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MS21100	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Caffeine , an adenosine receptor antagonist , has shown to improve performance in normal ambient temperature , presumably via an effect on dopaminergic neurotransmission through the antagonism of adenosine receptors . However , there is very limited evidence from studies that administered caffeine and examined its effects on exercise in the heat . Therefore , we wanted to study the effects of caffeine on performance and thermoregulation in high ambient temperature . Eight healthy trained male cyclists completed two experimental trials ( in 30 ° C ) in a double-blind-r and omized crossover design . Subjects ingested either placebo ( 6 mg/kg ) or caffeine ( 6 mg/kg ) 1 h prior to exercise . Subjects cycled for 60 min at 55 % Wmax , immediately followed by a time trial to measure performance . The significance level was set at p < 0.05 . Caffeine did not change performance ( p = 0.462 ) . Rectal temperature was significantly elevated after caffeine administration ( p < 0.036 ) . Caffeine significantly increased B-endorphin plasma concentrations at the end of the time trial ( p = 0.032 ) . The present study showed no ergogenic effect of caffeine when administered 1 h before exercise in 30 ° C . This confirms results from a previous study that examined the effects of caffeine administration on a short ( 15 min ) time trial in 40 ° C . However , caffeine increased core temperature during exercise . Presumably , the rate of increase in core temperature may have counteracted the ergogenic effects of caffeine . However , other factors such as interindividual differences in response to caffeine and changes in neurotransmitter concentrations might also be responsible for the lack of performance improvement of caffeine in high ambient temperature This study compared the effects of a single and divided dose of caffeine on endurance performance and on postexercise urinary caffeine and plasma paraxanthine concentrations . Nine male cyclists and triathletes cycled for 90 min at 68 % of maximal oxygen uptake , followed by a self-paced time trial ( work equivalent to 80 % of maximal oxygen uptake workload over 30 min ) with three r and omized , balanced , and double-blind interventions : 1 ) placebo 60 min before and 45 min into exercise ( PP ) ; 2 ) single caffeine dose ( 6 mg/kg ) 60 min before exercise and placebo 45 min into exercise ( CP ) ; and 3 ) divided caffeine dose ( 3 mg/kg ) 60 min before and 45 min into exercise ( CC ) . Time trial performance was unchanged with caffeine ingestion ( P = 0.08 ) , but it tended to be faster in the caffeine trials ( CP : 24.2 min and CC : 23.4 min ) compared with placebo ( PP : 28.3 min ) . Postexercise urinary caffeine concentration was significantly lower in CC ( 3.8 micro g/ml ) compared with CP ( 6.8 micro g/ml ) . Plasma paraxanthine increased in a dose-dependent fashion and did not peak during exercise . In conclusion , dividing a caffeine dose provides no ergogenic effect over a bolus dose but reduces postexercise urinary concentration AIM The purpose of this work was to determine the effects of caffeine ingestion on cycling time trial ( TT ) performance in well trained male subjects . METHODS Eight males , with the following physical characteristics ( Mean + /- SD ) age 30.2+/-10.1 years , height 180.3+/-7.1 cm , mass 70.4+/-5.1 kg , VO2max 63.6+/-4.4 mL.kg(-1).min(-1 ) undertook three 1 h TT performances on a VelotronPro cycle ergometer , in a double blind , r and om fashion . The trials were Control ( C ) , Placebo ( Pl ) and Caffeine ( CAF ) . The CAF and Pl were given 60 min prior to exercise in a dose of 6 mg.kg(-1 ) body mass . Prior to ingestion , 60 min post ingestion , and at the end of the TT , subjects gave 10 mL of venous blood which was analysed for lactate , glucose , and free fatty acids . Expired air was collected throughout each test by indirect calorimetry . RESULTS The cyclists rode significantly further in CAF trial ( 28.11+/-1.32 km ) than they did in the C ( 26.69+/-1.5 km , P < 0.03 ) or Pl ( 27.0+/-1.5 km , P < 0.03 ) trials . No significant differences were seen between C and Pl trials ( P > 0.88 ) . No differences between C and Pl were seen in heart rate data throughout the TT ( p > 0.05 ) . The free fatty acid ( FFA ) concentrations were significantly higher in the CAF trials both post ingestion ( P < 0.005 ) and post exercise ( P < 0.0001 ) than either C or Pl trials . CONCLUSION We concluded that performance was improved possibly based upon a greater reliance on fat metabolism , as indicated by increased FFA and a lower respiratory exchange ratio ( RER ) This study analyzed the effect of caffeine ingestion on performance during a repeated- measures , 100-km , laboratory cycling time trial that included bouts of 1- and 4-km high intensity epochs ( HIE ) . Eight highly trained cyclists participated in 3 separate trials ' placebo ingestion before exercise with a placebo carbohydrate solution and placebo tablets during exercise ( Pl ) , or placebo ingestion before exercise with a 7 % carbohydrate drink and placebo tablets during exercise ( Cho ) , or caffeine tablet ingestion before and during exercise with 7 % carbohydrate ( Caf ) . Placebo ( twice ) or 6 mg.kg(-1 ) caffeine was ingested 60 min prior to starting 1 of the 3 cycling trials , during which subjects ingested either additional placebos or a caffeine maintenance dose of 0.33 mg.kg(-1 ) every 15 min to trial completion . The 100-km time trial consisted of five 1-km HIE after 10 , 32 , 52 , 72 , and 99 km , as well as four 4-km HIE after 20 , 40 , 60 , and 80 km . Subjects were instructed to complete the time trial and all HIE as fast as possible . Plasma ( caffeine ) was significantly higher during Caf ( 0.43 + /- 0.56 and 1.11 + /- 1.78 mM pre vs. post Pl ; and 47.32 + /- 12.01 and 72.43 + /- 29.08 mM pre vs. post Caf ) . Average power , HIE time to completion , and 100-km time to completion were not different between trials . Mean heart rates during both the 1-km HIE ( 184.0 + /- 9.8 Caf ; 177.0 + /- 5.8 Pl ; 177.4 + /- 8.9 Cho ) and 4-km HIE ( 181.7 + /- 5.7 Caf ; 174.3 + /- 7.2 Pl ; 175.6 + /- 7.6 Cho ; p < .05 ) was higher in Caf than in the other groups . No significant differences were found between groups for either EMG amplitude ( IEMG ) or mean power frequency spectrum ( MPFS ) . IEMG activity and performance were not different between groups but were both higher in the 1-km HIE , indicating the absence of peripheral fatigue and the presence of a central ly-regulated pacing strategy that is not altered by caffeine ingestion . Caffeine may be without ergogenic benefit during endurance exercise in which the athlete begins exercise with a defined , predetermined goal measured as speed or distance Purpose Many studies have examined the effect of caffeine on exercise performance , but findings have not always been consistent . The objective of this study was to determine whether variation in the CYP1A2 gene , which affects caffeine metabolism , modifies the ergogenic effects of caffeine in a 10-km cycling time trial . Methods Competitive male athletes ( n = 101 ; age = 25 ± 4 yr ) completed the time trial under three conditions : 0 , 2 , or 4 mg of caffeine per kilogram body mass , using a split-plot r and omized , double-blinded , placebo-controlled design . DNA was isolated from saliva and genotyped for the −163A > C polymorphism in the CYP1A2 gene ( rs762551 ) . Results Overall , 4 mg·kg−1 caffeine decreased cycling time by 3 % ( mean ± SEM ) versus placebo ( 17.6 ± 0.1 vs 18.1 ± 0.1 min , P = 0.01 ) . However , a significant ( P < 0.0001 ) caffeine – gene interaction was observed . Among those with the AA genotype , cycling time decreased by 4.8 % at 2 mg·kg−1 ( 17.0 ± 0.3 vs 17.8 ± 0.4 min , P = 0.0005 ) and by 6.8 % at 4 mg·kg−1 ( 16.6 ± 0.3 vs 17.8 ± 0.4 min , P < 0.0001 ) . In those with the CC genotype , 4 mg·kg−1 increased cycling time by 13.7 % versus placebo ( 20.8 ± 0.8 vs 18.3 ± 0.5 min , P = 0.04 ) . No effects were observed among those with the AC genotype . Conclusion Our findings show that both 2 and 4 mg·kg−1 caffeine improve 10-km cycling time , but only in those with the AA genotype . Caffeine had no effect in those with the AC genotype and diminished performance at 4 mg·kg−1 in those with the CC genotype . CYP1A2 genotype should be considered when deciding whether an athlete should use caffeine for enhancing endurance performance PURPOSE To determine the effects of ingesting caffeine ( CAFF ) and sodium bicarbonate ( SB ) , taken individually and simultaneously , on 3-km cycling time-trial ( TT ) performance . METHOD Ten well-trained cyclists , age 24.2 ± 5.4 yr , participated in this acute-treatment , double-blind , crossover study that involved four 3-km cycling TTs performed on separate days . Before each TT , participants ingested either 3 mg/kg body mass ( BM ) of CAFF , 0.3 g · kg⁻¹ · BM⁻¹ of SB , a combination of the two ( CAFF+SB ) , or a placebo ( PLAC ) . They completed each 3-km TT on a laboratory-based cycle ergometer , during which physiological , perceptual , and performance measurements were determined . For statistical analysis , the minimal worthwhile difference was considered ~1 % based on previous research . RESULTS Pretrial pH and HCO₃ were higher in SB and CAFF+SB than in the CAFF and PLAC trials . Differences across treatments for perceived exertion and gastric discomfort were mostly unclear . Compared with PLAC , mean power output during the 3-km TT was higher in CAFF , SB , and CAFF+SB trials ( 2.4 % , 2.6 % , 2.7 % respectively ) , result ing in faster performance times ( -0.9 , -1.2 , -1.2 % respectively ) . Effect sizes for all trials were small ( 0.21 - 0.24 ) . CONCLUSIONS When ingested individually , both CAFF and SB enhance high-intensity cycling TT performance in trained cyclists . However , the ergogenic effect of these 2 popular supplements was not additive , bringing into question the efficacy of coingesting the 2 supplements before short- duration high-intensity exercise . In this study there were no negative effects of combining CAFF and SB , 2 relatively inexpensive and safe supplements BACKGROUND The ingestion of either caffeine ( C ) or ephedrine ( E ) has been shown to improve performance during high-intensity aerobic activity lasting 10 - 20 min , with an additive effect being found when the combination ( C + E ) was ingested . It was the purpose of this study to determine if the addition of E to C would improve performance in activity lasting longer than 20 min . METHODS One and one half hours after ingesting a placebo ( P ) , C ( 4 mg/kg ) , E ( 0.8 mg/kg ) , or C + E , 12 subjects performed a 10-km run while wearing a helmet and backpack weighing 11 kg . The trials were performed in a climatic suite at 12 - 13 degrees C , on a treadmill where the speed was regulated by the subject . VO(2 ) , VCO(2 ) , V(E ) , heart rate ( HR ) , and rating of perceived exertion ( RPE ) were measured during the run at 15 and 30 min , and again when the individual reached 9 km . Blood was sample d at 15 and 30 min and again at the end of the run and assayed for lactate , glucose , and catecholamines . RESULTS Run times ( mean + /- SD ) , in minutes , were for C ( 46.0 + /- 2 Output:	Conclusion Caffeine can be used effectively as an ergogenic aid when taken in moderate doses , such as during sports when a small increase in endurance performance can lead to significant differences in placements as athletes are often separated by small margins
MS21101	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To compare the treatment outcomes of sorafenib plus transarterial chemoembolization ( TACE ) vs TACE alone in patients with hepatocellular carcinoma ( HCC ) and hepatic vein tumor thrombus ( HVTT ) . Methods Twenty patients who were initially diagnosed with HCC and HVTT and received TACE combined with sorafenib during February 2009 to October 2013 were included in the study . To minimize selection bias , these patients were compared with 60 case-matched controls selected from a pool of 81 patients ( in a 1:3 ratio ) who received TACE alone during the same period . The primary end point was overall survival ( OS ) . The secondary end points were time to progression , disease control rate , and adverse events . Results After a median follow-up period of 12.5 months ( range , 1.03–44.23 months ) , the OS of the combined group was found to be significantly higher compared with the monotherapy group ( 14.9 vs 6.1 months , P=0.010 ) . The time to progression was found to be significantly longer in the combined group ( 4.9 vs 2.4 months , P=0.016 ) . Univariate and multivariate analyses revealed that the treatment allocation was an independent predictor of OS . Conclusion Sorafenib plus TACE was well tolerated and was more effective in treating patients with advanced HCC and HVTT . Future trials with prospect i ve larger sample s are required to vali date these results BACKGROUND In Japan and South Korea , transarterial chemoembolisation ( TACE ) is an important locoregional treatment for patients with unresectable hepatocellular carcinoma ( HCC ) . Sorafenib , a multikinase inhibitor , has been shown effective and safe in patients with advanced HCC . This phase III trial assessed the efficacy and safety of sorafenib in Japanese and Korean patients with unresectable HCC who responded to TACE . METHODS Patients ( n=458 ) with unresectable HCC , Child-Pugh class A cirrhosis and ≥25 % tumour necrosis/shrinkage 1 - 3 months after 1 or 2 TACE sessions were r and omised 1:1 to sorafenib 400 mg bid or placebo and treated until progression/recurrence or unacceptable toxicity . Primary end-point was time to progression/recurrence ( TTP ) . Secondary end-point was overall survival ( OS ) . FINDINGS Baseline characteristics in the two groups were similar ; > 50 % of patients started sorafenib>9 weeks after TACE . Median TTP in the sorafenib and placebo groups was 5.4 and 3.7 months , respectively ( hazard ratio ( HR ) , 0.87 ; 95 % confidence interval ( CI ) , 0.70 - 1.09 ; P=0.252 ) . HR ( sorafenib/placebo ) for OS was 1.06 ( 95 % CI , 0.69 - 1.64 ; P=0.790 ) . Median daily dose of sorafenib was 386 mg , with 73 % of patients having dose reductions and 91 % having dose interruptions . Median administration of sorafenib and placebo was 17.1 and 20.1 weeks , respectively . No unexpected adverse events were observed . INTERPRETATION This trial , conducted prior to the reporting of registration al phase III trials , found that sorafenib did not significantly prolong TTP in patients who responded to TACE . This may have been due to delays in starting sorafenib after TACE and /or low daily sorafenib doses BACKGROUND AND OBJECTIVES To compare the impact of concurrent TACE + sorafenib versus TACE alone on overall survival ( OS ) and time to progression ( TTP ) in patients with unresectable hepatocellular carcinoma ( uHCC ) . A secondary goal was to determine if sorafenib use increases the interval between courses of TACE . METHODS This study enrolled 150 patients with uHCC from June 2011 to June 2014 , including 50 treated with TACE + sorafenib and 100 treated with TACE alone . Factors associated with OS and TTP were identified by univariate and multivariate Cox-regression model analyses . Average TACE interval was defined as TTP/TACE frequency . RESULTS The median OS ( 21.7 vs. 11.5 months ) and TTP ( 10.2 vs. 6.7 months ) were longer in the TACE + sorafenib group compared to the TACE group . Patients receiving combination therapy had higher survival rate ( P < 0.032 ) and longer average interval to TACE ( P < 0.001 ) , but lower progression rate ( P < 0.001 ) . TACE + sorafenib therapy was associated with improved OS ( P ≤ 0.009 ) and TTP ( P ≤ 0.021 ) . The majority of AEs identified in patients receiving the combination therapy were classified as Grade s 1 and 2 , and skin-related reactions and fatigue were the most common . CONCLUSION Concurrent sorafenib with TACE provides survival benefits over TACE monotherapy , which may be related to a prolonged interval between subsequent TACE courses . J. Surg . Oncol . 2016;113:672 - 677 . © 2016 Wiley Periodicals , BACKGROUND & AIMS Transarterial chemoembolization with doxorubicin-eluting beads ( DC Bead ® ; DEB-TACE ) is effective in patients with Barcelona clinic liver cancer stage B hepatocellular carcinoma ( HCC ) . The multikinase inhibitor sorafenib enhances overall survival ( OS ) and time-to-tumor progression ( TTP ) in patients with advanced HCC . This exploratory phase II trial tested the efficacy and safety of DEB-TACE plus sorafenib in patients with intermediate stage HCC . METHODS Patients with intermediate stage multinodular HCC without macrovascular invasion ( MVI ) or extrahepatic spread ( EHS ) were r and omized 1:1 to DEB-TACE ( 150 mg doxorubicin ) plus sorafenib 400 mg twice daily or placebo . The primary endpoint was TTP by blinded central review . Secondary endpoints included time to MVI/EHS , OS , overall response rate ( ORR ) using modified response evaluation criteria in solid tumors , disease control rate ( DCR ) , time to unTACEable progression ( TTUP ) , and safety . RESULTS Of 307 patients r and omized , 154 received sorafenib and 153 received placebo . Median TTP for subjects receiving sorafenib plus DEB-TACE or placebo plus DEB-TACE was similar ( 169 vs. 166 days , respectively ; hazard ratio ( HR ) 0.797 , p=0.072 ) . Median time to MVI/EHS ( HR 0.621 , p=0.076 ) and OS ( HR 0.898 , p=0.29 ) had not been reached . The ORRs for patients in the sorafenib and placebo groups with post-baseline scans were 55.9 % and 41.3 % , respectively , and the DCRs were 89.2 % and 76.1 % , respectively . TTUP was lower with sorafenib than with placebo ( HR 1.586 ; 95 % confidence intervals , 1.200 - 2.096 ; median 95 vs. 224 days ) . No unexpected adverse events related to sorafenib were observed . CONCLUSION Sorafenib plus DEB-TACE was technically feasible , but the combination did not improve TTP in a clinical ly meaningful manner compared with DEB-TACE alone This prospect i ve non‐r and omized controlled trial aim ed to compare the efficacy of sorafenib in combination with transarterial chemoembolization ( TACE ) vs TACE alone for the treatment of patients with unresectable intermediate or advanced hepatocellular carcinoma PURPOSE To determine the safety and efficacy of transarterial chemoembolization ( TACE ) combined with sorafenib ( hereafter , TACE-sorafenib ) in patients with hepatocellular carcinoma ( HCC ) and portal vein tumor thrombus ( PVTT ) . MATERIAL S AND METHODS This study was approved by the institutional review board , and the requirement for informed consent was waived . The medical records of consecutive patients with HCC and PVTT who underwent TACE-sorafenib or TACE alone from January 2010 to December 2012 were retrospectively evaluated . Sorafenib ( 400 mg ) was administered twice daily . Outcomes of patients who underwent TACE-sorafenib were compared with outcomes of patients who underwent TACE by using the Kaplan-Meier method according to types of PVTT : PVTT in the main portal vein ( type A ) , PVTT in the first-order portal vein branch ( type B ) , and PVTT in second- or lower-order portal vein branches ( type C ) . RESULTS Ninety-one patients were included in the analysis ; 46 patients underwent TACE-sorafenib and 45 underwent TACE . TACE-sorafenib showed significant survival benefits compared with TACE in patients with type B ( median survival , 13 months vs 6 months ; P = .002 ) or type C ( median survival , 15 months vs 10 months ; P = .003 ) PVTT . TACE-sorafenib and main PVTT were the independent prognostic factors for survival at uni- and multivariate analysis . Liver function after TACE-sorafenib worsened only in patients with main PVTT . Sorafenib-related adverse events of grade 3 or higher occurred in 16 patients ( 35 % ) . CONCLUSION TACE-sorafenib side effects were acceptable , and this treatment may improve overall survival in patients with HCC with first-order or lower-branch PVTT when compared with patients who underwent TACE alone The oncologic community is faced with a steady increase in the incidence of hepatocellular carcinoma ( HCC ) [ 1 ] . Liver cancer represents the sixth most common cancer in the world ( 749 000 new cases ) and the third cause of cancer-related death ( 692 000 cases ) . The incidence varies from 3 out of 100 000 in Western countries , to more than 15 out of 100 000 in certain areas of the world , mapping the geographical distribution of viral hepatitis B ( HBV ) and hepatitis C ( HCV ) , the most important causes of chronic liver disease and HCC [ 2 ] . Most cases arise in those regions with limited re sources . The incidence of HCC increases progressively with advancing age in all population s , with a strong male preponderance . The association of chronic liver disease and HCC represents the basis for preventive strategies , including universal vaccination at birth against hepatitis B , programs to stop transmission and early antiviral eradication of viral hepatitis B and C [ III , A ] . It is unclear whether HBV vaccination will result in a decline in HCC as was seen in Taiwan , given the importance of other risk factors in Europe , such as alcoholic and non-alcoholic fatty liver disease . The control of other risk factors for chronic liver disease and cancer is more difficult to implement , such as cutting down on the consumption of alcohol and programs aim ing at a healthier lifestyle in the light of the obesity p and emic [ 3 , 4 ] . In Africa , reduction of exposure to aflatoxin B1 , especially in HBV-infected individuals , may lower the risk of HCC . HCC may evolve from subclasses of adenomas , and in < 10 % of cases HCC occurs in a normal liver . Surveillance of HCC involves the repeated application of screening tools in patients at risk for HCC and aims for the reduction in mortality of this patient population . The success of surveillance is influenced by the incidence of HCC in the target population , the availability and acceptance of efficient diagnostic tests and the availability of effective treatment . Costeffectiveness studies suggest surveillance of HCC is warranted in cirrhotic patients irrespective of its etiology [ 5 ] . Surveillance of non-cirrhotic patients is also advocated , especially in HBV carriers with serum viral load > 10 000 copies/ml [ 6 ] or HCVinfected patients with bridging fibrosis ( F3 ) [ III , A ] . Patients with HCV infection and advanced fibrosis remain at risk for HCC even after achieving sustained virological response following antiviral treatment [ III , A ] . Japanese cohort studies have shown that surveillance by abdominal ultrasound result ed in an average size of the detected tumors of 1.6 ± 0.6 cm , with < 2 % of the cases exceeding 3 cm [ 7 ] . In the Western world and in less experienced centers , sensitivity of finding early-stage HCC by ultrasound is considerably less effective [ 8 ] . There are no data to support the use of contrast-enhanced computed tomography ( CT ) or magnetic resonance imaging ( MRI ) for surveillance . In many centers , ultrasound surveillance is complemented with the determination of serum alphafetoprotein ( AFP ) , which can lead to a 6%–8 % gain in the tumor detection rate but at the price of false-positive results . A r and omized , controlled trial ( RCT ) of Chinese patients with chronic hepatitis B infection compared surveillance ( ultrasound and serum AFP measurements every 6 months ) versus no surveillance [ 9 ] . Despite low compliance with the surveillance program ( 55 % ) , HCC-related mortality was reduced by 37 % in the surveillance arm . Considering the most appropriate surveillance interval , a r and omized study comparing a 3 Output:	Conclusions The combination of transarterial chemoembolizaiton and sorafenib significantly improves outcomes of unresectable hepatocellular carcinoma compared with transarterial chemoembolization monotherapy , especially in Asian region
MS21102	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Rationale There is little evidence for the efficacy of h and washing for prevention of influenza transmission in re source -poor setting s. We tested the impact of intensive h and washing promotion on household transmission of influenza-like illness and influenza in rural Bangladesh . Methods In 2009–10 , we identified index case- patients with influenza-like illness ( fever with cough or sore throat ) who were the only symptomatic person in their household . Household compounds of index case- patients were r and omized to control or intervention ( soap and daily h and washing promotion ) . We conducted daily surveillance and collected oropharyngeal specimens . Secondary attack ratios ( SAR ) were calculated for influenza and ILI in each arm . Among controls , we investigated individual risk factors for ILI among household contacts of index case- patients . Results Among 377 index case- patients , the mean number of days between fever onset and study enrollment was 2.1 ( SD 1.7 ) among the 184 controls and 2.6 ( SD 2.9 ) among 193 intervention case- patients . Influenza infection was confirmed in 20 % of controls and 12 % of intervention index case- patients . The SAR for influenza-like illness among household contacts was 9.5 % among intervention ( 158/1661 ) and 7.7 % among control households ( 115/1498 ) ( SAR ratio 1.24 , 95 % CI 0.92–1.65 ) . The SAR ratio for influenza was 2.40 ( 95 % CI 0.68–8.47 ) . In the control arm , susceptible contacts < 2 years old ( RRadj 5.51 , 95 % CI 3.43–8.85 ) , those living with an index case-patient enrolled ≤24 hours after symptom onset ( RRadj 1.91 , 95 % CI 1.18–3.10 ) , and those who reported multiple daily interactions with the index case-patient ( RRadj 1.94 , 95 % CI 1.71–3.26 ) were at increased risk of influenza-like illness . Discussion H and washing promotion initiated after illness onset in a household member did not protect against influenza-like illness or influenza . Behavior may not have changed rapidly enough to curb transmission between household members . A reactive approach to reduce household influenza transmission through h and washing promotion may be ineffective in the context of rural Bangladesh . Trial Registration Clinical Trials.gov Please cite this paper as : Simmerman et al. ( 2011 ) Findings from a household r and omized controlled trial of h and washing and face masks to reduce influenza transmission in Bangkok , Thail and . Influenza and Other Respiratory Viruses 5(4 ) , 256–267 Background Evidence is needed on the effectiveness of non‐pharmaceutical interventions ( NPIs ) to reduce influenza transmission . Methodology We studied NPIs in households with a febrile , influenza‐positive child . Households were r and omized to control , h and washing ( HW ) , or h and washing plus paper surgical face masks ( HW + FM ) arms . Study nurses conducted home visits within 24 hours of enrollment and on days 3 , 7 , and 21 . Respiratory swabs and serum were collected from all household members and tested for influenza by RT‐PCR or serology . Principal Findings Between April 2008 and August 2009 , 991 ( 16·5 % ) of 5995 pediatric influenza‐like illness patients tested influenza positive . Four hundred and forty‐two index children with 1147 household members were enrolled , and 221 ( 50·0 % ) were aged < 6 years . Three hundred and ninety‐seven ( 89·8 % ) households reported that the index patient slept in the parents ’ bedroom . The secondary attack rate was 21·5 % , and 56/345 ( 16·3 % ; 95 % CI 12·4–20·2 % ) secondary cases were asymptomatic . H and ‐washing subjects reported 4·7 washing episodes/day , compared to 4·9 times/day in the HW + FM arm and 3·9 times/day in controls ( P = 0·001 ) . The odds ratios ( ORs ) for secondary influenza infection were not significantly different in the HW arm ( OR = 1·20 ; 95 % CI 0·76–1·88 ; P‐0.442 ) , or the HW + FM arm ( OR = 1·16 ; 95 % CI .0·74–1·82 ; P = 0.525 ) . Conclusions Influenza transmission was not reduced by interventions to promote h and washing and face mask use . This may be attributable to transmission that occurred before the intervention , poor facemask compliance , little difference in h and ‐washing frequency between study groups , and shared sleeping arrangements . A prospect i ve study design and a careful analysis of sociocultural factors could improve future NPI studies Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background The economical impact of absenteeism and reduced productivity due to acute infectious respiratory and gastrointestinal disease is normally not in the focus of surveillance systems and may therefore be underestimated . However , large community studies in Europe and USA have shown that communicable diseases have a great impact on morbidity and lead to millions of lost days at work , school and university each year . H and disinfection is acknowledged as key element for infection control , but its effect in open , work place setting s is unclear . Methods Our study involved a prospect i ve , controlled , intervention-control group design to assess the epidemiological and economical impact of alcohol-based h and disinfectants use at work place . Volunteers in public administrations in the municipality of the city of Greifswald were r and omized in two groups . Participants in the intervention group were provided with alcoholic h and disinfection , the control group was unchanged . Respiratory and gastrointestinal symptoms and days of work were recorded based on a monthly question naire over one year . On the whole , 1230 person months were evaluated . Results H and disinfection reduced the number of episodes of illness for the majority of the registered symptoms . This effect became statistically significant for common cold ( OR = 0.35 [ 0.17 - 0.71 ] , p = 0.003 ) , fever ( OR = 0.38 [ 0.14 - 0.99 ] , p = 0.035 ) and coughing ( OR = 0.45 [ 0.22 - 0.91 ] , p = 0.02 ) . Participants in the intervention group reported less days ill for most symptoms assessed , e.g. colds ( 2.07 vs. 2.78 % , p = 0.008 ) , fever ( 0.25 vs. 0.31 % , p = 0.037 ) and cough ( 1.85 vs. 2.00 % , p = 0.024 ) . For diarrhoea , the odds ratio for being absent became statistically significant too ( 0.11 ( CI 0.01 - 0.93 ) . Conclusion H and disinfection can easily be introduced and maintained outside clinical setting s as part of the daily h and hygiene . Therefore it appears as an interesting , cost-efficient method within the scope of company health support programmes . Trial registration numberIS RCT N : IS RCT Background There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza . We implemented a study of the feasibility and efficacy of face masks and h and hygiene to reduce influenza transmission among Hong Kong household members . Methodology /Principal Findings We conducted a cluster r and omized controlled trial of households ( composed of at least 3 members ) where an index subject presented with influenza-like-illness of < 48 hours duration . After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test , the household of the index subject was r and omized to 1 ) control or 2 ) surgical face masks or 3 ) h and hygiene . Households were visited within 36 hours , and 3 , 6 and 9 days later . Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture . The primary outcome measure was laboratory culture confirmed influenza in a household contact ; the secondary outcome was clinical ly diagnosed influenza ( by self-reported symptoms ) . We r and omized 198 households and completed follow up home visits in 128 ; the index cases in 122 of those households had laboratory-confirmed influenza . There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6 % . Clinical secondary attack ratios varied from 5 % to 18 % depending on case definitions . The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms . Adherence to interventions was variable . Conclusions / Significance The secondary attack ratios were lower than anticipated , and lower than reported in other countries , perhaps due to differing patterns of susceptibility , lack of significant antigenic drift in circulating influenza virus strains recently , and /or issues related to the symptomatic recruitment design . Lessons learnt from this pilot have informed changes for the main study in 2008 . Trial Registration Clinical Trials.gov NCT00425893 HK Clinical Trials.com The objective of this study was to identify possible hygiene behaviors associated with the incidence of ILI among adults in Beijing . In January 2011 , we conducted a multi-stage sampling , cross-sectional survey of adults living in Beijing using self-administered anonymous question naires . The main outcome variable was self-reported ILI within the past year . Multivariate logistic regression was used to identify factors associated with self-reported ILI . A total of 13003 participants completed the question naires . 6068 ( 46.7 % ) of all participants reported ILI during the past year . After adjusting for demographic characteristics , the variables significantly associated with a lower likelihood of reporting ILI were regular physical exercise ( OR 0.80 ; 95 % CI 0.74–0.87 ) , optimal h and hygiene ( OR 0.87 ; 95 % CI 0.80–0.94 ) , face mask use when going to hospitals ( OR 0.87 ; 95 % CI 0.80–0.95 ) , and not sharing of towels and h and kerchiefs ( OR 0.68 ; 95 % CI 0.63–0.73 ) . These results highlight that personal hygiene behaviors were potential preventive factors against the incidence of ILI among adults in Beijing , and future interventions to improve personal hygiene behaviors are needed in Beijing BACKGROUND Minimal research has been published evaluating the effectiveness of h and hygiene delivery systems ( ie , rubs , foams , or wipes ) at removing viruses from h and s. The purpose s of this study were to determine the effect of several alcohol-based h and sanitizers in removing influenza A ( H1N1 ) virus , and to compare the effectiveness of foam , gel , and h and wipe products . METHODS H and s of 30 volunteers were inoculated with H1N1 and r and omized to treatment with foam , gel , or h and wipe applied to half of each volunteer 's finger pads . The log(10 ) count of each subject 's treated and untreated finger pads were averaged . Log(10 ) reductions were calculated from these differences and averaged within treatment group . Between-treatment analysis compared changes from the untreated finger pads using analysis of covariance with treatment as a factor and the average log(10 ) untreated finger pads as the covariate . RESULTS Log(10 ) counts on control finger pads were 2.7 - 5.3 log(10 ) of the 50 % infectious dose for tissue culture ( TCID(50)/0.1 mL ) ( mean , 3.8 ± 0.5 log(10 ) TCID(50)/0.1 mL ) , and treated finger pad counts for all test products were 0.5 - 1.9 log(10 ) TCID(50)/0.1 mL ( mean , 0.53 ± 0.17 log(10 ) TCID(50)/0.1 mL ) . Treatments with all products result ed in a significant reduction in viral titers ( > 3 logs ) at their respective exposure times that were statistically comparable . CONCLUSIONS All 3 delivery systems ( foam , gel , and wipe ) produced significantly reduced viral counts on h and BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . R Output:	In light of its proven effectiveness in other setting s , there is no compelling evidence to stop using good h and hygiene practice to reduce the risk of influenza infection and transmission in the community setting
MS21103	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIMS Exercise limitation is common post-Fontan . Hybrid X-ray and magnetic resonance imaging ( XMR ) catheterization allows haemodynamic assessment by means of measurement of ventricular volumes and flow in major vessels with simultaneous invasive pressures . We aim to assess haemodynamic response to stress in patients with hypoplastic left heart syndrome ( HLHS ) post-Fontan . METHODS AND RESULTS Prospect i ve study of 13 symptomatic children ( NHYA 2 ) with HLHS post-Fontan using XMR catheterization . Three conditions were applied : baseline ( Stage 1 ) , dobutamine at 10 µg/kg/min ( Stage 2 ) , and dobutamine at 20 µg/kg/min ( Stage 3 ) . Seven consecutive patients received inhaled nitric oxide ( iNO ) at peak stress . Control MRI data were from normal healthy adults . In the HLHS patients , baseline mean pulmonary vascular resistance ( PVR ) was 1.51 ± 0.59 WU m(2 ) and aortopulmonary collateral flow was 17.7 ± 13.6 % of systemic cardiac output . Mean right ventricular end-diastolic pressure was 6.7 ± 2.5 mmHg which did not rise with stress . Cardiac index ( CI ) increased at Stage 2 in HLHS ( 40 % ) and controls ( 61 % ) but continued to increase at Stage 3 only in controls ( 19 % ) but not in HLHS . The blunted rise in CI in HLHS was due to a continuing fall in end-diastolic volume throughout stress , with no significant change in PVR or CI at peak stress in response to iNO . CONCLUSION Cardiac output post-Fontan in HLHS at peak stress is blunted due to a limitation in preload which is not responsive to inhaled pulmonary vasodilators in the setting of normal PVR Introduction The aim of this multicenter , prospect i ve study was to evaluate the long-term prognostic value of low-dose dobutamine stress echocardiography ( LDDSE ) in patients with aortic stenosis ( AS ) and depressed left ventricular ( LV ) function . Material and methods The study group comprised 39 patients ( 34 male , mean age 59 ±13 years ) with AS ( peak gradient > 25 mm Hg ) , LV ejection fraction ( LVEF ) ≤ 45 % and low transaortic gradient ( peak gradient ≤ 45 mm Hg , mean gradient ≤ 35 mm Hg ) . The qualification for subsequent therapeutic procedures was based on generally accepted indications . All patients underwent LDDSE and coronary angiography . Twelve months after LDDSE patients underwent control resting echocardiography and clinical evaluation . Results Twenty-seven ( 69.2 % ) patients had preserved contractile reserve . In this subgroup , true-severe AS was diagnosed in 12 patients , whereas pseudo-severe AS was found in 15 patients . Nine patients with true-severe AS , 2 patients with pseudo-severe AS and 7 patients without contractile reserve were referred for surgical treatment . The independent risk factors of death during follow-up were : aortic valve area ( AVA ) at peak stress < 0.8 cm2 ( OR 1.4 ; p = 0.003 ) and LVEF at rest < 35 % ( OR 6.8 ; p = 0.05 ) . The independent risk factors of composite end-point ( death or myocardial infa rct ions or pulmonary edema ) were : AVA at stress < 0.8 cm2 ( OR 4.0 ; p = 0.03 ) , absence of AVA increase during LDDSE ( OR 5.7 ; p = 0.005 ) , absence of contractile reserve ( OR 4.5 ; p = 0.01 ) and presence of significant CAD ( OR 6.9 ; p = 0.02 ) . Conclusions In patients with AS and depressed LVEF , LDDSE is a useful tool for long-term risk stratification Background The prognostic value of dobutamine stress hemodynamic data in the setting of low‐gradient aortic stenosis has been addressed in small , single‐center studies . Larger studies are needed to define the criteria for selecting the patients who will benefit from valve replacement . Methods and Results Six centers prospect ively enrolled 136 patients with aortic stenosis ( 96 men ; median age , 72 years [ range , 65 to 77 years ] ; median aortic valve area , 0.7 cm2 [ range , 0.6 to 0.8 ] ; mean transaortic gradient , 29 mm Hg [ range , 23 to 34 mm Hg ] ; cardiac index , 2.11 L min‐1 m‐2 [ range , 1.75 to 2.55 L min‐1 m‐2 ] ) . Left ventricular contractile reserve on the dobutamine stress Doppler study was present in 92 patients ( group I ) and absent in 44 patients ( group II ) . Operative mortality was 5 % ( 3 of 64 patients ) in group I compared with 32 % ( 10 of 31 patients ) in group II ( P=0.0002 ) . Predictors for operative mortality were the lack of contractile reserve ( odds ratio , 10.9 ; 95 % confidence interval [ CI ] , 2.6 to 43.4 ; P=0.001 ) and a mean transaortic gradient ≤20 mm Hg ( odds ratio , 4.7 ; 95 % CI , 1.1 to 21.0 ; P=0.04 ) . Predictors for long‐term survival were valve replacement ( hazard ratio , 0.30 ; 95 % CI , 0.17 to 0.53 ; P=0.001 ) and left ventricular contractile reserve ( hazard ratio , 0.40 ; 95 % CI , 0.23 to 0.69 ; P=0.001 ) . Conclusions In the setting of low‐gradient aortic stenosis , surgery seems beneficial for most of the patients with left ventricular contractile reserve . In contrast , the postoperative outcome of patients without reserve is compromised by a high operative mortality . Thus , dobutamine stress Doppler hemodynamics may be factored into the risk‐benefit analysis for each patient . ( Circulation . 2003;108:319‐324 . PURPOSE This study compared cardiac hemodynamics during supine cycle ergometry and dobutamine stress . METHODS Thirty-two healthy volunteers ( 19 female , 13 male , 23.5 + /- 3.5 yr old ) completed respective tests on separate days and in r and om order . Heart rate , blood pressure , and cardiac output were recorded at baseline and peak stress . Echocardiographic measures included left ventricular end-diastolic dimension , fractional shortening , heart rate corrected velocity of circumferential fiber shortening , end-systolic wall stress , and the difference between measured and predicted fiber shortening for measured wall stress . RESULTS Compared with peak exercise , dobutamine infusion result ed in lower cardiac output ( 12 + /- 2 vs 16 + /- 4 l x min(-1 ) , P < 0.0001 ) , heart rates ( 163 + /- 7 vs 175 + /- 12 beats x min(-1 ) , P < 0.0001 ) , and systolic blood pressure ( 160 + /- 22 vs 185 + /- 20 mm Hg , P < or = 0.0001 ) . Echocardiography demonstrated smaller left ventricular end-diastolic dimension ( 4.2 + /- 0.7 vs 4.5 + /- 0.7 cm , P = 0.013 ) , higher fractional shortening ( 0.55 + /- 0.07 vs 0.50 + /- 0.06 % , P < 0.001 ) , higher VCFc ( 2.07 + /- 0.36 vs 1.54 + /- 0.20 circs x s(-1 ) , P < 0.001 ) higher VCFdiff ( 0.94 + /- 0.35 vs 0.48 + /- 0.20 circs x s(-1 ) , P < 0.001 ) , and lower end-systolic wall stress ( 25 + /- 11 vs 42 + /- 16 g x cm(-2 ) , P < 0.001 ) . The stress-velocity relationship during dobutamine demonstrated higher y-intercept and steeper slope , indicating greater load-independent contractility . CONCLUSION The cardiovascular adaptation to exercise and dobutamine stress differ significantly . Cardiac output during peak exercise is greater than during peak dobutamine secondary to increased heart rate and stroke volume . Despite a greater increase in contractility and decrease in afterload , a smaller increase in cardiac output during dobutamine stress may be secondary to limited ventricular preload OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Exercise testing has an established role in the evaluation of patients with valvular heart disease and can aid clinical decision making . Because symptoms may develop slowly and indolently in chronic valve diseases and are often not recognized by patients and their physicians , the symptomatic , blood pressure , and electrocardiographic responses to exercise can help identify patients who would benefit from early valve repair or replacement . In addition , stress echocardiography has emerged as an important component of stress testing in patients with valvular heart disease , with relevant established and potential applications . Stress echocardiography has the advantages of its wide availability , low cost , and versatility for the assessment of disease severity . The versatile applications of stress echocardiography can be tailored to the individual patient with aortic or mitral valve disease , both before and after valve replacement or repair . Hence , exercise-induced changes in valve hemodynamics , ventricular function , and pulmonary artery pressure , together with exercise capacity and symptomatic responses to exercise , provide the clinician with diagnostic and prognostic information that can contribute to subsequent clinical decisions . Nevertheless , there is a lack of convincing evidence that the results of stress echocardiography lead to clinical decisions that result in better outcomes , and therefore large-scale prospect i ve r and omized studies focusing on patient outcomes are needed in the future To clarify the influence of body position on exercise prescription , 14 men ( mean age + /- st and ard deviation 60.0 + /- 6.1 years ) with coronary artery disease who underwent r and omized recumbent and upright cycle ergometer tests to volitional fatigue were studied . At 100 watts , heart rate ( HR ) , systolic blood pressure , oxygen consumption ( VO2 ) , rate pressure product and rating of perceived exertion were greater ( p less than 0.05 ) in the upright than in the recumbent position . At peak exercise , however , these variables were not significantly different . Regressions of relative HR versus VO2 for recumbent and upright cycle ergometry were comparable : y = 1.24x - 32.7 and y = 1.26x - 31.5 , respectively , where y = % maximal VO2 , and x = % maximal HR . These findings indicate that recumbent exercise prescriptions may be based on the peak HR and VO2 values obtained during upright cycle ergometry , and vice versa . However , differences in the cardiorespiratory responses at submaximal exercise preclude the interchangeability of upright and recumbent training work rates INTRODUCTION Despite high error ranges , age-predicted maximal heart rate ( APMHR ) is frequently used to gauge the achievement of adequate effort during an exercise test . The current analysis revisits this Output:	HR increase and age were inversely correlated at high stress intensities . Conclusion : This systematic review and meta- analysis presents pooled hemodynamic changes under light , moderate and high intensity exercise and pharmacological stress , while considering the potential influence of age .
