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MS2_dynamic_1_shot_test

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MS2_dynamic_1_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*** ***EXAMPLES*** INPUT: 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 ) BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo . Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . Dutasteride therapy , as compared with placebo , result ed in a reduction in the rate of acute urinary retention ( 1.6 % vs. 6.7 % , a 77.3 % relative reduction ) . The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia , except that in our study , as compared with previous studies , the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group ( 0.7 % [ 30 men ] vs. 0.4 % [ 16 men ] , P=0.03 ) . CONCLUSIONS Over the course of the 4-year study period , dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00056407 . BACKGROUND Benign prostatic hyperplasia is a progressive , and rogen-dependent disease result ing in enlargement of the prostate gl and and urinary obstruction . Preventing the conversion of testosterone to its tissue-active form , dihydrotestosterone , by inhibiting the enzyme 5 alpha-reductase could decrease the action of and rogens in their target tissues ; in the prostate the result might be a decrease OUTPUT: • Incidences of erectile dysfunction , ejaculate volume , decreased libido , and gynaecomastia were greater with 5-α-RI vs placebo . • 5-α-RIs reduce the risk of being diagnosed with prostate cancer among men who are screened regularly for prostate cancer . • Information is inadequate to assess the effect of 5-α-RIs on prostate cancer or all-cause mortality . • 5-α-RIs increase sexual and erectile dysfunction 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 ] ) OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: OBJECTIVE Age is considered to be the strongest predictive factor of postoperative cognitive dysfunction ( POCD ) after cardiac surgery . Coronary artery bypass grafting ( CABG ) without the use of cardiopulmonary bypass is considered to be less harmful to the patient , especially in terms of neurological complications . METHODS The study was a sub- study of the r and omized best bypass surgery trial that compares off-pump to on-pump treatment , with respect to peri- and postoperative morbidity in patients with a moderate to high-predicted preoperative risk . We investigated cognitive outcomes . A total of 120 elderly patients ( mean age 76 years , SD 4.5 years ) underwent cognitive testing before surgery , of which 90 patients ( 47 vs 43 ) were available for retesting at 1 year ( mean 370 days ) postoperatively , using a neuropsychological test battery that included seven parameters from four tests . POCD was defined as the occurrence of at least two deficits out of the seven possible scores . Secondary analysis was performed based on definition of 20 % decline in cognitive scores compared to baseline , and using z-score analysis . RESULTS The incidence of POCD was 19 % ( 95 % CI 9 - 33 ) in the off-pump group and 9 % ( 95 % CI 3 - 22 ) in the on-pump group ( p=0.18 ) . There were no significant differences in the incidence of cognitive decline between the off-pump and on-pump group regardless of the definition applied . CONCLUSIONS We were unable to detect that CABG surgery without cardiopulmonary bypass was associated with significantly better cognitive outcome in elderly high-risk patients 1 year after the operation BACKGROUND The objective of this r and omized clinical trial of elective coronary artery bypass grafting was to investigate whether intraoperative mean arterial pressure below autoregulatory limits of the coronary and cerebral circulations was a principal determinant of postoperative complications . The trial compared the impact of two strategies of hemodynamic management during cardiopulmonary bypass on outcome . Patients were r and omized to a low mean arterial pressure of 50 to 60 mm Hg or a high mean arterial pressure of 80 to 100 mm Hg during cardiopulmonary bypass . METHODS A total of 248 patients undergoing primary , nonemergency coronary bypass were r and omized to either low ( n = 124 ) or high ( n = 124 ) mean arterial pressure during cardiopulmonary bypass . The impact of the mean arterial pressure strategies on the following outcomes was assessed : mortality , cardiac morbidity , neurologic morbidity , cognitive deterioration , and changes in quality of life . All patients were observed prospect ively to 6 months after the operation . RESULTS The overall incidence of combined cardiac and neurologic complications was significantly lower in the high pressure group at 4.8 % than in the low pressure group at 12.9 % ( p = 0.026 ) . For each of the individual outcomes , the trend favored the high pressure group . At 6 months after coronary bypass for the high and low pressure groups , respectively , total mortality rate was 1.6 % versus 4.0 % , stroke rate 2.4 % versus 7.2 % , and cardiac complication rate 2.4 % versus 4.8 % . Cognitive and functional status outcomes did not differ between the groups . CONCLUSION Higher mean arterial pressures during cardiopulmonary bypass can be achieved in a technically safe manner and effectively improve outcomes after coronary bypass OBJECTIVE In a r and omized trial of 223 patients undergoing coronary artery surgery with cardiopulmonary bypass , we have reported a neuroprotective effect of mild hypothermia . To determine whether the beneficial effect of mild hypothermia was long-lasting , we repeated the psychometric tests in 131 patients after 5 years . METHODS Patients were cooled to 32 degrees C during aortic crossclamping and then r and omized to rewarming to either 34 degrees C or 37 degrees C , with no further rewarming until arrival in intensive care unit . Cognitive function was measured preoperatively and 1 week and 5 years postoperatively with a battery of 11 psychometric tests interrogating verbal memory , attention , and psychomotor speed and dexterity . RESULTS Patients who had greater cognitive decline 1 week after surgery showed poorer performance 5 years later . The magnitude of cognitive decline over 5 years was modest . The incidence of deficits defined as a 1 st and ard deviation [ SD ] decline in at least 1 of 3 factors was not different between temperature groups . Fewer patients in the hypothermic group had deficits that persisted over the 5 years , but this difference did not attain statistical significance ( RR = 0.64 , P = .16 ) . CONCLUSIONS The effect of surgery on cognitive function observed early after surgery is an important predictor of cognitive performance 5 years later . Although there was evidence of a neuroprotective effect of mild hypothermia early after surgery in the original cohort , the results after 5 years were inconclusive . In general , the magnitude of cognitive changes over 5 years was modest . We believe that further trials investigating the efficacy of mild hypothermia in patients having cardiac surgery are warranted BACKGROUND AND PURPOSE Percutaneous transluminal angioplasty ( PTA ) is currently being assessed for the treatment of carotid stenosis . In comparison with carotid endarterectomy ( CEA ) , there is evidence of an increased risk of cerebral microembolism during the procedure . We have sought evidence of any neuropsychological sequelae of carotid PTA and compared it with CEA to demonstrate the relative safety of the 2 treatment options . METHODS The neuro OUTPUT: It found that both the CABG and medical groups had small to moderate improvements in memory versus baseline at 1 year and no changes versus baseline at 6 years for all neuropsychological tests measured . Further , there were no between-group differences at any follow-up or in change from baseline to any follow-up . 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 seiz OUTPUT:

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

MS2_dynamic_1_shot202

***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*** ***EXAMPLES*** INPUT: Attention Deficit Hyperactivity Disorder ( ADHD ) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex ( dACC ) . In the current study , we investigated for the first time whether real-time fMRI neurofeedback ( rt-fMRI ) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning . An exploratory r and omized controlled treatment study with blinding of the participants was conducted . Participants with ADHD ( n = 7 in the neurofeedback group , and n = 6 in the control group ) attended four weekly MRI training sessions ( 60-min training time/session ) , during which they performed a mental calculation task at varying levels of difficulty , in order to learn how to up-regulate dACC activation . Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC . Before and after the training , ADHD symptoms and relevant cognitive functioning was assessed . Results showed that both groups achieved a significant increase in dACC activation levels over sessions . While there was no significant difference between the neurofeedback and control group in clinical outcome , neurofeedback participants showed stronger improvement on cognitive functioning . The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients . Due to the study ’s small sample size , potential clinical benefits need to be further investigated in future studies . Trial Registration : IS RCT Many patients show no or incomplete responses to current pharmacological or psychological therapies for depression . Here we explored the feasibility of a new brain self-regulation technique that integrates psychological and neurobiological approaches through neurofeedback with functional magnetic resonance imaging ( fMRI ) . In a proof-of-concept study , eight patients with depression learned to upregulate brain areas involved in the generation of positive emotions ( such as the ventrolateral prefrontal cortex ( VLPFC ) and insula ) during four neurofeedback sessions . Their clinical symptoms , as assessed with the 17-item Hamilton Rating Scale for Depression ( HDRS ) , improved significantly . A control group that underwent a training procedure with the same cognitive strategies but without neurofeedback did not improve clinical ly . R and omised blinded clinical trials are now needed to exclude possible placebo effects and to determine whether fMRI-based neurofeedback might become a useful adjunct to current therapies for depression Background : Spider phobics show an exaggerated fear response when encountering spiders . This fear response is aggravated by negative and irrational beliefs about the feared object . Cognitive re appraisal can target these beliefs , and therefore has a fear regulating effect . The presented study investigated if neurofeedback derived from functional magnetic resonance imaging ( fMRI ) would facilitate anxiety regulation by cognitive re appraisal , using spider phobia as a model of anxiety disorders . Feedback was provided based on activation in left dorsolateral prefrontal cortex and right insula , as indicators of engagement and regulation success , respectively . Methods : Eighteen female spider phobics participated in a r and omized , controlled , single-blinded study . All participants completed a training session in the MRI scanner . Participants assigned to the neurofeedback condition were instructed to shape their regulatory strategy based on the provided feedback . Participants assigned to the control condition were asked to adapt their strategy intuitively . Results : Neurofeedback participants exhibited lower anxiety levels than the control group at the end of the training . In addition , only neurofeedback participants achieved down-regulation of insula activation levels by cognitive re appraisal . Group differences became more pronounced over time , supporting learning as a mechanism behind this effect . Importantly , within the neurofeedback group , achieved changes in insula activation levels during training predicted long-term anxiety reduction . Conclusions : The conducted study provides first evidence that fMRI neurofeedback has a facilitating effect on anxiety regulation in spider phobia If an individual can learn to directly control activation of localized regions within the brain , this approach might provide control over the neurophysiological mechanisms that mediate behavior and cognition and could potentially provide a different route for treating disease . Control over the endogenous pain modulatory system is a particularly important target because it could enable a unique mechanism for clinical control over pain . Here , we found that by using real-time functional MRI ( rtfMRI ) to guide training , subjects were able to learn to control activation in the rostral anterior cingulate cortex ( rACC ) , a region putatively involved in pain perception and regulation . When subjects deliberately induced increases or decreases in rACC fMRI activation , there was a corresponding change in the perception of pain caused by an applied noxious thermal stimulus . Control experiments demonstrated that this effect was not observed after similar training conducted without rtfMRI information , or using rtfMRI information derived from a different brain region , or sham rtfMRI information derived previously from a different subject . Chronic pain patients were also trained to control activation in rACC and reported decreases in the ongoing level of chronic pain after training . These findings show that individuals can gain voluntary control over activation in a specific brain region given appropriate training , that voluntary control over activation in rACC leads to control over pain perception , and that these effects were powerful enough to impact severe , chronic clinical pain Abstract Attention Deficit Hyperactivity Disorder ( ADHD ) is associated with poor self‐control , underpinned by inferior fronto‐striatal deficits . Real‐time functional magnetic resonance neurofeedback ( rtfMRI‐NF ) allows participants to gain self‐control over dysregulated brain regions . Despite evidence for beneficial effects of electrophysiological‐NF on ADHD symptoms , no study has applied the spatially superior rtfMRI‐NF neurotherapy to ADHD . A r and omized controlled trial tested the efficacy of rtfMRI‐NF of right inferior prefrontal cortex ( rIFG ) , a key region that is compromised in ADHD and upregulated with psychostimulants , on improvement of ADHD symptoms , cognition , and inhibitory fMRI activation . To control for region‐specificity , an active control group OUTPUT: The vast majority of fMRI‐nf findings suggest that self‐regulation of specific brain signatures seems viable ; however , replication of concomitant behavioral outcomes remains sparse . We can certainly change brain activity with fMRI‐nf . HighlightsWe conducted a systematic review of 99 fMRI neurofeedback ( fMRI‐nf ) experiments.fMRI‐nf successfully drives BOLD regulation and behavioral change . BOLD regulation guarantees neither neural regulation nor clinical improvement . Psychosocial factors may contribute to regulation of BOLD signal and behavior . 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: Innovations in periradicular surgery for failed treatment of ortho grade root canal disease have been well-documented . We know of no prospect i ve studies that have compared success rates of conventional methods with these presumed advances . In this prospect i ve r and omised trial we compare the use of an ultrasonic retrotip with a microhead bur in the preparation of a retro grade cavity . Outcome was estimated clinical ly by estimation of pain , swelling , and sinus , and radiographically by looking at infill of bone and retro grade root filling 2 weeks and 6 months postoperatively . Both methods used other surgical techniques including microinstruments to place the retro grade root filling . The success rate of the ultrasonic method was higher ( all patients , n=26 ) than that of the microhead method ( n=19 of 21 ) . A larger study with longer follow up is required to consoli date this evidence OBJECTIVE R and omized clinical prospect i ve study to evaluate the application of MTA and IRM as retro grade sealers in surgical endodontics . STUDY DESIGN One hundred single-rooted teeth were surgically treated . After r and omization , MTA or IRM was used as a retrosealer . Radiographs were taken 1 week , 3 months , and 1 year postoperatively . Assessment was performed by 2 independent assessors 1 year after surgery . Both treatment groups were homogeneous in their composition , and clinical features and radiographic findings were classified according to Rud 's classification . RESULTS Complete healing was observed in 64 % of the MTA-treated teeth vs 50 % of the IRM-treated teeth . Incomplete healing was seen in 28 % ( MTA ) vs 36 % ( IRM ) , and unsatisfactory in 6 % ( MTA ) vs 14 % ( IRM ) . Only 1 failure was seen ( MTA ) . No statistically significant differences were found between the 2 retrofilling material s. CONCLUSION As root-end filling material s in this clinical prospect i ve r and omized design on single rooted teeth , MTA and IRM had the same clinical effectiveness This article covers a 4-year study that reports 320 cases in which endodontic surgery was performed for residual apical lesions or lesions that could not be treated in a conventional way . Four groups of 80 teeth each were formed and they were followed up after a 12-month interval . The first group comprised cases treated with a micro bur , retro grade filling and IRM ; the second , cases treated at the apical and radicular portions with a CO2 laser ; the third , cases in which the retro grade cavity was prepared with an ultrasonic device instead of a micro bur ; and the fourth group comprised cases treated in a similar way to the second group , i.e. , cases treated at the apical and radicular portions , but with a CO2 laser instead of a micro bur . After 12 months , the results showed a better prognosis with ultrasonic treatment . Regardless of technique , the CO2 laser did not improve the healing process OBJECTIVE To evaluate the pain experience following root-end resection and filling with Mineral Trioxide Aggregate or Intermediate Restorative Material . STUDY DESIGN Referred adult patients recruited using strict entry criteria were r and omly allocated to receive either material . A st and ardized surgical technique was employed . Postoperative instructions and a pain question naire were given to each patient to record the severity of their pain at 3 time intervals-3 - 5 hours , 24 hours , and 48 hours after surgery-on a st and ard visual analog scale ( VAS ) . Patients were also asked to record consumption of any self-prescribed analgesics , the type , and dosage . RESULTS At 3 - 5 hours after surgery , regardless of the material used , 90 % of all patients experienced some level of postoperative pain . Twenty-four hours after surgery 82 % of patients experienced pain , as did 72 % after 48 hours . Thirty-seven percent of patients did not take any analgesics at all . In order of popularity , the analgesics taken were ibuprofen , acetaminophen , and acetaminophen plus codeine phosphate . The VAS measurements were reduced over time in both treatment groups ( P < .001 ) . There was no statistically significant difference in the proportion of subjects taking analgesics in each treatment group . Patients who used analgesics showed higher median VAS measurements at all time periods ( P < .05 ) . CONCLUSIONS There was no significant difference in the pain experienced by both treatment groups . The postoperative pain was of a relatively short duration , at its maximum intensity early in the postoperative period but progressively decreased with time . Even if pain relief medication was needed , nonprescription analgesics were adequate and effective OBJECTIVES This prospect i ve r and omized study compared the outcome of retreatment and surgical intervention in root canal treated teeth with nonhealing periradicular pathosis . STUDY DESIGN One such tooth from each of 38 patients was r and omly allotted to retreatment or root-end resection and root-end filling . Treatment outcome after 1 year was evaluated and compared clinical ly and radiographically . RESULTS The success rate for surgery was higher than for conventional retreatment , but the difference was not statistically significant . CONCLUSIONS For management of nonhealing periradicular pathosis associated with root canal treated teeth , surgical intervention should be considered as an alternative to retreatment . In cases with a similar prognosis for both modes of treatment , the choice should be governed by consideration of intrinsic and extrinsic factors INTRODUCTION The purpose of the present study was to evaluate the clinical outcomes of endodontic microsurgery when super ethoxy-benzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) and mineral trioxide aggregate ( MTA ) were used as root-end filling material s in a prospect i ve r and omized controlled study . METHODS Of the 388 teeth eligible for endodontic microsurgery , 128 teeth were excluded from the study , and 260 teeth were r and omly assigned to either the Super EBA group or the MTA group with OUTPUT: Available evidence does not provide clinicians with reliable guidelines for treating periapical lesions . 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 OUTPUT:

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*** ***EXAMPLES*** 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 To study the relation of maternal periconceptional vitamin use to the risk of a congenital urinary tract anomaly ( CUTA ) , we conducted a case-control study using the Washington State Birth Defect Registry . We identified CUTA cases with no known chromosomal abnormality in seven counties in western Washington State occurring between January 1 , 1990 , and December 31 , 1991 . We r and omly selected a sample , as controls , of all infants delivered in five large hospitals in King County who did not have a birth defect and who were born in the same year as the cases . About 55 % of all infants in King County and a smaller proportion of infants in the other six counties are delivered in these five hospitals . We interviewed mothers of 118 cases and 369 controls to obtain information about their vitamin use during the pregnancy and during the year before the conception . After adjustment for maternal race , family income , county of maternal residence , and birth year , we found that women who used multivitamins during the first trimester had only 15 % the risk of bearing a child with a CUTA compared with women who did not take vitamins [ odds ratio ( OR ) = 0.15 ; 95 % confidence interval ( CI ) = 0.05–0.43 ] . The reduction was smaller for use restricted to the second or third trimesters ( OR = 0.31 ; 95 % CI = 0.09–1.02 ) . Among women who used vitamins during the first trimester , vitamin use before conception was not associated with any further reduction in the risk , nor did there appear to be an association with the amount or br and of vitamin used . Restricting the analysis to residents of King County did not change the results . Our results indicate that prenatal multivitamin use , particularly during the first trimester , may reduce the risk of a CUTA . Because all of the preparations taken by study participants contained many vitamins as well as folic acid , it was not possible to identify which one ( or several ) chemical(s ) may have been responsible for the reduced risk of a CUTA OBJECTIVE --To study the effect of periconceptional multivitamin supplementation on neural tube defects and other congenital abnormality entities . DESIGN --R and omised controlled trial of supplementation with multivitamins and trace elements . SETTING --Hungarian family planning programme . SUBJECTS--4156 pregnancies with known outcome and 3713 infants evaluated in the eighth month of life . INTERVENTIONS --A single tablet of a multivitamin including 0.8 mg of folic acid or trace elements supplement daily for at least one month before conception and at least two months after conception . MAIN OUTCOME MEASURES --Number of major and mild congenital abnormalities . RESULTS --The rate of all major congenital abnormalities was significantly lower in the group given vitamins than in the group given trace elements and this difference can not be explained totally by the significant reduction of neural tube defects . The rate of major congenital abnormalities other than neural tube defects and genetic syndromes was 9.0/1000 in pregnancies with known outcome in the vitamin group and 16.6/1000 in the trace element group ; relative risk 1.85 ( 95 % confidence interval 1.02 to 3.38 ) ; difference , 7.6/1000 . The rate of all major congenital abnormalities other than neural tube defects and genetic syndromes diagnosed up to the eighth month of life was 14.7/1000 informative pregnancies in the vitamin group and 28.3/1000 in the trace element group ; relative risk 1.95 ( 1.23 to 3.09 ) ; difference , 13.6/1000 . The rate of some congenital abnormalities was lower in the vitamin group than in the trace element group but the differences for each group of abnormalities were not significant . CONCLUSIONS --Periconceptional multivitamin supplementation can reduce not OUTPUT: No effects were shown in preventing Down syndrome , pyloric stenosis , undescended testis , or hypospadias . CONCLUSION Maternal consumption of folic acid-containing prenatal multivitamins is associated with decreased risk for several congenital anomalies , not only neural tube defects . 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 int OUTPUT:

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*** ***EXAMPLES*** INPUT: Few trials have evaluated the metabolic effects and health outcomes of lowering dietary n-6 PUFA . The objectives of the present paper were ( 1 ) to report the methods employed to lower dietary n-6 PUFA , while either increasing or maintaining n-3 PUFA intake and ( 2 ) to vali date our methods with 24 h recalls and erythrocyte fatty acid analyses . A total of sixty-seven subjects were r and omised to either ( 1 ) an average-n-3 PUFA , low-n-6 PUFA ( L6 ) intervention design ed to lower linoleic acid ( LA ; # 2·5 % of energy ( en% ) ) and arachidonic acid ( # 60 mg/d ) , while maintaining an average US intake of n-3 PUFA or ( 2 ) a high-n-3 PUFA , low-n-6 PUFA ( H3-L6 ) intervention design ed to lower n-6 LA , while increasing the n-3 PUFA a-linolenic acid ( ALA ; $ 1·5 en% ) and EPA þ DHA ( $ 1000 mg/d ) . Pre- and intraintervention nutrient intakes were estimated with six 24 h dietary recalls per subject . Both groups achieved the targeted reductions in dietary LA to # 2·5 en% ( median LA 2·45 ( 2·1 , 3·1 ) ; P,0·001 ) . Intakes of n-3 PUFA did not change for the L6 group . Target increases in n-3 ALA ( median 1·6 en% , ( 1·3 , 2·0 ) , P,0·001 ) and EPA þ DHA ( 1482 mg , ( 374 , 2558 ) , P,0·001 ) were achieved in the H3-L6 group . Dietary changes were vali date d by corresponding changes in erythrocyte n-6 and n-3 fatty acid composition . Dietary LA can be lowered to # 2·5 en% , with or without concurrent increases in dietary n-3 PUFA , in an outpatient clinical trial setting using this integrated diet method OBJECTIVE Evaluate the effect of high-oleic and conventional peanuts within a hypocaloric-diet on energy metabolism and body composition . METHODS This 4-week r and omized clinical trial included males with BMI of 29.7 ± 2.4 kg m(-2 ) and aged between 18 and 50 years . Participants were assigned to the groups : control ( CT , n = 22 ) that followed a hypocaloric-diet ; conventional peanuts ( CVP , n = 22 ) or high-oleic peanuts ( HOP , n = 21 ) that received the hypocaloric-diet including ( not adding ) 56 g day(-1 ) of peanuts . Glucose , fat oxidation , and body fatness and lean mass were the main outcomes . RESULTS Body weight and composition did not differ between groups . However , within group total body fat ( kg ) reduced with CVP and HOP , with a significant decrease in body fat percentage in HOP . While total lean mass ( kg ) decreased in CT , total lean mass ( % ) increased in HOP . Truncal lean mass decreased in the CT . At baseline , HOP had greater postpr and ial fat oxidation than the CVP . After 4-weeks , fasting fat oxidation increased in CVP and HOP . Fat oxidation increased in CT and HOP during the 200 min after meal intake compared to the fasting condition . CONCLUSION Regular peanut consumption , especially the high-oleic type , within a hypocaloric-diet increased fat oxidation and reduced body fatness in overweigh and obese men Background The Canola Oil Multicenter Intervention Trial ( COMIT ) was a r and omized controlled crossover study design ed to evaluate the effects of five diets that provided different oils and /or oil blends on cardiovascular disease ( CVD ) risk factors in individuals with abdominal obesity . The present objective is to report preliminary findings on plasma fatty acid profiles in volunteers with abdominal obesity , following the consumption of diets enriched with n-3 , n-6 and n-9 fatty acids . Methods COMIT was conducted at three clinical sites , Winnipeg , Manitoba , Canada , Québec City , Québec , Canada and University Park , Pennsylvania , United States . Inclusion criteria were at least one of the followings : waist circumference ( ≥90 cm for males and ≥84 cm for females ) , and at least one other criterion : triglycerides ≥1.7 mmol/L , high density lipoprotein cholesterol < 1 mmol/L ( males ) or < 1.3 mmol/L ( females ) , blood pressure ≥130 mmHg ( systolic ) and /or ≥85 mmHg ( diastolic ) , and glucose ≥5.5 mmol/L. Weight-maintaining diets that included shakes with one of the dietary oil blends were provided during each of the five 30-day dietary phases . Dietary phases were separated by four-week washout periods . Treatment oils were canola oil , high oleic canola oil , high oleic canola oil enriched with docosahexaenoic acid ( DHA ) , flax oil and safflower oil blend , and corn oil and safflower oil blend . A per protocol approach with a mixed model analysis was decided to be appropriate for data analysis . Results One hundred and seventy volunteers were r and omized and 130 completed the study with a dropout rate of 23.5 % . The mean plasma total DHA concentrations , which were analyzed among all participants as a measure of adherence , increased by more than 100 % in the DHA-enriched phase , compared to other phases , demonstrating excellent dietary adherence . Conclusions Recruitment and retention strategies were effective in OUTPUT: According to the studies examined in this review , diets enriched in OA can influence fat balance , body weight , and possibly energy expenditure . Importantly , abdominal fat and central obesity can be reduced following consumption of high-OA-containing meals . Mechanistically , OA-rich diets can be involved in the regulation of food intake , body mass , and energy expenditure by stimulating AMP-activated protein kinase signaling . Other proposed mechanisms include the prevention of the nucleotide-binding oligomerization domain-like receptor 3/caspase-1 inflammasome pathway , the induction of oleoylethanolamide synthesis , and possibly the downregulation of stearoyl-CoA desaturase 1 activity . 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 OUTPUT:

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

MS2_dynamic_1_shot206

***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*** ***EXAMPLES*** INPUT: Background —In patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications 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 OUTPUT:

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

MS2_dynamic_1_shot207

***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*** ***EXAMPLES*** INPUT: BACKGROUND The relationship between obesity and physical function is not well understood . Physical activity may be a key factor impacting on the relationship between obesity and physical function . METHODS Subjects included 171 community-dwelling women ( mean age = 74.3 , SD = 4.3 ) participating in a 14-year follow-up study to a walking intervention trial . Measures of obesity [ body mass index ( BMI ) ] and physical activity ( Modified Paffenbarger Question naire ) were collected in 1982 , 1985 , 1995 , and 1999 . Physical function was assessed in 1999 using the Functional Status Question naire ( FSQ ) and gait speed . RESULTS Measures of obesity from 1982 to 1995 and measures of physical activity from 1982 to 1995 were related to physical function in 1999 . However , hierarchical regression analysis to predict physical function in 1999 controlling for the presence of chronic conditions indicated that physical activity from 1982 to 1995 , and not obesity from 1982 to 1995 , was an independent predictor of physical function ( FSQ : adjusted R2 = 0.09 , F = 4.68 , P < 0.001 ; gait speed : adjusted R2 = 18.0 , F = 9.41 , P < 0.0001 . CONCLUSION Physical activity appears to be as important if not more important than body weight in predicting future physical function 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 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 Obesity is associated with diverse health risks , but the role of body weight as a risk factor for death remains controversial . METHODS We examined the association between body weight and the risk of death in a 12-year prospect i ve cohort study of 1,213,829 Koreans between the ages of 30 and 95 years . We examined 82,372 deaths from any cause and 48,731 deaths from specific diseases ( including OUTPUT: Exercise in overweight and obese older individuals improves anthropometric measures such as BMI and WC . The effect of exercise on serum lipids is unclear 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 OUTPUT:

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 .

MS2_dynamic_1_shot208

***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*** ***EXAMPLES*** 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 The main aim of this study was to test the effect of the triazolobenzodiazepine , estazolam , on auditory hallucinations . Fifty-eight patients ( 28 male , 30 female ) with auditory hallucinosis that had responded poorly to neuroleptics alone , were included ; most patients were chronic schizophrenics , and most patients were maintained on previous neuroleptic treatment during the trial . Each patient was treated for three consecutive 3-week periods , and r and omly allocated to receive estazolam ( 1 + 1 + 4 mg ) either in the first and third , or in the second period . Similar-looking placebo tablets were given in the control periods . These were seven drop-outs , three of them due to somnolence on estazolam . In both treatment groups there was a significant ( but not significantly different ) improvement during the first 3-week period , with regard to both global clinical state and auditory hallucinations . During the second and third periods , however , the two groups differed significantly , in that improvement of global state and hallucinosis was seen on estazolam , and deterioration on placebo . It is concluded that estazolam ( as an addition to neuroleptics ) had a significantly better effect than placebo on the global clinical state , on the frequency of , and attitude towards the hallucinations , and also on the single symptoms " Compulsive thoughts " and " Visual hallucinations " ( items in the Comprehensive Psychopathological Rating Scale ) . There were few side effects except drowsiness . Possible pharmacokinetic and pharmacodynamic interactions between benzodiazepines and neuroleptics are discussed briefly 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 Syndrome Scale-Excited Component ( PANSS-EC ) in session I and the change in the PANSS in session II . Safety was assessed by the frequency of the adverse events . Mean PANSS-EC improvement was significant after 5 days of treatment in both groups ( P>0.05 ) and was similar between the two treatment groups ( P<0.01 ) . Most patients ’ PANSS-EC scores improved or remained stable during the drawback/shift treatment period . Efficacy was not significantly different between the two treatment groups after the 6-week treatment ( P>0.05 ) . However , combination treatment exhibited greater efficacy , and adverse events , especially extrapyramidal symptoms , were lower with the oral treatment than with the intramuscular treatment in session I. These results show that RIS-OS in combination with clonazepam is an effective treatment , comparable with intramuscular haloperidol , and is well-tolerated for acute agitation in patients with schizophrenia Abstract Acute catatonic syndromes occurring in the context of various medical and neuropsychiatric conditions , including schizophrenia , have been shown to respond well to benzodiazepines ( BZD ) . However , there have been no studies specifically design ed to address the BZD treatment response of persistent catatonic states . Eighteen patients with clinical ly stable chronic schizophrenia , who also displayed enduring catatonic features , underwent a 12-week long , r and om assignment , double-blind , placebo-controlled cross-over trial with lorazepam ( 6 mg/day ) . A comprehensive assessment , including the subjects ’ clinical and motor ( catatonic as well as drug-induced movement disorders ) condition , was performed at baseline and four weekly intervals thereafter . Pre-existing medication was kept constant throughout the study . Lorazepam had no effect on the subjects’catatonic signs and symptoms , suggesting that acute and chronic catatonic syndromes associated with schizophrenic illness might have a different neurobiological basis Fifty-five schizophrenic out patients with negative symptoms were treated for up to six weeks by the addition of alprazolam ( mean dose , 4.2 mg/d ) , diazep OUTPUT: Conclusion Benzodiazepine superiority over placebo was found for global , psychiatric and behavioural outcomes , but inferiority to antipsychotics on longer-term global outcomes . 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 OUTPUT:

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 .

MS2_dynamic_1_shot209

***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*** ***EXAMPLES*** INPUT: OBJECTIVE The purpose of this preliminary study was to determine feasibility of a clinical trial to measure the effects of manual therapy on sternocleidomastoid active trigger points ( TrPs ) in patients with cervicogenic headache ( CeH ) . METHODS Twenty patients , 7 males and 13 females ( mean ± SD age , 39 ± 13 years ) , with a clinical diagnosis of CeH and active TrPs in the sternocleidomastoid muscle were r and omly divided into 2 groups . One group received TrP therapy ( manual pressure applied to taut b and s and passive stretching ) , and the other group received simulated TrP therapy ( after TrP localization no additional pressure was added , and inclusion of longitudinal stroking but no additional stretching ) . The primary outcome was headache intensity ( numeric pain scale ) based on the headaches experienced in the preceding week . Secondary outcomes included neck pain intensity , cervical range of motion ( CROM ) , pressure pain thresholds ( PPT ) over the upper cervical spine joints and deep cervical flexors motor performance . Outcomes were captured at baseline and 1 week after the treatment . RESULTS Patients receiving TrP therapy showed greater reduction in headache and neck pain intensity than those receiving the simulation ( P < .001 ) . Patients receiving the TrP therapy experienced greater improvements in motor performance of the deep cervical flexors , active CROM , and PPT ( all , P < .001 ) than those receiving the simulation . Between-groups effect sizes were large ( all , st and ardized mean difference , > 0.84 ) . CONCLUSION This study provides preliminary evidence that a trial of this nature is feasible . The preliminary findings show that manual therapy targeted to active TrPs in the sternocleidomastoid muscle may be effective for reducing headache and neck pain intensity and increasing motor performance of the deep cervical flexors , PPT , and active CROM in individuals with CeH showing active TrPs in this muscle . Studies including greater sample sizes and examining long-term effects are needed OBJECTIVE To evaluate the effects of a protocol involving soft tissue techniques and /or neural mobilization techniques in the management of patients with frequent episodic tension-type headache ( FETTH ) and those with chronic tension-type headache ( CTTH ) . DESIGN R and omized , double-blind , placebo-controlled before and after trial . SETTING Rehabilitation area of the local hospital and a private physiotherapy center . PARTICIPANTS Patients ( N=97 ; 78 women , 19 men ) diagnosed with FETTH or CTTH were r and omly assigned to groups A , B , C , or D. INTERVENTIONS ( A ) Placebo superficial massage ; ( B ) soft tissue techniques ; ( C ) neural mobilization techniques ; ( D ) a combination of soft tissue and neural mobilization techniques . MAIN OUTCOMES MEASURES The pressure pain threshold ( PPT ) in the temporal muscles ( points 1 and 2 ) and supraorbital region ( point 3 ) , the frequency and maximal intensity of pain crisis , and the score in the Headache Impact Test-6 ( HIT-6 ) were evaluated . All variables were assessed before the intervention , at the end of the intervention , and 15 and 30 days after the intervention . RESULTS Groups B , C , and D had an increase in PPT and a reduction in frequency , maximal intensity , and HIT-6 values in all time points after the intervention as compared with baseline and group A ( P<.001 for all cases ) . Group D had the highest PPT values and the lowest frequency and HIT-6 values after the intervention . CONCLUSIONS The application of soft tissue and neural mobilization techniques to patients with FETTH or CTTH induces significant changes in PPT , the characteristics of pain crisis , and its effect on activities of daily living as compared with the application of these techniques as isolated interventions This study research es the effectiveness of two manual therapy treatments focused on the suboccipital region for tension-type headache . A r and omized double-blind clinical trial was conducted over a period of four weeks with a follow-up at one month . Eighty-four patients with a mean age of 39.7 years ( SD 11.4 ) with tension-type headache were assigned to 4 groups which included the following manual therapy treatment : suboccipital soft tissue inhibition ; occiput-atlas-axis global manipulation ; combination of both techniques ; and a control group . The primary assessment consisted of collecting socio-demographic data and headache characteristics in a one-month base period , data such as age , gender , severity of pain , intensity and frequency of headache , among other . Outcome secondary assessment were : impact of headache , disability , ranges of motion of the craniocervical junction , frequency and intensity of headache , and pericranial tenderness . In the month prior to the study , average pain intensity , was rated at 6.49 ( SD 1.69 ) , and 66.7 % subjects suffered headaches of moderate intensity . After 8 weeks , statistically significant improvements were noted . OAA manipulative treatment and combined therapy treatments proved to be more effective than suboccipital soft tissue inhibition for tension-type headache . The treatment with suboccipital soft tissue inhibition , despite producing less significant results , also has positive effects on different aspects of headache The objective of the present study was to investigate the influence of headache-related disability on the recognition and management of migraine by French general practitioners ( GPs ) . Forty-nine teaching GPs at the Faculty of Medicine in the Nice-Sophia-Antipolis University were involved in this study . On one day , each patient who presented during the surgery hours of these GPs was invited to complete a question naire aim ed at identifying if he/she was a headache sufferer and , if so , whether the headache corresponded to migraine and had an impact on his/her functional ability . Functional disability was measured by the short-form of the Headache Impact Test ( HIT-6 ) . Being blind to the patients ' responses , the GPs completed a question naire for each patient aim ed at identifying if he/she considered the patient to OUTPUT: Summary Manual therapy should be considered as an effective approach in improving the quality of life in patients with TTH and MH , while in patients with CGH , the results were inconsistent . 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: To assess the improvements in symptoms , quality of life ( QoL ) , discomfort and satisfaction in patients with symptomatic benign prostatic hyperplasia ( BPH ) treated with dutasteride in clinical practice OBJECTIVES To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia ( LUTS/BPH ) . PATIENTS AND METHODS In all , 1522 men at risk of having progression events from LUTS/BPH were r and omized to receive alfuzosin 10 mg once daily ( 759 ) or placebo ( 763 ) for 2 years . Endpoints assessed were the occurrence of a first episode of acute urinary retention ( AUR ; primary ) and the need for BPH-related surgery . Post hoc analyses included a deterioration in the International Prostate Symptom Score ( IPSS ) of > or = 4 points and overall clinical progression of BPH ( occurrence of AUR and /or surgery and /or symptom deterioration ) . RESULTS Over 2 years , symptom deterioration was the most common progression event ( 14.3 % ) , followed by BPH-related surgery ( 5.8 % ) and AUR ( 2.0 % ) . Alfuzosin did not reduce the risk of AUR ( alfuzosin 2.1 % vs placebo 1.8 % , P = 0.82 ) but tended to reduce the risk of surgery ( 5.1 % vs 6.5 % , P = 0.18 ) ; the reduction in risk ( RR ) and 95 % confidence interval with alfuzosin was 22 ( -18 to 48)% ; and significantly reduced the risk of symptom deterioration ( 11.7 % vs 16.8 % ; P = 0.0013 ) ; the RR was 30 (10 - 46)% . The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo ( 16.3 % vs 22.1 % , P < 0.001 ) ; RR 26 (9 - 40)% . Alfuzosin also significantly improved the IPSS ( P = 0.017 ) , quality of life ( P < 0.001 ) and peak flow rate ( P = 0.001 ) compared with placebo . Baseline levels of prostate-specific antigen ( PSA ) predicted both AUR and BPH-related surgery events , while the baseline postvoid residual urine volume predicted symptom deterioration . The incidence of adverse events with alfuzosin was comparable to that with placebo . CONCLUSIONS Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH , defined by the occurrence of a deterioration in IPSS of > or = 4 points and /or AUR and /or BPH-related surgery , but does not reduce the primary occurrence of AUR . Alfuzosin significantly improves LUTS and quality of life over 2 years , and is well tolerated PURPOSE There are 2 main medical preparations available for lower urinary tract symptoms result ing from benign prostatic hyperplasia ( BPH ) . Choosing between an alpha-blocker and a 5alpha-reductase inhibitor requires trade-offs between their attributes or characteristics . We investigated the relative importance of and trade-offs between the attributes of the 5alpha-reductase inhibitor dutasteride and alpha-blockers in community dwelling men using a vali date d technique . MATERIAL S AND METHODS A discrete choice experiment was administered to 211 men older than 40 years who were r and omly selected from the general United Kingdom population . Attributes investigated in the discrete choice experiment were time to symptom improvement , sexual and nonsexual side effects , the risks of acute urinary retention ( AUR ) and surgery , cost and prostate size decrease . Using regression analysis the relative importance of these attributes , the trade-offs that men are willing to make between these attributes and the willingness to pay for each attribute were estimated . RESULTS All attributes were important to respondents . The most important attribute was side effects . The least preferred side effects was impotence , followed by decreased libido and dizziness . Respondents were willing to wait 13 , 2 and 8 months longer for symptom improvement in exchange for decreased prostate size , and the risks of AUR and surgery , respectively . Men reporting moderate symptoms were less concerned about sexual side effects , time to symptom improvement and the risk of AUR compared with men reporting mild symptoms . CONCLUSIONS Given the attribute levels of BPH medical treatment , overall community dwelling men preferred the 5alpha-reductase inhibitor over alpha-blockers . In the interests of shared decision making it is important to consider the importance of eliciting the preferences of patients with BPH BACKGROUND Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists ( alpha-blockers ) or 5alpha-reductase inhibitors . The long-term effect of these drugs , singly or combined , on the risk of clinical progression is unknown . METHODS We conducted a long-term , double-blind trial ( mean follow-up , 4.5 years ) involving 3047 men to compare the effects of placebo , doxazosin , finasteride , and combination therapy on measures of the clinical progression of benign prostatic hyperplasia . RESULTS The risk of overall clinical progression -- defined as an increase above base line of at least 4 points in the American Urological Association symptom score , acute urinary retention , urinary incontinence , renal insufficiency , or recurrent urinary tract infection -- was significantly reduced by doxazosin ( 39 percent risk reduction , P<0.001 ) and finasteride ( 34 percent risk reduction , P=0.002 ) , as compared with placebo . The reduction in risk associated with combination therapy ( 66 percent for the comparison with placebo , P<0. OUTPUT: Patients prefer therapies affecting long-term disease progression over those that provide short-term symptom improvement , which contrasts with the beliefs of their physicians . The evidence to date suggests that patients ' views and beliefs and those of their physician may not always be in agreement . Improved physician-patient communication will help determine the best treatment option for patients with BPH and may ensure greater compliance and treatment success 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: CONTEXT Incidence of end-stage renal disease due to hypertension has increased in recent decades , but the optimal strategy for treatment of hypertension to prevent renal failure is unknown , especially among African Americans . OBJECTIVE To compare the effects of an angiotensin-converting enzyme ( ACE ) inhibitor ( ramipril ) , a dihydropyridine calcium channel blocker ( amlodipine ) , and a beta-blocker ( metoprolol ) on hypertensive renal disease progression . DESIGN , SETTING , AND PARTICIPANTS Interim analysis of a r and omized , double-blind , 3 x 2 factorial trial conducted in 1094 African Americans aged 18 to 70 years with hypertensive renal disease ( glomerular filtration rate [ GFR ] of 20 - 65 mL/min per 1.73 m(2 ) ) enrolled between February 1995 and September 1998 . This report compares the ramipril and amlodipine groups following discontinuation of the amlodipine intervention in September 2000 . INTERVENTIONS Participants were r and omly assigned to receive amlodipine , 5 to 10 mg/d ( n = 217 ) , ramipril , 2.5 to 10 mg/d ( n = 436 ) , or metoprolol , 50 to 200 mg/d ( n = 441 ) , with other agents added to achieve 1 of 2 blood pressure goals . MAIN OUTCOME MEASURES The primary outcome measure was the rate of change in GFR ; the main secondary outcome was a composite index of the clinical end points of reduction in GFR of more than 50 % or 25 mL/min per 1.73 m(2 ) , end-stage renal disease , or death . RESULTS Among participants with a urinary protein to creatinine ratio of > 0.22 ( corresponding approximately to proteinuria of more than 300 mg/d ) , the ramipril group had a 36 % ( 2.02 [ SE , 0.74 ] mL/min per 1.73 m(2)/y ) slower mean decline in GFR over 3 years ( P = .006 ) and a 48 % reduced risk of the clinical end points vs the amlodipine group ( 95 % confidence interval [ CI ] , 20%-66 % ) . In the entire cohort , there was no significant difference in mean GFR decline from baseline to 3 years between treatment groups ( P = .38 ) . However , compared with the amlodipine group , after adjustment for baseline covariates the ramipril group had a 38 % reduced risk of clinical end points ( 95 % CI , 13%-56 % ) , a 36 % slower mean decline in GFR after 3 months ( P = .002 ) , and less proteinuria ( P<.001 ) . CONCLUSION Ramipril , compared with amlodipine , retards renal disease progression in patients with hypertensive renal disease and proteinuria and may offer benefit to patients without proteinuria The Losartan Intervention For Endpoint ( LIFE ) reduction in hypertension study is a double-blind , prospect i ve , parallel group study design ed to compare the effects of losartan with those of atenolol on the reduction of cardiovascular morbidity and mortality . A total of 9194 patients with hypertension and ECG left ventricular hypertrophy ( LVH ) by Cornell voltage- duration product and /or Sokolow-Lyon voltage criteria were enrolled in the study , with baseline clinical and ECG data available in 8785 patients ( 54 % women ; mean age , 67±7 years ) . ECG LVH by Cornell voltage- duration product criteria was present in 5791 patients ( 65.9 % ) and by Sokolow-Lyon voltage in 2025 patients ( 23.1 % ) . Compared with patients without ECG LVH by Cornell voltage- duration product criteria , patients with ECG LVH by this method were older ; more obese ; more likely to be female , white , and to have never smoked ; more likely to be diabetic and have angina ; and had slightly higher systolic , diastolic , and pulse blood pressures . In contrast , patients with ECG LVH by Sokolow-Lyon criteria were slightly younger ; less obese ; more likely to be male , black , and current smokers ; less likely to have diabetes ; more likely to have angina and a history of cerebrovascular disease ; and had higher systolic and pulse blood pressure but slightly lower diastolic blood pressure than patients without ECG LVH by this method . By use of multivariate logistic regression analyses , presence of ECG LVH by Cornell voltage- duration product criteria was predominantly associated with higher body mass index , increased age , and female gender , whereas presence of ECG LVH by Sokolow-Lyon voltage criteria was predominantly related to lower body mass index , male gender , and black race . Thus , hypertensive patients who meet Cornell product and Sokolow-Lyon voltage criteria are associated with different , but potentially equally adverse , risk factor profiles A double-blind , positively controlled , forced dose titration study comparing the efficacy and safety of atenolol , captopril , and verapamil sustained release as single agents in the treatment of black patients with mild to moderate hypertension ( diastolic blood pressure , 95 to 114 mm Hg ) was conducted . A total of 394 patients were r and omized to one of the three therapies . Mean blood pressures during a 2- to 4-week placebo treatment period ( baseline ) ranged from 100.4 to 100.7 mm Hg diastolic and 151.7 to 152.5 mm Hg systolic for the three groups . Of the patients , 355 ( of whom 345 had assessable data ) completed the OUTPUT: With the exception of -blockers for SBP , all the review ed antihypertensive drugs were more effective than placebo in reducing SBP and DBP as continuous measures , although the effect of -blockers on diastolic blood pressure was of marginal significance ( Figures 2 and 3 ) . 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 OUTPUT:

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

MS2_dynamic_1_shot212

***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*** ***EXAMPLES*** 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 AIM Short message service ( SMS ) is an applied technology of communication that enables the transfer of information and can be used as a part of medical efforts to motivate clients to improve their behavior regarding drug consumption . This study attempts to observe the differences in patients ' behavior as a result of either using SMS to motivate their drug consumption or by using only health providers and outreach workers to monitor them . METHODS This study used a post-test-only controlled-group design with a simple r and om sampling technique and was held in Malang , Indonesia . The sample in this study consisted of 45 patients with tuberculosis ( TB ) who received motivating SMS messages and 45 patients with only health providers and outreach workers to monitor them . RESULTS Fisher 's Exact test using a 95 % confidence interval showed that the result of this study had a P-value of 0.059 , which means that there was no difference in compliance with drug consumption between the patients who received SMS messages and the patients who were under the supervision of health providers and outreach workers . CONCLUSION It is highly recommended that the application of SMS be included in TB treatment and the evaluation of patients as an alternative method of controlling patients ' compliance with consuming anti-TB drugs at home Background Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems . Antenatal care has the potential to reduce maternal morbidity and improve newborns ’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining . We evaluated the association between a mobile phone intervention and antenatal care in a re source -limited setting . We aim ed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy . Methods This study was an open label pragmatic cluster-r and omised controlled trial with primary healthcare facilities in Zanzibar as the unit of r and omisation . 2550 pregnant women ( 1311 interventions and 1239 controls ) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery . 24 primary health care facilities in six districts were r and omized to either mobile phone intervention or st and ard care . The intervention consisted of a mobile phone text-message and voucher component . Primary outcome measure was four or more antenatal care visits during pregnancy . Secondary outcome measures were tetanus vaccination , preventive treatment for malaria , gestational age at last antenatal care visit , and antepartum referral . Results The mobile phone intervention was associated with an increase in antenatal care attendance . In the intervention group 44 % of the women received four or more antenatal care visits versus 31 % in the control group ( OR , 2.39 ; 95 % CI , 1.03 - 5.55 ) . There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant . Conclusions The wired mothers ’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services , more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred . Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in re source -limited setting s . Trial registration Clinical Trials.gov , NCT01821222 PURPOSE The current malaria treatment in Zambia is more than 97 % effective when the regimen is strictly adhered to . However , the mean adherence rate in sub-Saharan Africa is only 38 % to 48 % . Poor pharmacoadherence remains a significant barrier to malaria control and elimination . The purpose of this study was to determine if adherence rates to a six-dose artemesinin-based combination therapy ( ACT ) treatment differ between patients who received short message service ( SMS ) reminders and those who did not . This is the first study of its kind using SMS directly to the patient for ACT adherence in sub-Saharan Africa . DESIGN An experimental , r and omized controlled trial was conducted through a sample of 96 adult malaria patients at Fisenge Clinic in Zambia in OUTPUT: This systematic review shed light on the most prominent health outcomes that can be improved using mHealth technology interventions in developing countries . 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 OUTPUT:

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*** ***EXAMPLES*** INPUT: 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 OBJECTIVE To assess the relationships between shy-inhibited temperament in childhood and anxiety problems in early adolescence using a prospect i ve , longitudinal data set from a large community sample . METHOD Relationships between shyness ratings on age-appropriate temperament scales and anxiety problems were analyzed , looking both forward and backward in time from infancy to adolescence . RESULTS Forty-two percent of children rated as shy on 6 or more occasions over 8 surveys in childhood had anxiety problems in adolescence , compared with 11 % who were never shy . Persistence of shyness and its presence in middle childhood increased risk for anxiety . A highly reactive temperament added to shyness did not increase the risk for anxiety . Few children with an anxiety diagnosis in early adolescence had a history of shyness . CONCLUSIONS Prediction from childhood shyness to adolescent anxiety disorder is modest but clinical ly meaningful in a community sample . However , most shy children did not develop an anxiety disorder and most adolescents with anxiety disorders had not been especially shy BACKGROUND Recent evidence has suggested that the short allele of the serotonin transporter ( 5-HTT ) gene-linked polymorphic region ( 5-HTTLPR of the human serotonin gene [ SLC6A4 ] ) is associated with increased risk of depressive disorder but only among individuals exposed to social adversity . We report an investigation design ed to replicate this finding . METHODS Data were available from a non- clinical sample of 4,175 adult men and women , ages 41 - 80 years , selected from participants in the European Prospect i ve Investigation into Cancer and Nutrition in Norfolk ( EPIC-Norfolk , United Kingdom ) study . Evidence of past-year prevalent episodic major depressive disorder ( MDD ) , defined by restricted DSM-IV diagnostic criteria , was assessed through question naire . Adverse experiences in childhood and in adulthood ( during the five years preceding assessment ) were also assessed through self-report . The 5-HTTLPR variant was genotyped according to published protocol s. RESULTS One-year prevalent MDD criteria were met by 298 study participants . The experience of social adversity ( both in childhood and adulthood ) was strongly associated with increased rates of past-year prevalent MDD . No gene by environment ( GxE ) interactions between the 5-HTTLPR genotype , social adversity , and MDD were observed . CONCLUSIONS This study has not replicated a previous finding of a GxE interaction between the 5-HTTLPR genotype , social adversity , and depression One of the major neurobiological alterations in depressive disorders consists in a disturbed regulation of the hypothalamic-pituitary-adrenocortical ( HPA ) system . This is reflected by a pathological increase in the adrenocorticotropin ( ACTH ) and cortisol release after pretreatment with 1.5 mg dexamethasone ( DEX ) the previous night and a challenge with 100 μg corticotropin-releasing hormone ( CRH ) the next day . The changes evoked by this combined DEX-CRH test recede partially with an improvement of the psychopathological symptoms of depressed patients . It is still unclear , however , whether this long-lasting disturbance of the HPA system is due to acquired changes in the acute illness or whether it plays a causal role and could be considered as a trait or vulnerability marker for depression . In a previous study we have examined the HPA function of healthy prob and s with a high genetic load for affective disorders . We found that this group of high-risk prob and s ( HRPs ) showed abnormal DEX-CRH test results with a cortisol release that was between that of a control group and a group of patients with depression . In a follow-up study we now reexamined 14 of the 47 HRPs about 4 years after the index investigation and found surprisingly constant DEX-CRH test results , so that one of the requirements for a vulnerability marker is fulfilled BACKGROUND Major depressive disorder ( MDD ) is often complicated by anxiety symptoms , and anxiety disorders occur in approximately 30 % of mood cases . This study examined the influence of anxiety comorbidity on the hypothalamic-pituitary-adrenal ( HPA ) axis response to stress in patients with MDD . METHODS Untreated subjects with pure MDD ( n = 15 ) , MDD with comorbid anxiety disorders ( n = 18 ) , and pure anxiety disorders ( n = 15 ) were recruited by advertising . Age- and gender-matched control subjects were recruited for each subject with a psychiatric diagnosis ( n = 48 ) . All subjects underwent a social stressor , the Trier Social Stress Test ( TSST ) , and blood was collected for adrenocorticotropic hormone ( ACTH ) and cortisol assay . RESULTS When all depressed patients ( n = 33 ) were compared with their matched control subjects ( n = 33 ) , they showed a significantly greater ACTH response to the stressor ; however , this OUTPUT: RESULTS Depression is linked to hypercortisolemia in many patients , but not all patients present these hypothalamic-pituitary-adrenal axis dysfunction . The dexamethasone suppression test is not the most accurate test to measure the hypothalamic-pituitary-adrenal axis function , and its use in the first studies published probably jeopardized the results . Hypercortisolemia frequently occurs in patients with severe depression , melancholic , either psychotic or nonpsychotic type ; it is linked to the presence of a polymorphism in the promoter of the serotonin transporter gene , with a history of childhood abuse or neglect , or other significant stressful experiences like the loss of a parent during childhood and temperament leading to alterations in the response to stress . The alterations of the hypothalamic-pituitary-adrenal axis depend on many factors like severity and type of depression , genotype , history of exposure to stress , temperament , and probably resilience . All these factors together result in an endophenotype thought to be prone to depression 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 , OUTPUT:

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

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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*** ***EXAMPLES*** INPUT: Based on research demonstrating associations between folate , B-12 and B-6 vitamins and cognition and mood , we investigated the effects of short-term supplementation in 211 healthy younger , middle-aged and older women who took either 750 microg of folate , 15 microg of vitamin B-12 , 75 mg of vitamin B-6 or a placebo daily for 35 d. In addition , we examined associations between dietary intake of these vitamins and cognition and mood . Usual dietary intake status was estimated using a retrospective , self-report , quantified food frequency question naire . Participants completed alternate forms of st and ardized tests of cognitive processing re sources , memory , executive function , verbal ability and self-report mood measures before and after supplementation . Supplementation had a significant positive effect on some measures of memory performance only , and no effect on mood . Dietary intake status was associated with speed of processing , recall and recognition and verbal ability BACKGROUND Frail elders are at risk of suboptimal micronutrient status , functional decline , and neurologic disorders . The influence of oral multimicronutrients in physiologic doses and of moderately intense physical exercise on homocysteine ( Hcy ) , methylmalonic acid ( MMA ) , and neurologic functioning have not yet been investigated . OBJECTIVE Our goal was to determine the effects of enriched foods and exercise on blood vitamins , Hcy , MMA , and neuropsychological functioning in the frail . DESIGN A 17-wk r and omized controlled intervention trial was used to study 1 ) enriched foods plus a social program , 2 ) regular foods plus exercise , 3 ) enriched foods plus exercise , and 4 ) regular foods plus a social program . Enriched foods contained multiple micronutrients ( 25 - 100 % of the Dutch recommended dietary allowances ) ; exercises focused on strength , coordination , flexibility , and endurance . Vitamin ( cobalamin , red blood cell folate , and pyridoxal 5'-phosphate ) , Hcy , and MMA concentrations were measured and 2 neuropsychological tests were conducted . RESULTS Vitamin concentrations were higher in the supplemented groups than in the unsupplemented groups ( P < 0.001 ; total n = 130 ) . Compared with baseline , cobalamin in the supplemented groups was increased by 22 % , plasma folate by 101 % , red blood cell folate by 87 % , and pyridoxal 5'-phosphate by 68 % . Concentrations in the unsupplemented groups changed by -2 % , -6 % , 1 % , and -13 % , respectively . Hcy decreased by 25 % and MMA by 30 % in the supplemented groups , compared with a small increase in Hcy ( 2 % ) and decrease in MMA ( 9 % ) in the unsupplemented groups . Exercise did not significantly affect vitamin , Hcy , or MMA concentrations . No significant effect of either intervention was observed on the neuropsychological tests . CONCLUSIONS The decrease in Hcy and MMA in frail elders confirms a sub clinical metabolic deficiency state . Enriched foods containing physiologic amounts of micronutrients have a beneficial effect on these metabolites . No effects of B vitamins on mental health were identified Paulinia cupana ( guarana ) is a Brazilian plant given great prestige in popular medicine , for example as being a potent stimulator of brain functions . The authors assessed the effects of the long-term administration of guarana on the cognition of normal , elderly volunteers . Forty-five volunteers were studied , with a r and om distribution in three experimental groups : placebo ( n = 15 ) , caffeine ( n = 15 ) , and guarana ( n = 15 ) , in a double-blind study . There were no significant cognitive alterations in these volunteers Objective : To determine the efficacy of acetyl-l-carnitine ( ALCAR ) on the rate of decline in early-onset AD patients . Methods : A 1-year , multicenter , double-blind , placebo-controlled , r and omized trial was conducted . Subjects were 45 to 65 years old , with a diagnosis of probable AD according to National Institute of Neurological Communicative Disorders – Alzheimer ’s Disease and Related Disorders Association criteria and had a Mini-Mental State Examination ( MMSE ) score between 12 and 26 . They were treated with ALCAR ( 1 g tid ) or placebo . Primary outcome measures were the Alzheimer ’s Disease Assessment Scale – Cognitive Component and the Clinical Dementia Rating Scale . Secondary measures included the ADAS Non-Cognitive Subscale , the MMSE , an Activities of Daily Living Scale ( ADL ) , and a Clinician-Based Impression of Change ( CIBIC ) . Results : Two-hundred twenty-nine patients were enrolled and r and omized to drug treatment , with 117 taking placebo and 112 taking ALCAR . There were no significant differences between the two groups at baseline . For the primary outcome measures , there were no significant differences between the treatment groups on the change from baseline to endpoint in the intent-to-treat analysis . In the completer sample only , there was less deterioration in the MMSE for the ALCAR-treated subjects . There was no difference in rate of decline on the CIBIC and the ADL scale . There were no significant differences in the incidence of adverse events by treatment arm . Conclusion : Overall , in a prospect ively performed study in young-onset AD patients , ALCAR failed to slow decline . Less decline was seen on the MMSE in the completer sample only , with the difference being mediated by reducing decline in attention . A combination of ALCAR and a cholinesterase inhibitor should be tested for additivity OBJECTIVES To assess the longitudinal effects of acety-L-carn OUTPUT: Despite the heterogeneity in trial design , the results of this review suggest that nutritional supplements may improve the cognitive functioning of elderly persons and do no harm . 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-d OUTPUT:

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*** ***EXAMPLES*** 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 Study objective : To determine if a self help intervention , delivered via written interactive material s ( the “ Walk in to Work Out ” pack ) , could increase active commuting behaviour ( walking and cycling ) . Design : R and omised controlled trial . The intervention group received the “ Walk in to Work Out ” pack , which contained written interactive material s based on the transtheoretical model of behaviour change , local information about distances and routes , and safety information . The control group received the pack six months later . Focus groups were also conducted after six months . Setting : Three workplaces in the city of Glasgow , Scotl and , UK . Participants : 295 employees who had been identified as thinking about , or doing some irregular , walking or cycling to work . Main results : The intervention group was almost twice as likely to increase walking to work as the control group at six months ( odds ratio of 1.93 , 95 % confidence intervals 1.06 to 3.52 ) . The intervention was not successful at increasing cycling . There were no distance travelled to work , gender , or age influences on the results . Twenty five per cent ( 95 % confidence intervals 17 % to 32 % ) of the intervention group , who received the pack at baseline , were regularly actively commuting at the 12 month follow up . Conclusion : The “ Walk in to Work Out ” pack was successful in increasing walking but not cycling . The environment for cycling must be improved before cycling will become a popular option Aims : To evaluate the effect of site specific advice from a school travel coordinator on school travel patterns . Methods : Cluster r and omised controlled trial of children attending 21 primary schools in the London boroughs of Camden and Islington . A post-intervention survey measured the proportion of children walking , cycling , or using public transport for travel to school , and the proportion of parents/carers very or quite worried about traffic and abduction . The proportion of schools that developed and implemented travel plans was assessed . Results : One year post-intervention , nine of 11 intervention schools and none of 10 control schools had travel plans . Proportions of children walking , cycling , or using public transport on the school journey were similar in intervention and control schools . The proportion of parents who were very or quite worried about traffic danger was similar in the intervention ( 85 % ) and control groups ( 87 % ) . However , after adjusting for baseline and other potential confounding factors we could not exclude the possibility of a modest reduction in parental concern about traffic danger as a result of the intervention . Conclusions : Having a school travel coordinator increased the production of school travel plans but there was no evidence that this changed travel patterns or reduced parental fears . Given the uncertainty about effectiveness , the policy of providing school travel coordinators should only be implemented within the context of a r and omised controlled trial 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 OUTPUT: A r and omised controlled trial in the workplace setting , conducted in a pre-selected group who were already contemplating or preparing for active travel , found improved health-related quality of life on some sub scales , and increased walking . AUTHORS ' CONCLUSIONS There is insufficient evidence to determine whether organisational travel plans are effective for improving health or changing travel mode . 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 OUTPUT:

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*** ***EXAMPLES*** INPUT: AIMS This multicentre prospect i ve r and omised trial was undertaken to evaluate the usefulness of an electrophysiological study (EPS)-guided/implantable cardioverter defibrillator ( ICD ) strategy in patients at high risk of sudden death ( SD ) early after myocardial infa rct ion ( MI ) . Previous studies have shown the benefits of such a strategy only in high-risk patients late after MI . METHODS AND RESULTS We enrolled 143 survivors of acute MI ( < 1 month ) with left ventricular ejection fraction < or = 35 % and either frequent ( > or = 10/h ) premature ventricular complexes ( PVCs ) , or depressed heart rate variability ( SDNN < 70 ms ) or abnormal signal-averaged ECG , who were able to tolerate optimised beta-blocker therapy ( 68 + /- 40 mg/day of metoprolol ) . Of these , 138 were r and omised , in a 2:3 ratio , to two therapeutic strategies : conventional ( CONV ) strategy ( n = 59 ) or EPS-guided/ICD strategy ( n = 79 ) . The latter result ed in ICD implantation in 24 inducible patients and in CONV therapy in the remaining 55 . During a mean follow-up of 540 + /- 378 days , 26 patients ( 19 % ) died : nine ( 6.5 % ) SD , nine ( 6.5 % ) non-SD , and four ( 3 % ) non-cardiac death ; in four patients ( 3 % ) the cause of death was unknown . The actuarial overall mortality for the CONV and EPS-guided/ICD arms was 18 % vs 14 % after 1 year and 29.5 % vs 20 % after 2 years , respectively ( P = 0.3 and 0.2 ) . CONCLUSIONS Despite optimal therapy , mortality remains significant in high-risk patients following MI . Although there is a trend in favour of EPS-guided/ICD , our data are insufficient to demonstrate a survival benefit of this strategy early after MI STUDY OBJECTIVES Pocket hematoma is a common complication after pacemaker or implantable cardioverter defibrillator ( ICD ) implantation . Thus , we investigated the influence of patient comorbidity , implantation strategy , operator experience , antiplatelet therapy , and anticoagulation therapy on hematoma rate . DESIGN Between 1990 and 2002 , a total of 3,164 devices ( pectoral pacemakers , 2,792 ; ICDs , 372 ) were implanted at our institution . Predictors of hematoma occurrence were determined prospect ively and were analyzed by multivariate regression analysis . Operator experience was grade d by individual implantation number , as follows : low , < 50 ; medium , 50 to 100 ; and high , > 100 . RESULTS The incidence of pocket hematoma was 4.9 % , leading to prolonged hospitalization in 2.0 % of all patients . Reoperation for pocket hematoma was required in 1.0 % of patients . High-dose heparinization ( hazard ratio [ HR ] , 4.2 ) , combined acetylsalicylic acid (ASA)/thienopyridine treatment after coronary stenting ( HR , 5.2 ) , and low operator experience ( HR , 1.6 ) were independently predictive of hematoma development . Therapy with ASA alone did not increase the hematoma rate compared to patients who did receive antiplatelet or anticoagulation therapy ( 3.1 % vs 2.5 % , respectively ; difference not significant ) . In patients with nonvalvular atrial fibrillation , postoperative high-dose heparinization substantially increased the hematoma rate ( 10.7 % vs 2.9 % , respectively ; p < 0.001 ) without reducing the rate of arterial embolism within the first month after implantation ( 0.18 % vs 0.21 % , respectively ; difference not significant ) . The infection rate ( 0.28 % within 3 months after implantation ) was not influenced by the presence of the pocket hematoma . CONCLUSIONS The use of high-dose heparinization and combined ASA/thienopyridine treatment are highly predictive for the occurrence of intraoperative bleeding and pocket hematoma in patients who have undergone pacemaker and ICD surgery . We propose recommendations for the management of antiplatelet and anticoagulation therapy in patients undergoing these interventions AIMS Electrical storm ( ES ) is a life-threatening arrhythmia complication affecting patients treated with an implantable cardioverter defibrillator ( ICD ) . Despite its increasing importance , existing data on prognosis and management of ICD patients affected by ES are limited and conflicting . METHODS We prospect ively studied 169 consecutive patients receiving an ICD . Thirty-two patients presented with at least one episode of ES during the period of observation ( 33+/-26 months ) . ES patients were older ( 64+/-9 vs. 59+/-13 years , P=0.013 ) with more advanced congestive heart failure ( CHF ) but a similar incidence of an underlying organic heart disease . RESULTS Long-term total and cardiac mortality were both increased among ES patients . Seventeen of the 32 ES patients died as opposed to 19 of the 137 ICD patients without ES ( 53 vs. 14 % , P<0.001 ) . In multivariate Cox regression analysis adjusted for the main confounders , history of ES was significantly and independently associated with total and cardiac mortality ( risk ratio (RR)=2.13 , P=0.031 and RR=2.59 , P=0.019 , respectively ) . CONCLUSION ES is a relatively frequent complication affecting ICD patients treated for secondary prevention of sudden cardiac death ( SCD ) . Although OUTPUT: In a series of univariate meta-regression sensitivity analyses , none of the covariates we examined ( duration of follow-up , primary vs. secondary prevention , ischemic cause , presence of cardiac resynchronization therapy , NYHA class , mean age , mean LVEF , or mean QRS duration ) contributed to the moderate statistical heterogeneity observed in our meta- analysis of all-cause mortality . 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 OUTPUT:

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 .

MS2_dynamic_1_shot217

***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*** ***EXAMPLES*** INPUT: Background Type 2 diabetes is rapidly growing as a proportion of the disease burden in Australia as elsewhere . This study addresses the cost effectiveness of an integrated approach to assisting general practitioners ( GPs ) with diabetes management . This approach uses a central ized data base of clinical data of an Australian Division of General Practice ( a network of GPs ) to co-ordinate care according to national guidelines . Methods Long term outcomes for patients in the program were derived using clinical parameters after 5 years of program participation , and the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Outcomes Model , to project outcomes for 40 years from the time of diagnosis and from 5 years post-diagnosis . Cost information was obtained from a range of sources . While program costs are directly available , and costs of complications can be estimated from the UKPDS model , other costs are estimated by comparing costs in the Division with average costs across the state or the nation . The outcome and cost measures are used derive incremental cost-effectiveness ratios . Results The clinical data show that the program is effective in the short term , with improvement or no statistical difference in most clinical measures over 5 years . Average HbA1c levels increased by less than expected over the 5 year period . While the program is estimated to generate treatment cost savings , overall net costs are positive . However , the program led to projected improvements in expected life years and Quality Adjusted Life Expectancy ( QALE ) , with incremental cost effectiveness ratios of $ A8,106 per life-year saved and $ A9,730 per year of QALE gained . Conclusions The combination of an established model of diabetes progression and generally available data has provided an opportunity to establish robust methods of testing the cost effectiveness of a program for which a formal control group was not available . Based on this methodology , integrated health care delivery provided by a network of GPs improved health outcomes of type 2 diabetics with acceptable cost effectiveness , which suggests that similar outcomes may be obtained elsewhere Objectives : To determine the effects of a nurse led intermediate care programme in patients who have been hospitalised with an acute exacerbation of chronic obstructive pulmonary disease ( AE COPD ) . Design : R and omised controlled trial . Setting : Community and hospital care in west London . Participants : 122 patients with COPD . Intervention : A care package incorporating initial pulmonary rehabilitation and self-management education , provision of a written , personalised COPD action plan , monthly telephone calls and 3 monthly home visits by a specialist nurse for a period of 2 years . Main outcome measure : Hospital readmission rate . Secondary outcomes : Unscheduled primary care consultations and quality of life . Results : There were no differences in hospital admission rates or in exacerbation rates between the two groups . Self-management of exacerbations was significantly different and the intervention group were more likely to be treated with oral steroids alone or oral steroids and antibiotics , and the initiators of treatment for exacerbations were statistically more likely to be the patients themselves . 12 patients in the control group died during the 2 year period , eight as a result of COPD , compared with six patients in the intervention group , of whom one died from COPD . This is a significant difference . When the numbers were adjusted to reflect the numbers still alive at 2 years , in the intervention group patients reported a total of 171 unscheduled contacts with their general practitioner ( GP ) and in the control group , 280 contacts . The number needed to treat was 0.558—ie , for every one COPD patient receiving the intervention and self-management advice , there were 1.79 fewer unscheduled contacts with the GP . Conclusions : An intermediate care package incorporating pulmonary rehabilitation , self-management education and the receipt of a written COPD action plan , together with regular nurse contact , is associated with a reduced need for unscheduled primary care consultations and a reduction in deaths due to COPD but did not affect the hospital readmission rate OBJECTIVE To determine the long-term effects on total healthcare costs of the Improving Mood : Promoting Access to Collaborative Treatment ( IMPACT ) program for late-life depression compared with usual care . STUDY DESIGN R and omized controlled trial with enrollment from July 1999 through August 2001 . The IMPACT trial , conducted in primary care practice s in 8 delivery organizations across the United States , enrolled 1801 depressed primary care patients 60 years or older . Data are from the 2 IMPACT sites for which 4-year cost data were available . Trial enrollment across these 2 health maintenance organizations was 551 patients . METHODS Participants were r and omly assigned to the IMPACT intervention ( n = 279 ) or to usual primary care ( n = 272 ) . Intervention patients had access to a depression care manager who provided education , behavioral activation , support of antidepressant medication management prescribed by their regular primary care provider , and problem-solving treatment in primary care for up to 12 months . Care managers were supervised by a psychiatrist and a primary care provider . The main outcome measures were healthcare costs during 4 years . RESULTS IMPACT participants had lower mean total healthcare costs ( $ 29 422 ; 95 % confidence interval , $ 26 479-$32 365 ) than usual care patients ( $ 32 785 ; 95 % confidence interval , $ 27 648-$37 921 ) during 4 years . Results of a bootstrap analysis suggested an 87 % probability that the IMPACT program was associated with lower healthcare costs than usual care . CONCLUSION Compared with usual primary care , the IMPACT program is associated with a high probability of lower total healthcare costs during a 4-year period OBJECTIVE This study explored the cost-effectiveness of quality -improvement interventions for depression in primary care , relative to usual care , among patients with subthreshold depression or depressive disorder . METHODS A total of 746 primary care patients in managed care organizations with 12-month depressive disorder and 502 with current depressive symptoms but no disorder ( sub OUTPUT: Although it is widely believed that disease management programs reduce healthcare expenditures , the present study shows that evidence for this cl aim is still inconclusive . 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: There is limited information on the effects of vitamin D on serum 25 hydroxyvitamin D ( 25OHD ) in young people and none on African Americans . The main objective of this trial was to measure the effect of different doses of vitamin D3 on serum 25OHD and serum parathyroid hormone ( PTH ) in young women with vitamin D insufficiency ( serum 25OHD ≤ 20 ng/mL ( 50 nmol/L ) . A r and omized double-blind placebo-controlled trial of vitamin D3 was conducted in young white and African American women , age 25 to 45 years . A total of 198 healthy white ( 60 % ) and African American ( 40 % ) women were r and omly assigned to placebo , or to 400 , 800 , 1600 , or 2400 IU of vitamin D3 daily . Calcium supplements were added to maintain a total calcium intake of 1000 to 1200 mg daily . The primary outcomes of the study were the final serum 25OHD and PTH levels at 12 months . The absolute increase in serum 25OHD with 400 , 800 , 1600 , and 2400 IU of vitamin D daily was slightly greater in African American women than in white women . On the highest dose of 2400 IU/d , the mixed model predicted that mean 25OHD increased from baseline 12.4 ng/mL ( 95 % confidence interval [ CI ] , 9.2 - 15.7 ) to 43.2 ng/mL ( 95 % CI , 38.2 - 48.1 ) in African American women and from 15.0 ng/mL ( 95 % CI , 12.3 - 17.6 ) to 39.1 ng/mL ( 95 % CI , 36.2 - 42.0 ) in white women . There was no significant effect of vitamin D dose on serum PTH in either race but there was a significant inverse relationship between final serum PTH and serum 25OHD . Serum 25OHD exceeded 20 ng/mL in 97.5 % of whites on the 400 IU/d dose and between 800 and 1600 IU/d for African Americans . The recommended dietary allowance ( RDA ) suggested by the Institute of Medicine for young people is 600 IU daily . The increase in serum 25OHD after vitamin D supplementation was similar in young and old , and in white and African American women OBJECTIVE In observational studies , low serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease . RESEARCH DESIGN AND METHODS We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and /or impaired glucose tolerance ( IGT ) r and omly assigned to 20,000 IU/week vitamin D3 or placebo . An oral glucose tolerance test was performed at baseline and after 1 year . RESULTS Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively . With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year . There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly . Only analyzing subjects with 25(OH)D < 50 nmol/L did not change the results . CONCLUSIONS This study shows that vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and /or IGT CONTEXT Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality . Data from r and omized controlled trials are limited . OBJECTIVE The aim of this study was to test whether daily doses of vitamin D(3 ) at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease ( CVD ) risk . DESIGN We conducted a parallel-group , double-blind , placebo-controlled r and omized controlled trial . R and omization was computer generated . Participants and study investigators were blinded to intervention groupings throughout the trial . SETTING The study was conducted at the Clinical Research Facility , University of Aberdeen , United Kingdom . PARTICIPANTS A total of 305 healthy postmenopausal women aged 60 - 70 yr were recruited for the study . INTERVENTION Each woman received a daily capsule of 400 or 1000 IU vitamin D(3 ) or placebo r and omly allocated . MAIN OUTCOME MEASURES Primary outcomes were serum lipid profile [ total , high-density lipoprotein , and low-density lipoprotein cholesterol ; triglycerides ; and apolipoproteins A-1 and B100 ] , insulin resistance ( homeostatic model assessment ) , inflammatory biomarkers ( high-sensitivity C-reactive protein , IL-6 , soluble intracellular adhesion molecule-1 ) , and blood pressure . RESULTS A total of 265 ( 87 % ) participants completed all study visits . Small differences between groups for serum apol OUTPUT: In subgroup analyses , it was shown that the effect of vitamin D supplementation on risk of hypercalcemia , hypercalciuria , or kidney stones was not modified by baseline 25-hydroxyvitamin D , vitamin D dose and duration , or calcium co-supplementation . CONCLUSIONS Long-term vitamin D supplementation result ed in increased risks of hypercalcemia and hypercalciuria , which were not dose related . However , vitamin D supplementation did not increase risk of kidney stones . 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 OUTPUT:

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

MS2_dynamic_1_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*** ***EXAMPLES*** INPUT: Objective : To prospect ively compare the functional outcome associated with cemented and uncemented hemiarthroplasty . Design : Prospect i ve r and omized control trial . Setting : University-affiliated level 1 trauma center . Patients / Participants : All individuals design ated for hemiarthroplasty , older than 55 years , with a nonpathologic displaced femoral neck fracture and the ability to ambulate 10 feet independently before injury [ 269 patients ( 274 hips ) presented with displaced femoral neck fracture , 130 patients ( 48.3 % ) enrolled , and 5 patients ( 3.8 % ) withdrew ] . Intervention : Hip hemiarthroplasty with a cemented femoral prosthesis ( VerSys LD/Fx ; Zimmer , Warsaw , IN ) or an uncemented component ( VerSys Beaded FullCoat ; Zimmer , Warsaw , IN ) . Main Outcome Measures : Instrumental Activities of Daily Living and Physical Activities of Daily Living scales ( Older Americans Re sources and Services Instrument ) and the Energy/Fatigue Scale . Results : No statistically significant differences were present in the groups ' preoperative or intraoperative characteristics , including American Society of Anesthesiologists grade , operative time , anesthesia time , use of perioperative & bgr;-blockers , estimated blood loss , or the rate of intraoperative fracture . Postoperatively , no difference was found in hemoglobin level , transfusion rate , discharge disposition , or acute complication rate . At 30-day , 60-day , and 1-year follow-ups , no clinical ly or statistically significant differences were found in mortality , disposition , need for assistance with ambulation , Older Americans Re sources and Services Activities of Daily Living subscales , or the Energy/Fatigue Scale . Conclusions : In the treatment of nonpathologic displaced femoral neck fractures , the use of cemented and uncemented femoral components is associated with similar functional outcome at 1 year . Practitioners may inform their clinical decisions using these equally good results . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence Hip hemiarthroplasties are frequently performed for displaced femoral neck fractures . The purpose of this study was to identify the costs associated with cementless and cemented hemiarthroplasties , compare operative times , and identify complications . The hypothesis was that cementless hemiarthroplasties cost less than cemented hemiarthroplasties , require less operative time , and have fewer perioperative complications . A retrospective review was conducted of 2 surgeons ' patients admitted for displaced femoral neck fractures between 2006 and 2010 . Group 1 included 45 patients who underwent monopolar hemiarthroplasties with cementless femoral components via a st and ard posterior approach by a single surgeon . Group 2 included 49 patients who underwent monopolar hemiarthroplasties with cemented femoral components via a modified lateral approach by a single surgeon . Surgical and anesthesia times and the cost of implants and accessories were recorded . The cost for cementless components was $ 3275.60 ( femoral stem , $ 2800 ; monopolar head , $ 400 ; sleeve , $ 75.60 ) , whereas the cost of cemented components was $ 3694.47 ( femoral stem , $ 1800 ; monopolar head , $ 400 ; sleeve , $ 75.60 , 3 Simplex with tobramycin cement packets , $ 1221 ; cement mixer/irrigator with tip/ central izer and plug/pressurizer , $ 197.87 ) , a cost savings of 12.7 % ( $ 418.87 ) . Operative time was significantly reduced in group 1 vs group 2 ( mean , 32.9 vs 56.1 minutes , respectively ; P<.01 ) . Anesthesia time was also significantly reduced in group 1 ( mean , 82.3 vs 102.9 minutes , respectively ; P<.01 ) . The difference in mean anesthetic times demonstrates an overall cost savings of 18.6 % , or $ 1161.30 . No difference in complications was noted between the groups perioperatively . Regional cost variances , vendor-hospital contracts , and surgeons ' operative times are factors that may influence cost savings . This study demonstrates significantly lower operative and anesthetic times and observable cost savings with cementless femoral implants Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by OUTPUT: There was no statistically significant difference for any other outcome between the two methods of fixation . Conclusion In hemiarthroplasty of the hip using current generation stems , cemented stems result in fewer implant‐related complications and similar mortality compared with cementless stems 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 , OUTPUT:

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

MS2_dynamic_1_shot220

***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*** ***EXAMPLES*** INPUT: Background Gut microbiota is now known to control glucose metabolism . Previous studies have shown that probiotics and prebiotics may improve glucose metabolism , but their effects have not been studied in combination with drug therapy . The aim of this study was to investigate whether probiotics and prebiotics combined with drug therapy affect diabetic outcomes . Methods Two different study design s were used to test gut microbiota modulating treatments with metformin ( MET ) or sitagliptin ( SITA ) in male C57Bl/6J mice . In Design 1 , diabetes was induced with four-week feeding with a ketogenic , 72 kcal% fat diet with virtually no carbohydrates . Mice were then r and omly divided into four groups ( n = 10 in each group ) : ( 1 ) vehicle , ( 2 ) Bifidobacterium animalis ssp . lactis 420 ( B420 ) ( 109 CFU/day ) , ( 3 ) MET ( 2 mg/mL in drinking water ) , or ( 4 ) MET + B420 ( same doses as in the MET and B420 groups ) . After another 4 weeks , glucose metabolism was assessed with a glucose tolerance test . Fasting glucose , fasting insulin and HOMA-IR were also assessed . In Design 2 , mice were fed the same 72 kcal% fat diet to induce diabetes , but they were simultaneously treated within their respective groups ( n = 8 in each group ) : ( 1 ) non-diabetic healthy control , ( 2 ) vehicle , ( 3 ) SITA [ 3 mg/(kg*day ) ] ( 4 ) SITA with prebiotic polydextrose ( PDX ) ( 0.25 g/day ) , ( 5 ) SITA with B420 ( 109 CFU/day ) , and ( 6 ) SITA + PDX + B420 . Glucose metabolism was assessed at 4 weeks , and weight development was monitored for 6 weeks . Results In Design 1 , with low-dose metformin , mice treated with B420 had a significantly lower glycemic response ( area under the curve ) ( factorial experiment , P = 0.002 ) and plasma glucose concentration ( P = 0.02 ) compared to mice not treated with B420 . In Design 2 , SITA + PDX reduced glycaemia in the oral glucose tolerance test significantly more than SITA only ( area under the curve reduced 28 % , P < 0.0001 ) . In addition , B420 , PDX or B420+PDX , together with SITA , further decreased fasting glucose concentrations compared to SITA only ( −19.5 , −40 and −49 % , respectively , P < 0.01 for each comparison ) . The effect of PDX may be due to its ability to increase portal vein GLP-1 concentrations together with SITA ( P = 0.0001 compared to vehicle ) whereas SITA alone had no statistically significant effect compared to vehicle ( P = 0.14 ) . Conclusions This study proposes that combining probiotics and /or prebiotics with antidiabetic drugs improves glycemic control and insulin sensitivity in mice . Mechanisms could be related to incretin secretion Background Recently , the relationship between gut microbiota and obesity has been highlighted . The present r and omized , double-blind , placebo-controlled study aim ed to evaluate the efficacy of transglucosidase ( TGD ) in modulating blood glucose levels and body weight gain in patients with type 2 diabetes mellitus ( T2DM ) and to clarify the underlying mechanism by analyzing the gut microbiota of T2DM patients . Methods This study included 60 patients who received placebo or TGD orally ( 300 or 900 mg/day ) for 12 weeks , and blood and fecal sample s were collected before and after 12 weeks . Comparisons of fecal bacterial communities were performed before and after the TGD treatment and were performed between T2DM patients and 10 healthy individuals , using the terminal-restriction fragment length polymorphism analysis . Results The Clostridium cluster IV and subcluster XIVa components were significantly decreased , whereas the Lactobacillales and Bifidobacterium population s significantly increased in the T2DM patients compared with the healthy individuals . By dendrogram analysis , most of the healthy individuals ( 6/10 ) and T2DM patients ( 45/60 ) were classified into cluster I , indicating no significant difference in fecal bacterial communities between the healthy individuals and the T2DM patients . In the placebo and TGD groups , the bacterial communities were generally similar before and after the treatment . However , after 12 weeks of TGD therapy , the Bacteroidetes-to-Firmicutes ratio in the TGD groups significantly increased and was significantly higher compared with that in the placebo group , indicating that TGD improved the growth of the fecal bacterial communities in the T2DM patients . Conclusions Therefore , TGD treatment decreased blood glucose levels and prevented body weight gain in the T2DM patients by inducing the production of oligosaccharides in the alimentary tract and modulating gut microbiota composition . Trial registration UMIN-CTR A high-fat diet ( HFD ) induces obesity and the associated increases in blood glucose and inflammation through changes in gut microbiota , endotoxemia , and increased gut permeability . To counteract this , research ers have suggested that the use of probiotics that suppress production of proinflammatory lipopolysaccharide ( LPS ) . Here , we tested whether Lactobacillus sakei OK67 , which inhibits gut microbiota LPS production selected from among the lactic acid bacteria isolated from kimchi , exerted antihypoglycemic or anti-inflammatory effects in HFD-f OUTPUT: Among the commonly reported findings , the genera of Bifidobacterium , Bacteroides , Faecalibacterium , Akkermansia and Roseburia were negatively associated with T2D , while the genera of Ruminococcus , Fusobacterium , and Blautia were positively associated with T2D . 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 < OUTPUT:

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

MS2_dynamic_1_shot221

***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*** ***EXAMPLES*** INPUT: Healing of the extraction socket after tooth removal involves retention of the blood clot followed by a sequence of events that lead to changes in the alveolar process in a three dimensional fashion . This normal healing event results in a minimal loss of vertical height ( around 1 mm ) , but a substantial loss of width in the buccal-lingual plane ( 4 - 6 mm ) . During the first three months following extraction that loss has been shown to be significant and may result in both a hard tissue and soft tissue deformity affecting the ability to restore the site with acceptable esthetics . Procedures that reduce the resorptive process have been shown to be predictable and potentially capable of eliminating secondary surgery for site preparation when implant therapy is planned . The key element is prior planning by the dental therapist to act at the time of extraction to prevent the collapse of the ridge due to the loss of the alveolus . Several techniques have been employed as ridge preservation procedures involving the use of bone grafts , barrier membranes and biologics to provide a better restorative outcome . This review will explore the evidence behind each technique and their efficacy in accomplishing site preparation . The literature does not identify a single technique as superior to others ; however , all accepted therapeutic procedures for ridge preservation have been shown to be more effective than blood clot alone in r and omized controlled studies OBJECTIVE To volumetrically evaluate soft tissue changes of different ridge preservation techniques compared to spontaneous healing 6 months after tooth extraction . MATERIAL S AND METHODS In each of 40 patients , one single-rooted tooth was extracted and four treatment modalities were r and omly assigned to the following groups ( n = 10 each ) : A ) ß-tricalcium-phosphate-particles with a polylactid coating ( ß-TCP ) , B ) demineralized bovine bone mineral with 10 % collagen covered with a collagen matrix ( DBBM-C/CM ) , C ) DBBM with 10 % collagen covered with an autogenous soft tissue punch graft ( DBBM-C/PG ) , D ) spontaneous healing ( control ) . Impressions were obtained before extraction and 6 months later , casts were digitized and volumetric changes at the buccal soft tissues were determined . One-way anova was performed and pair-wise Wilcoxon rank sum test with Bonferroni-Holm method was applied for comparison of differences between two groups . RESULTS After 6 months , horizontal contour changes accounted for -1.7 ± 0.7 mm ( A ) , -1.2 ± 0.5 mm ( B ) , -1.2 ± 0.7 mm ( C ) and -1.8 ± 0.8 mm ( D ) . None of the group comparisons reached statistical significance . CONCLUSIONS Six months after tooth extraction all groups revealed a horizontal volume change in the buccal soft tissue contour . Application of DBBM-C/CM or DBBM-C/PG reduced the amount of volume resorption compared to ß-TCP or spontaneous healing without reaching statistically significant difference PURPOSE This r and omized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the β-TCP bone graft material that contains ErhBMP-2 . MATERIAL S AND METHODS This study involved 72 patients at the 3 study centers . The patients , who were divided into 2 groups : the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction . CT was taken before and 3 months after the transplantation and healing status was compared between the two groups . The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width . The paired t test was used to determine the significance of the changes ( P<.05 ) . RESULTS Changes in alveolar bone height were -1.087 ± 1.413 mm in the control group and -.059 ± 0.960 mm in the experimental group ( P<.01 ) . At 25 % extraction socket length [ ESL ] , the changes were 0.006 ± 1.149 mm in the control group and 1.279 ± 1.387 mm in the experimental group . At 50 % ESL , the changes were 0.542 ± 1.157 mm and 1.239 ± 1.249 mm , respectively ( P<.01 for 25 % ESL , and P<.05 for 50 % ESL ) . During the experiment , no adverse reactions to the graft material were observed . CONCLUSION ErhBMP-2 coated β-TCP/HA were found to be more effective in preserving alveolar bone than conventional β-TCP/HA alloplastic bone graft material The aim of the study was to determine the fate of demineralized freeze-dried bone allograft ( DFDBA ) used in conjunction with a barrier membrane in the management of extraction sockets and deficient alveolar ridges , and to compare the amount of bone formed with that found in untreated sites . Ten biopsies were obtained from 8 grafted patients . Five biopsies were harvested from untreated sites during routine implant placement and analyzed for comparison . In the socket management procedure , DFDBA was packed tightly into the socket and covered with an exp and ed polytetrafluoroethylene ( e-PTFE ) membrane . Primary closure was achieved in all cases . In the ridge regeneration procedure , cortical columns were placed in the ridge projecting outward approximately 3 mm to create and maintain space for DFDBA particles packed between them ; the columns were then covered by an e-PTFE membrane . Healing time ranged from 8 to 23 months . At the time of implant placement , bone cores ( 7 mm x 2 mm ) were harvested , fixed OUTPUT: After flapless extraction of teeth , and using a minimum healing period of 12 weeks as a temporal measure , xenografts and allografts result ed in the least loss of socket dimensions compared to alloplasts or sockets with no grafting . Histologic outcomes after a minimum of 12 weeks of healing showed that sockets grafted with alloplasts had the maximum amount of vital bone and the least amount of remnant graft material and remnant connective tissue . There is a limited but emerging body of evidence for the predictable regeneration of deficient buccal bone with socket grafting material s , need for barrier membranes , use of tissue engineering , and use of autogenous soft tissue grafts from the palate to cover the socket 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 ) OUTPUT:

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 .

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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*** ***EXAMPLES*** INPUT: BACKGROUND A prospect i ve study was conducted to compare the effect of an anterolateral approach in the supine position ( ALS ) with that of a direct lateral ( DL ) approach on gait motion , including trunk deflection , in walking after total hip arthroplasty . We hypothesized that trunk deflection in walking after ALS would be significantly improved in comparison with use of the DL approach . METHODS The subjects were 15 patients , with 7 in the ALS group and 8 in the DL group . Walking before and 9 and 28 weeks after surgery was analyzed using 3-dimensional motion analysis . RESULTS Walking velocity , stride length , hip joint range of motion in the sagittal plane in walking , and locomotion range of trunk inclination were significantly improved 28 weeks after surgery in both groups . In gait analysis , there were no significant differences between the 2 groups . CONCLUSION This study was conducted to compare the effect of ALS with that of a DL approach on locomotion in walking after total hip arthroplasty . Hip pain at 9 weeks after surgery was significantly improved using ALS compared to the DL approach , but there were no significant differences in gait function at 28 weeks after surgery using ALS or DL approach . Further long-term studies are required to examine differences between these procedures Introduction Minimally invasive total hip arthroplasty ( THA ) is cl aim ed to be superior to the st and ard technique , due to the potential reduction of soft tissue damage via a smaller and tissue-sparing approach . As a result of the lack of objective evidence of fewer muscle and tendon defects , controversy still remains as to whether minimally invasive total hip arthroplasty truly minimizes muscle and tendon damage . Therefore , the objective was to compare the influence of the surgical approach on abductor muscle trauma and to analyze the relevance to postoperative pain and functional recovery . Material s and methods Between June 2006 and July 2007 , 44 patients with primary hip arthritis were prospect ively included in the study protocol . Patients underwent cementless unilateral total hip arthroplasty either through a minimally invasive anterolateral approach ( ALMI ) ( n = 21 ) or a modified direct lateral approach ( mDL ) ( n = 16 ) . Patients were evaluated clinical ly and underwent MR imaging preoperatively and at 3 and 12 months postoperatively . Clinical assessment contained clinical examination , performance of abduction test and the survey of a function score using the Harris Hip Score , a pain score using a numeric rating scale ( NRS ) of 0–10 , as well as a satisfaction score using an NRS of 1–6 . Additionally , myoglobin and creatine kinase were measured preoperatively , and 6 , 24 and 96 h postoperatively . Evaluation of the MRI images included fatty atrophy ( rating scale 0–4 ) , tendon defects ( present/absent ) and bursal fluid collection of the abductor muscle . Results Muscle and tendon damage occurred in both groups , but more lateral gluteus medius tendon defects [ mDL 3/12mth . : 6 (37%)/4 ( 25 % ) ; ALMI : 3 (14%)/2 ( 9 % ) ] and muscle atrophy in the anterior part of the gluteus medius [ mean-st and ard ( 12 ) : 1.75 ± 1.8 ; mean-MIS ( 12 ) : 0.98 ± 1.1 ] were found in patients with the mDL approach . The clinical outcome was also poorer compared to the ALMI group . Significantly , more Trendelenburg ’s signs were evident and lower clinical scores were achieved in the mDL group . No differences in muscle and tendon damage were found for the gluteus minimus muscle . A higher serum myoglobin concentration was measured 6 and 24 h postoperatively in the mDL group ( 6 h : 403 ± 168 μg/l ; 24 h : 304 ± 182 μg/l ) compared to the ALMI group ( 6 h : 331 ± 143 μg/l ; 24 h : 268 ± 145 μg/l ) . Conclusion Abductor muscle and tendon damage occurred in both approaches , but the gluteus medius muscle can be spared more successfully via the minimally invasive approach and is accompanied by a better clinical outcome . Therefore , going through the intermuscular plane , without any detachment or dissection of muscle and tendons , truly minimizes perioperative soft tissue trauma . Furthermore , MRI emerges as an important imaging modality in the evaluation of muscle trauma in THA BACKGROUND Total hip replacement using a minimally invasive surgical approach is cl aim ed to enable recovering of motor function more quickly . The purpose of this prospect i ve As per the stylesheet , kindly provide section headings for abstract . and r and omized study was to test this cl aim by evaluating early patient functional outcomes by gait analysis . METHODS Seventeen patients were operated on using a traditional anterolateral approach ( AL ) , 16 using a minimally invasive direct anterior approach ( DA ) . Gait analysis was performed the day before surgery , and at 6 and 12 weeks after surgery . Time-distance and kinematics analyses were performed by a recently proposed anatomically-based gait analysis protocol . A static double-leg stance and five walking trials at self-selected speeds were recorded on a 9-m walkway . FINDINGS At 6 weeks follow-up , but in the DA group only , a statistically significant improvement with respect to preoperative status was observed for the percentage of single support and for the stride time . Between 6- and 12-week follow-up , the DA group showed a significant improvement in cadence , stride time and length , walking speed , hip flexion at foot contact , maximum hip flexion in swing , and hip total range of motion in the sagittal and the coronal planes . Between 6 and 12 weeks , OUTPUT: Conclusions In this meta- analysis , gait speed and peak hip flexion within 3 months after surgery were significantly higher in the DAA group than in the ALA group . 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 OUTPUT:

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

MS2_dynamic_1_shot223

***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*** ***EXAMPLES*** 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 RATIONALE Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis . OBJECTIVES To test whether vitamin D supplementation of patients with tuberculosis ( TB ) improved clinical outcome and reduced mortality . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau . We included 365 adult patients with TB starting antituberculosis treatment ; 281 completed the 12-month follow-up . The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment . MEASUREMENTS AND MAIN RESULTS The primary outcome was reduction in a clinical severity score ( TBscore ) for all patients with pulmonary TB . The secondary outcome was 12-month mortality . No serious adverse effects were reported ; mild hypercalcemia was rare and present in both arms . Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo . Overall mortality was 15 % ( 54 of 365 ) at 1 year of follow-up and similar in both arms ( 30 of 187 for vitamin D treated and 24 of 178 for placebo ; relative risk , 1.19 [ 0.58 - 1.95 ] ) . HIV infection was seen in 36 % ( 131 of 359 ) : 21 % ( 76 of 359 ) HIV-1 , 10 % ( 36 of 359 ) HIV-2 , and 5 % ( 19 of 357 ) HIV-1 + 2 . CONCLUSIONS Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB ; it is possible that the dose used was insufficient . Clinical trial registered with www.controlled-trials.com/is rct n ( IS RCT N35212132 ) 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 inter OUTPUT: There were no significant changes in the surrogate outcomes of lipid fractions , glucose , or diastolic or systolic blood pressure . 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 OUTPUT:

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 .

