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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: ABSTRACT A healthy intestinal microbiota is considered to be important for priming of the infants ' mucosal and systemic immunity . Breast-fed infants typically have an intestinal microbiota dominated by different Bifidobacterium species . It has been described that allergic infants have different levels of specific Bifidobacterium species than healthy infants . For the accurate quantification of Bifidobacterium adolescentis , Bifidobacterium angulatum , Bifidobacterium bifidum , Bifidobacterium breve , Bifidobacterium catenulatum , Bifidobacterium dentium , Bifidobacterium infantis , and Bifidobacterium longum in fecal sample s , duplex 5′ nuclease assays were developed . The assays , targeting rRNA gene intergenic spacer regions , were vali date d and compared with conventional PCR and fluorescent in situ hybridization methods . The 5′ nuclease assays were subsequently used to determine the relative amounts of different Bifidobacterium species in fecal sample s from infants receiving a st and ard formula or a st and ard formula supplemented with galacto- and fructo-oligosaccharides ( OSF ) . A breast-fed group was studied in parallel as a reference . The results showed a significant increase in the total amount of fecal bifidobacteria ( 54.8 % ± 9.8 % to 73.4 % ± 4.0 % ) in infants receiving the prebiotic formula ( OSF ) , with a diversity of Bifidobacterium species similar to breast-fed infants . The intestinal microbiota of infants who received a st and ard formula seems to resemble a more adult-like distribution of bifidobacteria and contains relatively more B. catenulatum and B. adolescentis ( 2.71 % ± 1.92 % and 8.11 % ± 4.12 % , respectively , versus 0.15 % ± 0.11 % and 1.38 % ± 0.98 % for the OSF group ) . In conclusion , the specific prebiotic infant formula used induces a fecal microbiota that closely resembles the microbiota of breast-fed infants also at the level of the different Bifidobacterium species Preterm infants have an impaired gut barrier function . We aim ed to determine the effects of enteral supplementation of a prebiotic mixture consisting of neutral oligosaccharides ( short-chain galacto-oligosaccharides (SCGOS)/long-chain fructo-oligosaccharides ( LCFOS ) ) and acidic oligosaccharides ( AOS ) on intestinal permeability of preterm infants as measured by the sugar absorption test in the first week of life . Furthermore , we determined host- and treatment-related factors associated with intestinal permeability . In a r and omised controlled trial , preterm infants with a gestational age < 32 weeks and /or birth weight ( BW ) < 1500 g received enteral supplementation of SCGOS/LCFOS/AOS or placebo ( maltodextrin ) between days 3 and 30 of life . Intestinal permeability , reflected by the urinary lactulose/mannitol ( L/M ) ratio after oral ingestion of lactulose and mannitol , was assessed at three time points : before the start of the study ( t = 0 ) , at day 4 ( t = 1 ) and at day 7 ( t = 2 ) of life . Data were analysed by generalised estimating equations . In total , 113 infants were included . Baseline patient and nutritional characteristics were not different between the SCGOS/LCFOS/AOS ( n 55 ) and the placebo groups ( n 58 ) . SCGOS/LCFOS/AOS had no effect on the L/M ratio between t = 0 and t = 2 . In both the groups , the L/M ratio decreased from t = 0 to t = 2 ( P < 0·001 ) . Low BW increased the L/M ratio ( P = 0·002 ) . Exclusive breast milk feeding and mixed breast milk/formula feeding during the first week of life decreased the L/M ratio ( P < 0·001 and P < 0·05 , respectively ) . In conclusion , enteral supplementation of a prebiotic mixture does not enhance the postnatal decrease in intestinal permeability in preterm infants in the first week of life BACKGROUND Galactooligosaccharides ( GOS ) and long-chain fructooligosaccharides ( lcFOS ) proliferate bifidobacteria in infant gut microbiota . However , it is not known how GOS and FOS influence the microbiota of pregnant women and whether a potential prebiotic effect is transferred to the offspring . OBJECTIVES We aim ed to test how supplementation with GOS and lcFOS ( GOS/lcFOS ) in the last trimester of pregnancy affects maternal and neonatal gut microbiota . Variables of fetal immunity were assessed as a secondary outcome . DESIGN In a r and omized , double-blind , placebo-controlled pilot study , 48 pregnant women were supplemented 3 times/d with 3 g GOS/lcFOS ( at a ratio of 9:1 ) or maltodextrin ( placebo ) from week 25 of gestation until delivery . Percentages of bifidobacteria and lactobacilli within total bacterial counts were detected by fluorescent in situ hybridization and quantitative polymerase chain reaction in maternal and neonatal ( days 5 , 20 , and approximately 182 ) stool sample s. Variables of fetal immunity were assessed in cord blood by using flow cytometry and cytokine multiplex-array analysis . RESULTS The proportions of bifidobacteria in the maternal gut were significantly higher in the supplemented group than in the placebo group ( 21.0 % and 12.4 % , respectively ; P = 0.026 ) ; the proportion of lactobacilli did not differ between the groups . In neonates , bifidobacteria and lactobacilli percentages , diversity and similarity indexes , and fetal immune parameters did not differ significantly between the 2 groups . Mother-neonate similarity indexes of bifidobacteria decreased over time . CONCLUSIONS GOS/lcFOS supplementation has a bifidogenic effect on maternal gut microbiota that is not transferred to neonates . The increased maternal bifidobacteria did not affect fetal immunity as measured by a comprehensive examination of cord blood immunity variables BACKGROUND Nondigestible carbohydrates ( NDCHs ) are fermented in the colon , where they can selectively promote the growth of bifidobacteria . OBJECTIVE Our aim was to determine the bifidogenic potential of different NDCHs used in human diets . DESIGN Two hundred healthy volunteers participated in this double-blind study . During phase 1 ( screening ) , 64 volunteers were r and omly assigned to 8 groups of 8 subjects each ; for 7 d , they ingested 10 g/d of 1 of the 7 NDCHs tested or of the placebo . During phase 2 ( dose-response study ) , 136 volunteers were r and omly assigned to 4 groups of 32 subjects who received 2.5 , 5.0 , 7.5 , or 10 g/d , respectively ( 8 subjects/dose ) , of one of the NDCHs that were proven to be bifidogenic during phase 1 and a fifth group of 8 subjects ( control subjects ) who received the placebo . Stools were recovered before and after NDCH consumption . RESULTS In phase 1 , 4 NDCHs were found to be bifidogenic : short-chain fructooligosaccharides ( P=0.008 ) , soybean oligosaccharides ( P=0.006 ) , galactooligosaccharides ( P < 0.0001 ) , and type III resistant starch ( P=0.02 ) ; lactulose , long-chain inulin , and isomaltooligosaccharides were not bifidogenic . In phase 2 , the effects of 7-d treatment on bifidobacteria concentrations were found to differ significantly among the 4 NDCHs ( P=0.009 for time x treatment interaction ) . However , no significant differences were found among doses , and there was no significant dose x time interaction . A low baseline bifidobacteria count was significantly associated with the bifidogenic response to treatment ( P < 0.001 ) . CONCLUSION This study showed the different bifidogenic properties among the substrates and underlined the importance of taking into account the baseline bifidobacteria counts when evaluating the effect of the treatment BACKGROUND Serious infectious morbidity is high in preterm infants . Enteral supplementation of prebiotics may reduce the incidence of serious infections , especially infections related to the gastrointestinal tract . OBJECTIVE The objective was to determine the effect of enteral supplementation of a prebiotic mixture consisting of neutral oligosaccharides ( (SC)GOS/(LC)FOS ) and acidic oligosaccharides ( AOS ) on serious infectious morbidity in preterm infants . DESIGN In a r and omized controlled trial , preterm infants ( gestational age < 32 wk and /or birth weight < 1500 g ) received enteral supplementation of 80 % (SC)GOS/(LC)FOS and 20 % AOS ( 1.5 g . kg(-1 ) . d(-1 ) ) or placebo ( maltodextrin ) between days 3 and 30 of life . Serious infectious morbidity was defined as a culture positive for sepsis , meningitis , pyelonephritis , or pneumonia . The analysis was performed by intention-to-treat and per- protocol , defined as > or = 50 % supplementation dose during the study period . RESULTS In total , 113 preterm infants were included . Baseline and nutritional characteristics were not different between groups . In the intention-to-treat analysis , the incidence of > or = 1 serious infection , > or = 1 serious endogenous infection , or > or = 2 serious infectious episodes was not significantly different in the (SC)GOS/(LC)FOS/AOS-supplemented and placebo groups . In the per- protocol analysis , there was a trend toward a lower incidence of > or = 1 serious endogenous infection and > or = 2 serious infectious episodes in the (SC)GOS/(LC)FOS/AOS-supplemented group than in the placebo group ( P = 0.09 and P = 0.07 , respectively ) . CONCLUSIONS Enteral supplementation of (SC)GOS/(LC)FOS/AOS does not significantly reduce the risk of serious infectious morbidity in preterm infants . However , there was a trend toward a lower incidence of serious infectious morbidity , especially for infections with endogenous bacteria . This finding suggests a possible beneficial effect that should be evaluated in a larger study . This trial was registered at is rct n.org as IS RCT N16211826 BACKGROUND Gut hormones play an important role in the adaptation of the immature neonatal gut , and their secretion may be modulated by prebiotics . Furthermore , prebiotics are well known for their hypolipidemic potentials . We tested the hypothesis that prebiotics could alter motilin and gastrin secretion and reduce lipids in healthy preterms . METHODS A total of 167 newborns were r and omized to either a prebiotics enriched formula containing dietary oligosaccharides ( short-chain galacto-oligo-saccharides/long-chain fructo-oligo-saccharides [ scGOS/lcFOS ] ) , at a concentration of 0.8 g/100 ml , or a common preterm formula . Day 1 and 16 basal motilin , gastrin concentrations , and lipids were evaluated together with growth parameters , gastric residue , bowel habits , and feeding tolerance . Adverse events including necrotizing enterocolitis ( NEC ) and septicemia were also recorded . RESULTS Mean motilin increase and day 16 mean values were greater for the intervention , compared with the control group ( P = .001 , P = .005 , respectively ) , while gastrin remained high in both groups . Mean cholesterol and low density lipoprotein ( LDL ) increase were significantly greater in the control , compared with the intervention ( P = .037 , and P = .001 ) group . Day 16 LDL levels were significantly higher in the control group . Mean weight was increased in the control group , while gastric residue was less and stool frequency was increased in the intervention group . NEC and septicemia were not statistically different between groups . CONCLUSION A prebiotics enriched formula result ed in significant surge of motilin relating to reduced gastric residue , compared with a common preterm formula . Mean cholesterol change was lower , while LDL was not increased in the prebiotics group , compared with the control group Background Human milk oligosaccharides have been shown to stimulate selectively the growth of Bifidobacteria and Lactobacilli in the intestine . In this study , the bifidogenic effect of an experimental prebiotic oligosaccharide mixture consisting of low-molecular-weight galactooligosaccharides and high-molecular-weight fructooligosaccharides was analyzed in 90 term infants . Methods Two test formulas were supplemented with either 0.4 g/dL or with 0.8 g/dL oligosaccharides . In the control formula , maltodextrin was used as placebo . At study day 1 and study day 28 , the fecal species , colony forming units ( cfu ) and p OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Current evidence from systematic review and meta- analysis revealed that probiotics are the most promising intervention in reduction of the incidence of NEC in VLBW neonates . As per the evidence , prebiotics modulate the composition of human intestine microflora to the benefit of the host by suppression of colonization of harmful microorganism and /or the stimulation of bifidobacterial growth , decreased stool viscosity , reduced gastrointestinal transit time , and better feed tolerance .