MS21104	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Although idiopathic membranous nephropathy ( IMN ) is the most common cause of adult-onset nephrotic syndrome , the management of IMN remains controversial . The aim of this prospect i ve study was to compare the efficacy and drug safety of tacrolimus with that of cyclophosphamide ( CTX ; control group ) in IMN patients receiving corticosteroid therapy . A total of 100 IMN patients with nephrotic syndrome were r and omly assigned to receive a combination of corticosteroid therapy and either CTX or tacrolimus . During a follow-up period of at least 18 months , the remission rate after 2 months in the tacrolimus group was 65.1 % , which was higher than that of the CTX group ( 44.2 % ) ( p = 0.02 ) . The mean time to partial or complete remission was 2.20 months in the tacrolimus group and 3.92 months in the CTX group ( p < 0.001 ) . We also found significantly greater improvements in the serum albumin levels in the tacrolimus group compared with the CTX group at the 2-month ( p = 0.003 ) and 3-month time points ( p = 0.01 ) . The serum creatinine levels remained stable in both groups . Although remission was quicker and more common in the tacrolimus group ( compared with the CTX group ) before 3 months , there was no superiority of tacrolimus after 6 months . Glucose intolerance , urinary tract infections , and pneumonia were the major side effects observed in this study . All of the side effects were mild and controlled , and there were fewer side effects in the tacrolimus group compared with the CTX group , indicating a better treatment tolerance in the tacrolimus group To assess whether chlorambucil or cyclophosphamide may have a better therapeutic index in patients with idiopathic membranous nephropathy , we compared two regimens based on a 6-mo treatment , alternating every other month methylprednisolone with chlorambucil or methylprednisolone with cyclophosphamide . Patients with biopsy-proven membranous nephropathy and with a nephrotic syndrome were r and omized to be given methylprednisolone ( 1 g intravenously for 3 consecutive days followed by oral methylprednisolone , 0.4 mg/kg per d for 27 d ) alternated every other month either with chlorambucil ( 0.2 mg/kg per d for 30 d ) or cyclophosphamide ( 2.5 mg/kg per d for 30 d ) . The whole treatment lasted 6 mo ; 3 mo with corticosteroids and 3 mo with one cytotoxic drug . Among 87 patients followed for at least 1 yr , 36 of 44 ( 82 % ; 95 % confidence interval [ CI ] , 67.3 to 91.8 % ) assigned to methylprednisolone and chlorambucil entered complete or partial remission of the nephrotic syndrome , versus 40 of 43 ( 93 % ; 95 % CI , 80.9 to 98.5 % ) assigned to methylprednisolone and cyclophosphamide ( P = 0.116 ) . Of patients who attained remission of the nephrotic syndrome , 11 of 36 in the chlorambucil group ( 30.5 % ) and 10 of 40 in the cyclophosphamide group ( 25 % ) had a relapse of the nephrotic syndrome between 6 and 30 mo . The reciprocal of plasma creatinine improved in the cohort groups followed for 1 yr for both treatment groups ( P < 0.01 ) and remained unchanged when compared with basal values in the cohort groups followed for 2 and 3 yr . Six patients in the chlorambucil group and two in the cyclophosphamide group did not complete the treatment because of side effects . Four patients in the chlorambucil group but none in the cyclophosphamide group suffered from herpes zoster . One patient per group developed cancer . It is concluded that in nephrotic patients with idiopathic membranous nephropathy both treatments may be effective in favoring remission and in preserving renal function for at least 3 yr BACKGROUND Evidence regarding the optimal dose of tacrolimus ( TAC ) in treatment of idiopathic membranous nephropathy ( IMN ) remains inconclusive . The objective of this study was to evaluate the efficacy and safety of low-dose TAC combined with prednisone for patients with IMN . METHODS We conducted a r and omized prospect i ve cohort study in IMN patients : 28 patients received oral TAC ( target whole blood concentration of 2 - 4 ng/mL ) plus prednisone for 12 months , and 28 patients received prednisone combined with intravenous cyclophosphamide ( CYC ) ( 750 mg/m2 body surface ) once every 4 weeks for 24 weeks . RESULTS Of the 56 patients who completed the 12-month treatment , complete remission ( CR ) occurred in 8 ( 28.6 % ) of the CYC group and 18 ( 64.3 % ) of the TAC group ; partial remission ( PR ) occurred in 10 ( 35.7 % ) of the CYC group and 7 ( 25.0 % ) of the TAC group . The probability of remission ( either CR or PR ) was higher in the TAC group than in the CYC group ( p = 0.0439 , by log-rank test ) . Furthermore , a significantly greater improvement in proteinuria and serum albumin levels was observed in the TAC group compared with the CYC group . Patients treated with TAC can often show a rapid increase in their serum albumin levels before any obvious reduction of urinary protein excretion . Side effects were mild and transitory in both groups . CONCLUSION The results demonstrated that the combined therapy of low-dose TAC and prednisone is an effective and safe therapeutic method for Chinese adults with IMN . Low-dose TAC accompanied by prednisone is enough to induce remission in the majority of patients with IMN BACKGROUND We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome . METHODS To vali date the hypothesis that the 2 treatments were equivalent , patients with biopsy-proven membranous nephropathy and nephrotic syndrome were r and omly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months ( group A ) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year ( group B ) . RESULTS The primary outcome measure is cumulative number of remissions as a first event . Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event . After a median follow-up of 24 months ( interquartile range , 15 to 25 months ) , there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d ( interquartile range , 4.0 to 7.3 g/d ) to 2.1 g/d ( interquartile range , 0.4 to 3.8 g/d ; P = 0.004 ) in group A and 6.0 g/d ( interquartile range , 4.4 to 8.5 g/d ) to 0.3 g/d ( interquartile range , 0.2 to 1.9 g/d ; P = 0.049 ) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy . CONCLUSION Most nephrotic patients with membranous nephropathy responded to either treatment . Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone , without significant differences between these 2 therapies Background Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy ( MN ) remains controversial . The effect of mycophenolate mofetil ( MMF ) versus cyclosporine ( CsA ) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center r and omized trial ( NCT01282073 ) . Methods A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were r and omly assigned to receive MMF combined with low-dose corticosteroids ( MMF group ) versus CsA combined with low-dose corticosteroids ( CsA group ) , respectively , and followed up for 48 weeks . Complete or partial remission rate of proteinuria and estimated glomerular filtration rate ( eGFR ) at 48 weeks were compared . Results The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day , respectively , in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day , respectively , in the CsA group . In total , 76.1 % of the MMF group and 66.7 % of the CsA group achieved remission at 48 weeks ( 95 % confidence interval , −0.18 to 0.38 ) . There was no difference in eGFR between the two groups . Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group ( P = 0.001 ) , but were unchanged in the no-response group . There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks . Conclusion In combination with low-dose corticosteroids , the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN , with similar adverse effects including gastrointestinal symptoms . Trial Registration Clinical Trials.gov Identifier : R and omized trials of rituximab in primary membranous nephropathy ( PMN ) have not been conducted . We undertook a multicenter , r and omized , controlled trial at 31 French hospitals ( NCT01508468 ) . Patients with biopsy-proven PMN and nephrotic syndrome after 6 months of nonimmunosuppressive antiproteinuric treatment ( NIAT ) were r and omly assigned to 6-month therapy with NIAT and 375 mg/m2 intravenous rituximab on days 1 and 8 ( n=37 ) or NIAT alone ( n=38 ) . Median times to last follow-up were 17.0 ( interquartile range , 12.5 - 24.0 ) months and 17.0 ( interquartile range , 13.0 - 23.0 ) months in NIAT-rituximab and NIAT groups , respectively . Primary outcome was a combined end point of complete or partial remission of proteinuria at 6 months . At month 6 , 13 ( 35.1 % ; 95 % confidence interval [ 95 % CI ] , 19.7 to 50.5 ) patients in the NIAT-rituximab group and eight ( 21.1 % ; 95 % CI , 8.1 to 34.0 ) patients in the NIAT group achieved remission ( P=0.21 ) . Rates of antiphospholipase A2 receptor antibody ( anti-PLA2R-Ab ) depletion in NIAT-rituximab and NIAT groups were 14 of 25 ( 56 % ) and one of 23 ( 4.3 % ) patients at month 3 ( P<0.001 ) and 13 of 26 ( 50 % ) and three of 25 ( 12 % ) patients at month 6 ( P=0.004 ) , respectively . Eight serious adverse events occurred in each group . During the observational phase , remission rates before change of assigned treatment were 24 of 37 ( 64.9 % ) and 13 of 38 ( 34.2 % ) patients in NIAT-rituximab and NIAT groups , respectively ( P<0.01 ) . Positive effect of rituximab on proteinuria remission occurred after 6 months . These data suggest that PLA2R-Ab levels are early markers of rituximab effect and that addition of rituximab to NIAT does not affect safety Idiopathic membranous nephropathy is a common cause of nephrotic syndrome whose pathogenesis may involve B-cell functions . Rituximab is a monoclonal antibody that binds to the CD20 antigen on B cells thereby deleting them . We conducted an open-label pilot trial of rituximab treatment in 15 severely nephrotic patients with proteinuria refractory to angiotensin-converting enzyme inhibition and /or receptor blockade but with adequately controlled blood pressure . Rituximab was given 2 weeks apart and , at 6 months , patients who remained proteinuric but had recovered B-cell counts were given a second course of treatment . Proteinuria was significantly decreased by about half at 12 months . Of the 14 patients who completed follow-up , full remission was achieved in two and partial remission in six patients based upon the degree of proteinuria . Side effects were minor ; however , we found no relationship between the response and number of B cells in the blood , CD20 cells in the kidney biopsy , degree of Output:	Thechanges of serum creatinine ( Scr ) was not significantly different between eachtreatments of immunosuppressive agents and the control , except for STE whichhas the possibility of increasing Scr ( SMD , 1.00 ( 95 % CI 0.36 to 1.64)).Comparisons among all treatments of immunosuppressive agents showed nostatistical significance in the outcome of relapse . Infection , gastrointestinal symptoms , and bone marrow suppression were the common adverseevents associated with most of the immunosuppressive therapies . This study demonstrates that TAC+TW , TAC and CTX are superior to other immunosuppressive agents in terms of TR and 24 hours UTP . Moreover , they are all at risk of infection , gastrointestinal symptoms , and myelosuppression . Furthermore , TAC could increase the risk of glucose intolerance or new-onset diabetes mellitus . Conversely , STE alone , LEF and MZB seem to have little advantage in clinical treatment of IMN .
MS21105	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Hemodialysis contributes to increased oxidative stress and induces transitory hypoxemia . Compartmentalization decreases the supply of solutes to the dialyzer during treatment . The aim of this study was to investigate the acute effects of intradialytic aerobic exercise on solute removal , blood gases and oxidative stress in patients with chronic kidney disease during a single hemodialysis session . METHODS Thirty patients were r and omized to perform aerobic exercise with cycle ergometer for lower limbs during 30 minutes with intensity between 60 - 70 % of maximal heart rate , or control group ( CG ) . Blood sample s were collected prior to and immediately after exercise or the equivalent time in CG . Analysis of blood and dialysate biochemistry as well as blood gases were performed . Mass removal and solute clearance were calculated . Oxidative stress was determined by lipid peroxidation and by the total antioxidant capacity . RESULTS Serum concentrations of solutes increased with exercise , but only phosphorus showed a significant elevation ( p = 0.035 ) . There were no significant changes in solute removal and in the acid-base balance . Both oxygen partial pressure and saturation increased with exercise ( p = 0.035 and p = 0.024 , respectivelly ) , which did not occur in the CG . The total antioxidant capacity decreased significantly ( p = 0.027 ) . CONCLUSION The acute intradialytic aerobic exercise increased phosphorus serum concentration and decreased total antioxidant capacity , reversing hypoxemia result ing from hemodialysis . The intradialytic exercise did not change the blood acid-base balance and the removal of solutes BACKGROUND Individuals on hemodialysis have low physical function and activity levels . Clinical trials have shown improvements in these parameters with exercise programming . Pedometers have not been extensively evaluated in individuals on hemodialysis . This r and omized clinical trial compared the effects of intradialytic cycling versus a pedometer program on physical function , physical activity and quality of life . METHODS Sixty patients were r and omly assigned to two study groups . The ergometer group cycled during each hemodialysis session for 24 weeks . Pedometer participants followed a home-based walking program for 24 weeks . The primary outcome was aerobic capacity [ VO2peak and 6-minute walk ( 6MW ) test ] . Secondary outcomes included lower extremity strength [ sit-to-st and ( SS ) test ] , flexibility [ sit- and -reach ( SR ) test ] , physical activity ( accelerometer ) and health-related quality of life . Measurements were collected at baseline and at 12 and 24 weeks . RESULTS At 12 and 24 weeks , there was no significant change in the VO2peak or 6MW test between or within study groups . SS testing in the ergometer group improved from 10.2 ( SD 3.4 ) to 11.4 ( SD 2.5 ) cycles from baseline to 24 weeks ( P < 0.005 ) . Similarly , in the pedometer group , SS cycles improved from 10.1 ( SD 3.3 ) to 12.2 ( SD 3.5 ) ( P < 0.005 ) . The SR test also significantly improved over time in both the study groups . No significant changes were noted for other secondary outcomes . CONCLUSIONS Both intradialytic cycling and pedometer programming improved aspects of physical function . Neither intervention had a significant effect on aerobic capacity . No significant differences in any outcomes were identified between interventions groups OBJECTIVES The purpose of this study is to determine whether a low-to-moderate intensity pre-conditioning exercise programme linked with exercise counselling could improve behavioural change , physical fitness , physiological condition and health-related quality of life of sedentary haemodialysis patients in The Netherl and s. METHODS Ninety-six haemodialysis patients of the Groningen Dialysis Center were r and omized into an exercise group ( n = 53 ) and a control group ( n = 43 ) . The exercise programme consists of cycling during dialysis together with a pre-dialysis strength training programme lasting 12 weeks . The intensity of the exercise programme is condition level 12 - 16 according to the rate of perceived exertion ( RPE ) . Motivational interviewing techniques were used for exercise counselling . Before and after the intervention , both groups were tested on behavioural change and physical fitness components such as reaction time , manual dexterity , lower extremity muscle strength and VO2 peak . Physiological conditions such as weight , blood pressure , haemoglobin and haematocrit values , cholesterol and Kt/V were obtained from the medical records . Health-related quality of life assessment included R AND -36 scores , symptoms and depression . RESULTS A group x time analysis with MANOVA ( repeated measures ) demonstrates that participation in a low-to-moderate intensity exercise programme linked with exercise counselling yields a significant increase in behavioural change , reaction time , lower extremity muscle strength , Kt/V and three components of quality of life , and no significant effects in the control group . CONCLUSION Participating in a low-to-moderate intensity pre-conditioning exercise programme showed beneficial effects on behavioural change , physical fitness , physiological conditions and health-related quality of life In chronic kidney disease ( CKD ) , oxidative stress ( OS ) plays a central role in the development of cardiovascular diseases . This pilot program aim ed to determine whether an intradialytic aerobic cycling training protocol , by increasing physical fitness , could reduce OS and improve other CKD-related disorders such as altered body composition and lipid profile . Eighteen hemodialysis patients were r and omly assigned to either an intradialytic training ( cycling : 30 min , 55%-60 % peak power , 3 days/week ) group ( EX ; n = 8) or a control group ( CON ; n = 10 ) for 3 months . Body composition ( from dual-energy X-ray absorptiometry ) , physical fitness ( peak oxygen uptake and the 6-minute walk test ( 6MWT ) ) , lipid profile ( triglycerides ( TG ) , total cholesterol , high-density lipoprotein , and low-density lipoprotein ( LDL ) ) , and pro/antioxidant status ( 15-F2α-isoprostanes ( F2-IsoP ) and oxidized LDL in plasma ; superoxide dismutase , glutathione peroxidase , and reduced/oxidized glutathione in erythrocytes ) were determined at baseline and 3 months later . The intradialytic training protocol did not modify body composition but had significant effects on physical fitness , lipid profile , and pro/antioxidant status . Indeed , at 3 months : ( i ) performance on the 6MWT was increased in EX ( + 23.4 % , p < 0.001 ) but did not change in CON , ( ii ) plasma TG were reduced in EX ( -23 % , p < 0.03 ) but were not modified in CON , and ( iii ) plasma F2-IsoP concentrations were lower in EX than in CON ( -35.7 % , p = 0.02 ) . In conclusion , our results show that 30 min of intradialytic training , 3 times per week for 3 months , are enough to exert beneficial effects on the most sensitive and reliable marker of lipid peroxidation ( IsoP ) while improving CKD-associated disorders ( lipid profile and physical fitness ) . Intradialytic aerobic cycling training represents a useful and easy strategy to reduce CKD-associated disorders . These results need to be confirmed with a larger r and omized study AimS keletal muscle atrophy and dysfunction with associated weakness may involve the respiratory muscles of dialysis patients . We evaluated the effect of moderate-intensity exercise on lung function and respiratory muscle strength . Methods Fifty-nine patients ( 25 F , aged 65 ± 13 years ) from two centers participating in the multicenter r and omized clinical trial EXerCise Introduction To Enhance Performance in Dialysis ( EXCITE ) were studied . Subjects were r and omized into a prescribed exercise group ( E ) , wherein subjects performed two 10-min walking sessions every second day at an intensity below the self-selected speed , or a control group ( C ) with usual care . Physical performance was assessed by the 6-min walk test ( 6MWT ) . Patient lung function and respiratory muscle strength were evaluated by spirometry and maximal inspiratory pressure ( MIP ) , respectively . Results Forty-two patients ( 14 F ) completed the study . At baseline , the groups did not differ in any parameters . In total , 7 patients ( 4 in E ; 3 in C ) showed an obstructive pattern . The pulmonary function parameters were significantly correlated with 6MWT but not with any biochemical measurements . Group E safely performed the exercise program . At follow-up , the spirometry parameters did not change in either group . A deterioration of MIP ( −7 % ; p = 0.008 ) was observed in group C , but not in group E ( + 3.3 % , p = ns ) . In E , an increase of 6MWT was also found ( + 12 vs. 0 % in C ; p = 0.038 ) . Conclusion In dialysis patients , a minimal dose of structured exercise improved physical capacity and maintained a stable respiratory muscle function , in contrast to the control group where it worsened OBJECTIVE To investigate if high-intensity constant work rate ( CWR ) would constitute a more appropriate testing strategy compared with incremental work rate ( IWR ) to assess the effectiveness of intradialytic aerobic training in patients with end-stage renal disease ( ESRD ) . DESIGN R and omized controlled trial . SETTING Nephrology unit at the university hospital . PARTICIPANTS Patients ( N=28 ; 47.0±11.9y ) under hemodialysis ( 4.4±4.3y ) were r and omly assigned to exercise and control groups . INTERVENTION Patients included in the exercise group underwent a moderate-intensity intradialytic aerobic training program 3 times per week for 12 weeks . MAIN OUTCOME MEASURES Cardiopulmonary and perceptual responses were obtained during an IWR and a high-intensity CWR test to the limit of tolerance on a cycle ergometer . RESULTS Training-induced increases in peak oxygen uptake ( Vo(2)peak ) and time to exercise intolerance ( Tlim ) . Mean improvement in Tlim ( 97.4%±75.6 % ) was significantly higher than increases in Vo(2)peak ( 12%±11.3 % ) ( P<.01 ) ; in fact , while Tlim improved 50 % to 200 % in 9 of 12 patients , Vo(2)peak increases were typically in the 15 % to 20 % range . CWR test revealed lower metabolic , ventilatory , cardiovascular , and subjective stresses at isotime ; in contrast , submaximal responses during the incremental work rate ( at the gas exchange threshold ) remained unaltered after training . CONCLUSIONS A laboratory-based measure of endurance exercise capacity ( high-intensity CWR test to Tlim ) was substantially more sensitive than oxygen uptake at the peak IWR test to unravel the physiologic benefits of an intradialytic aerobic training program in mildly impaired patients with ESRD Introduction Literature shows that patients undergoing hemodialysis present poor physical conditioning and low tolerance to exercise . They may also suffer from respiratory dysfunctions . The purpose of this study was to evaluate the effects of neuromuscular electrical stimulation on pulmonary function and functional capacity of patients with chronic kidney disease on hemodialysis . Methods Forty adult patients with chronic kidney disease on hemodialysis were prospect ively studied and r and omized into two groups ( control n = 20 and treatment n = 20 ) . The treatment group underwent bilateral femoral quadriceps muscles electrical stimulation for 30 minutes during hemodialysis , three times per week , for two months . The patients were evaluated by pulmonary function test , maximum respiratory pressures , maximum one-repetition test , and six-minute walk test ( 6MWT ) , before and after the treatment protocol . Results The treatment group presented increased maximum inspiratory ( MIP ) ( p = 0.02 ) and expiratory pressures ( MEP ) ( p < 0.0001 ) , muscular strength in maximum one-repetition test ( p < 0.001 ) , and distance covered in the 6MWT ( p = 0.03 ) , and decreased systolic blood pressure ( p < 0.001 ) and respiratory frequency ( p < 0.001 ) when compared with the control group . Conclusion Electrical neuromuscular stimulation had a positive impact on pulmonary function and functional capacity , leading to better physical performance in patients on hemodialysis Functional capacity of end-stage renal disease patients is dramatically impaired . Although exercise training programs appear to have beneficial morphological , functional and psychosocial effects in end-stage renal disease patients on hemodialysis ( HD ) , the adherence rate is high . The purpose of this study was to compare the effects of three modes of exercise training on aerobic capacity and to identify the most favourable , efficient and preferable to patients on HD with regard to functional improvements and participation rate in the programs . Fifty-eight volunteer patients were screened for low-risk status and selected from the dialysis population . The 48 patients who completed the study protocol were r and omly assigned either to one of the three training groups or to a control group . Sixteen of them ( Group A - mean age 46.4+/-13.9 years ) completed a 6-month supervised outpatient exercise renal rehabilitation program consisting of three weekly sessions of aerobic and strengthening training on the non-dialysis days ; 10 ( Group B - mean age 48.3+/-12.1 years ) completed a 6-month exercise program during HD ; 10 ( Group C - mean Output:	Thus , intradialytic exercise protocol s can improve cardiopulmonary function , exercise tolerance and ventilatory efficiency in chronic kidney disease patients
MS21106	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A number of pharmacologic treatments examined in recent r and omized clinical trials ( RCTs ) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated . Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies , such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ( “ assay sensitivity ” ) . Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development . Therefore , an Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was review ed and discussed . On the basis of this meeting and subsequent discussion s , the authors recommend consideration of a number of patient , study design , study site , and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments . Increased attention to and research on method ological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence ‐based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety In complex regional pain syndrome ( CRPS ) many clinical symptoms suggest involvement of the central nervous system . Neuropathic pain as the leading symptom is often resistant to therapy . In the present study we investigated the analgesic efficiency of repetitive transcranial magnetic simulation ( rTMS ) applied to the motor cortex contralateral to the CRPS-affected side . Seven out of ten patients reported decreased pain intensities . Pain relief occurred 30 s after stimulation , whereas the maximum effect was found 15 min later . Pain re-intensified increasingly 45 min after rTMS . In contrast , sham rTMS did not alter pain perception . These findings provide evidence that in CRPS I pain perception can be modulated by repetitive motor cortex stimulation The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials Output:	Cossins et al. , ( 2012 ) conclude that there is strong evidence that a number of treatments are effective . Further , where statistically significant results are robust , the true treatment effect may still be clinical ly trivial . For example , the authors conclude that there is strong evidence that repetitive transcranial magnetic stimulation ( rTMS ) is effective . Indeed , generally , in chronic pain , there is reason to doubt that rTMS delivers clinical ly meaningful reductions in pain ( O’Connell et al. , 2010 ) . In our view , while some treatments hold promise , there is currently no intervention for CRPS that can be considered to be supported by strong evidence of efficacy ; although we agree that the evidence is strong that intravenous regional blockade with guanethidine is ineffective .
MS21107	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE The purpose of this study was to evaluate three ventilator weaning strategies and to evaluate whether the use of continuous positive airway pressure ( CPAP ) via a nasopharyngeal or endotracheal tube would increase the likelihood of extubation failure in very low birth weight ( VLBW ) infants . STUDY DESIGN We studied prospect ively 87 preterm infants ( mean + /- SD ; birth weight : 1078 + /- 188 g ; gestational age : 28.8 + /- 2.2 weeks ) who were in the process of being weaned from intermittent m and atory ventilation ( IMV ) . Infants were assigned by systematic sampling to one of the following three treatment groups : ( 1 ) direct extubation from IMV ( D.EXT ) ( n = 30 ) ; ( 2 ) preextubation endotracheal CPAP ( ET-CPAP ) for 12 - 24 hr ( n = 28 ) ; or ( 3 ) postextubation nasopharyngeal CPAP ( NP-CPAP ) for 12 - 24 hr ( n = 29 ) . Failure was defined as the need for resumption of mechanical ventilation within 72 hr of extubation due to frequent or severe apnea and /or respiratory failure ( pH < 7.25 , PaCO2 > 60 mm Hg , and /or requirement for oxygen FiO2 > 60 % ) . RESULTS There were no significant differences in failure rates among the three procedures . Failures were 2/30 ( 7 % ) in D.EXT ; 4/28 ( 14 % ) in ET-CPAP ; and 7/29 ( 24 % ) in the NP-CPAP . There were also no differences in FiO2 , PaO2 , and respiratory rates before and after discontinuation of IMV among the three groups . PaCO2 values were slightly higher in the NP-CPAP group 12 - 24 hr after weaning from IMV . CONCLUSION We were unable to demonstrate a clear difference in extubation outcome by use of CPAP administered via an endotracheal or nasopharyngeal tube when compared to direct extubation from low-rate IMV in VLBW infants AIM To determine whether extubation to nasal continuous airway pressure ( NCPAP ) results in a greater proportion of infants remaining free of additional ventilatory support for one week after extubation compared with those extubated directly to headbox oxygen . METHODS A r and omised , controlled , clinical trial was conducted at the neonatal intensive care unit of the Royal Women ’s Hospital , Melbourne , of infants with birthweights between 600 and 1250 g , ventilated via an endotracheal tube for more than 12 hours , requiring less than 50 % oxygen , a ventilator rate ⩽ 20/minute , considered by the clinical management team to be ready for extubation . Infants were r and omly allocated either to NCPAP or to oxygen administered via a headbox . Success was defined by no requirement for additional ventilatory support over the week following extubation . Failure criteria were ( i ) apnoea ; ( ii ) absolute increase in oxygen requirement greater than 15 % above that required before extubation ; or ( iii ) respiratory acidosis ( pH<7.25 with pCO2 > 6.67 kPa ) . RESULTS Thirty one of 47 ( 66 % ) infants were successfully extubated to NCPAP compared with 18 of 45 ( 40 % ) for headbox oxygen . The increase in failure rate in the headbox group was due primarily to increased oxygen requirements in this group . Of the 27 who failed headbox oxygen , 26 were given a trial of NCPAP and 13 did not require endotracheal reintubation . There was no significant difference between the groups in the total number of days of assisted ventilation or the duration of inpatient stay . CONCLUSIONS NCPAP applied prophylactically after endotracheal extubation reduces the incidence of adverse clinical events that lead to failure of extubation in the seven days after extubation . This reduction is clinical ly important . The benefits of NCPAP do not seem to be associated with an increased incidence of unwanted side effects Sixty infants ( median gestational age 29 weeks ) with acute and 60 infants ( median gestational age 25 weeks ) with chronic respiratory distress were r and omised to be extubated either directly into a headbox or onto 3 cm H2O nasal continuous positive airway pressure ( CPAP ) . Our aim was to test the hypothesis that extubation onto nasal CPAP rather than directly into a headbox was more likely to be associated with successful extubation in infants with acute rather than chronic respiratory distress . Overall the failure rate of extubation was approximately 33 % , with no significant difference between the infants with acute and chronic respiratory distress . There was no significant difference in the failure rate of extubation among infants r and omised to receive nasal CPAP or headbox oxygen in either the acute or chronic respiratory distress groups We conducted a prospect i ve , r and omized controlled trial to determine whether extubation of very low birth weight infants was facilitated by the use of nasopharyngeal continuous positive airway pressure ( CPAP ) . Eligible infants included patients weighing 600 to 1500 gm at birth who required tracheal intubation within 48 hours of birth and who met specific predetermined criteria for extubation by day 14 of life . We also sought to determine whether varying the duration of nasopharyngeal CPAP influenced the likelihood of successful extubation . Infants underwent r and om assignment to receive nasopharyngeal CPAP until resolution of lung disease ( n = 40 ) , 6 hours of nasopharyngeal CPAP ( n = 42 ) , or oxygen supplementation delivered by hood ( n = 42 ) . Extubation failure was predefined as a requirement for > or = 80 % oxygen , pH < or = 7.20 , severe apnea , or predefined clinical deterioration , and extubation success was predefined as the ability to remain free of a requirement for mechanical ventilation for 7 days and a 66 % reduction in the need for supplemental oxygen . Each group was similar with regard to race , sex , and birth weight . Extubation was successful in 62 % , 61 % , and 60 % of infants . After stratification by birth weight , there were no significant differences in the rates of successful extubation among the treatment groups . We conclude that nasopharyngeal CPAP does not improve the likelihood of successful extubation of very low birth weight infants who are ready for extubation within the first 2 weeks of life AIM To determine if a weaning regimen on flow driver continuous positive airway pressure ( CPAP ) would decrease the number of ventilator days but increase the number of CPAP days when compared with a rescue regimen . METHODS Fifty eight babies of 24–32 weeks gestation with respiratory distress syndrome ( RDS ) were studied prospect ively . After extubation they were r and omly allocated to receive CPAP for 72 hours ( n=29 ) according to a weaning regimen , or were placed in headbox oxygen and received CPAP only if preset “ start CPAP ” criteria were met ( n=29 , rescue group ) . RESULTS There was no difference in successful extubation at 72 hours , 1 and 2 weeks , between the groups in terms of the number of reventilation episodes , reventilation days , or in total days of CPAP . Birthweight , gestational age , race , day of first extubation , antenatal or postnatal steroids , patent ductus arteriosus status and maximal mean airway pressure used were of no value in predicting success or failure at 72 hours , 1 , or 2 weeks . CONCLUSION The weaning regimen did not decrease the number of ventilator days or days on CPAP compared with the rescue regimen . The rescue regimen on flow driver CPAP seems to be a safe and effective method of managing a baby of 24–32 weeks gestation who has been ventilated for RDS or immature lung disease Using a preset protocol for early extubation , 50 babies were r and omly selected to post-extubation headbox or post-extubation nasal continuous positive airway pressure ( N-CPAP ) . All infants weighed less than 1500 g , had a gestational age of less than 34 weeks , and had been weaning from mechanical ventilation within seven days of life . The criteria for extubation included stable condition , fraction of inspired oxygen ( FIO2 ) of < or = 35 % , peak inspiratory pressure ( PIP ) of < or = 15 cm H2O ( 1.47 kPa ) , and ventilator rate of 6/minute . Before extubation , a loading dose of aminophylline was given followed by maintenance treatment . If reintubation was not required within 72 hours of the initial extubation the procedure was considered successful . The reintubation criteria included FIO2 > or = 70 % to maintain arterial oxygen tension ( PaO2 ) of > or = 50 mm Hg ( 6.67 kPa ) or pulse oximetry between 90 - 96 % and pH of < 7.25 , and arterial carbon dioxide tension ( PACO2 ) of > 60 mm Hg ( 8.00 kPa ) and severe or recurring apnoea . The overall success rate of early extubation was 66 % ( 33/50 ) . The individual successful extubation rate of post-extubation in the N-CPAP group and the post-extubation headbox group were 84 % ( 21/25 ) and 48 % ( 12/25 ) , respectively ( p = 0.017 ; chi 2 ) . There were no significant differences in clinical characteristics between the two groups . The most common cause of failure in early extubation was apnoea , and most occurred in the headbox group ( 9/12 ) . These results suggest that application of N-CPAP to a preset protocol for extubation can achieve a better success rate of early extubation in very low birthweight ( VLBW ) infants Nasal continuous positive airway pressure ( N-CPAP ) , applied immediately after extubation , was prospect ively evaluated in 18 neonates recovering from respiratory distress syndrome . Patients were r and omly assigned to N-CPAP ( group 1 , N=9 ) or a control group given oxygen by hood ( group 2 , N=9 ) . Groups were comparable in birth weight and duration of intubation . In the 24-hour period following extubation , group 1 showed a significantly lower mean respiratory rate ( 46 + /- 2 vs 74 + /- 4 ) , alveolar-arterial oxygen gradient ( 94 + /- 9 vs 134 + /- 12 mm Hg ) , PCO2 ( 45 + /- 1 vs 50 + /- 1 mm Hg ) , higher pH ( 7.33 + /- 0.01 vs 7.30 + /- 0.01 ) , and less atelectasis by roentgenographic scores . This was associated with considerably better clinical courses in group 1 when compared with group 2 , in which six patients required a late trial of N-CPAP because of respiratory deterioration and two patients needed reintubation . Postextubation N-CPAP has a striking beneficial effect on respiratory function and prevention of atelectasis A prospect i ve r and omized trial was performed in 58 neonates comparing nasal continuous positive airway pressure ( NCPAP ) vs oxyhood following extubation of neonates weighing less than 1 kg . All neonates had been ventilated for the treatment of respiratory distress syndrome for at least 24 hours and weighed less than 1 kg at the time of extubation . Clinical criteria for elective extubation included improving pulmonary status , fraction of inspired oxygen ( FIO2 ) less than or equal to 0.35 , mean airway pressure less than or equal to 7 cm H2O , ventilator rate less than or equal to 20 breaths per minute , and weight at least 80 % of birth weight . Informed consent was obtained and neonates were r and omized to NCPAP or oxyhood following extubation . Success was defined as remaining free of additional ventilatory support for at least 5 days . Failure criteria included FIO2 greater than or equal to 0.60 to maintain pulse oximetry greater than or equal to 93 % , PaCO2 greater than or equal to 60 mm Hg , pH less than or equal to 7.23 , or moderate to severe apnea . Results demonstrate that 22 ( 76 % ) of 29 neonates were successfully extubated to NCPAP while only 6 ( 21 % ) of 29 were successfully extubated to oxyhood ( P less than .0001 ) . There were no differences in baseline characteristics between the two groups . Of the 23 neonates who failed oxyhood , 21 were then given a trial of NCPAP and 58 % ( 12/21 ) remained extubated . Data indicate that using selected clinical criteria for elective extubation of neonates weighing less than 1 kg , NCPAP facilitates successful extubation Output:	MAIN RESULTS Nasal CPAP , when applied to preterm infants being extubated following IPPV , reduces the incidence of adverse clinical events ( apnea , respiratory acidosis and increased oxygen requirements ) indicating the need for additional ventilatory support . A reduction in the incidence of chronic lung disease at 28 days of age is also seen in the group extubated to NCPAP . REVIEW ER 'S CONCLUSIONS IMPLICATION S FOR PRACTICE nasal CPAP is effective in preventing failure of extubation and reducing oxygen use at 28 days of life in preterm infants following a period of endotracheal intubation and IPPV .
MS21108	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: With an increase in the presence of students with autism spectrum disorder ( ASD ) in the general physical education ( GPE ) classroom , underst and ing the current state of GPE teachers ' beliefs and behaviors for including these students is warranted . The current study aim ed to examine the beliefs and self-reported behaviors of GPE teachers ' inclusion of students with ASD . In addition , the study examined potential factors affecting their inclusion behaviors . Using a national stratified r and om sample , participants were 142 current GPE teachers who su bmi tted surveys anonymously online . Results from a regression analysis indicate that teachers ' experience , graduate coursework in adapted physical education ( APE ) , and perceptions of strength in undergraduate training in APE significantly predicted their self-reported behavior for including students with ASD . Although the participant response rate is considerably low , this study provides some support toward the importance of teacher education programs for inclusion training The study investigated the effects of a Special Olympics ( SO ) Unified Sport ( UNS ) soccer program on anthropometry , physical fitness and soccer skills of male youth athletes with and without intellectual disabilities ( ID ) who participated in a training group ( TRG ) and in a comparison group ( CG ) without specific training . Youth with ID ( WID ) were r and omly selected out of all the students between the ages 12 and 15 , with a diagnosis of educable mental retardation and no secondary disabilities , who were attending a special education school . Participants without ID ( WoID ) were r and omly selected from a regular secondary school out of the same age groups of male students . All participants were given permission by their parents or guardians to participate in the study . Participants in the TRG included 23 youth WID and 23 youth WoID . Mean ages were = 14.1 ( SD = 1.1 ) and 13.2 ( SD = 0.79 ) respectively . Fifteen WID , and 15 WoID comprised the CG . Mean ages were 14.51 ( SD = 0.81 ) and 13.78 ( SD = 0.49 ) respectively . Prior to and following the program measurements were conducted , and data were collected on students ' anthropometric and fitness components of the Brockport physical fitness test as well as a soccer skill performance based on the SO soccer skill test . Participants in the TRG trained 8 weeks , 1.5h per session , three times per week , in an after-school soccer program . CG did not participate in any sports program outside of the school physical education class . Dependent t tests and effect size calculations revealed that SO athletes and non-disabled partners scored significantly higher with regard to physical fitness and football skills in most variables compared with their CG . This Unified Program was successful in increasing fitness and soccer skill performance of youth WID as well as of those WoID The purpose of this study was to explore the effect of two awareness programs ( 6-day vs. 1-day programs ) on children 's attitudes toward peers with a visual impairment . Three hundred and forty-four Spanish physical education students ( 164 girls and 180 boys ) aged 10–15 years , took part in the study . A modified version of the Attitudes Toward Disability Question naire ( ATDQ ) was used , which includes three sub-scales : ( i ) cognitive perceptions , ( ii ) emotional perception , and ( iii ) behavioral readiness to interact with children with disabilities . The question naire was filled out during the regular physical education class before and immediately after the awareness activity . The 6-day didactical unit included a lecture on visual impairments and a video describing visual impairments and the game of 5-a-side soccer ( first lesson ) , sensibilization activities toward visual impairment ( second and third lessons ) , training and competitive 5-a-side soccer tasks using blindfolded goggles ( fourth and fifth lessons ) , and a sport show and chat with soccer players with a visual impairment ( sixth lesson ) . The 1-day awareness unit only included the final session of the didactical activity . Repeated measures analysis of variance revealed significant time effects in the cognitive , emotional , and behavioral subscales . Sex also was found to demonstrate significant effects , in which women showed more favorable results than men . A time-by-group intervention effect was only demonstrated in the cognitive sub-scale , and the 6-day didactic intervention was more effective than the 1-day awareness unit . Zweck dieser Studie war die Untersuchung der Wirkung von zwei Bewusstseinsschulungen ( 6-Tage-Schulung ggü . 1-Tages-Schulung ) auf die Haltung von Kindern gegenüber sehbehinderten Gleichaltrigen . An der Studie nahmen insgesamt 344 spanische Sportstudenten ( 164 Mädchen und 180 Jungen ) i m Alter von 10–15 Jahren teil . Dazu wurde eine modifizierte Version des ATDQ-Fragebogens ( Haltungen gegenüber Behinderungen ) zu Hilfe gezogen , die die folgenden drei Subskalen umfasst : ( i ) kognitive Wahrnehmung , ( ii ) emotionale Wahrnehmung und ( iii ) intendiertes Verhalten bei der Kommunikation mit Kindern mit Behinderungen . Der Fragebogen wurde i m Rahmen des üblicherweise stattfindenden Sportunterrichts vor und unmittelbar nach der Bewusstseinsaktivität ausgefüllt . Die 6-tägige Didaktikschulung umfasste einen Vortrag über Sehbehinderungen und ein Video mit Erklärungen zu Sehbehinderungen sowie 5er Fußball ( erste Stunde ) , Sensibilisierungsaktivitäten speziell bei Sehbehinderungen ( zweite und dritte Stunde ) , Training und 5er Fußballturnier mit lichtundurchlässiger Brille ( vierte und fünfte Stunde ) und eine Sportshow und ein Gespräch mit sehbehinderten Fußballspielern ( sechste Stunde ) . Die 1-tägige Bewusstseinsschulung umfasste nur die letzte Stunde der Didaktikaktivität . Varianzanalysen für Messwiederholungen deckten signifikante Zeitwirkungen in den kognitiven , emotionalen und verhaltensgesteuerten Subskalen auf . Sex wies auch signifikante Wirkungen auf , wobei Frauen positivere Ergebnisse aufwiesen als Männer . Ein Interventions effekt ( Zeit x Gruppe ) konnte nur in der kognitiven Subskala nachgewiesen werden , und die 6-tägige Didaktikintervention erwies sich als effektiver als die 1-tägige Bewusstseinsschulung . El objetivo de este trabajo es analizar el efecto de dos programas educativos ( 6 vs. 1 día ) sobre las actitudes hacia compañeros con discapacidad visual . Participaron 344 estudiantes españoles de educación física ( 164 chicas y 189 chicos ) , con edades comprendidas entre los 10 y 15 años . Se empleó una versión modificada del Cuestionario de Actitudes hacia la Discapacidad , el cual incluye tres sub-escalas : ( i ) idea , ( ii ) emoción , y ( iii ) predisposición a la acción para interactuar con personas con discapacidad . Los cuestionarios fueron cumplimentados durante las clases de educación física , antes y después del inicio de cada uno de los programas desarrollados . La unidad didáctica de 6 sesiones incluye una charla informativa acerca de la discapacidad visual y una videoproyección de fútbol a 5 ( 1a sesión ) , actividades de sensibilización hacia la discapacidad visual ( sesiones 2 y 3 ) , juegos de entrenamiento y aprendizaje del fútbol a 5 con gafas de privación sensorial ( sesiones 4 y 5 ) , y una demostración del deporte con una charla posterior con los jugadores asistentes ( 6a sesión ) . La actividad docente de 1 día incluye sólo la última de las sesiones indicadas . El análisis ANOVA de medidas repetidas muestra mejoras en los tres componentes de la actitud tras la aplicación de los programas . También se han encontrado diferencias en función del sexo de los alumnos , con actitudes más favorables por parte de las chicas . El análisis intra-grupo por género mostró efectos en el componente de idea , demostr and o que el programa de 6 sesiones era más efectivo que el de 1 día . Cette étude avait pour objet d'explorer l'effet de deux programmes de sensibilisation ( programmes de 6 jours et d'1 jour ) à l'attitude des enfants vis-à-vis de leurs pairs souffrant de déficience visuelle . Trois cent quarante-quatre élèves espagnols en classes d'éducation physique ( 164 filles et 180 garçons ) âgés de 10 à 15 ans ont participé à l'étude . Une version modifiée du question naire d'attitude à l'égard des personnes h and icapées ( ATDQ ) a été utilisée , qui comprenait trois sous-échelles : ( i ) les perceptions cognitives , ( ii ) la perception des émotions , et ( iii ) la volonté comportementale d'interagir avec les enfants h and icapés . Le question naire a été rempli durant les classes d'éducation physique régulières avant et immédiatement après l'activité de sensibilisation . L'unité didactique de 6 jours comprenait une conférence sur les déficiences visuelles et une vidéo décrivant les déficiences visuelles et le jeu de football à 5 ( première leçon ) , des activités de sensibilisation aux déficiences visuelles ( deuxième et troisième leçons ) , un entraînement et des activités de football à 5 compétitives avec des lunettes bloquant la vue ( quatrième et cinquième leçons ) , et une démonstration sportive et un débat avec des joueurs de football souffrant de déficiences visuelles ( sixième leçon ) . L'unité de sensibilisation d'1 journée incluait seulement la dernière séance de l'activité didactique . Des analyses de variance répétées des mesures ont révélé des effets temporels significatifs sur les sous-échelles cognitives , émotionnelles et comportementales . Le sexe s'est révélé un facteur déterminant , les filles présentant des résultats plus favorables que les garçons . Un effet d'intervention de temps par groupe n'a été démontré que sur la sous-échelle cognitive , et l'intervention didactique de 6 jours a été plus efficace que l'unité de sensibilisation d'1 journée Output:	The main findings indicated that perspectives of pre- and in-service teachers and studies of attitudes still dominate the research contributions .
