sample of 10 participants ranging in age from 39 to 64 years who received yoga instruction 2 times per week for 8 weeks . METHODS Respondents completed the Fibromyalgia Impact Question naire 1 time per week and provided weekly journal reports regarding their health status . Pre- and post-intervention manual tender point evaluations were also conducted OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Findings reveal a lack of reporting of intervention details , the need to report a disease-specific rationale for selection of the particular yoga style used for the intervention , and that a limited number of yoga styles have been investigated in persons with fibromyalgia

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background Children with attention deficit hyperactivity disorder ( ADHD ) are characterised by developmentally inappropriate levels of hyperactivity , impulsivity and /or inattention and are particularly impaired when performing tasks that require a high level of cognitive control . Methylpheni date ( MPH ) and motivational incentives may help improve cognitive control by enhancing the ability to monitor response accuracy and regulate performance accordingly . Methods Twenty-eight children with DSM-IV ADHD ( combined type ) aged 9–15 years and pairwise-matched typically developing children ( CTRL ) performed a go/no-go task in which the incentives attached to performance on no-go trials were manipulated . The ADHD group performed the task off and on their usual dose of MPH . CTRL children performed the task twice but were never medicated . EEG data were recorded simultaneously and two electrophysiological indices of error monitoring , the error-related negativity ( ERN ) and error positivity ( Pe ) were measured . Amplitudes of each ERP were compared between diagnostic groups ( CTRL , ADHD ) , medication days ( Off MPH , On MPH ) and motivational conditions ( baseline – low incentive , reward , response cost ) . Results Error rates were lower in the reward and response cost conditions compared with baseline across diagnostic groups and medication days . ERN and Pe amplitudes were significantly reduced in ADHD compared with CTRL , and were significantly enhanced by MPH . Incentives significantly increased ERN and Pe amplitudes in the ADHD group but had no effect in CTRL . The effects of incentives did not interact with the effects of MPH on either ERP . Effect sizes were computed and revealed larger effects of MPH than incentives on ERN and Pe amplitudes . Conclusions The findings reveal independent effects of motivational incentives and MPH on two electrophysiological markers of error monitoring in children with ADHD , suggesting that each may be important tools for enhancing or restoring cognitive control in these children The effect of a single oral dose of caffeine was examined in a r and omised double-blind placebo-controlled repeated- measures cross-over study . Eighteen children with AD/HD , aged between 8 and 13 years , were individually age- and gender-matched with a control group . All children participated in two sessions , one week apart . Skin conductance level ( SCL ) from a 3 min eyes-closed epoch , commencing 30 min after ingestion of caffeine or placebo , was examined . Across conditions , mean SCL was lower in the AD/HD group than controls , confirming hypoarousal in AD/HD . Caffeine produced an increase in SCL , and this increase did not differ between the groups . However , arousal increases were dose-dependent in controls , but not in AD/HD . Rather , caffeine-induced arousal increases in the AD/HD group were positively related to their hyperactivity/impulsivity levels . This suggests an anomalous arousal mechanism in AD/HD functionally related to impairment in one symptom dimension The timing of caffeine effects on arousal levels was examined . From previous work in our laboratory , an increase in skin conductance level ( SCL ) was used as the marker of arousal increase , and we sought to identify the timing of this and related effects following caffeine ingestion . A single oral dose of caffeine ( 250 mg ) was used in a r and omised double-blind placebo-controlled repeated- measures cross-over study . Eyes-closed resting electroencephalogram ( EEG ) and autonomic data ( SCL , heart rate , respiration rate , and systolic and diastolic blood pressure ) during 2 min epochs that commenced every 4 min after ingestion , were analysed . The SCL placebo data were used to identify potential arousal measures prior to examining caffeine effects . Caffeine was associated with increased SCL , increased respiratory rate and a global reduction in alpha power . There were no significant cardiovascular effects of caffeine-induced arousal . These caffeine results are consistent with our recent electrodermal and EEG studies of arousal , and confirm the potential use of caffeine as a simple means of experimentally modifying arousal levels without task-related confounds Rationale Previous research investigating the effects of stimulants , such as methylpheni date ( MPH ) , on children with attention deficit/hyperactivity disorder ( AD/HD ) has rarely included autonomic measures of arousal . Objective Our aim was to clarify the effects of MPH on central and autonomic measures in AD/HD children during a continuous performance task ( CPT ) using a naturalistic open-label study . Method Thirty-six boys ( 18 AD/HD and 18 control ) participated in a CPT over two trial periods , allowing a more valid estimate of the effects of medication , rather than assuming that retesting per se has no substantial impact . MPH was administered to the AD/HD group 1 h prior to the second trial . Errors and reaction time ( RT ) were recorded as measures of performance , electrodermal activity as an autonomic nervous system measure and event-related potentials ( ERPs ) as an index of central nervous system activity . Results AD/HD children made more errors than controls in the first session , but no group differences were found after medication . No significant differences were observed for RT . Skin conductance level was found to be lower in AD/HD children than controls , but this difference was also ameliorated after medication . Conversely , mean skin conductance response to target stimuli was found not to differ between groups during the initial test phase but became significantly different in phase 2 . ERP data showed topographic differences between groups in N1 , P2 , N2 and P3 at the initial test phase , which were reduced at the second test . ConclusionS timulant medication ameliorated some of the dysfunctions in AD/HD children , which are reflected in behavioural and ERP measures . These results , in combination with general differences in electrodermal activity , support a hypoarousal model of AD/HD , which can explain the action of MPH in these children Attention Deficit Hyperactivity Disorder ( ADHD ) is a developmental disorder that has previously been related to a decreased sensitivity to errors and feedback . Supplementary to the traditional performance measures , this study uses autonomic measures to study this decreased sensitivity in ADHD and the modulating effects of medication . Children with ADHD , on and off Methylpheni date ( Mph ) , and typically developing ( TD ) children performed a selective attention task with three feedback conditions : reward , punishment and no feedback . Evoked Heart Rate ( EHR ) responses were computed for correct and error trials . All groups performed more efficiently with performance feedback than without . EHR analyses , however , showed that enhanced EHR decelerations on error trials seen in TD children , were absent in the medication-free ADHD group for all feedback conditions . The Mph-treated ADHD group showed ' normalised ' EHR decelerations to errors and error feedback , depending on the feedback condition . This study provides further evidence for a decreased physiological responsiveness to errors and error feedback in children with ADHD and for a modulating effect of Mph OBJECTIVE This study examined the use of caffeine to manipulate arousal level without the confounds associated with task-related activation . From previous work in our laboratory , an increase in skin conductance level ( SCL ) and EEG alpha frequency , together with a global decrease in alpha power , were used as markers of arousal increase , and we sought to identify these effects with caffeine ingestion . METHODS We examined the effect of a single oral dose of caffeine ( 250 mg ) in a r and omised double-blind placebo-controlled repeated- measures cross-over study . Eighteen healthy university students ( mean age 21 years ; 13/18 females ) participated in two sessions 1 week apart . EEG and autonomic data ( SCL , heart rate , systolic and diastolic blood pressure , and respiration rate ) from a 2 min eyes-closed epoch , commencing approximately 30 min after ingestion of caffeine or placebo , were examined . RESULTS Caffeine was associated with increased SCL , a global reduction in EEG power in the alpha b and , and a global increase in alpha frequency . There were no cardiovascular effects . CONCLUSIONS The positive results are consistent with recent electrodermal and EEG studies of arousal and suggest that caffeine may be utilised as a task-free means of manipulating arousal in future investigations . Further work is necessary to clarify the absence of cardiovascular effects , and to integrate those data with emerging conceptualisations of arousal and activation . SIGNIFICANCE The present data support the use of caffeine as a simple tool to explore the role of arousal in both normal and atypical functioning , and this may be useful in determining the validity and importance of supposed hyper- or hypo-arousal in such syndromes as attention-deficit/hyperactivity disorder ( AD/HD ) This paper aims to examine the effects of methylpheni date ( MPH ) on integrated baseline and event-related psychophysiological measures in AD/HD . Thirty-four unmedicated AD/HD adolescents ( 11 - 17 years ; 6 females ) were first compared to 34 age- and sex-matched controls , and then re-tested at least 4 weeks after methylpheni date ( MPH ) medication . In each testing session , EDA was recorded simultaneously with EEG during a resting eyes open condition , and with ERPs during an auditory oddball task . Unmedicated AD/HD subjects were compared to controls and then AD/HD subjects were compared pre- and post-medication . Correlations between the change in EEG theta and the remaining psychophysiological variables were undertaken to provide information about post MPH treatment changes . In the unmedicated state , AD/HD was characterized by abnormally enhanced theta , across fronto- central sites , generally reduced P2 responses , with larger non-specific and oddball-elicited SCRs and poor behavioural performance on the oddball task . Following treatment , AD/HD showed a ' normalization ' of theta activity ( particularly in the right hemisphere ) , a reduction in the rate of decrement of EDA and a general increase in P3 amplitude . These findings suggest that methylpheni date is associated with a robust ' normalization ' of low frequency EEG activity during the resting brain state , but has less impact on task-related brain activity or phasic changes in autonomic function . This dissociation of resting and task-related activity may prove to be useful in elucidating the effects of stimulant versus new non-stimulant medications in AD/HD OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Our literature review identified ANS dysfunction in individuals with ADHD , more often in the direction of hypo-arousal than hyper-arousal , particularly at rest and during tasks requiring response regulation and sustained attention . Stimulant medications increased ANS activity and , in some studies , reinforcers and rewards produced a similar effect , suggesting that ANS function can be modified in ADHD .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results The aim of the present study was to compare intraindividually a type III fissure-sealant , glass ionomer cement with a resin-based sealant . One hundred and forty-eight first permanent molars were sealed in forty-seven children . After three years 20.8 percent of the resin and 34.7 percent of the glass ionomer cement sealants were partially lost , and 0 percent and 37.5 percent , respectively , were totally lost . One tooth ( 1.4 percent ) in the glass ionomer cement group and three teeth ( 4.2 percent ) in the resin group developed caries Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the The aim of the present trial was to ( 1 ) compare the caries-preventive effect of glass ionomer sealants , placed according to the atraumatic restorative treatment ( ART ) procedure , with composite resin sealants over time and ( 2 ) investigate the caries-preventive effect after complete disappearance of sealant material . Forty-six boys and 57 girls , mean age 7.8 years , were r and omly divided into two treatment groups in a parallel-group study design . A light-polymerized composite resin sealant material and a high-viscosity glass ionomer were each placed in 180 fully erupted first molars in their respective treatment groups . Evaluation took place annually for 5 years by calibrated examiners . After 5 years , 86 % composite resin and 88 % glass ionomer sealants did not survive . Three categories of re-exposure periods for caries development in pits and fissures after complete loss of sealants were distinguished : 0–1 , 1–2 and 2–3 years . In the 2- to 3-year group , 13 and 3 % of pits and fissures previously sealed with composite resin and glass ionomer , respectively , were diagnosed as having developed a dentine lesion . The relative risks ( 95 % CI ) of dentine lesion development in surfaces sealed with glass ionomer compared to those sealed with composite resin after 3 , 4 and 5 years were 0.22 ( 0.06–0.82 ) , 0.32 ( 0.14–0.73 ) and 0.28 ( 0.13–0.61 ) , respectively . The relative risks of dentine lesion development in pits and fissures previously sealed with glass ionomer compared with composite resin over re-exposure periods of 1–2 and 2–3 years were 0.26 ( 0.14–0.48 ) and 0.25 ( 0.09–0.68 ) , respectively . We conclude that the caries-preventive effect of high-viscosity glass ionomer sealants , placed using the ART procedure , was between 3.1 and 4.5 times higher than that of composite resin sealants after 3–5 years . Furthermore , high-viscosity ( ART ) glass ionomer sealants appear to have a four times higher chance of preventing caries development in re-exposed pits and fissures of occlusal surfaces in first molars than light-cured composite resin sealant material over a 1- to 3-year period . A well- design ed clinical trial using different types of oral health personnel should be implemented to confirm these initial results OBJECTIVE To compare the retention and the caries preventive effect of a glass-ionomer developed for fissure sealing ( Fuji III ) and a chemically polymerized resin-based fissure sealant ( Delton ) . DESIGN A split mouth r and omized design using contralateral teeth . SETTING WHO Regional Demonstration , Training and Research Center for Oral Health , Damascus , Syrian Arab Republic . SAMPLE AND METHODS 179 children , 7 years old at the start of the study , were recruited from schools close to the Center . Only children with at least one pair of permanent first molars that were caries free or only had incipient lesions were included in the study . Follow-up examinations for sealant retention were done after 6 months , 1 year , 2 years and 3 years . The number of children available for reexamination was 129 ( after 6 months ) ; 121 ( after 1 year ) ; OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The overall outcome of the computed data sets suggest no difference between the caries-preventive effects of GIC- and resin-based fissure sealants .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background : The evidence stemming from trials on restorative material s is shaped not only by trial findings , but also trial design and validity . We aim ed to evaluate both aspects in r and omized controlled dental restorative trials published from 2005–2015 . Methods : Using systematic review methodology , we retrieved trials comparing restorative or adhesive dental material s. Two authors independently assessed design , risk of bias , registration status , and findings of trials . Descriptive and regression analyses were performed . Results : 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included . Per trial , the median number of patients was 37 ( 25th/75th percentiles : 30/51 ) . Follow-up was 24 ( 20/48 ) months . Seventeen percent of trials reported on sample size calculations , 2 % had been registered . Most trials ( 90 % ) used US Public Health Service ( USPHS ) criteria , and had a high risk of bias . More recent trials were more likely to have been registered , to have reported on sample size calculations , to be of low risk of bias , and to use other than USPHS- criteria . Twenty-three percent of trials yielded significant differences between groups . The likelihood of such differences was significantly increased in older studies , studies with potential reporting bias , published in journals with high impact factor ( > 2 ) , longer follow-up periods , and not using USPHS- criteria . Conclusions : The majority of dental restorative trials published from 2005–2015 had limited validity . Risk of bias decreased in more recent trials . Future trials should aim for high validity , be registered , and use defined and appropriate sample sizes , follow-up periods , and outcome measures PURPOSE This longitudinal r and omized controlled clinical trial evaluated direct composite restorations for clinical acceptability as posterior restoratives in single- or multi-surface cavities and provides a survey of the 4-year results . MATERIAL S AND METHODS Three dentists placed 46 Quixfil ( Xeno III ) and 50 Tetric Ceram ( Syntac Classic ) composite restorations in stress-bearing Class I and II cavities in first or second molars ( 43 adult patients ) . Clinical evaluation was performed at baseline and after 4 years by 2 other dentists using modified USPHS criteria . At the last recall period , 37 Quixfil and 46 Tetric Ceram restorations were assessed . RESULTS A total of 89.2 % of Quixfil and 97.8 % of Tetric Ceram posterior composites were assessed to be clinical ly excellent or acceptable with predominating alfa scores . Up to the 4-year recall , four Quixfil restorations failed because of bulk fracture , partial tooth fracture ( 2x ) and postoperative symptoms . One Tetric Ceram restoration was lost due to problems with tooth integrity . No significant differences between the two composites could be detected at 4 years for any of the evaluated clinical criteria ( p > 0.05 ) . The comparison of restoration performance with time within both groups yielded a significant increase in marginal discoloration and decrease in marginal integrity for both material s. After 4 years , small restorations exhibited significantly less marginal discoloration than large restorations . CONCLUSION Clinical assessment of stress-bearing Quixfil and Tetric Ceram posterior composite restorations showed good clinical results with predominantly alfa scores for both material OBJECTIVES To analyze the relationship between the cavity depth and liners with postoperative sensitivity of resin composite restorations . METHODS A clinical follow-up was conducted on 319 resin composite restorations made in the final year of an undergraduate program over a 3-year period . Along with the analyses of cavity type , cavity depth , type of pulpal protection and the material s used , the postoperative sensitivity was also examined on each restoration . RESULTS Thirty-nine percent of the restorations had no protective layer ( Group 1 ) . As the depth of the prepared cavities increased , the restorations received one of the three pulpal protection methods ; a calcium hydroxide base ( Group 2 ) , glass ionomer cement ( Group 3 ) , or protection with a calcium hydroxide base in combination with glass ionomer cement ( Group 4 ) . The incidence of postoperative sensitivity showed no significant difference among Groups 1 , 2 and 3 , but was significantly lower in Group 1 than in Group 4 . The restorations made in shallow and medium depth cavities demonstrated significantly less-postoperative sensitivity than those made in deep cavities . The newer generation dentine-bonding agents showed a significantly lower incidence of postoperative sensitivity than the early generation group . CONCLUSIONS Postoperative sensitivity in resin composite restorations was not related to the absence of protective layers but increased with the depth of cavities restored with the resin composite . The type of dentine-bonding agents could also be responsible for postoperative sensitivity PURPOSE To evaluate the 3-year clinical durability of the flowable bulk-fill resin composite SDR in Class I and Class II restorations . MATERIAL S AND METHODS Thirty-eight pairs of Class I and 62 pairs of Class II restorations were placed in 44 male and 42 female patients ( mean age 52.4 years ) . Each patient received at least two extended Class I or Class II restorations that were as similar as possible . In all cavities , a one-step self-etching adhesive ( XenoV+ ) was applied . One of the cavities of each pair was r and omly assigned to receive the flowable bulk-fill resin composite SDR in increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface . The occlusal part was completed with an ormocer-based nanohybrid resin composite ( Ceram X mono+ ) . In the other cavity , only the resin composite CeramX mono+ was placed in 2 mm increments . The restorations were evaluated using slightly modified USPHS criteria at baseline and then annually for 3 years . Caries risk and bruxing habits of the participants were estimated . RESULTS No post-operative sensitivity was reported . At the 3-year follow-up , 196 restorations - 74 Class I and 122 Class II - were evaluated . Seven restorations failed ( 3.6 % ) , 4 SDR-CeramX mono+ and 3 CeramX mono+ only restorations , all of which were Class II . The main reason for failure was tooth fracture , followed by resin composite fracture . The annual failure rate ( AFR ) for all restorations ( Class I and II ) was 1.2 % for the bulkfilled restorations and 1.0 % for the resin composite-only restorations ( p > 0.05 ) . For the Class II restorations , the AFR was 2.2 % and 1.6 % , respectively . CONCLUSION The 4-mm bulk-fill technique showed good clinical effectiveness during the 3-year follow-up OBJECTIVE The objective of this split-mouth r and omized controlled study was to compare the 2-year clinical performance of two restorative techniques and material s for posterior permanent carious teeth . METHOD AND MATERIAL S After signing informed consent , 30 patients aged between 7 and 16 received two Class 1 restorations on cavities on permanent first or second molar teeth performed with one of two systems : incrementally placed conventional posterior composite resin ( Herculite Ultra , Kerr ) , and sonic-resin placement system ( SonicFill , Kerr ) with single-component self-etch adhesive system ( Kerr ) according to the manufacturers ' directions . Two blinded observers evaluated the restorations at three times ( baseline , and after 1 and 2 years ) according to the US Public Health Service modified criteria . Kruskal-Wallis test and Mann-Whitney U-test were used to compare the clinical performance of the restorative systems . RESULTS The restorative systems showed similar clinical performance at 2 years . At the end of 2 years in both groups , one restoration 's marginal staining Alpha ratings decreased . In the same period , two restorations in the conventional group and one in the SonicFill group received Bravo ratings for color match and surface roughness scorings . CONCLUSION The sonic-resin placement system demonstrated similar results to incrementally placed conventional composite resin in terms of clinical success . Considering the advantages of providing up to 5 mm in a single layer , and the adjustability of the viscosity , bulk-fill composite restorations seem to be a good alternative to posterior Class 1 composite restorations . CLINICAL RELEVANCE This study suggests that a new dental material for bulk-fill technology exhibits similar clinical success to incrementally placed composite resin OBJECTIVE The aim of this study was to evaluate the morphology of the resin-dentin interface formed in vivo with two posterior resin composite placement techniques ( incremental and bulk ) . METHOD AND MATERIAL S After approval from the patients , 12 Class II cavities with margins in enamel ( 2.5 x 2.5 x 4.5 mm ) were prepared in caries-free premolars scheduled to be extracted for orthodontic reasons ( n = 6 ) . The cavities were restored with Single Bond + Filtek P60 as a bulk condensable technique or Single Bond + Filtek Z250 as an oblique incremental technique . After 1 week , the teeth were extracted with minimal trauma to the restored area . After the teeth were sectioned , a polyvinyl siloxane impression was taken from the resin-dentin interface to control for artifacts created during preparation for scanning electron microscopy . The specimens were subsequently processed for and observed under a scanning electron microscope to assess gap formation . RESULTS The mean percentage of gap formation was 6.1 % for teeth restored with the incremental placement technique and 18.7 % for teeth restored with the bulk placement technique . The difference was statistically significant . CONCLUSION The incremental placement of posterior resin composites may still provide better seal than the new bulk condensable technique The objective of this longitudinal clinical r and omized trial was to evaluate the clinical performance of a nanofilled and a nanohybrid resin composite in Class I occlusal restorations of posterior teeth over the course of 54 months . Forty-one adolescents participated in the study . The teeth were restored with Adper Single Bond 2 ( 3 M ESPE ) and nanofilled ( Filtek Z350 , 3 M ESPE ) , nanohybrid ( Esthet-X , Dentsply ) and microhybrid Filtek Z250 ( 3 M ESPE ) used as a control . After 54 months , the restorations were evaluated in accordance with the modified United States Public Health Service criteria . The McNemar and Friedman tests were used for statistical analysis , at a level of significance of 5 % . Five failed restorations were observed during the follow-up . A change to unacceptable restoration occurred for one Esthet-X , two Filtek Z350 , and two Filtek Z250 restorations , which received the clinical ly unacceptable score , Charlie , for both anatomic form and marginal adaptation . Secondary caries and postoperative sensitivity occurred in one Filtek Z250 and one Filtek Z350 restoration . When the five evaluation periods ( baseline and six , 12 , 30 , and 54 months ) were compared , significant differences were found in the marginal adaptation of Filtek Z250 and Filtek Z350 . Significant differences in the roughness criteria ( p=0.005 ) were also observed when the three composites were compared after 54 months ( Filtek Z350 > Filtek Z250 > Esthet-X ) , always within clinical ly acceptable limits . The material s investigated showed acceptable clinical performance for Class I restoration after 54 months . Long-term reevaluations are necessary for a more detailed analysis of these composites Background : Recently , manufacturers have introduced bulk-fill composite resins that reportedly can be placed in increments of 4 mm or greater . Objective : The purpose of this article was to report the results of 12 months prospect i ve r and omized clinical trial that evaluated the clinical performance of one high-viscosity bulk-fill composite resin in Class II cavities of posterior teeth . Material s and Methods : Thirty-four participants had at least two Class II cavities included the study . Class II cavities restored with either a Tetric EvoCeram bulk-fi fill or universal nano-hybrid resin composite ( Tetric EvoCeram ) . A total of 74 restorations ( 37 with each material ) on 34 patients were placed according to the manufacturers ' instructions by one calibrated operator . Results : Seventy restorations were evaluated after 12 months evaluation period . No postoperative sensitivity , anatomic form , retention , and secondary caries were observed after 6 and 12 months . Regarding the items color match , marginal discoloration , and marginal adaptation , the statistical analysis did not detect any statistical significance between two material s ( P > 0.05 ) . Conclusion : After 12 months of clinical service , all restorations evaluated for both material s were classified as ideal , receiving predominantly Alfa scores for all parameters analyzed . Clinical Relevance : This study presents that high-viscosity bulk-fill resin composites ( RCs ) perform just as well as nano-hybrid RCs with the 2 mm RC layering technique , therefore could be alternative to conventional nano-hybrid RCs OBJECTIVE The objective of this 6 year prospect i ve r and omized equivalence trial was to evaluate the long-term clinical performance of a new nano-hybrid resin composite ( RC ) in Class II restorations in an intraindividual comparison with its well-established conventional hybrid RC predecessor . METHODS Each of 52 participants received at least two , as similar as possible , Class II restorations . The cavities were chosen at r and om to be restored with an experimental nano-hybrid RC ( Exite/Tetric EvoCeram ( TEC ) ; n=61 ) and a conventional hybrid RC ( Exite/Tetric Ceram ( TC ) ; n=61 ) . The restorations were evaluated with slightly modified USPHS criteria at bas OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusions The present systematic review and meta- analysis indicate similar clinical performances of bulk-fill and conventional resin composites over a follow-up period of 12 to 72 months . Clinical significance Based on the results of this study , the bulk-fill resin composites could be an alternative for direct restorations in posterior teeth .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The number of published systematic review s of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions . Systematic review s are subject to a range of biases and increasingly include non-r and omised studies of interventions . It is important that users can distinguish high quality review s. Many instruments have been design ed to evaluate different aspects of review s , but there are few comprehensive critical appraisal instruments . AMSTAR was developed to evaluate systematic review s of r and omised trials . In this paper , we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic review s that include r and omised or non-r and omised studies of healthcare interventions , or both . With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic review s , including those based on non-r and omised studies of healthcare interventions OBJECTIVE To evaluate efficacy , safety , and tolerability of long-acting injectable antipsychotic aripiprazole once-monthly 400 mg ( AOM 400 ) as maintenance treatment for bipolar I disorder ( BP-I ) . METHODS In a double-blind , placebo-controlled , 52-week r and omized withdrawal study conducted from August 2012 to April 2016 , patients with a DSM-IV-TR diagnosis of BP-I currently experiencing a manic episode were stabilized sequentially on oral aripiprazole and AOM 400 and then r and omized to AOM 400 or placebo . The primary end point was time from r and omization to recurrence of any mood episode . Other end points included proportion of patients with recurrence of any mood episode and recurrence by mood episode type . RESULTS Of 266 r and omized patients , 64 ( 48.1 % ) of 133 in the AOM 400 group and 38 ( 28.6 % ) of 133 in the placebo group completed the study . AOM 400 significantly delayed the time to recurrence of any mood episode compared with placebo ( hazard ratio : 0.45 ; 95 % CI , 0.30 to 0.68 ; P < .0001 ) . Significantly fewer patients ( P < .0001 ) experienced recurrence of any mood episode with AOM 400 ( 35/132 ; 26.5 % ) compared with placebo ( 68/133 ; 51.1 % ) , with the effects observed predominantly on manic episodes ( P < .0001 ) . Patients were not depressed at study entry , and between-group differences in depressive episodes were not significant ( P < .864 ) . The treatment-emergent adverse events ( incidence > 5 % ) that were reported at higher rates with AOM 400 than placebo were weight increase , akathisia , insomnia , and anxiety . CONCLUSIONS AOM 400 delayed the time to and reduced the rate of recurrence of mood episodes and was generally safe and well tolerated . These findings support the use of AOM 400 for maintenance treatment of BP-I. TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01567527 A double-blind cross-over trial of depot flupenthixol in recurrent manic depressive psychosis was carried out . All patients continued on lithium . Eleven patients completed the two-year trial . Flupenthixol appeared to have no prophylactic effect Background : Risperidone is the first atypical antipsychotic to become available in a long-acting , injectable formulation . This is the first prospect i ve study to assess the effectiveness of long-acting risperidone in a cohort of bipolar patients . Methods : Twenty-nine DSM-IV acutely manic bipolar in patients with a history of poor or partial adherence to medication entered the mirror- design observational study . They received naturalistic treatment for a manic episode plus long-acting , injectable risperidone for a mean period of 2 years . The following measures were used to assess the effectiveness of risperidone : the number of hospitalizations , the number of manic , mixed , and depressive episodes leading to hospitalization , the mean duration of hospitalizations , time to relapse , treatment adherence , aggression and suicide attempts . The Clinical Global Impressions ( CGI ) was used for clinical relevance as well . Results : During the follow-up , there was a significant decrease in the number of hospitalizations per patient ( Z−2.72 P<0.006 ) , in the number of manic or mixed episodes leading to hospitalization ( Z−2.68 P<0.007 ) but not in the hospitalizations due to depressive episodes , a decrease in the average length of hospitalization per patient ( Z−3.27 P<0.001 ) , a significant increase in the time to any new episode ( first relapse ) ( Z−3.28 , P<0.001 ) , and significant improvements in treatment adherence ( P<0.0001 ) and hetero-aggressive episodes ( P<0.0001 ) , but not suicide attempts ( P = NS ) . At study endpoint 14 patients ( 48 % ) were very much improved according to the CGI . Discussion : This observational long-term study provides support to long-acting injectable risperidone being effective for the maintenance treatment of mania and improving treatment adherence , reducing relapses and re-hospitalization rates In an open , prospect i ve 12 month study of perphenazine decanoate ( PD ) , 42 psyhchotic patients diagnosed according to DSM‐III were treated with a fixed depot interval and an individual dose , guided by gas chromatographic perphenazine plasma concentration monitoring combined with clinical evaluation . Degree of illness was rated using a social‐psychiatric CGI‐scale and extrapyramidal side effects were evaluated by means of a modified Simpson and Angus rating scale . After six months of treatment , a statistically significant improvement was found ( p < 0.001 ) . During the last six months a further slight reduction in mean CGI‐scores was observed . Mild to moderate extrapyramidal side effects occurred in 9 patients ( 21 % ) principally during the initial phase of therapy . No other side effects or changes in blood chemistry were found during the study . Plasma concentrations of perphenazine increased during the initial 3 months and stabilized hereafter . There were however , large intra‐ and inter‐individual variations in the perphenazine plasma concentration/dose ratio . In addition , it was observed that plasma concentrations of perphenazine were significantly higher in patients who had been treated with neuroleptics for more than 10 years compared to those who had been treted 5 years or less . This observation indicates gradual development of tolerance to neuroleptic treatment OBJECTIVE No large controlled trials have evaluated adjunctive maintenance treatment with long-acting injectable antipsychotics in patients with bipolar disorder . This study assessed whether adjunctive maintenance treatment with risperidone long-acting therapy ( RLAT ) , added to treatment-as-usual ( TAU ) medications for bipolar disorder , delays relapse in patients with bipolar disorder type I. METHODS This study included patients with bipolar disorder type I with > or = four mood episodes in the 12 months prior to study entry . Following a 16-week , open-label stabilization phase with RLAT plus TAU , remitted patients entered a 52-week , double-blind , placebo-controlled , relapse-prevention phase . R and omized patients continued treatment with adjunctive RLAT ( 25 - 50 mg every two weeks ) plus TAU ( n = 65 ) or switched to adjunctive placebo injection plus TAU ( n = 59 ) . The primary outcome measure was time to relapse to any mood episode . RESULTS Of 240 enrolled patients , 124 entered double-blind treatment . Time to relapse was longer in patients receiving adjunctive RLAT ( p = 0.010 ) . Relapse rates were 23.1 % ( n = 15 ) with adjunctive RLAT versus 45.8 % ( n = 27 ) with adjunctive placebo ; relative relapse risk was 2.3-fold higher with adjunctive placebo ( p = 0.011 ) . Completion rates were : adjunctive RLAT , 60.0 % ( n = 39 ) and adjunctive placebo , 42.4 % ( n = 25 ; p = 0.050 ) . Adverse event (AE)-related discontinuations were 4.6 % ( n = 3 ) and 1.7 % ( n = 1 ) , respectively . Common AEs ( adjunctive RLAT versus adjunctive placebo ) were : tremor ( 24.6 % versus 10.2 % ) , insomnia ( 20.0 % versus 18.6 % ) , muscle rigidity ( 12.3 % versus 5.1 % ) , weight increased ( 6.2 % versus 1.7 % ) , and hypokinesia ( 7.7 % versus 0.0 % ) . CONCLUSIONS Adjunctive RLAT significantly delayed time to relapse in patients with bipolar disorder type I who relapse frequently . Safety and tolerability of RLAT were generally consistent with that previously observed BACKGROUND Poor medication adherence is common among bipolar patients . METHOD We examined prospect i ve data from 2 cohorts of individuals from the Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) study ( 1999 - 2005 ) with bipolar disorder . Clinical and sociodemographic features associated with missing at least 25 % of doses of at least 1 medication were assessed using logistic regression , and a risk stratification model was developed and vali date d. RESULTS Of 3,640 subjects with 48,287 follow-up visits , 871 ( 24 % ) reported nonadherence on 20 % or more study visits . Clinical features significantly associated ( P < .05 ) with poor adherence included rapid cycling , suicide attempts , earlier onset of illness , and current anxiety or alcohol use disorder . Nonadherence during the first 3 months of follow-up was associated with less improvement in functioning at 12-month follow-up ( P < .03 ) . A risk stratification model using clinical predictors accurately classified 80.6 % of visits in an independent validation cohort . CONCLUSION Risk for poor medication adherence can be estimated and may be useful in targeting interventions The hypothesis that flupenthixol decanoate may serve as an alter‐native to prophylactically administered lithium in recurrent manicdepressive illness , bipolar and unipolar type , was tested in two groups of patients . In Group I the patients were allocated r and omly to maintenance treatment with either lithium or flupenthixol decanoate . The patients in Group II had previously been given lithium and were switched to flupenthixol decanoate because of unsatisfactory prophylactic effect of lithium , doubtful tablet compliance , troublesome side effects , or fear of later harmful effects . The flupenthixol decanoate dosage was 20 mg every 2–3 weeks . The study was not blind OBJECTIVE Schizoaffective disorder is a complex illness for which optimal treatment is not well established . Results of the first controlled , relapse-prevention study of paliperidone palmitate once-monthly injectable ( paliperidone monthly ) in schizoaffective disorder are presented . METHOD The study was conducted between September 20 , 2010 , and October 22 , 2013 . Patients with schizoaffective disorder ( confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders ) experiencing acute exacerbation of psychotic and depressive/manic symptoms were stabilized with paliperidone monthly as monotherapy or as adjunctive therapy to mood stabilizers or antidepressants and r and omly assigned ( 1:1 ) to paliperidone monthly or placebo in a 15-month , double-blind , relapse-prevention phase . R and omization was stratified by administration as monotherapy or adjunctive therapy and by study center . The primary endpoint was time to relapse . RESULTS 334 patients were evaluated . Paliperidone monthly significantly delayed time to relapse for psychotic , depressive , and manic symptoms compared with placebo ( P < .001 , log-rank test ) . Relapse risk was 2.49 times greater for placebo ( hazard ratio = 2.49 ; 95 % CI , 1.55 to 3.99 ; P < .001 , Cox proportional hazards model ) . Overall relapse rates were 33.5 % for placebo and 15.2 % for paliperidone monthly . For monotherapy , relapse risk was 3.38 times greater with placebo ( P = .002 ) , and for adjunctive treatment it was 2.03 times greater with placebo ( P = .021 ) . Paliperidone monthly was superior to placebo in maintaining functioning as measured by the Personal and Social Performance scale ( P = .014 , mixed-model repeated- measures analysis ) . The most common adverse events ( placebo , paliperidone monthly ) were increased weight ( 4.7 % , 8.5 % ) , insomnia ( 7.1 % , 4.9 % ) , schizoaffective disorder ( 5.9 % , 3.0 % ) , headache ( 3.5 % , 5.5 % ) , and nasopharyngitis ( 3.5 % , 5.5 % ) . Incidence of any extrapyramidal-related adverse event was 7.1 % for placebo and 8.5 % for paliperidone monthly . CONCLUSIONS Paliperidone monthly as monotherapy or OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Risperidone long-acting injectable was found to be effective in protecting from any mood/manic symptom compared to placebo , but not from depressive recurrences . Add-on or monotherapy paliperidone palmitate in SAD patients protected from psychotic , depressive , and manic symptoms . In patients with BD-I with a manic episode at study enrolment , aripiprazole monohydrate significantly delayed time to recurrence of manic episodes without inducing depressive episodes . LAIs are effective and well-tolerated maintenance treatments for BD and SAD . They showed better efficacy in preventing mania than depression . LAIs may be first-line for BD-I and SAD patients with a manic predominant polarity and with non-adherence problems

MS2_fixed_5_shot245

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND tibolone at usual doses of 2.5 mg/day in postmenopausal women has been shown to improve climacteric complaints , without affecting endometrial thickness and lipid profile or blood glucose . However , the potentially similar efficacy , but better tolerability , of a low dose of this drug ( 1.25 mg ) has never been established . METHODS 162 healthy , non-obese , post-menopausal women , aged 40 - 65 years , with an intact uterus were enrolled in a national , single centre , r and omised , double blind , placebo controlled , parallel group trial . After 1 week of runin , patients were treated for 24 weeks with placebo , tibolone 1.25 mg or 2.5 mg/day . During the study laboratory tests , endometrial ultrasound scans and mammography were performed . Occurrence of menopausal signs and symptoms , including vaginal bleeding , and quality of sexual life were also checked . RESULTS in the 120 patients terminating the study without major protocol violations , climacteric symptoms were similarly improved by tibolone 1.25 and 2.5 mg ( 78 % and 90 % reduction at week 24 for hot flushes , 36 % and 34 % for sweating episodes and 44 % and 51 % for vaginal dryness ) , but not by placebo . Benefits occurred earlier in the group treated with tibolone 2.5 mg . Quality of sexual life was almost invariably improved by tibolone as compared to placebo , but improvement occurred earlier in the tibolone 1.25 mg group . Severity of vaginal bleeding was not different between placebo and active treatment groups , except at week 12 when was higher . At the end of treatment vaginal bleeding occurred in 15 % of patients treated with placebo , 14 % treated with tibolone 1.25 mg and 12 % treated with tibolone 2.5 mg . Endometrial thickness and breast density were not changed by treatment , as well as FSH , 17-beta-estradiol , total cholesterol , HDL and LDL cholesterol , triglycerides and blood glucose . Adverse events were reported by 14.7 % , 26.7 % and 24.4 % of patients treated with placebo , tibolone 1.25 mg and tibolone 2.5 mg/day , respectively . CONCLUSIONS tibolone at doses of 1.25 or 2.5 mg/day given for 24 weeks to postmenopausal women displayed similar efficacy and safety profiles , though were more effective than placebo . Tibolone 1.25 mg induced a more gradual relief from climacteric symptoms and a more prompt improvement of sexual function In this report we evaluated the action of conjugated equine estrogens ( CEE ) on vaginal symptoms , cytology , pH , and flora in late postmenopausal women without any previous hormone therapy . The study was a r and omized , double-blind , placebo-controlled trial with 48 late postmenopausal women who received placebo or unopposed CEE ( 0.625mg/day of CEE orally ) during three months of treatment . Vaginal and sexual complaints were evaluated through daily diary cards . We analyzed vaginal changes through cytology and pH measurements . After three months of treatment , 20 % of placebo-treated patients and 80 % of the CEE-treated patients reported improvement in vaginal dryness and irritation . In the latter group , the vaginal cells and Lactobacillus increased and the vaginal pH decreased , without other changes in sexual complaints . We concluded that estrogen ameliorated the genital tract of late postmenopausal women without any previous hormone therapy OBJECTIVE In some women , hot flashes and other symptoms attributed to menopause persist for many years after the cessation of menses . The frequency and severity of such symptoms and response to hormone therapy in older women have not been well documented . METHODS We used data from the Heart and Estrogen/Progestin Replacement Study , a blinded , clinical trial among 2763 women with documented coronary disease and a uterus who were r and omized to receive either conjugated estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg in one tablet or placebo . Participants were queried at baseline and annually regarding menopausal symptoms . Breast symptoms were self‐reported , and uterine bleeding was recorded on a daily diary . RESULTS Symptoms associated with menopause were relatively common among Heart and Estrogen/Progestin Replacement Study participants , whose average age was 67 years and who averaged 18 years since menopause . At baseline , 16 % of women reported frequent hot flashes , 26 % vaginal dryness , 10 % genital irritation , 55 % trouble sleeping , and 53 % early awakening . Women assigned to hormone therapy reported less frequent hot flashes , vaginal dryness , and trouble sleeping compared with women assigned to placebo , but more frequent vaginal discharge , genital irritation , uterine bleeding , and breast symptoms . The reporting of breast symptoms among women in the hormone group decreased from 40 % at 1 year to 13 % by the 4th year . Uterine bleeding was reported by 31 % and spotting by an additional 33 % of women in the hormone group during the 1st year of treatment ; by the 4th year , these proportions had fallen to 11 % and 20 % , respectively . CONCLUSION Symptoms typically attributed to menopause are common in elderly women . Postmenopausal hormone therapy reduces hot flashes , trouble sleeping , and vaginal dryness , but at st and ard doses in elderly women is associated with vaginal discharge , genital irritation , uterine bleeding , and breast symptoms Objective : To determine the effects of raloxifene on sexual function in postmenopausal women with pre-existing vaginal atrophy treated with vaginal estrogen cream . Methods : A total of 187 naturally postmenopausal women , 42 - 80 years of age , with signs of genitourinary atrophy were enrolled in this 6-month , multicenter , parallel-group study . Subjects were r and omized to oral raloxifene HCl 60 mg daily or matching placebo ; the same subjects were also r and omized to receive one application of either vaginal conjugated estrogen cream 0.5 g twice weekly for 6 months or non-hormonal vaginal moisturizer twice weekly for 3 months , followed by conjugated estrogen cream for 3 months . Both investigators and subjects were masked to the identity of the oral medication . The vaginal preparations were administered in an open-label fashion . The Sexual Activity Question naire ( SAQ ) was administered at baseline and at 3 and 6 months . Safety was assessed throughout the study . Results : A total of 102 women were sexually active at baseline and , of these , 82 were also sexually active at the 6-month end-point . At 6 months , raloxifene and placebo , in the presence of vaginal conjugated estrogen cream , were both associated with improvement from baseline in vaginal dryness and reduced discomfort during sexual activity . There were no significant differences between raloxifene and placebo groups in any SAQ item . Enjoyment of sexual activity significantly increased from baseline with raloxifene but not with placebo . No difference in adverse events was observed between groups . Conclusion : Raloxifene had no negative effects on sexual function in postmenopausal women with vaginal atrophy who were treated concomitantly with vaginal estrogen cream The women in this study were either post-menopausal or ovariectomised for at least 1 yr prior to the study . They had also been treated for cancer of the cervix ( 27 women ) , endometrium ( 5 ) , ovaries ( 5 ) or breast ( 1 ) . All women presented with sexual troubles , mainly genital discomfort ( dyspareunia or vaginism ) . In a double-blind fashion , gynaecological capsules containing either an oestradiol diether ( ICD : promestriene ) or only the excipient were administered for 40 consecutive days . At the end of the treatment , the FSH , LH , oestrone ( E1 ) and oestradiol ( E2 ) plasma levels were not found to be significantly different from the pre-therapeutic values . These results suggest that promestriene acts on the vaginal mucosa , therefore not being converted back into the hormone from which it was derived . Also , in its dietheroxide form , promestriene is incapable of crossing the malpighian ( vaginal or epidermal ) epithelium and of reaching the general blood circulation . This discrepancy between the local anti-atrophic effects and the inability to exert systemic oestrogen activities singles out promestriene and justifies its therapeutic use when hormonally active oestrogens are contra-indicated , as in patients who have an oestrogen-sensitive cancer in their medical history Objective To assess the effect of combined hormone replacement therapy ( HRT ) on health related quality of life . Design R and omised placebo controlled double blind trial . Setting General practice s in United Kingdom ( 384 ) , Australia ( 94 ) , and New Zeal and ( 24 ) . Participants Postmenopausal women aged 50 - 69 at r and omisation ; 3721 women with a uterus were r and omised to combined oestrogen and progestogen ( n=1862 ) or placebo ( n=1859 ) . Data on health related quality of life at one year were available from 1043 and 1087 women , respectively . Interventions Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year . Main outcome measures Health related quality of life and psychological wellbeing as measured by the women ’s health question naire . Changes in emotional and physical menopausal symptoms as measured by a symptoms question naire and depression by the Centre for Epidemiological Studies depression scale ( CES-D ) . Overall health related quality of life and overall quality of life as measured by the European quality of life instrument ( EuroQol ) and visual analogue scale , respectively . Results After one year small but significant improvements were observed in three of nine components of the women ’s health question naire for those taking combined HRT compared with those taking placebo : vasomotor symptoms ( P<0.001 ) , sexual functioning ( P<0.001 ) , and sleep problems ( P<0.001 ) . Significantly fewer women in the combined HRT group reported hot flushes ( P<0.001 ) , night sweats ( P<0.001 ) , aching joints and muscles ( P=0.001 ) , insomnia ( P<0.001 ) , and vaginal dryness ( P<0.001 ) than in the placebo group , but greater proportions reported breast tenderness ( P<0.001 ) or vaginal discharge ( P<0.001 ) . Hot flushes were experienced in the combined HRT and placebo groups by 30 % and 29 % at trial entry and 9 % and 25 % at one year , respectively . No significant differences in other menopausal symptoms , depression , or overall quality of life were observed at one year . Conclusions Combined HRT started many years after the menopause can improve health related quality of life . Trial registration IS RCT N 63718836 Aim . To evaluate with vali date d instruments changes in quality of life and sexuality in women receiving hormonal replacement therapy ( AHT ) . Design . R and omised , double-blind , double-dummy study with two parallel treatment arms . Patients and methods . Forty-seven healthy post-menopausal women , aged 45–64 years , were evaluated using the Female Sexual Function Index ( FSFI ) and the menopause-specific quality of life question naire ( MENQOL ) . Of them , 40 diagnosed with sexual dysfunction were r and omised ( 1:1 ) to receive daily 0.625 mg of conjugated estrogens plus 1.25 mg of methyl-testosterone and 100 mg of micronised progesterone or placebo . After 3 months follow-up , FSFI and MENQOL question naires were administered for a second time . Results . Quality of life was unchanged in the placebo group whereas AHT significantly improved scores of vasomotor , psychological , physical and sexual symptoms . As expected , FSFI was not modified in the placebo group while in AHT group the FSFI score improved significantly . In addition , at the end of the study , 68.7 % of subjects of the AHT group did not fit did not fit the criteria for sexual dysfunction as per the FSFI ( p < 0.0001 ) . Conclusions . Adding methyl-testosterone to hormone therapy improves quality of life and sexuality in post-menopausal women with sexual dysfunction OBJECTIVES Guidelines recommend using the lowest effective dose of oestrogen for the management of vasomotor symptoms in postmenopausal women . The primary aim of this double-blind , multi-centre , r and omised study was to assess the efficacy of oral ultra-low dose continuous combined hormone replacement therapy with 17β-oestradiol and dydrogesterone . STUDY DESIGN 313 women with ≥50 moderate to severe hot flushes during the previous week were r and omised to 0.5 mg 17β-oestradiol/2.5 mg dydrogester OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

HT treatment with estrogens alone or in combination with progestogens was associated with a small to moderate improvement in sexual function , particularly in pain , when used in women with menopausal symptoms or in early postmenopause ( within five years of amenorrhoea ) , but not in unselected postmenopausal women . The current evidence does not suggest an important effect of tibolone or of SERMs alone or combined with estrogens on sexual function .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE --To compare the effects of uteroplacental circulation of two beta adrenoceptor blockers , atenolol ( cardioselective ) and pindolol ( non-selective with intrinsic sympathomimetic activity ) . DESIGN --Controlled double blind double dummy study . SETTING --Departments of obstetrics and gynaecology in two Swedish university hospitals . SUBJECTS--29 women with pregnancy induced hypertension in the third trimester , 13 r and omised to atenolol and 16 to pindolol . MAIN OUTCOME MEASURES --Pulsatility index in fetal aorta , umbilical artery , and maternal arcuate artery . Volumetric blood flow in fetal aorta and umbilical vein . RESULTS --Mean arterial blood pressure decreased by 9.0 ( 95 % confidence interval -13.0 to -5.0 ) mm Hg in the atenolol group and by 7.8 ( -11.4 to -4.2 ) mm Hg in the pindolol group . During atenolol treatment the pulsatility index increased significantly from 1.82 ( SD 0.20 ) to 2.07 ( 0.32 ) in the fetal thoracic descending aorta , from 1.44 ( 0.28 ) to 1.79 ( 0.27 ) in the abdominal aorta , and from 0.93 ( 0.17 ) to 1.05 ( 0.19 ) in the umbilical artery ; the volumetric blood flow in the umbilical vein decreased from 106 ( 28.8 ) to 84 ( 22.6 ) ml/min/kg . No such changes were seen after treatment with pindolol . Birth weight was similar in the two groups but placental weight was significantly different ( 529 ( 122 ) g in atenolol group v 653 ( 136 ) g in pindolol group ; p = 0.03 ) . CONCLUSION --The hypotensive effect was similar with both drugs , but only the beta 1 blocker atenolol had significant effects on fetal haemodynamics , although within normal ranges . The implication s of these findings can be only speculative , but negative fetal consequences of beta 1 adrenoceptor blockade can not be excluded One hundred and eighty three hypertensive pregnant women were r and omly assigned to antihypertensive treatment with oxprenolol ( 96 women ) or methyldopa ( 87 women ) . Control of hypertension was equivalent in both treatment groups , and in 64 ( 35 % ) cases hydralazine had to be added to the treatment to achieve the therapeutic goal ( diastolic blood pressure below 85 mm Hg ) . Five perinatal deaths occurred , one in the oxprenolol group and four in the methyldopa group . Detailed analysis confirmed a previous report of greater fetal growth in the group treated with oxprenolol ; this trend was present regardless of severity of hypertension and parity . With increasing duration of treatment the differences between the two groups diminished , and there was no difference after 10 weeks of treatment , a finding that may explain some of the reported discrepancies among therapeutic studies . As hypertension in pregnancy may pursue an accelerated course , necessitating urgent delivery , and there is no satisfactory method of predicting the duration of treatment in individual patients fetal benefit is most likely to be achieved by treatment with oxprenolol , provided that there is no maternal contraindication to treatment with beta blockers PURPOSE To evaluate the evolution of glycemic levels in newborns of hypertensive mothers according to maternal treatment . METHODS Prospect i ve r and omized study , including 93 newborns of mothers treated with isradipine ( n = 39 ) , atenolol ( n = 40 ) , or low sodium diet ( control group - n=14 ) . Glycemia was determined at birth ( mother and newborn by the oxidase glucose method ) and in the 1st , 3rd , 6th , 12th , and 24th hours after birth ( newborn by a test strip method ) . The evolution of glycemia was analyzed in each group ( Friedman test ) . The groups were compared regarding glycemia ( Kruskall-Wallis test ) , and linear regression models were constructed for the analyses ( independent variable = maternal glycemia ; dependent variables = umbilical cord , 3rd , and 6th hour glycemia ) . RESULTS There were no statistically significant differences among the mean blood glucose levels of the 3 groups in any of the assessment s. There was a correlation between maternal and umbilical cord blood glucose in the isradipine ( r = 0.61 ; P < .05 ) and control ( r = 0.84 ; P < .05 ) groups . Regarding glycemia levels of the mothers and newborns in the third and sixth hours postpartum , this correlation was present only in the control group ( maternal x third hour : r = 0.65 ; P < .05 ; maternal x sixth hour : r = 0.68 ; P < .05 ) . There were no correlations in the atenolol group . Hypoglycemia was detected in 51.3 % of the isradipine group , 60 % of the atenolol group , and 35.7 % of the control group , and it was more frequent in the first hour postpartum in all groups . CONCLUSIONS The results suggest a similar effect of the 3 types of treatment upon newborn glycemia . The correlation analysis suggests that isradipine could have effects upon newborn glycemia only after birth ( correlation only in umbilical cord blood ) , whereas atenolol could act earlier ( there was no correlation at any moment ) . The results also point to the need for glycemic control from the first hour postpartum of newborns of hypertensive mothers whether they have or have not undergone treatment with antihypertensive drugs OBJECTIVE --To determine the effect of atenolol on the outcome of pregnancy in women with essential hypertension . DESIGN -- Prospect i ve , r and omised , double blind , placebo controlled study . SETTING --Hospital clinic . PATIENTS --33 Women with mild essential hypertension ( systolic blood pressure 140 - 170 mm Hg or diastolic pressure 90 - 110 mm Hg on two occasions at least 24 hours apart ) consecutively referred to two obstetric medical clinics . Four patients in the placebo group were withdrawn from the study : control of blood pressure was inadequate in two , one developed breathlessness , and one changed her mind about participating . The mean gestation in the 29 remaining women on entry to the study was 15.9 weeks . MAIN OUTCOME MEASURES --Blood pressure and birth weight . INTERVENTION--14 Women received placebo . 15 Women received atenolol 50 mg daily initially , increasing until either the blood pressure was less than 140/90 mm Hg or a dose of 200 micrograms daily was reached . RESULTS --The mean blood pressure on entry was 148/86 mm Hg in the group given atenolol and 144/86 mm Hg in the group given placebo . During treatment the mean diastolic pressure was significantly reduced by atenolol compared with placebo ( to 74 v 81 mm Hg ; difference in means ( 95 % confidence interval ) 7.0 ( 2.9 to 10.0 ) mm Hg ) but the effect on systolic pressure was marginal ( 132 v 136 mm Hg ; 4.0 ( -1.4 to 8.6 ) mm Hg ) . Babies in the atenolol group had a significantly lower birth weight than those in the placebo group ( 2620 g v 3530 g ; 910 ( 440 to 1380)g ) . CONCLUSION --Atenolol given from the end of the first trimester in patients with mild hypertension is associated with intrauterine growth retardation . When taken in conjunction with the results of a previous study in which methyldopa was given these findings indicate that benefit is unlikely to result from treating mild essential hypertension in pregnancy OBJECTIVE To determine the haemostatic status in preeclampsia and to investigate the effects of short-term use of anti-hypertensive drugs , methyldopa and isradipine . METHODS Thirty preeclamptic ( PE ) women admitted to the hospital for observation and treatment were r and omized to receive either methyldopa or isradipine for 2 weeks . Their blood pressure were monitored for 24 h before treatment and again at 7 days and 14 days after treatment using the programmable automated ambulatory blood pressure ( ABP ) monitoring system . Blood sampling was performed before commencement of anti-hypertensive treatment , 7 days and 14 days after treatment and the haemostatic parameters studied was compared before treatment with normal pregnancy and the effect of anti-hypertensive treatment . Nineteen normal pregnant subjects with a total of 30 blood sampling at various gestation and good pregnancy outcome served as controls . The following haemostatic parameters were determined ; thrombelastography , fibrinogen , antithrombin III ( ATIII ) , thrombin-antithrombin (TAT)-complex , beta-thromboglobulin ( beta-TG ) , plasminogen activators ( t-PA , u-PA ) , plasminogen activator inhibitors ( PAI-1 , PAI-2 ) , and plasminogen . RESULTS Significant lowering of blood pressure was evident at Days 7 and 14 of therapy with either methyldopa or isradipine . Increased mean plasma fibrinogen and decreased ATIII levels were seen in preeclampsia together with decreased u-PA and t-PA activity levels in contrast to increased t-PA antigen and beta-TG . No significant differences were seen for TAT-complex , PAI-1 , plasminogen and D-dimer levels although their mean levels were higher than observed in non-pregnant subject except for PAI-2 , the level was significantly reduced when compared with normal pregnancy . Two-way analysis of variance showed no significant alteration on all haemostatic parameters studied in preeclamptic women receiving either methyldopa or isradipine after 7 and 14 days of therapy . CONCLUSION Enhance activation of coagulation was observed together with raised fibrinolysis in normal pregnancy and PE . However , in PE a further reduction in ATIII , u-PA and PAI-2 with increased fibrinogen and platelet activation could lead to an imbalance in the coagulation/fibrinolysis equilibrium which favours fibrin deposition . All these changes seen in PE including the coagulation kinetics were not altered by the short term effects of methyldopa and isradipine even though significantly lowered blood pressure were observed during therapy OBJECTIVE To assess the efficacy and safety of labetalol compared with methyldopa in the management of mild and moderate cases of pregnancy-induced hypertension ( PIH ) . METHODS One hundred four primigravidas with PIH were r and omly allocated to receive either labetalol ( group A ) or methyldopa ( group B ) . The dose of the drugs was doubled every 48 h to maintain a mean arterial blood pressure < or = 103.6 mmHg . Clinico-biochemical effects and frequency of side effects were studied . The statistical level of significance was taken at P < 0.05 . RESULTS Ten patients in group B ( 18.5 % ) developed significant proteinuria ( > 30 mg/dl ) whereas none developed proteinuria in group A. Labetalol was quicker and more efficient at controlling blood pressure , having a beneficial effect on renal functions and causing fewer side effects compared with methyldopa . The rate of induction of labor and rate of cesarean section for uncontrolled PIH was less in group A ( 48 % and 1 % , respectively ) compared with group B ( 63.0 % and 5.6 % , respectively ) . Moreover a higher Bishop score at induction of labor was noticed in group A. CONCLUSIONS Labetalol is better tolerated than methyldopa , gives more efficient control of blood pressure and may have a ripening effect on the uterine cervix Summary . Intravenous treatment with 10 mg of hydralazine or 100 mg of labetalol was r and omly allocated to 30 hypertensive pregnant women . Umbilical artery flow velocity waveforms were recorded using a pulsed Doppler duplex scanner ( ATL Mk V ) and umbilical artery pulsatility index ( PI ) and fetal heart rate ( FHR ) were derived from these recordings . Maternal blood pressure decreased significantly after both drugs . Maternal pulse rate increased after hydralazine but did not change significantly after labetalol . FHR did not change significantly after hydralazine but decreased after labetalol . PI decreased after hydralazine and increased after labetalol‐most fetuses showed little change but a few in each group showed large changes in PI , as did two of five additional patients studied . We attributed the decrease in PI in some fetuses after hydralazine to vasodilation , and the increase in PI in some fetuses after labetalol to vasoconstriction in the fetoplacental circulation , suggesting that fetal beta‐blockade may occur after maternal treatment with labetalol Atenolol was compared with placebo in a r and omised and double-blind prospect i ve study of 120 women with mild to moderate pregnancy-associated hypertension who were also initially managed conventionally by bed rest . Atenolol given once daily significantly reduced blood-pressure , prevented proteinuria , and reduced the number of hospital admissions . Loss of blood-pressure control leading to withdrawal from the study was commoner among the placebo group , whose babies had a high morbidity . Respiratory distress syndrome occurred OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Beta-blockers appear to be no more effective and probably equally as safe . It is unusual for women to change drugs due to side effects . REVIEW ER 'S CONCLUSIONS Improvement in control of maternal blood pressure with use of beta-blockers would be worthwhile only if it were reflected in substantive benefits for mother and /or baby , and none have been clearly demonstrated . Large r and omised trials are needed to determine whether antihypertensive therapy in general ( rather than beta-blocker therapy specifically ) results in greater benefit than risk , for treatment of mild-moderate pregnancy hypertension .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Aim The aim of this study was to evaluate the benefits and safety of long-term i.v . iron therapy in iron-deficient patients with heart failure ( HF ) . Methods and results CONFIRM-HF was a multi-centre , double-blind , placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction ≤45 % , elevated natriuretic peptides , and iron deficiency ( ferritin < 100 ng/mL or 100–300 ng/mL if transferrin saturation < 20 % ) . Patients were r and omized 1 : 1 to treatment with i.v . iron , as ferric carboxymaltose ( FCM , n = 152 ) or placebo ( saline , n = 152 ) for 52 weeks . The primary end-point was the change in 6-min-walk-test ( 6MWT ) distance from baseline to Week 24 . Secondary end-points included changes in New York Heart Association ( NYHA ) class , Patient Global Assessment ( PGA ) , 6MWT distance , health-related quality of life ( QoL ) , Fatigue Score at Weeks 6 , 12 , 24 , 36 , and 52 and the effect of FCM on the rate of hospitalization for worsening HF . Treatment with FCM significantly prolonged 6MWT distance at Week 24 ( difference FCM vs. placebo : 33 ± 11 m , P = 0.002 ) . The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 ( difference FCM vs. placebo : 36 ± 11 m , P < 0.001 ) . Throughout the study , an improvement in NYHA class , PGA , QoL , and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards . Treatment with FCM was associated with a significant reduction in the risk of hospitalizations for worsening HF [ hazard ratio ( 95 % confidence interval ) : 0.39 ( 0.19–0.82 ) , P = 0.009 ] . The number of deaths ( FCM : 12 , placebo : 14 deaths ) and the incidence of adverse events were comparable between both groups . Conclusion Treatment of symptomatic , iron-deficient HF patients with FCM over a 1-year period result ed in sustainable improvement in functional capacity , symptoms , and QoL and may be associated with risk reduction of hospitalization for worsening HF ( Clinical Trials.gov number NCT01453608 ) Aims Therapy with i.v . iron in patients with chronic heart failure ( CHF ) and iron deficiency ( ID ) improves symptoms , functional capacity , and quality of life . We sought to investigate whether these beneficial outcomes are independent of anaemia . Methods and results FAIR-HF r and omized 459 patients with CHF [ NYHA class II or III , LVEF ≤40 % ( NYHA II ) or ≤45 % ( NYHA III ) ] and ID to i.v . iron as ferric carboxymaltose ( FCM ) or placebo in a 2:1 ratio . We analysed the efficacy and safety according to the presence or absence of anaemia ( haemoglobin ≤120 g/L ) at baseline . Of 459 patients , 232 had anaemia at baseline ( 51 % ) . The effect of FCM on the primary endpoints of self-reported Patient Global Assessment ( PGA ) and NYHA class at week 24 was similar in patients with and without anaemia [ odds ratio ( OR ) for improvement , 2.48 vs. 2.60 , P = 0.97 for PGA and 1.90 vs. 3.39 , P = 0.51 for NYHA ) . Results were also similar for the secondary endpoints , including PGA and NYHA at weeks 4 and 12 , 6 min walk test distance , Kansas City Cardiomyopathy Question naire overall score , and European Quality of Life-5 Dimensions Visual Analogue Scale at most time points . Regarding safety , no differences were noticed in the rates of death or first hospitalization between FCM and placebo both in anaemic and in non-anaemic patients . Conclusions Treatment of ID with FCM in patients with CHF is equally efficacious and shows a similar favourable safety profile irrespective of anaemia . Iron status should be assessed in symptomatic CHF patients both with and without anaemia and treatment of ID should be considered BACKGROUND Iron deficiency may impair aerobic performance . This study aim ed to determine whether treatment with intravenous iron ( ferric carboxymaltose ) would improve symptoms in patients who had heart failure , reduced left ventricular ejection fraction , and iron deficiency , either with or without anemia . METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association ( NYHA ) functional class II or III , a left ventricular ejection fraction of 40 % or less ( for patients with NYHA class II ) or 45 % or less ( for NYHA class III ) , iron deficiency ( ferritin level < 100 microg per liter or between 100 and 299 microg per liter , if the transferrin saturation was < 20 % ) , and a hemoglobin level of 95 to 135 g per liter . Patients were r and omly assigned , in a 2:1 ratio , to receive 200 mg of intravenous iron ( ferric carboxymaltose ) or saline ( placebo ) . The primary end points were the self-reported Patient Global Assessment and NYHA functional class , both at week 24 . Secondary end points included the distance walked in 6 minutes and the health-related quality of life . RESULTS Among the patients receiving ferric carboxymaltose , 50 % reported being much or moderately improved , as compared with 28 % of patients receiving placebo , according to the Patient Global Assessment ( odds ratio for improvement , 2.51 ; 95 % confidence interval [ CI ] , 1.75 to 3.61 ) . Among the patients assigned to ferric carboxymaltose , 47 % had an NYHA functional class I or II at week 24 , as compared with 30 % of patients assigned to placebo ( odds ratio for improvement by one class , 2.40 ; 95 % CI , 1.55 to 3.71 ) . Results were similar in patients with anemia and those without anemia . Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality -of-life assessment s. The rates of death , adverse events , and serious adverse events were similar in the two study groups . CONCLUSIONS Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency , with or without anemia , improves symptoms , functional capacity , and quality of life ; the side-effect profile is acceptable . ( Clinical Trials.gov number , NCT00520780 ) Abstract Aims Iron deficiency is highly prevalent in Southeast Asians with heart failure ( HF ) and associated with worse outcomes . This trial aim ed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF . Methods and results Fifty patients hospitalized for acute decompensated HF , regardless of ejection fraction , with iron deficiency ( defined as serum ferritin < 300 ng/mL if transferrin saturation is < 20 % ) were r and omized to receive either one dose of intravenous ferric carboxymaltose ( FCM ) 1000 mg or placebo ( 0.9 % saline ) following HF stabilization and before discharge in two Singapore tertiary centres . The primary endpoint was difference in 6‐min walk test ( 6MWT ) distance over 12 weeks , while secondary endpoints were quality of life assessed using vali date d Kansas City Cardiomyopathy Question naire ( KCCQ ) and Visual Analogue Scale ( VAS ) . Improvement in 6MWT distance at Week 12 was observed in both FCM and placebo groups ( from 252 ± 123 to 334 ± 128 m and from 243 ± 67 to 301 ± 83 m , respectively ) . Unadjusted analysis showed 6MWT distance for FCM exceeded that for placebo , but adjustment for baseline covariates and time attenuated this effect { adjusted mean difference between groups : 0.88 m [ 95 % confidence interval ( CI ) −30.2 to 32.0 , P = 0.956]}. KCCQ overall summary and VAS were similar in both groups [ adjusted mean difference : KCCQ −1.48 ( 95 % CI −8.27 to 5.31 , P = 0.670 ) and VAS 0.26 ( 95 % CI −0.33 to 0.86 , P = 0.386 ) ] . FCM was well tolerated with no serious treatment‐related adverse events . Conclusions Intravenous FCM administered pre‐discharge in Southeast Asians hospitalized with decompensated HF is clinical ly feasible . Changes in 6MWT distance should be measured beyond Week 12 to account for background therapy effects Objective Iron supplementation in iron-deficiency anaemia is st and ard practice , but the benefits of iron supplementation in iron-deficient non-anaemic ( IDNA ) individuals remains controversial . Our objective is to identify the effects of iron therapy on fatigue and physical capacity in IDNA adults . Design Systematic review and meta- analysis of r and omised controlled trials ( RCTs ) . Setting Primary care . Participants Adults ( ≥18 years ) who were iron deficient but non-anaemic . Interventions Oral , intramuscular or intravenous iron supplementation ; all therapy doses , frequencies and duration s were included . Comparators Placebo or active therapy . Results We identified RCTs in Medline , Embase , Cochrane Central Register of Controlled Trials , Cumulative Index of Nursing and Allied Health , SportD iscus and CAB Abstract s from inception to 31 October 2016 . We search ed the WHO ’s International Clinical Trials Registry Platform for relevant ongoing trials and performed forward search es of included trials and relevant review s in Web of Science . We assessed internal validity of included trials using the Cochrane Risk of Bias tool and the external validity using the Grading of Recommendations Assessment , Development and Evaluation methodology . From 11 580 citations , we included 18 unique trials and 2 companion papers enrolling 1170 patients . Using a Mantel-Haenszel r and om-effects model , iron supplementation was associated with reduced self-reported fatigue ( st and ardised mean difference ( SMD ) −0.38 ; 95 % CI −0.52 to −0.23 ; I2 0 % ; 4 trials ; 714 participants ) but was not associated with differences in objective measures of physical capacity , including maximal oxygen consumption ( SMD 0.11 ; 95 % CI −0.15 to 0.37 ; I2 0 % ; 9 trials ; 235 participants ) and timed methods of exercise testing . Iron supplementation significantly increased serum haemoglobin concentration ( MD 4.01 g/L ; 95 % CI 1.22 to 6.81 ; I2 48 % ; 12 trials ; 298 participants ) and serum ferritin ( MD 9.23 µmol/L ; 95 % CI 6.48 to 11.97 ; I2 58 % ; 14 trials ; 616 participants ) . Conclusion In IDNA adults , iron supplementation is associated with reduced subjective measures of fatigue but not with objective improvements in physical capacity . Given the global prevalence of both iron deficiency and fatigue , patients and practitioners could consider consumption of iron-rich foods or iron supplementation to improve symptoms of fatigue in the absence of documented anaemia . PROSPERO registration number CRD42014007085 Purpose To determine the effect of intravenous iron supplementation on performance , fatigue and overall mood in runners without clinical iron deficiency . Methods Fourteen distance runners with serum ferritin 30–100 µg·L−1 were r and omly assigned to receive three blinded injections of intravenous ferric-carboxymaltose ( 2 ml , 100 mg , IRON ) or normal saline ( PLACEBO ) over four weeks ( weeks 0 , 2 , 4 ) . Athletes performed a 3,000 m time trial and 10 × 400 m monitored training session on consecutive days at week 0 and again following each injection . Hemoglobin mass ( Hbmass ) was assessed via carbon monoxide rebreathing at weeks 0 and 6 . Fatigue and mood were determined bi-weekly until week 6 via Total Fatigue Score ( TFS ) and Total Mood Disturbance ( TMD ) using the Brief Fatigue Inventory and Brunel Mood Scale . Data were analyzed using magnitude-based inferences , based on the unequal variances t-statistic and Cohen 's Effect sizes ( ES ) . Results Serum ferritin increased in IRON only ( Week 0 : 62.8±21.9 , Week 4 : 128.1±46.6 µg·L−1 ; p = 0.002 ) and remained elevated two weeks after the final injection ( 127.0±66.3 µg·L−1 , p = 0.01 ) , without significant changes in Hbmass . Supplementation had a moderate effect on T OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Quality -of-life scores ( Piper Fatigue Scale MD 0.73 , 95 % CI 0.29 to 1.18 ; I2 = 0 % ; studies = 3 ) and peak oxygen consumption ( MD 2.77 mL/kg/min , 95 % CI -0.89 to 6.43 ; I2 = 36 % ; 2 studies , 32 participants ) were associated with very low- quality evidence , and we remain uncertain about the role of intravenous iron for these metrics . Current evidence is insufficient to show benefit of intravenous iron preparations for the treatment of non-anaemic iron deficiency across a variety of patient population s , beyond stating that it may result in a small , clinical ly insignificant increase in haemoglobin concentration .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: AIMS Hydrotherapy , i.e. exercise in warm water , as a rehabilitation program has been considered potentially dangerous in patients with chronic heart failure ( CHF ) due to the increased venous return caused by the hydrostatic pressure . However , hydrotherapy has advantages compared to conventional training . We studied the applicability of an exercise programme in a temperature-controlled swimming pool , with specific reference to exercise capacity , muscle function , quality of life and safety . METHODS AND RESULTS Twenty-five patients with CHF ( NYHA II-III , age 72.1+/-6.1 ) were r and omised into either 8 weeks of hydrotherapy ( n=15 ) , or into a control group ( n=10 ) . The training program was well tolerated with no adverse events . Patients in the hydrotherapy group improved their maximal exercise capacity ( + 6.5 vs.-5.9 W , P=0.001 ) , isometric endurance in knee extension ( + 4 vs.-9 s , P=0.01 ) together with an improvement in the performance of heel-lift ( + 4 vs. -3 n.o . , P=<0.01 ) , shoulder abduction ( + 12 vs. -8 s , P=0.01 ) and shoulder flexion ( + 6 vs. + 4 , P=0.01 ) in comparison to patients in the control group . CONCLUSION Physical training in warm water was well tolerated and seems to improve exercise capacity as well as muscle function in small muscle groups in patients with CHF . This new approach broadens the variety of training regimes for older patients with CHF Abstract Background : No controlled studies have investigated whether balneotherapy is effective in atopic dermatitis ( AD ) . Objectives : To investigate the efficacy and safety of balneotherapy performed at Comano spa ( Trentino , Italy ) compared to topical corticosteroids ( TCS ) in the treatment of AD . Methods : This was an open , r and omized , clinical trial including 104 children ( aged 1–14 years ) with mild to moderate AD who were assigned either to balneotherapy ( n = 54 ) or TCS ( n = 50 ) once daily for 2 weeks . AD severity and quality of life were measured using the SCORAD , investigator global assessment ( IGA ) , patients ' self global assessment ( PSGA ) , children 's dermatology life quality index ( CDLQI ) and family dermatitis impact question naire ( FDIQ ) . Subjective measures were re-evaluated 4 months after the end of therapy . Results : Balneotherapy and TCS result ed in a significant reduction of all parameters at week 2 . TCS were more effective than balneotherapy regarding SCORAD ( 46 % ± 7.71 vs 26 % ± 9.4 , mean ± SD ; p < 0.03 ) . In contrast , IGA , PSGA , CDLQI and FDIQ improvement was similar . At month 4 , the number and duration of relapses were less in patients treated with balneotherapy compared to those treated with TCS ( p < 0.0001 ) . Conclusions : Balneotherapy at Comano spa appears to be beneficial in children with mild to moderate AD Thermal water inhalations have been traditionally used in the treatment of upper and lower chronic airway diseases . However , the benefit and the mechanism of this treatment have not been properly assessed . To determine whether inhaled salt-bromide-iodine thermal water improves lung function , quality of life and airway inflammation , 39 patients with chronic obstructive pulmonary disease ( COPD ) were r and omly assigned to receive 2-weeks inhalation treatment with thermal water ( active , no. = 20 ) or normal saline ( control , no. = 19 ) in single blind . Lung volumes were measured , Saint George 's respiratory question naire ( SGRQ ) was administered and induced sputum was performed before and after treatment . No changes in pre- and post-salbutamol lung volumes was observed after inhalation treatment in both groups . SGRQ score showed a significant improvement in active group compared with control group at the end of the trial . The concentration of total cells in induced sputum increased significantly in both active ( P < 0.05 ) and control groups ( P < 0.05 ) . Inhalation of thermal water induced a small but significant decrease in percentages of sputum neutrophils ( P < 0.01 ) and a parallel increase in macrophages ( P < 0.01 ) . In contrast , normal saline inhalation was not associated with changes in differential sputum cell counts . In conclusion , treatment with inhaled salt-bromide-iodine thermal water in COPD is associated with a reduced proportion of neutrophils in induced sputum suggesting that thermal water may have a mild anti-inflammatory effect on the airways . However , the short-term improvement in some components health-related quality of life was not related with changes in lung function or with the degree of airway inflammation The upper airway respiratory diseases ( i.e. common cold , allergic rhinitis , nonallergic/vasomotor rhinitis , acute and chronic rhinosinusitis and nasal polyposis ) in which nasal congestion is a common symptom are often undertreated due to the frequent inadequate efficacy and safety concern with current therapies . In scientific literature , few studies seem to support the hypothesis that nasal inhalatory treatment with thermal water promotes the improvement of nasal symptoms , even if the mechanisms by which the improvement from SPA therapy can be expected remain debated . A prospect i ve comparative study with a pre – post design has been performed consecutively enrolling 33 ( males 70 % ) patients of both genders older than 12 years of age , affected by chronic sinonasal inflammation . All patients underwent a 14-days course of radioactive water warm vapour inhalations followed by nasal aerosol of the same thermal water 10 min each once/day at Merano Therme . At the beginning and end of the study , in all the subjects , nasal function evaluation by active anterior rhinomanometry , mucociliary transport time ( MCTt ) determination and nasal cytology were performed . After the inhalatory treatment , the mucociliary function was improved and the pathologic mucociliary transport times recorded at the beginning of the study being significantly reduced to physiologic ones . Besides , before treatment , the cytologic picture showed an inflammatory cell infiltration ( eosinophils , neutrophils with/without bacteria , mast cells ) in 37 % of patients ; after therapy in 66 % of these patients , the rhinocytogram was normal . Our results suggest , according to the literature data , that SPA therapy with radioactive water could represent an alternative choice in chronic inflammatory diseases of the upper airways , nonresponsive to pharmacological therapy Bathing in water ( balneotherapy or spa therapy ) has been frequently and widely used in classical medicine as a cure for diseases . This paper review s the present literature on the use of balneotherapy in dermatologic , chronic musculoskeletal ( inflammatory and non-inflammatory ) , metabolic and psychological conditions . We performed a systematic review on related papers appearing in the Medline and Cochrane Library data base from 1966 to 2003 that included r and omized controlled and non-r and omized clinical trials using balneotherapy . We also determined to reflect where possible the chemical compositions of spas . The major dermatologic and musculoskeletal diseases that are frequently treated by balneotherapy with a remarkable rate of success are atopic dermatitis , psoriasis , rheumatoid arthritis ( RA ) , ankylosing spondylitis , osteoarthritis and low back pain . Moreover , the effects of spa therapy on several metabolic conditions are discussed . The mechanisms by which broad spectrums of diseases respond to spa therapy probably incorporate chemical , thermal and mechanical effects . The importance of balneotherapy either alone or as complement to other therapies should be considered after , or accompanying , orthodox medical treatments Objective . To assess the one-year effectiveness on weight loss of a 3-week balneotherapy program ( BT ) . Method . A Zelen double consent r and omised controlled trial to compare one-year BMI loss between a 3-week BT program versus usual care ( UC ) for overweight or obese patients ( BMI : 27–35 kg/m2 ) , associated or not with a dietary motivational interview ( DMI ) during the follow-up , using a 2 × 2 factorial design . Main analysis was a per protocol analysis comparing patients attending BT to patients managed by UC , matched on sex , overweight or obese status , DMI r and omisation and a propensity score to attend BT or to be managed by UC . Results . From the 257 patients who completed the follow-up , 70 patients of each group could be matched . Mean BMI loss was 1.91 kg/m2 [ 95%CI : 1.46 ; 2.35 ] for the BT patients and 0.20 kg/m2 [ −0.24 ; 0.64 ] for the UC patients ( P < 0.001 ) , corresponding to a significant BT benefit of 1.71 kg/m2 [ 1.08 ; 2.33 ] . There was no significant effect of DMI and no interaction with BT or UC . No adverse reaction was observed for patients attending BT . Conclusion . A 3-week BT program provided a significant one-year benefit over the usual GP dietary advice for overweight and obese patients Background : Inhalation of thermal water ( TW ) is traditionally used as part of the treatment of chronic obstructive pulmonary disease ( COPD ) , but its benefit and mechanisms are controversial . We previously observed a reduced proportion of neutrophils in induced sputum after treatment with TW . Objectives : The aim of this study was to determine whether inhalation of TW in COPD patients is associated with biochemical changes of airway lining fluid , including a reduction in the neutrophil chemoattractant leukotriene B4 ( LTB4 ) . Methods : Thirteen COPD patients were r and omly assigned to receive a 2-week course of TW and normal saline inhalation in a cross-over , single-blind study design . Exhaled breath condensate ( EBC ) was collected before and after treatments . LTB4 concentrations in EBC were determined by ELISA , and EBC pH was measured before and after argon deaeration . Results : No significant differences in LTB4 concentrations in EBC were detected with either treatment . A significant decrease in pH of non-deaerated EBC was observed after a st and ard course of TW ( median 7.45 , interquartile range 6.93–7.66 , vs. median 6.99 , interquartile range 6.57–7.19 ; p = 0.05 ) , which disappeared after argon deaeration . Conclusions : There is no evidence that TW treatment affects LTB4 concentration in EBC . The results of EBC pH measurements suggest that TW inhalation induces an imbalance of volatile components of the buffer system in airway lining fluid Conclusions : In order to confirm these preliminary results , a prospect i ve double-blind study has been instituted in Padova University ENT Section to compare the efficacy of sulphurous-arsenical-ferruginous thermal water nasal irrigations vs isotonic sodium chloride solution nasal irrigations after functional endoscopic sinus surgery for chronic sinusitis . Objectives : Despite their widespread use , much uncertainty exists about the indications and therapeutic mechanisms of nasal thermal water inhalations in the treatment of sinonasal chronic disease . The aim of the present study was to evaluate the effects of sulphurous-arsenical-ferruginous thermal water inhalations on nasal respiratory flow , mucociliary transport , nasal cytology , and chemo-physics of nasal mucus in a group of consecutive patients with chronic sinonasal disease . Patients and methods : Thirty-seven patients with chronic sinonasal disease underwent a 12-day course of sulphurous-arsenical-ferruginous thermal water warm vapour inhalations ( 38 ° C ) followed by nasal aerosol of the same thermal water ( 7 microns micelle ) . Results : This preliminary study showed that a course of sulphurous-arsenical-ferruginous thermal water inhalations determined a significant improvement in nasal flow and reduction of nasal resistance ; a statistically significant reduction of mean mucociliary transport time , from pathologic to physiologic values , has also been shown . Statistical analysis of our data confirmed that the presence of nasal bacteria was significantly reduced by thermal water inhalations The effectiveness of spa therapy in the management of patients with Parkinson 's disease ( PD ) has never been evaluated . This is assessed in this pilot study . A prospect i ve , r and omized , cross-over , controlled study was conducted in 31 PD patients who underwent a 20-week spa period , including spa therapy for 3 weeks , and a 20-week non-spa period . Effectiveness was assessed using quality of life scales ( PDQ-39 and SF-36 ) , motor scale ( UPDRS ) and psychological question naire ( GHQ-28 ) , at baseline and at 4 ( T4 ) and at 20 weeks ( T20 ) . Direct medical costs ( radiological and laboratory tests , physician fees , drug therapy , and ancillary care ) were recorded over each 20-week period . At T4 , spa therapy improved significantly several dimensions of PDQ-39 and SF-36 , part IV of the UPDRS , and GHQ-28 . At T20 , no difference in any parameter was found . The mean direct medical cost over 20 weeks ( euro;1,328 + /- 167 ; pound 776 + /- 97 per patient ) in the spa period was slightly but significantly reduced in comparison with that of the non-spa period ( euro;1380 + /- 523 ; pound 807 + /- 306 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