MS2_dynamic_1_shot224

***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*** ***EXAMPLES*** INPUT: In a double-blind , placebo-controlled study we investigated the effects of dietary fish oil supplementation on arterial wall characteristics in 20 patients with non-insulin-dependent diabetes mellitus . Estimates reflecting compliance values in the large arteries and more peripheral vasculature , as measured by pulse-contour analysis , improved significantly after 6 weeks of fish oil therapy compared with values recorded at baseline and after 6 weeks ' administration of olive oil . The large-artery compliance estimate increased from 1.50 ( confidence interval [ CI ] , 1.31 to 1.69 ) mL/mm Hg at baseline to 1.68 ( CI , 1.52 to 1.84 ) mL/mm Hg after fish oil administration ( P < .01 ) . The oscillatory compliance value increased from 0.015 ( CI , 0.011 to 0.019 ) mL/mm Hg at baseline to 0.022 ( CI , 0.016 to 0.028 ) mL/mm Hg after fish oil ingestion ( P < .05 ) . No changes occurred in arterial blood pressure , cardiac output , stroke volume , or systemic vascular resistance with either intervention . The improved compliance estimates with fish oil ingestion occurred without altering fasting blood glucose and cholesterol concentrations . These results support the hypothesis that fish oils alter vascular reactivity and favorably influence arterial wall characteristics in patients with non-insulin-dependent diabetes mellitus . These direct vascular effects , expressed at the level of the vessel wall , may contribute to the cardioprotective actions of fish oil in humans Objective : Fish oil supplement has been proposed as a non-pharmacological strategy to correct the atherogenic lipid profile associated with type 2 diabetes mellitus . However , fish oil may have deleterious effects on lipid peroxidation and glycemic control . Design : In this study , 44 type 2 diabetic patients were r and omized to vitamin E st and ardized ( 53.6 mg/day ) supplementation ( capsules ) with 4 g daily of either fish oil ( n=23 ) or corn oil ( n=21 ) for 8 weeks preceded by a 4 week run-in period of corn oil supplementation . LDL was isolated by density gradient ultracentrifugation and oxidized in vitro with Cu2 + . As a marker of in vivo oxidation malondialdehyde concentration in LDL ( LDL-MDA ) was measured . Results : Fish oil reduced both mean lag time ( before , 57.8 ; after , 48.8 min , P<0.001 ) and mean propagation rate ( before , 0.018 ΔOD/min ; after , 0.015 ΔOD/min , P<0.001 ) , whereas corn oil had no influence on lag time and propagation rate . The changes in lag time and propagation rate differed significantly between fish oil and corn oil treatment . LDL-MDA changes differed borderline significantly between groups ( FO , 110.4 pmol/mg protein ; CO , 6.7 pmol/mg protein ; P=0.057 ) . Fish oil supplementation had no influence on glycemic control as assessed from HbA1c and fasting blood glucose . Conclusion : According to our findings , fish oil supplementation leads to increased in vivo oxidation and increased in vitro oxidation susceptibility of LDL particles . More studies are needed to clarify the clinical importance of this finding . Sponsorship : Financially supported by The Danish Heart Association and Dansk Droge A/S. Dansk Droge A/S generously provided the fish oil and corn oil capsules Summary This study was conducted to examine the effect of ω3 fatty acid supplementation on plasma lipid , cholesterol and lipoprotein fatty acid content of non-insulin-dependent diabetic individuals consuming a higher ( 0.65 , n = 10 ) or lower ( 0.44 , n = 18 ) ratio of dietary polyunsaturated to saturated fatty acid ( P/S ) . The participants were initially given an olive oil supplement ( placebo ) equivalent to 35 mg of 18:1 · kg body weight–1 · day–1 for 3 months . This was followed by two ω3 supplement periods in a r and omized crossover . In these 3-month periods , participants were given a linseed oil supplement equivalent to 35 mg of 18:3ω3 · kg body weight–1 · day–1 or a fish oil supplement equivalent to 35 mg of 20:5ω3 + 22:6ω3 · kg body weight–1 · day–1 . At the end of each supplement period , a blood sample was drawn from each participant for lipid , lipoprotein , insulin , glucagon and C-peptide analyses . At the end of each 3-month period a 7-day dietary record was completed to calculate dietary fat intake and P/S ratio . Results indicate that fish oil significantly reduced plasma triacylglycerol level ( p < 0.05 ) and increased 20:5ω3 and 22:6ω3 content of all lipoprotein lipid classes . Linolenic acid supplementation had no effect on plasma triacylglycerol level , but it increased 18:3ω3 content of lipoprotein cholesterol ester fractions ( p < 0.05 ) . A slight increase in 20:5ω3 , but not 22:6ω3 , content was noted in lipoprotein lipid classes as a result of 18:3ω3 supplementation . LDL and HDL cholesterol , insulin , glucagon and C-peptide levels were not affected by either ω3 supplement . It is concluded that a modest intake of ω3 fatty acids , such as could be obtained from consuming fish regularly , will reduce plasma triglyceride level without affecting LDL or HDL cholester OUTPUT: No significant change in or total or HDL cholesterol , HbA1c , fasting glucose , fasting insulin or body weight was observed . The increase in VLDL remained significant only in trials of longer duration and in hypertriglyceridemic patients . The elevation in LDL cholesterol was non-significant in subgroup analyses . No adverse effects of the intervention were reported . Omega-3 PUFA supplementation in type 2 diabetes lowers triglycerides and VLDL cholesterol , but may raise LDL cholesterol ( although results were non-significant in subgroups ) and has no statistically significant effect on glycemic control or fasting insulin . 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 OUTPUT:

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

MS2_dynamic_1_shot225

***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*** ***EXAMPLES*** 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 Background Breast cancer among women is a relatively common with a more favorable expected survival rates than other forms of cancers . This study aim ed to determine the improved quality of life for post-mastectomy women through peer education . Methods Using pre and post test follow up and control design approach , 99 women with stage I and II of breast cancer diagnosis were followed one year after modified radical mastectomy . To measure the quality of life an instrument design ed by the European organization for research and treatment of cancer , known as the Quality of Life Question ( QLQ-30 ) and it 's breast cancer supplementary measure ( QLQ-BR23 ) at three points in time ( before , immediately and two months after intervention ) for both groups were used . The participant selection was a convenient sampling method and women were r and omly assigned into two experimental and control groups . The experimental group was r and omly assigned to five groups and peer educators conducted weekly educational programs for one month . Tabulated data were analyzed using chi square , t test , and repeated measurement multivariate to compare the quality of life differences over time . Results For the experimental group , the results showed statistically significant improvement in all performance aspects of life quality and symptom reduction ( P < 0.001 ) , while the control group had no significant differences in all aspects of life quality . Conclusion The findings of this study suggest that peer led education is a useful intervention for post-mastectomy women to improves their quality of life OBJECTIVES To determine the effect of acupuncture on hot flash frequency and intensity , quality of life , and sleep quality in patients undergoing hormonal therapy for prostate cancer . Hot flashes are a common adverse effect of hormonal therapy for prostate cancer . METHODS Men who had a hot flash score > 4 who were receiving and rogen deprivation therapy for prostate cancer underwent acupuncture with electrostimulation biweekly for 4 weeks , then weekly for 6 weeks , using a predefined treatment plan . The primary endpoint was a 50 % reduction in the hot flash score after 4 weeks of therapy , calculated from the patients ' daily hot flash diaries . The hot flash-related quality of life and sleep quality and biomarkers potentially related to hot flashes , including serotonin , calcitonin gene-related peptide , and urinary 5-hydroxyindoleacetic acid , were examined . RESULTS A total of 25 men were enrolled from September 2003 to April 2007 . Of these , 22 were eligible and evaluable . After 4 weeks , 9 ( 41 % , 95 % confidence interval 21%-64 % ) of 22 patients had had a > 50 % reduction in the hot flash score . Of the 22 patients , 12 ( 55 % , 95 % confidence interval 32%-76 % ) met this response definition at any point during the therapy course . No patient had a significant increase in hot flash score during therapy . A reduced hot flash score was associated with improvement in the hot flash-related quality of life and sleep quality . CONCLUSIONS Multiple placebo-controlled trials have demonstrated a 25 % response rate to placebo treatment for hot flashes . Of the 22 patients , 41 % had responded by week 4 and 55 % overall in the present pilot study , providing evidence of a potentially meaningful benefit . Additional studies of acupuncture for hot flashes in this population are warranted PURPOSE The purpose of our study was to evaluate the effect of cognitive behavioral therapy ( CBT ) , physical exercise ( PE ) , and of these two interventions combined ( CBT/PE ) on menopausal symptoms ( primary outcome ) , body image , sexual functioning , psychological well-being , and health-related quality of life ( secondary outcomes ) in patients with breast cancer experiencing treatment-induced menopause . PATIENTS AND METHODS Patients with breast cancer reporting treatment-induced menopausal symptoms ( N=422 ) were r and omly assigned to CBT ( n=109 ) , PE ( n=104 ) , CBT/PE ( n=106 ) , or to a waiting list control group ( n=103 ) . Self-report question naires were completed at baseline , 12 weeks , and 6 months . Multilevel procedures were used to compare the intervention groups with the control group over time . RESULTS Compared with the control group , the intervention groups had a significant decrease in levels of endocrine symptoms ( Functional Assessment of Cancer Therapy OUTPUT: The present guideline provides one overarching recommendation concerning the discussion of sexual health and dysfunction , which is aim ed at all people with cancer . Eleven additional recommendations made separately for men and women deal with issues such as sexual response , body image , intimacy and relationships , overall sexual functioning and satisfaction , and vasomotor and genital symptoms . CONCLUSIONS To our knowledge this clinical practice guideline is the first to comprehensively evaluate interventions for the improvement of sexual problems in people with cancer . 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 ( II OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** 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 OBJECTIVE We assessed the efficacy and safety of duloxetine ( 60 mg , once daily ) , compared with placebo , during a 13-week treatment period in Chinese patients with chronic pain due to osteoarthritis ( OA ) . DESIGN Patients were at least 40 years old ( male or female ) who met American College of Rheumatology clinical and radiographic criteria for the diagnosis of OA of the knee or hip . The primary efficacy measure in this phase 3 , r and omized , double-blind , placebo-controlled clinical trial was assessment of pain severity by the Brief Pain Inventory ( BPI ) 24-h Average Pain rating . The clinical trial was conducted at 17 study centers . Statistical approaches included mixed-effects model repeated measures and analysis of covariance . A Fisher exact test was applied to categorical variables . RESULTS Of 407 patients r and omized ( duloxetine : N = 205 ; placebo : N = 202 ) , 166 ( 81.0 % ) patients from the duloxetine group and 176 ( 87.1 % ) patients from the placebo group completed the 13-week treatment phase . The majority ( 76.4 % ) of patients was female ; mean age was 60.5 years . Duloxetine-treated patients reported significant pain reduction , compared with placebo treatment , on the BPI 24-h Average Pain rating ( least-squares mean ( LS Mean ) change from baseline to endpoint [ 95 % confidence interval ( CI ) ] , duloxetine : -2.23 ; placebo : -1.73 ; difference = -0.50 [ -0.80 , -0.20 ] ; P = 0.001 ) . The incidence of discontinuations due to adverse events was 9.0 % in duloxetine-treated patients and 4.5 % in placebo-treated patients ( P = 0.109 ) . CONCLUSIONS This study demonstrated the efficacy of duloxetine in Chinese patients with chronic pain due to OA . The safety profile of duloxetine observed in this study was consistent with that in previous duloxetine trials . This trial is registered with Clinical Trials.gov ( NCT01931475 ) Osteoarthritis ( OA ) is the most prevalent arthritis worldwide and is characterized by chronic pain and impaired physical function . We hypothesized that heightened pain in h and OA could be reduced with duloxetine or pregabalin . In this prospect i ve , r and omized clinical study , we recruited 65 participants , aged 40–75 years , with a Numerical Rating Scale ( NRS ) for pain of at least 5 . Participants were r and omized to one of the following three groups : duloxetine , pregabalin , and placebo . The primary endpoint was the NRS pain score , and the secondary endpoints included the Australian and Canadian H and Osteoarthritis Index ( AUSCAN ) pain , stiffness , and function scores and quantitative sensory testing by pain pressure algometry . After 13 weeks , compared to placebo , ANOVA found significant differences between the three groups ( P=0.0078 ) . In the intention-to-treat analysis , the pregabalin group showed improvement for NRS pain ( P=0.023 ) , AUSCAN pain ( P=0.008 ) , and AUSCAN function ( P=0.009 ) , but no difference between duloxetine and placebo ( P>0.05 ) was observed . In the per protocol analysis , NRS pain was reduced for pregabalin ( P<0.0001 ) and duloxetine ( P=0.029 ) compared to placebo . We conclude that central ly acting analgesics improve pain outcomes in people with h and arthritis , offering new treatment paradigms for OA pain & NA ; Hypertonic saline effectively excites muscle nociceptors . Muscle hyperalgesia was assessed in osteoarthritis ( OA ) by intramuscular infusion of 0.5 ml hypertonic saline ( 6 % ) into the tibialis anterior muscle in humans . OUTPUT: The results of our analyses indicate that duloxetine has statistically significant , moderate benefits on pain , function , and quality of life in knee OA patients for up to 13 weeks . Reported incidences of gastrointestinal adverse events were three to four times higher in participants who received duloxetine versus placebo . Duloxetine may be an effective treatment option for individuals with knee OA , but use of the drug is associated with a significantly higher risk of adverse events . 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 [ H OUTPUT:

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 .

MS2_dynamic_1_shot227

***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*** ***EXAMPLES*** INPUT: This study explored the diagnostic utility of the composite scores of Immediate Post-Concussion Assessment and Cognitive Testing ( ImPACT ) and Post Concussion Symptom Scale scores ( PCSS ) . Recently concussed high school athletes ( N=72 ) were tested within 72 h of sustaining a concussion , and data were compared to non-concussed high school athletes with no history of concussion ( N=66 ) . Between-groups MANOVA revealed a significant multivariate effect of concussion on test performance ( p<.001 ) ; univariate ANOVAS revealed all six measures contributed to the between-groups differences . A discriminant function analyses was conducted to measure the ability of the five ImPACT composite scores , as well as the PCSS to classify concussion status . One discriminant function was identified that consisted of the Visual Memory , Processing Speed , and Impulse Control composite scores PCSS , which correctly classified 85.5 % of the cases . Approximately 82 % of participants in the concussion group and 89 % of participants in the control group were correctly classified . Using these data , the sensitivity of ImPACT was 81.9 % , and the specificity was 89.4 % . As part of a formal concussion management program , ImPACT is a useful tool for the assessment of the neurocognitive and neurobehavioral sequelae of concussion , and can also provide post-injury cognitive and symptom data that can assist a practitioner in making safer return to play decisions STUDY OBJECTIVE To assess clinical features that might reliably predict the need for computed tomography ( CT ) imaging in pediatric head trauma . DESIGN / SETTING /TYPE OF PARTICIPANT : Prospect i ve cohort of 324 head CT scans performed on 322 consecutive trauma patients at an urban children 's hospital . RESULTS Sixty-two percent of patients were male . The mean age was 7.1 years ( 10 days to 20.6 years ) ; half were less than 5 years of age . The two most frequent mechanisms of injury were falls ( 32 % ) and motor vehicle accidents ( 25 % ) . Abnormalities were detected in 74 scans . Intracranial injuries were apparent in 39 patients ( 12 % ) ; 16 had a concomitant fracture . An isolated cranial abnormality was observed on 35 scans ( 11 % ) . Loss of consciousness , amnesia for the event , a Glasgow Coma Scale ( GCS ) of less than 15 , and the presence of a neurologic deficit were more common in children with intracranial injury ( P < .05 ) . Vomiting , seizures , and headache were not discriminating clinical features . No single characteristic consistently identified the children with an intracranial injury . Of the 195 children who were neurologically intact ( GCS , 15 ) at the time of presentation , 11 ( 5 % ) had evidence of intracranial pathology on CT scan . CONCLUSION This study demonstrates a poor correlation between the clinical symptoms of significant traumatic brain injury and findings on CT Objective Compare the visuomotor response times of children after a mild traumatic brain injury ( mTBI ) with those of noninjured children matched for age , sex , and premorbid level of physical activity . Design Prospect i ve cohort study . Setting Pediatric trauma center . Participants Thirty-eight children aged 7 to 16 years in each group . Children with mTBI had a mean Glasgow Coma Scale score of 14.8 and were considered normal on a neurological assessment carried out at the time of hospital discharge . Noninjured children were friends of those with mTBI . Intervention Assessment s of response time were conducted at 1 , 4 , and 12 weeks after mTBI and at corresponding time intervals for the control children . Main Outcome Measures The response speed subtest of the Bruininks-Oseretsky Test of Motor Proficiency ( BOTMP ) ; reaction and movement time for upper and lower extremities , for simple , choice , and reversed choice response time paradigms . Results Over the assessment period , children with mTBI performed worse than the control group only on the response speed subtest of the BOTMP . The mTBI children however tended to have slower movement times 1 week postinjury for the reversed choice response time paradigm for the lower extremities . Conclusions Some children with mTBI may have some problems in response time persisting until 12 weeks postinjury . Further research is required to better identify and underst and the severity of these problems and determine their impact , if any , on participation in physical activities STUDY OBJECTIVE We evaluate the diagnostic accuracy of clinical decision rules and physician judgment for identifying clinical ly important traumatic brain injuries in children with minor head injuries presenting to the emergency department . METHODS We prospect ively enrolled children younger than 18 years and with minor head injury ( Glasgow Coma Scale score 13 to 15 ) , presenting within 24 hours of their injuries . We assessed the ability of 3 clinical decision rules ( Canadian Assessment of Tomography for Childhood Head Injury [ CATCH ] , Children 's Head Injury Algorithm for the Prediction of Important Clinical Events [ CHALICE ] , and Pediatric Emergency Care Applied Research Network [ PECARN ] ) and 2 measures of physician judgment ( estimated of < 1 % risk of traumatic brain injury and actual computed tomography ordering practice ) to predict clinical ly important traumatic brain injury , as defined by death from traumatic brain injury , need for neurosurgery , intubation greater than 24 hours for traumatic brain injury , or hospital admission greater than 2 nights for traumatic brain injury . RESULTS Among the 1,009 children , 21 ( 2 % ; 95 % confidence interval [ CI ] 1 % to 3 % ) had clinical ly important traumatic brain injuries . Only physician practice and PECARN identified all clinical ly important traumatic brain injuries , with ranked sensitivities as follows : physician OUTPUT: Findings Vali date d tools are available to assist clinicians in the diagnosis and management of pediatric mTBI . A significant body of research exists to identify features that are associated with more serious TBI-associated intracranial injury , delayed recovery from mTBI , and long-term sequelae . Conclusions and Relevance This systematic review was used to develop an evidence -based clinical guideline for the diagnosis and management of pediatric mTBI . 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 OUTPUT:

: 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 .

MS2_dynamic_1_shot228

***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*** ***EXAMPLES*** 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 The main aim of this study was to test the effect of the triazolobenzodiazepine , estazolam , on auditory hallucinations . Fifty-eight patients ( 28 male , 30 female ) with auditory hallucinosis that had responded poorly to neuroleptics alone , were included ; most patients were chronic schizophrenics , and most patients were maintained on previous neuroleptic treatment during the trial . Each patient was treated for three consecutive 3-week periods , and r and omly allocated to receive estazolam ( 1 + 1 + 4 mg ) either in the first and third , or in the second period . Similar-looking placebo tablets were given in the control periods . These were seven drop-outs , three of them due to somnolence on estazolam . In both treatment groups there was a significant ( but not significantly different ) improvement during the first 3-week period , with regard to both global clinical state and auditory hallucinations . During the second and third periods , however , the two groups differed significantly , in that improvement of global state and hallucinosis was seen on estazolam , and deterioration on placebo . It is concluded that estazolam ( as an addition to neuroleptics ) had a significantly better effect than placebo on the global clinical state , on the frequency of , and attitude towards the hallucinations , and also on the single symptoms " Compulsive thoughts " and " Visual hallucinations " ( items in the Comprehensive Psychopathological Rating Scale ) . There were few side effects except drowsiness . Possible pharmacokinetic and pharmacodynamic interactions between benzodiazepines and neuroleptics are discussed briefly 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 Syndrome Scale-Excited Component ( PANSS-EC ) in session I and the change in the PANSS in session II . Safety was assessed by the frequency of the adverse events . Mean PANSS-EC improvement was significant after 5 days of treatment in both groups ( P>0.05 ) and was similar between the two treatment groups ( P<0.01 ) . Most patients ’ PANSS-EC scores improved or remained stable during the drawback/shift treatment period . Efficacy was not significantly different between the two treatment groups after the 6-week treatment ( P>0.05 ) . However , combination treatment exhibited greater efficacy , and adverse events , especially extrapyramidal symptoms , were lower with the oral treatment than with the intramuscular treatment in session I. These results show that RIS-OS in combination with clonazepam is an effective treatment , comparable with intramuscular haloperidol , and is well-tolerated for acute agitation in patients with schizophrenia Abstract Acute catatonic syndromes occurring in the context of various medical and neuropsychiatric conditions , including schizophrenia , have been shown to respond well to benzodiazepines ( BZD ) . However , there have been no studies specifically design ed to address the BZD treatment response of persistent catatonic states . Eighteen patients with clinical ly stable chronic schizophrenia , who also displayed enduring catatonic features , underwent a 12-week long , r and om assignment , double-blind , placebo-controlled cross-over trial with lorazepam ( 6 mg/day ) . A comprehensive assessment , including the subjects ’ clinical and motor ( catatonic as well as drug-induced movement disorders ) condition , was performed at baseline and four weekly intervals thereafter . Pre-existing medication was kept constant throughout the study . Lorazepam had no effect on the subjects’catatonic signs and symptoms , suggesting that acute and chronic catatonic syndromes associated with schizophrenic illness might have a different neurobiological basis Fifty-five schizophrenic out patients with negative symptoms were treated for up to six weeks by the addition of alprazolam ( mean dose , 4.2 mg/d ) , diazep OUTPUT: Conclusion Benzodiazepine superiority over placebo was found for global , psychiatric and behavioural outcomes , but inferiority to antipsychotics on longer-term global outcomes . 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 . Nin OUTPUT:

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 .

MS2_dynamic_1_shot229

***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*** ***EXAMPLES*** INPUT: 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 A prospect i ve r and omized clinical trial was conducted to test the effectiveness of long-term and short-term prophylaxis with cefuroxime in preventing morbidity after cesarean section . Sixty patients who required emergency cesarean section were r and omly assigned to one of three treatment groups : a control group of 20 patients receiving no prophylactic antibiotics ; a group of 20 patients receiving 24 hours of cefuroxime prophylaxis ( 0.75 gm 30 to 60 minutes before surgery and at 8 hours and 16 hours after surgery ) ; and a group of 20 patients receiving five days of cefuroxime prophylaxis ( 0.75 gm three times a day , the first dose being given postoperatively ) . The short-term and long-term prophylaxes were equally effective in reducing morbidity , assessed by postoperative temperatures , presence or absence of endometritis , and duration of postoperative hospital stay The effectiveness of a single prophylactic dose of two broad spectrum antibiotics , during Caesarean section , was compared and evaluated . In 119 consecutive cases at the Cantonal Hospital in Winterthur , Switzerl and , either 1 g i.v . cefotaxime or 1,2 g amoxicillin plus clavulanic acid were administered after clamping the umbilical cord during Caesarean section . The study shows that single dose prophylaxis of either regimen provides adequate cover in preventing morbidity in Caesarean section , in both high-risk and low-risk groups In a prospect i ve , r and omized trial , the efficacy of a single-dose , first-generation , long-acting cephalosporin was compared with a three-dose regimen in a group of 100 women undergoing cesarean section who were at high risk for postoperative febrile morbidity . Fifty women received a single 1 gm intravenous dose of cefazolin and 50 received 1 gm of the drug followed by two additional doses , 8 hours apart , to complete a three-dose regimen . Another 50 women , considered to be at low risk for postoperative febrile morbidity , were not given antibiotic prophylaxis . Outcomes of febrile morbidity ( 18 % vs 12 % ) and particularly morbidity caused by endometritis ( 6 % vs 8 % , respectively ) were similar for single-dose and three-dose groups . In the untreated low-risk group there were no cases of endometritis and the febrile morbidity was comparable to that of the prophylactically treated groups ( 14 % vs 15 % ) . Single-dose cefazolin prophylaxis appears to be comparable to multidose prophylaxis in reducing febrile morbidity after cesarean section The use of antibiotics for prophylaxis against infection among women undergoing nonelective cesarean section has become the st and ard of care in the United States . Many different antibiotics have been used successfully . Single-dose regimens administered after the cord is clamped have proven just as effective as multiple-dose regimens . Although the most frequently used class of antibiotics is the cephalosporin family , the single best agent has not been determined . This study was a double-blind , r and omized trial in which we compared a narrow-spectrum cephalosporin ( cefazolin ; n = 63 ) with an exp and ed-spectrum cephamycin ( cefoxitin ; n = 66 ) and with a broad-spectrum cephalosporin ( cefotaxime ; n = 60 ) used as a single-dose prophylaxis in patients undergoing a nonelective cesarean section . Of the 194 patients enrolled in the study , 189 were evaluable . There was no significant difference between the groups in mean age , gravidity , parity , duration of labor , duration of ruptured membranes , number of vaginal examinations , or socioeconomic status ( socioeconomic status was defined by third-party coverage ) . There was no significant difference among the antibiotics in the incidence of immediate or delayed postoperative infections . These data indicate that a less expensive , narrow-spectrum cephalosporin is as effective as more expensive , broader-spectrum cephamycins and cephalosporins as prophylaxis for patients undergoing nonelective cesarean section This study compared the efficacy of a single intravenous dose of Cefazolin alone or combined with an antibiotic containing preclosure-irrigation solution in patients undergoing cesarean section . A total of 308 patients were prospect ively assigned to two groups by r and omization . Group I received two grams of Cefazolin IV and abdomino-peritoneal irrigation with saline . Group II received one gram of Cefazolin IV and one gram in the saline irrigation solution . The rate of total postoperative morbidity was 2.3 times higher in Group I compared to Group II ( 16/154 or 10.4 % vs 7/154 or 4.5 % ) and morbidity at the operative site was six times higher ( 13/154 or 8.4 % vs 2/154 or 1.3 % ) A r and omized , prospect i ve , double-blind study OUTPUT: REVIEW ER 'S CONCLUSIONS Both ampicillin and first generation cephalosporins have similar efficacy in reducing postoperative endometritis . There does not appear to be added benefit in utilizing a more broad spectrum agent or a multiple dose regimen . 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– OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: Background Although literature provides support for cognitive behavioral therapy ( CBT ) as an efficacious intervention for social phobia , more research is needed to improve treatments for children . Methods Forty four Caucasian children ( ages 8 - 14 ) meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ; APA , 1994 ) were r and omly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells ( n = 21 ) or a wait-list control group ( n = 23 ) . The primary outcome measure was clinical improvement . Secondary outcomes included improvements in anxiety coping , dysfunctional cognitions , interaction frequency and comorbid symptoms . Outcome measures included child report and clinican completed measures as well as a diagnostic interview . Results Significant differences between treatment participants ( 4 dropouts ) and controls ( 2 dropouts ) were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children . Furthermore , in the treatment group , significantly more children were free of diagnosis than in wait-list group at post-test . Additional child completed and clinician completed measures support the results . Discussion The study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia . Future research will need to compare this treatment to an active treatment group . There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate . Conclusion Preliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children . Active comparators should be established with other evidence -based CBT programs for anxiety disorders , which differ significantly in their dosage and type of cognitive interventions from those of the manual under evaluation ( e.g. Coping Cat ) Most r and omized controlled trials of cognitive-behavioral therapy ( CBT ) for children with anxiety disorders have evaluated treatment efficacy using recruited sample s treated in research setting s. Clinical trials in school setting s are needed to determine if CBT can be effective when delivered in real world setting s. This study evaluated a modular CBT program for childhood anxiety disorders in two elementary schools . Forty children ( 5 - 12 years old ) with anxiety disorders , referred by teachers and school staff , were r and omly assigned to modular CBT or a 3-month waitlist . Clinicians worked with individual families as well as teachers and school staff . Evaluators blind to treatment condition conducted structured diagnostic interviews and caregivers and children completed symptom checklists at pre- and posttreatment . The primary study outcome , the Clinical Global Impressions-Improvement scale , yielded a positive treatment response at posttreatment for 95.0 % of CBT participants , as compared with only 16.7 % of the waitlist participants . CBT also outperformed the waitlist on diagnostic outcomes and caregiver-report measures of anxiety . Treatment effects did not extend beyond anxiety diagnoses and symptoms . Results suggest that modular CBT delivered within the elementary school setting may be effective for the treatment of child anxiety disorders . A replication of the study results with a larger sample is indicated This study evaluated the effectiveness of cognitive-behavioral treatment for childhood anxiety in a community clinic setting in Hong Kong , China . Forty-five clinical ly-referred children ( age 6 - 11 years ) were r and omly assigned to either a cognitive-behavioral treatment program or a waitlist-control condition . Children in the treatment condition showed significant reduction in anxiety symptoms-both statistically and clinical ly-whereas children in the waitlist condition did not . After the waitlist period was over , the control group also received the treatment program and showed a similar reduction in symptoms . For the full sample of 45 children , the effectiveness of the intervention was significant immediately after treatment and in 3- and 6-month follow-ups . In addition , children 's anxiety cognition and their ability to cope with anxiety-provoking situations fully mediated the treatment gains . These results offer empirical support for cognitive-behavioral treatment programs in a non-Western cultural context and plausible mediators for how cognitive-behavioral therapy works OBJECTIVE Examine the efficacy of a personalized , modular cognitive-behavioral therapy ( CBT ) protocol among early adolescents with high-functioning autism spectrum disorders ( ASDs ) and co-occurring anxiety relative to treatment as usual ( TAU ) . METHOD Thirty-one children ( 11 - 16 years ) with ASD and clinical ly significant anxiety were r and omly assigned to receive 16 weekly CBT sessions or an equivalent duration of TAU . Participants were assessed by blinded raters at screening , posttreatment , and 1-month follow-up . RESULTS Youth r and omized to CBT demonstrated superior improvement across primary outcomes relative to those receiving TAU . Eleven of 16 adolescents r and omized to CBT were treatment responders , versus 4 of 15 in the TAU condition . Gains were maintained at 1-month follow-up for CBT responders . CONCLUSIONS These data extend findings of the promising effects of CBT in anxious youth with ASD to early adolescents Acceptance and Commitment Therapy ( ACT ) has a growing empirical base in the treatment of anxiety among adults and children with other concerns . This study reports on the main outcomes of a r and omized controlled trial of ACT and traditional cognitive behavioral therapy ( CBT ) in children with a Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ) anxiety disorder . Participants were 193 children from urban Sydney , Australia , who were block-r and omized to a 10-week group-based program of ACT or CBT or a 10-week waitlist control ( WLC ) . Completers included 157 children ( ACT = 54 , CBT = 57 , WLC = 46 ; M = 11 years , SD OUTPUT: The overall results indicated that CBT is an effective treatment for childhood AD . The results showed that individual-based CBT is superior to wait-list and attention control . Group-based CBT is superior to wait-list control and treatment as usual . Remote-based CBT was superior to attention control and wait-list control . Family-based CBT was superior to treatment as usual , wait-list control , and attention control . Selective serotonin reuptake inhibitors were no more effective than individual-based CBT . Combination treatment was , however , more effective than individual-based CBT . Conclusion : To the best of our knowledge , no meta- analysis has thus far disentangled the effects of CBT modalities across various comparisons . This meta- analysis hence provides an important up date to the literature on the efficacy of CBT for treating anxiety disorders in young people 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 . OUTPUT:

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 .

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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*** ***EXAMPLES*** INPUT: Background About one-third of people older than 65 years fall at least once a year . Physical exercise has been previously demonstrated to improve gait , enhance physical fitness , and prevent falls . Nonetheless , the addition of cognitive training components may potentially increase these effects , since cognitive impairment is related to gait irregularities and fall risk . We hypothesized that simultaneous cognitive – physical training would lead to greater improvements in dual-task ( DT ) gait compared to exclusive physical training . Methods Elderly persons older than 70 years and without cognitive impairment were r and omly assigned to the following groups : 1 ) virtual reality video game dancing ( DANCE ) , 2 ) treadmill walking with simultaneous verbal memory training ( MEMORY ) , or 3 ) treadmill walking ( PHYS ) . Each program was complemented with strength and balance exercises . Two 1-hour training sessions per week over 6 months were applied . Gait variables , functional fitness ( Short Physical Performance Battery , 6-minute walk ) , and fall frequencies were assessed at baseline , after 3 months and 6 months , and at 1-year follow-up . Multiple regression analyses with planned comparisons were carried out . Results Eighty-nine participants were r and omized to three groups initially ; 71 completed the training and 47 were available at 1-year follow-up . DANCE/MEMORY showed a significant advantage compared to PHYS in DT costs of step time variability at fast walking ( P=0.044 ) . Training-specific gait adaptations were found on comparing DANCE and MEMORY : DANCE reduced step time at fast walking ( P=0.007 ) and MEMORY reduced gait variability in DT and DT costs at preferred walking speed ( both trend P=0.062 ) . Global linear time effects showed improved gait ( P<0.05 ) , functional fitness ( P<0.05 ) , and reduced fall frequency ( −77 % , P<0.001 ) . Only single-task fast walking , gait variability at preferred walking speed , and Short Physical Performance Battery were reduced at follow-up ( all P<0.05 or trend ) . Conclusion Long-term multicomponent cognitive – physical and exclusive physical training programs demonstrated similar potential to counteract age-related decline in physical functioning This study aim ed to evaluate the effectiveness of an innovative exercise program on muscle strength , balance , and gait kinematics in elderly community-dwellers . The exercise program included strength and balance training and the 8-form Tai Chi Chuan . The measurements were carried out at baseline and 12 weeks , and consisted of four physical performance tests , joint isokinetic strength tests , and three-dimensional gait analysis . Fifty-six community-dwelling older adults aged 60–80 years old were r and omly assigned to an intervention or control group . After 12 weeks , the intervention group showed a 17.6 % improvement in the timed up and go test , accompanied by a 54.7 % increase in the 30-second chair st and test score . Significant increases in the score of star excursion balance tests , and the strength of the extensor and flexor muscles at knee and ankle joints were also observed . In addition , the intervention group walked at a faster speed with a longer step length , shorter support phase , and a greater sagittal plane range of motion at the hip and ankle joints . No statistical improvements were seen in the control group . This study provided an effective , evidence -based falls prevention program that can be implemented in community setting s to improve physical fitness and reduce fall risks among community-dwelling older adults . The star excursion balance test could be a sensitive measure of physical performance for fall risk assessment in older people Background Fatigue , lack of motivation and low compliance can be observed in nursing home residents during the practice of physical activity . Because exercises should not be too vigorous , whole body vibration could potentially be an effective alternative . The objective of this r and omized controlled trial was to assess the impact of 3-month training by whole body vibration on the risk of falls among nursing home residents . Methods Patients were r and omized into two groups : the whole body vibration group which received 3 training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz frequency and a control group with normal daily life for the whole study period . The impact of this training on the risk of falls was assessed blindly by three tests : the Tinetti Test , the Timed Up and Go test and a quantitative evaluation of a 10-second walk performed with a tri-axial accelerometer . Results 62 subjects ( 47 women and 15 men ; mean age 83.2 ± 7.99 years ) were recruited for the study . No significant change in the studied parameters was observed between the treated ( n=31 ) and the control group ( n=31 ) after 3 months of training by controlled whole-body-vibrations . Actually , the Tinetti test increased of + 0.93 ± 3.14 points in the treated group against + 0.88 ± 2.33 points in the control group ( p = 0.89 when adjusted ) . The Timed Up and Go test showed a median evolution of - 1.14 ( − 4.75 - 3.73 ) seconds in the treated group against + 0.41 ( − 3.57- 2.41 ) seconds in the control group ( p = 0.06 ) . For the quantitative evaluation of the walk , no significant change was observed between the treated and the control group in single task as well as in dual task conditions . Conclusions The whole body vibration training performed with the exposition setting s such as those used in this research was feasible but seems to have no impact on the risk of falls among nursing home residents . Further investigations , in which , for example , the exposure parameters would be changed , seem necessary . Trial registration Trial registration number : Objective : To compare the effectiveness of unsupervised home and supervised group exercise on parameters related to risk of falling among older adults . Design : Prospect i ve , single-blind , r and omized and controlled trial . Setting : Nursing home . Subjects : The subjects were selected from 535 independent individuals who OUTPUT: CONCLUSIONS A multi-component exercise programme was found to be useful for reducing elderly adults ' risk of falling in nursing homes 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 OUTPUT:

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*** ***EXAMPLES*** 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 Post-trial monitoring of patients in the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) examined whether risk reductions for microvascular and macrovascular disease , achieved with the use of improved blood-pressure control during the trial , would be sustained . METHODS Among 5102 UKPDS patients with newly diagnosed type 2 diabetes mellitus , we r and omly assigned , over a 4-year period beginning in 1987 , 1148 patients with hypertension to tight or less-tight blood-pressure control regimens . The 884 patients who underwent post-trial monitoring were asked to attend annual UKPDS clinics for the first 5 years , but no attempt was made to maintain their previously assigned therapies . Annual question naires completed by patients and general practitioners were used to follow patients who were unable to attend the clinic in years 1 through 5 , and question naires were used for all patients in years 6 to 10 . Seven prespecified aggregate clinical end points were examined OUTPUT: Although direct evidence on benefits and harms of screening was not available , the recommendation was based on the ability of screening to identify persons with diabetes and evidence that more-intensive BP treatment was associated with reduced risk for cardiovascular events , including cardiovascular mortality , in patients with diabetes and hypertension . Do interventions for screen-detected or early diabetes , IFG , or IGT provide an incremental benefit in health outcomes compared with no interventions or initiating interventions after clinical diagnosis ? 4 . Is there evidence that more-intensive glucose , BP , or lipid control interventions improve health outcomes in adults with type 2 diabetes , IFG , or IGT compared with traditional control ? 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 3.1 OUTPUT:

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*** ***EXAMPLES*** INPUT: BACKGROUND Vitamin D deficiency and asthma are common at higher latitudes . Although vitamin D has important immunologic effects , its relation with asthma is unknown . OBJECTIVE We hypothesized that a higher maternal intake of vitamin D during pregnancy is associated with a lower risk of recurrent wheeze in children at 3 y of age . DESIGN The participants were 1194 mother-child pairs in Project Viva-a prospect i ve prebirth cohort study in Massachusetts . We assessed the maternal intake of vitamin D during pregnancy from a vali date d food-frequency question naire . The primary outcome was recurrent wheeze , ie , a positive asthma predictive index ( > or=2 wheezing attacks among children with a personal diagnosis of eczema or a parental history of asthma ) . RESULTS The mean ( + /-SD ) total vitamin D intake during pregnancy was 548 + /- 167 IU/d . By age 3 y , 186 children ( 16 % ) had recurrent wheeze . Compared with mothers in the lowest quartile of daily intake ( median : 356 IU ) , those in the highest quartile ( 724 IU ) had a lower risk of having a child with recurrent wheeze [ odds ratio ( OR ) : 0.39 ; 95 % CI : 0.25 , 0.62 ; P for trend < 0.001 ] . A 100-IU increase in vitamin D intake was associated with lower risk ( OR : 0.81 ; 95 % CI : 0.74 , 0.89 ) , regardless of whether vitamin D was from the diet ( OR : 0.81 ; 95 % CI : 0.69 , 0.96 ) or supplements ( OR : 0.82 ; 95 % CI : 0.73 , 0.92 ) . Adjustment for 12 potential confounders , including maternal intake of other dietary factors , did not change the results . CONCLUSION In the northeastern United States , a higher maternal intake of vitamin D during pregnancy may decrease the risk of recurrent wheeze in early childhood 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 BACKGROUND The effects of vitamin D supplementation in healthy prepubertal children on physiologic outcomes have not been investigated . OBJECTIVE The objective was to evaluate the effects of supplementation with 1000 IU vitamin D(3)/d on calcium absorption . DESIGN In a double-blind , placebo-controlled trial , we r and omly assigned 64 children to 1000 IU vitamin D(3)/d ( n = 32 ) or placebo ( n = 32 ) for 8 wk . Stable isotopes were used to assess calcium absorption . The main outcome measure was calcium absorption before and after supplementation . RESULTS All of the data are shown as means ± SDs . At baseline , vitamin D intake was 221 ± 79 IU/d and calcium intake was 830 ± 197 mg/d . Baseline serum 25-hydroxyvitamin D [ 25(OH)D ] was not significantly correlated with fractional or total calcium absorption . After 8 wk , with baseline values used as a covariate , no differences were seen in fractional or total calcium absorption based on supplementation group ( P = 0.75 and 0.36 , respectively ) . Supplemented children had a significant increase in 25(OH)D concentrations ( from 27.7 ± 7.4 to 36.0 ± 10.3 ng/mL ; P < 0.0001 ) and a decrease in parathyroid hormone ( from 21.4 ± 10.4 to 12.9 ± 7.1 pg/mL ; P < 0.001 ) ; no significant changes in the placebo OUTPUT: CONCLUSION Limited information is available addressing primary prevention of allergic diseases after vitamin D supplementation , and its potential impact remains uncertain 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 1 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: OBJECTIVE To monitor clinical , microbiological and host-derived alterations occurring around teeth and titanium implants during the development of experimental gingivitis/mucositis and their respective healing sequence in humans . MATERIAL AND METHODS Fifteen subjects with healthy or treated periodontal conditions and restored with dental implants underwent an experimental 3-week period of undisturbed plaque accumulation in the m and ible . Subsequently , a 3-week period with optimal plaque control was instituted . At Days 0 , 7 , 14 , 21 , 28 , 35 and 42 , the presence/absence of plaque deposits around teeth and implants was assessed , ( plaque index [ PlI ] ) and the gingival/mucosal conditions were evaluated ( gingival index[GI ] ) . Subgingival/submucosal plaque sample s and gingival/mucosal crevicular fluid ( CF ) sample s were collected from two pre-determined sites around each experimental unit . CF sample s were analyzed for matrix-metalloproteinase-8 ( MMP-8 ) and interleukin-1beta ( IL-1β ) . Microbial sample s were analyzed using DNA-DNA hybridization for 40 species . RESULTS During 3 weeks of plaque accumulation , the median PlI and GI increased significantly at implants and teeth . Implant sites yielded a greater increase in the median GI compared with tooth sites . Over the 6-week experimental period , the CF levels of MMP-8 were statistically significantly higher at implants compared with teeth ( P<0.05 ) . The CF IL-1β levels did not differ statistically significantly between teeth and implants ( P>0.05 ) . No differences in the total DNA counts between implant and tooth sites were found at any time points . No differences in the detection frequency were found for putative periodontal pathogens between implant and tooth sites . CONCLUSION Peri-implant soft tissues developed a stronger inflammatory response to experimental plaque accumulation when compared with that of their gingival counterparts . Experimental gingivitis and peri-implant mucositis were reversible at the biomarker level . Clinical ly , however , 3 weeks of resumed plaque control did not yield pre-experimental levels of gingival and peri-implant mucosal health indicating that longer healing periods are needed Background Due to the world-wide increase in treatments involving implant placement , the incidence of peri-implant disease is increasing . Late implant failure is the result of the inability to maintain osseointegration , whose most important cause is peri-implantitis . The aim of this study was to analyze the clinical , microbiological , and immunological aspects in the peri-implant sulcus fluid ( PISF ) of patients with healthy dental implants and patients with peri-implantitis . Methods PISF sample s were obtained from 24 peri-implantitis sites and 54 healthy peri-implant sites in this prospect i ve cross-sectional study . The clinical parameters recorded were : modified gingival index ( mGI ) , modified plaque index ( mPI ) and probing pocket depth ( PPD ) . The periodontopathogenic bacteria Tannerella forsythia , Treponema denticola and Porphyromonas gingivalis were evaluated , together with the total bacterial load ( TBL ) . PISF sample s were analyzed for the quantification of Interleukin (IL)-8 , IL-1β , IL-6 , IL-10 and Tumor Necrosis Factor (TNF)-α using flow cytometry ( FACS ) . Results The mGI and PPD scores in the peri-implantitis group were significantly higher than the healthy group ( p < 0.001 ) . A total of 61.5 % of the patients with peri-implantitis had both arches rehabilitated , compared with 22.7 % of patients with healthy peri-implant tissues ; there was no implant with peri-implantitis in cases that received m and ibular treatment exclusively ( p < 0.05 ) . Concentrations of Porphyromonas gingivalis ( p < 0.01 ) , association with bacteria Porphyromonas gingivalis and Treponema denticola ( p < 0.05 ) , as well as the TBL ( p < 0.05 ) are significantly higher in the peri-implantitis group . IL-1β ( p < 0.01 ) , IL-6 ( p < 0.01 ) , IL-10 ( p < 0.05 ) and TNF-α ( p < 0.01 ) are significantly higher at the sites with peri-implantitis compared to healthy peri-implant tissue , while IL-8 did not increase significantly . Conclusion The results of the present study involving a limited patient sample suggest that the peri-implant microbiota and which dental arch was rehabilitated involved could contribute to bone loss in peri-implantitis . A significant relationship is observed between the concentration of cytokines ( interleukins 1β , 6 and 10 and TNF-α ) and the inflammatory response in peri-implantitis tissue BACKGROUND While information on the prevalence of peri-implantitis is available , data describing onset and progression of the disease are limited . MATERIAL & METHODS A 9-year follow-up examination of 596 r and omly selected implant-carrying individuals identified 62 patients with moderate/severe peri-implantitis . Longitudinal assessment s of peri-implant marginal bone levels were used to construct a statistical model with bone loss as the dependent variable . A multilevel growth model estimated the pattern of bone loss for each implant/patient . Onset of peri-implantitis was determined by evaluating the cumulative percentage of implants/ patients presenting with estimated bone loss at each year following prosthesis delivery . RESULTS The analysis showed a non-linear , accelerating pattern of bone loss at the 105 affected implants . The onset of peri-implantitis occurred early , and 52 % and 66 % of implants presented with bone loss of > 0.5 mm at OUTPUT: Despite absence of meta- analysis , MMP-8 show to be a promising biomarker in detection of PI in literature . Within the limitations of this study , pro-inflammatory cytokines in PICF , such as IL-1ß and IL-6 , can be used as adjunct tools to clinical parameters to differentiate H from MU and PI 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:

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 .

MS2_dynamic_1_shot235

***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*** ***EXAMPLES*** INPUT: OBJECTIVES We tested a community-based intervention design ed to reduce cardiovascular disease risk in sedentary midlife and older women who were overweight or obese . METHODS In a r and omized controlled trial conducted in 8 counties in Arkansas and Kansas , counties were assigned to the intervention ( a 12-week twice-weekly heart health program ) group or to the delayed-intervention control group . Ten to fifteen women were selected from each site , and participants ' weight , waist circumference , diet , physical activity , and self-efficacy were measured before and after the intervention . Data were analyzed with multiple regressions . RESULTS Compared with the control group , participants in the intervention group had a significant decrease in body weight ( -2.1 kg ; 95 % confidence interval [ CI ] = -3.2 , -1.0 ) , waist circumference ( -2.3 in ; 95 % CI = -4.2 , -0.5 ) , and energy intake ( -390 kcal/day ; 95 % CI = -598 , -183 ) ; an increase in activity ( + 1637 steps/day ; 95 % CI = 712 , 2562 ) ; and an increase in self-efficacy for dietary and physical activity behaviors . CONCLUSIONS Our results suggest that a community-based program can improve self-efficacy , increase physical activity , and decrease energy intake , result ing in decreased waist circumference and body weight among at-risk women OBJECTIVE The objective of the present study was to evaluate the effectiveness of a minimal contact physical activity intervention that was maximally integrated into the existing structures of a women 's organization . METHODS The intervention included one group meeting , a self-help booklet , and five monthly reminder letters and was implemented in four units of a rural women 's organization . Two other units served as control group . Pretest and posttest measurements were completed by 81 women in the intervention group and 88 in the control group . Physical activity was assessed at baseline and at 6 months with accelerometers and the International Physical Activity Question naire ( IPAQ ) . RESULTS There was a significant interaction between time and group for the total accelerometer activity counts ( p = 0.007 ) . Total activity counts increased in the intervention group , whereas there was a decrease in the control group . No significant results were found with the IPAQ . CONCLUSIONS An intervention in a women 's organization was effective in increasing the objective ly measured physical activity levels of its members . These results indicate that women 's organizations can be valuable setting s for physical activity promotion programs . The minimal number of contact hours and the use of existing structures and communication channels are important strengths for later implementation Background : Unhealthy diet and lack of physical activity increase rural midlife and older women 's risk of chronic diseases and premature death , and they are behind urban residents in meeting Healthy People 2010 objectives . Objectives : The objective of this study was to compare a tailored intervention based on the Health Promotion Model with a generic intervention to increase physical activity and healthy eating among rural women . Methods : In a r and omized-by-site , community-based , controlled , clinical trial , Wellness for Women , 225 women aged 50 to 69 years were recruited in two similar rural areas . Over 12 months , women received by mail either 18 generic newsletters or 18 newsletters computer tailored on Health Promotion Model behavior-specific cognitions ( benefits , barriers , self-efficacy , and interpersonal support ) , activity , and eating . Outcomes at 6 and 12 months included behavioral markers and biomarkers of physical activity and eating . Data were analyzed by repeated- measures analysis of variance and chi-square tests ( & agr ; < .05 ) . Results : Both groups significantly increased stretching and strengthening exercise and fruit and vegetable servings and decreased percentage of calories from fat , whereas only the tailored group increased moderate or greater intensity activity and decreased percentage of calories from saturated fat from baseline to 6 months . Both groups increased stretching and strengthening exercise , whereas only the tailored group increased moderate or greater intensity activity and fruit and vegetable servings and decreased percentage of calories from fat from baseline to 12 months . Both groups had several changes in biomarkers over the study . A higher proportion of women receiving tailored newsletters met Healthy People 2010 criteria for moderate or greater intensity activity , fruit and vegetable servings , and percentage of calories from fat at 12 months . Discussion : Mailed computer-tailored and generic print newsletters facilitated the adoption of change in both activity and eating over 6 months . Tailored newsletters were more efficacious in facilitating change over 12 months Background : Preventive guidelines on cardiovascular risk management recommend lifestyle changes . Support for lifestyle changes may be a useful task for practice nurses , but the effect of such interventions in primary prevention is not clear . We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk . Methods : We performed a cluster r and omized controlled trial in 25 practice s that included 615 patients . The intervention consisted of nurse-led cardiovascular risk management , including risk assessment , risk communication , a decision aid and adapted motivational interviewing . The control group received a minimal nurse-led intervention . The self-reported outcome measures at one year were smoking , alcohol use , diet and physical activity . Nurses assessed 10-year cardiovascular mortality risk after one year . Results : There were no significant differences between the intervention groups . The effect of the intervention on the consumption of vegetables and physical activity was small , and some differences were only significant for subgroups . The effects of the intervention on the intake of fat , fruit and alcohol and smoking were not significant . We found no effect between the groups for cardiovascular 10-year risk . Interpretation : Nurse-led risk communication , use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk , despite significant within-group differences Background — OUTPUT: While there were decreases in blood pressure at 6 months , studies with a 5-year follow up found no decreases for both systolic and diastolic blood pressure . Overall results of studies into dietary modification programs also did not sustain an effect over a longer period of time . The results of this review suggest that in rural areas , lifestyle interventions delivered by primary care providers in primary care setting s to patients at low risk appeared to be of marginal benefit . Re sources and time in primary care might be better spent on patients at higher risk of cardiovascular disease , such as those with diabetes or existing heart disease 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 OUTPUT:

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 .