MS21109	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIMS To determine the effect of trophic feeding on clinical outcome in ill preterm infants . METHODS A r and omised , controlled , prospect i ve study of 100 preterm infants , weighing less than 1750 g at birth and requiring ventilatory support and parenteral nutrition , was performed . Group TF ( 48 infants ) received trophic feeding from day 3 ( 0.5–1 ml/h ) along with parenteral nutrition until ventilatory support finished . Group C ( 52 infants ) received parenteral nutrition alone . “ Nutritive ” milk feeding was then introduced to both groups . Clinical outcomes measured included total energy intake and growth over the first six postnatal weeks , sepsis incidence , liver function , milk tolerance , duration of respiratory support , duration of hospital stay and complication incidence . RESULTS Groups were well matched for birthweight , gestation and CRIB scores . Infants in group TF had significantly greater energy intake , mean difference 41.4 ( 95 % confidence interval 9 , 73.7 ) kcal/kg p=0.02 ; weight gain , 130 ( CI 1 , 250 ) g p = 0.02 ; head circumference gain , mean difference 0.7 ( CI 0.1 , 1.3 ) cm , p = 0.04 ; fewer episodes of culture confirmed sepsis , mean difference −0.7 ( −1.3 , −0.2 ) episodes , p = 0.04 ; less parenteral nutrition , mean difference −11.5 ( CI −20 , −3 ) days , p = 0.03 ; tolerated full milk feeds ( 165 ml/kg/day ) earlier , mean difference −11.2 ( CI −19 , −3 ) days , p = 0.03 ; reduced requirement for supplemental oxygen , mean difference −22.4 ( CI−41.5 , −3.3 ) days , p = 0.02 ; and were discharged home earlier , mean difference −22.1 ( CI −42.1 , −2.2 ) days , p = 0.04 . There was no significant difference in the relative risk of any complication . CONCLUSIONS Trophic feeding improves clinical outcome in ill preterm infants requiring parenteral nutrition . Key messages Timing of the introduction of milk feeds in sick low birthweight infants is controversial . Almost all infants with non-surgical illness can tolerate at least some milk as trophic feeds . Trophic feeding leads to improved energy intake , weight gain , milk tolerance , less sepsis and earlier hospital discharge . No increase in major complication rate is seen following trophic feeding A study was performed to determine if the addition of a fortifier to expressed breast milk ( EBM ) affected gastric emptying in low birthweight infants . Using ultrasonography , the gastric emptying of EBM alone was compared with that containing a fortifier , in a blind , crossover study . Twenty two low birthweight infants were studied : median ( range ) gestation 31.5 weeks ( 28 - 37 ) ; birthweight 1495 g ( 1000 - 2480 g ) . The gastric antral cross-sectional area ( ACSA ) was measured by ultrasonography before each feed and then sequentially after its completion until the ACSA returned to its pre-feed value . The half emptying time was calculated as the time taken for the ACSA to decrease to half the maximum increment . The mean difference ( st and ard error ) between half emptying times for EBM alone and for EBM with added fortifier was not significant : 1.48 ( 4.9 ) minutes . These data show that fortifying breast milk does not affect gastric emptying and suggests that the practice is unlikely to affect feed tolerance in low birthweight infants BACKGROUND Preterm children are at high risk of poor growth performance . In 2 r and omized trials , preterm infants fed preterm formula grew better in the neonatal period than those fed banked donor breast milk or st and ard term formula . OBJECTIVE Our objective was to test the hypothesis that for preterm infants , the neonatal period is a critical one for programming growth performance and that early diet influences long-term growth . DESIGN A total of 926 preterm infants were recruited into 2 parallel , r and omized trials of neonatal diet . In trial 1 , infants were fed either banked donor breast milk or preterm formula whereas in trial 2 , infants were fed either st and ard term formula or preterm formula . Within each trial , the allocated milk was the sole diet for some infants ( study A ) , whereas for others it was a supplement to maternal breast milk , given when not enough expressed breast milk was available ( study B ) . We followed up 781 of 833 survivors ( 94 % ) to age 7.5 - 8 y. Trained assessors obtained anthropometric measurements according to a st and ard protocol . RESULTS Despite significantly better neonatal growth performance in infants fed preterm formula ( compared with either banked donor breast milk or st and ard formula ) , early diet had no influence on weight , height , head circumference , or skinfold thicknesses at 9 or 18 mo postterm or at age 7.5 - 8 y. CONCLUSIONS These findings suggest that the preterm period is not a critical window for nutritional programming of growth , which contrasts with evidence from these trials showing that early diet influences later neurodevelopment Despite potential benefits , human milk may fail to meet preterm infants ' nutrient requirements . We tested the hypothesis that fortified breast milk , fed alone or with preterm formula , would improve neurodevelopment and growth at 18-mo follow-up without adverse short-term clinical or biochemical consequences . Two hundred seventy-five preterm infants from two medical centers ( birth weight < 1850 g ; mean gestation 29.8 + /- 2.7 wk ) whose mothers chose to provide breast milk were r and omly assigned to receive for a mean of 39 d a multinutrient fortifier or control supplement containing phosphate and vitamins . Breast milk comprised 47.6 % and 46.4 % of enteral intake in fortified and control groups , respectively ; preterm formula supplements were used when insufficient breast milk was available . Overall , there were no significant growth advantages with fortification ; although , when breast milk exceeded 50 % of intake , fortification promoted faster weight gain ( an advantage of 1.6 g.kg-1.d-1 ; 95 % CI : 0.1 , 3.1 ; P < 0.05 ) . Compared with control infants , the fortified group showed 1 ) higher plasma urea from week 2 ( P = 0.04 ) , 2 ) higher plasma calcium ( mean 2.34 + /- 0.01 compared with 2.27 + /- 0.02 mmol/L ; P = 0.003 ) , 3 ) a greater rise in alkaline phosphatase by week 6 ( P = 0.04 ) , 4 ) more clinical infections ( suspected plus proven ; 43 % compared with 31 % , P = 0.04 ) , 5 ) a nonsignificantly increased incidence of necrotizing enterocolitis ( 5.8 % compared with 2.2 % , P = 0.12 ) , and 6 ) higher white cell and platelet counts . Developmental scores at 18 mo were slightly but not significantly higher in the fortified group . This study confirmed that breast milk fortifiers can improve short-term growth ( when breast milk intakes are high ) ; but beneficial effects on long-term development remained unproven . Future research is required to evaluate potential adverse consequences and explore more optimal fortification strategies OBJECTIVE To compare the effects of continuous versus intermittent feedings on physical growth , gastrointestinal tolerance , and macronutrient retention in very low birth weight infants ( < 1500 gm ) . STUDY DESIGN Very low birth weight neonates stratified by birth weight were r and omly assigned to either continuous ( 24-hour ) or intermittent ( every 3 hours ) nasogastric feedings . Feedings with half-strength Similac Special Care formula were initiated between day 2 and 3 and were advanced isoenergetically to goal . Daily weights , volume/caloric intakes , weekly anthropometric and dynamic skin-fold thickness measurements , and data on feeding milestones and clinical complications were collected . Nitrogen , carbohydrate , and fat balance studies were performed on a subset of male subjects . RESULTS Eighty-two neonates with birth weights between 750 and 1500 gm who were born between 27 and 34 weeks of gestation were r and omly assigned to continuous ( n = 42 ) and intermittent ( n = 40 ) feeding groups . There were no significant differences in baseline demographics and severity of respiratory distress between groups . There were no significant differences in days to regain birth weight , days to full enteral feedings , days to discharge , and discharge anthropometric measurements between continuously fed and intermittently fed infants , both when evaluated together and according to 250 gm weight intervals . Retention rates of nitrogen , fat , total carbohydrate , and lactose were comparable in the continuously fed ( n = 17 ) and intermittently fed ( n = 13 ) male neonates . Very low birth weight neonates who were fed continuously did not have feeding-related complications . CONCLUSION Very low birth weight infants achieve similar growth and macronutrient retention rates and have comparable lengths of hospital stay whether they are fed with continuous or intermittent feedings OBJECTIVE To test the hypothesis that very low birth weight infants fed by continuous nasogastric gavage ( CNG ) would achieve full enteral feedings ( 100 kcal/kg/d ) at an earlier postnatal age and have less feeding intolerance ( FI ) than infants fed by intermittent bolus gavage ( IBG ) . METHODS Eighty infants were stratified by birth weight ( 700 to 1000 g and 1001 to 1250 g ) and r and omized into CNG or IBG feeding groups . CNG infants were comparable with IBG in birth weight , gestational age , sex , race , and day of onset of feeding ( 5.7 + /- 2.1 days vs 5.6 + /- 2.2 days , respectively ) . Feedings were given as undiluted Similac Special Care formula ( Ross Laboratories , Columbus , OH ) via a specific protocol design ed for each 50 to 100 g birth weight category . Feedings were advanced isoenergetically by a maximum of 25 mL/kg/d until an endpoint of 100/kcal/kg/d for at least 48 hours was reached . An infant whose feedings were withheld for > 12 hours based on predetermined criteria was considered to have an episode of FI . RESULTS Infants in the CNG group reached full enteral feeding at 17.1 + /- 8.9 days compared with 15.5 + /- 5.5 days in the IBG group ; these were not statistically different . Secondary outcome variables such as days to regain birth weight ( CNG , 12.6 + /- 5 days vs IBG , 12.5 + /- 3.7 days ) , days to reach discharge weight of 2040 g ( CNG , 60 + /- 13.4 days vs IBG , 62 + /- 13.6 days ) , and number of episodes of FI were not significantly different between feeding methods . FI was primarily associated with birth weight < /=1000 g ( 71 % ) vs 1001 to 1250 g ( 38 % ) . CONCLUSION Feeding methods are associated with similar outcomes when feeding regimens are comparable Forty three infants under 1400 g were fed by a bolus nasogastric , continuous nasogastric , or transpyloric route . There were more complications with transpyloric feeding and no identifiable benefits in the growth rate , oral energy input , or chosen biochemical indices of nutrition . Bolus or continuous nasogastric feeds rather than transpyloric are better routine methods in infants of low birth weight In a prospect i ve multicentre study on 926 preterm infants formally assigned to their early diet , necrotising enterocolitis developed in 51 ( 5.5 % ) . Mortality was 26 % in stringently confirmed cases . In exclusively formula-fed babies confirmed disease was 6 - 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk . Pasteurised donor milk seemed to be as protective as raw maternal milk . Among babies born at more than 30 weeks ' gestation confirmed necrotising enterocolitis was rare in those whose diet included breast milk ; it was 20 times more common in those fed formula only . Other risk factors included very low gestational age , respiratory disease , umbilical artery catheterisation , and polycythaemia . In formula-fed but not breast-milk-fed infants , delayed enteral feeding was associated with a lower frequency of necrotising enterocolitis . With the fall in the use of breast milk in British neonatal units , exclusive formula feeding could account for an estimated 500 extra cases of necrotising enterocolitis each year . About 100 of these infants would die Whether breast milk influences later neurodevelopment has been explored in non-r and omised studies , potentially confounded by social and demographic differences between feed groups . Here in a strictly r and omised prospect i ve multicentre trial , Bayley psychomotor and mental development indices ( PDI and MDI ) were assessed at 18 months postterm in survivors of 502 preterm infants assigned to receive , during their early weeks , mature donor breast milk or a preterm formula . These diets were compared as sole enteral feeds or as supplements to the mother 's expressed breast milk . No differences in outcome at 18 months were Output:	On the other h and , enteral feeding ( with milk , not water2 ) in the first five days of life promotes endocrine adaptation and the maturation of motility patterns,3 provides luminal nutrient , and probably benefits immune function.4Potential clinical benefits are therefore earlier tolerance of enteral feeds , reduced risk of infection , and earlier discharge . A systematic review of studies published to 1997 concluded that it reduced
MS21110	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE We aim ed to assess the health impact of a national control programme targeting schistosomiasis and intestinal nematodes in Ug and a , which has provided population -based anthelmintic chemotherapy since 2003 . METHODS We conducted longitudinal surveys on infection status , haemoglobin concentration and clinical morbidity in 1871 r and omly selected schoolchildren from 37 schools in eight districts across Ug and a at three time points - before chemotherapy and after one year and two years of annual mass chemotherapy . FINDINGS Mass treatment with praziquantel and albendazole led to a significant decrease in the intensity of Schistosoma mansoni - 70 % ( 95 % confidence interval ( CI ) : 66 - 73 % ) after one year and 82 % ( 95 % CI : 80 - 85 % ) after two years of treatment . Intensity of hookworm infection also decreased ( 75 % and 93 % ; unadjusted ) . There was a significant increase in haemoglobin concentration after one ( 0.135 g/dL ( 95 % CI : 0.126 - 0.144 ) ) and two years ( 0.303 g/dL ( 95 % CI : 0.293 - 0.312 ) ) of treatment , and a significant decrease in signs of early clinical morbidity . The impact of intervention on S. mansoni prevalence and intensity was similar to that predicted by mathematical models of the impact of chemotherapy on human schistosomiasis . Improvements in haemoglobin concentration were greatest among children who were anaemic or harbouring heavy S. mansoni infection at baseline . CONCLUSION Anthelmintic treatment delivered as part of a national helminth control programme can decrease infection and morbidity among schoolchildren and improve haemoglobin concentration OBJECTIVE To study the role of health education and community participation for the provision of facilities necessary for the control of urinary schistosomiasis in southern Ghana . HYPOTHESIS Health education facilitates community participation in the provision of facilities for the control of bilharzia . STUDY AREA Three rural communities drained by the Densu river in southern Ghana . PARTICIPANTS Individuals aged 14 years and above formed groups of 10 - 12 persons by age , sex , ethnic and educational background ; 15 - 16 groups were formed . INTERVENTIONS Based on existing structures , one community received active , another passive health education and the third had no education . All three communities received chemotherapy . DESIGN Study was carried out in three phases : pre-intervention phase -- during which baseline data on residents ' knowledge , attitude , beliefs and perception about bilharzia were collected using focus group discussion s ( FGD ) prior to the second phase , intervention . Another FGD was held after 18 months to evaluate the intervention -- third phase . RESULTS This study suggests that most community members were aware of schistosomiasis but not as a disease . Before the health education , some residents believed bilharzia was a sign of manhood while others attributed the red colour of the urine to the red colour of a variety of sugar cane eaten in the area . After the health education , residents in the three areas constructed h and -dug wells . In addition , those who received active health education constructed two toilets for the schools and weeded the banks of the rivers . Residents also associated the disease with the water snail . CONCLUSION Health education was useful in changing community perception on bilharzia The aim of the study was to assess the efficacy and side effects following single and repeated ( 6 weeks apart ) praziquantel treatment ( 40 mg/kg ) in a Schistosoma mansoni-endemic focus with long-st and ing transmission at Lake Albert in Ug and a between December 1996 and January 1997 . The results were based on 482 individuals , r and omly representing all age and both gender groups . The cure rate following the first and second treatments was 41.9 % and 69.1 % , respectively . The cure rate was higher in adults than in children , irrespective of intensity of infection . In addition , the cure rate declined markedly with increasing intensity of infection . The reduction in intensity of infection was marked , being 97.7 % and 99.6 % after the first and second treatments , respectively . A pre- and post-treatment symptom question naire revealed a broad range of side effects , including abdominal pain and diarrhoea . However , no serious or long-lasting complications affecting compliance were observed . The marked reductions in faecal egg excretion and the acceptable level of side effects point to a single praziquantel treatment ( 40mg/kg ) as the strategy of choice in such a highly endemic S. mansoni focus To determine the effect of targeted field administration of oral chemotherapeutic agents on the prevalence , intensity , and morbidity of Schistosoma haematobium infections , we initiated a long-term school-based program in the Msambweni area of Kwale District , Coast Province , Kenya . Prior to treatment , 69 % of the children examined ( ages 4 - 21 , n = 2,628 ) were infected ; 34 % had moderate or heavy infections ( greater than 100 eggs/10 ml urine ) . Infected individuals were r and omized to receive , during one year , either metrifonate ( 10 mg/kg x 3 doses ) or praziquantel , ( 40 mg/kg x 1 dose ) . At the end of the first year , prevalence of infection fell to 19 % ; only 2 % of the pupils remained in the moderately and heavily infected groups . Corresponding decreases in the prevalence of hematuria ( 54 % in 1984 vs. 16 % in 1985 ) and proteinuria ( 56 % in 1984 vs. 26 % in 1985 ) were noted . These were associated with significant declines in bladder thickening and irregularities noted during ultrasound examinations , but not with decreases in hydronephrosis . There was no significant difference in the post-treatment prevalence or intensity of infection after treatment with metrifonate as compared with praziquantel . These results demonstrate that field-applied chemotherapy with either agent offers a practical strategy for the control of S. haematobium infection and its associated morbidity BACKGROUND In sub-Saharan Africa , 112 million people are infected with Schistosoma haematobium , with the most intense infections in children 5 - 15 years old . METHODS We describe a longitudinal epidemiological study that evaluates the relationship between S. haematobium infection and associated morbidity in children before and after the large-scale administration of praziquantel for schistosomiasis and albendazole for soil-transmitted helminths . RESULTS At baseline , higher intensities of S. haematobium infection were observed in children with anemia and /or severe microhematuria , but there was no apparent association between the risk of undernutrition and intensity of S. haematobium infection . Significant reductions in the prevalence and intensity of S. haematobium infection 1 year after treatment were , however , observed . Children who benefited the most from anthelmintic treatment in terms of increased hemoglobin concentrations were those who had anemia at baseline and those with highly positive microhematuria scores at baseline . CONCLUSIONS This study suggests that even a single round of mass chemotherapy can have a substantial impact on S. haematobium infection and its associated morbidity in children To determine the effect of repeated , annual , age-targeted therapy on prevalence and intensity of Schistosoma haematobium infection in an endemic area , we treated all available , infected , school-age children ( n = 2 , 493 ) in the Msambweni area of Coast Province , Kenya with a r and omized protocol of oral metrifonate ( 10 mg/kg for three doses each year ) or praziquantel therapy ( 40 mg/kg as a single dose each year ) for a period of one to three years . During 1984 - 1987 , 1 , 101 children completed three years of therapy , 550 received two years , and 842 received a single year . Annual followup revealed significant long-term suppression of S. haematobium infection in the targeted school-age population . Both cross-sectional analysis and study of individual outcomes suggested maximal suppression of infection after two years of therapy . Suppression lasted more than two years after cessation of treatment , and was associated with reduced community transmission ( gauged by decreased prevalence among new study entrants and decreasing negative-to-positive conversion on annual parasitologic examinations ) . Comparison of metrifonate and praziquantel outcomes indicated greater suppression of infection and longer infection-free intervals for some subgroups given praziquantel . We conclude that annual population -based therapy targeted to schoolchildren has direct and indirect beneficial effects for endemic communities . In some specific situations , repeat therapy may not suppress transmission , and reduced drug efficacy may be observed after one to three years , suggesting the need for additional non-drug control measures in highly endemic villages Severity of urinary tract morbidity increases with intensity and duration of Schistosoma haematobium infection . We assessed the ability of yearly drug therapy to control infection intensity and reduce S. haematobium-associated disease in children 5 - 21 years old in an endemic area of Kenya . In year 1 , therapy result ed in reduced prevalence ( 66 % to 22 % , P < 0.001 ) and intensity of S. haematobium infection ( 20 to 2 eggs/10 mL urine ) , with corresponding reductions in the prevalence of hematuria ( 52 % to 19 % , P < 0.001 ) . There was not , however , a significant first-year effect on prevalence of urinary tract abnormalities detected by ultrasound . Repeat therapy in years 2 and 3 result ed in significant regression of hydronephrosis and bladder abnormalities ( 41 % to 6 % prevalence , P < 0.01 ) , and further reductions in proteinuria . Repeat age-targeted therapy was associated with decreased prevalence of infection among young children ( < 5 yr ) entering into the targeted age group . Two years after discontinuation of therapy , intensity of S. haematobium infection and ultrasound abnormalities remained suppressed , but hematuria prevalence began to increase ( to 33 % in 1989 ) . Reinstitution of annual therapy in 1989 and 1990 reversed this trend . We conclude that annual oral therapy provides an effective strategy for control of morbidity due to S. haematobium on a population basis , both through regression of disease in treated individuals , and prevention of infection in untreated subjects Chemotherapy with praziquantel is the cornerstone of schistosomiasis control . In view of recent concern about tolerance or resistance to praziquantel , monitoring its efficacy in different epidemiological setting s is required . We report a study among 253 schoolchildren in an area highly endemic for Schistosoma mansoni in western Côte d'Ivoire . After examining four consecutive stool specimens from each child , the first praziquantel treatment at 60 mg/kg divided into two doses was administered . Four weeks later , stool specimens were again screened over 4 consecutive days and revealed a cure rate of 71.6 % and an egg reduction rate of 79.9 % . There was a significant association between cure rate and intensity of infection prior to treatment with highest cure rates observed in light infections ( P < 0.01 ) . Praziquantel , at a single dose of 40 mg/kg , was again administered 35 days after the first treatment . The overall cure and egg reduction rates increased considerably . The association between cure rate and intensity of infection prior to the second treatment was significant but less pronounced . Twenty-two children remained S. mansoni positive after the two chemotherapy campaigns , and interestingly , many of these were only identified after repeated stool examinations . We argue that pre-patent infections may account for some of these ' treatment failures ' . However , further studies in other endemic setting s are needed , with parasitological diagnoses having a high sensitivity The aim of this study was to assess the effect of two doses of 40 mg/kg praziquantel with 2 weeks interval versus a st and ard single dose of 40 mg/kg on cure rates , egg reduction , intensity of infection , and micro-haematuria in Schistosoma haematobium infections . A r and omised controlled intervention study was carried out among school-aged children in two different endemic setting s with follow-up at 3 , 6 and 18 months following drug administration . Differences in cure rates between the two treatment regimens were not significant . However , in high transmission areas , the double treatment regimen was more effective in egg reduction than single treatment regimen and the difference in egg reduction between the two treatments was significant at 3 months ( P<0.005 ) , 6 months ( P<0.0001 ) and 18 months ( P<0.003 ) after treatment . There was a significant difference in the effect of the two treatments on prevalence of micro-haematuria at 18-month follow-up in both Koulikoro ( P<0.001 ) and Selingue ( P<0.003 ) . The study shows that although no significant difference could be observed in the overall cure-rates between the two treatment regimens , the effect of double treatment was a significant reduction in infection intensity as well as micro-haematuria which may have a great impact in reducing subtle morbidity A study was performed to determine the efficacy of praziquantel ( PZQ ) against Schistosoma haematobium . Children ( n = 592 ) infected with S. haematobium received either a single treatment with PZQ ( 40 mg/kg ) or two or three treatments with PZQ at three- Output:	In 10 reports meeting study criteria , improvements in parasitological treatment outcomes after two doses of praziquantel were greater for S. mansoni infection than for S. haematobium infection . / SIGNIFICANCE Although schedules for repeated treatment with praziquantel require greater inputs in terms of direct costs and community participation , there are incremental benefits to this approach at an estimated cost of $ 153 ( S. mansoni)-$211 ( S. haematobium ) per additional lifetime QALY gained by double treatment in school-based programs . More rapid reduction of infection-related disease may improve program adherence , and if , as an externality of the program , transmission can be reduced through more effective coverage , significant additional benefits are expected to accrue in the targeted communities
MS21111	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND AND PURPOSE Telemedicine can disseminate vascular neurology expertise and optimize recombinant tissue plasminogen activator ( rt-PA ) use for acute ischemic stroke in rural underserved communities . The purpose of this study was to prospect ively assess whether telemedicine or telephone was superior for decision-making . METHODS The study design is a pooled analysis of two identically design ed r and omized controlled trials conducted in a multistate hub and spoke telestroke network setting with acute stroke syndrome patients , comparing telemedicine versus telephone-only consultations . From each trial , common data elements were pooled to assess , principally , for correctness of thrombolysis decision-making . Secondary outcomes included rt-PA use rate , 90-day functional outcome , post-thrombolysis intracranial hemorrhage , and data completeness . RESULTS Two hundred seventy-six pooled patients were evaluated . Correct thrombolysis eligibility decisions were made more often with telemedicine ( 96 % telemedicine , 83 % telephone ; odds ratio [ OR ] 4.2 ; 95 % confidence interval [ CI ] 1.69 - 10.46 ; p=0.002 ) . Intravenous rt-PA usage was 26 % ( 29 % telemedicine , 24 % telephone ; OR 1.27 ; 95 % CI 0.71 - 2.25 ; p=0.41 ) . Ninety-day outcomes were not different for Barthel Index , modified Rankin Scale , or mortality . There was no difference in post-thrombolysis intracranial hemorrhage ( 8 % telemedicine , 6 % telephone ; p>0.999 ) . CONCLUSIONS This pooled analysis supports the hypothesis that stroke telemedicine consultations , compared with telephone-only , result in more accurate decision-making . Together with high rt-PA utilization rate , low post-rt-PA intracranial hemorrhage rate , and acceptable patient outcome , the results confirm that telemedicine is a viable consultative tool for acute stroke . The replication of the hub and spoke network infrastructure supports the generalizability of telemedicine when used in broader setting Background and Purpose — Telemedicine techniques can be used to address the rural – metropolitan disparity in acute stroke care . The Stroke Team Remote Evaluation Using a Digital Observation Camera ( STRokE DOC ) trial reported more accurate decision making for telemedicine consultations compared with telephone-only and that the California-based research network facilitated a high rate of thrombolysis use , improved data collection , low risk of complications , low technical complications , and favorable assessment times . The main objective of the STRokE DOC Arizona TIME ( The Initial Mayo Clinic Experience ) trial was to determine the feasibility of establishing , de novo , a single-hub , multirural spoke hospital telestroke research network across a large geographical area in Arizona by replicating the STRokE DOC protocol . Methods — Methods included prospect i ve , single-hub , 2-spoke , r and omized , blinded , controlled trial of a 2-way , site-independent , audiovisual telemedicine system design ed for remote examination of adult patients with acute stroke versus telephone consultation to assess eligibility for treatment with intravenous thrombolysis . The primary outcome measure was whether the decision to give thrombolysis was correct . Secondary outcomes were rate of thrombolytic use , 90-day functional outcomes , incidence of intracerebral hemorrhages , and technical observations . Results — From December 2007 to October 2008 , 54 patients were assessed , 27 of whom were r and omized to each arm . Mean National Institutes of Health Stroke Scale score at presentation was 7.3 ( SD 6.2 ) points . No consultations were aborted ; however , technical problems ( 74 % ) were prevalent in the telemedicine arm . Overall , the correct treatment decision was established in 87 % of the consultations . Both modalities , telephone ( 89 % correct ) and telemedicine ( 85 % correct ) , performed well . Intravenous thrombolytic treatment was used in 30 % of the telemedicine and telephone consultations . Good functional outcomes at 90 days were not significantly different . There were no statistically significant differences in mortality ( 4 % in telemedicine and 11 % in telephone ) or rates of intracerebral hemorrhage ( 4 % in telemedicine and 0 % in telephone ) . Conclusions — It is feasible to extend the original STRokE DOC trial protocol to a new state and establish an operational single-hub , multispoke rural hospital telestroke research network in Arizona . The trial was not design ed to have sufficient power to detect a difference between the 2 consultative modes : telemedicine and telephone-only . Whether by telemedicine or telephone consultative modalities , there were appropriate treatment decisions , high rates of thrombolysis use , improved data collection , low rates of intracerebral hemorrhage , and equally favorable time requirements . The learning curve was steep for the hub and spoke personnel of the new telestroke network , as reflected by frequent technical problems . Overall , the results support the effectiveness of highly organized and structured stroke telemedicine networks for extending expert stroke care into rural remote communities lacking sufficient neurological expertise Background and Purpose — Despite Food and Drug Administration approval of tissue-type plasminogen activator for stroke , obstacles in the US healthcare system prevent its widespread use . The Remote Evaluation for Acute Ischemic Stroke ( REACH ) program was developed to address these issues in rural setting s. A key component of stroke assessment in the REACH system is the National Institutes of Health Stroke Scale ( NIHSS ) evaluation . We sought to determine whether , using the REACH system , NIHSS values of bedside and remote evaluators would correspond . Methods — Twenty patients were recruited . On obtaining consent , a neurologist performed a bedside NIHSS evaluation on each patient . Within 1 hour , using any broadb and -connected workstation — either office or home personal computer and a l and line phone to speak with the patient — a second neurologist remotely evaluated the patient through the REACH system . Paired t tests and Pearson correlation coefficients were used to examine NIHSS reliability performed bedside and remotely . Results — NIHSS ranged from 1 to 24 . Correlations between bedside and remote locations ( r = 0.9552 , P = 0.0001 ) were very strong , and t tests indicate that the means were not different . Conclusions — The NIHSS can be reliably performed over the REACH system . This supports our endeavor to bring stroke expertise to rural community hospitals OBJECTIVE Patients with ischemic stroke treated with tissue plasminogen activator ( rt-PA ) have better outcomes when treated closer to the time of symptom onset and within the 3-hour window . We previously demonstrated the clinical use of TeleBAT , a mobile telemedicine system for stroke . We tested the impact of that system on time to treatment for patients with acute stroke . METHODS Validity and reliability were tested by comparing neurologic examination scores obtained using our wireless system , which transmits video of a patient from a moving ambulance to desktop computers , with those obtained using the National Institute of Neurological Disorders and Stroke training videotape . TeleBAT validity and good interrater reliability were defined a priori as a kappa statistic of r > 0.5 . We compared the average time to treatment for our TeleBAT-evaluated intervention group with that for our control group . The intervention group consisted of two actor patients with stroke mimicking 12 stroke scenarios and evaluated using TeleBAT . The control group consisted of patients with stroke evaluated and treated with rt-PA on arrival to the emergency department . Data were analyzed using st and ard t test . RESULTS National Institutes of Health Stroke Scale items calculated by the neurologists suggest TeleBAT is valid for assessing patients with stroke remotely . Interrater reliability was high : the neurologists gleaned the same information from TeleBAT transmissions . Kappa values for both validity and reliability exceeded 0.5 . The mean time to treatment for patients assessed by TeleBAT was 17 + /- 4 minutes compared with 33 + /- 17 minutes for our control group ( P = .0033 ) . CONCLUSION TeleBAT seems to be a valid and reliable means of evaluating stroke neurologic deficits . Time to treatment was shortened using ambulance transport time to evaluate patients as c and i date s for thrombolytic therapy . Future studies should use a r and omized design with patients with acute stroke BACKGROUND Thrombolytic therapy for acute ischemic stroke has been approached cautiously because there were high rates of intracerebral hemorrhage in early clinical trials . We performed a r and omized , double-blind trial of intravenous recombinant tissue plasminogen activator ( t-PA ) for ischemic stroke after recent pilot studies suggested that t-PA was beneficial when treatment was begun within three hours of the onset of stroke . METHODS The trial had two parts . Part 1 ( in which 291 patients were enrolled ) tested whether t-PA had clinical activity , as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale ( NIHSS ) or the resolution of the neurologic deficit within 24 hours of the onset of stroke . Part 2 ( in which 333 patients were enrolled ) used a global test statistic to assess clinical outcome at three months , according to scores on the Barthel index , modified Rankin scale , Glasgow outcome scale , and NIHSS : RESULTS In part 1 , there was no significant difference between the group given t-PA and that given placebo in the percentages of patients with neurologic improvement at 24 hours , although a benefit was observed for the t-PA group at three months for all four outcome measures . In part 2 , the long-term clinical benefit of t-PA predicted by the results of part 1 was confirmed ( global odds ratio for a favorable outcome , 1.7 ; 95 percent confidence interval , 1.2 to 2.6 ) . As compared with patients given placebo , patients treated with t-PA were at least 30 percent more likely to have minimal or no disability at three months on the assessment scales . Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred in 6.4 percent of patients given t-PA but only 0.6 percent of patients given placebo ( P < 0.001 ) . Mortality at three months was 17 percent in the t-PA group and 21 percent in the placebo group ( P = 0.30 ) . CONCLUSIONS Despite an increased incidence of symptomatic intracerebral hemorrhage , treatment with intravenous t-PA within three hours of the onset of ischemic stroke improved clinical outcome at three months Objective : VA Stroke Study ( VASt ) data were analyzed to determine whether neurologist management affected the process and outcome of care of patients with ischemic stroke . Methods : VASt prospect ively identified patients with stroke admitted to nine VA hospitals ( April 1995 to March 1997 ) . Demographics , stroke severity ( Canadian Neurologic Score ) , stroke subtype ( Trial of ORG 10172 in Acute Stroke Treatment [ TOAST ] classification ) , tests/ procedures , and discharge status ( independent , Rankin ≤ 2 , vs dead or dependent , Rankin 3 through 5 ) were compared between patients who were or were not cared for by a neurologist . Results : Of 1,073 enrolled patients , 775 ( neurologist care , n = 614 ; non-neurologist , n = 161 ) with ischemic stroke were admitted from home . Stroke severity ( Canadian Neurologic Score 8.7 ± 0.1 vs 8.4 ± 0.2 ; p = 0.44 ) , TOAST subtype ( p = 0.55 ) , and patient age ( 71.4 ± 0.4 vs 72.4 ± 0.7 ; p = 0.23 ) were similar for neurologists and non-neurologists . Neurologists more frequently obtained MRI ( 44 % vs 16 % ; p < 0.001 ) , transesophageal echocardiograms ( 12 % vs 2 % ; p < 0.001 ) , carotid ultrasounds ( 65 % vs 57 % ; p = 0.05 ) , cerebral angiography ( 8 % vs 1 % ; p = 0.001 ) , speech ( 35 % vs 18 % ; p < 0.001 ) , and occupational therapy ( 46 % vs 33 % ; p = 0.005 ) evaluations . Brain CT , transthoracic echocardiogram , 24-hour ambulatory ECG use , and hospitalization duration s ( 18.2 ± 0.8 vs 19.7 ± 4.1 days ; p = 0.725 ) were similar . Neurologists ’ patients were less likely to be dead ( 5.6 % vs 13.5 % ; OR = 0.38 ; 95 % CI 0.22 , 0.68 ; p = 0.001 ) and less likely to be dead or dependent ( 46.1 % vs 57.1 % ; OR = 0.64 ; 95 % CI 0.45 , 0.92 ; p = 0.019 ) at the time of discharge . The benefit remained after controlling for stroke severity and comorbidity ( OR = 0.63 ; 95 % CI 0.42 , 0.94 ; p = 0.025 ) . Conclusion : Neurologist care was associated with more extensive testing , but similar lengths of hospitalization and improved outcomes BACKGROUND To increase the Output:	Telestroke technology is now part of mainstream clinical stroke practice in North America and internationally .
MS21112	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Poverty undermines adherence to tuberculosis treatment . Economic support may both encourage and enable patients to complete treatment . In South Africa , which carries a high burden of tuberculosis , such support may improve the currently poor outcomes of patients on tuberculosis treatment . The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa . Methods This was a pragmatic , unblinded , two-arm cluster-r and omized controlled trial , where 20 public sector clinics acted as clusters . Patients with pulmonary tuberculosis in intervention clinics ( n = 2,107 ) were offered a monthly voucher of ZAR120.00 ( approximately US$ 15 ) until the completion of their treatment . Vouchers were redeemed at local shops for foodstuffs . Patients in control clinics ( n = 1,984 ) received usual tuberculosis care . Results Intention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics ( intervention 76.2 % ; control 70.7 % ; risk difference 5.6 % ( 95 % confidence interval : -1.2 % , 12.3 % ) , P = 0.107 ) . Low fidelity to the intervention meant that 36.2 % of eligible patients did not receive a voucher at all , 32.3 % received a voucher for between one and three months and 31.5 % received a voucher for four to eight months of treatment . There was a strong dose – response relationship between frequency of receipt of the voucher and treatment success ( P < 0.001 ) . Conclusions Our pragmatic trial has shown that , in the real world setting of public sector clinics in South Africa , economic support to patients with tuberculosis does not significantly improve outcomes on treatment . However , the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it . Among patients in intervention clinics who received the voucher at least once , treatment success rates were significantly improved . Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it . Trial registration Current Controlled TrialsIS RCT Background Poverty undermines the adherence of patients to tuberculosis treatment . A pragmatic cluster r and omized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients ’ adherence to treatment , and their treatment outcomes . Although the trial showed a modest improvement in the treatment success rates of the intervention group , this was not statistically significant , due in part to the low fidelity to the trial intervention . A qualitative process evaluation , conducted in the final few months of the trial , explained some of the factors that contributed to this low fidelity . Methods In-depth interviews were conducted with patients who received vouchers , nurses in intervention clinics , personnel in shops who administered the vouchers , and managers of the TB Control Programme . These interviews were analyzed thematically . Results The low fidelity to the trial intervention can be explained by two main factors . The first was nurses ’ tendency to ‘ ration ’ the vouchers , only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable . The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic date s , necessitating further visits to the clinics which they were not always able to make . Conclusions This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial . It highlights the value of process evaluations as tools to explain the results of r and omized trials and emphasizes the importance of implementers as ‘ street level bureaucrats ’ who may profoundly affect the way an intervention is administered . Trial registration Current Controlled Trials IS RCT N50689131 , registered 21 April 2009.The trial protocol is available at the following web address : http://www.hst.org.za/publications/ study - protocol -economic-incentives-improving- clinical - outcomes - patients -tb-south-africa Objective To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis . Design Parallel group r and omised controlled trial . Setting Three primary care clinics in Dili , Timor-Leste . Participants 270 adults aged ≥18 with previously untreated newly diagnosed pulmonary tuberculosis . Main outcome measures Completion of treatment ( including cure ) . Secondary outcomes included adherence to treatment , weight gain , and clearance of sputum smears . Outcomes were assessed remotely , blinded to allocation status . Interventions Participants started st and ard tuberculosis treatment and were r and omly assigned to intervention ( nutritious , culturally appropriate daily meal ( weeks 1 - 8 ) and food package ( weeks 9 - 32 ) ( n=137 ) or control ( nutritional advice , n=133 ) groups . R and omisation sequence was computer generated with allocation concealment by sequentially numbered , opaque , sealed envelopes . Results Most patients with tuberculosis were poor , malnourished men living close to the clinics ; 265/270 ( 98 % ) contributed to the analysis . The intervention had no significant beneficial or harmful impact on the outcome of treatment ( 76 % v 78 % completion , P=0.7 ) or adherence ( 93 % for both groups , P=0.7 ) but did lead to improved weight gain at the end of treatment ( 10.1 % v 7.5 % improvement , P=0.04 ) . Itch was more common in the intervention group ( 21 % v 9 % , P<0.01 ) . In a subgroup analysis of patients with positive results on sputum smears , there were clinical ly important improvements in one month sputum clearance ( 85 % v 67 % , P=0.13 ) and completion of treatment ( 78 % v 68 % , P=0.3 ) . Conclusion Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste . Further studies in different setting s and measuring different outcomes are required . Trial registration Clinical Trials NCT0019256 BACKGROUND Drug users are at increased risk for latent tuberculosis infection ( LTBI ) and also at increased risk for noncompletion of medication regimens for treatment of LTBI or tuberculosis disease . Directly observed therapy ( DOT ) provided by outreach workers , the use of incentives , or both have been suggested as a means to increase adherence . OBJECTIVE To compare the independent and combined effects of monetary incentives and outreach worker provision of DOT for LTBI treatment in a sample of active drug users . METHODS The research design was a r and omized controlled trial in a community outreach program setting . Participants consisted of a volunteer sample of 163 active injection drug and crack cocaine users placed on twice weekly DOT . Condition 1 of the interventions consisted of provision of DOT by an outreach worker at a location chosen by the participant ( active outreach ) and a $ 5 per visit incentive . Condition 2 was comprised of active outreach with no monetary incentive , and Condition 3 , provision of DOT at the study community site and a $ 5 per visit incentive . The main outcome measures were percentage of medication taken as prescribed and completion of medication regimen . RESULTS The percentage of prescribed medication taken was higher for those who received incentives , either with ( 71 % ) or without ( 68 % ) active outreach , compared to those who received active outreach alone ( 13 % ) . Only 4 % of participants assigned to Condition 2 completed treatment , compared to 53 % of Condition 1 participants , and 60 % of Condition 3 participants . CONCLUSIONS Monetary incentives were clearly superior to active outreach . Active outreach in combination with monetary incentives did not increase adherence over incentives alone SETTING Few studies have examined strategies for optimizing adherence to latent tuberculosis infection ( LTBI ) treatment programs in homeless population s. OBJECTIVES 1 ) To compare the effectiveness of an intervention program employing nurse case management and incentives ( NCMI ) vs. a control program with st and ard care and incentives on completion of LTBI treatment ; and 2 ) to compare the impact of the two programs on tuberculosis ( TB ) knowledge among participants . DESIGN A prospect i ve , two-group site-r and omized design conducted among 520 homeless adults residing in the Skid Row region of Los Angeles from 1998 to 2003 , assessing completion rates of a 6-month isoniazid ( INH ) treatment program and change in TB knowledge . RESULTS Using intent-to-treat analysis , 62 % of participants in the intervention program , compared with 39 % of controls , completed the full 6-month course of LTBI treatment with INH . Logistic regression modeling revealed that intervention participants had three times greater odds of completing INH treatment than controls . TB knowledge improved in both programs , but the increase was greater among the intervention participants ( P < 0.001 ) . CONCLUSIONS Nurse case management combined with education , incentives , and tracking dramatically improves both adherence to LTBI treatment and TB knowledge in homeless persons compared to a st and ard approach of outreach and incentives OBJECTIVES To test 2 interventions to improve adherence to isoniazid preventive therapy for tuberculosis in homeless adults . We compared ( 1 ) biweekly directly observed preventive therapy using a $ 5 monetary incentive and ( 2 ) biweekly directly observed preventive therapy using a peer health adviser , with ( 3 ) usual care at the tuberculosis clinic . METHODS R and omized controlled trial in tuberculosis-infected homeless adults . Outcomes were completion of 6 months of isoniazid treatment and number of months of isoniazid dispensed . RESULTS A total of 118 subjects were r and omized to the 3 arms of the study . Completion in the monetary incentive arm was significantly better than in the peer health adviser arm ( P = .01 ) and the usual care arm ( P = .04 ) , by log-rank test . Overall , 19 subjects ( 44 % ) in the monetary incentive arm completed preventive therapy compared with 7 ( 19 % ) in the peer health adviser arm ( P = .02 ) and 10 ( 26 % ) in the usual care arm ( P = .11 ) . The median number of months of isoniazid dispensed was 5 in the monetary incentive arm vs 2 months in the peer health adviser arm ( P = .005 ) and 2 months in the usual care arm ( P = .04 ) . In multivariate analysis , independent predictors of completion were being in the monetary incentive arm ( odds ratio , 2.57 ; 95 % CI , 1.11 - 5.94 ) and residence in a hotel or other stable housing at entry into the study vs residence on the street or in a shelter at entry ( odds ratio , 2.33 ; 95 % CI , 1.00 - 5.47 ) . CONCLUSIONS A $ 5 biweekly cash incentive improved adherence to tuberculosis preventive therapy compared with a peer intervention or usual care . Living in a hotel or apartment at the start of treatment also predicted the completion of therapy SETTING Screening for active tuberculosis ( TB ) and providing isoniazid ( INH ) preventive therapy in jails are important control measures . In San Francisco , however , historical data showed that 62 % of inmates were released before completing preventive therapy , and of those only 3 % attended the TB Clinic for follow-up . OBJECTIVE AND DESIGN A r and omized clinical trial to compare a $ 5 cash incentive plus st and ardized TB education with st and ardized TB education alone in encouraging released inmates to make a first visit to the clinic . RESULTS Of 79 persons enrolled in the trial , 77.2 % were released before INH completion . Rates of first visit were not significantly different for those receiving + 5 plus st and ardized education ( 25.8 % ) versus st and ardized education alone ( 23.3 % ) , but were higher than rates seen in historical data for inmates not receiving st and ardized education . Age was an important predictor of completion of a first visit ( odds ratio 1.09 , 95 % confidence interval 1.02 - 1.16 , P = 0.017 ) . Other variables predicting adherence included intent to adhere , more previous time in jail , stable housing , and being partnered versus alone , although these were not statistically significant . CONCLUSION St and ardized education may be important in improving follow-up after release . Further work on the role of a financial incentive in this population is needed Background : The efficacy of a nurse case-managed intervention was evaluated in sub sample s of participants with one of the following characteristics : female gender , African American ethnicity , recruited from a homeless shelter , a history of military service , lifetime injection drug use , daily alcohol and drug use , poor physical health , and a history of poor mental health . Objective : To determine whether a vali date d nurse case-managed intervention with incentives and tracking would improve adherence to latent tuberculosis infection treatment in sub sample s of homeless persons with characteristics previously identified in the literature as predictive of nonadherence . Methods : A prospect i ve 2-group site-r and omized design was conducted with 520 homeless adults residing in 12 homeless shelters and residential recovery sites in the Skid Row region of Los Angeles from 1998 to 2003 . Results : Daily drug users , participants with a history of injection drug use Output:	Authors ' conclusions Material incentives and enablers may have some positive short term effects on clinic attendance , particularly for marginal population s such as drug users , recently released prisoners , and the homeless , but there is currently insufficient evidence to know if they can improve long term adherence to TB treatment