HRM treatment is associated with clinical improvement in diseases of the skin , respiratory , circulatory , digestive and nervous system among others . The scientific literature of the last decade has shown that a number of non-musculoskeletal disorders are treated with different kinds of HRM .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Atrial fibrillation ( AF ) and left ventricular systolic dysfunction ( LVSD ) frequently co-exist despite adequate rate control . Existing r and omized studies of AF and LVSD of varying etiologies have reported modest benefits with a rhythm control strategy . OBJECTIVES The goal of this study was to determine whether catheter ablation ( CA ) for AF could improve LVSD compared with medical rate control ( MRC ) where the etiology of the LVSD was unexplained , apart from the presence of AF . METHODS This multicenter , r and omized clinical trial enrolled patients with persistent AF and idiopathic cardiomyopathy ( left ventricular ejection fraction [ LVEF ] ≤45 % ) . After optimization of rate control , patients underwent cardiac magnetic resonance ( CMR ) to assess LVEF and late gadolinium enhancement , indicative of ventricular fibrosis , before r and omization to either CA or ongoing MRC . CA included pulmonary vein isolation and posterior wall isolation . AF burden post-CA was assessed by using an implanted loop recorder , and adequacy of MRC was assessed by using serial Holter monitoring . The primary endpoint was change in LVEF on repeat CMR at 6 months . RESULTS A total of 301 patients were screened ; 68 patients were enrolled between November 2013 and October 2016 and r and omized with 33 in each arm ( accounting for 2 dropouts ) . The average AF burden post-CA was 1.6 ± 5.0 % at 6 months . In the intention-to-treat analysis , absolute LVEF improved by 18 ± 13 % in the CA group compared with 4.4 ± 13 % in the MRC group ( p < 0.0001 ) and normalized ( LVEF ≥50 % ) in 58 % versus 9 % ( p = 0.0002 ) . In those undergoing CA , the absence of late gadolinium enhancement predicted greater improvements in absolute LVEF ( 10.7 % ; p = 0.0069 ) and normalization at 6 months ( 73 % vs. 29 % ; p = 0.0093 ) . CONCLUSIONS AF is an underappreciated reversible cause of LVSD in this population despite adequate rate control . The restoration of sinus rhythm with CA results in significant improvements in ventricular function , particularly in the absence of ventricular fibrosis on CMR . This outcome challenges the current treatment paradigm that rate control is the appropriate strategy in patients with AF and LVSD . ( Catheter Ablation Versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction [ CAMERA-MRI ] ; ACTRN12613000880741 ) CONTEXT Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation ( AF ) . Pulmonary vein isolation ( PVI ) with radiofrequency ablation may cure AF , obviating the need for antiarrhythmic drugs and anticoagulation . OBJECTIVE To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF . DESIGN , SETTING , AND PARTICIPANTS A multicenter prospect i ve r and omized study conducted from December 31 , 2001 , to July 1 , 2002 , of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs . INTERVENTION Patients were r and omized to receive either PVI using radiofrequency ablation ( n=33 ) or antiarrhythmic drug treatment ( n=37 ) , with a 1-year follow-up . MAIN OUTCOME MEASURES Recurrence of AF , hospitalization , and quality of life assessment . RESULTS Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up . At the end of 1-year follow-up , 22 ( 63 % ) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 ( 13 % ) of 32 patients who received PVI ( P<.001 ) . Hospitalization during 1-year follow-up occurred in 19 ( 54 % ) of 35 patients in the antiarrhythmic drug group compared with 3 ( 9 % ) of 32 in the PVI group ( P<.001 ) . In the antiarrhythmic drug group , the mean ( SD ) number of AF episodes decreased from 12 ( 7 ) to 6 ( 4 ) , after initiating therapy ( P = .01 ) . At 6-month follow-up , the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey . There were no thromboembolic events in either group . Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 ( 6 % ) of 32 patients in the PVI group . CONCLUSION Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF . Larger studies are needed to confirm its safety and efficacy Objective To determine whether or not radiofrequency ablation ( RFA ) for persistent atrial fibrillation in patients with advanced heart failure leads to improvements in cardiac function . Setting Patients were recruited from heart failure outpatient clinics in Scotl and . Design and intervention Patients with advanced heart failure and severe left ventricular dysfunction were r and omised to RFA ( rhythm control ) or continued medical treatment ( rate control ) . Patients were followed up for a minimum of 6 months . Main outcome measure Change in left ventricular ejection fraction ( LVEF ) measured by cardiovascular MRI . Results 22 patients were r and omised to RFA and 19 to medical treatment . In the RFA group , 50 % of patients were in sinus rhythm at the end of the study ( compared with none in the medical treatment group ) . The increase in cardiovascular magnetic resonance ( CMR ) LVEF in the RFA group was 4.5±11.1 % compared with 2.8±6.7 % in the medical treatment group ( p=0.6 ) . The RFA group had a greater increase in radionuclide LVEF ( a prespecified secondary end point ) than patients in the medical treatment group ( + 8.2±12.0 % vs + 1.4±5.9 % ; p=0.032 ) . RFA did not improve N-terminal pro-B-type natriuretic peptide , 6 min walk distance or quality of life . The rate of serious complications related to RFA was 15 % . Conclusions RFA result ed in long-term restoration of sinus rhythm in only 50 % of patients . RFA did not improve CMR LVEF compared with a strategy of rate control . RFA did improve radionuclide LVEF but did not improve other secondary outcomes and was associated with a significant rate of serious complications . Clinical trials registration number NCT00292162 Background —Restoring sinus rhythm in patients with heart failure ( HF ) and atrial fibrillation ( AF ) may improve left ventricular ( LV ) function and HF symptoms . We sought to compare the effect of a catheter ablation strategy with that of a medical rate control strategy in patients with persistent AF and HF . Methods and Results — Patients with persistent AF , symptomatic HF , and LV ejection fraction < 50 % were r and omized to catheter ablation or medical rate control . The primary end-point was the difference between groups in LV ejection fraction at 6 months . Baseline LV ejection fraction was 32±8 % in the ablation group and 34±12 % in the medical group . Twenty-six patients underwent catheter ablation , and 24 patients were rate controlled . Freedom from AF was achieved in 21/26 ( 81 % ) at 6 months off antiarrhythmic drugs . LV ejection fraction at 6 months in the ablation group was 40±12 % compared with 31±13 % in the rate control group ( P=0.015 ) . Ablation was associated with better peak oxygen consumption ( 22±6 versus 18±6 mL/kg per minute ; P=0.014 ) and Minnesota living with HF question naire score ( 24±22 versus 47±22 ; P=0.001 ) compared with rate control . Conclusions —Catheter ablation is effective in restoring sinus rhythm in selected patients with persistent AF and HF , and can improve LV function , functional capacity , and HF symptoms compared with rate control . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : OBJECTIVES The aim of this study was to determine the independent hemodynamic effects of an irregular sequence of ventricular cycle lengths in patients with atrial fibrillation ( AF ) . BACKGROUND Atrial fibrillation may reduce cardiac output by several possible mechanisms , including loss of the atrial contribution to left ventricular filling , valvular regurgitation , increased ventricular rate or irregular RR intervals . This study was design ed to evaluate the effects of an irregular RR interval , independent of the average ventricular rate , on cardiac hemodynamic data during AF . METHODS Sixteen patients with AF were studied invasively . During intrinsically conducted AF ( mean rate 102 + /- 22 beats/ min ) , the right ventricular apex electrogram was recorded onto frequency-modulated ( FM ) tape . After atrioventricular node ablation , the right ventricular apex was stimulated in three pacing modes in r and omized sequence : 1 ) VVI at 60 beats/min ; 2 ) VVI at the same average rate as during intrinsically conducted AF ( 102 + /- 22 beats/min ) ; and 3 ) during VVT pacing in which the pacemaker was triggered by playback of the FM tape recording of the right ventricular apex electrogram previously recorded during intrinsically conducted AF ( VVT 102 + /- 22 beats/min ) . RESULTS Compared with VVI pacing at the same average rate , an irregular sequence of RR intervals decreased cardiac output ( 4.4 + /- 1.6 vs. 5.2 + /- 2.4 liters/min , p < 0.01 ) , increased pulmonary capillary wedge pressure ( 17 + /- 7 vs. 14 + /- 6 mm Hg , p < 0.002 ) and increased right atrial pressure ( 10 + /- 6 vs. 8 + /- 4 mm Hg , p < 0.05 ) . CONCLUSIONS An irregular sequence of RR intervals produces adverse hemodynamic consequences that are independent of heart rate BACKGROUND Pulmonary-vein isolation is increasingly being used to treat atrial fibrillation in patients with heart failure . METHODS In this prospect i ve , multicenter clinical trial , we r and omly assigned patients with symptomatic , drug-resistant atrial fibrillation , an ejection fraction of 40 % or less , and New York Heart Association class II or III heart failure to undergo either pulmonary-vein isolation or atrioventricular-node ablation with biventricular pacing . All patients completed the Minnesota Living with Heart Failure question naire ( scores range from 0 to 105 , with a higher score indicating a worse quality of life ) and underwent echocardiography and a 6-minute walk test ( the composite primary end point ) . Over a 6-month period , patients were monitored for both symptomatic and asymptomatic episodes of atrial fibrillation . RESULTS In all , 41 patients underwent pulmonary-vein isolation , and 40 underwent atrioventricular-node ablation with biventricular pacing ; none were lost to follow-up at 6 months . The composite primary end point favored the group that underwent pulmonary-vein isolation , with an improved question naire score at 6 months ( 60 , vs. 82 in the group that underwent atrioventricular-node ablation with biventricular pacing ; P<0.001 ) , a longer 6-minute-walk distance ( 340 m vs. 297 m , P<0.001 ) , and a higher ejection fraction ( 35 % vs. 28 % , P<0.001 ) . In the group that underwent pulmonary-vein isolation , 88 % of patients receiving antiarrhythmic drugs and 71 % of those not receiving such drugs were free of atrial fibrillation at 6 months . In the group that underwent pulmonary-vein isolation , pulmonary-vein stenosis developed in two patients , pericardial effusion in one , and pulmonary edema in another ; in the group that underwent atrioventricular-node ablation with biventricular pacing , lead dislodgment was found in one patient and pneumothorax in another . CONCLUSIONS Pulmonary-vein isolation was superior to atrioventricular-node ablation with biventricular pacing in patients with heart failure who had drug-refractory atrial fibrillation . ( Clinical Trials.gov number , NCT00599976 . IMPORTANCE Atrial fibrillation ( AF ) is the most common rhythm disorder seen in clinical practice . Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF . Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed ; however , its role as a first-line therapy needs further investigation . OBJECTIVE To compare radiofrequency ablation with antiarrhythmic drugs ( st and OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Surrogate outcomes showed a similar benefit favoring CA . Conclusion and Relevance Catheter ablation for AF in HFrEF is associated with improvement in patient-centered outcomes and surrogate outcomes when compared to st and ard medical therapy with or without device therapy

MS2_fixed_5_shot250

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Context Is it cost-effective to screen older adults for abdominal aortic aneurysm ( AAA ) ? Contribution This 7-year follow-up report of a large r and omized trial in the United Kingdom found that men age 65 to 74 years who were invited to have ultrasonography and surveillance for AAA had lower mortality rates than did those who were not invited ( hazard ratio , 0.53 [ CI , 0.42 to 0.68 ] ) . Cost-effectiveness for AAA-related deaths , based on costs applied to the events experienced by the men , was estimated at $ 19500 ( CI , $ 12400 to $ 39800 ) per life-year gained . Caution s Only men were studied . Actual costs of screening and surveillance may vary substantially in different setting s. The Editors A fast-growing body of literature is providing evidence in favor of screening men for abdominal aortic aneurysm ( AAA ) . Several large , r and omized trials published in the past few years ( 14 ) have consistently shown that screening reduces AAA-related mortality . A few observational studies of programs under way in localized areas have established the feasibility of systematic screening and have explored its practical implementation ( 57 ) . In addition to the mortality benefit , evidence indicating that screening is highly cost-effective is increasing ( 811 ) . In light of this evidence , national screening programs are now being considered in many countries ( 1214 ) . However , there is little evidence regarding long-term outcomes after AAA screening ; almost all of the evidence from r and omized trials is limited to the first 4 years after screening ( 14 ) . Moreover , long-term cost-effectiveness has been estimated only through health economic modeling ( 10 ) . We describe cost-effectiveness based on 7-year follow-up from the largest of the 4 trials of AAA screeningthe Multicentre Aneurysm Screening Study ( MASS ) ( 2 ) . The trial r and omly assigned approximately 67800 men age 65 to 74 years to receive an invitation to screening or to not receive an invitation . At 4-year follow-up , the trial reported a substantial relative reduction of 42 % ( 95 % CI , 22 % to 58 % ) in AAA-related mortality and an incremental cost-effectiveness ratio of $ 44900 ( CI , $ 24000 to $ 231000 ) per life-year gained ( 9 ) , which is at the borderline of the commonly accepted threshold for interventions . All values are reported in U.S. dollars ( U.K. 1 = U.S. $ 1.58 ) ( 15 ) . The costs of AAA screening are primarily incurred at the start of the program , but benefits continue to accrue in terms of life-years gained in patients in whom AAA rupture is avoided through elective surgery . It is therefore expected that cost-effectiveness of screening will improve over time . The mid-term results of MASS provide reliable , trial-based information regarding clinical outcomes and cost-effectiveness over a longer period . Methods The details of the MASS protocol were described previously ( 2 ) , but a brief summary is provided ( Figure 1 ) . Between 1997 and 1999 , a population -based sample of 70495 men age 65 to 74 years from 4 centers in the United Kingdom was identified by obtaining records for every man in this age range who was registered with a family physician ( registered persons account for approximately 98 % of the population ) . Persons who were ineligible for the trial ( incorrect details , known AAA , previous AAA surgery , or terminal illness ) were excluded before r and omization . The remaining 67770 men were r and omly assigned to receive an invitation to ultrasonography for AAA or to not receive an invitation to ultrasonography . At screening , men with an aortic diameter of 3.0 cm or greater were defined as having an AAA and were subsequently invited for recall scans to monitor growth of the aneurysm . Men with an aortic diameter of 3.0 to 4.4 cm were rescreened every year , and those with an aortic diameter of 4.5 to 5.4 cm were rescreened every 3 months . Participants were considered for elective surgery when the aortic diameter reached 5.5 cm , aortic expansion was 1.0 cm or more in 1 year , or they experienced symptoms attributable to the aneurysm . Men with an aortic diameter less than 3.0 cm on the initial scan were not rescreened . Blood pressure was also measured ; although family physicians were informed of these measurements , no further intervention was provided through the screening program . We obtained approval from local ethics committees at each center , and all patients who had screening provided signed informed consent . Figure 1 . Study flow diagram . Additional data on follow-up scans and AAA surgeries were collected from hospital records . Deaths up to 31 March 2005 were confirmed by the U.K. Office of National Statistics after matching of the unique National Health Service number for each person . Follow-up ranged from 5.9 to 8.2 years ( mean , 7.1 years ) . The primary outcome of interest , AAA-related mortality , is defined as all deaths within 30 days of any AAA surgery ( elective or emergency ) plus all deaths with International Classification of Diseases , Ninth Revision , codes 441.3 ( ruptured abdominal aortic aneurysm ) , 441.4 ( abdominal aortic aneurysm without mention of rupture ) , 441.5 ( ruptured aortic aneurysm at unspecified site ) , or 441.6 ( aortic aneurysm at unspecified site without mention of rupture ) . The use of codes 441.5 and 441.6 may result in inclusion of some thoracic aortic aneurysm deaths . Investigation of the accuracy of cause-of-death coding on the death certificates was done by an independent mortality working party that was blinded to group allocation . The results of this analysis showed that inaccuracies in coding did not have an important impact on study outcomes ( 2 ) . Statistical Analysis All analyses were done by using Stata , version 9 ( Stata Corp. , College Station , Texas ) . Deaths related to AAA ( primary analysis ) and all-cause mortality ( secondary analysis ) were compared between the 2 r and omized groups by using unadjusted Cox regression by intention-to-treat analysis . Adjustment for age at baseline did not influence the results . The proportional hazards assumption was tested by using Schoenfeld residuals . An unbiased r and omization-based estimate of the benefit of screening was also obtained ( 16 ) . This estimate is calculated by subtracting from the control group a subgroup that is equivalent in terms of survival to the nonadherent subgroup in the invited group . Thus , the remaining controls are comparable to the group of invited patients who attended screening . Life-years gained are estimated as the area between the KaplanMeier curves for both groups ( 17 ) . The cost-effectiveness of screening is estimated from a health service perspective for follow-up truncated at 7 years , with adjustment for censoring ( 18 ) . Details of the costing exercise in the trial at 20002001 prices were reported previously ( 9 ) . The unit costs obtained ( U.K. 1 = U.S. $ 1.58 for the year 2000 [ 15 ] ) are inflated to the 20042005 financial-year level by using annual hospital and community health services pay and price inflation indices ( 19 ) . Costs are applied to the following events on the basis of individual re source use : invitation to screening ( $ 2.46 ) , reinvitation after nonresponse ( $ 2.42 ) , initial scan ( $ 35.95 ) , recall scan ( $ 86.74 ; done in the hospital rather than in the community and including costs for periodic routine meetings with a consultant ) , consultation for elective surgery ( $ 583.79 ) , elective AAA surgery ( $ 13015.74 ) , and emergency AAA surgery ( $ 21054.32 ) . Costs relating to scans of incidentally detected AAAs in the control group are not included ( data not available ) , but costs relating from result ant AAA repair surgery are included . Sensitivity analyses were done by using 1 ) costs retained at the 20002001 financial-year level for comparison with previous publications , 2 ) quality -adjusted life-years based on age-related reductions , 3 ) U.S.-based unit cost estimates for scans and surgeries , 4 ) an increase of 50 % in the cost of a consultation ( a U.S.-based estimate was not available , but this analysis reflects possible additional assessment s ) , 5 ) 3 and 4 combined . Quality -of-life adjustments are made only on the basis of age , with an adjustment of 0.78 for life-years gained between the ages 65 and 74 years and an adjustment of 0.75 for life-years gained at ages older than 75 years ( 20 ) . The U.S.-specific estimates for scans ( initial and recall ) are based on Medicare reimbursement for AAA screening at $ 90.95 ( Current Procedural Terminology code G0389 ) ( 21 ) , and U.S.-specific costs for surgeries are based on previously published estimates ( 22 , 23 ) that were inflated to 2004 prices ( 24 ) : $ 18160 for elective procedures and $ 31106 for emergency procedures . Discounting is applied at the current recommended values of 3 % per annum for costs and effects ( 25 ) . Estimates of AAA-related costs and effects take into account the rate of nonAAA-related deaths across both groups over time . The Fieller method is used to calculate bounds for the CI for cost-effectiveness ( 26 , 27 ) . Role of the Funding Source This study was funded by the Medical Research Council . The funding source had no role in the design , implementation , or analysis of the study . Results Figure 1 shows the flow of participants through the trial . Numbers differ slightly from earlier publications because of identification of a few duplicate records in the data base . Of 67770 r and omly assigned men , 33883 were invited to be screened : 27204 ( 80 % ) attended and 1334 ( 4.9 % ) AAAs were identified . The mean age at r and omization was 69.2 years in both groups . Loss to follow-up because of death was 2.1 % overall ( 2.2 % in the control group and 2.1 % in the invited group ) . Loss to clinical follow-up ( nonattendance at recall scans ) was 19 % at 4 years and 24 % at 7 years . The Appendix Table shows surgeries and deaths within 30 days in each of the r and omly assigned groups . A few endovascular operations are included in these figures6 in the control group and 14 in the invited group . As expected , the total number of elective procedures is greater in the invited group than in the control group BACKGROUND Opposing views have been published on the importance of ultrasound screening for abdominal aortic aneurysms . The Multicentre Aneurysm Screening Study was design ed to assess whether or not such screening is beneficial . METHODS A population -based sample of men ( n=67800 ) aged 65 - 74 years was enrolled , and each individual r and omly allocated to either receive an invitation for an abdominal ultrasound scan ( invited group , n=33839 ) or not ( control group , n=33961 ) . Men in whom abdominal aortic aneurysms ( > or =3 cm in diameter ) were detected were followed-up with repeat ultrasound scans for a mean of 4.1 years . Surgery was considered on specific criteria ( diameter > or = 5.5 cm , expansion > or = 1 cm per year , symptoms ) . Mortality data were obtained from the Office of National Statistics , and an intention-to-treat analysis was based on cause of death . Quality of life was assessed with four st and ardised scales . The primary outcome measure was mortality related to abdominal aortic aneurysm . FINDINGS 27147 of 33839 ( 80 % ) men in the invited group accepted the invitation to screening , and 1333 aneurysms were detected . There were 65 aneurysm-related deaths ( absolute risk 0.19 % ) in the invited group , and 113 ( 0.33 % ) in the control group ( risk reduction 42 % , 95 % CI 22 - 58 ; p=0.0002 ) , with a 53 % reduction ( 95 % CI 30 - 64 ) in those who attended screening . 30-day mortality was 6 % ( 24 of 414 ) after elective surgery for an aneurysm , and 37 % ( 30 of 81 ) after emergency surgery . INTERPRETATION Our results provide reliable evidence of benefit from screening for abdominal aortic aneurysms Objectives To compare attendance and prevalence of abdominal aortic aneurysm ( AAA ) in population based r and omised trials of sonographic screening in the United Kingdom , Western Australia , and Denmark . Methods 65 290 men were r and omised to screening in the four trials , and data were collected and analysed from 46 397 aortic scans for men aged between 64 and 83 years who attended one of four community screening programmes . Comparisons were made for age st and ardised population s ( 65–74 years ) . Results Age st and ardised attendance varied between 74 % and 81 % , and was highest in the United Kingdom and lowest in Western Australia . Age st and ardised prevalence of AAAs of OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Electronic reminders are a simple EMR addition that can provide evidence -based education while improving adherence rates with preventive health screening measures

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND A role for vitamin D deficiency in Parkinson disease ( PD ) has recently been proposed . OBJECTIVE To compare the prevalence of vitamin D deficiency in a research data base cohort of patients with PD with the prevalence in age-matched healthy controls and patients with Alzheimer disease ( AD ) . DESIGN Survey study and blinded comparison of plasma 25-hydroxyvitamin D ( 25[OH]D ) concentrations of stored sample s in a clinical research data base at Emory University School of Medicine . SETTING Referral center ( PD and AD patients ) , primary care clinics , and community setting ( controls ) . PARTICIPANTS Participants were recruited into the study between May 1992 and March 2007 . Every fifth consecutively enrolled PD patient was selected from the clinical research data base . Unrelated AD ( n = 97 ) and control ( n = 99 ) participants were r and omly selected from the data base after matching for age , sex , race , APOE genotype , and geographic location . MAIN OUTCOME MEASURES Prevalence of suboptimal vitamin D and mean 25(OH)D concentrations . RESULTS Significantly more patients with PD ( 55 % ) had insufficient vitamin D than did controls ( 36 % ) or patients with AD ( 41 % ; P = .02 , chi(2)test ) . The mean ( SD ) 25(OH)D concentration in the PD cohort was significantly lower than in the AD and control cohorts ( 31.9 [ 13.6 ] ng/mL vs 34.8 [ 15.4 ] ng/mL and 37.0 [ 14.5 ] ng/mL , respectively ; P = .03 ) . CONCLUSIONS This report of 25(OH)D concentrations in a predominantly white PD cohort demonstrates a significantly higher prevalence of hypovitaminosis in PD vs both healthy controls and patients with AD . These data support a possible role of vitamin D insufficiency in PD . Further studies are needed to determine the factors contributing to these differences and eluci date the potential role of vitamin D in pathogenesis and clinical course of PD Significant reduction in bone mineral density ( BMD ) occurs in patients with Parkinson 's disease ( PD ) , correlating with immobilization and with vitamin D deficiency , and increasing the risk of hip fracture , especially in elderly women . As a biological indicator of compromised vitamin K status , an increased serum concentration of undercarboxylated osteocalcin ( Oc ) has been associated with reduced BMD in the hip and an increased risk of fracture in otherwise healthy elderly women . We evaluated treatment with vitamin K(2 ) ( menatetrenone ; MK-4 ) in maintaining BMD and reducing the incidence of nonvertebral fractures in elderly female patients with PD . In a r and om and prospect i ve study of PD patients , 60 received 45 mg of MK-4 daily for 12 months , and the remaining 60 ( untreated group ) did not . At baseline , patients of both groups showed vitamin D and K(1 ) deficiencies , high serum levels of ionized calcium , and glutaminic residue ( Glu ) Oc , and low levels of parathyroid hormone ( PTH ) and 1,25-dihydroxyvitamin D [ 1,25-(OH)(2)D ] , indicating that immobilization-induced hypercalcemia inhibits renal synthesis of 1,25-(OH)(2)D and compensatory PTH secretion . BMD in the second metacarpals increased by 0.9 % in the treated group and decreased by 4.3 % in the untreated group ( p < 0.0001 ) . Vitamin K(2 ) level increased by 259.8 % in the treated group . Correspondingly , significant decreases in Glu Oc and calcium were observed in the treated group , in association with an increase in both PTH and 1,25-(OH)(2)D. Ten patients sustained fractures ( eight at the hip and two at other sites ) in the untreated group , and one hip fracture occurred among treated patients ( p = 0.0082 ; odds ratio = 11.5 ) . The treatment with MK-4 can increase the BMD of vitamin D- and K-deficient bone by increasing vitamin K concentration , and it can also decrease calcium levels through inhibition of bone resorption , result ing in an increase in 1,25-(OH)(2)D concentration OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Low vitamin D levels are associated with an increased risk of PD

MS2_fixed_5_shot252

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: We investigated factors associated with falls in a community-based prospect i ve study of 761 subjects 70 years and older . The group experienced 507 falls during the year of monitoring . On entry to the study a number of variables had been assessed in each subject . Variables associated with an increased risk of falling differed in men and women . In men , decreased levels of physical activity , stroke , arthritis of the knees , impairment of gait , and increased body sway were associated with an increased risk of falls . In women , the total number of drugs , psychotropic drugs and drugs liable to cause postural hypotension , st and ing systolic blood pressure of less than 110 mmHg , and evidence of muscle weakness were also associated with an increased risk of falling . Most falls in elderly people are associated with multiple risk factors , many of which are potentially remediable . The possible implication s of this in diagnosis and prevention are discussed Objective : Comparison of two flooring types – carpet and vinyl – in the bed areas , and two modes of physiotherapy – conventional therapy and additional leg strengthening exercises – in avoiding falls . Design : R and omized 2 × 2 controlled trial . Setting : Elderly care rehabilitation ward in a community hospital . Subjects : Fifty-four consecutive patients referred for rehabilitation . Outcome measures : The incidence of falls , and the change in strength . Results : There were 10 falls on carpet , and only a single fall on vinyl floor covering ( relative risk 8.3 , 95 % confidence interval 0.95–73 , p = 0.05 ) . There were four falls in those receiving additional exercise , and seven falls in those receiving only conventional physiotherapy ( relative risk 0.21 , 95 % confidence interval 0.04–1.2 , p = 0.12 ) . Fifty-nine per cent of patients were able to complete strength measurements on admission and discharge . In these , h and grip strength improved more in those given additional exercise than conventional physiotherapy ( 2.1 kg versus – 0.3 kg , p < 0.05 ) . Conclusion : There is no evidence to support either intervention in preventing falls on a rehabilitation ward , but within this low-powered study , there was a strong trend towards vinyl being superior Regular exercise has been recommended to improve balance , strength , and coordination in older persons . In this study , 44 persons , aged 50 to 75 years ( mean 62.4 yrs ) underwent assessment s of quadriceps strength , reaction time , neuromuscular control , and body sway on two occasions before beginning a 10-week exercise program . The subjects were retested for the same measures at the end of the program . The mean number of classes attended for the 40 subjects who were retested was 16.2 ( range 11 to 19 ) . On completion of the program , the subjects showed improved performance in the tests of quadriceps strength , reaction time , body sway on a firm surface with the eyes closed , and a compliant surface with the eyes open and closed . In contrast , a group of nonexercisers showed no improvements in any of the test measures . These results suggest that exercise may play a role in improving a number of sensorimotor systems that contribute to stability in older persons CONTEXT Hip fractures are common in the elderly , and despite st and ard rehabilitation , many patients fail to regain their prefracture ambulatory or functional status . OBJECTIVE To determine whether extended outpatient rehabilitation that includes progressive resistance training improves physical function and reduces disability compared with low-intensity home exercise among physically frail elderly patients with hip fracture . DESIGN , SETTING , AND PATIENTS R and omized controlled trial conducted between August 1998 and May 2003 among 90 community-dwelling women and men aged 65 years or older who had had surgical repair of a proximal femur fracture no more than 16 weeks prior and had completed st and ard physical therapy . INTERVENTION Participants were r and omly assigned to 6 months of either supervised physical therapy and exercise training ( n = 46 ) or home exercise ( control condition ; n = 44 ) . MAIN OUTCOME MEASURES Primary outcome measures were total scores on a modified Physical Performance Test ( PPT ) , the Functional Status Question naire physical function subscale ( FSQ ) , and activities of daily living scales . Secondary outcome measures were st and ardized measures of skeletal muscle strength , gait , balance , quality of life , and body composition . Participants were evaluated at baseline , 3 months , and 6 months . RESULTS Changes over time in the PPT and FSQ scores favored the physical therapy group ( P = .003 and P = .01 , respectively ) . Mean change ( SD ) in PPT score for physical therapy was + 6.5 ( 5.5 ) points ( 95 % confidence interval [ CI ] , 4.6 - 8.3 ) , and for the control condition was + 2.5 ( 3.7 ) points ( 95 % CI , 1.4 - 3.6 points ) . Mean change ( SD ) in FSQ score for physical therapy was + 5.2 ( 5.4 ) points ( 95 % CI , 3.5 - 6.9 ) and for the control condition was + 2.9 ( 3.8 ) points ( 95 % CI , 1.7 - 4.0 ) . Physical therapy also had significantly greater improvements than the control condition in measures of muscle strength , walking speed , balance , and perceived health but not bone mineral density or fat-free mass . CONCLUSION In community-dwelling frail elderly patients with hip fracture , 6 months of extended outpatient rehabilitation that includes progressive resistance training can improve physical function and quality of life and reduce disability compared with low-intensity home exercise BACKGROUND Muscle size and strength decrease with aging , and the result ant muscle weakness has been implicated in increased risk of falls in older adults . These falls have large economic and functional costs . METHODS The purpose of this r and omized , controlled study was to determine if an 8-week , 3-day per week intense ( 77.8 + /- 3.4 % of 1-repetition maximum [ 1RM ] ) strength training program could improve functional ability related to the risk of falling in subjects aged 61 - -87 years ( mean 72 , SD 6.3 ) . Twelve strength-training-naive subjects performed two sets of 10 repetitions for six lower body exercises while 12 subjects served as nonintervention controls . Subjects were tested pre- , mid- , and postintervention for strength gain and on three tests of functional ability . RESULTS Postintervention strength was significantly better ( p < .017 ) in all training subjects across all exercises , and no injuries were reported as a result of either training or 1RM testing . After controlling for preintervention differences , repeated measure analysis of covariance ( ANCOVA ) found a significant difference between experimental and nonintervention control subjects for postintervention maximal walking speed [ F(1,19 ) = 5.03 , p < .05 ] . There were no significant between-group differences for 1-leg blind balance time or 5-repetition sit-to-st and performance [ F(1,19 ) = .082 ; F(1,19 ) = .068 , respectively , p > .05 ] . CONCLUSIONS These findings suggest that strength training alone does not appear to enhance st and ing balance or sit-to-st and performance in active , community-dwelling older adults but that it may improve maximal walking speed . The relationship between strength gain and risk of falls remains unclear . The data do reinforce the notion that intense strength training is a safe and effective way to increase muscle strength in this population Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists OBJECTIVE To determine whether a 12-month program of regular exercise can improve dynamic postural stability in older women . DESIGN R and omized controlled trial of 12 months ' duration . SETTING Conducted as part of the R and wick Falls and Fractures Study , in Sydney , Australia . PARTICIPANTS One hundred and twelve community-dwelling women aged 60 to 85 years ( mean age 71.2 , SD = 5.4 ) . OUTCOME MEASURES Quantitative measures of dynamic postural stability : maximal balance range and coordinated stability . MAIN RESULTS Exercise and control subjects were tested before , midway through , and at the end of the trial . The stability measures had good test-retest reliability , and test performances were significantly associated with measures of lower limb muscle strength , reaction time , neuromuscular control , and body sway . At initial testing , exercisers and controls performed similarly in the two stability measures . The mean number of classes attended for the 48 exercise subjects who completed the program was 58.4 ( range 26 - 77 ) . At the end of the trial , the exercise subjects showed significantly improved performance in both the maximal balance range and coordinated stability tests , with no improvement evident in the controls . Improvements in coordinated stability were associated with corresponding improvements in ankle dorsiflexion , hip extension , and hip flexion strength . CONCLUSION These findings show that exercise can significantly improve dynamic postural stability in older persons and eluci date some possible mechanisms by which such improvements may be mediated OBJECTIVE To determine whether a 12-month program of regular exercise can improve balance , reaction time , neuromuscular control , and muscle strength and reduce the rate of falling in older women . DESIGN A r and omized , controlled trial of 12 months duration . SETTING Conducted as part of the R and wick Falls and Fractures Study in Sydney , Australia . PARTICIPANTS One hundred ninety-seven women aged 60 to 85 years ( mean age 71.6 , SD = 5.4 ) who were r and omly recruited from the community . OUTCOME MEASURES Accidental falls , postural sway , reaction time , neuromuscular control , and lower limb muscle strength . MAIN RESULTS Exercise and control subjects were tested before , midway through , and at the end of the trial . At initial testing , exercisers and controls performed similarly in all tests and were well matched in relevant health and lifestyle factors . The mean number of classes attended for the 75 exercise subjects who completed the program was 60.0 ( range 26 - 82 ) . At the end of the trial , the exercise subjects showed improved performance in all five strength measures , in reaction time , neuromuscular control , body sway on a firm surface with the eyes open , and body sway on a compliant surface with the eyes open and closed . In contrast , there were no significant improvements in any of the test measures in the controls . In one test measure , hip flexion strength , the exercisers showed continued improvement throughout the study year . There was no significant difference in the proportion of fallers between the exercise and control subjects . Interesting trends were evident , however , between falls frequency and adherence to the exercise program . CONCLUSIONS These findings show that exercise can produce long-term benefits with regard to improving sensorimotor function in older persons . The findings also suggest that high compliance to an exercise program may reduce falls frequency , although further studies are required to conclusively demonstrate that exercise offers an effective means of preventing falls BACKGROUND Age-related decline in muscle power may be an early indicator of balance deficits and fall risk , even in nonfrail adults . This study examined the dose-dependent effect of power training on balance performance in healthy older adults . METHODS One hundred twelve community-dwelling healthy older adults ( 69 + /- 6 years ) were r and omized to 8 - 12 weeks of power training at 20 % ( LOW ) , 50 % ( MED ) , or 80 % ( HIGH ) of maximal strength , or a nontraining control ( CON ) group . Participants trained twice weekly ( five exercises ; three sets of eight rapid concentric/slow eccentric repetitions ) using pneumatic resistance machines . Balance , muscle performance ( strength , power , endurance , contraction velocity ) , and body composition were measured . RESULTS Power training significantly improved balance performance ( p = .006 ) in participants who underwent power training compared to controls . Low intensity power training produced the greatest improvement in balance performance ( p = .048 ) . Average contraction velocity at low load ( 40 % one repetition maximum [ 1RM ] ) at baseline independently predicted improvement in balance following training ( r = -.29 , p = .004 ) . CONCLUSIONS Power training improves balance , particularly using a low load , high velocity regimen , in older adults with initial lower muscle power and slower contraction . Further studies are warranted to define the mechanisms underlying this adaptation , as well as the optimum power training intensity for a range of physiological and clinical outcomes in older adults with varying levels of health status and functional independence OBJECTIVES To determine whether a 12-month program of group exercise can improve physical functioning and reduce the rate of falling in frail older people . DESIGN Cluster r and omized , controlled trial of 12 months duration . SETTING Retirement villages in Sydney and Wollongong , Australia . PARTICIPANTS Five hundred fifty-one people aged 62 to 95 ( mean+/-st and ard deviation=79.5+/-6.4 ) who were living in self- and intermediate-care OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

It is also possible that PRT alone is not a robust intervention for balance control . This is the first systematic synthesis of the literature to examine the effectiveness of PRT alone on balance performance in older adults . The limited evidence presented in currently published data has not consistently shown that the use of PRT in isolation improves balance in this population .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: UNLABELLED Chronic diseases of the musculoskeletal system rank first as causes of early retirement in Germany . Therefore orthopaedic rehabilitation has to identify patients with work-related problems and to promote return to work through differential treatment and vocational counselling . In the framework of the IopKo-Project such measures were developed and evaluated . These measures encompass : ( 1 ) an intensive and multiprofessional diagnostic pathway which allows early detection and treatment of mental disorders and job related problems ; ( 2 ) homogeneous treatment groups based on multiprofessional diagnostics ; ( 3 ) differential treatments , among these a multidisciplinary programme for patients with chronic low back pain or high risk of chronification ( Rückenfit ) ; ( 4 ) interactive training modules which mediate principles of performance and disability expertise , the legal bases of retirement pensioning , and measures to support occupational rehabilitation ; and ( 5 ) a work hardening training programme . METHOD To evaluate the effects of these measures in comparison to a control group with usual care , a prospect i ve longitudinal study was conducted . A total of 307 patients were assigned to the multidisciplinary in-patient treatment programme , whereas 176 patients in the control group had a st and ard rehabilitation programme . RESULTS The results show positive moderate and strong effects in the intervention group concerning function , pain , psychic strains as well as the number of sick days and return to work rates 10 months after discharge . The effects in the intervention group exceeded the effects achieved in the control group . PATIENTS WITH HIGH RISK OF CHRONIFICATION : Beside the full sample , a subgroup of patients with chronic pain or high risk of chronification was analyzed , who had received a multidisciplinary functional restoration treatment . Also for this subgroup we found moderate and strong effects of treatment for function , psychic strains and sick days superior to those in the control group . CONCLUSION By this study we were able to show that orthopedic rehabilitation in a multimodal and multidisciplinary setting with a focus on activating and motivating therapy can have sustainable positive effects on pain , function and psychic well-being as well as on economic parameters . We interpret these persistent and superior effects in the treatment group ( 1 ) as a result of multiprofessional diagnosis and assignment which helps to subdivide the inhomogeneous group of patients with unspecific back pain into more homogeneous and thus more effective subgroups , ( 2 ) as a result of increased motivation by closed treatment groups , ( 3 ) as a result of intense and multilevel counselling of work related problems , ( 4 ) as a result of work hardening modules , and ( 5 ) as a result of direct and efficient treatment of psychic strains . The results also demonstrate the significance of inpatient rehabilitation , which will be efficient if differential treatment - adequate to the problems of the patient - is offered BACKGROUND Breast cancer may adversely affect work experience . We assessed whether there was evidence of discrimination at work , defined as negative or involuntary changes in employment situation ( including changes in position , wages , and other conditions ) , associated with a breast cancer diagnosis in a population -based retrospective cohort study conducted in Quebec , Canada . METHODS The study was based on the consecutive series of women aged less then 60 years when first treated for breast cancer ( identified through the Quebec Tumor Registry ) and a r and om sample of frequency-matched women living in Quebec ( identified from provincial health care files ) who had never been diagnosed with cancer . Eligibility for the study was restricted to women who were employed at the time of diagnosis ( for breast cancer survivors ) or the same calendar period ( for women in the comparison group ) . We conducted telephone interviews of eligible women 3 years after diagnosis for 646 survivors or after the matched calendar period for 890 women in the comparison group . Binomial regression was used to evaluate the relationship between having breast cancer and work situation . All statistical tests were two-sided . RESULTS Working conditions were similar between the two groups at the beginning of follow-up . After 3 years , slightly more survivors ( 21 % ) than women in the comparison group ( 15 % ) were unemployed ( adjusted relative risk for being unemployed = 1.29 , 95 % confidence interval = 1.05 to 1.59 ) , although most women who were not working ( 84 % of unemployed survivors and 76 % of unemployed women in the comparison group ) said that the decision to stop working was their own . Among women still employed , no deterioration in working conditions was observed in either group . CONCLUSION We found little evidence that women diagnosed with breast cancer experience discrimination at work . This information may be helpful for working women concerned about employment after breast cancer Objective To evaluate the effectiveness of an integrated care programme , combining a patient directed and a workplace directed intervention , for patients with chronic low back pain . Design Population based r and omised controlled trial . Setting Primary care ( 10 physiotherapy practice s , one occupational health service , one occupational therapy practice ) and secondary care ( five hospitals ) . Participants 134 adults aged 18 - 65 sick listed for at least 12 weeks owing to low back pain . Intervention Patients were r and omly assigned to usual care ( n=68 ) or integrated care ( n=66 ) . Integrated care consisted of a workplace intervention based on participatory ergonomics , involving a supervisor , and a grade d activity programme based on cognitive behavioural principles . Main outcome measures The primary outcome was the duration of time off work ( work disability ) due to low back pain until full sustainable return to work . Secondary outcome measures were intensity of pain and functional status . Results The median duration until sustainable return to work was 88 days in the integrated care group compared with 208 days in the usual care group ( P=0.003 ) . Integrated care was effective on return to work ( hazard ratio 1.9 , 95 % confidence interval 1.2 to 2.8 , P=0.004 ) . After 12 months , patients in the integrated care group improved significantly more on functional status compared with patients in the usual care group ( P=0.01 ) . Improvement of pain between the groups did not differ significantly . Conclusion The integrated care programme substantially reduced disability due to chronic low back pain in private and working life . Trial registration Current Controlled Trials IS RCT N28478651 Study Design . R and omized parallel-group comparative trial with a 6-month follow-up period . Objective . To compare , in chronic low back pain patients , the effectiveness of a functional restoration program , including intensive physical training , occupational therapy , and psychological support to an active individual therapy consisting of 3 hours physical therapy per week during 5 weeks . Summary of Background Data . Controlled studies conducted in the United States showed a benefit of functional restoration in patients with low back pain , especially on return to work . R and omized Canadian and European trials had less favorable results . In France , there has been up to now no r and omized study . Controlled studies suggested a positive effect of functional restoration programs . Methods . Eighty-six patients with low back pain were r and omized to either the functional restoration ( 44 patients ) or the active individual therapy ( 42 patients ) program . One person in each group never started the program . Two patients did not complete the functional restoration program , and one was lost to follow-up at 6 months . The mean number of sick-leave days in the 2 previous years was 6 months . Results . After adjustment on the variable ≪ workplace enrolled in an ergonomic program ≫ , the mean number of sick-leave days was significantly lower in the functional restoration group . Physical criteria and treatment appreciation were also better . There was no significant difference in the intensity of pain , the quality of life and functional indexes , the psychological characteristics , the number of contacts with the medical system , and the drug intake . Conclusions . This study demonstrates the effectiveness of a functional restoration program on important outcome measures , such as sick leave , in a country that has a social system that protects people facing difficultiesat work Background The causes of prolonged disability due to back pain are multiply determined , involving medical , social , and environmental factors . Possible solutions to the problem of prolonged back pain disability have emerged from recent research but few efforts have been made to transfer evidence -based programs to large community setting s. Objective This article describes three phases of the process of transfer of evidence from rehabilitation research to community practice in the province of Quebec . Methods and Results Phase A : Based on literature review and expert knowledge , the Sherbrooke model was developed and assessed through a population -based , r and omized clinical trial . Results at 1-year follow-up showed quicker return to regular work and improvement of quality of life ; the 6-year follow-up showed the cost-effectiveness of the method .Phase B : Based on the Sherbrooke model experience and recent evidence , a new program addressing the disability paradigm was developed and implemented in the province of Quebec ( Canada ) . Results at 1- and 3-year follow-ups showed that only 24 % of workers were not working owing to their musculoskeletal disorder . The program is presently being tested through a population -based , r and omized clinical trial in a population of construction workers . Phase C : To implement the program at a provincial level , a network for management , research and education in work rehabilitation was developed . An external assessment is presently planned to evaluate return to work and economic outcomes and quality of implementation of the program in various setting BACKGROUND Major depression has far-reaching consequences for work functioning and absenteeism . In most cases depression is treated by medication and clinical management . The addition of occupational therapy ( OT ) might improve outcome . We determined the cost-effectiveness of the addition of OT to treatment as usual ( TAU ) . METHOD Sixty-two adults with major depression and a mean absenteeism of 242 days were r and omized to TAU ( out-patient psychiatric treatment ) or TAU+OT [ 6 months , including ( i ) diagnostic phase with occupational history and work reintegration plan , and ( ii ) therapeutic phase with individual sessions and group sessions ] . Main outcome domains were depression , work resumption , work stress and costs . Assessment s were at baseline and at 3 , 6 , 12 and 42 months . RESULTS The addition of OT to TAU : ( i ) did not improve depression outcome , ( ii ) result ed in a reduction in work-loss days during the first 18 months , ( iii ) did not increase work stress , and ( iv ) had a 75.5 % probability of being more cost-effective than TAU alone . CONCLUSION Addition of OT to good clinical practice does not improve depression outcome , improves productivity without increasing work stress and is superior to TAU in terms of cost-effectiveness Coronary catheter revascularisation is less costly than bypass surgery due to lower direct ( medical ) and indirect costs ( loss of work ) . Many studies show that the time patients stay out of work following coronary intervention is much longer than necessary . This leads to a considerable increase of indirect costs , which can far exceed the medical costs of the treatment . This prospect i ve r and omised study was done to determine whether specific information to patient and family doctor results in an earlier return to work . After catheter revascularisation 100 working patients ( mean age 52.4 years ) were r and omised either to the intervention group ( information to patient and family doctor ) or to the control group ( no specific information about return to work ) . Four months later 81 patients had returned to their previous jobs ( mean sick leave 18.9 + /- 24.8 days ) while 19 were still out of work . In the control group , the rate was 79 % and the mean sick leave was 16.4 + /- 22.0 days ( median 7 ) ; in the intervention group 83 % had returned to work after a mean of 21.5 + /- 27.4 days ( median 10 ) . There was no significant difference between the two groups , neither according to the rate of returned workers nor to the duration of sick leave . In the subgroup of patients with a private insurance ( 23 % of all ) 96 % started to work again ( mean sick leave 5.7 + /- 5.1 days median 3.5 ) , while the rate was 77 % in the group of panel patients ( mean sick leave 23.7 + /- 27.4 days , median 11 ) . The difference in sick leave between these two groups was highly significant ( p = 0.0003 ) . Specific information to the patient and family doctor has no effect on the time patients stay out of work following catheter revascularisation . It seems that the observed delay depends on social and psychological factors that can not be influenced directly OBJECTIVES --The aim was to combat occurrence of chronic occupational back pain . METHODS --A multidisciplinary model to manage back pain that includes both clinical and ergonomic approaches has been developed . Early detection , early clinical and ergonomic evaluations , and early active treatment make up the cornerstone of management . Detection of cases starts after four weeks of absence from work . An ergonomic intervention is implemented at six weeks . A medical specialist is involved at eight weeks . If return to work is not possible after 12 weeks , a functional recovery therapy followed by a therapeutic return to work is implemented . A multidisciplinary team decides if return to original or modified work is possible or if vocational rehabilitation is necessary . This model has been implemented by the investigators in the Sherbrooke ( Quebec , Canada ) area , and is presently being evaluated through a r and omised trial in 31 industrial settlements ( about 20,000 workers ) . A cluster r and omisation of industries and workers will allow separate testing of ergonomic and clinical interventions . RESULTS --One year after implementation , 31 of 35 of the eligible industrial sites participated in the study and 79 of 88 of the eligible workers affected by recent back pain had agreed to participate . Ergonomic and clinical interventions have been implemented as planned . Only three workers dropped out . Hence this global clinical and ergonomic management programme has been shown to be feasible in a general population . CONCLUSION --A global management programme of back pain joining ergonomic and clinical intervention with a multidisciplinary approach has not been tested yet . Linking these two strategies in a same multidisciplinary team represents a systemic approach to this multifactorial ailment . During the first year of this trial we did not find any conflict between these two intervent OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Results show systematic review ing of OTIs on RTW was challenging due to varying population s , different outcome measures , and poor descriptions of methodology . There is evidence that OTIs as part of rehabilitation programs , increase RTW rates , although the method ological evidence of most studies is weak .

MS2_fixed_5_shot254

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: While weight-management interventions are effective in attenuating antipsychotic-induced weight , there is no available evidence on their long-term effectiveness . This study sought to investigate the 2-year effects of an early behavioural intervention ( EBI ) design ed to prevent antipsychotic-induced weight gain in first-episode psychosis ( FEP ) patients . Sixty-one FEP patients were r and omized to receive either EBI or treatment-as-usual . Intention-to-treat and observed-cases analysis showed that patients in the EBI group gained significantly less weight than those allocated to routine care at intervention completion ( 3-month follow-up ) with treatment effects maintained over 3months . Differences between groups were no longer significant by 12months . Weight-management interventions may need to be offered for longer periods to maintain preventative effects . Alternatively , booster sessions may need to be regularly delivered after intervention completion Obesity and diabetes have caused problems for individuals with schizophrenia long before atypical antipsychotic agents . The prevalence of obesity , insulin resistance , impaired glucose tolerance , type 2 diabetes mellitus , dyslipidemia , and the Metabolic Syndrome has increased in people with schizophrenia as compared to the general population . Risk reduction studies for persons with obesity , diabetes , and cardiovascular disease indicate that cognitive/behavioral interventions that promote motivation and provide strategies to overcome the barriers in adherence to diet and activity modification are effective interventions for weight management and risk reduction . In the l and mark multi-center r and omized-controlled trial study , the Diabetes Prevention Project ( DPP ) , a cognitive/behavioral intervention , was more successful in producing weight loss and preventing diabetes than the drugs metformin , troglitazone or placebo . This pilot study examined the effectiveness of a cognitive/behavioral group intervention , modified after the DPP program , in individuals with schizophrenia or schizoaffective disorder taking atypical antipsychotics in a large urban public mental health system . Outcome measures included body weight , body mass index , waist-hip ratios , and fasting glucose levels . Both groups demonstrated elevated fasting glucose levels and were obese with a mean BMI of 33 . The group that received the cognitive/behavioral group intervention lost more weight than the treatment as usual group . The CB group participants lost an average of 5.4 lb or 2.9 % of body weight , and those in the control group lost 1.3 lb or 0.6 % body weight . The range of weight loss for the treatment group was from 1 to 20 lb . This pilot study has demonstrated that weight loss is possible with cognitive/behavioral interventions in a population with a psychotic disorder Background Weight gain is common for people with schizophrenia and this has serious implication s for health and well being . Objectives To determine the effects of both pharmacological ( excluding medication switching ) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia . Search methods We search ed key data bases and the Cochrane Schizophrenia Group 's trials register ( April 2006 ) , reference sections within relevant papers , h and search ed key journals , and contacted the first author of each relevant study and other experts to collect further information . Selection criteria We included all clinical r and omised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain ( diet and exercise counselling ) with st and ard care or other treatments for people with schizophrenia or schizophrenia-like illnesses . Data collection and analysis We reliably selected , quality assessed and extracted data from studies . As weight is a continuous outcome measurement , weighted mean differences ( WMD ) of the change from baseline were calculated . The primary outcome measure was weight loss . Main results Twenty-three r and omised controlled trials met the inclusion criteria for this review . Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct . In terms of prevention , two cognitive/behavioural trials showed significant treatment effect ( mean weight change ) at end of treatment ( n=104 , 2 RCTs , WMD -3.38 kg CI -4.2 to -2.0 ) . Pharmacological adjunct treatments were significant with a modest prevention of weight gain ( n=274 , 6 RCTs , WMD - 1.16 kg CI -1.9 to -0.4 ) . In terms of treatments for weight loss , we found significantly greater weight reduction in the cognitive behavioural intervention group ( n=129 , 3 RCTs , WMD -1.69 kg CI -2.8 to -0.6 ) compared with st and ard care . Authors ' conclusions Modest weight loss can be achieved with selective pharmacological and non pharmacological interventions . However , interpretation is limited by the small number of studies , small sample size , short study duration and by variability of the interventions themselves , their intensity and duration . Future studies adequately powered , with longer treatment duration and rigorous methodology will be needed in further evaluating the efficacy and safety of weight loss interventions for moderating weight gain . At this stage , there is insufficient evidence to support the general use of pharmacological interventions for weight management in people with schizophrenia BACKGROUND The main objective was to assess the efficacy of a weight management program design ed for out patients taking olanzapine for schizophrenia or schizoaffective disorder and to compare these patients with a r and omized control group . The effects of the weight management program were also assessed with regard to safety and quality of life . METHOD Forty-eight patients were enrolled in a 12-week , r and omized , multicenter weight management study . Thirty-three patients were r and omly allocated to an intervention group in which they received olanzapine within a weight management program . Fifteen patients were allocated to a control group in which they were given olanzapine treatment as usual out patients . Weight , body mass index ( BMI ) , and measurements of safety and quality of life were evaluated . The study was conducted from January 7 , 2003 , to September 16 , 2003 . RESULTS Thirty-six patients ( 75 % ) completed this study . We found significant differences in weight ( -3.94 + /- 3.63 kg vs. -1.48 + /- 1.88 kg , p = .006 ) and BMI ( -1.50 + /- 1.34 vs. -0.59 + /- 0.73 , p = .007 ) change from baseline to endpoint between the intervention and control groups , respectively . Significant differences in weight reduction were initially observed at week 8 ( p = .040 ) . No significant differences were found with regard to the safety outcomes . When the ratio of low-density lipoproteins to high-density lipoproteins was calculated , change from baseline was greater in the intervention group than the control group ( -0.19 vs. -0.04 ) , but the difference was not statistically significant ( p = .556 ) . After the completion of the weight management program , there was a trend toward statistical difference in the physical health score changes between the weight management and control groups ( 1.12 in the intervention group vs. -0.93 in the control group , p = .067 ) . CONCLUSION The weight management program was effective in terms of weight reduction in patients with schizophrenia or schizoaffective disorder taking olanzapine and was also found to be safe in terms of psychiatric symptoms , vital signs , and laboratory data . In addition , such a weight management program might improve quality of life in patients with schizophrenia or schizoaffective disorder with respect to their physical well-being Background : Increasing numbers of reports have raised concerns about significant increases in weight and adiposity over both short- and long-term treatment in patients treated with antipsychotics ( APs ) . The management of overweight and obesity in patients treated with APs has included pharmacological interventions , dietary suggestions , and behavioral strategies . Nevertheless , current evidence does not support the use of pharmacological management of this specific type of obesity , and only a limited number of studies have been published regarding prevention and treatment of weight gain with other strategies . Objective : The aim of this study was to evaluate the effectiveness of an educational intervention ( EI ) that combines low-calorie diet with increased physical activity to prevent and treat weight gain in patients treated with APs . Method : Data were from 53 subjects whose body mass index ( BMI ) had increased by more than 7 % after starting an AP therapy and who consented to participate in a 12-week educational intervention study aim ed at preventing further weight gain and , when possible , at inducing a weight loss . Weight and BMI were measured at baseline ( at each of the monthly follow-up visits ) and at study completion 12 weeks from entry in the study . Results : Twenty-six patients completed the 12-week program . Completers showed a significant mean body weight decrease of 3.15 kg , with a mean BMI reduction of 1.2 ( kg/m2 ) at the end of the 3-month period . Conclusions : Educational intervention can be an important tool for the management of weight increase in patients treated with APs . A larger prospect i ve and controlled study is now needed to confirm our findings The objective was to explore the impact on physical health of a lifestyle programme among persons with psychiatric disabilities , and their caregivers . Their satisfaction with the intervention was also assessed . Somatic comorbidity and an increased mortality related to the lifestyle among persons with psychiatric disabilities are well known . Few r and omized controlled trials have been aim ed specifically at lifestyle issues among persons with a psychiatric disability . This trial includes clients with psychiatric disabilities living in supported housing and their staff . Forty-one persons with a DSM-?V diagnosis of severe mental illness from psychiatric disability from 10 supported housing facilities and 41 of their caregivers participated in this 12-month study during 2005–2006 in Sweden . The supported housing facilities with residents and staff were r and omly assigned to either a health intervention programme or a control programme with an aesthetic content . The presence of metabolic syndrome and changes in the mean of physiological parameters such as Hba1c , P-glucose , P-insulin , lipids , blood pressure , physical working capacity , body mass index , Heart Score were investigated and participants ’ satisfaction assessed . There was a significant reduction in the mean of metabolic syndrome criteria in the intervention group compared with the control group at the follow-up . The participants expressed satisfaction with the programme . The results indicate that health interventions on lifestyle issues when involving carers are appreciated , feasible and could be successful in reducing some health-related risk factors among persons with psychiatric disabilities BACKGROUND Obesity is common in persons with schizophrenia . Besides its adverse health effects , obesity reduces quality of life and contributes to the social stigma of schizophrenia . METHOD This 14-week , multicenter , open-label , rater-blinded , r and omized study evaluated the effects of a group-based behavioral treatment ( BT ) for weight loss in overweight and obese stable patients with DSM-IV schizophrenia or schizoaffective disorder who had been switched from olanzapine to risperidone . Participants were r and omly assigned to receive BT or usual clinical care ( UC ) . BT included 20 sessions during which patients were taught to reduce caloric intake . In UC , patients were encouraged to lose weight but received no special advice about weight reduction . The primary outcome measure was change in body weight . RESULTS Seventy-two patients were enrolled . The mean + /- SD weight loss at endpoint was significant in both groups ( p < .05 ) and numerically greater in patients receiving BT than in those receiving UC ( -2.0 + /- 3.79 and -1.1 + /- 3.11 kg , respectively ) . More patients in the BT group than in the UC group had lost > or = 5 % of their body weight at endpoint ( 26.5 % [ 9/34 ] and 10.8 % [ 4/37 ] , respectively ; p = .082 ) . A post hoc analysis of patients attending at least 1 BT session showed that significantly more patients in the BT than the UC group had lost > or = 5 % of their body weight at endpoint ( 32.1 % [ 9/28 ] vs. 10.8 % [ 4/37 ] , respectively , p = .038 ) and at week 14 ( complete population ; 40.9 % [ 9/22 ] and 14.3 % [ 4/28 ] , respectively , p = .027 ) . CONCLUSION BT may be an effective method for weight reduction in patients with chronic psychotic illness OBJECTIVE Patients with schizophrenia treated with clozapine often gain weight . This study evaluated the effects of dietary control and physical activity among obese in patients with schizophrenia being treated with clozapine . METHODS Fifty-three clozapine-treated obese patients with schizophrenia in a veterans hospital in eastern Taiwan who had a body mass index greater than 27 ( weight divided by height in meters squared ) and who were taking clozapine were r and omly assigned to a study group of 28 or a control group of 25 . The study group was placed on a diet that reduced calorie intake by 200 to 300 kcal per day ( to 1,300 to 1,500 kcal per day for women and to 1,600 to 1,800 kcal per day for men ) and a six-month regimen of regular physical activity in which participants used approximately 600 to 750 kcal per week ( level walking and walking on stairs for 60 minutes three days per week ) . Anthropometric , metabolic , and hormonal parameters were measured after three and six months by using anthropometry , an enzyme autoanalyzer , immunoassay , and enzyme-linked immunosorbent assay . RESULTS Compared with the control group , the study group showed a significant decrease in body weight OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Results The results of the meta- analysis show an effect toward the experimental group . Notably , prevention studies with individual psychoeducational programmes that include diet and /or physical activity seem to have the highest impact . Conclusions When compared with treatment as usual in psychotic patients , preventive and individual lifestyle interventions that include diet and physical activity generally prove to be effective in reducing weight . This percentage is below the 5 % to 10 % weight loss deemed sufficient to improve weight-related complications such as hypertension , type II diabetes , and dyslipidemia . However , it is reported that outcomes associated with metabolic risk factors may have greater health implication s than weight changes alone .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: PURPOSE The Comparison of Ophthalmic Medications for Tolerability ( COMTOL ) question naire was developed for use in clinical trials to compare the tolerability of topical ophthalmic medications used in the treatment of glaucoma . The question naire captures the frequency and bother of common side effects ( i.e. , ocular and other local effects , and effects on visual function ) of topical therapy for lowering intraocular pressure . In addition , the question naire measures the extent to which these side effects and any associated limitations in routine living activities interfere with health-related quality of life , medication compliance , and patient satisfaction with the medication . This study was design ed to assess the measurement characteristics of the COMTOL question naire . METHODS The internal consistency , reliability , reproducibility , construct validity , discriminant validity , and responsiveness of the question naire were assessed in 70 adult patients with glaucoma in a clinical trial comparing timolol and pilocarpine . RESULTS The question naire showed good-to-excellent internal consistency ( 0.73 to 0.98 ) , reliability ( 0.76 to 0.94 ) , and reproducibility ( 0.75 to 0.93 ) . In general , there was a strong correlation in the expected direction between the frequency and bother of side effects and patient-perceived global measures . The question naire discriminated between patients receiving timolol and patients receiving pilocarpine . The question naire demonstrated significant responsiveness to change . CONCLUSIONS The COMTOL question naire showed acceptable measurement characteristics for inclusion as a tolerability measure to supplement spontaneous adverse event reporting in clinical trials of topical ophthalmic therapy Purpose To provide initial validation of the Treatment Satisfaction Survey-Intraocular Pressure ( TSS-IOP ) quality -of-life survey that analyses specific issues related to side effects , patient satisfaction , and compliance . Methods A prospect i ve , observational cohort of 250 consecutive patients with primary open-angle glaucoma or ocular hypertension was administered the TSS-IOP survey . Results Factors that correlated with patient satisfaction included perceived effectiveness of the medicine ( F=7.47 , P<0.001 ) , ocular irritation ( F=6.06 , P<0.001 ) , conjunctival hyperaemia ( F=4.40 , P<0.001 ) , ease of use ( F=8.52 , P<0.001 ) , and convenience of use ( F=6.90 , P<0.001 ) . Patient compliance , acceptance of their illness , and knowledge of glaucoma were also related to perceived effectiveness of the medicine ( P<0.001 ) , ease of use ( P<0.05 ) and convenience ( P<0.001 ) . Physician ratings of patient pressure control , side effects , and instillation problems also were significantly correlated to patient satisfaction ( R=0.13–0.26 , P=0.05–0.001 ) . The physician ratings of patient compliance , however , were not significantly related to any dimension of patient satisfaction ( P>0.05 ) . Among monotherapy prostagl and in treatments , latanoprost demonstrated statistically greater satisfaction than bimatoprost or travoprost regarding conjunctival hyperaemia ( P<0.05 ) and eye irritation ( P<0.01 ) . Conclusions This study provides initial evidence that patient satisfaction may be related to compliance , perceived effectiveness of treatment , adverse side effects , ease and convenience of use , acceptance of illness , and knowledge of glaucoma PURPOSE To verify the quality of life in a Brazilian glaucoma population and the influence of possible modifiers ( e.g. , visual acuity , visual field impairment ) . METHODS Forty-five consecutive patients from CEROF - Federal University of Goiás , Brazil were included prospect ively in the study . The quality of life was assessed using the Portuguese version of the VFQ . Possible modifiers were evaluated , initially separately with the Spearman 's Correlation and then together in a regression model . RESULTS The mean age was 59.6 ± 12.4 years . The mean quality of life score was 79 ± 15 ( range 45 - 100 ) . Age ( r = −0.402 , p = 0.006 ) , visual acuity in the better eye ( r = −0.497 , p = 0.001 ) and in the worse eye ( r = −0.608 , p < 0.001 ) , Hodapp-Parrish- And erson visual field grading scale in the better ( r = −0.353 , p = 0.01 ) and worse eye ( r = −0.387 , p = 0.009 ) , visual field Mean Deviation ( MD ) in the better ( r = 0.355 , p = 0.01 ) and worse eye ( r = 0.320 , p = 0.04 ) and ability to perform a visual field test in both eyes ( r = −0.397 , p = 0.007 ) were significantly correlated with the quality of life scores . However , only age ( younger , better quality of life , p = 0.008 ) and visual acuity in the better eye ( direct relation , p = 0.04 ) were significant in the regression model ( r = 0.633 , r2 = 0.401 ) . CONCLUSIONS The VFQ may be a useful tool to assess the quality of life in glaucoma patients . The preliminary results indicate that age and visual acuity in the better eye are the main factors related to the quality of life in these patients PURPOSE To evaluate the relationship between visual disability and the remaining visual field in glaucoma patients . DESIGN Prospect i ve noncomparative survey . PARTICIPANTS One hundred forty-seven Japanese patients with glaucoma were examined . METHODS Using a previously developed question naire , we assessed the relationship between visual disability indices and both the visual field examined using program 30 - 2 of the Humphrey Field Analyzer and visual acuity . MAIN OUTCOME MEASURES Pearson 's correlation coefficients between visual disability indices and the 22 visual field and 2 visual acuity measurements were calculated . Multiple regression analysis with stepwise variable selection identified factors significantly contributing to visual disability . RESULTS We identified a significant correlation between visual disability and both the visual field and visual acuity measurements collected . Of the factors examined , retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye significantly contributed to all the item and total disability indices ( DIs ) , measurements of the degree of visual disability as evaluated by the question naire ; visual acuity in the worse eye contributed to two of the seven item DIs , as well as the total DI . The R value for total DI ( R = 0.87 , P < 0.0001 ) indicated that approximately 76 % of the visual disability could be explained by these factors . CONCLUSIONS The Japanese glaucoma patients ' visual disability is explained primarily by retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye and secondarily by visual acuity in the worse eye PURPOSE To evaluate the effect of treatment , visual function , and other factors on vision-targeted health-related quality of life ( HRQOL ) of patients with early glaucoma . DESIGN R and omized clinical trial . PARTICIPANTS Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field ( VF ) defects , 50 to 80 years old ( 66 % female ) . METHODS Patients were r and omized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s ) or no initial treatment and had ophthalmologic examinations every 3 months . A Swedish translation of the 25-item National Eye Institute Visual Function Question naire ( NEI VFQ-25 ) was self-administered at 2 follow-up visits ( 3 and 6 years after r and omization ) . MAIN OUTCOME Multiple linear regression analyses determined the effect of treatment and other factors on ( 1 ) VFQ-25 composite scores at the first administration and ( 2 ) change in scores between administrations . RESULTS Two hundred thirty-three patients had 1 NEI VFQ-25 administration and 167 patients had 2 administrations . Internal consistency reliability was high for the composite VFQ-25 score ( Cronbach alpha = 0.88 ) and satisfactory ( alpha > or = 0.76 ) for most subscale scores . At the first administration , the composite score was high ( 88.8+/-11.7 ) . Mean subscale scores were also generally high ( 98.0 - 58.3 ) and were similar for each study group when analyzed separately . Most lower subscale scores were modestly but significantly related to worse visual acuity ( VA ) or mean deviation ( MD ) ( better eye , r = 0.15 - 0.35 ) . Composite scores were similar for treated and untreated patients . Lower composite scores were associated with low VA in the better eye ( worse than 0.70 ) and worse perimetric MD ( < 4.16 decibels ) and nuclear lens opacities ( Lens Opacities Classification System II grade > or = 2 ) , but not with age , gender , VF progression , intraocular pressure , cardiovascular disease , or hypertension . Between VFQ-25 administrations , larger decreases in the composite score were associated with larger decreases in VA ( P<0.05 ) , female gender ( P = 0.001 ) , and older age at first administration ( P = 0.006 ) . Treatment ( assigned at r and omization or later in the study ) was not associated with change in HRQOL . CONCLUSIONS Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients . However , visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment The final development of the Sickness Impact Profile ( SIP ) , a behaviorally based measure of health status , is presented . A large field trial on a r and om sample of prepaid group practice enrollees and smaller trials on sample s of patients with hyperthyroidism , rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses . Test-retest reliability ( r = 0.92 ) and internal consistency ( r = 0.94 ) were high . Convergent and discriminant validity was evaluated using the multitrait – multi method technique . Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores . The relationship between the SIP and criterion measures were moderate to high and in the direction hypotheszed . A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis . The final SIP contains 136 items in 12 categories . Overall , category , and dimension scores may be calculated PURPOSE The Tube Versus Trabeculectomy ( TVT ) Study will compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous intraocular surgery . DESIGN Multicenter r and omized clinical trial . METHODS SETTING 17 Clinical Centers . STUDY POPULATION Patients 18 to 85 years of age who have undergone previous trabeculectomy , cataract extraction with intraocular lens implantation , or both and have inadequately controlled glaucoma with intraocular pressure ( IOP ) > or=18 mm Hg and < or=40 mm Hg on tolerated medical therapy . INTERVENTIONS Study patients were r and omized to undergo placement of a 350-mm(2 ) Baerveldt glaucoma implant or trabeculectomy with mitomycin C ( 0.4 mg/ml for 4 minutes ) . MAIN OUTCOME MEASURES IOP , complication rates , visual acuity , visual field , quality of life , reoperations for glaucoma , and need for supplemental medical therapy . RESULTS A total of 212 patients were enrolled between October 1999 and April 2004 . The age of the study population was 71.0 + /- 10.4 years ( mean + /- SD ) , and 53 % were women . The baseline IOP was 25.3 + /- 5.3 mm Hg ( mean + /- SD ) . There were no significant differences in the demographic and ocular characteristics between the 2 treatment groups . CONCLUSIONS Practice patterns vary in the surgical management of glaucoma , and there are differing opinions among glaucoma surgeons regarding the preferred surgical approach in patients who have undergone previous cataract extraction and /or failed filtering surgery . Forthcoming data from the TVT Study should provide valuable information comparing two surgical procedures commonly used in this patient population This 3-month multicenter , open-label study of 89 geriatric patients with glaucoma evaluated the substitution of brimonidine twice daily for topical beta blockers that had been used for at least 6 months . The primary outcome measures were reduction in intraocular pressure ( IOP ) from baseline at 2 hours postdose , change in cardiac and respiratory function , quality of life , and patient satisfaction . Patients were queried about adverse events at each visit and completed a quality -of-life question naire at the final evaluation . In this cohort with a mean age of 75.4 years , the average duration of topical beta-blocker therapy was 5 years . Brimonidine twice daily produced an additional mean reduction in IOP of 8.2 % ( 1.4 mm Hg;P < .001 ) . Eighty-eight percent of patients ( 60/68 ) reported being at least as satisfied with brimonidine as with their previous beta-blocker regimen , and 46 % ( 31/68 ) reported OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The National Eye Institute Visual Function Question naire-25 , Impact of Vision Impairment and Treatment Satisfaction Survey-Intraocular Pressure had the highest number of positive ratings in the content validity assessment . Conclusion This study provides a descriptive catalogue of vision-specific PRO instruments , to inform the choice of an appropriate measure of patient-reported outcomes in a glaucoma context