MS2_dynamic_1_shot236

***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*** ***EXAMPLES*** INPUT: BACKGROUND In a previous study of 225 patients with sick-sinus syndrome r and omised to either single-chamber atrial pacing ( n=110 ) or single-chamber ventricular pacing ( n=115 ) , we found that after a mean follow-up of 3.3 years , atrial pacing was associated with significantly less atrial fibrillation and thromboembolism whereas there was no significant difference in mortality and heart failure between the two groups . We aim ed to find out whether this beneficial effect of atrial pacing is maintained during extended follow-up of up to 8 years . METHODS Follow-up visits for all patients were at 3 months , 12 months , then once a year at which patients had a physical examination , ECG recording , and pacemaker check-up . Endpoints were mortality , cardiovascular death , atrial fibrillation , thromboembolic events , heart failure , and atrioventricular block . Data was analysed on Dec 31 , 1996 . FINDINGS At long-term follow-up , 39 patients from the atrial group had died versus 57 from the ventricular group ( relative risk 0.66 [ 95 % CI 0.44 - 0.99 ] ; p=0.045 ) . 19 patients from the atrial group and 39 patients from the ventricular group died from a cardiovascular cause ( 0.47 [ 0.27 - 0.82 ] ; p=0.0065 ) . The cumulative incidences of atrial fibrillation and chronic atrial fibrillation were also significantly lower in the atrial group than in the ventricular group ( 0.54 [ 0.33 - 0.89 ] , p=0.012 and 0.35 [ 0.16 - 0.76 ] , p=0.004 , respectively ) . Thromboembolic events occurred in 13 patients in the atrial group and 26 in the ventricular group ( 0.47 [ 0.24 - 0.92 ] , p=0.023 ) . Heart failure was less severe in the atrial group than in the ventricular group ( p<0.05 ) . In multivariate analysis , atrial pacing was significantly associated with freedom from thromboembolic events ( 0.47 [ 0.24 - 0.92 ] , p=0.028 ) and survival from cardiovascular death ( 0.52 [ 0.30 - 0.91 ] , p=0.022 ) , but no longer with overall survival ( 0.71 [ 0.46 - 1.08 ] , p=0.11 ) or chronic atrial fibrillation ( 0.45 [ 0.20 - 1.05 ] , p=0.063 ) . Atrioventricular block occurred in four patients in the atrial group ( 0.6 % annual risk ) . INTERPRETATION The beneficial effect of atrial pacing found in our previous study is enhanced substantially over time . Patients with sick-sinus syndrome should be treated with an atrial rather than ventricular-pacing system because after long-term follow-up , atrial pacing is associated with a significantly higher survival , less atrial fibrillation , fewer thromboembolic complications , less heart failure , and a low-risk of atrioventricular block OBJECTIVES To evaluate the long-term functional and hemodynamic effects of right ventricular outflow tract ( RVOT ) pacing by comparison with right ventricular apical ( RVA ) pacing . BACKGROUND Acute studies have suggested that RVOT pacing could significantly improve cardiac performance in comparison with RVA pacing but no data are available in chronically implanted patients . METHODS Sixteen patients with chronic atrial tachyarrhythmia and complete AV block were included . Left ventricular ejection fraction ( LVEF ) was > or = 40 % in ten and < 40 % in six . Patients were implanted with a st and ard DDDR pacemaker connected to two ventricular leads . A screw-in lead was placed at the RVOT and connected to the atrial port . A second lead was positioned at the RVA and connected to the ventricular port . Right ventricular outflow tract and RVA pacing was achieved by programming either the AAIR or the VVIR mode respectively . Four months later patients were r and omized so as to undergo either RVOT or RVA pacing for three months according to a blind crossover protocol . Apart from the pacing mode , programming remained unchanged throughout the study . At the end of each period , NYHA class , LVEF , exercise time and maximal oxygen uptake were assessed . RESULTS No significant difference was observed between the two modes for all the parameters analyzed . These identical results were observed in all patients globally , in patients with LVEF > or = 40 % as in those with LVEF < 40 % . CONCLUSIONS Within the limits of this study , no symptomatic improvement or hemodynamic benefit was noted after three months of RVOT pacing , by comparison with RVA pacing Background Dual‐chamber ( DDDR ) pacing preserves AV synchrony and may reduce heart failure ( HF ) and atrial fibrillation ( AF ) compared with ventricular ( VVIR ) pacing in sinus node dysfunction ( SND ) . However , DDDR pacing often results in prolonged QRS duration s ( QRSd ) as the result of right ventricular stimulation , and ventricular desynchronization may result . The effect of pacing‐induced ventricular desynchronization in patients with normal baseline QRSd is unknown . Methods and Results Baseline QRSd was obtained from 12‐lead ECGs before pacemaker implantation in MOST , a 2010‐patient , 6‐year , r and omized trial of DDDR versus VVIR pacing in SND . Cumulative percent ventricular paced ( Cum%VP ) was determined OUTPUT: R and omized-controlled trials provided inconclusive results with respect to exercise capacity , functional class , quality of life , and survival . 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 OUTPUT:

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

MS2_dynamic_1_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*** ***EXAMPLES*** INPUT: BACKGROUND To assess the effects of comprehensive cardiac rehabilitation compared with usual care on physical activity and mental health for patients treated with catheter ablation for atrial fibrillation . METHODS The patients were r and omized 1:1 stratified by paroxysmal or persistent atrial fibrillation and sex to cardiac rehabilitation consisting of 12 weeks physical exercise and four psycho-educational consultations plus usual care ( cardiac rehabilitation group ) versus usual care . The primary outcome was Vo2 peak . The secondary outcome was self-rated mental health measured by the Short Form-36 question naire . Exploratory outcomes were collected . RESULTS 210 patients were included ( mean age : 59 years , 74 % men ) , 72 % had paroxysmal atrial fibrillation prior to ablation . Compared with usual care , the cardiac rehabilitation group had a beneficial effect on Vo2 peak at four months ( 24.3mL kg-1 min-1 versus 20.7mL kg-1 min-1 , p of main effect=0.003 , p of interaction between time and intervention=0.020 ) . No significant difference between groups on Short Form-36 was found ( 53.8 versus 51.9 points , P=.20 ) . Two serious adverse events ( atrial fibrillation in relation to physical exercise and death unrelated to rehabilitation ) occurred in the cardiac rehabilitation group versus one in the usual care group ( death unrelated to intervention ) ( P=.56 ) . In the cardiac rehabilitation group 16 patients versus 7 in the usual care group reported non-serious adverse events ( P=.047 ) . CONCLUSION Comprehensive cardiac rehabilitation had a positive effect on physical capacity compared with usual care , but not on mental health . Cardiac rehabilitation caused more non-serious adverse events Background Natural history of paroxysmal atrial fibrillation ( AF ) is not very well documented . Clinical experience suggests that paroxysmal AF could progress to chronic AF with estimates ranging between 15 and 30 % over a period of 1–3 years . We performed an epidemiologic study to eluci date the natural history of paroxysmal AF , this study estimated its incidence in a general practice setting , identified associated factors and analyzed the progression into chronic AF as well as the mortality rate . Methods Using the UK General Practice Research Data base ( GPRD ) , we identified patients aged 40–89 years with a first-recorded episode of paroxysmal AF during 1996 . Risk factors were assessed using 525 incident paroxysmal AF cases confirmed by the general practitioner ( GP ) and a r and om sample of controls . We follow-up paroxysmal AF patients and estimated their mortality rate and progression to chronic AF . Results The incidence of paroxysmal AF was 1.0 per 1,000 person-years . Major risk factors for paroxysmal AF were age and prior valvular heart disease , ischaemic heart disease , heart failure and hyperthyroidism . During a mean follow-up of 2.7 years , 70 of 418 paroxysmal AF patients with complete information progressed to chronic AF . Risk factors associated with progression were valvular heart disease ( OR 2.7 , 95 % CI 1.2–6.0 ) and moderate to high alcohol consumption ( OR 3.0 , 95 % CI 1.1–8.0 ) . Paroxysmal AF patients did not carry an increased risk of mortality , compared to an age and sex matched sample of the general population . There was a suggestion of a small increased risk among patients progressing to chronic AF ( RR 1.5 , 96 % CI 0.8–2.9 ) . Conclusion Paroxysmal AF is a common arrhythmia in the general practice setting , increasing with age and commonly associated with other heart diseases . It sometimes is the initial presentation and then progress to chronic AF . A history of valvular heart disease and alcohol consumption are associated with this progression Aims This prospect i ve pilot- study was performed to assess whether regular moderate physical activity elevates the parasympathetic tone to the atrio-ventricular node and decreases VR during permanent AF . Background Adequate ventricular rate ( VR ) control in patients with permanent atrial fibrillation ( AF ) is not easy to accomplish . Methods 10 patients ( mean age 59 ± 10 years ) with permanent AF ( duration : 10 ± 8 years ) underwent moderate physical exercise adjusted to their individual physical capability ( 45 min walking/jogging twice a week ) . To analyze VR control physical exercise tests and Holter-ECG recordings were performed before and after 4 months . In addition , stepwise lactate tests and psycho-pathometric examinations were obtained . Results After 4 months of training , there was a trend toward a decrease of mean VR in 24 h Holter-ECGs by 12 % from 76 ± 20 to 67 ± 12 bpm ( P = 0.05 ) while there was no significant decrease of the minimal VR ( 38 ± 8 vs. 36.3 ± 4.5 bpm , P = 0.54 ) . At a lactate threshold of 2 mmol/l there was a trend towards an increase of the running speed from 105 ± 11 to 116 ± 12 m/min ( P = 0.05 ) . A significant VR decrease of 8 % ( range 5–10 % ) was observed at almost all exercise levels during exercise treadmill testing . Increases of exercise capacity and decreases of VR were accompanied by subjective improvements of health perception . Conclusion Regular moderate physical activity decreases VR at rest and during exercise while increasing exercise capacity . Physical training should be taken into account for ventricular rate control during AF AIMS The management of patients with atrial fibrillation ( AF ) is often inadequate due to deficient adherence to the guidelines . A nurse-led AF clinic providing OUTPUT: Due to few r and omised patients and outcomes , we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events . The evidence showed no clinical ly relevant effect on health-related quality of life . Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity , but due to the low number of patients and the moderate to very low- quality of the underpinning evidence , we could not be certain of the magnitude of the effect . 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: PURPOSE We compared postoperative outcomes in patients treated with laparoendoscopic single site varicocele ligation with or without testicular artery and lymphatic preservation . MATERIAL S AND METHODS A total of 80 patients with left varicocele were r and omly divided into 2 groups and treated with laparoendoscopic single site varicocele ligation with preservation of the testicular artery and lymphatics ( 40 in group 1 ) or complete ligation of the testicular vessels and lymphatics ( 40 in group 2 ) . Operative time , hospital stay , return to normal activity , postoperative visual analog scale pain scores and complications were analyzed . In patients with subfertility preoperative and 3-month postoperative semen analyses were performed . In patients with scrotal pain preoperative and 12-month postoperative visual analog scale pain scores were analyzed . RESULTS A total of 35 patients per group completed the study . Hospital stay , return to normal activity and postoperative pain scores did not differ between the groups . No major complications were observed . Mean ± SD operative time was 60.7 ± 10.7 and 48.6 ± 6.0 minutes in groups 1 and 2 , respectively ( p < 0.001 ) . Patients with subfertility , including 22 in group 1 and 21 in group 2 , showed improved semen parameters 3 months postoperatively but postoperative values did not differ between the groups . The 17 patients in each group with scrotal pain showed decreased pain scores 12 months postoperatively with no difference between the groups . CONCLUSIONS Laparoendoscopic single site varicocele ligation is feasible . No differences in postoperative outcomes and complications were observed when preserving or not preserving the testicular artery and lymphatics To evaluate , in a r and omized prospect i ve trial in children and adolescents , the feasibility of isosulphan blue‐based lymphatic vessel preservation during laparoscopic varicocelectomy and its impact on the complication rate , as the operative management of varicoceles remains controversial A surgical method of varicocelectomy , in which the internal spermatic veins together with the testicular artery are ligated as a whole in the retroperitoneal space , has been proposed as a simple and reliable procedure . We evaluated the effects of ligating the testicular artery at varicocelectomy on fertility . A total of 34 subfertile patients with a left varicocele was r and omized into an artery-preserved or artery-ligated group at open varicocelectomy and the change in semen quality was prospect ively studied . The artery-preserved group showed improvements in sperm density and total sperm count , while the artery-ligated group showed improvements in sperm density , total sperm count and sperm motility . The results indicated identical improvement in semen quality in both groups of patients . Testicular volume , measured by a punched-out orchidometer , did not change in any of the patients in the ligated group , except for 1 with a grade 3 varicocele , although this decrease could not be detected by sonography . The effects of artery-preserving and artery-ligating varicocelectomy on postoperative pregnancy rates were investigated by examining 116 patients retrospectively . The pregnancy rates of 37.8 % and 23.8 % in the artery-preserved and artery-ligated groups , respectively , were not significantly different . Despite the theoretical advantage of artery preservation , our study did not show any significant difference between artery-preserving varicocelectomy and the artery-ligating operation when improvements in semen quality and postoperative pregnancy rate were evaluated Objective : To prospect ively compare the recurrence rate and short postoperative outcome after r and omized laparoscopic varix ligation with internal spermatic artery ( ISA ) preservation versus laparoscopic varix ligation with ISA ligation . Material and methods : Twenty-five patients with 35 varicocele who required varix ligation for infertility in 13 patients , scrotal pain in 15 patients and scrotal swelling in 2 patients who underwent one of two procedures : laparoscopic varix ligation with ISA prservation ( Group A ) or laparoscopic varix ligation with ISA ligation ( Group B ) were postoperatively evaluated for short post operative outcome and underwent percutaneous spermatic venograms to detect recurrence . Fisher 's Exact Test was used for statistical analysis . Results : Recurrence through parallel collaterals was noted in 39 % and 5.9 % in Group A and Group B respectively as demonstrated on percutaneous spermatic venous venography ( PSV ) ( statistically significant p = 0.0408 ) . Preoperative pain completely resolved in all patients in Group B and persisted in 45 % in Group A. However , this was not statistically significant ( p = 0.088 ) . No testicular atrophy or hydrocele formation was noted in either group . Conclusions : Laparoscopic varix ligation with ISA ligation has lower recurrence rate than laparoscopic varix ligation without ISA ligation and may provide better varicocele related pain control with no increase in hydrocele or testicular atrophy rate . We recommend ISA ligation routinely during laparoscopic varix ligation Objectives : Testicular blood supply and semen quality were compared in two groups of patients undergoing laparoscopic varicocelectomy : group I ( n = 27 ) with spermatic artery ligation and group II ( n = 48 ) with spermatic artery preservation . Methods : Laparoscopic varicocelectomy was performed on 75 patients divided on the basis of whether ligation took place during surgery or not . The blood flow parameter ( resistance index – RI ) measured using color Doppler sonography was the index of vascular efficiency selected . Results : Mean RI was 0.69 in group I and 0.65 in group II . The difference was not significant . Both groups showed OUTPUT: Conclusion With the advantages of less recurrence , easier operating and less time spending , and comparable results in other respects , artery non-preserving is preferable to artery preserving in laparoscopic varicocelectomy , although there is a relatively high incidence of hydrocele formation . 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 OUTPUT:

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 .

MS2_dynamic_1_shot239

***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*** ***EXAMPLES*** INPUT: Aims Atrial fibrillation ( AF ) is associated with adverse outcome . Whether recently discovered genetic risk markers improve AF risk prediction is unknown . Methods and results We derived and vali date d a novel AF risk prediction model from 32 possible predictors in the Women 's Health Study ( WHS ) , a cohort of 20 822 women without cardiovascular disease ( CVD ) at baseline followed prospect ively for incident AF ( median : 14.5 years ) . We then created a genetic risk score ( GRS ) comprised of 12 risk alleles in nine loci and assessed model performance in the validation cohort with and without the GRS . The newly derived WHS AF risk algorithm included terms for age , weight , height , systolic blood pressure , alcohol use , and smoking ( current and past ) . In the validation cohort , this model was well calibrated with good discrimination [ C-index ( 95 % CI ) = 0.718 ( 0.684–0.753 ) ] and improved all reclassification indices when compared with age alone . The addition of the genetic score to the WHS AF risk algorithm model improved the C-index [ 0.741 ( 0.709–0.774 ) ; P = 0.001 ] , the category-less net reclassification [ 0.490 ( 0.301–0.670 ) ; P < 0.0001 ] , and the integrated discrimination improvement [ 0.00526 ( 0.0033–0.0076 ) ; P < 0.0001 ] . However , there was no improvement in net reclassification into 10-year risk categories of < 1 , 1–5 , and 5+% [ 0.041 ( −0.044–0.12 ) ; P = 0.33 ] . Conclusion Among women without CVD , a simple risk prediction model utilizing readily available risk markers identified women at higher risk for AF . The addition of genetic information result ed in modest improvements in predictive accuracy that did not translate into improved reclassification into discrete AF risk categories BACKGROUND Cigarette smoking increases the risk of coronary heart disease , but whether smoking increases atrial fibrillation ( AF ) is uncertain . OBJECTIVE The purpose of this study was to determine the association of cigarette smoking with incident AF in a population -based cohort of blacks and whites . METHODS We determined the risk of incident AF through December 2002 in relation to baseline ( 1987 - 1989 ) smoking status and cigarette-years of smoking in over 15,000 participants of the prospect i ve Atherosclerosis Risk in Communities ( ARIC ) study . RESULTS Over a mean follow-up of 13.1 years , 876 incident AF events were identified . Compared to never smokers , the multivariable-adjusted hazard ratios ( HRs ) for AF were 1.32 ( 95 % confidence interval [ CI ] 1.10 - 1.57 ) in former smokers , 2.05 ( 95 % CI 1.71 - 2.47 ) in current smokers , and 1.58 ( 95 % CI 1.35 - 1.85 ) in ever smokers . In the highest tertile of accumulated smoking amount ( > 675 cigarette-years ) , the incidence of AF was 2.10 times greater ( 95 % CI 1.74 - 2.53 ) than in those who never smoked . Associations were similar by gender , race , type of event ( AF and atrial flutter ) , and when only AF events identified by study exam ECGs were included . Finally , individuals who quit smoking exhibited a trend indicating a slightly lower risk of developing AF ( HR 0.88 , 95 % CI 0.65 - 1.17 ) compared to those who continued to smoke . CONCLUSION Smoking was associated with the incidence of AF , with more than a two-fold increased risk of AF attributed to current smoking . In addition , a trend toward a lower incidence of AF appeared among smokers who quit compared to continued smokers BACKGROUND Cigarette smoking is a known risk factor for cardiovascular disease ( CVD ) , but its relationship to the development of hypertension is unclear . Previous epidemiological studies have shown inconsistent results , having demonstrated inverse and positive associations between cigarette smoking and the development of hypertension . METHODS We analyzed 13,529 male participants from the Physicians ' Health Study free of baseline hypertension and CVD who provided information about smoking status . Smoking status was categorized as never , past , or current < 20 cigarettes/day , or current > or = 20 cigarettes/day . Incident hypertension was defined as either the initiation of antihypertensive treatment , self-reported systolic blood pressure ( BP ) > or = 140 mm Hg , or diastolic BP > or = 90 mm Hg . RESULTS Over a median follow-up of 14.5 years , 4,904 men developed hypertension . We modeled the risk of developing hypertension by baseline smoking status adjusting for known risk factors for hypertension or CVD . In a fully adjusted Cox proportional hazards model , we found that compared with never smokers , past smokers and current smokers had corresponding relative risks ( RRs ) of 1.08 and 1.15 of developing hypertension . The risk for smokers did not appear to differ based on number of cigarettes smoked daily . Further , the RR of hypertension was higher for men with normal vs. prehypertensive levels of systolic ( SBP ) or diastolic BP ( DBP ) . CONCLUSIONS This prospect i ve cohort data suggests that cigarette smoking may be a modest but important risk factor for the development of hypertension The validity of atrial fibrillation ( AF ) diagnoses in national registers for use as endpoints in OUTPUT: Conclusions The current meta- analysis suggests that smoking is associated with an increased risk of atrial fibrillation in a dose-dependent matter , but the association is weaker among former smokers compared to current smokers 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 , OUTPUT:

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*** ***EXAMPLES*** 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 Background Type 2 diabetes is a major health problem in many countries including India . Yoga may be an effective type 2 diabetes prevention strategy in India , particularly given its cultural familiarity . Methods This was a parallel , r and omized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes . Primary outcomes included : changes in BMI , waist circumference , fasting blood glucose , postpr and ial blood glucose , insulin , insulin resistance , blood pressure , and cholesterol . We also looked at measures of psychological well-being including changes in depression , anxiety , positive and negative affect and perceived stress . Forty-one participants with elevated fasting blood glucose in Bangalore , India were r and omized to either yoga ( n = 21 ) or a walking control ( n = 20 ) . Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks . R and omization and allocation was performed using computer-generated r and om numbers and group assignments delivered in sealed , opaque envelopes generated by off-site study staff . Data were analyzed based on intention to treat . Results This study was feasible in terms of recruitment , retention and adherence . In addition , yoga participants had significantly greater reductions in weight , waist circumference and BMI versus control ( weight −0.8 ± 2.1 vs. 1.4 ± 3.6 , p = 0.02 ; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2 , p < 0.01 ; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6 , p = 0.05 ) . There were no between group differences in fasting blood glucose , postpr and ial blood glucose , insulin resistance or any other factors related to diabetes risk or psychological well-being . There were significant reductions in systolic and diastolic blood pressure , total cholesterol , anxiety , depression , negative affect and perceived stress in both the yoga intervention and walking control over the course of the study . Conclusion Among Indians with elevated fasting blood glucose , we found that participation in an 8-week yoga intervention was feasible and result ed in greater weight loss and reduction in waist circumference when compared to a walking control . Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being . Trial registration Clinical Trials.gov Identified NCT00090506 BACKGROUND AND OBJECTIVE : Most clinic-based weight control treatments for youth have been design ed for preadolescent children by using family-based care . However , as adolescents become more autonomous and less motivated by parental influence , this strategy may be less appropriate . This study evaluated a primary care – based , multicomponent lifestyle intervention specifically tailored for overweight adolescent females . METHODS : Adolescent girls ( N = 208 ) 12 to 17 years of age ( mean ± SD : 14.1 ± 1.4 years ) , with a mean ± SD BMI percentile of 97.09 ± 2.27 , were assigned r and omly to the intervention or usual care control group . The gender and developmentally tailored intervention included a focus on adoptable healthy lifestyle behaviors and was reinforced by ongoing feedback from the teen ’s primary care physician . Of those r and omized , 195 ( 94 % ) completed the 6-month posttreatment assessment , and 173 ( 83 % ) completed the 12-month follow-up . The primary outcome was reduction in BMI z score . RESULTS : The decrease in BMI z score over time was significantly greater for intervention participants compared with usual care participants ( −0.15 in BMI z score among intervention participants compared with −0.08 among usual care participants ; P = .012 ) . The 2 groups did not differ in OUTPUT: Despite method ological drawbacks , yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals 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 RCT OUTPUT:

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*** ***EXAMPLES*** INPUT: The current study was design ed to investigate the changes that occur in depression , anxiety , obsessive — compulsive symptoms and health-related quality of life during methylpheni date ( MPH ) treatment in children with attention-deficit hyperactivity disorder ( ADHD ) . Forty-five treatment naive children with ADHD , aged 8—14 , were assessed based on self , parent and teacher reports at the baseline and at the end of the first and third month of MPH treatment regarding changes in inattention , hyperactivity , impulsivity , depression , anxiety and obsessive — compulsive symptoms . Changes in the quality of life were also noted . Repeated measures of analysis of variance ( ANOVA ) tests with Bonferroni corrections were conducted in order to evaluate the data . Symptoms of inattention , hyperactivity and impulsivity were significantly reduced ( p < 0.017 ) following a three-month MPH treatment . There were significant decreases in depression ( p = 0.004 ) , trait anxiety ( p = 0.000 ) and checking compulsion symptom scores ( p = 0.001 ) . Moreover , parents reported significant improvements in psychosocial ( p = 0.001 ) and total scores ( p = 0.009 ) of quality of life , despite no change in physical health scores ( p > 0.05 ) . Children ’s ratings of quality of life measures showed no significant changes in physical health and psychosocial scores ( p > 0.05 ) , while total scores significantly improved ( p = 0.001 ) after the treatment . Over a three-month MPH treatment , depression , trait anxiety and checking compulsion symptoms decreased and quality of life seemed to improve along with those of inattention , hyperactivity and impulsivity The psychiatric outcome is reported for a large sample of hyperactive children ( N = 123 ) , meeting research diagnostic criteria , and normal control children ( N = 66 ) followed prospect ively over an 8-year period into adolescence . Over 80 % of the hyperactives were attention deficit hyperactivity disorder ( ADHD ) and 60 % had either oppositional defiant disorder and /or conduct disorder at outcome . Rates of antisocial acts were considerably higher among hyperactives than normals , as were cigarette and marijuana use and negative academic outcomes . The presence of conduct disorder accounted for much though not all of these outcomes . Family status of hyperactives was much less stable over time than in the normal subjects . The use of research criteria for diagnosing children as hyperactive identifies a pattern of behavioral symptoms that is highly stable over time and associated with considerably greater risk for family disturbance and negative academic and social outcomes in adolescence than has been previously reported Measurement of health-related quality of life ( HRQOL ) in attention-deficit-hyperactivity disorder ( ADHD ) gives a more complete picture of day-to-day functioning and treatment effects than behavioural rating alone . The aim of this pilot study was to investigate the impact of the combined diagnoses of developmental coordination disorder ( DCD ) and ADHD on HRQOL , and the effectiveness of methylpheni date ( MPH ) on HRQOL . HRQOL was established using the Dutch-Child-AZL-TNO- Quality -of-Life ( DUX-25 ) and the TNO-AZL-Child- Quality -of-Life ( TACQOL ) question naires , completed by children and parents . HRQOL of these children was compared with that of 23 age- and sex-matched healthy controls . Twenty-three children ( 21 males , two females ; mean age 8 y 6 mo , [ SD 3 mo ] range 7 y-10 y 8 mo ) with ADHD/DCD entered a 4-week , open-label MPH study , after MPH-sensitivity was established , in a double-blind , placebo-controlled trial . In these children 's self- and proxy reports , impact of both DCD and ADHD was reflected in lower general well-being ( self and proxy report p=0.001 ) due to lower functioning in motor ( selfp=0.026 ; proxy 0.001 ) , autonomic ( self p<0.001 ; proxy p=0.047 ) , cognitive ( self p=0.001 ; proxy p=0.01 ) , and social ( self and proxy p<0.001 ) domains . HRQOL scores improved in 18 children receiving MPH ( p=0.001 ) versus controls . The ADHD /DCD group also demonstrated a significant improvement in ADHD symptoms ( p<0.001 ) and motor functioning ( p<0.001 ) . Additional motor therapy will still be needed in about half of the children with ADHD/DCD receiving MPH , within multimodal treatment including educational and psychosocial assistance Editor 's Note : In order to encourage dissemination of the STROBE Statement , this article is being published simultaneously in Annals of Internal Medicine , Epidemiology , and PLoS Medicine . It is freely accessible on the Annals of Internal Medicine Web site ( www.annals.org ) and will also be published on the Web sites of Epidemiology and PLoS Medicine . The authors jointly hold the copyright of this article . For details on further use , see the STROBE Web site ( www.strobe-statement.org ) . Rational health care practice s require knowledge about the etiology and pathogenesis , diagnosis , prognosis , and treatment of diseases . R and omized trials provide valuable evidence about treatments and other interventions . However , much of clinical or public health knowledge comes from observational research ( 1 ) . About 9 of 10 research papers published in clinical specialty journals describe observational research ( 2 , 3 ) . The STROBE Statement Reporting of observational research is often not detailed and clear enough to assess the strengths and weaknesses of the investigation ( 4 , 5 ) . To improve the reporting of observational research , we developed a checklist of items that should be addressed : the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) Statement ( Appendix Table ) . Items relate to the title , abstract , introduction , methods , OUTPUT: In the majority of studies review ed , children rated their QoL more highly than their parents . There was some evidence for greater agreement on the physical health domain than psychosocial domains 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 OUTPUT:

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*** ***EXAMPLES*** 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 Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement BACKGROUND Childhood malnutrition is common in Malawi , and the st and ard treatment , which follows international guidelines , results in poor recovery rates . Higher recovery rates have been seen in pilot studies of home-based therapy with ready-to-use therapeutic food ( RUTF ) . OBJECTIVE The objective was to compare the recovery rates among children with moderate and severe wasting , kwashiorkor , or both receiving either home-based therapy with RUTF or st and ard inpatient therapy . DESIGN A controlled , comparative , clinical effectiveness trial was conducted in southern Malawi with 1178 malnourished children . Children were systematic ally allocated to either st and ard therapy ( 186 children ) or home-based therapy with RUTF ( 992 children ) according to a stepped wedge design to control for bias introduced by the season of the year . Recovery , defined as reaching a weight-for-height z score > -2 , and relapse or death were the primary outcomes . The rate of weight gain and the prevalence of fever , cough , and diarrhea were the secondary outcomes . RESULTS Children who received home-based therapy with RUTF were more likely to achieve a weight-for-height z score > -2 than were those who received st and ard therapy ( 79 % compared with 46 % ; P < 0.001 ) and were less likely to relapse or die ( 8.7 % compared with 16.7 % ; P < 0.001 ) . Children who received home-based therapy with RUTF had greater rates of weight gain ( 3.5 compared with 2.0 g . kg(-1 ) . d(-1 ) ; difference : 1.5 ; 95 % CI : 1.0 , 2.0 g . kg(-1 ) . d(-1 ) ) and a lower prevalence of fever , cough , and diarrhea than did children who received st and ard therapy . CONCLUSION Home-based therapy with RUTF is associated with better outcomes for childhood malnutrition than is st and ard therapy Maintaining greater than 95 % adherence to antiretroviral medication is necessary in order to have the greatest therapeutic impact on HIV infection . Furthermore , evidence suggests that adherence rates of between 70 % and 89 % are significantly associated with viral rebound and the development of drug resistance . Adherence rates at and above the 95 % level are difficult for patients to achieve and maintain . Our aim was to determine if an adherence intervention could improve adherence among patients attending an ambulatory care clinic at a large public hospital . The intervention was delivered by a multidisciplinary team of health care professionals and consisted of education coupled with the provision of devices design ed to assist patient memory and adherence . A crucial component of the intervention consisted of the identification of patient specific barriers to adherence and the development of strategies to circumvent these problems . Adherence was assessed using patient self-report over the past 4 , 7 , and 28 days and by calculation of the Morisky score . The study was conducted as a r and omised controlled trial using the stepped wedge design with a total of 68 subjects r and omised to receive the intervention over a 20-week period . OUTPUT: Results The 12 studies included in this review describe evaluations of a wide range of interventions , across different diseases in different setting s. However the stepped wedge design appears to have found a niche for evaluating interventions in developing countries , specifically those concerned with HIV . 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 OUTPUT:

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

MS2_dynamic_1_shot243

***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*** ***EXAMPLES*** INPUT: Three intermediary base material s , a zinc oxide-eugenol ( Cavitec ) and two calcium hydroxide liners ( Life and Dycal ) , were selected at r and om for use as a base beneath amalgam or composite restorations on humans following complete caries removal . Life and Dycal , selected at r and om , were also used as direct and indirect pulp capping agents as clinical ly indicated . Clinical evaluations of signs and symptoms were made before treatment and at one-week , six-month , and one-year intervals following treatment . Histological evaluations were performed on three complete caries removal teeth and 18 direct pulp capping teeth six months following treatment . No significant differences in clinical symptomatology result ed between the material s in the complete caries removal group or the indirect and direct pulp capping groups Objectives Root canal therapy ( RCT ) and tooth extraction have been conventional treatment options for management of human mature teeth with irreversible pulpitis . Excellent short-term treatment outcomes of vital pulp therapy with calcium-enriched mixture cement ( VPT/CEM ) , as a new treatment option , on postoperative pain relief was demonstrated ; if intermediate- and long-term treatment outcomes of the new treatment are also non-inferior compared to RCT , then VPT/CEM may become a viable treatment option for management of mature teeth with irreversible pulpitis . Material s and methods In 23 healthcare centers , 407 9- to 65-year-old patients were r and omly allocated into two study arms including one-visit RCT ( reference treatment ; n = 202 ) and VPT/CEM ( alternative treatment ; n = 205 ) . Six- and twelve-month clinical and radiographic successes were assessed . Results Mean follow-up times at 6- and 12-month follow-ups were “ 6.70 ± 0.68 and 6.72 ± 0.71 months ” and “ 12.96 ± 0.67 and 12.90 ± 0.66 months ” in the available cases of RCT and VPT/CEM arms , respectively . Favorable clinical success rates in the two study arms did not show statistical difference ; however , the radiographic success rate in the VPT/CEM was significantly greater than RCT arm at the two follow-ups ( P < 0.001 ) . The patients ’ age had no effect on the treatment outcomes ( P = 0.231 ) . Conclusions Treatment outcomes of VPT/CEM may be superior to RCT in mature molars with irreversible pulpitis . The performance of bio material s such CEM cement may assist in the shift towards more biologic treatments . Clinical relevance VPT/CEM may be a realistic alternative treatment for human mature molar teeth with symptoms of irreversible pulpitis ; the use of VPT/CEM is highly beneficial for patients as well as general dentists 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 Aim : This r and omized , multicenter clinical trial by Maltz et al. [ 1 ] evaluated the effectiveness of two treatments for deep caries lesions — partial caries removal ( PCR ) and stepwise excavation (SW)—with respect to the primary outcome of pulp vitality for a 3-year follow-up period . Material and methods : Inclusion criteria were as follows : patients with permanent molars presenting deep caries lesions ( lesion affecting ≥1/2 of the dentin on radiographic examina tion ) , positive response to a cold test , absence of spontaneous pain , negative sensitivity to percussion , and absence of periapical lesions ( radiographic examination ) . Teeth r and omly assigned to PCR ( test ) received incomplete caries removal and filling in a single session . Outcome success was evaluated by assessment of pulp vitality , determined by pulp sensitivity to a cold test and the absence of periapical lesions . Data were analyzed by a Weibull regression model with shared frailty term ( survival analysis ) . Results : At baseline , 299 treatments were executed : PCR 152 and SW 147 . By the end of the 3-year follow-up period , 213 teeth had been evaluated . Adjusted survival rates were 91 % for PCR and 69 % for SW ( p=0.004 ) . Conclusion : These results suggest that there is no need to reopen a cavity and perform a second excavation for pulp vitality to be preserved ( Clinical trials registration NCT00887952 ) . Conflict of interest The corresponding author states that there are no conflicts of interest . Ziel : Diese r and omisierte , multizentrische klinische Studie untersuchte die Effektivitat von zwei Therapieansatzen zur Beh and lung tiefer karioser Lasionen : partielle Kariesentfernung ( PCR ) und mehrstufige Exkavation ( SW ) . Die primar zu untersuchende Auswirkung war die Vitalitat uber 3 Jahre . Material und Method e : Einschlusskriterien waren : Patienten OUTPUT: The overall evidence was insufficient to assess which of indirect pulp capping , stepwise excavation , direct excavation and pulp capping/partial pulpotomy , pulpotomy or pulpectomy is the most effective treatment approach for teeth with deep caries . CONCLUSIONS Because of the lack of good studies it is not possible to determine whether an injured pulp by deep caries can be maintained or whether it should be removed and replaced with a root canal filling . 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 OUTPUT:

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 .

MS2_dynamic_1_shot244

***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*** ***EXAMPLES*** INPUT: BACKGROUND Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents . AIMS To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia . METHOD A 38-week , double-blind , active-controlled , non-inferiority study ; r and omisation ( 2:2:1 ) to aripiprazole once-monthly 400 mg , oral aripiprazole ( 10 - 30 mg/day ) or aripiprazole once-monthly 50 mg ( a dose below the therapeutic threshold for assay sensitivity ) . ( TRIAL REGISTRATION clinical trials.gov , NCT00706654 . ) RESULTS A total of 1118 patients were screened , and 662 responders to oral aripiprazole were r and omised . Kaplan-Meier estimated impending relapse rates at week 26 were 7.12 % for aripiprazole once-monthly 400 mg and 7.76 % for oral aripiprazole . This difference ( -0.64 % , 95 % CI -5.26 to 3.99 ) excluded the predefined non-inferiority margin of 11.5 % . Treatments were superior to aripiprazole once-monthly 50 mg ( 21.80 % , P < or = 0.001 ) . CONCLUSIONS Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole , and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate PURPOSE The aim of this longitudinal study was to determine whether the depot formulation of an antipsychotic reduces violence in out patients with schizophrenia as compared to oral administration of the same antipsychotic . METHODS Forty-six previously violent patients with schizophrenia were r and omised to receive treatment with oral or depot zuclopenthixol for 1 year . Clinicians interviewed patients at baseline and every month thereafter to assess treatment adherence . An interviewer blinded to treatment assignments interviewed an informant about any violent behaviour during the previous month . RESULTS Violence during the follow-up year was inversely proportional to treatment adherence , better compliance , and greater reduction of positive symptoms . Lower frequency of violent acts was observed in the depot group . The level of insight at baseline was not significantly associated with violence recidivism . Regardless of route of administration , treatment non-adherence was the best predictor of violence . CONCLUSIONS Some patients with schizophrenia and prior violent behaviour may benefit from the depot formulation of antipsychotic medication OBJECTIVE Potency equivalents for anti-psychotic drugs are required to guide clinical dosing and for design ing and interpreting research studies . Available dosing guidelines are limited by the methods and data from which they were generated . METHOD With a two-step Delphi method , the authors surveyed a diverse group of international clinical and research experts , seeking consensus regarding antipsychotic dosing . The authors determined median clinical dosing equivalents and recommended starting , target range , and maximum doses for 61 drugs , adjusted for selected clinical circumstances . RESULTS Participants ( N=43 ) from 18 countries provided dosing recommendations regarding treatment of psychotic disorders for 37 oral agents and 14 short-acting and 10 long-acting parenteral agents . With olanzapine 20 mg/day as reference , estimated clinical equivalency ratios of oral agents ranged from 0.025 for sulpiride to 10.0 for trifluperidol . Seventeen patient and treatment characteristics , including age , hepatic and renal function , illness stage and severity , sex , and diagnosis , were associated with dosing modifications . CONCLUSIONS In the absence of adequate prospect i ve , r OUTPUT: Similarly , no differences emerged in terms of dropouts for adverse events , extrapyramidal symptoms , prolactin increase ( except for a small advantage for LAI risperidone ) , weight gain , non-response rate , relapse rate , and dropouts for inefficacy ( except for a small advantage for oral olanzapine ) . In conclusion , there is no robust evidence to support doctors in choosing LAI instead of oral formulations in order to obtain better tolerability and efficacy 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: 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 Silicone vaginal rings for the continuous release of 17 beta-oestradiol ( E2 ) with 2 constant in vitro release rates were used for the treatment of symptoms of urogenital atrophy in 2 groups of postmenopausal women . The very low dose of 7 micrograms/24 h was found to alleviate atrophic symptoms effectively and to induce significant maturation of vaginal and urethral epithelium . After a brief initial peak , the serum levels of E2 over 3 mth of treatment remained close to the detection limit . The ' undetectable ' E2 release pattern was reflected only in increased levels of oestrone sulphate . There was no evidence of a systemic metabolic response and patient acceptance of the method was excellent . Continuous low-dose release of E2 via vaginal rings consequently offers an alternative means of administering local oestrogen therapy which may be particularly suitable for geriatric patients OBJECTIVE : To evaluate the efficacy of two vaginal doses of estradiol ( E2 ) compared with placebo in the treatment of atrophic vaginitis . METHODS : In a multi-center , r and omized , double-blind , parallel-group study , 230 postmenopausal women received treatment with 25 mcg or 10 mcg E2 or placebo for 12 weeks . Efficacy was measured through composite score of three vaginal symptoms and grading of vaginal health . Additional analyses included maturation of vaginal and urethral mucosa . Safety assessment s included endometrial biopsy , adverse events , changes in laboratory tests , and physical examinations . After 12 weeks of treatment , all patients were switched to the open-label extension and received treatment with 25 mcg E2 up to week 52 . RESULTS : Vaginal tablets with 25 mcg and 10 mcg E2 showed significant ( P<.001 ) improvement in composite score of vaginal health . Other results with 10 mcg E2 were not entirely consistent with those for 25 mcg E2 . Over 12 weeks , both active treatments result ed in greater decreases in vaginal pH than placebo . There were no significant differences between the 25 mcg and 10 mcg E2 groups in terms of improvements in maturation value or composite score of three vaginal symptoms . The efficacy was maintained to week 52 with 25 mcg E2 . CONCLUSION : Vaginal tablets with 25 mcg and 10 mcg E2 provided relief of vaginal symptoms , improved urogenital atrophy , decreased vaginal pH , and increased maturation of the vaginal and urethral epithelium . Those improvements were greater with 25 mcg than with 10 mcg E2 . Both doses were effective in the treatment of atrophic vaginitis . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00465192 and NCT00464971 LEVEL OF EVIDENCE : Objective : The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens ( CE ) cream for treatment of atrophic vaginitis . Methods : Postmenopausal women ( N = 423 ) with moderate-to-severe vaginal atrophy were r and omized to CE cream 0.3 mg or placebo once daily ( 21 days on/7 days off ) or twice weekly for 12 weeks , followed by open-label treatment with CE cream for 40 weeks consistent with their prior regimen . Primary endpoints were changes in vaginal maturation index ( VMI ; percentage of superficial cells ) , vaginal pH , and severity of participant-reported most bothersome symptom ( vaginal dryness , itching , burning , or dyspareunia ) at week 12 . Endometrial safety was assessed by transvaginal ultrasound and endometrial biopsy for 52 weeks . Results : At week OUTPUT: Compared with placebo , vaginal estrogens improved dryness , dyspareunia , urinary urgency , frequency , and stress urinary incontinence ( SUI ) and urgency urinary incontinence ( UUI ) . Urinary tract infection rates decreased . The various estrogen preparations had similar efficacy and safety ; serum estradiol levels remained within postmenopausal norms for all except high-dose conjugated equine estrogen cream . Endometrial hyperplasia and adenocarcinoma were extremely rare among those receiving vaginal estrogen . Comparing vaginal estrogen with nonhormonal moisturizers , patients with two or more symptoms of vulvovaginal atrophy were substantially more improved using vaginal estrogens , but those with one or minor complaints had similar symptom resolution with either estrogen or nonhormonal moisturizer . : All commercially available vaginal estrogens effectively relieve common vulvovaginal atrophy-related complaints and have additional utility in patients with urinary urgency , frequency or nocturia , SUI and UUI , and recurrent UTIs . Nonhormonal moisturizers are a beneficial alternative for those with few or minor atrophy-related symptoms and in patients at risk for estrogen-related neoplasia . 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 , OUTPUT:

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*** ***EXAMPLES*** INPUT: OBJECTIVE Our purpose was to study the effects of isradipine , a dihydropyridine calcium channel blocker , on mother and fetus in the treatment of hypertensive disorders of pregnancy . STUDY DESIGN The investigation was performed as a two-group , parallel , double-blind multicenter study of isradipine versus placebo . Fifty-four women were r and omized to treatment with isradipine slow-release capsules given orally 5 mg twice a day and 57 to a placebo group . RESULTS Isradipine lowered the maternal mean arterial blood pressure effectively in women with nonproteinuric hypertension but did not do so in women with proteinuria at recruitment or appearing during treatment . Blood flow in the umbilical artery and maternal renal and liver function were not influenced by treatment . Isradipine had few side effects and was well tolerated . CONCLUSION Calcium channel blockade with isradipine is effective for treatment of nonproteinuric hypertension but not in preeclampsia The effect of nifedipine ( Adalat ; Bayer-Miles)--a calcium channel blocker , which has a well-established place in nonobstetric hypertension -- was compared with dihydralazine in 33 primigravidas with severe hypertension of pregnancy . Patients with a diastolic blood pressure greater than 110 mmHg before drug administration were r and omly assigned to treatment with either nifedipine or dihydralazine . Both drugs were found to be equally efficacious . Nifedipine , however , showed an earlier onset of action in lowering systolic blood pressure and had the advantage of oral administration The objective was to compare the fetal and maternal effects between parenteral hydralazine and sublingual nifedipine used like antihypertensive drugs in the management of severe preeclampsia . Study design was prospect i ve , comparative , longitudinal , r and omized clinical trial . It was carried out at Centro Medico Nacional IMSS Torreon , Coah . Gynecology and Obstetrics Department . The patients were women in the last trimester of pregnancy with severe preeclampsia were r and omized to receive parenteral hydralazine or sublingual nifedipine as antihypertensive drugs . The only difference observed in this study was the Apgar of neonates whose mothers received hydralazine , that was significatively lesser than the Apgar of neonates whose mothers received nifedipine . Both medicaments are a good alternative as antihypertensive drugs in severe preeclampsia . Neonates whose mothers received Nifedipine had a higher Apgar Objective To determine whether nifedipine or prazosin is the more appropriate second‐line antihypertensive agent in pregnancy At r and om , two therapeutic schemes for severe preeclampsia during the puerperium , were evaluated . Group A ( n = 20 ) was left without antihypertensive medication and sublingual nifedipine was used only in case of diastolic pressure of 110 mmHg or more . Group B ( n = 18 ) receive Hydralazine 40 mlg . per os , every 6 hrs . ; in this group also , nifedipine was administered in case of diastolic pressure of 110 mmHg or more . The only differences were that in group B the intervals for the administration of nifedipine were much shorter than in group A ; also , in the same group the need for another antihypertensive was more frequent ( 5 of 18 vs 1 of 20 patients ) OBJECTIVE We sought to compare the efficacies of oral nifedipine and intravenous labetalol in the acute management of hypertensive emergencies of pregnancy . STUDY DESIGN We performed a r and omized double-blind trial of oral nifedipine ( 10 mg ) and intravenous labetalol ( 20 mg ) in 50 peripartum patients with sustained systolic blood pressure of > /=170 mm Hg or diastolic blood pressure of > /=105 mm Hg . Both agents were repeated at sequentially escalating dosages every 20 minutes until a therapeutic goal of systolic blood pressure of < 160 mm Hg and diastolic blood pressure of < 100 mm Hg was achieved . Crossover occurred if the treatment goal was not achieved after 5 doses . Primary outcome was time to achievement of the therapeutic goal . Secondary outcome variables were agent failure , urinary output , and adverse effects . Data were analyzed by unpaired t test , Mann-Whitney U test , and analysis of variance for repeated measures . RESULTS The time to achieve the blood pressure goal was significantly shorter with nifedipine ( mean + /- SD , 25 + /- 13.6 minutes ) than with labetalol ( 43.6 + /- 25.4 minutes ; P = .002 ) . No patients required crossover therapy . Urine output was significantly increased ( P < .001 ) at 1 hour after nifedipine dosing ( 99 + /- 99 mL ) compared with labetalol ( 44.8 + /- 19.1 mL ) and remained significantly increased at 2 , 6 , 12 , 18 , and 24 hours after initial administration . Adverse effects were infrequent . There were no differences in maternal age , gestational age , number of antepartum patients , or enrollment blood pressures between groups . CONCLUSIONS Both oral nifedipine and intravenous labetalol are effective in the management of acute hypertensive emergencies of pregnancy ; however , nifedipine controls hypertension more rapidly and is associated with a significant increase in urinary output Objective : To compare the effects of a single oral dose of nifedipine with those of intravenous dihydralazine on central haemodynamics in pregnant women with severe pre-eclampsia . Design : A prospect i ve comparative study . Setting : The High Risk OUTPUT: There were no differences in adverse maternal or fetal outcomes . Oral nifedipine , and possibly labetalol and methyldopa , are suitable options for treatment of severe hypertension in pregnancy/postpartum 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 underg OUTPUT:

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*** ***EXAMPLES*** 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 ) BACKGROUND Despite preoperative anaemia treatment , a risk of postoperative anaemia remains . This r and omized , controlled study evaluated the efficacy of i.v . ferric carboxymaltose ( FCM ) as postoperative anaemia treatment after total knee arthroplasty ( TKA ) . METHODS TKA patients with postoperative anaemia [ haemoglobin ( Hb ) 8.5 - 12.0 g dl(-1 ) ] without prior transfusions were r and omly assigned to FCM [ 700 - 1000 mg iron ( according to calculate iron deficit on postoperative day 2 ) ] or ferrous glycine sulphate ( FS ; 100 mg iron daily from day 7 onwards ) and followed for Hb , iron status , quality -of-life ( EQ-5D ) , and performance ( 6 min walk test ) until day 30 . RESULTS Of 161 preoperatively non-anaemic patients , 122 ( 75.8 % ) developed anaemia after operation ( within 24 h ) and were enrolled in this study ( 60 FCM , 62 FS ) . Hb substantially decreased until day 4 in both groups , and partly recovered by day 30 . FCM-treated patients achieved Hb ≥12.0 g dl(-1 ) more frequently ( 42.3 % vs 23.5 % ; P=0.04 ) and showed a trend towards higher Hb increase from day 4 to day 30 [ + 1.7 ( 1.2 ) vs + 1.3 ( 1.0 ) ; P=0.075 ] compared with FS-treated patients . Patients with postoperative Hb < 10 g dl(-1 ) experienced better Hb increase with FCM [ + 2.4 ( 0.3 ) g dl(-1 ) ] than FS [ + 1.1 ( 0.4 ) g dl(-1 ) ; P=0.018 ] . Patients being iron-deficient at enrolment ( 56.7 % ) had a higher Hb increase with FCM [ + 1.9 ( 0.3 ) g dl(-1 ) ] than FS [ + 1.2 ( 0.2 ) g dl(-1 ) ; P=0.03 ] . Total EQ-5D and performance outcomes were comparable between the groups , but FCM was associated with better scores for ' usual activities ' . No i.v . iron-related adverse events were reported . CONCLUSIONS Preoperatively non-anaemic TKA patients are at high risk of postoperative anaemia . Postoperative i.v . FCM provided significant benefit over oral FS , particularly in patients with preoperative iron deficiency , severe postoperative anaemia , or both . CLINICAL TRIAL REGISTRATION EudraCT 2010 - 023038 - 22 ; Clinical Trials.gov NCT01913808 We conducted a r and omized study analyzing the impact of darbepoetin alfa ( DA ) administration with or without intravenous ( i.v . ) iron on erythroid recovery after autologous hematopoietic cell transplantation ( HCT ) . Patients were r and omized between no DA OUTPUT: There were no statistically significant differences in mortality between iron and inactive control . In all comparisons , there were no differences in the results comparing patients with and without heart failure . Both oral and parenteral iron are shown to decrease the proportion of people who require blood transfusion and increase haemoglobin levels , without any benefit on mortality . 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 OUTPUT:

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*** ***EXAMPLES*** 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 BACKGROUND Peak oxygen uptake ( pVO2 ) is used for risk stratification in chronic heart failure ( CHF ) , but little is known about the prognostic impact of pVO2-changes in patients on chronic beta-blocker ( BBL ) therapy . We therefore prospect ively evaluated individual pVO2-changes at a 6-month interval in patients all receiving BBL . METHODS 194 patients with stable CHF on stable medication were included ( V1 ) and underwent clinical evaluation and exercise testing . Testing was repeated ( V2 ) at 5.7+/-1.5 months after V1 and patients were followed > 12 months after V2 . Death or hospitalisation due to cardiac reasons was the predefined EP ( EPP , end-point positive ; n=62 ; EPN , end-point negative ; n=113 ) . RESULTS Initial characteristics did not differ between EPP and EPN . Multivariate cox regression analysis revealed that change of pVO2 ( EPP : -0.6+/-2.6 ml/kg min ; EPN : + 2.5+/-3.3 ml/kg min ; p<0.001 ) was independent to pVO2 , LVEF , NTproBNP and NYHA at V2 for prediction of the combined end-point during follow-up . An increase of pVO2 by 10 % was identified as an adequate cut-off value for risk stratification and ROC- analysis showed the significant incremental prognostic value of the determination of pVO2 changes in combination with pVO2 . CONCLUSIONS Serial measurements of pVO2 yield additional information for risk stratification in clinical ly homogenous CHF patients receiving BBL . This is the first study demonstrating this fact within a narrow predefined interval with all patients on BBL Background —There is evidence that aerobic exercise improves functional capacity in patients with New York Heart Association ( NYHA ) class II and III chronic heart failure . However , it is unknown whether dancing is safe and able to improve functional capacity in patients with chronic heart failure . Methods and Results —We prospect ively studied 130 patients with stable chronic heart failure ( 107 men ; mean age , 59±11 years ) in New York Heart Association class II and III and left ventricle ejection fraction < 40 % . Patients were r and omized to supervised aerobic exercise training at 70 % of peak & OV0312;o2 3 times a week for 8 weeks ( group E , n=44 ) or to a dance protocol of alternate slow ( 5 minutes ) and fast ( 3 minutes ) waltz lasting 21 minutes ( group D , n=44 ) . A group that did not undergo exercise training served as control ( group C , n=42 ) . On study entry and at 8 weeks , all patients underwent cardiopulmonary exercise testing on a cycle ergometer until volitional fatigue , 2D-echo with Doppler , and endothelium-dependent dilation of the brachial artery . Heart rate was 111±15 bpm during exercise training and 113±19 bpm during dancing ( P=0.59 ) . Peak & OV0312;o2 , anaerobic threshold , & OV0312;e/&OV0312;co2 slope , and & OV0312;o2/W slope were all similarly improved in both E and D groups ( + 16 % and 18 % , 20 % and 21 % , 14 % and 15 % , 18 % and 19 % , respectively ; P not significant for all comparisons ; P<0.001 versus controls ) . Endothelium-dependent relaxation was also similarly improved ( group E , from 2.6±1.3 % to 5.2±1.5 % , P<0.001 versus control ; group D , from 2.2±1.4 % to 5.0±1.5 % , P<0.001 versus control for both E and D ) . The change in peak & OV0312;o2 in E and D groups was correlated with changes in peak velocity of early filling wave/peak velocity of late filling ratio ( r=−0.58 , P<0.001 ) and endothelium-dependent dilation ( r=0.64 , P<0.001 ) . Untoward events were rare in both E and D groups . Conclusions —In patients with stable chronic heart failure , waltz dancing is safe and able to improve functional capacity and endothelium-dependent dilation similar to traditional aer OUTPUT: The results suggested that dance therapy compared with control had a positive impact on peak VO2 and HRQOL . Non-significant difference in VO2 peak and HRQOL for participants in the exercise group compared with dance therapy . Conclusions : Dance therapy may improve peak VO2 and HRQOL in patients with chronic heart failure ( CHF ) and could be considered for inclusion in cardiac rehabilitation programmes 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 ( MCT OUTPUT:

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*** ***EXAMPLES*** INPUT: Background — Atrial fibrillation ( AF ) is common among patients with heart failure and preserved ejection fraction ( HFpEF ) , but its clinical profile and impact on exercise capacity remain unclear . RELAX ( Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in HFpEF ) was a multicenter r and omized trial testing the impact of sildenafil on peak VO2 in stable out patients with chronic HFpEF . We sought to compare clinical features and exercise capacity among patients with HFpEF who were in sinus rhythm ( SR ) or AF . Methods and Results — RELAX enrolled 216 patients with HFpEF , of whom 79 ( 37 % ) were in AF , 124 ( 57 % ) in SR , and 13 in other rhythms . Participants underwent baseline cardiopulmonary exercise testing , echocardiogram , biomarker assessment , and rhythm status assessment before r and omization . Patients with AF were older than those in SR but had similar symptom severity , comorbidities , and renal function . & bgr;-blocker use and chronotropic indices were also similar . Despite comparable left ventricular size and mass , AF was associated with worse systolic ( lower EF , stroke volume , and cardiac index ) and diastolic ( shorter deceleration time and larger left atria ) function compared with SR . Pulmonary artery systolic pressure was higher in AF . Patients with AF had higher N-terminal pro-B-type natriuretic peptide , aldosterone , endothelin-1 , troponin I , and C-telopeptide for type I collagen levels , suggesting more severe neurohumoral activation , myocyte necrosis , and fibrosis . Peak VO2 was lower in AF , even after adjustment for age , sex , and chronotropic response , and VE/VCO2 was higher . Conclusions — AF identifies an HFpEF cohort with more advanced disease and significantly reduced exercise capacity . These data suggest that evaluation of the impact of different rate or rhythm control strategies on exercise tolerance in patients with HFpEF and AF is warranted . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00763867 Background — Isolated atrial fibrillation ( AF ) is associated with mild enlargement of the left atrium ( LA ) and left ventricular ( LV ) diastolic dysfunction . The impact of ablation of isolated AF on left chamber size and function is unclear , and whether diastolic dysfunction is the cause or the consequence of AF remains unknown . The objective of this prospect i ve study was to evaluate the impact of sinus rhythm restoration by catheter ablation on LV diastolic dysfunction , LA morphology , and mechanical function . Methods and Results — Forty-eight patients with isolated AF were studied by serial echocardiographic studies at baseline and at 1- , 3- , 6- , 9- , and 12-month intervals after radiofrequency ablation . LA dimensions and mechanical function and LV systolic and diastolic functions were evaluated at each time interval . Diastolic function was assessed with conventional Doppler parameters and new indexes such as tissue Doppler imaging , mitral flow propagation velocity , and combined criteria . LV diastolic dysfunction was present in paroxysmal and chronic AF patients with a reduction of tissue Doppler imaging lateral early diastolic peak velocity in 37 % ( P<0.001 ) and 48 % ( P<0.01 ) , respectively , compared with healthy control subjects . At the end of the follow-up , LA area decreased significantly by 18 % ( P<0.001 ) in paroxysmal and 23 % ( P<0.05 ) in chronic AF patients . Diastolic function improved significantly with an increase in lateral early diastolic peak velocity of 29 % ( P<0.001 ) in paroxysmal AF and 46 % ( P<0.05 ) in chronic AF patients . A significant increase in LV ejection fraction was also noted for both groups : 7.7 % and 18.8 % , respectively . Conclusions — This study demonstrates reverse morphological remodeling of the LA and improvement of LV diastolic and systolic functions after restoration of sinus rhythm by ablation for isolated AF . Because patients with isolated AF have none of the traditional causes of LV diastolic dysfunction , our findings suggest that AF may be partly the cause rather than the consequence of diastolic dysfunction Background —Early detection of structural changes in left atrium ( LA ) before atrial fibrillation ( AF ) development could be helpful in identification of those at higher risk for AF . Using cardiac magnetic resonance imaging , we examined the association of LA volume and function , and incident AF in a multiethnic population free of clinical cardiovascular diseases . Methods and Results —In a case – cohort study embedded in MESA ( Multi-Ethnic Study of Atherosclerosis ) , baseline LA size and function assessed by cardiac magnetic resonance feature-tracking were compared between 197 participants with incident AF and 322 participants r and omly selected from the whole MESA cohort . Participants were followed up for 8 years . Incident AF cases had a larger LA volume and decreased passive , active , and total LA emptying fractions and peak global LA longitudinal strain ( peak LA strain ) at baseline . In multivariable analysis , elevated LA maximum volume index ( hazard ratio , 1.38 per SD ; 95 % confidence interval , 1.01–1.89 ) and decreased peak LA strain ( hazard ratio , 0.68 per SD ; 95 % confidence interval , 0.48–0.96 ) , and passive and total LA emptying fractions ( hazard ratio for passive LA emptying fractions , 0.55 per SD ; 95 % confidence interval , 0.40–0.75 and hazard ratio for active LA emptying fractions , 0.7 OUTPUT: An integrated evaluation should be also applied to patients with a high arrhythmic risk , in whom eccentric LA remodelling and higher LA stiffness are associated with a greater AF risk . Evaluation of LA size , volume , function and structure are m and atory in the management of patients with HT , HFpEF and AF . A multi-modality approach could provide additional information , identifying subjects with more severe LA remodelling . 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 cardiov OUTPUT:

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

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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*** ***EXAMPLES*** INPUT: The long‐term effects of abdominal aortic aneurysm ( AAA ) screening were investigated in extended follow‐up from the UK Multicentre Aneurysm Screening Study ( MASS ) r and omized trial 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 OUTPUT: Conclusions : Population ‐based one‐time screening for AAA with ultrasound in asymptomatic men aged 65 years and older remains beneficial during the longer term after screening has ceased , with significant reductions in AAA mortality and AAA rupture rate , and hence avoids unnecessary AAA‐related deaths . The sensitivity analyses also showed that the benefits of AAA screening were more pronounced in men at a mean age of < 70 years with a relatively lower prevalence of AAA than in men at a mean age of > 70 years with a relatively higher prevalence of AAA . 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 OUTPUT:

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*** ***EXAMPLES*** INPUT: This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence The Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D comprehensively review ed the evidence for both skeletal and nonskeletal health outcomes and concluded that a causal role of calcium and vitamin D in skeletal health provided the necessary basis for the 2011 Estimated Average Requirement ( EAR ) and Recommended Dietary Allowance ( RDA ) for ages older than 1 year . For nonskeletal outcomes , including cancer , cardiovascular disease , diabetes , infections , and autoimmune disorders , r and omized clinical trials were sparse , and evidence was inconsistent , inconclusive as to causality , and insufficient for Dietary Reference Intake ( DRI ) development . The EAR and RDA for calcium range from 500 to 1,100 and 700 to 1,300 mg daily , respectively , for ages 1 year and older . For vitamin D ( assuming minimal sun exposure ) , the EAR is 400 IU/day for ages older than 1 year and the RDA is 600 IU/day for ages 1 to 70 years and 800 IU/day for 71 years and older , corresponding to serum 25-hydroxyvitamin D ( 25OHD ) levels of 16 ng/mL ( 40 nmol/L ) for EARs and 20 ng/mL ( 50 nmol/L ) or more for RDAs . Prevalence of vitamin D inadequacy in North America has been overestimated based on serum 25OHD levels corresponding to the EAR and RDA . Higher serum 25OHD levels were not consistently associated with greater benefit , and for some outcomes U-shaped associations with risks at both low and high levels were observed . The Tolerable Upper Intake Level for calcium ranges from 1,000 to 3,000 mg daily , based on calcium excretion or kidney stone formation , and from 1,000 to 4,000 IU daily for vitamin D , based on hypercalcemia adjusted for uncertainty result ing from emerging risk relationships . Urgently needed are evidence -based guidelines to interpret serum 25OHD levels relative to vitamin D status and intervention Background : Low 25-hydroxyvitamin D [ 25(OH)D ] levels are commonly found in HIV – hepatitis C virus ( HCV ) coinfected patients and are associated with liver fibrosis . No association between 25(OH)D levels and response to pegylated interferon & agr;-2a/2b plus ribavirin ( PEGIFN + RBV ) has yet been reported for HIV – HCV coinfected patients . Design : Epidemiological characteristics , HIV and HCV infection parameters , liver biopsies , as well as data on virologic response was available in 65 patients who received chronic hepatitis C ( CHC ) therapy with PEGIFN + RBV within a prospect i ve trial . 25(OH)D levels were retrospectively assessed using stored screening serum sample s obtained within 35 days prior to CHC treatment . Methods : According to their 25(OH)D levels , patients were assigned to the normal ( > 30 ng/ml ; D-NORM ) , the insufficiency ( 10–30 ng/ml ; D-INSUFF ) , or the deficiency ( < 10 ng/ml ; D-DEF ) group . HCV-GT 1/4 , high HCV-RNA load ( > 6 × 105 IU/ml ) , advanced liver fibrosis ( METAVIR F3/F4 ) , and IL28B rs12979860non-C/C were considered as established risk factors for treatment failure in HIV – HCV coinfected patients . Results : Thirty-seven ( 57 % ) and 15 ( 23 % ) patients presented with D-INSUFF and D-DEF , respectively , whereas only 13 ( 20 % ) patients had normal 25(OH)D levels . Substantial differences in cEVR ( D-NORM 92 % vs. D-INSUFF 68 % vs. D-DEF 47 % ; P = 0.008 ) and SVR ( D-NORM 85 % vs. D-INSUFF 60 % vs. D-DEF 40 % ; P = 0.029 ) rates were observed between 25(OH)D subgroups . Especially in difficult-to-treat patients with multiple ( three to four ) established risk factors , low 25(OH)D levels were clearly associated with lower rates of SVR [ patients without 25(OH)D deficiency 52 % vs. D-DEF 0 % ; P = 0.012 ] . Conclusion : Low 25(OH)D levels may impair virologic response to PEGIFN + RBV therapy , especially in difficult-to-treat patients . Vitamin D supplementation should be considered and evaluated prospect ively in HIV – HCV coinfected patients receiving CHC treatment OUTPUT: CONCLUSION Low vitamin D status is common in chronic Hepatitis C patients and is associated with advanced liver fibrosis 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:

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

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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*** ***EXAMPLES*** 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 Background In line with a rapidly ageing global population , the rise in the frequency of falls will lead to increased healthcare and social care costs . This study will be one of the few r and omized controlled trials evaluating a multifaceted falls intervention in a low-middle income , culturally-diverse older Asian community . The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adults . Methods Three hundred community-dwelling older Malaysian adults with a history of ( i ) two or more falls , or ( ii ) one injurious fall in the past 12 months will be recruited . Baseline assessment will include cardiovascular , frailty , fracture risk , psychological factors , gait and balance , activities of daily living and visual assessment s. Fallers will be r and omized into 2 groups : to receive tailored multifactorial interventions ( intervention group ) ; or given lifestyle advice with continued conventional care ( control group ) . Multifactorial interventions will target 6 specific risk factors . All participants will be re-assessed after 12 months . The primary outcome measure will be fall recurrence , measured with monthly falls diaries . Secondary outcomes include falls risk factors ; and psychological measures including fear of falling , and quality of life . Discussion Previous studies evaluating multifactorial interventions in falls have reported variable outcomes . Given likely cultural , personal , lifestyle and health service differences in Asian countries , it is vital that individually-tailored multifaceted interventions are evaluated in an Asian population to determine applicability of these interventions in our setting . If successful , these approaches have the potential for widespread application in geriatric healthcare services , will reduce the projected escalation of falls and fall-related injuries , and improve the quality of life of our older community . Trial registration IS RCT Summary The present study was conducted to determine the effect of 5-month exercise program on the prevention of falls in the elderly . The exercise training , which consisted of calisthenics , body balance training , muscle power training , and walking ability training 3 days/week improved the indices of the flexibility , body balance , muscle power , and walking ability and reduced the incidence of falls compared with non-exercise controls . The present study showed the beneficial effect of the exercise program aim ed at improving flexibility , body balance , muscle power , and walking ability in preventing falls in the elderly . Introduction The present study was conducted to determine the effect of exercise on the prevention of falls in the elderly . Methods Sixty-eight elderly ambulatory volunteers were r and omly divided into two groups : the exercise and control groups . The daily exercise , which consisted of calisthenics , body balance training ( t and em st and ing , t and em gait , and unipedal st and ing ) , muscle power training ( chair-rising training ) , and walking ability training ( stepping ) , were performed 3 days/week only in the exercise group . No exercise was performed in the control group . Results After the 5-month exercise program , the indices of the flexibility , body balance , muscle power , and walking ability significantly improved in the exercise group compared with the control group . The incidence of falls was significantly lower in the exercise group than in the control group ( 0.0 % vs. 12.1 % , P = 0.0363 ) . The exercise program was safe and well tolerated in the elderly . Conclusions The present study showed the beneficial effect of the exercise program aim ed at improving flexibility , body balance , muscle power , and walking ability in preventing falls in the elderly AIM To examine the effectiveness of cognitive-behavioural strategies with/without intense Tai Chi exercise in reducing fear of falling among community-dwelling elderly adults . Background . Fear of falling is a major health problem among community-dwelling older persons . The prevalence of this fear ranges from 29 % to 77 % , indicating the importance of developing effective strategies to reduce fear of falling among elderly adults . METHODS Data were collected from January to December 2007 . A r and omized controlled trial with three groups ( control , cognitive-behavioural and cognitive-behavioural with Tai Chi ) . Participants were assessed at baseline for demographic data , falls-related history , and fear of falling . Data on these variables plus falls , mobility , social support behaviour and satisfaction , and quality of life were also collected at 2 and 5 months after interventions . RESULTS Participants in the three groups differed significantly in both measures of fear of falling ( F = 20·89 , P < 0·001 ; F = 6·09 , P < 0·001 ) and mobility ( F = 30·33 , P < 0·001 ) , social support behaviour and satisfaction ( F = 3·32 , P < 0·05 and F = 6·35 , P < 0·001 , respectively ) , and quality of life ( F = 16·66 , P < 0·001 ) . In addition , participants who received the cognitive-behavioural intervention with Tai Chi had significantly lower fear of falling scores ( P < 0·001 ) and higher mobility ( P < 0·001 ) , social support satisfaction ( P < 0·01 ) and quality of life ( P < 0·001 ) OUTPUT: Conclusion There is a small but growing research base of falls prevention RCTs from Asian countries , with exercise approaches being most research ed and effective . 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 OUTPUT:

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*** ***EXAMPLES*** INPUT: Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment Introduction It was postulated that workers , at the sub-acute stage after injury , respond differently to clinical and occupational interventions offered in a workers ’ compensation environment . Individual worker risk of disability , it was further believed , would influence the effectiveness of early intervention . The objective of the current pilot study was to evaluate return to work ( RTW ) outcomes following proactive , combined clinical , occupational and case management-based interdisciplinary early intervention , provided in a workers ’ compensation environment 4–10 weeks of onset of back pain , to workers with medium and high risk for disability . Methods The project was a controlled study comparing conventional workers ’ compensation case management with integrated , interdisciplinary and multimodal early intervention ( hereinafter referred to as “ EI ” ) . At baseline , risk status was determined by a vali date d Risk for Disability Question naire by Carragee et al. ( Spine 5(1):24–35 , 2005 ) . Seventeen workers at high risk of protracted disability and 20 workers at moderate risk of disability received conventional case management , and 17 workers assessed at high risk of protracted disability and 18 workers at moderate risk of disability received the Early Intervention . Results At 3 months post back pain onset , no statistically significant differences were identified in RTW outcomes between conventional case management and the Early Intervention . However , by 6 months post back pain onset , workers at high risk of work disability who received the Early Intervention were significantly more likely to RTW than high risk workers who received conventional case management . In contrast , moderate risk workers continued to exhibit no statistically significant differences in RTW outcomes . Conclusion Multimodal Early Intervention in the workers ’ compensation case management context is likely effective for workers with sub-acute back pain who are at high risk of occupational disability . The comprehensive Early Intervention is , however , likely redundant for workers who are not at high risk for disability and should not be applied indiscriminately . Further studies are required to determine longer-term Early Intervention outcomes , and to replicate the findings using a r and omized control design . Also , with a larger sample size , it will be possible to determine predictors of occupational outcomes & 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 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 OUTPUT: However , effects were smaller in larger and better- quality studies , suggesting publication bias . No intervention was clearly superior , although effort-intensive interventions were less effective than simple ones . No cost-benefit analyses established statistically significant net economic benefits . 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 OUTPUT:

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 .

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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*** ***EXAMPLES*** INPUT: Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease , lifestyle and the use of medications , which are related to weight gain . Methods A multicentric , r and omized , controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program ( LWP ) . The program consists of a one-hour weekly session to discuss topics like dietary choices , lifestyle , physical activity and self-esteem with patients and their relatives . Patients were r and omized into two groups : st and ard care ( SC ) and st and ard care plus intervention ( LWP ) . Primary outcome was defined as the weight and body mass index ( BMI ) . Results 160 patients participated in the study ( 81 in the intervention group and 79 in the SC group ) . On an intent to treat analysis , after three months the patients in the intervention group presented a decrease of 0.48 kg ( CI 95 % -0.65 to 1.13 ) while the st and ard care group showed an increase of 0.48 kg ( CI 95 % 0.13 to 0.83 ; p=0.055 ) . At six-month follow-up , there was a significant weight decrease of −1.15 kg , ( CI 95 % -2.11 to 0.19 ) in the intervention group compared to a weight increase in the st and ard care group ( + 0.5 kg , CI 95 % -0.42–1.42 , p=0.017 ) . Conclusion In conclusion , this was a multicentric r and omized clinical trial with a lifestyle intervention for individuals with schizophrenia , where the intervention group maintained weight and presented a tendency to decrease weight after 6 months . It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight . Clinical trials.gov The study objective was to evaluate the feasibility of a telephone delivered intervention consisting of motivational interviewing and cognitive behavioural strategies aim ed at improving diet and physical activity in people diagnosed with psychotic disorders . Twenty participants diagnosed with a non-acute psychotic disorder were recruited . The intervention consisted of eight telephone delivered sessions targeting fruit and vegetable ( F&V ) consumption and leisure screen time , as well as smoking and alcohol use ( as appropriate ) . F&V frequency and variety , and overall diet quality ( measured by the Australian Recommended Food Score , ARFS ) , leisure screen time , overall sitting and walking time , smoking , alcohol consumption , mood , quality of life , and global functioning were examined before and 4-weeks post-treatment . Nineteen participants ( 95 % ) completed all intervention sessions , and 17 ( 85 % ) completed follow-up assessment s. Significant increases from baseline to post-treatment were seen in ARFS fruit , vegetable and overall diet quality scores , quality of life and global functioning . Significant reductions in leisure screen time and overall sitting time were also seen . Results indicated that a telephone delivered intervention targeting key cardiovascular disease risk behaviours appears to be feasible and relatively effective in the short-term for people diagnosed with psychosis . A r and omized controlled trial is warranted to replicate and extend these findings The objective of this multicenter r and omised clinical trial was to examine the effect of exercise versus occupational therapy on mental and physical health in schizophrenia patients BACKGROUND The aim of this r and omized clinical trial follow-up at three months was to evaluate the effectiveness of an educational intervention with a focus on diet and physical activity ( PA ) to change the amount of PA , body mass index ( BMI ) and the waist circumference ( WC ) in patients with severe mental illness . METHODS We recruited 332 out patients with severe mental disorders undergoing treatment with antipsychotic medication from Mental Healthcare Centers of Barcelona . They were r and omly assigned to an intervention or a control group . The patients in the intervention group participated in a group PA and diet educational program . The blinded measurements at 0 and 3 months were : the level of PA ( IPAQ question naire ) , BMI , WC , blood pressure , dietary habits ( PREDIMED question naire ) , quality of life ( SF-36 question naire ) and laboratory parameters ( cholesterol , triglycerides , glucose ) . RESULTS The average age was 46.7 years and 55 % were males . Schizophrenia had been diagnosed in 67.1 % of them . At 3 months , the average weekly walking METs rose significantly in the IG 266.05 METs ( 95%CI : 16.86 to 515.25 ; P=0.036 ) . The total MET average also rose although not significantly : 191.38 METs ( 95%CI : 1.38 to 381.38 ; P=0.086 ) . However , the BMI decreased significantly more in the CG , by 0.26kg/m(2 ) ( 95%CI : 0.02 to 0.51 ; P=0.038 ) , than in the IG . There were no significant differences in the WC . CONCLUSIONS The short-term results suggest that the intervention increases the level of PA , but does not improve physical or laboratory parameters . TRIAL REGISTRATION Clinical trials.gov NCT01729650 ( effectiveness of a physical activity and diet program in patients with psychotic disorder [ CAPiCOR ] ) BACKGROUND People with psychosis often experience weight gain , which places them at risk of cardiovascular disease , diabetes , and early death . OBJECTIVE To determine the uptake , adherence , and clinical effectiveness of a healthy living intervention design ed to reduce weight gain . METHOD An exploratory r and omized controlled trial , comparing the intervention with treatment as usual ( T OUTPUT: Depressive symptoms and older age were associated with less vigorous PA in meta-regression analyses . Our data confirm that people with schizophrenia engage in significantly less moderate and vigorous PA versus controls . 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 OUTPUT:

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*** ***EXAMPLES*** 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 The relationship between adherence to highly active antiretroviral therapy ( HAART ) and RNA-HIV viral load outcomes has been extensively shown . Although there are different procedures for assessing treatment adherence , there is no ideal method . We present the SERAD ( Self-Reported Adherence ) question naire , a qualitative and quantitative self-reported instrument design ed to provide an easier adherence measurement . We also compared the question naire to three other methods to evaluate adherence to HAART regimens in HIV-infected patients . Two prospect i ve , observational , longitudinal studies were developed : a single-center pilot study followed by a multicenter study . A total of 530 HIV-infected out patients was prospect ively included , 66 in the pilot study and 464 in the multicenter study . Four methods were used to study adherence to HAART regimens : the SERAD question naire , pill count , electronic monitoring , and plasma drug monitoring . Pearson 's correlations and Bl and and Altman 's method were developed . The SERAD question naire showed good feasibility and significant validity . Adequate levels of agreement between methods were observed , particularly when adherence was high . Differences increased as adherence fell . Moreover , the question naire was completed correctly , the interviewers did not report uncovered aspects , and the information was collected easily . Our results suggest that the SERAD question naire is a feasible and useful instrument for assessing adherence to HAART regimens in HIV-infected patients , and makes it possible to obtain reliable qualitative and quantitative information related to treatment adherence Nonadherence to immunosuppressants in renal transplant recipients is a major factor affecting graft survival , but it is difficult to detect accurately in clinical practice . Adherence was measured in 153 adult renal transplant recipients using self-report question naires and interview , clinician rating , and cyclosporine levels . The sensitivity and specificity of these measures were determined by comparison with electronic monitoring in a r and omly selected sub sample of 58 subjects . Measures of adherence in current clinical use do not perform well when tested against electronic monitoring . Self-report at a confidential interview was the best measure of adherence for the detection of both missed doses and erratic timing of medication . However , the use of a confidential interview is not directly applicable to a clinical setting . Further research on how best to facilitate disclosure in clinical setting s may be the best way to develop adherence measures for use in routine practice The Hill-Bone Compliance to High Blood Pressure Therapy Scale assesses patient behaviors for three important behavioral domains of high blood pressure treatment : 1 ) reduced sodium intake ; 2 ) appointment keeping ; and 3 ) medication taking . This scale is comprised of 14 items in three subscales . Each item is a four point Likert type scale . The content validity of the scale was assessed by a relevant literature review and an expert panel , which focused on cultural sensitivity and appropriateness of the instrument for low literacy . Internal consistency reliability and predictive validity of the scale were evaluated using two community based sample s of hypertensive adults enrolled in clinical trials of high blood pressure care and control . The st and ardized alpha for the total scale were 0.74 and 0.84 , and the average interitem correlations of the 14 items were 0.18 and 0.28 , respectively . The construct and predictive validity of the scale was assessed by factor analysis and by testing of theoretically derived hypotheses regarding whether the scale demonstrated consistent and expected relationships with related variables . In this study , high compliance scale scores predicted significantly lower levels of blood pressure and blood pressure control . Moreover , high compliance scale scores at the baseline were significantly associated with blood pressure control at both baseline and at follow up in the two independent sample s. This brief instrument provides a simple method for clinicians in various setting s to use to assess patients ' self reported compliance levels and to plan appropriate interventions Objectives Many question naires on adherence to antiretroviral therapy are in use , but the validity of patients ’ responses has not been tested . The Medication Adherence Self-Report Inventory ( MASRI ) has been developed and tested for its validity against objective measures and treatment outcome . Design Prospect i ve study comparing question naire responses with MEMS TrackCap ( MC , a medication event monitoring system ) , pill count ( PC ) and plasma HIV viraemia in a publicly funded specialist HIV clinic . Participants Patients self-medicating antiretro OUTPUT: DISCUSSION The three selected self-report scales may assist transplant professionals in detecting nonadherence . However , these scales were only vali date d in patients with HIV . 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 exam OUTPUT:

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*** ***EXAMPLES*** INPUT: BACKGROUND Epidemiological studies have shown television watching to be a risk factor for the development of obesity in children . The effect of reducing television watching and other sedentary behaviors as a component of a comprehensive obesity treatment program has not been thoroughly tested . OBJECTIVE To compare the influence of targeting decreases in sedentary behavior vs. increases in physical activity in the comprehensive treatment of obesity in 8- to 12-year-old children . DESIGN R and omized , controlled outcome study . SETTING Childhood obesity research clinic . DESIGN Ninety families with obese 8- to 12-year-old children were r and omly assigned to groups that were provided a comprehensive family-based behavioral weight control program that included dietary , and behavior change information but differed in whether sedentary or physically active behaviors were targeted and the degree of behavior change required . RESULTS Results during 2 years showed that targeting either decreased sedentary behaviors or increased physical activity was associated with significant decreases in percent overweight and body fat and improved aerobic fitness . Self-reported activity minutes increased and targeted sedentary time decreased during treatment . Children substituted nontargeted sedentary behaviors for some of their targeted sedentary behaviors . CONCLUSION These results support reducing sedentary behaviors as an adjunct in the treatment of pediatric obesity BACKGROUND Sedentary behavior is a risk factor for cardiometabolic disease . Regularly interrupting sedentary behavior with activity breaks may lower this risk . OBJECTIVE We compared the effects of prolonged sitting , continuous physical activity combined with prolonged sitting , and regular activity breaks on postpr and ial metabolism . DESIGN Seventy adults participated in a r and omized crossover study . The prolonged sitting intervention involved sitting for 9 h , the physical activity intervention involved walking for 30 min and then sitting , and the regular-activity-break intervention involved walking for 1 min 40 s every 30 min . Participants consumed a meal-replacement beverage at 60 , 240 , and 420 min . RESULTS The plasma incremental area under the curve ( iAUC ) for insulin differed between interventions ( overall P < 0.001 ) . Regular activity breaks lowered values by 866.7 IU · L(-1 ) · 9 h(-1 ) ( 95 % CI : 506.0 , 1227.5 IU · L(-1 ) · 9 h(-1 ) ; P < 0.001 ) when compared with prolonged sitting and by 542.0 IU · L(-1 ) · 9 h(-1 ) ( 95 % CI : 179.9 , 904.2 IU · L(-1 ) · 9 h(-1 ) ; P = 0.003 ) when compared with physical activity . Plasma glucose iAUC also differed between interventions ( overall P < 0.001 ) . Regular activity breaks lowered values by 18.9 mmol · L(-1 ) · 9 h(-1 ) ( 95 % CI : 10.0 , 28.0 mmol · L(-1 ) · 9 h(-1 ) ; P < 0.001 ) when compared with prolonged sitting and by 17.4 mmol · L(-1 ) · 9 h(-1 ) ( 95 % CI : 8.4 , 26.3 mmol · L(-1 ) · 9 h(-1 ) ; P < 0.001 ) when compared with physical activity . Plasma triglyceride iAUC differed between interventions ( overall P = 0.023 ) . Physical activity lowered values by 6.3 mmol · L(-1 ) · 9 h(-1 ) ( 95 % CI : 1.8 , 10.7 mmol · L(-1 ) · 9 h(-1 ) ; P = 0.006 ) when compared with regular activity breaks . CONCLUSION Regular activity breaks were more effective than continuous physical activity at decreasing postpr and ial glycemia and insulinemia in healthy , normal-weight adults . This trial was registered with the Australian New Zeal and Clinical Trials registry as ACTRN12610000953033 This study evaluated the feasibility of a home-based intervention to reduce sugar-sweetened beverage intake and television viewing among children . Lower income parents of overweight children aged 5 - 12 years ( n = 40 ) were r and omized to a home environment intervention to reduce television viewing with locking devices and displace availability of sugar-sweetened beverages with home delivery of non-caloric beverages ( n = 25 ) , or to a no-intervention control group ( n = 15 ) for 6 months . Data were collected at baseline and 6 months . After 6 months , television viewing hours per day was significantly lower in the intervention group compared with the control group ( 1.7 [ SE = .02 ] vs. 2.6 [ SE = .25 ] hours/day , respectively , P < .01 ) . Sugar-sweetened beverage intake was marginally significantly lower among intervention group compared to control group children ( 0.21 [ SE = .09 ] vs. 0.45 [ SE = .10 ] , respectively , P < .09 ) . Body mass index ( BMI ) z-score was not significantly lower among intervention compared to control children . Among a lower income sample of children , a home-based intervention reduced television viewing , but not sugar-sweetened beverage intake or BMI z-score BakckgroundThe first aim was to examine the effect of the UP4FUN pilot intervention on children ’s total sedentary time . The second aim was to investigate if the intervention had an effect on children ’s physical activity ( PA ) level . Finally , we aim ed to investigate demographic differences ( i.e. age , gender , ethnicity , living status and having siblings ) between children in the intervention group who improved in sedentary time and PA at post-test and children in the intervention group who worsened in sedentary time and OUTPUT: Although descriptions of intervention strategies were not always clearly reported , we identified encouragement of a TV turnoff week and implementing st and ing desks in classrooms as promising strategies . Due to a lack of high quality studies and inconsistent findings , we found no convincing evidence for the effectiveness of existing interventions targeting solely sedentary behaviour . 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 = OUTPUT:

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*** ***EXAMPLES*** INPUT: Background To investigate the risk of first-time acute coronary syndrome ( ACS ) , stroke and venous thromboembolism ( VTE ) in patients with ankylosing spondylitis ( AS ) , psoriatic arthritis ( PsA ) and undifferentiated spondyloarthritis ( uSpA ) , compared to each other and to the general population ( GP ) . Methods This is a prospect i ve nationwide cohort study . Cohorts with AS ( n = 6448 ) , PsA ( n = 16,063 ) and uSpA ( n = 5190 ) patients and a GP ( n = 266,435 ) cohort , were identified 2001–2009 in the Swedish National Patient and Population registers . The follow-up began 1 January 2006 , or 6 months after the first registered spondyloarthritis ( SpA ) diagnosis thereafter , and ended at ACS/stroke/VTE event , death , emigration or 31 December 2012 . Crude and age- and sex-st and ardized incidence rates ( SIRs ) and hazard ratios ( HRs ) were calculated for incident ACS , stroke or VTE , respectively . Results St and ardized to the GP cohort , SIRs for ACS were 4.3 , 5.4 and 4.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort , respectively , compared to 3.2 in the GP cohort . SIRs for stroke were 5.4 , 5.9 and 5.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort compared to 4.7 in the GP cohort . Corresponding SIRs for VTE were 3.6 , 3.2 and 3.5 events per 1000 person-years at risk compared to 2.2 in the GP cohort . Age- and sex-adjusted HRs ( 95 % CI ) for ACS events were significantly increased in AS ( 1.54 ( 1.31–1.82 ) ) , PsA ( 1.76 ( 1.59–1.95 ) ) and uSpA ( 1.36 ( 1.05–1.76 ) ) compared to GP . Age-adjusted HRs for ACS was significantly decreased in female AS patients ( 0.59 ( 0.37–0.97 ) ) compared to female PsA patients . Age- and sex-adjusted HRs for stroke events were significantly increased in AS ( 1.25 ( 1.06–1.48 ) ) and PsA ( 1.34 ( 1.22–1.48 ) ) , and nonsignificantly increased in uSpA ( 1.16 ( 0.91–1.47 ) ) compared to GP . For VTE the age- and sex-adjusted HRs for AS , PsA and uSpA were equally and significantly increased with about 50 % compared to GP . Conclusions Patients with AS , PsA and uSpA are at increased risk for ACS and stroke events , which emphasizes the importance of identification of and intervention against cardiovascular risk factors in SpA patients . Increased alertness for VTE is warranted in patients with STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention Fernández-de-las-Peñas C , Alonso-Blanco C , Alguacil-Diego IM , Miangolarra-Page JC : One-year follow-up of two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2006;85:559–567 . Objective : To assess the long-term effects on functional and mobility outcomes of two exercise interventions for the management of patients with ankylosing spondylitis . Design : In an extended 12-mo follow-up of a r and omized controlled trial , 40 patients who were OUTPUT: Conflicting evidence was found as to whether supervision of exercise improved adherence . Adherence to prescribed exercise in SpA was poorly reported and predominately for people with AS . The levels of adherence and factors affecting prescribed exercise in SpA remain unclear . 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 OUTPUT:

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

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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*** ***EXAMPLES*** INPUT: We conducted a r and omized , double-blind trial to evaluate the early and late analgesic effect of preoperative wound infiltration with bupivacaine 0.25 % ( 40 mL ) compared to placebo ( NaCl 0.9 % , 40 mL ) in patients undergoing major surgery . Forty-one patients scheduled for elective hysterectomy during general anesthesia were included . The pain management focused on pain prevention , including preoperative administration of nonsteroidal antiinflammatory drugs ( NSAIDs ) , and peroperative administration of opioids . Postoperatively patients received buprenorphine and /or acetaminophen on dem and . A significant difference between treatments was evident in the 3-day postoperative trial period . With identical pain scores in the two groups , the requested total amount of buprenorphine was greater in the placebo group ( 2.0 [ 0 - 5.1 ] mg ) ( median and [ range ] ) than in the bupivacaine group ( 0.8 [ 0 - 2.8 ] mg ) ( P < 0.05 ) . The dem and for analgesics occurred earlier in those who received placebo ( 225 min ) than in those who received bupivacaine ( 345 min ) , but did not reach the level of significance . In conclusion , preoperative wound infiltration with bupivacaine improved immediate and late postoperative pain management after hysterectomy compared to placebo . ( Anesth Analg 1996;83:376 - 81 This study tests the null hypothesis that there is no difference between sciatic nerve block ( SNB ) and periarticular anesthetic infiltration ( PI ) as adjuncts to femoral nerve blockade ( FNB ) in total knee arthroplasty in terms of postoperative opioid requirements . Fifty-two patients undergoing total knee arthroplasty were r and omized to receive either ( a ) combined FNB-SNB or ( b ) combined FNB-PI . Average morphine consumption in the first 24 ( 20 vs 23 mg ) and 48 hours ( 26 vs 33 mg ) showed no significant difference . Visual Analogue Scale scores , knee flexion ( 60 ° vs 67.5 ° ) and extension lag ( 0 ° vs 5 ° ) were comparable . Anesthetic time , surgical time , and length of hospital stay ( 5.5 vs 6 days ) were similar . This study showed no significant difference between the 2 groups . The PI offers a practical and potentially safer alternative to SNB BACKGROUND Pain after total knee arthroplasty ( TKA ) is usually severe . Recently , the usefulness of local periarticular injection analgesia ( PAI ) and peripheral nerve block ( PNB ) has been reported . We report a prospect i ve blinded r and omized trial of PAI versus PNB in patients undergoing primary TKA , in accordance with the CONSORT statement 2010 . METHODS A total of 210 patients undergoing TKA under spinal anesthesia were r and omized to receive PNB group or PAI group . In the PNB group , femoral nerve block and sciatic nerve block were performed . In the PAI group , a special mixture containing ropivacaine , saline , epinephrine , morphine hydrochloride , and dexamethasone was injected into the periarticular soft tissue . Pain intensity at rest was assessed using a numerical rating scale ( NRS : 0 - 10 ) after surgery . Use of a diclofenac sodium suppository ( 25 mg ) was allowed for all patients at any time after surgery , and the diclofenac sodium suppository usage was assessed . The NRS for patient satisfaction at 48 hours after surgery was examined . RESULTS The average NRS for pain at rest up to 48 hours after surgery was low in both groups . Within 48 hours after surgery , the diclofenac sodium suppository usage was similar in both groups . There were no significant differences in the NRS for patient satisfaction in both groups . CONCLUSIONS The analgesic effects of PAI and PNB are similar . PAI may be considered superior to PNB because it is easier to perform . LEVEL OF EVIDENCE Therapeutic Level 1 Background : Pain is one of the major concerns of patients underwent Total Knee Arthroplasty ( TKA ) ; appropriate pain management is a key factor in patient 's early physical fitness to move , physiotherapy , and most importantly , patient satisfaction . Objectives : In this study the analgesic effect of single injection femoral nerve block ( SFNB ) was compared with local infiltration analgesia ( LIA ) . Patients and Methods : Forty patients who underwent TKA under spinal anesthesia were r and omized to receive single femoral nerve block ( group F ) or intra-periarticular infiltration ( group I ) . Group F received single injection 20cc ropivacaine ( 10mg/cc ) and in group I , a combination of 300 mg ropivacaine , 30 mg ketorolac and 0.5 mg epinephrine diluted to a volume of 150cc and locally injected in and around the knee joint in 3 stages . Postoperative pain intensity measured by Visual Analog Scale ( VAS ) . Morphine consumption , mobilization time and patients ’ satisfaction evaluated as well . Results : Group I had significantly lower morphine consumption in the first postoperative day ( 10 vs. 12.5 mg , P-value < 0.05 ) . Within 6 hours postoperatively , VAS score was statistically lower in group I compared to group F ( 3 vs. 4 , P-value < 0.05 ) . However , within 12 hours it was statistically higher in group I than group F ( 6 vs. 5 , P-value < 0.05 ) . Other parameters were not statistically different in two groups . Conclusions : Both methods LIA and SFNB OUTPUT: The primary outcomes were cumulative i.v . There were no clinical differences in functional outcomes or rates of complications . Local infiltration analgesia provides similar postoperative analgesia after total knee arthroplasty to femoral nerve block . 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. OUTPUT:

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

MS2_dynamic_1_shot259

***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*** ***EXAMPLES*** 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 OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review PURPOSE To evaluate whether platform switching could preserve marginal bone around implants up to 6 months after loading . MATERIAL S AND METHODS 15 patients were selected for a r and omised controlled trial . Each patient received one customised wide body implant , with the external hex connection located eccentrically , allowing an extra 1 mm switch on one side . The hex was positioned at r and om at the mesial or distal side and the implant was loaded after 6 months of non-submerged healing . Patients were examined at 3 , 6 and 12 months after surgery , during which a radiograph was taken to evaluate bone levels . At 12 months , the mucosal thickness was measured using a perio-probe . RESULTS All implants survived and the mean overall bone loss , calculated from both the switched and non-switched side , was 0.39 mm ( SD 0.33 , range 0.00 - 1.45 ) , 0.85 mm ( SD 0.59 , range 0.10 - 2.50 ) and 0.80 mm ( SD 0.46 , 0.26 - 1.89 ) after 3 , 6 and 12 months , respectively . The bone loss continued up to 6 months but stabilised thereafter ( P = 0.615 ) . Significantly more bone loss was observed at the non-switched side compared to the switched side at 3 months ( 0.51 mm versus 0.28 mm , P = 0.019 ) , 6 months ( 1.05 mm versus 0.64 mm , P = 0.002 ) and 12 months ( 0.94 mm versus 0.66 mm , P = 0.002 ) . The mean mucosal thickness was 4.22 mm ( SD 1.45 ; range 1.50 - 7.00 ) , and was not significantly different between the switched and non-switched sides ( P = 0.882 ) . However , using a post-hoc analysis with the mean thickness as a threshold , the mean bone loss OUTPUT: Metaregression of the selected studies failed to demonstrate an association among MBL and confounding factors . The current study demonstrates that implants placed with an initially thicker peri-implant soft tissue have less radiographic MBL in the short term 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 micro OUTPUT:

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

MS2_dynamic_1_shot260

***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*** ***EXAMPLES*** INPUT: Objective . To evaluate the quality of life ( QOL ) of untreated children with newly diagnosed attention-deficit/hyperactivity disorder ( ADHD ) , compared with asthmatic and healthy children . Methods . This prospect i ve , case-control study included a group of 120 children , 6 to 12 years of age , with newly diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition . Subjects were matched according to age , gender , and health care area with 2 control groups , ie , 93 asthmatic children and 120 healthy children . Sociodemographic characteristics and Child Health Question naire scores were collected . Results . The QOL of children with ADHD was rated worse than that of asthmatic or healthy children for most Child Health Question naire domains . The greatest differences were found in behavior , social limitations attributable to physical problems , emotional impact on parents , and family activities . Almost every psychosocial domain was more affected in comparison with asthmatic children and both psychosocial and physical domains in comparison with healthy children . Conclusions . ADHD interferes with the daily lives of children , parents , and families even more than asthma , primarily in areas related to psychosocial functioning , although evidence of impaired physical functioning also emerged . Delays in recognition , assessment , and management of ADHD may affect negatively the QOL of those children 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 To gain a complete picture of a child 's health-status , measurement of health-related quality of life ( HRQL ) is necessary . Since parents do not accurately perceive children 's HRQL , information must be obtained from the children themselves . The aim of this study was to determine the minimum age and reading skills required by children to complete competently the Paediatric Asthma Quality of Life Question naire ( PAQLQ ) , the Health Utilities Index ( HUI ) , the Feeling Thermometer and the St and ard Gamble , and to evaluate the validity of each for measuring HRQL in children with asthma . Fifty two children ( age 7 - 17 yrs ) with symptomatic asthma participated in a 9 week single cohort study with HRQL and clinical asthma control assessed every 4 weeks . All children provided very reliable data for the PAQLQ and the HUI but they needed > or = grade 6 reading skills to complete the St and ard Gamble and > or = grade 2 skills for the Feeling Thermometer . In those children who were able to provide reliable data , the PAQLQ had the best discriminative and evaluative measurement properties , followed closely by the Feeling Thermometer . Measurement properties in the St and ard Gamble were weaker and although the HUI was very reliable it was not actually measuring asthma-specific HRQL . The Paediatric Asthma Quality of Life Question naire may be used with confidence in clinical studies and practice to provide a profile of children 's day-to-day experiences . In those children with adequate skills to complete the test reliably , the Feeling Thermometer provides a good estimate of the value that children place on their asthma health status OBJECTIVE To examine the relationship between attention deficit disorder with hyperactivity in childhood and criminality in adolescence and adulthood in 89 hyperactive and 87 normal control subjects . METHOD In this prospect i ve study , adolescent follow-up intervals ranged from 13 to 21 years and adult follow-up ranged from 18 to 23 years . The official arrest records for all subjects were obtained . RESULTS Hyperactive subjects had significantly higher juvenile ( 46 % versus 11 % ) and adult ( 21 % versus 1 % ) arrest rates . Juvenile and adult incarceration rates were also significantly higher . Childhood conduct problems predicted later criminality , and serious antisocial behavior in adolescence predicted adult criminality . CONCLUSIONS Hyperactive children are at risk for both juvenile and adult criminality . The risk for becoming an adult offender is associated with conduct problems in childhood and serious antisocial behavior ( repeat offending ) in adolescence . Hyperactive children who do not have conduct problems are not at increased risk for later criminality Objective To describe the methodology and to present the baseline findings of the Attention-deficit/hyperactivity Disorder Observational Research in Europe ( ADORE ) study , the primary objective of which is to describe the relationship between treatment regimen prescribed and quality of life of children with ADHD in actual practice . Methods In this 2-year prospect i ve observational study , data on diagnosis , prescribed treatment and outcomes of ADHD were collected at seven time points by paediatricians and child psychiatrists on 1,573 children recruited in 10 European countries . The data presented here from the 1,478 patients included in the analyses describe the baseline condition , initial treatment regimen prescribed and quality of life of families with children with ADHD . Results Patients had a mean age of 9.0 years ( SD 2.5 ) and 84 % were male . Physicians diagnoses were made using DSM-IV ( 43 % ) , ICD-10 ( 32 % ) and both DSM-IV and ICD-10 ( 12 % ) . OUTPUT: Robust negative effects on QoL are reported by the parents of children with ADHD across a broad range of psycho-social , achievement and self evaluation domains . Children with ADHD rate their own QoL less negatively than their parents and do not always seeing themselves as functioning less well than healthy controls . ADHD has a comparable overall impact on QoL compared to other mental health conditions and severe physical disorders . Increased symptom level and impairment predicts poorer QoL. The presence of comorbid conditions or psychosocial stressors helps explain these effects . There is emerging evidence that QoL improves with effective treatment . In conclusion , ADHD seriously compromises QoL especially when seen from a parents ’ perspective . 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 sympt OUTPUT:

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*** ***EXAMPLES*** INPUT: 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 BACKGROUND There is a pressing need for cost-effective population -based interventions to tackle early-onset antisocial behaviour . As this is determined by many factors , it would seem logical to devise interventions that address several influences while using an efficient means of delivery . The aim of this trial was to change four risk factors that predict poor outcome : ineffective parenting , conduct problems , attention deficit/hyperactivity disorder ( ADHD ) symptoms , and low reading ability . METHODS A r and omised controlled trial was carried out in eight schools in London , Engl and . Nine hundred and thirty-six ( 936 ) 6-year-old children were screened for antisocial behaviour , then parents of 112 high scorers were r and omised to parenting groups held in schools or control ; 109 were followed up a year later . The intervention lasted 28 weeks and was novel as it had components to address both child behaviour ( through the Incredible Years programme ) and child literacy ( through a new ' SPOKES ' programme to help parents read with their children ) . Fidelity of implementation was emphasised by careful training of therapists and weekly supervision . Controls received an information helpline . Assessment of conduct problems was by parent interview , parenting by direct observation and child reading by psychometric testing . RESULTS At follow-up parents allocated to the intervention used play , praise and rewards , and time out more often than controls , and harsh discipline less ; effect sizes ranged from .31 to .59 sd ( p-values .046 to .005 ) . Compared to control children , whose behaviour did n't change , intervention children 's conduct problems reduced by .52sd , ( p < .001 ) , dropping from the 80th to the 61st percentile ; oppositional-defiant disorder ( ODD ) halved from 60 % to 31 % ( p = .003 ) . ADHD symptoms reduced by .44sd ( p = .002 ) , and reading age improved by six months ( .36sd , p = .027 ) . Teacher-rated behaviour did n't change . The programme cost pound2,380 ( $ 3,800 ) per child . CONCLUSIONS Effective population -based early intervention to improve the functioning of with antisocial behaviour is practically feasible by targeting multiple risk factors and emphasising implementation fidelity OBJECTIVE A community-based r and omized controlled trial ( RCT ) was conducted in urban areas characterized by high levels of disadvantage to test the effectiveness of the Incredible Years BASIC parent training program ( IYBP ) for children with behavioral problems . Potential moderators of intervention effects on child behavioral outcomes were also explored . METHOD Families were included if the child ( aged 32 - 88 months ) scored above a clinical cutoff on the Eyberg Child Behavior Inventory ( ECBI ) . Participants ( n = 149 ) were r and omly allocated on a 2:1 ratio to an intervention group ( n = 103 ) or a waiting-list control group ( n = 46 ) . Child behavior , parenting skills , and parent well-being were assessed at baseline and 6 months later using parent-report and independent observations . An intention-to-treat analysis of covariance was used to examine postintervention differences between groups . RESULTS Statistically significant differences in child disordered behavior favored the intervention group on the ECBI Intensity ( effect size = 0.7 , p < .001 ) and Problem subscales ( effect size = 0.75 , p < .001 ) . Intervention effects on child hyperactive-inattentive behaviors and social competence , as well as parent competencies and well-being , were also found . Moderator analyses showed that the effects of the IYBP intervention on the primary child outcomes were not moderated by child or family demographic characteristics or risk factors . CONCLUSION The results demonstrate the effectiveness of the IYBP in alleviating problem behavior among children and in improving well-being among families living in disadvantaged areas . The findings also highlight the importance of parental intervention in early childhood for parents and children most in need of support The effectiveness of the Incredible Years Basic parent programme ( IYBP ) in reducing child conduct problems and improving parent competencies and mental health was examined in a 12-month follow-up . Pre- to post-intervention service use and related costs were also analysed . A total of 103 families and their children ( aged 32–88 months ) , who previously participated in a r and omised controlled trial of the IYBP , took part in a 12-month follow-up assessment . Child and parent behaviour and well-being were measured using psychometric and observational measures . An intention-to-treat analysis was carried out using a one-way repeated measures ANOVA . Pairwise comparisons were subsequently conducted to determine whether treatment outcomes were sustained 1 year post-baseline assessment . Results indicate that post-intervention improvements in child conduct problems , parenting behaviour and parental mental health were maintained . Service use and associated costs continued to decline . The results indicate that parent-focused interventions , implemented in the early years , can result in improvements in child and parent behaviour and well-being 12 months later . A reduced reliance on formal services is also indicated The present study evaluated the effectiveness of a parent training and emotion socialization program design ed specifically for hyperactive preschoolers . Participants were 31 preschool-aged children whose parents were r and omly assigned to a parent training ( PT ) or waitlist ( WL ) control group . PT parents took part in a 14-week parenting program that involved teaching parenting strategies for managing hyperactive and disruptive behavior as well as emotion socialization strategies for improving children 's em OUTPUT: Based on independent assessment , results were only significant for negative parenting . Program type , intervention modality , and child diagnostic status did not moderate the effect . Conclusion : PT was partially supported as an efficacious intervention for preschool children with ADHD or ADHD symptoms with moderate ESs on parent-rated outcomes , but no significant results on independently assessed ADHD symptoms 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 Aut OUTPUT:

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*** ***EXAMPLES*** 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 ) BACKGROUND Despite preoperative anaemia treatment , a risk of postoperative anaemia remains . This r and omized , controlled study evaluated the efficacy of i.v . ferric carboxymaltose ( FCM ) as postoperative anaemia treatment after total knee arthroplasty ( TKA ) . METHODS TKA patients with postoperative anaemia [ haemoglobin ( Hb ) 8.5 - 12.0 g dl(-1 ) ] without prior transfusions were r and omly assigned to FCM [ 700 - 1000 mg iron ( according to calculate iron deficit on postoperative day 2 ) ] or ferrous glycine sulphate ( FS ; 100 mg iron daily from day 7 onwards ) and followed for Hb , iron status , quality -of-life ( EQ-5D ) , and performance ( 6 min walk test ) until day 30 . RESULTS Of 161 preoperatively non-anaemic patients , 122 ( 75.8 % ) developed anaemia after operation ( within 24 h ) and were enrolled in this study ( 60 FCM , 62 FS ) . Hb substantially decreased until day 4 in both groups , and partly recovered by day 30 . FCM-treated patients achieved Hb ≥12.0 g dl(-1 ) more frequently ( 42.3 % vs 23.5 % ; P=0.04 ) and showed a trend towards higher Hb increase from day 4 to day 30 [ + 1.7 ( 1.2 ) vs + 1.3 ( 1.0 ) ; P=0.075 ] compared with FS-treated patients . Patients with postoperative Hb < 10 g dl(-1 ) experienced better Hb increase with FCM [ + 2.4 ( 0.3 ) g dl(-1 ) ] than FS [ + 1.1 ( 0.4 ) g dl(-1 ) ; P=0.018 ] . Patients being iron-deficient at enrolment ( 56.7 % ) had a higher Hb increase with FCM [ + 1.9 ( 0.3 ) g dl(-1 ) ] than FS [ + 1.2 ( 0.2 ) g dl(-1 ) ; P=0.03 ] . Total EQ-5D and performance outcomes were comparable between the groups , but FCM was associated with better scores for ' usual activities ' . No i.v . iron-related adverse events were reported . CONCLUSIONS Preoperatively non-anaemic TKA patients are at high risk of postoperative anaemia . Postoperative i.v . FCM provided significant benefit over oral FS , particularly in patients with preoperative iron deficiency , severe postoperative anaemia , or both . CLINICAL TRIAL REGISTRATION EudraCT 2010 - 023038 - 22 ; Clinical Trials.gov NCT01913808 We conducted a r and omized study analyzing the impact of darbepoetin alfa ( DA ) administration with or without intravenous ( i.v . ) iron on erythroid recovery after autologous hematopoietic cell transplantation ( HCT ) . Patients were r and omized between no DA OUTPUT: There were no statistically significant differences in mortality between iron and inactive control . In all comparisons , there were no differences in the results comparing patients with and without heart failure . Both oral and parenteral iron are shown to decrease the proportion of people who require blood transfusion and increase haemoglobin levels , without any benefit on mortality . 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 % OUTPUT:

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*** ***EXAMPLES*** INPUT: This study examined the effects of aerobic exercise without weight loss , a hypocaloric high monounsaturated fat diet , and diet plus exercise ( D+E ) on total abdominal and visceral fat loss in obese postmenopausal women with type 2 diabetes . Thirty-three postmenopausal women ( body mass index , 34.6 + /- 1.9 kg/m(2 ) ) were assigned to one of three interventions : a hypocaloric high monounsaturated fat diet alone , exercise alone ( EX ) , and D+E for 14 wk . Aerobic capacity , body composition , abdominal fat distribution ( magnetic resonance imaging ) , glucose tolerance , and insulin sensitivity were measured pre- and postintervention . Body weight ( approximately 4.5 kg ) and percent body fat ( approximately 5 % ) were decreased ( P < 0.05 ) with the D and D+E intervention , whereas only percent body fat ( approximately 2.3 % ) decreased with EX . Total abdominal fat and sc adipose tissue ( SAT ) were reduced with the D and D+E interventions ( P < 0.05 ) , whereas visceral adipose tissue ( VAT ) decreased with the D+E and EX intervention , but not with the D intervention . EX result ed in a reduction in total abdominal fat , VAT , and SAT ( P < 0.05 ) despite the lack of weight loss . The reductions in total abdominal fat and SAT explained 32.7 % and 9.7 % , respectively , of the variability in the changes in fasting glucose levels , whereas the reductions in VAT explained 15.9 % of the changes in fasting insulin levels ( P < 0.05 ) . In conclusion , modest weight loss , through either D or D+E , result ed in similar improvements in total abdominal fat , SAT , and glycemic status in postmenopausal women with type 2 diabetes ; however , the addition of exercise to diet is necessary for VAT loss . These data demonstrate the importance of exercise in the treatment of women with type 2 diabetes Background —C-reactive protein ( CRP ) has been proposed as an independent risk factor for cardiovascular disease and has been positively associated with body weight and body fatness . We examined the hypothesis that weight loss would reduce plasma CRP levels in obese postmenopausal women . Methods and Results —In a sample of 61 obese ( body mass index , 35.6±5.0 kg/m2 ) , postmenopausal women ( age , 56.4±5.2 years ) , we found that plasma CRP levels were positively associated with dual x-ray absorptiometry – measured total body fatness ( r = 0.36 , P < 0.005 ) and CT-measured intra-abdominal body fat area ( r = 0.30 , P < 0.02 ) . Significant correlations were also found between plasma CRP and triglyceride levels ( r = 0.33 , P < 0.009 ) and glucose disposal measured by the hyperinsulinemic-euglycemic clamp technique ( r = −0.29 , P < 0.03 ) . Twenty-five of the 61 women tested at baseline completed a weight loss protocol . The average weight loss was 14.5±6.2 kg ( −15.6 % , P < 0.0001 ) , with losses of 10.4±5.4 kg fat mass ( −25.0 % , P < 0.0001 ) and 2.8±1.4 kg fat-free mass ( −6.0 % , P < 0.0001 ) . Visceral and subcutaneous fat areas were reduced by −36.4 % and −23.7 % , respectively ( P < 0.0001 ) . Plasma CRP levels were significantly reduced by weight loss : average −32.3 % , from 3.06 ( + 0.69 , −1.29 ) to 1.63 ( + 0.70 , −0.75 ) & mgr;g/mL ( P < 0.0001 , medians and interquartile differences ) . Changes in body weight and in total body fat mass were both positively associated with plasma CRP level reductions . Conclusions —Adiposity was a significant predictor of plasma CRP in postmenopausal women on a cross-sectional basis . Moreover , caloric restriction – induced weight loss decreased plasma CRP levels . Weight loss may represent an important intervention to reduce CRP levels , which may mediate part of its cardioprotective effects in obese postmenopausal women The effects of energy restriction ( diet ) in combination with either aerobic ( DA ) or resistance exercise ( DR ) on adipose tissue ( AT ) distribution were evaluated in 24 obese women ( DA , n = 10 ; DR , n = 14 ) . AT distribution was measured by magnetic resonance imaging ( MRI ) . Comparison between groups demonstrated that the relative losses observed for body weight , subcutaneous AT ( SAT ) , and visceral AT ( VAT ) volume were not significantly different ( P > 0.05 ) . A significant reduction in the volume ratio of VAT to SAT was observed for both groups ( P < 0.01 ) . Comparison of arm , abdomen and torso , and lower-body regions revealed that the regional mobilization of SAT was not significantly different between groups ( P > 0.05 ) and that for both groups there was a preferential mobilization of SAT from the abdominal region ( P < 0.05 ) . Within the VAT depot , significant reductions were observed for both intraperitoneal and extraperitoneal AT ( P < 0.01 ) . These findings suggest that the combination of moderate energy restriction and either resistance or aerobic exercise induces significant reductions in VAT and SAT , with a preferential loss of VAT , and are thus effective means of reducing total and upper-body obesity in obese women BACKGROUND Dietary fat has been reported to OUTPUT: Modest weight loss generated preferential loss of VAT , but with greater weight loss this effect was attenuated . The method of weight loss was not an influence with one exception . Very-low-calorie diets ( VLCDs ) provided exceptional short-term ( < 4 weeks ) preferential VAT loss . Conclusions : Visceral adipose tissue is lost preferentially with modest weight loss , but the effect is attenuated with greater weight loss . Acute caloric restriction , using VLCD , produces early preferential loss of VAT . These observations may help to explain the metabolic benefits of modest weight loss 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 OUTPUT:

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

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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*** ***EXAMPLES*** INPUT: Background Total hip arthroplasty is associated with a better long term outcome and lesser reoperation rates in the elderly but the risk of complications are beleived to be higher in very elderly patients . The study aims to compare the short-term results of cemented and cementless total hip arthroplasty ( THA ) in active patients > 80 years of age with femoral neck fractures . Methods Sixty-two consecutive patients underwent THA during the study period ( cemented—31 and cementless—31 ) . The mean age was 84 years ( 81–94 years ) . Patients in both groups were comparable in their preoperative variables . Functional and radiological assessment s were carried out using vali date d outcome measures . Complications were recorded . Results Fifty-one patients were available for final analysis after accounting for deaths and cases lost in follow-up . Of the 51 patients , 25 ( 49 % ) regained their pre-injury mobility status and 36 ( 70 % ) were community ambulant . Cementless THA was associated with significantly less surgical time , blood loss , transfusion rates and hospital stay . The overall mortality rates , complications , functional and radiological results were similar in both groups though the number of deaths in the perioperative period was significantly high in patients undergoing cemented THA . ConclusionS atisfactory improvement in function with low reoperation rates can be achieved irrespective of the technique used . Complication rates are higher when compared to younger patients undergoing the procedure . Risks and benefits should be carefully assessed and explained before subjecting these patients to THA BACKGROUND More than 220,000 persons 65 years and older fracture a hip every year in the United States . Although hip fractures have been considered as a single , homogeneous condition , there are two major anatomic types of proximal femoral fractures : intertrochanteric and femoral neck . The present study 's objective was to determine if the two types of hip fracture have different patient characteristics and sequelae . METHODS A prospect i ve study of 923 elderly patients admitted to seven Baltimore hospitals for a hip fracture between 1984 and 1986 . RESULTS Patients with intertrochanteric fractures were slightly older , sicker on hospital admission , had longer hospital stays , and were less likely at 2 months postfracture to have recovered activities of daily living than femoral neck fracture patients . Intertrochanteric fracture patients also had higher mortality rates at 2 and 6 months after fracturing . Long-term recovery ( 1 year ) did not differ between fracture type . CONCLUSIONS It appears that intertrochanteric fracture patients have intrinsic factors ( older age , poor health ) impacting upon their risk of fracture and ability to recover . Differences in patient characteristics and sequelae do exist between femoral neck and intertrochanteric hip fracture patients that impact upon recovery Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons . Sixty patients ( 56 % ) had died in the cemented group and 63 ( 60 % ) in the uncemented group . Respectively , three and two patients ( 2.7 % and 1.9 % ) were completely lost to followup . Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group ( 86.2 versus 76.3 ; mean difference 9.9 ; 95 % confidence interval [ CI ] , 1.9–17.9 ) . The prevalence of postoperative periprosthetic femoral fractures was 7.4 % in the uncemented group and 0.9 % in the cemented group ( hazard ratio [ HR ] , 9.3 ; 95 % CI , 1.16–74.5 ) . Barthel Index and EQ-5D scores were not different between the groups . Between 1 and 5 years , we found no additional infections or dislocations . The mortality rate was not different between the groups ( HR , 1.2 ; 95 % CI , 0.82–1.7 ) . Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures . The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures . Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence Background The treatment of unstable intertrochanteric fractures in elderly is still controversial . The purpose of this study is to present treatment strategies for unstable intertrochanteric fractures with hemiarthroplasty using st and ard uncemented collared femoral st OUTPUT: Conclusion Cemented bipolar hemiarthroplasty and cementless bipolar hemiarthroplasty performed on elderly patients with unstable intertrochanteric fracture revealed similar mortality and complication rates ; however , the rate of LLD greater than 1 cm was significantly higher in the cemented group compared with the cementless group 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 OUTPUT:

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 .

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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*** ***EXAMPLES*** INPUT: BACKGROUND Although question naires are used frequently with patients to self-report the severity of dyspnea as related to activities of daily living , the reliability of these instruments has not been established . The two purpose s of this study were to examine the test-retest reliability of three widely used dyspnea instruments and to compare dyspnea scores at different stages of disease . METHODS At paired baseline visits , 101 stable patients with COPD were tested ; at paired follow-up visits at 3 months , 89 of these patients were tested . At each visit , patients rated dyspnea with three instruments presented in r and om order and then performed post-bronchodilator therapy lung function tests . RESULTS Patient-reported dyspnea scores and lung function were similar at baseline ( interval , 6 + /- 5 days ) and follow-up visits ( interval , 4 + /- 2 days ) . Intraclass correlation coefficients at baseline and at follow-up were 0.82 and 0.82 , respectively , for the modified Medical Research Council scale ; 0.90 and 0.84 , respectively , for the self-administered computerized versions of the baseline dyspnea index and transition dyspnea indexes ; and 0.95 and 0.89 for the University of San Diego Shortness of Breath Question naire results . Dyspnea ratings were significantly related to the stage of disease severity based on percent predicted FEV(1 ) ( p < 0.001 ) . CONCLUSIONS Test-retest reliability was acceptable for patient-reported dyspnea scores using three clinical instruments at baseline and at the 3-month follow-up . Our results demonstrate for the first time that patient-reported dyspnea ratings are related to the stage of disease severity Reproducibility and validity are prerequisites for a useful clinical scale . We therefore prospect ively tested the reproducibility and validity of the New York Heart Association criteria and the Canadian Cardiovascular Society criteria for the assessment of cardiac functional class and compared these criteria with a new Specific Activity Scale based on the metabolic costs of specific activities . The New York Heart Association estimates made by two physicians had a reproducibility of only 56 % , and only 51 % of the estimates agreed with treadmill exercise performance . Functional estimates based on the Canadian Cardiovascular Society criteria were significantly more reproducible ( 73 % ) , but not significantly more valid . The Specific Activity Scale was as reproducible as the Canadian Cardiovascular Society criteria , and its 68 % validity was significantly higher than the validities of the other systems . The easily administered Specific Activity Scale was equally reproducible and valid when used by a nonphysician . It was especially better than the other systems for the evaluation of true class II patients and was significantly less likely to underestimate treadmill performance . Although no set of questions can perfectly predict exercise tolerance , the Specific Activity Scale deserves wider prospect i ve testing PURPOSE Overweight and obese subjects often perceive increased breathlessness during minor exertion and therefore avoid exercise . Respiratory muscle endurance training ( RMET ) can reduce the perception of breathlessness . We hypothesized that RMET 1 month before and during a 6-month ( 3 months supervised + 3 months unsupervised ) exercise and nutrition counseling program ( EN ) would improve the benefits of EN . METHODS Twenty-six overweight and obese subjects with significant perception of breathlessness during exercise ( age = 33 ± 9 yr , body mass index ( BMI ) = 31.3 ± 4.9 kg·m(-2 ) ) were r and omized to RMET+EN ( R+EN ) or EN alone . R+EN performed 30 min of normocapnic hyperpnea 5 wk(-1 ) before and 2 wk(-1 ) during EN . EN consisted of two strength and three endurance training sessions per week , as well as prescribed nutritional composition and a 2.1-kJ ( 500-kcal ) energy deficit per day . Both groups had an equal number of laboratory visits during the 7 months . Before and after 4 and 7 months , subjects performed a 12-min time trial ( TT ; 6 + 6 min , 2-min pause ) and an incremental cycling test ( ICT ) to exhaustion , and blood lipids were assessed . RESULTS Weight loss was significant and similar in both groups ( -4.2 vs -3.7 kg ; both P < 0.05 ) . During the first 4 months , distance covered in 12 min improved more ( P < 0.05 ) with R+EN ( 1678 vs 1824 m ; P < 0.001 ) than with EN alone ( 1638 vs 1698 m ; P < 0.05 ) , whereas after R+EN , breathlessness during the ICT was reduced . Blood lipids of the pooled group improved in those subjects with pathologic values before the study . Despite reduced training compliance during the unsupervised period , subjects of both groups maintained the benefits attained during the supervised period . CONCLUSIONS R+EN improved TT performance more than EN alone , despite similar weight loss , possibly owing to the reduced perception of breathlessness OBJECTIVE Our objective was to study the effects of physical training combined with dietary measures in obese adults . In a second step , we sought to compare two training protocol s and establish the additional contribution of strength training . METHODS We performed a r and omized , prospect i ve survey from July 2004 to November 2007 . Included patients were r and omized into three groups : a control group ( G1 ) , a group ( G2 ) performing dietary measures and a programme of treadmill training at 60 % of each individual 's maximum heart rate ( HRmax ) and a group ( G3 ) who followed the G2 programme supplemented with strength training . All patients underwent an initial and final assessment of anthropometric & cardiovascular parameters , muscle strength , dyspnoea during activities of daily living , metabolic disorders , psychological status and quality of life . RESULTS The greatest weight loss ( 7.24 % ) was observed OUTPUT: If sensation drives behavior , comprehensive data on the sensation of breathlessness might assist in underst and ing the behavioral consequences of interventions 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 OUTPUT:

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 .

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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*** ***EXAMPLES*** INPUT: Objectives Describe proportions of individuals with patellofemoral pain ( PFP ) with an unfavourable recovery over 12 months ; identify clinical predictors of poor recovery at 3 and 12 months ; and determine baseline values of predictors that identify those with poor 12-month prognosis . Methods An observational analysis utilised data from 310 individuals with PFP enrolled in two r and omised clinical trials . Thirteen baseline variables ( participant , PFP , study characteristics ) were investigated for their prognostic ability . Pain , function and global recovery were measured at 3 and 12 months . Multivariate backward stepwise regression analyses ( treatment-adjusted , p<0.10 ) were performed for each follow-up measure . Receiver operator characteristic curves identified cut-points associated with unfavourable recovery at 12 months . Results 55 % and 40 % of participants had an unfavourable recovery at 3 and 12 months , respectively . Longer baseline pain duration was significantly associated with poor 3-month and 12-month recovery on measures of pain severity ( β 11.36 to 24.94 ) , Anterior Knee Pain ( AKP ) Scale ( −4.44 to −11.33 ) and global recovery ( OR : 2.32 to 6.11 ) . Greater baseline pain severity and lower AKP Scale score were significantly associated with poor recovery on multiple measures ( p<0.05 ) . Baseline duration > 2 months and AKP Scale score < 70/100 were associated with unfavourable 12-month recovery . Conclusions A substantial number of individuals with PFP have an unfavourable recovery over 12 months , irrespective of intervention . Knee pain duration > 2 months is the most consistent prognostic indicator , followed by AKP Scale score < 70 . Sports medicine practitioners should utilise interventions with known efficacy in reducing PFP , and promote early intervention to maximise prognosis . Trial registration Australian study : Australian Clinical Trials Registry ( ACTRN012605000463673 ) , Clinical Trials.gov ( NCT00118521 ) ; Dutch study : International St and ard R and omised Controlled Trial Number Register ( IS RCT N83938749 We examined the effects of medially wedged foot orthoses on knee and hip joint mechanics during running in females with and without patellofemoral pain syndrome ( PFPS ) . We also tested if these effects depend on st and ing calcaneal eversion angle . Twenty female runners with and without PFPS participated . Knee and hip joint transverse and frontal plane peak angle , excursion , and peak internal knee and hip abduction moment were calculated while running with and without a 6 ° full-length medially wedged foot orthoses . Separate 3-factor mixed ANOVAs ( group [ PFPS , control ] x condition [ medial wedge , no medial wedge ] x st and ing calcaneal angle [ everted , neutral , inverted ] ) were used to test the effect of medially wedged orthoses on each dependent variable . Knee abduction moment increased 3 % ( P = .03 ) and hip adduction excursion decreased 0.6 ° ( P < .01 ) using medially wedged foot orthoses . No significant group x condition or calcaneal angle x condition effects were observed . The addition of medially wedged foot orthoses to st and ardized running shoes had minimal effect on knee and hip joint mechanics during running thought to be associated with the etiology or exacerbation of PFPS symptoms . These effects did not appear to depend on injury status or st and ing calcaneal posture Anterior knee pain ( AKP ) is a common injury among runners and effectively treated with posted insoles and foot orthotics . While clinical ly effective , the underlying biomechanical mechanisms that bring about these improvements remain debatable . Several method ological factors contribute to the inconsistent biomechanical findings , including errors associated with removing and reattaching markers , inferring foot motion from markers placed externally on a shoe , and redefining segmental coordinate systems between conditions . Therefore , the purpose of this study was to evaluate the influence of medially posted insoles on lower extremity kinematics in runners with and without AKP while trying to limit the influence of these method ological factors . Kinematics of 16 asymptomatic and 17 runners with AKP were collected while running with and without insoles . Reflective markers were attached to the surface of the calcaneus and kept in place ( as opposed to detached ) between conditions , eliminating the error associated with reattaching markers and redefining segmental coordinate systems . Using these methods , no significant interactions between insole and injury and the main effect of injury were detected ( p>0.05 ) ; therefore , means were pooled across injury . Insoles , on average , reduced peak eversion by 3.6 ° ( 95 % confidence interval -2.9 ° to -4.3 ° ) , peak eversion velocity by 53.2 ° /s ( 95 % confidence interval -32.9 to -73.4 ) and eversion range of motion by 1.33 ( 95 % confidence interval -0.8 to -1.9 ) . However , while insoles systematic ally reduced eversion variables , they had small influences on the transverse plane kinematics of the tibia or knee , indicating that they may bring about their clinical effect by influencing other variables Treadmills are often used in research to analyse kinematic and physiological variables . The success of transfering the results to overground running depends on the comparability of the values between the two situations . The aim of the present study was to compare the kinematics and muscle activities in overground and treadmill running . Ten male physical education students with experience in treadmill running were asked to run with a speed of 4.0 and 6.0 m/s both overground and on a Woodway treadmill . The 3D-kinematics of the limbs were studied using a two camera video tracking system . Additionally the surface EMG of six lower limb mus OUTPUT: Significant effects on pain and function were determined . A slight effect on kinematics of the lower limb and muscle activation of selected lower limb muscles was identified . Foot orthoses seem to be an effective treatment device in the therapy for PFPS . An immediate and long-term reduction in pain and an improvement of function occurred following the intervention . There was just a slight change in lower limb kinematics and muscle activation of selected lower limb muscles . The relationship between biomechanical effects of orthoses and pain still seems to be unclear 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 OUTPUT:

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 .

MS2_dynamic_1_shot267

***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*** ***EXAMPLES*** 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 ) BACKGROUND Little is known about the influence of practice schedules on motor learning and skills transfer in children with and without developmental coordination disorder ( DCD ) . Underst and ing how practice schedules affect motor learning is necessary for motor skills development and rehabilitation . AIMS The study investigated whether active video games ( exergames ) training delivered under variable practice led to better learning and transfer than repetitive practice . METHODS AND PROCEDURES 111 children aged 6 - 10 years ( M=8.0 , SD=1.0 ) with no active exergaming experience were r and omized to receive exergames training delivered under variable ( Variable Game Group ( VGG ) , n=56 ) or repetitive practice schedule ( Repetitive Game Group ( RGG ) , n=55 ) . Half the participants were identified as DCD using the DSM-5 criteria , while the rest were typically developing ( TD ) , age-matched children . Both groups participated in two 20min sessions per week for 5 weeks . OUTCOMES AND RESULTS Both participant groups ( TD and DCD ) improved equally well on game performance . There was no significant difference in positive transfer to balance tasks between practice schedules ( Repetitive and Variable ) and participant groups ( TD and DCD ) . CONCLUSIONS AND IMPLICATION S Children with and without DCD learn balance skills quite well when exposed to exergames . Gains in learning and transfer are similar regardless of the form of practice schedule employed . WHAT THIS PAPER ADDS This is the first paper to compare the effect of practice schedules on learning in children with DCD and those with typical development . No differences in motor learning were found between repetitive and variable practice schedules . When children with and without DCD spend the same amount of time on exergames , they do not show any differences in acquisition of motor skills . Transfer of motor skills is similar in children with and without DCD regardless of differences in practice schedules Background Adolescents with low motor competence participate less in physical activity and tend to exhibit decreased physical fitness compared to their peers with high motor competence . It is therefore essential to identify new methods of enhancing physical fitness in this population . Active video games ( AVG ) have been shown to improve motor performance , yet investigations of its impact on physical fitness are limited . The objective of this study was to examine the impact of the grade d Wii protocol in adolescent girls with probable Developmental Coordination Disorder ( p-DCD ) . Methods A single-group pre-post design was conducted to assess the impact of a newly developed Wii protocol in adolescent girls attending school in a low income community of Cape Town , South Africa . Sixteen participants ( aged 13 - 16 years ) with p-DCD ( ≤16th percentile on the MABC-2 test ) were recruited . Participants received 45 min Wii training for 14 weeks . Outcome measures included the six-minute walk distance and repeated sprint ability . Information on heart rate , enjoyment and perceived exertion ratings were also collected . Results Significant improvements in aerobic and anaerobic fitness were observed . The participants reported high enjoyment scores and low perceived exertion ratings . The grade d Wii protocol was easily adaptable and required little re sources ( space , equipment and expertise ) to administer . Conclusions The findings provide preliminary evidence to support the use of the grade d Wii protocol for promoting physical fitness in adolescent girls with p-DCD . Further studies are needed to confirm these results and to vali date the clinical efficacy of the protocol in a larger sample with a more robust design 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=8 OUTPUT: Mixed effects of video game intervention on outcome were found , with conflicting evidence across studies . Studies that reported on feasibility found most children enjoyed and adhered to the video game interventions . 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 OUTPUT:

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 .

MS2_dynamic_1_shot268

***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*** ***EXAMPLES*** 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 Although inflammatory activity is known to play a role in depression , no work has examined whether experimentally induced systemic inflammation alters neural activity that is associated with anhedonia , a key diagnostic symptom of depression . To investigate this , we examined the effect of an experimental inflammatory challenge on the neural correlates of anhedonia-namely , reduced ventral striatum ( VS ) activity to reward cues . We also examined whether this altered neural activity related to inflammatory-induced increases in depressed mood . METHODS Participants ( n = 39 ) were r and omly assigned to receive either placebo or low-dose endotoxin , which increases proinflammatory cytokine levels in a safe manner . Cytokine levels were repeatedly assessed through hourly blood draws ; self-reported and observer-rated depressed mood were assessed regularly as well . Two hours after drug administration , neural activity was recorded as participants completed a task in which they anticipated monetary rewards . RESULTS Results demonstrated that subjects exposed to endotoxin , compared with placebo , showed greater increases in self-reported and observer-rated depressed mood over time , as well as significant reductions in VS activity to monetary reward cues . Moreover , the relationship between exposure to inflammatory challenge and increases in observer-rated depressed mood was mediated by between-group differences in VS activity to anticipated reward . CONCLUSIONS The data reported here show , for the first time , that inflammation alters reward-related neural responding in humans and that these reward-related neural responses mediate the effects of inflammation on depressed mood . As such , these findings have implication s for underst and ing risk of depression in persons with underlying inflammation OBJECTIVE The authors sought to test the causal hypothesis that serotonergic function modulates aspects of the normal spectrum of individual differences in affective experience and social behavior in humans . METHOD A selective serotonin reuptake inhibitor ( SSRI ) , paroxetine , 20 mg/day ( N = 26 ) , or placebo ( N = 25 ) was administered to normal volunteers in a double-blind manner for 4 weeks , and personality variables and social behavior were assessed at baseline and at weeks 1 and 4 of treatment . RESULTS Relative to placebo , SSRI administration reduced focal indices of hostility through a more general decrease in negative affect , yet did not alter indices of positive affect . In addition , SSRI administration increased a behavioral index of social affiliation . Changes in both negative affect and affiliative behavior were significantly related to volunteers ' plasma SSRI levels at the end of the experiment . CONCLUSIONS Central serotonergic function may modulate a dimension of normal personality characterized by reduced negative affective experience and increased affiliative behavior . SSRI administration has significant and detectable effects on these measures even in the absence of baseline clinical depression or other psychopathology UNLABELLED Neuropsychiatric disorders ( e.g. , autism , schizophrenia ) are partially characterized by social cognitive deficits , including impairments in the ability to perceive others ' emotional states , which is an aspect of social cognition known as theory of mind ( ToM ) . There is also evidence that inflammation may be implicated in the etiology of these disorders , but experimental data linking inflammation to deficits in social cognition is sparse . Thus , we examined whether exposure to an experimental inflammatory challenge led to changes in ToM. One hundred and fifteen ( n=115 ) healthy participants were r and omly assigned to receive either endotoxin , which is an inflammatory challenge , or placebo . Participants completed a social cognition task , the Reading the Mind in the Eyes ( RME ) test , at baseline and at the peak of the inflammatory response for the endotoxin group . The RME test , a vali date d measure of ToM , evaluates how accurately participants can identify the emotional state of another person by looking only at their eyes . We found that endotoxin ( vs. placebo ) led to decreases in performance on the RME test from baseline to the peak of inflammatory response , indicating that acute inflammation can lead to decreases in the ability to accurately and reliably comprehend emotional information from others . Given that deficits in ToM are implicated in neuropsychiatric disorders , including those which may have an inflammatory basis , these results may have implication s for underst and ing the links between inflammation , social cognition , and neuropsychiatric disorders . CLINICAL TRIALS REGISTRATION Clinical Trials.gov NCT01671150 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 antidepress OUTPUT: Acute experimental inflammation causes negative biases in social and emotional processing that could explain observed associations between inflammation and depression 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: A double-blind trial was conducted in 138 patients with superficial transitional cell carcinoma of the bladder following transurethral resection to evaluate the prophylaxis of recurrence by an oral Lactobacillus casei preparation ( BLP ) . Patients were stratified into the following 3 subgroups : ( A ) with primary multiple tumors ; ( B ) with recurrent single tumors , and ( C ) with recurrent multiple tumors . In each group , patients were r and omly allocated to receive BLP or placebo . BLP showed a better prophylactic effect in subgroups A and B than placebo , whereas no significant difference was observed in subgroup C. Cox multivariate analysis showed that the outcome with BLP was significantly better than with placebo ( p = 0.01 ) . Slight and tolerable adverse reactions occurred in 3 patients receiving BLP and in 3 of the placebo-treated patients . Oral administration of BLP was thus safe and effective for preventing recurrence of superficial bladder cancer Bacterial infections frequently occur early after liver transplantation . We recently reported significant progress with a synbiotic composition , consisting of one lactic acid bacteria ( LAB ) and one fiber , which reduced the infection rate from 48 % ( with selective bowel decontamination ) to 13 % . Now , our aim is to study if a combination of different LAB and fibers would further improve outcome Objective . To investigate the effect of 2 different species of probiotics in preventing infections in infants attending child care centers . Methods . A double-blind , placebo-controlled , r and omized trial was conducted from December 1 , 2000 , to September 30 , 2002 , at 14 child care centers in the Beer-Sheva area of Israel in healthy term infants 4 to 10 months old . Infants were assigned r and omly to formula supplemented with Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( American Type Culture Collection 55730 ) , or no probiotics . Duration of feeding , including follow-up , for each participant was 12 weeks . All infants were fed only the assigned formula and were not breastfed due to parental decision before recruitment to the study . Probiotic or prebiotic food products or supplements were not allowed . Main outcome measures were number of days and number of episodes with fever ( > 38 ° C ) and number of days and number of episodes with diarrhea or respiratory illness . Results . Participants ( n = 201 ) were similar regarding gestational age , birth weight , gender , and previous breastfeeding . The controls ( n = 60 ) , compared with those fed B lactis ( n = 73 ) or L reuteri ( n = 68 ) , had significantly more febrile episodes ( mean [ 95 % confidence interval ] : 0.41 [ 0.28–0.54 ] vs 0.27 [ 0.17–0.37 ] vs 0.11 [ 0.04–0.18 ] , respectively ) . The controls also had more diarrhea episodes ( 0.31 [ 0.22–0.40 ] vs 0.13 [ 0.05–0.21 ] vs 0.02 [ 0.01–0.05 ] , respectively ) and episodes of longer duration ( 0.59 [ 0.34–0.84 ] vs 0.37 [ 0.08–0.66 ] vs 0.15 [ 0.12–0.18 ] days , respectively ) . The L reuteri group , compared with BB-12 or controls , had a significant decrease of number of days with fever , clinic visits , child care absences , and antibiotic prescriptions . Rate and duration of respiratory illnesses did not differ significantly between groups . Conclusions . Child care infants fed a formula supplemented with L reuteri or B lactis had fewer and shorter episodes of diarrhea , with no effect on respiratory illnesses . These effects were more prominent with L reuteri , which was also the only supplement to improve additional morbidity parameters Objective : Patients undergoing pancreas resection carry several risk factors for nosocomial bacterial infections . Pre- and probiotics ( synbiotics ) are potentially useful for prevention of these infections . Summary Background Data : First trials in patients following major abdominal surgery including liver transplantation using one Lactobacillus ( LAB ) and one fiber showed significant reduction of infection rates and reduced length of antibiotic therapy compared with a control group . The present study was design ed to analyze whether a combination of different LAB and fibers would further improve outcome . Methods : A prospect i ve r and omized monocentric double-blind trial was undertaken in 80 patients following pylorus-preserving pancreatoduodenectomy ( PPPD ) . All patients received enteral nutrition immediately postoperatively . One group ( A ) received a composition of 4 LAB and 4 fibers , and another group ( B ) received placebo ( fibers only ) starting the day before surgery and continuing for 8 days . Thirty-day infection rate , length of hospital stay , duration of antibiotic therapy , noninfectious complications , and side effects were recorded . Results : The incidence of postoperative bacterial infections was significantly lower with LAB and fibers ( 12.5 % ) than with fibers only ( 40 % ) . In addition , the duration of antibiotic therapy was significantly shorter in the latter group . Fibers and LAB were well tolerated . Conclusion : Early enteral nutrition supplemented with a mixture of LAB and fibers reduces bacterial infection rates and antibiotic therapy following PPPD BACKGROUND Animal studies suggest that prebiotics and probiotics exert protective effects against tumor development in the colon , but human data supporting this suggestion are weak . OBJECTIVE The objective was to verify whether the prebiotic concept ( selective interaction with colonic flora of nondigested carboh OUTPUT: In addition , probiotics may be useful for preventing respiratory infections , dental caries , necrotizing enterocolitis , and certain aspects of inflammatory bowel disease . Data also suggest that probiotics may promote good health in day care and work setting s , and may enhance growth in healthy as well as ill and malnourished children . Specific strains are effective in specific disease states . 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 OUTPUT:

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

MS2_dynamic_1_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*** ***EXAMPLES*** INPUT: One hundred and thirty-two patients discharged from a rheumatology unit were r and omly allocated to general practitioner care , attendance at hospital outpatient clinics , or follow-up by a senior occupational therapist attached to the hospital treatment team . At the end of 1 and 2 years a number of clinical and functional tests were applied , and information was gathered about the provision and use of aids and the provision of domestic support . In addition the st and ard of overall care was judged by an independent assessor . Although no significant intergroup differences in disease activity or function emerged , it is clear that patients prefer continuing contact with the hospital team , and this may lead to differences appearing in the future . The financial advantages of therapist follow-up are discussed A h and exerciser with an electronic counter and a visual display was used to measure compliance objective ly , to investigate the effects of visual feedback on compliance , and to assess the impact of exercise on seven mild and five moderate rheumatoid arthritis patients . A multiple time-series design varying the onset of the visual display was utilized . Compliance was assessed weekly over the 7 weeks of the study . Pretest and posttest measures of various indicators of h and functioning were taken by an occupational therapist . Visual display of the number of exercises completed decreased the number of noncompliant patients from six to two , with the maximum degree of noncompliance reduced from 44 to 5 % . Thus the use of visual display is effective in producing compliance to exercise regimens . In light of the small sample size , however , no definitive conclusions can be drawn regarding the effects of exercise on h and functioning OBJECTIVE To investigate the immediate and short-term effects of 3 commercial wrist orthoses on grip strength and function . METHODS Thirty-six patients with definite rheumatoid arthritis participated in the r and omized , controlled , cross-over design study of 3 commercial wrist extensor orthoses . Dominant-h and dynamometric grip strength was assessed at both initial and followup sessions while splinted and nonsplinted . Functional impact was assessed using a written question naire . RESULTS All 3 commercial orthoses reduced grip strength when first donned . After a 1-week adjustment period , one orthosis , the Smith and Nephew Roylan D-Ring ( Roylan ) , afforded splinted grip strength equal to that of the nonsplinted grip strength . The other 2 orthoses continued to reduce grip strength , and afforded splinted grip strength significantly below that of the Roylan . The Roylan was deemed comfortable by more subjects than the other orthoses . CONCLUSIONS The belief that commercial orthotic use increases grip strength , either immediately or after 1 week , is not supported by this study 's data . Different styles of commercial wrist orthoses appear to have differing influence on splinted grip strength OBJECTIVES This study compared soft versus hard resting h and splints on pain and h and function in 39 persons with rheumatoid arthritis . Splint preference was also evaluated to determine its effects on splint wear compliance . METHOD A repeated measures research design was used to compare the two experimental conditions , wearing a soft splint versus a hard splint on the dominant h and for 28 days at night only , and an unsplinted control period of 28 days . RESULTS Arthritis pain was considerably less during both splinted periods when compared with the pretest . Subjects identified fewer joints as being painful during the soft splint condition than during the unsplinted condition . There were no significant differences among conditions on h and function measures . Splint preference was 57 % for the soft splint , 33 % for the hard splint , and 10 % for no splint . Splint wear compliance was significantly better with the soft splint ( 82 % ) than with the hard splint ( 67 % ) . CONCLUSION The findings indicate that resting h and splints are effective for pain relief and that persons with rheumatoid arthritis are more likely to prefer and comply with soft splint use for this purpose . Individualized splint prescription that focuses on client comfort and preference may enhance splint wear compliance OBJECTIVE Five styles of commercial static wrist extensor orthoses were compared to determine whether any style , or styles , afforded better power grip strength or finger dexterity . Because wrist extensor orthoses are intended for use during functional tasks , their influence on h and function is of great importance . METHOD Twenty-three right-h and -dominant women without upper extremity dysfunction participated in this crossover study . Dominant-h and finger dexterity and power grip strength were evaluated while wearing each of five commercial orthoses-Kendall-Futuro # 33 ( Futuro ) , AliMed Freedom Long ( AliMed Long ) , AliMed Freedom Short ( AliMed Short ) , Smith & Nephew Rolyan D-Ring ( Rolyan ) , and LMB Wrist Rest (LMB)-- and while using the dominant h and without an orthosis ( free h and ) . Finger dexterity was assessed with the unimanual subtest of the Purdue Pegboard . Grip strength was assessed with a Jamar hydraulic dynamometer . RESULTS Four of the study orthoses ( Futuro , AliMed Short , Rolyan , and LMB ) afforded finger dexterity that did not differ significantly from that of the free h and . The AliMed Long orthosis slowed finger speed when compared with the speeds afforded by both the LMB orthosis and the free h and . The Rolyan orthosis permitted a power grip strength that was not significantly different from the free h and . The other four commercial orthoses reduced grip strength when compared with the strength observed when wearing a Rolyan orthosis and when gripping with a free h and . CONCLUSION The five styles of commercial orthoses affect power grip and finger dexterity differently . When power grip or finger dexterity are priorities , differences among the orthoses furnish grounds for initial suggestions , although medical needs and patient preference should be the overriding factors in the final selection of an orthosis Consecutive new attendees at a rheumatology clinic were r and omly allocated to one of three groups . All groups received routine care , but one received no other intervention , one an educational booklet on arthritis OUTPUT: Patients with rheumatoid arthritis ( RA ) show a reduction in physical capacities compared with healthy persons . 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: BACKGROUND / OBJECTIVES Obesity is related to inflammation and cardiovascular disease . The increase in saturated fatty acid intake ( SFA ) can potentiate cardiovascular risks . The aim of this study was to assess the influence of change in SFA on carotid intima-media thickness ( cIMT ) , metabolic profile and anti/pro-inflammatory adipokines in obese adolescents . METHODS Sixty obese adolescents were subjected to 1 year of interdisciplinary intervention ( nutrition , psychology , physical exercise and clinical therapy ) . Blood glucose , insulin , lipid profile , leptin and adiponectin were analysed . Insulin resistance was estimated by HOMA-IR and HOMA-AD . cIMT was measured by ultrasonography . Dietetic intake was calculated by 3-day dietary record . Volunteers were analysed according to tertiles of change ( Δ ) in SFA intake : Low-SFA reduction<3.68 g ; Moderate-SFA reduction 3.68 - 13.67 g ; and High-SFA reduction>13.67 g. RESULTS Moderate and High-SFA tertiles presented reduction in insulin , leptin/adiponectin ratio , cIMT and increase in adiponectin and adiponectin/leptin ratio . Adiponectin/leptin ratio was predictor of cIMT . HOMA-IR , total cholesterol and LDL-cholesterol reduced only in High-SFA tertile , and was associated with SFA independent of visceral fat . Negative correlations between Δ of SFA and adiponectin and adiponectin/leptin ratio were observed . CONCLUSION Obese adolescents with moderate and high reduction in SFA presented improvements on pro/anti-inflammatory biomarkers and cIMT , leading to reduction in cardiovascular risks Background The effect of exercise on subjective appetite and short-term food intake has received little investigation in children . Despite a lack of reported evaluation of short- duration activity programs , they are currently being implemented in schools as a means to benefit energy balance . The purpose of this study was to determine the effect of duration of exercise at the ventilation threshold ( VeT ) on subjective appetite and short-term food intake in normal weight boys and girls aged 9 to 14 years . Methods On 4 separate mornings and in r and om order , boys ( n = 14 ) and girls ( n = 15 ) completed 2 rest or 2 exercise treatments for 15 ( short- duration ; SD ) or 45 min ( long- duration ; LD ) at their previously measured VeT , 2 h after a st and ardized breakfast . Subjective appetite was measured at regular intervals during the study sessions and food intake from a pizza meal was measured 30 min after rest or exercise . Results An increase in average appetite , desire to eat , and hunger ( p < 0.05 ) was attenuated by SD exercise , but was further increased ( p < 0.05 ) by LD exercise . However , food intake after SD and LD exercise was similar to after rest in both boys and girls ( p = 0.55 ) . The energy cost of SD and LD exercise result ed in a lower net energy balance compared to resting during the study measurement period in boys ( SD : Δ = -418 ± 301 kJ ; LD : Δ = -928 ± 196 kJ ) and in girls ( SD : Δ = -297 ± 105 kJ ; LD : Δ = -432 ± 115 kJ ) . Conclusion Neither SD nor LD exercise at the VeT increased short-term food intake and SD exercise attenuated increases in appetite . Thus , SD exercise programs in schools may be an effective strategy for maintaining healthier body weights in children Purpose To compare two modalities of exercise training ( i.e. , Endurance Training [ ET ] and High-Intensity Interval Training [ HIT ] ) on health-related parameters in obese children aged between 8 and 12 years . Methods Thirty obese children were r and omly allocated into either the ET or HIT group . The ET group performed a 30 to 60-minute continuous exercise at 80 % of the peak heart rate ( HR ) . The HIT group training performed 3 to 6 sets of 60-s sprint at 100 % of the peak velocity interspersed by a 3-min active recovery period at 50 % of the exercise velocity . HIT sessions last ∼70 % less than ET sessions . At baseline and after 12 weeks of intervention , aerobic fitness , body composition and metabolic parameters were assessed . Results Both the absolute ( ET : 26.0 % ; HIT : 19.0 % ) and the relative VO2 peak ( ET : 13.1 % ; HIT : 14.6 % ) were significantly increased in both groups after the intervention . Additionally , the total time of exercise ( ET : 19.5 % ; HIT : 16.4 % ) and the peak velocity during the maximal grade d cardiorespiratory test ( ET : 16.9 % ; HIT : 13.4 % ) were significantly improved across interventions . Insulinemia ( ET : 29.4 % ; HIT : 30.5 % ) and HOMA-index ( ET : 42.8 % ; HIT : 37.0 % ) were significantly lower for both groups at POST when compared to PRE . Body mass was significantly reduced in the HIT ( 2.6 % ) , but not in the ET group ( 1.2 % ) . A significant reduction in BMI was observed for both groups after the intervention ( ET : 3.0 % ; HIT : 5.0 % ) . The responsiveness analysis revealed a very similar pattern of the most responsive variables among groups . Conclusion HIT and ET were equally effective in improving important health related parameters in obese youth BACKGROUND OUTPUT: CONCLUSION Structured physical activity interventions favour decreased daily energy intake in obese adolescents 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 OUTPUT:

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

MS2_dynamic_1_shot272

***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*** ***EXAMPLES*** 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 PURPOSE this paper describes a clinic and community-based diabetes intervention program design ed to improve dietary , physical activity , and self-care behaviors of older African American women with type 2 diabetes . It also describes the study to evaluate this program and baseline characteristics of participants . METHODS The New Leaf ... Choices for Healthy Living With Diabetes program consists of 4 clinic-based health counselor visits , a community intervention with 12 monthly phone calls from peer counselors , and 3 group sessions . A r and omized , controlled trial to evaluate the effectiveness of this intervention is described . RESULTS Seventeen focus groups of African American women were used to assessed the cultural relevance /acceptability of the intervention and measurement instruments . For the r and omized trial , 200 African American women with type 2 diabetes were recruited from 7 practice s in central North Carolina . Mean age was 59 , mean diabetes duration was 10 years , and participants were markedly overweight and physically inactive . CONCLUSIONS Participants found this program to be culturally relevant and acceptable . Its effects on diet , physical activity , and self-care behaviors will be assessed in a r and omized trial PURPOSE Few culturally competent health programs have been design ed for Mexican Americans , a group that bears a disproportionate burden of Type 2 diabetes . In Starr County , a Texas-Mexico border community , investigators design ed and tested a culturally competent intervention aim ed at improving the health of this target population . The purpose of this article is to describe the development process of this diabetes education and support group intervention . METHODS The development stages were ( 1 ) community assessment , ( 2 ) intervention design , ( 3 ) selection or development of outcomes , ( 4 ) pilot testing , and ( 5 ) a r and omized clinical investigation . RESULTS Focus group participants identified knowledge deficits regarding diabetes and self-management strategies , and suggested characteristics of an effective intervention for Mexican Americans . Outcome measures included metabolic control indicators , a newly developed knowledge instrument , and an existing health belief instrument . Preliminary analyses indicated that the intervention was successful in significantly improving metabolic control in the target population . CONCLUSIONS Developing successful diabetes interventions for minority groups requires a number of stages , careful planning , assessment of cultural characteristics of the target population , and a systematic approach to implementation OBJECTIVE To determine whether diabetes care directed by nurses following detailed protocol s and algorithms and supervised by a diabetologist results in meeting the evidence -based American Diabetes Association ( ADA ) process and outcome measures more often than care directed under usual care in a minority population . RESEARCH DESIGN AND METHODS Studies were mainly conducted in two Los Angeles County clinics . In clinic A , nurse-directed diabetes care was provided to 252 patients ( 92 % Hispanic and 2 % African-American ) referred by their primary care providers . These patients were hierarchically matched with 252 diabetic patients in clinic B ( 79 % Hispanic and 19 % African American ) . When nurse-directed care was abruptly discontinued in clinic A for administrative reasons , it was reestablished in clinic B. Those patients were r and omly selected from a teaching clinic , and the outcomes in 114 patients who completed 1 year were compared with outcomes derived the year before receiving nurses ' care . The following process and outcome measures were assessed in the study : 1 ) number of visits , 2 ) diabetes education , 3 ) nutritional counseling , 4 ) HbA(1c ) , 5 ) lipid profiles , 6 ) eye exams , 7 ) foot exams , 8) renal evaluations , and 9 ) ACE inhibitor therapy in appropriate patients . RESULTS For patients under nurse-directed diabetes care in both clinics A and B , almost all process measures were carried out significantly more frequently than for the appropriate control patients . Under the care of nurses in clinic A , HbA(1c ) levels fell 3.5 % from 13.3 to 9.8 % in the 120 patients who were followed OUTPUT: —This systematic review provides evidence for the effectiveness of interventions to improve diabetes care among socially disadvantaged population s and identifies key intervention features that may predict success . 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 OUTPUT:

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*** ***EXAMPLES*** 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 Background The fermentation of dietary fiber to various organic acids is a beneficial function provided by the microbiota in the human large intestine . In particular , butyric acid contributes to host health by facilitating maintenance of epithelial integrity , regulating inflammation , and influencing gene expression in colonocytes . We sought to increase the concentration of butyrate in 20 healthy young adults through dietary supplementation with resistant starch ( unmodified potato starch — resistant starch ( RS ) type 2 ) . Methods Fecal sample s were collected from individuals to characterize butyrate concentration via liquid chromatography and composition of the microbiota via surveys of 16S rRNA-encoding gene sequences from the Illumina MiSeq platform . R and om Forest and LEfSe analyses were used to associate responses in butyrate production to features of the microbiota . Results RS supplementation increased fecal butyrate concentrations in this cohort from 8 to 12 mmol/kg wet feces , but responses varied widely between individuals . Individuals could be categorized into three groups based upon butyrate concentrations before and during RS : enhanced , high , and low ( n = 11 , 3 , and 6 , respectively ) . Fecal butyrate increased by 67 % in the enhanced group ( from 9 to 15 mmol/kg ) , while it remained ≥11 mmol/kg in the high group and ≤8 mmol/kg in the low group . Microbiota analyses revealed that the relative abundance of RS-degrading organisms — Bifidobacterium adolescentis or Ruminococcus bromii — increased from ~2 to 9 % in the enhanced and high groups , but remained at ~1.5 % in the low group . The lack of increase in RS-degrading bacteria in the low group may explain why there was no increase in fecal butyrate in response to RS . The microbiota of individuals in the high group were characterized by an elevated abundance of the butyrogenic microbe Eubacterium rectale ( ~6 % in high vs. 3 % in enhanced and low groups ) throughout the study . Conclusions We document the heterogeneous responses in butyrate concentrations upon RS supplementation and identify characteristic of the microbiota that appear to underlie this variation . This study complements and extends other studies that call for personalized approaches to manage beneficial functions provided by gut microbiomes Background Roux-en-Y gastric bypass ( RYGB ) is an effective means to achieve sustained weight loss for morbidly obese individuals . Besides rapid weight reduction , patients achieve major improvements of insulin sensitivity and glucose homeostasis . Dysbiosis of gut microbiota has been associated with obesity and some of its co-morbidities , like type 2 diabetes , and major changes of gut microbial communities have been hypothesized to mediate part of the beneficial metabolic effects observed after RYGB . Here we describe changes in gut microbial taxonomic composition and functional potential following RYGB . Methods We recruited 13 morbidly obese patients who underwent RYGB , carefully phenotyped them , and had their gut microbiomes quantified before ( n = 13 ) and 3 months ( n = 12 ) and 12 months ( n = 8) after RYGB . Following shotgun metagenomic sequencing of the fecal microbial DNA purified from stools , we characterized the gut microbial composition at species and gene levels followed by functional annotation . Results In parallel with the weight loss and metabolic improvements , gut microbial diversity increased within the first 3 months after RYGB and remained high 1 year later . RYGB led to altered relative abundances of 31 species ( P < 0.05 , q < 0.15 ) within the first 3 months , including those of Escherichia coli , Klebsiella pneumoniae , Veillonella spp . , Streptococcus spp . , Alistipes spp . , and Akkermansia muciniphila . Sixteen of these species maintained their altered relative abundances during the following 9 months . Interestingly , Faecalib OUTPUT: Restrictive diets decreased the microbiota abundance , correlated with nutrient deficiency rather than weight loss and generally reduced the butyrate producers Firmicutes , Lactobacillus sp. and Bifidobacterium sp. The impact of surgical intervention depended on the given technique and showed a similar effect on butyrate producers , in addition to increasing the presence of the Proteobacteria phylum , which is related to changes in the intestinal absorptive surface , pH and digestion time . Probiotics differed in strain and duration with diverse effects on the microbiota , and they tended to reduce body fat . Prebiotics had a bifidogenic effect and increased butyrate producers , likely due to cross-feeding interactions , contributing to the gut barrier and improving metabolic outcomes . All of the interventions under consideration had impacts on the gut microbiota , although they did not always correlate with weight loss . These results show that restrictive diets and bariatric surgery reduce microbial abundance and promote changes in microbial composition that could have long-term detrimental effects on the colon . In contrast , prebiotics might restore a healthy microbiome and reduce body fat 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 : OUTPUT:

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*** ***EXAMPLES*** INPUT: Background To investigate the risk of first-time acute coronary syndrome ( ACS ) , stroke and venous thromboembolism ( VTE ) in patients with ankylosing spondylitis ( AS ) , psoriatic arthritis ( PsA ) and undifferentiated spondyloarthritis ( uSpA ) , compared to each other and to the general population ( GP ) . Methods This is a prospect i ve nationwide cohort study . Cohorts with AS ( n = 6448 ) , PsA ( n = 16,063 ) and uSpA ( n = 5190 ) patients and a GP ( n = 266,435 ) cohort , were identified 2001–2009 in the Swedish National Patient and Population registers . The follow-up began 1 January 2006 , or 6 months after the first registered spondyloarthritis ( SpA ) diagnosis thereafter , and ended at ACS/stroke/VTE event , death , emigration or 31 December 2012 . Crude and age- and sex-st and ardized incidence rates ( SIRs ) and hazard ratios ( HRs ) were calculated for incident ACS , stroke or VTE , respectively . Results St and ardized to the GP cohort , SIRs for ACS were 4.3 , 5.4 and 4.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort , respectively , compared to 3.2 in the GP cohort . SIRs for stroke were 5.4 , 5.9 and 5.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort compared to 4.7 in the GP cohort . Corresponding SIRs for VTE were 3.6 , 3.2 and 3.5 events per 1000 person-years at risk compared to 2.2 in the GP cohort . Age- and sex-adjusted HRs ( 95 % CI ) for ACS events were significantly increased in AS ( 1.54 ( 1.31–1.82 ) ) , PsA ( 1.76 ( 1.59–1.95 ) ) and uSpA ( 1.36 ( 1.05–1.76 ) ) compared to GP . Age-adjusted HRs for ACS was significantly decreased in female AS patients ( 0.59 ( 0.37–0.97 ) ) compared to female PsA patients . Age- and sex-adjusted HRs for stroke events were significantly increased in AS ( 1.25 ( 1.06–1.48 ) ) and PsA ( 1.34 ( 1.22–1.48 ) ) , and nonsignificantly increased in uSpA ( 1.16 ( 0.91–1.47 ) ) compared to GP . For VTE the age- and sex-adjusted HRs for AS , PsA and uSpA were equally and significantly increased with about 50 % compared to GP . Conclusions Patients with AS , PsA and uSpA are at increased risk for ACS and stroke events , which emphasizes the importance of identification of and intervention against cardiovascular risk factors in SpA patients . Increased alertness for VTE is warranted in patients with STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention Fernández-de-las-Peñas C , Alonso-Blanco C , Alguacil-Diego IM , Miangolarra-Page JC : One-year follow-up of two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2006;85:559–567 . Objective : To assess the long-term effects on functional and mobility outcomes of two exercise interventions for the management of patients with ankylosing spondylitis . Design : In an extended 12-mo follow-up of a r and omized controlled trial , 40 patients who were OUTPUT: Conflicting evidence was found as to whether supervision of exercise improved adherence . Adherence to prescribed exercise in SpA was poorly reported and predominately for people with AS . The levels of adherence and factors affecting prescribed exercise in SpA remain unclear . 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 OUTPUT:

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

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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*** ***EXAMPLES*** 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 The aim of this population -based matched case-control study was to evaluate the effect of risk factors for hip fracture in Oslo , Norway , which has some of the highest incidence rates ever reported . The study population comprised all non-institutionalized persons 50 years or older living in the catchment area of two Oslo hospitals , and cases were 246 patients admitted for hip fracture during a 1-year period . The controls were r and omly selected from the study population , matched 1:1 for age and sex . Hip fracture was associated with lean body stature , smoking , low grip strength and decreased levels of physical activity , and inversely with length of education . In addition , hip fracture was inversely related to indicators of total food intake ( number of meals per day , frequency of dinners , and slices of bread per day ) . A relation between hip fracture and low vitamin D intake was also suggested , whereas no association with dietary calcium intake was found . Finally , increased risk of fracture was seen in persons reporting two or more hospital admissions in the previous 2 years , and in those reporting weight reduction due to poor appetite during the previous year . In conclusion , the risk factor pattern for hip fracture was much the same in the elderly population of Oslo as previously described in other population s with a lower incidence of fracture . This study also indicates a relation between hip fracture and low food intake Abstract : Low bone mineral density ( BMD ) is one of the most important elements for the diagnosis of osteoporosis and screening people with higher risk of fractures . To establish the criterion value of BMD for the diagnosis of osteoporosis and to estimate the prevalence rate of osteoporosis in Japanese women , we performed a Japanese population -based osteoporosis ( JPOS ) study . The subjects were 4550 women aged 15 through 79 years r and omly selected from seven municipalities throughout Japan . The sample size was determined to ensure that the observed mean BMD would remain within 2.5 % from the real value with a probability of 0.95 in each of the 5-year age groups . The study comprised bone mass measurements by dual-energy X-ray absorptiometry at the spine ( L2–4 ) , hip and distal forearm , body size measurements and detailed interviews on medical and gynecologic history . After excluding those subjects with apparent or suggested abnormalities affecting bone mass from 3985 women ( 87.6 % ) who completed the study , 3465 women remained and served as the subjects . We present 5-year age-specific mean values of BMD and cut-off values for the diagnosis of osteoporosis according to World Health Organization ( WHO ) and the Japanese Society of Bone and Mineral Research ( JSBMR ) criteria . The cut-off levels at the spine and the distal radius proposed in this study were similar to those proposed by the JSBMR but the cut-off level at the femoral neck in this study was 4.7 % higher than that of the JSBMR . The prevalence rates of osteoporosis according to WHO criteria in the present subjects aged 50 through 79 years were calculated as 38.0 % at the spine , 11.6 % at the femoral neck and 56.8 % at the distal one-third site of the radius , and those in the Japanese female population of the same age were estimated to be 35.1 % , 9.4 % and 51.2 % , respectively . A fivefold difference was observed among the prevalence rates at different skeletal sites , which suggests that the different definitions of osteoporosis should be established for the different skeletal sites . The prevalence OUTPUT: The result of the present systematic review gives the evidence showing that calcium supplementation or optimal dietary calcium intake increases bone density in childhood and adolescence and reduces the risk of fracture due to osteoporosis in the elderly people regardless of the gender . 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 OUTPUT:

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

MS2_dynamic_1_shot276

***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*** ***EXAMPLES*** INPUT: In this prospect i ve r and omised study two treatments after non-traumatic medial meniscal tear diagnosed with radiological examination and magnetic resonance imaging were compared ; arthroscopic partial meniscectomy followed by supervised exercise or supervised exercise alone . The aim was to evaluate knee function and physical activity . Ninety patients ( mean age 56 years ) were evaluated using the Knee Injury and Osteoarthritis Outcome Score , the Lysholm Knee Scoring Scale , the Tegner Activity Scale and a Visual Analogue Scale for knee pain prior to the intervention , after 8 weeks of exercise and after 6 months . According to the outcome scores arthroscopic partial medial meniscectomy combined with exercise did not lead to greater improvement than exercise alone . After the intervention both groups reported decreased knee pain , improved knee function and a high satisfaction ( P < 0.0001 ) . Forty-one per cent of the patients returned to their pre-injury activity level after 6 months . In conclusion , when evaluated with outcome scores , arthroscopic partial medial meniscectomy followed by supervised exercise was not superior to supervised exercise alone in terms of reduced knee pain , improved knee function and improved quality of life Background — Arthroscopic meniscal surgery is the most common orthopedic procedure , and the incidence has increased in Denmark over the last 10 years . Concomitantly , several r and omized controlled trials have shown no benefit of arthroscopic procedures including arthroscopic partial meniscectomy in middle-aged and older individuals suffering from knee pain with or without knee osteoarthritis . We examined the annual incidence of meniscal procedures together with age , sex , and diagnosis for patients who underwent meniscal procedures in the period 2000–2011 in Denmark . Methods — Data on age , sex , diagnosis , and surgical procedures were extracted from the Danish National Patient Register for the years 2000–2011 , for all records containing meniscal surgery as a primary or secondary procedure . Results — The overall annual incidence of meniscal procedures per 100,000 persons in Denmark doubled from 164 in 2000 to 312 in 2011 ( i.e. 8,750 procedures to 17,368 procedures ) . A 2-fold increase was found for patients aged between 35 and 55 , and a 3-fold increase was found for those older than 55 . Middle-aged and older patients accounted for 75 % of all 151,228 meniscal procedures carried out between 2000 and 2011 . Interpretation — The incidence of meniscal procedures performed in Denmark doubled from 2000 to 2011 , with the largest increase in middle-aged and older patients . This increase contrasts with the mounting evidence showing no added benefit of arthroscopic partial meniscectomy over non-surgical treatments . Our observations illustrate the long delay in the dissemination , acceptance , and implementation of research evidence into the practice of arthroscopic surgery PURPOSE To determine whether preoperative magnetic resonance ( MR ) imaging could help identify factors associated with poor clinical outcome after arthroscopic partial meniscectomy ( APM ) in middle-aged and elderly patients with meniscal tears . MATERIAL S AND METHODS The prospect i ve , institutional review board-approved , HIPAA-compliant study was performed with informed consent in 53 men and 47 women ( average ages , 54.5 and 56.6 years , respectively ) . Patients underwent knee MR imaging before APM ; clinical symptoms were evaluated preoperatively and 1 year postoperatively with International Knee Documentation Committee ( IKDC ) question naire . Overall severity of knee joint degeneration and severity of each feature of joint degeneration were assessed with Boston Leads Osteoarthritis Knee ( BLOK ) scoring system . Tear length was measured , and type of meniscal tear was classified . Spearman correlation coefficients and relative risks showed the relationship between clinical outcome after APM ( difference between preoperative and postoperative IKDC scores ) and severity of joint degeneration . RESULTS Seventy-four patients with isolated medial APM had a significant ( P < .05 ) inverse correlation between clinical outcome and severity of cartilage loss and bone marrow edema in the medial femoral condyle and medial tibial plateau . Fifteen patients with isolated lateral APM had a significant ( P < .05 ) inverse correlation between clinical outcome and severity of cartilage loss in the lateral femoral condyle and lateral tibial plateau and bone marrow edema in the lateral femoral condyle . One hundred patients with APM had a significant ( P < .05 ) inverse correlation between clinical outcome and severity of meniscal extrusion , total BLOK score , and meniscal tear length . A significantly ( P < .05 ) increased relative risk that a patient would not definitely improve after APM was observed if a meniscal root tear was present . CONCLUSION Poorer clinical outcome after APM was associated with greater severity of cartilage loss and bone marrow edema in the same compartment as the meniscal tear , greater severity of meniscal extrusion , greater overall severity of joint degeneration , a meniscal root tear , and a longer meniscal tear at preoperative MR imaging Introduction Arthroscopic partial meniscectomy ( APM ) to treat degenerative meniscus injury is the most common orthopaedic procedure . However , valid evidence of the efficacy of APM is lacking . Controlling for the placebo effect of any medical intervention is important , but seems particularly pertinent for the assessment of APM , as the symptoms commonly attributed to a degenerative meniscal injury ( medial joint line symptoms and perceived disability ) are subjective and display considerable fluctuation , and accordingly difficult to gauge objective ly . Methods and analysis A multicentre , parallel r and omised , placebo surgery controlled trial is being carried out to assess the efficacy of APM for patients from OUTPUT: There was no difference in the side effects between patients with AT and the control group . AT in OA patients is not useless because there is evidence that a subgroup of patients with non-traumatic flap tears of the medial meniscus or patients with crystal arthropathy benefit from arthroscopy . 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 minim OUTPUT:

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 .

MS2_dynamic_1_shot277

***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*** ***EXAMPLES*** 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 OBJECTIVE To test the hypothesis that a custom-fit valgus knee brace and custom-made lateral wedge foot orthotic will have greatest effects on decreasing the external knee adduction moment during gait when used concurrently . DESIGN Proof-of-concept , single test session , crossover trial . SETTING Biomechanics laboratory within a tertiary care center . PARTICIPANTS Patients ( n=16 ) with varus alignment and knee osteoarthritis ( OA ) primarily affecting the medial compartment of the tibiofemoral joint ( varus gonarthrosis ) . INTERVENTIONS Custom-fit valgus knee brace and custom-made full-length lateral wedge foot orthotic . Amounts of valgus angulation and wedge height were tailored to each patient to ensure comfort . MAIN OUTCOME MEASURES The external knee adduction moment ( % body weight [BW]*height [ Ht ] ) , frontal plane lever arm ( cm ) , and ground reaction force ( N/kg ) , determined from 3-dimensional gait analysis completed under 4 r and omized conditions : ( 1 ) control ( no knee brace , no foot orthotic ) , ( 2 ) knee brace , ( 3 ) foot orthotic , and ( 4 ) knee brace and foot orthotic . RESULTS The reduction in knee adduction moment was greatest when concurrently using the knee brace and foot orthotic ( effect sizes ranged from 0.3 to 0.4 ) . The mean decrease in first peak knee adduction moment compared with control was .36 % BW*Ht ( 95 % confidence interval [ CI ] , -.66 to -.07 ) . This was accompanied by a mean decrease in frontal plane lever arm of .59 cm ( 95 % CI , -.94 to -.25 ) . CONCLUSIONS These findings suggest that using a custom-fit knee brace and custom-made foot orthotic concurrently can produce a greater overall reduction in the knee adduction moment , through combined effects in decreasing the frontal plane lever arm We examined if a subject-specific amount of lateral wedge added to a foot orthosis could alter knee mechanics to potentially reduce the progression of knee osteoarthritis in patients with medial knee osteoarthritis . Twenty individuals with medial knee osteoarthritis ( > /=2 Kellgren Lawrence grade ) were prescribed a custom laterally wedged foot orthotic device . The prescribed wedge amount was the minimal wedge amount that provided the maximum amount of pain reduction during a lateral step-down test . Following an accommodation period , all subjects returned to the laboratory for a gait analysis . Knee mechanics were collected as the subjects walked at an intentional walking speed . Walking in the laterally wedged orthotic device significantly reduced the peak adduction moment during early stance ( p < 0.01 ) compared to the nonwedged device . Similarly , the wedged orthotic device significantly reduced the knee adduction excursion from heel strike to peak adduction ( p < 0.01 ) compared to the nonwedged device . No differences in the peak adduction moment during propulsion or peak adduction during stance were observed between the orthotic conditions . A subject-specific laterally wedged orthotic device was able to reduce the peak knee adduction moment during early stance , which is thought to be associated with the progression of knee osteoarthritis . Previous studies on this device have reported issues associated with foot discomfort when using wedge amounts > 7 degrees ; however , no such issues were reported in this study . Therefore , providing a custom laterally wedged orthotic device may potentially increase compliance while still potentially reducing disease progression 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 . Cor OUTPUT: The primary findings were consistent reductions in the knee adduction moment with lateral wedge insoles , although increases in ankle eversion with these insoles were also found . Conclusion Lateral wedge insoles produce small reductions in knee adduction angles and external moments , and moderate increases in ankle eversion . The addition of an arch support to a lateral wedge minimises ankle eversion change , and also minimises adduction moment reductions . 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 OUTPUT:

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_dynamic_1_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*** ***EXAMPLES*** INPUT: Systematic studies of infants with autism have not been previously carried out . Taking advantage of a new prospect i ve screening instrument for autism in infancy ( S. Baron-Cohen et al. , 1996 ) , the present study found that , compared with developmentally delayed and normally developing children , 20-month-old children with autism were specifically impaired on some aspects of empathy , joint attention , and imitation . Infants with autism failed to use social gaze in the empathy and joint attention tasks . Both the infants with autism and the infants with developmental delay demonstrated functional play , but very few participants in either group produced spontaneous pretend play . In the developmental delay group , but not the autism group , pretend play was shown following prompting . The implication s of these findings for developmental accounts of autism and for the early diagnosis of the disorder are discussed Nonconscious behavioral mimicry occurs when a person unwittingly imitates the behaviors of another person . This mimicry has been attributed to a direct link between perceiving a behavior and performing that same behavior . The current experiments explored whether having a goal to affiliate augments the tendency to mimic the behaviors of interaction partners . Experiment 1 demonstrated that having an affiliation goal increases nonconscious mimicry , and Experiment 2 further supported this proposition by demonstrating that people who have unsuccessfully attempted to affiliate in an interaction subsequently exhibit more mimicry than those who have not experienced such a failure . Results suggest that behavioral mimicry may be part of a person 's repertoire of behaviors , used nonconsciously , when there is a desire to create rapport Autism spectrum disorder ( ASD ) is a neurodevelopmental disorder associated with impaired social and emotional skills , the anatomical substrate of which is still unknown . In this study , we compared a group of 14 high-functioning ASD adults with a group of controls matched for sex , age , intelligence quotient , and h and edness . We used an automated technique of analysis that accurately measures the thickness of the cerebral cortex and generates cross-subject statistics in a coordinate system based on cortical anatomy . We found local decreases of gray matter in the ASD group in areas belonging to the mirror neuron system ( MNS ) , argued to be the basis of empathic behavior . Cortical thinning of the MNS was correlated with ASD symptom severity . Cortical thinning was also observed in areas involved in emotion recognition and social cognition . These findings suggest that the social and emotional deficits characteristic of autism may reflect abnormal thinning of the MNS and the broader network of cortical areas subserving social cognition We investigated whether individuals with autism spectrum disorders ( ASD ) would show attentional modulation for social ( face ) and non-social ( house ) stimuli . Sixteen individuals with ASD and 16 matched control participants completed a task in which pairs of face and house stimuli were present on every trial , with one of the pairs r and omly assigned to attended locations and the other to unattended locations . Both mass-univariate ( SPM ) and region of interest analyses suggested that responses to houses were modulated by attention in both groups , but that only the control participants demonstrated attentional modulation of face-selective regions . Thus , the participants with ASD demonstrated a lack of attentional modulation which was particularly evident for the social stimulus . Analyses of effective connectivity indicated that these results were due to a failure of attention to modulate connectivity between extrastriate areas and V1 . We discuss how these results may suggest a mechanism to explain the reduced salience of social stimuli in ASD To examine mirror neuron abnormalities in autism , high-functioning children with autism and matched controls underwent fMRI while imitating and observing emotional expressions . Although both groups performed the tasks equally well , children with autism showed no mirror neuron activity in the inferior frontal gyrus ( pars opercularis ) . Notably , activity in this area was inversely related to symptom severity in the social domain , suggesting that a dysfunctional ' mirror neuron system ' may underlie the social deficits observed in autism OUTPUT: The only well localised measure of mirror system function is fMRI . In fMRI studies , those using emotional stimuli have reported group differences , but studies using non-emotional h and action stimuli do not . Overall , there is little evidence for a global dysfunction of the mirror system in autism . Current data can be better understood under an alternative model in which social top-down response modulation is abnormal in autism . 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:

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 .

MS2_dynamic_1_shot279

***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*** ***EXAMPLES*** INPUT: Background Raised C-reactive protein ( CRP ) is a risk factor for type 2 diabetes . According to the Mendelian r and omization method , the association is likely to be causal if genetic variants that affect CRP level are associated with markers of diabetes development and diabetes . Our objective was to examine the nature of the association between CRP phenotype and diabetes development using CRP haplotypes as instrumental variables . Methods and Findings We genotyped three tagging SNPs ( CRP + 2302 G > A ; CRP + 1444 T > C ; CRP + 4899 T > G ) in the CRP gene and measured serum CRP in 5,274 men and women at mean ages 49 and 61 y ( Whitehall II Study ) . Homeostasis model assessment -insulin resistance ( HOMA-IR ) and hemoglobin A1c ( HbA1c ) were measured at age 61 y. Diabetes was ascertained by glucose tolerance test and self-report . Common major haplotypes were strongly associated with serum CRP levels , but unrelated to obesity , blood pressure , and socioeconomic position , which may confound the association between CRP and diabetes risk . Serum CRP was associated with these potential confounding factors . After adjustment for age and sex , baseline serum CRP was associated with incident diabetes ( hazard ratio = 1.39 [ 95 % confidence interval 1.29–1.51 ] , HOMA-IR , and HbA1c , but the associations were considerably attenuated on adjustment for potential confounding factors . In contrast , CRP haplotypes were not associated with HOMA-IR or HbA1c ( p = 0.52–0.92 ) . The associations of CRP with HOMA-IR and HbA1c were all null when examined using instrumental variables analysis , with genetic variants as the instrument for serum CRP . Instrumental variables estimates differed from the directly observed associations ( p = 0.007–0.11 ) . Pooled analysis of CRP haplotypes and diabetes in Whitehall II and Northwick Park Heart Study II produced null findings ( p = 0.25–0.88 ) . Analyses based on the Wellcome Trust Case Control Consortium ( 1,923 diabetes cases , 2,932 controls ) using three SNPs in tight linkage disequilibrium with our tagging SNPs also demonstrated null associations . Conclusions Observed associations between serum CRP and insulin resistance , glycemia , and diabetes are likely to be noncausal . Inflammation may play a causal role via upstream effectors rather than the downstream marker CRP Background C-reactive protein ( CRP ) is associated with immune , cardiometabolic , and psychiatric traits and diseases . Yet it is inconclusive whether these associations are causal . Methods and Findings We performed Mendelian r and omization ( MR ) analyses using two genetic risk scores ( GRSs ) as instrumental variables ( IVs ) . The first GRS consisted of four single nucleotide polymorphisms ( SNPs ) in the CRP gene ( GRSCRP ) , and the second consisted of 18 SNPs that were significantly associated with CRP levels in the largest genome-wide association study ( GWAS ) to date ( GRSGWAS ) . To optimize power , we used summary statistics from GWAS consortia and tested the association of these two GRSs with 32 complex somatic and psychiatric outcomes , with up to 123,865 participants per outcome from population s of European ancestry . We performed heterogeneity tests to disentangle the pleiotropic effect of IVs . A Bonferroni-corrected significance level of less than 0.0016 was considered statistically significant . An observed p-value equal to or less than 0.05 was considered nominally significant evidence for a potential causal association , yet to be confirmed . The strengths ( F-statistics ) of the IVs were 31.92–3,761.29 and 82.32–9,403.21 for GRSCRP and GRSGWAS , respectively . CRP GRSGWAS showed a statistically significant protective relationship of a 10 % genetically elevated CRP level with the risk of schizophrenia ( odds ratio [ OR ] 0.86 [ 95 % CI 0.79–0.94 ] ; p < 0.001 ) . We vali date d this finding with individual-level genotype data from the schizophrenia GWAS ( OR 0.96 [ 95 % CI 0.94–0.98 ] ; p < 1.72 × 10−6 ) . Further , we found that a st and ardized CRP polygenic risk score ( CRPPRS ) at p-value thresholds of 1 × 10−4 , 0.001 , 0.01 , 0.05 , and 0.1 using individual-level data also showed a protective effect ( OR < 1.00 ) against schizophrenia ; the first CRPPRS ( built of SNPs with p < 1 × 10−4 ) showed a statistically significant ( p < 2.45 × 10−4 ) protective effect with an OR of 0.97 ( 95 % CI 0.95–0.99 ) . The CRP GRSGWAS showed that a 10 % increase in genetically determined CRP level was significantly associated with coronary artery disease ( OR 0.88 [ 95 % CI 0.84–0.94 ] ; p < 2.4 × 10−5 ) and was nominally associated with the risk of inflammatory bowel disease ( OR 0.85 [ 95 % CI 0.74–0.98 ] ; p < 0.03 ) , Crohn disease ( OR 0.81 [ 95 % CI 0.70–0.94 ] ; p < 0 OUTPUT: Only for one biomarker was there strong observational evidence of association and evidence from genetic association studies that was compatible with an underlying causal association . In additional search for T2D prediction , we found only half of biomarkers were examined with formal evidence of predictive value for a minority of these biomarkers . Most biomarkers did not enhance the strength of prediction , but the strongest evidence for prediction was for biomarkers that quantify measures of glycaemia . 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 OUTPUT:

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 .

MS2_dynamic_1_shot280

***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*** ***EXAMPLES*** INPUT: BACKGROUND AND AIM Some studies recently reported a favourable effect for cis-9 , trans-11 conjugated linoleic acid ( CLA ) on plasma lipoprotein profile of healthy subjects . Aim of this crossover intervention study was to evaluate the influence of a short-term dietary intake of a cheese derived from sheep 's milk naturally rich in CLA on several atherosclerotic biomarkers , in comparison with a commercially available cheese . METHODS AND RESULTS Ten subjects ( 6 F ; 4 M ) with a median age of 51.5 followed for 10 weeks a diet containing 200 g/week of cheese naturally rich in CLA ( intervention period ) and for the same period a diet containing a commercially available cheese of the same quantity ( placebo period ) . Consumption of the dairy product naturally rich in cis-9 , trans-11 CLA determined a significant ( p<0.05 ) reduction in inflammatory parameters such as interleukin-6 ( pre : 8.08+/-1.57 vs. post : 4.58+/-0.94 pg/mL ) , interleukin-8 ( pre : 45.02+/-5.82 vs. post : 28.59+/-2.64 pg/mL ) , and tumour necrosis factor-alpha ( pre : 53.58+/-25.67 vs. post : 32.09+/-17.42 pg/mL ) whereas no significant differences in the placebo period were observed . With regard to haemorheological parameters , the test period significantly ameliorated erythrocytes ' filtration rate ( pre : 7.61+/-0.71 % vs. post : 9.12+/-0.97 % ; p=0.03 ) with respect to the placebo period . Moreover , a reduction in the extent of platelet aggregation , induced by arachidonic acid [ pre : 87.8+/-1.76 % vs. post : 77.7+/-3.56 % ; p=0.04 ] was observed during the test period in comparison with the placebo period . CONCLUSIONS Dietary short-term intake of the tested dairy product naturally rich in cis-9 , trans-11 CLA appeared to cause favourable biochemical changes of atherosclerotic markers BACKGROUND AND AIMS Epidemiological studies have demonstrated an association between high-polyphenol intake and reduced incidence of atherosclerosis . The healthy effects of cocoa-polyphenols may be due to their antioxidant and anti-inflammatory actions , although the exact mechanisms are unknown and depend on the matrix in which cocoa-polyphenols are delivered . Nuclear factor κB ( NF-κB ) is a key molecule in the pathophysiology of atherosclerosis involved in the regulation of adhesion molecules(AM ) and cytokine expression and its activation is the first step in triggering the inflammatory process . The aim of this study was to evaluate the effect of acute cocoa consumption in different matrices related to the bioavailability of cocoa-polyphenols in NF-κB activation and the expression of AM . METHODS AND RESULTS Eighteen healthy volunteers r and omly received 3 interventions : 40 g of cocoa powder with milk ( CM ) , with water ( CW ) , and only milk ( M ) . NF-κB activation in leukocytes and AM ( sICAM , sVCAM , E-selectin ) were measured before and 6h after each intervention . Consumption of CW significantly decreased NF-κB activation compared to baseline and to CM ( P < 0.05 , both ) , did not change after CM intervention , and significantly increased after M intervention ( P = 0.014 ) . sICAM-1 concentrations significantly decreased after 6h of CW and CM interventions ( P ≤ 0.026 ; both ) and E-selectin only decreased after CW intervention ( P = 0.028 ) . No significant changes were observed in sVCAM-1 concentrations . CONCLUSIONS The anti-inflammatory effect of cocoa intake may depend on the bioavailability of bioactive compounds and may be mediated at least in part by the modulation of NF-κB activation and downstream molecules reinforcing the link between cocoa intake and health BACKGROUND & AIMS The study examined the value of n-3 LC-PUFA-enriched yogurt as means of improving cardiovascular health . DESIGN Fifty three mildly hypertriacylglycerolemic subjects ( TAG ≥ 1.7 mmol/L ) participated in a r and omized , placebo-controlled , double-blind , parallel design ed study . The subjects consumed 1 ) control yoghurt ; 2 ) yoghurt enriched with 0.8 g n-3 LC-PUFA/d ; or 3 ) yoghurt enriched with 3 g n-3 LC-PUFA/d for a period of 10 wks . Blood sample s were taken at the beginning and the end of the study period . RESULTS Following daily intake of 3 g n-3 LC-PUFA for 10 weeks , n-3 LC-PUFA levels increased significantly in plasma and red blood cells ( RBC ) with concomitant increase in the EPA-derived mediators ( PGE₃ , 12- , 15- , 18-HEPE ) in plasma whilst cardiovascular risk factors such as HDL , TAG , AA/EPA ratio , and n-3 index were improved ( P < 0.05 ) ; the decrease of TAG and increase in HDL were associated with the CD36 genotype . CONCLUSION The observed increase of n-3 LC-PUFA in RBC and plasma lipids due to intake of n-3 LC-PUFA enriched yoghurt result ed in a reduction of cardiovascular risk factors and inflammatory mediators showing that OUTPUT: When the subjects were stratified according to their health status , the IS was strongly indicative of an anti-inflammatory activity in subjects with metabolic disorders and of a pro-inflammatory activity in subjects allergic to bovine milk . 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 di OUTPUT:

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

MS2_dynamic_1_shot281

***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*** ***EXAMPLES*** INPUT: Abstract Objective : To evaluate the effectiveness of combinations of three methods to promote physical activity . Design : R and omised controlled trial . Baseline assessment with post-intervention follow up at 12 weeks and 1 year . Setting : One urban general practice , 1995 - 7 . Participants : 523 adults aged 40 to 64 years , r and omised to four intervention groups and a control group . Interventions : Brief ( one interview ) or intensive ( six interviews over 12 weeks ) motivational interviewing based on the stages of change model of behaviour change , with or without financial incentive ( 30 vouchers entitling free access to leisure facilities ) . Main outcome measures : Physical activity score ; sessions of moderate and vigorous activity in the preceding four weeks . Results : Response rate was 81 % at 12 weeks and 85 % at one year . More participants in the intervention group reported increased physical activity scores at 12 weeks than controls ( 38 % v 16 % , difference 22 % , 95 % confidence interval for difference 13 % to 32 % ) , with a 55 % increase observed in those offered six interviews plus vouchers . Vigorous activity increased in 29 % of intervention participants and 11 % of controls ( difference 18 % , 10 % to 26 % ) , but differences between the intervention groups were not significant . Short term increases in activity were not sustained , regardless of intensity of intervention . Conclusions : The most effective intervention for promoting adoption of exercise was the most intensive . Even this did not promote long term adherence to exercise . Brief interventions promoting physical activity that are used by many schemes in the United Kingdom are of question able effectiveness . Key messages Schemes promoting physical activity are currently popular in general practice in Britain , but few have been rigorously evaluated and their effectiveness is unknown . In this study , the most effective intervention for promoting adoption of physical activity was the most intensive , involving six motivational interviews and a financial incentive A comparatively brief intervention ( one interview ) was only effective in the short term in around a third of participants Short term increases in physical activity were not maintained at one year follow up and even the most intensive intervention was ineffective in promoting long term adherence to increased physical activity . National and local government , health authorities , and primary healthcare teams should be cautious about current and future expenditure on , and implementation of , exercise prescription or referral BACKGROUND Using peer volunteers as delivery agents may improve translation of evidence -based physical activity promotion programs for older adults . This study examined whether tailored support from older peer volunteers could improve initiation and long-term maintenance of physical activity behavior . METHODS Participants were r and omized to 2 16-week , group-based programs : ( 1 ) peer-delivered , theory-based support for physical activity behavior change ; or ( 2 ) an intervention typically available in community setting s ( basic education , gym membership , and pedometer for self-monitoring ) , attention-matched with health education . Moderate-to-vigorous physical activity ( MVPA ) was assessed via daily self-report logs at baseline , at the end of the intervention ( 16 weeks ) , and at follow-up ( 18 months ) , with accelerometry validation ( RT3 ) in a r and om sub sample . RESULTS Seven peer volunteers and 81 sedentary adults were recruited . Retention at the end of the trial was 85 % and follow-up at 18 months was 61 % . Using intent-to-treat analyses , at 16 weeks , both groups had similar significant improvements in MVPA . At 18 months , the group supplemented with peer support had significantly more MVPA . CONCLUSIONS Trained peer volunteers may enhance long-term maintenance of physical activity gains from a community-based intervention . This approach has great potential to be adapted and delivered inexpensively in community setting Background Following an extensive recruitment campaign , a 16-week lunchtime intervention to increase walking was implemented with insufficiently physically active University employees to examine programme feasibility and the effects of the programme in increasing walking behaviour , and in improving well-being and work performance . Methods / design A feasibility study in which participants were r and omised to an immediate treatment or a delayed treatment control ( to start at 10 weeks ) group . For the first ten weeks of the intervention , participants took part in three facilitator-led group walks per week each of thirty minutes duration and were challenged to accumulate another sixty minutes of walking during the weekends . In the second phase of the intervention , the organised group walks ceased to be offered and participants were encouraged to self-organise their walks . Motivational principles were employed using contemporary motivational theory . Outcome measures ( including self-reported walking , step counts , cardiovascular fitness , general and work-related well-being and work performance ) were assessed at baseline , at the end of the 16-week intervention and ( for some ) four months after the end of the intervention . Process and outcome assessment s were also taken throughout , and following , the intervention . Discussion The results of the intervention will determine the feasibility of implementing a lunchtime walking programme to increase walking behaviour , well-being and performance in sedentary employees . If successful , there is scope to implement definitive trials across a range of worksites with the aim of improving both employee and organisational health . Trial registration Current Controlled Trials IS RCT N81504663 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 OUTPUT: Despite this , there was some indication that the most effective interventions were those that offered both individual and group support for changing PA levels using a tailored approach . Although we found evidence to support the effectiveness of face-to-face interventions for promoting PA , at least at 12 months , the effectiveness of these interventions was not supported by high quality studies . Due to the clinical and statistical heterogeneity of the studies , only limited conclusions can be drawn about the effectiveness of individual components of the interventions . 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 200 OUTPUT:

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*** ***EXAMPLES*** 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 Tonic muscle nociceptive discharge evoked chemically from the foot extensor digitorum brevis muscle in man produces a depression of Ia excitation and Ib inhibition of the soleus ( Sol ) motoneurones ( Mns ) . The possibility that both these changes partly result from presynaptic inhibition of Ia fibres projecting to Sol Mns and to interneurones mediating group I non-reciprocal inhibition is tested . Convergence of Ia fibres on these interneurones was deduced from evidence that reducing the excitatory effect of the extensor Ia fibres ( by potentiation of their presynaptic inhibition ) result ed in Ib disinhibition . Nociceptive-induced potentiation of Ia presynaptic inhibition was deduced from the following congruent results obtained by two independent methods : ( 1 ) depression of heteronymous Ia monosynaptic facilitation of the quadriceps muscle to Sol Mns ; ( 2 ) potentiation of presynaptic inhibition of Sol Ia fibres evoked by mechanical activation of the tibialis anterior primary spindle afferents . It is concluded that nociceptive volleys arising from dorsal foot muscles facilitate the activity of interneurones intercalated in pathways responsible for presynaptic inhibition of Sol Ia fibres . It is also proposed that the same Ia presynaptic inhibition depresses the excitability of interneurones mediating group I non-reciprocal inhibition , thus result ing in Ib disinhibition of Sol Mns Objectives : To describe postural sway and its associations to background factors , low back pain and functional capacity . To evaluate the changes in postural sway after three months of therapeutic exercise in the gym or at home . Design : A one-year r and omized experimental trial evaluated postural sway in three study groups : intensive training , home exercise and control group . Setting : Subjects were recruited from seven local occupational health care centres in Central Finl and and were examined at Central Finl and Hospital by medical doctors . Measurements and therapeutic exercise programmes were carried out in the Research Laboratory of Sport and Health Sciences at Jyväskylä University . Subjects : Initially , 49 male and 41 female subjects ( aged 20–55 years ) with nonspecific and subacute low back pain were examined . Main outcome measures : Postural sway using a force platform , the Oswestry Index , as well as a measure of low back pain intensity were measured at the initial stage of the study , directly after interventions , as well as at three and nine months after the interventions . Results : The background variables were not strongly correlated with postural sway . No changes occurred in the amplitude of sway during the study , but the sway velocity of the home exercise group increased . Conclusions : Postural sway measurements with a force platform may be suitable for detecting impairments of balance performance among subjects with pronounced functional or OUTPUT: Patients with NSLBP exhibit greater postural instability than healthy controls , signified by greater COP excursions and a higher mean velocity . While the decreased postural stability in NSLBP sufferers further appears to be associated with the presence of pain , it seems unrelated to the exact location and pain duration . No correlation between the pain intensity and the magnitude of COP excursions could be identified 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 OUTPUT:

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*** ***EXAMPLES*** INPUT: Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies With this study we tested the hypothesis that 6 wk of endurance training increases maximal cardiac output ( Qmax ) relatively more by elevating blood volume ( BV ) than by inducing structural and functional changes within the heart . Nine healthy but untrained volunteers ( Vo2max 47 ± 5 ml·min(-1)·kg(-1 ) ) underwent supervised training ( 60 min ; 4 times weekly at 65 % Vo2max for 6 wk ) , and Qmax was determined by inert gas rebreathing during cycle ergometer exercise before and after the training period . After the training period , blood volume ( determined in duplicates by CO rebreathing ) was reestablished to pretraining values by phlebotomy and Qmax was quantified again . Resting echography revealed no structural heart adaptations as a consequence of the training intervention . After the training period , plasma volume ( PV ) , red blood cell volume ( RBCV ) , and BV increased ( P < 0.05 ) by 147 ± 168 ( 5 ± 5 % ) , 235 ± 64 ( 10 ± 3 % ) , and 382 ± 204 ml ( 7 ± 4 % ) , respectively . Vo2max was augmented ( P < 0.05 ) by 10 ± 7 % after the training period and decreased ( P < 0.05 ) by 8 ± 7 % with phlebotomy . Concomitantly , Qmax was increased ( P < 0.05 ) from 18.9 ± 2.1 to 20.4 ± 2.3 l/min ( 9 ± 6 % ) as a consequence of the training intervention , and after normalization of BV by phlebotomy Qmax returned to pretraining values ( 18.1 ± 2.5 l/min ; 12 ± 5 % reversal ) . Thus the exercise training-induced increase in BV is the main mechanism increasing Qmax after 6 wk of endurance training in previously untrained subjects Gender differences in maximal accumulated oxygen deficit ( MAOD ) were examined before and after 4 and 8 wk of high-intensity interval training . Untrained men ( n = 7 ) and women ( n = 7 ) cycled at 120 % of pretraining peak oxygen uptake ( VO2 peak ) to exhaustion ( MAOD test ) pre- , mid- , and posttraining . A posttraining timed test was also completed at the MAOD test power output , but this test was stopped at the time to exhaustion achieved during the pretraining MAOD test . The 14.3 + /- 5.2 % increase in MAOD observed in men after 4 wk of training was not different from the 14.0 + /- 3.0 % increase seen in women ( P > 0.05 ) . MAOD increased by a further 6.6 + /- 1.9 % in men , and this change was not different from the additional 5.1 + /- 2.3 % increase observed in women after the final 4 wk of training . VO2 peak measured during incremental cycling increased significantly ( P < 0.01 ) in male but not in female subjects after 8 wk of training . Moreover , the accumulated oxygen ( AO2 ) uptake was higher in men during the posttraining timed test compared with the pretraining MAOD test ( P < 0.01 ) . In contrast , the AO2 uptake was unchanged from pre- to posttraining in female subjects . The increase in MAOD with training was not different between men and women , suggesting an enhanced ability to produce ATP anaerob OUTPUT: Pooled evidence demonstrates greater improvements in VO2max in healthy men compared with women in response to a given dose of ET , suggesting the presence of sexual dimorphism in the trainability of aerobic capacity 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 OUTPUT:

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 .

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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*** ***EXAMPLES*** 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 OBJECTIVE Musculoskeletal soft tissue injuries consume considerable re sources in personal suffering , medical care , work absenteeism , and compensation benefits . Our aim was to determine specific clinical and behavioral factors that prognostically influence return to work following musculoskeletal work related injuries . METHODS A longitudinal cohort study was conducted on 148 r and omly selected workers who had not returned to work in 3 months following musculoskeletal soft tissue injury . The cohort was identified from the files of the Workers ' Compensation Board of Ontario , Canada . The workers were interviewed and assessed at 3 , 9 , 15 , and 21 months after injury . The WHO Classification of Impairment , Disabilities and H and icap was used as the conceptual framework . The analysis employed a proportional hazards regression model with allowance for time dependent covariates . RESULTS The rate of return to work for men was 1.5 times that for women , and 20 % less for every 10 year increase in age . Controlling for sex and age , psychological distress and functional disability were associated with a slower rate of return to work . The rate of return to work for workers who were provided with modified jobs was 2 times higher than for those with no such accommodation in employment . CONCLUSION The negative effect of psychological distress and functional disability on return to work rates must be considered in the design and delivery of rehabilitation programming for workers with musculoskeletal soft tissue injuries . The employer 's provision of a " modified job " is important in the prevention of continued disability Study Design . R and omized controlled trial . Objectives . To investigate the effectiveness and costs of a mini-intervention , provided in addition to the usual care , and the incremental effect of a work site visit for patients with subacute disabling low back pain . Summary of Background Data . There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain . Methods . A total of 164 patients with subacute low back pain were r and omized to a mini-intervention group ( A ) , a work site visit group ( B ) , or a usual care group ( C ) . Groups A ( n = 56 ) and B ( n = 51 ) underwent one assessment by a physician plus a physiotherapist . Group B received a work site visit in addition . Group C served as controls ( n = 57 ) and was treated in municipal primary health care . All patients received a leaflet on back pain . Pain , disability , specific and generic health-related quality of life , satisfaction with care , days on sick leave , and use and costs of health care consumption were measured at 3- , 6- , and 12-month follow-ups . Results . During follow-up , fewer subjects had daily pain in Groups A and B than in Group C ( Group A vs. Group C , P = 0.002 ; Group B vs. Group C , P = 0.030 ) . In Group A , pain was less bothersome ( Group A vs. Group C , P = 0.032 ) and interfered less with daily life ( Group A vs. Group C , P = 0.040 ) than among controls . Average days on sick leave were 19 in Group A , 28 in Group B , and 41 in Group C ( Group A vs. Group C , P = 0.019 ) . Treatment satisfaction was better in the intervention groups than among the controls , and costs were lowest in the mini-intervention group . Conclusions . Mini-intervention reduced daily back pain symptoms and sickness absence , improved adaptation to pain and patient satisfaction among patients with subacute low back pain , without increasing health care costs . A work site visit did not increase effectiveness Aims : To develop a model of prognosis for time receiving workers ’ compensation wage replacement benefits in the first year . Methods : A prospect i ve cohort of 907 injured workers off work because of soft tissue injuries was followed for one year through structured telephone interviews and administrative data sources . Workers were recruited at workers ’ compensation cl aim registration . Only those still off work at four weeks post- registration were included in the analysis . Data from several domains ( demographics , clinical factors , workplace factors , recovery expectations ) were collected at approximately two weeks and a subset again at four weeks . Outcome was duration on total temporary wage replacement benefits . Variable selection was carried out in two steps using content experts and backward elimination with the Cox model . Results : Body region specific functional status , change in pain , workplace offers of arrangements for return to work , and recovery expectations were independently predictive of time on benefits . Change in pain and workplace offers interacted , so the largest mutual association occurred for those OUTPUT: There was strong evidence that work disability duration is significantly reduced by work accommodation offers and contact between healthcare provider and workplace ; and moderate evidence that it is reduced by interventions which include early contact with worker by workplace , ergonomic work site visits , and presence of a RTW coordinator . For these five intervention components , there was moderate evidence that they reduce costs associated with work disability duration . Conclusions : Our systematic review provides the evidence base supporting that workplace-based RTW interventions can reduce work disability duration and associated costs , however the evidence regarding their impact on quality -of-life outcomes was much weaker 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 OUTPUT:

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 .