MS21113	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE The aim of the study was to compare the differences in the long-term clinical and radiologic effects for three different treatment strategies with implant-supported overdentures in the edentulous m and ible , with a special emphasis on smoking . MATERIAL S AND METHODS In a r and omized- controlled clinical trial , 110 edentulous patients participated . Thirty-six patients were treated with an overdenture supported by two implants with ball attachments ( 2IBA ) , 37 patients with an overdenture supported by two implants with a bar ( 2ISB ) and 37 patients with an overdenture supported by four implants with a triple bar ( 4ITB ) . After a mean evaluation period of 8.3 years , the clinical and radiographic parameters were evaluated . RESULTS Ninety-four out of the original 110 patients ( = 85 % ) were evaluated . In the 2IBA group , the plaque index was significantly lower ( vs. 2ISB , P=0.013 ; vs. 4ITB , P=0.001 ) than in the other groups , but there was no correlation with the other peri-implant parameters . In the 4ITB group , the marginal bone loss was significantly higher than that in the two implant groups . The maximal probing depth was correlated with peri-implant bone loss ( P=0.011 ) . Smoking almost doubled marginal bone loss irrespective of the treatment strategy chosen . CONCLUSIONS Patients with two implants show less marginal bone loss than those with four implants . Smoking is a risk factor for the survival of dental implants in the long run AIM This 1-year prospect i ve RCT compared the outcome of minimally ( turned ) and moderately rough ( TiUnite ) implant surfaces . MATERIAL AND METHODS Two subgroups of patients were formed ; one group ( n = 10 ) where all teeth had been extracted due to severe periodontitis , another group ( n = 8) with teeth in the antagonistic jaw with a history of periodontitis and some remaining medium pockets ( 4 - 6 mm ) . Implants ( n = 85 , 43 turned & 42 TiUnite ) were installed r and omly in each patient . After 3 - 6 months of submerged healing , healing abutments were connected , followed by final abutments 2 weeks later , all with the same surface characteristics as the supporting implant . Peri-implant parameters and intra-oral radiographs were recorded up to 1 year after abutment connection . RESULTS Two turned implants failed in the partial edentulous group during the initial healing period ( CSR : 95 % ) and none of the TiUnite ( CSR : 100 % ) surface . No statistically significant differences in clinical parameters could be observed between both surfaces . The partial edentulous subgroup showed more bone loss compared to the full edentulous subgroup . CONCLUSION Moderately rough implants have a similar clinical outcome ( at 1 year of loading in periodontitis susceptible patients ) compared to minimally rough implants The aim of this prospect i ve longitudinal study of patients treated for generalized aggressive periodontitis ( GAP ) was the clinical , microbiologic , and radiologic longitudinal evaluation of implants placed into bone regenerated by the guided bone regeneration ( GBR ) technique . Ten patients with GAP who had lost either one or two maxillary incisors or premolars through periodontal disease and whose alveolar bone was neither high nor wide enough for implant placement were enrolled in the study . GBR was carried out in a two-stage procedure using titanium-reinforced extended polytetrafluoroethylene membranes and titanium screws . No bone graft or bone substitute material s were used . After 6 to 8 months , the membranes and supporting screws were removed , and a total of 15 implants ( Nobel Biocare ) were placed . The control group comprised 10 periodontally healthy patients who had a total of II implants ( Nobel Biocare ) placed in the maxilla ( incisor and premolar region ) without GBR because of aplasia , trauma , or endodontic lesions . All patients were examined 2 to 4 weeks before extraction of the nonretainable teeth ( baseline ) and again immediately after placement of the superstructure . Further examinations were performed within the framework of a 3-month recall schedule over a 3-year period . At each session , clinical parameters ( probing pocket depths , bleeding on probing , gingival recession , clinical attachment level , Gingival Index , and Plaque Index ) were recorded at teeth and implants , and the composition of the subgingival microflora was determined by dark-field microscopy and DNA probe . Intraoral radiographs were taken for control purpose s at baseline , immediately after insertion of the superstructure , and 1 and 3 years later . The GBR technique yielded a horizontal and vertical bone gain of 4.5 to 7.0 mm in the GAP patients . The clinical , microbiologic , and radiologic findings indicated healthy periodontal and periimplant conditions in both patient groups throughout the study . However , a slightly increased attachment loss ( 0.65 mm ) and bone loss ( 1.78 mm ) were recorded at the implants in the regenerated bone after 3 years of loading . The 3-year implant survival rate was 100 % in both groups . The possibility of continuous attachment loss and bone loss occurring at teeth and implants in regenerated bone can not be ruled out in patients treated for aggressive periodontitis . The prognosis for the retention of the teeth and implants is thus open to question The relationship between periodontitis and peri-implantitis remains a matter of debate . The present study compared , " within " r and omly chosen partially edentulous patients ( n=84 subjects , 97 jaws ) , the marginal bone loss around teeth and implants during 5 years ( range 3 to 11 years ) following the first year of bone remodelling . The patients had all been rehabilitated by means of screw-shape c.p . titanium implants with a machined surface ( Brånemark system ) . During the 5 years observation interval , periodontal parameters ( marginal bone and attachment loss , the latter for teeth only ) were collected together with data on confounding factors ( smoking , oral hygiene , tooth loss ) . Marginal bone loss was measured through long-cone intra-oral radiographs . The mean " interval " bone loss was significantly ( P=0.0001 ) higher around teeth ( 0.48+/-0.95 mm ) than around implants ( 0.09+/-0.28 mm ) . The corresponding data for the " worst " performing tooth ( 0.99+/-1.25 mm ) and implant ( 0.19+/-0.32 mm ) per subject showed the same tendency . Neither attachment nor bone loss around teeth correlated with marginal bone loss around implants . This study indicated that the rate of bone loss around screw-shape c.p . titanium implants with a machined surface ( Brånemark system implants ) was not influenced by the progression rate of periodontal destruction around the remaining teeth within the same jaw The roughness of intraoral hard surfaces plays an important role in bacterial adhesion and colonization . Earlier studies have shown that rough surfaces accumulate up to 25 times more subgingival plaque than do smooth sites . In the present study , the influence of surface smoothing was studied . In six partially edentulous patients waiting for a fixed prosthesis supported by endosseous titanium implants , four titanium abutments with different surface roughness were r and omly placed . After 1 month of intraoral exposure , subgingival plaque sample s from each abutment were compared within each patient by means of differential phase-contrast microscopy . After 3 months , supragingival and subgingival plaque sample s were taken from all abutments for differential phase-contrast microscopy and culturing . Probing depth , recession , and bleeding upon probing were scored at the same visit . Differential phase-contrast microscopy showed that subgingivally , only the two roughest abutments harbored spirochetes after 1 month . After 3 months , subgingivally , the composition of the flora showed little variation on the different abutment types , although spirochetes were only noticed around the roughest abutments . Anaerobic culturing result ed in comparable amounts of colony-forming units for all abutment types , both supragingivally and subgingivally . Subgingivally , the microbiologic composition did not show major interabutment differences . Clinical ly , small differences in probing depth were observed . The roughest abutment showed some attachment gain ( 0.2 mm ) during 3 months , whereas all other abutments had an attachment loss ranging from 0.8 to greater than 1 mm . The results indicate that a reduction in surface roughness ( less than a roughness of 0.2 micron ) had no major effect on the microbiologic composition , supragingivally or subgingivally . These observations indicate the existence of a threshold roughness below which no further impact on the bacterial adhesion and /or colonization should be expected . However , clinical evaluation seems to indicate that a certain surface roughness is necessary for increased resistance to clinical probing Bacterial adhesion to intra-oral , hard surfaces is firmly influenced by the surface roughness to these structures . Previous studies showed a remarkable higher subgingival bacterial load on rough surfaces when compared to smooth sites . More recently , the additional effect of a further smoothening of intra-oral hard surfaces on clinical and microbiological parameters was examined in a short-term experiment . The results indicated that a reduction in surface roughness below R(a ) = 0.2 microns , the so-called " thresholds R(a ) " , had no further effect on the quantitative/qualitative microbiological adhesion or colonisation , neither supra- nor subgingivally . This study aims to examine the long-term effects of smoothening intra-oral hard transgingival surfaces . In 6 patients expecting an overdenture in the lower jaw , supported by endosseus titanium implants , 2 different abutments ( transmucosal part of the implant ) : a st and ard machined titanium ( R(a ) = 0.2 microns ) and one highly polished and made of a ceramic material ( R(a ) = 0.06 microns ) were r and omly installed . After 3 months of intra-oral exposure , supra- and subgingival plaque sample s from both abutments were compared with each other by means of differential phase-contrast microscopy ( DPCM ) . Clinical periodontal parameters ( probing depth , gingival recession , bleeding upon probing and Periotest-value ) were recorded around each abutment . After 12 months , the supra- and subgingival sample s were additionally cultured in aerobic , CO2-enriched and anaerobic conditions . The same clinical parameters as at the 3-month interval were recorded after 12 months . At 3 months , spirochetes and motile organisms were only detected subgingivally around the titanium abutments . After 12 months , however , both abutment-types harboured equal proportions of spirochetes and motile organisms , both supra- and subgingivally . The microbial culturing ( month 12 ) failed to detect large inter-abutment differences . The differences in number of colony- forming units ( aerobic and anaerobic ) were within one division of a logarithmic scale . The aerobic culture data showed a higher proportion of Gram-negative organisms in the subgingival flora of the rougher abutments . From the group of potentially " pathogenic " bacteria , only Prevotella intermedia and Fusobacterium nucleatum were detected for anaerobic culturing and again the inter-abutment differences were negligible . Clinical ly , the smoothest abutment showed a slightly higher increase in probing depth between months 3 and 12 , and more bleeding on probing . The present results confirm the findings of our previous short-term study , indicating that a further reduction of the surface roughness , below a certain " threshold R(a ) " ( 0.2 microns ) , has no major impact on the supra- and subgingival microbial composition AIM This 3-year prospect i ve r and omized controlled trial compared the clinical , microbiological and biochemical outcome of minimally ( Turned , Tur ) and moderately rough ( TiUnite ( ® ) , TiU ) implant surfaces in a split-mouth design . MATERIAL AND METHODS The study population included 14 subjects : nine fully edentulous and five partially edentulous subjects with a history of periodontitis . Implants ( n = 78 , 39 Tur and 39 TiU ) were installed r and omly in each patient . Peri-implant clinical parameters and intra-oral radiographs were recorded after 3 years of loading . Subgingival plaque and peri-implant crevicular fluid sample s were collected and analysed using culture and quantitative polymerase chain reaction for the biofilm , and enzyme-linked immunosorbent assay for the concentration of osteoprotegerin and receptor activator of nuclear factor kappa-B lig and , respectively . RESULTS No statistically significant differences in clinical , microbiological and biochemical parameters could be observed when comparing the Tur and TiU implant surfaces . CONCLUSION After 3 years of loading , in periodontitis susceptible patients , the moderately rough , TiU implants demonstrated a similar clinical outcome compared with the smoother , turned implants . Longer follow-up and studies using different implant types are needed to confirm the statement that minimally and moderately rough implant surfaces perform similar , both from a clinical and from a microbiological point of view BACKGROUND Many longitudinal studies of different implant systems have been published but few controlled r and omized investigations have been reported . A 1-year report of a comparative study of ITI Dental Implant System implants ( Straumann AG , Waldenburg , Switzerl and ) and Brånemark System implants ( Nobel Biocare AB , Gothenburg , Sweden ) has been published by the present authors . This paper is a 3-year follow-up of that r and omized study . PURPOSE The aim of the study was to compare the outcome of fixed partial Output:	Implant with rough surfaces were more favourable for plaque accumulation during short-term follow-up . On a long-term , turned implants surfaces were associated with more plaque and higher peri-implant bone loss . Conclusions Within the limitations of the present study , rough implant surface does not seem to increase the incidence of peri-implantitis in comparison to turned implants surface
MS21114	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Patients ' deaths in the ICU have been associated with a high burden of psychologic symptoms in families . This study identifies characteristics associated with psychologic symptoms in family members . METHODS Families of patients dying in the ICU or within 30 h of ICU discharge in 11 hospitals previously participated in a r and omized trial . In the current study , we assessed these families for symptoms of posttraumatic stress disorder ( PTSD ) and depression with follow-up surveys . Outcomes included vali date d measures of PTSD ( PTSD Checklist ) and depressive ( Patient Health Question naire ) symptoms . Predictors included family member mental-health history , involvement in decision making , and demographics . RESULTS Surveys were completed by 226 families . Response rate was 46 % in the original r and omized trial and 82 % in this study . Prevalence ( 95 % CI ) of PTSD and depressive symptoms were 14.0 % ( 9.7%-19.3 % ) and 18.4 % ( 13.5%-24.1 % ) , respectively . Family characteristics associated with increased symptoms included : female gender ( PTSD , P = .020 ; depression , P = .005 ) , knowing the patient for a shorter duration ( PTSD , P = .003 ; depression , P = .040 ) , and discordance between family members ' preferences for decision making and their actual decision-making roles ( PTSD , P = .005 ; depression , P = .049 ) . Depressive symptoms were also associated with lower educational level ( P = .002 ) . Families with psychologic symptoms were more likely to report that access to a counselor ( PTSD , P < .001 ; depression , P = .003 ) and information about spiritual services might have been helpful while the patient was in the ICU ( PTSD , P = .024 ; depression , P = .029 ) . CONCLUSIONS Families demonstrated a high prevalence of psychologic symptoms after a death in the ICU . Characteristics associated with symptoms may help target interventions to reduce these symptoms . TRIAL REGISTRATION clinical trials.gov ; Identifier : NCT00685893 OBJECTIVES To analyze the utilization of intensive care unit ( ICU ) days in a Canadian medical-surgical ICU and to identify ICU patients with prolonged ICU length of stay ( LOS ) . DESIGN Prospect i ve descriptive study . SETTING A Canadian tertiary care medical-surgical ICU . PATIENTS Consecutive patients admitted to an adult medical-surgical ICU . Neurosurgical , cardiac surgical , and coronary care unit patients were excluded . MEASUREMENTS For each ICU admission , patient demographics , diagnosis , Acute Physiology and Chronic Health Evaluation II ( APACHE II ) score , ICU LOS , and hospital mortality were collected . The patients ' risk of death was calculated using the APACHE II equation . Admissions were stratified by ICU LOS into four groups : 1 to 2 , 3 to 6 , 7 to 13 , and > or = 14 days . Among the four LOS groups , the number of ICU days and observed and predicted death rates were compared . Admissions were also stratified by risk of death into five probability range quintiles . Among the five risk groups , ICU LOS was compared between survivors and nonsurvivors . RESULTS A total of 1,960 admissions utilized 9,298 ICU days . ICU LOS ( mean + /- SEM ) was 4.74 + /- 0.2 ( median , 2 ; range , 1 to 178 ) days . Short-stay patients ( ICU LOS < or = 2 days ) accounted for 60.3 % of total admissions but consumed only 16.4 % of total ICU days . Long-stay patients ( ICU LOS > or = 14 days ) accounted for 7.3 % of total admissions but consumed 43.5 % of total ICU days . Among the long-stay patients , the most common reasons for admission were pneumonia , multiple trauma , neuromuscular weakness , and septic shock . The mortality for long-stay patients approached 50 % . When analyzed by patients ' mortality risks , those with a risk of death > 0.8 ( predicted to die ) or < 0.2 ( predicted to live ) whose outcomes were opposite to that predicted had twice the ICU LOS compared with patients whose outcomes were consistent with prediction . CONCLUSION In a Canadian medical-surgical ICU , patients with ICU LOS > or = 14 days accounted for 7.3 % of total admissions but consumed 43.5 % of total ICU days . Identification of patients with prolonged ICU LOS who would ultimately die in the ICU may lead to earlier withdrawal of therapy in these patients , result ing in a substantial reduction in suffering and cost savings . In our study population , outcome prediction using the APACHE II equation did not provide sufficient power to accurately discriminate between nonsurvivors and survivors Objective : To revise and up date the Acute Physiology and Chronic Health Evaluation ( APACHE ) model for predicting intensive care unit ( ICU ) length of stay . Design : Observational cohort study . Setting : One hundred and four ICUs in 45 U.S. hospitals . Patients : Patients included 131,618 consecutive ICU admissions during 2002 and 2003 , of which 116,209 met inclusion criteria . Interventions : None . Measurements and Main Results : The APACHE IV model for predicting ICU length of stay was developed using ICU day 1 patient data and a multivariate linear regression procedure to estimate the precise ICU stay for r and omly selected patients who comprised 60 % of the data base . New variables were added to the previous APACHE III model , and advanced statistical modeling techniques were used . Accuracy was assessed by comparing mean observed and mean predicted ICU stay for the excluded 40 % of patients . Aggregate mean observed ICU stay was 3.86 days and mean predicted 3.78 days ( p < .001 ) , a difference of 1.9 hrs . For 108 ( 93 % ) of 116 diagnoses , there was no significant difference between mean observed and mean predicted ICU stay . The model accounted for 21.5 % of the variation in ICU stay across individual patients and 62 % across ICUs . Correspondence between mean observed and mean predicted length of stay was reduced for patients with a short ( ≤1.7 days ) or long ( ≥9.4 days ) ICU stay and a low ( < 20 % ) or high ( > 80 % ) risk of death on ICU day 1 . Conclusions : The APACHE IV model provides clinical ly useful ICU length of stay predictions for critically ill patient groups , but its accuracy and utility are limited for individual patients . APACHE IV benchmarks for ICU stay are useful for assessing the efficiency of unit throughput and support examination of structural , managerial , and patient factors that affect ICU stay BACKGROUND Ten percent to 20 % of trauma patients admitted to the intensive care unit ( ICU ) will die from their injuries . Providing appropriate end-of-life care in this setting is difficult and often late in the patients ' course . Patients are young , prognosis uncertain , and conflict common around goals of care . We hypothesized that early , structured communication in the trauma ICU would improve end-of-life care practice . METHODS Prospect i ve , observational , prepost study on consecutive trauma patients admitted to the ICU before and after a structured palliative care intervention was integrated into st and ard ICU care . The program included part I , early ( at admission ) family bereavement support , assessment of prognosis , and patient preferences , and part II ( within 72 hours ) interdisciplinary family meeting . Data on goals of care discussion s , do-not-resuscitate ( DNR ) orders and withdrawal of life support ( W/D ) were collected from physician rounds , family meetings , and medical records . RESULTS Eighty-three percent of patients received part I and 69 % part II intervention . Discussion of goals of care by physicians on rounds increased from 4 % to 36 % of patient-days . During intervention , rates of mortality ( 14 % ) , DNR ( 43 % ) , and W/D ( 24 % ) were unchanged , but DNR orders and W/D were instituted earlier in hospital course . ICU length of stay was decreased in patients who died . CONCLUSIONS Structured communication between physician and families result ed in earlier consensus around goals of care for dying trauma patients . Integration of early palliative care alongside aggressive trauma care can be accomplished without change in mortality and has the ability to change the culture of care in the trauma ICU Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more STUDY OBJECTIVES To assess the impact of a proactive case finding approach to end-of-life care for critically ill patients experiencing global cerebral ischemia ( GCI ) after cardiopulmonary resuscitation and multiple organ system failure ( MOSF ) in comparison to historical control subjects . DESIGN Comparative study of retrospective and prospect i ve cohorts . SETTING Medical ICU of a university hospital . INTERVENTIONS Patterns of end-of life care for patients with MOSF and GCI obtained through a retrospective chart review were compared to proactive case finding facilitated by the inpatient palliative care service . Interventions included identification of patient 's advance directives or preferences about end-of life care , if any ; assistance with discussion of the prognosis and treatment options with patients or their surrogates ; and implementation of palliative care strategies when treatment goals changed to a focus on comfort measures . RESULTS Although our retrospective data demonstrated a high percentage of do-not-resuscitate decisions for the patients under investigation , a considerable time lag elapsed between identification of the poor prognosis and the establishment of end-of-life treatment goals ( 4.7 + /- 2.4 days and 3.5 + /- 0.5 days for patients with MOSF and GCI , respectively [ mean + /- SE ] ) . The proactive case finding approach decreased hospital length of stay ( mean , 20.6 + /- 4.1 days vs 15.1 + /- 2.5 days and 8.6 + /- 1.6 days vs 4.7 + /- 0.6 days for MOSF and GCI patients , respectively ; p = 0.063 and < 0.001 , respectively ) . More importantly , a proactive palliative care intervention decreased the time between identification of the poor prognosis and the establishment of comfort care goals ( 7.3 + /- 2.9 days vs 2.2 + /- 0.8 days and 6.3 + /- 1.2 days vs 3.5 + /- 0.4 days for MOSF and GCI patients , respectively ; p < 0.05 for both ) , decreased the time dying patients with MOSF remained in the ICU , and reduced the use of nonbeneficial re sources , thus reducing the cost of care . CONCLUSIONS Proactive interventions from a palliative care consultant within this subset of patients decreased the use of nonbeneficial re sources and avoided protracted dying PURPOSE We sought to determine the effects of a communication process that was design ed to encourage the use of advanced supportive technology when it is of benefit , but to limit its burdens when it is ineffective . We compared usual care with a proactive , multidisciplinary method of communicating that prospect ively identified for patients and families the criteria that would determine whether a care plan was effective at meeting the goals of the patient . This process allowed caregivers to be informed of patient preferences about continued advanced supportive technology when its continuation would result in a compromised functional outcome or death . MATERIAL S AND METHODS We performed a before- and -after study in 530 adult medical patients who were consecutively admitted to a university tertiary care hospital for intensive care . Multidisciplinary meetings were held within 72 hours of critical care admission . Patients , families , and the critical care team discussed the care plan and the patients ' goals and expectations for the outcome of critical care . Clinical " milestones " indicative of recovery were identified with time frames for their occurrence . Follow-up meetings were held to discuss palliative care options when continued advanced supportive technology was not achieving the patient 's goals . We measured length of stay , mortality , and provider team and family consensus in 134 patients before the intensive communication intervention and in 396 patients after the intervention . RESULTS Intensive communication significantly reduced the median length of stay from 4 days ( interquartile range , 2 to 11 days ) to 3 days ( 2 to 6 days , P = 0.01 by survival analysis ) . This reduction remained significant after adjustment for acute physiology and chronic health evaluation ( APACHE ) 3 score [ risk ratio ( RR ) = 0.81 ; 95 % confidence interval ( CI ) , 0.66 to 0.99 ; P = 0.04 ) . Subgroup analysis revealed that this reduction occurred in our target group , patients with acuity scores in the highest quartile who died ( RR = 0.60 ; 95 % CI , 0.38 to 0.92 ; P = 0.02 ) . The intervention , which allowed dying patients earlier access to palliative care , was not associated with increased mortality . CONCLUSIONS Intensive communication was associated with a reduction in critical care use by patients who died . Our multidisciplinary process targeted advanced supportive technology to patients who survived and allowed the earlier withdrawal of advanced supportive technology when it was ineffective CONTEXT Patients , families , and surgeons often have high expectations of life-saving surgery following liver transplantation ( LT ) , despite the presence of a severe life-limiting underlying illness . Hence , transition from curative to palli Output:	There was no difference in mortality rate in ICU and hospital between the protocol ized intervention and control groups . Conclusions Protocol ized family support intervention for enhanced communication and shared decision-making with the family reduced ICU LOS in critically ill patients without impacting mortality
MS21115	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Majority of studies on evaluation of emergency management courses have focused on outcomes such as knowledge and skills demonstrated in non- clinical or traditional testing manner . Such surrogate outcomes may not necessarily reflect vital changes in practice . The aim of this study was to determine if and to what extent , specific training in the management of life threatening emergencies result ed in an increased in compliance with established care guidelines of doctors working in the emergency departments of public sector hospitals in Pakistan . METHODS A cluster r and omised controlled trial was conducted in three districts hospitals in three cities ( Khairpur , Vehari and Peshawar ) of Pakistan . Thirty-six doctors , 18 in intervention ( trained in ESS-EMNCH training ) and 18 in control ( untrained ) , were enrolled and 248 life threatening emergency events , 124 in each group , were observed for the correct use of the Airway , Breathing , Circulation ( ABC ) structured approach . The outcome measure was structured approach defined a priori . Data was analysed by using STATA software . RESULTS At individual level , 79 ( 63.7 % ) life threatening episodes were managed according to the structured approach in the intervention group and 46 ( 37.1 % ) were managed according to the structured approach in controls ( OR 2.98 , 95%CI 1.78 - 4.99 , p-value=0.0001 ) . At cluster level , the mean percentage ( 95 % CI ) of the structured approach used by doctors in the intervention group [ 62.9 % ( 50.4 - 75.3 % ) ] , was significantly higher than those in the control group , [ 36.3 % ( 26.3 - 46.4 ) ] ( p-value=0.001 ) . CONCLUSIONS 5-day training of ESS-EMNCH significantly increased the compliance with established care guidelines of doctors during their management of life threatening emergency episodes in the public sector hospitals in Pakistan Objectives : To assess the effect of high-fidelity simulation ( SIM ) on cognitive performance after a training session involving several mock resuscitations design ed to teach and reinforce Pediatric Advanced Life Support ( PALS ) algorithms . Methods : Pediatric residents were r and omized to high-fidelity simulation ( SIM ) or st and ard mannequin ( MAN ) groups . Each subject completed 3 study phases : ( 1 ) mock code exercises ( asystole , tachydysrhythmia , respiratory arrest , and shock ) to assess baseline performance ( PRE phase ) , ( 2 ) a didactic session review ing PALS algorithms , and ( 3 ) repeated mock code exercises requiring identical cognitive skills in a different clinical context to assess change in performance ( POST phase ) . SIM subjects completed all 3 phases using a high-fidelity simulator ( SimBaby , Laerdal Medical , Stavanger , Norway ) , and MAN subjects used SimBaby without simulated physical findings ( ie , as a st and ard mannequin ) . Performance in PRE and POST was measured by a scoring instrument design ed to measure cognitive performance ; scores were scaled to a range of 0 to 100 points . Improvement in performance from PRE to POST phases was evaluated by mixed modeling using a r and om intercept to account for within-subject variability . Results : Fifty-one subjects ( SIM , 25 ; MAN , 26 ) completed all phases . The PRE performance was similar between groups . Both groups demonstrated improvement in POST performance . The improvement in scores between PRE and POST phases was significantly better in the SIM group ( mean [ SD ] , 11.1 [ 4.8 ] vs. 4.8 [ 1.7 ] , P = 0.007 ) . Conclusions : The use of high-fidelity simulation in a PALS training session result ed in improved cognitive performance by pediatric house staff . Future studies should address skill and knowledge decays and team dynamics , and clearly defined and reproducible outcome measures should be sought AIM Advanced simulation tools are increasingly being incorporated into cardiopulmonary resuscitation ( CPR ) training . These educational methods have been shown to improve trainee performance in simulated setting s , but translation into clinical practice remains unknown for many aspects of CPR quality . This study attempts to measure the impact of simulation-based training for resuscitation team leaders on some measures of CPR quality during actual in-hospital resuscitation attempts . METHODS In this prospect i ve , r and omized interventional cluster trial , internal medicine resident physicians ( post-graduate year 2 ) were r and omized using a r and om number generator to participate in a 4-h , immersive simulation course in cardiopulmonary resuscitation leadership using a high-fidelity simulator with video debriefing prior to serving as resuscitation team leaders at an academic medical center . Objective metrics of actual resuscitation performance were obtained from a CPR-sensing monitor/defibrillator . RESULTS Thirty-two residents were r and omized to receive simulation training or no additional training between April and July 2007 and data were collected following 98 actual resuscitations between July 2007 and June 2008 . CPR quality from resuscitations led by 14 simulation-trained and 16 control group residents was similar in terms of mean compression depth ( 48 vs 49 mm ; p = 0.53 ) ; compression rate ( 107 vs 104 min⁻¹ ; p = 0.30 ) ; ventilation rate ( 12 vs 12 min⁻¹ ; p = 0.45 ) and no-flow fraction ( 0.08 vs 0.07 ; p = 0.34 ) . CONCLUSIONS Although we failed to detect any significant differences in objective measures of CPR quality , we have demonstrated that CPR-sensing technology has the potential for use in assessing the impact of a simulation curriculum on some aspects of actual resuscitation performance . A larger study , performed in a setting with lower baseline performance , would be required to assess the specific simulation curriculum Objective To investigate the effect of in situ simulation ( ISS ) versus off-site simulation ( OSS ) on knowledge , patient safety attitude , stress , motivation , perceptions of simulation , team performance and organisational impact . Design Investigator-initiated single-centre r and omised superiority educational trial . Setting Obstetrics and anaesthesiology departments , Rigshospitalet , University of Copenhagen , Denmark . Participants 100 participants in teams of 10 , comprising midwives , specialised midwives , auxiliary nurses , nurse anaesthetists , operating theatre nurses , and consultant doctors and trainees in obstetrics and anaesthesiology . Interventions Two multiprofessional simulations ( clinical management of an emergency caesarean section and a postpartum haemorrhage scenario ) were conducted in teams of 10 in the ISS versus the OSS setting . Primary outcome Knowledge assessed by a multiple choice question test . Exploratory outcomes Individual outcomes : scores on the Safety Attitudes Question naire , stress measurements ( State-Trait Anxiety Inventory , cognitive appraisal and salivary cortisol ) , Intrinsic Motivation Inventory and perceptions of simulations . Team outcome : video assessment of team performance . Organisational impact : suggestions for organisational changes . Results The trial was conducted from April to June 2013 . No differences between the two groups were found for the multiple choice question test , patient safety attitude , stress measurements , motivation or the evaluation of the simulations . The participants in the ISS group scored the authenticity of the simulation significantly higher than did the participants in the OSS group . Expert video assessment of team performance showed no differences between the ISS versus the OSS group . The ISS group provided more ideas and suggestions for changes at the organisational level . Conclusions In this r and omised trial , no significant differences were found regarding knowledge , patient safety attitude , motivation or stress measurements when comparing ISS versus OSS . Although participant perception of the authenticity of ISS versus OSS differed significantly , there were no differences in other outcomes between the groups except that the ISS group generated more suggestions for organisational changes . Trial registration number NCT01792674 Background Newborn deaths comprise nearly half of under-5 deaths in Ghana , despite the fact that skilled birth attendants ( SBAs ) are present at 68 % of births , which implies that evidence -based care during labor , birth and the immediate postnatal period may be deficient . We assessed the effect of a low-dose , high-frequency ( LDHF ) training approach on long-term evidence -based skill retention among SBAs and impact on adverse birth outcomes . Methods From 2014 to 2017 , we conducted a cluster-r and omized trial in 40 hospitals in Ghana . Eligible hospitals were stratified by region and r and omly assigned to one of four implementation waves . We assessed the relative risks ( RRs ) of institutional intrapartum stillbirths and 24-h newborn mortality in months 1–6 and 7–12 of implementation as compared to the historical control period , and in post-intervention facilities compared to pre-intervention facilities during the same period . All SBAs providing labor and delivery care were invited to enroll ; their knowledge and skills were assessed pre- and post-training , and 1 year later . Results Adjusting for region and health facility type , the RR of 24-h newborn mortality in the 40 enrolled hospitals was 0·41 ( 95 % CI 0·32–0·51 ; p < 0.001 ) in months 1–6 and 0·30 ( 95 % CI 0·21–0·43 ; p < 0·001 ) in months 7–12 compared to baseline . The adjusted RR of intrapartum stillbirth was 0·64 ( 95 % CI 0·53–0·77 ; p < 0·001 ) in months 1–6 and 0·48 ( 95 % CI 0·36–0·63 ; p < 0·001 ) in months 7–12 compared to baseline . Four hundred three SBAs consented and enrolled . After 1 year , 200 SBAs assessed had 28 % ( 95 % CI 25–32 ; p < 0·001 ) and 31 % ( 95 % CI 27–36 ; p < 0·001 ) higher scores than baseline on low-dose 1 and 2 content skills , respectively . Conclusions This training approach results in a sustained decrease in facility-based newborn mortality and intrapartum stillbirths , and retained knowledge and skills among SBAs after a year . We recommend use of this approach for future maternal and newborn health in-service training and programs . Trial registration Retrospectively registered on 25 September 2017 at Clinical Trials , identifier NCT03290924 Background Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries . These differences have been related to poor access to and poor quality of obstetric and neonatal care . Methods This trial tested the hypothesis that teams of health care providers , administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations . In seven geographic areas in five low-income and one middle-income country , most with high perinatal mortality rates and substantial numbers of home deliveries , we performed a cluster r and omized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport , community birth attendant training in problem recognition , and facility staff training in the management of obstetric and neonatal emergencies . The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Results Despite extensive effort in all sites in each of the three intervention areas , no differences emerged in the primary or any secondary outcome between the intervention and control clusters . In both groups , the mean perinatal mortality was 40.1/1,000 births ( P = 0.9996 ) . Neither were there differences between the two groups in outcomes in the last six months of the project , in the year following intervention cessation , nor in the clusters that best implemented the intervention . Conclusions This cluster r and omized comprehensive , large-scale , multi-sector intervention did not result in detectable impact on the proposed outcomes . While this does not negate the importance of these interventions , we expect that achieving improvement in pregnancy outcomes in these setting s will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial , and without them provider training and community mobilization will not be sufficient . Our results highlight the critical importance of evaluating outcomes in r and omized trials , as interventions that should be effective may not be . Trial registration Clinical Trials.gov Objective : To determine if high fidelity simulation based team training can improve clinical team performance when added to an existing didactic teamwork curriculum . Setting : Level 1 trauma center and academic emergency medicine training program . Participants : Emergency department ( ED ) staff including nurses , technicians , emergency medicine residents , and attending physicians . Intervention : : ED staff who had recently received didactic training in the Emergency Team Coordination Course ( ETCC ® ) also received an 8 hour intensive experience in an ED simulator in which three scenarios of graduated difficulty were encountered . A comparison group , also ETCC trained , was assigned to work together in the ED for one 8 hour shift . Experimental and comparison teams were observed in the ED before and after the intervention . Design : Single , crossover , prospect i ve , blinded and controlled observational study . Teamwork ratings using previously vali date d behaviorally anchored rating scales ( BARS ) were completed by outside trained observers in the ED . Observers were blinded to the identification of the teams . Results : There were no significant differences between experimental and comparison groups at baseline . The experimental team showed a trend towards improvement in the quality of team behavior ( p = 0.07 ) ; the comparison group showed no change in team behavior during the two observation periods ( p = 0.55 ) . Members of the experimental team rated simulation based training as a useful educational method . Conclusion : High Output:	We are uncertain if there are any benefits of interactive training of healthcare providers on the management of life-threatening emergencies in hospital as the certainty of the evidence is very low . We were unable to identify any factors that may have allowed us to identify an essential element of these interactive training courses .
MS21116	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Tuberculosis ( TB ) is a major cause of morbidity and mortality among children infected with HIV . Strategies to prevent TB in children include isoniazid preventive therapy ( IPT ) and antiretroviral therapy ( ART ) . IPT and ART have been reported to reduce TB incidence in adults but there are few studies in children . Objective To investigate the combined effect of IPT and ART on TB risk in children infected with HIV . Methods A cohort analysis was done within a prospect i ve , double-blinded , placebo-controlled trial of isoniazid ( INH ) compared with placebo in children infected with HIV in Cape Town , South Africa , a high TB incidence setting . In May 2004 the placebo arm was terminated and all children were switched to INH . ART was not widely available at the start of the study , but children were started on ART following the establishment of the national ART program in 2004 . Data were analysed using Cox proportional hazard regression . Results After adjusting for age , nutritional status and immunodeficiency at enrolment , INH alone , ART alone and INH combined with ART reduced the risk of TB disease by 0.22 ( 95 % CI 0.09 to 0.53 ) , 0.32 ( 95 % CI 0.07 to 1.55 ) and 0.11 ( 95 % CI 0.04 to 0.32 ) respectively . INH reduced the risk of TB disease in children on ART by 0.23 ( 95 % CI 0.05 to 1.00 ) . Conclusions The finding that IPT may offer additional protection in children on ART has significant public health implication s because this offers a possible strategy for reducing TB in children infected with HIV . Widespread use of this strategy will however require screening of children for active TB disease . Trial registration Trial registration — Clinical Trials NCT00330304 The data from 2 U. S. Public Health Service trials of isoniazid preventive therapy were review ed in an effort to evaluate the risk of death from cancer among persons who received such therapy . Each of these prospect i ve trials used r and om assignment to either isoniazid or placebo . More than 25,000 persons participated in each of the trials . The length of follow-up ranged from 10 to 14 years in one trial and from 9 to 11 years in the other . No significant difference in the incidence of death from cancer was noted between groups treated with placebo or with isoniazid in either of the studies . This was true even when deaths due to specific types of cancer and age-specific cancer death rates were compared . These data do not support a carcinogenic effect of isoniazid in humans BACKGROUND The dual epidemic of human immunodeficiency virus ( HIV ) and tuberculosis is a major cause of sickness and death in sub-Saharan Africa . We conducted a double-blind , r and omized , placebo-controlled trial of preexposure isoniazid prophylaxis against tuberculosis in HIV-infected children and uninfected children exposed to HIV during the perinatal period . METHODS We r and omly assigned 548 HIV-infected and 804 HIV-uninfected infants ( 91 to 120 days of age ) to isoniazid ( 10 to 20 mg per kilogram of body weight per day ) or matching placebo for 96 weeks . All patients received bacille Calmette-Guérin ( BCG ) vaccination against tuberculosis within 30 days after birth . HIV-infected children had access to antiretroviral therapy . The primary outcome measures were tuberculosis disease and death in HIV-infected children and latent tuberculosis infection , tuberculosis disease , and death in HIV-uninfected children within 96 to 108 weeks after r and omization . RESULTS Antiretroviral therapy was initiated in 98.9 % of HIV-infected children during the study . Among HIV-infected children , protocol -defined tuberculosis or death occurred in 52 children ( 19.0 % ) in the isoniazid group and 53 ( 19.3 % ) in the placebo group ( P=0.93 ) . Among HIV-uninfected children , there was no significant difference in the combined incidence of tuberculosis infection , tuberculosis disease , or death between the isoniazid group ( 39 children , 10 % ) and the placebo group ( 45 children , 11 % ; P=0.44 ) . The rate of tuberculosis was 121 cases per 1000 child-years ( 95 % confidence interval [ CI ] , 95 to 153 ) among HIV-infected children as compared with 41 per 1000 child-years ( 95 % CI , 31 to 52 ) among HIV-uninfected children . There were no significant differences in clinical or severe laboratory toxic effects between treatment groups . CONCLUSIONS Primary isoniazid prophylaxis did not improve tuberculosis-disease-free survival among HIV-infected children or tuberculosis-infection-free survival among HIV-uninfected children immunized with BCG vaccine . Despite access to antiretroviral therapy , the burden of tuberculosis remained high among HIV-infected children . ( Funded by the National Institutes of Health and Secure the Future ; Clinical Trials.gov number , NCT00080119 . ) OBJECTIVE To compare the adverse effects and treatment adherence between 2 months of rifampin plus pyrazinamide ( 2RZ ) and 6 months of isoniazid ( 6H ) . BACKGROUND Patients with silicosis in Hong Kong are at high risk of acquiring tuberculosis . A previous study showed that treatment with 6H reduced the risk of silico-tuberculosis by one half . METHOD Patients with silicosis and a Mantoux skin test reaction > or = 10 mm were r and omized to receive either 2RZ or 6H daily . Liver function testing was done monthly during the initial 2 months . The adverse effects and treatment adherence were compared between the two regimens . RESULTS Forty patients ( mean age , 61.6 + /- 9.1 years ) and 36 patients ( mean age , 57.6 + /- 9.7 years ) were r and omized to the 2RZ and 6H arms , respectively ( p > 0.05 ) [ + /- SD ] . Baseline characteristics were comparable . Nineteen patients in the 2RZ arm had peak alanine transaminase ( ALT ) levels > 1.5 times the upper limit of normal ( ULN ) in comparison with only five study subjects of the 6H arm ( 47.5 % vs 13.9 % , p < 0.01 ) . Fourteen patients ( 35 % ) in the 2RZ arm and 1 patient ( 2.8 % ) in the 6H arm had peak ALT levels more than five times the ULN ( p < 0.001 ) . Only seven patients had symptoms suggestive of hepatitis ; none of the patients had jaundice . All recovered after withholding treatment . In the 2RZ study arm , none of the baseline characteristics predicted hepatotoxicity . Other adverse effects were generally mild and comparable between both study arms . Treatment was stopped prematurely in 45 % and 36.1 % of patients in the 2RZ and 6H arms , respectively ( p = 0.43 ) . The main reasons were hepatotoxicity for the 2RZ arm and voluntary withdrawal after experiencing other minor adverse effects for the 6H arm . CONCLUSION A higher incidence of hepatotoxicity was associated with rifampin plus pyrazinamide than isoniazid in the treatment of latent tuberculosis infection among patients with silicosis in Hong Kong This article reports the findings from a clinical study that examined the impact of health education and counseling on the decision of a patient infected with tuberculosis ( TB ) to complete a regimen of isoniazid ( INH ) chemoprophylaxis for 6 months to prevent TB . Forty patients were divided into two groups ; both groups were administered a question naire to collect demographic data and medical history . One group received additional health education and counseling independent of clinic staff , and the other group only received health education and counseling from clinic staff . The proportion of patients in the first group who completed INH for 6 months ( 63.6 % ) was significantly greater than the proportion of patients in the second group ( 11.1 % ) . These findings suggest that health education and counseling did make an impact on the decision of a patient infected with TB to conform with a rational choice when provided with information and a supportive relationship about the consequences of TB infection SETTING An 8-month isoniazid ( INH , H ) and ethambutol ( EMB , E ) based regimen recommended by the World Health Organization ( WHO ) had never been evaluated in a r and omised controlled multicentre trial . OBJECTIVE To compare , in a non-inferiority study design , two 8-month INH+EMB-based regimens with a st and ard INH and rifampicin ( RMP , R ) based regimen . DESIGN A total of 1355 patients with newly diagnosed smear-positive pulmonary tuberculosis were r and omly allocated to receive 1 ) daily EMB , INH , RMP and pyrazinamide ( PZA , Z ) for 2 months , followed by EMB+INH for 6 months ( 2EHRZ/6HE ) ; 2 ) the same drugs in the intensive phase but given three times weekly , followed by the same continuation phase of daily EMB+INH ( 2(EHRZ)(3)/6HE ) ; or 3 ) a control regimen with the same intensive phase as in regimen 1 , followed by 4 months of daily RMP+INH ( 2EHRZ/4HR ) . All patients were to be seen and sputum examinations for microscopy and culture carried out at regular intervals up to 30 months after r and omisation . RESULTS At 30 months , failure/relapse rates were 11.7 % of 281 2EHRZ/6HE , 15.3 % of 301 2(EHRZ)(3)/6HE and 6.0 % of 282 2EHRZ/4HR patients ( χ(2 ) , 2 degrees of freedom = 12.8 , P = 0.002 ) . CONCLUSION These results confirm earlier findings demonstrating the inferiority of the INH+EMB-based regimens to the st and ard 6-month regimen . The WHO has withdrawn its recommendation of these regimens Rationale Treatment for latent tuberculosis infection with isoniazid for 9 months ( 9INH ) has poor completion and serious adverse events , while treatment for 4 months with daily rifampin ( 4RIF ) has significantly higher completion and fewer adverse events . Objectives To compare the health system costs of 4RIF and 9INH . Methods In a r and omised trial conducted in five Canadian centres , one Brazilian and one Saudi Arabian centre , consenting subjects were r and omised to receive 4RIF or 9INH . Health system costs were estimated from healthcare utilisation including scheduled and unscheduled visits , investigations and drugs . All activities for all subjects were evaluated using financial information from 2007 from the Montreal Chest Institute . Costs were expressed in Canadian dollars . Results Total health system cost per patient allocated to 4RIF was $ 854 compared with $ 970 for 9INH ( p<0.0001 ) . The average cost per patient for the 328 of 420 ( 78 % ) who completed 4RIF therapy was $ 1094 compared with $ 1625 for the 254 of 427 ( 60 % ) completing 9INH ( p<0.0001 ) . Costs were modestly increased in patients with minor intolerance and substantially increased if the treating physician stopped treatment because of possible adverse events . Total costs related to management of adverse events with 9INH were $ 48 142 compared with $ 25 684 for 4RIF ( p=0.008 ) . Using these data , incremental cost-effectiveness analyses showed that 4RIF would be cost saving and prevent more cases within 2 years if efficacy exceeded 74 % , and cost saving if efficacy exceeded 65 % . Conclusions The 4RIF regimen was significantly cheaper per patient completing treatment because of better completion and fewer adverse events . RCT registration number NCT00170209 BACKGROUND Cases of severe and fatal liver injury were reported after a 2-month course of rifampin-pyrazinamide therapy was recommended in 2000 as an alternative to isoniazid for treatment of latent tuberculosis infection . We estimated rates of rifampin-pyrazinamide-associated liver injury and compared these with historical rates for isoniazid . METHODS We conducted a survey of state and city tuberculosis programs and other health care setting s in the United States where rifampin-pyrazinamide was prescribed . The number of rifampin-pyrazinamide therapy initiations was collected , as well as the number of occurrences of ( 1 ) asymptomatic aspartate aminotransferase serum concentration > 5 times the upper limit of normal , ( 2 ) symptomatic hepatitis ( in which the patient was not hospitalized ) , ( 3 ) hospitalization for liver injury , ( 4 ) death with liver injury , and ( 5 ) treatment completion . We also search ed a national pharmacy cl aims data base ( Verispan ) . Rates of these events were calculated . RESULTS Among 139 programs , 110 ( 79 % Output:	The directly-observed , shorter regimen had higher treatment completion ( 82 % vs 69 % , RR 1.19 , 95 % CI 1.16 to 1.22 , moderate quality evidence ) , and less hepatotoxicity ( 0.4 % versus 2.4 % ; RR 0.16 , 95 % CI 0.10 to 0.27 ; high quality evidence ) , though treatment-limiting adverse events were more frequent ( 4.9 % versus 3.7 % ; RR 1.32 , 95 % CI 1.07 to 1.64 moderate quality evidence ) AUTHORS ' CONCLUSIONS Trials to date of shortened prophylactic regimens using rifampicin alone have not demonstrated higher rates of active TB when compared to longer regimens with INH . Treatment completion is probably higher and adverse events may be fewer with shorter rifampicin regimens . Shortened regimens of rifampicin with INH may offer no advantage over longer INH regimens . Rifampicin combined with pyrazinamide is associated with more adverse events . A weekly regimen of rifapentine plus INH has higher completion rates , and less liver toxicity , though treatment discontinuation due to adverse events is probably more likely than with INH
MS21117	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND In the phase 3 KEYNOTE-024 trial , treatment with pembrolizumab conferred longer progression-free survival than did platinum-based therapy in patients with treatment-naive , advanced non-small-cell lung cancer ( NSCLC ) with a programmed cell death-lig and 1 ( PD-L1 ) tumour proportion score of 50 % or greater ( PD-L1-positive ) . Here we report the prespecified exploratory endpoint of pembrolizumab versus chemotherapy on patient-reported outcomes ( PROs ) . METHODS In this multicentre , international , r and omised , open-label , phase 3 trial , we recruited patients with treatment-naive , stage IV NSCLC in 102 sites in 16 countries . Eligible patients had measurable disease ( per RECIST version 1.1 ) and an Eastern Cooperative Oncology Group ( ECOG ) performance status 0 or 1 . Patients were r and omly assigned ( 1:1 ) via an interactive voice response system and integrated web response system to receive either pembrolizumab 200 mg every 3 weeks ( 35 cycles ) or investigator-choice platinum-doublet chemotherapy ( 4 - 6 cycles or until documented disease progression or unacceptable toxicity ) . R and omisation was stratified according to geography , ECOG performance status , and histology . PROs were assessed at day 1 of cycles 1 - 3 , every 9 weeks thereafter , at the treatment discontinuation visit , and at the 30-day safety assessment visit using the European Organisation for the Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire Core 30 items ( QLQ-C30 ) , the EORTC Quality of Life Question naire Lung Cancer 13 items ( QLQ-LC13 ) , and the European Quality of Life 5 Dimensions-3 Level ( EQ-5D-3L ) question naire . The key exploratory PRO endpoints ( analysed for all patients who received at least one dose of study treatment and completed at least one PRO instrument at at least one timepoint ) were baseline-to-week-15 change in the QLQ-C30 global health status (GHS)/ quality -of-life ( QOL ) score and time to deterioration of the composite of cough , chest pain , and dyspnoea in the QLQ-LC13 . This study is registered with Clinical Trials.gov , number NCT02142738 , and is ongoing but no longer enrolling patients . FINDINGS Between Sept 19 , 2014 , and Oct 29 , 2015 , 305 patients were r and omly assigned to pembrolizumab ( n=154 ) or chemotherapy ( n=151 ) . Three patients in each group did not complete any PRO instruments at any timepoints , and so 299 patients were included in the full analysis set . Of these patients , one in each group did not complete any PRO instruments before week 15 , and so were not included in analyses of change from baseline to week 15 . PRO compliance was greater than 90 % at baseline and approximately 80 % at week 15 for both groups . Least-squares mean baseline-to-week-15 change in QLQ-C30 GHS/QOL score was 6·9 ( 95 % CI 3·3 to 10·6 ) for pembrolizumab and -0·9 ( -4·8 to 3·0 ) for chemotherapy , for a difference of 7·8 ( 2·9 to 12·8 ; two-sided nominal p=0·0020 ) . Fewer pembrolizumab-treated patients had deterioration in the QLQ-LC13 composite endpoint than did chemotherapy-treated patients ( 46 [ 31 % ] of 151 patients vs 58 [ 39 % ] of 148 patients ) . Time to deterioration was longer with pembrolizumab than with chemotherapy ( median not reached [ 95 % CI 8·5 to not reached ] vs 5·0 months [ 3·6 to not reached ] ; hazard ratio 0·66 , 95 % CI 0·44 - 0·97 ; two-sided nominal p=0·029 ) . INTERPRETATION Pembrolizumab improves or maintains health-related QOL compared with that for chemotherapy , and might represent a new first-line st and ard of care for PD-L1-expressing , advanced NSCLC . FUNDING Merck & Composite outcomes , in which multiple end points are combined , are frequently used as primary outcome measures in r and omized trials and are often associated with increased statistical efficiency . However , such measures may prove challenging for the interpretation of results . In this article , we examine the use of composite outcomes in major clinical trials , assess the arguments for and against them , and provide guidance on their application and reporting . To assess incidence and quality of reporting , we systematic ally review ed the use of composite end points in clinical trials in Annals of Internal Medicine , BMJ , Circulation , Clinical Infectious Diseases , Journal of the American College of Cardiology , JAMA , Lancet , New Engl and Journal of Medicine , and Stroke from 1997 through 2001 using a sensitive search strategy . We selected for review 167 original reports of r and omized trials ( with a total of 300 276 patients ) that included a composite primary outcome that incorporated all-cause mortality . Sixty-three trials ( 38 % ) were neutral both for the primary end point and the mortality component . Sixty trials ( 36 % ) reported significant results for the primary outcome measure but not for the mortality component . Only 6 trials ( 4 % ) were significant for the mortality component but not for the primary composite outcome , whereas 19 trials ( 11 % ) were significant for both . Twenty-two trials ( 13 % ) were inadequately reported . Our review suggests that reporting of composite outcomes is generally inadequate , implying that the results apply to the individual components of the composite outcome rather than only to the overall composite . Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials BACKGROUND In the phase 3 RADIANT-4 trial , everolimus increased progression-free survival compared with placebo in patients with advanced , progressive , non-functional , well-differentiated gastrointestinal or lung neuroendocrine tumours ( NETs ) . We now report the health-related quality of life ( HRQOL ) secondary endpoint . METHODS RADIANT-4 is a multicentre , r and omised , double-blind , placebo-controlled , phase 3 trial done in 97 centres in 25 countries worldwide . Adults ( aged ≥18 years ) were eligible for the study if they had pathologically confirmed , advanced ( unresectable or metastatic ) , non-functional , well-differentiated ( grade 1 or 2 ) NETs of lung or gastrointestinal origin . Patients were r and omly allocated ( 2:1 ) using block r and omisation ( block size of three ) by an interactive voice response system to receive oral everolimus ( 10 mg per day ) or placebo , both with best supportive care , with stratification by tumour origin , WHO performance status , and previous somatostatin analogue treatment . HRQOL was assessed with the Functional Assessment of Cancer Therapy-General ( FACT-G ) question naire at baseline ( visit 2 , day 1 ) , every 8 weeks ( ± 1 week ) during the study for the first 12 months after r and omisation , and every 12 weeks thereafter until study drug discontinuation . The primary endpoint , reported previously , was progression-free survival assessed by central review ; HRQOL was a prespecified secondary endpoint . The prespecified secondary outcome measure was time to definitive deterioration ( ≥7 points ) in FACT-G total score . Analyses were done on the full analysis set , consisting of all r and omised patients , by intention to treat . Only data obtained while receiving the r and omly allocated treatment were included in this analysis . Enrolment for RADIANT-4 was completed on Aug 23 , 2013 , but the trial is ongoing pending final analysis of the key secondary endpoint of overall survival . This trial is registered with Clinical Trials.gov , number NCT01524783 . FINDINGS Between April 3 , 2012 , and Aug 23 , 2013 , 302 patients were enrolled ; 205 were r and omly allocated everolimus and 97 were assigned placebo . At baseline , 193 ( 94 % ) of 205 patients assigned everolimus and 95 ( 98 % ) of 97 allocated placebo had completed either fully or partly the FACT-G question naire ; at week 48 , 70 ( 83 % ) of 84 patients assigned everolimus and 22 ( 85 % ) of 26 allocated placebo completed FACT-G. Median time to definitive deterioration in FACT-G total score was 11·27 months ( 95 % CI 9·27 - 19·35 ) with everolimus and 9·23 months ( 5·52-not estimable ) with placebo ( adjusted hazard ratio 0·81 , 95 % CI 0·55 - 1·21 ; log-rank p=0·31 ) . INTERPRETATION HRQOL was maintained for patients with advanced , non-functional , gastrointestinal or lung NETs , with no relevant differences noted between the everolimus and placebo groups . In view of the previous RADIANT-4 findings of longer progression-free survival with everolimus , our findings suggest that everolimus delays disease progression while preserving overall HRQOL , even with the usual toxic effects related to active targeted drug treatment for cancer . FUNDING Novartis Pharmaceuticals Purpose In the phase III KEYNOTE-045 study ( Clinical Trials.gov identifier : NCT02256436 ) , pembrolizumab significantly prolonged overall survival compared with investigator 's choice of chemotherapy in patients with previously treated advanced urothelial cancer . Here , we report the results of health-related quality -of-life ( HRQoL ) analyses from the KEYNOTE-045 trial . Patients and Methods Patients were r and omly assigned 1:1 to pembrolizumab 200 mg or investigator 's choice of docetaxel 75 mg/m2 , paclitaxel 175 mg/m2 , or vinflunine 320 mg/m2 administered intravenously every 3 weeks . Key prespecified HRQoL analyses were time to deterioration ( TTD ) and mean change from baseline to week 15 in European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 global health status/ quality -of-life score . Results Of 542 patients who were r and omly assigned , 519 were included in HRQoL analyses ( pembrolizumab , n = 266 ; chemotherapy , n = 253 ) . HRQoL compliance was > 95 % at baseline and approximately 88 % at week 15 for both groups . Pembrolizumab prolonged TTD in global health status/ quality -of-life score compared with chemotherapy ( median , 3.5 months v 2.3 months ; hazard ratio , 0.72 ; nominal one-sided P = .004 ) . Mean ( 95 % CI ) change from baseline to week 15 in global health status/ quality -of-life score was 0.69 ( -2.40 to 3.77 ) with pembrolizumab and -8.36 ( -11.84 to -4.89 ) with chemotherapy ( mean difference , 9.05 points ; 95 % CI , 4.61 to 13.50 ; nominal two-sided P < .001 ) . Conclusion Pembrolizumab prolonged TTD in HRQoL compared with chemotherapy . Patients who were treated with pembrolizumab had stable or improved global health status/ quality of life , whereas those who were treated with investigator 's choice of chemotherapy experienced declines in global health status/ quality of life . Combined with efficacy and safety outcomes , these data support pembrolizumab as st and ard of care for patients with platinum-refractory advanced urothelial cancer In the Intergroupe Francophone de Cancérologie Thoracique 0501 trial the carboplatin-paclitaxel chemotherapy increased toxicity ( most frequent , decreased neutrophil count , asthenia ) . We longitudinally compared health-related quality of life ( HRQoL ) of the two treatment arms . In total , 451 patients aged 70–89 years with advanced non-small cell lung cancer ( NSCLC ) were r and omly assigned to receive carboplatin plus paclitaxel or vinorelbine or gemcitabine . HRQoL was assessed by means of the European Organisation for Research and Treatment of Cancer QLQ-C30 question naire at baseline , week 6 and week 18 . Using a five-point decrease as the minimal clinical ly important difference , patients treated with the chemotherapy doublet exhibited a significant longer time until definitive deterioration ( TUDD ) for two HRQoL dimensions : physical functioning ( median TUDD : 2.04 for the doublet versus 1.71 months for monotherapy ; log-rank p=0.01 ) and nausea and vomiting ( median : not reached versus 4.83 , respectively ; log-rank p=0.046 ) . Cox multivariate analysis revealed the carboplatin and Output:	This review highlights the lack of st and ardization of the TTD approach for the analysis of PRO data in RCTs .