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The purpose s of this study were to : 1 ) describe the patterns of screen-based sedentary behaviors , and 2 ) examine the association between screen-based sedentary behavior and cardiovascular disease ( CVD ) risk factors in representative Korean children and adolescents , aged 12 to 18 yr , in the Korean National Health and Nutrition Examination Survey . Screen-based sedentary behavior was measured using self-report question naires that included items for time spent watching TV and playing PC/video games . Physical activity was measured using items for frequency and duration of moderate-to-vigorous physical activity ( MVPA ) . CVD risk factors such as body mass index ( BMI ) , waist circumference , LDL cholesterol , HDL cholesterol , total cholesterol , triglycerides , glucose , systolic blood pressure , and diastolic blood pressure were measured . Boys spent more time playing PC/video games , and girls spent more time watching TV . After adjusting for age , gender , annual household income , and MVPA , an additional hour of watching TV was significantly associated with the risk of overweight ( OR 1.17 [ 95 % CI 1.03 - 1.33 ] ) , high abdominal adiposity ( OR 1.27 [ 1.06 - 1.51 ] ) , and low HDL cholesterol ( OR 1.27 [ 1.10 - 1.47 ] ) . An additional hour spent playing PC/video games also increased the risk of high abdominal adiposity ( OR 1.20 [ 1.03 - 1.40 ] ) . Prospect i ve observations and interventions are needed to determine causal relationships between screen-based sedentary behavior and CVD risk profiles in Korean youth PURPOSE The objectives of this study were to describe longitudinal trends in adolescent physical activity in a sample of U.S. adolescents and to assess the effect of multiple individual , parental , and environmental factors on initial level and rates of change in adolescent physical activity . METHODS Study subjects were 12,812 boys and girls 10 to 18 years of age who were participating in the Growing Up Today Study and their mothers . We used accelerated longitudinal analysis to describe trajectories of physical activity from 1997 - 1999 , and r and om effects linear mixed models to determine which factors were independently associated with baseline physical activity and changes in physical activity over time . RESULTS Mean hours of physical activity ranged from 7.3 - 11.6 hours per week in boys and from 8.0 - 11.2 hours per week in girls . Physical activity was best modeled as a quadratic function of age , increasing until early adolescence and declining after age 13 in boys and girls . Multivariable modeling demonstrated that variables associated with physical activity level at baseline in boys and girls were age , body mass index , psychosocial variables , personal attitudes about body shape , perceived peer attitudes about body shape/fitness , parental attitudes about physical activity , parental physical activity , and environmental barriers to physical activity . Age was the only factor that predicted change in physical activity over time . CONCLUSIONS Interventions to increase physical activity in adolescents should begin before adolescence . Interventions may be more effective if they are multimodal and focus on modifiable individual , parental , and environmental factors Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making . However , there are no structured reporting requirements for studies of this design to assist authors , editors , and readers . The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies . The checklist criteria concerned recruitment , data collection , biases , and data analysis and descriptive issues relevant to study rationale , study population , and generalizability . Two raters independently assessed 49 r and omly selected articles describing stroke research published from 1999 to 2003 in six journals : American Journal of Epidemiology , Journal of Epidemiology and Community Health , Stroke , Annals of Neurology , Archives of Physical Medicine and Rehabilitation , and American Journal of Physical Medicine and Rehabilitation . On average , 17 of the 33 checklist criteria were reported . Criteria describing the study design were better reported than those related to internal validity . No relation was found between study type ( etiologic or prognostic ) or word count and quality of reporting . A flow diagram for summarizing participant flow through a study was developed . Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research To cite this article : Vahlkvist S , Inman MD , Pedersen S. Effect of asthma treatment on fitness , daily activity and body composition in children with asthma . Allergy 2010 ; 65 : 1464–1471 AIMS Girls with Type 1 diabetes often gain excessive weight during puberty . The aims of this study were to compare objective ly assessed physical activity and energy intake in girls with Type 1 diabetes with those in healthy age-matched controls . METHODS This prospect i ve cohort study comprised 26 girls with Type 1 diabetes and 49 control girls . The mean age of the diabetic girls was 15.7 + /- 2.1 years and that of the control girls 15.8 + /- 2.1 years . In the diabetic group , mean haemoglobin A1c was 7.6 + /- 1.4 % and daily insulin dosage was 1.1 + /- 0.3 U/kg . Physical activity was measured during 7 consecutive days with a uniaxial accelerometer , and energy intake was assessed concurrently with a 7-day food diary . RESULTS There was a tendency towards lower total amount of physical activity in the diabetes group but the difference between the study groups did not reach statistical significance ( Diabetes : 464 + /- 123 counts/min/day ; CONTROLS 523 + /- 138 counts/min/day ; P = 0.06 ) . No difference was found between the groups regarding total energy intake ( Diabetes : 8.5 + /- 1.8 MJ/day ; CONTROLS 8.4 + /- 2.6 MJ/day ) . The carbohydrate intake was lower and the protein and fibre intakes were higher in girls with diabetes . No association was observed between physical activity , energy intake and HbA1c . CONCLUSIONS In this prospect i ve cohort study , we found a tendency towards lower physical activity but no differences in energy intake between girls with Type 1 diabetes and age-matched controls . Larger studies are needed to further explore the importance of the total amount of physical activity for excessive weight gain in adolescent girls with Type 1 diabetes OBJECTIVE To compare objective ly assessed physical activity levels , between asthmatic children and non-asthmatic controls . METHODS From a r and om community sample of 794 children aged 8 - 9 years , in a case-control design , 104 children with ever doctor 's diagnosis of asthma and 99 non-asthmatic controls were recruited and had assessment of physical activity with biaxial accelerometers for 7 days . RESULTS Children with active ( also reporting at least one episode of wheezing in the last 12 months ) and inactive ( no wheezing in past 12 months ) asthma appeared to have similar physical activity and sedentary activity levels compared to non-asthmatic children . However , girls with active asthma had significantly lower moderate-to-vigorous physical activity ( MVPA ) levels than their peers with adjusted geometric mean ratio of 0.59 ( 95 % CI : 0.369 , 0.929 , P-value = 0.024 ) . No difference in physical and sedentary activity levels was observed between asthmatic and non-asthmatic boys . The difference between genders in the comparison of MVPA levels in asthmatics and controls was statistically significant ( P-value of likelihood ratio test [ LRT ] for effect modification by gender = 0.034 ) . CONCLUSIONS Unlike boys , girls with active asthma appear to be less active than their healthy peers , and this gender difference might explain the inconsistent evidence from previous reports on physical activity levels in asthmatic children . Further studies are needed to confirm the gender interaction in the childhood asthma-physical activity relation and the implication s on current guidelines for physical exercise prescriptions in asthmatic children PURPOSE We established accelerometer count ranges for the Computer Science and Applications , Inc. ( CSA ) activity monitor corresponding to commonly employed MET categories . METHODS Data were obtained from 50 adults ( 25 males , 25 females ) during treadmill exercise at three different speeds ( 4.8 , 6.4 , and 9.7 km x h(-1 ) ) . RESULTS Activity counts and steady-state oxygen consumption were highly correlated ( r = 0.88 ) , and count ranges corresponding to light , moderate , hard , and very hard intensity levels were < or = 1951 , 1952 - 5724 , 5725 - 9498 , > or = 9499 cnts x min(-1 ) , respectively . A model to predict energy expenditure from activity counts and body mass was developed using data from a r and om sample of 35 subjects ( r2 = 0.82 , SEE = 1.40 kcal x min(-1 ) ) . Cross validation with data from the remaining 15 subjects revealed no significant differences between actual and predicted energy expenditure at any treadmill speed ( SEE = 0.50 - 1.40 kcal x min(-1 ) ) . CONCLUSIONS These data provide a template on which patterns of activity can be classified into intensity levels using the CSA accelerometer BACKGROUND Patients with type 1 diabetes mellitus ( T1DM ) may experience poor muscle health as a result of chronic hyperglycemia . Despite this , muscle function in children with T1DM with good or poor glycemic control has yet to be examined in detail . OBJECTIVE To assess differences in muscle-related fitness variables in children with T1DM with good glycemic control ( T1DM-G ) , as well as those with poor glycemic control ( T1DM-P ) , and non-diabetic , healthy controls . SUBJECTS Eight children with T1DM-G [ glycosylated hemoglobin ( HbA1c ) ≤ 7.5 % for 9 months ] , eight children with T1DM-P ( HbA1c ≥ 9.0 % for 9 months ) , and eight healthy controls completed one exercise session . METHODS Anaerobic and aerobic muscle functions were assessed with a maximal isometric grip strength test , a Wingate test , and an incremental continuous cycling test until exhaustion . Blood sample s were collected at rest to determine HbA1c at the time of testing . Physical activity was monitored over 7 d using accelerometry . RESULTS Children with T1DM-P displayed lower peak oxygen consumption ( VO2peak ) values ( mL/kg/min ) compared to healthy controls ( T1DM-P : 33.2 ± 5.6 , controls : 43.5 ± 6.3 , p < 0.01 ) , while T1DM-G ( 43.5 ± 6.3 ) had values similar to controls and T1DM-P. There was a negative relationship between VO2peak and HbA1c% ( r = -0.54 , p < 0.01 ) . All groups were similar in all other fitness variables . There were no group differences in physical activity variables . CONCLUSION Children with T1DM-G did not display signs of impaired muscle function , while children with T1DM-P have signs of altered aerobic muscle capacity OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

MVPA in children/adolescents with chronic disease appear to be well below guideline recommendations , although comparable with activity levels of their healthy peers except for children with malignancies .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE To determine geographical variation in the prevalence of rheumatoid arthritis ( RA ) and spondyloarthropathies ( SpA ) in France . METHODS The survey sample was drawn from 7 areas of France . Households were r and omly selected using the national telephone directory , and an individual within each household was r and omly chosen by the next-birthday method . All cases of suspected RA and SpA were confirmed by the patient 's rheumatologist or by clinical examination . St and ardized estimates of prevalence were compared between regions and groups of regions . RESULTS In total 15,219 anonymous telephone numbers were selected . An average response rate of 64 % led to a total of 9395 respondents included in the study . The highest regional rates of RA were observed in the south ( range 0.59 - 0.66 % ) , and the lowest in the north ( range 0.14 - 0.24 % ) , with a national rate of 0.31 % ( 95 % CI 0.18 - 0.48 % ) . Regional heterogeneity was observed for SpA , with the highest rates in Bretagne ( 0.47 % ) and the Sud-Est ( 0.53 % ) and a national rate of 0.30 % ( 95 % CI 0.17 - 0.46 % ) . CONCLUSION This study is the largest of its kind conducted in France . It shows inter-regional variations , mainly in RA , with a higher prevalence in the south of the country . The many potential reasons for the heterogeneity observed , including genetic and environmental factors , warrant further research BACKGROUND It is 40 yr since the last age- and sex-specific estimates of the prevalence of rheumatoid arthritis ( RA ) for the UK were published . Since then the classification criteria for RA have been revised and there has been evidence of a fall in the incidence of RA , especially in women . OBJECTIVES To estimate the age- and sex-specific point prevalence of RA ( defined as fulfilment of a modification of the 1987 ACR classification criteria for RA on the day of assessment ) . The estimate was made in the primary care setting in Norfolk , UK . METHODS A stratified r and om sample was drawn from seven age and gender b and s. The 7050 individuals selected were mailed a screening question naire . Positive responders were invited to attend for a clinical examination . The sample was matched against the names in the Norfolk Arthritis Register ( NOAR ) , a register of incident cases of inflammatory polyarthritis which has been in existence since 1990 . RESULTS The overall response rate was 82 % . Sixty-six cases of RA were identified . Extrapolated to the population of the UK , the overall minimum prevalence of RA is 1.16 % in women and 0.44 % in men . A number of incident cases of RA previously notified to NOAR were not identified as cases in the survey because they had entered into treatment-induced remission . In addition , some cases who failed to attend for examination had significant disability . These prevalence figures are therefore an underestimate . CONCLUSIONS The prevalence of RA in women , but not in men , in the UK may have fallen since the 1950s Background —Rheumatoid arthritis may be associated with an increased risk of cardiovascular disease . We compared the incidence rates of myocardial infa rct ion and stroke in subjects with and without rheumatoid arthritis . Methods and Results —A prospect i ve cohort study was conducted among the 114 342 women participating in the Nurses ’ Health Study who were free of cardiovascular disease and rheumatoid arthritis at baseline in 1976 . All self-reported cases of rheumatoid arthritis were confirmed by medical record review . Fatal and nonfatal myocardial infa rct ions and strokes were similarly confirmed . Multivariate pooled logistic regression was used to adjust for potential cardiovascular risk factors . Five hundred twenty-seven incident cases of rheumatoid arthritis and 3622 myocardial infa rct ions and strokes were confirmed during 2.4 million person-years of follow-up . The adjusted relative risk of myocardial infa rct ion in women with rheumatoid arthritis compared with those without was 2.0 ( 95 % confidence interval [ CI ] , 1.23 to 3.29 ) . For stroke , the adjusted relative risk was 1.48 ( 95 % CI , 0.70 to 3.12 ) . Women who had rheumatoid arthritis for at least 10 years had a risk for myocardial infa rct ion of 3.10 ( 95 % CI , 1.64 to 5.87 ) . Conclusion —In this large prospect i ve cohort of women , participants with rheumatoid arthritis had a significantly increased risk of myocardial infa rct ion but not stroke compared with those without rheumatoid arthritis . If these data are confirmed , aggressive coronary heart disease prevention strategies should be tested for persons with rheumatoid arthritis OBJECTIVES To investigate the maintenance of physical activity 12 months after two 1-year Internet-based physical activity interventions in patients with RA . METHODS This follow-up study was a r and omized comparison of an Internet-based individualized training ( IT ) and a general training ( GT ) programme in sedentary RA patients . Outcome measures included physical activity ( meeting public health recommendations for moderate physical activity , i.e. 30 min for at least 5 days/week ; or vigorous physical activity , i.e. 20 min for at least 3 days/week ) , functional ability and quality of life ( QoL ) . RESULTS Of the 152 RA patients who completed the initial study , 110 ( 72 % ) were available at follow-up . At 24 months , the proportions of patients meeting public health recommendations for moderate intensity physical activity were significantly higher compared with baseline in both the IT and GT groups ( 19 and 24 % , respectively , P < 0.05 ) , whereas the proportions of patients meeting the recommendation for vigorous activity was only significantly higher compared with baseline in the IT group ( P < 0.05 ) but not in the GT group . There were no differences between the IT and GT groups concerning proportions of patients meeting moderate or vigorous physical activity recommendations at 24 months . Apart from a significantly higher RAQoL score in the IT group at 24 months compared with baseline , there were no significant differences within or between the programmes regarding functional ability or QoL. CONCLUSION In RA patients , the effectiveness of both an individualized and a general 1-year Internet-based physical activity programme is sustained with respect to moderate intensity physical activity up to 12 months after the interventions OBJECTIVE To evaluate the impact of a 2-year program of strength training on muscle strength , bone mineral density ( BMD ) , physical function , joint damage , and disease activity in patients with recent-onset ( < 2 years ) rheumatoid arthritis ( RA ) . METHODS In this prospect i ve trial , 70 RA patients were r and omly assigned to perform either strength training ( all major muscle groups of the lower and upper extremities and trunk , with loads of 50 - 70 % of repetition maximum ) or range of motion exercises ( without resistance ) twice a week ; all were encouraged to engage in recreational activities 2 - 3 times a week . All patients completed training diaries ( evaluated bi-monthly ) and were examined at 6-month intervals . All were treated with medications to achieve disease remission . Maximum strength of the knee extensors , trunk flexors and extensors , and grip strength was measured with dynamometers . BMD was measured at the femoral neck and lumbar spine by dual x-ray densitometry . Disease activity was determined by the Disease Activity Score , the extent of joint damage by the Larsen score , and functional capacity by the Health Assessment Question naire ( HAQ ) ; walking speed was also measured . RESULTS Sixty-two patients ( 31 per group ) completed the study . Strength training compliance averaged 1.4 - 1.5 times/week . The maximum strength of all muscle groups examined increased significantly ( 19 - 59 % ) in the strength-training group , with statistically significant improvements in clinical disease activity parameters , HAQ scores , and walking speed . While muscle strength , disease activity parameters , and physical function also improved significantly in the control group , the changes were not as great as those in the strength-training group . BMD in the femoral neck and spine increased by a mean + /- SD of 0.51 + /- 1.64 % and by 1.17 + /- 5.34 % , respectively , in the strength-training group , but decreased by 0.70 + /- 2.25 % and 0.91 + /- 4.07 % in the controls . Femoral neck BMD in the 17 patients with high initial disease activity ( and subsequent use of oral glucocorticoids ) remained constantly at a statistically significantly lower level than that in the other 45 patients . CONCLUSION Regular dynamic strength training combined with endurance-type physical activities improves muscle strength and physical function , but not BMD , in patients with early RA , without detrimental effects on disease activity OBJECTIVES Cardiovascular disease ( CVD ) is responsible for 50 % of the excess mortality for patients with RA . This study aim ed to evaluate a novel 8-week cognitive behavioural patient education intervention design ed to effect behavioural change with regard to modifiable CVD risk factors in people with RA . METHODS This was a non-blinded r and omized controlled trial with a delayed intervention arm . Participants were r and omly assigned to receive the cognitive behavioural education intervention or a control information leaflet at a ratio of 1:1 . The primary outcome measure was patient 's knowledge of CVD in RA ; secondary measures were psychological measures relating to effecting behaviour change , actual behaviour changes and clinical risk factors . Data were collected at baseline , 2 and 6 months . RESULTS A total of 110 participants consented ( 52 in the intervention group and 58 in the control group ) to participate in the study . At 6 months , those in the intervention group had significantly higher knowledge scores ( P < 0.001 ) ; improved behavioural intentions to increase exercise ( P < 0.001 ) , eat a low-fat diet ( P = 0.01 ) and lose weight ( P = 0.06 ) ; and lower mean diastolic blood pressure by 3.7 mmHg , whereas the control group 's mean diastolic blood pressure increased by 0.8 mmHg . There was no difference between the groups on actual behaviours . CONCLUSIONS Patient education has a significant role to play in CVD risk factor modification for patients with RA , and the detailed development of this programme probably contributed to its successful results . It is disappointing that behaviours , as we measured them , did not change . The challenge , as always , is how to translate behavioural intentions into action . Larger studies , powered specifically to look at behavioural changes , are required . Trial registration . National Institute for Health Research , UKCRN 4566 The purpose of this study is to evaluate the effects of targeting both the motivation and action phases of behaviour change in a 5-week intervention to increase physical activity ( PA ) among patients with rheumatoid arthritis ( RA ) not meeting current PA recommendations . In a r and omised controlled trial , a control group — which received a group-based patient education session led by a physical therapist — was compared to a treatment group which received the education session plus a motivational interview from a physical therapist and two self-regulation coaching sessions from a rheumatology nurse . Outcomes included leisure-time PA , days per week with at least 30 min of moderate-intensity PA , self-efficacy and autonomous motivation ( cognitions which predict PA initiation and maintenance ) , disease activity , functional status , depressive symptoms and fatigue . Effects were assessed using mixed models repeated measures . Of the 78 patients r and omised , 76 and 67 completed the post-treatment and follow-up assessment s , respectively . Significant treatment effects were found for leisure-time PA ( p = 0.022 ) , active days/week ( p = 0.016 ) , self-efficacy ( p = 0.008 ) and autonomous motivation ( p = 0.001 ) . At post-treatment and 6-months follow-up , significantly more treated patients than controls met current PA recommendations . No significant effects were found for disease activity , functional status , depressive symptoms or fatigue . Combining motivation- and action-focused intervention approaches improved PA-related cognitions and led to improved uptake and maintenance of leisure-time PA . However , further research is necessary to identify ways of helping patients with RA transition to— and maintain — more intensive forms of PA which are more likely to improve disease activity and functional status OBJECTIVE To examine the reliability , validity , and responsiveness of a continuous ambulatory activity monitor in patients with rheumatoid arthritis ( RA ) . METHODS Forty-one patients with RA , participating in a r and omized controlled trial examining the effect of an intensive exercise program , were assessed by means of the Dynaport ADL ( activities of daily living ) monitor ( AM ) . The time spent on activities ( locomotion , st and ing , and active sitting ) during 24 hours and the intensity of trunk movement during these activities were recorded . To determine test-retest reliability 20 patients were reassessed with the AM one week after the first assessment . Construct validity of the AM was determined by comparing the AM results with physical fitness measures ( muscle strength , endurance , joint mobility ) , disease activity , and functional status . As well , 37 patients were assessed 18 months after the first assessment to determine responsiveness . RESULTS All AM measurements showed satisfactory test-retest reliability ( ICC 0.63 - 0.76 ) . AM measures were significantly associated with physical fitness , functional status , and disease activity , indicating construct validity of the OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

There has been varied success of behaviour change interventions in promoting physical activity behaviour in people who have RA .

MS2_fixed_5_shot258

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Autologous bone graft is the so-called gold st and ard for reconstruction of bone defects and nonunions . The most frequent complication is donor site pain . The iliac crest is a common source for autologous bone graft . The purpose of this study was to determine whether a continuous infusion of 0.5 % bupivacaine into the iliac crest harvest site provides pain relief that is superior to the relief provided by systemic narcotic pain medication alone in patients undergoing reconstructive orthopaedic trauma procedures . METHODS A prospect i ve , double-blind r and omized study of patients over eighteen years of age who were undergoing harvesting of iliac crest bone graft was conducted . The patients were r and omized to the treatment arm ( bupivacaine infusion pump ) or the placebo arm . Postoperatively , all study patients received morphine sulfate with use of a patient-controlled analgesia pump . The patients recorded the pain at the donor and recipient sites with use of a scale ranging from 0 to 10 . The use of systemic narcotic medication was recorded . Independent- sample s t tests were used to assess differences in perceived pain relief between the treatment and control groups at zero , eight , sixteen , twenty-four , thirty-two , forty , and forty-eight hours after surgery . Pain was also assessed at two and six weeks postoperatively . RESULTS Sixty patients were enrolled . Across all data points , except pain at the recipient site at twenty-four hours , no significant differences in the perception of pain were found between the bupivacaine group and the placebo group . On the average , patients in the treatment group reported more pain than those in the control group . No significant difference was found between the two groups with regard to the amount of narcotic medication used . CONCLUSIONS No difference in perceived pain was found between the groups . The results of this small , unstratified study indicate that continuous infusion of bupivacaine at iliac crest bone-graft sites during the postoperative period is not an effective pain-control measure in hospitalized patients receiving systemic narcotic medication In r and omized controlled trials , no single definition of response is ideal for all purpose s. We propose a method to present in a simple fashion the likelihood of response over a full range of response levels , which will facilitate a better underst and ing of clinical trial data . We present the technique called the cumulative proportion of responders analysis ( CPRA ) and its application to four pain clinical trial data sets as examples . The CPRA can be used to present the proportion of responders over the entire range of possible cut-off points as a graph . This allows the reader to compare treatment groups at any responder level that is valid for their patient population . Whether as a primary or secondary approach to a clinical trial of pain therapy , the display of data in a CPRA format may be useful in the underst and ing of results and applicability to patient care Although nonsteroidal antiinflammatory drugs ( NSAIDs ) improve postoperative pain relief after cesarean delivery , they carry potential side effects ( e.g. , bleeding ) . Perioperative cyclooxygenase (COX)-2 inhibitors show similar analgesic efficacy to nonsteroidal antiinflammatory drugs in many surgical models but have not been studied after cesarean delivery . We design ed this r and omized double-blind study to determine the analgesic efficacy and opioid-sparing effects of valdecoxib after cesarean delivery . Healthy patients undergoing elective cesarean delivery under spinal anesthesia were r and omized to receive oral valdecoxib 20 mg or placebo every 12 h for 72 h postoperatively . As a result of cyclooxygenase-2 inhibitors safety concerns that became apparent during this study , the study was terminated early after evaluating 48 patients . We found no differences in total analgesic consumption between the valdecoxib and placebo groups ( 121 ± 70 versus 143 ± 77 morphine mg-equivalents , respectively ; P = 0.26 ) . Pain at rest and during activity were similar between the groups despite adequate post hoc power to have detected a clinical ly significant difference . There were also no differences in IV morphine requirements , time to first analgesic request , patient satisfaction , side effects , breast-feeding success , or functional activity . Postoperative pain was generally well controlled . Adding valdecoxib after cesarean delivery under spinal anesthesia with intrathecal morphine is not supported at this time Background : Central pain in multiple sclerosis ( MS ) is common and often refractory to treatment . Methods : We conducted a single-center , 5-week ( 1-week run-in , 4-week treatment ) , r and omized , double-blind , placebo-controlled , parallel-group trial in 66 patients with MS and central pain states ( 59 dysesthetic , seven painful spasms ) of a whole-plant cannabis-based medicine ( CBM ) , containing delta-9-tetrahydrocannabinol : cannabidiol ( THC : CBD ) delivered via an oromucosal spray , as adjunctive analgesic treatment . Each spray delivered 2.7 mg of THC and 2.5 of CBD , and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours . Results : Sixty-four patients ( 97 % ) completed the trial , 34 received CBM . In week 4 , the mean number of daily sprays taken of CBM ( n = 32 ) was 9.6 ( range 2 to 25 , SD = 6.0 ) and of placebo ( n = 31 ) was 19.1 ( range 1 to 47 , SD = 12.9 ) . Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale . CBM was superior to placebo in reducing the mean intensity of pain ( CBM mean change −2.7 , 95 % CI : −3.4 to −2.0 , placebo –1.4 95 % CI : −2.0 to −0.8 , comparison between groups , p = 0.005 ) and sleep disturbance ( CBM mean change –2.5 , 95 % CI : −3.4 to −1.7 , placebo –0.8 , 95 % CI : −1.5 to −0.1 , comparison between groups , p = 0.003 ) . CBM was generally well tolerated , although more patients on CBM than placebo reported dizziness , dry mouth , and somnolence . Cognitive side effects were limited to long-term memory storage . Conclusions : Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Background : Ketamine potentiates intravenous or epidural morphine analgesia . The authors hypothesized that very-low-dose ketamine infusion reduces acute and long-term postthoracotomy pain . Methods : Forty-nine patients scheduled to undergo open thoracotomy were r and omly assigned to receive one of two anesthesia regimens : continuous epidural infusion of ropivacaine and morphine , along with intravenous infusion of ketamine ( 0.05 mg · kg−1 · h−1 [ approximately 3 mg/h ] , ketamine group , n = 24 ) or placebo ( saline , control group , n = 25 ) . Epidural analgesia was continued for 2 days after surgery , and infusion of ketamine or placebo was continued for 3 days . Pain was assessed at 6 , 12 , 24 , and 48 h after surgery . Patients were asked about their pain , abnormal sensation on the wound , and inconvenience in daily life at 7 days and 1 , 3 , and 6 months after surgery . Results : The visual analog scale scores for pain at rest and on coughing 24 and 48 h after thoracotomy were lower in the ketamine group than in the control group ( pain at rest , 9 ± 11 vs. 25 ± 20 and 9 ± 11 vs. 18 ± 13 ; pain on coughing , 26 ± 16 vs. 50 ± 17 and 30 ± 18 vs. 43 ± 18 , mean ± SD ; P = 0.002 and P = 0.01 , P < 0.0001 and P = 0.02 , respectively ) . The numerical rating scale scores for baseline pain 1 and 3 months after thoracotomy were significantly lower in the ketamine group ( 0.5 [ 0–4 ] vs. 2 [ 0–5 ] and 0 [ 0–5 ] vs. 1.5 [ 0–6 ] , median [ range ] , respectively ; P = 0.02 ) . Three months after surgery , a higher number of control patients were taking pain medication ( 2 vs. 9 ; P = 0.03 ) . Conclusions : Very-low-dose ketamine ( 0.05 mg · kg−1 · h−1 ) potentiated morphine-ropivacaine analgesia and reduced postthoracotomy pain Although clonidine has been shown to increase the duration of local anesthetic action and prolong postoperative analgesia when included in single-injection nerve blocks , the only controlled investigation of the efficacy of this practice to improve analgesia for continuous perineural local anesthetic infusion failed to discern any clinical ly relevant benefits . For this study , we used a larger dose of clonidine in an attempt to improve analgesia . Patients ( n = 20 ) undergoing moderately painful orthopedic surgery of the shoulder received an interscalene brachial plexus block ( 40 mL of mepivacaine 1.5 % , epinephrine 2.5 & mgr;g/mL , and clonidine 50 & mgr;g ) and a perineural catheter before surgery . After surgery , ropivacaine 0.2 % or ropivacaine 0.2 % plus clonidine 2 & mgr;g/mL was delivered via the catheter for 3 days ( basal rate , 5 mL/h ; patient-controlled bolus , 5 mL ; lockout , 1 h ) . Investigators and patients were blind to r and om group assignment . The primary outcome variable was design ated as the most intense pain during the day after surgery . Secondary end-points included additional pain scores , patient-controlled bolus doses , oral analgesic use , sleep quality , and catheter- or infusion-related complications . There were no statistically significant differences between groups for any of the variables investigated . We conclude that adding clonidine 2 & mgr;g/mL to a ropivacaine interscalene perineural infusion does not decrease breakthrough pain intensity the day after surgery . For the additional end-points , our negative findings are only suggestive of a lack of effect and require further study for verification Background : Neuropathic pain in spinal cord injury is a common challenging therapeutic condition . The current study examines the analgesic effect of the sodium channel blocker lidocaine on neuropathic pain in patients with spinal cord injury and the predictive role of concomitant evoked pain on pain relief with lidocaine . Methods : Twenty-four spinal cord injury patients with neuropathic pain at or below the level of injury were r and omized and completed a double-blind crossover trial of 5 mg/kg lidocaine and placebo infused over 30 min . Twelve patients reported evoked pain , and 12 patients had no evoked pain . Spontaneous and evoked pains were assessed using a visual analog scale and quantitative sensory testing . Results : Lidocaine significantly reduced spontaneous pain in all patients ( P < 0.01 ) and in each of the two groups with ( P < 0.01 ) and without ( P = 0.048 ) evoked pain , with no difference in number of responders ( pain reduction ≥ 33 % ) between the patients with ( n = 6 ) and without ( n = 5 ) evoked pain . Lidocaine significantly relieved both at-level and below-level neuropathic pain and decreased brush-evoked dysesthesia but not cold allodynia , pinprick hyperalgesia , or pain evoked by repetitive pinprick . Conclusions : Lidocaine reduced neuropathic pain at and below the level of injury irrespective of the presence or absence of evoked pain . Results are consistent with a central -acting effect of sodium channel blockers acting on neuronal hyperexcitability . Agents ( such as anticonvulsants or antiarrhythmics ) with sodium channel – blocking properties may be a treatment option for spinal cord injury pain BACKGROUND : Gabapentin , an oral non-opioid analgesic , has been used to decrease pain after a variety of surgical procedures . We hypothesized that premedication with gabapentin would minimize tourniquet-related pain in patients receiving IV regional anesthesia ( IVRA ) . METHODS : Patients undergoing elective h and surg OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The aim of this study of the present experiment was to study the marginal periimplant tissues at intentionally non-submerged ( 1-stage implants ) and initially submerged and subsequently exposed implants ( 2-stage implants ) . 5 beagle dogs , about 1-year-old , were used , 3 months after the extraction of the m and ibular premolars , fixtures of the Astra Tech Implants Dental System , the Brånemark System and the Bonefit -- ITI system were installed . In each m and ibular quadrant , 1 fixture of each implant system was installed in a r and omised order . The installation procedure followed the recommendations given in the manuals for each system . Thus , following installation , the bone crest coincided with the fixture margin of the Astra Tech Implants Dental System and the Brånemark System , whereas the border between the plasma sprayed and the machined surface of the Bonefit-ITI implant system was positioned at the level of the bone crest . Following a healing period of 3 months , abutment connection was carried out in the 2-stage systems ( the Astra Tech Implants Dental System and the Brånemark system ) . A 6-month period of plaque control was initiated . The animals were sacrificed and biopsies representing each important region dissected . The tissue sample s were prepared for light microscopy and exposed to histometric and morphometric measurements . The mucosal barrier which formed to the titanium surface following 1-stage and 2-stage implant installations comprised an epithelial and a connective tissue component , which for that 3 systems studied , had similar dimensions and composition . The amount of lamellar bone contained in the periimplant region close to the fixture part of the 3-implant systems was almost identical . It is suggested that correctly performed implant installation may ensure proper conditions for both and hard tissue healing , and that the geometry of the titanium implant seems to be of limited importance This paper describes the 5-year results of a comparative study between Astra Tech and Brånemark system implants . The aim was to compare the systems primarily with regard to bone level changes , and also with regard to other variables of interest . Sixty-six patients with edentulous jaws were included in the study . R and omisation schedules were used to allocate the patients to the two implant systems . 184 Astra Tech implants with a titanium-blasted surface and 187 Brånemark implants with a turned surface were used . The implants were inserted with a two-stage technique and the insertion followed the routines for the respective implant system . All patients were provided with full-arch fixed bridges . All patients were followed up with clinical and radiographic examinations from fixture insertion to the 5-year follow-up . The total mean bone level change in the upper jaw between fixture insertion and the 5-year examination was -1.74+/-0.45 mm at the Astra implants and -1.98+/-0.21 at the Brånemark implants . The corresponding values for the lower jaw were -1.06+/-0.19 for Astra and -1.38+/-0.17 for Brånemark . The major postoperative changes of the marginal bone level took place between fixture insertion and baseline . During this period , there was also a different pattern of bone remodelling between the implant systems . Between baseline ( prosthesis connection ) and the 5-year examination , the marginal bone level changes were small , with no difference between the implant systems . The implant stability was examined with the supraconstructions removed . At the 5-year examination , the survival rate for Astra Tech implants was 98.4 % and for the Brånemark implants it was 94.6 % . The difference was not statistically significant Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series , presents an overview of research methodology most commonly used in the dental literature The purpose of the investigation was to gain more underst and ing of marginal inflammatory reactions around osseointegrated implants . The significance of the lacking periodontal ligament of implants was examined in the initial breakdown phase of supporting tissues by comparing clinical and radiographic manifestations of ligature-induced marginal inflammation related to osseointegrated implants with those around ankylosed and normal control teeth in 8 cynomolgus monkeys ( Macaca fascicularis ) . Bilateral extraction of the first and second m and ibular molars was carried out initially , and 12 weeks later 2 implants were placed in each side . Ankylosis of the second maxillary molars was established by extracting and replanting the teeth after a drying period . When ankylosis and osseointegration were established , ligature-induced marginal inflammation was induced in the right or left side at r and om around implants , ankylosed teeth and normal control teeth ( second maxillary premolar ) for 7 weeks . Although the clinical manifestations as expressed by plaque score , gingival score , probing depth and attachment loss were quite similar , the radiographic features differed . Significant loss of bone height was limited to implants and ankylosed teeth and did not occur in relation to normal control teeth . Furthermore , the bone loss around implants was significantly greater than the loss around ankylosed teeth . Bone loss was limited to implants and ankylosed teeth ; the study therefore suggests that the presence of marginal inflammation around implants and ankylosed teeth may have more serious implication s than does marginal inflammation around teeth with a periodontal ligament . However , variations in microbiota and susceptibility of different jaw positions to periodontal breakdown may influence the results of this study The aim of the present experiment was to study the location and composition of plaque associated lesions in the mucosa adjacent to implant systems that differed with respect to both geometry and dimension . At day 0 extraction of the m and ibular premolars were performed . After a healing period of 3 months , fixtures of the Astra Tech Implants , Dental System , the Brånemark System and the ITI Dental Implant System were installed . In each m and ibular quadrant 1 fixture of each implant system was installed in a r and omized order . A period of plaque control was initiated . Following another 3 months of healing , abutment connection was performed in the 2-stage systems ( the Astra Tech Implants , Dental System and the Brånemark System ) . After 1 month , the plaque control measures were ab and oned and plaque formation was allowed for 5 months . The animals were killed and biopsies representing each implant region obtained . The tissue sample s were prepared for light microscopy and exposed to histometric and morphometric measurements . The present study demonstrated that plaque formation result ed in the establishment of an ICT lateral to a pocket epithelium . The lesion was found to be similar regarding extension and composition in the peri-implant mucosa of the 3 implant systems tested . The vertical extension of the ICT was in all systems within 91 - 99 % of the vertical dimension of the junctional epithelium . The marginal bone level , measured from the abutment/fixture ( PS ) border , did not differ between the three systems This investigation is the result of a multicenter research project between the Catholic University of Leuven and the University of Madrid with the purpose of study ing histometrically and ultrastructurally periimplant marginal tissue reactions in mendium-term Brånemark implants . 12 patients were selected and distributed according to predefined clinical and radiological parameters into a periimplant infection group ( A ) and a non-periimplant infection group ( B ) . Biopsies were taken from these patients and analyzed by means of microscopy ( LM ) , histometry ( HM ) and transmission electron microscopy ( TEM ) . With LM group A showed pathological features consistent with an advanced gingivitis lesion , while group B showed signs of healthy gingiva in the connective tissue and vauolae formation in the epithelium . With HM , group A showed significantly higher transmigration of inflammatory cells in the epithelium than group B. In the connective tissue , group A showed a higher % of inflammatory infiltrate with significantly higher numbers of plasma cells and mononuclear cells than group B. With TEM , group A showed an ultrastructural picture consistent with plaque-induced periodontitis , while group B showed a rather healthy connective tissue and vacuolae formation in the epithelium . These results suggest that supracrestal marginal tissues around osseointegrated implants react to plaque bacteria similarly to periodontal tissues around teeth by chronic inflammation BACKGROUND Progressive peri-implant bone losses , which are accompanied by inflammatory lesions in the soft tissues , are referred to as peri-implantitis . The aim of this study was to compare the effects of photodynamic therapy ( PDT ) and conventional technique on microbial reduction in ligature-induced peri-implantitis in dogs . METHODS Eighteen third premolars from nine Labrador retriever dogs were extracted and the implants were submerged . After osseointegration , peri-implantitis was induced . After 4 months , ligature was removed and natural bacterial plaque was allowed to form for another 4 months . The animals were then r and omly divided into two groups . In the conventional group , they were treated using mucoperiosteal flaps for scaling the implant surface and chlorexidine ( conventional ) irrigation . In the PDT group , only mucoperiosteal scaling was carried out before photodynamic therapy . Inside the peri-implant pocket , a paste-based azulene photosensitizer was placed and then a GaAlAs low-power laser ( lambda=660 nm , P=40 mW , E=7.2 J for 3 minutes ) was used . Microbiological sample s were obtained before and immediately after treatment . Before treatment , one implant was removed and analyzed by scanning electron microscopy to vali date the contamination . RESULTS The results of this study showed that Prevotella sp. , Fusobacterium sp. , and S. Beta-haemolyticus were significantly reduced for both groups . After treatment , no significant differences were observed between the groups . CONCLUSION These findings suggest that photodynamic therapy is a non-invasive method that could be used to reduce microorganisms in peri-implantitis After 3 years , 82 of the original 92 patients remain in this prospect i ve multicenter study of single-tooth restorations supported by Brånemark implants . Since the 1-year follow-up , 6 more patients have been lost , but no additional implants have failed in those patients examined at the 3-year follow-up visit . After 1 year of function , 97.2 % of the implants survived in 88 patients , and between the 1- and 3-year follow-up , 100 % survived in 82 patients , giving a 3-year cumulative success rate of 97.2 % . No changes were observed in the status of gingivitis , pocket depth , periodontal pocket bleeding index , and tooth and implant mobility from those reported after 1 year . Marginal bone resorption remained at a low level -- less than 0.1 mm annually during the second and third years . Abutment screw loosening continued , but at a significantly reduced rate from that reported after 1 year . When used , gold rather than titanium abutment screws remained secure BACKGROUND Today , implants are placed using both non-submerged and submerged approaches , and in 1- and 2-piece configurations . Previous work has demonstrated that peri-implant crestal bone reactions differ radiographically under such conditions and are dependent on a rough/smooth implant border in 1-piece implants and on the location of the interface ( microgap ) between the implant and abutment/restoration in 2-piece configurations . The purpose of this investigation was to examine histometrically crestal bone changes around unloaded non-submerged and submerged 1- and 2-piece titanium implants in a side-by-side comparison . METHODS A total of 59 titanium implants were r and omly placed in edentulous m and ibular areas of 5 foxhounds , forming 6 different implant subgroups ( types A-F ) . In general , all implants had a relatively smooth , machined coronal portion as well as a rough , s and blasted and acid-etched ( SLA ) apical portion . Implant types A-C were placed in a non-submerged approach , while types D-F were inserted in a submerged fashion . Type A and B implants were 1-piece implants with the rough/smooth border ( r/s ) at the alveolar crest ( type A ) or 1.0 mm below ( type B ) . Type C implants had an abutment placed at the time of surgery with the interface located at the bone crest level . In the submerged group , types D-F , the interface was located either at the bone crest level ( type D ) , 1 mm above ( type E ) , or 1 mm below ( type F ) . Three months after implant placement , abutment connection was performed in the submerged implant groups . At 6 months , all animals were sacrificed . Non-decalcified histology was analyzed by evaluating peri-implant crestal bone levels . RESULTS For types A and B , mean crestal bone levels were located adjacent ( within 0.20 mm ) to the rough/smooth border ( r/s ) . For type C implants , the mean distance ( + /- st and ard deviation ) between the interface and the crestal bone level was 1.68 mm ( + /- 0.19 mm ) with an r/s border to first bone-to-implant contact ( fB OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Evidence analysis shows that the present knowledge about biologic width around implants is mainly derived from animal studies and that clinical controlled human studies are insufficient

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: There is increased global recognition of attention deficit hyperactivity disorder ( ADHD ) as a serious medical condition with long-term consequences . Although originally conceived of as a childhood disorder , ADHD is being increasingly recognized in adults . Individual geographic regions may have specific interests and objectives for the study of ADHD . A systematic review of long-term outcomes ( LTOs ) in ADHD was conducted to evaluate research on ADHD LTOs on a global scale . Studies that were at least 2 years in duration were examined . A total of 351 studies were identified in the final analysis . We identified nine outcomes of interest and classified studies by specific geographical regions , age groups studied and study design by region and over time . Published studies of LTOs in ADHD have increased in all geographical regions over the past three decades , with a peak number of 42 publications in 2008 . This rise in publications on ADHD LTOs may reflect a rise in global interest and recognition of consequences and impairment associated with ADHD . Although many world regions have published on ADHD LTOs , the majority of studies have emerged from the US and Canada , followed by Europe . While investigators in the US and Canada were predominantly interested in drug addiction as a LTO , European research ers were more interested in antisocial behavior , and Eastern Asian investigators focused on both of these LTOs as well as self-esteem . Geographical differences in the focus of ADHD LTO studies may reflect regional variations in cultural values . Proportionally fewer prospect i ve longitudinal studies and proportionally more retrospective and cross-sectional studies have been published in more recent decades . Finally , more studies focusing on ADHD in adolescents and adults have been conducted in recent years , and particularly adolescents in Eastern Asia . These changes in basic study design may reflect an increase in the recognition that ADHD is a lifetime chronic disorder . This systematic review analysis of publication trends in ADHD LTOs reflects geographically based interests that change over time OBJECTIVE In the intent-to-treat analysis of the Multimodal Treatment Study of Children With ADHD ( MTA ) , the effects of medication management ( MedMgt ) , behavior therapy ( Beh ) , their combination ( Comb ) , and usual community care ( CC ) differed at 14 and 24 months due to superiority of treatments that used the MTA medication algorithm ( Comb+MedMgt ) over those that did not ( Beh+CC ) . This report examines 36-month outcomes , 2 years after treatment by the study ended . METHOD For primary outcome measures ( attention-deficit/hyperactivity disorder [ ADHD ] and oppositional defiant disorder [ ODD ] symptoms , social skills , reading scores , impairment , and diagnostic status ) , mixed-effects regression models and orthogonal contrasts examined 36-month outcomes . RESULTS At 3 years , 485 of the original 579 subjects ( 83.8 % ) participated in the follow-up , now at ages 10 to 13 years , ( mean 11.9 years ) . In contrast to the significant advantage of MedMgt+Comb over Beh+CC for ADHD symptoms at 14 and 24 months , treatment groups did not differ significantly on any measure at 36 months . The percentage of children taking medication > 50 % of the time changed between 14 and 36 months across the initial treatment groups : Beh significantly increased ( 14 % to 45 % ) , MedMed+Comb significantly decreased ( 91 % to 71 % ) , and CC remained constant ( 60%-62 % ) . Regardless of their treatment use changes , all of the groups showed symptom improvement over baseline . Notably , initial symptom severity , sex ( male ) , comorbidity , public assistance , and parental psychopathology ( ADHD ) did not moderate children 's 36-month treatment responses , but these factors predicted worse outcomes over 36 months , regardless of original treatment assignment . CONCLUSIONS By 36 months , the earlier advantage of having had 14 months of the medication algorithm was no longer apparent , possibly due to age-related decline in ADHD symptoms , changes in medication management intensity , starting or stopping medications altogether , or other factors not yet evaluated We report a prospect i ve longitudinal study of 101 male adolescents ( ages 16 to 23 years ) who had been diagnosed hyperactive in childhood ( ages 6 to 12 years ) , compared with 100 normal controls . The DSM-III diagnoses were made blind to group membership . Information was obtained for 98 % of the original cohort . The full attention deficit disorder with hyperactivity ( ADDH ) syndrome persisted in 31 % of the prob and s vs in 3 % of the controls . The only other two conditions that distinguished the groups significantly were conduct and substance use disorders . These disorders aggregated significantly among the prob and s with continued ADDH . The results indicate that the greatest risk factor for the development of antisocial behavior and drug abuse is the maintenance of ADDH symptoms . Substance use disorders followed the onset of conduct disorder in the overwhelming majority of the cases Treatment with psychostimulant medication has been shown to improve scholastic functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) . However , the extent to which long-term academic gains are apparent in those having received such treatment remains elusive . This study examined prospect ively the relationship of childhood stimulant treatment to academic functioning during adolescence . Children ( n = 169 ) were initially recruited and diagnosed with ADHD when they were 7 - 11 years old . A sub sample of those with childhood ADHD ( n = 90 ) was reevaluated on average 9.13 ( SD = 1.5 ) years later . Prob and s who did and did not receive treatment with stimulant medication were compared to each other and to a never-ADHD comparison group ( n = 80 ) on three subtests from the Wechsler Individual Achievement Test-II ( WIAT-II ) , as well as high school grade point average ( GPA ) and number of retentions in school as derived from school records . Analyses of covariance controlling for severity of childhood ADHD symptoms indicated that prob and s treated with psychostimulant medication achieved better academic outcomes , as measured by WIAT-II subtests and high school GPA , than those not treated with psychostimulants ( p < .05 ) . However , treated prob and s did not fare as well as the never-ADHD comparison group . Psychostimulant treatment for children with ADHD may benefit long-term adolescent academic performance , although the extent of improvement is likely to vary as a function of multiple factors OBJECTIVES To determine any long-term effects , 6 and 8 years after childhood enrollment , of the r and omly assigned 14-month treatments in the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder ( MTA ; N = 436 ) ; to test whether attention-deficit/hyperactivity disorder ( ADHD ) symptom trajectory through 3 years predicts outcome in subsequent years ; and to examine functioning level of the MTA adolescents relative to their non-ADHD peers ( local normative comparison group ; N = 261 ) . METHOD Mixed-effects regression models with planned contrasts at 6 and 8 years tested a wide range of symptom and impairment variables assessed by parent , teacher , and youth report . RESULTS In nearly every analysis , the originally r and omized treatment groups did not differ significantly on repeated measures or newly analyzed variables ( e.g. , grade s earned in school , arrests , psychiatric hospitalizations , other clinical ly relevant outcomes ) . Medication use decreased by 62 % after the 14-month controlled trial , but adjusting for this did not change the results . ADHD symptom trajectory in the first 3 years predicted 55 % of the outcomes . The MTA participants fared worse than the local normative comparison group on 91 % of the variables tested . CONCLUSIONS Type or intensity of 14 months of treatment for ADHD in childhood ( at age 7.0 - 9.9 years ) does not predict functioning 6 to 8 years later . Rather , early ADHD symptom trajectory regardless of treatment type is prognostic . This finding implies that children with behavioral and sociodemographic advantage , with the best response to any treatment , will have the best long-term prognosis . As a group , however , despite initial symptom improvement during treatment that is largely maintained after treatment , children with combined-type ADHD exhibit significant impairment in adolescence . Innovative treatment approaches targeting specific areas of adolescent impairment are needed BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes OBJECTIVE Deficits in executive functioning , including working memory ( WM ) deficits , have been suggested to be important in attention-deficit/hyperactivity disorder ( ADHD ) . During 2002 to 2003 , the authors conducted a multicenter , r and omized , controlled , double-blind trial to investigate the effect of improving WM by computerized , systematic practice of WM tasks . METHOD Included in the trial were 53 children with ADHD ( 9 girls ; 15 of 53 inattentive subtype ) , aged 7 to 12 years , without stimulant medication . The compliance criterion ( > 20 days of training ) was met by 44 subjects , 42 of whom were also evaluated at follow-up 3 months later . Participants were r and omly assigned to use either the treatment computer program for training WM or a comparison program . The main outcome measure was the span-board task , a visuospatial WM task that was not part of the training program . RESULTS For the span-board task , there was a significant treatment effect both post-intervention and at follow-up . In addition , there were significant effects for secondary outcome tasks measuring verbal WM , response inhibition , and complex reasoning . Parent ratings showed significant reduction in symptoms of inattention and hyperactivity/impulsivity , both post-intervention and at follow-up . CONCLUSIONS This study shows that WM can be improved by training in children with ADHD . This training also improved response inhibition and reasoning and result ed in a reduction of the parent-rated inattentive symptoms of ADHD OBJECTIVE To compare delinquent behavior and early substance use between the children in the Multimodal Treatment Study of Children With ADHD ( MTA ; N = 487 ) and those in a local normative comparison group ( n = 272 ) at 24 and 36 months postr and omization and to test whether these outcomes were predicted by the r and omly assigned treatments and subsequent self-selected prescribed medications . METHOD Most MTA children were 11 to 13 years old by 36 months . Delinquency seriousness was coded ordinally from multiple measures /reporters ; child-reported substance use was binary . RESULTS Relative to local normative comparison group , MTA children had significantly higher rates of delinquency ( e.g. , 27.1 % vs. 7.4 % at 36 months ; p = .000 ) and substance use ( e.g. , 17.4 % vs. 7.8 % at 36 months ; p = .001 ) . Children r and omized to intensive behavior therapy reported less 24-month substance use than other MTA children ( p = .02 ) . R and om effects ordinal growth models revealed no other effects of initial treatment assignment on delinquency seriousness or substance use . By 24 and 36 months , more days of prescribed medication were associated with more serious delinquency but not substance use . CONCLUSIONS Cause- and -effect relationships between medication treatment and delinquency are unclear ; the absence of associations between medication treatment and substance use needs to be re-evaluated at older ages . Findings underscore the need for continuous monitoring of these outcomes as children with attention-deficit/hyperactivity disorder enter adolescence OBJECTIVE To evaluate the predictors of persistence and the timing of remission of attention-deficit hyperactivity disorder ( ADHD ) . METHOD Subjects were 6- to 17-year old Caucasian , non-Hispanic boys with and without ADHD . DSM-III-R structured diagnostic interviews and blind raters were used to examine psychiatric diagnoses , cognitive achievement , social , school , and family functioning at a 4-year follow-up assessment . RESULTS At the 4-year follow-up assessment , OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The following broad trends emerged : ( 1 ) without treatment , people with ADHD had poorer long-term outcomes in all categories compared with people without ADHD , and ( 2 ) treatment for ADHD improved long-term outcomes compared with untreated ADHD , although not usually to normal levels . Conclusions This systematic review provides a synthesis of studies of ADHD long-term outcomes . Current treatments may reduce the negative impact that untreated ADHD has on life functioning , but does not usually ' normalize ' the recipients

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE Impairments associated with attention-deficit/hyperactivity disorder ( ADHD ) and noncompliance are prevalent in children with autism spectrum disorder ( ASD ) . However , ADHD response to stimulants is well below rates in typically developing children , with frequent side effects . Group studies of treatments for noncompliance are rare in ASD . We examined individual and combined-effectiveness of atomoxetine ( ATX ) and parent training ( PT ) for ADHD symptoms and noncompliance . METHOD In a 3-site , 10-week , double-blind , 2 × 2 trial of ATX and PT , 128 children ( ages 5 - 14 years ) with ASD and ADHD symptoms were r and omized to ATX , ATX+PT , placebo+PT , or placebo . ATX was adjusted to optimal dose ( capped at 1.8 mg/kg/day ) over 6 weeks and maintained for 4 additional weeks . Nine PT sessions were provided . Primary outcome measures were the parent-rated DSM ADHD symptoms on the Swanson , Nolan and Pelham ( SNAP ) scale and Home Situations Question naire ( HSQ ) . RESULTS On the SNAP , ATX , ATX+PT and placebo+PT were each superior to placebo ( effect sizes 0.57 - 0.98 ; p values of .0005 , .0004 , and .025 , respectively ) . For noncompliance , ATX and ATX+PT were superior to placebo ( effect sizes 0.47 - 0.64 ; p values .03 and .0028 , respectively ) . ATX was associated with decreased appetite but was otherwise well tolerated . CONCLUSION Both ATX and PT result ed in significant improvement on ADHD symptoms , whereas ATX ( both alone and combined with PT ) was associated with significant decreases on measures of noncompliance . ATX appears to have a better side effects profile than psychostimulants in the population with ASD . CLINICAL TRIAL REGISTRATION INFORMATION Atomoxetine , Placebo and Parent Management Training in Autism ; http:// clinical trials.gov/ ; NCT00844753 BACKGROUND Risperidone is a second generation antipsychotic agent , with potent serotonin 5-HT2A and dopamine D2 receptor blocking effects . Specifically , risperidone possesses a unique balance of serotonin and dopamine antagonism , namely that its affinity for 5-HT2A receptors is significantly greater than its affinity for D2 receptors . Risperidone is well-established medication , with the proven effects on positive and negative symptoms of schizophrenia . The aim of research was to establish the effectiveness and safety of risperidone in patients with schizophrenia . SUBJECTS AND METHODS The sample consisted of 60 subjects , age ranged was between 18 - 60 years , both genders , who met the criteria for the diagnosis various types of schizophrenia , according to ICD-10 ( International Statistical Classification of Diseases ) . They were enrolled in the study as outpatient and inpatient setting . All subjects signed informed consent before entering into this study which had been conducted at the Psychiatric Clinic , University Clinical Center Sarajevo . Study was design ed for 8-week , open-label , flexible-dose observational study . The subjects had to have a total score > -40 on Positive and Negative scale -two parts of the Positive and Negative Syndrome Scale ( PANSS ) , and to be able to discontinue current antipsychotic medications . The primary efficacy parameter was the percent of score difference between baseline and week 8 of therapy on two above-mentioned PANSS subscales . The difference was considered as significant improvement if decrease from the baseline was 20 % or more . The secondary efficacy parameter was subjective clinical evaluation of efficacy with five possible answers : very good , good , moderate , not satisfactory , not possible to evaluate . It was measured at the end of observational period by the investigator . RESULTS All 60 enrolled patients completed the study . After the 8 weeks of treatment , 54/60 patients ( 90 % ) had clinical ly significant improvement of 20 % or more decreased total PANSS score ( Positive and Negative subscale ) . In 6/60 patients ( 10 % ) clinical improvement was also reported with less of 20 % decreased total PANSS score . The side effects were registered in 8/60 patients ( 13.32 % ) . The mild extrapyramidal symptoms registered in 1/60 ( 11.66 % ) patients , whom dose of risperidone was reduced . Increase of prolactine in 7/60 ( 11.66 % ) , patients , whose dose of risperidone also were reduced . Average weight gain was 0.84 kg . CONCLUSION In this study Risperidone has shown very good effectiveness and safety Some open-label studies suggest that risperidone can be useful in the treatment of certain target symptoms in children with autism . We aim ed to study whether the use of risperidone in comparison with placebo improved functioning in children with autism with regard to behavior ( aggressiveness , hyperactivity , irritability ) , social and emotional responsiveness , and communication skills . We conducted a r and omized , double-blind , placebo-controlled trial with 40 consecutive children with autism , whose ages ranged from 2 to 9 years , who were receiving either risperidone or placebo given orally at a dose of 1 mg/day for 6 months . Autism symptoms were monitored periodically . The outcome variables were total scores on the Childhood Autism Rating Scale ( CARS ) and the Children 's Global Assessment Scale ( CGAS ) after 6 months . Of the 40 children enrolled , 39 completed the trial over a period of 18 months ; 19 received risperidone , and 20 received placebo . In the risperidone group , 12 of 19 children showed improvement in the total Childhood Autism Rating Scale score and 17 of 19 children in the Children 's Global Assessment Scale score compared with 0 of 20 children for the Childhood Autism Rating Scale score and 2 of 20 children for the Children 's Global Assessment Scale score in the placebo group ( P < .001 and P = .035 , respectively ) . Risperidone also improved social responsiveness and nonverbal communication and reduced the symptoms of hyperactivity and aggression . Risperidone was associated with increased appetite and a mild weight gain , mild sedation in 20 % , and transient dyskinesias in three children . Risperidone improved global functioning and social responsiveness while reducing hyperactivity and aggression in children with autism and was well tolerated . ( J Child Neurol 2006;21:450—455 ; DOI 10.2310/7010.2006.00099 ) OBJECTIVE Many children with pervasive developmental disorders ( PDDs ) have serious , functionally impairing behavioral problems . We tested whether combined treatment ( COMB ) with risperidone and parent training ( PT ) in behavior management is superior to medication alone ( MED ) in improving severe behavioral problems in children with PDDs . METHOD This 24-week , three-site , r and omized , parallel-groups clinical trial enrolled 124 children , aged 4 through 13 years , with PDDs , accompanied by frequent tantrums , self-injury , and aggression . The children were r and omized 3:2 to COMB ( n = 75 ) or MED ( n = 49 ) . The participants received risperidone monotherapy from 0.5 to 3.5 mg/day ( with switch to aripiprazole if risperidone was ineffective ) . Parents in the COMB group ( n = 75 ; 60.5 % ) received a mean of 10.9 PT sessions . The primary measure of compliance was the Home Situations Question naire ( HSQ ) score . RESULTS Primary : intent-to-treat r and om effects regression showed that COMB was superior to MED on HSQ ( p = .006 ) [ effect size at week 24 ( d ) = 0.34 ] . The HSQ score declined from 4.31 ( ± 1.67 ) to 1.23 ( ± 1.36 ) for COMB compared with 4.16 ( ± 1.47 ) to 1.68 ( ± 1.36 ) for MED . Secondary : groups did not differ on Clinical Global Impressions-Improvement scores at endpoint ; compared with MED , COMB showed significant reductions on Aberrant Behavior Checklist Irritability ( d = 0.48 ; p = .01 ) , Stereotypic Behavior ( d = 0.23 ; p = .04 ) , and Hyperactivity/Noncompliance subscales ( d = 0.55 ; p = .04 ) . Final risperidone mean dose for MED was 2.26 mg/day ( 0.071 mg/kg ) , compared with 1.98 mg/day for COMB ( 0.066 mg/kg ) ( p = .04 ) . CONCLUSIONS Medication plus PT result ed in greater reduction of serious maladaptive behavior than MED in children with PDDs , with a lower risperidone dose INTRODUCTION Early intervention in autism spectrum disorders ( ASDs ) appears promising and may represent a window of opportunity for more effective treatment . Whereas the safety and efficacy of risperidone have been established for children aged 5 and older , they has not been adequately tested in preschool children . METHODS A r and omized placebo-controlled study of risperidone in preschool children was conducted in a sample of young children , most of whom were also undergoing intensive behavioral treatment . RESULTS Preschool children tolerated low-dose risperidone well with no serious adverse effects observed over a 6-month treatment period . Weight gain and hypersalivation were the most common side effects reported , and hyperprolactinemia without lactation or related signs was observed . Significant differences between groups found at baseline complicated the analyses ; however , controlling for some of these differences revealed that preschoolers on risperidone demonstrated greater improvements in autism severity . The change in autism severity scores from baseline to 6-month follow up for the risperidone group was 8 % compared to 3 % for the placebo group . Notably , both groups significantly improved over the 6-month treatment period . CONCLUSIONS Study findings suggest that risperidone is well tolerated in preschoolers over a 6-month period , but that only minimally greater improvement in target symptoms was evident in the risperidone group , possibly due to the differences between groups at baseline or due to the small sample size . Although these findings are not sufficient to direct treatment , they suggest that larger-scale , double-blind , placebo-controlled investigations of risperidone in preschoolers with ASDs should now be conducted Objective . To investigate the efficacy and safety of risperidone for the treatment of disruptive behavioral symptoms in children with autism and other pervasive developmental disorders ( PDD ) . Methods . In this 8-week , r and omized , double-blind , placebo-controlled trial , risperidone/placebo solution ( 0.01–0.06 mg/kg/day ) was administered to 79 children who were aged 5 to 12 years and had PDD . Behavioral symptoms were assessed using the Aberrant Behavior Checklist ( ABC ) , Nisonger Child Behavior Rating Form , and Clinical Global Impression-Change . Safety assessment s included vital signs , electrocardiogram , extrapyramidal symptoms , adverse events , and laboratory tests . Results . Subjects who were taking risperidone ( mean dosage : 0.04 mg/kg/day ; 1.17 mg/day ) experienced a significantly greater mean decrease on the irritability subscale of the ABC ( primary endpoint ) compared with those who were taking placebo . By study endpoint , risperidone-treated subjects exhibited a 64 % improvement over baseline in the irritability score almost double that of placebo-treated subjects ( 31 % ) . Risperidone-treated subjects also exhibited significantly greater decreases on the other 4 subscales of the ABC ; on the conduct problem , insecure/anxious , hyperactive , and overly sensitive subscales of the Nisonger Child Behavior Rating Form ( parent version ) ; and on the Visual Analog Scale of the most troublesome symptom . More risperidone-treated subjects ( 87 % ) showed global improvement in their condition compared with the placebo group ( 40 % ) . Somnolence , the most frequently reported adverse event , was noted in 72.5 % versus 7.7 % of subjects ( risperidone vs placebo ) and seemed manageable with dose/dose-schedule modification . Risperidone-treated subjects experienced statistically significantly greater increases in weight ( 2.7 vs 1.0 kg ) , pulse rate , and systolic blood pressure . Extrapyramidal symptoms scores were comparable between groups . Conclusions . Risperidone was well tolerated and efficacious in treating behavioral symptoms associated with PDD in children BACKGROUND Atypical antipsychotic agents , which block postsynaptic dopamine and serotonin receptors , have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances . However , data on the safety and efficacy of atypical antipsychotic agents in children are limited . METHODS We conducted a multisite , r and omized , double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums , aggression , or self-injurious behavior in children 5 to 17 years old . The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

In acute treatment , the pooled mean change score of the Aberrant Behavior Checklist for irritability subscale ( ABC-I ) and response rate for the risperidone-treated group had a greater significance than that of the placebo-treated group . According to the discontinuation phase , the overall pooled relapse rate of the risperidone-treated group was significantly less than that of the placebo-treated group . The rates of pooled overall discontinuation and discontinuation due to adverse events rates were not different between the two groups in acute and long-term treatments . Conclusion In relation to the current systematic review , risperidone is efficacious in the treatment of symptoms in children and adolescents with ASD . Although its acceptability is comparable to placebo , treatment with risperidone is well tolerated in children and adolescents with ASD

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Iron-deficiency anemia in non-dialysis-dependent chronic kidney disease ( NDD-CKD ) frequently requires parenteral iron replacement , but existing therapies often require multiple administrations . We evaluated the efficacy and cardiovascular safety of ferric carboxymaltose ( FCM ) , a non-dextran parenteral iron permitting large single-dose infusions , versus iron sucrose in patients with iron-deficiency anemia and NDD-CKD . METHODS A total of 2584 participants were r and omized to two doses of FCM 750 mg in one week , or iron sucrose 200 mg administered in up to five infusions in 14 days . The primary efficacy endpoint was the mean change to highest hemoglobin from baseline to Day 56 . The primary composite safety endpoint included all-cause mortality , nonfatal myocardial infa rct ion , nonfatal stroke , unstable angina , congestive heart failure , arrhythmias and hyper- and hypotensive events . RESULTS The mean hemoglobin increase was 1.13 g/dL in the FCM group and 0.92 g/dL in the iron sucrose group ( 95 % CI , 0.13 - 0.28 ) . Similar results were observed across all subgroups , except Stage 2 CKD . More subjects in the FCM group achieved a hemoglobin increase of ≥ 1.0 g/dL between baseline and Day 56 ( 48.6 versus 41.0 % ; 95 % CI , 3.6 - 11.6 % ) . There was no significant difference between FCM and iron sucrose recipients with respect to the primary composite safety endpoint , including the major adverse cardiac events of death , myocardial infa rct ion , or stroke . A significant difference in the number of protocol -defined , predominantly transient hypertensive episodes was observed in the FCM group . CONCLUSIONS Two 750-mg infusions of FCM are a safe and effective alternative to multiple lower dose iron sucrose infusions in NDD-CKD patients with iron-deficiency anemia Background . Iron deficiency is a common cause of anaemia and hyporesponsiveness to erythropoiesis-stimulating agents ( ESAs ) in non-dialysis-dependent chronic kidney disease ( ND-CKD ) patients . Current intravenous iron agents can not be administered in a single high dose because of adverse effects . Ferric carboxymaltose , a non-dextran parenteral iron preparation , can be rapidly administered in high doses . Methods . This open-label trial r and omized 255 subjects with glomerular filtration rates ≤ 45 mL/min/1.73 m2 , haemoglobin ≤ 11 g/dL , transferrin saturation ≤ 25 % , ferritin ≤ 300 ng/mL , and stable ESA dose to either intravenous ferric carboxymaltose 1000 mg over 15 min ( with up to two additional doses of 500 mg at 2-week intervals ) or oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days . Results . In the modified intent-to-treat population , the proportion of subjects achieving a haemoglobin increase ≥ 1 g/dL at any time was 60.4 % with ferric carboxymaltose and 34.7 % with oral iron ( P < 0.001 ) . At Day 42 , mean increase in haemoglobin was 0.95 ± 1.12 vs 0.50 ± 1.23 g/dL ( P = 0.005 ) , mean increase in ferritin was 432 ± 189 ng/mL vs 18 ± 45 ng/mL ( P < 0.001 ) and mean increase in transferrin saturation was 13.6 ± 11.9 % vs 6.1 ± 8.1 % ( P < 0.001 ) . Treatment-related adverse events were significantly fewer with ferric carboxymaltose than with oral iron ( 2.7 % and 26.2 % , respectively ; P < 0.0001 ) . Conclusions . We conclude that 1000 mg ferric carboxymaltose can be rapidly administered , is more effective and is better tolerated than oral iron for treatment of iron deficiency in ND-CKD patients This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration . In a r and omized , double-blinded , placebo-controlled study , 90 premenopausal women presenting with fatigue , serum ferritin ≤ 50 ng/mL , and hemoglobin ≥ 120 g/L were r and omized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose or intravenous placebo . Fatigue and serum iron status were assessed at baseline and after 6 and 12 weeks . Median fatigue at baseline was 4.5 ( on a 0 - 10 scale ) . Fatigue decreased during the initial 6 weeks by 1.1 in the iron group compared with 0.7 in the placebo group ( P = .07 ) . Efficacy of iron was bound to depleted iron stores : In patients with baseline serum ferritin ≤ 15 ng/mL , fatigue decreased by 1.8 in the iron group compared with 0.4 in the placebo group ( P = .005 ) , and 82 % of iron-treated compared with 47 % of placebo-treated patients reported improved fatigue ( P = .03 ) . Drug-associated adverse events were observed in 21 % of iron-treated patients and in 7 % of placebo-treated patients ( P = .05 ) ; none of these events was serious . Intravenous administration of iron improved fatigue in iron-deficient , nonanemic women with a good safety and tolerability profile . The efficacy of intravenous iron was bound to a serum ferritin concentration ≤ 15 ng/mL. This study was registered at the International St and ard R and omized Controlled Trial Number Register ( www.is rct n.org ) as IS RCT N78430425 Background Unexplained fatigue is often left untreated or treated with antidepressants . This r and omized , placebo-controlled , single-blinded study evaluated the efficacy and tolerability of single-dose intravenous ferric carboxymaltose ( FCM ) in iron-deficient , premenopausal women with symptomatic , unexplained fatigue . Methods Fatigued women ( Piper Fatigue Scale [ PFS ] score ≥5 ) with iron deficiency ( ferritin < 50 µg/L and transferrin saturation < 20 % , or ferritin < 15 µg/L ) and normal or borderline hemoglobin ( ≥115 g/L ) were enrolled in 21 sites in Austria , Germany , Sweden and Switzerl and , blinded to the study drug and r and omized ( computer-generated r and omization sequence ) to a single FCM ( 1000 mg iron ) or saline ( placebo ) infusion . Primary endpoint was the proportion of patients with reduced fatigue ( ≥1 point decrease in PFS score from baseline to Day 56 ) . Results The full analysis included 290 women ( FCM 144 , placebo 146 ) . Fatigue was reduced in 65.3 % ( FCM ) and 52.7 % ( placebo ) of patients ( OR 1.68 , 95%CI 1.05–2.70 ; p = 0.03 ) . A 50 % reduction of PFS score was achieved in 33.3 % FCM- vs. 16.4 % placebo-treated patients ( p<0.001 ) . At Day 56 , all FCM-treated patients had hemoglobin levels ≥120 g/L ( vs. 87 % at baseline ) ; with placebo , the proportion decreased from 86 % to 81 % . Mental quality -of-life ( SF-12 ) and the cognitive function scores improved better with FCM . ‘ Power of attention ’ improved better in FCM-treated patients with ferritin < 15 µg/L. Treatment-emergent adverse events ( placebo 114 , FCM 209 ; most frequently headache , nasopharyngitis , pyrexia and nausea ) were mainly mild or moderate . Conclusion A single infusion of FCM improved fatigue , mental quality -of-life , cognitive function and erythropoiesis in iron-deficient women with normal or borderline hemoglobin . Although more side effects were reported compared to placebo , FCM can be an effective alternative in patients who can not tolerate or use oral iron , the common treatment of iron deficiency . Overall , the results support the hypothesis that iron deficiency can affect women ’s health , and a normal iron status should be maintained independent of hemoglobin levels . Trial Registration Clinical Trials.gov Background : Secondary thrombocytosis is a common clinical feature . In patients with cancer , it is a risk factor for venous thromboembolic events . In inflammatory bowel disease ( IBD ) , thrombocytosis is so far considered a marker of active disease and may contribute to the increased thromboembolic risk in this population . Observed effects of iron therapy on normalization of platelet counts led us to hypothesize that iron itself may regulate megakaryopoiesis . Here , we want to test the effect of iron replacement on platelet count and activity in IBD-associated thrombocytosis . Methods : We performed a r and omized , single-blinded placebo-controlled trial testing the effect of ferric carboxymaltose ( FCM ) in patients with IBD with secondary thrombocytosis ( platelets > 450 G/L ) . Changes in platelet counts , hemoglobin , iron parameters , disease activity , megakaryopoietic growth factors , erythropoietin , and platelet activity were assessed . Patients received placebo or up to 1500 mg iron as FCM . Endpoints were evaluated at week 6 . Results : A total of 26 patients were included in the study , 15 patients were available for the per protocol analysis . A drop in platelets > 25 % ( primary endpoint ) was observed in 4 of 8 ( 50 % , iron group ) and 1 of 7 patients ( 14 % , placebo group , P = 0.143 ) . Mean platelet counts dropped on FCM but not on placebo ( 536 G/L to 411 G/L versus 580 G/L to 559 G/L ; P = 0.002 ) . Disease activity and megakaryopoietic growth factors remained unchanged and hemoglobin and iron parameters increased on FCM . The normalization of platelet counts was associated with a decrease in platelet aggregation and P-selectin expression . Conclusion : FCM lowers platelet counts and platelet activation in patients with IBD-associated secondary thrombocytosis Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Abstract Objective : Iron deficiency is a common but treatable comorbidity in chronic heart failure ( CHF ) that is associated with impaired health-related quality -of-life ( HRQoL ) . This study evaluates the cost-effectiveness of the intravenous iron preparation ferric carboxymaltose ( FCM ) for the treatment of iron deficiency in CHF from a Swedish healthcare perspective . Methods : A cost-effectiveness analysis with a time horizon of 24 weeks was performed to compare FCM treatment with placebo . Data on health outcomes and medical re source use were mainly taken from the FAIR-HF trial and combined with Swedish cost data . An incremental cost-effectiveness ratio ( ICER ) was calculated as well as the change in per-patient costs for primary care and hospital care . Results : In the FCM group compared with placebo , quality -adjusted life years ( QALYs ) are higher ( difference = 0.037 QALYs ) , but so are per-patient costs [ ( difference = SEK 2789 ( € 303 ) ] . Primary care and hospital care equally share the additional costs , but within hospitals there is a major shift of costs from inpatient care to outpatient care . The ICER is SEK 75,389 ( € 8194 ) per QALY . The robustness of the result is supported by sensitivity analyses . Conclusions : Treatment of iron deficiency in CHF with FCM compared with placebo is estimated to be cost-effective . The ICER in the base case scenario is twice as high as previously thought , but noticeably below OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusions All currently available intravenous iron preparations appear to be safe and effective , but ferric carboxymaltose seems to provide a better and quicker correction of haemoglobin and serum ferritin levels in iron-deficient patients