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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*** ***EXAMPLES*** INPUT: Objectives : Drinking green tea is associated with many health benefits , including increased fat oxidation . We tested the hypothesis that epigallocatechin-3-gallate ( EGCG ) , the main green tea catechin , increases fat oxidation in obese men . Methods : Ten healthy overweight/obese males ( body mass index 31.3±0.8 kg/m2 ) were studied in a r and omized , placebo-controlled , double-blind crossover trial . Study supplements were low EGCG ( 300 mg ) , high EGCG ( 600 mg ) , caffeine ( 200 mg ) , EGCG/caffeine ( 300 mg/200 mg ) or placebo and were taken orally for 3 days . At the third day of supplementation , O2 consumption and CO2 production was measured by indirect calorimetry to assess energy expenditure and fat oxidation over 4 h each after overnight fasting and after a st and ardized test meal . Results : Energy expenditure was not affected by any supplementation , neither after overnight fasting nor after the test meal . During the first 2 h after overnight fasting , fat oxidation increased by 7.7 ( not significant , NS ) , 15.2 ( NS ) , 26.3 ( P<0.05 vs placebo ) and 35.4 % ( P<0.01 vs placebo and low EGCG ) , for low EGCG , high EGCG , caffeine and EGCG/caffeine , respectively . During the first 2 h after the meal , the mean increase in fat oxidation was 33.3 ( P<0.05 vs placebo ) , 20.2 ( NS ) , 34.5 ( P<0.05 vs placebo ) and 49.4 % ( P<0.05 vs placebo ) for low EGCG , high EGCG , caffeine and EGCG/caffeine , respectively . Conclusions : Low EGCG increases postpr and ial fat oxidation in obese men and this to the same extent as 200 mg caffeine , whereas high EGCG does not exert this effect . Fasting fat oxidation is increased only by caffeine ( with or without EGCG ) . There is no synergism of low EGCG and 200 mg caffeine . Energy expenditure is not affected by EGCG It has been reported that green tea has a thermogenic effect , due to its caffeine content and probably also to the catechin , epigallocatechin-3-gallate ( EGCG ) . The main aim of the present study was to compare the effect of a mixture of green tea and Guarana extracts containing a fixed dose of caffeine and variable doses of EGCG on 24 h energy expenditure and fat oxidation . Fourteen subjects took part to this r and omized , placebo-controlled , double-blind , cross-over study . Each subject was tested five times in a metabolic chamber to measure 24 h energy expenditure , substrate oxidation and blood pressure . During each stay , the subjects ingested a capsule of placebo or capsules containing 200 mg caffeine and a variable dose of EGCG ( 90 , 200 , 300 or 400 mg ) three times daily , 30 min before st and ardized meals . Twenty-four hour energy expenditure increased significantly by about 750 kJ with all EGCG-caffeine mixtures compared with placebo . No effect of the EGCG-caffeine mixture was observed for lipid oxidation . Systolic and diastolic blood pressure increased by about 7 and 5 mmHg , respectively , with the EGCG-caffeine mixtures compared with placebo . This increase was significant only for 24 h diastolic blood pressure . The main finding of the study was the increase in 24 h energy expenditure with the EGCG-caffeine mixtures . However , this increase was similar with all doses of EGCG in the mixtures Objectives : The development of obesity is characterized by an increase in adipose tissue mass and by concomitant and profound changes in almost all organ functions leading to diseases such as hypertension , diabetes mellitus and coronary heart disease . Recent data from human studies indicate that the consumption of green tea and green tea extracts may help reduce body weight , mainly body fat , by increasing postpr and ial thermogenesis and fat oxidation . However , human studies investigating the metabolic effects of the most predominant tea catechin , EGCG , alone are absent . Methods : In a r and omized double blind , placebo-controlled , cross-over pilot study , six overweight men were given 300 mg EGCG/d for 2d . Fasting and postpr and ial changes in energy expenditure ( EE ) and substrate oxidation were assessed . Results : Resting EE did not differ significantly between EGCG and placebo treatments , although during the first postpr and ial monitoring phase , respiratory quotient ( RQ ) values were significantly lower with EGCG compared to the placebo . Conclusions : These findings suggest that EGCG alone has the potential to increase fat oxidation in men and may thereby contribute to the anti-obesity effects of green tea . However , more studies with a greater sample size and a broader range of age and BMI are needed to define the optimum dose Background The efficacy of natural products ( NPs ) is being evaluated using r and omized controlled trials ( RCTs ) with increasing frequency , yet a search of the literature did not identify a widely accepted critical appraisal instrument developed specifically for use with NPs . The purpose of this project was to develop and evaluate a critical appraisal instrument that is sufficiently rigorous to be used in evaluating RCTs of conventional medicines , and also has a section specific for use with single entity NPs , including herbs and natural source d chemicals . Methods Three phases of the project included : 1 ) using experts and a Delphi process to reach consensus on a list of items essential in describing OUTPUT: AUTHORS ' CONCLUSIONS Green tea preparations appear to induce a small , statistically non-significant weight loss in overweight or obese adults . Because the amount of weight loss is small , it is not likely to be clinical ly important . Green tea had no significant effect on the maintenance of weight loss . The remaining adverse events were judged to be mild to moderate 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 c OUTPUT:

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*** ***EXAMPLES*** 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 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 OBJECTIVE To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study consisted of a 12-month r and omized controlled trial of 147 health plan members with type 2 diabetes and obesity ( BMI > or=27 kg/m(2 ) ) . Participants were r and omized to lifestyle case management or usual care . Case management entailed individual and group education , support , and referral by registered dietitians ; intervention cost was US dollars 350 per person . Individuals treated with usual care received educational material . Both groups received ongoing primary care . Outcomes were difference between groups for change in weight ( kilograms ) , waist circumference ( centimeters ) , HbA(1c ) , fasting lipid levels , use of prescription medications , and health-related quality of life . RESULTS Case management result ed in greater weight loss ( P < 0.001 ) , reduced waist circumference ( P < 0.001 ) , reduced HbA(1c ) level ( P = 0.02 ) , less use of prescription medications ( P = 0.03 ) , and improved health-related quality of life ( P < 0.001 ) compared with usual care . The 12-month group difference in weight loss and waist circumference was 3.0 kg ( 95 % CI -5.4 to -0.6 ) and -4.2 cm ( -6.8 to -1.6 ) . HbA(1c ) differences were greatest at 4 months ( -0.59 % , P = 0.006 ) but not significant by 12 months ( -0.19 % , P = 0.45 ) . Participants in the OUTPUT: Interventions generally demonstrated improvement in HRQL . Conclusions : A variety of interventions can improve HRQL among adults with diabetes , but the magnitude of effects varied with the interventions . 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 GB OUTPUT:

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*** ***EXAMPLES*** INPUT: Background Total hip arthroplasty is associated with a better long term outcome and lesser reoperation rates in the elderly but the risk of complications are beleived to be higher in very elderly patients . The study aims to compare the short-term results of cemented and cementless total hip arthroplasty ( THA ) in active patients > 80 years of age with femoral neck fractures . Methods Sixty-two consecutive patients underwent THA during the study period ( cemented—31 and cementless—31 ) . The mean age was 84 years ( 81–94 years ) . Patients in both groups were comparable in their preoperative variables . Functional and radiological assessment s were carried out using vali date d outcome measures . Complications were recorded . Results Fifty-one patients were available for final analysis after accounting for deaths and cases lost in follow-up . Of the 51 patients , 25 ( 49 % ) regained their pre-injury mobility status and 36 ( 70 % ) were community ambulant . Cementless THA was associated with significantly less surgical time , blood loss , transfusion rates and hospital stay . The overall mortality rates , complications , functional and radiological results were similar in both groups though the number of deaths in the perioperative period was significantly high in patients undergoing cemented THA . ConclusionS atisfactory improvement in function with low reoperation rates can be achieved irrespective of the technique used . Complication rates are higher when compared to younger patients undergoing the procedure . Risks and benefits should be carefully assessed and explained before subjecting these patients to THA BACKGROUND More than 220,000 persons 65 years and older fracture a hip every year in the United States . Although hip fractures have been considered as a single , homogeneous condition , there are two major anatomic types of proximal femoral fractures : intertrochanteric and femoral neck . The present study 's objective was to determine if the two types of hip fracture have different patient characteristics and sequelae . METHODS A prospect i ve study of 923 elderly patients admitted to seven Baltimore hospitals for a hip fracture between 1984 and 1986 . RESULTS Patients with intertrochanteric fractures were slightly older , sicker on hospital admission , had longer hospital stays , and were less likely at 2 months postfracture to have recovered activities of daily living than femoral neck fracture patients . Intertrochanteric fracture patients also had higher mortality rates at 2 and 6 months after fracturing . Long-term recovery ( 1 year ) did not differ between fracture type . CONCLUSIONS It appears that intertrochanteric fracture patients have intrinsic factors ( older age , poor health ) impacting upon their risk of fracture and ability to recover . Differences in patient characteristics and sequelae do exist between femoral neck and intertrochanteric hip fracture patients that impact upon recovery Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons . Sixty patients ( 56 % ) had died in the cemented group and 63 ( 60 % ) in the uncemented group . Respectively , three and two patients ( 2.7 % and 1.9 % ) were completely lost to followup . Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group ( 86.2 versus 76.3 ; mean difference 9.9 ; 95 % confidence interval [ CI ] , 1.9–17.9 ) . The prevalence of postoperative periprosthetic femoral fractures was 7.4 % in the uncemented group and 0.9 % in the cemented group ( hazard ratio [ HR ] , 9.3 ; 95 % CI , 1.16–74.5 ) . Barthel Index and EQ-5D scores were not different between the groups . Between 1 and 5 years , we found no additional infections or dislocations . The mortality rate was not different between the groups ( HR , 1.2 ; 95 % CI , 0.82–1.7 ) . Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures . The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures . Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence Background The treatment of unstable intertrochanteric fractures in elderly is still controversial . The purpose of this study is to present treatment strategies for unstable intertrochanteric fractures with hemiarthroplasty using st and ard uncemented collared femoral st OUTPUT: Conclusion Cemented bipolar hemiarthroplasty and cementless bipolar hemiarthroplasty performed on elderly patients with unstable intertrochanteric fracture revealed similar mortality and complication rates ; however , the rate of LLD greater than 1 cm was significantly higher in the cemented group compared with the cementless group 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 OUTPUT:

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*** ***EXAMPLES*** 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 PURPOSE Creative expression ( CE ) programs are emerging interventions to improve the quality of care and life of persons with dementia ( PWDs ) in long-term care setting s. However , limited empirical evidence exists to support the effectiveness of these programs . Here , we report the findings from an assessment of the impact of TimeSlips ( TS ) , a group storytelling program that encourages CE among PWDs and those who care for them . DESIGN AND METHODS Instruction in TS was provided through a 10-week on-site training . An observational study using an experimental design was conducted in 20 nursing home facilities in 2 states , 10 of which were r and omly selected to implement TS . Two weeks after the implementation of TS at the intervention sites , we conducted 4 days of direct observation , using a time-sampling approach , of residents and staff in each facility . Using surveys , we also assessed staff job satisfaction , attitudes toward residents , and burnout . RESULTS Compared with residents in the control facilities , those in the TS facilities were more engaged and more alert . In TS facilities , there were more frequent staff-resident interactions , social interactions , and social engagement . Also , staff who participated in the TS program had more positive views of residents with dementia and devalued residents less than did the control group staff . There were no differences in staff job satisfaction and burnout among staff in the TS and non-TS facilities . IMPLICATION S Implementing the TS program in nursing facilities improves the care environment for PWDs . However , additional studies are needed to offer further insights into the mechanisms by which TS improves both staff and resident outcomes OBJECTIVE This study evaluated the impact of an eight-session training program for aged care staff in managing dementia-related challenging behaviours . Participation in the training program with an additional five-session peer support group was compared with both participation in training only and a wait-list control condition . METHODS Outcomes were evaluated for 90 participating staff members and 113 residents with challenging behaviours from six aged care facilities . Measures of staff attitudes and the behaviours of staff and residents were collected pre- and post-intervention , and at six month follow-up . RESULTS Staff members in both dementia training groups reported improved attitudes regarding their knowledge and skills in managing residents with challenging behaviours , immediately after the training and six months later . Facility supervisors rated the nursing performance of trained staff more positively , particularly those who participated in a peer support group . The dementia training programs , whether with or without the inclusion of peer support , did not impact on levels of staff burnout or substantially reduce the level of challenging behaviours among aged care residents . CONCLUSIONS While training programs may impact positively on staff performance , organisational characteristics of aged care facilities , including low levels of management support for staff training initiatives , limit the potential outcomes . Method ological limitations are discussed BACKGROUND Abuse of older adults may occur to a disproportionate extent in institutions . Lack of familiarity with protocol s when managing abuse once it occurs is one of the reasons why it persists . Educational interventions are one of the ways to improve knowledge and management in this area . OBJECTIVE To compare the effectiveness of attending an educational course ( Group 1 ) to printed educational material ( Group 2 ) in improving management of abuse of older people . To determine if positive attitude and low burnout scores are related to improvement . DESIGN R and omized controlled trial . SETTING North London , UK . SUBJECTS Nurses , care assistants and social workers working with older people . METHODS Staff answered question naires pre- and post-intervention . RESULTS The study was completed by 64 ( 81 % ) of staff . Baseline scores on knowledge and management abusive scenarios were low . Those r and omized to Group 1 improved after intervention and Group 2 deteriorated ( Group 1=3.7 [ st and ard deviation=8.1 ] , ANOVA F=23.0 ; P=0.0001 and Group 2=-2.9 [ st and ard deviation=10.0 ] ) . There was a ceiling effect with those who knew more learning less . The significant independent variables in regression analysis to predict learning were being r and omized to Group 1 ( P=0.003 ; odds ratio=6.8 ; 95 % confidence interval=1.9 - 24.5 ) and low baseline knowledge and management score , ( P=0.015 , odds ratio=4.8 , confidence interval=1.4 - 16.9 ) . Most staff had a positive attitude towards people with dementia ; positive attitude score correlated with baseline knowledge , but did not predict learning . CONCLUSION Identifying , documenting and reporting abuse of older people is not carried out consistently . Whilst an educational course goes some way in improving this , it needs to be targeted to take into account the baseline knowledge BACKGROUND This study examines the effectiveness of a nursing home staff training program design ed to improve the interaction between residents with dementia and their caregivers . METHODS A three-arm cluster-r and omized and controlled population of 96 caregivers and 210 residents was used . Caregivers of the intervention group ( IG ) received a three-month training program in dementia care . Data were gathered at baseline , immediately after the training and at a six-month follow-up- assessment . Short- and long-term effects of the training program were assessed in comparison OUTPUT: CONCLUSION Work-directed and combined interventions are able to achieve beneficial longer-term effects on staff burnout . Person-directed interventions achieve short-term results in reducing staff burnout . 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 OUTPUT:

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

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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*** ***EXAMPLES*** INPUT: Objective —To evaluate the responsiveness of the Shoulder Disability Question naire ( SDQ ) . Methods —The study was conducted within the framework of an observational study on shoulder disorders in primary care . After first presentation of their complaints to the general practitioner and after one and six months , participants completed the SDQ , a single question on functional status ( FSQ ) , and an ordinal 11 point scale for the severity of pain ( PSS ) . Responsiveness of the SDQ was evaluated compared with that of the FSQ and PSS , by calculating responsiveness ratios and by plotting receiver operating characteristic ( ROC ) curves . Recovery according to the patient was used as an external criterion for clinical ly relevant improvement ( complete recovery or much improved on a six point Likert scale was denoted as clinical ly relevant improvement ) . Results —A total of 349 consecutive patients with shoulder disorders were enrolled in the observational study . Response rates ranged between 96 % and 89 % . Responsiveness ratios were slightly higher for the PSS compared with the SDQ ( 2.53 versus 2.22 at one month , 2.24 versus 1.89 at six months ) . The area under the ROC curve was 0.84 for both the SDQ and the PSS , and 0.72 for the FSQ . Conclusion —The results of this study confirm the responsiveness of the SDQ , making it a useful instrument to assess functional disability in longitudinal studies OBJECTIVE To compare different assessment s following shoulder surgery for impingement syndrome with or without rotator cuff tear or repair . METHODS A prospect i ve study of 93 patients was conducted . St and ard assessment s were performed before , at 6 months , and at 4 years following shoulder surgery using the patient-based Oxford Shoulder Score ( OSS ) , the Medical Outcomes Study Short Form-36 ( SF-36 ) question naire , and a surgeon-assessed Constant Shoulder Score . Patients were categorized according to the surgery received in relation to the presence of cuff tears : full repair , partial repair , cuff tear/no repair , no tear/no repair . RESULTS Most patients ( 57 % ) received subacromial decompression for impingement with no cuff tear . This group had the fewest pre- and postoperative symptoms . The category of patients who received only partial repair of a cuff tear had worse scores on all outcome assessment s compared with other groups . Patient-based measures were more stable over time than the Constant . CONCLUSION The shoulder-specific measures had greater sensitivity than the SF-36 in registering significant differences in outcomes between comparison groups at 6 months and 4 years Background : In a prospect i ve study , upper limb morbidity and perceived disability/activities of daily life ( ADLs ) were assessed before and 1 year after sentinel lymph node biopsy ( SLNB ) or axillary lymph node dissection ( ALND ) . Methods : A total of 204 patients with stage I/II breast cancer ( mean age , 55.6 years ; SD , 11.6 years ) entered the study , and 189 patients ( 93 % ) could be evaluated after 1 year . Fifty-eight patients ( 31 % ) underwent only SLNB , and 131 ( 69 % ) underwent ALND . Assessment s performed before surgery ( t0 ) and 1 year after surgery ( t1 ) , included pain , shoulder range of motion , muscle strength , upper arm/forearm circumference , and perceived shoulder disability/ADL . Results : Considerable treatment-related upper limb morbidity was observed . Significant ( P < .05 ) changes between t0 and t1 were found in all assessment s except strength of elbow flexors . Patients in the ALND group showed significantly more changes in the range of motion in forward flexion , abduction , and abduction/external rotation ; grip strength and strength of shoulder abductors ; circumference of upper arm and forearm ; and perceived shoulder disability in ADLs compared with the SLNB group . Multivariate linear regression analysis showed that ALND could predict a decrease of range of motion in forward flexion , abduction , strength of shoulder abductors , grip strength , and shoulder-related ADLs and an increase in the circumference of the upper arm . Radiation of the axilla ( 19 patients ) predicts an additional decrease in shoulder range of motion . Conclusions : One year after treatment of breast cancer , there is significantly less upper limb morbidity after SLNB compared with ALND . ALND is a predictor for upper limb morbidity This study assessed pain , neurological symptoms , oedema of the ipsilateral arm , anxiety and depression occurring in women treated surgically for breast cancer , the impact of these symptoms on daily life and how they evolved during the 1 year follow-up . Ninety-three consecutive patients with non-metastasised breast cancer who were treated during 1993 - 94 were examined before surgery and after 1 , 6 and 12 months . They were asked about pain , neurological symptoms and oedema in the breast scar region and /or ipsilateral arm . Sensory testing was performed , and gripping force and the circumference of the arm were measured . Anxiety and depression were evaluated . One year after surgery , 80 % of the women had treatment-related symptoms in the breast scar region and virtually all patients had symptoms in the ipsilateral arm . The incidence of chronic post-treatment pain was higher after conservative surgery than after radical surgery ( breast area : 33 % vs 17 % , NS ; ipsilateral arm : 23 % vs 13 % , NS ) . Numbness occurred in 75 % and oedema of the ipsilateral arm in over 30 % of the patients after both radical and conservative surgery . Phantom sensations in the breast were reported by 25 % of the patients . No difference in psychic morbidity was detected after the two types of surgery . Both the anxiety and depression scores were highest before surgery , decreasing with time , and were significantly correlated with preoperative stressful events A self-administered question na OUTPUT: Based on the current evidence , we recommend administering the DASH to assess patient-reported upper extremity function in breast cancer survivors because the DASH has the most consistently large effects sizes for construct validity and responsiveness . 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 ) per OUTPUT:

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*** ***EXAMPLES*** INPUT: OBJECTIVE To study the relationship between dietary intake and the development of type 2 diabetes among Chinese adults . DESIGN A prospect i ve cohort study . Dietary assessment was carried out using a vali date d FFQ . Principal component analysis was used to identify dietary patterns . Dietary glycaemic load and variety of snacks were also calculated . SETTING A hospital-based centre at the Queen Mary Hospital in Hong Kong SAR , China . SUBJECTS A total of 1010 Chinese adults aged 25 - 74 years who participated in a territory-wide dietary and cardiovascular risk factor prevalence survey in 1995 - 1996 were followed up for 9 - 14 years for the development of diabetes . RESULTS A total of 690 ( 68·3 % ) individuals completed follow-up during 2005 - 2008 and seventy-four cases of diabetes were identified over the follow-up period . Four dietary patterns were identified ( ' more snacks and drinks ' , ' more vegetables , fruits and fish ' , ' more meat and milk products ' and ' more refined grains ' ) . After adjustment for age , sex , BMI , waist-to-hip ratio , smoking , alcohol intake , participation in exercise/sports and family history of diabetes , the more vegetables , fruits and fish pattern was associated with a 14 % lower risk ( OR per 1 sd increase in score = 0·76 ; 95 % CI 0·58 , 0·99 ) , whereas the more meat and milk products pattern was associated with a 39 % greater risk of diabetes ( OR per 1 sd increase in score = 1·39 ; 95 % CI 1·04 , 1·84 ) . Dietary glycaemic load , rice intake , snack intake and variety of snacks were not independently associated with diabetes . CONCLUSIONS The more vegetables , fruits and fish pattern was associated with reduced risk and the more meat and milk products pattern was associated with an increased risk of diabetes Dietary patterns reflecting food habits may be associated with chronic diseases , yet little is known about the stability of these patterns . The objective of this study was to observe over time the stability of dietary patterns measured with exploratory and confirmatory factor analysis . Four r and om sub sample s of 1000 women between 49 and 70 y old were chosen from > 60,000 women included in the Swedish Mammography Cohort . Subjects in these sub sample s were administered a FFQ 4 , 5 , 6 , or 7 y after the baseline question naire ; 3607 of the women responded ( 90 % response rate ) . The stability of dietary patterns was evaluated with Spearman correlation coefficients between pattern scores at baseline and follow-ups and by a test of internal stability , which evaluated the significance of changes within patterns between baseline and follow-up . We found 3 major dietary patterns : a healthy pattern , a Western pattern , and an alcohol pattern . Correlations between explored dietary pattern scores at baseline and at follow-up decreased from 0.59 ( P < 0.01 ) after 4 y to 0.50 ( P < 0.01 ) after 7 y for the healthy pattern , from 0.47 ( P < 0.01 ) to 0.39 ( P < 0.01 ) for the Western pattern and from 0.54 ( P < 0.01 ) to 0.46 ( P < 0.01 ) for the alcohol pattern . After 4 and 5 y , there was no evidence for internal instability in any of the 3 patterns . The Western pattern became internally unstable after 6 and 7 y and the alcohol pattern was unstable after 7 y. Our findings for this specific population suggest that in longitudinal studies , dietary exposures should be up date d after at least 7 BACKGROUND Effects of diet on blood lipids are best known in white men , and effects of type of carbohydrate on triacylglycerol concentrations are not well defined . OBJECTIVE Our goal was to determine the effects of diet on plasma lipids , focusing on subgroups by sex , race , and baseline lipid concentrations . DESIGN This was a r and omized controlled outpatient feeding trial conducted in 4 field centers . The subjects were 436 participants of the Dietary Approaches to Stop Hypertension ( DASH ) Trial [ mean age : 44.6 y ; 60 % African American ; baseline total cholesterol : < or = 6.7 mmol/L ( < or = 260 mg/dL ) ] . The intervention consisted of 8 wk of a control diet , a diet increased in fruit and vegetables , or a diet increased in fruit , vegetables , and low-fat dairy products and reduced in saturated fat , total fat , and cholesterol ( DASH diet ) , during which time subjects remained weight stable . The main outcome measures were fasting total cholesterol , LDL cholesterol , HDL cholesterol , and triacylglycerol . RESULTS Relative to the control diet , the DASH diet result ed in lower total ( -0.35 mmol/L , or -13.7 mg/dL ) , LDL- ( -0.28 mmol/L , or -10.7 mg/dL ) , and HDL- ( -0.09 mmol/L , or -3.7 mg/dL ) cholesterol concentrations ( all P < 0.0001 ) , without significant effects on triacylglycerol . The net reductions in total and LDL cholesterol in men were greater than those in women by 0.27 mmol/L , or 10.3 mg/dL ( P = 0.052 ) , and by 0.29 mmol/L , or 11.2 mg/dL ( P < 0.02 ) , respectively . Changes in lipids did not differ significantly by race or baseline lipid concentrations , except for HDL OUTPUT: Comparison of the effects of different diets revealed that dietary patterns containing fiber-rich foods have a protective role in managing diabetes mellitus . “ Healthy ” , “ Mediterranean ” , “ Prudent ” , and “ DASH ” dietary patterns were associated with lower risk of hyperglycemia . Conclusions : The adherence to the Mediterranean , Prudent , or DASH diets could control hyperglycemia . The higher intake of vegetables , fruits , nuts , whole grains , and lower intake of red meat could reduce the risk of type 2 diabetes mellitus 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 Coll OUTPUT:

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*** ***EXAMPLES*** INPUT: Long-term treatment of chronic bronchitis with chest physiotherapy with or without positive expiratory pressure ( PEP ) by mask was studied in 43 patients r and omly allocated to PEP treatment ( PEP group , 20 patients ) and conventional chest physiotherapy ( control group , 23 patients ) . After instruction , the treatments were self-administered twice daily for 12 months ( 34 patients ) and 5 months ( 9 patients ) . Twice weekly , patients filled in a diary concerning symptoms . The PEP group had significantly less cough and less mucus production . The number of acute exacerbations were calculated from the diaries and were lower in the PEP group compared to the control group , and 85 percent of the patients in the PEP group were free from acute exacerbations versus 48 percent in the control group . The PEP group also used less antibiotics and mucolytics . The PEP group had a small increase in FEV1 of mean 62 ml compared to a small decrease of 43 ml for the control group . Treatment with a simple PEP device can reduce morbidity in patients with chronic bronchitis and may preserve lung function from a more rapid decline BACKGROUND Supplemental oxygen in patients with chronic obstructive pulmonary disease ( COPD ) and exercise hypoxaemia improves exercise capacity and dyspnoea . However , the benefit of oxygen during pulmonary rehabilitation in these patients is still unknown . METHODS Twenty five patients with stable COPD ( mean ( SD ) forced expiratory volume in one second ( FEV1 ) 0.76 ( 0.29 ) l and 30.0 (9.89)% predicted , arterial oxygen tension ( Pao 2 ) 8.46 ( 1.22 ) kPa , arterial carbon dioxide tension ( Paco 2 ) 6.32 ( 1.01 ) kPa ) and significant arterial desaturation on exercise ( 82.0 (10.4)% ) were entered onto a pulmonary rehabilitation programme . Patients were r and omised to train whilst breathing oxygen ( OT ) ( n = 13 ) or air ( AT ) ( n = 12 ) , both at 4 l/min . Assessment s included exercise tolerance and associated dyspnoea using the shuttle walk test ( SWT ) and Borg dyspnoea score , health status , mood state , and performance during daily activities . RESULTS The OT group showed a significant reduction in dyspnoea after rehabilitation compared with the AT group ( Borg mean difference –1.46 ( 95 % CI –2.72 to –0.19 ) ) but there were no differences in other outcome measures : SWT difference –23.6 m ( 95 % CI –70.7 to 23.5 ) , Chronic Respiratory Disease Question naire 3.67 ( 95 % CI –7.70 to 15.1 ) , Hospital Anxiety and Depression Scale 1.73 ( 95 % CI –2.32 to 5.78 ) , and London Chest Activity of Daily Living Scale –2.18 ( 95 % CI –7.15 to 2.79 ) . At baseline oxygen significantly improved SWT ( mean difference 27.3 m ( 95 % CI 14.7 to 39.8 ) and dyspnoea ( –0.68 ( 95 % CI –1.05 to –0.31 ) ) compared with placebo air . CONCLUSIONS This study suggests that supplemental oxygen during training does little to enhance exercise tolerance although there is a small benefit in terms of dyspnoea . Patients with severe disabling dyspnoea may find symptomatic relief with supplemental oxygen Limited information is available regarding the physiological responses to different types of exercise training in patients with severe chronic obstructive pulmonary disease ( COPD ) . The aim of this study was two fold : firstly , to investigate the physiological response to training at 60 % of achieved peak load in patients with severe COPD ; and secondly to study the effects of interval ( I ) versus continuous ( C ) training in these patients . Twenty-one patients with COPD ( mean+/-SD forced expiratory volume in one second : 37+/-15 % of predicted , normoxaemic at rest ) were evaluated at baseline and after 8 weeks ' training . Patients were r and omly allocated to either I or C training . The training was performed on a cycle ergometer , 5 days a week , 30 min daily . The total work load was the same for both training programmes . C training result ed in a significant increase in oxygen consumption ( V'O2 ) ( 17 % , p<0.05 ) and a decrease in minute ventilation (V'E)/V'O2 ( p<0.01 ) and V'E/carbon dioxide production ( V'CO2 ) ( p<0.05 ) at peak exercise capacity , while no changes in these measures were observed after interval training . During submaximal exercise a significant decrease was observed in lactic acid production , being most pronounced in the C-trained group ( -31 % , p<0.01 versus -20 % , p<0.05 ) . Only in the I-trained group did a significant increase in peak work load ( 17 % , p<0.05 ) and a decrease in leg pain ( p<0.05 ) occur . Training did not result in a significant improvement in lung function , but maximal inspiratory mouth pressure increased in both groups by 10 % ( C : p<0.05 ) and 23 % ( I : p<0.01 ) . The present study shows a different physiological response pattern to interval or continuous training in chronic obstruction pulmonary disease , which might be a reflection of specific training effects in either oxidative or glycolytic muscle metabolic pathways . Further work is required to determine the role of the different exercise programmes and the particular category of patients for whom this might be beneficial Pulmonary rehabilitation is beneficial for patients with chronic lung disease . However , long-term maintenance has been difficult OUTPUT: Conclusions : Strong recommendations support the use of physical exercise training to improve health-related quality of life and functional exercise capacity . 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- OUTPUT:

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 .

MS2_dynamic_1_shot292

***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*** ***EXAMPLES*** INPUT: Background Atrial fibrillation ( AF ) is a common problem after CABG . Prevention with prophylactic drug therapy has had limited success , therefore alternative approaches are required . This study investigated the role of biatrial pacing compared with no pacing on AF incidence after isolated first-time CABG . Methods and Results During surgery , temporary pacing leads were placed in the lateral wall of the right atrium and at the roof of the left atrium in Bachmann ’s bundle to allow bipolar pacing and sensing at each site . After surgery , all patients were connected to an external pacemaker ( Chorum ELA ) that also acted as a Holter monitor . Patients were consecutively r and omized to either 4 days of biatrial pacing at a base rate of 80 bpm or to no pacing ( control group , base rate 30 bpm ) . End points included an episode of AF lasting > 1 hour on pacemaker Holter , clinical ly detected AF , intensive care unit ( ICU ) and hospital stay , and postoperative complications . One hundred thirty patients were r and omized . Biatrial pacing significantly reduced both monitored ( 13.8 % versus 38.5 % , P = 0.001 ) and clinical ( 10.8 % versus 33.8 % , P = 0.002 ) episodes of AF . Median ICU ( 19 versus 24 hours , P = NS ) and mean hospital stay ( 7.7±6.9 versus 9.7±10 , P = NS ) did not significantly change . The number of postoperative complications was lower in the biatrial group ( 13 versus 35 , P = 0.001 ) . Conclusions Biatrial pacing after CABG significantly decreases the incidence of AF . This is associated with reduced postoperative complications and a trend toward reduced ICU and hospital stay OBJECTIVES The purpose of this study was to investigate the efficacy and safety of amiodarone and propafenone in the conversion of chronic atrial fibrillation in a prospect i ve , r and omized , placebo-controlled study . BACKGROUND The effectiveness of amiodarone and propafenone in the treatment of patients with chronic atrial fibrillation has not been adequately studied . METHODS One hundred one patients ( 48 men , mean age 64 + /- 9 years ) with atrial fibrillation lasting > 3 weeks participated in the study . Thirty-four patients received amiodarone ( 300 mg intravenously over 1 h , followed by 20 mg/kg over the next 24 h plus 600 mg orally , in three doses , for 1 week , then 400 mg/day orally , for three weeks ) , 32 received propafenone ( 2 mg/kg intravenously over 15 min , followed by 10 mg/kg over 24 h and then 450 mg/day orally , for one month ) and the remaining 35 served as control subjects . All patients received digoxin and anticoagulant treatment as indicated ( International Normalized Ratio 2 to 3 ) . RESULTS Conversion to sinus rhythm was achieved in 16 ( 47.05 % ) patients who received amiodarone , in 13 ( 40.62 % ) who received propafenone and in none of the control subjects ( p < 0.001 for both groups vs. control subjects ) . Those who converted had smaller atria than those who did not and atrial fibrillation of shorter duration in both the amiodarone and propafenone groups . Treatment was discontinued in one patient of the propafenone group because of significant QRS widening . CONCLUSIONS Amiodarone and propafenone appear to be safe and equally effective in the termination of chronic atrial fibrillation . Left atrial diameter and arrhythmia duration are independent predictors of conversion OBJECTIVE The purpose of this study was to determine the efficacy of atrial pacing in the prevention of atrial fibrillation following cardiovascular surgery . BACKGROUND Although pharmacologic therapy has been used to help prevent postoperative atrial fibrillation , it suffers from limited efficacy and adverse effects . In the nonoperative setting , novel pacing strategies have been shown to reduce recurrences of atrial fibrillation and prolong arrhythmia-free periods in patients with paroxysmal atrial arrhythmias . METHODS A total of 154 patients ( 115 men ; mean age , 65 + /- 10 years ; ejection fraction , 53 + /- 10 % ) undergoing cardiac surgery ( coronary artery bypass surgery , 88.3 % ; aortic valve replacement , 4.5 % ; coronary bypass + aortic valve replacement , 7.1 % ) had right and left atrial epicardial pacing electrodes placed at the time of surgery . Patients were r and omized to either no pacing , right atrial ( RAP ) , left atrial ( LAP ) or biatrial pacing ( BAP ) for 72 h after surgery . Beta-adrenergic blocking agents were administered concurrently to all patients following surgery . RESULTS There was a reduction in the incidence of postoperative atrial fibrillation from 37.5 % in patients receiving no postoperative pacing to 17 % ( p < 0.005 ) in patients assigned to one of the three pacing strategies . The length of hospital stay was reduced by 22 % from 7.8 + /- 3.7 days to 6.1 + /- 2.3 days ( p = 0.003 ) in patients assigned to postoperative atrial pacing . The incidence of atrial fibrillation was lower in each of the paced groups ( RAP , 8 % ; LAP , 20 % ; BAP , 26 % ) compared with patients who did not receive postoperative pacing ( 37.5 % ) . CONCLUSION Postoperative atrial pacing , in conjunction with beta-blockade , OUTPUT: No significant effect on all-cause or cardiovascular mortality was demonstrated . Prophylaxis to prevent atrial fibrillation after cardiac surgery with any of the studied pharmacological or non-pharmacological interventions may be favored because of its reduction in the rate of atrial fibrillation , decrease in the length of stay and cost of hospital treatment and a possible decrease in the rate of stroke . 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 rh OUTPUT:

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 )

MS2_dynamic_1_shot293

***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*** ***EXAMPLES*** 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 OUTPUT: A number of patient characteristics , hospital characteristics , physician characteristics , care processes and " other " factors were associated with door to balloon time . Prognostic factors for longer times include : pre-hospital delay in presentation , cerebrovascular disease , absence of chest pain , lower PCI volume and specialization hospital , lower sum ST elevation , absence of Q waves and left bundle branch block . Underst and ing prognostic factors for door to balloon time can likely lead to improved quality of care for STEMI 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 OUTPUT:

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

MS2_dynamic_1_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*** ***EXAMPLES*** 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 RATIONALE Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis . OBJECTIVES To test whether vitamin D supplementation of patients with tuberculosis ( TB ) improved clinical outcome and reduced mortality . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau . We included 365 adult patients with TB starting antituberculosis treatment ; 281 completed the 12-month follow-up . The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment . MEASUREMENTS AND MAIN RESULTS The primary outcome was reduction in a clinical severity score ( TBscore ) for all patients with pulmonary TB . The secondary outcome was 12-month mortality . No serious adverse effects were reported ; mild hypercalcemia was rare and present in both arms . Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo . Overall mortality was 15 % ( 54 of 365 ) at 1 year of follow-up and similar in both arms ( 30 of 187 for vitamin D treated and 24 of 178 for placebo ; relative risk , 1.19 [ 0.58 - 1.95 ] ) . HIV infection was seen in 36 % ( 131 of 359 ) : 21 % ( 76 of 359 ) HIV-1 , 10 % ( 36 of 359 ) HIV-2 , and 5 % ( 19 of 357 ) HIV-1 + 2 . CONCLUSIONS Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB ; it is possible that the dose used was insufficient . Clinical trial registered with www.controlled-trials.com/is rct n ( IS RCT N35212132 ) 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 inter OUTPUT: There were no significant changes in the surrogate outcomes of lipid fractions , glucose , or diastolic or systolic blood pressure . 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 OUTPUT:

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

MS2_dynamic_1_shot295

***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*** ***EXAMPLES*** INPUT: Background —Accelerated neonatal growth increases the later propensity to cardiovascular disease ( CVD ) in animals , whereas slower growth is thought to have a beneficial effect . To test this hypothesis in humans , we measured flow-mediated endothelium-dependent dilation ( FMD ) in a population subject to slower early growth and in healthy controls . Methods and Results —High-resolution vascular ultrasound was used to measure the change in brachial artery diameter in response to reactive hyperemia in adolescents age 13 to 16 years who were either part of a cohort born preterm and followed up prospect ively ( n=216 ) or controls born at term ( n=61 ) . Greater weight gain or linear growth in the first 2 weeks postnatally was associated with lower FMD at adolescence ( regression coefficient , −0.026-mm change in mean arterial diameter per 100-g increase in weight ; 95 % CI , −0.040 to −0.012 mm ; P = 0.0003 ) independent of birthweight and potential confounding factors . Mean FMD in the half of the preterm population with the lowest rates of early growth was higher than in both the half with the greatest growth ( P = 0.001 ) and subjects born at term ( P = 0.03 ) . Conclusions —FMD was 4 % lower in adolescents with the highest compared with the lowest rate of weight gain in the first 2 weeks after birth , a substantial negative effect similar to that for insulin-dependent diabetes mellitus or smoking in adults . Our findings are consistent with the adverse effects of accelerated neonatal growth on long-term cardiovascular health and suggest that postnatal growth patterns could explain the previously reported association between birthweight and later CVD Background Participant drop-out occurs in all longitudinal studies , and if systematic , may lead to selection biases and erroneous conclusions being drawn from a study . Aims We investigated whether drop out in the Avon Longitudinal Study of Parents And Children ( ALSPAC ) was systematic or r and om , and if systematic , whether it had an impact on the prediction of disruptive behaviour disorders . Method Teacher reports of disruptive behaviour among currently participating , previously participating and never participating children aged 8 years in the ALSPAC longitudinal study were collected . Data on family factors were obtained in pregnancy . Simulations were conducted to explain the impact of selective drop-out on the strength of prediction . Results Drop out from the ALSPAC cohort was systematic and children who dropped out were more likely to suffer from disruptive behaviour disorder . Systematic participant drop-out according to the family variables , however , did not alter the association between family factors obtained in pregnancy and disruptive behaviour disorder at 8 years of age . Conclusions Cohort studies are prone to selective drop-out and are likely to underestimate the prevalence of psychiatric disorder . This empirical study and the simulations confirm that the validity of regression models is only marginally affected despite range restrictions after selective drop-out Background —Low birth weight predisposes to later coronary disease . To further eluci date the mechanisms behind this association and their timing , vascular endothelial function — a key factor in early pathophysiology of atherosclerosis — was studied in 54 infants born either before the third trimester or at term . Methods and Results —All subjects were studied at 3 months of postnatal age . A laser-Doppler technique was used to measure skin perfusion before and after transdermal iontophoresis of acetylcholine ( ACh ; an endothelium-dependent vasodilator ) . In infants born at term ( n=19 ; birth weight range : 2230 to 4205 g ) , maximum perfusion after ACh was 109±8 perfusion units ( PU , mean±SEM ) in normal – birth weight controls compared with 56±13 PU among those who had been small for gestational age at birth ( P < 0.01 ) . In infants born preterm ( n=35 ; birth weight range , 722 to 1868 g ) , ACh induced similar perfusion responses among subjects appropriate for gestational age ( 113±16 PU ) and in those small for gestational age at birth ( 109±19 PU ) . Conclusions —Impairment in human endothelial function associated with low birth weight occurs or emerges late in pregnancy . Very preterm birth attenuates this association . Different gene – environment interactions in the third trimester may contribute to this finding Background — Few population studies addressed the prognostic significance of aortic pulse wave velocity ( APWV ) above and beyond other cardiovascular risk factors . Methods and Results — We studied a sex- and age-stratified r and om sample of 1678 Danes aged 40 to 70 years . We used Cox regression to investigate the prognostic value of APWV , office pulse pressure ( PP ) , and 24-hour ambulatory PP while adjusting for mean arterial pressure ( MAP ) and other covariates . Over a median follow-up of 9.4 years , the incidence of fatal and nonfatal cardiovascular end points , cardiovascular mortality , and fatal and nonfatal coronary heart disease amounted to 154 , 62 , and 101 cases , respectively . We adjusted for sex , age , body mass index , MAP measured in the office ( conventional PP and APWV ) or by ambulatory monitoring ( 24-hour PP ) , smoking , and alcohol intake . With these adjustments , APWV maintained its prognostic significance in relation to each end point ( P<0.05 ) , whereas office and 24-hour PP lost their predictive value ( P>0.19 ) , except for office PP in relation to coronary heart disease ( P=0.02 ) . For each 1-SD increment in APWV ( 3.4 m/s ) , the risk of an event increased by 16 % to 20 % . In sensitivity analyses , APWV still predicted all cardiovascular events after st and ar OUTPUT: Systolic blood pressure was higher in subjects born preterm than term , but there were no differences in endothelial dysfunction or arterial stiffness . The systematic review revealed no clear association between prematurity and vascular function 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 OUTPUT:

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

MS2_dynamic_1_shot296

***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*** ***EXAMPLES*** INPUT: 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 BACKGROUND The appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study OUTPUT: The proportion of daily energy provided by carbohydrate intake is not an important determinant of response to dietary management , especially when considering longer term trials . 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-carbo OUTPUT:

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

MS2_dynamic_1_shot297

***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*** ***EXAMPLES*** INPUT: OBJECTIVE The purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA ) combination tablet , relative to ezetimibe ( EZE ) and simvastatin ( SIMVA ) monotherapy , in patients with primary hypercholesterolemia . METHODS This was a r and omized , multicenter , double-blind , placebo-controlled , factorial design study After a 6- to 8-week washout period and 4-week , single-blind , placebo run in , hypercholesterolemic patients ( low-density lipoprotein cholesterol [ LDL-C ] , 145 - 250 mg/dL ; triglycerides [ TG ] , < or = 350 mg/dL ) were r and omized equally to 1 of 10 daily treatments for 12 weeks : EZE/SIMVA 10/10 , 10/20 , 10/40 , or 10/80 mg ; SIMVA 10 , 20 , 40 , or 80 mg ; EZE 10 mg ; or placebo . The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [ CRP ] . RESULTS There were 1528 patients r and omized to treatment ( 792 women , 736 men ) ; mean ( SD ) age ranged from 54.9 ( 112 ) years to 56.4 ( 10.6 ) years across pooled treatment groups . The treatment groups were well balanced for baseline demographics . Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone ( P < 0.001 ) . Depending on dose , EZE/SIMVA was associated with reductions in LDL-C of -44.8 % to -602 % , non-high-density lipoprotein cholesterol of -40.5 % to -55.7 % , and TG of -22.5 % to -30.7 % ; high-density lipoprotein cholesterol increased by 5.5 % to 9.8 % . EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone ( P < 0.001 ) . More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations < 100 mg/dL ( 78.6 % vs 45.9 % ; P < 0.001 ) . EZE/SIMVA was generally well tolerated , with a safety profile similar to SIMVA monotherapy There were no significant differences between EZE/SIMVA and SIMVA in the incidence of consecutive liver transaminase levels > or =3 times the upper limit of normal ( ULN ) ( 1 .5 % for EZE/SIMVA and 1.1 % for SIMVA ; P = NS ) or creature kinase levels > or = 10 times ULN ( 0.0 % for EZE/SIMVA and 02 % for SIMVA ; P = NS ) . CONCLUSION The EZE/SIMVA tablet was a highly effective and well-tolerated LDL-C-lowering therapy in this study of patients with primary hypercholesterolemia Background —Despite the established efficacy of statins , many patients do not achieve recommended LDL cholesterol ( LDL-C ) goals . Contributing factors may be inadequate dosing , increased risk for adverse effects with high-dose monotherapy , and increased potential for intolerance and adverse effects with combinations of available agents . Methods and Results —In a double-blind study , 628 patients with baseline LDL-C 145 to 250 mg/dL and triglycerides ≤350 mg/dL were r and omly assigned to receive 1 of the following for 12 weeks : ezetimibe ( 10 mg/d ) ; atorvastatin ( 10 , 20 , 40 , or 80 mg/d ) ; ezetimibe ( 10 mg ) plus atorvastatin ( 10 , 20 , 40 , or 80 mg/d ) ; or placebo . The primary efficacy end point was percentage reduction in LDL-C for pooled ezetimibe plus atorvastatin versus pooled atorvastatin treatment groups . Ezetimibe plus atorvastatin significantly improved LDL-C , HDL cholesterol ( HDL-C ) , triglycerides , total cholesterol : HDL-C , and high-sensitivity C-reactive protein ( hs-CRP ) compared with atorvastatin alone ( P < 0.01 ) . Coadministration of ezetimibe provided a significant additional 12 % LDL-C reduction , 3 % HDL-C increase , 8 % triglyceride reduction , and 10 % hs-CRP reduction versus atorvastatin alone . Ezetimibe plus atorvastatin provided LDL-C reductions of 50 % to 60 % , triglyceride reductions of 30 % to 40 % , and HDL-C increases of 5 % to 9 % , depending on atorvastatin dose . LDL-C reductions with ezetimibe plus 10 mg atorvastatin ( 50 % ) and 80 mg atorvastatin alone ( 51 % ) were similar . Conclusions —Ezetimibe plus atorvastatin was well tolerated , with a safety profile similar to atorvastatin alone and to placebo . When coadministered with atorvastatin , ezetimibe provided significant incremental reductions in LDL-C and triglycerides and increases in HDL-C. Coadministration of ezetimibe and atorvastatin offers a well OUTPUT: Ezetimibe monotherapy appeared to be well tolerated with a safety profile similar to placebo . In a meta- analysis restricted to short-term trials in hypercholesterolaemia , significant potentially favourable changes in lipid and lipoprotein levels relative to baseline occurred with ezetimibe monotherapy . 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- OUTPUT:

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

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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*** ***EXAMPLES*** INPUT: BACKGROUND Pain control after thoracotomy prevents postsurgical complications and improves respiratory function . The gold st and ard for post-thoracotomy analgesia is the epidural catheter . The aim of this study was to compare it with a new technique that involves placement of a catheter in the paravertebral space at the end of surgery under a surgeon 's direct vision . METHODS From November 2011 to June 2012 , 52 patients were r and omized into 2 groups depending on catheter placement : an epidural catheter for group A and a paravertebral catheter for group B. At 12 , 24 , 48 , and 72 hours after surgery , the following parameters were recorded : ( 1 ) pain control using the patient 's completion of a visual analog scale module , ( 2 ) respiratory function using forced expiratory volume in 1 second and ambient air saturation , and ( 3 ) blood cortisol values as an index of systemic reaction to pain . RESULTS Statistically significant differences ( P < .05 ) were found in favor of group B for both cough and rest pain control ( P = .002 and .002 , respectively ) and respiratory function in terms of forced expiratory volume in 1 second and ambient air saturation levels ( P = .023 and .001 , respectively ) . No statistically significant differences were found in blood cortisol trends between the 2 groups ( P > .05 ) . Collateral effects such as vomiting , nausea , low pressure , or urinary retention were observed only in group A. No collateral effects were recorded in the paravertebral group . CONCLUSIONS According to our data , drugs administered through a paravertebral catheter are very effective . Moreover , it does not present contraindications to its positioning or collateral effects . More studies are necessary to confirm data we collected AIM Epidural analgesia is considered to be the best method of pain relief after major surgery despite its side-effects , which include hypotension , respiratory depression , urinary retention , incomplete or failed block , and , in rare cases , paraplegia . Paravertebral block is an alternative technique that may offer a comparable analgesic effect and a better side-effect profile . This study measured postoperative pain and respiratory function in patients r and omized to receive either paravertebral block or epidural analgesia for pain control after thoracic surgery . METHODS Twenty-four adult patients undergoing thoracic surgery were enrolled in a prospect i ve and r and omized clinical study . Patients were r and omly allocated to receive either postoperative continuous paravertebral analgesia ( N=12 ) or epidural analgesia ( N=12 ) starting at pleura closure . Postoperative use of morphine , visual analogue scores , and spirometer data were collected for 72 hours after surgery as markers of pain relief . RESULTS There was a statistically significant ( P=0.003 ) increase in median ( 25th-75th percentiles ) patient-controlled use of morphine , with values of 36 ( 22 - 42 ) mg in the paravertebral group vs. 9 ( 2 - 22 ) mg in the epidural group . This increase in morphine usage in the paravertebral group was statistically significant at 6 , 24 , 48 , and 72 hours after surgery . Postoperative pain measured with the visual analogue score was not significantly different in the two groups . Spirometer values at 72 h were better in the epidural group than in the paravertebral group ( P=0.03 ) . CONCLUSIONS Epidural analgesia is more efficient than paravertebral continuous block at reducing pain after thoracic surgery DESIGN A prospect i ve , r and omized , open study . The regional technique used was not blinded . SETTING A university teaching hospital . PARTICIPANTS Forty-eight patients undergoing video-assisted thoracoscopic surgery ( VATS ) for tumor resection . INTERVENTIONS Patients received either continuous extrapleural block or continuous epidural block using ropivacaine for a period of 60 hours after surgery . MEASUREMENTS AND MAIN RESULTS To evaluate postoperative pain control , the primary and secondary endpoints were the visual analog scale ( VAS ) on movement and the amount of rescue analgesia , respectively . There were no significant differences between the extrapleural and epidural block groups with regard to VAS at rest and during movement assessed at 4 , 12 , 24 , 36 , and 48 hours after surgery , dosage of intravenous morphine ( extrapleural : 12.9 ± 11.3 , epidural : 10.2 ± 6.9 mg ) , supplemental nonsteroidal anti-inflammatory drugs , incidence of postoperative nausea and vomiting ( extrapleural : 12/20 , epidural : 11/20 ) , postoperative ambulation ( extrapleural : 18 at postoperative day [ POD ] 1 and 20 at POD 2 , epidural : 19 at POD 1 and 20 at POD 2 ) and hospital stay after surgery ( extrapleural : 12.7 ± 6.3 , epidural : 12.6 ± 4.7 days ) . CONCLUSIONS Although this study did not show the superiority of continuous extrapleural block relative to continuous epidural in VATS patients , the results suggest that both methods provided effective analgesia with a relatively small dose of rescue morphine . Although the analgesic effects of these techniques were comparable , extrapleural block has the advantage of safety and precise placement of the catheter and can be considered an alternative to epidural block in VATS patients Background : Relevant discharge information about the use of analgesic medication and other strategies may help patients to manage their pain more effectively and prevent postoperative persistent pain . Aims : To examine patients ’ pain characteristics , analgesic intake and the impact of an educational pain management booklet intervention on post OUTPUT: No statistically significant difference in pain relief was reported . The continuous paravertebral block has equivalent analgesic effects to epidural analgesia , wound infiltration and st and ard care , but is associated with a lower incidence of nausea and vomiting , hypotension and urinary retention than epidural analgesia 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 , OUTPUT:

: 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 ) .

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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*** ***EXAMPLES*** INPUT: OBJECTIVE To evaluate the short-term efficacy and side effects associated with two methylpheni date hydrochloride ( MPH ) dosing patterns . METHODS Twenty-five boys with attention deficit hyperactivity disorder ( ADHD ) participated in a 5-week , triple-blind , placebo-controlled , crossover evaluation of MPH administered twice ( b.i.d . ) versus thrice ( t.i.d . ) per day ( mean dose = 8.8 + /- 5 mg , .30 + /- .1 mg/kg/dose ) . Four dosing conditions ( placebo , titration [ gradual increase to target dose ] , b.i.d . , and t.i.d . ) were used . Dependent measures obtained on a weekly basis included : parent and teacher ratings of child behavior , parent-child conflicts , parent report of stimulant side effects , child self-report of mood symptoms , a sleep log , laboratory measures of attention , and actigraphic recording of sleep activity . RESULTS All dosing conditions result ed in significant effects on ADHD symptoms when compared with baseline . Relative to placebo , t.i.d . dosing was characterized by improvement on the greatest number of behavioral measures , and both b.i.d . and t.i.d . were generally more effective than titration . Direct comparisons of b.i.d . and t.i.d . dosing revealed that t.i.d . was associated with greater improvement on the Conners Parent Rating Scale Impulsivity/Hyperactivity factor , with a similar marginally significant effect for the ADD-H Teacher Rating Scale Hyperactivity factor . The analysis of clinical ly significant change favored a three-times-a-day dosing schedule over placebo on both parent and teacher ratings of impulsivity/hyperactivity and attention . Compared with placebo , appetite suppression was rated , on average , as more severe in the t.i.d . and titration conditions , but not in the b.i.d . condition . However , the number of subjects who exhibited any or severe appetite suppression did not differ significantly between the b.i.d . and t.i.d . schedules . Although there was no difference in sleep duration for children on b.i.d . and t.i.d . schedules , total sleep time appeared to decrease slightly on t.i.d . relative to placebo according to both parent ratings and actigraphic assessment . There were no significant differences between b.i.d . and t.i.d . on any other side effects or sleep variables . CONCLUSIONS For many children with ADHD , t.i.d . dosing may be optimal . There are few differences in acute side effects between b.i.d . and t.i.d . MPH dosing . The dosing schedule should be selected according to the severity and time course of ADHD symptoms rather than in anticipation of dosing schedule-related side effects Background This study examined augmenting atomoxetine with extended-release methylpheni date in children whose attention-deficit/hyperactivity disorder ( ADHD ) previously failed to respond adequately to stimulant medication . Methods Children with ADHD and prior stimulant treatment ( N = 25 ) received atomoxetine ( 1.2 mg/kg/day ) plus placebo . After 4 weeks , patients who were responders ( n = 4 ) were continued on atomoxetine/placebo while remaining patients were r and omly assigned to either methylpheni date ( ATX/MPH ) ( 1.1 mg/kg/day ) or placebo augmentation ( ATX/PB ) for another 6 weeks . Patients and sites were blind to timing of active augmentation . Safety measures included vital signs , weight , and adverse events . Efficacy was assessed by ADHD rating scales . Results Categorical increases in vital signs occurred for 5 patients ( 3 patients in ATX/MPH , 2 patients in ATX/PBO ) . Sixteen percent discontinued the study due to AE , but no difference between augmentation groups . Atomoxetine treatment was efficacious on outcome measures ( P ≤ .001 ) , but methylpheni date did not enhance response . Conclusion Methylpheni date appears to be safely combined with atomoxetine , but conclusions limited by small sample . With atomoxetine treatment , 43 % of patients achieved normalization on ADHD ratings Abstract Hypotheses concerning unexpected , psychostimulant-related effects reported in previous studies were examined by separating behavioral/physical complaints highly specific to methylpheni date ( MPH ) from those that ( a ) may mimic core/ secondary symptoms of the disorder , or ( b ) are commonly reported by unmedicated children in the general population . Sixty-five children with attention-deficit/hyperactivity disorder ( ADHD ) participated in a double-blind , placebo-controlled , within-subject ( crossover ) experimental design and received a placebo and four MPH doses in counterbalanced order following baseline assessment . Behavioral and physical complaints were significantly higher under baseline relative to placebo and the four immediate-release MPH conditions ( 5 mg , 10 mg , 15 mg , and 20 mg ) across three symptom categories : ADHD core/ secondary symptoms ; symptoms commonly reported in the general population , including unmedicated children with ADHD ; and symptoms highly specific to MPH . No significant differences were found among active drug conditions . Past unexpected findings of psychostimulant effects in ADHD may be due to the inclusion of scale items that reflect core/ secondary features of ADHD and normally occurring behavioral/physical complaints in children OBJECTIVE To evaluate the efficacy and safety of osmotic-release methylpheni date ( OROS-MPH ) compared with placebo for attention-deficit/hyperactivity disorder ( ADHD ) , and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy ( CBT ) for substance use disorders ( SUD ) . METHOD This was a 16-week , r and omized , controlled , multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents ( aged 13 through OUTPUT: Methylpheni date increases the risks of decreased appetite , weight loss , and abdominal pain in children and adolescents with attention deficit hyperactivity disorder . No differences in the risks of gastrointestinal adverse events according to type , dose , or duration of administration were found 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 . CONCLUS OUTPUT:

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 .