MS21118	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Data on the duration of major depressive episodes ( MDE ) in the general population are sparse . AIMS To assess the duration of MDE and its clinical and socio-demographic determinants in a study group drawn from the general population with newly originated episodes of major depression . METHOD The Netherl and s Mental Health Survey and Incidence Study is a prospect i ve epidemiological survey in the adult population ( n=7076 ) , using the Composite International Diagnostic Interview . Duration of MDE over 2 years was assessed with a Life Chart Interview . RESULTS The median duration of MDE was 3.0 months ; 50 % of participants recovered within 3 months , 63 % within 6 months , 76 % within 12 months and nearly 20 % had not recovered at 24 months . Determinants of persistence were severity of depression and comorbid dysthymia . A recurrent episode predicted shorter duration . CONCLUSIONS Although half of those affected with MDE recovered rapidly , the risk of chronicity ( duration 24 months or more ) was considerable . This underlines the necessity of diagnosing and treating those at risk CONTEXT Given the public health significance of late-life depression and anxiety , and the limited capacity of treatment , there is an urgent need to develop effective strategies to prevent these disorders . OBJECTIVE To determine the effectiveness of an indicated stepped-care prevention program for depression and anxiety disorders in the elderly . DESIGN R and omized controlled trial with recruitment between October 1 , 2004 , and October 1 , 2005 . SETTING Thirty-three primary care practice s in the northwestern part of the Netherl and s. PARTICIPANTS A total of 170 consenting individuals , 75 years and older , with subthreshold symptom levels of depression or anxiety who did not meet the full diagnostic criteria for the disorders . INTERVENTION Participants were r and omly assigned to a preventive stepped-care program ( n = 86 ) or to usual care ( n = 84 ) . Stepped-care participants sequentially received a watchful waiting approach , cognitive behavior therapy-based bibliotherapy , cognitive behavior therapy-based problem-solving treatment , and referral to primary care for medication , if required . MAIN OUTCOME MEASURES The cumulative incidence of DSM-IV major depressive disorder or anxiety disorder after 12 months as measured using the Mini International Neuropsychiatric Interview . RESULTS The intervention halved the 12-month incidence of depressive and anxiety disorders , from 0.24 ( 20 of 84 ) in the usual care group to 0.12 ( 10 of 86 ) in the stepped-care group ( relative risk , 0.49 ; 95 % confidence interval , 0.24 to 0.98 ) . CONCLUSIONS Indicated stepped-care prevention of depression and anxiety in elderly individuals is effective in reducing the risk of onset of these disorders and is valuable as seen from the public health perspective Abstract Objectives : To determine whether problem solving treatment combined with antidepressant medication is more effective than either treatment alone in the management of major depression in primary care . To assess the effectiveness of problem solving treatment when given by practice nurses compared with general practitioners when both have been trained in the technique . Design : R and omised controlled trial with four treatment groups . Setting : Primary care in Oxfordshire . Participants : Patients aged 18 - 65 years with major depression on the research diagnostic criteria —a score of 13 or more on the 17 item Hamilton rating scale for depression and a minimum duration of illness of four weeks . Interventions : Problem solving treatment by research general practitioner or research practice nurse or antidepressant medication or a combination of problem solving treatment and antidepressant medication . Main outcome measures : Hamilton rating scale for depression , Beck depression inventory , clinical interview schedule ( revised ) , and the modified social adjustment schedule assessed at 6 , 12 , and 52 weeks . Results : Patients in all groups showed a clear improvement over 12 weeks . The combination of problem solving treatment and antidepressant medication was no more effective than either treatment alone . There was no difference in outcome irrespective of who delivered the problem solving treatment . Conclusions : Problem solving treatment is an effective treatment for depressive disorders in primary care . The treatment can be delivered by suitably trained practice nurses or general practitioners . The combination of this treatment with antidepressant medication is no more effective than either treatment alone . Key messages Problem solving treatment is an effective treatment for depressive disorders in primary care Problem solving treatment can be delivered by suitably trained practice nurses as effectively as by general practitioners The combination of problem solving treatment and antidepressant medication is no more effective than either treatment alone Problem solving treatment is most likely to benefit patients who have a depressive disorder of moderate severity and who wish to participate in an active psychological We evaluated , among depressed medical patients who are high utilizers of health care , whether improved vs unimproved depression is associated with differences in the course of functional disability . At baseline , 6 months , and 12 months , depression and disability were assessed among a sample of enrollees in health maintenance organizations ( N = 145 ) in the top decile of users of ambulatory health care who exceeded the 70th percentile of health maintenance organization population norms for depression . Improved depression was defined as a reduction of at least one third in depressive symptoms averaged across the two follow-up times . At the 12-month follow-up , persons with severe-improved depression experienced a 36 % reduction in disability days ( 79 days per year to 51 days per year ) and a 45 % reduction in disability score . Persons with moderate-improved depression experienced a 72 % reduction in disability days ( 62 days per year to 18 days per year ) and a 40 % reduction in disability score . In contrast , persons with severe-unimproved depression reported 134 disability days per year at baseline , while persons with moderate-unimproved depression reported 77 disability days per year at baseline . Neither group with unimproved depression showed improvement in either disability days or disability score during the 1-year follow-up period . High utilizers of health care with severe-unimproved depression were more likely to have current major depression and to be unemployed . Improved ( relative to unimproved ) depression was associated with borderline differences in the severity of physical disease and in the percent married . We conclude that depression and disability showed synchrony in change over time . However , depression and disability may show synchrony in change with disability because both depression and disability are controlled by some other factor that influences the chronicity of depression ( eg , chronic disease or personality disorder ) . The finding of synchronous change of depression and disability provides a rationale for r and omized controlled trials of depression treatments among depressed and disabled medical patients to determine whether psychiatric intervention might improve functional status in such patients . Such research is needed to determine whether there is a causal relationship between depression offset and reductions in functional disability BACKGROUND The current nonr and omized clinical trial explored changes over time in children with an anxiety disorder during stepped care , manual-based cognitive behaviour therapy ( CBT ) . METHODS Clinical ly anxious children ( 8 - 12 years , n = 133 ) and their parents participated in child focused CBT ( 10 sessions ) . If assessment s indicated additional treatment was necessary , participants could step up to a second and possibly third treatment phase ( each 5 sessions ) including more parental involvement . RESULTS After the first treatment phase 45 % of the Intention-To-Treat sample was free of any anxiety disorder ; after the second and third phase an additional 17 % and 11 % respectively . In total , 74 % of the children no longer met criteria for any anxiety disorder following treatment . Child and parent reported anxiety and depression symptoms of children improved significantly during all treatment phases , as well as child reported anxiety sensitivity and negative affect . Children participating in more treatment showed significant improvements during additional treatment phases , indicating that late change occurred for the subgroup that had not changed during the first phase . CONCLUSIONS Stepped care offers a st and ardized , assessment based , yet tailored treatment approach for children with anxiety disorders . A more intensive treatment is offered when initial CBT is insufficient , providing children additional opportunities to reach the desired outcome INTRODUCTION Worldwide , health systems are improving access to empirically supported psychological therapies for anxiety and depression . Evaluations of this effort are limited by the cross sectional nature of studies , short implementation periods , poor data completeness rates and lack of clinical ly significant and reliable change metrics . OBJECTIVE Assess the impact of implementing stepped care empirically supported psychological therapies by measuring the prospect i ve outcomes of patients referred over a two year period to one Improving Access to Psychological Therapies service in the UK . METHOD We collected demographic , therapeutic and outcome data on depression ( PHQ-9 ) and anxiety ( GAD-7 ) from 7859 consecutive patients for 24 months between 1st July 2006 and 31st August 2008 , following up these patients for a further one year . RESULTS 4183 patients ( 53 % ) received two or more treatment sessions . Uncontrolled effect size for depression was 1.07 ( 95 % CI : 0.88 to 1.29 ) and for anxiety was 1.04 ( 0.88 to 1.23 ) . 55.4 % of treated patients met reliable improvement or reliable and clinical ly significant change criteria for depression , 54.7 % for anxiety . Patients received a mean of 5.5 sessions over 3.5h , mainly low-intensity CBT and phone based case management . Attrition was high with 47 % of referrals either not attending for an assessment or receiving an assessment only . CONCLUSIONS Recovery rates for patients receiving stepped care empirically supported treatments for anxiety and depression in routine practice are 40 to 46 % . Only half of all patients referred go on to receive treatment . Further work is needed to improve routine engagement of patients with anxiety and depression OBJECTIVES To determine the effects of implementing stepped care evidence -based psychological treatments for anxiety and depression in routine practice using a collaborative care implementation model . DESIGN Observational prospect i ve cohort study /Phase IV field trial . METHODS We collected data on depression and anxiety from a prospect i ve cohort of 3,994 consecutive patients referred to the UK Improving Access to Psychological Therapies demonstration site in Doncaster for 12 months from August 2006 using PHQ-9 and GAD-7 . We collected demographic and process information including the type and methods of treatments received . We calculated effect sizes , remission , and recovery rates for patients competing treatment and those who dropped out or were considered to be unsuitable . RESULTS Two thous and seven hundred and ninety-five patients received an assessment , out of which 2,017 received two or more appointments . Out of these , 869 had completed treatment by the census date , 743 remained in treatment , 319 had dropped out , and 85 had been found to be unsuitable . Pre-post treatment effect sizes for anxiety and depression in those patients completing treatment were 1.39 and 1.41 , respectively , with post-treatment relative risks of depression and anxiety 0.29 and 0.34 . The combined remission and recovery rates were 76 % for depression and 74 % for anxiety . The mean number of treatment sessions was 5.15 in a mean time of 2 h and 45 min . On an average , patients received at least three of these contacts by telephone . Outcomes are comparable with benchmarked trials , review s , and routine data sets . CONCLUSIONS Combining low-intensity stepped care psychological treatment with a telephony-based collaborative care organizational system can deliver good clinical outcomes in routine practice OBJECTIVE To determine the clinical predictors and rate of relapse for major depression in primary care . DESIGN A cohort study of subjects in 2 r and omized trials of depressed patients diagnosed and prescribed antidepressant medicine by primary care physicians . Baseline , 7-month , and 19-month assessment s were conducted . SETTING A large primary care clinic of a staff-model health maintenance organization . PATIENTS Two hundred fifty-one primary care patients who did not satisfy Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition ( DSM-III-R ) criteria for major depression at 7 months . MAIN OUTCOME MEASURES Relapse was defined as ( 1 ) satisfying DSM-III-R criteria for major depression at 19 months , or ( 2 ) reporting an interval episode of 2 weeks or more of depressed mood and symptoms between 7 and 19 months . Predictors examined included demographic characteristics , medical comorbidity , disability , and psychological symptoms . Depressive symptoms were measured by Inventory of Depressive Symptoms and Hopkins Symptoms Checklist . RESULTS Of the patients , 37.1 % reported relapse of depression in the 12-month relapse-risk period . The 2 major risk factors associated with relapse were ( 1 ) persistence of subthreshold depressive symptoms 7 months after the initiation of antidepressant therapy ( odds ratio , 3.3 ; 95 % confidence interval , 2.74 - 3.93 ) and ( 2 ) history of 2 or more episodes of major depression , or chronic mood symptoms for 2 years ( odds ratio , 2.1 ; 95 % confidence interval , 1.41 - 2.76 ) . Patients with both risk factors were approximately 3 times more likely to relapse than patients with neither . CONCLUSIONS The relapse rate among primary care patients treated for depression approached that of specialty sample s , with more than one third reporting relapse in 1 year . Clinical characteristics can help target high-risk patients for relapse prevention efforts Output:	Evidence suggested that stepped care interventions for depression are at least as effective as usual care . However , the clinical and organisational superiority of stepped care is yet to be scientifically verified . Differential benefits of stepped care may ultimately depend on service quality .
MS21119	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Adult height has been found in some but not all studies to be associated positively with overall cancer incidence as well as several site-specific cancers . The Physicians ' Health Study ( PHS ) , a r and omized trial of beta-carotene and aspirin in the primary prevention of cancer and cardiovascular disease in men , provided an opportunity to examine the association between height and total malignant neoplasms ( excluding non-melanoma skin cancer ) , as well as site-specific cancers including prostate , colorectal , and lung cancer . The PHS is comprised of 22,071 US male physicians in the United States , a population homogeneous for adult socioeconomic status , aged 40 to 84 years in 1982 . Participants were classified into five height categories at study entry . After an average follow-up of over 12 years , there were 2,566 cases of incident total malignant neoplasms , including 1,047 prostate , 341 colorectal , and 170 lung cancer cases . Height was associated positively with both total malignant neoplasms and prostate cancer . Compared with men in the shortest category(≤ 67 inches ) , relative risks and 95 percent confidence intervals (CI)for total malignant neoplasms for men whose height ( in inches ) was 68 - 69,70 - 71 , 72 , and 73 + were , respectively : 1.13 ( CI = 0.99 - 1.28 ) , 1.15 ( CI = 1.02 - 1.30 ) , 1.29 ( CI = 1.12 - 1.49 ) , and 1.21 ( CI = 1.05 - 1.39 ) , P trend 0.001,adjusted for age , r and omized treatment assignments , body mass index ( wt/ht2 ) , cigarette smoking , alcohol use , and exercise frequency . For prostatecancer , the corresponding RR values were 1.23 ( CI = 1.00 - 1.51 ) , 1.26 ( CI = 1.04 - 1.54 ) , 1.59 ( CI = 1.27 - 1.98 ) , and 1.26 ( CI = 1.00 - 1.59 ) , P trend 0.005.For colorectal cancer , in some but not all height categories compared with the shortest , there were elevated RRs without a significant linear trend : RR= 1.51 ( CI = 1.06 - 2.14 ) , 1.14 ( CI = 0.80 - 1.62 ) , 1.19 ( CI = 0.79 - 1.80 ) , and 1.53 ( CI = 1.04 - 2.25 ) , P trend 0.23 . In contrast , there was no evidence of an association of height with lung cancer . These data indicate a positive association between height and risk of total malignant neoplasms , as well as of prostate cancer and , possibly , colorectal cancer Background : Because of its nutrients and anabolic hormones , cow 's milk may promote height growth , which in turn has been related to breast cancer risk . We prospect ively investigated associations between dairy intakes and height growth . Methods : A cohort of 5,101 girls from throughout the United States completed annual surveys ( 1996 - 2001 , 2003 ) , providing height , weight , and past-year diet . At baseline , all were premenarchal , ages 9 years and above , with no serious medical conditions . We studied three outcomes : annual height growth , peak growth velocity , and adult height . Multivariate models estimated the effects of milk , cheese , yogurt , and energy on subsequent growth , adjusted for race/ethnicity , age , prior height , and body mass index . Other models studied fats and proteins . Results : Premenarchal girls who drank > 3 servings per day of milk grew 0.11 in . ( P = 0.02 ) more the following year than girls consuming < 1 serving per day . Yogurt ( + 0.13 in./cup ; P = 0.02 ) , but not cheese or total calories , predicted height growth . In a separate model , dairy protein ( + 0.034 in./10 g ; P < 0.001 ) predicted height growth . Larger peak velocities were seen among girls reporting , at baseline , more milk ( > 3 glasses per day versus < 1 ; + 0.14 in . , P = 0.01 ) , more yogurt ( + 0.17 in./cup , P = 0.02 ) , and , in a separate model , more dairy protein ( + 0.039 in./10 g ; P = 0.003 ) . Baseline milk and dairy protein predicted taller adults . Dairy protein was more important than dairy fat , for all outcomes . Nondairy animal protein and vegetable protein were never significant , nor were nondairy animal fat and vegetable fat . Conclusion : Of the foods/nutrients studied , dairy protein had the strongest association with height growth . These findings suggest that a factor in the nonlipid phase of milk , but not protein itself , has growth-promoting action in girls . ( Cancer Epidemiol Biomarkers Prev 2009;18(6):1881–7 AIM To examine whether peanut consumption is associated with a reduced risk of colorectal cancer in a prospect i ve cohort with a 10-year follow-up . METHODS In 1990 - 1992 , residents ( 12026 men and 11917 women aged 30 to 65 years ) in 7 townships , Taiwan , were interviewed and recruited into a cancer-screening cohort and annually followed up . Colorectal cancer cases in this cohort were identified from cancer registry and death certificates . Incidence rates of this disease by the end of 2001 were calculated by gender for the primary study variable and covariates . The dietary intake was assessed by means of weekly food frequency measures , including frequently consumed food groups and folk dishes including sweet potato , bean products , peanut products , pickled foodstuffs , nitrated or smoked foodstuffs . RESULTS During the study period , 107 new colorectal cancer cases ( 68 men and 39 women ) were confirmed . The multivariate Cox 's proportional hazard model showed that the relative risk ( RR ) of peanut consumption was 0.73 [ 95 % confidence interval ( CI ) = 0.44 - 1.21 ] for men and 0.42 ( 95 % CI = 0.21 - 0.84 ) for women . However , frequent intake of pickled foodstuffs was harmful for women ( RR = 2.15 , 95 % CI = 0.99 - 4.65 ) . The risk of colorectal cancer was also elevated among cigarette smokers but not significant ( P<0.05 ) . CONCLUSION This study suggests that frequent intake of peanut and its products may reduce colorectal cancer risk in women , demonstrating the anti-proliferating effect of peanut intake To investigate the relation of dietary intakes of sucrose , meat , and fat , and anthropometric , lifestyle , hormonal , and reproductive factors to colon cancer incidence , data were analyzed from a prospect i ve cohort study of 35,215 Iowa ( United States ) women , aged 55–69 years and without a history of cancer , who completed mailed dietary and other question naires in 1986 . Through 1990 , 212 incident cases of colon cancer were documented . Proportional hazards regression was used to adjust for age and other risk factors . Risk factors found to be associated significantly with colon cancer included : ( i ) sucrose-containing foods and beverages other than ice cream/milk ; relative risks ( RR ) across the quintiles=1.00 , 1.73 , 1.56 , 1.54 , and 2.00 ( 95 % confidence intervals [ CI ] for quintiles two and five exclude 1.0 ) ; ( ii ) sucrose ; RR across the quintiles=1.00 , 1.70 , 1.81 , 1.82 , and 1.45 ( CI for quintiles two through four exclude 1.0 ) ; ( iii ) height ; RR=1.23 for highest to lowest quintile ( P for trend-0.02 ) ; ( iv ) body mass index ; RR=1.41 for highest to lowest quintile ( P for trend=0.03 ) ; and ( v ) number of livebirths , RR=1.59 for having had one to two livebirths and 1.80 for having had three or more livebirths compared with having had none ( P for trend=0.04 ) . These data support hypotheses that sucrose intake or being tall or obese increases colon cancer risk ; run contrary to the hypothesis that increased parity decreases risk ; support previous findings of no association with demographic factors other than age , cigarette smoking , or use of oral contraceptives or estrogen replacement therapy ; and raise questions regarding previous associations with meat , fat , protein , and physical activity . Cancer Causes and Control 1994 , 5 , 38–52 The relation between diet and female colorectal cancer was analyzed in a prospect i ve study of 14,727 women aged 34 - 65 years , who were enrolled at mammographic screening clinics in New York and Florida from 1985 to 1991 . They were followed through the end of 1994 ( average 7.1 yrs ) by a combination of direct contact through mail and telephone and record linkages with regional tumor registries , result ing in 100 incident cases of colorectal cancer . There was no overall positive or inverse association of colorectal cancer risk with intakes of total calories , total or subclasses of fat , carbohydrate , or dietary fiber , whereas there was an inverse association with total protein . Among major food groups , there was a progressive decline in risk of colorectal cancer with increasing intake of fish and shellfish ( relative risk for 4th vs. 1st quartile = 0.49 , 95 % confidence interval = 0.27 - 0.89 ) . A similar inverse association was also observed for consumption of dairy products , and this association was explained mainly by calcium , not by other nutrients , such as fat or protein . The results of the present study indicated that certain dietary components of fish or dairy products may protect against colorectal cancer , whereas the relations with red meat or total fat remained unclear Cancer is a leading cause of death , and the dietary pattern in Korea is changing rapidly from a traditional Korean diet to a Westernised diet . In the present study , we investigated the effects of dietary factors on cancer risk with a prospect i ve cohort study . Among 26,815 individuals who participated in cancer screening examinations from September 2004 to December 2008 , 8024 subjects who completed a self-administered question naire concerning demographic and lifestyle factors , and a 3 d food record were selected . As of September 2013 , 387 cancer cases were identified from the National Cancer Registry System , and the remaining individuals were included in the control group . The hazard ratio ( HR ) of cancer for the subjects older than or equal to 50 years of age was higher ( HR 1.80 , 95 % CI 1.41 , 2.31 ; P < 0.0001 ) than that for the other subjects . Red meat consumption , Na intake and obesity ( BMI ≥ 25 kg/m² ) were positively associated with overall cancer incidence in men ( HR 1.41 , 95 % CI 1.02 , 1.94 ; P= 0.0382 ) , gastric cancer ( HR 2.34 , 95 % CI 1.06 , 5.19 ; P= 0.0365 ) and thyroid cancer ( HR 1.56 , 95 % CI 1.05 , 2.31 ; P= 0.0270 ) , respectively . Participants who had at least three dietary risk factors among the high intakes of red meat and Na , low intakes of vegetables and fruits , and obesity suggested by the World Cancer Research Fund/American Institute for Cancer Research at baseline tended to have a higher risk of cancer than the others ( HR 1.26 , 95 % CI 0.99 , 1.60 ; P= 0.0653 ) . In summary , high intakes of red meat and Na were significant risk factors of cancer among Koreans BACKGROUND Although obesity has been linked to an increased risk of colorectal cancer ( CRC ) , the risk associated with long-term status or change of body fat distribution has not been fully eluci date d. METHODS Using repeated anthropometric assessment s in the Nurses ' Health Study and Health Professionals Follow-up Study , we prospect ively investigated cumulative average waist circumference , hip circumference and waist-to-hip ratio , as well as their 10-year changes over adulthood , in relation to CRC risk over 23 - 24 years of follow-up . Cox proportional hazards models were used to calculate the hazard ratio ( HR ) and 95 % confidence interval ( CI ) . RESULTS High waist circumference , hip circumference and waist-to-hip ratio were all associated with a higher CRC risk in men , even after adjusting for body mass index . The association was attenuated to null in women after adjusting for body mass index . Ten-year gain of waist circumference was positively associated with CRC risk in men ( P for trend = 0.03 ) , but not in women ( P for trend = 0.34).Compared with men maintaining their waist circumference , those gaining wa Output:	The significant association for BMI and CRC risk was stronger in men than in women . Conclusion The positive association between height and risk of CRC suggests that life factors during childhood and early adulthood might play a role in CRC aetiology . Higher general and abdominal body fatness during adulthood are risk factors of CRC and these associations are stronger in men than in women
MS21120	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background The evidence that exercise intervention is effective for treatment of chronic low back pain comes from trials that are not placebo-controlled . Objective The purpose of this study was to investigate the efficacy of motor control exercise for people with chronic low back pain . Design This was a r and omized , placebo-controlled trial . Setting The study was conducted in an outpatient physical therapy department in Australia . Patients The participants were 154 patients with chronic low back pain of more than 12 weeks ’ duration . Intervention Twelve sessions of motor control exercise ( ie , exercises design ed to improve function of specific muscles of the low back region and the control of posture and movement ) or placebo ( ie , detuned ultrasound therapy and detuned short-wave therapy ) were conducted over 8 weeks . Measurements Primary outcomes were pain intensity , activity ( measured by the Patient-Specific Functional Scale ) , and patient 's global impression of recovery measured at 2 months . Secondary outcomes were pain ; activity ( measured by the Patient-Specific Functional Scale ) ; patient 's global impression of recovery measured at 6 and 12 months ; activity limitation ( measured by the Rol and -Morris Disability Question naire ) at 2 , 6 , and 12 months ; and risk of persistent or recurrent pain at 12 months . Results The exercise intervention improved activity and patient 's global impression of recovery but did not clearly reduce pain at 2 months . The mean effect of exercise on activity ( measured by the Patient-Specific Functional Scale ) was 1.1 points ( 95 % confidence interval [CI]=0.3 to 1.8 ) , the mean effect on global impression of recovery was 1.5 points ( 95 % CI=0.4 to 2.5 ) , and the mean effect on pain was 0.9 points ( 95 % CI=−0.01 to 1.8 ) , all measured on 11-point scales . Secondary outcomes also favored motor control exercise . Limitation Clinicians could not be blinded to the intervention they provided . Conclusions Motor control exercise produced short-term improvements in global impression of recovery and activity , but not pain , for people with chronic low back pain . Most of the effects observed in the short term were maintained at the 6- and 12-month follow-ups Objective .—The aim of this study was to determine whether clinical indicators of cutaneous allodynia predict the success of migraine therapy with sumatriptan using a brief question naire Objective To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease . Design R and omised , participant and single assessor blinded , placebo controlled trial . Setting Metropolitan region of Melbourne , Victoria , Australia . Participants 120 participants with chronic ( > 3 months ) rotator cuff disease recruited through medical practitioners and from the community . Interventions The active treatment comprised a manual therapy and home exercise programme ; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel . Participants in both groups received 10 sessions of individual st and ardised treatment over 10 weeks . For the following 12 weeks , the active group continued the home exercise programme and the placebo group received no treatment . Main outcome measures The primary outcomes were pain and function measured by the shoulder pain and disability index , average pain on movement measured on an 11 point numerical rating scale , and participants ’ perceived global rating of overall change . Results 112 ( 93 % ) participants completed the 22 week trial . At 11 weeks no difference was found between groups for change in shoulder pain and disability index ( 3.6 , 95 % confidence interval −2.1 to 9.4 ) or change in pain ( 0.7 , −0.1 to 1.5 ) ; both groups showed significant improvements . More participants in the active group reported a successful outcome ( defined as “ much better ” ) , although the difference was not statistically significant : 42 % ( 24/57 ) of active participants and 30 % ( 18/61 ) of placebo participants ( relative risk 1.43 , 0.87 to 2.34 ) . The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks ( between group difference 7.1 , 0.3 to 13.9 ) , although no significant difference existed between groups for change in pain ( 0.9 , −0.03 to 1.7 ) or for the percentage of participants reporting a successful treatment outcome ( relative risk 1.39 , 0.94 to 2.03 ) . Several secondary outcomes favoured the active group , including shoulder pain and disability index function score , muscle strength , interference with activity , and quality of life . Conclusion A st and ardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists ’ contact in middle aged to older adults with chronic rotator cuff disease . However , greater improvements were apparent at follow-up , particularly in shoulder function and strength , suggesting that benefits with active treatment take longer to manifest . Trial registration Clinical trials NCT00415441 & NA ; Widespread sensory hypersensitivity is present in acute whiplash and is associated with poor recovery . Decreased nociceptive flexion reflex ( NFR ) thresholds ( spinal cord hyperexcitability ) are a feature of chronic whiplash but have not been investigated in the acute to chronic injury stage . This study compared the temporal development of sensory hypersensitivity and NFR responses from soon after injury to either recovery or to transition to chronicity . It also aim ed to identify predictors of persistent spinal cord hyperexcitability . Pressure and cold pain thresholds , NFR responses ( threshold and pain VAS ) were prospect ively measured in 62 participants at <3 weeks , 3 and 6 months post whiplash injury and in 22 healthy controls on two occasions a month apart . Pain levels and psychological distress ( GHQ‐28 ; IES ) were measured at baseline . Whiplash participants were classified at 6 months post‐injury using the Neck Disability Index : recovered ( ≤8 % ) , mild pain and disability ( 10–28 % ) or moderate/severe pain and disability ( ≥30 % ) . All whiplash groups demonstrated spinal cord hyperexcitability ( lowered NFR thresholds ) at 3 weeks post‐injury . This hyperexcitability persisted in those with moderate/severe symptoms at 6 months but resolved in those who recovered or reported lesser symptoms at 6 months . In contrast generalized sensory hypersensitivity ( pressure and cold ) was only ever present in those with persistent moderate/severe symptoms and remained unchanged throughout the study period . This suggests different mechanisms underlie sensory hypersensitivity and NFR responses . In multivariate analyses only initial NDI scores ( p = 0.003 ) were a unique predictor of persistent spinal cord hyperexcitability indicating possible ongoing peripheral nociception following whiplash injury The aim of this study was to evaluate the function of pain modulating systems subserving diffuse noxious inhibitory controls ( DNICs ) in primary headaches . DNICs were examined in 24 migraineurs , 17 patients with chronic tension-type headache ( CTTH ) and 20 healthy subjects by means of nociceptive flexion RIII reflex and the cold pressor test ( CPT ) as heterotopic noxious conditioning stimulation ( HNCS ) . The subjective pain thresholds ( Tp ) and the RIII reflex threshold ( Tr ) were significantly lower in CTTH vs. controls . In controls a significant inhibition of the RIII reflex was observed during the CPT ( -30± , P < 0.05 ) . Conversely , migraine and CTTH patients showed facilitation ( + 31± , P < 0.05 and + 40± , P < 0.01 , respectively ) of the RIII reflex during the HNCS . This study demonstrates a dysfunction in systems subserving DNICs in both migraine and CTTH . Impairment of endogenous supraspinal pain modulation systems may contribute to the development and /or maintenance of central sensitization in primary headaches UNLABELLED Pain catastrophizing is among the most robust predictors of pain outcomes , and a disruption in endogenous pain-inhibitory systems is 1 potential mechanism that may account for increased pain among individuals who report higher pain catastrophizing . Pain catastrophizing may negatively influence diffuse noxious inhibitory controls ( DNIC ) , a measure of endogenous pain inhibition , through complex anatomical circuitry linking cortical responses to pain with processes that modulate pain . The current study examined whether DNIC mediated the relationship between catastrophizing and pain among 35 healthy young adults and examined the moderating effects of sex to determine whether the magnitude or direction of associations differed among men and women . DNIC was assessed using pressure pain thresholds on the forearm before and during a cold pressor task . Using bias-corrected bootstrapped confidence intervals , results showed that diminished DNIC was a significant partial mediator of the relation between greater pain-related catastrophizing and more severe pain ratings . Participant sex moderated these associations ; higher catastrophizing predicted lower DNIC for men and women , however , the effect of catastrophizing on pain ratings was partially mediated by DNIC for women only . These findings further support the primary role of pain catastrophizing in modulation of pain outcomes . PERSPECTIVE These findings support the hypothesis that the heightened pain reported by individuals higher in pain catastrophizing may be related to a disruption in the endogenous modulation of pain , operationalized by assessing DNIC . Whether interventions that reduce pain catastrophizing affect pain outcomes via effects on DNIC is in need of investigation OBJECTIVE To investigate to what extent a single 60-minute session of transcutaneous electrical nerve stimulation ( TENS ) would modify chronic clinical pain , acute experimental pain , and the flexion reflex evoked in chronic low back pain patients . STUDY DESIGN Thirty young subjects with chronic low back pain were r and omly allocated to two groups , receiving either TENS or placebo stimulation to the lumbosacral region for 60 minutes . The flexion reflex was elicited by an electrical stimulation applied to the subject 's right sole and recorded electromyographically from the biceps femoris and the tibialis anterior muscles . MAIN OUTCOME MEASURES Subjective sensation of low back pain and the electrically induced pain were measured by two separate visual analog scales , termed VAS(LBP ) and VAS(FR ) , respectively . Data obtained before , during , and 60 minutes after TENS and placebo stimulations were analyzed using repeated measures ANOVA . RESULTS The VAS(LBP ) score was significantly reduced to 63.1 % of the prestimulation value after TENS ( p<.001 ) , but the reduction was negligible after placebo stimulation ( to 96.7 % , p = .786 ) . In contrast , no significant change was found in the VASFR score ( p = .666 ) and the flexion reflex area ( p = .062 ) during and after stimulation within each group and between the two groups ( p = .133 for VASFR and p = .215 for flexion reflex area ) . CONCLUSIONS The same TENS protocol had different degrees of antinociceptive influence on chronic and acute pain in chronic low back pain patients OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVE To determine whether abnormalities of peripheral and central nociceptive sensory input processing exist outside areas of spontaneous pain in patients with fibromyalgia ( FM ) as compared with controls , by using quantitative sensory testing ( QST ) and a neurophysiologic paradigm independent from subjective reports . METHODS A total of 164 out patients with FM who were attending a self-management program were invited to participate in the study . Data for 85 patients were available and were compared with those for 40 non-FM controls matched for age and sex . QST was performed Output:	The results indicate that there is evidence of central hyperexcitability in people with chronic musculoskeletal pain . Our review also suggests that shorter inter-pulse duration tends to yield smaller variability in NFR threshold .