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE The aim of this study was to evaluate the levels of adipose tissue related hormones , cytokines , and antioxidative substances in obese women before and after intervention with diet alone or with diet plus an inhibitor of gastrointestinental lipase-orlistat . DESIGN Seventy-one obese women of childbearing age were included in the study and were r and omly assigned into two groups according to the type of intervention : group A1 ( n=35 ) included women who received orlistat as well as a hypocaloric diet , and group A2 ( n=36 ) included women who were only on hypocaloric diet . The intervention period lasted 6 months . Anthropometric parameters , such as Body Weight ( BW ) , Body Mass Index ( BMI ) , Waist Circumference ( WC ) , and % Body fat ( BF ) were recorded . Insulin , leptin , resistin , interleukin-6 ( IL-6 ) , insulin like growth factor 1 ( IGF-1 ) , tumor necrosis factor alpha ( TNFalpha ) , adiponectin , hsC-reactive protein ( CRP ) , glutathione peroxidase , and isoprostane were determined by appropriate methodology prior to and following the 6-month intervention period . Insulin resistance was measured using the homeostasis model assessment index ( HOMA-IR ) . All participants had normal glucose tolerance . RESULTS In both groups B MI values were lower after intervention and all measured parameters were ameliorated . A statistically significant difference was found between group A1 ( orlistat plus diet ) and group A2 ( diet only ) with regard to the levels of triglycerides , CRP , TNF-alpha , IGF-1 , and isoprostane , even after correcting for weight loss . CONCLUSION Hypocaloric diet plus orlistat in obese women is superior to diet alone with regard to the changes observed in adipokines , CRP , TNFalpha , triglycerides , IGF-1 , and oxidative stress following intervention The aim of this study was to determine if orlistat , an inhibitor of fat absorption , combined with caloric restriction in overweight subjects with nonalcoholic steatohepatitis results in weight loss and improved liver histology . Fifty overweight subjects ( body mass index = > or=27 ) with biopsy proven nonalcoholic steatohepatitis were r and omized to receive a 1,400 Kcal/day diet plus vitamin E ( 800 IU ) daily with or without orlistat ( 120 mg three times a day ) for 36 weeks . Liver biopsies were repeated at week 36 . Twenty-three subjects in the orlistat/diet/vitamin E group and 18 in the diet/vitamin E group completed the study . The mean age was 47 + /- 9.0 ( st and ard deviation ) years and mean body mass index was 36.4 + /- 6.3 kg/m(2 ) . Four subjects were diabetic . The orlistat group lost a mean of 8.3 % body weight compared to 6.0 % in the diet plus vitamin E group ( not significant ) . Both groups also had similarly improved serum aminotransferases , hepatic steatosis , necroinflammation , ballooning , and nonalcoholic fatty liver disease activity scores . Stratified according to weight loss instead of treatment group , a loss of > or=5 % body weight ( n = 24 ) compared to < 5 % body weight ( n = 17 ) correlated with improvement in insulin sensitivity ( P = 0.001 ) and steatosis ( P = 0.015 ) . Comparing subjects who lost > or=9 % of body weight ( n = 16 ) , to those that did not ( n = 25 ) , improved insulin sensitivity ( P < 0.001 ) , adiponectin ( P = 0.03 ) , steatosis ( P = 0.005 ) , ballooning ( P = 0.04 ) , inflammation ( P = 0.045 ) , and nonalcoholic fatty liver disease activity score ( P = 0.009 ) were seen . Increases in adiponectin strongly correlated with improved ballooning and nonalcoholic fatty liver disease activity score ( P = 0.03 ) . Orlistat did not enhance weight loss or improve liver enzymes , measures of insulin resistance , and histopathology . However , subjects who lost > or=5 % of body weight over 9 months improved insulin resistance and steatosis , and those subjects who lost > or=9 % also achieved improved hepatic histologic changes We investigated the effects of different weight loss protocol s on leptin levels in obese females with the aim of addressing the leptin resistance which has been found to be an aggravating factor in obesity . Twenty-four obese females enrolled to one of three 12-week weight loss protocol s : orlistat-induced weight loss ( OWL , n=8 ) , exercise-induced weight loss ( EWL , n=8 ) and orlistat plus exercise-induced weight loss ( OEWL , n=8 ) . Serum leptin levels were measured in duplicate by radioimmunoassay . There were significant reductions ( P<0.01 ) in body weight and fat mass after the 12 week period in all groups : -11.4+/-0.5 kg and -9.8+/-0.5 kg ( OEWL ) , -8.3+/-0.8 kg and -5.7+/-0.9 kg ( OWL ) , -8.9+/-1.2 kg and -7.4+/-1.2 kg ( EWL ) , respectively . Serum leptin levels were also decreased markedly in all groups : -59.2 % ( OEWL1 ) , -37.8 % ( OWL ) and -48.6 % ( EWL ) ( P<0.01 all ) . In addition , there were marked decreases in leptin levels for each kilogram of fat mass after the 12 week period : -48.2+/-7.2 % ( OEWL ) , -27.8+/-4.8 % ( OWL ) and -39.3+/-4.3 % ( EWL ) ( P<0.01 all ) . Decreases in serum leptin levels expressed per kilogram of fat mass were significantly higher in the OEWL group compared to the OWL group ( P=0.03 ) . Consequently , an exercise training program in adjunct to pharmacotherapy provides higher weight reduction and fat mass loss in obesity treatment . It also seems to have further beneficial effects on leptin resistance , as indicated by decreases in leptin levels expressed per kilogram of fat mass OBJECTIVE To assess the impact of weight reduction on serum adipocytokines , C-reactive protein ( CRP ) , and insulin sensitivity in hypertensive female patients with central obesity . METHODS This study was performed using the data base and stored serum sample s of female patients who had participated in an intervention study focused on weight loss . Thirty hypertensive women aged 18 to 65 , body mass index ( BMI ) > 27 kg/m2 , and central obesity were selected . They were r and omly assigned to receive either a low-calorie diet plus orlistat 120 mg three times daily or a low-calorie diet alone for 16 weeks . Patients who experienced weight loss greater than 5 % ( n = 24 ) were assessed for blood pressure , anthropometric parameters , visceral fat , insulin resistance ( HOMA-R - homeostasis model assessment of insulin resistance ) and sensitivity ( ISI - Insulin Sensitivity Index ) indices , plus serum lipids , adipocytokines ( adiponectin , leptin , IL-6 , and TNF-alpha ) and CRP levels . RESULTS After BMI had been reduced by approximately 5 % in both groups , visceral fat , fasting glucose , triglycerides , and TNF-alpha decreased . Only the orlistat group , which was more insulin resistant at baseline , showed a significant reduction in blood glucose after oral glucose load , in addition to increased insulin sensitivity . CONCLUSION This study 's findings indicate that a weight loss greater than 5 % is associated with improved inflammatory status and decreased insulin resistance , regardless of changes in adiponectin and TNF-a levels . The greatest improvements in insulin sensitivity experienced by the orlistat-treated patients could not be attributed to the use of this drug because of the higher number of insulin-resistant subjects in this group BACKGROUND Orlistat has been shown to increase adiponectin and reduce progression to type 2 diabetes in obese Caucasians . Some effects of orlistat are thought to be independent of weight loss by altering gut flora and the production of endotoxin lipopolysaccharide ( LPS ) . We studied the effect of dietary treatment with and without orlistat in South Asian individuals with impaired glucose tolerance ( IGT ) on adiponectin and inflammatory markers including LPS . METHODS South Asian individuals were r and omised to either dietary treatment with orlistat or dietary treatment alone . At the end of 12 months , a comparison was made between the two groups for differences in anthropomorphic measurements and serum markers . RESULTS Three hundred and five individuals underwent oral glucose tolerance test of whom 40 had IGT . Complete baseline and 1-year data was available for 31 patients . After 1 year , patients in the orlistat group demonstrated a greater but insignificant decrease in weight ( 4.5 + /- 0.1 kg ) , and a significant increase in adiponectin ( 6.73 + /- 3.2 microg/ml ) and decrease in LPS ( 4.55 + /- 1.98 EU/ml ) compared with- the diet-alone group . In the orlistat group the reduction in LPS was correlated with the increase in adiponectin ( p < 0.005 ) . CONCLUSION The increase in adiponectin levels in the orlistat group would suggest that orlistat may reduce the progression to type 2 diabetes in South Asian individuals by raising serum adiponectin . The finding that LPS levels are also reduced by orlistat and that this reduction correlates with the increase in adiponectin raises the possibility that the increase in adiponectin may be mediated via an effect on LPS levels Aim : To evaluate the effects of 1-year treatment with orlistat compared with placebo on different inflammatory parameters in type 2 obese diabetic patients . Material s and methods : Two hundred and fifty-four type 2 diabetic patients were r and omized to take orlistat 120 mg three times a day or placebo for 12 months . We evaluated at baseline and after 3 , 6 , 9 and 12 months : leptin , tumor necrosis factor (TNF)-α , adiponectin ( ADN ) , vaspin and high-sensitivity C-reactive protein ( HS-CRP ) , body weight , waist circumference , body mass index ( BMI ) , lipid profile , glycemic profile , fasting plasma insulin ( FPI ) and homeostasis model assessment insulin resistance index ( HOMA-IR ) . Results : Regarding inflammatory parameters , there was a significant improvement of ADN and TNF-α , and a faster decrease of leptin and HS-CRP in the orlistat group compared with the control group . We also recorded a significant reduction of body weight and BMI with orlistat , but not with placebo . A faster improvement of glycemic profile and FPI was obtained with orlistat compared with the controls . Also , there was a significant reduction of lipid profile with orlistat , not reached with placebo . Conclusions : Orlistat was more effective than placebo in ameliorating inflammatory parameters such as ADN and TNF-α , and anthropometric parameters To evaluate the effects of 1-year treatment with orlistat plus L-carnitine compared to orlistat alone on body weight , glycemic and lipid control , and inflammatory parameters in obese type 2 diabetic patients . Two hundred and fifty-eight patients with uncontrolled type 2 diabetes mellitus ( T2DM ) [ glycated hemoglobin ( HbA(1c ) ) > 8.0 % ] in therapy with different oral hypoglycemic agents or insulin were enrolled in this study and r and omized to take orlistat 120 mg three times a day plus L-carnitine 2 g one time a day or orlistat 120 mg three times a day . We evaluated the following parameters at baseline and after 3 , 6 , 9 , and 12 months : body weight , body mass index ( BMI ) , glycated hemoglobin ( HbA(1c ) ) , fasting plasma glucose ( FPG ) , postpr and ial plasma glucose ( PPG ) , fasting plasma insulin ( FPI ) , homeostasis model assessment insulin resistance index ( HOMA-IR ) , total cholesterol ( TC ) , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , triglycerides ( Tg ) , adiponectin ( ADN ) , leptin , tumor necrosis factor-α ( TNF-α ) , vaspin , and high-sensitivity C-reactive protein ( Hs-CRP ) . We observed a better decrease in body weight , glycemic profile , HOMA-IR , LDL-C , and ADN and a faster improvement in FPI , TC , Tg , leptin , TNF-α , Hs-CRP with orlistat plus L-carnitine compared to orlistat alone . We also recorded an improvement in vaspin with orlistat plus l-carnitine not reached with orlistat alone . Orlistat plus L-carnitine gave a better improvement in body OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

In meta-regression , changes in plasma concentrations of adiponectin , leptin and CRP were associated with duration of treatment , but not with either change in BMI or baseline BMI values . CONCLUSION Orlistat is effective in increasing plasma concentrations of adiponectin and decreasing those of leptin and CRP

MS2_fixed_5_shot264

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background Late infection is the second most frequent early complication after total hip arthroplasty ( THA ) and the most frequent after hemiarthroplasty . Known risk factors for infection after THA include posttraumatic osteoarthritis , previous surgery , chronic liver disease , corticoid therapy , and excessive surgical time . However , risk factors for hemiarthroplasty are not clearly established . Questions / purpose sWe therefore determined the preoperative and intraoperative risk factors for late infection ( more than 3 months after surgery ) in patients with hemiarthroplasties and THAs . Methods We retrospectively compared 47 patients with a hip arthroplasty ( 23 hemiarthroplasties , 24 total hip arthroplasties ) and late infection with 200 r and omly-selected patients with primary arthroplasty ( 100 hemiarthroplasties , 100 total hip arthroplasties ) during the same time period of time without any infection during followup . Potential risk factors were identified from medical records . Minimum followup was 12 months ( mean , 27 months ; range , 12–112 months ) for the study group and 18 months ( mean , 84 months ; range , 18–144 months ) for the control group . Results The following factors were more frequent in late infected hemiarthroplasties : female gender ; previous surgery ; obesity ( body mass index greater than 30 kg/m2 ) ; glucocorticoid and immunosuppressant treatments ; prolonged surgical time ; inadequate antibiotic prophylaxis ; prolonged wound drainage ; hematoma ; dislocation ; and cutaneous , urinary , and /or abdominal infections . The following were more frequent in infected total hip arthroplasties : posttraumatic osteoarthritis ; previous surgery ; glucocorticoids ; chronic liver disease ; alcohol and intravenous drug abuse ; prolonged surgical time ; prolonged wound drainage ; dislocation ; subsequent surgery ; and cutaneous , urinary , respiratory and abdominal infections . Diabetes did not appear to be a risk factor . Conclusions Our data suggest there are specific risk factors for infection in hemiarthroplasties . The major risk factors for late infection in hip arthroplasty must be recognized so they can be minimized or controlled if not possible to employ prophylactic measures .Level of Evidence Level III , prognostic study . See Guidelines for Authors for a complete description of levels of evidence Background The benefits of robotic techniques for implanting femoral components during THA are still controversial . Questions / Purpose sThe purpose of this study was to prospect ively compare the results and complications of robotic-assisted and h and -rasping stem implantation techniques . Method The minimum followup was 5 years ( mean , 67 months ; range , 60–85 months ) . One hundred forty-six primary THAs on 130 patients were included in this study . Robot-assisted primary THA was performed on 75 hips and a h and -rasping technique was used on 71 hips . Results At 2 and 3 years postoperatively , the Japanese Orthopaedic Association ( JOA ) clinical score was slightly better in the robotic-assisted group . At 5 years followup , however , the differences were not significant . Postoperative limb lengths of the robotic-milling group had significantly less variance than the h and -rasping group . At 2 years postoperatively , there was significantly more stress shielding of the proximal femur in the h and -rasping group ; this difference was more significant 5 years postoperatively . Conclusions Substantially more precise implant positioning seems to have led to less variance in limb-length ine quality and less stress shielding of the proximal femur 5 years postoperatively . Level of Evidence Level II , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence The ROBODOC ® system was design ed to address potential human errors in performing cementless total hip replacement . The system consists of a preoperative planning computer workstation ( called ORTHODOC ) and a five-axis robotic arm with a high speed milling device as an end effector . The combined experience of the United States Food and Drug Administration multicenter trial and the German postmarket use of the system are reported . The United States study is controlled and r and omized with 136 hip replacements performed at three centers ( 65 ROBODOC ® and 62 control ) . Followup was 1 year on 127 hip replacements and 2 years on 93 hip replacements . No differences were found in the Harris hip scores or the Short Form Health Survey outcomes question naire . Length of stay also was not different , but the surgical time and blood loss were greater in the ROBODOC ® group . This was attributed to a learning curve at each center . Radiographs were evaluated by an independent bone radiologist and showed statistically better fit and positioning of the femoral component in the ROBODOC ® group . Complications were not different , except for three cases of intraoperative femoral fracture in the control group and none in the ROBODOC ® group . The German study reports on 858 patients , 42 with bilateral hip replacements and this includes 30 revision cases for a total of 900 hip replacements . The Harris hip score rose from 43.7 to 91.5 . In these cases the surgical time declined quickly from 240 minutes for the first case to 90 minutes . No intraoperative femoral fractures occurred in 900 cases . Other complications were comparable with total hip replacements performed using conventional techniques . The ROBODOC ® system is thought to be safe and effective in producing radiographically superior implant fit and positioning while eliminating femoral fractures AIM Robotic assisted total hip arthroplasty remains controversial , since wider exposure of the proximal femur and placement of the leg in maximal hip adduction and external rotation using a rigid leg-holder apparatus may impair significantly the hip abductors . Consequently , it is the purpose of this study to analyse and report both clinical outcome and hip abductor function following robotic assisted versus conventional total hip arthroplasty . MATERIAL AND METHODS 36 robotic-assisted ( CASPAR , Orto-Maquet , Rastatt , Germany ) and 35 conventional cementless total hip arthroplasties were followed on average for 18 months regarding incidence of complications , Harris hip score , the scoring system according to Merle d'Aubigné and Postel , hip abductor function ( using a spring-balance ) , and incidence of Trendelenburg 's sign ( according to the Kuhfuss-classification ) . Statistical analysis was performed in case of continuous data using the t test and the Mann-Whitney test , respectively , and in case of categorical data using Fisher 's exact test and the chi-squared test , respectively . The level of significance was set as p < 0.05 . RESULTS Average duration of surgery ( CASPAR : 100.6 min ; conventional : 51.5 min ; p < 0.0001 ) as well as average loss of haemoglobin ( CASPAR : 4.5 mg/dL ; conventional : 3.3 mg/dL ; p = 0.0002 ) differed significantly , whereas the incidence of complications ( CASPAR : two dislocations , one sciatic paresis , one deep infection ; conventional : one dislocation , two fissures ) , revision rate ( CASPAR : 5.6 % ; conventional : 2.9 % ) , and incidence of heterotopic ossifications ( CASPAR : 30.6 % ; conventional : 17.1 % ) was comparable following both procedures ( p > 0.05 ) . Improvement of the Harris hip score also was comparable in both groups ( CASPAR : 40.9 to 86.1 points ; conventional : 39.5 to 88.0 points ; p = 0.21 ) , whereas improvement of the score according to Merle d'Aubigné and Postel was significantly greater following the manual procedure ( CASPAR : 10.1 to 16.0 points ; conventional : 8.3 to 16.6 points ; p < 0.0001 ) . Differences between the two groups were also significant regarding hip abductor function ( CASPAR : 76.1 % ; conventional : 93.8 % of the contralateral hip ; p < 0.0001 ) and incidence of Trendelenburg 's sign ( CASPAR : 61.1 % ; conventional : 25.7 % ; p = 0.0014 ) . CONCLUSION The significant functional impairment following robotic assisted THA should be taken critically into consideration prior to initiating such procedure The ROBODOC system has provided better fit and fill of the stem and less destruction of the bony architecture than with manual surgery . These benefits might affect femoral periprosthetic bone remodeling . We evaluated the effects of robotic milling in cementless total hip arthroplasty ( THA ) in a longitudinal 24-month follow-up study using dual energy X-ray absorptiometry ( DEXA ) and plain radiographs of 29 patients ( 31 hips ) after ROBODOC THA and 24 patients ( 27 hips ) after manual THA with the same stem design . To minimize the influence of other factors on bone remodeling , only female osteoarthritis patients , who had no drugs that might affect bone metabolism were enrolled . Significantly less bone loss occurred at the proximal periprosthetic areas in the ROBODOC group . In zone 1 , the decrease was 15.5 versus 29.9 % using conventional rasping ; in zone 7 , the loss was 17.0 % with ROBODOC compared to 30.5 % with conventional rasping ( p < 0.05 ) . On radiographs , endosteal spot welds in the proximal medial portion were more pronounced in the ROBODOC group ( 48 vs. 11 % in the conventional group , p < 0.05 ) . Our results suggest that robotic milling is effective in facilitating proximal load transfer around the femoral component and minimizing bone loss after cementless THA We performed a prospect i ve , r and omised controlled trial of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery . A total of 27 patients ( 28 knees ) awaiting unicompartmental knee arthroplasty were r and omly allocated to have the operation performed conventionally or with the assistance of the Acrobot . The primary outcome measurement was the angle of tibiofemoral alignment in the coronal plane , measured by CT . Other secondary parameters were evaluated and are reported . All of the Acrobot group had tibiofemoral alignment in the coronal plane within 2 degrees of the planned position , while only 40 % of the conventional group achieved this level of accuracy . While the operations took longer , no adverse effects were noted , and there was a trend towards improvement in performance with increasing accuracy based on the Western Ontario and McMaster Universities Osteoarthritis Index and American Knee Society scores at six weeks and three months . The Acrobot device allows the surgeon to reproduce a pre-operative plan more reliably than is possible using conventional techniques which may have clinical advantages Abstract Restoration of femoral offset and acetabular inclination may have an effect on polyethylene ( PE ) wear in THA . We therefore assessed the effect of femoral offset and acetabular inclination ( angle ) on acetabular conventional ( not highly cross-linked ) PE wear in uncemented THA . We prospect ively followed 43 uncemented THAs for a minimum of 49 months ( mean , 64 months ; range , 49–88 months ) . Radiographs were assessed for femoral offset , acetabular inclination , and conventional PE wear . The mean ( ± st and ard deviation ) linear wear rate in all THAs was 0.14 mm/year ( ± 0.01 mm/year ) and the mean volumetric wear rate was 53.1 mm3/year ( ± 5.5 mm3/year ) . In THAs with an acetabular angle less than 45 ° , the mean wear was 0.12 mm/year ( ± 0.01 mm/year ) compared with 0.18 mm/year ( ± 0.02 mm/year ) in those with a reconstructed acetabular angle greater than 45 ° . Reproduction of a reconstructed femoral offset to within 5 mm of the native femoral offset was associated with a reduction in conventional PE wear ( 0.12 mm/year versus 0.16 mm/year ) . Careful placement of the acetabular component to ensure an acetabular angle less than 45 ° in the reconstructed hip allows for reduced conventional PE wear . Level of Evidence : Level II , prospect i ve study . See Guidelines for Authors for a complete description of levels of evidence Background Improper acetabular component orientation in THA has been associated with increased dislocation rates , component impingement , bearing surface wear , and a greater likelihood of revision . Therefore , any reasonable steps to improve acetabular component orientation should be considered and explored . Questions / purpose sWe therefore sought to compare THA with a robotic-assisted posterior approach with manual alignment techniques through a posterior approach , using a matched-pair controlled study design , to assess whether the use of the robot made it more likely for the acetabular cup to be positioned in the safe zones described by Lewinnek et al. and Callanan et al. Methods Between September 2008 and September 2012 , 160 THAs were performed by the senior surgeon . Sixty-two patients ( 38.8 % ) underwent THA using a conventional posterior approach , 69 ( 43.1 % ) underwent robotic-assisted THA using the posterior approach , and 29 ( 18.1 % ) underwent radiographic-guided anterior-approach THAs . From September 2008 to June 2011 , all patients were offered anterior or posterior approaches regardless of BMI and anatomy . Since introduction of OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusion The results of this meta- analysis suggest that robotic-assisted THA has certain advantages over conventional THA , including the results of component positioning and rates of intraoperative complications .

MS2_fixed_5_shot265

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The natural history of mitochondrial diseases is poorly understood , limiting our ability to offer prognostic advice to patients or to evaluate therapy . One major obstacle to improving our underst and ing is the lack of a clinical rating scale to monitor the extensive clinical spectrum of mitochondrial disease . In this article , the authors describe the development and validation of a practical and semiquantitative rating scale , the Newcastle Mitochondrial Disease Adult Scale . Objective : To develop a reliable and valid new rating scale for measuring the functional impact of muscular dystrophy . Design : Prospect i ve and longitudinal investigation . Setting : Three academic medical centres in Taiwan and the Muscular Dystrophy Association of Taiwan . Measures : The Brooke Scale , the Vignos Scale , the Barthel Index , muscular strength , contracture severity , and predicted forced vital capacity ( FVC% ) . Methods : Scale development was in three stages . In stage I , a preliminary pool of 53 items was generated from patient interviews ( n-/25 ) , literature review , existing functional rating scales and expert opinion . In stage II , these items were administered to 85 patients with muscular dystrophy . The result ing data were analysed to construct a rating scale ( the Muscular Dystrophy Functional Rating Scale , MDFRS ) that encompassed four unidimensional constructs : mobility , basic activities of daily living , arm function and impairment . In stage III , the measurement properties of this rating scale were assessed in 121 muscular dystrophy patients different from those examined with the preliminary instrument . Results : Internal consistency reliability was excellent for all domains of the final 33-item scale , with values of Cronbach ’s alpha ranging from 0.84 to 0.97 . Intraclass correlation coefficients for test-retest and inter-rater reliability were 0.99 for all domains of the MDFRS . The MDFRS showed moderate to high correlations with a range of functional rating scales measuring similar aspects and impairment parameters ( Spearman ’s rho=0.65 - 0.91 ; P<0.001 , each ) . Confirmatory factor analysis supported a unitary construct of the four-dimensional MDFRS . The MDFRS had small floor and ceiling effects in the study sample s. Sensitivity to change was confirmed by large st and ardized response means for the MDFRS total score . Conclusions : The MDFRS is a reliable and valid disease-specific measure of functional status for patients with muscular dystrophy INTRODUCTION The Motor Function Measure ( MFM ) is widely used to assess severity and progression of neuromuscular diseases . Validity was established in a group of patients aged 6 - 60 years with suspected or confirmed diagnosis of neuromuscular diseases , Duchenne Muscular Dystrophy being the most frequent diagnosis in the population tested . OBJECTIVES Our aim was to check the validity of the MFM in a hospital department specialized in neuromuscular diseases in the follow-up of adult out- patients presenting a myopathy , such population being very different from the MFM validation group in terms of age and sub-groups of myopathy . METHODS One hundred patients were r and omly selected in the Reference Center for Neuromuscular Diseases of Nice ( France ) between 2005 and 2007 . Were collected : the MFM score , manual muscular testing ( MMT ) of lower and upper limb , face and spine , Brooke and Vignos scores . MFM and its three dimensions D1 ( st and ing position and transfers ) , D2 ( axial and proximal limb motor function ) and D3 ( distal motor function ) were compared to the other scores with the Spearman Correlation Coefficient and the Principal Component Analysis . RESULTS Patients were aged 18 - 78 years . The most frequent diagnoses were Steinert 's Muscular Dystrophy ( DM1 ) and Facio-ScapuloHumeral Dystrophy ( FSHD ) ( 30 % and 29 % ) . MFM was significantly correlated to all other scores except for Face MMT . However , Face MMT was correlated to D1 and D2 in DM1 patients and to D2 in FSHD patients . DISCUSSION Our results confirm the validity of the MFM in adult patients with muscular diseases . However , the MFM global score and its three dimensions D1 , D2 and D3 are variously correlated with the facial and axial muscle testing . Therefore , we recommend using separately the three dimensions D1 , D2 , D3 ( rather than the global score ) and , if more accuracy is required , the facial and axial muscle testing Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields STUDY OBJECTIVES The purpose was to investigate a possible relationship between different parameters of physical function , spirometric measurements , and the approaching need for mechanical ventilation . DESIGN A nonr and omized , prospect i ve , descriptive study of 11 patients with spinal muscular atrophy type II ( SMA-II ) and 14 patients with Duchenne muscular dystrophy ( DMD ) . At a home visit , the anthropometric indices of age , height , and weight were recorded , the degree of disability was scored , and measurement of the strength of eight muscle groups and spirometry was performed . The interdependence of the variables was analyzed and the intergroup differences evaluated . Eighteen months later , it was found that one of the authors ( B.J. ) , who was blind to the results of the first examination had instituted home mechanical ventilation on seven of the patients . The data were analyzed retrospectively for their predictive value as indicators of approaching ventilator dependency . RESULTS The seven patients who needed mechanical ventilation were the patients with DMD with the highest disability score ( Egen Klassifikation [ EK ] sum > 20 ) and the smallest values for FVC < 1.2 L ( FVC% < 30 ) . We found a significant correlation ( p = 0.002 ) between FVC% and the EK sum at the first examination and between the FVC% and the time until treatment with mechanical ventilation was instituted ( p = 0.023 ) . Although 7 of the 11 patients with SMA type II had FVC below 1.2 L and some of them had an EK sum score higher ( indicating more disability ) than some patients with DMD who needed mechanical ventilation , none of them required mechanical ventilation . CONCLUSION In this investigation , a combination of EK sum and FVC% provided a better indication of the approaching need for mechanical ventilation in the patients with DMD than the variables separately Therapeutic trials in muscular dystrophy have often been inconclusive . A protocol has been design ed which selects patients with Duchenne muscular dystrophy and permits accurate measurement of their status . An integral part of the protocol is a system for checking on the consistency of the data obtained using a computer program Abstract Sporadic inclusion body myositis ( s-IBM ) is an acquired inflammatory muscle disease of unknown cause . In general , s-IBM presents with slowly progressive , asymmetric weakness , and atrophy of skeletal muscle . There is a mild transitory or nil responsiveness to st and ard immunosuppressive treatment . A controlled cross-over study of ¶22 s-IBM patients over 3 months showed a partial improvement in those treated with high-dose intravenous immunoglobulin therapy ( IVIG ) versus placebo . The present study included 22 patients aged 32–75 years and with a mean duration of disease of 5.2 ± 3.6 years . They were r and omized by a double-blind , placebo-controlled , cross-over design to monthly infusions of ¶2 g/kg bodyweight IVIG or to placebo for 6 months each , followed by the alternative treatment . After 6 and 12 months the response to treatment was evaluated , using a modified Medical Research Council scale , Neuromuscular Symptom Score ( NSS ) , the patient ’s own assessment of improvement , arm outstretched time , and electromyography . No serious side effects were seen , in particular no viral infection and no major cardiac or neurological complications . Overall there was no progression of the disease in 90 % of patients , unlike that which might have been expected in untreated patients . A mild and significant improvement ( 11 % ) in clinical symptoms was found using NSS , but not with other test procedures . There was a trend to mild improvement in treated patients when using other tests . Individual responses to treatment was heterogeneous . The validity of this study may be reduced by mismatch of groups with regard to age at onset and variability in disease expression . The findings of this study largely confirm those of a previous IVIG trial . Treatment with IVIG may be mildly effective in s-IBM by preventing disease progression or inducing mild improvement . Long-term studies are needed to evaluate further the benefit of IVIG therapy in s-IBM A multiclinic , collaborative study has been design ed to assess the natural progression and efficacy of treatment of Duchenne muscular dystrophy . This article describes the protocol for the evaluation technique and the method used to establish within ( intraobserver ) and between ( interobserver ) reliability of the protocol evaluation procedures . St and ardized patient evaluations were used , and consistency of evaluation was monitored by a computer . The reliability of the measures was analyzed 1 ) within observers by comparing the results of each of the first three tests done by each evaluator for all patients and 2 ) between observers by comparing , at multicenter group meetings , the results of each of the four evaluators ' tests of the same patient . We have demonstrated reliability for an evaluation method that will provide an objective foundation on which to cl aim a drug or therapeutic procedure does or does not have an effect in treating Duchenne muscular dystrophy Case reports and open-label studies suggest that coenzyme Q(10 ) ( CoQ(10 ) ) treatment may have beneficial effects in mitochondrial disease patients ; however , controlled trials are warranted to clinical ly prove its effectiveness . Thirty patients with mitochondrial cytopathy received 1200 mg/day CoQ(10 ) for 60 days in a r and omized , double-blind , cross-over trial . Blood lactate , urinary markers of oxidative stress , body composition , activities of daily living , quality of life , forearm h and grip strength and oxygen desaturation , cycle exercise cardiorespiratory variables , and brain metabolites were measured . CoQ(10 ) treatment attenuated the rise in lactate after cycle ergometry , increased ( ∽1.93 ml ) VO(2)/kg lean mass after 5 minutes of cycling ( P < 0.005 ) , and decreased gray matter choline-containing compounds ( P < 0.05 ) . Sixty days of moderate- to high-dose CoQ(10 ) treatment had minor effects on cycle exercise aerobic capacity and post-exercise lactate but did not affect other clinical ly relevant variables such as strength or resting lactate Fatigue in patients with mitochondrial cytopathies is associated with decreased basal and postactivity muscle phosphocreatine ( PCr ) . Creatine monohydrate supplementation has been shown to increase muscle PCr and high-intensity power output in healthy subjects . We studied the effects of creatine monohydrate administration ( 5 g PO b.i.d . x 14 days -- > 2 g PO b.i.d . x 7 days ) in 7 mitochondrial cytopathy patients using a r and omized , crossover design . Measurements included : activities of daily living ( visual analog scale ) ; ischemic isometric h and grip strength ( 1 min ) ; basal and postischemic exercise lactate ; evoked and voluntary contraction strength of the dorsiflexors ; nonischemic , isometric , dorsiflexion torque ( NIDFT , 2 min ) ; and aerobic cycle ergometry with pre- and post-lactate measurements . Creatine treatment result ed in significantly ( P < 0.05 ) increased h and grip strength , NIDFT , and postexercise lactate , with no changes in the other measured variables . We concluded that creatine monohydrate increased the strength of high-intensity anaerobic and aerobic type activities in patients with mitochondrial cytopathies but had no apparent effects upon lower intensity aerobic activities OBJECTIVE Polymyositis is a rare inflammatory muscular disease of unknown cause . Corticosteroids and immunosuppressive drugs are the first choice of therapy but are not always effective and may cause serious side effects . Many studies have shown that polyvalent intravenous immunoglobulin ( IVIG ) may be of interest for the treatment of dermatomyositis . We carried out an open , prospect i ve study to evaluate the efficacy of IVIG in subjects with polymyositis that was refractory to traditional treatments , and we evaluated the benefits of this therapy over a long-term period of followup . METHODS Thirty- OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

RESULTS We found that none of the 19 instruments have sufficiently comprehensive reporting of measurement or feasibility performance as would be required by regulatory authorities .

MS2_fixed_5_shot266

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Many PROMs used for evaluation of ankle osteoarthritis are not vali date d for this purpose . We hypothesize that frequently used PROMs have an early ceiling or floor effect . METHODS We prospect ively collected data from patients with ankle osteoarthritis between 2011 and 2013 . At baseline visit patients completed the Foot and Ankle Outcome Score , the Ankle Osteoarthritis Score , the American Orthopaedic Foot and Ankle Society scale , a visual analogue scale for pain and quality of life . Outcomes were analyzed for floor or ceiling effects . RESULTS 197 patients were included in the study . A floor effect was present for the AOFAS and VAS for pain in all groups . Floor and ceiling effect are absent for the FAOS outcome measure for all groups . CONCLUSIONS Physicians should be aware of floor or ceiling effects when evaluating treatment using patient reported outcome measures . The FAOS outcome measure lacks early ceiling or floor effects Responsiveness , the ability to detect meaningful clinical change , is a critical attribute of instruments used to evaluate outcomes of treatments . The authors hypothesized that self-administered symptom severity and functional status question naires are more responsive to clinical improvement after carpal tunnel release than traditional physical examination measures of strength and sensibility . Data were obtained from a r and omized clinical trial of endoscopic versus open carpal tunnel release conducted in four university medical centers . Patients were evaluated before surgery and 3 months after surgery . Seventy-four patients indicating that they were more than 80 % satisfied with the results of surgery were assumed to have clinical ly meaningful improvement and were the focus of the analysis . Evaluations included question naires assessing symptom severity , functional status , and activities of daily living as well as measurement of grip , pinch , and abductor pollicus brevis strength , and 2-point discrimination and Semmes-Weinstein pressure sensibility . Responsiveness was calculated with the st and ardized response mean ( mean change/st and ard deviation of change ) as well as the effect size ( mean change/st and ard deviation of baseline values ) . The symptom severity scale was four times as responsive , and the functional status and activities of daily living scales were twice as responsive , as the measures of strength and sensibility . Self-administered symptom severity and functional status scales are much more responsive to clinical improvement than measures of neuromuscular impairment and should serve as primary outcomes in clinical studies of therapy for carpal tunnel syndrome OBJECTIVES The authors evaluated the relative responsiveness to change of generic versus disease-specific and unweighted versus weighted health status measures in carpal tunnel syndrome ( CTS ) . METHODS Data were obtained from 196 subjects followed in a prospect i ve community-based cohort study in Maine who underwent carpal tunnel release ( The Maine Carpal Tunnel Syndrome Study ) . Patients were evaluated before and 6 months after surgery . The disease-specific , unweighted severity score was derived from the vali date d Carpal Tunnel Syndrome Assessment Question naire . Patients were asked to rate the importance of each symptom included in the severity score . Each severity question was weighted by its importance , creating a disease-specific weighted score . Generic instruments were the SF-36 , SF-12 , and a Quality of Life Rating Scale . Sensitivity to change was calculated with the st and ardized response mean ( SRM , mean change/st and ard deviation of change ) as well as the effect size ( ES , mean change/st and ard deviation of baseline values ) . The ability of the instruments to distinguish clinical ly important differences was assessed by correlating the changes in scores with global ratings on satisfaction and perceived improvement as external criteria . RESULTS The disease-specific weighted score ( SRM : 1.56 , ES : 1.99 ) was more responsive than the unweighted score ( SRM : 1.36 , ES : 1.57 ) . The Quality of Life Rating Scale , SF-36 , and SF-12 subscales were less sensitive to change , with st and ardized response means and effect sizes that ranged from -0.23 to 0.88 . The ability to distinguish clinical ly important differences was higher for the two disease-specific scales . The coefficients of correlation with the external criteria ranged from 0.50 to 0.56 for the unweighted score and 0.56 to 0.62 for the weighted score and were significantly stronger than the correlations between external measures and the most responsive subscale of the SF-36 ( Bodily Pain subscale , r = 0.36 ) . The SF-12 health survey performed as well as the SF-36 in term of responsiveness and ability to distinguish clinical ly important change . CONCLUSIONS Disease-specific measures were superior to generic measures in capturing clinical change after carpal tunnel release , and a weighted score was slightly more responsive than the unweighted score . The SF-12 showed comparable psychometric properties compared with the longer 36-item Short-Form Survey Background : The increasing use of computerized adaptive tests ( CATs ) to generate outcome measures during rehabilitation has prompted questions concerning score interpretation . Objective : The purpose of this study was to describe meaningful interpretations of functional status ( FS ) outcome measures estimated with a body part – specific CAT developed from the Lower-Extremity Functional Scale ( LEFS ) . Design : This investigation was a prospect i ve cohort study of 8,714 people who had hip impairments and were receiving physical therapy in 257 outpatient clinics in 31 states ( United States ) between January 2005 and June 2007 . Methods : Four approaches were used to clinical ly interpret outcome data . First , the st and ard error of the estimate was used to construct the 90 % confidence interval for each CAT-generated score estimate . Second , percentile ranks were applied to FS scores . Third , 2 threshold approaches were used to define individual subject – level change : statistically reliable change and clinical ly important change . The fourth approach was a functional staging method . Results : The precision of a single score was estimated from the FS score ±4 . On the basis of the score distribution , 25th , 50th , and 75th percentile ranks corresponded to intake FS scores of 40 , 48 , and 59 and discharge FS scores of 50 , 61 , and 75 , respectively . The reliable change index supported the conclusion that changes in FS scores of 7 or more units represented statistically reliable change , and receiver operating characteristic analyses supported the conclusion that changes in FS scores of 6 or more units represented minimal clinical ly important improvement . Participants were classified into 5 hierarchical levels of FS using a functional staging method . Limitations : Because this study was a secondary analysis of prospect ively collected data via a proprietary data base management company , generalizability of results may be limited to participating clinics . Conclusions : The results demonstrated how outcome measures generated from the hip LEFS CAT can be interpreted to improve clinical meaning . This finding might facilitate the use of patient-reported outcomes by clinicians during rehabilitation services Background : The use of patient-reported outcomes continues to exp and beyond the scope of clinical research to involve st and ard of care assessment s across orthopedic practice s. It is currently unclear how to interpret and apply this information in the daily care of patients in a foot and ankle clinic . We prospect ively examined the relationship between preoperative patient-reported outcomes ( PROMIS Physical Function , Pain Interference and Depression scores ) , determined minimal clinical important differences for these values , and assessed if these preoperative values were predictors of improvement after operative intervention . Methods : Prospect i ve collection of all consecutive patient visits to a multisurgeon tertiary foot and ankle clinic was obtained between February 2015 and April 2016 . This consisted of 16 023 unique visits across 7996 patients , with 3611 new patients . Patients undergoing elective operative intervention were identified by ICD-9 and CPT code . PROMIS physical function , pain interference , and depression scores were assessed at initial and follow-up visits . Minimum clinical ly important differences ( MCIDs ) were calculated using a distribution-based method . Receiver operating characteristic ( ROC ) curves were calculated to determine whether preoperative PROMIS scores were predictive of achieving MCID . Cutoff values for PROMIS scores that would predict achieving MCID and not achieving MCID with 95 % specificity were determined . Prognostic pre- and posttest probabilities based off these cutoffs were calculated . Patients with a minimum of 7-month follow-up ( mean 9.9 ) who completed all PROMIS domains were included , result ing in 61 patients . Results : ROC curves demonstrated that preoperative physical function scores were predictive of postoperative improvement in physical function ( area under the curve [ AUC ] 0.83 ) . Similarly , preoperative pain interference scores were predictive of postoperative pain improvement ( AUC 0.73 ) and preoperative depression scores were also predictive of postoperative depression improvement ( AUC 0.74 ) . Patients with preoperative physical function T score below 29.7 had an 83 % probability of achieving a clinical ly meaningful improvement in function as defined by MCID . Patients with preoperative physical function T score above 42 had a 94 % probability of failing to achieve MCID . Patients with preoperative pain above 67.2 had a 66 % probability of achieving MCID , whereas patients with preoperative pain below 55 had a 95 % probability of failing to achieve MCID . Patients with preoperative depression below 41.5 had a 90 % probability of failing to achieve MCID . Conclusion : Patient-reported outcomes ( PROMIS ) scores obtained preoperatively predicted improvement in foot and ankle surgery . Threshold levels in physical function , pain interference , and depression can be shared with patients as they decide whether surgery is a good option and helps place a numerical value on patient expectations . Physical function scores below 29.7 were likely to improve with surgery , whereas those patients with scores above 42 were unlikely to make gains in function . Patients with pain scores less than 55 were similarly unlikely to improve , whereas those with scores above 67 had clinical ly significant pain reduction postoperatively . Reported prognostic cutoff values help to provide guidance to both the surgeon and the patient and can aid in shared decision making for treatment . Level of Evidence : Level II , prognostic study The patient-reported outcomes measurement information system ( PROMIS ) physical function item bank v1 ( PPFIB ) contains 124 item response theory ( IRT ) calibrated items ( Rose et al. 2008 . J Clin Epidemiol 61:17–33).We report the psychometric properties of these items within an outpatient , orthopaedic patient population . In particular , we investigated whether a single unidimensional IRT scale can adequately define physical function of patients presenting with primarily upper or lower extremity orthopaedic complaints . We conducted a prospect i ve study at an orthopaedic outpatient clinic to collect data from 865 adult patients with all 124 PROMIS physical function items and seven demographic items . Items were evaluated by a Rasch model . Total variance ( 60.6 % ) across the 124 items was explained by a single Rasch dimension . The variance explained by the second dimension was 7.7 % , reflecting differential item functioning in the upper and lower extremity patients . The upper extremity physical function items had a pronounced ceiling effect . A single physical function dimension accounts for most of the item variance in the PPFIB , suggesting that the items are measuring predominantly one single construct . Separate subscales for lower versus upper extremities , especially with additional items at the upper trait level of the upper extremity subscale , may further enhance evaluation of physical function in orthopaedic patients The use of retrospectively acquired preoperative AOFAS rating scores in clinical research to assess the outcomes of elective foot and ankle surgery has not been vali date d. The data obtained utilizing this methodology may misrepresent the results and lead to spurious conclusions . This investigation compared preoperative AOFAS Ankle-Hindfoot scores obtained before and after surgery from patients who had undergone elective surgery to determine if retrospectively acquired scores match those collected prospect ively . Only two out of 47 patients ( 4 % ) recalled identical AOFAS scores . The mean difference between the preoperative scores ( preoperative score obtained after surgery minus preoperative score obtained before surgery ) was −5.3 points . Fifteen patients ( 32 % ) had preoperative scores that differed by 20 points or more . Kappa statistics found little agreement among the five elements that comprised the two preoperative scores when responses obtained before and after surgery were compared to one another . The results suggest that preoperative clinical rating scores obtained after elective surgery are a poor predictor of the patient 's preoperative condition and that studies which employ retrospectively acquired preoperative AOFAS clinical rating scores may overestimate the benefit of surgery Abstract Of the various methods for measuring pain the visual analogue scale seems to be the most sensitive . For assessing response to treatment a pain-relief scale has advantages over a pain scale . Pain can not be said to have been relieved unless pain or pain relief has been directly measured A Foot Function Index ( FFI ) was developed to measure the impact of foot pathology on function in terms of pain , disability and activity restriction . The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales . Both total and sub-scale scores are produced . The FFI was examined for test-retest reliability , internal consistency , and construct and criterion validity . A total of 87 patients with rheumatoid arthritis were used in the study . Test-retest reliability of the FFI total and sub-scale scores ranged from 0.87 to 0.69 . Internal consistency ranged from 0.96 to 0.73 . With the exception of two items , factor analysis supported the construct validity of the total index and the sub-scales . Strong correlation between the FFI total and sub-scale scores and clinical measures of foot pathology supported the criterion validity of the index . The FFI should prove useful for both clinical and research purpose The assessment of a measure of chronic pain , should be reliable , valid and sensitive to change . Our study evaluated the OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

While there are many different scoring systems available for foot and ankle specialists to use to assess or demonstrate the effectiveness of treatments , the AOFAS , while it is an unvali date d scoring system , is the most commonly used scoring system in this review . This review presents data about commonly used patient reported outcomes systems in foot and ankle surgery .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Impaired motor development can significantly affect a child 's life and may result in an increased risk of a range of physical and psychological disorders . Active video game ( AVG ) interventions have been demonstrated to enhance motor skills in children with Developmental Coordination Disorder ( DCD ) ; however a home-based intervention has not been assessed . OBJECTIVES The primary aim of this study was to compare the changes in motor coordination between a 16 week period of AVG use , with 16 weeks of normal activities ( NAG ) . The secondary aim was to compare the child and parent perceptions of their physical performance between the AVG and NAG conditions . METHODS Twenty-one 9 - 12 year olds ( 10 males ) were confirmed to be at risk of DCD ( ⩽ 16th percentile Movement Assessment Battery for Children-2nd edition ( MABC-2 ) and ⩽ 15th percentile Developmental Coordination Disorder Question naire ( DCDQ ) ) and participated in this crossover r and omised and controlled trial . Data was collected at study entry , after the first 16 week condition and following the final 16 week condition , including ; ( 1 ) the MABC-2 , ( 2 ) three-dimensional motion analysis of single leg balance and finger-nose tasks , and ( 3 ) parent perception of physical skills . Participant perception of physical skills was collected only after the first and second conditions . RESULTS There was no significant difference between AVG and NAG for any of the primary variables including the MABC-2 , balance centre-of-mass path distance and finger-nose path distance . There was no significant intervention effect for secondary measures of motor coordination ; however the children perceived their motor skills to be significantly enhanced as a result of the AVG intervention in comparison to the period of no intervention . CONCLUSION A 16 week home based AVG intervention did not enhance motor skills in children with DCD , although they perceived their physical skills to be significantly improved . TRIAL REGISTRATION Australia and New Zeal and Clinical trials Registry ( ACTRN 12611000400965 ) [ Purpose ] The purpose of the study was to evaluate the effects of conventional neurological treatment and a virtual reality training program on eye-h and coordination in children with cerebral palsy . [ Subjects ] Sixteen children ( 9 males , 7 females ) with spastic diplegic cerebral palsy were recruited and r and omly assigned to the conventional neurological physical therapy group ( CG ) and virtual reality training group ( VRG ) . [ Methods ] Eight children in the control group performed 45 minutes of therapeutic exercise twice a week for eight weeks . In the experimental group , the other eight children performed 30 minutes of therapeutic exercise and 15 minutes of a training program using virtual reality twice a week during the experimental period . [ Results ] After eight weeks of the training program , there were significant differences in eye-h and coordination and visual motor speed in the comparison of the virtual reality training group with the conventional neurological physical therapy group . [ Conclusion ] We conclude that a well- design ed training program using virtual reality can improve eye-h and coordination in children with cerebral palsy The purpose of this study was to investigate the effects of training with the Wii-balance board on balance and balance-related skills of children with poor motor performance . Twenty-nine children ( 23 boys , 6 girls ; aged 7 - 12 years ) participated in this study and were r and omly assigned to an experimental and control group . All children scored below the 16th percentile on a st and ardized test of motor ability and balance skills ( Movement Assessment Battery for children ( M-ABC-2 ) ) . Before and after a six-week Wii-intervention ( M=8h , 22 min , SD=53 min ) , the balance skills of the experimental group and control group were measured with the M-ABC-2 and the Bruininks-Oseretsky test of motor proficiency ( BOT-2 ) . Both groups improved on all tests . The M-ABC-2 and the BOT-2 total balance-scores of the experimental group improved significantly from pre to post intervention , whereas those of the control group showed no significant progress . This result ed in significant interaction-effects , favoring the experimental children . No transfer-effects of the intervention on balance-related skills were demonstrated . Our findings showed that the Wii-balance board is an effective intervention for children with poor balance control . Further development and investigation of the intervention could be directed toward the implementation of the newly acquired balance-skills in daily life AIM The aim of this study was to evaluate the interrater reliability and convergent validity of the American Academy for Cerebral Palsy and Developmental Medicine 's ( AACPDM ) methodology for conducting systematic review s ( group design studies ) . METHOD Four clinicians independently rated 24 articles for the level of evidence and conduct using AACPDM methodology . Study conduct was also assessed using the Effective Public Health Practice Project scale . Raters were r and omly assigned to one of two pairs to resolve discrepancies . The level of agreement between individual raters and pairs was calculated using kappa ( α=0.05 ) and intraclass correlations ( ICCs ; α=0.05 ) . Spearman 's rank correlation coefficient was calculated to evaluate the relationship between raters ' categorization of quality categories using the two tools . RESULTS There was acceptable agreement between raters ( κ=0.77 ; p<0.001 ; ICC=0.90 ) and between assigned pairs ( κ=0.83 ; p<0.001 ; ICC=0.96 ) for the level of evidence ratings . There was acceptable agreement between pairs for four of the seven conduct questions ( κ=0.53 - 0.87 ) . ICCs ( all raters ) for conduct category ratings ( weak , moderate , and strong ) also indicated good agreement ( ICC=0.76 ) . Spearman 's rho indicated a significant positive correlation for the overall quality category comparisons of the two tools ( 0.52 ; p<0.001 ) . CONCLUSIONS The AACPDM rating system has acceptable interrater reliability . Evaluation of its study quality ratings demonstrated reasonable agreement when compared with a similar tool The aim of the present study was to determine the user satisfaction of the EyeToy for the training of the upper limb in children with cerebral palsy ( CP ) . User satisfaction was measured in 12 children with CP , using a postexperience question naire , primarily based on a presence question naire . In general , children with CP were satisfied with and motivated by the EyeToy training . In addition , a first evaluation study was performed to determine the effect of this training method on the upper limb function . Ten children with CP were r and omly assigned to the intervention ( mean age 11 years , 9 months ; SD 2,3 ) and the control group ( mean age 12 years , 3 months ; SD 3,2 ) . After a treatment period of 6 weeks , the intervention group completed a user satisfaction question naire . Functional outcome was measured using the Melbourne Assessment scores . Percentage scores of the Melbourne Assessment of 7 of the 10 children were the same or changed only 1 % to 2 % from baseline to followup . However , in the experimental group , two children improved more , 9 % and 13 % respectively . In conclusion , it can be said that the EyeToy is a motivational training tool for the training of children with CP and has the potential to improve upper extremity function BACKGROUND / PURPOSE Improvement in mobility function has been the primary goal in the rehabilitation of children with cerebral palsy . Few studies have examined the effectiveness of task-oriented strength training for children with cerebral palsy . The purpose of this study was to examine the effects of task-oriented strength training on mobility function in children with cerebral palsy . STUDY DESIGN A single-blind , r and omized controlled trial with pre-training and post-training evaluations . MATERIAL S AND METHODS Ten children with cerebral palsy ( GMFCS levels I-III ) were r and omly assigned to an experimental group ( N = 5 ) or control group ( N = 5 ) . Mobility function was assessed using the Gross Motor Function Measure ( GMFM ) and the Timed " Up and Go " ( TUG ) test . Participants in the control group received conventional physical therapy focused on improving walking and balance through facilitation and normalization of movement patterns . Participants in the experiment group received task-oriented strength training focused on strengthening the lower extremities and practicing functional tasks similar to those the child performs during daily activities . RESULTS After the 5-week training period there were significant improvements in the experimental group for dimension D ( p = 0.009 ) , and dimension E ( p = 0.009 ) of the GMFM . The experimental group significantly reduced the time taken to complete the TUG ( p = 0.017 ) . CONCLUSION / SIGNIFICANCE This study supports the efficacy of task-oriented strength training for improving mobility function in children with cerebral palsy . The findings demonstrate that the application of a task-oriented strength training program is linked to positive functional outcomes . The results suggest that children with cerebral palsy may benefit from a task-oriented strength training program . Further studies with a larger r and omized sample and longer post-intervention follow-up are necessary to document the long-term effects of participation in task-oriented strength training programs in the cerebral palsy population [ Purpose ] Motor control and muscle strength impairments are the prime reasons for motor behavior disorders in children with spastic cerebral palsy . These impairments lead to histological changes in muscle growth and the learning of motor skills . Therefore , such children experience reduced muscle force generation and decreased muscle flexibility . We investigated the effect of training with Nintendo Wii Fit games on motor performance in children with spastic cerebral palsy . [ Subjects and Methods ] Forty children with cerebral palsy spastic diplegia aged 6–10 years diagnosed with level-3 functional capabilities according to the Gross Motor Classification System ( GMFCS ) were enrolled . Participants were divided r and omly into equal groups : group ( A ) that practice d with the Nintendo Wii Fit game for at least 20 minutes/day for 12 weeks and group ( B ) that underwent no training ( control group ) . The Movement Assessment Battery for Children-2 ( mABC-2 ) was used to assess motor performance , because it mainly involves motor tasks very similar to those involved in playing Nintendo Wii Fit games , e.g. , goal -directed arm movements , balancing , and jumping . [ Results ] There were significant improvements in the subscales of the motor performance test of those who practice d with the Nintendo Wii , while the control group showed no significant changes . [ Conclusion ] Using motion interactive games in home rehabilitation is feasible for children with cerebral palsy INTRODUCTION This study aim ed to evaluate if use of an activity promoting computer game , used in the home ( Nintendo Wii Fit ; Nintendo Co Ltd , Japan ) , could influence balance related outcome measures in children with cerebral palsy . METHOD Eighteen children with hemiplegic or diplegic cerebral palsy were recruited for the study . A r and omised cross-over design was used with children tested at baseline , after five weeks of playing Wii Fit games and after five weeks without any intervention . Outcome measures of interest included : performance on the modified sensory organisation test , reactive balance test and rhythmic weight shift test . RESULTS No significant difference was observed between testing occasions for any of the balance measures investigated ( p > 0.05 ) . CONCLUSION Our results suggest that use of a Nintendo Wii balance board and Wii Fit software for a minimum of thirty minutes per day in the patient 's own home , over a five week period , is not effective as a balance training tool in children with cerebral palsy Neuromotor Task Training ( NTT ) and Nintendo Wii Fit Training ( Wii training ) are both task-based interventions used to improve performance in children with motor coordination problems . The aim of this study was to compare the efficacy of these two interventions on the motor performance , isometric strength and cardiorespiratory fitness ( aerobic and anaerobic capacity ) of children with Developmental Coordination Disorder ( DCD ) attending mainstream schools in a low-income setting . A pragmatic , quasi-experimental study design was utilized . Children between the ages of 6 - 10 years , who scored at or below the 16th percentile on the Movement Assessment Battery for Children-2 ( MABC-2 ) and whose teacher reported a functional motor problem , were allocated to either NTT ( n=37 ) or Wii training ( n=19 ) groups depending on school of attendance . The MABC-2 , a h and -held dynamometer , the Functional Strength Measure , the Muscle Power Sprint Test and the 20 m Shuttle Run Test were used to assess performance at baseline and after the intervention . The main findings show that the mean motor performance scores of both groups improved over the study period . However , significant differences in improvement were detected between groups , with the NTT group showing greater improvement in motor performance , functional strength and cardiorespiratory fitness . No improvements in isometric strength were seen in either group . The Wii training group showed significant improvement in anaerobic performance . This study provides evidence to support the use of both the Wii Training and NTT for children with DCD . However , in comparison to Wii training , the NTT approach yields superior results across measures of motor proficiency , cardiorespiratory fitness and functional strength . The decision to use either approach may be influenced by re sources and time constraints This quasi-experimental study compared the effect of st and ard occupational therapy ( SOT ) and virtual reality using Wii gaming technology ( VRWii ) on children with Down syndrome ( DS ) . Children ( n = 105 ) were r and omly assigned to intervention with either SOT or VRWii , while another 50 served as controls . All children were assessed with measures of sensorimotor functions . At post-intervention , the treatment groups significantly outperformed the control group on all measures . Participants in the VRWii group had a greater pre-post change on motor proficiency , visual-integrative abilities , and sensory OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

All articles showed improvement in outcomes with AVG , although differences were not consistently significant compared with conventional therapy . However , AVG is feasible and shows potential for improving outcomes in this population .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background Selective serotonin reuptake inhibitors ( SSRIs ) are typically thought to have a delay of several weeks in the onset of their clinical effects . However , recent reports suggest they may have a much earlier therapeutic onset . A reduction in amygdala responsivity has been implicated in the therapeutic action of SSRIs . Aims To investigate the effect of a single dose of an SSRI on the amygdala response to emotional faces . Method Twenty-six healthy volunteers were r and omised to receive a single oral dose of citalopram ( 20 mg ) or placebo . Effects on the processing of facial expressions were assessed 3 h later using functional magnetic resonance imaging . Results Volunteers treated with citalopram displayed a significantly reduced amygdala response to fearful facial expressions compared with placebo . Conclusions Such an immediate effect of an SSRI on amygdala responses to threat supports the idea that antidepressants have an earlier onset of therapeutically relevant effects than conventionally thought BACKGROUND Patients with schizophrenia often suffer from cognitive deficits and negative symptoms that are poorly responsive to antipsychotics including clozapine . Clozapine-induced sedation can worsen cognition and impair social and occupational functioning . OBJECTIVES To evaluate the efficacy , tolerability , and safety of modafinil for negative symptoms , cognition , and wakefulness/fatigue in DSM-IV-diagnosed schizophrenia patients treated with clozapine . METHOD A double-blind , placebo-controlled , flexible-dosed 8-week pilot trial was conducted between September 2003 and September 2007 , adding modafinil up to 300 mg/d to stabilized schizophrenia out patients receiving clozapine . Psychopathology , cognition , and wakefulness/fatigue were assessed with st and ard rating scales . RESULTS Thirty-five patients were r and omly assigned to treatment with study drug and included in the analysis . Modafinil did not reduce negative symptoms or wakefulness/fatigue or improve cognition compared to placebo . Modafinil was well tolerated and did not worsen psychosis . CONCLUSIONS Results of this pilot trial do not support routine use of modafinil to treat negative symptoms , cognitive deficits , or wakefulness/fatigue in patients on clozapine . However , given our limited power to detect a treatment effect and the clear possibility of a type II error , larger trials are needed to resolve or refute a potential therapeutic effect of uncertain magnitude . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00573417 Rationale Cognitive impairments are important determinants of functional outcome in psychosis , which are inadequately treated by antipsychotic medication . Modafinil is a wake-promoting drug that has been shown to improve attention , memory and executive function in the healthy population and in patients with schizophrenia . Objectives We aim ed to establish modafinil ’s role in the adjunctive treatment of cognitive impairments in the first episode of psychosis , a time when symptoms may be more malleable than at chronic stages of the disease . Methods Forty patients with a first episode of psychosis participated in a r and omised , double-blind , placebo-controlled crossover design study assessing the effects of a single dose of 200 mg modafinil on measures of executive functioning , memory , learning , impulsivity and attention . Results Modafinil improved verbal working memory ( d = 0.24 , p = 0.04 ) , spatial working memory errors ( d = 0.30 , p = 0.0004 ) and strategy use ( d = 0.23 , p = 0.03 ) . It also reduced discrimination errors in a task testing impulsivity . Modafinil showed no effect on impulsivity measures , sustained attention , attentional set-shifting , learning or fluency . Conclusions Modafinil selectively enhances working memory in first episode psychosis patients , which could have downstream effects on patients ’ social and occupational functioning Abstract : In a double-blind , parallel groups study , 60 healthy student volunteers ( 29 men and 31 women , aged 19 - 22 years ) were r and omly allocated to receive placebo , 100 or 200 mg modafinil . Two hours later , in the early evening , they completed an extensive cognitive battery . The 3 groups did not differ in self-ratings of sleepiness or tiredness before the testing session , and there were no treatment-associated changes in these or in mood ratings during the tests . Modafinil was without effect in several tests of reaction time and attention , but the 200-mg group was faster at simple color naming of dots and performed better than placebo in the Rapid Visual Information Processing test of sustained attention . Modafinil was without effect on spatial working memory , but the 100-mg group performed better in the backward part of the digit span test . Modafinil was without effect on verbal short-term memory ( story recall ) , but 100 mg improved digit span forward , and both doses improved pattern recognition , although this was accompanied by a slowing of response latency in the 200-mg group . There were no significant effects of modafinil compared with placebo in tests of long-term memory , executive function , visuospatial and constructional ability , or category fluency . These results suggest that the benefits of modafinil are not clearly dose-related , and those from 100 mg are limited to the span of immediate verbal recall and short-term visual recognition memory , which is insufficient for it to be considered as a cognitive enhancer in non-sleep-deprived individuals Abstract Rationale . Modafinil , a novel wake-promoting agent , has been shown to have a similar clinical profile to that of conventional stimulants such as methylpheni date . We were therefore interested in assessing whether modafinil , with its unique pharmacological mode of action , might offer similar potential as a cognitive enhancer , without the side effects commonly experienced with amphetamine-like drugs . Objectives . The main aim of this study was to evaluate the cognitive enhancing potential of this novel agent using a comprehensive battery of neuropsychological tests . Methods . Sixty healthy young adult male volunteers received either a single oral dose of placebo , or 100 mg or 200 mg modafinil prior to performing a variety of tasks design ed to test memory and attention . A r and omised double-blind , between-subjects design was used . Results . Modafinil significantly enhanced performance on tests of digit span , visual pattern recognition memory , spatial planning and stop-signal reaction time . These performance improvements were complemented by a slowing in latency on three tests : delayed matching to sample , a decision-making task and the spatial planning task . Subjects reported feeling more alert , attentive and energetic on drug . The effects were not clearly dose dependent , except for those seen with the stop-signal paradigm . In contrast to previous findings with methylpheni date , there were no significant effects of drug on spatial memory span , spatial working memory , rapid visual information processing or attentional set-shifting . Additionally , no effects on paired associates learning were identified . Conclusions . These data indicate that modafinil selectively improves neuropsychological task performance . This improvement may be attributable to an enhanced ability to inhibit pre-potent responses . This effect appears to reduce impulsive responding , suggesting that modafinil may be of benefit in the treatment of attention deficit hyperactivity disorder OBJECTIVE Antidepressants that inhibit the reuptake of serotonin ( SSRIs ) or norepinephrine ( SNRIs ) are effective in the treatment of disorders such as depression and anxiety . Cognitive psychological theories emphasize the importance of correcting negative biases of information processing in the nonpharmacological treatment of these disorders , but it is not known whether antidepressant drugs can directly modulate the neural processing of affective information . The present study therefore assessed the actions of repeated antidepressant administration on perception and memory for positive and negative emotional information in healthy volunteers . METHOD Forty-two male and female volunteers were r and omly assigned to 7 days of double-blind intervention with the SSRI citalopram ( 20 mg/day ) , the SNRI reboxetine ( 8 mg/day ) , or placebo . On the final day , facial expression recognition , emotion-potentiated startle response , and memory for affect-laden words were assessed . Question naires monitoring mood , hostility , and anxiety were given before and after treatment . RESULTS In the facial expression recognition task , citalopram and reboxetine reduced the identification of the negative facial expressions of anger and fear . Citalopram also abolished the increased startle response found in the context of negative affective images . Both antidepressants increased the relative recall of positive ( versus negative ) emotional material . These changes in emotional processing occurred in the absence of significant differences in ratings of mood and anxiety . However , reboxetine decreased subjective ratings of hostility and elevated energy . CONCLUSIONS Short-term administration of two different antidepressant types had similar effects on emotion-related tasks in healthy volunteers , reducing the processing of negative relative to positive emotional material . Such effects of antidepressants may ameliorate the negative biases in information processing that characterize mood and anxiety disorders . They also suggest a mechanism of action potentially compatible with cognitive theories of anxiety and depression Modafinil , a novel cognitive enhancer , selectively improves neuropsychological task performance in healthy volunteers and adult patients with attention deficit hyperactivity disorder ( ADHD ) . It has been argued that persistent cognitive deficits in patients with schizophrenia are responsible for the failure of many patients to rehabilitate socially even when psychotic symptoms are in remission . The present study examined the potential of modafinil as a cognitive enhancer in schizophrenia . Twenty chronic patients with a diagnosis of schizophrenia were entered into a double-blind , r and omized , placebo-controlled crossover study using a 200 mg dose of modafinil . Modafinil had some cognitive enhancing properties in schizophrenia similar to those observed in healthy adults and adult patients with ADHD . Improvement was seen on short-term verbal memory span , with trends towards improved visual memory and spatial planning . This was accompanied by slowed response latency on the spatial planning task . No effect on stop-signal performance was seen . Importantly , significant improvement in attentional set shifting was seen , despite no effect of modafinil on this task being seen in healthy volunteers or ADHD patients . Modafinil may have potential as an important therapy for cognitive impairment in patients with schizophrenia , particularly because of its beneficial effects on attentional set shifting Methamphetamine (MA)-dependent individuals exhibit deficits in cognition and prefrontal cortical function . Therefore , medications that improve cognition in these subjects may improve the success of therapy for their addiction , especially when cognitive behavioral therapies are used . Modafinil has been shown to improve cognitive performance in neuropsychiatric patients and healthy volunteers . We therefore conducted a r and omized , double-blind , placebo-controlled , cross-over study , using functional magnetic resonance imaging , to examine the effects of modafinil on learning and neural activity related to cognitive function in abstinent , MA-dependent , and healthy control participants . Modafinil ( 200 mg ) and placebo were administered orally ( one single dose each ) , in counterbalanced fashion , 2 h before each of two testing sessions . Under placebo conditions , MA-dependent participants showed worse learning performance than control participants . Modafinil boosted learning in MA-dependent participants , bringing them to the same performance level as control subjects ; the control group did not show changes in performance with modafinil . After controlling for performance differences , MA-dependent participants showed a greater effect of modafinil on brain activation in bilateral insula/ventrolateral prefrontal cortex and anterior cingulate cortices than control participants . The findings suggest that modafinil improves learning in MA-dependent participants , possibly by enhancing neural function in regions important for learning and cognitive control . These results suggest that modafinil may be a suitable pharmacological adjunct for enhancing the efficiency of cognitive-based therapies for MA dependence Changes in serotonin neurotransmission have also been implicated in the etiology and treatment of impulse control disorders , depression , and anxiety . We have investigated the effect of enhancing serotonin function on fundamental brain processes that we have proposed are abnormal in these disorders . In all , 12 male volunteers received citalopram ( 7.5 mg intravenously ) and placebo pretreatment in a single-blind crossover design before undertaking Go/No-go , Loss/No-loss , and covert ( aversive ) face emotion recognition tasks during functional magnetic resonance imaging ( fMRI ) . Blood oxygenation level dependent responses were analyzed using Statistical Parametric Mapping ( SPM2 ) . The tasks activated prefrontal and subcortical regions generally consistent with literature with lateral orbitofrontal cortex ( BA47 ) common to the three tasks . Citalopram pretreatment enhanced the right BA47 responses to the No-go condition , but attenuated this response to aversive faces . Attenuations were seen following citalopram in the medial orbitofrontal ( BA11 ) responses to the No-go and No-loss ( ie relative reward compared with Loss ) conditions . The right amygdala response to aversive faces was attenuated by citalopram . These results support the involvement of serotonin in modulating basic processes involved in psychiatric disorders but argue for a process-specific , rather than general effect . The technique of combining drug challenge with fMRI ( pharmacoMRI ) has promise for investigating human psychiatric disorders OBJECTIVES Modafinil has recently been approved for the treatment of shift work sleep disorder , making it potentially available for shift-working emergency physicians . The authors ' objectives were to determine whether modafinil improved cognitive performance of emergency physicians following overnight shifts and to record symptoms and subjective evaluations OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

A review of its effects in schizophrenia suggests that modafinil facilitates cognitive functions , with pro-mnemonic effects and problem solving improvements . The systematic review on the neurochemical modulation of the modafinil suggests that its mnemonic enhancing properties might be the result of glutamatergic and dopaminergic increased neuronal activation in the hippocampus and in the prefrontal cortex respectively . Other neurotransmitters were also activated by modafinil in various limbic brain areas , suggesting that the drug acts on these brain regions to influence emotional responses .

MS2_fixed_5_shot269

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: UNLABELLED The aim of the study is to compare the role of killed ( KP ) Lactobacillus acidophilus with living ( LP ) in reducing incidence of sepsis ( NS ) and necrotizing enterocolitis ( NEC ) in neonates . R and omized double blind placebo study , included 150 neonates admitted to NICU at day 1 , sixty received oral ( LP ) and 60 received ( KP ) and 30 received placebo . One gram of stools was collected on admission , at day 7 , at end of the study , as well as on suspected NEC or NS and was sent for culture . RESULTS LP and KP were preventive factors for NEC with absolute risk reduction ( AAR ) 16 , 15 % , respectively and 18 % for NS compared to placebo . Incidence of NEC and NS did not differ significantly between neonates supplemented with LP and those with KP . Preterm neonates supplemented with KP showed significantly lower incidence of NEC compared to placebo , while incidence of NS showed no significant difference between both groups . There is significant reduction in NS and NEC among neonates with positive Lactobacillus colonization of gut compared to those none colonized at day 7 ( 27.9 vs. 85.9 % , 0 vs. 7.8 % ) and at day 14 ( 48.7 vs. 91.7 % for NS and 0 vs. 20.8 % for NEC ) . Overall comparison between the three groups showed statistical significant reduction in the incidence of NEC . Present conclusions are that early gut colonization with beneficial bacteria lowers the incidence of NEC and NS . KP retained similar benefits to live bacteria BACKGROUND Probiotics are used for the prevention of necrotizing enterocolitis ( NEC ) because of their positive effects on intestinal motor function , modulation of inflammatory response , and mucosal barrier function . OBJECTIVE The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage ≥ 2 by the criteria of Bell in very-low-birth-weight preterm infants . DESIGN A double-blind , r and omized , controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth . The intervention group was composed of 119 infants who received human milk with probiotic supplementation ( B. breve and L. casei ) and a control group of 112 infants who received human milk containing no probiotics . The primary outcome was the occurrence of NEC stage ≥ 2 as defined by Bell 's modified criteria . RESULTS Four confirmed cases of NEC stage ≥ 2 by Bell 's criteria occurred only in the control group . CONCLUSIONS Oral supplementation of B. breve and L. casei reduced the occurrence of NEC ( Bell 's stage ≥ 2 ) . It was considered that an improvement in intestinal motility might have contributed to this result . This trial was registered at www.is rct in.org as number 67165178 ( International St and ard R and omized Controlled Trial ) ABSTRACT The gastrointestinal microbiota of preterm infants in a neonatal intensive care unit differs from that of term infants . In particular , the colonization of preterm infants by bifidobacteria is delayed . A double-blind , placebo-controlled , r and omized clinical study was performed on 69 preterm infants to investigate the role of Bifidobacterium lactis Bb12 supplementation in modifying the gut microbiota . Both culture-dependent and culture-independent approaches were used to study the gut microbiota . Bifidobacterial numbers , determined by fluorescence in situ hybridization , were significantly higher in the probiotic than in the placebo group ( log10 values per g of fecal wet weight : probiotic , 8.18 + 0.54 [ st and ard error of the mean ] ; placebo , 4.82 + 0.51 ; P < 0.001 ) . A similar trend for bifidobacterial numbers was also obtained with the culture-dependent method . The infants supplemented with Bb12 also had lower viable counts of Enterobacteriaceae ( log10 values of CFU per g of fecal wet weight : probiotic , 7.80 + 0.34 ; placebo , 9.03 + 0.35 ; P = 0.015 ) and Clostridium spp . ( probiotic , 4.89 + 0.30 ; placebo , 5.99 + 0.32 ; P = 0.014 ) than the infants in the placebo group . Supplementation of B. lactis Bb12 did not reduce the colonization by antibiotic-resistant organisms in the study population . However , the probiotic supplementation increased the cell counts of bifidobacteria and reduced the cell counts of enterobacteria and clostridia BACKGROUND It is known that the bifidobacteria flora play important roles in mucosal host defense and can prevent infectious diseases . Because bacterial population s develop during the first day of life , the authors examined whether the early administration of bifidobacteria has a positive effect on the health of low birth weight infants . METHODS The effects of oral administration of Bifidobacterium breve ( B. breve ) supplements were studied in a controlled trial with low birth weight infants ( average birth weight 1489 g ) . The infants were divided into three groups : Group A and B received a dose of 1.6 x 10(8 ) cells of B. breve supplement twice a day , commencing either from several hours after birth ( group A ) or 24 h after birth ( group B ) . Group C , the control group , received no supplement . RESULTS There were no significant differences in birth weight , treatment with antibiotics , and the starting time of breast-feeding among the three groups . A Bifidobacterium-predominant flora was formed at an average of 2 weeks after birth in group A and at an average of 4 weeks after birth in group B , while no Bifidobacterium was isolated in eight out of 10 infants in group C during the observation period of 7 weeks . In comparison between group A and B , Bifidobacterium was detected significantly earlier in group A , and the number of Enterobacteriaceae present in the infants at 2 weeks after birth was significantly lower in group A. CONCLUSION The results of the present study suggest that very early administration of B. breve to low birth weight infants is useful in promoting the colonization of the Bifidobacterium and the formation of a normal intestinal flora Objective : To evaluate the efficacy of probiotics in the prevention of gastrointestinal colonization by C and ida species , of late-onset sepsis and neurological outcome in preterm newborns . Study Design : A prospect i ve study was conducted in 249 preterms who were subdivided into three groups : one group ( n=83 ) was supplemented with Lactobacillus ( L. ) reuteri , one group with L. rhamnosus ( n=83 ) and the other with no supplementation ( n=83 ) . The fungal colonization in the gastrointestinal tract , the late onset of sepsis and clinical parameters were recorded . A neurological structured assessment was further performed at 1 year of age . Result : C and ida stool colonization was significantly higher ( P<0.01 ) in the control group than in the groups treated with probiotics . The L. reuteri group presented a significantly higher reduction in gastrointestinal symptoms than did the L. rhamnosus and control groups . Infants treated with probiotics showed a statistically significant lower incidence of abnormal neurological outcome than did the control group . Conclusion : The use of both probiotics seems to be effective in the prevention of gastrointestinal colonization by C and ida , in the protection from late-onset sepis and in reducing abnormal neurological outcomes in preterms BACKGROUND AND OBJECTIVE : It has been suggested that probiotics may decrease infant mortality and nosocomial infections because of their ability to suppress colonization and translocation of bacterial pathogens in the gastrointestinal tract . We design ed a large double-blinded placebo-controlled trial using Lactobacillus reuteri to test this hypothesis in preterm infants . METHODS : Eligible infants were r and omly assigned during the first 48 hours of life to either daily probiotic administration or placebo . Infants in the intervention group were administered enterally 5 drops of a probiotic preparation containing 108 colony-forming units of L reuteri DSM 17938 until death or discharge from the NICU . RESULTS : A total of 750 infants ≤2000 g were enrolled . The frequency of the primary outcome , death , or nosocomial infection , was similar in the probiotic and placebo groups ( relative risk 0.87 ; 95 % confidence interval : 0.63–1.19 ; P = .376 ) . There was a trend toward a lower rate of nosocomial pneumonia in the probiotic group ( 2.4 % vs 5.0 % ; P = .06 ) and a nonsignificant 40 % decrease in necrotizing enterocolitis ( 2.4 % vs 4.0 % ; P = .23 ) . Episodes of feeding intolerance and duration of hospitalization were lower in infants ≤ 1500 g ( 9.6 % vs 16.8 % [ P = .04 ] ; 32.5 days vs 37 days [ P = .03 ] ) . CONCLUSIONS : Although L reuteri did not appear to decrease the rate of the composite outcome , the trends suggest a protective role consistent with what has been observed in the literature . Feeding intolerance and duration of hospitalization were decreased in premature infants ≤1500 Background : Nosocomial infections endanger preterm infants . Objective : The aim of the present controlled r and omized trial was to investigate whether Bifidobacterium lactis reduces the incidence of nosocomial infections in infants with very low birth weight ( VLBW ; < 1,500 g ) < 30 weeks of gestation . Patients and Methods : In a r and omized controlled trial , 183 VLBW infants < 30 weeks of gestation were stratified according to gestational age ( 23–26 and 27–29 weeks ) and early antibiotic therapy ( days 1–3 , yes or no ) and r and omly assigned to have their milk feedings supplemented with B. lactis ( 6 × 2.0 × 109 CFU/kg/day , 12 billion CFU/kg/day ) or placebo for the first 6 weeks of life . Primary outcome was the ‘ incidence density ’ of nosocomial infections defined as periods of elevated C-reactive protein ( > 10 mg/l ) from day 7 after initiation of milk feedings until the 42nd day of life ( number of nosocomial infections/total number of patient days ) . The main secondary outcome was necrotizing enterocolitis ( NEC ; ≧stage 2 ) . Results : There were 93 infants in the B. lactis group and 90 in the placebo group . There was no significant difference between the two groups with regard to the incidence density of nosocomial infections ( 0.021 vs. 0.016 ; p = 0.9 , χ2 test ) . There were 2 cases of NEC in the B. lactis group and 4 in the placebo group . None of the blood cultures grew B. lactis . Conclusion : In the present setting , B. lactis at a dosage of 6 × 2.0 × 109 CFU/kg/day ( 12 billion CFU/kg/day ) did not reduce the incidence density of nosocomial infections in VLBW infants . No adverse effect of B. lactis was observed Background A r and omised , double-blind clinical trial was undertaken in order to assess the effectiveness of probiotics in the prevention of necrotising enterocolitis ( NEC ) in newborns weighing < 1500 g. Methods We studied a group of 150 patients who were r and omised in two groups after parental consent was obtained , to receive either a daily feeding supplementation with a multispecies probiotic ( Lactobacillus acidophilus , Lactobacillus rhamnosus , Lactobacillus casei , Lactobacillus plantarum , Bifidobacteruim infantis , Streptococcus thermophillus ) 1 g per day plus their regular feedings or to receive their regular feedings with nothing added ( control group ) , over the period of January 2007 through June 2010 . Clinicians in care of the infants were blinded to the group assignment . Results The primary outcome was the development of NEC . Both groups were comparable , with no differences during hospitalisation , including the type of nutrition received . Blood cultures obtained from cases that developed sepsis did not reveal lactobacillus or Bifidobacteria growth . No differences were detected in terms of NEC risk reduction ( RR : 0.54 , 95 % CI 0.21 to 1.39 ) although we did observe a clear trend in the reduction of NEC frequency in the studied cases : 6 ( 8 % ) versus 12 ( 16 % ) in the control group . When the combined risk of NEC or death was calculated as a post hoc analysis , we found a significantly lower risk ( RR : 0.39 , 95 % CI 0.17 to 0.87 ) for the study group . Conclusions Probiotics may offer potential benefits for premature infants and are a promising strategy in the reduction of the risk of NEC in preterm newborns BACKGROUND OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants .

MS2_fixed_5_shot270

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Clinical measurement in rheumatoid arthritis ( RA ) has focused on articular problems . Although measures like the Health Assessment Question naire ( HAQ ) are widely used to determine functional impairment , there is a need to determine the overall effect of RA on general health status . We evaluated the relationship of a generic health status measure-the Nottingham Health Profile (NHP)-to the clinical , laboratory and radiological changes in the EULAR core data set for RA . Two hundred consecutive out- patients with RA were recruited . Their mean age was 58.9 yr and mean disease duration 11.3 yr . Patients completed the NHP and the following assessment s were made : the EULAR Core Data Set , the duration of morning stiffness , the Disease Activity Score ( DAS ) , rheumatoid factor ( RF ) levels , and Larsen 's score for X-rays of h and s and wrists . RA patients had higher scores on the NHP than both a r and om population sample and a second sample of patients with a variety of common diseases . NHP scores were not related to age or disease duration in RA . There was little relationship between perceived distress and the Larsen score , RF , ESR and C-reactive protein levels . Moderate associations were seen between NHP scores and disease activity measures , including the number of tender and swollen joints , pain and the duration of early morning stiffness , and also with a disability measure-the HAQ . NHP scores were highly related to disease activity measured by DAS . High DAS scores were associated with high scores in the energy level , pain and sleep sections of the NHP . The NHP gives relevant information about RA patients . They have high scores for pain , physical mobility and energy level sections , and also have high distress for sleep and emotional reactions OBJECTIVE This study vali date d a brief measure of fatigue in rheumatoid arthritis ( RA ) , the Functional Assessment of Chronic Illness Therapy ( FACIT ) Fatigue Scale . METHODS The FACIT Fatigue was tested along with measures previously vali date d in RA : the Multidimensional Assessment of Fatigue ( MAF ) and Medical Outcomes Study Short-Form 36 ( SF-36 ) Vitality . The sample included 636 patients with RA enrolled in a 24 week double blind , r and omized clinical trial ( RCT ) of adalimumab versus placebo . RESULTS The FACIT Fatigue showed good internal consistency ( alpha = 0.86 to 0.87 ) , strong association with SF-36 Vitality ( r = 0.73 to 0.84 ) and MAF ( r = -0.84 to -0.88 ) , and the ability to differentiate patients according to clinical change using the American College of Rheumatology ( ACR ) response criteria ( ACR 20/50/70 ) . Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures . A minimally important difference in FACIT Fatigue change score of 3 - 4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo . CONCLUSION The FACIT Fatigue is a brief , valid measure for monitoring this important symptom and its effects on patients with RA OBJECTIVE Fatigue is commonly reported by patients with rheumatoid arthritis ( RA ) but is rarely a treatment target . The aim of this study was to explore the concept of fatigue as experienced by patients with RA . METHODS Fifteen patients with RA and fatigue ( > or = 7 on a 10-cm visual analog scale ) were individually interviewed and asked about the description , cause , consequence , and management of fatigue . Transcripts were systematic ally analyzed by 2 research ers independently , relevant phrases were coded , and earlier transcripts were checked for the emerging codes . A r and om sample of analyses were independently review ed . A total of 191 codes arising from the data were grouped into 46 categories and overarching themes . RESULTS Vivid descriptions reflect 2 types of fatigue : severe weariness and dramatic overwhelming fatigue . RA fatigue is different from normal tiredness because it is extreme , often not earned , and unresolving . Participants described physical , cognitive , and emotional components and attributed fatigue to inflammation , working the joints harder , and unrefreshing sleep . Participants described far-reaching effects on physical activities , emotions , relationships , and social and family roles . Participants used self-management strategies but with limited success . Most did not discuss fatigue with clinicians but when they did , they felt it was dismissed . Participants held negative views on the management of fatigue . CONCLUSION The data show that RA fatigue is important , intrusive , and overwhelming , and patients struggle to manage it alone . These data on the complexity of fatigue experiences will help clinicians design measures , interventions , and self-managment guidance We report a prospect i ve , r and omized pilot study comparing a new workbook-based program , design ed to teach patients with rheumatoid arthritis ( RA ) energy conservation behaviors , with st and ard occupational therapy ( OT ) . Sixteen patients took part in the new program and nine received the st and ard therapy . Data on the number of tender or swollen joints , grip strength , walk time , activities of daily living , psychologic adjustment to illness , and daily activity log , were measured before and three months after intervention . Eleven percent of those who received st and ard therapy and 50 % of those who received the workbook increased their amount of physically active time ( p = .10 ) . Twenty-two percent of the control group and 50 % of those in the workbook group achieved a better balance of rest and physical activity ( p = .07 ) . We conclude that the adoption of energy conservation behaviors is different in the two groups . This initial study suggests that interrupting physical activity with rest periods may result in increased physical activity in patients with RA The effects of 12 weeks of low-impact aerobic exercise on fatigue , aerobic fitness , and disease activity were examined in a quasi-experimental time series study of 25 adults with rheumatoid arthritis ( RA ) . Measures were obtained preintervention , midtreatment ( after 6 weeks of exercise ) , end of treatment ( after 12 weeks of exercise ) , and at a 15-week follow-up . ANOVAS for repeated measures showed that those subjects who participated more frequently reported decreased fatigue , while those who participated less frequently reported an increase in fatigue . All subjects , on average , showed increased aerobic fitness and increased right and left h and grip strength , decreased pain , and decreased walk time . There were no significant increases in joint count or sedimentation rate . Significant improvements in measures at the 15-week follow-up also were found . Findings indicate that persons with RA who participate in appropriate exercises may lessen fatigue levels and experience other positive effects without worsening their arthritis Summary Three experimental question naires were compared with the Influence of Rheumatic Diseases on Health and Lifestyle ( IRGL ) question naire , a Dutch version of the Arthritis Impact Measurement Scales . Sixty-two patients with osteoarthritis ( OA ) and 35 patients with rheumatoid arthritis ( RA ) , all of whom underwent hip arthroplasty , completed the study . Results showed that visual analogue scales for pain , stiffness , fatigue , and anxiety were strongly correlated with a number of the IRGL scales . Patient preference scales were sensitive to change and provided additional information on aspects of the patients ' quality of life ( QOL ) that were felt to be important by the patients themselves . The question naire on performance in various roles in life was insensitive to change . In existing question naires , there is an attempt to represent the concept of QOL in terms of its most important aspects . Such realizations of the concept of QOL are not entirely suitable for application in clinical trials . The IRGL is overly complex , and its sometimes comprehensive scales do not deal with the possible effects of treatment . Neither of these properties is conducive to sensitivity to change . Visual analogue scales reduce the complexity . A simpler representation of QOL that can evaluate aspects relevant to treatment is recommended A double-blind , cross-over trial compared the antiinflammatory and analgesic effects as well as tolerability of diclofenac sodium ( Voltaren ) and ibuprofen . Twenty-four out patients with rheumatoid arthritis were included . A single-blind placebo period was inserted between the two active treatments . The daily dose of diclofenac sodium was 50 mg bid and that of ibuprofen 400 mg tid . The duration of each treatment period was 14 days . The efficacy was measured by the following criteria : Articular index ( Lansbury ) , morning stiffness , fatigue , pain ( measured on a visual analogue scale ) , consumption of rescue-analgesics , status of the arthritic condition , and patient preference . No significant differences were found between diclofenac sodium and ibuprofen , but regarding consumption of analgesic , global evaluation , rheumatic activity , and activity index , a slight trend towards a better effect of diclofenac sodium was found . The study had an adequate sensitivity as it could distinguish placebo from the active treatments for all parameters evaluated . No patient was withdrawn for unwanted effects . None of the laboratory data showed abnormalities of clinical relevance When any drug trial is being carried out it is essential that some criterion of improvement be available to assess the efficacy . In the ideal case there is one single measure , reliably and validly assessed , which is acceptable as this criterion . More frequently , however , there are several possible criteria . The usual practice is to deal with each separately and then in the discussion to point out which symptoms responded to treatment . Clinical ly this has obvious advantages in suggesting the appropriate applications of the treatment , but reliability will be increased if the various scores can be combined in some meaningful way . The unsophisticated way to do this is to add together the various scores , but there may be some clinical justification for weighting major symptoms more than minor ones and this can be done . In rheumatoid arthritis , Lansbury ( 1958 ) has been a keen advocate of indices . His Articular Index weighted the score on each joint by the area of joint ( Lansbury and Haut , 1956 ) and his Systemic Index based on morning stiffness , fatigue , aspirin need , grip strength , and erythrocyte sedimentation rate was believed to measure the inflammatory aspects of the disease ( Lansbury , 1956 ) . A double-blind cross-over trial of indomethacin , previously undertaken ( Wright , Walker , and McGuire , 1969 ) in 24 patients with rheumatoid arthritis to investigate the value of the drug compared with phenylbutazone and placebo , was set up in such a way that the Lansbury Systemic Index could be evaluated and the place of other indices determined . The results of this aspect of the study are reported in this paper This paper presents the design and evaluation of an occupational therapy program developed at the National Institutes of Health for teaching energy conservation and joint protection to adults with rheumatoid arthritis . An existing model for educational diagnosis in health education was used to identify program , behavioral , and educational objectives for the new program . The use of this model result ed in measurable objectives , which were used as outcome measures in the r and omized research evaluation of the new program . The dependent variables measured were activity-of-daily-living status , psychosocial adjustment to illness , knowledge , disease activity , pain , and fatigue . None were significantly different after the intervention . The independent variables measured included components of balancing rest and physical activity . After 3 months , a greater percentage of the subjects receiving the workbook-based occupational therapy program than those receiving traditional occupational therapy demonstrated an application of the behaviors the intervention was design ed to change OBJECTIVE To investigate whether treatment of anemia of chronic disease ( ACD ) in patients with rheumatoid arthritis ( RA ) with recombinant human erythropoietin ( rHu-Epo ) in combination with intravenous ( i.v . ) iron influences health related quality of life ( HRQoL ) and clinical outcome including disease activity . METHODS Thirty patients with ACD and RA were treated with 150 IU/kg rHu-Epo twice weekly for 12 weeks . As well , in case of functional iron deficiency 200 mg of iron-sucrose per week was given intravenously . Vitality and fatigue as dimensions of HRQoL were evaluated by the vitality subscale of the Short Form-36 ( SF-36-VT ) and the Multidimensional Assessment of Fatigue ( MAF ) . Muscle strength was measured by the Muscle Strength Index . RESULTS All 28 patients completing the study responded to treatment ; 23/28 patients developed functional iron deficiency and received i.v . iron ( mean absolute dose 710 + /- 560 mg ) . Average hemoglobin concentration increased from 10.7 + /- 1.1 to 13.2 + /- 1.0 g/dl after a mean treatment period of 8.7 + /- 2.3 weeks . Muscle strength increased from 43.5 + /- 11.2 to 49.1 + /- 12.9 and SF-36-VT from 28.2 % + /- 14.3 % to 47.1 % + /- 20.8 % . while fatigue decreased ( MAF from 34.7 + /- 9.3 to 25.0 + /- 11.3 ) . Among the disease activity variables the number of swollen/tender joints , erythrocyte sedimentation rate , Disease Activity Score , and RA Disease Activity Index improved significantly during treatment . CONCLUSION Treatment of ACD in RA patients with rHu-Epo and i.v . iron is safe and effective in correction of anemia , increases muscle strength . improves vitality , and lowers fatigue . In addition we observed a reduction of disease activity ABSTRACT Cardiorespiratory function and exercise tolerance appear very limited in persons with rheumatoid arthritis ( RA ) . Many studies have demonstrated that aerobic exercise training is beneficial to prevent physical deconditioning without inducing OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

However , the 4 generic scales would benefit from further validation in patients with RA , the VAS requires st and ardization , and the MAF would benefit from further sensitivity data .

MS2_fixed_5_shot271

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The purpose of this study was to examine ethnic differences in the metabolic responses to a 16-week intervention design ed to improve insulin sensitivity ( SI ) , adiposity , and inflammation in obese African-American and Latino adolescents . A total of 100 participants ( African Americans : n = 48 , Latino : n = 52 ; age : 15.4 ± 1.1 years , BMI percentile : 97.3 ± 3.3 ) were r and omly assigned to interventions : control ( C ; n = 30 ) , nutrition ( N ; n = 39 , 1 × /week focused on decreasing sugar and increasing fiber intake ) , or nutrition + strength training ( N+ST ; n = 31 , 2 × /week ) . The following were measured at pre- and postintervention : strength , dietary intake , body composition ( dual-energy X-ray absorptiometry/magnetic resonance imaging ) and glucose/insulin indexes ( oral glucose tolerance test (OGTT)/intravenous glucose tolerance test ( IVGTT ) ) and inflammatory markers . Overall , N compared to C and N+ST reported significant improvements in SI ( + 16.5 % vs. -32.3 % vs. -6.9 % respectively , P < 0.01 ) and disposition index ( DI : + 15.5 % vs. -14.2 % vs. -13.7 % respectively , P < 0.01 ) . N+ST compared to C and N reported significant reductions in hepatic fat fraction ( HFF : -27.3 % vs. -4.3 % vs. 0 % respectively , P < 0.01 ) . Compared to N , N+ST reported reductions in plasminogen activator inhibitor-1 ( PAI-1 ) ( -38.3 % vs. + 1.0 % , P < 0.01 ) and resistin ( -18.7 % vs. + 11.3 % , P = 0.02 ) . There were no intervention effects for all other measures of adiposity or inflammation . Significant intervention by ethnicity interactions were found for African Americans in the N group who reported increases in total fat mass , 2-h glucose and glucose incremental areas under the curve ( IAUC ) compared to Latinos ( P 's < 0.05 ) . These interventions yielded differential effects with N reporting favorable improvements in SI and DI and N+ST reporting marked reductions in HFF and inflammation . Both ethnic groups had significant improvements in metabolic health ; however some improvements were not seen in African Americans Adiponectin is an adipose-specific plasma protein whose plasma concentrations are decreased in obese subjects and type 2 diabetic patients . This protein possesses putative antiatherogenic and anti-inflammatory properties . In the current study , we have analyzed the relationship between adiponectin and insulin resistance in rhesus monkeys ( Macaca mulatta ) , which spontaneously develop obesity and which subsequently frequently progress to overt type 2 diabetes . The plasma levels of adiponectin were decreased in obese and diabetic monkeys as in humans . Prospect i ve longitudinal studies revealed that the plasma levels of adiponectin declined at an early phase of obesity and remained decreased after the development of type 2 diabetes . Hyperinsulinemic-euglycemic clamp studies revealed that the obese monkeys with lower plasma adiponectin showed significantly lower insulin-stimulated peripheral glucose uptake ( M rate ) . The plasma levels of adiponectin were significantly correlated to M rate ( r = 0.66 , P < 0.001 ) . Longitudinally , the plasma adiponectin decreased in parallel to the progression of insulin resistance . No clear association was found between the plasma levels of adiponectin and its mRNA levels in adipose tissue . These results suggest that reduction in circulating adiponectin may be related to the development of insulin resistance CONTEXT Hypoadiponectinemia and chronic sub clinical inflammation in adults are associated with the development of diabetes and cardiovascular disease . The potential relationship between adiponectin and inflammation and its modulation by lifestyle intervention in the pediatric obese population remain unclear . OBJECTIVES The objectives were to investigate in adolescents 1 ) the relationship between adiponectin and obesity-related inflammatory factors , C-reactive protein , and IL-6 ; and 2 ) the effect of a lifestyle intervention on adiponectin and whether these effects are related to changes in inflammatory factors . RESEARCH METHODS AND PROCEDURES Twenty-one obese and age-matched lean adolescents ( age , 14 - 18 yr ; Tanner stage , > or = IV ) were studied cross-sectionally . Fifteen obese adolescents also underwent a r and omized , controlled physical activity-behavior-diet-based lifestyle intervention for 3 months . Associations among adiponectin , fat mass , insulin resistance , and inflammatory factors at baseline as well as after the intervention were assessed . RESULTS Plasma adiponectin concentration was lower ( P < 0.001 ) in the obese vs. age-matched lean adolescents . Significant inverse relationships were observed between adiponectin and inflammatory factors , insulinemia , insulin resistance , and fat mass . Intervention produced a 34 % increase in adiponectin concentration ( P = 0.0004 ) despite negligible weight loss but with reductions in fat mass , hyperinsulinemia , insulin resistance , and inflammatory factors ( all P < 0.01 ) . CONCLUSIONS The data suggest that in adolescents , obesity-related hypoadiponectinemia is associated with sub clinical inflammation , and a short-term lifestyle intervention augments adiponectin concentrations . These effects appear to be related to reductions in fat mass and inflammatory factors . Based on our current underst and ing of adiponectin physiology , reversal of hypoadiponectinemia in obese adolescents may protect against risks for cardiovascular disease and diabetes Background Obesity is significant problem involving eating behavior and peripheral metabolic conditions . The effect of carbohydrate and fat restriction on appetite regulation , fibroblast growth factor 21 ( FGF21 ) and leptin in children has not been defined . Our objective was to compare the effect of both diets . Methods One hundred and twenty children with body mass index ( BMI ) higher than the equivalent of 30 kg/m2 for an adult , as corrected for gender and age were r and omly assigned to ( n = 60 ) a low-carbohydrate ( L-CHO ) diet or ( n = 60 ) a low-fat ( L-F ) diet for 2 months . Fifty-three ( 88.3 % ) subjects on the low-carbohydrate-diet and 45 ( 75 % ) on the low-fat diet completed the study . Anthropometric measures , leptin and FGF21 levels were measured before and after the intervention . Comparison of the data for both of the diet groups was carried out using the t-test for independent variables . Intragroup comparisons before and after of each of the dietary treatments were performed using ANOVA for repeated measures . Factors associated with FGF21 , leptin levels and satiety , were analyzed by multiple regression . Results After both of the diets , weight , leptin , food responsiveness , and enjoyment of food significantly decreased and high density lipoprotein cholesterol ( HDL ) increased , but FGF21 decreased . Before and after both of the interventions FGF21 was associated with triglycerides . Before the diet , satiety was associated with lower screen time ( p < 0.04 ) and insulin levels ( p < 0.05 ) . Conclusions Both dietary restrictions improved the metabolic and hormonal parameters of obese children . FGF21 is an indicator of a beneficial metabolic response in younger children . After 2 months an adaptation of the eating behavior to food restriction was observed BACKGROUND Gut hormones change with weight loss in adults but are not well studied in obese youth . OBJECTIVE The primary aim was to evaluate how gut hormones and subjective appetite measure change with dietary weight loss in obese adolescents . METHODS Participants were a subset of those taking part in the ' Eat Smart Study ' . They were aged 10 - 17 years with body mass index ( BMI ) > 90th centile and were r and omized to one of three groups : wait-listed control , structured reduced carbohydrate or structured low-fat dietary intervention for 12 weeks . Outcomes were fasting glucose , insulin , leptin , adiponectin , total amylin , acylated ghrelin , active glucagon-like peptide-1 , glucose-dependent insulinotropic polypeptide ( GIP ) , pancreatic polypeptide ( PP ) and total peptide tyrosine-tyrosine . Pre- and postpr and ial subjective sensations of appetite were assessed using visual analogue scales . RESULTS Of 87 ' Eat Smart ' participants , 74 participated in this sub- study . The mean ( st and ard deviation ) BMI z-score was 2.1 ( 0.4 ) in the intervention groups at week 12 compared with 2.2 ( 0.4 ) in the control group . Fasting insulin ( P = 0.05 ) and leptin ( P = 0.03 ) levels decreased , while adiponectin levels increased ( P = 0.05 ) in the intervention groups compared with control . The intervention groups were not significantly different from each other . A decrease in BMI z-score at week 12 was associated with decreased fasting insulin ( P < 0.001 ) , homeostatic model of assessment -insulin resistance ( P < 0.001 ) , leptin ( P < 0.001 ) , total amylin ( P = 0.03 ) , GIP ( P = 0.01 ) , PP ( P = 0.02 ) and increased adiponectin ( P < 0.001 ) . There was no significant difference in appetite sensations . CONCLUSIONS Modest weight loss in obese adolescents leads to changes in some adipokines and gut hormones that may favour weight regain Little is known about the effects of different intensities of physical training on plasma leptin . This study examined the effect of two intensities of physical training on leptin in obese teenagers , and explored correlates at baseline and in response to 8 months of physical training . The participants were 55 obese youths 12 - 16 years of age who completed both baseline and posttesting . The youths were r and omized to engage in lifestyle education only ( LSE ) , moderate-intensity physical training and LSE , or high-intensity physical training and LSE . Baseline leptin was positively associated with fat mass . Girls had higher leptin levels at lower levels of fasting insulin than boys . The 8-mo physical training doses prescribed to obese teenagers did not result in significant group differences in mean change in leptin , although there was large variability in individual response . The change in leptin was inversely associated with baseline leptin and change in cardiovascular fitness . Diet , physical activity level , visceral adiposity , and glucose concentrations were not associated with leptin , neither at baseline nor in response to physical training . At baseline , total fat mass rather than visceral adiposity was associated with higher leptin levels . Over the 8-mo intervention period , regardless of group membership , youths who had the lowest increase in cardiovascular fitness tended to have the highest increase in leptin Objective : A high-protein diet may decrease food intake through regulating satiety and appetite hormones and can be an effective strategy for weight loss . Few studies exist on obese Chinese adolescents . Methods and Material s : 156 obese Chinese adolescents were enrolled and r and omly assigned to one of two isoenergetic breakfasts , either with egg or steamed bread . Subsequent lunchtime food intake was recorded 4 h later . Appetite was assessed with a visual analog scale . Anorexigenic hormones peptide YY ( PYY ) , glucagon-like peptide-1 ( GLP-1 ) and orexigenic hormone ghrelin were determined with radioimmunoassay at 0 , 30 , and 180 min . Body weight was recorded . The tests were repeated 3 months later . Analysis was performed between two tests and then two groups . Pearson 's correlation was used for association analysis . Results : Subsequent lunchtime food intake and body weight were decreased while satiety was increased in subjects on an egg breakfast , which is associated with an increase of serum PYY and GLP-1 ( p < 0.001 , respectively ) . There were strong correlations between weight loss , appetite , subsequent food intake and changes of appetite hormones . Conclusion : A high-protein breakfast promotes weight loss in obese Chinese adolescents , possibly through its regulation of satiety , subsequent food intake and appetite hormones Abstract The objective of this study is to evaluate the effect of interdisciplinary therapy in the parameters of the oxidative stress and the anti-inflammatory responses of obese adolescents . We selected 57 participants , who were r and omly divided into 2 groups : interdisciplinary therapy group and a control group . After 6 months of intervention , 17 participants of the interdisciplinary therapy group and 8 of the control group returned for re-evaluation . The interdisciplinary therapy group participated in a treatment with 4 weekly sessions of exercise , a weekly group therapy session and a weekly nutritional education session . Blood parameters OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Leptin levels decreased as BMI decreased . Evidence regarding the relationships of ghrelin and adiponectin with BMI was inconclusive . Conclusions : Despite known effects of maturation on hormones , studies did not consistently differentiate findings by maturational stage . BMI and leptin levels have a positive relationship , but evidence on ghrelin and adiponectin was inconclusive

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention . The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income < $ 10,000 . Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients Abstract OBJECTIVE : To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians . DESIGN : R and omized , controlled trial . SETTING : Veterans Affairs general medical clinic . PATIENTS : 275 veterans who had NIDDM and were receiving primary care from general internists . INTERVENTION : Nurse-initiated contacts were made by telephone at least monthly to provide patient education ( with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia ) , reinforce compliance with regimens , monitor patients ’ health status , facilitate resolution of identified problems , and facilitate access to primary care . MEASUREMENTS : Glycemic control was assessed using glycosylated hemoglobin ( GHb ) and fasting blood sugar ( FBS ) levels . Health-related quality of life ( HRQOL ) was measured with the Medical Outcomes Study SF-36 , and diabetes-related symptoms were assessed using patients ’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month . MAIN RESULTS : At one year , between-group differences favored intervention patients for FBS ( 174.1 mg/dL vs 193.1 mg/dL , p=0.011 ) and GHb ( 10.5 % vs 11.1 % , p=0.046 ) . Statistically significant differences were not observed for either SF-36 scores ( p=0.66 ) or diabetes-related symptoms ( p=0.23 ) . CONCLUSIONS : The intervention , design ed to be a pragmatic , low-intensity adjunct to care delivered by physicians , modestly improved glycemic control but not HRQOL or diabetes-related symptoms Purpose The purpose of this study was to determine if improvements observed in clinical , behavioral , and psychosocial outcomes measured at 12 months following a multifaceted diabetes care intervention were sustained at 3-year follow-up . Methods This study was a multilevel , nonblinded , cluster design , r and omized controlled trial that took place in an under-served suburb of Pittsburgh , Pennsylvania , between 1999 and 2005 . Eleven primary care practice s , and their patients , were r and omly assigned to 3 groups : chronic care model ( CCM ) intervention ( n = 30 ) , provider education only ( PROV ) ( n = 38 ) , and usual care ( UC ) ( n = 51 ) . Subjects were followed for 3 years . Results Improvements observed at 12-month follow-up in glycemic ( —0.5 % ) and blood pressure control ( —4.8 mm Hg ) , and the proportion of participants who self-monitor their blood glucose ( 86.7%-100 % ) , were sustained at 3-year follow-up in the CCM group . Additional improvements occurred in non-HDLc levels in all study groups and quality of well-being scores in the CCM intervention group . All associations remained after controlling for medication treatment intensification . Conclusions We have demonstrated that improvements in outcomes can be sustained over time following a multifaceted diabetes care intervention . Future research in this area is necessary to underst and if improvements in outcomes can be sustained following diabetes self-management education ( DSME ) and what type of patient fares the best from multifaceted diabetes care interventions Objectives To examine the impact of a successful 12-month behavioral intervention to improve diabetes control on health care utilization in American Samoa . Methods A cluster-r and omized design was used to assign 268 diabetes patients to a nurse-community health worker intervention or usual care . Hospitalizations , emergency department , and primary care physician visits were collected retrospectively for 1 year prior to , and during , the intervention to assess changes in health care utilization . The association of utilization changes with change in HbA1c during the intervention was assessed . Results Adjusted incidence rate ratios ( RR ) for primary care physician visits were significantly higher in the community health worker relative to the usual care group ( RR = 1.71 ; 95 % CI , 1.25–2.33 ) . There was no main intervention effect on emergency department utilization , but visits in the prior year modified the intervention effect on emergency department visits . Increased primary care physician utilization was associated with greater decreases in HbA1c ( b = −0.10 , SE = 0.04 , p = 0.01 ) . Conclusions A culturally adapted community health worker diabetes intervention in American Samoa significantly increased primary care physician visits , and decreased emergency department visits among those with high emergency department usage in the prior year . These changes suggest important and beneficial impacts on health system utilization from the diabetes intervention in a low re source and high-risk population OBJECTIVE Latinos with type 2 diabetes ( T2D ) face major healthcare access and disease management disparities . We examined the impact of the Diabetes Among Latinos Best Practice s Trial ( DIALBEST ) , a community health worker (CHW)–led structured intervention for improving glycemic control among Latinos with T2D . RESEARCH DESIGN AND METHODS A total of 211 adult Latinos with poorly controlled T2D were r and omly assigned to a st and ard of healthcare ( n = 106 ) or CHW ( n = 105 ) group . The CHW intervention comprised 17 individual sessions delivered at home by CHWs over a 12-month period . Sessions addressed T2D complications , healthy lifestyles , nutrition , healthy food choices and diet for diabetes , blood glucose self-monitoring , and medication adherence . Demographic , socioeconomic , lifestyle , anthropometric , and biomarker ( HbA1c , fasting blood glucose , and lipid profile ) data were collected at baseline and 3 , 6 , 12 , and 18 months ( 6 months postintervention ) . Groups were equivalent at baseline . RESULTS Participants had high HbA1c at baseline ( mean 9.58 % [ 81.2 mmol/mol ] ) . Relative to participants in the control group , CHWs had a positive impact on net HbA1c improvements at 3 months ( −0.42 % [ −4.62 mmol/mol ] ) , 6 months ( −0.47 % [ −5.10 mmol/mol ] ) , 12 months ( −0.57 % [ −6.18 mmol/mol ] ) , and 18 months ( −0.55 % [ −6.01 mmol/mol ] ) . The overall repeated- measures group effect was statistically significant ( mean difference −0.51 % [ −5.57 mmol/mol ] , 95 % CI −0.83 , −0.19 % [ −9.11 , −2.03 mmol/mol ] , P = 0.002 ) . CHWs had an overall significant effect on fasting glucose concentration that was more pronounced at the 12- and 18-month visits . There was no significant effect on blood lipid levels , hypertension , and weight . CONCLUSIONS DIALBEST is an effective intervention for improving blood glucose control among Latinos with T2D BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p<0·001 ) . These differences persisted to 12 months , despite less use of diabetes drugs . Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health P OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusions The available evidence suggests that diabetes self-management education can reduce all-cause mortality risk in type 2 diabetes patients .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Objective To highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans ( ITF prebiotics ) in obese women . Methods A double blind , placebo controlled , intervention study was performed with 30 obese women treated with ITF prebiotics ( inulin/oligofructose 50/50 mix ; n=15 ) or placebo ( maltodextrin ; n=15 ) for 3 months ( 16 g/day ) . Blood , faeces and urine sampling , oral glucose tolerance test , homeostasis model assessment and impedancemetry were performed before and after treatment . The gut microbial composition in faeces was analysed by phylogenetic microarray and qPCR analysis of 16S rDNA . Plasma and urine metabolic profiles were analysed by 1H-NMR spectroscopy . Results Treatment with ITF prebiotics , but not the placebo , led to an increase in Bifidobacterium and Faecalibacterium prausnitzii ; both bacteria negatively correlated with serum lipopolysaccharide levels . ITF prebiotics also decreased Bacteroides intestinalis , Bacteroides vulgatus and Propionibacterium , an effect associated with a slight decrease in fat mass and with plasma lactate and phosphatidylcholine levels . No clear treatment clustering could be detected for gut microbial analysis or plasma and urine metabolomic profile analyses . However , ITF prebiotics led to subtle changes in the gut microbiota that may importantly impact on several key metabolites implicated in obesity and /or diabetes . Conclusions ITF prebiotics selectively changed the gut microbiota composition in obese women , leading to modest changes in host metabolism , as suggested by the correlation between some bacterial species and metabolic endotoxaemia or metabolomic signatures Abstract Background and aims Freeze-dried powdered yacon ( FDY ) can be considered a prebiotic product due to its fructooligosaccharides ( FOS ) content . The effect of 9 weeks of daily intake of FDY containing 7.4 g of FOS on glucose , lipid metabolism and intestinal transit in a group of elderly people was investigated . Methods Seventy-two elderly ( mean age 67.11 ± 6.11 ) men and women were studied for 9 weeks in a double-blind , placebo-controlled experiment . They were r and omly assigned to the supplement group ( which received 7.4 g of FOS as FDY ) or the control group . At the beginning and end of the study , anthropometric measurements , blood sampling , clinical analyses and dietary intake were assessed . Results A daily intake of FDY containing 7.4 g of FOS for 9 weeks was associated with a mean decrease in serum glucose ( p = 0.013 ) , but supplementation did not reduce serum lipids in the study group . The administered dose did not adversely affect intestinal transit . It did not cause bloating , flatulence or intestinal discomfort . Conclusion Freeze-dried powdered yacon is a good source of FOS , and daily consumption can have a favourable effect on serum glucose in the elderly . It is also practical , easy and safe to use and store The primary aim of this study was to estimate the relation between cholesterol reduction and total mortality and coronary heart disease ( CHD ) incidence . Secondarily , the clinical issues of whether the efficacy of cholesterol lowering is dependent on the treatment modality , presence of CHD at baseline , or the simultaneous introduction of other interventions was explored . All r and omized clinical intervention trials of cholesterol reduction were used in an overview analysis of total mortality rate and CHD incidence ; analysis was performed with weighted linear regression . The trials include those that used primary and secondary intervention , diet and drugs , and single or multifactor design . Nineteen trials were analyzed for total mortality , and of the 19 , 16 were analyzed for CHD incidence rate . Net difference in cholesterol change between study groups was used as the independent variable , and the three previously mentioned dichotomous design characteristics were used as additional independent variables . For every 1 % reduction in cholesterol , an estimated 2.5 % reduction in CHD incidence is indicated ( 95 % CL : 1.1 , 3.9 ) . With regard to CHD drug trials tended toward better efficiency in cholesterol lowering than did dietary trials . With regard to total mortality , this efficiency was higher in secondary than in primary preventive trials . The efficiency was also somewhat dependent on the baseline cholesterol level . This study shows that cholesterol reduction is effective in lowering CHD incidence , but cholesterol reduction must be at least 8 - 9 % to be effective in lowering total mortality BACKGROUND Experimental studies suggest that gut microbiota deviations predispose toward energy storage and obesity . OBJECTIVE We wanted to establish whether early gut microbiota composition can guide weight development throughout early childhood . DESIGN Overweight and obese children ( n = 25 ) were selected from a prospect i ve follow-up study at the age of 7 y and identified according to the International Obesity Task Force criteria . Normal-weight children ( n = 24 ) were selected from the same cohort and matched for gestational age and body mass index at birth , mode of delivery , probiotic supplementation , duration of breastfeeding , use of antibiotics during infancy , and frequencies of atopic diseases and atopic sensitization . Early fecal microbiota composition was analyzed by fluorescent in situ hybridization ( FISH ) with microscopic and flow cytometry detection and by quantitative real-time polymerase chain reaction ( qRT-PCR ) . RESULTS The bifidobacterial numbers in fecal sample s during infancy , as assessed by the FISH with flow cytometry , were higher in children remaining normal weight , [ median : 2.19 x 10(9 ) cells/g ( interquartile range : 1.10 - 5.28 x 10(9 ) cells/g ) ] than in children becoming overweight [ 1.20 x 10(9 ) cells/g ( 0.48 - 1.59x 10(9 ) cells/g ) ; P = 0.02 ] . A similar tendency was found by FISH with microscopic detection and qRT-PCR . The microbiota aberrancy during infancy in children becoming overweight was also associated with a greater number of Staphylococcus aureus [ 0.64 x 10(6 ) cells/g ( 0.33 - 1.00 x 10(6 ) cells/g ) ] than in children remaining normal weight [ 0.27 x 10(6 ) cells/g ( 0.17 - 0.50 x 10(6 ) cells/g ) ; P = 0.013 ] . CONCLUSION Aberrant compositional development of the gut microbiota precedes overweight , offering new possibilities for preventive and therapeutic applications in weight management BACKGROUND A high-carbohydrate , low-fat diet is recommended for the prevention of atherosclerosis , because it reduces plasma cholesterol concentrations . However , such a diet can increase plasma triacylglycerol concentrations -- an undesirable side effect . The addition of nondigestible carbohydrate could reduce the risk of elevated triacylglycerol concentrations . OBJECTIVE The objective was to determine whether the addition of a moderate dose of inulin to a moderately high-carbohydrate diet would decrease hepatic lipogenesis and plasma triacylglycerol concentrations and have a cholesterol-lowering action . DESIGN Eight healthy subjects were studied twice in a double-blind , r and omized , placebo-controlled crossover study after consuming for 3 wk a moderately high-carbohydrate , low-fat diet ( 55 % of total energy ) plus an oral placebo or 10 g high-performance inulin/d . Hepatic lipogenesis and cholesterol synthesis ( deuterated water method ) , plasma lipid concentrations , fatty acid synthase , acetyl-CoA carboxylase 1 , and sterol responsive element binding protein 1c messenger RNA concentrations were measured in adipose tissue at the end of the 2 diet periods . RESULTS Plasma triacylglycerol concentrations and hepatic lipogenesis were lower after inulin than after placebo ingestion ( P < 0.05 ) , but cholesterol synthesis and plasma cholesterol concentrations were not significantly different between the 2 groups . None of the adipose tissue messenger RNA concentrations changed significantly after inulin ingestion . CONCLUSIONS The addition of high-performance inulin to a moderately high-carbohydrate , low-fat diet has a beneficial effect on plasma lipids by decreasing hepatic lipogenesis and plasma triacylglycerol concentrations . These results support the use of nondigestible carbohydrate for reducing risk factors for atherosclerosis BACKGROUND Fructooligosaccharides have been cl aim ed to lower fasting glycemia and serum total cholesterol concentrations , possibly via effects of short-chain fatty acids produced during fermentation . OBJECTIVE We studied the effects of fructooligosaccharides on blood glucose , serum lipids , and serum acetate in 20 patients with type 2 diabetes . DESIGN In a r and omized , single-blind , crossover design , patients consumed either glucose as a placebo ( 4 g/d ) or fructooligosaccharides ( 15 g/d ) for 20 d each . Average daily intakes of energy , macronutrients , and dietary fiber were similar with both treatments . RESULTS Compliance , expressed as the proportion of supplements not returned , was near 100 % during both treatments . Fructooligosaccharides did not significantly affect fasting concentrations ( mmol/L ) of serum total cholesterol ( 95 % CI : -0.07 , 0.48 ) , HDL cholesterol ( -0.04 , 0.04 ) , LDL cholesterol ( -0.06 , 0.34 ) , serum triacylglycerols ( -0.21 , 0.44 ) , serum free fatty acids ( -0.08 , 0.04 ) , serum acetate ( -0.01 , 0.01 ) , or blood glucose ( -0.37 , 0.40 ) . CONCLUSIONS We conclude that 20 d of dietary supplementation with fructooligosaccharides had no major effect on blood glucose , serum lipids , or serum acetate in patients with type 2 diabetes . This lack of effect was not due to changes in dietary intake , insufficient statistical power , or noncompliance of the patients Short-chain fructooligosaccharides ( FOS ) are prebiotics , which escape digestion in the small intestine and are fermented by the colonic microflora into short-chain fatty acids . Recently , we found that the daily consumption of 20 g FOS decreased basal hepatic glucose production in healthy subjects without any effect on insulin-stimulated glucose metabolism . In this study , we evaluated the effects of the chronic ingestion of FOS on plasma lipid and glucose concentrations , hepatic glucose production and insulin resistance in type 2 diabetics . Type 2 diabetic volunteers ( n = 10 ; 6 men , 4 women ) received either 20 g/d FOS or sucrose for 4 wk in a double-blind crossover design . FOS did not modify fasting plasma glucose and insulin concentrations or basal hepatic glucose production . The plasma glucose response to a fixed exogenous insulin bolus did not differ at the end of the two periods . Erythrocyte insulin binding also did not differ . Serum triacylglycerol , total and HDL cholesterol , free fatty acid , apolipoproteins A1 and B and lipoprotein ( a ) concentrations were not modified by the chronic ingestion of FOS . We conclude that 4 wk of 20 g/d of FOS had no effect on glucose and lipid metabolism in type 2 diabetics Background Inulin has been suggested to have beneficial effects on lipids , especially on triglyceridemia . Few data are available about the effects of inulin on Lipoprotein(a ) , a low-density lipoprotein-like particle considered as an independent risk factor for atherosclerosis . Adding inulin to pasta could be a preventive strategy for delaying the onset of atherosclerosis . Aim of the study was to evaluate the effects of inulin-enriched pasta on lipid profile and on Lipoprotein(a ) in young healthy subjects . Methods Twenty-two young healthy male volunteers entered a r and omized double blind cross-over study consisting of a 2-weeks run-in period , a baseline assessment , two 5-weeks study periods ( 11 % inulin-enriched or control pasta ) , and an 8-weeks wash-out period in between . Serum lipid concentrations were evaluated by routine biochemical analyses and plasma Lipoprotein(a ) concentrations by ELISA . The size of apolipoprotein(a ) isoforms was determined by Western blot and immunodetection . Results Significant differences at baseline and in the treatment groups were found for HDL-cholesterol ( P = 0.004 ) , total cholesterol/HDL-cholesterol ratio ( P = 0.006 ) , triglycerides ( P = 0.04 ) , and Lipoprotein(a ) ( OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusions : In summary , the use of ITF may have benefits for LDL-c reduction across all study population s , whereas HDL-c improvement and glucose control were demonstrated only in the T2DM subgroup . Overall , ITF supplementation may provide a novel direction for improving the lipid profile and glucose metabolism

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: A study was performed to evaluate the extent to which the medical literature may be misleading as a result of selective publication of r and omized clinical trials ( RCTs ) with results showing a statistically significant treatment effect . Three hundred eighteen authors of published trials were asked whether they had participated in any unpublished RCTs . The 156 respondents reported 271 unpublished and 1041 published trials . Of the 178 completed unpublished RCTs with a trend specified , 26 ( 14 % ) favored the new therapy compared to 423 of 767 ( 55 % ) published reports ( p less than 0.001 ) . For trials that were completed but not published , the major reasons for nonpublication were " negative " results and lack of interest . From the data provided , it appears that nonpublication was primarily a result of failure to write up and su bmi t the trial results rather than rejection of su bmi tted manuscripts . The results of this study imply the existence of a publication bias of importance both to meta- analysis and the interpretation of statistically significant positive trials Abstract . A cohort of 25 patients with spondylarthropathy ( SpA ) participated in a 3-year follow-up study of functional changes before and after an intensive 3-week inpatient course . They answered questions in the following functional status/disability indices : Bath ankylosing spondylitis functional index ( BASFI ) , Dougados functional index ( DFI ) , health assessment question naire for spondylarthropathy ( HAQ-S ) , Bath ankylosing spondylitis disease activity index ( BASDAI ) , Bath ankylosing spondylitis patient global assessment ( BAS-G ) , and horizontal visual analogue scale for stiffness ( stiffness VAS ) before and after the course and 3 years later by mail . A control group of 18 consecutive SpA patients from the waiting list for an inpatient course filled in the same question naires as study patients 3 months before entry and again 3 weeks later at home without rehabilitation . During the waiting time for the inpatient course , control group global assessment s ( BASDAI , BAS-G , and stiffness-VAS ) worsened slightly , and BASFI but not HAQ-S and DFI scores remained unchanged in the 3 weeks without treatment . The results of the 25 study patients showed small and not significant improvements in all functional index scores ( BASFI –0.5 points , DFI –1.1 , and HAQ-S –0.17 ) , whereas improvements were significant in BASDAI , BAS-G , and stiffness-VAS ( –13 mm , –13 mm , and –11 mm , respectively ) after the 3-week inpatient course . At 3-year follow-up , these small changes had disappeared and the changes were not significant . The global indices and BASFI worsened slightly ( 0.4 ) from baseline results , while DFI was slightly better ( –0.4 ) and HAQ-S remained at the post-treatment level after 3 years . Thus , BASFI was the most sensitive to changes , whereas DFI and HAQ-S were relatively insensitive . All six indices correlated highly significantly with each other ( ICC 0.53–0.94 ) . The natural course of spondylarthropathy leads to progression of functional impairments , which seems to be preventable with intensive rehabilitation , at least in the short term . Among the three functional indices , BASFI seems to be the most sensitive tool BACKGROUND Although exercise is a commonly recommended treatment for ankylosing spondylitis ( AS ) , little is known about the effectiveness of unsupervised recreational and back exercises . We examined the effects of recreational exercise and back exercises on patient-reported pain severity , stiffness severity , and functional disability in a prospect i ve longitudinal study of 220 patients with AS . METHODS Participants provided information on exercise habits and health status every 6 months using mailed question naires ( median follow-up , 4.5 years ) . Pain severity and stiffness severity were measured using visual analog scales , and functional disability was measured using the Health Assessment Question naire ( HAQ ) Disability Index . RESULTS Among all patients , there were no associations between either the number of exercise minutes per week or the number of days of back exercise per week and short-term ( 6-month ) changes in pain , stiffness , or HAQ Disability Index . However , among those who had AS for 15 years or less , pain scores were 0.18 points lower ( on a scale of 0 - 3 ; P = .04 ) , and stiffness scores were 6.4 points lower ( on a scale of 0 - 100 ; P = .005 ) during periods with more than 200 minutes per week of exercise compared with periods with 0 to 30 minutes of exercise per week . Among those who had AS for more than 15 years , pain scores were 0.11 points lower ( on a scale of 0 - 3 ; P = . 03 ) , and HAQ Disability Indexes were 0.08 points lower ( on a scale of 0 - 3 ; P<.001 ) during periods with 5 to 7 days per week of back exercise compared with periods when back exercises were not performed . Less intense levels of exercise were not associated with improvements in health status . CONCLUSIONS Unsupervised recreational exercise improves pain and stiffness , and back exercise improves pain and function in patients with AS , but these effects differ with the duration of AS . Health status is improved when patients perform recreational exercise at least 30 minutes per day and back exercises at least 5 days per week . Arch Intern Med . 2000;160:2969 - Sixteen individuals with rheumatoid arthritis ( RA ) and 19 individuals with ankylosing spondylitis ( AS ) participated in this 3-year follow-up study . The individuals in each disease group were allocated to an experimental group ( E group ) and a comparison group ( C group ) . They were investigated by question naire , clinical examination of the stomatognathic system , and laboratory tests . The individuals of the two E groups had performed a physical training program of the stomatognathic system during 3 weeks . After 3 years most of the patients in the E groups reported an unaltered or decreased severity of symptoms and signs from the stomatognathic system compared with the initial status . The clinical dysfunction score according to Helkimo ( CDS ) was lower in the RA group , and the mouth opening capacity was larger than before training . In the AS group there was no long-term change in the CDS but an increase of mouth opening capacity . The general inflammatory disease process in the RA group showed an increased activity during this follow-up period as assessed by erythrocyte sedimentation rate . This study suggests that local physical training of the stomatognathic system has a positive effect in individuals with RA Summary Long-term effects of three or four-week inpatient physiotherapy and exercise courses were studied in 141 adult patients with ankylosing spondylitis ( AS ) . Eight cervical and thoracolumbar range of motion ( ROM ) measurements and straight leg raise test , vital capacity ( VC ) and fitness index were measured at the beginning and end of an intensive course and 15 months later . All nine mobility measurements , vital capacity and fitness index were significantly improved after the course . Fifteen months later only chest expansion and vital capacity had significantly deteriorated from the baseline , while CR , FFD and fitness index were still significantly better . Disease duration did not influence treatment results .We conclude that it is possible by means of intensive rehabilitation courses to prevent for more than one year deterioration of spinal function and fitness in AS patients irrespective of disease duration Fifty-three patients with ankylosing spondylitis ( AS ) were r and omly allocated ; 26 experimental patients received physiotherapy and disease education , 27 control patients received neither . The primary treatment outcome was change in spinal mobility measured at 4 months by fingertip-to-floor distance . Experimental patients had more improvement in fingertip-to-floor distance ( p2 less than 0.004 ) and in function ( p2 less than 0.001 ) than control patients . Physiotherapy with disease education is effective in the treatment of patients with AS OBJECTIVE Cost effectiveness analysis is helpful in setting priorities for funding of health care programs . We studied the cost effectiveness of supervised group physical therapy compared to unsupervised exercises at home in patients with ankylosing spondylitis ( AS ) . METHODS A total of 144 patients with AS ( modified New York criteria ; mean age : 43 years ) were r and omized to unsupervised daily individualized exercises at home for 9 months or the same plus supervised group physical therapy ( 3 h weekly ) . At baseline and after 9 months we measured spinal mobility ( thoracolumbar flexion and extension ) , fitness ( maximum work capacity by ergometry ) , and patient 's global assessment of change as measured on a visual analog scale . We used a question naire at baseline and a diary during the trial to measure AS related direct medical costs , such as doctor visits , paramedical treatment , medication and hospitalization . RESULTS The mean effects of group therapy and home exercises were , respectively , + 0.9 cm ( 16 % ) and + 0.5 cm ( 9 % ) for mobility , + 7 watts ( 4 % ) and -2 watts ( -1 % ) for fitness , and + 1.7 ( 34 % ) and + 0.3 ( 6 % ) for global health . These 3 differences were significant ( p < 0.01 for mobility , p = 0.05 for fitness and p < 0.01 for global health ) . During the trial total medical costs decreased by an average of US $ 379 ( 44 % ) for group therapy , and by $ 257 (35%)/patient/year for the " home " group . Additional costs of group therapy were estimated at $ 531/patient/year ( $ 177 for accommodation , $ 256 for therapist and $ 98 for material s ) . After the study 75 % of the patients wanted to continue group physical therapy and were willing to pay for it . CONCLUSION Compared to therapy at home , additional benefits of group therapy cost $ 531/year , but reduced direct medical costs by $ 122/year . Hence , the beneficial effects of group therapy cost $ 409/patient with AS/year Two sets of criteria have been proposed to discriminate spondylarthropathies ( SA ) from other rheumatic diseases . To evaluate their performance , we conducted a cross-sectional study in the patients observed during one week in 28 French Departments of Rheumatology by 91 staff-teaching physicians . The physicians had to apply these criteria to all their patients and had to classify them as definite SA , definite other rheumatic disease or possible SA . The analysis performed on the 2,088 patients with a definite diagnosis ( 124 SA and 1,964 controls ) showed the following results : ( table ; see text ) Of the 140 patients with possible SA , 37 fulfilled both sets of criteria , 22 the ESSG criteria alone and 12 the Amor criteria alone . These data suggest that a ) the overall performance of these two sets of criteria is similar ; b ) this performance is better in the group of patients with a definite diagnosis ; c ) the patients without a definite diagnosis require a longer follow-up to assess the clinical relevance of these two sets of criteria PURPOSE Group physical therapy in patients with ankylosing spondylitis was studied to determine whether beneficial effects persisted after cessation of the intervention . METHODS After a 9-month period of supervised group physical therapy , 68 patients were r and omized for another 9 months to unsupervised daily exercises at home ( discontinuation group ) or continuation of weekly sessions of supervised group physical therapy ( continuation group ) . Endpoints were spinal mobility ( thoraco-lumbar flexion and extension , chest expansion , cervical rotation ) , fitness ( maximum work capacity ) , functioning ( Sickness Impact Profile ( SIP ) , Health Assessment Question naire for the Spondylarthropathies [ HAQ-S ] , Functional Index [ FI ] ) , and patient 's global health assessment on a visual analogue scale . RESULTS Time for exercises at home was significantly higher in the continuation than in the discontinuation group ( mean duration 1.9 versus 1.2 hr per week , P < 0.05 ) . The continuation group improved in global health ( mean improvement 1.6 ; 32 % ) and in SIP score . Scores for thoraco-lumbar mobility and HAQ-S did not change very much , whereas chest expansion , cervical rotation , fitness , and FI deteriorated . The average attendance for group therapy sessions was 62 % . The discontinuation group improved only marginally ( 0.2 ; 4 % ) in global health , whereas all other endpoints decreased . Only for global health and HAQ-S were the differences statistically significant in favor of the continuation group . CONCLUSIONS Global health and functioning are sustained or even improved further if group physical therapy is continued . Spinal mobility decreased slightly in both groups OBJECTIVE Our previous r and omized clinical trial showed a 4-month home physiotherapy program was effective for patients with ankylosing spondylitis . This followup study reports on 22 control patients who received the previously withheld treatment and 24 experimental patients who received followup treatment as needed . METHODS The primary outcome measure was spinal mobility measured by fingertip-to-floor distance using a portable measuring device specially design ed and vali date d for this study . RESULTS Following treatment , fingertip-to-floor distance did not change in control patients ( P2 = 0.145 ) . Between 4 and 8 months , fingertip-to-floor distance did not change in experimental patients ( P2 = 0.143 ) ; however , initial improvement achieved was maintained . The experimental group at 4 months was better than the control group at 8 months ( P2 = 0.038 ) . CONCLUSION The home physiotherapy treatment program must be delivered as rigorously as it was in OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

There is not sufficient evidence yet available to base recommendations for or against the use of physiotherapy interventions for ankylosing spondylitis

MS2_fixed_5_shot275

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Objective This study aims to determine whether vitamin D levels are associated with menopause-related symptoms in older women . Methods A r and omly selected subset of 1,407 women , among 26,104 potentially eligible participants of the Women ’s Health Initiative Calcium and Vitamin D trial of postmenopausal women aged 51 to 80 years , had 25-hydroxyvitamin D [ 25(OH)D ] levels measured at the Women ’s Health Initiative Calcium and Vitamin D trial baseline visit . Information about menopause-related symptoms at baseline was obtained by question naire and included overall number of symptoms and composite measures of sleep disturbance , emotional well-being , and energy/fatigue , as well as individual symptoms . After exclusions for missing data , 530 women ( mean [ SD ] age , 66.2 [ 6.8 ] y ) were included in these analyses . Results Borderline significant associations between 25(OH)D levels and total number of menopausal symptoms were observed ( with P values ranging from 0.05 to 0.06 for fully adjusted models ) ; however , the effect was clinical ly insignificant and disappeared with correction for multiple testing . No associations between 25(OH)D levels and composite measures of sleep disturbance , emotional well-being , or energy/fatigue were observed ( P ’s > 0.10 for fully adjusted models ) . Conclusions There is no evidence for a clinical ly important association between serum 25(OH)D levels and menopause-related symptoms in postmenopausal women BACKGROUND It is unknown whether supplementation with calcium and vitamin D has an impact on menopause-related symptoms . METHODS As part of the Women 's Health Initiative Calcium/Vitamin D Supplementation Trial ( CaD ) , women were r and omized at 40 clinical sites to elemental calcium carbonate 1000 mg with vitamin D 400 IU daily or placebo . At the CaD baseline visit ( year 1 or year 2 ) and during a mean follow-up of 5.7 years , participants provided data on menopause-related symptoms via question naires . Generalized linear mixed effects techniques were used to address research questions . RESULTS After excluding participants with missing data ( N=2125 ) , we compared menopause-related symptoms at follow-up visits of 17,101 women r and omized to CaD with those of 17,056 women given the placebo . Women in the CaD arm did not have a different number of symptoms at follow-up compared to women taking the placebo ( p=0.702 ) . Similarly , there was no difference between sleep disturbance , emotional well-being , or energy/fatigue at follow-up in those who were r and omized to CaD supplementation compared to those taking the placebo . CONCLUSIONS Our data suggest that supplementation with 1000 mg of calcium plus 400 IU of vitamin D does not influence menopause-related symptoms over an average of 5.7 years of follow-up among postmenopausal women with an average age of 64 at the WHI baseline visit Background : Most of the women suffer from vaginal atrophy and dryness , and therefore , efficient and safe treatment is needed to improve vaginal lubrication . Vitamin D has several important functions which may be effective in proliferation and repair of the epithelial tissue . This study aim ed to evaluate the effect of vitamin D vaginal suppositories on maturation index , pH , and dryness in postmenopausal women . Material s and Methods : Women were enrolled in this double-blind clinical trial , in whom menopause occurred at least one year ago . Those women who had an abnormal Papanicolaou smear , had undergone hormonal treatment , or have had vaginal infection in the previous year were excluded . Forty-four women who found eligible were r and omized into two equal groups , the treatment and control groups , which received vitamin D and placebo vaginal suppository daily for 8 weeks , respectively . Vaginal pH and maturation value were measured at the beginning and end of the study . Pain , dryness , and paleness were assessed before treatment and at the end of the 2 , 4 , and 8 weeks of treatment . Results : In the treatment group , the number ( Mean ± SD ) of superficial cells increased ( 69.76 ± 12.4 ) and vaginal pH decreased ( 1.42 ± 0.67 ) significantly compared to the control group after 56 days . The mean pain significantly reduced after 8 weeks in the treatment group ( 1.23 ± 0.53 ) compared to the control group 1.95 ± 0.74 ( P < 0.001 ) . The mean of dryness and paleness reduced significantly in the treatment group versus control at 56 days . Conclusions : Vitamin D is effective in improving the maturation index and decreased the pH and dryness of the vaginal atrophy due to menopause Fracture prevention is one of the public health priorities worldwide . Estrogen deficiency is the major factor in the pathogenesis of postmenopausal osteoporosis , the most common metabolic bone disease . Different effective treatments for osteoporosis are available . Hormone replacement therapy ( HRT ) at different doses rapidly normalizes turnover , preserves bone mineral density ( BMD ) at all skeletal sites , leading to a significant , reduction in vertebral and non-vertebral fractures . Tibolone , a selective tissue estrogenic activity regulator ( STEAR ) , is effective in the treatment of vasomotor symptoms , vaginal atrophy and prevention/treatment of osteoporosis with a clinical efficacy similar to that of conventional HRT . Selective estrogen receptor modulators ( SERMs ) such as raloxifene and bazedoxifene reduce turnover and maintain or increase vertebral and femoral BMD and reduce the risk of osteoporotic fractures . The combination of bazedoxifene and conjugated estrogens , defined as tissue selective estrogen complex ( TSEC ) , is able to reduce climacteric symptoms , reduce bone turnover and preserve BMD . In conclusion , osteoporosis prevention can actually be considered as a major additional benefit in climacteric women who use HRT for treatment of climacteric symptoms . The use of a st and ard dose of HRT for osteoporosis prevention is based on biology , epidemiology , animal and pre clinical data , observational studies and r and omized , clinical trials . The antifracture effect of a lower dose HRT or TSEC is supported by the data on BMD and turnover , with compelling scientific evidence Introduction : Role of Vitamin D is very well known for the functioning of many body organs . However , its role in the postmenopausal women in relation to various genitourinary disorders has been recognized recently . The main objective of this study was to evaluate role of Vitamin D in vaginal health , prolapse , bladder and bowel function , and bacterial vaginosis ( BV ) . Material s and Methods : This was a r and omized controlled study in which 200 geriatric female patients of 65–78 years of age divided into two groups comprising study and control group with 100 participants in each . Detailed obstetrical , gynecological , and clinical history was elicited . Detailed examination regarding the prolapse , urinary and bowel functions , and bacterial infections was done followed by follow-up of 3 and 6 months each . Chi-square and independent t-test used for data analysis . Results : Mean modified vaginal health index ( MVHI ) among patients with pelvic floor diseases was statistically significant with P = 0.0472 . There was a visible increasing trend in Vitamin D deficiency with increase in time since menopause ( P = 0.1193 ) . Patients with pelvic floor disease had mean Vitamin D statistically significant with P = 0.0462 . With increase in Vitamin D levels , MVHI was found to be better . The association of mean Vitamin D levels among patients with urinary incontinence as compared to controls was significant with P = 0.0460 . Association of mean Vitamin D levels in patients with fecal incontinence and BV as compared to controls was not statistically significant with P = 0.6304 and 0.79 , respectively . Low Vitamin D levels were associated with high mean parathyroid hormone ( PTH ) levels statistically significant with P = 0.034 . MVHI was found to increase significantly with Vitamin D supplementation at 3 and 6 months ' follow-up . There was increase in Vitamin D and calcium levels and fall in serum PTH levels at 3 and 6 months . Conclusions : Vitamin D levels were associated with a decreased risk of pelvic floor disorders , improved MVHI in women in geriatric age group BACKGROUND it is known that vitamin D increases the population of superficial cells , so the objective of the present work was to evaluate the effect in Mexican postmenopausal women who were using or not oral calcitriol . METHODS postmenopausal women with vaginal dryness that received at r and om : calcium 500 mg orally every 24 h or calcitriol 0.25 μg every 24 h during two months . At the beginning of treatment and at two months a vaginal Pap smear was performed . The maturation index was determined and the estrogenic value was calculated . Vaginal dryness was evaluated using an analog visual scales and vaginal by the moistening of a pH test strip . Student 's t test was used for statistical analysis . RESULTS 23 postmenopausal women were studied and divided as follows : group I ( calcium ) = 11 women and group II ( calcitriol ) = 12 women . In the analyzed parameters only the average of superficial cells was significantly greater at the end of treatment in the calcitriol group . CONCLUSION calcitriol use increased the average of superficial cells in vaginal cytology , but did n't modify vaginal dryness OBJECTIVES We assessed the effects of the discontinuation of long-st and ing transdermal estrogen replacement therapy ( > 4 years ) and substitution of this treatment by calcium or raloxifene on the vaginal epithelium and climateric symptoms in a study population of osteoporotic women . METHODS A total of 136 women ( mean age 55.5 years ) were r and omized to calcium ( 500 mg elemental calcium , 400 IU Vitamin D3 ) ( n=40 ) , raloxifene ( 60 mg/day ) ( n=48 ) , or estrogen patches ( 3.9 mg estradiol ) and progesterone ( 100 mg/day ) ( n=48 ) . Treatment was given for 1 year . The vaginal maturation value ( VMV ) , serum estradiol levels , and climateric symptoms using a 12-item modification of the SF-36 quality of life question naire were evaluated at baseline and at 6 and 12 months . RESULTS At 6 months , mean VMV decreased significantly ( P<0.001 ) in the calcium ( -51.8 % ) and raloxifene ( -18.6 % ) groups compared with baseline and the estrogen/progesterone group . At 12 months , significant decreases of mean VMV in the calcium ( -38.7 % ) and raloxifene groups ( -32 % ) ( P<0.001 ) were also observed . Serum estradiol levels and changes of VMV correlated significantly at 6 months ( rho=0.361 , P<0.01 ) and at 12 months ( rho=0.269 , P<0.035 ) . A significantly higher number of patients complained of hot flushes and palpitations in the calcium and raloxifene groups than in the estrogen/progesterone group . Raloxifene-treated women reported a significantly higher number of adverse events at 6 months compared to the other treatment groups . CONCLUSIONS Withdrawal and change of long-st and ing transdermal hormone replacement therapy by treatment with calcium or raloxifene result ed in worsening of vaginal atrophy assessed by the VMV , although it was not clinical ly perceived by the patients . However , increases in dyspareunia and urinary leaks were reported . Menopausal complaints related to vasomotor symptoms worsened in the calcium- and raloxifene-treated groups and persisted throughout the study period AIM Affective and behavioural disorders possibly concomitant to the vasomotor menopausal symptoms worsen quality of life . A rational formulation containing soy isoflavones ( 60 mg ) , lactobacilli ( 500 millions spores ) , calcium ( 141 mg ) and vitamin D3 ( 5 microg ) was added of Magnolia bark extract ( 60 mg ) and magnesium ( 50 mg ) ( Estromineral serena , ES ) . The Magnolia extract active principles interact with GABA system and exhibit a sedative central action . Magnesium intervenes in enzymatic reactions of the energetic metabolism and protects the bone integrity . Aim of this controlled study was to compare the clinical activity and safety of ES versus calcium+vitamin D3 ( Ca+D ) in menopause . METHODS A controlled , r and omised , multicentre study was carried out in symptomatic menopausal women with sleep or mood alterations . Women received 1 tablet/day of ES or Ca+D for 24 weeks . Symptoms during the treatment and final judgements on efficacy and acceptability were evaluated . RESULTS Eighty-nine women ( 44 ES and 45 Ca+D , mean age 53.8 years , in menopause since 56.6 months ) participated to the study . Flushing , noct OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Although the level of evidence for the effects of vitamin D on vaginal health is low in our study , we concluded that vitamin D may improve the vaginal health of women , especially during menopause

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: This pilot double blind r and omised controlled study aim ed to investigate whether the midvastus ( MV ) approach without patellar eversion in total knee arthroplasty ( TKA ) result ed in improved recovery of function compared to the medial parapatellar ( MP ) approach . Patients were r and omly allocated to either the MV approach or the MP approach . Achievements of inpatient mobility milestones were recorded . Knee kinematics , muscle strength , Timed Up and Go , WOMAC , and daily step count were assessed before and up to six months after surgery . Cohen 's effect size d was calculated to inform the sample size in future trials . Twenty-eight participants ( 16 males , 12 females ) participated . Patient mobility milestones such as straight leg raise were achieved on average 1.3 days ( 95 % CI −3.4 to 0.7 , d = 0.63 ) earlier in the MV group . Knee extensor strength at 6 weeks after surgery was higher ( 95 % CI −0.38 to 0.61 , d = 0.73 ) in the MV group . No trends for differences between the groups were observed in knee kinematics , TUG , WOMAC , or step count . Our results suggest a short term advantage in the first 6 weeks after surgery of the MV approach over the MP approach , but a larger study is required to confirm these findings . This trial is registered with NCT056445 BACKGROUND It has been shown before that when compared with the medial para-patellar approach , the mid-vastus approach for TKR results in less post-operative pain for patients and more rapid recovery of straight leg raise . As far as we are aware the post-operative length of stay of the two groups of patients has not been compared . We postulated that the reduced pain and more rapid recovery of straight leg raise would translate into an earlier , safe , discharge home for the mid-vastus patients compared with those who underwent a traditional medial para-patellar approach . METHODS Twenty patients operated on by each of five established knee arthroplasty surgeons were evaluated prospect ively with regard to their pre and post-operative range of movement , time to achieve straight leg raise post-operatively and length of post-operative hospital stay . Only one of the surgeons performed the mid-vastus approach , and the measurements were recorded by physiotherapists who were blinded as to the approach used on each patient . RESULTS The results were analysed using a st and ard statistical software package , and although the mean length of stay was lower for the mid-vastus patients , the difference did not reach a level of significance ( p = 0.13 ) . The time taken to achieve straight leg raise post-operatively was significantly less in the mid-vastus group ( p<0.001 ) . CONCLUSION Although this study confirms previous findings that the mid-vastus approach reduces the time taken for patients to achieve straight leg raise , when compared with the medial para-patellar approach , on its own it does not translate into a significantly shorter length of hospital stay . In order to reduce the length of post-operative hospital stay with an accelerated rehabilitation program for TKR , a multi-disciplinary approach is required . Patient expectations , GP support , physiotherapists and nursing staff all have a role to play and the mid-vastus approach , in permitting earlier straight leg raising , significantly contributes to this BACKGROUND During total knee arthroplasty ( TKA ) , surgical exposure requires mobilization technique of the patella . With this trial , we intended to investigate the effect of patella eversion on clinical outcome measures in simultaneous bilateral TKA . METHODS We prospect ively enrolled 44 patients ( 88 knees ) from April 2008 to June 20l4.One knee was operated with patella eversion ( group A ) and the other with patella lateral retraction ( group B ) r and omly . Follow-up results , including the operation time , complications , and the time of achieving straight leg raise ( SLR ) and 90 ° knee flexion , were recorded . The data of range of motion ( ROM ) and Visual Analogue Scale score were collected separately at 7 days , 3 months , 6 months , and 1 year postoperatively . RESULTS The time of achieving SLR was 2.7 ± 0.8 days in group A and 2.1 ± 0.7 DAYS in group B , which were significantly different ( P = .032 ) . Significant difference was found on active and passive ROM during the follow-up times between groups A and B , except the passive ROM at 6 months postoperatively . No significant difference was found on operation time , complications , patella baja or tilt , time of achieving 90 ° knee flexion , and Visual Analogue Scale score during the follow-up times . CONCLUSIONS Patellar eversion was adverse to the early knee function recovery after TKA ; it would delay the time of achieving SLR and decrease the passive and active ROM . In addition , more carefully and scientifically design ed r and omized controlled trials are still required to further prove the cl aim Background Minimally invasive knee arthroplasty seeks to diminish the problems of traditional extensile exposures aim ing for more rapid rehabilitation of patients after surgery . Questions / purpose s To determine if the subvastus approach results in less perioperative pain and blood loss , shorter hospital stay , and improved function at both early and long-term followup . Methods One hundred patients were enrolled in a prospect i ve , r and omized trial . Fifty were operated on using a minimally invasive subvastus approach and the other 50 by a conventional , peripatellar approach . Minimum followup was 3 years . A repeated- measures analysis of variance was used to compare the Knee Society score and range of motion during followup . Results The minimally invasive approach result ed in greater perioperative bleeding but no increase in transfusions . No differences were found in postoperative pain between groups nor did hospital stay show any differences . The range of motion on the third day after surgery was greater in the minimally invasive group . No differences were found in surgical time , femoral or tibial component orientation or outliers , or complication rates . Both Knee Society score and range of motion were superior using the minimally invasive subvastus approach during followup out to 36 months . Conclusions The minimally invasive subvastus approach can result in improved long-term Knee Society scores and range of motion of total knee arthroplasty without increased risk of component malalignment , surgical time , or complication rate . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence The purpose of this prospect i ve study was to analyze the biochemical markers of muscle damage and inflammation in patients treated with the mini-midvastus approach or the medial parapatellar approach for total knee arthroplasty . Of 60 patients who underwent unilateral total knee arthroplasty , 30 were treated with the mini-midvastus approach ( MMV group ) and 30 were treated with the medial parapatellar approach ( MPP group ) . Serum creatine kinase , myoglobin , lactate dehydrogenase , glutamic oxaloacetic transaminase , C-reactive protein , interleukin-6 , and interleukin-1β levels were measured preoperatively , immediately postoperatively ( except for C-reactive protein level ) , and on postoperative days 1 , 2 , and 3 . Student 's t test , Pearson 's chi-square test , and Fisher 's exact test were used to compare the outcomes between the 2 groups . Compared with the MPP group , a significant increase in serum creatine kinase level existed in the MMV group on postoperative days 2 ( P=.08 ) and 3 ( P=.09 ) and cumulatively ( P=.02 ) . However , significantly elevated C-reactive protein and interleukin-6 levels existed in the MPP group . According to the serum creatine kinase levels , the mini-midvastus approach has no superiority over the medial parapatellar approach in terms of sparing muscle and may cause more muscle damage . Further study is warranted to determine the correlation between biochemical markers and functional deficits A prospect i ve r and omized study was performed on 20 patients undergoing one-stage bilateral knee arthroplasty . One knee was exposed using a st and ard median parapatellar arthrotomy and the other knee with a subvastus arthrotomy . All patients underwent quantitative strength testing before surgery and at 1 week , 1 month , and 3 months after surgery . The knees were also evaluated for range of motion , and patients , who were blinded as to the approach used , completed question naires at each evaluation period as to their preference , if any , regarding knee pain and level of function . There was no difference in the range of motion between knees exposed with the paramedian or subvastus arthrotomy at any time period . The subvastus knees demonstrated significantly greater strength at the 1-week and 1-month intervals , but there was no strength difference at the 3-month interval . There were more lateral releases performed in the paramedium knees , and three minor complications were related to the subvastus approach . Patients who expressed a preference chose the subvastus knee 4:1 over the paramedian knee . The subvastus approach offers a reasonable alternative to the paramedian arthrotomy and preserves greater quadriceps strength in the early postoperative period Purpose Whether minimally invasive total knee arthroplasty ( MIS-TKA ) could offer better and faster recovery without the deviation of post-operative prosthesis position and limb alignment is still controversial . This prospect i ve and r and omized study was conducted to compare the clinical and radiological outcomes between patients who underwent the mini-subvastus approach of MIS-TKA and those who underwent the medial parapatellar approach of traditional TKA . Methods Fifty patients , including 50 knees , who required TKA due to osteoarthritis were r and omized to the mini-subvastus group ( group I ) or the medial parapatellar group ( group II ) . All patients accepted the same method of anaesthesia , equal support therapy and identical rehabilitation exercise after surgery . The evaluation system included operation time , tourniquet time , blood loss , skin incision length in flexion , straight leg raising time , the time of lower limb muscle strength up to grade 4 , the time of walking with aid or without aid , the time of walking up and down the stairs , the active flexion angle , range of movement ( ROM ) , the Knee Society Scores ( KSS ) , visual analogue score for pain ( VAS ) , hospital stays and radiographic outcomes . Results The mini-subvastus approach offered smaller skin incision length in flexion , but at the cost of operation time ( P < 0.001 ) . No significant difference was found in tourniquet time and blood loss . The patients in group I could achieve straight leg raising , the lower limb muscle strength up to grade 4 , walking with or without aid , and walking up and down the stairs earlier ( P < 0.001 ) . The active flexion angle , ROM , VAS and KSS in group I were superior to those in group II until six months post-operatively ( P < 0.001 ) , but the differences was not apparent at 12 months post-operatively . More importantly , there was no significant difference between the two groups on radiological outcomes ( P > 0.05 ) . Conclusions The mini-subvastus approach could offer faster recovery , less pain and shorter hospital stays without compromising the principles of proper prosthesis position and limb alignment compared with the medial parapatellar approach & NA ; The purpose of this r and omized study was to compare clinical and surgical outcomes of total knee replacements ( TKRs ) in the early postoperative period using midvastus approach versus medial parapatellar approach in Asian population in a double blind manner . Forty‐two knees each were operated using midvastus approach and the medial parapatellar approach . Clinical parameters that were evaluated included Knee Society score ( KSS ) ; knee pain using visual analogue scale ( VAS ) on day 1 , 1 week , and 1 month ; time required to straight leg raise ( SLR ) ; patellar tracking ; mean extensor lag at 1 week and 1 month ; and time of discharge from the hospital . Surgical parameters that were evaluated included tourniquet time , incidence of lateral retinacular release , estimated blood loss , and any complications during the surgery . KSS at 1 week and 1 month postoperatively were significantly higher in the midvastus group as compared with medial parapatellar group ; though similar at 3 months , 6 months , and 1 year . The patients in midvastus group required fewer number of lateral retinacular releases ; achieved SLR earlier ; had less mean extensor lag at 1 week ; had less mean VAS score at day 1 , 1 week , and 1 month ; and had shorter hospital stay . There was no significant difference in the mean tourniquet time and estimated blood loss . One patient had patellar maltracking in the medial parapatellar group as compared with none in midvastus group . Midvastus approach to TKR results in quicker functional recovery with early discharge and rehabilitation in the Asian population as compared with medial parapatellar approach Abstract Simultaneous bilateral TKAs subject patients to more arduous and painful functional recovery and increased risk of hemodynamic complications than staged bilateral TKAs . Minimally invasive TKA ( MIS-TKA ) reportedly results in more rapid return of function by limiting the amount of soft tissue disruption . We asked whether bilateral MIS-TKA had advantages over conventional TKA with respect to faster functional recovery . We prospect ively r and omized 30 patients into an MIS group ( mini-medial parapatellar approach , 15 patients ) and a conventional group ( conventional medial parapatellar approach , 15 patients ) . We recorded range of motion and the time required to regain the ability to walk without assistance . Functional recovery in the MIS group was faster in rehabilitation milestones of walking without assistance and gain in range of OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The MSV approach ranked better concerning clinical scores ( the lowest visual analogic scale , the higher KSS and KSFS ) and functional outcomes ( the shortest straight leg raise , the greatest degree of flexion and range of motion ) . Concerning perioperative data , the MSV evidence d the shortest hospital stay , while the MPP the shortest surgical duration and lowest estimated blood loss . According to the main findings of the present study , the mini-subvastus approach for total knee arthroplasty demonstrated superior overall compared to the other approaches .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Objective Mechanical factors , in particular increased medial knee joint load , are believed to be important in the structural progression of knee osteoarthritis . This study evaluated the relationship of medial knee load during walking to indices of structural disease progression , measured on MRI , in people with medial knee osteoarthritis . Methods A longitudinal cohort design utilising a subset of participants ( n=144 , 72 % ) enrolled in a r and omised controlled trial of lateral wedge insoles was employed . Medial knee load parameters including the peak knee adduction moment ( KAM ) and the KAM impulse were measured at baseline using three-dimensional gait analysis during walking . MRI at baseline and at 12 months was used to assess structural indices . Multiple regression with adjustment for covariates assessed the relationship between medial knee load parameters and the annual change in medial tibial cartilage volume . Binary logistic regression was used for the dichotomous variables of progression of medial tibiofemoral cartilage defects and bone marrow lesions ( BML ) . Results A higher KAM impulse , but not peak KAM , at baseline was independently associated with greater loss of medial tibial cartilage volume over 12 months ( β=29.9 , 95 % CI 6.3 to 53.5 , p=0.01 ) . No significant relationships were seen between medial knee load parameters and the progression of medial tibiofemoral cartilage defects or BML . Conclusion This study suggests knee loading , in particular the KAM impulse , may be a risk factor for loss of medial tibial cartilage volume . As knee load is modifiable , load-modifying treatments may potentially slow disease progression STUDY DESIGN Prospect i ve cohort study . OBJECTIVES To characterize knee cartilage change in individuals with knee osteoarthritis ( KOA ) who have completed a therapeutic exercise program . BACKGROUND While therapeutic exercise is frequently used successfully to improve pain and function in individuals with KOA , no studies have reported the volume of cartilage change or individual factors that may impact volume of cartilage change in those completing an exercise program for KOA . METHODS Thirteen individuals with KOA underwent magnetic resonance imaging to quantify cartilage volume change in the weight-bearing regions of the medial and lateral femoral condyles and the entire surface of the tibial plateaus from baseline to 1-year follow-up . Body structure and function measures were taken for body mass index , knee axis alignment , knee motion , and knee strength . Activity limitations and activity levels were also measured prior to the therapeutic exercise program , using the Western Ontario and McMaster Universities Osteoarthritis Index and the Physical Activity Scale for the Elderly . At 6 months from baseline , follow-up clinical measurements of knee strength and motion were performed . At 1 year from baseline , imaging of the knee cartilage and knee alignment were performed , and participants completed the Western Ontario and McMaster Universities Osteoarthritis Index and Physical Activity Scale for the Elderly . RESULTS The central region of the medial femoral condyle ( cMF ) had a median volume of cartilage loss of 3.8 % . The other 3 knee tibiofemoral articular surfaces had minimal median cartilage volume change . Individuals were dichotomized into progressors ( n = 6 ) and nonprogressors ( n = 7 ) , based on the st and ard error of measurement of cartilage volume change for the cMF . Progressors were younger , had a larger body mass index , had a higher Kellgren-Lawrence grade in the medial compartment of the knee , and had a greater increase in knee varus alignment from baseline to 1-year follow-up . The progressors also had frontal plane hip and knee kinetics during baseline gait analysis that potentially increased medial knee joint loading . CONCLUSION The loss of cMF cartilage volume was highly variable and the median loss of cartilage was within the range previously reported . Seven of the 13 individuals did not have cMF cartilage volume loss greater than the st and ard error of measurement . Change in cartilage volume of the cMF may be influenced to a greater extent by personal factors than by completion of a therapeutic exercise program . Additional research is needed to decipher the interactions among therapeutic exercise and personal characteristics that impact knee cartilage loss Objective This study aim ed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis ( OA ) declined after one month of wear , and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month . Methods Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i ) no insoles and ; ii ) insoles wedged laterally 5 ° in r and om order . Testing occurred at baseline and after one month of use of the insoles . Participants recorded daily use of insoles in a log-book . Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse , compared across conditions and time with repeated measures general linear models . Correlations were obtained between total insole use and change in gait parameters with used insoles at one month , and change scores were compared between high and low users of insoles using general linear models . Results There was a significant main effect for condition , whereby insoles significantly reduced the adduction moment ( all p < 0.001 ) . However there was no significant main effect for time , nor was an interaction effect evident . No significant associations were observed between total insole use and change in gait parameters with used insoles at one month , nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time . Conclusion Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use , suggesting that significant wedge degradation does not occur over the short-term In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis . Design R and omised controlled trial . Setting Community in Melbourne , Australia . Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis . Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months . Main outcome measures Primary symptomatic outcome was change in overall knee pain ( past week ) measured on an 11 point numerical rating scale . Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans . Secondary clinical outcomes included changes in measures of pain , function , stiffness , and health related quality of life . Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions . Results Between group differences did not differ significantly for the primary outcomes of change in overall pain ( −0.3 points , 95 % confidence intervals −1.0 to 0.3 ) and change in medial tibial cartilage volume ( −0.4 mm3 , 95 % confidence interval −15.4 to 14.6 ) , and confidence intervals did not include minimal clinical ly important differences . None of the changes in secondary outcomes showed differences between groups . Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles . Trial registration Australian New Zeal and Clinical Trials Registry ACTR12605000503628 and Clinical Trials.gov NCT00415259 Background Osteoarthritis of the knee involving predominantly the medial tibiofemoral compartment is common in older people , giving rise to pain and loss of function . Many people experience progressive worsening of the disease over time , particularly those with varus malalignment and increased medial knee joint load . Therefore , interventions that can reduce excessive medial knee loading may be beneficial in reducing the risk of structural progression . Traditional quadriceps strengthening can improve pain and function in people with knee osteoarthritis but does not appear to reduce medial knee load . A neuromuscular exercise program , emphasising optimal alignment of the trunk and lower limb joints relative to one another , as well as quality of movement performance , while dynamically and functionally strengthening the lower limb muscles , may be able to reduce medial knee load . Such a program may also be superior to traditional quadriceps strengthening with respect to improved pain and physical function because of the functional and dynamic nature . This r and omised controlled trial will investigate the effect of a neuromuscular exercise program on medial knee joint loading , pain and function in individuals with medial knee joint osteoarthritis . We hypothesise that the neuromuscular program will reduce medial knee load as well as pain and functional limitations to a greater extent than a traditional quadriceps strengthening program . Methods / Design 100 people with medial knee pain , radiographic medial compartment osteoarthritis and varus malalignment will be recruited and r and omly allocated to one of two 12-week exercise programs : quadriceps strengthening or neuromuscular exercise . Each program will involve 14 supervised exercise sessions with a physiotherapist plus four unsupervised sessions per week at home . The primary outcomes are medial knee load during walking ( the peak external knee adduction moment from 3D gait analysis ) , pain , and self-reported physical function measured at baseline and immediately following the program . Secondary outcomes include the external knee adduction moment angular impulse , electromyographic muscle activation patterns , knee and hip muscle strength , balance , functional ability , and quality -of-life . Discussion The findings will help determine whether neuromuscular exercise is superior to traditional quadriceps strengthening regarding effects on knee load , pain and physical function in people with medial knee osteoarthritis and varus malalignment . Trial Registration Australian New Zeal and Clinical Trials Registry reference : Osteoarthritic knee pain affects patient mobility . Relief of knee pain in osteoarthritis has been reported to increase loading of the knee during gait , but it is unknown whether such pain relief enhances knee loading during more dem and ing activities such as stair-stepping . The gait of 19 patients and stair-stepping of 14 patients with painful medial compartment osteoarthritis of the knee was assessed before and after pain-relieving intraarticular injection of the knee and compared with those of 21 healthy control subjects . There were significant increases in gait velocity , cadence , maximum external knee adduction moment ( indicating increased loading in the medial compartment of the knee ) , and maximum external hip adduction and ankle abduction moments immediately after the injection . With the exception of velocity and ankle abduction moment , these variables were returned to levels that were not statistically different from those of the control subjects . However , no significant differences were found during stair-stepping in the external adduction-abduction moments about the knee , hip , or ankle after injection . Furthermore , the postinjection magnitudes of these variables during stair-stepping were significantly less than those of the controls . Therefore , although the relief of knee pain is sufficient to enhance gait function in osteoarthritis of the knee , it is insufficient to enhance stair-stepping function OBJECTIVE To evaluate the effects of a modified shoe that incorporates both lateral wedging and a variable-stiffness sole on knee joint loading in 3 population s : individuals with symptomatic and radiographic knee osteoarthritis ( OA ) , asymptomatic overweight individuals , and asymptomatic healthy weight individuals . METHODS Ninety participants ( 30 per group ) underwent a 3-dimensional gait analysis across 3 test conditions : modified shoes , st and ard control shoes , and barefoot . For each condition , the first peak knee adduction moment ( KAM ) and knee flexion moment ( KFM ) ( both expressed as Nm/[body weight × height]% ) as well as the KAM impulse ( expressed as Nm.s/[body weight × height]% ) were determined . RESULTS The modified shoes significantly reduced the peak KAM as compared to the control shoes in both the OA ( P = 0.002 ) and the overweight ( P = 0.03 ) groups . In the OA group , there was no significant difference in peak KAM when walking in the modified shoe as compared to walking barefoot . In the overweight and the healthy weight groups , the peak KAM when walking in the modified shoe was significantly higher than that when walking barefoot ( P < 0.001 ) . Irrespective of group , the KAM impulse was significantly reduced when walking in the modified shoe as compared to the control shoe ( P < 0.001 ) and was significantly higher during both shoe conditions as compared to walking barefoot ( P < 0.001 ) . There was no change in the KFM between walking conditions for any group . CONCLUSION The findings illustrate that a shoe incorporating both a lateral wedge and a variable-stiffness sole can significantly reduce medial knee joint load . Further research examining the effects of these OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

There is very limited and low- quality evidence to support for a causal link between knee joint loading during walking and structural progression of knee OA .