MS2_fixed_5_shot1

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The effects of the soluble fiber konjac glucomannan ( GM ) on serum cholesterol concentrations were investigated in 63 healthy men in a double-blind crossover , placebo-controlled study . After a 2-wk baseline period , the subjects were given 3.9 g GM or placebo daily for 4 wk . After a washout period of 2 wk , crossover took place , followed by another 4 wk of treatment . The subjects were encouraged not to change their ordinary diets or general lifestyle during the investigation . GM fibers reduced total cholesterol ( TC ) concentrations by 10 % ( P < 0.0001 ) , low-density-lipoprotein cholesterol ( LDL-C ) concentrations by 7.2 % ( P < 0.007 ) , triglycerides by 23 % ( P < 0.03 ) , and systolic blood pressure by 2.5 % ( P < 0.02 ) . High-density-lipoprotein cholesterol ( HDL-C ) and the ratio of LDL-C to HDL-C did not change significantly . No change in diastolic blood pressure or body weight was observed . No adverse effects were observed . The results of this study show that GM is an effective cholesterol-lowering dietary adjunct BACKGROUND Fiber supplements added to a caloric diet have additional effects on weight reduction in overweight subjects . The aim of this study was to compare the effect of various commercial fiber supplements ( glucomannan , guar gum and alginate ) on weight reduction in healthy overweight subjects . MATERIAL / METHODS One hundred and seventy six men and women were included to receive either active fiber substance or placebo in r and omized placebo-controlled studies . The fiber supplements consisted of the viscous fibers glucomannan ( Chrombalance ) , glucomannan and guar gum ( Appe-Trim ) and glucomannan , guar gum and alginat ( Glucosahl ) . RESULTS All fiber supplements plus a balanced 1200 kcal diet induced significantly weight reduction more than placebo and diet alone , during a five week observation period . However , there were no significant differences between the different fibers in their ability to induce weight reduction , which was approximately 0.8 kg/week ( 3.8 + /- 0.9 , 4.4 + /- 2.0 , 4.1 + /- 0.6 in the Chrombalance , Appe-Trim and Glucosahl group , respectively ) . CONCLUSIONS Glucomannan induced body weight reduction in healthy overweight subjects , whereas the addition of guar gum and alginate did not seem to cause additional loss of weight Dietary fibres are frequently used for the treatment of paediatric obesity . The aim of this clinical trial is to evaluate the efficacy of glucomannan in the child obesity management . This experimental design was double blinded with a block r and omisation , alpha = 0.05 , beta = 0.2 and delta = 50 % . The study involved 60 children under 15 years of age ( mean age 11.2 years , mean overweight 46 % ) , 30 of them under glucomannan treatment ( 1 g twice a day for two months ) and 30 under placebo and the same schedule . The drug and the placebo were indistinguishable both for the family and the physician . During the two months study period the children followed a normocaloric diet evaluated every two weeks by a dietetic record book . At the beginning of the study the drug and the placebo groups were comparable in regards to anthropometric data . At the end , the mean overweight of the drug group was decreased from 49.5 % to 41 % and that of the placebo group from 43.9 % to 41.7 % . Both decreases were significant ( p < 0.01 ) , but no significant difference was observed between the drug and the placebo groups . The only significant difference concerned the lipid metabolism . The children under glucomannan treatment manifested a significant decrease of alpha-lipoprotein and an increase of pre-beta-lipoprotein and triglycerides ; the children under placebo manifested only a decrease of triglycerides and apo beta-lipoprotein . We suggest that this metabolic alteration may derive from a primary decrease of alpha-lipoprotein , most likely because of an inadequate water intake . ( ABSTRACT TRUNCATED AT 250 WORDS Carbohydrate-restricted diets ( CRDs ) promote weight loss , reductions in plasma triacylglycerol ( TAG ) levels , and increases in high-density lipoprotein cholesterol ( HDL-C ) levels but may cause undesirable low-density lipoprotein cholesterol ( LDL-C ) responses in some people . The objective of the present study was to determine the effect of adding soluble fiber to a CRD on plasma LDL-C and other traditionally measured markers of cardiovascular disease . Using a parallel-arm , double-blind , placebo-controlled design , 30 overweight and obese men ( body mass index , 25 - 35 kg/m(2 ) ) were r and omly assigned to supplement a CRD with soluble fiber ( Konjac-mannan , 3g/d ) ( n = 15 ) or placebo ( n = 15 ) . Plasma lipids , anthropometrics , body composition , blood pressure , and nutrient intake were evaluated at baseline and at 6 and 12 weeks . Compliance was excellent as assessed by 7-day weighed dietary records and ketonuria . Both groups experienced decreases in ( P < .01 ) body weight , percent body fat , systolic blood pressure , waist circumference , and plasma glucose levels . After 12 weeks , HDL-C and TAG improved significantly in the fiber ( 10 % and -34 % ) and placebo ( 14 % , -43 % ) groups . LDL-C decreased by 17.6 % ( P < .01 ) at week 6 and 14.1 % ( P < .01 ) at week 12 in the fiber group . Conversely , LDL-C reductions were significant in the placebo group only after 12 weeks ( -6.0 % , P < .05 ) . We conclude that although clearly effective at lowering LDL-C , adding soluble fiber to a CRD during active and significant weight loss provides no additional benefits to the diet alone . Furthermore , a CRD led to clinical ly important positive alterations in cardiovascular disease risk factors AIM This paper evaluates the effect of the adjunct of the hydrosoluble fiber glucomannan to a Step-One-Diet in 40 plasma hypercholesterolemic children , during a r and omized controlled trial , to reduce plasma cholesterol . METHODS All the subjects recruited underwent an 8-week run in diet period ; a Step-One-Diet was prescribed . After that , they were r and omly allocated to one of two groups : Step-One-Diet only ( control ) , and Step-One-Diet plus glucomannan in gelatine capsules . After another 8 weeks of treatment , the results were compared within and between the two groups . RESULTS Glucomannan treated group showed decreased values in plasma total cholesterol ( TC ) and low density lipoprotein cholesterol ( LDL-C ) vs. control group after 8 weeks of treatment . The percentage decrease showed a statistically significant difference between sex groups . Decreases were observed in favor of female vs. male children in TC ( 24 % vs. 9 % ) and LDL-C ( 30 % vs. 9 % ) . CONCLUSIONS These results suggest that glucomannan may represent a rationale adjunct to diet therapy in primary prevention in high risk hypercholesterolemic children To evaluate the effectiveness of highly purified glucomannan in childhood obesity a study has been carried out in 23 obese children ( 12 boys and 11 girls , aged 5.2 - 15.8 years ) , with excess weight of 51 + /- 16 % , treated with 2 - 3 caps twice a day of glucomannan fibres ( DICOMAN 5:2 - 3 gr/die ) , and in 30 obese children ( aged 5 - 18 years ) with excess weight of 51 + /- 10 % , studied as controls . After a three-days food recall , a balanced diet with adequate caloric intake was provided to all obese children . In all patients before and 2 - 4 months after the auxological data ( weight , height , weight excess ) and laboratory data ( serum levels of cholesterol , HDL , triglycerides , glucose , fructosamine , glycosylated hemoglobin , RBC , WBC , hemoglobin , iron , calcium , Cu and Zn ) have been determined . Excess weight and triglycerides levels were significantly decreased in treated obese patients than in obese controls 4 months after the beginning of the study . A decrease of cholesterol levels was also observed in treated obese patients , but not in controls , whereas serum iron , calcium , copper and zinc persisted unchanged . No important side-effects were observed in treated patients . On the basis of our results highly purified glucomannan fibres may be employed with effectiveness in obese and dyslipidemic children together with diet Objective : The purpose of this study was to determine whether supplements of plant sterols and /or glucomannan improve lipid profile and cholesterol bio synthesis in mildly hypercholesterolemic type II diabetic and non-diabetic subjects and to compare the response of these two subject groups to the treatments . Design : A r and omized , crossover study consisting of four phases of 21 days , with each phase separated by a 28-day washout . Setting : The Mary Emily Clinical Nutrition Research Unit of McGill University . Subjects : Eighteen non-diabetic individuals and 16 type II diabetic individuals aged 38–74 years . Interventions : Subjects were supplemented with plant sterols ( 1.8 g/day ) , glucomannan ( 10 g/day ) , a combination of glucomannan and plant sterols , and a placebo , provided in the form of bars . Results : Overall plasma cholesterol concentrations were lowered ( P<0.05 ) after combination treatment ( 4.72±0.20 mmol/l ) compared to control ( 5.47±0.18 mmol/l ) . Plasma low-density lipoprotein ( LDL ) cholesterol concentrations were decreased ( P<0.05 ) after glucomannan ( 3.16±0.14 mmol/l ) and combination treatments ( 2.95±0.16 mmol/l ) compared to control ( 3.60±0.16 mmol/l ) . The results of lipid profiles did not differ between subject groups . Overall plasma lathosterol concentrations , an index of cholesterol bio synthesis , were lowered ( P<0.05 ) after the combination treatment compared to the plant sterol treatment . Conclusions : The results suggest that glucomannan and a combination of glucomannan and plant sterols substantially improves plasma LDL cholesterol concentrations . Sponsorship : Forbes Medi-Tech Inc. , Vancouver , British Columbia , Canada Objectives : The present study was design ed to evaluate effects of konjac glucomannan ( KGM ) supplement ( 3.6 g/day ) for 28 days on blood lipid and glucose levels in hyperlipidemic type 2 diabetic patients and the possible mechanism for the reductions in blood lipid levels . Methods : Twenty-two diabetic subjects ( age 64.2 + 8.4 years , BMI 25.5 + 3.2 kg/m2 ) with elevated blood cholesterol levels ( fasting glucose between 6.7–14.4 mmol/L ) , but currently not taking lipid-lowering medication , were recruited to participate in a two 28-day period , r and omized , double-blind , crossover clinical trial . Fasting blood sample s drawn on the initial and final days of each period were determined for plasma lipids and glucose levels . Feces collected at the end of each experimental period were analyzed for neutral sterol and bile acid contents . Results : Compared with placebo , KGM effectively reduced plasma cholesterol ( 11.1 % , p = 0.0001 , adjusted α = 0.006 ) , LDL-cholesterol ( 20.7 % , p = 0.0004 , adjusted α = 0.006 ) , total/HDL cholesterol ratio ( 15.6 % , p = 0.0005 , adjusted α = 0.007 ) , ApoB ( 12.9 % , p = 0.0001 , adjusted α = 0.006 ) and fasting glucose ( 23.2 % , p = 0.002 , adjusted α = 0.008 ) . Plasma triglyceride , HDL-cholesterol , LDL/HDL cholesterol , postpr and ial glucose and body weight were not significant after adjustment by the Bonferroni-Hochberg procedure . Fecal neutral sterol and bile acid concentrations were increased by 18.0 % ( p = 0.004 ) and 75.4 % ( p < 0.001 ) , respectively , with KGM supplement . Conclusions : The KGM supplement improved blood lipid levels by enhancing fecal excretion of neutral sterol and bile acid and alleviated the elevated glucose levels in diabetic subjects . KGM could be an adjunct for the treatment of hyperlipidemic diabetic subjects An eight-week double-blind trial was conducted to test purified glucomannan fiber as a food supp OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The use of glucomannan did not appear to significantly alter any other study endpoints . Pediatric patients , patients receiving dietary modification , and patients with impaired glucose metabolism did not benefit from glucomannan to the same degree . Glucomannan appears to beneficially affect total cholesterol , LDL cholesterol , triglycerides , body weight , and FBG , but not HDL cholesterol or BP