MS21121	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To compare the effects of intravenously injected with inhaled salbutamol in ventilator dependent infants with chronic lung disease ( CLD ) . Design Prospect i ve r and omized study in which each patient served as his/her own control . Setting Multidisciplinary neonatal and pediatric ICU . Patients 8 ventilator dependent premature infants with CLD . Interventions Salbutamol , 10 μg/kg was given intravenously , and 10–19 h later , twice 100 μg as pressurized aerosol , or vice versa , sequence r and omized . The pressurized aerosol was delivered by a metered dose inhaler into a newly developed aerosol holding chamber , integrated into the inspiratory limb of the patient circuit . Respiratory system mechanics were assessed by the single breath occlusion method before and 10 and 60 min after drug administration . Measurements and results Compliance improved significantly after intravenous injection ( 0.48±0.18 to 0.67±0.16 , p<0.01 and 0.59±0.23 ml/cmH2O/kg , NS , ( mean±1 SD ) and after inhalation ( 0.46±0.19 to 0.64±0.32,p<0.01 and 0.56±0.31 ml/cmH2O/kg , NS ) . Resistance decreased after i.v . use ( 0.38±0.17 to 0.25±0.11,p<0.001 and 0.25±0.10 cmH2O/ml/s , NS ) and after inhalation ( 0.35±0.12 to 0.27±0.09,p<0.01 and 0.28±0.12 cmH2O/ml/s , NS ) . Heart rate increased significantly after both routes of application , whereas mean arterial pressure , respirator setting s , FIO2 , transcutaneous SO2 and capillary PCO2 did not change . Conclusions Inhaled and intravenous salbutamol improves pulmonary mechanics to the same extent with comparable side effects , and may therefore be used to facilitate weaning from respirators UNLABELLED Several studies have demonstrated that normal infants exhibit bronchoconstriction after inhalation of nonspecific agonists and that the induced airway narrowing can be reversed by the inhalation of a beta-agonist . However , there are very limited data on baseline airway tone and the airway response to a beta-agonist in this subject population . The purpose of our study was to evaluate in normal infants baseline airway responsiveness to the inhaled beta-agonist , albuterol , using changes in maximal expiratory flows . Forty-one healthy infant volunteers with no history of respiratory disease or recurrent wheezing ( ages 5.4 to 141.4 wk ) were studied . Maximal expiratory flow- volume curves were obtained at baseline and 10 min after inhalation of albuterol ( n = 28 ) or placebo ( n = 13 ) using a metered-dose inhaler with a spacer . The mean percent change was significantly greater ( p < 0.05 ) in the albuterol versus placebo group for FEV(0.5 ) ( 2.2 % versus -1.5 % ) , FEF(75 % ) ( 10.6 % versus -3.1 % ) , and FEF(85 % ) ( 12.9 % versus 0.5 % ) . Six of 28 albuterol-treated infants demonstrated increases in FEF(75 % ) greater than two st and ard deviations from the mean change in FEF(75 % ) seen in the placebo group . These infants were younger and more frequently exposed to maternal smoking during pregnancy . We conclude that normal healthy infants have overall levels of baseline airway tone that are similar to that reported in adults and older children ; however , among the infants we evaluated the response to an inhaled bronchodilator was greatest in the youngest infants and in those exposed to tobacco smoking . KEYWORDS airway responsiveness ; asthma ; tobacco smoke ; infant pulmonary function ; Abstract Early inflammatory lesions and bronchial hyperresponsiveness are characteristics of the respiratory distress in premature neonates and are susceptible to aggravation by assisted ventilation . We hypothesized that treatment with inhaled salbutamol and beclomethasone might be of clinical value in the prevention of bronchopulmonary dysplasia ( BPD ) in ventilator-dependent premature neonates . The study was double-blinded and placebo controlled . We studied 173 infants of less than 31 weeks of gestational age , who needed ventilatory support at the 10th postnatal day . They were r and omised to four groups and received either placebo + placebo , placebo + salbutamol , placebo + beclomethasone or beclomethasone + salbutomol , respectively for 28 days . The major criteria for efficacy were : diagnosis of BPD ( with score of severity ) , mortality , duration of ventilatory support and oxygen therapy . The trial groups were similar with respect to age at entry ( 9.8–10.1 days ) , gestational age ( 27.6–27.8 weeks ) , birth weight and oxygen dependence . We did not observe any significant effect of treatment on survival , diagnosis and severity of BPD , duration of ventilatory support or oxygen therapy . For instance , the odds-ratio ( 95 % confidence interval ) for severe or moderate BPD were 1.04 ( 0.52–2.06 ) for inhaled beclomethasone and 1.54 ( 0.78–3.05 ) for inhaled salbutamol . Conclusion This r and omised prospect i ve trial does not support the use of treatment with inhaled beclomethasone , salbutamol or their combination in the prevention of BPD in premature ventilated neonates Objective .This r and omized , controlled trial was design ed to determine the efficacy of inhaled fluticasone propionate on oxygen therapy weaning in a population of preterm infants who were born at < 32 weeks of gestation and experienced moderate bronchopulmonary dysplasia ( BPD ) . Methods .Thirty-two infants who were ≤32 weeks of gestation , had moderate BPD that required supplemental oxygen ( fraction of inspired oxygen ≥0.25 ) , and were aged between 28 and 60 days were r and omized . Fluticasone propionate 125 μg twice daily for 3 weeks and once daily for a fourth week was delivered to infants who weighed between 500 and 1200 g. The dosage was doubled for infants who weighed ≥1200 g. Results .Compared with placebo , treatment had no effect on either duration of supplemental O2 therapy or ventilatory support as assessed by survival analysis . At 28 days , a trend toward a lower cortisol/creatinine ratio in the treatment group was noted compared with placebo ( 25.1 ± 18.9 vs 43 ± 14.4 ) . In the fluticasone group at 28 days , the systolic arterial pressure ( 78 ± 3 vs 68 ± 3 mm Hg ) and diastolic arterial pressure ( 43 ± 3.4 mm Hg vs 38 ± 2.0 mm Hg ) were higher compared with baseline fluticasone values . The chest radiograph score was lower than baseline ( 2.8 ± 1.4 vs 3.7 ± 2.2 ) in the fluticasone group at 28 days . This study has a statistical power of 1.0 to detect a significant difference in the duration of oxygen supplementation of > 21 days between the study groups . Conclusion .We conclude that fluticasone propionate reduces neither supplemental O2 use nor the need for ventilatory support in this patient population . However , fluticasone does have a positive radiologic effect in lowering chest radiograph scores . In addition , our data point to a possible association among inhaled fluticasone treatment and higher arterial blood pressure . Thus , the results of this investigation do not support the use of inhaled corticosteroids in the treatment of oxygen-dependent infants who have established moderate BPD AIMS To compare the efficacy of salbutamol delivered by metered dose inhaler ( MDI ) , jet nebuliser , and ultrasonic nebuliser in ventilated infants with chronic lung disease . METHODS Twenty preterm ventilated infants with chronic lung disease were enrolled in two studies . In study 1 ( n=10 ) , each infant was given 200 μg of salbutamol at 4 hour intervals and in r and om sequence from a metered dose inhaler – spacer device , a jet nebuliser , and an ultrasonic nebuliser with a small medication cup . The infants were monitored for heart rate , transcutaneous pO2 , pCO2 , and oxygen saturation , respiratory system resistance and compliance before and after each treatment . Infants in study 2 ( n=10 ) were similarly studied except for the use of a different jet nebuliser . RESULTS The mean ( SEM ) maximum percentage decreases in respiratory system resistance , observed at 30 minutes after aerosol delivery were study 1 : MDI : 44.3 (4.3)% ; jet : 32.3 (3.4)% ; ultrasonic : 56.1 (3.2)% ; study 2 : MDI : 28.6 (1.0)% ; jet : 16.9 (1.4)% ; ultrasonic : 42.1 (1.6)% . During the first hour after treatment , a significantly faster heart rate and higher transcutaneous pO2 were associated with the use of the ultrasonic nebuliser or MDI than with the jet nebulisers in both studies . The use of the ultrasonic nebuliser but not the other devices also result ed in a lower transcutaneous pCO2 and improved respiratory system compliance in study 2 . CONCLUSIONS These findings suggest that among the devices tested , the delivery of salbutamol aerosol to the lower respiratory tract was greatest using the ultrasonic nebuliser , and least with the jet nebulisers Abstract Bronchodilators are often used in the treatment of patients with bronchopulmonary dysplasia ( BPD ) . However , few studies evaluate their efficacy in patients with stable disease beyond the newborn period . Therefore , pulmonary function was measured before and after aerosol treatment with salbutamol ( 0.25 ml Ventolin 0.5 % ) and subsequently after aerosol with ipratropium bromide ( 0.25 ml Atrovent 0.025 % ) . Studies were performed at the corrected postnatal age of 52±2 weeks in 52 patients who had been ventilated after birth because of newborn lung disease . Twenty-two of these 52 patients had developed BPD . Pulmonary function was measured after sedation and using the PEDS system . Expiratory resistance ( median 52.1 versus 39.1 cmH2O/l/s ; P<.008 ) and inspiratory resistance ( median 42.5 vs 27.8 cmH2O/l/s ; P<.04 ) were significantly worse in BPD patients at the age of 1 year . Half of the BPD patients had a decrease in pulmonary resistance after salbutamol . However , there was no statistically significant decrease in pulmonary resistance after salbutamol or ipratropium in the BPD patients as a group . After salbutamol pulmonary resistance significantly worsened in the patients who did not develop BPD . Conclusion Although individual patients may benefit , routine administration of bron chodilators seems not warranted in stable BPD patients at the age of 1 year Objective : To identify factors associated with bronchodilator administration to infants with bronchopulmonary dysplasia ( BPD ) and evaluate inter-institutional prescribing patterns . Study Design : A retrospective cohort study of < 29-week-gestation infants with evolving BPD defined at age 28 days within the Pediatric Health Information System data base . Controlling for observed confounding with r and om-effects logistic regression , we determined demographic and clinical variables associated with bronchodilator use and evaluated between-hospital variation . Result : During the study period , 33 % ( N=469 ) of 1429 infants with BPD received bronchodilators . Lengthening mechanical ventilation duration increased the odds of receiving a bronchodilator ( odds ratio 19.6 ( 11 to 34.8 ) at ⩾54 days ) . There was profound between-hospital variation in use , ranging from 0 to 81 % . Conclusion : Bronchodilators are frequently administered to infants with BPD at US children ’s hospitals with increasing use during the first hospital month . Increasing positive pressure exposure best predicts bronchodilator use . Frequency and treatment duration vary markedly by institution even after adjustment for confounding variables Parenteral glucocorticoids have been shown to be effective in the treatment of oxygen- and ventilator-dependent bronchopulmonary dysplasia . We conducted a r and omized , prospect i ve study using a nebulized , water-soluble form of beclomethasone dipropionate for the treatment of infants with oxygen- and ventilator-dependent lung disease . Newborn infants with chest x-ray changes consistent with bronchopulmonary dysplasia at 14 days of age were r and omly assigned , in a paired sequential fashion by birth weight , to treatment ( beclomethasone ) or placebo ( saline solution ) groups . Treatment included three nebulized doses of beclomethasone ( 50 micrograms ) or saline solution per day for 28 days . Measured variables included tidal volume , total dynamic compliance , and airway resistance . Weight gain Output:	Whether inhaled bronchodilators and inhaled corticosteroids improve long-term outcomes in BPD remains unclear . There appears to be heterogeneity in treatment responses , and may be related to varying modes of administration .
MS21122	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: HYPOTHESIS Local application of autologous platelet rich plasma ( PRP ) improves tendon healing in patients undergoing arthroscopic rotator cuff repair . STUDY DESIGN Prospect i ve , r and omized , controlled , double blind study ; considering an alpha level of 5 % , a power of 80 % , 22 patients for group are needed . MATERIAL S AND METHODS Fifty-three patients who underwent shoulder arthroscopy for the repair of a complete rotator cuff tear were r and omly divided into 2 groups , using a block r and omization procedure . A treatment group ( N = 26 ) consisted of those who received an intraoperative application of PRP in combination with an autologous thrombin component . A control group ( N = 27 ) consisted of those who did not receive that treatment . Patients were evaluated with vali date d outcome scores . A magnetic resonance image ( MRI ) was performed in all cases at more than 1 year post-op . All patients had the same accelerated rehabilitation protocol . RESULTS The 2 groups were homogeneous . The pain score in the treatment group was lower than the control group at 3 , 7 , 14 , and 30 days after surgery ( P < .05 ) . On the Simple Shoulder Test ( SST ) , University of California ( UCLA ) , and Constant scores , strength in external rotation , as measured by a dynamometer , were significantly higher in the treatment group than the control group at 3 months after surgery ( strength in external rotation [ SER ] : 3 ± 1.6 vs 2.1 ± 1.3 kg ; SST : 8.9 ± 2.2 vs 7.1 ± 2.7 ; UCLA : 26.9 ± 3 vs 24.2 ± 4.9 ; Constant : 65 ± 9 vs 57.8 ± 11 ; P < .05 ) . There was no difference between the 2 groups after 6 , 12 , and 24 months . The follow-up MRI showed no significant difference in the healing rate of the rotator cuff tear . In the subgroup of grade 1 and 2 tears , with less retraction , SER in the PRP group was significant higher at 3 , 6 , 12 , and 24 months postoperative ( P < .05 ) . CONCLUSION The results of our study showed autologous PRP reduced pain in the first postoperative months . The long-term results of subgroups of grade 1 and 2 tears suggest that PRP positively affected cuff rotator healing AIM The value of MRI for pre-operative evaluation of the rotator cuff is proven . In spite of its clinical relevance , there have been only few studies on MR imaging of patients who have already been operated . Thus , the question rises to what extent the post-operative MRI can contribute to the evaluation of the integrity of the rotator cuff . METHOD At least 10 months after successful open repair of the supraspinatus tendon , mostly combined with Neer 's anterior acromioplasty , an MR scan was performed on 33 shoulders . Only patients satisfied with the outcome of surgery and showing a Constant score of 65 to 100 points were included . RESULTS More than half the patients had positive direct diagnostic criteria for a full- or partial-thickness tear of the supraspinatus tendon , in the form of signal intensity or morphological alterations . In addition , the indirect diagnostic criteria described by Zlatkin , such as the absence of the subacromial-subdeltoid fat or the appearance of subacromial-subdeltoid fluid , were often positive . Atrophy of the supraspinatus muscle , as a further indirect diagnostic criterion of a rupture , was also frequently noted . CONCLUSION Taking the excellent clinical outcome of our patients into consideration , this study shows that caution should be taken in evaluating postoperative MR images . There is a high risk of over-interpreting MR findings Periosteal augmentation of tendons in the course of refixation to bone has been shown to be a suitable method for early primarily stable osteofibroblastic integration . The aim of this study was to evaluate the clinical and radiological results of open rotator cuff reconstruction using an autologous periosteal flap augmentation technique . The research was performed as a prospect i ve cohort study . Twenty-three prospect i ve patients ( average age 59.7 years ) with degenerative rotator cuff tears were operated on with an open technique and a subtendinous periosteal flap augmentation using bioabsorbable suture anchors and a modified Mason – Allen technique . Clinical evaluation consisted of the Constant-Score and the Simple Shoulder test . Radiological evaluation included st and ard radiographs and magnetic resonance imaging ( MRI ) . Twenty patients were evaluated at a mean follow-up of 14.4 months . The average Constant Score increased significantly from 51.7 to 80.9 points ( p<0.05 ) with 12 excellent , seven good and one satisfactory result . The Simple Shoulder test showed a significant increase of an average of 4.8–10.7 questions answered with yes ( p<0.05 ) . Four patients ( 20 % ) demonstrated a retear of the tendon on postoperative MRI . Ectopic ossifications in the supraspinatus tendon were found in four patients ( 20 % ) but these had no impact on the final clinical results . Open rotator cuff repair augmented with an autologous periosteal flap shows high patient satisfaction level with low rerupture rates . Mid- and long-term results remain to be seen . The potential benefits compared with conventional open or arthroscopic rotator cuff surgery must be examined in prospect i ve r and omized studies BACKGROUND Controversy exists regarding the optimal technique for arthroscopic rotator cuff repair . The purpose of this multicenter , r and omized , double-blind controlled study was to compare the functional outcomes and healing rates after use of single-row and double-row suture techniques for repair of the rotator cuff . METHODS Ninety patients undergoing arthroscopic rotator cuff repair were r and omized to receive either a single-row or a double-row repair . The primary objective was to compare the Western Ontario rotator cuff index ( WORC ) score at twenty-four months . Secondary objectives included comparison of the constant and american shoulder and elbow surgeons ( ASES ) scores and strength between groups . Anatomical outcomes were assessed with magnetic resonance imaging ( MRI ) or ultrasonography to determine the postoperative healing rates . RESULTS Baseline demographic data including age ( p = 0.29 ) , sex ( p = 0.68 ) , affected side ( p = 0.39 ) , and rotator cuff tear size ( p = 0.28 ) did not differ between groups . The WORC score did not differ significantly between groups at any time point ( p = 0.48 at baseline , p = 0.089 at three months , p = 0.52 at six months , p = 0.83 at twelve months , and p = 0.60 at twenty-four months ) . The WORC score at each postoperative time point was significantly better than the baseline value . The Constant score , ASES score , and strength did not differ significantly between groups at any time point . Logistic regression analysis demonstrated that a smaller initial tear size and double-row fixation were associated with higher healing rates . CONCLUSIONS No significant differences in functional or quality -of-life outcomes were identified between single-row and double-row fixation techniques . A smaller initial tear size and a double-row fixation technique were associated with higher healing rates as assessed with ultrasonography or MRI . LEVEL OF EVIDENCE Therapeutic level I. See Instructions for Authors for a complete description of levels of evidence Objectives To retrospectively evaluate fatty degeneration ( FD ) of rotator cuff muscles on CTA using Goutallier ’s grading system and quantitative measurements with comparison between pre- and postoperative states . Material s and methods IRB approval was obtained for this study . Two radiologists independently review ed pre- and postoperative CTAs of 43 patients ( 24 males and 19 females , mean age , 58.1 years ) with 46 shoulders confirmed as full-thickness tears with r and om distribution . FD of supraspinatus , infraspinatus/teres minor , and subscapularis was assessed using Goutallier ’s system and by quantitative measurements of Hounsfield units ( HUs ) on sagittal images . Changes in FD grade s and HUs were compared between pre- and postoperative CTAs and analyzed with respect to preoperative tear size and postoperative cuff integrity . The correlations between qualitative grade s and quantitative measurements and their inter-observer reliabilities were also assessed . Results There was statistically significant correlation between FD grade s and HU measurements of all muscles on pre- and postoperative CTA ( p < 0.05 ) . Inter-observer reliability of fatty degeneration grade s were excellent to substantial on both pre- and postoperative CTA in supraspinatus ( 0.8685 and 0.8535 ) and subscapularis muscles ( 0.7777 and 0.7972 ) , but fair in infraspinatus/teres minor muscles ( 0.5791 and 0.5740 ) ; however , quantitative Hounsfield units measurements showed excellent reliability for all muscles ( ICC : 0.7950 and 0.9346 for SST , 0.7922 and 0.8492 for SSC , and 0.9254 and 0.9052 for IST/TM ) . No muscle showed improvement of fatty degeneration after surgical repair on qualitative and quantitative assessment s ; there was no difference in changes of fatty degeneration after surgical repair according to preoperative tear size and post-operative cuff integrity ( p > 0.05 ) . The average dose-length product ( DLP , mGy · cm ) was 365.2 mGy · cm ( range , 323.8 - 417.2 mGy · cm ) and estimated average effective dose was 5.1 mSv . Conclusions Goutallier grade s correlated well with HUs of rotator cuff muscles . Reliability was excellent for both systems , except for FD grade of IST/TM muscles , which may be more reliably assessed using quantitative measurements In 13 patients , the development of supraspinatus muscle atrophy and fatty infiltration after rotator cuff tendon repair was quantified prospect ively via magnetic resonance imaging . Intraoperative electrical nerve stimulation at repair showed that the maximal supraspinatus tension ( up to 200 N ) strongly correlated with the anatomic cross-sectional muscle area and with muscle fatty infiltration ( ranging from 12 N/cm(2 ) in Goutallier stage 3 to 42 N/cm(2 ) in Goutallier stage 0 ) . Within 1 year after successful tendon repair ( n = 8) , fatty infiltration did not recover , and atrophy improved partially at best ; however , if the repair failed ( n = 5 ) , atrophy and fatty infiltration progressed significantly . The ability of the rotator cuff muscles to develop tension not only correlates with their atrophy but also closely correlates with their degree of fatty infiltration . With current repair techniques , atrophy and fatty infiltration appear to be irreversible , despite successful tendon repair . Unexpectedly , not only weak but also very strong muscles are at risk for repair failure Background Subacromial impingement syndrome is a frequently observed disorder in orthopedic practice . Lasting symptoms and impairment may occur when a subsequent atraumatic rotator cuff rupture is also present . However , degenerative ruptures of the rotator cuff can also be observed in asymptomatic elderly individuals . Treatment of these symptomatic degenerative ruptures may be conservative or surgical . Acceptable results are reported for both treatment modalities . No evidence -based level-1 studies have been conducted so far to compare these treatment modalities . The objective of this study is to determine whether there is a difference in outcome between surgical reconstruction and conservative treatment of a degenerative atraumatic rotator cuff tendon rupture . Methods / Design A r and omized controlled trial will be conducted . Patients aged between 45 and 75 with a symptomatic atraumatic rotator cuff rupture as diagnosed by MRI will be included . Exclusion criteria are traumatic rotator cuff rupture , frozen shoulder and diabetes mellitus . Patients will be r and omized into two groups . Conservative treatment includes physical therapy according to a st and ardized protocol , NSAIDs and , if indicated , subacromial infiltration with a local anesthetic and corticosteroids . Surgical reconstruction is performed under general anesthesia in combination with an interscalenus plexus block . An acromioplasty with reconstruction of the rotator cuff tendon is performed , as described by Rockwood et al. Measurements take place preoperatively and 6 weeks , 3 months , 6 months and 1 year postoperatively . The primary outcome measure is the Constant score . Secondary measures include both disease-specific and generic outcome measures , and an economic evaluation . Additionally , one year after inclusion a second MRI will be taken of all patients in order to determine whether extent and localization of the rupture as well as the amount of fatty degeneration are prognostic factors . Discussion Both surgical as conservative treatment of a symptomatic atraumatic rotator cuff tendon rupture is used in current practice . There is a lack of level-1 studies comparing surgical vs. conservative treatment . This r and omized controlled trial has been design ed to determine whether the surgical treatment of a degenerative atraumatic rotator cuff tendon rupture may lead to a better functional and radiological outcome than conservative treatment after one year of follow-up . Trial registration numberNetherl and s Trial Register ( NTR ) : Purpose The purpose of this study was to compare arthroscopic rotator cuff repair with single-row and double-row techniques because research has demonstrated the superiority of double-row repair from a biological and Output:	With the data available , only the presence of structural integrity showed good intra- and inter-observer agreement .
MS21123	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background .There have been major reductions in the availability of inpatient psychiatric care in the United States in recent years . Objective .The objective of this study was to evaluate the clinical impact of cost-cutting changes in the delivery of inpatient psychiatric care . Design .This was a nonequivalent control group pre/post design . Subjects . Outcome data on 6,397 veterans treated between 1993 and 2000 at 35 specialized VA inpatient and residential programs for posttraumatic stress disorder ( PTSD ) were used to compare changes in effectiveness ( measured as patient improvement from admission to 4 months after discharge ) at programs that either shortened their average length of stay or converted from a hospital-based program to a low-cost residential rehabilitation program . For comparison , outcome data are also presented over the same years from both inpatient PTSD programs and residential PTSD programs that did not experience program change . Measures . Measures addressed baseline characteristics and 4-month postdischarge outcome measures of PTSD symptoms , substance abuse , violent behavior , and employment . Results .Analyses of covariance showed no significant change in outcomes at inpatient programs that either reduced their length of stay or did not change at all . However , effectiveness declined on some measures at inpatient programs that converted to residential treatment during this period but improved at residential treatment programs that had been established before this period of change . Conclusions .Although there was no deterioration in effectiveness related to reduced length of inpatient stay , programs that converted to a residential model showed decreased effectiveness OBJECTIVE To study the relation between posttraumatic stress disorder ( PTSD ) psychiatric comorbidity and suicidal ideation in a representative sample of Ohio Army National Guard soldiers . METHOD Using retrospective data collected on the telephone from a r and om sample of 2,616 National Guard soldiers who enrolled in a 10-year longitudinal study ( baseline data collected November 2008-November 2009 ) , we examined ( 1 ) the prevalence of other psychopathologies among those with DSM-IV-diagnosed PTSD compared to those without PTSD and ( 2 ) the association between PTSD comorbidity and suicidal ideation ( reporting thoughts of being better off dead or hurting themselves ) . All analyses were carried out using logistic regression . RESULTS Of guard members with PTSD in the last year , 61.7 % had at least 1 other psychopathology ; 20.2 % had at least 2 other co-occurring conditions . The most common co-occurring psychopathology was depression . While those with PTSD overall were 5.4 ( 95 % CI , 3.8 - 7.5 ) times more likely to report suicidality than those without PTSD , those who had at least 2 additional conditions along with PTSD were 7.5 ( 95 % CI , 3.0 - 18.3 ) times more likely to report suicidal ideation at some point in their lifetime than those with PTSD alone . CONCLUSIONS Soldiers with PTSD were at increased risk for suicidality , and , among those with PTSD , those with at least 2 additional conditions were at the highest risk of suicidal ideation . Future research should address the mechanisms that contribute to multimorbidity in this population and the appropriate treatment methods for this high-risk group Trauma risk management ( TRiM ) is an intensive posttraumatic stress disorder ( PTSD ) psychoeducational management strategy based on peer-group risk assessment developed by the UK Royal Navy ( RN ) . TRiM seeks to modify attitudes about PTSD , stress , and help-seeking and trains military personnel to identify at-risk individuals and refer them for early intervention . This quasiexperimental study found that TRiM training significantly improved attitudes about PTSD , stress , and help-seeking from TRiM-trained personnel . There was a nonsignificant effect on attitudes to seeking help from normal military support networks and on general health . Within both the military and civilian population s , stigma is a serious issue preventing help-seeking and reducing quality of life . The results suggest that TRiM is a promising antistigma program within organizational setting Output:	Having a history of PTSD is associated with higher rates of morbidity and mortality and increased the risk for suicidal behavior . The association between PTSD and suicidal behavior was confirmed by the presence of other risk factors and high rates of comorbidity .
MS21124	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background The North-Eastern part of Sri Lanka had already been affected by civil war when the 2004 Tsunami wave hit the region , leading to high rates of posttraumatic stress disorder ( PTSD ) in children . In the acute aftermath of the Tsunami we tested the efficacy of two pragmatic short-term interventions when applied by trained local counselors . Methods A r and omized treatment comparison was implemented in a refugee camp in a severely affected community . 31 children who presented with a preliminary diagnosis of PTSD were r and omly assigned either to six sessions Narrative Exposure Therapy for children ( KIDNET ) or six sessions of meditation-relaxation ( MED-RELAX ) . Outcome measures included severity of PTSD symptoms , level of functioning and physical health . Results In both treatment conditions , PTSD symptoms and impairment in functioning were significantly reduced at one month post-test and remained stable over time . At 6 months follow-up , recovery rates were 81 % for the children in the KIDNET group and 71 % for those in the MED-RELAX group . There was no significant difference between the two therapy groups in any outcome measure . Conclusion As recovery rates in the treatment groups exceeded the expected rates of natural recovery , the study provides preliminary evidence for the effectiveness of NET as well as meditation-relaxation techniques when carried out by trained local counselors for the treatment of PTSD in children in the direct aftermath of mass disasters . Trial registration Clinical Trials.gov Identifier : BACKGROUND There are no psychosocial interventions to address both educational needs and psychological distress among displaced children in post-conflict setting s. AIMS To assess the psychosocial status of displaced children enrolled in the Rapid-Ed intervention ; and to determine whether the Rapid-Ed intervention alleviated traumatic stress symptoms that interfere with learning among war-affected children in Sierra Leone . METHOD A r and omly selected sample of 315 children aged 8 - 18 years who were displaced by war were interviewed about their war experiences and reactions to the violence before and after participating in the 4-week Rapid-Ed intervention combining basic education with trauma healing activities . RESULTS High levels of intrusion , arousal and avoidance symptoms were reported at the pre-test interviews conducted 9 - 12 months after the war . Post-test findings showed statistically significant decreases in intrusion and arousal symptoms ( P<0.0001 ) , a slight increase in avoidance reactions ( P<0.0001 ) and greater optimism about the future . CONCLUSIONS The findings suggest potential for combining basic education with trauma healing activities for children in post-conflict setting s , but confirmatory studies using a control group are needed . Conducting research in post-conflict setting s presents unique challenges Cognitive theories point to reduction in dysfunctional posttraumatic cognitions ( PTCs ) as one mechanism involved in recovery from posttraumatic stress symptoms ( PTSS ) , yet research findings have shown individual differences in the recovery process . We tested the cognitive mediation hypothesis above in a previously published psychosocial group intervention among war-affected children . We also examined heterogeneity in children 's PTCs during the intervention . We used a cluster r and omized trial of Smith et al. 's ( 2002 ) teaching recovery techniques ( TRT ) intervention among 482 Palestinians 10 - 13 years of age ( n = 242 for intervention group , n = 240 for control group ) . Children reported PTSS , PTCs , and depressive symptoms at baseline , midpoint , postintervention , and at 6-month follow-up . Path analysis results showed that TRT was not effective in reducing dysfunctional PTCs , and the reductions did not mediate intervention effects on PTSS . Using latent class growth analysis , we chose the model with 3 differing trajectories in the intervention group : high , decreasing , moderate , downward trending , and severe , stable levels of PTCs . Higher PTSS and depressive symptoms at baseline were associated with membership in the severe , stable trajectory . The intervention did not produce the kind of beneficial cognitive change needed in the cognitive mediation conceptualization . Nevertheless , cognitive changes differed substantially across children during the intervention , and were associated with their preintervention mental health status . These findings call for more detailed examination of the process of cognitive mediation Effective evidence -based intervention for traumatic bereavement is one of the current major research issues in the field of Post Traumatic Stress Disorder ( PTSD ) in children and adolescents . The “ Writing for Recovery ” group intervention is a new treatment approach developed by the Children and War Foundation for traumatized and bereaved children and adolescents after disasters . The purpose of this project was an empirical examination of this intervention with 12- to 18-year-old war bereaved Afghani refugees . Eighty-eight war bereaved Afghani refugees were screened using the Traumatic Grief Inventory for Children ( TGIC ) . From those with the highest total score , 61 were r and omly assigned to either an experimental ( n = 29 ) or control group ( n = 32 ) . The experimental group received six sessions of group training on 3 consecutive days in their school . The difference of TGIC scores between the experimental group in pretest and posttest was significant ( p = 0.001 ) . Results of analysis of covariance also showed a significant effect of Writing for Recovery on the experimental group ( p < 0.001 ) . It is concluded that “ Writing for Recovery ” is an effective group intervention for bereaved children and adolescents after disasters Background : Preventative and treatment programs for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade . However , there is still much contention about evidence -based and culturally sensitive interventions for children . The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioral outcomes of war-affected children resettled in Australia . Methods and Findings : A cluster r and omized controlled trial with pre-test , post-test , and 3-month follow-up design was employed . A total of 82 participants ( aged 10–17 years ) were r and omized by school into the 8-week intervention ( n = 45 ) or the waiting list ( WL ) control condition ( n = 37 ) . Study outcomes included symptoms of post-traumatic stress disorder , depression , internalizing and externalizing problems , as well as psychosocial functioning . A medium intervention effect was found for depression symptoms . Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition , F(1 , 155 ) = 5.20 , p = 0.024 , partial η2 = 0.07 . This improvement was maintained at the 3-month follow-up , F(2 , 122 ) = 7.24 , p = 0.001 , partial η2 = 0.20 . Conclusions : These findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes , when compared to a waiting list control group . Trial Registration : Australian New Zeal and Clinical Trials Registry ACTRN12611000 948998 CONTEXT Prior qualitative work with internally displaced persons in war-affected northern Ug and a showed significant mental health and psychosocial problems . OBJECTIVE To assess effect of locally feasible interventions on depression , anxiety , and conduct problem symptoms among adolescent survivors of war and displacement in northern Ug and a. DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial from May 2005 through December 2005 of 314 adolescents ( aged 14 - 17 years ) in 2 camps for internally displaced persons in northern Ug and a. INTERVENTIONS Locally developed screening tools assessed the effectiveness of interventions in reducing symptoms of depression and anxiety , ameliorating conduct problems , and improving function among those who met study criteria and were r and omly allocated ( 105 , psychotherapy-based intervention [ group interpersonal psychotherapy ] ; 105 , activity-based intervention [ creative play ] ; 104 , wait-control group [ individuals wait listed to receive treatment at study end ] ) . Intervention groups met weekly for 16 weeks . Participants and controls were reassessed at end of study . MAIN OUTCOME MEASURES Primary measure was a decrease in score ( denoting improvement ) on a depression symptom scale . Secondary measures were improvements in scores on anxiety , conduct problem symptoms , and function scales . Depression , anxiety , and conduct problems were assessed using the Acholi Psychosocial Assessment Instrument with a minimum score of 32 as the lower limit for clinical ly significant symptoms ( maximum scale score , 105 ) . RESULTS Difference in change in adjusted mean score for depression symptoms between group interpersonal psychotherapy and control groups was 9.79 points ( 95 % confidence interval [ CI ] , 1.66 - 17.93 ) . Girls receiving group interpersonal psychotherapy showed substantial and significant improvement in depression symptoms compared with controls ( 12.61 points ; 95 % CI , 2.09 - 23.14 ) . Improvement among boys was not statistically significant ( 5.72 points ; 95 % CI , -1.86 to 13.30 ) . Creative play showed no effect on depression severity ( -2.51 points ; 95 % CI , -11.42 to 6.39 ) . There were no statistically different improvements in anxiety in either intervention group . Neither intervention improved conduct problem or function scores . CONCLUSIONS Both interventions were locally feasible . Group interpersonal psychotherapy was effective for depression symptoms among adolescent girls affected by war and displacement . Other interventions should be investigated to assist adolescent boys in this population who have symptoms of depression . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00280319 PURPOSE As we build the evidence base of interventions for depression among war-affected youth , it is critical to underst and factors moderating treatment outcomes . The current study investigated how gender and history of abduction by Lord 's Resistance Army rebels moderated treatment outcomes for war-affected youth . METHODS The study -a three-armed , r and omized , controlled trial-was conducted with internally displaced war-affected adolescents in northern Ug and a. Participants with significant depression symptoms ( N = 304 ; 57 % female ; 14 - 17 years of age ) were r and omly assigned to an interpersonal psychotherapy group ( IPT-G ) , a creative play/recreation group , or a wait-list control condition . Secondary analyses were conducted on data from this r and omized controlled trial . RESULTS A history of abduction by Lord 's Resistance Army rebels was reported by 42 % of the sample . Gender and abduction history interacted to moderate the effectiveness of IPT-G for the treatment of depression . In the IPT-G intervention arm , treatment effectiveness was greatest among female subjects without an abduction history , with effect size = 1.06 . IPT-G was effective for the treatment of depression for both male and female subjects with a history of abduction ( effect size = .92 and .50 , respectively ) . Male subjects with no abduction history in IPT-G showed no significant improvement compared with those in the control conditions . CONCLUSIONS Abduction history and gender are potentially important moderators of treatment effects , suggesting that these factors need to be considered when providing interventions for war-affected youth . IPT-G may be an effective intervention for female subjects without an abduction history , as well as for both male and female former child soldiers , but less so for male subjects without an abduction history CONTEXT Little is known about the efficacy of mental health interventions for children exposed to armed conflicts in low- and middle-income setting s. Childhood mental health problems are difficult to address in situations of ongoing poverty and political instability . OBJECTIVE To assess the efficacy of a school-based intervention design ed for conflict-exposed children , implemented in a low-income setting . DESIGN , SETTING , AND PARTICIPANTS A cluster r and omized trial involving 495 children ( 81.4 % inclusion rate ) who were a mean ( SD ) age of 9.9 ( 1.3 ) years , were attending r and omly selected schools in political violence-affected communities in Poso , Indonesia , and were screened for exposure ( > or = 1 events ) , posttraumatic stress disorder , and anxiety symptoms compared with a wait-listed control group . Nonblinded assessment took place before , 1 week after , and 6 months after treatment between March and December 2006 . INTERVENTION Fifteen sessions , over 5 weeks , of a manualized , school-based group intervention , including trauma-processing activities , cooperative play , and creative-expressive elements , implemented by locally trained paraprofessionals . MAIN OUTCOME MEASURES We assessed psychiatric symptoms using the Child Posttraumatic Stress Scale , Depression Self-Rating Scale , the Self-Report for Anxiety Related Disorders 5-item version , and the Children 's Hope Scale , and assessed function impairment as treatment outcomes using st and ardized symptom checklists and locally developed rating scales . RESULTS Correcting for clustering of participants within schools , we found significantly more improvement in posttraumatic stress disorder symptoms ( mean change difference , 2.78 ; 95 % confidence interval [ CI ] , 1.02 to 4.53 ) and maintained hope ( mean change difference , -2.21 ; 95 % CI , -3.52 to -0.91 ) in the treatment group than in the wait-listed group . Changes in traumatic idioms ( stress-related physical symptoms ) ( mean change difference , 0.50 ; 95 % CI , -0.12 to 1 Output:	The effect sizes lagged behind the effects observed in traumatized minors in general , and often were small or non-significant .
MS21125	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat BACKGROUND : Colorectal cancer is the second leading cause of death from cancer in Western countries . Early detection by colorectal cancer screening can effectively cut its mortality rate . CT colonography represents a promising , minimally invasive alternative to conventional methods of colorectal carcinoma screening . AIMS : The purpose of this prospect i ve single institutional study was to compare the abilities of routine clinical CT colonography and conventional colonoscopy to detect colorectal neoplasms using second-look colonoscopy to clarify discrepant results . PATIENTS AND METHODS : CT colonography was performed in 100 symptomatic patients using contrast enhanced multidetector CT followed by conventional colonoscopy on the same day . If results were discrepant , a second-look colonoscopy was performed after unblinding . CT colonographic findings were compared with those of conventional colonoscopy . RESULTS : Conventional colonoscopy found 122 colorectal neoplasms in 49 patients . The overall sensitivity of CT colonography at detecting patients with at least one polyp 6 mm or larger was 76 % and its specificity was 88 % . Its by-patient sensitivity for polyps 10 mm or larger was 95 % and its specificity was 98 % . By-polyp sensitivities were 71 % for polyps 10 mm or larger , and 61 % for polyps 6 mm or larger . A second-look colonoscopy was performed in 19 patients and two initial false-positive findings of CT colonography were reclassified as true-positive . For conventional colonoscopy , this produced a by-polyp sensitivity of 94 % for detection of lesions 6 mm and larger . CONCLUSIONS : CT colonography had both a high by-patient sensitivity and specificity for detection of clinical ly important colorectal neoplasms 10 mm or larger . This suggests that CT colonography has the potential to become a valuable clinical screening method for colorectal neoplasms CONTEXT Conventional colonoscopy is the best available method for detection of colorectal cancer ; however , it is invasive and not without risk . Computed tomographic colonography ( CTC ) , also known as virtual colonoscopy , has been reported to be reasonably accurate in the diagnosis of colorectal neoplasia in studies performed at expert centers . OBJECTIVE To assess the accuracy of CTC in a large number of participants across multiple centers . DESIGN , SETTING , AND PARTICIPANTS A nonr and omized , evaluator-blinded , noninferiority study design of 615 participants aged 50 years or older who were referred for routine , clinical ly indicated Output:	CT colonography is highly sensitive for colorectal cancer , especially when both cathartic and tagging agents are combined in the bowel preparation . Given the relatively low prevalence of colorectal cancer , primary CT colonography may be more suitable than OC for initial investigation of suspected colorectal cancer , assuming reasonable specificity .
MS21126	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND : Acute otitis media ( AOM ) is a common childhood illness and the leading indication for antibiotic prescriptions for US children . Xylitol , a naturally occurring sugar alcohol , can reduce AOM when given 5 times per day as a gum or syrup , but a more convenient dosing regimen is needed for widespread adoption . METHODS : We design ed a pragmatic practice -based r and omized controlled trial to determine if viscous xylitol solution at a dose of 5 g 3 times per day could reduce the occurrence of clinical ly diagnosed AOM among otitis-prone children 6 months through 5 years of age . RESULTS : A total of 326 subjects were enrolled , with 160 allocated to xylitol and 166 to placebo . In the primary analysis of time to first clinical ly diagnosed AOM episode , the hazard ratio for xylitol versus placebo recipients was 0.88 ( 95 % confidence interval [ CI ] 0.61 to 1.3 ) . In secondary analyses , the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group ( difference 0.06 ; 95 % CI –0.25 to 0.13 ) ; total antibiotic use was 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group ( difference 0.4 ; 95 % CI –1.8 to 2.7 ) . The lack of effectiveness was not explained by nonadherence to treatment , as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 ( 95 % CI 0.56 to 1.57 ) . CONCLUSIONS : Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinical ly diagnosed AOM among otitis-prone children PURPOSE The aim of this study was to evaluate the lactic acid concentration in supragingival plaque from caries-active pre-school children after a short-term use of either xylitol- or sorbitol-containing chewing gums . MATERIAL AND METHODS The investigation consisted of a prospect i ve crossover design with 10 healthy children aged 2 - 4 years each with at least two caries lesions within the dentine ( ds > or = 2 ) . The children were instructed to chew 6 pieces of a test or a control gum every day for a 14-day period . The test gum contained 65 % xylitol and the control gum was sweetened with sorbitol . At baseline and after 14 days , salivary mutans streptococci were enumerated with a chair-side test ( Strip mutans ) and dental plaque was collected from the upper maxillary incisors . After a washout period of 6 weeks , the same procedure was repeated with the corresponding test or control gum . Lactic acid was determined enzymatically in glucose-challenged plaque suspensions . RESULTS The lactic acid concentration was significantly reduced ( p<0.05 ) by 22 % compared with baseline following the xylitol gum regimen but was unaltered after the control gum . The levels of salivary mutans streptococci were mainly unaffected by both chewing gums . CONCLUSION A 14-day use of xylitol-containing chewing gums , corresponding to a daily amount of 5 grams of xylitol , could diminish glucose-initiated lactic acid formation in supragingival plaque in caries-active pre-school children CONTEXT Adenoidectomy and adenotonsillectomy are commonly performed in US children to reduce the occurrence of persistent or recurrent otitis media , but evidence supporting the efficacy of the operations is limited . OBJECTIVES To test the efficacy of adenoidectomy and adenotonsillectomy in children with persistent or recurrent otitis media who had not previously undergone tube placement and to compare the relative efficacy of adenoidectomy alone vs adenotonsillectomy in such children . DESIGN Two parallel r and omized clinical trials . SETTING AND PARTICIPANTS A total of 461 children aged 3 to 15 years were enrolled at Children 's Hospital of Pittsburgh , Pa , between April 1980 and April 1994 . Four hundred ten children were observed for up to 3 years . INTERVENTIONS Children without recurrent throat infection or tonsillar hypertrophy ( 304 enrolled ; 266 followed up ) were r and omized to either an adenoidectomy , adenotonsillectomy , or control group ; children who had such conditions ( 157 enrolled ; 144 followed up ) were r and omized to an adenotonsillectomy or control group . MAIN OUTCOME MEASURES Occurrence rate of episodes of acute otitis media by treatment group and estimated proportion of time with otitis media . RESULTS In both trials , most subjects were eligible because of recurrent acute otitis media , with or without persistent otitis media with effusion . A total of 47 children assigned to surgical treatment groups had no surgery . The efficacy of surgery in both trials was modest and limited mainly to the first follow-up year . The largest differences in that year were found in the 3-way trial between the adenotonsillectomy group and the control group : mean annual rate of episodes of acute otitis media , 1.4 vs 2.1 ( P<.001 ) ; and mean estimated percentage of time with otitis media , 18.6 % vs 29.9 % ( difference , 11.3 % ; 95 % confidence interval , 4.4%-18.2 % ; P=.002 ) . Perioperative and postoperative complications or other adverse events occurred not infrequently , especially among subjects undergoing adenotonsillectomy ( 14.6 % ) . CONCLUSIONS Our study showed limited and short-term efficacy of both adenoidectomy and adenotonsillectomy ; given the risks , morbidity , and costs of these procedures , these data suggest that neither operation should ordinarily be considered as a first surgical intervention in children whose only indication is recurrent acute otitis media Abstract Objective : To examine whether xylitol , which reduces the growth of Streptococcus pneumoniae , might have clinical importance in the prevention of acute otitis media . Design : A double blind r and omised trial with xylitol administered in chewing gum . Setting : Eleven day care nurseries in the city of Oulu . Most of the children had had problems with recurrent acute otitis media . Subjects : 306 day care children : 149 children in the sucrose group ( 76 boys ; mean ( SD ) age 4.9 ( 1.5 ) years ) and 157 in the xylitol group ( 80 boys ; 5.0 ( 1.4 ) years ) . Intervention : Either xylitol ( 8.4 g a day ) or sucrose ( control ) chewing gum for two months . Main outcome measures : The occurrence of acute otitis media and antimicrobial treatment received during the intervention and nasopharyngeal carriage of S pneumoniae . Results : During the two month monitoring period at least one event of acute otitis media was experienced by 31/149 ( 20.8 % ) children who received sucrose compared with 19/157 ( 12.1 % ) of those receiving chewing gum containing xylitol ( difference 8.7 % ; 95 % confidence interval 0.4 % to 17.0 % ; P = 0.04 ) . Significantly fewer antimicrobials were prescribed among those receiving xylitol : 29/157 ( 18.5 % ) children had at least one period of treatment versus 43/149 ( 28.9 % ) ( difference 10.4 % ; 0.9 % to 19.9 % ; P = 0.032 ) . The carriage rate of S pneumoniae varied from 17.4 % to 28.2 % with no difference between the groups . Two children in the xylitol group experienced diarrhoea , but no other adverse effects were noted among the xylitol users . Conclusion : Xylitol seems to have a preventive effect against acute otitis media . Key messages It also inhibits the growth of S pneumoniae When given to children with recurrent otitis mediain chewing gum xylitol reduced the occurrence of otitis media by about 40 % The daily dose required is not known , but 8.4 g given daily in a chewing gum seems to be effective Xylitol had no effect on the nasopharyngeal car- riage of OBJECTIVES To evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children and to evaluate the effect of xylitol in reducing acute otitis media in a subsequent study . DESIGN Double-blind r and omized controlled trial . SETTING Communities in the Republic of the Marshall Isl and s. PARTICIPANTS One hundred eight children aged 9 to 15 months were screened , and 100 were enrolled . Intervention Children were r and omized to receive xylitol topical oral syrup ( administered by their parents ) twice a day ( 2 xylitol [ 4.00-g ] doses and 1 sorbitol dose ) ( Xyl-2 x group ) or thrice per day ( 3 xylitol [ 2.67-g ] doses ) ( Xyl-3x group ) vs a control syrup ( 1 xylitol [ 2.67-g ] dose and 2 sorbitol doses ) ( control group ) . MAIN OUTCOME MEASURES The primary outcome end point of the study was the number of decayed primary teeth . A secondary outcome end point was the incidence of acute otitis media for reporting in a subsequent report . RESULTS Ninety-four children ( mean [ SD ] age , 15.0 [ 2.7 ] months at r and omization ) with at least 1 follow-up examination were included in the intent-to-treat analysis . The mean ( SD ) follow-up period was 10.5 ( 2.2 ) months . Fifteen of 29 of the children in the control group ( 51.7 % ) had tooth decay compared with 13 of 32 children in the Xyl-3x group ( 40.6 % ) and eight of 33 children in the Xyl-2x group ( 24.2 % ) . The mean ( SD ) numbers of decayed teeth were 1.9 ( 2.4 ) in the control group , 1.0 ( 1.4 ) in the Xyl-3x group , and 0.6 ( 1.1 ) in the Xyl-2x group . Compared with the control group , there were significantly fewer decayed teeth in the Xyl-2x group ( relative risk , 0.30 ; 95 % confidence interval , 0.13 - 0.66 ; P = .003 ) and in the Xyl-3x group ( 0.50 ; 0.26 - 0.96 ; P = .04 ) . No statistical difference was noted between the 2 xylitol treatment groups ( P = .22 ) . CONCLUSION Xylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in preventing early childhood caries BACKGROUND The decision to seek medical advise for children during upper respiratory infections is largely based on the parental assumption that the child 's symptoms are related to acute otitis media . The symptoms related to acute otitis media , however , are considered nonspecific . METHODS Altogether 857 healthy day-care children ( mean age , 3.7 years ) were followed up for 3 months , and the symptoms of each child were compared during upper respiratory infections with and without acute otitis media . RESULTS A total of 138 children had upper respiratory infections with and without acute otitis media . The symptom with the strongest association with acute otitis media was earache [ relative risk ( RR ) , 21.3 ; 95 % confidence intervals ( CI ) , 7.0 to 106 , P < 0.0001 ] but sore throat ( RR = 3.2 ; CI = 1.1 to 11 ; P = 0.027 ) , night restlessness ( RR = 2.6 ; CI = 1.1 to 6.9 ; P = 0.024 ) and fever ( RR = 1.8 ; CI = 1.1 to 3.2 ; P = 0.025 ) also had significant associations . Logistic regression analysis showed 71 % of the cases to be correctly diagnosed on the basis of the symptoms of earache and night restlessness . The parents were able to predict the presence of acute otitis media with a sensitivity and specificity of 71 and 80 % , respectively ( positive predictive value , 51 % ; negative predictive value , 90 % ) . CONCLUSIONS Despite the limited value of symptoms in differentiating acute otitis media from upper respiratory infection , the parents are able to predict acute otitis media somewhat reliably . More symptoms than have been reported earlier appeared to be associated with acute otitis media OBJECTIVE Xylitol , given as 2 g orally five times-a-day , significantly reduces the incidence of acute otitis media ( AOM ) in children . A less frequent dosing schedule , if tolerable and efficacious , would promote the more widespread use of this treatment . We sought to determine the tolerability and acceptability in young children of oral xylitol solution at doses of 5 g three times-a-day ( TID ) and 7.5 g once daily ( QD ) . METHODS The study was a 3-month r and omized placebo-controlled trial of the tolerability and acceptability of oral xylitol solution in 120 Output:	There is moderate quality evidence showing that the prophylactic administration of xylitol among healthy children attending daycare centres can reduce the occurrence of AOM . There is inconclusive evidence with regard to the efficacy of xylitol in preventing AOM among children with respiratory infection , or among otitis-prone children .