MS2_fixed_5_shot278

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Recent studies have demonstrated that dyslexia is associated with deficits in the temporal encoding of sensory information . While most previous studies have focused on information processing within a single sensory modality , it is clear that the deficits seen in dyslexia span multiple sensory systems . Surprisingly , although the development of linguistic proficiency involves the rapid and accurate integration of auditory and visual cues , the capacity of dyslexic individuals to integrate information between the different senses has not been systematic ally examined . To test this , we studied the effects of task-irrelevant auditory information on the performance of a visual temporal-order-judgment ( TOJ ) task . Dyslexic subjects ’ performance differed significantly from that of control subjects , specifically in that they integrated the auditory and visual information over longer temporal intervals . Such a result suggests an extended temporal “ window ” for binding visual and auditory cues in dyslexic individuals . The potential deleterious effects of this finding for rapid multisensory processes such as reading are discussed OBJECTIVE To highlight emerging evidence for clinical and biological links between autism/pervasive developmental disorder ( PDD ) and schizophrenia , with particular attention to childhood-onset schizophrenia ( COS ) . METHOD Clinical , demographic , and brain developmental data from the National Institute of Mental Health ( and other ) COS studies and selected family , imaging , and genetic data from studies of autism , PDD , and schizophrenia were review ed . RESULTS In the two large studies that have examined this systematic ally , COS is preceded by and comorbid with PDD in 30 % to 50 % of cases . Epidemiological and family studies find association between the disorders . Both disorders have evidence of accelerated trajectories of anatomic brain development at ages near disorder onset . A growing number of risk genes and /or rare small chromosomal variants ( microdeletions or duplications ) are shared by schizophrenia and autism . CONCLUSIONS Biological risk does not closely follow DSM phenotypes , and core neurobiological processes are likely common for subsets of these two heterogeneous clinical groups . Long-term prospect i ve follow-up of autistic population s and greater diagnostic distinction between schizophrenia spectrum and autism spectrum disorders in adult relatives are needed BACKGROUND This project examined the intermodal perception of temporal synchrony in 16 young children ( ages 4 to 6 years ) with autism compared to a group of children without impairments matched on adaptive age , and a group of children with other developmental disabilities matched on chronological and adaptive age . METHOD A preferential looking paradigm was used , where participants viewed non-linguistic , simple linguistic or complex linguistic events on two screens displaying identical video tracks , but one offset from the other by 3 seconds , and with the single audio track matched to only one of the displays . RESULTS As predicted , both comparison groups demonstrated significant non-r and om preferential looking to violations of temporal synchrony with linguistic and non-linguistic stimuli . However , the group with autism showed an impaired , chance level of responding , except when presented with non-linguistic stimuli . CONCLUSIONS Several explanations are offered for this apparently autism-specific , language -specific pattern of responding to temporal synchrony , and potential developmental sequelae are discussed BACKGROUND Recent research has indicated that autism is not a discrete disorder and that family members of autistic prob and s have an increased likelihood of exhibiting autistic symptoms with a wide range of severity , often below the threshold for a diagnosis of an autism spectrum disorder . OBJECTIVE To examine the distribution and genetic structure of autistic traits in the general population using a newly established quantitative measure of autistic traits , the Social Responsiveness Scale ( formerly known as the Social Reciprocity Scale ) . METHODS The sample consisted of 788 pairs of twins aged 7 to 15 years , r and omly selected from the pool of participants in a large epidemiologic study ( the Missouri Twin Study ) . One parent of each pair of twins completed the Social Responsiveness Scale on each child . The data were subjected to structural equation modeling . RESULTS Autistic traits as measured by the Social Responsiveness Scale were continuously distributed and moderately to highly heritable . Levels of severity of autistic traits at or above the previously published mean for patients with pervasive developmental disorder not otherwise specified were found in 1.4 % of boys and 0.3 % of girls . Structural equation modeling revealed no evidence for the existence of sex-specific genetic influences , and suggested specific mechanisms by which females may be relatively protected from vulnerability to autistic traits . CONCLUSIONS These data indicate that the social deficits characteristic of autism spectrum disorders are common . Given the continuous distribution of these traits , it may be arbitrary where cutoffs are made between research design ations of being " affected " vs " unaffected " with a pervasive developmental disorder . The genes influencing autistic traits appear to be the same for boys and girls . Lower prevalence ( and severity ) of autistic traits in girls may be the result of increased sensitivity to early environmental influences that operate to promote social competency OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

By further separating studies into unisensory and multisensory ( bimodal : audiovisual ) ones , subgroup analysis indicated heterogeneous and unstable effects for unisensory temporal binding in the ASD group , but a more consistent and severe impairment in multisensory temporal integration represented by an enlarged temporal binding window in both clinical groups . Such multisensory dysfunction is associated with symptoms like hallucinations and impaired social communications .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Vitamin D deficiency is widely prevalent and has been associated with many diseases . It has been suggested that vitamin D has effects on the immune system and inhibits inflammation . The aim of our study was to investigate whether vitamin D has an inhibitory effect on systemic inflammation by assessing the association between serum levels of vitamin D and C-reactive protein . We studied the association between serum 25-hydroxyvitamin D and C-reactive protein through linear regression in 9,649 participants of the Rotterdam Study , an observational , prospect i ve population -based cohort study . We used genetic variants related to vitamin D and CRP to compute a genetic risk score and perform bi-directional Mendelian r and omization analysis . In linear regression adjusted for age , sex , cohort and other confounders , natural log-transformed CRP decreased with 0.06 ( 95 % CI : -0.08 , -0.03 ) unit per st and ard deviation increase in 25-hydroxyvitamin D. Bi-directional Mendelian r and omization analyses showed no association between the vitamin D genetic risk score and lnCRP ( Beta per SD = -0.018 ; p = 0.082 ) or the CRP genetic risk score and 25-hydroxyvitamin D ( Beta per SD = 0.001 ; p = 0.998 ) . In conclusion , higher levels of Vitamin D are associated with lower levels of C-reactive protein . In this study we did not find evidence for this to be the result of a causal relationship OBJECTIVE —Accumulating epidemiological evidence suggests that hypovitaminosis D may be associated with type 2 diabetes and related metabolic risks . However , prospect i ve data using the biomarker serum 25-hydroxyvitamin D [ 25(OH)D ] are limited and therefore examined in the present study . RESEARCH DESIGN AND METHODS —A total of 524 r and omly selected nondiabetic men and women , aged 40–69 years at baseline , with measurements for serum 25(OH)D and IGF-1 in the population -based Ely Study , had glycemic status ( oral glucose tolerance ) , lipids , insulin , anthropometry , and blood pressure measured and metabolic syndrome risk ( metabolic syndrome z score ) derived at baseline and at 10 years of follow-up . RESULTS —Age-adjusted baseline mean serum 25(OH)D was greater in men ( 64.5 nmol/l [ 95 % CI 61.2–67.9 ] ) than women ( 57.2 nmol/l [ 54.4,60.0 ] ) and varied with season ( highest late summer ) . Baseline 25(OH)D was associated inversely with 10-year risk of hyperglycemia ( fasting glucose : β = −0.0023 , P = 0.019 ; 2-h glucose : β = −0.0097 , P = 0.006 ) , insulin resistance ( fasting insulin β = −0.1467 , P = 0.010 ; homeostasis model assessment of insulin resistance [ HOMA-IR ] : β = −0.0059 , P = 0.005 ) , and metabolic syndrome z score ( β = −0.0016 , P = 0.048 ) after adjustment for age , sex , smoking , BMI , season , and baseline value of each metabolic outcome variable . Associations with 2-h glucose , insulin , and HOMA-IR remained significant after further adjustment for IGF-1 , parathyroid hormone , calcium , physical activity , and social class . CONCLUSIONS —This prospect i ve study reports inverse associations between baseline serum 25(OH)D and future glycemia and insulin resistance . These associations are potentially important in underst and ing the etiology of abnormal glucose metabolism and warrant investigation in larger , specifically design ed prospect i ve studies and r and omized controlled trials of supplementation Background & objectives : Patients with diabetes and vitamin-D insufficiency have increased insulin resistance . Similar observations among individuals with prediabetes are not well documented . The aim of this study was to find the occurrence of vitamin-D insufficiency/deficiency among individuals with prediabetes and to evaluate the relationship between vitamin-D status and insulin resistance . Methods : One hundred fifty seven individuals with prediabetes who fulfilled all the inclusion and exclusion criteria underwent clinical examination , anthropometric measurements ( waist circumference , waist-hip ratio , waist-height ratio ) and blood sampling after overnight fast for estimation of fasting blood glucose , fasting insulin , 25(OH)vitamin-D , intact parathyroid hormone ( iPTH ) and lipid profile . One hour post 75 g glucose ( 1hPG ) blood glucose during oral glucose tolerance test was measured . Results : Vitamin-D deficiency/insufficiency was found in 115 ( 73.25 % ) individuals with prediabetes . Severe vitamin-D deficiency ( < 10 ng/ml ) was seen in 14.65 per cent individuals . Individuals with the lowest vitamin-D levels ( < 10 ng/ml ) had the highest insulin resistance ( HOMA2-IR : 2.04 ± 0.67 ) . Serum 25(OH)D had a statistically significant inverse correlation with insulin resistance ( HOMA2-IR ; r=-0.33 ; P=0.008 ) , and positive correlation with insulin sensitivity ( QUICKI ; r=0.39 ; P=0.002 ) , after adjusting for BMI and HbA1c . There was no correlation between vitamin-D status and estimated beta cell mass ( HOMA-β ) . The mean waist-height ratio among individuals with prediabetes was 0.57 ( normal<0.5 ) indicating a high risk of cardiovascular morbidity . Individuals with elevated 1hPG>155 mg/dl had significantly higher BMI and worse insulin resistance , and 1hPG correlated well with 2 hour post glucose blood glucose ( r=0.57 ; P<0.001 ) . Interpretations & conclusions : Vitamin-D deficiency/insufficiency may have some role in the development/worsening of insulin resistance in individuals with prediabetes in our country who have a high cardiovascular risk . Prospect i ve studies on a large group of individuals need to be done to confirm the findings Background and Aims . Despite growing interest in the protective role that vitamin D may have in health outcomes , little research has examined the mechanisms underlying this role . This study aim ed to test two hypotheses : ( 1 ) serum 25-hydroxyvitamin D [ 25(OH)D ] is inversely associated with type 2 diabetes mellitus ( T2DM ) and elevated hemoglobin A1c ; ( 2 ) these associations are mediated by serum C-reactive protein ( CRP ) . Methods . Participants aged 20 and older in 2001–2006 National Health and Nutrition Examination Surveys ( n = 8,655 ) with measures of serum 25(OH)D , CRP , hemoglobin A1c , and other important covariates were included in the present study . Logistic regression and path analysis methods were applied to test the study hypotheses . Results . Decreased serum 25(OH)D concentration was significantly associated with increased odds of T2DM . In males , an estimated 14.9 % of the association between 25(OH)D and hemoglobin A1c was mediated by serum CRP . However , this mediation effect was not observed in females . Conclusion . Using a nationally representative sample , the present study extends previous research and provides new evidence that the effect of decreased serum vitamin D concentration on T2DM may proceed through increased systemic inflammation in males . Longitudinal studies and r and omized control trials are needed to confirm the present findings OBJECTIVE To study daily intake of calcium , phosphorus and vitamin D , to determine the biochemical findings of rickets and the effect of sunlight exposure and vitamin D supplementation in school girls with hypovitaminosis D. METHODS A cross-sectional study was conducted on school girls aged 11 - 15 years selected r and omly from various areas of Tehran , Iran . Dietary information and amount of sunlight exposure were estimated by a 7 day recalling method using self-reported question naire . Hypovitaminosis D defined as low serum 25-hydroxyvitamin D concentration with two or more others abnormal biochemical findings . Girls with hypovitaminoses D were r and omly divided into two groups . The faces and h and s of girls in group 1 were exposed to sunlight for one hour per day for twenty days , while those in group 2 were administered vitamin D capsules , 50,000 IU per day for the same period . RESULTS four-hundred fourteen girls evaluated , mean daily calcium intake , sunlight exposure and vitamin D acquirement were 360 mg , 10 minutes and 119 IU , respectively . Mean serum 25-hydroxyvitamin D concentration was 30 ng/ml among all girls whereas in 15 ( 3.63 % ) of 414 girls was 7.8 ng/ml . Abnormal biochemical findings in these girls included hypocalcemia ( n=4 ) , hypophosphatemia ( n=5 ) , raised serum alkaline phosphatase ( n=13 ) , and parathyroid hormone ( n=15 ) . After intervention , mean serum 25-hydroxyvitamin D concentration in sunlight exposure ( n=8 ) and vitamin D ( n=7 ) supplementation increased to 14.4+/-4 ng/ml and 23+/-4 ng/ml respectively . There was a significant difference between the two groups ( p<0.05 ) . CONCLUSION Vitamin D deficiency developed in rapid growth period of girls without clear clinical rickets in sunny temperate climate city in Iran which vitamin D supplementation improved biochemical findings better than sunlight exposure OBJECTIVE To examine cross-sectional relationships between plasma vitamin D and cardiometabolic risk factors in young adults . DESIGN Data were collected from interviews , physical examinations and biomarker measurements . Total plasma 25-hydroxyvitamin D ( 25(OH)D ) was measured using LC-t and em MS . Associations between 25(OH)D and cardiometabolic risk factors were modelled using weighted linear regression with robust estimates of st and ard errors . SETTING Individuals born in Jerusalem during 1974 - 1976 . SUBJECTS Participants of the Jerusalem Perinatal Study ( n 1204 ) interviewed and examined at age 32 years . Participants were over sample d for low and high birth weight and for maternal pre-pregnancy obesity . RESULTS Mean total 25(OH)D concentration among participants was 21·7 ( sd 8·9 ) ng/ml . Among males , 25(OH)D was associated with homeostatic model assessment of insulin resistance ( natural log-transformed , β=-0·011 , P=0·004 ) after adjustment for BMI . However , these associations were not present among females ( P for sex interaction=0·005 ) . CONCLUSIONS We found evidence for inverse associations of 25(OH)D with markers of insulin resistance among males , but not females , in a healthy , young adult Caucasian population . Prospect i ve studies and studies conducted on other population s investigating sex-specific effects of vitamin D on cardiometabolic risk factors are warranted PURPOSE We examined the cross-sectional associations among cardiorespiratory fitness ( CRF ) , different measures of adiposity , and serum vitamin D levels in women . METHODS Between 2007 and 2010 , 1320 women completed a health examination . Measures included body mass index ( BMI ) , waist circumference ( WC ) , waist/hip ratio , percent body fat , CRF based on a maximal treadmill exercise test , and measurement of serum vitamin D. Participants were classified by CRF as unfit ( lowest 20 % ) and fit ( remaining 80 % ) based on age , as well as by clinical cutoff points for adiposity measures , and by categories of serum vitamin D. We examined trends of CRF and adiposity exposures across serum vitamin D categories . We calculated odds ratios ( OR ) of serum vitamin D insufficiency or deficiency across levels of adiposity exposures before and after adjustment for CRF . RESULTS We observed a significant positive trend for CRF across incremental serum vitamin D categories ( p<0.001 ) . When compared to ORs for normal weight women , ORs for serum vitamin D insufficiency or deficiency were significantly higher for overweight women within each adiposity exposure ( p<0.05 ) . When grouped into categories of fit and unfit ( upper 80 % and lower 20 % of CRF distribution , respectively ) , serum vitamin D was significantly lower in unfit than in fit women within each stratum of WC and waist/hip ratio and within the normal weight BMI stratum . CONCLUSIONS Serum vitamin D levels are positively associated with CRF and negatively associated with different measures of adiposity in women . Higher CRF attenuates the relationship between adiposity level and serum vitamin D. Future prospect i ve studies are warranted Summary The various factors that may contribute to vitamin D deficiency or insufficiency were examined among healthy Saudi pre- and postmenopausal women . Vitamin D OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

In conclusion , the deficiency of vitamin D is associated with an increased level of BMI in the studies of both diabetic and non-diabetic subjects .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Immune-modulating effects of CLA have been reported in animals , but results are inconsistent . In humans , CLA has shown no effects or only minor effects on immune function . The objective of this study was to evaluate the immune-modulating effects of 3 g cis-9,trans-11 ( c9,t11 ) vs. trans-10,cis-12 ( t10,c12 ) CLA isomers in a population with a high risk of coronary heart disease characterized by moderate overweight ( body-mass index , 25–32.5 kg/m2 ) in combination with LDL-phenotype B ( ≥35 % small LDL cholesterol , density≥1.040 g/mL ) . After a run-in period of 1 wk , 42 men and women were r and omly allocated to the c9,t11 CLA group , the t10,c12 CLA group , or the placebo group . Effects of 13 wk of consumption of 3 g of CLA isomers on cytokine production by ex vivo lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells ( P BMC ) and whole blood , and on plasma C-remononuclear protein ( CRP ) concentrations were evaluated . To generate hypotheses for future studies , protein expression patterns of 42 cytokines , chemokines , and growth factors were evaluated with an antibody array in pooled , nonstimulated , fasting plasma sample s. LPS induced interleukin (IL)-6 , IL-8 , and tumor necrosis factor-α production by P BMC , and whole blood as well as plasma CRP concentrations were not significantly changed by the c9,t11 , and the t10,c12 CLA isomers . The cytokine expression profile in nonstimulated plasma suggested that both CLA isomers induced a specific inflammatory signature , in which the c9,t11 CLA group showed more activity in terms of numbers of proteins regulated . We conclude that daily consumption of 3 g of c9,t11 or t10,c12 CLA isomer did not affect LPS-stimulated cytokine production by P BMC or whole blood and plasma CRP levels . Inflammatory signatures in fasting , nonstimulated plasma as determined by an antibody array may indicate enhanced immune function by both CLA isomers After 12 mo in a r and omized , double-blind , placebo-controlled trial of conjugated linoleic acid ( CLA ) supplementation ( 2 groups received CLA as part of a triglyceride or as the free fatty acid , and 1 group received olive oil as placebo ) , 134 of the 157 participants who concluded the study were included in an open study for another 12 mo . The goals of the extension study were to evaluate the safety [ with clinical chemistry analyses and reported adverse events ( AEs ) ] and assess the effects of CLA on body composition [ body fat mass ( BFM ) , lean body mass ( LBM ) , bone mineral mass ( BMM ) ] , body weight , and BMI . All subjects were supplemented with 3.4 g CLA/d in the triglyceride form . Circulating lipoprotein(a ) and thrombocytes increased in all groups . There was no change in fasting blood glucose . Aspartate amino transferase , but not alanine amino transferase , increased significantly . Plasma total cholesterol and LDL cholesterol were reduced , whereas HDL cholesterol and triglycerides were unchanged . The AE rate decreased compared with the first 12 mo of the study . Body weight and BFM were reduced in the subjects administered the placebo during the initial 12 mo study ( -1.6 + /- 3.2 and -1.7 + /- 2.8 kg , respectively ) . No fat or body weight changes occurred in the 2 groups given CLA during the initial 12 mo . LBM and BMM were not affected in any of the groups . Changes in body composition were not related to diet and /or training . In conclusion , this study shows that CLA supplementation for 24 mo in healthy , overweight adults was well tolerated . It confirms also that CLA decreases BFM in overweight humans , and may help maintain initial reductions in BFM and weight in the long term BACKGROUND The intake of trans fatty acids ( TFA ) from industrially hydrogenated vegetable oils ( iTFA ) is known to have a deleterious effect on cardiovascular health , the effects of TFA from ruminants ( rTFA ) are virtually unknown . OBJECTIVE The purpose of the present study was to compare the effects of rTFA and iTFA on plasma LDL concentrations and other cardiovascular disease risk factors in healthy subjects . DESIGN In a double-blind , r and omized crossover controlled study , 38 healthy men were fed each of 4 experimental isoenergetic diets lasting 4 wk each . The 4 diets were high in rTFA ( 10.2 g/2500 kcal ) , moderate in rTFA ( 4.2 g/2500 kcal ) , high in iTFA ( 10.2 g/2500 kcal ) , and low in TFA from any source ( 2.2 g/2500 kcal ) ( control diet ) . RESULTS Plasma LDL-cholesterol concentrations were significantly higher after the high- rTFA diet than after the control ( P = 0.03 ) or the moderate- rTFA ( P = 0.002 ) diet . Plasma LDL-cholesterol concentrations also were significantly ( P = 0.02 ) higher after the iTFA diet than after the moderate-rTFA diet . Plasma HDL-cholesterol concentrations were significantly ( P = 0.02 ) lower after the high-rTFA diet than after the moderate-rTFA diet . Finally , all risk factors were comparable between the control and the moderate-rTFA diets . CONCLUSIONS These results suggest that , whereas a high dietary intake of TFA from ruminants may adversely affect cholesterol homeostasis , moderate intakes of rTFA that are well above the upper limit of current human consumption have neutral effects on plasma lipids and other cardiovascular disease risk factors A mixture of trans-10 , cis-12 ( t10,c12 ) and cis-9 , trans-11 ( c9,t11 ) conjugated linoleic acid ( CLA mixture ) reduced atherosclerosis in animals , thus the effect of these isomers on endothelial dysfunctions leading to inflammation and atherosclerosis is of interest . We gave 75 healthy postmenopausal women a daily supplement of 5.5 g of oil rich in either CLA mixture , an oil rich in the naturally occurring c9,t11 CLA ( CLA milk ) , respectively , or olive oil for 16 wk in a double-blind , r and omized , parallel intervention study . We sample d blood and urine before and after the intervention . The ratios of total cholesterol : HDL cholesterol and concentrations of C-reactive protein , fibrinogen , and plasminogen activator inhibitor-1 were significantly higher in women supplemented with the CLA mixture than in those supplemented with CLA milk . Plasma triacylglycerol was significantly higher and HDL cholesterol was lower in women supplemented with the CLA mixture than with olive oil . Both CLA supplements increased lipid peroxidation , a marker of in vivo oxidative stress measured as urinary free 8-iso-prostagl and in F(2alpha ) . However , the CLA mixture increased lipid peroxidation more than the CLA milk did . The plasma cytokines interleukin-6 and tumor necrosis factor-alpha were not affected by the treatments , nor were any of the other variables measured . In conclusion , oil containing trans-10,cis-12 CLA has several adverse effects on classical and novel markers of coronary vascular disease , whereas the c9,t11 CLA isomer is more neutral , except for a small but significant increase in lipid peroxidation compared with olive oil BACKGROUND Animal studies have suggested that conjugated linoleic acid ( CLA ) , a natural component of ruminant meat and dairy products , may confer beneficial effects on health . However , little information on the effects of CLA on immune function is available , especially in humans . Furthermore , the effects of individual isomers of CLA have not been adequately investigated . OBJECTIVE This study investigated the effects of supplementing the diet with 3 doses of highly enriched cis-9,trans-11 CLA ( 0.59 , 1.19 , and 2.38 g/d ) or trans-10,cis-12 CLA ( 0.63 , 1.26 , and 2.52 g/d ) on immune outcomes in healthy humans . DESIGN The study had a r and omized , double-blind , crossover design . Healthy men consumed 1 , 2 , and 4 capsules sequentially that contained 80 % of either cis-9,trans-11 CLA or trans-10,cis-12 CLA for consecutive 8-wk periods . This regimen was followed by a 6-wk washout and a crossover to the other isomer . RESULTS Both CLA isomers decreased mitogen-induced T lymphocyte activation in a dose-dependent manner . There was a significant negative correlation between mitogen-induced T lymphocyte activation and the proportions of both cis-9,trans-11 CLA and trans-10,cis-12 CLA in peripheral blood mononuclear cell lipids . However , CLA did not affect lymphocyte sub population s or serum concentrations of C-reactive protein and did not have any consistent effects on ex vivo cytokine production . CONCLUSION CLA supplementation results in a dose-dependent reduction in the mitogen-induced activation of T lymphocytes . The effects of cis-9,trans-11 CLA and trans-10,cis-12 CLA were similar , and there was a negative correlation between mitogen-induced T lymphocyte activation and the cis-9,trans-11 CLA and trans-10,cis-12 CLA contents of mononuclear cells Conjugated linoleic acid ( CLA ) has been shown to reduce body fat mass ( BFM ) in animals . To investigate the dose-response relationships of conjugated linoleic acid with regard to BFM in humans , a r and omized , double-blind study including 60 overweight or obese volunteers ( body mass index 25 - 35 kg/m(2 ) ) was performed . The subjects were divided into five groups receiving placebo ( 9 g olive oil ) , 1.7 , 3.4 , 5.1 or 6.8 g conjugated linoleic acid per day for 12 wk , respectively . Dual-energy X-ray absorptiometry was used to measure body composition [ measurements at wk 0 ( baseline ) , 6 and 12 ] . Of the 60 subjects , 47 completed the study . Eight subjects withdrew from the study due to adverse events ; however , no differences among treatment groups were found regarding adverse events . Repeated- measures analysis showed that a significantly higher reduction in BFM was found in the conjugated linoleic acid groups compared with the placebo group ( P : = 0.03 ) . The reduction of body fat within the groups was significant for the 3.4 and 6.8 g CLA groups ( P : = 0.05 and P : = 0.02 , respectively ) . No significant differences among the groups were observed in lean body mass , body mass index , blood safety variables or blood lipids . The data suggest that conjugated linoleic acid may reduce BFM in humans and that no additional effect on BFM is achieved with doses > 3.4 g CLA/d Conjugated linoleic acid ( CLA ) alters body composition in animal models , but few studies have examined the effects of CLA supplementation on body composition and clinical safety measures in obese humans . In the present study , we performed a r and omized , double-blind , placebo-controlled trial to examine the changes in body composition and clinical laboratory values following CLA ( 50:50 ratio of cis-9 , trans-11 and trans-10 , cis-12 isomers ) supplementation for 12 wk in otherwise healthy obese humans . Forty-eight participants ( 13 males and 35 females ) were r and omized to receive placebo ( 8 g safflower oil/d ) , 3.2 g/d CLA , or 6.4 g/d CLA for 12 wk . Changes in body fat mass and lean body mass were determined by dual-energy X-ray absorptiometry . Resting energy expenditure was assessed by indirect calorimetry . Clinical laboratory values and adverse-event reporting were used to monitor safety . Lean body mass increased by 0.64 kg in the 6.4 g/d CLA group ( P < 0.05 ) after 12 wk of intervention . Significant decreases in serum HDL-cholesterol and sodium , hemoglobin , and hematocrit , and significant increases in serum alkaline phosphatase , C-reactive protein , and IL-6 , and white blood cells occurred in the 6.4 g/d CLA group , although all values remained within normal limits . The intervention was well tolerated and no severe adverse events were reported , although mild gastrointestinal adverse events were reported in all treatment groups . In conclusion , whereas CLA may increase lean body mass in obese humans , it may also increase markers of inflammation in the short term BACKGROUND Short-term trials showed that conjugated linoleic acid ( CLA ) may reduce body fat mass ( BFM ) and increase lean body mass ( LBM ) , but the long-term effect of CLA was not examined . OBJECTIVE The objective of the study was to ascertain the 1-y effect of CLA on body composition and safety in healthy overweight adults consuming OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusion The current systematic review and meta- analysis showed that the long-term consumption of CLA increases the levels of CRP and Lp(a )

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Mediation analyses in faith-based physical activity ( PA ) interventions targeting African-American adults are lacking . The purpose of this study was to examine the psychosocial mediators of a faith-based PA intervention with African-American adults . Churches were r and omly assigned to receive immediate or delayed ( 1-year later ) training in PA program implementation . A sub sample of participants from r and omly selected churches took part in telephone surveys at baseline and at 1 year . The primary outcome was percentage of participants meeting PA recommendations . MacKinnon 's product of coefficients was used to test for mediation . Participants ( n = 418 ) from 20 churches completed the baseline and 1-year follow-up surveys . There were no statistically significant changes in PA behavior at 1 year . The intervention had a marginally significant effect on increasing the amount of instrumental church support received by church members . However , none of the psychosocial variables tested were found to be significant mediators of the intervention . Mediation analyses provided insight into potential reasons as to why the Health-e-AME intervention did not change PA . The intervention did not successfully change the targeted mediators hypothesized to change PA . Potential reasons for these shortcomings as well as issues to address in future faith-based studies are discussed OBJECTIVE To evaluate the effectiveness of a worksite health promotion program on improving cardiovascular disease risk factors . METHODS In St Louis , Missouri from 2005 to 2006 , 151 employees ( 134 F , 17 M , 81 % overweight/obese ) participated in a cohort-r and omized trial comparing assessment s + intervention ( worksite A ) with assessment s only ( worksite B ) for 1 year . All participants received personal health reports containing their assessment results . The intervention was design ed to promote physical activity and favorable dietary patterns using pedometers , healthy snack cart , WeightWatchers(R ) meetings , group exercise classes , seminars , team competitions , and participation rewards . Outcomes included BMI , body composition , blood pressure , fitness , lipids , and Framingham 10-year coronary heart disease risk . RESULTS 123 participants , aged 45+/-9 yr , with BMI 32.9+/-8.8 kg/m(2 ) completed 1 year . Improvements ( P < or = 0.05 ) were observed at both worksites for fitness , blood pressure , and total- , HDL- , and LDL-cholesterol . Additional improvements occurred at worksite A in BMI , fat mass , Framingham risk score , and prevalence of the metabolic syndrome ; only the changes in BMI and fat mass were different between worksites . CONCLUSION A multi-faceted worksite intervention promoted favorable changes in cardiovascular disease risk factors , but many of the improvements were achieved with worksite health assessment s and personalized health reports in the absence of an intervention Background Physical Activity Across the Curriculum ( PAAC ) is a 3-year elementary school-based intervention to determine if increased amounts of moderate intensity physical activity performed in the classroom will diminish gains in body mass index ( BMI ) . It is a cluster-r and omized , controlled trial , involving 4905 children ( 2505 intervention , 2400 control ) . Methods We collected both qualitative and quantitative process evaluation data from 24 schools ( 14 intervention and 10 control ) , which included tracking teacher training issues , challenges and barriers to effective implementation of PAAC lessons , initial and continual use of program specified activities , and potential competing factors , which might contaminate or lessen program effects . Results Overall teacher attendance at training sessions showed exceptional reach . Teachers incorporated active lessons on most days , result ing in significantly greater student physical activity levels compared to controls ( p < 0.0001 ) . Enjoyment ratings for classroom-based lessons were also higher for intervention students . Competing factors , which might influence program results , were not carried out at intervention or control schools or were judged to be minimal . Conclusion In the first year of the PAAC intervention , process evaluation results were instrumental in identifying successes and challenges faced by teachers when trying to modify existing academic lessons to incorporate physical activity BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the " no stretching " ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted Introduction Proactive worksite strategies that change the physical or sociocultural environment(s ) to incorporate obligatory physical activity may be necessary to engage sedentary people . This study describes implementation and evaluation of an intervention , Pausa para tu Salud ( Pause for Your Health ) , that integrated a brief period of group exercise into the workday . Methods An uncontrolled pretest – post-test study design tested the effects of integrating daily 10-minute exercise breaks during paid work time during January 2003 through January 2004 . A total of 335 Mexican Ministry of Health office workers provided baseline data as a part of routine annual clinical screening examinations . Results Baseline mean body mass index and waist circumferences were 27.8 kg/m2 and 87.6 cm for women and 26.6 kg/m2 and 89.7 cm for men . Complete data were available for 271 ( 80.9 % ) employees at 1-year follow-up . Two-tailed , paired t-test comparisons were used . Body mass index decreased by 0.32 kg/m2 ( P = .05 ) , and waist circumference by 1.6 cm ( P = .0009 ) overall . The body mass index decrease , however , was significant only for men ( −0.43 kg/m2 , P = .03 ) . Multivariate analyses revealed a significant decrease in diastolic blood pressure among women ( z = −2.04 , P = .042 ) . Conclusion The intervention was associated with significant improvements in both measures of body composition . Substantive health and organizational benefits may result from integrating brief periods of physical activity into the workday if these findings are replicated in r and omized controlled trials in other worksites In summary , employees ' flexibility and mood showed modest improvements following the implementation of a plant-wide , 10-minute , daily flexibility and strength program . The initial six-week pilot study , administered prior to the plant-wide program implementation , successfully assessed program feasibility , assessed the efficiency of program implementation , identified administrative and logistical concerns , and generated pilot data needed to secure managerial support . Despite the noted significant increases in grip strength in the pilot study , no increases were observed following the six months of plant-wide implementation . This may be related to the differences in low average pretest grip strength for the pilot study compared to the higher scores for the main study population . The pilot study subjects may have received a sufficient exercise stimulus to increase grip strength over the course of six weeks . In contrast , this may not have been the case for the main study subjects due to their higher initial mean grip strength . An increased number of exercises design ed to directly impact grip strength may be needed to improve this parameter The appropriateness of recess in the elementary program continues to be question ed although generally it is believed to be useful by elementary principals despite a dearth of supportive data . This study was a developmental study of the effects of physical activity on concentration . Comparison of passive and directed physical education activities on the concentration of second- , third- , and fourth- grade children was made . The Woodcock-Johnson Test of Concentration showed better performance by the fourth grade rs and within Grade 4 in favor of the physical activity group . A structured physical activity or a classroom activity immediately prior to a concentration task was not detrimental to children in Grade s 2 and 3 . Fourth- grade children performed significantly better on a test of concentration after engaging in a physical activity Exercise during growth has a positive influence on bone mineral accrual , yet little is known about how bone geometry and strength adapt to loading during growth . Our primary objective was to compare changes in proximal femur bone geometry and strength between 31 prepubertal ( Tanner Stage 1 ) boys who participated in a school-based , high-impact circuit intervention ( 12 min , three times a week ) for 20 months and 33 maturity-matched controls . Our secondary objective was to compare changes in total body ( TB ) , proximal femur ( PF ) , and lumbar spine ( LS ) bone mineral content ( BMC ) and bone area ( BA ) in these groups . We assessed geometric variables and bone strength at the narrow neck ( NN ) , intertrochanteric ( TR ) region , and femoral shaft regions by applying the Hip Structure Analysis program to proximal femur dual energy X-ray absorptiometry scans ( DXA , Hologic QDR 4500 ) . Further , we assessed total body , lumbar spine , and proximal femur BMC and BA by DXA and derived total body lean mass and fat mass from total body scans . Intervention ( 10.2 + /- 0.5 years ) and control boys ( 10.1 + /- 0.5 years ) had similar baseline height ( 140.8 vs. 141.3 cm ) and weight ( 36.9 vs. 35.4 kg ) , and average 20-month physical activity scores ( Physical Activity Question naire for Children , PAQ-C ) and calcium intakes ( 861 vs. 852 mg/day , food frequency question naire ) . Twenty-month height and weight changes were not significantly different between groups ; lean mass changed more ( P < 0.05 ) in intervention boys ( 22.8 % ) than control boys ( 18.6 % ) . At the NN region , intervention boys had greater bone expansion on both the periosteal ( + 2.6 % , P = 0.1 ) and endosteal ( + 2.7 % , P = 0.2 ) surfaces , result ing in significantly greater changes in section modulus ( bone bending strength ) ( + 7.5 % , P = 0.02 , ANCOVA , adjusting for height change , final Tanner Stage , and baseline bone values ) . Changes at the intertrochanteric and femoral shaft regions were not significantly different between groups . Femoral neck ( FN ) BMC changes were significantly greater in intervention boys ( + 4.3 % , P < 0.01 ) ; changes in BA and BMC for other regions were not significantly different between groups . In summary , a school-based , high-impact exercise intervention implemented three times a week for 12 min is an effective strategy for site-specific gains in bone strength at the narrow neck region of the proximal femur OBJECTIVE The objective was to test the hypothesis that a community-based environmental change intervention could prevent weight gain in young children ( 7.6 + /- 1.0 years ) . RESEARCH METHODS AND PROCEDURES A non-r and omized controlled trial was conducted in three culturally diverse urban cities in Massachusetts . Somerville was the intervention community ; two socio-demographically-matched cities were control communities . Children ( n = 1178 ) in grade s 1 to 3 attending public elementary schools participated in an intervention design ed to bring the energy equation into balance by increasing physical activity options and availability of healthful foods within the before- , during- , after-school , home , and community environments . Many groups and individuals within the community ( including children , parents , teachers , school food service providers , city departments , policy makers , healthcare providers , before- and after-school programs , restaurants , and the media ) were engaged in the intervention . The main outcome measure was change in BMI z-score . RESULTS At baseline , 44 % ( n = 385 ) , 36 % ( n = 561 ) , and 43 % ( n = 232 ) of children were above the 85th percentile for BMI z-score in the intervention and the two control communities , respectively . In the intervention community , BMI z-score decreased by -0.1005 ( p = 0.001 , 95 % confidence interval , -0.1151 to -0.0859 ) compared with children in the control communities after controlling for baseline covariates . DISCUSSION A community-based environmental change intervention decreased BMI z-score in children at high risk for obesity . These results are significant given the obesigenic environmental backdrop against which the intervention occurred . This model demonstrates promise for communities throughout the country confronted with escalating childhood obesity rates PURPOSE To present the development and feasibility testing of a sociocultural environmental change intervention strategy aim ed at integrating physical activity into workplace routine . DESIGN R and omized , controlled , post-test only , intervention trial . Setting . Los Angeles County Department of Health Services ' worksites . PARTICIPANTS Four hundred forty-nine employees , predominantly sedentary , overweight , middle-aged women of color , distributed across 26 meetings . INTERVENTION A single 10-min exercise break during work time involving moderate intensity , low-impact aerobic dance and calisthenic movements to music . MEASURES Primary -level of participation , particularly among OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Interventions integrating physical activity into organizational routine during everyday life have demonstrated modest but consistent benefits , particularly for physical activity , and these are promising avenues of investigation . The proportionately longer-term outcomes available in these studies compared with individual-level studies suggest that physical activity promotion strategies at the organizational level may be more sustainable

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Study Design . Three factors mixed- design with 1 between-subject and 2 within-subject factors . Objective . To compare the main effects and interactions of postural and cognitive difficulty on quiet stance between subjects with and without nonspecific low back pain ( LBP ) . Summary of Background Data . The interference between postural control and cognitive tasks depends on factors such as sensorimotor/cognitive integrity . Changes in peripheral sensory and muscular systems as well as cognitive processes have been observed in LBP patients . It was hypothesized that the effect of cognitive task on postural performance might be different in subjects with nonspecific LBP as compared with healthy individuals . To the authors ’ knowledge this has not been investigated before . Methods . Postural stability was measured by center of pressure parameters while nonspecific LBP ( n = 22 ) and healthy ( n = 22 ) subjects r and omly performed quiet st and ing task with 3 levels of difficulty ( rigid-surface eyes open , rigid-surface eyes-closed , and foam-surface eyes-closed ) in isolation or concurrently with an easy or difficult digits backward cognitive task . Results . Subjects with nonspecific LBP had less postural sway than healthy subjects , while postural sway decreased with increase in the level of cognitive difficulty . Nonspecific LBP and healthy subjects had larger postural sway at more difficult sensory conditions such as rigid-surface eyes-closed and foam-surface eyes-closed . The response to dual-tasking was not significantly different between the 2 groups . Conclusion . The dual-tasking did not change the postural performance of nonspecific LBP subjects with low level of pain and disability differently compared to healthy subjects This study evaluated the degree to which the disturbance to posture from respiration is compensated for in healthy normals and whether this is different in people with recurrent low back pain ( LBP ) , and to compare the changes when respiratory dem and is increased . Angular displacement of the lumbar spine and hips , and motion of the centre of pressure ( COP ) , were recorded with high resolution and respiratory phase was recorded from ribcage motion . With subjects st and ing in a relaxed posture , recordings were made during quiet breathing , while breathing with increased dead-space to induce hypercapnoea , and while subjects voluntarily increased their respiration to match ribcage expansion that was induced in the hypercapnoea condition . The relationship between respiration and the movement parameters was measured from the coherence between breathing and COP and angular motion at the frequency of respiration , and from averages triggered from the respiratory data . Small angular changes in the lumbopelvic and hip angles were evident at the frequency of respiration in both groups . However , in quiet st and ing , the LBP subjects had a greater displacement of their COP that was associated with respiration than the control subjects . The LBP group had a trend for less hip motion . There were no changes in the movement parameters when respiratory dem and increased involuntarily via hypercapnoea , but when respiration increased voluntarily , the amplitude of motion and the displacement of the COP increased in both groups . The present data suggest that the postural compensation to respiration counteracts at least part of the disturbance to posture caused by respiration and that this compensation may be less effective in people with LBP Study Design . A study of postural control during one‐footed and externally disturbed two‐footed stance among healthy control subjects and patients with chronic low back pain at the beginning of a functional back restoration program and 6 months later at follow‐up examination . Objectives . To study postural control cross‐sectionally among control subjects and patients with low back pain , and to evaluate the effects of functional restoration on the postural control parameters in a follow‐up examination . Summary of Background Data . Deficits of motor skills and coordination have been reported in association with musculoskeletal disorders . It has been found that patients with chronic low back pain have impaired psychomotor control , but the impairment is reversible with successful low back rehabilitation . It is insufficiently known how functional activation and intensive physical training affect postural control . Methods . Sixty‐one healthy volunteers ( 32 men , 29 women ) and altogether 99 patients with low back pain participated in the study . Sixty‐eight patients ( 33 men , 35 women ) had moderate and 31 ( 18 men , 13 women ) had severe low back pain . Postural stability was measured with a force platform . In two‐footed stance , vibration stimulation on calf and back muscles was used to disturb the balance . Center point of force‐velocity ( cm/sec ) , average position shift in anteroposterior direction ( cm ) , and maximal position shift in lateral direction ( cm ) were used as the parameters . Results . Reliability of all tests was acceptable . Center point of force‐velocity was the most sensitive parameter and the one‐footed measurement the most sensitivetest for evaluating postural stability . At the beginning , the patients with severe low back pain had poorer one‐footed postural control compared with the control subjects ( P = 0.0003 ) . The subgroup of patients with moderate low back pain participated in the restoration program . The outcome of the restoration program was considered good if the disability because of low back pain ( Oswestry index ) decreased during the restoration program and poor if the disability increased or did not change . The one‐footed postural stability remained primarily at the same level as the initial results in the control and good outcome groups , but became significantly poorer in the poor outcome group . The difference between poor outcome and control groups was statistically significant ( P = 0.04 ) . Conclusions . Impaired postural stability seems to be one factor in multidimensional symptomatology of patients with chronic low back trouble . Postural stability is easily disturbed in case of impairment in strength , coordination , or effective coupling of muscles in the lumbar and pelvic area . Patients with chronic low back pain seem to experience impairment in these functions , which should be taken into consideration when back rehabilitation programs are planned STUDY DESIGN A cross-sectional study in patients with recurrent/chronic low back trouble and healthy control subjects . OBJECTIVE To evaluate the effect of paraspinal muscle fatigue on the ability to sense a change in lumbar position . SUMMARY OF BACKGROUND DATA Protection against spinal injury requires proper anticipation of events , appropriate sensation of body position , and reasonable muscular responses . Lumbar fatigue is known to delay lumbar muscle responses to sudden loads . It is not known whether the delay is because of failure in the sensation of position , output of the response , or both . METHODS Altogether , 106 subjects ( 57 patients with low back trouble [ 27 men and 30 women ] and 49 healthy control subjects [ 28 men and 21 women ] ) participated in the study . Their ability to sense a change in lumbar position while seated on a special trunk rotation unit was assessed . A motor rotated the seat with an angular velocity of 1 degree per second . The task in the test involved reacting to the perception of lumbar movement ( rotation ) by releasing a button with a finger movement . The test was performed twice , before and immediately after a fatiguing procedure . During the endurance task , the participants performed upper trunk repetitive extensions against a resistance , with a movement amplitude adjusted between 25 degrees flexion and 5 degrees extension , until exhaustion . RESULTS Patients with chronic low back trouble had significantly poorer ability than control subjects on the average to sense a change in lumbar position ( P = 0.007 ) , which was noticed before and after the fatiguing procedure . Lumbar fatigue induced significant impairment in the sensation of position change ( P < 0.000001 ) . CONCLUSIONS Lumbar fatigue impairs the ability to sense a change in lumbar position . This feature was found in patients and control subjects , but patients with low back trouble had poorer ability to sense a change in lumbar position than control subjects even when they were not fatigued . There seems to be a period after a fatiguing task during which the available information on lumbar position and its changes is inaccurate OBJECTIVE To determine whether body balance is perturbed more in low back pain patients than in healthy subjects , under the concept of posturo-kinetic capacity . DESIGN Comparison of posturographic and respiratory parameters between low back pain and healthy subjects . BACKGROUND It has been demonstrated that respiratory movements constitute a perturbation to posture , compensated by movements of the spine and of the hips , and that low back pain is frequently associated with a loss of back mobility . METHOD Ten low back pain patients and ten healthy subjects performed five posturographic tests under three different respiratory rate conditions : quiet breathing ( spontaneous ) , slow breathing ( 0.1 Hz ) and fast breathing ( 0.5 Hz ) . RESULTS Intergroup comparison showed that the mean displacements of the center of pressure were greater for the low back pain group , especially along the antero-posterior axis , where respiratory perturbation is primarily exerted . Inter-condition comparison showed that in slow and fast breathing relatively to quiet breathing , the mean displacement of the center of pressure along the antero-posterior axis was significantly increased only for the low back pain group . CONCLUSION According to the results , respiration presented a greater disturbing effect on body balance in low back pain subjects . RELEVANCE This study provides information on the causes of the impaired body balance associated with chronic low back pain , which could be used to improve treatment strategy Study Design : A control group study with repeated measures . Objective : To compare trunk repositioning parameters in chronic low back pain ( LBP ) and healthy subjects . Summary and background data : Recent evidence suggests that chronic LBP patients exhibit deficits in trunk proprioception and motor control . Trunk repositioning and the various spatio-temporal parameters related to it can be used to evaluate sensori-motor control and movement strategies . Methods : Fifteen control subjects and 16 chronic LBP subjects participated in this study . Subjects were required to reproduce different trunk position in flexion ( 15 ° , 30 ° and 60 ° ) and extension ( 15 ° ) . In the learning phase preceding each condition , visual feedback was provided . Following these learning trials , subjects were asked to perform ten consecutive trials without any feedback . Movement time , movement time variability and peak velocity were obtained and a temporal symmetry ratio was calculated . Peak angular position variability and absolute error in peak angular position were also calculated to evaluate spatial accuracy . Results : Two subgroups of LBP patients were identified . One subgroup of LBP subjects demonstrated longer movement time and smaller peak velocities and symmetry ratios than normal subjects . No group difference was observed for peak angular position variability and absolute error in peak angular position . Conclusion : Chronic LBP patients , when given a sufficient learning period , were able to reproduce trunk position with a spatial accuracy similar to control subjects . Some LBP subjects , however , showed modifications of movement time , peak velocity and acceleration parameters . We propose that the presence of persistent chronic pain could induce an alteration or an adaptation in the motor responses of chronic LBP subjects Insight into the mechanisms of altered postural control in persons with low back pain ( LBP ) could lead to better interventions for patients with LBP . This study investigated ( 1 ) whether persons with recurrent LBP have an altered body inclination , and ( 2 ) whether anticipation of postural instability further alters body inclination . Thirty-three young healthy individuals and 56 young persons with recurrent LBP participated in this study . The upright st and ing posture was evaluated by means of two piezo-resistive electrogoniometers and a force platform for the conditions as follows : ( 1 ) quiet stance with and without vision , and ( 2 ) in anticipation of postural instability due to a ballistic arm movement or ankle muscle vibration . No differences in body inclination were observed when visual information was available between the two groups ( P>0.05 ) . However , significant more forward inclination was seen in the persons with recurrent LBP when vision was occluded ( + 7.4 % ) and in anticipation of postural instability ( + 19 % ) ( P<0.05 ) compared to the healthy individuals . The results suggest that young persons with recurrent LBP have an altered body inclination that might be caused by anticipation of postural instability . The adopted forward inclined posture may potentially be a factor in the recurrence of LBP Study Design . A clinical trial comparing a back pain group with a pain‐free group . Objectives . To investigate whether proprioceptive deficits existed in a group of individuals reporting low back pain . Summary of Background Data . Little work has so far been conducted on the measurement of proprioception in the spine . Those studies that have been carried out , however , have failed to identify proprioceptive deficits in individuals with back pain . Previous work on peripheral joints has revealed that proprioception is affected with muscular or joint injury or degeneration . Methods . Forty individuals took part in the study , 20 with back pain and 20 with no pain . Participants were required to reproduce a predetermined target position , in st and ing and four‐point kneeling , 10 times in 30 seconds . A computer screen was used to provide visual feedback on position . A mean deviation from the target position was obtained for each individual . A measurement of left elbow position sense was conducted in five individuals from each group to establish differences in short‐term motor memory between the groups . Results . There were no differences between the subject groups in terms of short‐term motor memory ( P > 0.05 ) . A two‐way analysis of variance between subject groups and position to identify differences in accuracy ( deviation from the target ) found that there were differences between subject groups in either position ( P < 0.05 ) . There was no significant difference in accuracy between the positions used ( P > 0.05 ) . Conclusions . Differences in proprioception do exist between individuals with back pain and those free from back pain . Further research needs to be undertaken on proprioceptive exercise programs and their effect on back pain BACKGROUND Low back pain is associated with abnormal movement strategies due to changes in neuromuscular control . A plausible contributing factor to low back pain is poor control of trunk muscles , thus underst and ing motor control alterations in this population can guide rehabilitation . Quantification of postural responses following support surface translations is one way to examine motor control impairments in people with low back pain . METHODS Twenty-four healthy subjects [ mean 33 ( SD 11 ) years ] who had no low back pain and 26 subjects [ mean 39 ( SD 13 ) years ] with chronic , recurrent low back OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

This systematic review covered all the relevant literature , but none of the included studies offered a valid , reliable and feasible method to assess neuromotor capacity in everyday physiotherapy clinical practice

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background Exercise training has now become established practice in patients with chronic heart failure . Women are often under-represented in intervention studies compared to men . For this reason it was our aim to conduct a combined endurance and muscle strength training program to evaluate its effect on clinical performance data and health-related psychosocial factors in women and men . Methods One hundred and sixteen women , mean age 69 ± 9 years , body mass index ( BMI ) 25.8 ± 4.9 , and 169 men , mean age 66 ± 9 years , BMI 26.6 ± 3.6 underwent combined endurance/resistance training . The training program lasted 29 ± 7 days and comprised bicycle ergometer training , a 6-min walk test as a training unit and muscle strength training for the lower and upper extremities . Results Differences between women and men were found in clinical parameters . In particular , statistically significant differences were revealed between the women and men with regard to cardiopulmonary performance . Quality of life was significantly improved on discharge with regard to both physical and mental health , whereas anxiety and depression showed no significant alteration . Conclusion A specialized in-hospital program for women and men combining endurance/resistance training and education is feasible . But our program revealed a very low level of cardiopulmonary performance in women . Women need to be encouraged and motivated to participate in such programs Exercise is now considered an important component of management in chronic heart failure ( CHF ) , but little is known about central hemodynamic changes that occur during different exercise modalities in these patients . Seventeen patients ( ejection fraction 25 + /- 2 % ) undertook brachial artery and right heart catheterization and oxygen consumption assessment at rest , during submaximal and peak cycling ( Cyc ) , and during submaximal upper and lower limb resistance exercise . Cardiac output ( CO ) increased relative to baseline during peak Cyc ( P < 0.05 ) but did not change during submaximal Cyc or upper or lower limb exercise . Heart rate ( HR ) was lowest during upper limb exercise and progressively increased during lower limb exercise , submaximal Cyc , and peak Cyc , with significant differences between each of these ( P < 0.01 ) . Conversely , stroke volume ( SV ) decreased during submaximal Cyc and lower limb exercise and was lower during peak and submaximal Cyc and lower limb exercise than during upper limb exercise ( P < 0.05 ) . CHF patients are dependent on increases in HR to increase CO during exercise when SV may decline . Resistance exercise , performed at appropriate intensity , induces a similar hemodynamic burden to aerobic exercise in patients with CHF BACKGROUND We aim ed to determine the role of skeletal muscle mitochondrial ATP production rate ( MAPR ) in relation to exercise tolerance after resistance training ( RT ) in chronic heart failure ( CHF ) . METHODS AND RESULTS Thirteen CHF patients ( New York Heart Association functional class 2.3 + /- 0.5 ; Left ventricular ejection fraction 26 + /- 8 % ; age 70 + /- 8 years ) underwent testing for peak total body oxygen consumption ( VO(2peak ) ) , and resting vastus lateralis muscle biopsy . Patients were then r and omly allocated to 11 weeks of RT ( n = 7 ) , or continuance of usual care ( C ; n = 6 ) , after which testing was repeated . Muscle sample s were analyzed for MAPR , metabolic enzyme activity , and capillary density . VO(2peak ) and MAPR in the presence of the pyruvate and malate ( P+M ) substrate combination , representing carbohydrate metabolism , increased in RT ( P < .05 ) and decreased in C ( P < .05 ) , with a significant difference between groups ( VO(2peak ) , P = .005 ; MAPR , P = .03 ) . There was a strong correlation between the change in MAPR and the change in peak total body oxygen consumption ( VO(2peak ) ) over the study ( r = 0.875 ; P < .0001 ) , the change in MAPR accounting for 70 % of the change in VO(2peak ) . CONCLUSIONS These findings suggest that mitochondrial ATP production is a major determinant of aerobic capacity in CHF patients and can be favorably altered by muscle strengthening exercise BACKGROUND Resistance training increases the skeletal muscle strength and functional ability of chronic heart failure patients . However , there is limited data regarding the effect of resistance training on the hemodynamic responses and peak oxygen consumption ( peak VO(2 ) ) of chronic heart failure patients treated with beta-blocker . This study examined the effect of resistance training on hemodynamics , peak aerobic capacity , muscle strength and quality of life of chronic heart failure patients on beta-blockers medication . METHODS Fifteen men diagnosed with chronic heart failure were matched to either a resistance training program or non-training control group . At baseline and after 8 weeks of resistance training patients performed both Balke incremental and maximal strength tests and completed quality of life question naires . RESULTS The resistance training group demonstrated a significant increase of walking time and peak VO(2 ) by 11.7 % ( p=0.002 ) and approximately 19 % ( p<0.05 ) , respectively . Peak VO(2 ) was significantly correlated with both walking time ( r=0.54 , p=0.038 ) and change in total weight lifted ( r=0.55 , p=0.034 ) . Quality of life significantly increased by 87 % ( p=0.030 ) . The improvement in quality of life was correlated with post training peak VO(2 ) ( r=0.58 , p=0.025 ) and total weight lifted during the post maximal strength test ( r=-0.52 , p=0.047 ) . CONCLUSIONS The benefits from resistance training for chronic heart failure patients on beta-blocker medication included an increased aerobic and exercise capacity , skeletal muscle strength and most importantly , an improvement in the quality of life , which is the main goal of cardiac rehabilitation programs . Furthermore , with appropriate supervision , it is recommended that resistance exercise be added to the exercise rehabilitation program of these patients when possible CONTEXT Guidelines recommend that exercise training be considered for medically stable out patients with heart failure . Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes . OBJECTIVE To test the efficacy and safety of exercise training among patients with heart failure . DESIGN , SETTING , AND PATIENTS Multicenter , r and omized controlled trial of 2331 medically stable out patients with heart failure and reduced ejection fraction . Participants in Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) were r and omized from April 2003 through February 2007 at 82 centers within the United States , Canada , and France ; median follow-up was 30 months . INTERVENTIONS Usual care plus aerobic exercise training , consisting of 36 supervised sessions followed by home-based training , or usual care alone . MAIN OUTCOME MEASURES Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality , cardiovascular mortality or cardiovascular hospitalization , and cardiovascular mortality or heart failure hospitalization . RESULTS The median age was 59 years , 28 % were women , and 37 % had New York Heart Association class III or IV symptoms . Heart failure etiology was ischemic in 51 % , and median left ventricular ejection fraction was 25 % . Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12 . A total of 759 patients ( 65 % ) in the exercise training group died or were hospitalized compared with 796 patients ( 68 % ) in the usual care group ( hazard ratio [ HR ] , 0.93 [ 95 % confidence interval { CI } , 0.84 - 1.02 ] ; P = .13 ) . There were nonsignificant reductions in the exercise training group for mortality ( 189 patients [ 16 % ] in the exercise training group vs 198 patients [ 17 % ] in the usual care group ; HR , 0.96 [ 95 % CI , 0.79 - 1.17 ] ; P = .70 ) , cardiovascular mortality or cardiovascular hospitalization ( 632 [ 55 % ] in the exercise training group vs 677 [ 58 % ] in the usual care group ; HR , 0.92 [ 95 % CI , 0.83 - 1.03 ] ; P = .14 ) , and cardiovascular mortality or heart failure hospitalization ( 344 [ 30 % ] in the exercise training group vs 393 [ 34 % ] in the usual care group ; HR , 0.87 [ 95 % CI , 0.75 - 1.00 ] ; P = .06 ) . In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics , the HRs were 0.89 ( 95 % CI , 0.81 - 0.99 ; P = .03 ) for all-cause mortality or hospitalization , 0.91 ( 95 % CI , 0.82 - 1.01 ; P = .09 ) for cardiovascular mortality or cardiovascular hospitalization , and 0.85 ( 95 % CI , 0.74 - 0.99 ; P = .03 ) for cardiovascular mortality or heart failure hospitalization . Other adverse events were similar between the groups . CONCLUSIONS In the protocol -specified primary analysis , exercise training result ed in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points . After adjustment for highly prognostic predictors of the primary end point , exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437 Objective : To determine the short- and long-term effects of an intensive , concentrated rehabilitation programme in patients with chronic heart failure . Design : R and omized controlled trial , with one-month and six-year evaluations . Setting : Residential rehabilitation centre in Switzerl and . Subjects : Fifty patients with chronic heart failure , r and omized to exercise or control groups . Interventions : A rehabilitation programme lasting one month , including educational sessions , a low-fat diet , and 2 hours of individually prescribed exercise daily . Main measures : Exercise test responses , health outcomes and physical activity patterns . Results : Peak Vo2 increased 21.4 % in the exercise group during the rehabilitation programme ( P<0.05 ) , whereas peak Vo2 did not change among controls . After the six-year follow-up period , peak Vo2 was only slightly higher than that at baseline in the trained group ( 7 % , NS ) , while peak Vo2 among controls was unchanged . During long-term follow-up , 9 and 12 patients died in the exercise and control groups , respectively ( P = 0.63 ) . At six years , physical activity patterns tended to be higher in the exercise group ; the mean energy expenditure values over the last year were 2704 ± 1970 and 2085 ± 1522 kcal/week during recreational activities for the exercise and control groups , respectively . However , both groups were more active compared to energy expenditure prior to their cardiac event ( P<0.001 ) . Conclusions : Six years after participation in a residential rehabilitation programme , patients with chronic heart failure had slightly better outcomes than control subjects , maintained exercise capacity and engaged in activities that exceed the minimal amount recommended by guidelines for cardiovascular health INTRODUCTION Resistance training ( RT ) has been shown to improve chronic heart failure ( CHF ) patients ' functional ability and quality of life . Despite these benefits RT has not always been recommend as a form of exercise principally because of a concern for acceleration of the left ventricular ( LV ) remodeling process . This study investigated the effects of 8 weeks RT on the LV structure and function of patients with CHF . METHOD Fifteen men who suffered from CHF were divided into either a RT program or non-training control group . Before and after 8 weeks of training patients underwent resting echocardiography to assess their end-diastolic and end-systolic dimensions ( EDD and ESD , respectively ) , ejection fraction ( EF ) , fractional shortening ( FS ) and stroke volume ( SV ) . RESULTS A repeated measured ANOVA showed that 8 weeks of RT had no significant effect on the LV measurements ( group x time , p>0.05 ) . Post training comparison , however , revealed that the EF and FS of the training group was significantly higher than in the control group ( 40.9+/-10.5 % vs. 30.3+/-4.6 % , p=0.029 and 25.0+/-7.0 % vs. 17.4+/-3.1 % , p=0.020 respectively ) . CONCLUSION RT is a suitable method of training for CHF patients since it does not cause a reduction of LV contractility function or enhance myocardial deterioration as measured by EF and FS PURPOSE The aim of this study was to compare the effects of endurance training alone ( ET ) with combined endurance and strength training ( CT ) on hemodynamic and strength parameters in patients with congestive heart failure ( CHF ) . METHODS Twenty male patients with CHF were r and omized into one of two training regimens consisting of endurance training or a combination of endurance and resistance training . Group ET had 40-min interval cycle ergometer endurance training three times per week . Group CT combined endurance and strength training with the same interval endurance training for OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Resistance training increased 6-minute walk distance compared to no training , but had no other benefits on cardiac function , exercise capacity , or quality of life if used alone or as an adjunct to aerobic training in people with chronic heart failure .