MS2_fixed_5_shot2

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: The aims of this study were 1 ) to evaluate whether subjects suffering from acute mountain sickness ( AMS ) during exposure to high altitude have signs of autonomic dysfunction and 2 ) to verify whether autonomic variables at low altitude may identify subjects who are prone to develop AMS . Forty-one mountaineers were studied at 4,559-m altitude . AMS was diagnosed using the Lake Louise score , and autonomic cardiovascular function was explored using spectral analysis of R-R interval and blood pressure ( BP ) variability on 10-min resting recordings . Seventeen subjects ( 41 % ) had AMS . Subjects with AMS were older than those without AMS ( P < 0.01 ) . At high altitude , the low-frequency ( LF ) component of systolic BP variability ( LF(SBP ) ) was higher ( P = 0.02 ) and the LF component of R-R variability in normalized units ( LF(RR)NU ) was lower ( P = 0.001 ) in subjects with AMS . After 3 mo , 21 subjects ( 43 % with AMS ) repeated the evaluation at low altitude at rest and in response to a hypoxic gas mixture . LF(RR)NU was similar in the two groups at baseline and during hypoxia at low altitude but increased only in subjects without AMS at high altitude ( P < 0.001 ) and did not change between low and high altitude in subjects with AMS . Conversely , LF(SBP ) increased significantly during short-term hypoxia only in subjects with AMS , who also had higher resting BP ( P < 0.05 ) than those without AMS . Autonomic cardiovascular dysfunction accompanies AMS . Marked LF(SBP ) response to short-term hypoxia identifies AMS-prone subjects , supporting the potential role of an exaggerated individual chemoreflex vasoconstrictive response to hypoxia in the genesis of AMS OBJECTIVE : Although a history of previous acute mountain sickness ( AMS ) is commonly used for providing advice and recommending its prophylaxis during subsequent exposure , the intraindividual reproducibility of AMS during repeated high-altitude exposure has never been examined in a prospect i ve controlled study . METHODS : In 27 nonacclimatized children and 29 adults , AMS was assessed during the first 48 hours after rapid ascent to 3450 m on 2 consecutive occasions 9 to 12 months apart . RESULTS : During the first exposure , 18 adults ( 62 % ) and 6 children ( 22 % ) suffered from AMS ; during the second exposure , 14 adults ( 48 % ) and 4 children ( 15 % ) suffered from this problem ( adults versus children , P ≤ .01 ) . Most importantly , the intraindividual reproducibility of AMS was very different ( P < .001 ) between children and adults . None of the 6 children having suffered from AMS during the first exposure suffered from AMS during the second exposure , but 4 children with no AMS during the first exposure did experience this problem during the second exposure . In contrast , 14 of the 18 adults who suffered from AMS on the first occasion also presented with this problem during the second exposure , and no new case developed in those who had not experienced AMS on the first occasion . CONCLUSIONS : In adults , a history of AMS is highly predictable of the disease on subsequent exposure , whereas in children it has no predictive value . A history of AMS should not prompt practitioners to advise against reexposure to high altitude or to prescribe drugs for its prophylaxis in children Study Objective : Despite causing significant morbidity throughout the mountainous regions of the world , the pathophysiology of acute mountain sickness ( AMS ) remains poorly understood . This study aims to improve the underst and ing of altitude illness by determining if vascular endothelial growth factor ( VEGF ) plays a role in the development of AMS . The purpose of this study was to determine if elevated plasma VEGF correlates with increased symptoms of AMS at high altitude . Patients and Methods : This is a prospect i ve study of a cohort of healthy climbers on Denali ( Mount McKinley ) in Alaska at 14 , 200 feet . Baseline demographics , medications , rates of ascent , and AMS scores were recorded . Pulse oximetry measurements and venous blood sample s were obtained . Comparisons were made between mountaineers with and without AMS . Results : Seventy-two climbers were approached for participation in the study ; 21 ( 29 % ) refused . Of the 51 climbers participating in the study , 14 subjects ( 27.5 % ) had symptoms of AMS and 37 subjects ( 72.5 % ) were free of symptoms of AMS . Plasma VEGF levels were 79.14 pg/dl ( SD : 121.44 ) and 57.57pg/dl ( SD : 102.71 ) in the AMS and non-AMS groups , respectively . These results were nonsignificant . Similarly , comparison of sex , age , rate of ascent , pulse oximetry values , or history of altitude illness did not reveal significant differences between the AMS and non-AMS groups . Conclusion : This study does not provide evidence in support of the theory that plasma VEGF correlates with symptoms of AMS Forty-seven climbers participated in a double-blind , r and omized trial comparing acetazolamide 250 mg , dexamethasone 4 mg , and placebo every eight hours as prophylaxis for acute mountain sickness during rapid , active ascent of Mount Rainier ( elevation 4,392 m ) . Forty-two subjects ( 89.4 percent ) achieved the summit in an average of 34.5 hours after leaving sea level . At the summit or high point attained above base camp , the group taking dexamethasone reported less headache , tiredness , dizziness , nausea , clumsiness , and a greater sense of feeling refreshed ( p less than or equal to 0.05 ) . In addition , they reported fewer problems of runny nose and feeling cold , symptoms unrelated to acute mountain sickness . The acetazolamide group differed significantly ( p less than or equal to 0.05 ) from other groups at low elevations ( 1,300 to 1,600 m ) , in that they experienced more feelings of nausea and tiredness , and they were less refreshed . These drug side effects probably obscured the previously established prophylactic effects of acetazolamide for acute mountain sickness . Separate analysis of an acetazolamide subgroup that did not experience side effects at low elevations revealed a prophylactic effect of acetazolamide similar in magnitude to the dexamethasone effect but lacking the euphoric effects of dexamethasone . This study demonstrates that prophylaxis with dexamethasone can reduce the symptoms associated with acute mountain sickness during active ascent and that acetazolamide can cause side effects that may limit its effectiveness as prophylaxis against the disease OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

Ensuring that the characteristics of the history and future ascents are similar may improve the clinical utility of AMS history

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: Abstract . This study documented postoperative morbidity during the first 4 months following anterior cruciate ligament ( ACL ) reconstruction using either patellar tendon or hamstring tendon autograft . Sixty-five patients undergoing primary arthroscopically assisted single-incision ACL reconstruction were r and omized to have a central third bone patellar tendon bone autograft ( PT ) or a doubled semitendinosus/doubled gracilis autograft ( HS ) . Postoperatively patients undertook a st and ard ' accelerated ' rehabilitation protocol . Patients were review ed after 2 weeks , 8 weeks , and 4 months . At each review the location and severity of general knee pain and the presence and severity of anterior knee pain ( AKP ) were recorded as were the presence and size of an effusion as well as the active and passive flexion and passive extension deficits compared to the contralateral limb . Pain on kneeling , KT-1000 measured side to side difference in anterior tibial displacement , isokinetic assessment of quadriceps and hamstring peak torque deficits , IKDC score and Cincinnati sports activity level were also recorded after 4 months . After 2 weeks more patients in the PT group complained of AKP and reported that the pain was more severe . After 8 weeks there was no significant difference between the groups for any variable . After 4 months the severity of general pain experienced and the incidence of pain on kneeling were greater in the PT group . The PT group also demonstrated a significantly greater quadriceps peak torque deficit at 240 ° /s . IKDC scores were higher in the HS group , but Cincinnati sports activity scores were higher in the PT group . Although we observed a lower morbidity in the HS group , primarily related to pain , the severity of pain in both groups was relatively low and , in light of the higher mean sports activity level observed in the PT group at 4 months the clinical impact of the difference may not be significant BACKGROUND There are no controlled , prospect i ve studies comparing the 10-year outcomes of anterior cruciate ligament ( ACL ) reconstruction using patellar tendon ( PT ) and 4-str and hamstring tendon ( HT ) autografts . HYPOTHESIS Comparable results are possible with HT and PT autografts . STUDY DESIGN Cohort study ; Level of evidence , 2 . METHODS One hundred eighty ACL-deficient knees that met inclusion criteria underwent ACL reconstruction ( 90 HT autograft , 90 PT autograft ) by one surgeon and were treated with an accelerated rehabilitation program . All knees were observed in a prospect i ve fashion with subjective , objective , and radiographic evaluation at 2 , 5 , 7 , and 10-year intervals . RESULTS At 10 years , there were no differences in graft rupture rates ( 7/90 PT vs. 12/90 HT , P = .24 ) . There were 20 contralateral ACL ruptures in the PT group , compared with 9 in the HT group ( P = .02 ) . In all patients , graft rupture was associated with instrumented laxity > 2 mm at 2 years ( P = .001 ) . Normal or near-normal function of the knee was reported in 97 % of patients in both groups . In the PT group , harvest-site symptoms ( P = .001 ) and kneeling pain ( P = .01 ) were more common than in the HT group . More patients reported pain with strenuous activities in PT knees than in HT knees ( P = .05 ) . Radiographic osteoarthritis was more common in PT knees than the HT-reconstructed knees ( P = .04 ) . The difference , however , was composed of patients with mild osteoarthritis . Other predictors of radiographic osteoarthritis were < 90 % single-legged hop test at 1 year and the need for further knee surgery . An " ideal " outcome , defined as an overall International Knee Documentation Committee grade of A or B and a radiographic grade of A at 10 years after ACL reconstruction , was associated with <3 mm of instrumented laxity at 2 years , the absence of additional surgery in the knee , and HT grafts . CONCLUSIONS It is possible to obtain excellent results with both HT and PT autografts . We recommend HT reconstructions to our patients because of decreased harvest-site symptoms and radiographic osteoarthritis Two commercially available knee ligament arthrometers ( KT-1000 MEDmetric Corporation , San Diego , California and Kneelax MR Systems , Haarlem , The Netherl and s ) were used to measure anterior tibial translation . In this study 91 subjects with no history of knee pathology were tested using both devices . Both normal knees were tested and comparison of recorded anterior translation ( millimeters ) was performed . Absolute numbers at forces of 67N , 89N , 134N , and manual maximum displacements were recorded . Side-to-side differences were calculated and data were compared . There was a significant difference found between the absolute values of each device . The KT-1000 was found to record greater values in millimeters of translation . Although the absolute values were significantly different , the side-to-side differences were not significantly different between devices Background : Numerous studies have compared patellar tendon ( PT ) and hamstring tendon ( HS ) anterior cruciate ligament ( ACL ) reconstructions in the short to midterm , but fewer long-term results have been published . Hypothesis : There will be no difference in functional outcome between ACL reconstruction performed with PT and HS grafts , but PT grafts will have more donor site morbidity . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : Sixty-five patients undergoing ACL reconstruction were r and omized to receive either a PT graft or a 4-str and HS graft . Early results were reported at 4 , 8 , 12 , 24 , and 36 months . Forty-seven patients ( 22 of 31 PT and 25 of 34 HS ) were review ed at a mean of 15.3 years . Results : Four graft ruptures ( 1 PT , 3 HS ) and 6 contralateral ACL injuries ( 4 PT , 2 HS ) occurred in the group that was review ed . There was no statistically significant difference between the groups for any of the variables measured . There was a similar incidence of anterior knee pain and kneeling pain in both groups . The previously observed increased extension deficit in the PT group at 3 years was not present at 15 years , and there was no significant between-group difference in knee laxity . A higher proportion of patients in the PT group were participating in sport on a weekly basis ( 73 % PT , 48 % HS ; P = .05 ) . There was no difference in the degree of osteoarthritis between the groups . Conclusion : This r and omized controlled trial showed that HS and PT ACL reconstructions have comparable results at an average 15-year follow-up . Contrary to the study hypothesis , some of the graft differences seen at earlier review were not present at 15 years , and patients with PT grafts were more active in sport participation . Overall , both graft types provided good long-term subjective and objective outcomes Background : Short-term and mid-term differences between hamstring and patellar tendon autografts for anterior cruciate ligament ( ACL ) reconstruction are well documented . Systematic review s highlight the lack of long-term results between the two grafts . Hypothesis : Seventeen years after ACL reconstruction , no difference will be found in functional outcome , quality of life , and graft failure between patients with patellar tendon ( PT ) or semitendinosus and gracilis tendon ( STG ) autografts ; however , a significant difference will be seen in the prevalence of osteoarthritis . Study Design : R and omized controlled trial ; Level of evidence , 2 . Methods : Sixty-four patients were included in this prospect i ve study ( 32 in each group ) . A single surgeon performed primary ACL reconstruction in alternating sequence . Forty-eight patients ( 24 in each group ) were evaluated 17 years after ACL reconstruction : A clinical assessment was made based on the International Knee Documentation Committee ( IKDC ) form , instrumented laxity was measured with KT-1000 arthrometer , and radiography of the operated knee was conducted and assessed for degenerative disease . The Lysholm question naire and the Short Form–36 version 2 question naire were filled out by the patients . Results : At the 17-year follow-up , no statistically significant differences were seen with respect to graft failure ( 2 reruptures in the semitendinosus and gracilis tendon [ STG ] group [ 6.3 % ] and 3 reruptures in the PT group [ 9.4 % ] ) and functional outcome . Increased instrumented laxity ( > 3 mm ) measured with KT-1000 arthrometer was seen in significantly more patients in the STG group ( 8 in the STG group compared with 2 in the PT group ; P = .03 ) with a mean side-to-side difference of 2.17 ± 1.86 mm in the STG group compared with 1.33 ± 1.93 mm in the PT group . A significant difference was found in frequency of knee osteoarthritis (OA)—100 % in the PT group compared with 71 % in the STG group ( P = .004 ) . Patients in the PT group tended to have higher grade OA according to the IKDC grading system , with an average grade of 1.46 in the PT group compared with 1 in the STG group ( P = .055 ) . The degenerative changes in the PT group were more common in the medial and patellofemoral compartments ( P = .003 and P = .04 , respectively ) . Conclusion : Both autografts provided good to excellent subjective outcomes . No significant differences were noted in graft failure and clinical instability . However , significantly more patients in the STG group had increased instrumented anteroposterior translation measured with KT-1000 arthrometer , and there was a greater prevalence of knee OA at 17 years after surgery in the PT group Background Functional outcome question naires have become a common part of patient follow-up in the orthopaedic community . The modified Cincinnati Knee Rating System and the International Knee Documentation Committee ( IKDC ) subjective scale were design ed to provide clinicians with information regarding a patient ’s functional and clinical status after knee surgery . Hypothesis The functional outcome data reported on the modified Cincinnati Knee Rating System and the IKDC subjective question naire are equivalent . Study Design Cohort study ( diagnosis ) ; Level of evidence , 2 . Methods Between 2000 and 2007 , all patients with complex knee disorders seen in our orthopaedic clinic were prospect ively followed and given simultaneously the modified Cincinnati Knee Rating System and the IKDC subjective question naires to report their functional outcomes . The total scores of each instrument were compared at each time of evaluation . As a measure of responsiveness , the st and ardized response means were calculated . A second within-patient analysis was also performed to determine if the results would be different when looked at by the patient . Results There were a total of 130 patients with a total of 444 modified Cincinnati Knee Rating System question naires and 462 IKDC subjective complete question naires included in the study . Overall total scores on both the modified Cincinnati Knee Rating System and the IKDC subjective question naires were equivalent in a population analysis . Overall total scores showed improvement in function over time from preoperative measurement through the 2-year follow-up . The individual patient analysis demonstrated that , for a specific patient , it was possible that up to 34 % of the population would report a total score of more than 10 points difference , depending on the scale selected . Conclusion The modified Cincinnati Knee Rating System and the IKDC subjective rating question naires reported by patient population provide similar results . The practitioner who is not performing a population -based study but following individual patients for recovery will find that the individual question naires may offer different functional limitations . Individual differences were lost in the population means , with the approximate balance of positive and negative score differences masking the individual patient differences PURPOSE To evaluate the subjective outcomes , knee stability , and donor-site morbidity after revision ACL reconstruction using either autologous ipsilateral quadriceps tendon or contralateral semitendinosus-gracilis tendon . METHODS A sample size calculation suggested that we needed 25 patients in each group to detect e quality between both groups . Therefore , we evaluated 30 consecutive patients who underwent an ACL revision surgery with ipsilateral bone-quadriceps tendon grafts and 30 consecutive patients with the contralateral semitendinosus-gracilis grafts between January 2010 and December 2012 . Because of follow-up and exclusion criteria , finally 51 patients were evaluated . All patients were followed prospect ively for at least 2 years with KT1000 arthrometer testing and the International Knee Documentation Committee ( IKDC ) objective grading . At the 24-month follow-up , additional clinical scores were evaluated : the Knee Injury Osteoarthritis Outcome Score ( KOOS ) , the Lysholm score , assessing pain during kneeling , and anterior knee pain . RESULTS The KT1000 postoperative arthrometer side-to-side difference was 2.0 ± 1.2 mm for the quadriceps group and 3.0 ± 2.9 mm for the semitendinosus-gracilis group . The difference was not statistically significant ( P = .461 ) . There was also no difference in the rate of positive pivot-shift tests between groups ( P = .661 ) . The Lysholm score was 82.5 ± 18 in the quadriceps group and 73.8 OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The QT autograft detected comparable rate of Lachman test > 3 mm , Pivot shift test > 3 m and instrumental laxity > 3 mm . The QT autograft showed a lower rate of autograft failure above all . The QT autograft detected the reduced rate of AKP than the PT . Quadriceps tendon autograft may represent a feasible option for primary ACL reconstruction .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: OBJECTIVES To investigate the effects of darifenacin controlled-release ( CR ) and oxybutynin extended-release ( ER ) on cognitive function ( particularly memory ) in older subjects . METHODS Healthy subjects ( n=150 ) > /=60 years were r and omised to darifenacin , oxybutynin ER or placebo in a multicentre , double-blind , double-dummy , parallel-group , 3-week study . Doses were administered according to US labels : oxybutynin ER 10 mg once daily ( od ) , increasing to 15 mg od then 20 mg od by week 3 ; darifenacin 7.5 mg od in weeks 1 and 2 , then 15 mg od in week 3 . The primary end point was accuracy on the Name-Face Association Test ( delayed recall ) at week 3 . RESULTS Results of the Name-Face Association Test at week 3 showed no significant difference between darifenacin and placebo on delayed recall ( mean difference , -0.06 , p=0.908 ) . In contrast , oxybutynin ER result ed in memory impairment , with significantly lower scores than placebo and darifenacin ( mean differences , -1.30 , p=0.011 and -1.24 , p=0.022 , respectively ) for delayed recall on the Name-Face Association Test at week 3 . Additional tests of delayed recall indicated significant memory impairment with oxybutynin ER versus placebo at certain time points , whereas darifenacin was similar to placebo . No between-treatment differences were detected in self-rated memory , demonstrating that subjects were unaware of memory deterioration . CONCLUSIONS While darifenacin had no significant effects on memory versus placebo , oxybutynin ER caused significant memory deterioration ( magnitude of effect comparable to brain aging of 10 years ) . The results also demonstrate that subjects may not recognise/report memory deterioration INTRODUCTION Anti-cholinergic medications have been associated with increased risks of cognitive impairment , premature mortality and increased risk of hospitalisation . Anti-cholinergic load associated with medication increases as death approaches in those with advanced cancer , yet little is known about associated adverse outcomes in this setting . METHODS A sub study of 112 participants in a r and omised control trial who had cancer and an Australia modified Karnofsky Performance Scale ( AKPS ) score ( AKPS ) of 60 or above , explored survival and health service utilisation ; with anti-cholinergic load calculated using the Clinician Rated Anti-cholinergic Scale ( modified version ) longitudinally to death . A st and ardised starting point for prospect ively calculating survival was an AKPS of 60 or above . RESULTS Baseline entry to the sub- study was a mean 62 + /- 81 days ( median 37 , range 1 - 588 ) days before death ( survival ) , with mean of 4.8 ( median 3 , SD 4.18 , range 1 - 24 ) study assessment s in this time period . Participants spent 22 % of time as an inpatient . There was no significant association between anti-cholinergic score and time spent as an inpatient ( adjusted for survival time ) ( p = 0.94 ) ; or survival time . DISCUSSION No association between anti-cholinergic load and survival or time spent as an inpatient was seen . Future studies need to include cognitively impaired population s where the risks of symptomatic deterioration may be more substantial BACKGROUND