MS21127	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : To test the effectiveness of different systems of reminding patients about their appointments in order to reduce the rate of failed attendance . The expense in implementing a reminder system for patients was also estimated . Design : A clinical study in a single-h and ed dental practice .Subjects : Patients were reminded about their appointment using either postal , manual telephone or automated telephone reminders ( or all three combined ) . A control group received no reminders . 500 patient attendances were recorded in each group . Results : Patients failed to attend for 130 of the 2500 appointments considered in the study . There was a significant reduction in the failed attendance rate from 9.4 % ( with no reminder ) to a minimum of 3 % when a reminder was given to the patient before the appointment . However , there was no significant difference among the four reminder test groups , indicating that the form of the reminder made no difference to the failure rate . Conclusions : Reminding patients using postal or manual telephone techniques is effective at improving attendance . All of the reminder methods , telephone and postal , provided net cost savings rather than additional Background Several studies have recently demonstrated that a post-treatment communication to explain the importance of an oral hygiene can improve the orthodontic patients ’ compliance over a period of 66 days . The main goal of this study is to evaluate the effects of a structured follow-up communication after orthodontic appliance application on oral hygiene compliance after 30–40 days . Methods Eighty-four orthodontic participants enrolled from patients who were beginning fixed orthodontic treatment at the Orthodontic Department , Gaslini Hospital , Genova , between July and October 2014 were r and omly assigned to one of three trial arms . Before the bonding , all patients underwent a session of oral hygiene aim ed at obtaining an plaque index of “ zero . ” At the following orthodontic appointment , the plaque index was calculated for each patient in order to assess oral hygiene compliance . The first group served as control and did not receive any post-procedure communication , the second group received a structured text message giving reassurance , and the third group received a structured telephone call . Participants were blinded to group assignment and were not made aware that the text message or the telephone call was part of the study . ( The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS-Istituto G. Gaslini 845/2014 , and it is not registered in the trial ’s register . ) Results Thirty patients were r and omly assigned to the control group , 28 participants to the text message group , and 26 to the telephone group . Participants who received a post-treatment communication reported higher level of oral hygiene compliance than participants in the control group . The plaque index was 0.3 ( interquartile range ( Iqr ) , 0.60 ) and 0.75 ( Iqr , 1.30 ) , respectively , with a significant difference ( P = 0.0205 ) . Conclusions A follow-up procedure after orthodontic treatment may be an effective tool to increase oral hygiene compliance also over a short period OBJECTIVE To evaluate the influence of an app-based approach in a protocol for domestic oral hygiene maintenance in a group of adolescent patients wearing fixed multibracket appliances . MATERIAL S AND METHODS Eighty adolescent patients scheduled to start an orthodontic multibracket treatment were r and omly divided into two groups of 40 . Plaque index ( PI ) , gingival index ( GI ) , white spots ( WS ) , and caries presence were recorded in all patients , and they were instructed regarding domestic oral hygiene maintenance on the day of braces application ( t0 ) and every 3 months ( t1 , t2 , t3 , t4 ) during the first year of treatment . Study group ( SG ) patients were enrolled in a WhatsApp chat room-based competition and instructed to share monthly with the other participants two self-photographs ( selfies ) showing their oral hygiene status . RESULTS SG patient participation in the chat room was regular and active throughout the observation period . At t2 , t3 , and t4 , SG patients had significantly lower values of both PI and GI and a lower incidence of new WS and caries , compared with the control group . CONCLUSION Integration of new " social " technologies in a st and ard oral hygiene motivation protocol is effective in improving compliance of adolescent patients and in improving their oral health status during orthodontic multibracket treatment OBJECTIVE To determine if text message reminders regarding oral hygiene compliance have an influence on the level of compliance within an orthodontic population . MATERIAL S AND METHODS In this prospect i ve , r and omized , controlled clinical trial , 42 orthodontic patients were assigned to a text message or control group . Parents of patients assigned to the text message group received a reminder text message one weekday each week . Oral hygiene compliance was measured using bleeding index ( BI ) , modified gingival index ( MGI ) , and plaque index ( PI ) , and visual examination of white spot lesion ( WSL ) development at baseline ( T0 ) , two appointments after baseline ( T1 ) , and four appointments after baseline ( T2 ) . RESULTS BI , MGI , and PI scores were significantly lower in the text message group than in the control group at T2 . CONCLUSION A text message reminder system is effective for improving oral hygiene compliance in orthodontic patients Background Telephone or text-message reminders have been shown to significantly reduce the rate of missed appointments in different medical setting s. Since text-messaging is less re source -dem and ing , we tested the hypothesis that text-message reminders would be as effective as telephone reminders in an academic primary care clinic . Methods A r and omized controlled non-inferiority trial was conducted in the academic primary care division of the Geneva University Hospitals between November 2010 and April 2011 . Patients registered for an appointment at the clinic , and for whom a cell phone number was available , were r and omly selected to receive a text-message or a telephone call reminder 24 hours before the planned appointment . Patients were included each time they had an appointment . The main outcome was the rate of unexplained missed appointments . Appointments were not missed if they were cancelled or re-scheduled before or independently from the intervention . We defined non-inferiority as a difference below 2 % in the rate of missed appointments and powered the study accordingly . A satisfaction survey was conducted among a r and om sample of 900 patients ( response rate 41 % ) . Results 6450 patients were included , 3285 in the text-message group and 3165 in the telephone group . The rate of missed appointments was similar in the text-message group ( 11.7 % , 95 % CI : 10.6 - 12.8 ) and in the telephone group ( 10.2 % , 95 % CI : 9.2 - 11.3 p = 0.07 ) . However , only text message reminders were cost-effective . No patient reported any disturbance by any type of reminder in the satisfaction survey . Three quarters of surveyed patients recommended its regular implementation in the clinic . Conclusions Text-message reminders are equivalent to telephone reminders in reducing the proportion of missed appointments in an academic primary care clinic and are more cost-effective . Both types of reminders are well accepted by patients PURPOSE This prospect i ve longitudinal study compared the patterns of oral health behaviors between low and high socioeconomic status ( SES ) families participating in the Iowa Fluoride Study for a period of 9 years . METHODS Information on oral health behaviors , including consumption of juices/juice drinks , soda pop , and powder-based drinks , dental visits , and tooth-brushing frequency , was collected longitudinally at periodic intervals from 6 to 108 months of age . Dental exams were conducted at 5 and 9 years of age . Classification of low socioeconomic status ( SES ; n=70 ) and high-SES ( n= 128 ) children was based on baseline family income and mothers ' education levels , with middle SES excluded . RESULTS Low SES children consistently had significantly greater consumption of soda pop and powder-based beverages . There were , however , virtually no differences at any time point between groups in : ( 1 ) tooth-brushing frequency ; ( 2 ) use of dentifrice ; or ( 3 ) fluoride concentration in drinking water . Furthermore , the mean number of decayed and filled surfaces was significantly higher in the low-SES group . CONCLUSIONS Results suggest that beverage consumption patterns are a key difference between high- and low-socioeconomic status families and could in part explain differences in caries experience between subjects of different SES . Modification of the pattern of soda pop and powder-based beverage consumption in the low-SES groups might reduce their caries experience OBJECTIVE To investigate the effects on plaque index ( PI ) scores of manual or electric toothbrush with or without repeated oral hygiene instructions ( OHI ) and motivation on patients wearing fixed orthodontic appliances . MATERIAL S AND METHODS One month after the orthodontic fixed appliance bonding on both arches , 60 patients were r and omly assigned to four groups ; groups E1 ( n = 15 ) and E2 ( n = 15 ) received a powered rotating-oscillating toothbrush , and groups M1 ( n = 15 ) and M2 ( n = 15 ) received a manual toothbrush . Groups E1 and M1 received OHI and motivation at baseline ( T0 ) and after 4 , 8 , 12 , 16 , and 20 weeks ( T4 , T8 , T12 , T16 , and T20 , respectively ) by a Registered Dental Hygienist ; groups E2 and M2 received OHI and motivation only at baseline . At each time point a blinded examiner scored plaque of all teeth using the modified Quigley-Hein PI . RESULTS In all groups the PI score decreased significantly over time , and there were differences among groups at T8 , T12 , T16 , and T20 . At T8 , PI scores of group E1 were lower than those of group E2 , and at T12 , T16 , and T20 , PI scores of groups M1 and E1 were lower compared to those of groups M2 and E2 . A linear mixed model showed that the effect of repeated OHI and motivation during time was statistically significant , independently from the use of manual or electric toothbrush . CONCLUSIONS The present results showed that repeated OHI and motivation are crucial in reducing PI score in orthodontic patients , independent of the type of toothbrush used Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge , no attempt has been made to quantify them . Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia . Methods Participants in a dementia trial were r and omised to intensive follow-up ( with comprehensive assessment visits at baseline and two , four and six months post r and omisation ) or minimal follow-up ( with an abbreviated assessment at baseline and a full assessment at six months ) . Our primary outcomes were cognitive functioning ( ADAS-Cog ) and participant and carer-rated quality of life ( QOL-AD ) . Results We recruited 176 participants , mainly through general practice s. The main analysis was based on Intention to treat ( ITT ) , with available data . In the ANCOVA model with baseline score as a co-variate , follow-up group had a significant effect on outcome at six months on the ADAS-Cog score ( n = 140 ; mean difference = -2.018 ; 95%CI -3.914 , -0.121 ; p = 0.037 favouring the intensive follow-up group ) , and on participant-rated quality of life score ( n = 142 ; mean difference = -1.382 ; 95%CI -2.642 , -0.122 ; p = 0.032 favouring minimal follow-up group ) . There was no significant difference on carer quality of life . Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia result ed in a better outcome than minimal follow-up , as measured by their cognitive functioning . Trial registration Current controlled trials : IS RCT INTRODUCTION Fixed orthodontic treatment is frequently associated with increased plaque accumulation leading to gingivitis and white spot lesions ( WSLs ) . AIM This study evaluated the role of text message reminder on oral hygiene of orthodontic patients . MATERIAL S AND METHODS A total of 60 patients under fixed orthodontic treatment were r and omly divided into two equal groups as control group and study ( text message ) group . Text message group received reminders about oral hygiene , while the control group did not receive any messages . Oral hygiene of both the groups was evaluated at baseline , 2 , and 3 months using plaque indices ( PIs ) along with WSL status . Data were statistically analyzed using Statistical Package for the Social Sciences ( SPSS ) statistical software , version 19 , with chi-square test and t-test . RESULTS At the baseline , plaque score was higher in the study group over control group ( p > 0.038 ) , whereas it was decreased after 3 months in the test group ( p > 0.001 ) . For WSL , there was no significant difference at baseline , but it was significantly lower in study group ( p > 0.003 ) . CONCLUSION Oral hygiene status improved with text message reminder Objectives To evaluate the effect of issuing a patient reminder plus a confirmation slip on the attendance of orthodontic new patients . Output:	There is moderate-to-high quality of evidence that reminders have a positive effect on OH and adherence to appointments in orthodontic patients . These effects were demonstrated in the short- and long-term .
MS21128	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Glucosamine and chondroitin sulfate are used to treat osteoarthritis . The multicenter , double-blind , placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial ( GAIT ) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis . METHODS We r and omly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily , 1200 mg of chondroitin sulfate daily , both glucosamine and chondroitin sulfate , 200 mg of celecoxib daily , or placebo for 24 weeks . Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia . Assignment was stratified according to the severity of knee pain ( mild [ N=1229 ] vs. moderate to severe [ N=354 ] ) . The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24 . RESULTS The mean age of the patients was 59 years , and 64 percent were women . Overall , glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent . As compared with the rate of response to placebo ( 60.1 percent ) , the rate of response to glucosamine was 3.9 percentage points higher ( P=0.30 ) , the rate of response to chondroitin sulfate was 5.3 percentage points higher ( P=0.17 ) , and the rate of response to combined treatment was 6.5 percentage points higher ( P=0.09 ) . The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group ( P=0.008 ) . For patients with moderate-to-severe pain at baseline , the rate of response was significantly higher with combined therapy than with placebo ( 79.2 percent vs. 54.3 percent , P=0.002 ) . Adverse events were mild , infrequent , and evenly distributed among the groups . CONCLUSIONS Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee . Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain . ( Clinical Trials.gov number , NCT00032890 . ) The aim of this study was to verify the clinical responses to Thai massage ( TM ) and Thai herbal compression ( THC ) for treating osteoarthritis ( OA ) of the knee in comparison to oral ibuprofen . This study was a r and omized , evaluator-blind , controlled trial . Sixty patients with OA of the knee were r and omly assigned to receive either a one-hour session of TM or THC ( three times weekly ) or oral ibuprofen ( three times daily ) . The duration of treatment was three weeks . The clinical assessment s included visual analog scale assessing pain and stiffness , Lequesne 's functional index , time for climbing up ten steps , and physician 's and patient 's overall opinions on improvement . In a within-group comparison , each treatment modality caused a significant improvement of all variables determined for outcome assessment s. In an among group comparison , all modalities provided nearly comparable clinical efficacy after a three-week symptomatic treatment of OA of the knee , in which a trend toward greatest improvement was likely to be found in THC group . In conclusion , TM and THC generally provided comparable clinical efficacy to oral ibuprofen after three weeks of treatment and could be considered as complementary and alternative treatments for OA of the knee Objective . Two studies evaluated efficacy and safety of tanezumab versus naproxen for treatment of knee or hip osteoarthritis ( OA ) . Methods . R and omized controlled studies [ NCT00830063 ( Study 1015 , n = 828 ) and NCT00863304 ( Study 1018 , n = 840 ) ] of subjects with hip or knee OA compared intravenous tanezumab ( 5 mg or 10 mg ) to placebo and naproxen ( 500 mg twice daily ) . Co primary outcomes were Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) Pain , WOMAC Physical Function ( 0–10 numerical rating scale ) , and patient ’s global assessment of OA at Week 16 . Results . In both studies , tanezumab reduced pain versus placebo [ least squares mean differences , 95 % CI , tanezumab 5 mg : −1.21 ( −1.72 , −0.70 ) ; −1.13 ( −1.65 , −0.62 ) ; tanezumab 10 mg : −0.91 ( −1.42 , −0.40 ) ; −0.80 ( −1.32 , −0.29 ) ] , and improved function and global scores . Tanezumab 5 mg produced greater pain reduction [ −0.76 ( −1.28 , −0.25 ) ; −0.69 ( −1.21 , −0.17 ) ] , and favorable functional and global outcomes versus naproxen . Pain reductions with tanezumab 10 mg versus naproxen did not reach significance , unlike functional ( both studies ) and global ( 1 study ) outcomes ; thus , tanezumab 10 mg was not superior to naproxen , and predefined statistical testing procedures were not met , allowing for conclusion of superiority of tanezumab 5 mg over naproxen despite replicated favorable co primary outcomes . Tanezumab was associated with greater incidence of peripheral sensory adverse events ( paresthesia , hyperesthesia , hypoesthesia , burning sensation ) , pain in extremity , peripheral edema , and arthralgia . Overall frequency and discontinuations as a result of adverse events were similar to placebo and naproxen . Conclusion . Tanezumab provides efficacious treatment of knee or hip OA and may have therapeutic utility in patients with OA who experience inadequate analgesia with nonsteroidal antiinflammatory drugs Purpose Osteoarthritic pain is largely considered to be inflammatory pain . Sensory nerve fibers innervating the knee have been shown to be significantly damaged in rat models of knee osteoarthritis ( OA ) in which the subchondral bone junction is destroyed , and this induces neuropathic pain ( NP ) . Pregabalin was developed as a pain killer for NP ; however , there are no reports on pregabalin use in OA patients . The purpose of this study was to investigate the efficacy of pregabalin for pain in OA patients . Material s and Methods Eighty-nine knee OA patients were evaluated in this r and omized prospect i ve study . Patients were divided into meloxicam , pregabalin , and meloxicam+pregabalin groups . Pain scores were evaluated before and 4 weeks after drug application using a visual analogue scale ( VAS ) , and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Pain scales among groups were compared using a Kruskal-Wallis test . Results Before drug application , there was no significant difference in VAS and WOMAC scores among the three groups ( p>0.05 ) . Significant pain relief was seen in the meloxicam+pregabalin group in VAS at 1 , 2 , and 4 weeks , and WOMAC score at 4 weeks , compared with the other groups ( p<0.05 ) . No significant pain relief was seen in the meloxicam only group in VAS during 4 weeks and WOMAC score at 4 weeks compared with the pregabalin only group ( p>0.05 ) . Conclusion Meloxicam+pregabalin was effective for pain in OA patients . This finding suggests that OA pain is a combination of inflammatory and NP OBJECTIVE To assess the efficacy and safety of 12-week treatment with ketoprofen in ultradeformable phospholipid vesicles in patients with OA knee pain and to compare the efficacy with that of ketoprofen-free vehicle and celecoxib . METHODS ; A multicentre , double-blind controlled study in which patients with knee OA and moderate pain were r and omized to one of the six arms : topical ketoprofen 50 or 100 mg in ultradeformable vesicles ( IDEA-033 ) , 2.2 or 4.4 g ketoprofen-free vehicle ( TDT 064 ) , oral celecoxib 100 mg or matching oral placebo , all bd . The primary outcome was change from baseline in the WOMAC pain subscale at week 12 . RESULTS A total of 1395 patients received treatment . Baseline mean WOMAC pain scores ranged from 4.7 to 4.8 across groups . The mean reduction in WOMAC pain score at week 12 was -1.9 ( -40.8 % ) for ketoprofen 50 mg , -1.9 ( -40.9 % ) for ketoprofen 100 mg , -1.9 ( -39.8 % ) for 2.2 g TDT 064 , -1.8 ( -37.8 % ) for 4.4 g TDT 064 , -1.9 ( -40.4 % ) for celecoxib and -1.4 ( -29.3 % ) for oral placebo . IDEA-033 was not statistically superior to TDT 064 . All topical treatments were statistically superior to oral placebo and non-inferior to celecoxib . The most frequent types of treatment-related adverse events reported were gastrointestinal for oral ( 15.9 % for celecoxib ) and dermal for topical applications ( 12.2 % for ketoprofen 100 mg ) . CONCLUSION IDEA-033 was not superior to ketoprofen-free vehicle , but both formulations were superior to oral placebo and non-inferior to celecoxib in reducing OA knee pain . TRIAL REGISTRATION Clinical Trials.gov , http:// clinical trials.gov/ , NCT00716547 OBJECTIVE To evaluate the efficacy and tolerability of aceclofenac , 200 mg/day , and paracetamol , 3000 mg/day , in the treatment of osteoarthritis ( OA ) of the knee . METHODS This was a double-blind , parallel-group , multicentre clinical trial involving patients with symptomatic OA of the knee , conducted in Spain . Patients were r and omly allocated to aceclofenac 100 mg twice daily ( n=82 ) or paracetamol 1000 mg three times daily ( n=86 ) . Patients were assessed at baseline and 6 weeks . Primary efficacy measures were severity of pain ( visual analogue scale , VAS ) , Lequesne OA knee index , and patient 's and physician 's global assessment of disease activity . Severity of knee pain at rest or walking , stiffness , knee swelling and tenderness , and assessment of health-related quality of life ( Health Assessment Question naire , Western Ontario and McMaster Universities Osteoarthritis Index , and Short Form 36 ) were included as secondary endpoints . RESULTS Both treatment groups showed significant improvement compared with their baseline values in the four primary endpoints . Mean between-treatment differences favoured aceclofenac over paracetamol on pain ( VAS , 7.64 mm [ 95 % confidence interval ( CI ) , 0.44 - 14.85 mm ] ) , Lequesne OA index ( 1.41 [ 95 % CI , 0.45 - 2.36 ] ) , and patient 's ( 0.33 [ 95 % CI , 0.06 - 0.61 ] ) and physician 's ( 0.23 [ 95 % CI , 0.01 - 0.47 ] ) global assessment s. Adverse events were similar for both drugs ( paracetamol , 29 % patients vs aceclofenac , 32 % ; P=0.71 ) . Four patients withdrew in each group due to adverse events . Patients tended to prefer aceclofenac to paracetamol ( P=0.001 ) , and more treated with paracetamol withdrew from the study due to lack of efficacy ( n=8 vs n=1 , P=0.035 , for paracetamol and aceclofenac , respectively ) . CONCLUSION At 6 weeks , patients with symptomatic OA of the knee showed a greater improvement in pain and functional capacity with aceclofenac than paracetamol with no difference in tolerability The aim of this 13-week , multicenter , r and omized , double-blind , double-dummy , placebo- and positive-internal (celecoxib)-controlled , parallel-group study was to demonstrate the efficacy , safety , and tolerability of lumiracoxib in primary hip osteoarthritis ( OA ) patients . Eligible patients ( n = 1,262 ; ACR criteria ) were r and omized ( 1:1:1 ) to receive lumiracoxib 100 mg once daily ( o.d . ) ( n = 427 ) , celecoxib 200 mg o.d . ( n = 419 ) , or matching placebo o.d . ( n = 416 ) administered orally . The primary objective was to compare lumiracoxib 100 mg o. Output:	The effects of oral NSAIDs , COX-2 inhibitors , and opioids in controlling pain were similar to what has been demonstrated in previous literature . Topical NSAIDs were found to have a greater RC than oral NSAIDs
MS21129	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective Our objective was to examine the effects of exercise training ( EXS ) on quality of life ( QoL ) in highly active antiretroviral therapy (HAART)-treated HIV-positive ( HIV+ ) subjects with body fat redistribution ( BFR ) in Rw and a. Methods The effects of a r and omised controlled trial of EXS on QoL were measured using World Health Organisation Quality of Life (WHOQOL)-BREF in HIV+ subjects with BFR r and omised to EXS ( n = 50 ; BFR + EXS ) or no exercise training ( n = 50 ; BFR + noEXS ) . Results At 6 months , scores on the psychological [ 1.3 ( 0.3 ) vs. 0.5 ( 0.1 ) ; P < 0.0001 ] , independence [ 0.6 ( 0.1 ) vs. 0.0 ( 0.0 ) ; P < 0.0001 ] , social relationships [ 0.6 ( 0.2 ) vs. 0.0 ( 0.0 ) ; P < 0.0001 ] and HIV HAART-specific QoL domains [ 1.4 ( 0.2 ) vs. −0.1 ( 0.2 ) ; P < 0.0001 ] improved more in BFR + EXS than BFR + noEXS group , respectively . Self-esteem [ 1.3 ( 0.8 ) vs. 0.1 ( 0.6 ) ; P < 0.001 ] , body image [ 1.5 ( 0.6 ) vs. 0.0 ( 0.5 ) ; P < 0.001 ] and emotional stress [ 1.6 ( 0.7 ) vs. 0.2 ( 0.5 ) ; P < 0.001 ] improved more in the BFR + EXS group than BFR + noEXS group , respectively . Psychological [ 1.5 ( 0.2 ) vs. 1.1 ( 0.3 ) ; P < 0.0001 ] , social relationship [ 0.8 ( 0.2 ) vs. 0.4 ( 0.2 ) ; P < 0.0001 ] , and HIV HAART-specific well-being [ 1.8 ( 0.2 ) vs. 1.0 ( 0.0 ) ; P < 0.0001 ] improved more in BFR + EXS female than male subjects . Conclusions Exercise training improved several components of QoL in HAART-treated HIV+ African subjects with BFR . Exercise training is an inexpensive and efficacious strategy for improving QoL in HIV+ African subjects , which may improve HAART adherence and treatment initiatives in re source -limited areas of sub-Saharan Africa QUESTION What is the effect of a six-month , supervised , aerobic and resistance exercise program on self-efficacy in men living with human immunodeficiency virus ( HIV ) ? DESIGN R and omised , controlled trial . PARTICIPANTS 40 ( 5 dropouts ) men living with HIV , aged 18 years or older . INTERVENTION The experimental group participated in a twice-weekly supervised aerobic and resistance exercise program for six months and the control group participated in a twice-weekly unsupervised walking program and attended a monthly group forum . OUTCOME MEASURES The primary outcome measure was self-efficacy using the General Self-Efficacy Scale . Secondary outcome measures were cardiovascular fitness using the Kasch Pulse Recovery test , and health-related quality of life using the Medical Outcomes Study HIV Health Survey . Measures were taken by an assessor blinded to group allocation . RESULTS By six months , the experimental group had improved their self-efficacy by 6.8 points ( 95 % CI 3.9 to 9.7 , p < 0.001 ) and improved their cardiovascular fitness by reducing their heart rate by 20.2 bpm ( 95 % CI -25.8 to -14.6 , p < 0.001 ) more than the control group . Health-related quality of life improved in only two out of the eleven dimensions : the experimental group improved their overall health by 20.8 points ( 95 % CI 2.0 to 39.7 , p = 0.03 ) and their cognitive function by 14 points ( 95 % CI 0.7 to 27.3 , p = 0.04 ) more than the control group . CONCLUSION The findings of this study add to the known benefits of exercise for the HIV-infected population Currently infection with the human immunodeficiency virus-1 ( HIV-1 ) is in most instances a chronic disease that can be controlled by effective antiretroviral therapy ( ART ) . However , chronic use of ART has been associated with a number of toxicities ; including significant reductions in bone mineral density ( BMD ) and disorders of the fat metabolism . The peroxisome proliferator-activated receptor gamma ( PPARγ ) transcription factor is vital for the development and maintenance of mature and developing adipocytes . Alterations in PPARγ expression have been implicated as a factor in the mechanism of HIV-1-associated lipodystrophy . Both reduced BMD and lipodystrophy have been well described as complications of HIV-1 infection and treatment , and a question remains as to their interdependence . Interestingly , both adipocytes and osteoblasts are derived from a common precursor cell type ; the mesenchymal stem cell . The possibility that dysregulation of PPARγ ( and the subsequent effect on both osteoblastogenesis and adipogenesis ) is a contributory factor in the lipid- and bone-abnormalities observed in HIV-1 infection and treatment has also been investigated . This review deals with the hypothesis that dysregulation of PPARγ may underpin the bone abnormalities associated with HIV-1 infection , and treats the current knowledge and prospect i ve developments , in our underst and ing of PPARγ involvement in HIV-1-associated bone disease OBJECTIVES : Human Immunodeficiency Virus ( HIV ) infection worsens the frailty of elderly people , compromising their quality of life . In this study we prospect ively evaluated eleven patients living with HIV and 21 controls older than 60 years and without prior regular physical activity , who engaged in a one-year progressive resistance exercise program to compare its effects on muscular strength , physical fitness and body composition . METHODS : Exercises for major muscular groups were performed 2 times/week , under professional supervision . Strength increase was evaluated bimonthly , while body composition , lipid and glycaemic profiles ( only of those living with HIV ) and physical fitness were evaluated before and after the one-year training . RESULTS : The participants living with HIV were lighter , had smaller Body Mass Index and were initially much weaker than controls . However , their strength increased more ( 1.52 - 2.33 times the baseline values for those living with HIV x 1.21 - 1.48 times for controls , p<0.01 ) , nullifying the differences initially seen . These effects were seen independently of gender , age or baseline physical activity . In addition , those living with HIV improved their fasting glucose levels and showed a tendency to improve their lipids after the one year training program . These effects were slightly more pronounced among those not using protease inhibitors , although not significantly . CONCLUSIONS : Resistance exercise safely increased the strength of older patients living with HIV adults , allowing them to achieve performance levels observed among otherwise healthy controls . These findings favor the recommendation of resistance exercise for elderly adults living with HIV adults PURPOSE The purpose s of the present study were to assess the effects of a 12-wk laboratory based aerobic exercise program on cardiopulmonary function , CD4 cell count , and physician-assessed health status among symptomatic pre-AIDS HIV-infected individuals ( N = 28 ) and to assess the degree to which ill health was associated with exercise relapse . METHODS Responses to grade d exercise test , physician-assessed health status , and CD4 cell counts were determined at baseline and 12-wk follow-up for participants r and omly assigned to exercise or control conditions , and reasons for exercise noncompliance were recorded . RESULTS Approximately 61 % of exercise-assigned participants complied ( > 50 % attendance ) with the exercise program , and analyses of exercise relapse data indicated that obesity and smoking status , but not exercise-associated illness , differentiated compliant from noncompliant exercisers . Compliant exercisers significantly improved peak oxygen consumption ( VO2peak ; 12 % ) , oxygen pulse ( O2pulse ; 13 % ) , tidal volume ( TV ; 8 % ) , ventilation ( VE ; 17 % ) , and leg power ( 25 % ) to a greater degree than control participants and noncompliant exercisers ( all P < 0.05 ) . Although no group differences in health status were found , a significant interaction effect indicated that noncompliant exercisers ' CD4 cells declined ( 18 % ) significantly , whereas compliant exercisers ' cell counts significantly increased ( 13 % ; P < 0.05 ) . CONCLUSION We conclude that although aerobic exercise can improve cardiopulmonary functioning in symptomatic HIV-infected individuals with minimal health risks , attention to factors associated with exercise adherence is warranted PURPOSE Highly active antiretroviral therapy has improved the prognosis of human immuno deficiency virus type 1 (HIV-1)-infected individuals , but it has been associated with the development of metabolic and fat distribution abnormalities known as the lipodystrophy syndrome . This study tested the hypothesis that aerobic exercise training added to a low-lipid diet may have favorable effects in HIV-1-infected individuals with dyslipidemia and lipodystrophy . METHODS Thirty healthy subjects , carriers of HIV-1 , with dyslipidemia and lipodystrophy , all of whom were using protease inhibitors and /or non-nucleoside reverse transcriptase inhibitors , were r and omly assigned to participate in either a 12-wk program of aerobic exercise or a 12-wk stretching and relaxation program . All subjects received recommendations for a low-lipid diet . Before and after intervention , peak oxygen uptake , body composition , CD4 , viral load , lipid profile , and plasma endothelin-1 levels were measured . RESULTS Peak oxygen uptake increased significantly in the diet and exercise group ( mean + /- SD : 32 + /- 5 mL x kg(-1 ) x min(-1 ) before ; 40 + /- 8 mL x kg(-1 ) x min(-1 ) after ) but not in the diet only group ( 34 + /- 7 mL x kg(-1 ) x min(-1 ) before ; 35 + /- 8 mL x kg(-1 ) x min(-1 ) after ) . Body weight , body fat , and waist-to-hip ratio decreased significantly and similarly in the two groups . There were no significant changes in immunologic variables in either group . Likewise , plasma triglycerides , total cholesterol , and HDL cholesterol levels did not change significantly in either group . Plasma endothelin-1 levels were elevated in both groups and presented no significant changes during the study . CONCLUSION HIV-seropositive individuals with lipodystrophy and dyslipidemia su bmi tted to a short-term intervention of low-lipid diet and aerobic exercise training are able to increase their functional capacity without any consistent changes in plasma lipid levels Loss of lean body and muscle mass characterizes the acquired immunodeficiency syndrome ( AIDS ) wasting syndrome ( AWS ) . Testosterone and exercise increase muscle mass in men with AWS , with unclear effects on muscle composition . We examined muscle composition in 54 eugonadal men with AWS who were r and omized to 1 ) testosterone ( 200 mg i m weekly ) or placebo and simultaneously to 2 ) resistance training or no training in a 2 x 2 factorial design . At baseline and after 12 wk , we performed assessment s of whole body composition by dual-energy X-ray absorptiometry and single-slice computed tomography for midthigh cross-sectional area and muscle composition . Leaner muscle has greater attenuation . Baseline muscle attenuation correlated inversely with whole body fat mass ( r = -0.52 , P = 0.0001 ) . This relationship persisted in a model including age , body mass index , testosterone level , viral load , lean body mass , and thigh muscle cross-sectional area ( P = 0.02 ) . Testosterone ( P = 0.03 ) and training ( P = 0.03 ) increased muscle attenuation . These data demonstrate that thigh muscle attenuation by computed tomography varies inversely with whole body fat and increases with testosterone and training . Anabolic therapy in these patients increases muscle leanness Patients on highly active antiretroviral therapy ( HAART ) spend less time on vigorous activities due to lower aerobic capacity with functional limitations that can be attributed to a detraining effect , result ing in a poor quality of life ( QoL ) . The overall aims of rehabilitation are to restore , to maintain , and to enhance the QoL and this detraining effect could possibly be reversed by a rehabilitation program . This r and omized controlled prospect i ve longitudinal descriptive study evaluated the impact of a rehabilitation program of moderate-intensity cycling and treadmill walking exercises with a home program on the QoL for individuals on HAART . Fifty-two participants with baseline QoL values formed the experimental and control groups with a 3-month pretest and posttest using the short-form health survey ( SF-36 ) question naire . No adverse effects from exercises were experienced , and 20 ( 77 % ) of the experimental and 16 ( 62 % ) of the controls completed the program . A significantly higher number of women dropped out ( P Output:	Conclusions There was evidence that engaging in moderate intensity aerobic exercises ( 55–85 % Maximum heart rate-MHR ) , for 30–60 min , two to five times/week for 6–24 weeks significantly improves role activity limitation due to physical health problems , otherwise physical(aerobic or/ and resistance ) exercises have no significant effects on CD4 + count and other domains of QoL. Also , there is lack of evidence on the impact of exercises on BMD in PLWHA due to the paucity of RCTs . The moderate grade evidence for this review suggests that further research may likely have an important impact on our confidence in the estimate of effects and may change the estimate
MS21130	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE To evaluate postoperative corneal swelling as a predictor of corneal endothelial cell loss after phacoemulsification cataract surgery . DESIGN Prospect i ve observational case series . METHODS Thirty patients planned for routine phacoemulsification cataract surgery were included . Ultrasonic pachymetry and specular microscope endothelial photography of the central and nasal portions of the cornea and Orbscan II slit-scan tomography were performed preoperatively and the day after surgery . The 30 patients were selected from 41 patients based on their increase in central corneal thickness : the first 10 cases with a < 5 % increase , the first 10 with a 6 % to 20 % increase , and the first 10 with a > or = 20 % increase . The same measurements were repeated after 1 , 2 , and 3 months . The primary outcome measures were corneal endothelial cell loss and increase in pachymetry . Several other parameters were also registered , including age , degree of cataract , visual acuity , phacoemulsification time and energy , total operation time , and the amount of infusion fluid used . RESULTS The central corneal swelling at postoperative day 1 was strongly correlated with the central corneal endothelial cell loss at 3 months ( R(2 ) = 0.785 , P < .001 ) . CONCLUSIONS In this series , with large variations in the corneal swelling at the first postoperative day , the degree of permanent corneal endothelial damage was reflected in the degree of early postoperative corneal swelling . Measuring the difference in pachymetry at postoperative day 1 is a useful way to assess the effects on the corneal endothelium exerted by the phacoemulsification procedure This study investigated whether diabetic-like corneal sensory deficits occur in the galactose-fed rat model of diabetic ocular complications and if such deficits could be prevented using either of two structurally different aldose reductase ( AR ) inhibitors , CT-112 or AL-1576 . S-D rats were r and omly grouped to receive a diet of Purina chow with either 50 % starch ( n=25 ) or 50 % D-galactose ( n=65 ) . Some of the galactosemic rats received either 0.25 % CT-112 topically 3x daily ( n=15 ) or 28 mg/kg body wt/day AL-1576 systemically ( n=10 ) . The control and untreated galactosemic rats in the CT-112 portion of the study received equivalent topical doses of the vehicle . Sensitivity measurements were made with a Cochet-Bonnet Aesthesiometer mounted on a micromanipulator . The filament was applied to the central corneal surface ( mean pressure of 0.96 g/mm2 ) and viewed using a slit-lamp biomicroscope . Ten consecutive stimuli were conducted on each cornea and the average number of blink-responses was expressed as a percent of total stimuli effected . Mean initial corneal sensitivities were similar in all groups . Corneal sensitivity in the galactosemic rat was reduced ( p<0.01 ) at each monthly measurement compared to control . Animals treated with CT-112 or AL-1576 showed a significant increase in the mean blink-response compared to untreated galactose-fed rats and did not differ significantly from controls towards the completion of the 7 month study . Animals treated with AL-1576 did not develop cataracts , whereas those treated topically with CT-112 and untreated galactose-fed rats developed bilateral nuclear cataracts within 3 weeks . This is the first study to demonstrate decreased corneal sensitivity in the galactose-fed rat model and its amelioration with AR inhibitors . Thus , aldose reductase , the first enzyme of the polyol pathway , may have an important role in the pathogenesis of decreased corneal sensitivity . The model could be useful for investigating the pathogenic mechanism(s ) involved in reduced corneal sensitivity associated with diabetic keratopathy in humans Purpose : To compare endothelial damage induced by different cataract incision sites and sizes using specular microscopy . Setting : Department of Ophthalmology , Hospital of San Donà di Piave , Venice , Italy . Methods : Eighty‐one eyes having phacoemulsification were r and omly assigned to 1 of 3 groups of 27 eyes each : 3.5 mm clear corneal incision ( CCI ) with silicone foldable intraocular lens ( IOL ) implantation ; 5.5 mm sutured CCI with poly(methyl methacrylate ) ( PMMA ) IOL implantation ; 5.5 mm scleral tunnel with PMMA IOL implantation . All incisions were centered at the 120‐degree semimeridian ; that is , they were superotemporal in right eyes and superonasal in left eyes . Noncontact specular microscopy was performed in the center and at the 12 o'clock position preoperatively as well as 1 week and 1 , 3 , and 12 months postoperatively . The endothelial cell density , mean cell area , cell size variation coefficient , percentage of hexagonality , and corneal thickness were considered . Results : Progressive endothelial cell loss and an increase in mean cell area occurred in all groups during the follow‐up . The cell loss percentages relative to the endothelial center appeared similar among the groups and slightly although not significantly lower in the scleral tunnel group . The scleral tunnel group had a statistically significant lower cell loss percentage at the 12 o'clock position than the 2 CCI groups at all follow‐ups . Conclusions : The scleral tunnel group had less postoperative endothelial damage than the 2 CCI groups , with a statistically significant difference at the 12 o'clock position . This is probably because the scleral tunnel incision is placed more posteriorly and therefore induces less direct and indirect endothelial trauma Purpose : To investigate the corneal endothelial cell density and morphology in patients with and without diabetes after phacoemulsification with intraocular lens implantation . Methods : A clinical prospect i ve study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery . No difference in preoperative age was observed between the 2 groups ( P = 0.90 ) . Sample size was based on a power calculation ( power 0.90 ; P = 0.05 ) . The patients without diabetes had a casual blood glucose test performed to disclose undetected diabetes . The patients with diabetes had a serum glycosylated hemoglobin ( HbA1c ) test performed to reveal the glycemic control . The endothelial cell density , variation in endothelial cell size ( CV ) , percentage of hexagonal cells , and central corneal thickness ( CCT ) were recorded at baseline and at 3 months postoperatively . Results : The mean decrease in endothelial cell density at 3 months in the diabetic group was 154 cells per square millimeter ( 6.2 % ) and 42 cells per square millimeter ( 1.4 % ) in the control group . The difference in cell loss between the 2 groups was significant ( P = 0.04 ) . A significant decrease in the percentage of hexagonal cells was also seen in the diabetic group ( P = 0.01 ) . There was no statistically significant change in CV or CCT . Visual acuity increased significantly and equally in the 2 groups . Conclusions : The present study reveals a significantly greater loss of corneal endothelial cells in a diabetic group under good glycemic control , compared with nondiabetic group 3 months after phacoemulsification . The morphological changes in the endothelial cells in patients with well-controlled diabetes were not reflected in impaired function as judged by CCT Purpose : To evaluate intraoperative endothelial damage after planned extracapsular cataract extraction ( ECCE ) with different capsulotomy techniques and phacoemulsification . Setting s : San Carlos University Hospital , Castroviejo Institute , Madrid , Spain . Methods : In this prospect i ve , r and omized study , 60 patients with senile cataract scheduled for cataract surgery were divided into three groups of 20 each : Group 1 had phacoemulsification ; Group 2 , planned ECCE with continuous curvilinear capsulorhexis ; and Group 3 , ECCE with letter‐box capsulotomy . Preoperatively and 3 months postoperatively , endothelial cell density , percentage of hexagonality , and the cell size variation coefficient were determined by contact specular microscopy ; endothelial permeability was examined by anterior segment fluorophotometry and central comeal thickness , by ultrasonic pachymetry . Results were analyzed using the two‐tailed Students t‐test and analysis of variance . Results : In all three groups , endothelial permeability and cell loss increased significantly from the preoperative values , but there were no significant differences among the postoperative values . Mean cell loss was 11.8 % in Group 1 , 12.8 % in Group 2 , and 10.1 % in Group 3 . There were no differences between the preoperative and postoperative morphometric indexes . Postoperative pachymetric measurements were not significant . Conclusions : Endothelial response was not statistically significantly different among the surgical techniques , although endothelial damage was lower in Group 3 , which could indicate a protective effect of the anterior capsule during cataract extraction . Endothelial barrier function remained disturbed despite the apparent morphological stabilization Purpose : Cataract surgery is known to change the corneal endothelial cell density and morphology . In patients with diabetes , this change is more pronounced . This prospect i ve cohort study was conducted to assess and compare the endothelial cell loss and change in central corneal thickness ( CCT ) after manual small incision cataract surgery ( SICS ) in patients with diabetes versus age-matched patients without diabetes . Methods : Consecutive patients with diabetes ( 153 ) in the age group 40 - 70 years and age-matched patients without diabetes ( 163 ) undergoing manual SICS were enrolled . Preoperative and 1 week , 6 weeks , and 3 months postsurgery assessment s of corneal endothelial loss and change in CCT were done using specular microscopy and ultrasound pachymetry . Results : There was a steady drop in the endothelial density in both the groups postoperatively , with the percentage of endothelial loss at 6 weeks and 3 months being 9.26 ± 9.55 and 19.24 ± 11.57 , respectively , in patients with diabetes and 7.67 ± 9.2 and 16.58 ± 12.9 , respectively , in controls . The percentage of loss between 6 weeks and 3 months was found to be of significant difference ( P < 0.023 ) . In both the groups , an initial increase in CCT till the second postoperative week was followed by a reduction of CCT in the subsequent follow-up ( sixth week ) and a further reduction in the last follow-up ( 3 months ) . The change in CCT between the second and sixth weeks was significantly higher in the diabetic group ( P = 0.045 ) . Conclusions : The diabetic endothelium was found to be under greater metabolic stress and had less functional reserve after manual SICS than the normal corneal endothelium Purpose : To evaluate central endothelial cell loss ( ECL ) following clear corneal cataract surgery using two different incision sizes and the effect of ultrasound time ( UST ) and power on postoperative ECL and various cell parameters . Methods : Fifty‐eight patients had phacoemulsification through temporal , two‐step clear corneal tunnel incisions . In Group A ( n = 28 ) , a one‐piece , plate‐haptic , foldable silicone intraocular lens ( IOL ) was implanted through a 3.5 mm sutureless incision . In Group B ( n = 30 ) , a poly(methyl methacrylate ) IOL was implanted through a 5.0 mm incision with one radial suture . The central endothelial cell counts were recorded preoperatively and postoperatively at 2 to 5 days , after 6 months , and after 1 year . Color‐coded , computer‐assisted specular microscopy was used for special cell analysis after 1 year . Results : Collective data showed an ECL of 7.9 ± 4.1 % ( mean ± st and ard deviation ) at 2 to 5 days postoperatively , 6.7 ± 2.9 % after 6 months , and 7.3 ± 3.3 % after 1 year . A direct linear relationship was found between ECL and UST and power : ECL increased as UST and power increased . After 1 year , ECL in Group A was 4.2 % with UST ≤1 1/2 minutes , 6.7 % with UST ≥ 1 1/2 to 2 1/2 min , and 9.6 % with UST > 2 1/2 to 3 1/2 min ; in Group B , it was 6.0 % , 7.5 % , and 11.4 % , respectively . Specular microscopy showed normal , age‐related cell parameters 1 year postoperatively . Conclusions : Phacoemulsification with 3.5 mm clear corneal incisions produced slightly less ECL ( 6.7 % ) than phacoemulsification with 5.0 mm incisions ( 7.9 % ) . Total ECL of 7.3 % at 1 year postoperatively compared favorably with ECL rates of other cataract extraction methods PURPOSE To investigate whether modern phacoemulsification surgery results in more damage to the corneal endothelium than extracapsular cataract extraction ( ECCE ) , and to examine which preoperative , operative , and post Output:	Diabetic corneas are more vulnerable to stress and trauma , result ing in greater morphological abnormalities and longer recovery time
MS21131	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The objective of this study was to determine the prevalence of , and factors associated with , sexual violence in childhood , adolescence and adulthood , among injection drug using men and women . The Vancouver Injection Drug User Study is a prospect i ve cohort of injection drug users ( IDU ) begun in 1996 . The analysis included all individuals who completed the baseline question naire who responded to a question about sexual assault . Multivariate modeling was used to determine and to what extent a history of sexual violence at different ages is predictive of HIV risk and other health risk behaviors . HIV prevalence was calculated as the total current number of HIV-positive individuals in the cohort . Of the 1437 eligible individuals , 36 % reported a lifetime history of sexual violence ; 68 % of women , and 19 % of men ( p<0.001 ) . After adjusting for fixed sociodemographics , these individuals were more likely to have ever been in the sex trade , to knowingly share needles/rigs with HIV-positive people , to have attempted suicide , to have ever accidentally overdosed , to binge on alcohol , and to have been diagnosed with a mental disorder/disability . The prevalence of child sexual abuse in this cohort is 21 % ; 33 % for women , and 13 % for men . The data show a dose-response relationship between age at first sexual violence and most risk behaviors examined . These relationships are further mediated by gender . The prevalence of HIV among individuals who ever experienced sexual violence was 25 % , compared to 19 % among those who never experienced sexual violence ( p=0.006 ) . Sexual violence , and especially child sexual abuse , is highly prevalent among this cohort , particularly among women . Child sexual abuse has worse consequences for both genders than sexual violence later in life . Nevertheless , women and men are affected differently by sexual violence at different ages , and this has significant implication s for health promotion programs , and specifically HIV prevention Homeless young adults ages 18 - 25 exhibit high rates of alcohol and other drug ( AOD ) use , and sexual risk behaviors such as unprotected sex . Yet few programs exist for this population that are both effective and can be easily incorporated into setting s serving this population . This pilot cluster cross-over r and omized controlled trial evaluates AWARE , a voluntary four session group-based motivational interviewing ( MI ) intervention to reduce AOD use and sexual risk behavior . We evaluated AWARE with 200 homeless young adults using drop-in center services in Los Angeles County ( mean age=21.8years ; 73 % male ; 79 % heterosexual ; 31 % non-Hispanic White , 25 % African American , 24 % Hispanic , 21 % multiracial/other ) . Surveys were completed at baseline and three months after program completion . Retention in the AWARE program was excellent ( 79 % attended multiple sessions ) and participants reported high levels of satisfaction with the program . AWARE participants self-reported positive change in their past 3month and past 30day alcohol use ( ps≤0.05 ) , motivation to change drug use ( ps<0.05 ) , and condom use self-efficacy ( p=0.05 ) compared to the control group . Among those with multiple sex partners , AWARE participants showed a decrease in unprotected sexual events ( p<0.05 ) , whereas the control group did not . Results from this pilot evaluation are promising , suggesting that a brief group-MI risk reduction intervention can be effective in helping homeless young adults make positive changes in their alcohol and condom use . Further work is needed to more fully evaluate the efficacy of AWARE on AOD behavior and sexual risk behavior outcomes Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers The number of published systematic review s of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions . Systematic review s are subject to a range of biases and increasingly include non-r and omised studies of interventions . It is important that users can distinguish high quality review s. Many instruments have been design ed to evaluate different aspects of review s , but there are few comprehensive critical appraisal instruments . AMSTAR was developed to evaluate systematic review s of r and omised trials . In this paper , we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic review s that include r and omised or non-r and omised studies of healthcare interventions , or both . With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic review s , including those based on non-r and omised studies of healthcare interventions PURPOSE We evaluate the efficacy of a short family intervention in reducing sexual risk behavior , drug use , and delinquent behaviors among homeless youth . METHODS A r and omized controlled trial of 151 families with a homeless adolescent aged 12 to 17 years . Between March 2006 and June 2009 , adolescents were recruited from diverse sites in Southern California and were assessed at recruitment ( baseline ) , and at 3 , 6 , and 12 months later . Families were r and omly assigned to an intervention condition with five weekly home-based intervention sessions or a control condition ( st and ard care ) . Main outcome measures reflect self-reported sexual risk behavior , substance use , and delinquent behaviors over the past 90 days . RESULTS Sexual risk behavior ( e.g. , mean number of partners ; p < .001 ) , alcohol use ( p = .003 ) , hard drug use ( p < .001 ) , and delinquent behaviors ( p = .001 ) decreased significantly more during 12 months in the intervention condition compared with the control condition . Marijuana use , however , significantly increased in the intervention condition compared with the control condition ( p < .001 ) . CONCLUSIONS An intervention to reengage families of homeless youth has significant benefits in reducing risk over 12 months BACKGROUND Although numerous interventions have been demonstrated to reduce targeted adolescent risk behaviors for brief periods , sustained behavior changes covering multiple risk behaviors have been elusive . OBJECTIVE To determine whether a parental monitoring intervention ( Informed Parents and Children Together [ ImPACT ] ) with and without boosters can further reduce adolescent truancy , substance abuse , and sexual risk behaviors and can alter related perceptions 24 months after intervention among youth who have all received an adolescent risk-reduction intervention , Focus on Kids ( FOK ) . DESIGN R and omized , controlled , 3-celled longitudinal trial . SETTING Thirty-five low-income , urban community sites . PARTICIPANTS Eight hundred seventeen African American youth aged 13 to 16 at baseline . Intervention All youth participated in FOK , an 8-session , theory-based , small group , face-to-face risk-reduction intervention , 496 youth and parents received the 1-session ImPACT intervention ( a videotape and discussion ) , 238 of the ImPACT youth also received four 90-minute FOK boosters delivered in small groups . MAIN OUTCOME MEASURES Responses at baseline and 24 months after intervention to a question naire assessing risk and protective behaviors and perceptions . Analyses used General Linear Modeling , intraclass correlation coefficient , analysis of covariance , and multiple comparisons with least significant difference test adjustment . RESULTS After adjusting for the intraclass correlation coefficient , 6 of 16 risk behaviors were significantly reduced ( P < or = .05 ) among youth receiving ImPACT compared with youth who only received FOK ( respectively , mean number of days suspended , 0.65 vs 1.17 ; carry a bat as a weapon , 4.1 % vs 9.6 % ; smoked cigarettes , 12.5 % vs 22.7 % ; used marijuana , 18.3 % vs 26.8 % ; used other illicit drugs , 1.4 % vs 5.6 % ; and , asked sexual partner if condom always used , 77.9 % vs 64.9 % ) . Four of the 7 theory-based subscales reflected significant protective changes among youth who received ImPACT . ImPACT did not produce any significant adverse effects on behaviors or perceptions . CONCLUSION A parent monitoring intervention can significantly broaden and sustain protection beyond that conferred through an adolescent risk-reduction intervention Outreach and service linkage are key for engaging marginalized population s , such as homeless youth , in services . Research to date has focused primarily on engaging individuals already receiving some services through emergency shelters , clinics , or other programs . Less is known about those who are not connected to services and , thus , likely the most vulnerable and in need of assistance . The current study sought to engage non-service-connected homeless youth ( N = 79 ) into a strengths-based outreach and advocacy intervention . Youth were r and omly assigned to receive 6 months of advocacy that focused on linking youth to a drop-in center ( n = 40 ) or to a crisis shelter ( n = 39 ) . All youth were assessed at baseline and 3 , 6 , and 9 months post-baseline . Findings indicated that youth prefer drop-in center services to the shelter . Also , the drop-in center linkage condition was associated with more service linkage overall ( B = 0.34 , SE = 0.04 , p < 0.01 ) and better alcohol-l [ B = −0.39 , SE = 0.09 , t(75 ) = −4.48 , p < 0.001 ] and HIV-related outcomes [ B = 0.62 , SE = 0.10 , t(78 ) = 6.34 , p < 0.001 ] compared to the shelter linkage condition . Findings highlight the importance of outreach and service linkage for reconnecting service-marginalized youth , and drop-in centers as a primary service option for homeless youth BACKGROUND AND OBJECTIVES : " Housing First " has been shown to improve housing stability in homeless individuals with mental illness , but had not been empirically tested in homeless youth . We aim ed to evaluate the effect of " Housing First " on housing stability in homeless youth aged 18 to 24 years participating in At Home/Chez Soi , a 24-month r and omized trial of " Housing First " in 5 Canadian cities . METHODS : Homeless individuals with mental illness were r and omized to receive " Housing First " ( combined with assertive community treatment or intensive case management depending on their level of need ) or treatment as usual . We defined our primary outcome , housing stability , as the percent of days stably housed as a proportion of days for which residence data were available . RESULTS : Of 2148 participants who completed baseline interviews and were r and omized , 7 % ( n = 156 ) were youth aged 18 to 24 years ; 87 received " Housing First " and 69 received treatment as usual . In an adjusted analysis , youth in " Housing First " were stably housed a mean of 437 of 645 ( 65 % ) days for which data were available compared with youth in treatment as usual , who were stably housed a mean of 189 of 582 ( 31 % ) days for which data were available , result ing in an adjusted mean difference of 34 % ( 95 % confidence interval , 24%–45 % ; P < .001 ) . CONCLUSIONS : " Housing First " was associated with improved housing stability in homeless youth with mental illness . Future research should explore whether adaptations of the model for youth yield additional improvements in housing stability and other outcomes While research on homeless adolescents and young adults evidencing substance use disorder is increasing , there is a dearth of information regarding effective interventions , and more research Output:	Housing first , a structural intervention , led to improvements in housing stability . Many interventions showed inconsistent results compared to services as usual or other interventions , but often led to improvements over time in both the intervention and comparison group . The equity analysis showed that equity variables were inconsistently measured , but there was data to suggest differential outcomes based upon gender and ethnicity . This review identified a variety of interventions for youth experiencing homelessness . Promising interventions include cognitive behavioural therapy for addressing depression , family-based therapy for substance use outcomes , and housing programs for housing stability .