MS2_fixed_5_shot284

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: This study evaluated a two-year multidisciplinary early intervention pilot programme for back-injured nurses employed at a large teaching hospital , using a pre- versus post-programme analysis . The purpose was to ascertain whether this programme could reduce the incidence , morbidity , time lost and cost due to back injuries in the 250 nurses employed on ten targeted high-risk wards . Injuries in the remaining 1395 nurses employed on the other 45 wards were monitored concurrently for comparison . The programme consisted of prompt assessment , treatment and rehabilitation through modified work . Evaluative data were gathered by one research nurse on st and ardized forms at the time of injury , weekly until return to work , and at a six-month follow-up . Time lost and cost data for up to one-year post-injury were derived from workers ' compensation statements . Compared to the two years prior to introduction of the programme , the rates of back injuries and lost-time back injuries decreased by 23 % and 43 % , respectively , on the targeted wards , while these increased on the control wards . Combined expenditure was 32 % lower per injury and 34 % lower per lost-time injury for those in the targeted group who consented to take part in the programme compared to their counterparts on the control wards , as the increased assessment and treatment costs per case attributable to the programme were more than offset by the savings in lower compensation ( wage loss ) costs . This programme thus reduced the incidence and time lost due to back injuries and was cost-beneficial This study reports the evaluation of an intervention design edto reinforcetobacco abstinence amongelementary schoolchildren in a school transition period . This intervention was developed according to the principles of Intervention Mapping . A total of 765 grade 5 students ( ages 10 - 12 ) was recruited in 32 elementary schools . A quasi-experimental longitudinal design was used to evaluate the outcomes . Results observed 2 and 8 months postintervention are reported here . It is shown that although the behavior remained largely unchanged by the intervention , some of its determinants were modified . Behavioral intention , behavioral and normative beliefs , perceived self-efficacy , and role beliefs were changed at one or both postintervention measures . An interesting feature of these results relates to the fact that the most positive outcomes were seen among at-risk children . Discussion considers the advisability to develop , implement , and evaluate evidence -based interventions targeting the psychosocial factors underlying maintenance of tobacco smoking abstinence in elementary school & NA ; A cognitive – behavioral return‐to‐work focused program was evaluated in a r and omized controlled design , and the effects were compared between two groups of women with musculoskeletal pain . One group of patients ( n=36 ) had a history of long‐term sick leave ( > 12 months ) at the start of the program and the other ( n=36 ) had a history of short‐term sick leave ( 2–6 months ) . The outpatient treatment program , conducted by a psychologist , included 12 sessions with the primary aim to help the patients return‐to‐work . The treatment first included teaching of coping strategies such as applied relaxation , stress management , grade d activity training and pacing . Thereafter the patients were taught how to manage difficulties at their return‐to‐work and how to generalize coping strategies to different risk factors at their work places . The control condition received treatment‐as‐usual . The results showed that the cognitive – behavioral return‐to‐work program was more effective than the treatment‐as‐usual control condition in reducing the number of days on sick leave for patients on short‐term sick leave , but not for patients on long‐term sick leave . The treatment program also helped the patients on short‐term sick leave to increase their ability to control and decrease pain and to increase their general activity level compared to the control condition . These results underscore the need for an early return‐to‐work focused rehabilitation to prevent long‐term sick leave and disability Study Design . Modifying effects in multivariate analyses of a r and omized controlled trial . Objectives . To identify prognostic factors for the effect of a brief intervention ( “ modifiers ” ) at a spine clinic on return to work in patients with subacute low back pain . Summary of Background Data . A previous study of a brief intervention showed significant reduction of sick leave , compared with usual primary healthcare treatment . R and omized controlled trials give data only on the group as an average . Identifying prognostic factors that interact with the treatment ( “ modifiers ” ) may identify specific groups requiring this or other types of treatment . Methods . A total of 457 patients who had been sick-listed 8 to 12 weeks for low back pain were r and omized into an intervention group ( spine clinic with medical examination , information , reassurance , encouragement to engage in physical activity , n = 237 ) , and a control group ( primary health care , n = 220 ) . All subjects filled out question naires . Logistic regression and tests for interaction were used to identify prognostic factors and modifiers for return to work in the two groups , at 3 and 12 months of follow-up . Results . At 3 months of follow-up , the strongest modifying effect on return to work was the perception of constant back strain when working and beliefs about reduced ability to work . At 12 months , gastrointestinal complaints were the strongest modifier for the effect of the intervention . Conclusion . The spine clinic intervention seems to have a main effect on work absenteeism via interacting with the concerns of being unable to work This paper describes a participatory ergonomics program aim ed at early return to regular work of workers suffering from subacute occupational back pain and assesses the perceptions of the participants on the implementation of ergonomic solutions in the workplace . The participatory ergonomics program was used in the rehabilitation of workers suffering from subacute back pain for more than 6 weeks , a program that was associated with an increased rate of return to work . The perceptions of the participatory ergonomics participants were assessed 6 months after completion of the ergonomic intervention through a question naire sent to employer representatives , union representatives and injured workers of participating workplaces . About half of the ergonomic solutions were implemented according to the perception of the participants , with a substantial agreement between respondents Study Design . Population ‐based r and omized clinical trial . Objectives . To develop and test a model of management of subacute back pain , to prevent prolonged disability . Summary of Background Data . The present management of back pain seems inadequate , and development of innovative models has been urged . Methods . A model for the treatment of subacute work‐related back pain has been developed and evaluated in a population ‐based r and omized clinical trial . Workers ( n = 130 ) from eligible workplaces in the Sherbrooke area ( N = 31 ) , who had been absent from work for more than 4 weeks for back pain , were r and omized , based on their workplace , in one of four treatment groups : usual care , clinical intervention , occupational intervention , and full intervention ( a combination of the last two ) . The duration of absence from regular work and from any work was evaluated using survival analysis . Functional status and pain were compared at study entry and after 1 year of follow‐up . Results . The full intervention group returned to regular work 2.41 times faster than the usual care intervention group ( 95 % confidence interval 1.19‐4.89 ; P = 0.01 ) . The specific effect of the occupational intervention accounted for the most important part of this result , with a rate ratio of return to regular work of 1.91 ( 95 % confidence interval = 1.18‐3.10 ; P < 0.01 ) . Pain and disability scales demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups , compared with the trend in the usual care intervention group . Conclusions . Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain Low back pain patients ( n=142 ) on sick leave for at least 8 weeks were given a multi-modal cognitive behavioural treatment program ( MMCBT ) that lasted for 4 weeks . Before treatment , all patients were tested with a comprehensive test battery . The outcome at 12-month follow-up was predictable from the pretest , but only when combining medical and psychological data . Patients who returned to work ( Returners , 50 % ) in the MMCBT group were characterised by less pain , more psychological strength , were evaluated by the physiotherapist as having a good prognosis for return to work , and were less educated . Patients who did not return to work ( Non-returners ) in the MMCBT group felt tense and unfit , felt hopelessness concerning the future , were less physically active , thought their complaints would worsen if they continued working , and reported fewer difficulties driving a car . Returners to work ( 58 % ) in the r and omised control group ( n=81 ) , who received ordinary physical therapy , were characterised by high levels of energy , less subjective health complaints , less exhaustion for a condition test , and did not work in positions giving a constant load on the back . There was no significant differences between number of patients who had returned to work in the MMCBT and the control group . Non-returners in the control group lacked energy , trained less regularly , worked in occupations that gave an almost constant load on the back , and did not expect to be back to work in the course of a couple of weeks . It seems to be important to develop further diagnostic tools to identify those who might benefit from extensive or specific treatments . Copyright 1998 European Federation of Chapters of the International Association for the Study of Pain Study Design . A 5-year follow-up of a r and omized , controlled trial . Objective . To evaluate the long-term health and economic consequences of a cognitive behavioral intervention . Summary of Background Data . Linton and And ersson ( Spine 2000;25:2825–31 ) provide 1 of only a few studies on the preventive effects of a cognitive behavioral intervention . The present study is a 5-year follow-up . Methods . In the original study , 213 participants were r and omized to the cognitive-behavioral group intervention or to usual care plus information on self-care ( information comparison group ) . Of participants , 97 % completed a follow-up question naire 5 years after the intervention , and supplemental records were obtained from the National Insurance Authority . Results . The cognitive behavioral group had significantly less pain , was more active , enjoyed better quality of life , and had better general health relative to the information comparison group . There was no difference on health care use . The risk of long-term sick leave was 3 times higher in the information comparison group . The cognitive behavioral group had significantly less lost productivity costs and a lower total cost/y/person ( 16,514 Swedish kronor ) compared to the information comparison group ( 45,990 Swedish kronor ) . Conclusions . A cognitive-behavioral group intervention produces long-term health and economic benefits . Usual medical care might be improved considerably by implementing these psychologic methods The aim of this study was to determine whether grade d activity restored occupational function in industrial blue-collar workers who were sick-listed for 8 weeks because of subacute , nonspecific , mechanical low back pain ( LBP ) . Patients with LBP , who had been examined by an orthopedic surgeon and a social worker , were r and omly assigned to either an activity group ( n = 51 ) or a control group ( n = 52 ) . Patients with defined orthopedic , medical , or psychiatric diagnoses were excluded before r and omization . The grade d activity program consisted of four parts : ( 1 ) measurements of functional capacity ; ( 2 ) a work-place visit ; ( 3 ) back school education ; and ( 4 ) an individual , submaximal , gradually increased exercise program , with an operant-conditioning behavioral approach , based on the results of the tests and the dem and s of the patient 's work . Records of the amount of sick leave taken over a 3-year period ( ie , the 1-year periods before , during , and after intervention ) were obtained from each patient 's Social Insurance Office . The patients in the activity group returned to work significantly earlier than did the patients in the control group . The median number of physical therapist appointments before return to work was 5 , and the average number of appointments was 10.7 ( SD = 12.3 ) . The average duration of sick leave attributable to LBP during the second follow-up year was 12.1 weeks ( SD = 18.4 ) in the activity group and 19.6 weeks ( SD = 20.7 ) in the control group . Four patients in the control group and 1 patient in the activity group received permanent disability pensions . The grade d activity program made the patients occupationally functional again , as measured by return to work and significantly reduced long-term sick leave STUDY DESIGN Cluster r and omized controlled trial . OBJECTIVE To evaluate the effectiveness of two strategies to improve the use of active sick leave ( ASL ) for patients with low back pain . SUMMARY OF BACKGROUND DATA ASL is a public sickness benefit scheme offered to promote early return to modified work for temporarily disabled workers . It was poorly used , and the authors design ed two community interventions to strengthen the implementation of ASL based on the results of a study of barriers to use among back pain patients , employers , general practitioners ( GPs ) , and local National Insurance Administration staff . METHODS Sixty-five municipalities in three counties in Norway , r and omly assigned to a passive intervention , a proactive intervention , or a control group . The interventions were targeted at patients on sick leave for low back pain for more than 16 days ( n = 6176 ) , their GPs , employers , and local insurance officers . The passive intervention included reminders about ASL on the sick leave form that GPs must complete , a st and ard agreement to facilitate ASL , targeted information , and a desktop summary for GPs of clinical practice guidelines for low back pain , emphasizing the importance of advice to stay active . The proactive intervention included these elements plus a re source person to facilitate the use of ASL and a continuing education workshop for GPs . The main outcome measure reported here is the proportion of eligible patients that used ASL . RESULTS ASL was used significantly more in the proactive intervention municipalities ( 17.7 % ) compared with the passive intervention and control municipal OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The key features of the program include ; having trained personnel coordinate the RTW process , identifying and ranking barriers and solutions to RTW from the perspective of all important stakeholders , mediating practical solutions at the workplace and , empowering the injured worker in RTW decision-making .

MS2_fixed_5_shot285

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: BACKGROUND Current interest in the role of functional foods in weight control has focused on plant ingredients capable of interfering with the sympathoadrenal system . OBJECTIVE We investigated whether a green tea extract , by virtue of its high content of caffeine and catechin polyphenols , could increase 24-h energy expenditure ( EE ) and fat oxidation in humans . DESIGN Twenty-four-hour EE , the respiratory quotient ( RQ ) , and the urinary excretion of nitrogen and catecholamines were measured in a respiratory chamber in 10 healthy men . On 3 separate occasions , subjects were r and omly assigned among 3 treatments : green tea extract ( 50 mg caffeine and 90 mg epigallocatechin gallate ) , caffeine ( 50 mg ) , and placebo , which they ingested at breakfast , lunch , and dinner . RESULTS Relative to placebo , treatment with the green tea extract result ed in a significant increase in 24-h EE ( 4 % ; P < 0.01 ) and a significant decrease in 24-h RQ ( from 0.88 to 0.85 ; P < 0.001 ) without any change in urinary nitrogen . Twenty-four-hour urinary norepinephrine excretion was higher during treatment with the green tea extract than with the placebo ( 40 % , P < 0.05 ) . Treatment with caffeine in amounts equivalent to those found in the green tea extract had no effect on EE and RQ nor on urinary nitrogen or catecholamines . CONCLUSIONS Green tea has thermogenic properties and promotes fat oxidation beyond that explained by its caffeine content per se . The green tea extract may play a role in the control of body composition via sympathetic activation of thermogenesis , fat oxidation , or both The consumption of green tea has been associated with cardiovascular and metabolic diseases . There have been some studies on the influence of green tea on the mineral status of obese subjects , but they have not yielded conclusive results . The aim of the present study is to examine the effects of green tea extract on the mineral , body mass , lipid profile , glucose , and antioxidant status of obese patients . A r and omized , double-blind , placebo-controlled study was conducted . Forty-six obese patients were r and omly assigned to receive either 379 mg of green tea extract , or a placebo , daily for 3 months . At baseline , and after 3 months of treatment , the anthropometric parameters , blood pressure , and total antioxidant status were assessed , as were the levels of plasma lipids , glucose , calcium , magnesium , iron , zinc , and copper . We found that 3 months of green tea extract supplementation result ed in decreases in body mass index , waist circumference , and levels of total cholesterol , low-density cholesterol , and triglyceride . Increases in total antioxidant level and in zinc concentration in serum were also observed . Glucose and iron levels were lower in the green tea extract group than in the control , although HDL-cholesterol and magnesium were higher in the green tea extract group than in the placebo group . At baseline , a positive correlation was found between calcium and body mass index , as was a negative correlation between copper and triglycerides . After 3 months , a positive correlation between iron and body mass index and between magnesium and HDL-cholesterol , as well as a negative correlation between magnesium and glucose , were observed . The present findings demonstrate that green tea influences the body 's mineral status . Moreover , the results of this study confirm the beneficial effects of green tea extract supplementation on body mass index , lipid profile , and total antioxidant status in patients with obesity This study was undertaken to investigate the effects of green tea on weight reduction in obese Thais . A r and omized , controlled trial involving 60 obese subjects ( body mass index , BMI > 25 kg/m2 ) was conducted . All subjects consumed a Thai diet containing 3 meals ( 8373.6 kJ/day ) for 12 weeks , prepared by the Nutritional Unit at Srinagarind Hospital . The diet contained 65 % carbohydrates , 15 % protein , and 20 % fat . Body weight , BMI , body composition , resting energy expenditure , and substrate oxidation were measured at baseline , and during weeks 4 , 8 , and 12 of the study . Serum levels of leptin and urine VMA were measured at baseline and during the 12th week . Differences over time and between the treatments ( green tea or placebo ) over time were determined using two-factor ANOVA with repeated measures . In comparing the two groups , differences in weight loss were 2.70 , 5.10 , and 3.3 kg during the 4th , 8th , and 12th weeks of the study , respectively . At the 8th and 12th weeks of the study , body weight loss was significantly different ( P < 0.05 ) . At the 8th week , the difference in resting energy expenditure was 183.38 kJ/day ( P < 0.001 ) , the difference in the respiratory quotient was 0.02 ( P < 0.05 ) , and no significant differences existed in satiety score , food intake , or physical activity . Urine VMA was significantly different in the 12th week of the study ( P < 0.05 ) . We conclude that green tea can reduce body weight in obese Thai subjects by increasing energy expenditure and fat oxidation This study evaluated the influence of a green tea catechin beverage on body composition and fat distribution in overweight and obese adults during exercise-induced weight loss . Participants ( n = 132 with 107 completers ) were r and omly assigned to receive a beverage containing approximately 625 mg of catechins with 39 mg caffeine or a control beverage ( 39 mg caffeine , no catechins ) for 12 wk . Participants were asked to maintain constant energy intake and engage in > or=180 min/wk moderate intensity exercise , including > or=3 supervised sessions per week . Body composition ( dual X-ray absorptiometry ) , abdominal fat areas ( computed tomography ) , and clinical laboratory tests were measured at baseline and wk 12 . There was a trend ( P = 0.079 ) toward greater loss of body weight in the catechin group compared with the control group ; least squares mean ( 95 % CI ) changes , adjusted for baseline value , age , and sex , were -2.2 ( -3.1 , -1.3 ) and -1.0 ( -1.9 , -0.1 ) kg , respectively . Percentage changes in fat mass did not differ between the catechin [ 5.2 ( -7.0 , -3.4 ) ] and control groups [ -3.5 ( -5.4 , 1.6 ) ] ( P = 0.208 ) . However , percentage changes in total abdominal fat area [ -7.7 ( -11.7 , -3.8 ) vs. -0.3 ( -4.4 , 3.9 ) ; P = 0.013 ] , subcutaneous abdominal fat area [ -6.2 ( -10.2 , -2.2 ) vs. 0.8 ( -3.3 , 4.9 ) ; P = 0.019 ] , and fasting serum triglycerides ( TG ) [ -11.2 ( -18.8 , -3.6 ) vs. 1.9 ( -5.9 , 9.7 ) ; P = 0.023 ] were greater in the catechin group . These findings suggest that green tea catechin consumption enhances exercise-induced changes in abdominal fat and serum TG Objectives : To study the effects of green tea on body weight , and biochemical and hormonal profiles in obese Chinese women with polycystic ovary syndrome ( PCOS ) . Methods : Thirty-four obese Chinese women with PCOS were r and omized into either treatment with green tea capsules or placebo for 3 months . The anthropomentric measurements , and biochemical and hormonal profiles before and after treatment in each group were compared . Results : The body weight of the green tea group decreased by a nonsignificant 2.4 % after treatment ; whereas the body weight , body mass index ( BMI ) , and body fat content of the control group were significantly higher after 3 months . There were no differences in any of the hormone levels measured in either group . The biochemical profiles of the two groups were also similar except that there was a small but significant rise in the triglyceride level in the green tea group . Fewer patients in the green tea group remained amenorrhoeic , but this was not significantly different from the control group . Conclusions : Green tea supplementation did not significantly reduce body weight in obese women with PCOS , nor did it alter the glucose or lipid metabolism The present study was conducted to investigate whether green tea may improve weight maintenance by preventing or limiting weight regain after weight loss of 5 to 10 % in overweight and moderately obese subjects . The study had a r and omised , parallel , placebo-controlled design . A total of 104 overweight and moderately obese male and female subjects ( age 18 - 60 years ; BMI 25 - 35 kg/m(2 ) ) participated . The study consisted of a very-low-energy diet intervention ( VLED ; 2.1 MJ/d ) of 4 weeks followed by a weight-maintenance period of 13 weeks in which the subjects received green tea or placebo . The green tea contained caffeine ( 104 mg/d ) and catechins ( 573 mg/d , of which 323 mg was epigallocatechin gallate ) . Subjects lost 6.4 ( sd 1.9 ) kg or 7.5 ( sd 2.2 ) % of their original body weight during the VLED ( P<0.001 ) . Body-weight regain was not significantly different between the green tea and the placebo group ( 30.5 ( sd 61.8 ) % and 19.7 ( sd 56.9 ) % , respectively ) . In the green tea treatment , habitual high caffeine consumption was associated with a higher weight regain compared with habitual low caffeine consumption ( 39 ( sd 17 ) and 16 ( sd 11 ) % , respectively ; P<0.05 ) . We conclude that weight maintenance after 7.5 % body-weight loss was not affected by green tea treatment and that habitual caffeine consumption affected weight maintenance in the green tea treatment Regular consumption of green tea may be cardioprotective . In the present study we investigated the health effects of dietary supplementation with green tea catechins and the potential modifying effect of the catechol-O-methyltransferase ( COMT ) Val/Met genotype . Subjects ( sedentary males , aged 40 - 69 years , with BMI ≥ 28 and ≤ 38 kg/m(2 ) ) were r and omly assigned to consume decaffeinated green tea extract ( DGT ; 530 mg containing about 400 mg total catechins/capsule , twice daily ) and placebo in a complete cross-over design . Ambulatory blood pressure and biomarkers of metabolic function ( cholesterol , TAG , glucose and insulin ) were measured at weeks 0 and 6 . Although a marked increase in the concentration of plasma epigallocatechin gallate ( EGCG ) , urinary epigallocatechin ( EGC ) and urinary 4'-O-methyl EGC was found after DGT treatment , no effect on blood pressure or biomarkers of metabolic function was observed . However , a period × treatment interaction ( P < 0·05 ) was detected for body-weight change . Despite a similar increase in estimated energy intake during intervention period 1 , body weight decreased by 0·64 ( sd 2·2 ) kg and increased by 0·53 ( sd 1·9 ) kg in the DGT and placebo groups , respectively ( P = 0·025 ) , suggesting a protective effect of green tea catechins on weight gain . Additionally , the COMT Val/Met genotype influenced urinary accumulation of EGC and 4'-O-methyl EGC ( P < 0·01 ) . Mean concentrations were lower in individuals homozygous for the high-activity G-allele , possibly reflecting increased metabolic flux and a more rapid conversion to downstream metabolic species , compared with individuals carrying at least one copy of the low-activity A-allele . Additional studies are needed to confirm these findings and further explore the modifying effect of genotype AIMS To examine the effect of green tea extract ( GTE ) on obese women and to explore the relationship between GTE and obesity-related hormone peptides . METHODS A r and omized , double-blind , placebo-controlled clinical trial was conducted from July 2006 to June 2007 in Taipei Hospital , Taiwan . Seventy-eight of 100 obese women aged between 16 and 60 years with BMI > 27 kg/m(2 ) and who had not received any other weight control maneuvers within the last 3 months completed this study . The subjects were r and omly divided into Groups A and B. Group A ( n=41 ) received GTE while Group B ( n=37 ) took cellulose as a placebo , one capsule ( 400 mg ) three times each day for 12 weeks . The body weight ( BW ) , body mass index ( BMI ) and waist circumflex ( WC ) were measured at the beginning of the study and after 12 weeks of treatment with GTE . The data were compared and expressed as % reduction . RESULTS There was only a 0.3 % reduction in BW ( 0.15 kg ) after 12 weeks of treatment with GTE . There was no statistical difference in % reduction in BW , BMI and WC between the GTE and placebo groups . Within group comparison revealed that the GTE group had significant reduction in LDL- OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Research has been very varied , however , daily consumption of green tea with doses of EGCG between 100 and 460 mg/day has shown greater effectiveness on body fat and body weight reduction in intervention periods of 12 weeks or more . In addition , the use of caffeine doses between 80 and 300 mg/day has been shown to be an important factor for this effects , when the participants did not have a high caffeine intake ( > 300 mg/day ) prior to the intervention

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE To prospect ively examine the effect of weight loss 1 year after laparoscopic adjustable gastric b and surgery on a broad range of health outcomes in 50 diabetic subjects . RESEARCH DESIGN AND METHODS A total of 50 ( 17 men , 33 women ) of 51 patients with type 2 diabetes , from a total of 500 consecutive patients , were studied preoperatively and again 1 year after surgery . RESULTS Preoperative weight and BMI ( means + /- SD ) were 137 + /- 30 kg and 48.2 + /- 8 kg/m(2 ) , respectively ; at 1 year , weight and BMI were 110 + /- 24 kg and 38.7 + /- 6 kg/m(2 ) , respectively . There was significant improvement in all measures of glucose metabolism . Remission of diabetes occurred in 32 patients ( 64 % ) , and major improvement of glucose control occurred in 13 patients ( 26 % ) ; glucose metabolism was unchanged in 5 patients ( 10 % ) . HbA(1c ) was 7.8 + /- 3.2 % preoperatively and 6.2 + /- 2.7 % at 1 year ( P < 0.001 ) . Remission of diabetes was predicted by greater weight loss and a shorter history of diabetes ( pseudo r(2 ) = 0.44 , P < 0.001 ) . Improvement in diabetes was related to increased insulin sensitivity and beta-cell function . Weight loss was associated with significant improvements in fasting triglyceride level , HDL cholesterol level , hypertension , sleep , depression , appearance evaluation , and health-related quality of life . Early complications occurred in 6 % of patients ( wound infections in 4 % , respiratory support in 2 % ) , and late complications occurred in 30 % of patients ( gastric prolapse in 20 % , b and erosion in 6 % , and tubing leaks in 4 % ) . All late complications were successfully revised surgically . CONCLUSIONS Modern laparoscopic weight-loss surgery is effective in managing the broad range of health problems experienced by severely obese individuals with type 2 diabetes . Surgery should be considered as an early intervention BACKGROUND A very-low-energy diet ( VLED ) can result in substantial , rapid weight loss and is increasingly prescribed before obesity surgery to minimize risk and difficulty by reducing liver size and abdominal adiposity . Despite its growing popularity , a VLED in this setting has received little attention . OBJECTIVE The aim of this study was to investigate the efficacy and acceptability of a preoperative VLED . DESIGN In a prospect i ve observational study , 32 subjects ( n = 19 men and 13 women ) with a mean ( + /-SD ) age of 47.5 + /- 8.3 y and a body mass index ( in kg/m(2 ) ) of 47.3 + /- 5.3 consumed a VLED for 12 wk . Primary outcomes included changes in liver volume ( LV ) and in visceral and subcutaneous adipose tissue ( VAT/SAT ) . Changes in body weight , anthropometric measures , and biochemical variables were also recorded , and compliance with , acceptability of , and side effects of treatment were assessed . Changes in LV and VAT/SAT area were measured by computed tomography and magnetic resonance imaging at baseline and weeks 2 , 4 , 8 , and 12 . RESULTS Mean ( + /-SD ) LV , VAT/SAT , and body weight decreased significantly ( P < 0.001 for all ) . The degree of LV reduction was directly related to the reduction in relative body weight ( r = 0.54 , P = 0.001 ) and initial LV ( r = 0.43 , P = 0.015 ) . Eighty percent of the reduction in LV occurred between weeks 0 and 2 ( P < 0.001 ) . Reductions in body weight and VAT were uniform over the 12-wk period . Attrition was 14 % . Acceptability was adequate but waned over time , and mild transitory side effects occurred . CONCLUSIONS Given the observed early reduction in LV and the progressive reduction in VAT , we suggest that the minimum duration for a preoperative VLED be 2 wk . Ideally , the duration should be 6 wk to achieve maximal LV reduction and significant reductions in VAT and body weight without compromising compliance and acceptability BACKGROUND Gastric bypass ( GBP ) is the most common operation performed in the United States for morbid obesity . However , weight loss is poor in 10 % to 15 % of patients . We sought to determine the independent factors associated with poor weight loss after GBP . DESIGN Prospect i ve cohort study . We examined demographic , operative , and follow-up data by means of multivariate analysis . Variables investigated were age , sex , race , marital and insurance status , initial weight and body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) , comorbidities ( diabetes mellitus , hypertension , joint disease , sleep apnea , hyperlipidemia , and psychiatric disease ) , laparoscopic vs open surgery , gastric pouch area , gastrojejunostomy technique , and alimentary limb length . SETTING University tertiary referral center . PATIENTS All patients at our institution who underwent GBP from January 1 , 2003 , through July 30 , 2006 . MAIN OUTCOME MEASURES Weight loss at 12 months defined as poor ( < or = 40 % excess weight loss ) or good ( > 40 % excess weight loss ) . RESULTS Follow-up data at 12 months were available for 310 of the 361 patients ( 85.9 % ) undergoing GBP during the study period . Mean preoperative BMI was 52 ( range , 36 - 108 ) . Mean BMI and excess weight loss at follow-up were 34 ( range , 17 - 74 ) and 60 % ( range , 8%-117 % ) , respectively . Thirty-eight patients ( 12.3 % ) had poor weight loss . Of the 4 variables associated with poor weight loss in the univariate analysis ( greater initial weight , diabetes , open approach , and larger pouch size ) , only diabetes ( odds ratio , 3.09 ; 95 % confidence interval , 1.35 - 7.09 [ P = .007 ] ) and larger pouch size ( odds ratio , 2.77;95 % confidence interval , 1.81 - 4.22 [ P < .001 ] ) remained after the multivariate analysis . CONCLUSIONS Gastric bypass results in substantial weight loss in most patients . Diabetes and larger pouch size are independently associated with poor weight loss after GBP OBJECTIVE To assess the cost-effectiveness of Roux-en-Y gastric bypass for treating type 2 diabetes mellitus ( T2DM ) in the United States compared with st and ard medical management , using clinical data from a prospect i ve observational study conducted at an academic medical center . STUDY DESIGN Our study used a predictive health economic model ( the CORE Diabetes Model ) to project the long-term costs and clinical effectiveness of Roux-en-Y gastric bypass as a treatment for T2DM using the prospect i ve observational study as the basis for our clinical effectiveness assumptions . METHODS The CORE Diabetes Model used Monte Carlo simulation with tracker variables to estimate the lifetime costs and clinical outcomes of Roux-en-Y gastric bypass compared with st and ard medical management of obese T2DM patients . Sensitivity analyses were performed on key clinical assumptions , discount rates , and shorter time horizons . RESULTS The base-case scenario yielded an incremental cost-effectiveness ratio ( ICER ) of $ 21,973 per quality -adjusted life-year ( QALY ) gained . In sensitivity analyses , shortening the time horizon to 5 and 10 years and excluding the negative impact of increased body mass index on the patient 's quality of life had the greatest adverse impact on the ICERs ( ie , higher cost per QALY ) . CONCLUSIONS Under base-case assumptions , Roux-en-Y gastric bypass is cost-effective in the treatment of T2DM in the United States with an ICER below $ 50,000 per QALY gained . Sensitivity analyses indicated that bariatric surgery is not cost-effective over shorter time horizons , or if the negative quality -of-life impact of increased body mass index is ignored Objective This report documents that the gastric bypass operation provides long-term control for obesity and diabetes . Summary Background Data Obesity and diabetes , both notoriously resistant to medical therapy , continue to be two of our most common and serious diseases . Methods Over the last 14 years , 608 morbidly obese patients underwent gastric bypass , an operation that restricts caloric intake by ( 1 ) reducing the functional stomach to approximately 30 mL , ( 2 ) delaying gastric emptying with a c. 0.8 to 1.0 cm gastric outlet , and ( 3 ) excluding foregut with a 40 to 60 cm Roux-en-Y gastrojejunostomy . Even though many of the patients were seriously ill , the operation was performed with a perioperative mortality and complication rate of 1.5 % and 8.5 % , respectively . Seventeen of the 608 patients ( <3 % ) were lost to follow-up . Results Gastric bypass provides durable weight control . Weights fell from a preoperative mean of 304.4 lb ( range , 198 to 615 lb ) to 192.2 lb ( range , 104 to 466 ) by 1 year and were maintained at 205.4 lb ( range , 107 to 512 lb ) at 5 years , 206.5 lb ( 130 to 388 lb ) at 10 years , and 204.7 lb ( 158 to 270 lb ) at 14 years . The operation provides long-term control of non-insulin-dependent diabetes mellitus ( NIDDM ) . In those patients with adequate follow-up , 121 of 146 patients ( 82.9 % ) with NIDDM and 150 of 152 patients ( 98.7 % ) with glucose impairment maintained normal levels of plasma glucose , glycosylated hemoglobin , and insulin . These antidiabetic effects appear to be due primarily to a reduction in caloric intake , suggesting that insulin resistance is a secondary protective effect rather than the initial lesion . In addition to the control of weight and NIDDM , gastric bypass also corrected or alleviated a number of other comorbidities of obesity , including hypertension , sleep apnea , cardiopulmonary failure , arthritis , and infertility Aims /hypothesisBoth energy restriction ( ER ) per se and weight loss improve glucose metabolism in obese insulin-treated type 2 diabetic patients . Short-term ER decreases basal endogenous glucose production ( EGP ) but not glucose disposal . In contrast the blood glucose-lowering mechanism of long-term ER with substantial weight loss has not been fully eluci date d. The aim of this study was to investigate the effect of loss of 50 % of excess weight [ 50 % excess weight reduction ( EWR ) ] on EGP , whole-body insulin sensitivity and the disturbed myocellular insulin-signalling pathway in ten obese insulin-treated type 2 diabetic patients . Methods A euglycaemic – hyperinsulinaemic clamp with stable isotopes ( [6,6 - 2H2]glucose and [2H5]glycerol ) combined with skeletal muscle biopsies was performed during a very low energy diet ( VLED ; 1,883 kJ/day ) on day 2 and again after 50 % EWR . Oral blood glucose-lowering agents and insulin were discontinued 3 weeks prior to the VLED and at the start of the VLED , respectively . Results Loss of 50 % EWR ( 20.3 ± 2.2 kg from day 2 to day of 50 % EWR ) normalised basal EGP and improved insulin sensitivity , especially insulin-stimulated glucose disposal ( 18.8 ± 2.0 to 39.1 ± 2.8 μmol kg fat-free mass−1 min−1 , p = 0.001 ) . The latter was accompanied by improved insulin signalling at the level of the recently discovered protein kinase B/Akt substrates AS160 and PRAS40 along with a decrease in intramyocellular lipid ( IMCL ) content . Conclusions /interpretationConsiderable weight loss in obese , insulin-treated type 2 diabetic patients normalises basal EGP and improves insulin sensitivity result ing from an improvement in insulin signal transduction in skeletal muscle . The decrease in IMCL might contribute to this effect Background : Biliopancreatic diversion with duodenal switch ( BPD-DS ) is an operation which provides one of the greatest maintained weight losses of any bariatric procedure . We looked at the safety and efficacy of laparoscopic BPD-DS for morbid obesity . Methods : A 150 - 200 ml sleeve gastrectomy was created and anastomosed to the distal 250 cm of divided ileum . The median length of the common channel was 100 cm . All patients were prospect ively followed up to 12 months . Results : 40 consecutive patients underwent laparoscop OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Bariatric surgery leads to marked and long-lasting weight reduction . A large proportion of patients undergoing bariatric surgery have DM2 . Glycemic control improves in the months after laparoscopic adjustable gastric b and ing , but it improves more rapidly and completely after laparoscopic Roux-en-Y gastric bypass surgery . Thus , both types of surgery are capable of improving or even curing DM2 , but the mechanisms may differ

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: In a prospect i ve study , the authors used a porous tantalum monoblock acetabular component for primary total hip arthroplasty between November 1997 and June 1999 . A total of 156 consecutive primary total hip arthroplasty were done in 143 patients younger than 75 years . A total of 151 hips had a follow-up time from 8 to 10 years . The average preoperative total Harris hip score of 44.0 + /- 13.8 increased to 97.0 + /- 6.2 at the latest follow-up . The average preoperative Oxford hip score of 43.3 + /- 6.5 improved to 13.9 + /- 2.3 at the latest follow-up . Radiographic evaluation including the Ein-Bild-Röntgen-Analyse ( EBRA ) digital system showed no radiographic evidence of gross polyethylene wear , progressive radiolucencies , osteolytic lesions , acetabular fracture , or component subsidence . There were 7 ( 4.5 % ) postoperative complications all unrelated to the acetabular component We report a prospect i ve , stratified study of 60 PCA-cups and 60 RM-polyethylene cups which have been followed for a median time of 90 months , with annual radiography . The radiological migration of cups was measured by the computer-assisted EBRA method . A number of threshold migration rates from 1 mm in the first year to 1 mm in five years have been assessed and related to clinical ly determined revision rates . A total of 28 cups showed a total migration of 1 mm or more within the first two years ; 13 of these cups have required revision and been exchanged . The survival curves of cups which had previously shown early migration were considerably different from those without early migration . For cups with a migration of less than 1 mm within the first two years the mean survival at 96 months was 0.96 + /- 0.02 ; for migrating cups , it was 0.63 + /- 0.11 ( log-rank test , p=0.0001 ; chi-square value=39.4 ) . Early migration is a good predictor for late loosening of hip sockets Total hip arthroplasty ( THA ) with well design ed cementless acetabular implants has shown excellent results . The purpose of this study was to assess our clinical and radiological outcomes using an uncemented cup . We conducted a prospect i ve cohort study including all consecutive primary THAs performed with the Morscher press-fit cup , an uncemented non-modular acetabular component , between March 1996 and December 1998 . Patients were evaluated at ten years with clinical and radiological follow-up , patient satisfaction and question naire assessment using the Harris hip score ( HHS ) , Merle d’Aubigné and Postel score , the UCLA score , the 12-item short-form health survey ( SF-12 ) and a visual analog scale . Five hundred sixty-one THAs were performed in 518 patients . At 120 months ( ± 7.3 months ) , 303 patients with 335 THAs were still available for follow-up . None of the patients had required cup revision for aseptic loosening . At ten years , the cup survivorship was 98.8 % ( 95 % CI 97.4–99.5 ) with cup revision for any cause as an endpoint . No radiolucencies were seen around the cups , but osteolytic defects involved 21 stems ( 8.3 % ) . Mean total linear polyethylene wear was 0.9 mm . The Morscher acetabular replacement cup provides excellent results at ten years . There were no revisions for aseptic loosening of the cup , and no osteolytic defects were found around the cup . Patient satisfaction was high and the clinical results were very good Summary Fifty-nine PCA cups and 61 hydroxyapatite-coated RM cups were included in a prospect i ve r and omised study with a mean follow up of 5.2 years . Clinical evaluation revealed better results with the RM cup . Radiological criteria of loosening could be applied only with considerable restrictions as different parameters were assessed : progressively loosened beads in PCA cups and faded contour in RM cups . Migration was measured by a computer assisted method ( EBRA ) . PCA cups showed significantly more longitudinal migration 2 years after operation and subsequently . High migration values correlated with a limp . Loosening as defined by migration was of clinical relevance , could be measured early and predicted the survival rate . RésuméCinquante-neuf cotyles PCA et 61 cotyles RM , recouverts d'hydroxyapatite , ont été rassemblés dans une étude prospect i ve r and omisée . La durée d'observation moyenne est de 5,2 ans . L'évaluation clinique , douleur , mobilité , marche , est en faveur du cotyle RM . Les critères radiologiques d'instabilité sont difficiles à apprécier , d'autant qu'il faut évaluer des paramètres différents : fragments progressivement libérés dans les cotyles PCA et irrégularités des contours dans les cotyles RM . Le déplacement a été étudié selon une nouvelle technique computérisée EBRA . Les cotyles PCA ont présenté une migration appréciable , surtout longitudinale , dès la 2ème année post-opératoire et ultérieurement une migration moyenne de 0,6 mm à 5 ans . Il existe une corrélation entre les déplacements importants et la boiterie . L'instabilité cotyloïdienne définie par le déplacement semble correspondre au résultat clinique , même à un stade précoce Our study reports a sub-group of patients with developmental dysplasia from a previously published larger series , with particular emphasis on the use of the uncemented RM acetabular component . We evaluated the long term results of 93 consecutive uncemented THAs in 80 patients using the titanium-coated RM acetabular component and the CLS femoral component in a prospect i ve study . Eighteen hips in 16 patients had osteoarthritis secondary to developmental dysplasia of the hip . The mean follow-up was 19.6 years ( 18.2 to 20.9 ) . Fourteen patients with 15 hips were clinical ly and radiographically examined and evaluated . Two patients with 3 hips died . No patient was lost to follow-up . No implant had to be revised , and no cases showed evidence of radiographic loosening . Nine acetabular components were not completely covered by host bone but this did not affect the outcome . At the latest follow-up the mean Harris Hip Score was 92 ( 81 to 100 ) . The mean annual wear rate was 0.12 mm . The RM acetabular component performed well over 20 years in this selected group of patients . Complete acetabular containment was not needed , thus allowing reliable reconstruction of the anatomical centre of rotation To evaluate different modes of cementless fixation of hemispherical cups , we operated on 87 hips in 81 patients using 4 different means of cup fixation . The hips were r and omly assigned to fixation with press-fit technique only ( PF ) , or with augmentation with screws ( S ) , pegs ( P ) , or hydroxyapatite ( HA ) coating . The patients were evaluated with radiostereometric analysis ( RSA ) for cup migration and wear , conventional radiography for osteolysis , and Harris Hip Score for clinical outcome over 5 years . The fixation of the cups did not differ between the groups , but HA showed a tendency to decrease proximal migration . HA-coated cups displayed the best interface with hardly any signs of radiolucent lines , indicating a superior sealing effect of the HA coating . Cups with screws or pegs had more radiolucent lines and osteolytic lesions than the other groups . Radiolucent lines were correlated to higher proximal migration , young age , and female gender ( r2=.2 ) . The wear rate of the ethylene oxide-sterilized polyethylene liner was high ( 0.2 mm/y ) but did not differ between the groups . Two cups with a perioperative fracture of the acetabular rim showed large initial migration but stabilized thereafter This study evaluated 185 cementless Mathys coated and uncoated acetabular cups inserted for total hip replacement since September 1984 . All of the cups were high-density polyethylene . Sixty were uncoated ( group A ) , 96 were coated with hydroxyapatite ( group B ) , and 29 were coated with titanium ( group C ) . Cup survival was assessed clinical ly , histologically , and radiographically , and a computer-assisted EBRA method was used to evaluate cup migration . After a mean follow-up of 8 years , five cups in group A that had previously shown migration were revised as a result of aseptic loosening , while no loosening of hip sockets occurred in groups B and C. These results suggest that Mathys cups should be used only if coated with hydroxyapatite or titanium . Furthermore , the histologic evaluation in four cups from groups B and C revealed normal bone formation without inflammation or fibrotic tissue around the cups , promising long-term survival OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Results Best evidence analysis showed no difference in polyethylene wear rate , the frequency of cup migration , and aseptic loosening between monoblock and modular acetabular components . No convincing evidence was found for the cl aim that lower frequencies of acetabular osteolysis are observed with the use of monoblock cups compared with modular uncemented cups . Conclusions The purported benefits of monoblock cups were not substantiated by this systematic review of controlled studies in that polyethylene wear rates and frequencies of cup failure and acetabular osteolysis were similar to those observed with modular implants .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design Objectives To establish a protocol for the treatment of fragility fractures in the hospital setting based on treatment of osteoporosis . Material s and methods An intervention protocol was implemented in patients with fragility fractures based on ( 1 ) indicating the diagnosis of osteoporotic fracture in the summary of discharge ; ( 2 ) “ lifestyle recommendations ” ; and ( 3 ) therapy for osteoporosis . Thirty-one hospitals were involved and they were informed of the importance of protocol compliance . In the first phase , a retrospective study was conducted to establish the number of low-energy fractures treated and the percentage of them that had complied with the protocol ( n = 887 ) . Then , prospect ively , the same data were collected for the patients managed for 1 year ( n = 6,826 ) in three sections of 4-month intervals . Results The percentage of compliance increased from 8.2 to 57.2 % in the first point , from 12.6 to 42.4 % in the second , and from 10.3 to 43.2 % in the third . Conclusion The implementation of programs to improve osteoporosis treatment is very useful for ensuring adherence in the management of osteoporosis following admission due to fragility fracture BACKGROUND Although osteoporosis is strongly associated with hip fractures , the initiation of osteoporosis treatment following hip fractures occurs at surprisingly low rates of between 5 % and 30 % . Currently , most patients receiving treatment have been referred back to their primary care physician for osteoporosis management . The purpose of this study was to compare the effect of osteoporosis management initiated by the orthopaedic team and osteoporosis management initiated by the primary care physician on the rates of treatment at six months . METHODS A prospect i ve r and omized trial was conducted to assess the difference in the rate of osteoporosis treatment when an in-house assessment of osteoporosis was initiated by the orthopaedic surgeon and follow-up was conducted in a specialized orthopaedic osteoporosis clinic compared with osteoporosis education and " usual " care . RESULTS Sixty-two patients were enrolled in the study . Thirty-one patients each were in the control and intervention groups . The percentage of patients who were on pharmacologic treatment for osteoporosis at six months after the fracture was significantly greater when the evaluation was initiated by the orthopaedic surgeon and was managed in a specialized orthopaedic osteoporosis clinic ( 58 % ) than when treatment was managed by a primary care physician ( 29 % ) ( p = 0.04 ) . CONCLUSIONS An active role by orthopaedic surgeons in the management of osteoporosis improves the rate of treatment at six months following a hip fracture BACKGROUND In a r and omized trial of patients with hip fractures , we previously demonstrated that a hospital-based case manager could increase rates of appropriate osteoporosis treatment to 51 % compared with 22 % for usual care ( P < .001 ) . Alongside that trial , we conducted an economic analysis . METHODS Patients with hip fractures were r and omized to usual care ( n = 110 ) or a case manager ( n = 110 ) and followed up for 1 year . Time-motion studies were used to determine intervention costs . From a third-party health care payer perspective and over the patient 's remaining lifetime , a Markov decision-analytic model was constructed to determine cost-effectiveness of the intervention compared with usual care . Costs and benefits were discounted at 3 % and expressed in 2006 Canadian dollars . RESULTS The intervention cost CaD $ 56 per patient . Compared with usual care , the intervention strategy was dominant : for every 100 patients case managed , 6 fractures ( 4 hip fractures ) were prevented , 4 quality -adjusted life-years were gained , and CaD $ 260 000 was saved by the health care system . Irrespective of the number of patients case managed , the intervention reached a break-even threshold within 2 years . The intervention dominated usual care over the entire spectrum of 1-way sensitivity analyses and was cost-saving in 82 % of probabilistic model simulations . CONCLUSIONS Compared with usual care , we found that using a case manager for patients with hip fractures increased rates of appropriate osteoporosis treatment . The intervention dominated usual care , and the analysis suggests that systems implementing an intervention similar to ours should expect to see a reduction in fractures , gains in life expectancy , and substantial cost savings . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00175175 Background : Osteoporosis is a common disease characterized by decreased bone mass and increased fracture risk in postmenopausal women and the elderly . Hip fractures are among the most common consequences of osteoporosis and unfortunately usually occur late in the course of the disease . When a patient is admitted to the hospital with a fragility hip fracture , a unique opportunity for diagnosis and treatment presents itself . Fortunately , several medications have proven to be effective in lowering the risk of future fractures . The purpose s of the present study were to test the hypothesis that most fragility hip fractures go untreated and to determine whether educational efforts to raise physician awareness have led to an improvement in osteoporosis treatment rates . Methods : A retrospective cohort study was performed with use of the patient data bases at two university medical centers and one university-affiliated community hospital . The charts of 300 r and omly selected patients were sorted with use of ICD-9 ( International Classification of Diseases , Ninth Revision ) codes for femoral neck fractures . There were 100 patients from each center , with twenty-five patients from each year between 1997 and 2000 . The admitting diagnosis , mechanism of injury , admission medications , procedures performed during hospitalization , and discharge medications were then extracted and analyzed . During this period , the National Osteoporosis Foundation established guiding principles for the treatment of fragility fractures . Results : Of the seventy-five patients from all centers for each year from 1997 to 2000 , 11 % , 13 % , 24 % , and 29 % , respectively , were discharged with a prescription for some medication targeting osteopenia , either supplemental calcium or an antiosteoporotic medication ( estrogen , calcitonin , a bisphosphonate , or raloxifene ) . A trended chi-square analysis of this increase revealed a p value of < 0.001 , indicating that this improvement in treatment was unlikely due to chance alone . Fifty-eight ( 19.3 % ) of the 300 patients in the study received a prescription at the time of discharge . However , forty of these patients ( 13.3 % of the overall group ) received calcium and only eighteen ( 6.0 % of the overall group ) received a medication to actively prevent bone resorption and treat osteoporosis . In addition , no patient underwent a bone density scan while in the hospital . Conclusions : Elderly patients and postmenopausal women who are admitted to the hospital and diagnosed with a low-energy femoral neck fracture have been undertreated for osteoporosis . However , over the four years of the present study , there was a significant increase in the rate of treatment . It is hoped that treatment rates will continue to increase in the future with continued educational efforts Background : Missed opportunities for osteoporosis detection and treatment following fractures , especially in the elderly , are common . Clinical pharmacy specialist ( CPS ) intervention may positively impact this deficiency . Objective : To examine the impact of a CPS-managed intervention to identify , screen , and initiate appropriate osteoporosis pharmacotherapy in elderly patients after an atraumatic fracture . Methods : This was a prospect i ve quality improvement analysis . Hospitalized and ambulatory patients who had a diagnosis of atraumatic fracture between July 2002 through August 2003 but were not on osteoporosis pharmacotherapy were identified by CPSs . Bone mineral density ( BMD ) screening and osteoporosis pharmacotherapy recommendations were made by a CPS when appropriate . Descriptive analyses were performed to determine the proportion of patients initiated on osteoporosis pharmacotherapy or receiving a recommended BMD evaluation . Results : A total of 137 ( 40 inpatient and 97 ambulatory ) female patients were included . The mean ages ± SD of inpatient and ambulatory patients were 83 ± 8 and 70 ± 7 years , respectively . Overall , 50 % ( n = 69 ) of patients either initiated their recommended osteoporosis pharmacotherapy ( 48 % [ n = 19 ] and 30 % [ n = 29 ] of inpatient and ambulatory patients , respectively ) or received a recommended BMD screening ( 42 ambulatory patients were recommended and 50 % [ n = 21 ] completed a BMD test ) . Of the patients who completed a BMD test , 17 ( 81 % ) were osteoporotic . All 17 were initiated on osteoporosis pharmacotherapy . Conclusions : Using a systematic approach to identify patients in need of osteoporosis pharmacotherapy , a CPS-managed intervention result ed in clinical ly meaningful osteoporosis treatment initiation rates Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making . However , there are no structured reporting requirements for studies of this design to assist authors , editors , and readers . The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies . The checklist criteria concerned recruitment , data collection , biases , and data analysis and descriptive issues relevant to study rationale , study population , and generalizability . Two raters independently assessed 49 r and omly selected articles describing stroke research published from 1999 to 2003 in six journals : American Journal of Epidemiology , Journal of Epidemiology and Community Health , Stroke , Annals of Neurology , Archives of Physical Medicine and Rehabilitation , and American Journal of Physical Medicine and Rehabilitation . On average , 17 of the 33 checklist criteria were reported . Criteria describing the study design were better reported than those related to internal validity . No relation was found between study type ( etiologic or prognostic ) or word count and quality of reporting . A flow diagram for summarizing participant flow through a study was developed . Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research Introduction Older patients with fragility fractures are not commonly tested or treated for osteoporosis . Compared to usual care , a previously reported intervention led to 30 % absolute increases in osteoporosis treatment within 6 months of wrist fracture . Our objective was to examine longer-term outcomes , reproducibility , and cost-effectiveness of this intervention . Methods We conducted an extended analysis of a non-r and omized controlled trial with blinded ascertainment of outcomes that compared a multifaceted intervention to usual care controls . Patients > 50 years with a wrist fracture treated in two Emergency Departments in the province of Alberta , Canada were included ; those already treated for osteoporosis were excluded . Overall , 102 patients participated in this study ( 55 intervention and 47 controls ; median age : 66 years ; 78 % were women ) . The interventions consisted of faxed physician reminders that contained osteoporosis treatment guidelines endorsed by opinion leaders and patient counseling . Controls received usual care ; at 6-months post-fracture , when the original trial was completed , all controls were crossed-over to intervention . The main outcomes were rates of osteoporosis testing and treatment within 6 months ( original study ) and 1 year ( delayed intervention ) of fracture , and 1-year persistence with treatments started . From the perspective of the healthcare payer , the cost-effectiveness ( using a Markov decision-analytic model ) of the intervention was compared with usual care over a lifetime horizon . Results Overall , 40 % of the intervention patients ( vs. 10 % of the controls ) started treatment within 6 months post-fracture , and 82 % ( 95%CI : 67–96 % ) had persisted with it at 1-year post-fracture . Delaying the intervention to controls for 6 months still led to equivalent rates of bone mineral density ( BMD ) testing ( 64 vs. 60 % in the original study ; p = 0.72 ) and osteoporosis treatment ( 43 vs. 40 % ; p = 0.77 ) as previously reported . Compared with usual care , the intervention strategy was dominant – per patient , it led to a $ 13 Canadian ( U.S. $ 9 ) cost savings and a gain of 0.012 quality -adjusted life years . Base-case results were most sensitive to assumptions about treatment cost ; for example , a 50 % increase in the price of osteoporosis medication led to an incremental cost-effectiveness ratio of $ 24,250 Canadian ( U.S. $ 17,218 ) per quality -adjusted life year gained . Conclusions A pragmatic intervention directed at patients and phys OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Applying different numerator and denominator combinations meant that the same observed number of patients could have result ed in different reported rates .

MS2_fixed_5_shot289

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Study Design A prospect i ve cohort study nested in a r and omized controlled trial . Objectives To determine and compare responsiveness and minimal clinical ly important change of the modified Constant score ( CS ) and the Oxford Shoulder Score ( OSS ) . Background The OSS and the CS are commonly used to assess shoulder outcomes . However , few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinical ly important change . Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after arthroscopic decompression surgery for subacromial impingement syndrome . The assessment at baseline and at 3 months included the OSS , the CS , and the European Quality of Life-5 Dimensions-3 Level ( EQ-5D-3L ) index . Responsiveness was assessed as follows : by correlation analysis between the change scores of the OSS , CS , and EQ-5D-3L index , and the Patient Global Impression of Change ( PGIC ) scale ; by receiver-operating-characteristic ( ROC ) curve analysis using the PGIC scale as an external anchor ; and by effect-size statistics . Results At 3 months , a follow-up assessment of 112 patients ( 89 % ) was conducted . The change scores of the CS and the OSS were more strongly correlated with the external anchor ( PGIC scale ) than the change score of the EQ-5D-3L index . The areas under the ROC curves exceeded 0.80 for both shoulder scores , with no significant differences between them , and comparable effect-size estimates were observed for the CS and the OSS . Minimal clinical ly important change ROC values were 6 points for the OSS and 11 points for the CS , with upper 95 % cutoff limits of 12 and 22 points , respectively . Conclusion The CS and the OSS were both suitable for assessing improvement after decompression surgery INTRODUCTION This prospect i ve cohort study in consecutive shoulder patients sought to determine the minimal , clinical ly important difference of the Danish version of the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire and to evaluate patient responsiveness to it . The study was undertaken at the Outpatient Clinic of the Department of Orthopaedic Surgery , Viborg Regional Hospital , Denmark . MATERIAL AND METHODS During clinical examination , patients completed a baseline question naire including the DASH question naire , the EuroQol-5D index and the EuroQol-VAS . A follow-up question naire concerning the patient 's global impression of change was posted to the patients eight to nine weeks after the initial assessment . Responsiveness was analysed by correlation analysis and receiver-operating characteristic curve statistics . Using the optimal cut-off point of the receiver-operating characteristic curve , the minimal , clinical ly important difference was determined . RESULTS A total of 81 patients with a variety of shoulder diagnoses were included . Only the DASH question naire demonstrated significant differences in change scores ( p = 0.001 ) . The area under the curve was 0.76 ( 95 % confidence interval 0.62 - 0.90 ) , and a minimal clinical ly important difference of 12 points was found . CONCLUSION The DASH question naire provides a response outcome measure in Danish-speaking orthopaedic shoulder patients . FUNDING This work was supported by the Regional Hospital of Central Jutl and Research Foundation . TRIAL REGISTRATION not relevant Background Subacromial pain syndrome ( SPS ) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability . Evidence suggests that structured physiotherapy may be as effective as surgery in this condition with significant improvements demonstrated in trials involving scapular retraining , rotator cuff strengthening and flexibility exercises . Most published programs typically utilise isotonic concentric and /or eccentric strengthening modes . Recently , immediate analgesic effects and muscle strength gains following heavy-load isometric exercises in lower limb tendinopathy conditions have been observed . It is pertinent to ascertain whether such outcomes can be replicated in SPS/rotator cuff tendinopathy . The primary aim of this study is to establish the feasibility of undertaking a full-scale r and omised controlled trial ( RCT ) that compares the effects of isometric , isotonic concentric and isotonic eccentric rotator cuff contractions when used as part of a semi-st and ardised exercise-based physiotherapy program in patients diagnosed with SPS . The secondary aim is to explore potential trends or treatment effects of the exercise intervention . Methods Thirty-six participants diagnosed with SPS will be r and omised to one of three intervention groups and undergo a one-on-one exercise-based physiotherapy intervention , involving scapular and rotator cuff muscle retraining and strengthening . Each group will utilise a different mode of rotator cuff strengthening — isometric , isotonic concentric or isotonic eccentric . Rotator cuff tendon responses to isometric loading are not yet established in the literature ; hence , individualised , progressive loading will be used in this pilot study in accordance with symptoms . The intervention will involve two phases : during Phase 1 ( weeks 1–6 ) participants undertake the active group-specific physiotherapy treatment ; in Phase 2 ( weeks 6–12 ) , they undertake a progressive , but no longer group-specific exercise program . To determine feasibility , an evaluation of key study parameters including ( a ) ease of recruitment ( rate and number as well as suitability of the assessment algorithm ) , ( b ) adherence to all phases of the exercise intervention including home program compliance and logbook completion , ( c ) participant non-completion ( drop out number and rate ) and ( d ) adverse events ( nature and number ) will be undertaken . Secondary outcomes will measure immediate effects : ( i ) within-treatment changes in pain perception ( verbal rating scale ( VRS ) and shoulder muscle strength ( h and -held dynamometer ) as well as longer-term changes : ( ii ) shoulder-related symptoms and disability ( Western Ontario Rotator Cuff Index ( WORC ) and Shoulder Pain and Disability Index ( SPADI ) ) , ( iii ) perception of pain ( 11-point numerical rating scale ( NRS ) , ( iv ) shoulder muscle strength ( h and -held dynamometer ) and ( v ) perceived global rating of change score . The immediate within-treatment assessment of pain and muscle strength will be undertaken in treatments 2 and 3 , and the longer term measures will be collected at the primary ( conclusion of Phase 1 at 6 weeks ) and secondary ( conclusion of Phase 2 at 12 weeks ) end-points of the study . Discussion The findings of this pilot study will permit evaluation of this study design for a full-scale RCT .Trial registration Australian New Zeal and Clinical Trials Registry , In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials # # # What you need to know What is the role of arthroscopic surgery in degenerative knee disease ? An expert panel produced these recommendations based on a linked systematic review triggered by a r and omised trial published in The BMJ in June 2016 , which found that , among patients with a degenerative medial meniscus tear , knee arthroscopy was no better than exercise therapy . The panel make a strong recommendation against arthroscopy for degenerative knee disease . Box 1 shows all of the articles and evidence linked in this Rapid Recommendation package . The infographic provides an overview of the absolute benefits and harms of arthroscopy in st and ard GRADE format . Table 1 below shows any evidence that has emerged since the publication of this article . Box 1 # # # Linked articles in this BMJ Rapid Recommendations Background The aim of this study was to assess the psychometric properties , namely acceptability , validity , reliability , interpretability and responsiveness of the EuroQol EQ-5D ( EQ-5D visual analogue ( VAS ) and EQ-5D ( utility ) ) , Short Form 12 Dimensions ( SF-12 ) , SF-6D and Michigan H and Outcome Question naire ( MHQ ) in patients with rheumatoid arthritis ( RA ) of the h and . Methods The empirical investigation was based upon data from a r and omised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the h and s and /or wrists . Participants completed the EQ-5D , SF-12 and MHQ at baseline and at 4 and 12 months follow up . Acceptability was measured using completion rates over time ; construct validity using the “ known groups ” approach , based on pain troublesomeness ; convergent validity using spearman ’s rho correlation ( ρ ) ; reliability using internal consistency ( Cronbach ’s alpha ) ; interpretability using minimal important differences ( MID ) ; and responsiveness using effect sizes and st and ardised response means ( SRM ) stratified by level of self-rated improvement in h and and wrist function or level of self-rated benefit and satisfaction from trial treatments . Results At baseline , the study population had a mean age of 62.4 years , a mean MHQ score of 52.1 and included 76 % women . The EQ-5D ( utility ) had the highest completion rates across time points . All instruments discriminated between pre-specified groups based on pain troublesomeness . Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D ( ρ = 0.65 ) and SF-6D ( ρ = 0.63 ) utility scores . The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months , whilst minimal important differences varied considerably across PROMs . Conclusions The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the h and . The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purpose Background : Dysfunction in the kinetic chain caused by poor scapula stabilization can contribute to shoulder injuries and Shoulder Impingement Syndrome ( SIS ) . The purpose of this study was to compare the effectiveness of two treatment approaches scapular stabilization based exercise therapy and physical therapy in patients with SIS . Methods : The study is a r and omized clinical trial in which 68 patients with SIS were r and omly assigned in two groups of exercise therapy ( ET ) and physical therapy ( PT ) and received 18 sessions of treatment . Pain , shoulders ' range of abduction and external rotation , shoulder protraction , scapular rotation and symmetry as well as postural assessment and Pectoralis minor length were evaluated pre and post intervention . The paired- sample t test and the independent sample t test were applied respectively to determine the differences in each group and between two groups . Results : Our findings indicated significant differences in abduction and external rotation range , improvement of forward shoulder translation and increase in the flexibility of the involved shoulder between the two groups ( respectively ; p=0.024 , p=0.001 , p<0/0001 , p<0/0001 ) . No significant difference was detected in pain reduction between the groups ( p=0.576 ) . Protraction of the shoulder ( p<0.0001 ) , forward head posture ( p<0/0001 ) and mid thoracic curvature ( p<0.0001 ) revealed a significant improvement in the ET group . Apparent changes occurred in scapular rotation and symmetry in both groups but no significant differences were observed between the two groups ( respectively ; p=0.183 , p=0.578 ) . Conclusion : The scapular stabilization based exercise intervention was successful in increasing shoulder range , decreasing forward head and shoulder postures and Pectoralis minor flexibility Abstract Purpose : Investigate test -- retest reliability and validity of five shoulder outcome measures in people during their active rehabilitation after a shoulder fracture . Method : This prospect i ve longitudinal study assessed shoulder function in 20 people ( 16 women , mean age 68.1 years ) with surgical or conservative management at 6 , 12 and 13 weeks post proximal humeral fracture using three patient-reported ( Disabilities of Arm , Shoulder and H and ; Oxford Shoulder Score ; Subjective Shoulder Value ) and two clinician-administered ( Constant Score ; UCLA Shoulder score ) outcome measures . Results : Content analysis categorised items into multiple domains of functioning for each outcome measure . Construct validity testing between measures found moderate to strong correlations ( r = 0.43–0.92 ) . Longitudinal validity ( responsiveness ) , represented by correlations between change scores , was moderate to strong ( r = 0.44–0.83 ) . Although ICCs2,1 for test – retest reliability ranged from 0.75 to 0.93 , Limits of Agreement between measurements were relatively wide ( 10–23 % of available range of scores ) . Minimal clinical ly important difference estimates varied between anchor- and distribution-based methods . Conclusions : The five outcome measures assessing shoulder function provided values for reliability and validity that meet measurement requirements for use in groups of people after a proximal humeral fracture . However , the use of these outcome measures might be limited by low absolute agreement between measurements and their content covering multiple domains of functioning . Implication s for Rehabilitation Linking the International Classification of Functioning , Disability and Health ( ICF ) to the content of common shoulder function outcome measures showed that multiple domains of functioning OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Our review provides anchor-based MID estimates , as well as a rating of their credibility , for PROMs for patients with shoulder conditions . The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain , and could also prove useful for authors addressing other interventions for shoulder problems .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Background : Many foods and nutrients have been suggested to influence life expectancy . However , previous studies have not examined the relationship between dietary patterns and cause-specific mortality . Our study prospect ively examines the relationship of dietary patterns with total mortality and cause-specific mortality in a population -based cohort study of Chinese women . Methods : The Shanghai Women 's Health Study is a population -based cohort study of 74,942 women age 40 to 70 years at the time of recruitment ( September 1996 to May 2000 ) . Detailed dietary information was collected using a vali date d , quantitative food frequency question naire . The cohort has been followed using a combination of in-person interviews and record linkage with various registries . Dietary patterns , derived from principal component analysis , were examined for their relation to total mortality and cause-specific mortality using Cox regression models . Results : After an average of 5.7 years of follow-up ( 423,717 person-years of observation ) , there were 1565 deaths . We derived 3 major dietary patterns ( vegetable-rich , fruit-rich , and meat-rich ) . The adjusted hazard ratios for the fruit-rich diet were 0.94 ( 95 % CI = 0.89–0.98 ) for all causes of death and 0.89 ( 0.81–0.99 ) , 0.79 ( 0.69–0.91 ) , and 0.51 ( 0.39–0.65 ) for death caused by cardiovascular disease , stroke , and diabetes , respectively . The meat-rich diet was associated with increased risk of diabetes ( HR = 1.18 ; 95 % CI = 0.98–1.42 ) and a slightly elevated risk of total mortality . Conclusion : In general , a fruit-rich diet was related to lower mortality , whereas a meat-rich diet appeared to increase the probability of death OBJECTIVE The objective of this study was to determine whether cinnamon improves blood glucose , triglyceride , total cholesterol , HDL cholesterol , and LDL cholesterol levels in people with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 60 people with type 2 diabetes , 30 men and 30 women aged 52.2 + /- 6.32 years , were divided r and omly into six groups . Groups 1 , 2 , and 3 consumed 1 , 3 , or 6 g of cinnamon daily , respectively , and groups 4 , 5 , and 6 were given placebo capsules corresponding to the number of capsules consumed for the three levels of cinnamon . The cinnamon was consumed for 40 days followed by a 20-day washout period . RESULTS After 40 days , all three levels of cinnamon reduced the mean fasting serum glucose ( 18 - 29 % ) , triglyceride ( 23 - 30 % ) , LDL cholesterol ( 7 - 27 % ) , and total cholesterol ( 12 - 26 % ) levels ; no significant changes were noted in the placebo groups . Changes in HDL cholesterol were not significant . CONCLUSIONS The results of this study demonstrate that intake of 1 , 3 , or 6 g of cinnamon per day reduces serum glucose , triglyceride , LDL cholesterol , and total cholesterol in people with type 2 diabetes and suggest that the inclusion of cinnamon in the diet of people with type 2 diabetes will reduce risk factors associated with diabetes and cardiovascular diseases BACKGROUND & AIMS Multiple studies have evaluated the hypoglycemic effect of cinnamon in patients with diabetes mellitus ( DM ) type II , with conflicting results . Differences in Baseline Body Mass Index ( BMI ) of patients may be able to explain the observed differences in the results . This study was design ed to evaluate the effect of cinnamon supplementation on anthropometric , glycemic and lipid outcomes of patients with DM type II based on their baseline BMI . METHODS The study was design ed as a triple-blind placebo-controlled r and omized clinical trial , using a parallel design . One hundred and forty patients referred to Diabetes Clinic of Yazd University of Medical Sciences with diagnosis of DM type II were r and omly assigned in four groups : cinnamon ( BMI ≥ 27 , BMI < 27 ) and Placebo ( BMI ≥ 27 , BMI < 27 ) . Patients received cinnamon bark powder or placebo in 500 mg capsules twice daily for 3 months . Anthropometric , glycemic and lipid outcomes were measured before and after the intervention . RESULT Cinnamon supplementation led to improvement of all anthropometric ( BMI , body fat , and visceral fat ) , glycemic ( FPG , 2hpp , HbA1C , Fasting Insulin , and Insulin Resistance ) , and lipids ( Cholesterol Total , LDL-c and HDL-c ) outcomes ( except for triglycerides level ) . All observed changes ( except for Cholesterol Total and LDL-c ) were significantly more prominent in patients with higher baseline BMI ( BMI ≥ 27 ) . CONCLUSION Based on the study findings , cinnamon may improve anthropometric parameters , glycemic indices and lipid profile of patients with type II diabetes . These benefits are significantly more prominent in patients with higher baseline BMI ( BMI ≥ 27 ) . The trial protocol was registered in Iranian Registry of Clinical Trials data base ( registration ID : I RCT 2017031133015N1 ) Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more AIMS Various spices display insulin-potentiating activity in vitro , and in particular , cinnamon spice and its phenolic extracts have been shown to exhibit these capabilities . In vivo study shows that cinnamon may have beneficial effects on glucose homeostasis ; therefore the aim of this study was to further investigate this phenomenon in humans . METHODS Seven lean healthy male volunteers , aged 26 + /- 1 years , body mass index 24.5 + /- 0.3 kg/m(2 ) ( mean + /- s.e.m . ) , underwent three oral glucose tolerance tests ( OGTT ) supplemented with either a 5 g placebo ( OGTT(control ) ) , 5 g of cinnamon ( OGTT(cin ) ) , or 5 g of cinnamon taken 12 h before ( OGTT(cin12hpre ) ) in a r and omized-crossover design . RESULTS Cinnamon ingestion reduced total plasma glucose responses ( AUC ) to oral glucose ingestion [ -13 % and -10 % for OGTT(cin ) ( p < 0.05 ) and OGTT(cin12hpre ) ( p < 0.05 ) , respectively ] , as well as improving insulin sensitivity as assessed by insulin sensitivity index measures based on Matsuda 's model in both OGTT(cin ) ( p < 0.05 ) and OGTT(cin12hpre ) ( p < 0.05 ) trials compared with OGTT(control ) . CONCLUSIONS These data illustrate that cinnamon spice supplementation may be important to in vivo glycaemic control and insulin sensitivity in humans , and not only are its effects immediate , they also appear to be sustained for 12 Cinnamon ( 肉桂 ròu guì ) has in vitro insulin potentiating activity , and proanthocyanidins from cinnamon prevent in vitro formation of advanced glycation end products . Some human studies were equivocal , but several have shown beneficial effects of cinnamon supplementation on circulating glucose , lipids , and /or insulin . This placebo-controlled double-blind trial tested the effects of a dried water extract of cinnamon ( Cinnamomum cassia ) on circulating glucose , lipids , insulin , and insulin resistance . Men and women from Beijing and Dalian , China , were invited to participate if they had fasting serum glucose > 6.1 mmol/L or 2-h glucose > 7.8 mmol/L. Participants , ( 173 were enrolled and 137 completed the study ) were r and omly assigned to receive either a spray-dried , water extract of cinnamon ( CinSulin ® ) , 250 mg/capsule , or a placebo , twice a day for two months . Mean ± SEM age of participants was 61.3 ± 0.8 years , BMI was 25.3 ± 0.3 and M/F ratio was 65/72 . After 2 mo , fasting glucose decreased ( p < 0.001 ) in the cinnamon extract-supplemented group ( 8.85 ± 0.36 to 8.19 ± 0.29 mmol/L ) compared with the placebo group ( 8.57 ± 0.32 to 8.44 ± 0.34 mmol/L , p = 0.45 ) . Glucose 2 h after a 75 g carbohydrate load , fasting insulin , and HOMA-IR also decreased with cinnamon extract compared with placebo . Total and LDL-cholesterol decreased with cinnamon extract and HDL-cholesterol decreased in both the cinnamon-extract and placebo groups . In conclusion , supplementation with 500 mg of water-extract of cinnamon for two months reduced fasting insulin , glucose , total cholesterol , and LDL cholesterol and enhanced insulin sensitivity of subjects with elevated blood glucose Objective : Type 2 diabetes is the most common metabolic disorder worldwide . Traditional herbs and spices can be used to control blood glucose concentrations . The objective of this study was to evaluate the effects of the daily intake of three grams cinnamon over eight weeks on glycemic status , lipid profiles and body composition in type 2 diabetic patients . Methods : A double blind , r and omized , placebo controlled clinical trial was conducted on 44 patients with type 2 diabetes . Participants were r and omly assigned to take either a three g/day cinnamon supplement ( n=22 ) or a placebo ( n=22 ) for eight weeks . Weight , height , body fat mass and systolic and diastolic blood pressure were measured at baseline and after intervention . The fasting blood glucose , insulin , HbA1c , total cholesterol , LDL C , HDL C , Apo lipoprotein A I and B were measured at baseline and endpoint . Results : From 44 subjects participated in this study 37 completed the study . There were no significant differences in baseline characteristics , dietary intake and physical activity between groups . In the treatment group , the levels of fasting blood glucose , HbA1c , triglyceride , weight , BMI and body fat mass decreased significantly compared to baseline , but not in placebo group . No significant differences were observed in glycemic status indicators , lipid profile and anthropometric indicators between the groups at the end of intervention . Conclusion : These data suggest that cinnamon may have a moderate effect in improving glycemic status indicators For thous and s of years , cinnamon has been used as a traditional treatment in China . However , there are no studies to date that investigate whether cinnamon supplements are able to aid in the treatment of type 2 diabetes in Chinese subjects . We hypothesized cinnamon should be effective in improving blood glucose control in Chinese patients with type 2 diabetes . To address this hypothesis , we performed a r and omized , double-blinded clinical study to analyze the effect of cinnamon extract on glycosylated hemoglobin A(1c ) and fasting blood glucose levels in Chinese patients with type 2 diabetes . A total of 66 patients with type 2 diabetes were recruited and r and omly divided into 3 groups : placebo and low-dose and high-dose supplementation with cinnamon extract at 120 and 360 mg/d , respectively . Patients in all 3 groups took gliclazide during the entire 3 months of the study . Both hemoglobin A(1c ) and fasting blood glucose levels were significantly reduced in patients in the low- and high-dose groups , whereas they were not changed in the placebo group . The blood triglyceride levels were also significantly reduced in the low-dose group . The blood levels of total cholesterol , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol , and liver transaminase remained unchanged in the 3 groups . In conclusion , our study indicates that cinnamon supplementation is able to significantly improve blood glucose control in Chinese patients with type 2 diabetes Experimental and some clinical evidence suggests that ingestion of cinnamon may improve metabolic measures in individuals with diabetes ; however , few human studies have been design ed to examine this association as their primary objective . In this study adult subjects 30 years of age or older with type 2 diabetes were r and omized to treatment with 1,200 mg/day cinnamon or matched placebo . Blood pressure , hemoglobin A1c , fasting blood glucose , lipid profile , physical examination , and blood and urine chemistry were measured at baseline and at the 12-week follow-up end-of-treatment visit . In total , 59 subjects ( 40.7 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The cinnamon administrations significantly reduced FM at the dosages of ≥2 g/d , when administered for ≥12 weeks . Cinnamon administration result ed in BW and WC reduction in non-linear fashion ( P = 0.04 ) . Cinnamon supplementation significantly affects obesity measures .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: One hundred twenty patients undergoing coronary artery surgery completed a r and omized controlled study design ed to investigate whether prophylactic chest physiotherapy affected the incidence of postoperative pulmonary complications . Group 1 patients received no preoperative or postoperative chest physiotherapy . Group 2 patients received preoperative education and instruction in breathing and coughing exercises and postoperative supervision and assistance in performing the same . These exercises were supervised by a physiotherapist twice per day on the first 2 postoperative days and once per day on the 3rd and 4th postoperative days . Physiotherapy for group 3 patients was the same as for group 2 patients except that patients were seen by a physiotherapist 4 times per day on the first 2 postoperative days and twice per day on the 3rd and 4th postoperative days . Group 2 and 3 patients were instructed to practice breathing and coughing exercises every hour . Overall , an incidence of clinical ly significant postoperative pulmonary complications of 7.5 percent was demonstrated . In general , these patients demonstrated lower levels of preoperative pulmonary function and very low early postoperative oxygenation compared with those who did not develop pulmonary complications . There was no indication that the incidence or severity of fever , hypoxemia , chest roentgenologic abnormalities or clinical ly significant postoperative pulmonary complications was different between groups . These results suggest that the necessity for prophylactic chest physiotherapy after routine coronary artery surgery should be review ed The prediction of postoperative pulmonary complications is an underinvestigated field . We conducted a prospect i ve cohort study ( with postoperative pulmonary complications ascertained by an investigator blinded to perioperative variables ) to determine the risk factors for pulmonary complications after elective nonthoracic surgery . Of 1,055 consecutive patients attending the Pre-Admission Clinic of a university hospital ( mean age 55 years , 50 % men , 15 % with history of obstructive airways disease ) , 28 ( 2.7 % ) suffered a postoperative pulmonary complication within 7 days of surgery : 13 patients developed respiratory failure requiring ventilatory support , 9 pneumonia , 5 atelectasis requiring bronchoscopic intervention , and 1 pneumothorax requiring intervention . Mean lengths of stay were substantially prolonged for those patients who developed pulmonary complications within 7 days of surgery : 27.9 days versus 4.5 days , p = 0.006 . Eight variables were statistically significantly associated with pulmonary complications on bivariate analyses . Multivariate analyses revealed that four were independently associated with increased risk of pulmonary complications : age ( odds ratio [ OR ] 5.9 for age > /= 65 years , p < 0.001 ) , positive cough test ( OR 3.8 , P = 0.01 ) , perioperative nasogastric tube ( OR 7.7 , p < 0.001 ) , and duration of anesthesia ( OR 3.3 for operations lasting at least 2.5 hours , p = 0.008 ) . Thus , several perioperative factors predict an increased risk for pulmonary complications after elective nonthoracic surgery Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials The role of pre-operative short-term pulmonary rehabilitation in patients with chronic obstructive pulmonary disease who undergo coronary artery bypass graft surgery has been assessed for the first time prospect ively . Forty-five patients posted for coronary artery bypass graft surgery were r and omised to receive either short-term pulmonary rehabilitation ( group I ) or no such programme ( group II ) . Patients of both the groups were evenly matched with respect to age , sex , body surface area , duration and severity of chronic obstructive pulmonary disease and coronary artery disease . Normal individuals who evenly matched with the study group were assessed for normal respiratory function parameters . Pre-operative and post-operative peak expiratory flow rate , inspiratory capacity , post-operative ventilation time , post-operative pulmonary complication and hospital stay were determined in both the groups . Peak expiratory flow rate ( 220.0 + /- 12.9 and 324.3 + /- 84.3 in group I , 218.0 + /- 16.4 and 260.5 + /- 35.2 in group II ) and inspiratory capacity ( 844.0 + /- 147.4 and 1100.0 + /- 158.1 in group I , 830.0 + /- 117.4 and 1090 + /- 137 in group II ) were significantly lower before and after surgery respectively in both groups compared to normal values . Even though both groups showed a significant rise in post-operative peak expiratory flow rate and inspiratory capacity after surgery , the post-operative peak expiratory flow rate and inspiratory capacity in group I was significantly higher than in group II . In group I , the post-operative ventilation time ( 24.5 + /- 6.00 hours ) , post-operative complications ( n = 4 ) and hospital stay ( 12.4 + /- 3.6 days ) were significantly lower than in group II ( 35.2 + /- 22.3 hours , n = 11 , 18.8 + /- 6.6 days respectively ) . These data suggest that short-term pulmonary rehabilitation is feasible and effective in improving pulmonary functions before and after surgery and in reducing surgical morbidity and cost of medical care significantly BACKGROUND Peak oxygen uptake ( Vo(2peak ) ) strongly predicts mortality in cardiac patients . We compared the effects of aerobic interval training ( AIT ) versus moderate continuous training ( MCT ) on Vo(2peak ) and quality of life after coronary artery bypass grafting ( CABG ) . METHODS Fifty-nine CABG patients were r and omized to either AIT at 90 % of maximum heart rate or MCT at 70 % of maximum heart rate , 5 d/wk , for 4 weeks at a rehabilitation center . Primary outcome was Vo(2peak ) , at baseline , after rehabilitation ( 4 weeks ) , and after 6 months of home-based exercise ( 6 months ) . RESULTS Vo(2peak ) increased between baseline and 4 weeks in AIT ( 27.1 + /- 4.5 vs 30.4 + /- 5.5 mL.kg(-1).min(-1 ) , P < .001 ) and MCT ( 26.2 + /- 5.2 vs 28.5 + /- 5.6 mL.kg(-1).min(-1 ) , P < .001 ; group difference , not significant ) . Aerobic interval training increased Vo(2peak ) between 4 weeks and 6 months ( 30.4 + /- 5.5 vs 32.2 + /- 7.0 mL.kg(-1).min(-1 ) , P < .001 ) , with no significant change in MCT ( 28.5 + /- 5.6 vs 29.5 + /- 5.7 mL.kg(-1).min(-1 ) ) . Quality of life improved in both groups from baseline to 4 weeks , remaining improved at 6 months . There were no changes in echocardiographic systolic and diastolic left ventricular function . Adiponectin increased between 4 weeks and 6 months in both groups ( group differences , not significant ) . CONCLUSIONS Four weeks of intense training increased Vo(2peak ) significantly after both AIT and MCT . Six months later , the AIT group had a significantly higher Vo(2peak ) than MCT . The results indicate that AIT and MCT increase Vo(2peak ) similarly in the short term , but with better long-term effect of AIT after CABG BACKGROUND The impact of short-term preoperative pulmonary rehabilitation on exercise capacity of patients with chronic obstructive pulmonary disease undergoing lobectomy for non-small cell lung cancer is evaluated . METHODS A prospect i ve observational study was design ed . Inclusion criteria consisted of an indication to lung resection because of a clinical stage I or II non-small cell lung cancer and a chronic obstructive disease on preoperative pulmonary function test . In such conditions , maximal oxygen consumption by a cardio-pulmonary exercise test was evaluated ; when this result ed as being < or = 15 ml/kg/min a pulmonary rehabilitation programme lasting 4 weeks was considered . Twelve patients fulfilled inclusion criteria , completed the preoperative rehabilitation programme and underwent a new functional evaluation prior to surgery . The postoperative record of these patients was collected . RESULTS On completion of pulmonary rehabilitation , the resting pulmonary function test and diffuse lung capacity of patients was unchanged , whereas the exercise performance was found to have significantly improved ; the mean increase in maximal oxygen consumption proved to be at 2.8 ml/kg/min ( p<0.01 ) . Eleven patients underwent lobectomy ; no postoperative mortality was noted and mean hospital stay was 17 days . Postoperative pulmonary complication was recorded in 8 patients . CONCLUSIONS Short-term preoperative pulmonary rehabilitation could improve the exercise capacity of patients with chronic obstructive pulmonary disease who are c and i date s for lung resection for non-small cell lung cancer OBJECTIVE To evaluate the effects of st and ardized western acupuncture and physiotherapy on pain and functional ability in patients with severe osteoarthritic knee pain awaiting knee arthroplasty . METHODS Three-arm , assessor-blind , r and omized controlled trial . PARTICIPANTS 181 patients awaiting knee arthroplasty . INTERVENTIONS acupuncture for 6 weeks ; physiotherapy for 6 weeks ; st and ardized advice . MAIN OUTCOME MEASURES Oxford Knee Score question naire ( OKS ) ( primary ) ; 50 m timed walk , and duration of hospital stay following knee arthroplasty . RESULTS There was no baseline difference between groups . At 7 weeks , there was a 10 % reduction in OKS in the acupuncture group which was a significant difference between the acupuncture and the control group : Mean ( s.d . ) acupuncture 36.8 ( 7.20 ) ; physiotherapy 39.2 ( 8.22 ) ; control 40.3 ( 8.48 ) ( P = 0.0497 ) . These effects were no longer present at 12 weeks . There was a trend ( P = 0.0984 ) towards a shorter in-patient stay of 1 day for the physiotherapy group [ mean 6.50 days ( s.d . 2.0 ) ] compared with the acupuncture group [ mean 7.77 days ( s.d . 3.96 ) ] . CONCLUSIONS We have demonstrated that patients with severe knee osteoarthritis can achieve a short-term reduction in OKS when treated with acupuncture . However , we failed to demonstrate any other clinical ly or statically significant effects between the groups . Both interventions can be delivered effectively in an out-patient group setting at a district general hospital . Further study is needed to evaluate the combined effects of these treatments Backround . The purpose of the trial was to evaluate the effect on length of stay of individually tailored rehabilitation for clients who were undergoing hip or knee arthroplasty . Method . Clients ( n = 133 ) with complex needs ( comorbid conditions or limited social support ) were r and omly assigned to receive preoperative usual care ( UC ) or rehabilitation ( R ) . Usual care clients received a single preoperative clinic visit . Rehabilitation clients were individually assessed and received multi disciplinary rehabilitation to optimize functional capacity , education about the in-hospital phase and early discharge planning . All rehabilitation subjects received interdisciplinary counseling/education focused on preparation for discharge home . The intervention for approximately half the rehabilitation clients was a single , cost-effective session , while others received physical conditioning . Results . Clients receiving rehabilitation achieved discharge criteria earlier ( R = 5.4 , UC = 8 days ) and had a shorter actual length of stay ( R = 6.5 , UC = 10.5 days ) . Clinical Implication s. This preoperative , individually tailored , rehabilitation program reduced length of stay OBJECTIVE We evaluated the usefulness of analyzing expired gas during exercise testing for the prediction of postoperative cardiopulmonary complications in patients with esophageal carcinoma . BACKGROUND DATA Radical esophagectomy with 3-field lymphadenectomy is performed in patients with thoracic esophageal carcinoma but has a high risk of postoperative complications . To reduce the surgical risk , we performed preoperative risk analysis using 8 factors . Although hospital OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Preoperative exercise therapy consisting of inspiratory muscle training or exercise training prior to cardiac or abdominal surgery led to a shorter hospital stay and reduced postoperative complication rates . By contrast , length of hospital stay and complication rates of patients after joint replacement surgery were not significantly affected by preoperative exercise therapy consisting of strength and /or mobility training . Conclusion : Preoperative exercise therapy can be effective for reducing postoperative complication rates and length of hospital stay after cardiac or abdominal surgery .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE Prospect i ve r and omised study comparing patients with atrial fibrillation ( AF ) of more than 6 months duration after mitral valve surgery plus biatrial modified radiofrequency Maze procedure using Medtronic Cardioblate System ( Cardioblate group , n=24 ) vs mitral valve surgery plus intensive rhythm control strategy ( control group , n=25 ) . METHODS Patients were blinded to r and omisation . Preoperatively , at discharge , and at 3-month and 1-year follow-up , echocardiography , quality of life assessment s and ECGs were done . In both groups , sinus rhythm ( SR ) restoration was attempted by intra- and postoperative DC cardioversion and class III antiarrhythmic medication . All patients received warfarin . Amiodarone and warfarin was considered for discontinuation after 3 months in SR , 24-h Holter or event monitor excluding AF . RESULTS Both groups underwent mitral valve replacement or repair ( Cardioblate vs control : 16:8 vs 10:15 ) , had similar gender ( male : 33 % vs 56 % ) , age ( 66+/-8 years vs 68+/-9 years ) , additional aortic valve replacement ( 7 vs 6 patients ) , tricuspid annuloplasty ( 13 vs 13 patients ) , and CABG ( 10 vs 16 patients ) . There was 0 % operative mortality , 0 % postoperative cerebrovascular accidents , but 2 late deaths in the control group . At discharge , 3- and 12-month follow-up , more patients in the Cardioblate group returned to normal SR compared to control ( 29 % , 57 % and 75 % vs 20 % , 43 % and 39 % ; p=0.030 ) . Return of functional atrial contraction in patients in SR at 1 year was comparable between groups ( 63 % vs 89 % , NS ) , and more likely in non-rheumatic pathology and preoperative AF of shorter duration . The effectiveness of atrial contraction was 36+/-14 % vs 43+/-18 % of transmitral flow and there was no difference between groups . Amiodarone treatment decreased more in Cardioblate group over time ( 92 % , 55 % and 29 % vs 52 % , 52 % and 21 % ; p=0.003 ) , whereas warfarin decrease was comparable ( 100 % , 100 % and 71 % vs 100 % , 95 % and 82 % ; NS ) . CONCLUSIONS Radiofrequency Maze ablation additional to mitral valve surgery result ed in a higher SR conversion rate ( 75 % ) , despite control group treatment with intensive rhythm control strategy having a higher SR conversion rate ( 39 % ) compared to literature ( approximately 25 % ) . Maze ablation result ed in normalisation of atrial function in 63 % of patients converted to SR OBJECTIVES Various modifications have been proposed to the original Cox 's Maze procedure due to concerns about the long bypass and cross clamp times . The efficacy of these procedures has been studied and reported . We conducted a r and omised prospect i ve study to compare three procedures , differing in extent , of ablation in patients in atrial fibrillation who were undergoing surgery for rheumatic valvular heart disease . These procedures utilised radiofrequency in the bipolar mode . The extent of ablation was ( 1 ) biatrial ( replication of the Cox Maze ) ( 2 ) left atrial portion of the Cox Maze and ( 3 ) pulmonary vein isolation along with a control group ( the No Maze group ) . Conversion rate to sinus rhythm was studied over a mid-term follow-up period . METHODS A total of 160 patients were studied with 40 patients in each group . Antiarrhythmic drugs were not used in the three months preceding surgery and for seven days postoperatively . The patients underwent surgery for their valve disease along with the ablative procedure as per r and omisation using radiofrequency microbipolar coagulation and cryoablation . They were followed up and were evaluated for symptomatic improvement , rhythm with ECG documentation and 2D echocardiography . RESULTS Follow-up was available for 133 patients . Mid-term results showed that sinus rhythm was restored in 62.5 % patients of Biatrial Maze group and 57.5 % in the Left Atrial Maze . In the Pulmonary Vein Isolation Maze group , 67.5 % patients converted to NSR whereas in the No Maze group only 20 % patients were in sinus rhythm ( p value for all the groups was 0.001 when compared to the No Maze group ) . The incidence of other arrhythmias was not significant and there were no other major complications . All the patients in sinus rhythm at follow-up were in NYHA functional class I-II and showed good effort tolerance . CONCLUSIONS Results achieved with the three ablative procedures are comparable . Therefore lesser procedures viz . Left Atrial Maze and the Pulmonary Vein Isolation Maze procedures must be studied further with the additional use of antiarrhythmic drugs AIMS The efficacy of epicardial left atrial ( LA ) cryoablation in eliminating atrial fibrillation ( AF ) in patients undergoing mitral valve surgery ( MVS ) is unknown . We hypothesized that MVS combined with LA cryoablation is superior to MVS alone . METHODS AND RESULTS Sixty-nine patients with permanent AF , included at four centres , underwent MVS with or without epicardial LA cryoablation . The primary endpoint was regained sinus rhythm . Risk factors for failed AF cryoablation were eluci date d. Sixty-five out of 69 patients reached the primary endpoint . At 6 and 12 months follow-up , 73.3 % of patients who underwent cryoablation had regained sinus rhythm at both follow-ups , compared with 45.7 and 42.9 % of patients , respectively , who underwent MVS alone ( group differences , at 6 months P = 0.024 , after 12 months P = 0.013 ) . The in-hospital complication rate was 11.4 % in the MVS group and 26.5 % in the cryoablation group ( P = 0.110 ) . Risk factors for failed elimination of AF by cryoablation were duration of permanent AF ( P = 0.012 ) and presence of coronary artery disease ( P = 0.047 ) , according to multiple logistic regression analysis . CONCLUSION This first prospect i ve r and omized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone Background —Although the Cox-Maze III procedure is effective for treating permanent atrial fibrillation ( AF ) , its high complexity limits its use . The Saline-Irrigated Cooled-tip Radiofrequency Ablation ( SICTRA ) System is an alternative source of energy used to ablate AF . The aim of this study was to evaluate the effectiveness of the SICTRA for the treatment of permanent AF in patients with rheumatic mitral valve ( MV ) disease . Methods and Results —Between February 2002 and April 2003 , 70 patients with permanent AF and rheumatic MV disease were r and omly assigned to undergo a modified Maze III procedure using SICTRA associated with MV surgery ( group A ) or MV surgery alone ( group B ) . Groups A and B were similar in terms of baseline characteristics . The in-hospital mortality rate was 2.3 % ( 1 death ) in group A versus 0 % ( no deaths ) in group B ( P>0.99 ) . The additional time required for the left-sided radiofrequency ablation in group A was 14.2±5.1 minutes and for right-sided ablation was 12.3±4.2 minutes . The mean postoperative follow-up periods were 13.8±3.4 and 11.5±7.3 months , respectively , in groups A and B. The overall mid-term survival rate was 95.1 % in group A and 92.8 % in group B ( P>0.99 ) . The cumulative rates of sinus rhythm were 79.4 % in group A and 26.9 % in group B ( P=0.001 ) . Doppler echocardiography documented biatrial transport function in 90.3 % of group A patients in sinus rhythm . Conclusions —The SICTRA is effective for treating permanent AF associated with rheumatic MV disease OBJECTIVE Radiofrequency or the use of microwave energy in combination with atrial size reduction during open heart surgery have been reported to be effective in up to 75 % in the treatment of permanent atrial fibrillation . However , no data from prospect i ve r and omized trials using microwave energy are available . METHODS Forty-three patients with permanent atrial fibrillation undergoing open-heart surgery were r and omly stratified into treatment group receiving microwave ablation and atrial size reduction ( n=24 ) or control group ( n=19 ) . Patients in either group were treated with amiodarone or sotalol for 3 months if sinus rhythm or any atrioventricular rhythm was successfully restored . Follow-up time points were at 3 , 6 and 12 month after surgery . RESULTS In the treatment group 22 out of 24 patients ( 91,7 % ) were successfully converted to sinus rhythm by using intraoperative microwave ablation therapy whereas only six out of 19 ( 31.5 % ) patients converted to sinus rhythm directly after surgery . At 12-month follow-up there were still a significantly higher percentage of patients in the treatment group free from atrial fibrillation when compared to control ( 80 vs. 33.3 % , P=0.036 ) . CONCLUSION The preliminary data from this first prospect ively r and omized trial indicate that microwave ablation combined with atrial size reduction is a safe and highly efficient treatment in permanent atrial fibrillation We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 AIMS Our aim was to compare the long-term effects on rhythm and quality of life ( QoL ) after left atrial epicardial radiofrequency ( RF ) ablation vs. no ablation in patients undergoing cardiac surgery . METHODS AND RESULTS Thirty-nine patients with ECG documented atrial fibrillation ( AF ) scheduled for coronary artery bypass grafting ( CABG ) with or without concomitant valve surgery were consecutively elected for epicardial RF ablation . Thirty-nine age- and gender-matched patients scheduled for CABG with or without concomitant valve surgery only and with documented AF served as controls . The follow-up after ablation was 32 + /- 11 months . The percentage of patients in sinus rhythm ( SR ) at long-term follow-up was 62 vs. 33 % ( P = 0.03 ) after ablation and no ablation , respectively . SR at 3 months was highly predictive of that at 32 months ( sensitivity 95 % , positive predictive value 86 % ) . Long-term SR was associated with better QoL , fewer symptoms , higher ejection fraction , and smaller left and right atria than AF . CONCLUSION SR at 3 months was highly predictive of long-term SR that was associated with clinical improvement when compared with patients still in AF . AF at 3 months did not preclude a later stabilization to SR CONTEXT Although left atrial radiofrequency ablation ( RFA ) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery , its efficacy to restore sinus rhythm and any result ing benefits have not been examined in the context of an adequately powered r and omized trial . OBJECTIVE To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003 . A total of 101 patients referred for mitral valve surgery with at least 6 months ' history of uninterrupted atrial fibrillation were assessed for eligibility ; 97 were enrolled . Patients were followed up for 12 months . INTERVENTION Patients were r and omly assigned to undergo mitral valve surgery and RFA of the left atrium ( n = 49 ) or mitral valve surgery alone ( controls ; n = 48 ) . MAIN OUTCOME MEASURES The primary outcome measure was presence of sinus rhythm at 12 months ; secondary measures were patient functional OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Results The consensus panel agreed on the following statements in patients with AF undergoing cardiac surgery concomitant surgical ablation : 1 . Improves the achievement of sinus rhythm at discharge and 1 year ( level A ) ; this effect is sustained up to 5 years ( level B ) . 2 . 3 . Does not increase the risk of perioperative mortality ( level A ) , stroke ( level A ) , myocardial infa rct ion ( level B ) , cardiac tamponade ( level A ) , reoperative bleeding ( level A ) , esophageal injury ( level B ) , low cardiac output ( level A ) , intraaortic balloon ( level B ) , congestive heart failure ( level B ) , ejection fraction ( EF ; level B ) , pleural effusion ( level A ) , pneumonia ( level A ) , renal dysfunction ( level B ) , and mediastinitis ( level A ) . The incidence of esophageal injury remains to be low ( level B ) . 4 . Does not reduce mortality at 1 year ( level A ) . 5 . 6 . Increases cardiopulmonary bypass and cross-clamp times ( level A ) , with no difference in intensive care unit and hospital length of stay ( level A ) . Conclusions Given these evidence -based statements , the consensus panel stated that , in patients with persistent and permanent AF undergoing cardiac surgery , concomitant surgical ablation is recommended to increase incidence of sinus rhythm at short- and long-term follow-up ( class 1 , level A ) ; to reduce the risk of stroke and thromboembolic events ( class 2a , level B ) ; to improve EF ( class 2a , level A ) ; and to exercise tolerance ( class 2a , level A ) and long-term survival ( class 2a , level B )