Observational studies report a relationship between anticholinergic drug scale ( ADS ) score and cognitive function . This study investigated whether a reduced ADS score improved cognitive function in a frail elderly population . METHODS This r and omized , controlled , single-blinded trial , recruited long-term residents with an ADS score of greater than or equal to 3 from 22 nursing homes in Norway . The participants were r and omly allocated ( 1:1 ) to intervention or control . The intervention was a pharmacist-initiated reduction of ADS score after multidisciplinary drug review s. Primary end point was Consortium to Establish a Registry for Alzheimer 's Disease 10-wordlist test for immediate recall . Secondary end points were Mini-Mental Sate Examination , delayed recall and recognition of words , saliva flow , and serum anticholinergic activity (SAA).The participants were retested after 4 and 8 weeks , and the study groups were compared after adjusting for baseline differences . RESULTS Eighty-seven patients were included . The median ADS score was reduced by 2 units ( p < .0001 ) in the intervention group and remained unchanged in the control group . After 8 weeks , the adjusted mean difference in immediate recall was 0.54 words between the intervention and control group ( 95 % confidence interval [ CI ] : -0.91 , 2.05 ; p = .48 ) . The study groups did not differ significantly in any of the other cognitive end points , salvia flow , or SAA at either follow-up ( p > .18 ) . CONCLUSION Pharmacist-initiated drug changes significantly reduced ADS score but did not improve cognitive function in nursing home residents . Moreover , the drug changes did not reduce SAA or mouth dryness significantly , which might indicate limited applicability of the ADS score to prevent prescription risks in this population PURPOSE Overactive bladder is common in the elderly population , which is susceptible to cognitive disorders and drug induced cognitive impairment . Existing overactive bladder treatments may cause adverse events , such as cognitive impairment , due to antagonism of the M1 receptor in the central nervous system . In this study we evaluated the effect of darifenacin , an M3 selective antagonist , on cognitive function in elderly volunteers without clinical dementia . MATERIAL S AND METHODS This double-blind , 3-period crossover study r and omized 129 volunteers 65 years or older with no/mild cognitive impairment to receive 3 of 5 treatments , namely darifenacin controlled release ( 3.75 , 7.5 or 15 mg once daily ) , darifenacin immediate-release ( 5 mg 3 times daily ) or matching placebo for 14 days . Each treatment period was separated by 7 days of washout . Cognitive function tests were completed at baseline and at treatment end . RESULTS For the primary end points of memory scanning sensitivity , speed of choice reaction time and word recognition sensitivity , there were no statistically significant differences for darifenacin vs placebo . There were no statistically significant differences in secondary variables except memory scanning speed , which increased in all groups relative to baseline , but improvement was greater with placebo than with 3.75 mg darifenacin . Darifenacin treatment was not associated with changes in alertness , contentment or calmness , which are likely to be clinical ly relevant . Darifenacin was well tolerated . CONCLUSIONS : In elderly volunteers 2 weeks of treatment with darifenacin had no effect on cognitive function compared with baseline and it was not significantly different from placebo . This may be related to its M3 receptor selectivity with negligible M1 receptor antagonism Abstract Objective To assess the potential of anticholinergic drugs as a cause of non-degenerative mild cognitive impairment in elderly people . Design Longitudinal cohort study . Setting 63 r and omly selected general practice s in the Montpellier region of southern France . Participants 372 people aged > 60 years without dementia at recruitment . Main outcome measures Anticholinergic burden from drug use , cognitive examination , and neurological assessment . Results 9.2 % of subjects continuously used anticholinergic drugs during the year before cognitive assessment . Compared with non-users , they had poorer performance on reaction time , attention , delayed non-verbal memory , narrative recall , visuospatial construction , and language tasks but not on tasks of reasoning , immediate and delayed recall of wordlists , and implicit memory . Eighty per cent of the continuous users were classified as having mild cognitive impairment compared with 35 % of non-users , and anticholinergic drug use was a strong predictor of mild cognitive impairment ( odds ratio 5.12 , P = 0.001 ) . No difference was found between users and non-users in risk of developing dementia at follow-up after eight years . Conclusions Elderly people taking anticholinergic drugs had significant deficits in cognitive functioning and were highly likely to be classified as mildly cognitively impaired , although not at increased risk for dementia . Doctors should assess current use of anticholinergic drugs in elderly people with mild cognitive impairment before considering administration of acetylcholinesterase inhibitors OBJECTIVES To examine the longitudinal relationship between cumulative exposure to anticholinergic medications and memory and executive function in older men . DESIGN Prospect i ve cohort study . SETTING A Department of Veterans Affairs primary care clinic . PARTICIPANTS Five hundred forty-four community-dwelling men aged 65 and older with diagnosed hypertension . MEASUREMENTS The outcomes were measured using the Hopkins Verbal Recall Test ( HVRT ) for short-term memory and the instrumental activity of daily living ( IADL ) scale for executive function at baseline and during follow-up . Anticholinergic medication use was ascertained using participants ' primary care visit records and quantified as total anticholinergic burden using a clinician-rated anticholinergic score . RESULTS Cumulative exposure to anticholinergic medications over the preceding 12 months was associated with poorer performance on the HVRT and IADLs . On average , a 1-unit increase in the total anticholinergic burden per 3 months was associated with a 0.32-point ( 95 % confidence interval (CI)= 0.05 - 0.58 ) and 0.10-point ( 95 % CI=0.04 - 0.17 ) decrease in the HVRT and IADLs , respectively , independent of other potential risk factors for cognitive impairment , including age , education , cognitive and physical function , comorbidities , and severity of hypertension . The association was attenuated but remained statistically significant with memory ( 0.29 , 95 % CI=0.01 - 0.56 ) and executive function ( 0.08 , 95 % CI=0.02 - 0.15 ) after further adjustment for concomitant non-anticholinergic medications . CONCLUSION Cumulative anticholinergic exposure across multiple medications over 1 year may negatively affect verbal memory and executive function in older men . Prescription of drugs with anticholinergic effects in older persons deserves continued attention to avoid deleterious adverse effects The pathogenesis of delirium in acute stroke is incompletely understood . The use of medications with anticholinergic ( ACH ) activity is associated with an increased frequency of delirium . We hypothesized that the intake of medications with ACH activity is associated with delirium in acute stroke patients . Delirium was assessed using the DSM‐IV‐TR criteria and the Delirium Rating Scale , in a sample of consecutive patients with an acute ( ≤4 days ) cerebral infa rct or intracerebral haemorrhage ( ICH ) . We performed a gender and age matched case – control study . Twenty‐two delirious stroke patients ( cases ) and 52 non‐delirious patients ( controls ) were compared concerning the intake of ACH medications ( i ) before stroke , ( ii ) during hospitalization but before the assessment . The variables associated with delirium on bivariate analysis were entered in a stepwise logistic regression analysis . The final regression model ( Nagelkerke R2 = 0.65 ) retained non‐neuroleptics ACH medication during hospitalization ( OR = 24.4 ; 95 % CI = 2.18–250 ) , medical complications ( OR = 20.8 ; 95 % CI = 3.46–125 ) , ACH medication taken before stroke ( OR = 17.5 ; 95 % CI = 1.00–333.3 ) and ICH ( OR = 16.9 ; 95 % CI = 2.73–100 ) as independent predictors of delirium . This preliminary result indicates that drugs with subtle ACH activity play a role in the pathogeneses of delirium in acute stroke . Medication with ACH activity should be avoided in acute stroke patients BACKGROUND The use of drugs with anticholinergic adverse effects is often deemed inappropriate in elderly ( aged > or = 65 years ) patients , yet studies continue to show extensive use in this population at high risk for adverse drug events ( ADEs ) . The burden of drug-related anticholinergic symptoms in community-dwelling elderly patients has not been well described . OBJECTIVE The aim of this study was to assess the prevalence of anticholinergic symptoms , corresponding symptom burden , and anticholinergic-related ADEs in a sample of community-dwelling elderly veterans . METHODS This prospect i ve cohort study was conducted at the primary care clinics at the Veterans Affairs Medical Center ( VAMC ) , Iowa City , Iowa . The study sample included r and omly selected patients with intact cognitive function attending the VAMC and prescribed > or = 5 scheduled medications . Data on current prescription and nonprescription drug use were elicited by a trained research assistant and a clinical pharmacist from patient interviews and electronic medical records . The prevalence and severity of 7 anticholinergic symptoms ( dry mouth , constipation , blurred vision , confusion , urinary hesitation , dry eyes , and drowsiness ) were assessed at baseline . The occurrence of ADEs at 12 weeks was compared between patients using anticholinergic drugs and those not using them . RESULTS OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

medicines with anti-cholinergic properties have a significant adverse effect on cognitive and physical function , but limited evidence exists for delirium or mortality outcomes

MS2_fixed_5_shot5

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: We have recently demonstrated that glucocorticoid ( GC ) suppresses bone formation and enhances bone resorption , with result ant bone loss . This altered bone turnover is not due to the action of parathyroid hormone ( PTH ) , but appears to be related to the suppression of osteoprotegerin ( OPG ) . As vitamin K2 ( menatetrenone ) has been used for the treatment of osteoporosis , the present study was carried out to evaluate the effect of vitamin K2 on GC-induced bone loss . Twenty patients with chronic glomerulonephritis treated with GC for the first time were chosen for this study . Ten patients received GC alone ( group A ) and the other 10 patients each received 15 mg of vitamin K2 per day in addition to GC ( group B ) . Markers of bone metabolism , including serum OPG , osteocalcin ( OC ) , bone-specific alkaline phosphatase activity ( BAP ) , PTH , tartrate-resistant acid phosphatase ( TRAP ) , and bone mineral density ( BMD ) , were measured before and during the treatment . OPG was significantly decreased in group A ( P < 0.001 ) , while no significant change was seen in group B. TRAP was markedly increased in both groups , more particularly in group A ( P < 0.01 ) . PTH was decreased in group A , but was increased in group B. OC was decreased at month 1 but subsequently increased until month 12 in both groups . BAP had decreased at month 3 in group A ( P < 0.05 ) , but not in group B. BMD of the lumbar spine was significantly reduced after 6 months ( P < 0.01 ) , and 12 months ( P < 0.001 ) of treatment in group A , whereas there was no remarkable change in group B. The present study demonstrated that the inhibition exerted by vitamin K2 of the reduction in OPG induced by GC may , at least in part , play a role in the prevention and treatment of GC-induced bone loss BACKGROUND Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption . In a phase 2 clinical trial , strontium ranelate , an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption , has been shown to reduce the risk of vertebral fractures and to increase bone mineral density . METHODS To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial , we r and omly assigned 1649 postmenopausal women with osteoporosis ( low bone mineral density ) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years . We gave calcium and vitamin D supplements to both groups before and during the study . Vertebral radiographs were obtained annually , and measurements of bone mineral density were performed every six months . RESULTS New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group , with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period ( relative risk , 0.59 ; 95 percent confidence interval , 0.48 to 0.73 ) . Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck ( P<0.001 for both comparisons ) . There were no significant differences between the groups in the incidence of serious adverse events . CONCLUSIONS Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures It has been previously shown that the level of circulating undercarboxylated osteocalcin ( ucOC ) is elevated in elderly women in comparison with young , healthy , premenopausal ones . To underst and the mechanism of the increase in the ucOC in the elderly and to assess its potential consequences on bone fragility , we have measured ucOC in the sera of 195 elderly institutionalized women 70 - 101 yr of age . In 45 women ( 23 % ) serum ucOC was above the upper limit of the normal range for young women . The level of ucOC was negatively correlated with 25OHD ( r = -0.32 , P < 0.001 ) even after excluding the effect of age , parathyroid hormone ( PTH ) , and creatinine by partial correlation ( r = -0.24 , P < 0.002 ) . During an 18-mo follow-up , 15 women sustained a hip fracture and their baseline ucOC level was higher ( P < 0.01 ) in women who subsequently sustained hip fracture than in the nonfracture group contrasting with no significant differences for serum calcium , phosphate , alkaline phosphatase , creatinine , PTH , 250HD , and total and carboxylated OC . The risk of hip fracture was increased in women with elevated ucOC ( relative ratio 5.9 , 99.9 % Cl 1.5 - 22.7 , P < 0.001 ) . During 1 yr of calcium/vitamin D2 treatment , ucOC decreased ( P < 0.05 ) , especially in those with the initially increased values ( from 2.22 + /- 0.35 to 1.41 + /- 0.29 ng/ml , P < 0.005 ) contrasting with an increase in the placebo group ( P < 0.05 ) . In conclusion , the increase in ucOC in the elderly reflects not only some degree of vitamin K deficiency but also their poor vitamin D status , suggesting that vitamin D may be important , either directly or indirectly through its effect on bone turnover , for achieving a normal gamma-carboxylation of OC . The ucOC , but not conventional calcium metabolism parameters , predicts the subsequent risk of hip fracture , suggesting that serum ucOC reflects some changes in bone matrix associated with increased fragility BACKGROUND Vitamin K mediates the gamma-carboxylation of glutamyl residues on several bone proteins , notably osteocalcin . High serum concentrations of undercarboxylated osteocalcin and low serum concentrations of vitamin K are associated with lower bone mineral density and increased risk of hip fracture . However , data are limited on the effects of dietary vitamin K. OBJECTIVE We investigated the hypothesis that high intakes of vitamin K are associated with a lower risk of hip fracture in women . DESIGN We conducted a prospect i ve analysis within the Nurses ' Health Study cohort . Diet was assessed in 72327 women aged 38 - 63 y with a food-frequency question naire in 1984 ( baseline ) . During the subsequent 10 y of follow-up , 270 hip fractures result ing from low or moderate trauma were reported . RESULTS Women in quintiles 2 - 5 of vitamin K intake had a significantly lower age-adjusted relative risk ( RR : 0.70 ; 95 % CI : 0.53 , 0.93 ) of hip fracture than women in the lowest quintile ( < 109 microg/d ) . Risk did not decrease between quintiles 2 and 5 and risk estimates were not altered when other risk factors for osteoporosis , including calcium and vitamin D intakes , were added to the models . Risk of hip fracture was also inversely associated with lettuce consumption ( RR : 0.55 ; 95 % CI : 0.40 , 0.78 ) for one or more servings per day compared with one or fewer servings per week ) , the food that contributed the most to dietary vitamin K intakes . CONCLUSIONS Low intakes of vitamin K may increase the risk of hip fracture in women . The data support the suggestion for a re assessment of the vitamin K requirements that are based on bone health and blood coagulation BACKGROUND Vitamin K has been suggested to have a role in bone metabolism , and low vitamin K intake has been related to low bone density and increased risk of osteoporotic fracture . OBJECTIVE The objective of this study was to determine whether phylloquinone ( vitamin K(1 ) ) intake and biochemical indicators of vitamin K status are related to bone mineral content ( BMC ) and markers of bone formation and bone resorption in girls . DESIGN Vitamin K status [ plasma phylloquinone concentration and percentage of undercarboxylated osteocalcin ( % ucOC ) ] was measured at baseline in a study of 245 healthy girls aged 3 - 16 y. Cross-linked N-telopeptide of type 1 collagen ( NTx ) breakdown , osteocalcin , and bone-specific alkaline phosphatase were measured to reflect bone resorption and formation . BMC of the total body , lumbar spine , and hip and dietary phylloquinone intake were measured annually for 4 y. RESULTS Phylloquinone intake ( median : 45 microg/d ) was not consistently associated with bone turnover markers or BMC . Better vitamin K status ( high plasma phylloquinone and low % ucOC ) was associated with lower bone resorption and formation . Plasma phylloquinone was inversely associated with NTx and osteocalcin concentrations ( P < 0.05 ) , and % ucOC was positively associated with NTx and bone-specific alkaline phosphatase concentrations ( P < 0.05 ) . Indicators of vitamin K status were not consistently associated with current BMC or gain in BMC over the 4-y study period . CONCLUSIONS Better vitamin K status was associated with decreased bone turnover in healthy girls consuming a typical US diet . R and omized phylloquinone supplementation trials are needed to further underst and the potential benefits of phylloquinone on bone acquisition in growing children Background : Low bone mass leading to stress fractures is a well-known and yet unsolved problem among female athletes . Purpose : To quantify the rate of bone loss in healthy female athletes and investigate the effects of estrogen and vitamin K supplementation on bone loss . Study Design : Prospect i ve cohort study . Methods : We classified 115 female endurance athletes into amenorrheic , eumenorrheic , or estrogen-supplemented groups and r and omized them to receive either placebo or vitamin K1 . The bone mineral densities of the subjects ' femoral neck and lumbar spine were measured at baseline and after 2 years . Results : Bone mineral density in the lumbar spine remained constant , but bone density in the femoral neck had decreased significantly after 2 years in all three subgroups . The decrease was higher in amenorrheic ( —6.5 % ± 4.0 % ) than in eumenorrheic ( —3.2 % ± 4.1 % ) and estrogen-supplemented athletes ( —3.9 % ± 3.1 % ) . Supplementation with vitamin K did not affect the rate of bone loss . Conclusions : The rate of bone loss in all three subgroups of female athletes was unexpectedly high ; neither estrogen nor vitamin K supplementation prevented bone loss . Clinical Relevance : High-intensity training maintained over several years must be regarded in women as a risk factor for osteoporosis , and protocol s for optimal treatment should be developed The effect of maternal phylloquinone supplementation on vitamin K in breast milk was studied to establish : ( 1 ) if phylloquinone is the source of menaquinone-4 in breast milk ; ( 2 ) the dose-effect relationship between intake and obtainable levels . Four groups of lactating mothers with a full-term healthy infant participated and took oral phylloquinone supplements of 0.0 ( n 8) , 0.8 ( n 8) , 2.0 ( n 8) , and 4.0 ( n 7 ) mg/d for 12d , starting at day 4 post-partum . Milk sample s were collected on days 4 , 8 , 16 , and 19 . Blood sample s were collected on days 4 and 16 . Vitamin K and vitamin E concentrations , the latter for reason of comparison , were assayed . Phylloquinone and menaquinone-4 were present in all milk sample s : 5.84 ( SD 2.31 ) and 2.98 ( SD 1.51 ) nmol/l ( n 31 ) respectively , in colostrum ( day 4 sample ) . A strong correlation between the vitamers was found ( r 0.78 , P<0.001 ) . Breast-milk phylloquinone levels were raised in a dose-dependent manner : 4- , 12- , and 30-fold on day 16 for the 08 , 2.0 , and 4.0 mg group respectively . In addition , menaquinone-4 levels were higher : 2.5- ( P<0.05 ) and 7-fold ( P<0.001 ) in the 2.0 and 4.0 mg groups respectively . Plasma of supplemented subjects contained 3- , 5- , and 10-fold higher phylloquinone levels on day 16 . Detectable menaquinone-4 was found in ten of thirty-one day 4 plasma sample s. All day 16 plasma sample s of the 4 mg supplemented group contained the vitamin . There was no correlation between the K-vitamers in plasma . Vitamin E and phylloquinone appear to differ in their distribution in breast milk , milk : plasma concentration ratios were < or = 1 and 3 - 5 for vitamin E and phylloquinone respectively . The milk : plasma concentration ratio of OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

This systematic review suggests that supplementation with phytonadione and menaquinone-4 reduces bone loss . In the case of the latter , there is a strong effect on incident fractures among Japanese patients

MS2_fixed_5_shot6

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** INPUT: To compare the use of r and omized controls ( RCTs ) and historical controls ( HCTs ) for clinical trials , we search ed the literature for therapies studied by both methods . We found six therapies for which 50 RCTs and 56 HCTs were reported . Forty-four of 56 HCTs ( 79 percent ) found the therapy better than the control regimen , but only 10 of 50 RCTs ( 20 percent ) agreed . For each therapy , the treated patients in RCTs and HCTs of the same therapy was largely due to differences in outcome for the control groups , with HCT control patients generally doing worse than the RCT control groups . Adjustment of the outcomes of the HCTs for prognostic factors , when possible , did not appreciably change the results . The data suggest that biases in patient selection may irretrievably weight the outcome of HCts in favor of new therapies . RCTs may miss clinical ly important benefits because of inadequate attention to sample size . The predictive value of each might be improved by reconsidering the use of p less than 0.05 as the significance level for all types of clinical trials , and by the use of confidence intervals around estimates of treatment effects A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity Study Design . The study was carried out as an open , r and omized , multicenter , parallel‐group study with an observation period of 12 months . Four Norwegian physiotherapy institutes took part . Patients were subsequently followed for 12 months of home exercise on their own , without the supervision of a physiotherapist . Objectives . 1 ) To investigate and compare the effects of two different exercise programs on low back problems in patients after a 1‐year training program under the supervision of a physiotherapist . 