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Aim Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) . We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation . Methods and results Patients r and omized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = 14 264 ) were grouped by baseline AF category : paroxysmal or persistent . Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) . Of 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF . Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P < 0.0001 ) , and more likely to have previously used vitamin K antagonists ( 64 vs. 56 % , P < 0.0001 ) compared with patients with paroxysmal AF . In patients r and omized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) . Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) . Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) . Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) . Conclusion In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF Aims Uncertainty exists over the importance of device-detected short- duration atrial arrhythmias . Continuous atrial diagnostics , through home monitoring ( HM ) technology ( BIOTRONIK , Berlin , Germany ) , provides a unique opportunity to assess frequency and quantity of atrial fibrillation ( AF ) episodes defined as atrial high-rate events ( AHRE ) . Methods and results Prospect i ve data from 560 heart failure ( HF ) patients ( age 67 ± 10 years , median ejection fraction 27 % ) patients with a cardiac resynchronization therapy ( CRT ) device capable of HM from two multi-centre studies were analysed . Atrial high-rate events burden was defined as the duration of mode switch in a 24-h period with atrial rates of > 180 beats for at least 1 % or total of 14 min per day . The primary endpoint was incidence of a thromboembolic ( TE ) event . Secondary endpoints were cardiovascular death , hospitalization because of AF , or worsening HF . Over a median 370-day follow-up AHRE occurred in 40 % of patients with 11 ( 2 % ) patients developing TE complications and mortality rate of 4.3 % ( 24 deaths , 16 with cardiovascular aetiology ) . Compared with patients without detected AHRE , patients with detected AHRE>3.8 h over a day were nine times more likely to develop TE complications ( P= 0.006 ) . The majority of patients ( 73 % ) did not show a temporal association with the detected atrial episode and their adverse event , with a mean interval of 46.7 ± 71.9 days ( range 0–194 ) before the TE complication . Conclusion In a high-risk cohort of HF patients , device-detected atrial arrhythmias are associated with an increased incidence of TE events . A cut-off point of 3.8 h over 24 h was associated with significant increase in the event rate . Routine assessment of AHRE should be considered with other data when assessing stroke risk and considering anti-coagulation initiation and should also prompt the optimization of cardioprotective HF therapy in CRT patients OBJECTIVE This study was performed to characterize the risk of stroke in elderly patients with recurrent intermittent atrial fibrillation ( AF ) . BACKGROUND Although intermittent AF is common , relatively little is known about the attendant risk of stroke . METHODS A longitudinal cohort study was performed comparing 460 participants with intermittent AF with 1,552 with sustained AF treated with aspirin in the Stroke Prevention in Atrial Fibrillation studies and followed for a mean of two years . Independent risk factors for ischemic stroke were identified by multivariate analysis . RESULTS Patients with intermittent AF were , on average , younger ( 66 vs. 70 years , p < 0.001 ) , were more often women ( 37 % vs. 26 % p < 0.001 ) and less often had heart failure ( 11 % vs. 21 % OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusion Patients with an AHRE burden over 6 min have an increased risk for stroke .

MS2_fixed_5_shot294

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women OBJECTIVE Low vitamin D levels predict the development of diabetes . This double-blind , r and omized , control study in subjects with prediabetes and hypovitaminosis D evaluated whether high doses of vitamin D for 1 year affected insulin secretion , insulin sensitivity , and the development of diabetes . RESEARCH DESIGN AND METHODS A total of 1,551 subjects ≥40 years of age not known to have diabetes were screened with A1C levels . Subjects with A1C levels of 5.8–6.9 % underwent an oral glucose tolerance test ( OGTT ) . Subjects with prediabetes and 25-OH vitamin D ( 25-OHD ) levels < 30 ng/mL were r and omized to receive weekly placebo ( n = 53 ) or vitamin D ( n = 56 ) with doses based on body weight and baseline 25-OHD levels . OGTTs were performed 3 , 6 , 9 , and 12 months later . Insulin secretion and sensitivity were measured , and the proportion of subjects developing diabetes was assessed . RESULTS 25-OHD levels rapidly rose from 22 to nearly 70 ng/mL after vitamin D supplementation with a mean weekly dose of 88,865 IU . There were no differences between the placebo and vitamin D groups regarding fasting plasma glucose , 2-h glucose , or insulin secretion and sensitivity or in the percent developing diabetes or returning to normal glucose tolerance . No subjects experienced increased serum or urinary calcium levels . At 12 months , A1C levels were significantly slightly less ( 0.2 % ) in the vitamin D group . CONCLUSIONS In individuals with prediabetes and hypovitaminosis D , doses of vitamin D supplementation design ed to raise serum 25-OHD levels into the upper-normal range for 1 year had no effect on insulin secretion , insulin sensitivity , or the development of diabetes compared with placebo administration Background It is undetermined whether calcium supplementation has an effect on obesity or body composition in postmenopausal women . The purpose of the study is to detect the effect of calcium supplementation on indices of obesity and body composition . Methods This is a secondary analysis of data from a population -based , double-blind , placebo-controlled , r and omized trial design ed to determine the effects of calcium and vitamin D on osteoporotic fractures . The cohort included 1179 postmenopausal women who were r and omly assigned into one of three groups : 1 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus vitamin D placebo ( Ca-only group ) ; 2 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus supplemental vitamin D3 ( 1100 IU/d ) ( Ca + D group ) ; or , 3 ) two placebos ( placebo group ) . After applying the exclusion criteria for this analysis , 870 subjects were included in this study . The primary outcomes for the present study were changes in body mass index , trunk fat , trunk lean , and percentage of trunk fat after calcium supplementation . Results Changes in trunk fat , trunk lean , and percentage of trunk fat were significantly different between the calcium intervention groups ( Ca-only group or Ca + D group ) and the placebo group during the trial ( P < 0.05 ) . The calcium intervention groups gained less trunk fat and maintained more trunk lean when compared to the placebo group . No significant difference was observed for body mass index between groups . Conclusion Calcium supplementation over four years has a beneficial effect on body composition in postmenopausal women BACKGROUND Adequate calcium intake can have a favorable effect on some metabolic variables . OBJECTIVE The objective of the study was to determine the effects of daily calcium intake and of supplementation with calcium and vitamin D ( calcium+D ) during a weight-loss intervention on blood pressures , plasma lipid and lipoprotein concentrations , and glucose and insulin concentrations in low calcium consumers . DESIGN Healthy , overweight or obese women ( n = 63 ) with a daily calcium intake of < 800 mg/d were r and omly assigned in a double-blind manner to 1 of 2 groups : the group consuming 2 tablets/d of a calcium + vitamin D supplement ( 600 mg elemental calcium and 200 IU vitamin D/tablet ) or the group consuming placebo ; both groups observed a 700 kcal/d energy restriction . These 63 women then completed a 15-wk weight-loss intervention . RESULTS Initial daily calcium intake was significantly correlated with plasma HDL cholesterol ( r = 0.41 , P < 0.001 ) and with 2-h postload glycemia ( r = -0.29 , P < 0.05 ) during an oral-glucose-tolerance test , independent of fat mass and waist circumference . After the 15-wk intervention , significantly greater decreases in total : LDL and LDL : HDL ( P < 0.01 for both ) and of LDL cholesterol ( P < 0.05 ) were observed in the calcium+D group than in the placebo group . The differences in total : HDL and LDL : HDL were independent of changes in fat mass and in waist circumference . A tendency for more beneficial changes in HDL cholesterol , triacylglycerol , and total cholesterol was also observed in the calcium+D group ( P = 0.08 ) . CONCLUSION Consumption of calcium+D during a weight-loss intervention enhanced the beneficial effect of body weight loss on the lipid and lipoprotein profile in overweight or obese women with usual low daily calcium intake BACKGROUND Changes in body composition in men and women occur with age , but these changes are affected by numerous covariate factors . OBJECTIVE The study examined patterns of change in body composition and determined the effects of long-term patterns of change in physical activity in older men and women and in menopausal status and estrogen use in women . DESIGN Serial measures of height , weight , body mass index ( BMI ) , total body fat ( BF ) , percentage BF , and fat-free mass ( FFM ) from underwater weighing of 102 men and 108 women enrolled in the Fels Longitudinal Study were analyzed . Physical activity levels and menopausal status were included as covariates . RESULTS There were significant age-related decreases in FFM and height and increases in total BF , percentage BF , weight , and BMI . Physical activity was associated with decreases in total BF , percentage BF , weight , and BMI in men and were associated with increases in FFM and decreases in total BF and percentage BF in women . Postmenopausal women had significantly higher total BF and percentage BF than did pre- and perimenopausal women . The longer the time since menopause the greater were the increases in weight , BMI , total BF , and percentage BF ; however , estrogen use attenuated these increases . CONCLUSIONS Low FFM can be improved by increased physical activity . The effects of an intervention program on body composition can be masked if only body weight or BMI is measured . The effects of physical activity were more profound in postmenopausal than in premenopausal women , and estrogen use had beneficial effects on body composition BACKGROUND Ergocalciferol ( vitamin D(2 ) ) supplementation plays a role in fall prevention , but the effect in patients living in the community in sunny climates remains uncertain . We evaluated the effect of ergocalciferol and calcium citrate supplementation compared with calcium alone on the risk of falls in older women at high risk of falling . METHODS A 1-year population -based , double-blind , r and omized controlled trial of 302 community-dwelling ambulant older women aged 70 to 90 years living in Perth , Australia ( latitude , 32 degrees S ) , with a serum 25-hydroxyvitamin D concentration of less than 24.0 ng/mL and a history of falling in the previous year . Participants were r and omized to receive ergocalciferol , 1000 IU/d , or identical placebo ( hereinafter , ergocalciferol and control groups , respectively ) . Both groups received calcium citrate , 1000 mg/d . Fall data were collected every 6 weeks . RESULTS Ergocalciferol therapy reduced the risk of having at least 1 fall over 1 year after adjustment for baseline height , which was significantly different between the 2 groups ( ergocalciferol group , 53.0 % ; control group , 62.9 % ; odds ratio [ OR ] , 0.61 ; 95 % confidence interval [ CI ] , 0.37 - 0.99 ) . When those who fell were grouped by the season of first fall or the number of falls they had , ergocalciferol treatment reduced the risk of having the first fall in winter and spring ( ergocalciferol group , 25.2 % ; control group , 35.8 % ; OR , 0.55 ; 95 % CI , 0.32 - 0.96 ) but not in summer and autumn , and reduced the risk of having 1 fall ( ergocalciferol group , 21.2 % ; control group , 33.8 % ; OR , 0.50 ; 95 % CI , 0.28 - 0.88 ) but not multiple falls . CONCLUSION Patients with a history of falling and vitamin D insufficiency living in sunny climates benefit from ergocalciferol supplementation in addition to calcium , which is associated with a 19 % reduction in the relative risk of falling , mostly in winter OBJECTIVE A possible role for vitamin D deficiency in contributing to the winter increase in cardiovascular disease mortality was investigated by testing the effect of vitamin D supplementation on blood pressure and other cardiovascular risk factors during winter . DESIGN R and omised double-blind trial of vitamin D supplementation in winter . SUBJECTS Men and women , mean age 70 years ( range 63 - 76 ) recruited from general practitioner age-sex registers in Cambridge ( UK ) . INTERVENTION 95 people received a single oral dose of 2.5 mg cholecalciferol and 94 received the placebo at baseline interviews during December 1991 . Follow-up assessment was 5 weeks later during January 1992 . RESULTS Comparing follow-up with baseline assessment , serum 25-hydroxyvitamin D increased in the treated group and decreased slightly in the placebo group [ mean ( s.d . ) change : 7.2 ( + /- 3.8 ) vs -1.4 ( + /- 1.1 ) ng/ml , P = 0.0001 ] ; while parathyroid hormone decreased in the treated , and increased in the placebo , group [ -0.27 ( + /- 0.78 ) vs 0.13 ( + /- 0.75 ) pmol/l , P = 0.0004 ] . However , the mean change in blood pressure was similar in both groups : systolic -5 ( + /- 13 ) vs -5 ( + /- 16 ) mmHg , P = 0.81 ; diastolic -1 ( + /- 9 ) vs -1 ( + /- 9 ) , P = 0. OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

CONCLUSIONS Supplementation with vitamin D showed no effect on adiposity measures in adults

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVES The aim of this study was to examine the association between brachial artery flow-mediated dilation ( FMD ) and cardiovascular events in a cohort of initially asymptomatic post-menopausal women , with adjustment for the presence of the major cardiovascular risk factors . BACKGROUND Conventional major cardiovascular risk factors ( cigarette smoking , hypercholesterolemia , hypertension , and diabetes ) fail to explain nearly 50 % of cardiovascular events . Defining the magnitude of future risk for the development of clinical events is a major focus of effective primary prevention . Evaluation of endothelial function , utilizing the noninvasive measurement of the brachial artery FMD , may serve as a screening tool to individualize high-risk patients . METHODS We conducted a prospect i ve study on 2,264 post-menopausal women , age 54 + /- 6 years . The length of the follow-up was 45 + /- 13 months ( range 6 to 65 months ) . RESULTS During observation , 90 major events were recorded . Risk-adjusted relative risk values result ed 1.0 , 1.33 ( 95 % confidence interval [ CI ] 1.09 to 4.09 ) , and 4.42 ( 95 % CI 2.97 to 8.01 ) for women in the higher , intermediate , and lower tertile of FMD , respectively ( p < 0.0001 for trend ) . The event rate for women in the lower tertile ( FMD < or=4.5 % ) was greater than the combined event rate noted in the other 2 tertiles ( women in the lower tertile accounted for 51 events [ 56.6 % of total events ] ) . When added to age and other conventional cardiovascular risk factors ( smoking habits , presence of hypercholesterolemia , history of diabetes , hypertension ) , FMD contributed significantly to the model predicting cardiovascular events ( likelihood ratio chi-square change : 10.22 ; p < 0.0001 ) . CONCLUSIONS In post-menopausal women , the knowledge of FMD provided incremental prognostic information regarding the risk of developing cardiovascular events Background Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) surgery is known to have a significant effect on obesity-related comorbidities such as hypertension curing it in some ( 50–70 % ) while improving control in others . Our aim was to observe the changes in blood pressure ( BP ) in a cohort of 100 patients followed prospect ively for 1 year after LRYGB . Methods BP measurements were recorded prospect ively in 100 consecutive patients preoperatively and then postoperatively at weeks 1 , 5 , 9 , and months 6 and 12 . In order to reduce bias , three BP measurements were made by the same nurse at each office visit and the mean recorded . Pre- and postoperative usage of antihypertensive medication was also noted . Results Eighty-nine women and 11 men underwent LRYGB and their BP monitored for 1 year . There was an 85 % follow-up rate with mean % excess body weight loss of 60 . Reductions in systolic ( 9 mmHg ) and diastolic ( 7 mmHg ) BP measurements were seen as early as week 1 postoperatively and maintained for the duration of the observation period ( P < 0.05 ) . Furthermore , postoperative usage of antihypertensive medication is reduced to a third of preoperative use . Conclusion LRYGB is associated with an early reduction in BP and antihypertensive medication usage which is maintained at 1 year after surgery . This early impact on blood pressure occurs before any significant weight loss is achieved thereby suggesting a hormonal mechanism that may be involved for the changes observed Background Obesity has been widely recognized as a chronic inflammatory condition and associated with elevated inflammatory indicators including C-reactive protein ( CRP ) and white blood cell count ( WBC ) . Recent studies have shown elevated CRP or WBC is a significant risk factor for cardiac events and stroke but the clinical significance of CRP and WBC has not been clearly studied in morbidly obese patients . This study is aim ed at the clinical significance of WBC and CRP in morbidly obese patients and the change after bariatric surgery . Methods The study was a prospect ively controlled clinical study . From December 1 , 2001 to January 31 , 2006 , of 640 ( 442 females and 198 males ) consecutive morbid obese patients enrolled in a surgically supervised weight loss program with at least 1 year ’s follow-up were examined . Results Of the patients , 476 ( 74.4 % ) had elevated CRP and 100 ( 15.6 % ) had elevated WBC at preoperative study . CRP and WBC were significantly related and both increased with increasing body mass index ( BMI ) . CRP is also increased with increasing waist , glucose level , hemoglobin , albumin , Ca , insulin , C-peptide , and metabolic syndrome while WBC is increased with metabolic syndrome but decreased with increasing age . Multivariate analysis confirmed fasting glucose level and hemoglobin are independent predictors of the elevation of CRP while age is the only independent predictor for elevated WBC . Both WBC and CRP levels decreased rapidly after obesity surgery . These improvements result ed in a 69.8 % reduction of CRP and 26.4 % reduction of WBC 1 year after surgery . Although individuals who underwent laparoscopic gastric bypass lost significantly more weight ( 36.8 ± 11.7 kg vs. 17.3 ± 10.8 kg ; p = 0.000 ) and achieved a lower BMI ( 27.8 ± 4.6 vs. 35.0 ± 5.5 ; p = 0.000 ) than individuals who underwent laparoscopic gastric b and ing , there was no difference in the resolution of elevated CRP 1 year after surgery ( 95.9 % vs. 84.5 % ; p = 0.169 ) and WBC ( 99.4 % vs. 98.3 % ; p = 0.323 ) . Conclusions Both baseline WBC and CRP are elevated in morbid obese patients but CRP has a better clinical significance . Significant weight reduction 1 year after surgery markedly reduced CRP and WBC with a resolution rate of 93.9 % and 98.2 % separately . Obesity surgery performed by laparoscopic surgery is recommended for obese patients with elevated CRP or WBC OBJECTIVES To compare the potential years of life saved ( YOLS ) associated with risk factor modification in the primary and secondary prevention of cardiovascular disease ( CVD ) . METHODS The CVD life expectancy model estimates the risk of death due to coronary disease , stroke , and other causes based on the levels of independent risk factors ( such as age , blood pressure , and blood lipid levels ) found in the cohort of the Lipid Research Clinics . The model was vali date d by comparing its predictions with the observed fatal outcomes of 9 r and omized clinical trials . We then estimated the YOLS associated with treating hyperlipidemia or hypertension among hypothetical patient groups with and without CVD at baseline . We defined high-risk patients as those with 3 risk factors ( hyperlipidemia , cigarette smoking , and hypertension ) and low-risk patients as those with isolated hypertension or hyperlipidemia . RESULTS The fatal events predicted by the model were consistent with the clinical trial results . Among men and women with hyperlipidemia without CVD , the forecasted benefits of lipid therapy were substantially greater among high-risk groups vs low-risk groups ( 4.74 - 0.78 YOLS vs 2.50 - 0.25 YOLS , respectively ) . Among those with CVD , the forecasted benefits of treatment were similar for both high-risk and low-risk groups ( 4.65 - 0.65 YOLS vs 3.84 - 0.58 YOLS , respectively ) . The results for hypertension therapy also demonstrated greater benefits for high-risk vs low-risk patients undergoing primary prevention therapy ( 1.34 - 0.29 YOLS vs 0.85 - 0.13 YOLS , respectively ) , and the forecasted benefits in secondary prevention were similar ( 1.26 - 0.23 YOLS vs 1.00 - 0.23 YOLS , respectively ) . CONCLUSIONS The clinical approach to risk factor modification in primary prevention should be different from that in secondary prevention . The forecasted benefits of therapy among patients without CVD are greatest in the presence of other risk factors . Among those with CVD , the benefits of therapy are equivalent , thereby obviating the need to target high-risk patients This study was design ed to assess the effects of bariatric weight loss surgery on structural , functional , and inflammatory markers of coronary atherosclerosis . Obesity is a worldwide epidemic and an independent risk factor for coronary atherosclerosis . It remains unclear whether surgically induced weight loss reduces cardiovascular risk . This prospect i ve study enrolled 50 consecutive subjects with morbid obesity who underwent Roux-en-Y gastric bypass surgery ( GBS ) after failed attempts at medical weight loss . Subjects were recruited through a comprehensive weight loss center affiliated with an academic tertiary care hospital . All subjects had body mass indexes > or = 40 kg/m(2 ) or body mass indexes of 35 to 40 kg/m(2 ) with > or = 2 co-morbid obesity-related conditions . Markers of coronary atherosclerosis , including brachial artery flow-mediated dilation , carotid intima-media thickness , and high-sensitivity C-reactive protein , were measured before GBS and 6 , 12 , and 24 months after GBS . There were statistically significant improvements in all measured markers of coronary atherosclerosis after GBS . The mean body mass index decreased from 47 to 29.5 kg/m(2 ) at 24 months ( p < 0.001 ) , the mean carotid intima-media thickness regressed from 0.84 to 0.50 mm at 24 months ( p < 0.001 ) , mean flow-mediated dilation improved from 6.0 % to 14.9 % at 24 months ( p < 0.05 ) , and mean high-sensitivity C-reactive protein decreased from 1.23 to 0.65 mg/dl at 6 months ( p < 0.001 ) and to 0.35 mg/dl at 24 months ( p < 0.001 ) . In conclusion , GBS results in significant improvements in inflammatory , structural , and functional markers of coronary atherosclerosis Background : The objective of this study was to determine the weight loss , changes in co-morbidities , medication usage and general health status at 1 year after laparoscopic adjustable gastric b and ing ( LAGB ) . Methods : Prospect i ve data were obtained from all subjects undergoing LAGB . These measurements included a medical history and review of systems , medications , height and weight and the SF-36 general health survey . Patients were seen for b and adjustments as needed throughout the year . At the 1-year follow-up visit , patients were weighed and interviewed about the status of their health conditions and their current medications , and the SF-36 was repeated . Results : Between November 2002 and November 2003 , 195 patients had LAGB . The majority of subjects were female ( 82.8 % ) , married ( 65.1 % ) , and white ( 94.9 % ) . Complications occurred in 18 subjects ( 9.2 % ) . These included 3 slipped b and s ( 1.5 % ) , 4 port problems ( 2.1 % ) , 8 patients with temporary stoma occlusion ( 4.1 % ) , 1 explantation ( 0.5 % ) , and 1 mortality ( 0.5 % ) . Mean BMI decreased from 45.8 kg/m2 ( ± 7.7 ) to 32.3 kg/m2 ( ± 7.0 ) . Mean percent excess body weight lost was 45.7 % ( ± 17.1 ) during the first year . Major improvements occurred in arthritis , asthma , depression , diabetes , gastro-esophageal reflux disease , hyperlipidemia , hypertension , joint and back pain , sleep apnea and stress incontinence . Medication usage declined remarkably . Quality of life ( QoL ) by the SF-36 showed highly significant improvements . Conclusions : At 1 year after LAGB , patients had experienced significant weight loss , resolution of comorbidities , decreases in medication usage , and improvements in BACKGROUND Roux-en-Y gastric bypass is currently considered the gold st and ard surgical option for the treatment of morbid obesity . Open RYGB is associated with a high risk of complications . Laparoscopic RYGB has been shown to reduce perioperative morbidity and improve recovery . OBJECTIVES To review our experience with laparoscopic RYGB during a 19 month period . METHODS The data were collected prospect ively . The study group comprised all patients who underwent laparoscopic RYGB for treatment of morbid obesity as their primary operation between February 2006 and July 2007 . The reported outcome included surgical results , weight loss , and improved status of co-morbidities , with follow-up of up to 19 months . RESULTS The mean age of the 50 patients was 36.7 years . Mean body mass index was 44.7 kg/m2 ( range 35 - 76 kg/m2 ) ; OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

In conclusion , this review highlights the benefits of bariatric surgery in reducing or eliminating risk factors for CVD . It provides further evidence to support surgical treatment of obesity to achieve CVD risk reduction

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P < 0.001 intervention effect ) . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P < 0.001 ) . The lower versus higher carbohydrate groups maintained lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to reduce carbohydrate intake to less than 30 g per day . Participants on the conventional diet were instructed to reduce caloric intake by 500 calories per day , with less than 30 % of calories derived from fat , in accordance with the National Heart , Lung , and Blood Institute guidelines ( 3 ) . Outcome Measures We collected data , including weight ( single calibrated scale , SR Instruments , Inc. , Tonaw and a , New York ) , medical history ( self-reported ) , and blood pressure , at baseline , 6 months , and 1 year . Fasting blood specimens were obtained for glucose , hemoglobin A1c , and serum lipid levels ( Synchron LX20 , Beckman Coulter , Inc. , Fullerton , California ) . Low-density lipoprotein ( LDL ) cholesterol level was calculated by using the Friedewald formula ( 9 ) . We defined the presence of diabetes by a historical fasting blood glucose level greater than 6.94 mmol/L ( > 125 mg/dL ) or use of antidiabetic medications . The metabolic syndrome was considered present if a participant had 3 or more of the following ( 10 ) : central obesity , fasting blood glucose level of 6.11 mmol/L ( 110 mg/dL ) or greater , fasting triglyceride level of 1.70 mmol/L ( 150 mg/dL ) or greater , high-density lipoprotein ( HDL ) cholesterol level less than 1.04 mmol/L ( < 40 mg/dL ) for men or less than 1.30 mmol/L ( < 50 mg/dL ) for women , blood pressure of 130/85 mm Hg or greater , or antihypertensive therapy . We assumed that all participants had central obesity because of the uniform severity of their obesity ( BMI range , 35.0 to 79.4 kg/m2 ) . Serum insulin was measured by radioimmunoassay ( Laboratory Corporation of America Holdings [ LabCorp ] , Burlington , North Carolina ] ) . Insulin resistance in nondiabetic persons was estimated by the quantitative insulin sensitivity check ( QUICK ) index : 1/[(log ( fasting insulin ( U/mL ) ) + ( log fasting glucose(mg/dL ) ) ] . Statistical Analysis Our primary end point was total weight loss at 1 year . Secondary analyses included the change from baseline in serum lipid levels , insulin sensitivity , and glycemic control . We estimated that we would need 100 persons ( 50 per group ) , assuming a 2-sided type I error of 5 % , for the study to have 80 % power to detect a 5-kg greater mean weight loss in the low-carbohydrate group than in the conventional diet group . These calculations were based on an anticipated maximum weight loss by 6 months , with weight stabilization in both diet groups between 6 months and 1 year . To compensate for an anticipated dropout rate of 25 % , we set our enrollment target at 135 persons . R and omization was performed by using a pre-established algorithm generated from a r and om set of numbers that was constructed and held in a separate center and concealed from those enrolling persons during r and omization . We used stratified r and omization , with blocking within strata , to ensure assignment of approximately equal numbers of women , diabetic persons , and severely obese persons ( BMI 40 kg/m2 ) to each study group . Changes in weight , dietary intake , and metabolic data were compared between the 2 diets by r and om-coefficient analysis ( 11 ) . This type of analysis was selected to allow for a variable number of observations for participants and to take into account that the repeated observations of the outcome variables over time for individuals were correlated . The r and om-coefficient analysis model takes these correlations into account by allowing the intercept to vary r and omly among persons . We used a restricted maximum likelihood analysis , which assumed that changes were distributed according to a bivariate normal distribution and that data were missing at r and om . The outcome variables were changes from baseline in weight , dietary macronutrient consumption , and metabolic measurements . For all of these analyses , the covariates included an indicator variable for time ( 6 months and 1 year ) , diet group , and a diet group by time interaction term . This diet group by time interaction term was kept in the model , regardless of its statistical significance ( P = 0.063 for the weight loss analysis ) . Separate analyses to adjust for baseline differences between diet groups were also made by entering the following covariates to each of these models : age ; race ( white or African American ) ; sex ; baseline BMI ; baseline caloric intake ; and the presence or absence of hypertension , use of lipid-lowering therapy , diabetes , active sm OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

For most comparisons , the credibility of evidence was rated very low to moderate , with the exception for the DASH vs. the low-fat dietary approach for which the quality of evidence was rated high . Conclusion : The present network meta- analysis suggests that the DASH dietary approach might be the most effective dietary measure to reduce blood pressure among hypertensive and pre-hypertensive patients based on high quality evidence

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Objective . To evaluate the effects of ezetimibe/simvastatin ( EZE/SIMV ) and rosuvastatin ( ROSUV ) on oxidative stress ( OS ) markers in patients with diabetic polyneuropathy ( DPN ) . Methods . We performed a r and omized , double-blind , placebo-controlled phase III clinical trial in adult patients with Type 2 Diabetes Mellitus ( T2DM ) and DPN , as evaluated by composite scores and nerve conduction studies ( NCS ) . Seventy-four subjects with T2DM were allocated 1 : 1 : 1 to placebo , EZE/SIMV 10/20 mg , or ROSUV 20 mg for 16 weeks . All patients were assessed before and after treatment : primary outcomes were lipid peroxidation ( LPO ) , and nitric oxide ( NO ) surrogate levels in plasma ; secondary outcomes included NCS , neuropathic symptom scores , and metabolic parameters . Data were expressed as mean ± SD or SEM , frequencies , and percentages ; we used nonparametric analysis . Results . LPO levels were reduced in both statin arms after 16 weeks of treatment ( p < 0.05 versus baseline ) , without changes in the placebo group . NO levels were not significantly affected by statin treatment , although a trend towards significance concerning increased NO levels was noted in both statin arms . No significant changes were observed for the NCS or composite scores . Discussion . EZE/SIMV and ROSUV are superior to placebo in reducing LPO in subjects with T2DM suffering from polyneuropathy . This trial is registered with NCT02129231 Simvastatin reduces the blood concentration of cholesterol by inhibiting hydroxymethylglutaryl-coenzyme A reductase , the rate-limiting enzyme in cholesterol synthesis , and thereby reduces the risk of cardiovascular disease . In addition , simvastatin treatment leads to a reduction in fluxes in mitochondrial respiratory complexes I and II and might thereby reduce the formation of reactive oxygen species , which have been implicated in the pathogenesis of arteriosclerosis . Therefore , we hypothesized that simvastatin may reduce oxidative stress in humans in vivo . We conducted a r and omized , double-blinded , placebo-controlled study in which subjects were treated with either 40 mg of simvastatin or placebo for 14 days . The endpoints were six biomarkers for oxidative stress , which represent intracellular oxidative stress to nucleic acids , lipid peroxidation and plasma antioxidants , that were measured in urine and plasma sample s. A total of 40 participants were included , of which 39 completed the trial . The observed differences between simvastatin and placebo groups in the primary outcomes , DNA and RNA oxidation , were small and nonsignificant ( p=0.68 ) , specifically , 3 % in the simvastatin group compared to 7.1 % in the placebo group for DNA oxidation and 7.3 % in the simvastatin group compared to 3.4 % in the placebo group . The differences in biomarkers related to plasma were not statistically significant between the treatments groups , with the exception of total vitamin E levels , which , as expected , were reduced in parallel with the reduction in plasma cholesterol . In healthy young male volunteers , short-term simvastatin treatment , which considerably reduces cholesterol , does not lead to a clinical ly relevant reduction in a panel of measures of oxidative stress . Whether simvastatin has effects on oxidative stress in diseased population s , such as diabetes or hemochromatosis , where oxidative stress is prominent , is unknown but seems unlikely Lipid-lowering therapy has been reported to reduce several oxidative stress ( OS ) markers in hypercholesterolemia . Since OS is frequently associated with renal dysfunction , we aim ed to investigate the effect of hypolipidemic drugs on oxidative stress and plasma taurine ( Tau ) , a sulfur amino acid with a marked antioxidant effect , in chronic kidney disease ( CKD ) . We enrolled 30 CKD r and omized to receive three different hypolipidemic regimens for 12 months : simvastatin alone ( 40 mg/day ) or ezetimibe/simvastatin combined therapy ( 10/20 or 10/40 mg/day ) . Low molecular weight ( LMW ) thiols including homocysteine , cysteine , cysteinylglycine , glutathione , and glutamylcysteine in their reduced and total form and oxidative stress indices as malondialdehyde ( MDA ) and allantoin/uric acid ( All/UA ) ratio were also evaluated . Tau concentration significantly increased throughout the therapy . The rise of taurine was more striking for the group with the concomitant administration of ezetimibe/simvastatin 10/40 mg/day ( + 31.6 % after 1 year of therapy ) . A significant decrease of both MDA and All/UA ratio was observed during therapy for all patients ( −19 % for both MDA and All/UA ratio ) with a more pronounced effect in patients treated with ezetimibe/simvastatin 10/40 mg/day ( −26 % for MDA and −28 % for All/UA ratio ) . Besides , an increase of thiols reduced forms was found ( + 20.7 % of LMW thiols redox status ) with a greater effect in subjects treated with ezetimibe/simvastatin 10/40 mg/day ( + 24.7 % ) . Moreover , we demonstrated that oxidative stress improvement during therapy was correlated with increased taurine levels . We hypothesize that taurine may be responsible for the oxidative stress improvement observed during lipid-lowering treatment through the reduction of superoxide anion production at the respiratory chain activity level BACKGROUND AND STUDY AIMS The prevalence of non-alcoholic fatty liver disease ( NAFLD ) appears to be increasing . The aim of the present study was to investigate the relationship between hepatic antioxidant paraoxonase 1 ( PON1 ) activity , lipid peroxidation and antioxidant enzymes in patients with NAFLD and the effect of atorvastatin . PATIENTS AND METHODS This study was conducted on 50 patients with NAFLD and 20 normal subjects matched for age and sex . All of them were subjected to the following investigations : abdominal ultrasonography , serum PON1 activity level , liver function tests , serum lipid profile , fasting and postpr and ial blood glucose and serum levels of malondialdehyde ( MDA ) and glutathione peroxidase ( GP ) . NAFLD patients were further r and omly classified into two groups ( 25 patients each ) , groups Ia and Ib . Only group Ia received atorvastatin 40 mg tablet for 8months . RESULTS Obesity , dyslipidaemia and impaired glucose tolerance were prevalent in group I. There was a significant decrease in serum PON1 activity with a significant increase in MDA and GP activity ( i.e. , there is a significant increase in lipid peroxidation rate ) in group I compared with group II . After atorvastatin therapy , there was a significant increase in serum PNO1 activity and significant decrease in serum MDA levels . CONCLUSION Patients with NAFLD show enhanced oxidative stress which may lead to non-alcoholic steatohepatitis ( NASH ) . Reduced PON1 activity and increased MDA could be considered a biochemical marker for lipid peroxidation , which require follow-up in patients with NAFLD . Atorvastatin may have a role in prevention of , or delay , the transformation of liver steatosis into NASH Abstract —Recent evidence suggests that some benefit from the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors may occur independent of lipid lowering . We aim ed to determine the effect of simvastatin on coronary endothelial function , endothelial NO synthase ( eNOS ) expression , and oxidative stress in experimental hypercholesterolemia ( HC ) in the absence of cholesterol lowering . Pigs were r and omized to 3 experimental groups : normal diet ( N group ) , high cholesterol diet ( HC group ) , and HC diet with simvastatin ( HC+S group ) for 12 weeks . Low density lipoprotein cholesterol was similarly increased in the HC and HC+S groups compared with the N group . In vitro analysis of coronary large- and small-vessel endothelium-dependent vasorelaxation was performed . The mean vasorelaxation of epicardial vessels to bradykinin was significantly attenuated in the HC group compared with the N group ( 32.3±1.2 % versus 42.9±1.6 % , respectively;P < 0.0001 ) . This attenuation was significantly reversed in the HC+S group ( 38.7±1.5 % , P < 0.005 versus HC group ) . The maximal vasorelaxation to substance P was significantly attenuated in the HC group compared with the N group ( 50.5±11.9 % versus 79.3±5.3 % , respectively;P < 0.05 ) . This attenuated response was normalized in the HC+S group ( 74.9±4.1 % , P < 0.05 versus HC group ) . The maximal arteriolar vasorelaxation to bradykinin was also significantly attenuated in the HC group compared with the N group ( 71.9±4.9 % versus 96.8±1.34 % , respectively;P < 0.005 ) . This was reversed in the HC+S group ( 98.4±0.6 % , P < 0.0001 versus HC group ) . Western blotting of coronary tissue homogenates for eNOS demonstrated a decrease in protein levels in the HC group compared with the N group , with normalization in the HC+S group . Elevation of plasma F2-isoprostanes and thiobarbituric acid – reactive substances , markers of oxidative stress , occurred in the HC compared with the N group . These changes were reversed in the HC+S group . In summary , simvastatin preserves endothelial function in coronary epicardial vessels and arterioles in experimental HC ( in the absence of cholesterol lowering ) in association with an increase in coronary eNOS levels and a decrease in oxidative stress . These alterations may play a role in the reduction in cardiac events after treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors The aim of this study was to investigate the modulating effect of atorvastatin on serum paraoxonase 1 enzyme ( PON1 ) activity in type 2 diabetic Egyptian patients with or without nephropathy . The present study was carried out on the following groups : control group , which consisted of 30 healthy persons ; Group I , which consisted of 20 type 2 diabetic patients without nephropathy ; and Group II , which consisted of 20 type 2 diabetic patients with nephropathy . All the patients selected were under an antidiabetic regimen of insulin , and patients receiving antihypertensive agents were excluded from the follow-up study to avoid drug interaction fallacies . Twenty-two patients ( 15 without nephropathy and seven with nephropathy ) received atorvastatin in individually adjusted oral dosage ( range 10 - 20 mg ) once per day for 12 weeks . All cases were subjected to thorough clinical examination and history taking and measurement of serum levels of PON1 activity , malondialdehyde ( MDA ) , glutathione reductase activity , fasting glucose , total cholesterol , triglycerides , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , urea , and creatinine . Urine sample s were collected for determination of proteinuria . The obtained results showed that PON1 activity and HDL significantly decreased and fasting glucose significantly increased in Group I and Group II when compared to the control group , with significant difference in their levels between Group II and Group I. MDA , total cholesterol , and LDL levels significantly increased and glutathione reductase activity significantly decreased in Group I and Group II when compared to the control group . Urea , creatinine , and proteinuria levels showed significant increase in Group II when compared to the control group and Group I , with nonsignificant difference between control group and Group I. Atorvastatin therapy caused a significant increase in PON1 activity , and serum levels of MDA and glutathione reductase activity were significantly decreased and increased , respectively . Also , total cholesterol , triglyceride and LDL-cholesterol levels were significantly reduced with a significant increase in HDL-cholesterol levels . There was a significant modest reduction in serum urea and creatinine levels as well as in proteinuria level . Fasting glucose level was significantly reduced under the antidiabetic regimen of insulin through the follow-up period . PON1 activity showed a significant negative correlation with glucose and LDL , and a significant positive correlation with HDL in all the studied groups . It could be concluded that atorvastatin with its pleiotropic effects could provide optimal therapeutic intervention to control not only dyslipidemia , but also oxidative stress status with consequent improvement in the course of type 2 diabetes and diabetic nephropathy . More specifically , restoration of PON1 activity by atorvastatin opens a window to investigate other drugs that could provide a new adjuvant therapeutic line for better control of diabetes and diabetic nephropathy . Further research is also recommended to study the distribution of PON1 genetic polymorphism among the Egyptian population to explain the variability in its activity and its relationship with OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Conclusions : This systematic review and meta- analysis showed that statin treatment significantly reduces systemic MDA concentrations .

MS2_fixed_5_shot298

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: PURPOSE : Colorectal surgery is associated with postoperative ileus , which contributes to delayed discharge . This study was design ed to investigate the effect of thoracic epidural anesthesia and analgesia on gastrointestinal function after colorectal surgery under st and ardized controlled postoperative care . METHODS : Forty-two patients diagnosed with either colonic cancer , diverticulitis , polyps , or adenoma , and scheduled for elective colorectal surgery , were r and omly assigned to either postoperative patient-controlled analgesia ( PCA ) with intravenous morphine ( n=21 ) or epidural analgesia with a mixture of bupivacaine and fentanyl ( n=21 ) . Postoperative early oral feeding and assistance to mobilization were offered to all patients . Pain visual analog scale ( 1–100 mm ) , passage of flatus and bowel movements , length of hospital stay , and readiness for discharge were recorded . RESULTS : Pain visual analog scale ( visual analog scale , 1–100 mm ) at rest , on coughing , and daily on mobilization was significantly lower in the epidural group compared with the patient-controlled analgesia group . Median values for the visual analog scale group were 7 ( 95 percent confidence interval , 2–18 ) mm , 19 ( 95 percent confidence interval , 4–38 ) mm , and 10 ( 95 percent confidence interval , 5–33 ) mm , respectively , and , for the patient-controlled analgesia group , were 24 ( 95 percent confidence interval , 18–51 ) mm , 59 ( 95 percent confidence interval , 33–74 ) mm , and 40 ( 95 percent confidence interval , 29–79 ) mm , respectively ( P<0.01 ) . Intake of protein and calories and time out of bed were similar in both groups . Mean time intervals ± st and ard deviation from surgery to first flatus and first bowel movement occurred earlier in the epidural group , 1.9±0.6 days and 3.1±1.7 days , respectively , compared with patient-controlled analgesia , 3.6±1.5 days and 4.6 ± 1.6 days , respectively ( P<0.01 ) . Postoperative complications occurred in 33 percent of the patient-controlled analgesia group and 28 percent of the epidural group . There was no significant difference in length of hospital stay between the two groups with a mean of 7.3±3.7 days in the patient-controlled analgesia group and 8.5±4.2 days in the epidural group . Readiness for discharge was similar in both groups . CONCLUSION : Thoracic epidural analgesia has distinct advantages over patient-controlled analgesia morphine in providing superior quality of analgesia and shortening the duration of postoperative ileus . However , discharge home was not faster , indicating that other perioperative factors influence the length of hospital stay One hundred and thirty-two elderly patients undergoing emergency hip surgery were r and omly allocated to receive subarachnoid block ( SAB ) or general anaesthesia ( GA ) . Using the 125.I fibrinogen uptake test , deep vein thrombosis was found to occur in 17 of 37 patients in the SAB group and 30 of 39 patients in the GA group ( P 0.05 ) . Blood loss was 513 ml ( + /- SEM 44 ) in the SAB group and 714 ml ( + /- SEM 67 ) in the GA group ( P less than 0.01 ) . Hypoxaemia was present preoperatively ( mean PaO2 9.2 kPa ) . Immediately following general anaesthesia , the mean fall in PaO2 was 0.86 kPa compared with preoperative values but only 0.16 kPa following subarachnoid block ( P less than 0.01 ) . At 24 hours postoperatively the fall in PaO2 was similar in both groups and recovered only slowly during the first week . Twelve patients died , three in the SAB group and nine in the GA group . This difference in mortality was not statistically significant The effects of thoracic epidural anesthesia ( TEA ) on total body oxygen supply-dem and ratio are complex due to potential influences on both O2 delivery ( & OV0422;O2 ) and consumption ( & OV0312;O2 ) . One hundred and five patients undergoing abdominal aortic surgery were r and omly assigned to one of three groups to compare the cardiovascular and metabolic responses associated with ( 1 ) thoracic epidural anesthesia plus light general anesthesia ( group TEA ) ; ( 2 ) general anesthesia with halothane ( group H ) ; and ( 3 ) neuroleptanalgesia ( group NLA ) . Values of cardiac index ( CI ) and & OV0422;O2 were less intra operatively in the TEA group than in the H or NLA groups , while & OV0312;O2 values were similar . & OV0312;O2 during recovery was greater in both the TEA and NLA groups than in the H group . Consequently the oxygen supply-dem and ratio ( & OV0422;O2/&OV0312;O2 ) was less in the TEA group throughout the perioperative period and about 30 % below baseline values during early recovery . At comparable & OV0312;O2 , CI and mixed venous O2 saturation were always less in the TEA group than in the NLA group . Heart rate was slowest intra operatively during TEA , and stroke work was less with TEA than with NLA . As cardiac filling pressure and systemic vascular resistance did not differ among the three groups , reduced adaptation of CI to tissue O2 needs during TEA was attributed to negative inotropic and chronotropic effects of the sympathetic blockade . We conclude that in patients undergoing abdominal aortic surgery , TEA has no apparent advantage over general anesthesia BACKGROUND This study was undertaken to determine if thoracic epidural analgesia is of practical benefit after bowel resection . METHODS Patients were prospect ively r and omized to receive either a thoracic epidural or patient-controlled analgesia for pain control after bowel resection . A st and ardized postoperative protocol was instituted after surgery . RESULTS Pain scores were significantly lower in the epidural group . Return of bowel function , and interval to discharge was not different between groups . Cost and complication rates were significantly higher in the epidural group . CONCLUSIONS Although pain scores were significantly lower in the epidural group , this did not translate into a quicker return of bowel function or earlier discharge of the patient . Furthermore , the epidural group had a significantly higher complication rate and cost . Therefore , while thoracic epidural analgesia provides superior pain control , it does not offer a significant advantage over patient-controlled analgesia in return of bowel function after bowel resection Fifty-five patients presenting with fractured neck of femur were r and omly allocated to either a st and ard general anaesthetic or spinal block in the lateral position combined with light sedation . The comparability of the two groups was established . There was little difference in the intra-operative course of postoperative morbidity in the two groups . There was a statistically significant difference in post-operative mortality between two groups , the general anaesthetic group showing a much higher mortality than the spinal group One hundred and one patients were r and omly allocated to have their peripheral vascular surgery performed under general anaesthesia ( 51 patients ) or spinal anaesthesia ( 50 patients ) . Intraoperative haemodynamic changes were markedly different between the two groups with a higher incidence of hypotension in the spinal group ( 72 % vs 31 % ) and a higher incidence of hypertension in the general anaesthesia group ( 22 % vs 0 % ) . Blood loss was significantly less in the spinal group ( 560 , SD 340 , ml vs 792 , SD 440 , ml ) . Postoperatively three patients from the general anaesthesia group died from causes unrelated to the anaesthesia , and one had a myocardial infa rct . Two patients in the spinal group had myocardial infa rcts , both had been treated for bradycardia and hypotension intraoperatively , and one died . There was a significantly higher incidence of postoperative chest infection in the general anaesthesia group ( 33 % vs 16 % ) . There was no significant difference between the groups in the incidence of postoperative confusion , or lower limb amputation rate or need for further surgery prior to hospital discharge One hundred and forty-eight patients undergoing " pin- and -plate " repair of fractured neck of femur received either subarachnoid blockade or general anaesthesia . The patients were followed up for 1 year after surgery . At the end of the year , 34 % had died and 50 % had returned home . Twelve per cent were either in hospital or in institutional care ; 4 % were lost to follow up . The mean duration of acute plus convalescent hospital bed occupancy was 84.4 days . There was a significantly lower mortality in the subarachnoid anaesthetic group by 14 days after surgery . The majority of the deaths in the general anaesthetic group were clustered between 6 and 16 days . However , at the end of 2 months the mortality rates were similar in both groups . It is conceivable that the difference in the distribution of deaths between the groups was a result of thrombo-embolism Forty elderly patients ( mean age 78.9 years ) undergoing acute surgery for hip fracture were given at r and om either spinal analgesia with bupivacaine 0.75 % or general anaesthesia with diazepam , fentanly and N2O/O2 . Mental function was studied pre‐operatively with an abbreviated mental test and 1 week and 3 months postoperatively in both groups . Mortality and number of complications was similar in the two groups , but a shorter time of ambulation was seen in the spinal group compared to the general anaesthetic group . No persistent impairment in mental function was found after acute hip surgery under spinal or general anaesthesia and the only advantage of regional technique was a shorter time of ambulation We assessed the efficacy and side effects of postoperative analgesia with three different pain regimens in 90 patients undergoing major abdominal surgery . The patients were r and omly assigned to one of three groups : epidural morphine ( EM ) or sufentanil ( ES ) , both combined with bupivacaine , or IM morphine ( IM ) at fixed intervals . Before incision , patients in the epidural groups received sufentanil or morphine in bupivacaine via a thoracic catheter , followed by a continuous infusion 1 h later . General anesthesia consisted of N2 O/O2 and isoflurane for all groups . Patients in all groups received IV sufentanil as part of their anesthetic management . Patients in the IM group received IV sufentanil 1 [ micro sign]g/kg before incision , and patients in all groups received sufentanil 10 [ micro sign]g for inadequate analgesia . Postoperatively , the epidural or IM treatment was continued for > or = to5 days . Postoperative analgesia at rest and during coughing and movement was significantly better in the epidural groups than in the IM group during the 5 consecutive days . There were no significant differences between the epidural groups . The incidence of most side effects was similar in all groups . We conclude that epidural analgesia provided better pain relief than IM analgesia , even if the latter was optimized by fixed-dose administration at fixed intervals and included adjustments on dem and . Epidural sufentanil and morphine , both combined with bupivacaine , seemed to be equally effective with similar side effects . Implication s : Postoperative analgesia with epidural sufentanil or morphine and bupivacaine after major abdominal surgery seemed to be better than the conventional method of IM morphine treatment , despite optimal administration , i.e. , fixed doses at fixed intervals with regular adjustments . Analgesic efficacy and side effects of epidural sufentanil and morphine were similar . ( Anesth Analg 1998;87:1346 - 53 The choice between regional versus general anaesthesia for elderly patients undergoing hip surgery is debated . It is vitally important to see if the type of anaesthetic administered affects per- and postoperative morbidity and mortality . Seventy women more than 75 yr old suitable for spinal anaesthesia were included in this study . They were r and omly divided into two groups : in one ( n = 35 ) , general anaesthesia was given with sodium thiopentone , fentanyl , enflurane and vecuronium ; in the other ( n = 35 ) , spinal anaesthesia was performed with 3 ml 0.5 % bupivacaine in isobaric solution . During the anaesthetic period , there were no statistically significant differences between both groups in systolic arterial pressure falls or in increases in the heart rate X systolic arterial pressure product . No serious cardiovascular collapse was encountered . Seven patients ( 20 % ) receiving general anaesthesia had mental changes against four only ( 14.2 % ) in the spinal group . In patients having general anaesthesia , 22.9 % developed bronchopneumonia as opposed to 8.6 % in the spinal anaesthesia group ( p less than 0.05 ) . The mortality rate at three months was rather similar in the two groups . It was concluded that , in order to reduce the incidence of postoperative central dysfunction and bronchopneumonia , spinal anaesthesia should be preferred in geriatric patients for lower limb surgery It has long been held that the acute-phase and neuroendocrine response to stress requires afferent neural input for its propagation . To further OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

: Compared with general anesthesia , neuraxial anesthesia may reduce the 0-to-30-day mortality for patients undergoing a surgery with an intermediate-to-high cardiac risk ( level of evidence moderate ) .

MS2_fixed_5_shot299

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The purpose of this study was to examine in a controlled trial the effects of atomoxetine on the management of attention deficit-hyperactivity disorder ( ADHD ) symptoms and functional impairments at school and at home . Participants were 153 children ( age 8 to 12 years ) diagnosed with attention-deficit hyperactivity disorder who were r and omized to double-blind treatment with either atomoxetine ( n = 101 ) or placebo ( n = 52 ) . Findings revealed significant improvements both for parent and teacher ratings of behavior for children receiving atomoxetine therapy . Children also were reported to evidence a trend toward better response to active medication than to placebo for health-related quality of life as rated by parents . No significant effects were revealed for the teacher ratings of academic productivity . Data were interpreted to provide support for the efficacy of atomoxetine on the symptoms associated with ADHD . The effects of atomoxetine on other functional outcomes including academic performance and health-related outcomes are of interest , albeit less compelling for this particular investigation , than for the effects on overt symptom display BACKGROUND Despite the persistence of attention-deficit/hyperactivity disorder ( ADHD ) into adolescence , little is known about the efficacy and tolerability of stimulant medications in this age group . OBJECTIVE To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system ( OROS ) methylpheni date . DESIGN Adolescents ( N = 220 ) having a confirmed Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylpheni date that improved symptoms to predefined criteria . Subjects successfully completing the dose titration phase ( n = 177 ) ( ie , tolerated and responded to treatment and adhered to the protocol ) were r and omized to receive 2 weeks ' treatment with their individualized dosage of OROS methylpheni date ( 18 , 36 , 54 , or 72 mg once daily ) or placebo . Treatment effectiveness was measured using investigator , parent , and adolescent assessment s of ADHD . RESULTS A significant reduction from baseline in the investigator-rated ADHD Rating Scale , the primary efficacy measure , was found with OROS methylpheni date treatment compared with placebo . Similar findings were noted with parent- and adolescent-report measures . Based on a Clinical Global Impression improvement subscale score of much or very much improved , 52 % of subjects in the OROS methylpheni date group improved compared with 31 % receiving placebo . Thirty-seven percent of subjects required the maximum dosage of 72 mg/d . The incidence of drug-related adverse events was similar between the 2 study groups . CONCLUSION In adolescents , once-daily OROS methylpheni date significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d INTRODUCTION Lisdexamfetamine dimesylate ( LDX ) , a prodrug stimulant , is indicated for attention-deficit/hyperactivity disorder ( ADHD ) in children 6 - 12 years of age and in adults . In short-term studies , once-daily LDX provided efficacy throughout the day . This study presented here was conducted to assess the long-term safety , tolerability , and effectiveness of LDX in 6- to 12-year-olds with ADHD . METHODS This open-label , multicenter , single-arm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition-Text Revision criteria for ADHD . Following 1-week screening and washout periods , subjects were titrated to LDX 30 , 50 , or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months . The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness . RESULTS Of 272 subjects receiving LDX , 147 completed the study . Most adverse events were mild to moderate and occurred during the first 4 weeks . There were no clinical ly meaningful changes in blood pressure or electrocardiographic parameters . From baseline to endpoint , mean ADHD Rating Scale scores improved by 27.2 points ( P<.0001 ) . Improvements occurred during each of the first 4 weeks , and were maintained throughout . Based on Clinical Global Impression-Improvement scale scores , > 80 % of subjects at endpoint and > 95 % of completers at 12 months were rated " improved . " CONCLUSION Long-term 30 , 50 , and 70 mg/day LDX was generally well tolerated and effective in children with ADHD OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years OBJECTIVE The efficacy and safety of dexmethylpheni date extended release ( d-MPH-ER ) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD This multicenter , r and omized , double-blind , placebo-controlled , parallel-group , two-phase study included 97 patients ( ages 6 - 17 years ) with DSM-IV-defined ADHD . The study was carried out between 2001 and 2003 . After a 2-week evaluation phase , patients were r and omized to d-MPH-ER or placebo for 7 weeks . Flexible d-MPH-ER dosing ( 30 mg/day ) was permitted for 5 weeks , then patients remained on their optimal dose during the last 2 study weeks . The primary efficacy measure was change from baseline to final rating in Conners ADHD/DSM-IV Scale-Teacher version ( CADS-T ) total subscale score . Secondary efficacy variables included changes from baseline to final visit in CADS-T Inattentive and Hyperactive-Impulsive subscale scores , CADS-P DSM-IV total subscale score and Inattentive and Hyperactive-Impulsive subscale scores , Clinical Global Impressions-Improvement ( CGI-I ) and CGI-Severity ( CGI-S ) scale scores , and Child Health Question naire Parent Form 50 scores . RESULTS d-MPH-ER improved CADS-T total scores significantly compared with placebo ( p < .001 ) , and 67.3 % of d-MPH-ER patients were rated much improved or very much improved on CGI-I at final visit versus 13.3 % of placebo patients ( p < .001 ) . More patients taking d-MPH-ER ( 49.1 % ) than placebo ( 25.5 % ) spontaneously reported adverse events suspected as drug related . CONCLUSIONS Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents Objective : To review the primary and secondary findings from the Multimodal Treatment study of ADHD ( MTA ) published over the past decade as three sets of articles . Method : In a two-part article — Part I : Executive Summary ( without distracting details ) and Part II : Supporting Details ( with additional background and detail required by the complexity of the MTA)—we address confusion and controversy about the findings . Results : We discuss the basic features of the gold st and ard used to produce scientific evidence , the r and omized clinical trial , for which was used to contrast four treatment conditions : medication management alone ( MedMgt ) , behavior therapy alone ( Beh ) , the combination of these two ( Comb ) , and a community comparison of treatment “ as usual ” ( CC ) . For each of the three assessment points we review three areas that we believe are important for appreciation of the findings : definition of evidence from the MTA , interpretation of the serial presentations of findings at each assessment point with a different definition of long-term , and qualification of the interim conclusions about long-term effects of treatments for ADHD . Conclusion : We discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families , clinicians , and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD . ( J. of Att . Dis . 2008 ; 12(1 ) 4 - 14 OBJECTIVE Clinical experience suggests that some ( but not all ) patients with attention-deficit/hyperactivity disorder ( ADHD ) are highly responsive to the nonstimulant atomoxetine . We conducted a retrospective analysis of r and omized controlled trials ( RCTs ) to identify potential baseline ( moderator ) and on-treatment ( mediator ) predictors of responses . METHOD Data from 6 U.S. RCTs among patients aged 6 to 18 years were pooled ( N = 1,069 ; subjects treated with atomoxetine , n = 618 ) . Subjects were categorized as much improved ( > or = 40 % decrease in ADHD Rating Scale-IV-Parent Version : Investigator Administered and Scored total score ) , minimally improved ( 25%- < 40 % decline ) , or nonresponders ( < 25 % decrease ) . Logistic regression , analyses of variance , and repeated- measures analyses were used to explore associations between baseline and on-treatment variables , achieving a much improved response at trial endpoint ( 6 - 9 weeks ) . RESULTS Forty-seven percent of patients showed a much improved clinical response , and 40 % did not respond . Only 13 % of the patients had a minimal response . No baseline characteristics predicted achieving a much improved clinical response ; the only predictor of achieving this response was being at least minimally improved by treatment week 4 ( sensitivity = 81 % , specificity = 72 % , positive predictive value = 75 % , and negative predictive value = 79 % ) . CONCLUSIONS Clinical response to atomoxetine was bimodal , with most subjects being either responders who were much improved or nonresponders . There were no demographic or clinical predictors of response . However , subjects who ultimately achieved a much improved response were likely to be at least minimal responders by week 4 . The recommendation to consider either augmenting or switching treatment in patients who do not achieve at least this level of response to atomoxetine by 4 weeks offers a method for limiting the extended duration of titration to subjects who are most likely to benefit further , while minimizing the duration of exposure in those less likely to achieve an excellent response INTRODUCTION This study compared two atomoxetine titration dosing schedules and two atomoxetine maintenance doses for treating adolescent attention-deficit/hyperactivity disorder ( ADHD ) inattention and hyperactivity/impulsivity . METHODS Adolescents ( N = 267 ) were r and omized to a slow or fast titration schedule . Patients who responded continued on a 40-week maintenance treatment , r and omized to either 0.8 or 1.4 mg/kg/day . RESULTS During the acute period , significant benefit was demonstrated with both titration schedules on the ADHD Rating Scale total score . Although patients in both groups maintained benefit relative to week 0 , statistically significant loss of benefit was found for patients maintained on 0.8 mg/kg/day but not on 1.4 mg/kg/day . A similar pattern was observed on the Clinical Global Impressions-ADHD-Severity scores and Life Participation Scale for ADHD-Child Version scores . Mean grade s for most subjects improved for patients in both maintenance treatment groups although most improvements were not statistically significant . CONCLUSIONS In adolescents with ADHD , treatment benefit at 8 weeks was better maintained long-term with 1.4 mg/kg/day than with 0.8 mg/kg/day . Improvement in adaptive functioning and age-appropriate developmental function was also demonstrated . Atomoxetine 0.8 and 1.4 mg/kg/day were equally well tolerated . CLINICAL TRIALS REGISTRY Maintenance of benefit with atomoxetine hydrochloride in adolescents with ADHD , NCT00191035 OBJECTIVES This report presents both age-adjusted and unadjusted statistics from the 2009 National Health Interview Survey ( NHIS ) on selected health measures for children under age 18 , classified by sex , age , race , Hispanic origin , family structure , parent education , family income , poverty status , health insurance coverage , place of residence , region , and current health status . The topics covered are asthma , allergies , learning disability , attention deficit hyperactivity disorder ( ADHD ) , prescription medication use , respondent-assessed health status , school days missed due to illness or injury , usual place of health OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

All included treatments result ed in ADHD improvement . On the basis of this literature review , a consistent pattern of improvement in pediatric ADHD patients ' core symptoms emerged across studies , study design s , and recommended treatment approaches .