2 ) To investigate the effect supervision by , and motivation from , physiotherapists has on training compliance and efficacy . Summary of Background Data . After ordinary physiotherapy treatment for low back problems , patients were r and omly allocated either to a conventional training program design ed by physiotherapists or to a training program using a new Norwegian‐developed training apparatus called the TerapiMaster . The study included 153 patients with low back problems , all of whom had been referred to physiotherapy by their general practitioners . One hundred twenty‐six patients were followed for an additional 12 months when performing home exercise programs on their own . Methods . Monitoring patient satisfaction with the training program , compliance with the program , and absenteeism from work during the training period . Results . Patient satisfaction with both training programs was high , with about 83 % of participating patients completing the study in accordance with the protocol . Mean absenteeism ( SD ) during the preceding year totaled 82.5 days ( 19.8 ) in the conventional training group and 61.6 days ( 14.7 ) in the TerapiMaster group . Significant reductions to 17.2 days ( 6.0 ) and 15.4 days ( 5.3 ) in the two groups , respectively , were recorded during the training period , corresponding to a 75 % to 80 % reduction compared with the preceding 1‐year period . Mean absenteeism showed a further significant decline during the 12‐month period without supervised training . The average values were 9.9 days ( 3.2 ) for conventional training and 9.3 days ( 3.1 ) for the TerapiMaster , respectively . Conclusions . Both exercise programs reduced absenteeism significantly ( 75‐80 % ) . No difference in the effects of the two different programs was discernible . Regular follow‐up through encouragement and variation in the training programs appear to be important factors for motivating patients to adhere to regular exercise programs for low back problems . This thesis was corroborated by the 12‐month study of unsupervised exercise CONTEXT Low back pain is a frequent and costly health problem . Prevention of low back pain is important both for the individual patient and from an economic perspective . OBJECTIVE To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry . DESIGN A r and omized controlled trial with a factorial design . SETTING The cargo department of an airline company in the Netherl and s. PARTICIPANTS A total of 312 workers were r and omized , of whom 282 were available for the 6-month follow-up . INTERVENTIONS Subjects were r and omly assigned to 4 groups : ( 1 ) education ( lifting instructions ) and lumbar support , ( 2 ) education , ( 3 ) lumbar support , and ( 4 ) no intervention . Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours . Lumbar supports were recommended to be used during working hours for 6 months . MAIN OUTCOME MEASURES Low back pain incidence and sick leave because of back pain during the 6-month intervention period . RESULTS Compliance with wearing the lumbar support at least half the time was 43 % . In the 282 subjects for whom data were available , no statistically significant differences in back pain incidence ( 48 [ 36 % ] of 134 with lumbar support vs 51 [ 34 % ] of 148 without , P=.81 ) or in sick leave because of low back pain ( mean , 0.4 days per month with lumbar support vs 0.4 days without , P=.52 ) were found among the intervention groups . In a subgroup of subjects with low back pain at baseline , lumbar supports reduced the number of days with low back pain per month ( median , 1.2 vs 6.5 days per month ; P=.03 ) . CONCLUSIONS Overall , lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave . The results of the subgroup analysis need to be confirmed by future research . Based on our results , the use of education or lumbar supports can not be recommended in the prevention of low back pain in industry We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 The aim of the present controlled study was to evaluate the effect of a general fitness program , performed by an occupational health service , using pre-post assessment for a number of different outcome measures . A total of 160 employees working in the central home care service district of Umeå , Sweden were asked to participate in a program of a 1-year long exercise program . Of the 160 selected , 54 subjects declined to participate and nine subjects were rejected after a medical check up . The remaining 97 subjects participated in a schedule consisting of pre-post medical and physiotherapy examinations , question naires concerning sociodemography , musculoskeletal and general health complaints and work environment , physiological tests of cardiovascular fitness , and of strength and endurance of shoulder flexors and knee extensors , and registration of sick leave . The subjects were r and omly assigned to an exercise ( treatment ) or control group . The exercise group trained twice a week for 1 year using a mixed program including exercises for coordination , strength/endurance , and fitness . The test schedule was repeated for both groups after 1 year . The exercise intervention was associated with positive changes in prevalence and intensity of musculoskeletal and psychosomatic complaints , better physiotherapy status ( less muscle tightness , better neck mobility , and less tender points ) , increased shoulder strength and increased coordination in thigh muscles . However , the exercise group reported worse situations post-exercise concerning aspects of their physical and psychosocial work-environment ( i.e. , concerning ergonomy , influence , appreciation and communication with work manager ) , which might have been due to stress associated with the exercise situation Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Back-related injuries have become a major health problem in the workplace , affecting as many as 35 percent of the work force and accounting for about 25 percent of all compensation cl aims . This study evaluates a back injury prevention program among employees in a northern California county in 1989 - 90 . Six divisions of the county government were selected for the study because they had the highest prevalence of back pain experienced and the most back-related injuries in recent years . Four of the six divisions were r and omly selected as the intervention group and the remaining two , the control group . Overall , 77 percent or 205 of the targeted employees in the intervention group participated in the study . The intervention group was given an identical health risk assessment ( HRA ) before and after the 1-year back injury prevention program that offered employees a combination of education , training , physical fitness activities , and ergonomic improvement . The control group was neither given the HRA nor offered the program . The back injury and cost data of both the control and intervention groups were collected before and after the 1-year intervention . The results showed a modest overall decline in back pain prevalence rates , but significant improvement in satisfaction and reduction in risky behaviors . Cost-benefit analysis showed the net benefit of introducing back injury prevention program was $ 161,108 , and the return on investment is 179 percent . Therefore , the study offers suggestive evidence for the initial benefits of a back injury prevention program and lends support to the widely held belief that health promotion in the workplace can reduce employee health risks , increase healthful behaviors and attitudes , and improve attitudes toward the employer organization . Whether such intervention will continue to reap benefits in future years depends , to a large extent , on a favorable work environment and the maintenance and continuation of positive behavioral changes This study was design ed to determine which method of instruction in body mechanics results in the higher subsequent use of the techniques taught . Two groups were formed from nursing personnel at a rural general medical-surgical hospital in the southwestern United States . Subjects from the direct care nursing staff were r and omly assigned to one of the two groups . One group attended two hours of classroom instruction in body mechanics , while the other completed an independent study module . Subjects were pre- and posttested using the Work-Related Body Mechanics Evaluation ( Carlton , 1987 ) while performing a st and ardized lifting task in the clinical setting . Using analysis of covariance , no significant differences were found in the posttest scores of the two groups This study was funded in part by NIH grant AR36308 The authors thank the employees of the United States Postal Service and the American Postal Workers Union ( APWU ) , Boston Metro Area Local , and Maith and lers Local 301 for their help and cooperation ; therapists from the Department of Rehabilitation Services , Bngham and Women 's Hospital for help in training workers ; and Ms Nancy Tanner for BACKGROUND Low back injuries are common and costly , accounting for 15 to 25 percent of injuries covered by workers ' compensation and 30 to 40 percent of the payments made under that program . The high costs of injury , the lack of effective treatment . and the evidence that there are behavioral risk factors have led to widespread use of employee education programs that teach safe lifting and h and ling . The effectiveness of those programs , however , has received little rigorous evaluation . METHODS We evaluated an educational program design ed to prevent low back injury in a r and omized , controlled trial involving about 4000 postal workers . The program , similar to that in wide use in so-called back schools , was taught by experienced physical therapists OUTPUT: ***EXAMPLES*** INPUT: OBJECTIVE To determine if an evidence -based practice bundle would result in a significantly lower rate of surgical site infections ( SSIs ) when compared with st and ard practice . DESIGN Single-institution , r and omized controlled trial with blinded assessment of main outcome . The trial opened in April 2007 and was closed in January 2010 . SETTING Veterans Administration teaching hospital . PATIENTS Patients who required elective transabdominal colorectal surgery were eligible . A total of 241 subjects were approached , 211 subjects were r and omly allocated to 1 of 2 interventions , and 197 were included in an intention-to-treat analysis . INTERVENTIONS Subjects received either a combination of 5 evidence d-based practice s ( extended arm ) or were treated according to our current practice ( st and ard arm ) . The interventions in the extended arm included ( 1 ) omission of mechanical bowel preparation ; ( 2 ) preoperative and intraoperative warming ; ( 3 ) supplemental oxygen during and immediately after surgery ; ( 4 ) intraoperative intravenous fluid restriction ; and ( 5 ) use of a surgical wound protector . MAIN OUTCOME MEASURE Overall SSI rate at 30 days assessed by blinded infection control coordinators using st and ardized definitions . RESULTS The overall rate of SSI was 45 % in the extended arm of the study and 24 % in the st and ard arm ( P = .003 ) . Most of the increased number of infections in the extended arm were superficial incisional SSIs ( 36 % extended arm vs 19 % st and ard arm ; P = .004 ) . Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk ( 95 % confidence interval , 1.36 - 4.56 ; P = .003 ) independent of other factors traditionally associated with SSI . CONCLUSIONS An evidence -based intervention bundle did not reduce SSIs . The bundling of interventions , even when the constituent interventions have been individually tested , does not have a predictable effect on outcome . Formal testing of bundled approaches should occur prior to implementation A controlled , r and omized study of the efficacy of a plastic wound ring drape ( Opdrape , Triplus ) to prevent contamination and infection in elective colorectal operations is reported . Seventy patients were operated upon with the wound ring drape and 70 patients without . All patients received preoperative systemic antibiotic prophylaxis . Abdominal wound infection was observed in seven of 70 ( 10 per cent ) patients with the wound ring drape and six of 70 ( 9 per cent ) without ( N.S. ) . An operative swab for bacteriologic evaluation was obtained from 85 per cent of the wounds . There was no evidence that the drape protected the wound from contamination with intestinal bacterial flora . It was concluded that the wound ring drape prevents neither contamination nor infection PURPOSE : Surgical site infection following colorectal surgery is a frequent and costly problem . Barrier protection at the time of this form of surgery has been used with varying results . The aim of this r and omized study was to examine the efficacy of barrier retractional wound protection in the prevention of surgical site infections in open , elective colorectal surgery . METHODS : One hundred thirty consecutive patients undergoing open elective colorectal resectional surgery were r and omly assigned to have either barrier retractional wound protection or st and ard wound retraction . Patients were then followed up for a minimum of 30 days postoperatively . The primary end point was surgical site infection as defined by the Centers for Disease Control and Prevention . The secondary end point was performance of the wound protector as assessed by operating surgeons . RESULTS : There was a significant reduction in the incidence of incisional surgical site infections when the wound protector was used : 3 of 64 ( 4.7 % ) vs 15 of 66 ( 22.7 % ) ; P = .004 . Most surgical site infections were diagnosed after discharge from the hospital ( 78 % ) , and there was no difference in the rates of reoperation , readmission , or formal wound drainage between the 2 groups . Surgeons found the wound protector to be helpful with retraction during surgery , with 88 % ( 7/8 ) adopting it as part of their st and ard setup . CONCLUSIONS : In this study the use of barrier wound protection in elective open colorectal resectional surgery result ed in a clinical ly significant reduction in incisional surgical site infections . Barrier wound protection of this nature should be considered routine in this type of surgery A novel design for intervention studies is presented , the so called PROBE study ( Prospect i ve R and omized Open , Blinded End-point ) . This design is compared to the classical double-blind design . Among the advantages of the PROBE design are lower cost and greater similarity to st and ard clinical practice , which should make the results more easily applicable in routine medical care . Since end-points are evaluated by a blinded end-point committee it is obvious that there should be no difference between the two types of trials in this regard A study is reported of the influence of plastic wound protectors on the incidence of wound infection in patients having abdominal operations involving the opening of the alimentary tract or biliary system BACKGROUND We prospect ively investigated whether the wound-protective Alexis ( Applied Medical , Rancho Santa Margarita , CA ) wound retractor was effective in preventing surgical site infection ( SSI ) . METHODS We examined the actual condition of SSI in a 12-month r and omized , controlled trial consisting of 221 patients who had undergone nontraumatic gastrointestinal surgery . The patients were divided into a With Alexis retractor group ( n = 111 ) and a Without Alexis retractor group ( n = 110 ) . We also analyzed SSI separately on the basis of surgical sites such as gastric surgery or colorectal surgery . RESULTS Overall estimation showed a significant decrease in wound infection ( superficial incisional SSI ) in the With Alexis retractor group . In the analysis based on surgical sites , a significant decrease in wound infection was noted in the With Alexis retractor group , the members of which had undergone colorectal surgery . There was no significant difference between the two groups in the occurrence of organ/space SSI , including anastomotic leak or intraperitoneal abscess . CONCLUSION It was suggested that the use of the Alexis wound retractor would protect surgical wounds from contamination by bacteria and thus prevent infection The preventive effects of a plastic wound drape ( Vi-drape ) on wound contamination and subsequent infection was investigated in 289 appendicectomies r and omized into treatment and control groups . Sample s for quantitative culture of enterobacteria using a simple technique were obtained from the drape , the wound under the drape and from the wounds of patients being operated without the drape . The drape reduced the number of wound bacteria by an average of 94 % or 1.2 logarithms . The overall rate of postoperative wound infection was 7.6 % in the treatment group and 9.1 % in the control group ( N.S ) . Evidence is presented that the drape might prevent infection in patients with contaminated operations A r and omized controlled trial has been performed to assess the value of plastic wound drapes in the prevention of surgical wound infection . One hundred and forty‐four patients undergoing abdominal surgery were allocated to one of three groups ; a control group ( A ) in which st and ard cloth towels were applied to the abdominal wound , group B in which an adhesive plastic drape was added and group C in which a plastic ring protector was inserted into the wound Abstract A new plastic device for isolating the edges of incisions into body cavities is described and illustrated . The device , called an incision liner , has certain advantages over conventional technics of covering wound margins . In a group of patients who underwent abdominal operations the use of the incision liner seemed to be effective in minimizing the incidence and severity of wound infections OUTPUT: Our results suggest that wound protectors reduce rates of SSI after gastrointestinal and biliary surgery INPUT: Chronic Obstructive Pulmonary Disease ( COPD ) is the fourth-leading cause of chronic morbidity and mortality in North America and its burden continues to increase . Tiotropium has been shown to reduce exacerbations , hospitalizations , symptoms , and improve health-related quality of life in patients with COPD . Its effect on mortality and its effects relative to long-acting beta-agonists ( LABAs ) , however , remain unknown . To examine the association between tiotropium use compared to LABA use on all-cause mortality in older patients with COPD , a longitudinal , population -based cohort study was conducted in Ontario , Canada . Subjects were individuals 65 years and older discharged from hospital with a diagnosis of COPD between January 1 , 2003 and March 31 , 2006 . The hazard of receiving a prescription for tiotropium compared to a long-acting beta-agonist on all-cause mortality at 180 days post-hospital discharge , controlling for a number of potential confounders , was eliminated . Data from 7218 eligible patients were analyzed . Of these , 1046 ( 14.5 % ) died in the follow-up period . Patients who received tiotropium were 20 % less likely to die than those receiving a long-acting beta-agonist ( hazard ratio 0.80 , 95 % confidence interval 0.70 to 0.93 ) . In conclusion , in older patients recently discharged from hospital for COPD , receiving tiotropium was found to be associated with reduced mortality at 6 months compared to receiving a long-acting beta-agonist . This result suggests that tiotropium might also be associated with decreased mortality compared to no treatment at all . R and omized placebo-control trials are needed to confirm these findings Background Exercise training improves exercise tolerance in chronic obstructive pulmonary disease ( COPD ) . Tiotropium 18 μg once daily induces sustained bronchodilation throughout the day and reduces hyperinflation , one of the pathophysiological factors contributing to exertional dyspnea in COPD patients . Aim To determine whether tiotropium enhances the effects of exercise training in patients with COPD . Design Multicenter , 25 week r and omized , double-blind , placebo-controlled , parallel-group study . Setting Twelve Italian Pulmonary Units practicing pulmonary rehabilitation . Patients and intervention Two hundred thirty four COPD patients ( 196 males ; mean age : 67.4 ± 7.6 ; forced expiratory volume at 1 second ( FEV1 ) : 41.4 ± 13.0 % predicted ) were r and omised to tiotropium 18 μg or placebo inhalation capsules taken once daily . Both groups underwent a 8 week pulmonary rehabilitation program ( PR ) consisting of 3 exercise training session per week . Measurements Baseline , at the end of PR and after 12 weeks , patients completed pulmonary function testing , six minute walking test ( 6MWT ) , the Baseline and Transition Dyspnea Index ( BDI and TDI ) , and the St. George ’s Respiratory Question naire ( SGRQ ) . Results Relative to placebo , tiotropium had larger trough and post- study drug FEV1 responses on all test days . At the end of and 12 weeks following PR , patients on tiotropium showed no statistically significant differences in 6MWT compared to patients on placebo . Compared to the period immediately prior to PR , the mean improvement in 6MWT was only 29.7 meters ( 7.1 % ) for the combined cohort . Mean TDI focal scores at the end of PR were 3.60 for tiotropium and 2.25 for placebo ( p < 0.01 ) . At 12 weeks after PR , TDI focal scores were 2.71 for tiotropium and 2.11 for placebo ( p = 0.16 ) . Reduction in all four SGRQ component scores , indicating an improvement in health-related quality of life , was observed for the tiotropium group over the duration of the study compared to placebo but the differences were not statistically significant . During the study period , there were fewer exacerbations and exacerbation days in the tiotropium group . Conclusion Although significant improvements were observed with perceived dyspnea , compared to placebo , the addition of tiotropium to pulmonary rehabilitation did not improve the 6MWT BACKGROUND : A study was performed to compare the adrenal suppression caused by inhaled fluticasone propionate and budesonide on a microgram equivalent basis , each given by metered dose inhaler to asthmatic patients . METHODS : Twelve asthmatic patients of mean age 29.9 years , with a forced expiratory volume in one second ( FEV1 ) 92.9 % predicted and forced expiratory flow 25 - 75 % ( FEF25 - 75 ) 69.5 % predicted , on less than or equal to 400 micrograms/day inhaled corticosteroid , were studied in a double blind placebo controlled crossover design comparing single doses of inhaled budesonide 400 , 1000 , 1600 , 2000 micrograms and fluticasone propionate 500 , 1000 , 1500 , 2000 micrograms . Doses were administered at 22.00 hours by metered dose inhaler with mouth rinsing and measurements were made in the laboratory 10 hours later . RESULTS : Serum cortisol levels compared with placebo ( mean 325.2 nmol/l ) were suppressed by fluticasone at doses of 1500 micrograms ( 211.6 nmol/l ) and 2000 micrograms ( 112.3 nmol/l ) and by budesonide at 2000 micrograms ( 243.4 nmol/l ) . Fluticasone propionate 2000 micrograms produced lower absolute serum cortisol levels than budesonide 2000 micrograms ( 95 % CI for difference 42.9 to 219.2 ) . The dose ratio ( geometric mean ) for the relative potency was 2.89 fold ( 95 % CI 1.19 to 7.07 ) . In terms of percentage suppression versus placebo , fluticasone propionate also produced greater effects ( means and 95 % CI for difference ) : budesonide 1600 micrograms ( 16.0 ) versus fluticasone propionate 1500 micrograms ( 40.9 ) ( 95 % CI -0.6 to 50.6 ) , budesonide 2000 micrograms ( 26.0 ) versus fluticasone 2000 micrograms ( 65.2 ) ( 95 % CI 10.5 to 67.8 ) . Individual serum cortisol levels at the two highest doses showed 15 of 24 patients below the normal limit of the reference range ( 150 nmol/l ) for fluticasone and five of 24 for budesonide . Fluticasone propionate also caused greater ACTH suppression than budesonide ( as % versus placebo ) : budes

The trials suggest that work place exercise is effective , braces and education are ineffective , and workplace modification plus education is of unknown value in preventing low back pain

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