MS21132	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Fifty premenopausal patients requiring hysterectomy as treatment for symptomatic uterine leiomyomas , which were the size of 14 to 18 weeks ' gestation , were r and omized into two groups to determine whether preoperative gonadotropin-releasing hormone agonist would increase the feasibility of vaginal rather than abdominal hysterectomy . The control group ( group A ; n = 25 ) did not receive preoperative gonadotropin-releasing hormone agonist , but patients in Group B ( n = 25 ) received 2 months of gonadotropin-releasing hormone agonist before undergoing hysterectomy . Patients in the two groups were similar with respect to age , gravidity , parity , pretreatment uterine size , and hemoglobin and hematocrit levels . Patients in group B had an increase in hemoglobin levels ( 10.75 to 12.12 gm/dl , p less than 0.05 ) and a decrease in uterine volume ( 1086.7 to 723.4 ml , p less than 0.05 ) after 8 weeks of agonist therapy and were more likely to undergo vaginal hysterectomy ( 76.0 % vs 16 % ) . Patients in group B also had shorter hospitalizations ( 5.2 vs 3.8 days , p less than 0.05 ) . We conclude that the administration of gonadotropin-releasing hormone agonist for 2 months followed by vaginal hysterectomy is preferable to abdominal hysterectomy in selected patients with uterine leiomyomas A. J. M. AUDEBERT , P. MADENELAT * , D. Q U E R L E U ? , G. P O N T O N N I E R ~ , C . R A C I N E T ~ , R.R E N A U D ~ , J.-Y. GILLET * * , D. R A U D R A N T ? ~ , J. LANSAC:~ , J.-P. B R E T T E ~ Cnbitiet Medical . Bordeaus : * Hdpital Bichat , Paris ; ? Centre Hospitalier , Roubai.r ; 1 Hdpital de la Grave , Toulouse ; $ Centre Hospiialier Sud , Ecliirolles : Hfipital Central , Strasbourg ; * * Hi?pital Saint Roch , Nice ; ttH6pital de I'Hdtel Dieu , Lyon ; : $ Hdpital de Tours , Tours ; and # Hipito1 Monwti . Brest . OBJECTIVE Our purpose was to examine the effects of RU 486 and leuprolide acetate on uterine artery blood flow and uterine volume . STUDY DESIGN Patients were r and omly assigned to group A ( eight patients ) receiving 25 mg of RU 486 daily for 3 months or group B ( six patients ) receiving 3.75 mg of leuprolide acetate monthly for 3 months . Uterine artery blood flow change was determined by resistive index by means of vaginal color Doppler ultrasonography . Uterine volume was measured before and during the study with abdominal ultrasonography . RESULTS Both groups showed an increase in resistive index . Patients receiving RU 486 had uterine artery blood flow decreased by 40 % , and those receiving leuprolide acetate had a 21 % decrease . We noted a significant decrease in uterine volume compared with pretreatment in both groups at 3 months . There was no significant decrease between groups . CONCLUSION Both RU 486 ( 25 mg daily ) and leuprolide acetate ( 3.75 mg monthly ) are effective in decreasing blood flow to the uterus ( increasing resistive index ) and decreasing uterine volume at 3 months . A significant decrease in uterine artery blood flow may provide a mechanism for the decrease in uterine size and the decrease in uterine blood loss at the time of surgery Summary . Twenty‐four women with symptomatic multiple uterine myomas were allocated r and omly to treatment with buserelin , 1200μg/day intranasally , for 3 months followed by myomectomy ( n = 8) or to immediate myomectomy ( n = 16 ) . Pre‐operative treatment with buserelin reduced the mean uterine volume from 432 ( SD 165 ) to 242 ( SD 82 ) ml ( P < 0.01 ) but intra‐operative blood loss and postoperative morbidity were not significantly less in this group . Six months after operation , pelvic examination was normal in all the patients . However , ultrasonography with transvaginal probe demonstrated the presence of myomas of < 1.5 cm in five women ( 63 % ) treated pre‐operatively with the analogue and in two women ( 13 % ) who underwent immediate surgery ( P < 0.05 ) . Induction of a period of hypo‐oestrogenism before myomectomy seems to favour short‐term recurrence of uterine myomas , limiting the efficacy of surgery OBJECTIVE Aims of our study were as follows : ( 1 ) to evaluate the therapeutic efficacy of the preoperative administration of a gonadotropin-releasing hormone analog before laparoscopic myomectomy and ( 2 ) to assess whether any ultrasonographic parameter of the fibroids ( number , size , Doppler velocimetry , or echogenicity ) was of prognostic value . STUDY DESIGN A prospect i ve r and omized study was performed on 67 patients with symptomatic uterine fibroids that were mainly intramural ; these patients were undergoing laparoscopic myomectomy . Patients were r and omized either to preoperative administration of two injections of a depot formulation of leuprolide acetate 28 days apart ( group A , n = 35 ) or to direct surgery ( group B , n = 32 ) . In each group we studied the number , volume , and echogenicity of the larger fibroids ; the resistance index of uterine arteries and of fibroid vessels ; hematologic parameters ; operative time ; and blood loss . RESULTS The two groups did not differ significantly in basal ultrasonographic parameters and hematologic data . Postoperatively , the red blood cell count and the serum hemoglobin and iron levels were significantly ( p < 0.05 ) lower in group B. Both blood loss ( p < 0.01 ) and operative time ( p < 0.05 ) were significantly lower in group A. However , the operative time was significantly longer when the main fibroid was markedly hypoechoic , probably because the increased softness of the tumor after leuprolide acetate pretreatment makes its enucleation much more cumbersome . CONCLUSION Our data confirm the therapeutic efficacy of preoperative administration of a gonadotropin-releasing hormone analog before laparoscopic myomectomy in reducing the blood loss and in decreasing the operative time . This preoperative course of leuprolide acetate in hypoechoic fibroids , because of the further reduction of the density of the myomas , causes a significant ( p < 0.05 ) increase in operative time Objective To investigate the effect of the gonadotrophin releasing hormone (GnRH)‐agonist goserelin , given by monthly subcutaneous injection for three months prior to total abdominal hysterectomy for uterine leiomyomata , on the pre‐operative symptoms , difficulty of operation and operative blood loss The present study was undertaken in order to evaluate the usefulness or otherwise of preoperative gonadotrophin-releasing hormone ( GnRH ) analogue treatment prior to laparoscopic myomectomy . From June 1993 through December 1996 , 60 premenopausal women aged between 25 and 42 years and with a sonographic diagnosis of intramural or subserous myomas were selected for laparoscopic myomectomy at the Department of Obstetrics and Gynaecology of the Catholic University of The Sacred Heart , Rome . According to a computer-generated sequence , 30 patients were su bmi tted to three cycles of GnRH analogue treatment prior to surgery , whereas no preoperative treatment was prescribed to the other 30 patients . Laparoscopic myomectomy was successfully performed in all patients for a total of 174 myomas excised laparoscopically . The patients ' mean age , the number of myomas per patient , the mean diameter of the myomas , parity and estimated blood loss were similar in both groups . The operative time was significantly longer in the group of patients su bmi tted to GnRH analogue treatment than that of the group of patients not su bmi tted to any preoperative medical therapy ( 157.5 + /- 74.71 versus 112.33 + /- 54.71 min ; P = 0.01 ) . No intra-operative complications occurred . In no case was blood transfusion necessary . Two patients developed post-operative fever ( temperature > 38 degrees C. ) . The mean length of hospital stay was 2.39 days and was similar in both groups . Thirteen spontaneous pregnancies occurred among 24 infertile patients ( 54.1 % ) . The pregnancy rate for these patients was similar in both groups . The viable term delivery rate was 45.8 % . The authors conclude that laparoscopic myomectomy is a feasible and safe procedure . The post-operative pregnancy rate for infertile patients is similar to that following laparotomic myomectomy . The present study suggests that preoperative GnRH analogue treatment does not offer any significant advantages for laparoscopic myomectomy Objective . To investigate the usefulness of a routine short term treatment with gonadotropin releasing hormone agonist ( D‐Trp‐6‐LHRH depot ) before abdominal hysterectomy for leiomyoma The recurrence of myomas and myoma-related symptoms was evaluated in women participating in a r and omized , double-blind , P-controlled study of the efficacy of LA depot before myomectomy . After 27 to 38 months of follow-up , the recurrence of myomas was found to be greater when at least four myomas were resected . Myoma recurrence was not associated with pretreatment or preoperative uterine volume , resected myoma mass , or preoperative medical therapy To determine whether pre-operative treatment with gonadotrophin-releasing hormone ( GnRH ) analogue may have a beneficial effect on surgery outcome , 53 patients with symptomatic fibroid uteri awaiting myomectomy or transabdominal hysterectomy ( TAH ) , were r and omly divided into a study group ( n = 29 ) and a control group ( n = 24 ) . The study group of patients were treated by an i.m . injection of D-Trp6 LHRH microcapsules at 2 months and 1 month prior to surgery . The control group had no pre-operative treatment . Haemoglobin concentration and oestradiol , follicle-stimulating hormone and luteinizing hormone concentrations were measured at 2 months and 1 month prior to surgery , and at surgery . The duration of surgery was shorter in the study group ( 49 versus 70 min in the hysterectomy group ) and intra-operative blood loss was less ( 208 versus 309 ml in the hysterectomies and 320 versus 476 ml in the myomectomies ) . Pre-operative treatment with GnRH-agonists which induces shrinkage of the uterus and fibroids is therefore efficient in shortening the duration of surgery , and diminishing the intra-operative blood loss in surgery for fibroid uteri . Such pre-operative treatment is therefore a useful addition to surgery in cases with symptomatic fibroid uteri OBJECTIVE To compare the effects of goserelin acetate treatment with or without iron with iron alone . DESIGN Multinational , multicenter , prospect i ve , r and omized , double-blind study . PATIENTS Premenopausal women with menorrhagia or metrorrhagia and anemia associated with uterine leiomyomata awaiting hysterectomy . INTERVENTION Patients were r and omized to one of three 12-week treatment groups namely goserelin acetate 3.6 mg once monthly plus placebo iron ; 3.6 mg goserelin acetate once monthly plus 600 mg/d iron ; or sham injection once monthly plus 600 mg/d iron . MAIN OUTCOME MEASURE Preoperative hemoglobin concentration ; preoperative uterine and fibroid volumes and operative blood loss . RESULTS Considering the entry and preoperative hemoglobin concentrations , there was a difference in least square means of just over 1 g/dL between the goserelin acetate plus iron and iron only groups and 2.6 g/dL between the goserelin acetate plus iron and goserelin acetate only group . These differences were both statistically significant . Uterine and fibroid volumes were decreased in the goserelin acetate-treated patients by between 37 % and 40 % and 44 % and 47 % , respectively , compared with 7 % decreases for both in the iron only group . The differences in absolute changes were statistically significant for both the goserelin acetate-treated groups versus the iron-treated group . The least square geometric mean operative blood loss was greatest in the iron only group . CONCLUSION In the patient with uterine leiomyomata and anemia , goserelin acetate in combination with iron therapy has shown significant advantages over the iron alone in restoring hematologic normality , decreasing uterine and fibroid volumes , and reducing operative blood loss Objective To determine the effectiveness of leuprolide acetate depot plus iron compared with iron alone in the preoperative treatment of anemia Output:	MAIN RESULTS Pre- and post-operative haemoglobin ( Hb ) and haematocrit ( HCT ) were significantly improved by GnRH analogue therapy prior to surgery , and uterine volume , uterine gestational size and fibroid volume were all reduced . Pelvic symptoms were also reduced but some adverse events were more likely during GnRH analogue therapy . Hysterectomy appeared to be easier after pre-treatment with GnRH analogue therapy ; there was reduced operating time and a greater proportion of hysterectomy patients were able to have a vaginal rather than an abdominal procedure . Duration of hospital stay was also reduced . Blood loss and rate of vertical incisions were reduced for both myomectomy and hysterectomy . Evidence of increased risk of fibroid recurrence after GnRH analogue pre-treatment in myomectomy patients was equivocal and few data were available to assess change in post-operative fertility . Lynestrenol did not offer any advantage over GnRH analogue therapy before fibroid surgery . REVIEW ER 'S CONCLUSIONS The use of GnRH analogues for 3 to 4 months prior to fibroid surgery reduce both uterine volume and fibroid size . They are beneficial in the correction of pre-operative iron deficiency anaemia , if present , and reduce intra-operative blood loss . If uterine size is such that a mid-line incision is planned , this can be avoided in many women with the use of GnRH analogues . For patients undergoing hysterectomy , a vaginal procedure is more likely following the use of these agents
MS21133	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIM To evaluate associations between glycaemic control and periodontitis progression among Gullah African Americans with type-2 diabetes mellitus ( T2DM ) . MATERIAL S AND METHODS From an ongoing clinical trial among T2DM Gullah , we extracted a cohort previously in a cross-sectional study ( N=88 ) . Time from baseline ( previous study ) to follow-up ( trial enrollment , before treatment interventions ) ranged 1.93 - 4.08 years [ mean=2.99 , st and ard deviation (SD)=0.36 ] . We evaluated tooth site-level periodontitis progression [ clinical attachment loss ( CAL ) worsening of > or = 2 mm , periodontal probing depth ( PPD ) increases of > or = 2 mm and bleeding on probing ( BOP ) from none to present ] by glycaemic control status ( well-controlled = HbA(1c)<7 % , poorly-controlled = HbA(1c ) > or = 7 % ) using multivariable generalized estimating equations logistic regression , nesting tooth sites/person . RESULTS Poorly-controlled T2DM ( 68.18 % ) was more prevalent than well-controlled T2DM ( 31.82 % ) . Proportions of tooth sites/person with CAL progression between baseline and follow-up ranged 0.00 - 0.59 ( mean=0.12 , SD=0.12 ) , while PPD and BOP progression ranged 0.00 - 0.44 ( mean=0.09 , SD=0.11 ) and 0.00 - 0.96 ( mean=0.24 , SD=0.18 ) , respectively . Site-level PPD at baseline was a significant effect modifier of associations between poorly-controlled T2DM and site-level CAL and PPD progression [ adjusted odds ratios ( OR ) according to poorly-controlled T2DM among PPD at baseline=3 , 5 and 7 mm , respectively : CAL progression=1.93 , 2.64 , and 3.62 , PPD progression=1.98 , 2.76 , and 3.84 ; p<0.05 for all ] . Odds of site-level BOP progression were increased ( OR=1.24 ) for poorly-controlled T2DM , yet the results were not significant ( p=0.32 ) . CONCLUSIONS These findings from a distinct , homogenous population further support the clinical relevance of identifying patients with poor glycaemic control and periodontitis , particularly among those with disparities for both diseases AIM To evaluate the clinical , microbiological and immunological effects of systemic doxycycline as an adjunct to scaling and root planing ( SRP ) in chronic periodontitis patients with well-controlled type 2 diabetes . MATERIAL S AND METHODS Sixty-six patients compliant to oral hygiene ( Hygiene Index < 20 % ) allocated to either a test ( systemic doxycycline for 21 days ) or a control ( placebo ) group participated in the present r and omized controlled trial ( RCT ) . Clinical assessment s were recorded at baseline , 3 and 6 months after therapy and included clinical attachment level ( CAL ) , set as the primary outcome of the study , probing pocket depth ( PPD ) , recession ( RE ) and bleeding on probing ( BOP ) . At the same time points , counts of 15 subgingival species were evaluated by " checkerboard " DNA-DNA hybridization , gingival crevicular fluid sample s were analysed for matrix metalloproteinase-8 ( MMP-8 ) by ELISA and HbA1c levels were determined . Comparisons between and within groups were performed by non-parametric tests ( Mann-Whitney , Wilcoxon signed-ranks and z-test for proportions with Bonferroni corrections ) at the 0.05 level . RESULTS No major differences were noticed in clinical and microbiological parameters of periodontal disease or levels of MMP-8 between the two groups . CONCLUSIONS Adjunctive systemic doxycycline does not seem to significantly enhance the effects of SRP in well-controlled diabetes type 2 patients Purpose The purpose of study was to compare glycemic control using glycated hemoglobin levels ( HbA1c ) in diabetic patients with chronic generalized periodontitis ( CGP ) undergoing scaling and root planing ( SRP ) with and without systemic doxycycline . Methods Fifty subjects with type 2 diabetes mellitus ( T2DM ) and CGP receiving antidiabetic therapy were selected for study . The selected subjects were r and omly assigned to two groups ( test group [ TG ] and control group [ CG ] ) comprising 25 patients each . The TG received SRP followed by systemic doxycycline . The CG received treatment with SRP only . The periodontal parameters were recorded at baseline ( day zero ) , and every 1 month for 4 months and included probing depth , clinical attachment level , plaque index , gingival index , and HbA1c level were recorded at baseline ( day zero ) and at the end of 4 months . Results A statistically significant effect was demonstrated for the periodontal parameters for both the TG and CG . HbA1c values did not show a statistically significant difference in the treatment group as compared to the CG . Conclusions The authors concluded that nonsurgical periodontal therapy improved glycemic control in patients with T2DM in both groups , but no statistical difference was observed with adjunctive systemic doxycycline therapy . A further study with a larger sample size is required Current evidence suggests that periodontal infection may aggravate diabetes control . The aim of this study was to determine the changes in the frequency with which Porphyromonas gingivalis , Tannerella forsythia , Treponema denticola and Aggregatibacter actinomycetemcomitans were detected in patients with diabetes with the use of non-surgical therapy plus azithromycin in a r and omized clinical trial . One hundred and five ( 105 ) patients with diabetes and chronic periodontitis were r and omly assigned to three treatment groups : subgingival mechanical therapy with azithromycin , subgingival mechanical therapy with placebo and supragingival prophylaxis with azithromycin . Complete periodontal clinical examinations and detection of periodontal pathogens using polymerase chain reaction were carried out at baseline , 3 , 6 and 9 months after periodontal therapy . The frequency with which Porphyromonas gingivalis , Treponemadenticola and Aggregatibacter actinomycetemcomitans were detected decreased at 3 months in all groups . Tannerella forsythia increased after3 months in all groups . All organisms had similar frequencies at 9 months in all groups . Subgingival mechanical therapy with adjunctive azithromycin had no additional effect on the frequency with which the periodontal pathogens investigated were detected in patients with diabetes AIM Diabetic patients have more severe periodontal destruction , but periodontal therapy can improve metabolic control . Recently , interest has focused on the use of subantimicrobial dose doxycycline ( SDD ) as a treatment paradigm . Therefore , this study was undertaken to evaluate clinical efficacy of SDD with scaling and root planning ( SRP ) in chronic periodontitis patients with diabetes . METHODS AND MATERIAL S Twenty chronic periodontitis patients with diabetes mellitus were r and omly allocated to either a test and a control group . Clinical measurements were recorded at baseline and at six months for probing pocket depth ( PPD ) , clinical attachment level ( CAL ) , and gingival recession ( GR ) . After SRP , patients in the test group were instructed to take SDD 20-mg capsules twice a day while patients in the control group took a placebo twice a day . Both groups were on this regimen for a six-month period . RESULTS A greater reduction in mean PPD was demonstrated in patients in the test group compared to the control group . The mean CAL increase observed in the test group was significantly greater ( 0.67 mm ) than that in the control group . CONCLUSION It can be concluded that SRP , in conjunction with the SDD therapy described , is more effective then SRP alone in terms of CAL gain and PPD reduction in diabetic patients with severe periodontal disease . CLINICAL SIGNIFICANCE Given the widespread prevalence of both chronic periodontitis and diabetes , the proposed treatment approach will prove to be of great value and contribute significantly to the overall health of the patients Objectives : To evaluate the effects of systemic doxycycline on clinical and microbiological parameters of diabetic subjects with chronic periodontitis . Methods : This 9-month multi-center , r and omized , parallel , single-blinded study was conducted from different hospitals in Riyadh , Saudi Arabia between April 2010 and December 2010 . A total of 76 diabetic subjects with chronic periodontitis were r and omized into 2 groups : control group ( CG ) received only scaling and root planing ( SRP ) , and the treatment group ( TG ) receiving systemic doxycycline during the reevaluation visit 45 days after the completion of SRP . Probing pocket depth , clinical attachment level , gingival index , plaque index , and bleeding on probing were collected at baseline , 45 days after SRP , and one , 3 , and 6 months after the use of systemic doxycycline . Microbiological analysis comprised the detection of Tannerella forsythia ( Tf ) , Aggregatibacter actinomycetemcomitans ( Aa ) , Porphyromonas gingivalis ( Pg ) , and Prevotella intermedia ( Pi ) by polymerase chain reaction method . Results : Sixty-eight ( 33 CG and 35 TG ) subjects completed the study . Greater reduction in the population of Tf , Pg , and Pi were observed in TG compared with CG in the first month after the administration of systemic doxycycline . The TG showed a significant improvement in gingival index scores compared with the CG ( p<0.05 ) by the end of the first and 6 months after the administration of doxycycline . Conclusion : Adjunct systemic doxycycline can be associated with a reduction of Tf , Pg , and Pi in the first month after the administration of doxycycline with an improvement in the GI OBJECTIVE To investigate the effectiveness of short-term adjunctive subantimicrobial dose doxycycline ( SDD ) treatment in patients with diabetes mellitus type 2 and chronic periodontitis ( CP ) . METHODS Thirty-four patients with CP and type 2 diabetes mellitus were included in the placebo-controlled , double-blind study . After scaling and root planing ( SRP ) , patients were r and omly assigned to two groups , receiving either SDD or placebo bid for 3 months . The probing depth ( PD ) , clinical attachment level ( CAL ) , bleeding on probing ( BOP ) , approximal plaque index , glycated hemoglobin ( HbA1c ) level were recorded and gingival crevicular fluid ( GCF ) sample s were collected at baseline and after 3-month therapy for the estimation of matrix metalloproteinase-8 levels . RESULTS Clinical attachment level , PD , and BOP improved significantly in both groups after therapy ( P < 0.05 ) . The statistically significant difference between the two groups after the therapy was observed only in PD in tooth sites with initial PD ≥ 4 mm ( SRP + placebo : 3.41 ± 0.6 mm vs SRP + SDD : 2.92 ± 0.5 mm , P < 0.05 ) . GCF matrix metalloproteinase-8 levels were significantly reduced only in SRP + SDD group ( P < 0.01 ) . There were no changes in HbA1c levels after therapy . CONCLUSION The short-term administration of SDD gives significant benefit at tooth sites with moderate disease ( PD ≥ 4 mm ) when compared to SRP alone in patients with diabetes and CP Periodontal disease is a common infection-induced inflammatory disease among individuals suffering from diabetes mellitus . The purpose of this study was to assess the effects of treatment of periodontal disease on the level of metabolic control of diabetes . A total of 113 Native Americans ( 81 females and 32 males ) suffering from periodontal disease and non-insulin dependent diabetes mellitus ( NIDDM ) were r and omized into 5 treatment groups . Periodontal treatment included ultrasonic scaling and curettage combined with one of the following antimicrobial regimens : 1 ) topical water and systemic doxycycline , 100 mg for 2 weeks ; 2 ) topical 0.12 % chlorhexidine ( CHX ) and systemic doxycycline , 100 mg for 2 weeks ; 3 ) topical povidone-iodine and systemic doxycycline , 100 mg for 2 weeks ; 4 ) topical 0.12 % CHX and placebo ; and 5 ) topical water and placebo ( control group ) . Assessment s were performed prior to and at 3 and 6 months after treatment and included probing depth ( PD ) , clinical attachment level ( CAL ) , detection of Porphyromonas gingivalis in subgingival plaque and determination of serum glucose and glycated hemoglobin ( HbA1c ) . After treatment all study groups showed clinical and microbial improvement . The doxycycline-treated groups showed the greatest reduction in probing depth and subgingival Porphyromonas gingivalis compared to the control group . In addition , all 3 groups receiving systemic doxycycline showed , at 3 months , significant reductions ( P < or = 0.04 ) in mean HbA1c reaching nearly 10 % from the pretreatment value . Effective treatment of periodontal infection and reduction of periodontal inflammation is Output:	The results of the meta-analyses presented a modest additional benefit of 0.14 mm ( 95 % confidence interval : 0.08 - 0.20 ) in reducing PPD but no further benefit in CAL gain . CONCLUSION When the data for all antibiotic protocol s were considered together for the treatment of periodontitis patients with DM , a significant , albeit small , reduction of PPD and no improvement in CAL gain was observed . When the antibiotic protocol s were analysed separately , the combination of amoxicillin plus metronidazole yielded the best results for PPD
MS21134	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : This study examined the role of demographic characteristics , psychological factors , and family functioning on attendance in a r and omized controlled trial of a family-based pediatric obesity program . Method : Participants included 155 children between the ages of 4 and 7 years ( M age = 5.77 , 57.4 % female , 73.6 % black , M body mass index = 25.5 ) and their primary caregivers who were r and omized to the treatment group . Three groups of participants were created based on their patterns of attendance during the program : ( 1 ) noncompleters , ( 2 ) partial completers , and ( 3 ) completers . Results : Results indicated no differences among the attendance groups in child gender , child body mass index , or child psychological functioning . Significant group differences were found with respect to race/ethnicity , parent marital status , and family income , such that noncompleters were more likely to be racial/ethnic minorities , to living in single parent households , and to have lower incomes than partial completers and completers . After controlling for the effects of these sociodemographic risk factors , noncompleters , and partial completers reported more family dysfunction characterized by high levels of disengagement than completers . Conclusion : Adapting existing weight management programs to include a focus on family engagement in the early stages of treatment may help to improve participation in family-based obesity interventions targeting high risk , socioeconomically disadvantaged youth Background When implemented at scale , the impact on health and health inequalities of public health interventions depends on who receives them in addition to intervention effectiveness . Methods The MEND 7–13 ( Mind , Exercise , Nutrition … Do it ! ) programme is a family-based weight management intervention for childhood overweight and obesity implemented at scale in the community . We compare the characteristics of children referred to the MEND programme ( N=18 289 referred to 1940 programmes ) with those of the population eligible for the intervention , and assess what predicts completion of the intervention . Results Compared to the MEND-eligible population , proportionally more children who started MEND were : obese rather than overweight excluding obese ; girls ; Asian ; from families with a lone parent ; living in less favourable socioeconomic circumstances ; and living in urban rather than rural or suburban areas . Having started the programme , children were relatively less likely to complete it if they : reported ‘ abnormal ’ compared to ‘ normal ’ levels of psychological distress ; were boys ; were from lone parent families ; lived in less favourable socioeconomic circumstances ; and had participated in a relatively large MEND programme group ; or where managers had run more programmes . Conclusions The provision and /or uptake of MEND did not appear to compromise and , if anything , promoted participation of those from disadvantaged circumstances and ethnic minority groups . However , this tendency was diminished because programme completion was less likely for those living in less favourable socioeconomic circumstances . Further research should explore how completion rates of this intervention could be improved for particular groups General Practitioners ( GPs ) have an important role to play in recognition of and intervention against childhood obesity in Irel and . Data were collected prospect ively on a cohort of children aged 4 - 14 and their parents ( n = 101 pairs ) who attended consecutively to a semi-rural group general practice . Parents estimated their child 's weight status . Actual weight status was determined for both parent and child using the United States Centres ' for Disease Control 's BMI -for-age references . 15 ( 14.9 % ) of the children and 49 ( 51.6 % ) of the parents were overweight or obese . While 71 ( 95.5 % ) of normal weight status children were correctly identified , parents showed poor concordance in identifying their children as overweight 2 ( 18.2 % ) or obese 0 ( 0 % ) . BMI was only evidently recorded in the clinical records of 1 out of 15 cases of overweight children identified . With parents failing to recognise childhood obesity , GPs have a responsibility in tackling this problem at a family level BACKGROUND The primary care setting offers the opportunity to reach children and parents to encourage healthy lifestyle behaviours , and improve weight status among children . OBJECTIVE Test the feasibility of Helping H AND ( Healthy Activity and Nutrition Directions ) , an obesity intervention for 5- to 8-year-old children in primary care clinics . METHODS A r and omized controlled pilot study of Helping H AND , a 6-month intervention , targeted children with body mass index 85 - 99%tile and their parents . Intervention group attended monthly sessions and self-selected child behaviours and parenting practice s to change . Control group received regular paediatric care and was wait-listed for Helping H AND . Session completion , participant satisfaction , child anthropometrics , dietary intake , physical activity , TV viewing and behaviour-specific parenting practice s were measured pre and post intervention . RESULTS Forty parent-child dyads enrolled : 82.5 % were Hispanic , 80 % had a girl and 65 % reported income ≤ $ 30 , 000/year . There was 20 % attrition from Helping H AND ( attended < 4/6 sessions ) . Families self-selected 4.35 ( SD 1.75 ) behaviours to target during the 6-month programme and each of the seven behaviours was selected by 45 - 80 % of the families . There were no between group differences in the child 's body mass index z-score , dietary intake or physical activity post intervention . Intervention group viewed 14.9 ( SE 2.3 ) h/week of TV post intervention versus control group 23.3 ( SE 2.4 ) h/week ( P < 0.05 ) . CONCLUSION Helping H AND is feasible , due to low attrition , good programme attendance , and clinical ly relevant improvements in some child and parenting behaviours OBJECTIVE To explore factors influencing participation and attrition in a family-led weight-management programme for obese Pacific children . DESIGN Qualitative study used bilingual in-depth interviews at exit and end of an 8-week weight-management programme . SETTING New Zeal and . SUBJECTS Forty-two parents/ primary caregivers of obese children who were r and omised in the intervention weight-management programme . RESULTS Programmatic factors that enhanced retention included : simultaneous delivery to both children and parents as participants ; delivery of the programme in small group setting s at local community venues ; enabling trustworthy and accountable relationships ; providing re sources for travel to venues and regular telephone/text messaging follow-up calls reinforcing programme goals ; and day and time scheduling . Suggested programme improvements included having ethnic-specific Isl and - language delivery and practical sessions like cooking classes and shopping expeditions at local food stores . The research found that unpredictable external life crises like extended family deaths , a change in job shift , family illnesses ( both acute and those requiring chronic management ) and long-term family visitations affected participation and momentum . A loss of momentum through managing life crises was often difficult to overcome for participants , leading them to drop out of the weight-management programme . Most drop-out participants preferred to defer their programme participation with hopes of re-committing to future programmes at another time . CONCLUSIONS In order for weight-management programmes to be effective , participants must be able to complete them . Identifying factors that predict participation and attrition may serve as a basis for programme improvement OBJECTIVE The purpose of the current study is to describe the development , implementation , and success of recruitment and adherence strategies of 303 African American preadolescent girls and their primary caregiver in the Girls health Enrichment Multi-site Studies ( GEMS ) program . METHODS A socio-ecologic model was used to guide selection and implementation of recruitment and retention strategies which were continuously monitored and revised in response . Strategy mode and frequency associated with program enrollment , engagement , and retention were analyzed . RESULTS Successful recruitment approaches included radio messages ( 23.1 % ) , school fliers ( 20.1 % ) , and friend referral ( 15 % ) . Initially 463 potential participants responded , 320 girls were screened , and 303 enrolled . Significant increases in participant accrual were observed between Wave 4 ( n=28 ) and Wave 5 ( n=91 ) after using a team recruitment approach . Implementing case management strategies and providing make-up sessions also served to keep participants current and engaged in the program . In year 2 , community field trips replaced the more structured sessions providing participants with experiential learning opportunities . Overall intervention attendance rates ranged from 79.7 % to 90.5 % among waves . Further , 75.9 % and 80.2 % , respectively , of participants attended 1-year and 2-year follow-ups . CONCLUSION Multiple recruitment strategies and flexible , responsive approaches to recruitment and retention guided by the socio-ecologic model facilitated optimal implementation of an intervention for preadolescent girls . Through the application of the socio-ecologic model research ers and program leaders will be able to identify strategies to enhance the probability of successful outcomes Output:	Results suggest that parents provided the impetus for programme initiation , and this was driven largely by a concern for their child 's psychological health and wellbeing . More often than not , children went along without any real reason or interest in attending . Over the course of the programme , however , children 's positive social experiences such as having fun and making friends fostered the desire to continue .
MS21135	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: IMPORTANCE Chronic periodontitis , a destructive inflammatory disorder of the supporting structures of the teeth , is prevalent in patients with diabetes . Limited evidence suggests that periodontal therapy may improve glycemic control . OBJECTIVE To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin ( HbA1c ) in persons with type 2 diabetes and moderate to advanced chronic periodontitis . DESIGN , SETTING , AND PARTICIPANTS The Diabetes and Periodontal Therapy Trial ( DPTT ) , a 6-month , single-masked , multicenter , r and omized clinical trial . Participants had type 2 diabetes , were taking stable doses of medications , had HbA1c levels between 7 % and less than 9 % , and untreated chronic periodontitis . Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers . INTERVENTIONS The treatment group ( n = 257 ) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months . The control group ( n = 257 ) received no treatment for 6 months . MAIN OUTCOMES AND MEASURES Difference in change in HbA1c level from baseline between groups at 6 months . Secondary outcomes included changes in probing pocket depths , clinical attachment loss , bleeding on probing , gingival index , fasting glucose level , and Homeostasis Model Assessment ( HOMA2 ) score . RESULTS Enrollment was stopped early because of futility . At 6 months , mean HbA1c levels in the periodontal therapy group increased 0.17 % ( SD , 1.0 ) , compared with 0.11 % ( SD , 1.0 ) in the control group , with no significant difference between groups based on a linear regression model adjusting for clinical site ( mean difference , -0.05 % [ 95 % CI , -0.23 % to 0.12 % ] ; P = .55 ) . Periodontal measures improved in the treatment group compared with the control group at 6 months , with adjusted between-group differences of 0.28 mm ( 95 % CI , 0.18 to 0.37 ) for probing depth , 0.25 mm ( 95 % CI , 0.14 to 0.36 ) for clinical attachment loss , 13.1 % ( 95 % CI , 8.1 % to 18.1 % ) for bleeding on probing , and 0.27 ( 95 % CI , 0.17 to 0.37 ) for gingival index ( P < .001 for all ) . CONCLUSIONS AND RELEVANCE Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis . These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00997178 Abstract s on this page have been chosen and edited by Dr Trevor Watts Abstract Periodontal treatment improved periodontal health but did not affect glycaemic control AIMS : The purpose of this study is to investigate the effect of improved periodontal health on glycemic control in type 2 diabetes mellitus ( type 2 DM ) patients who have generalized periodontitis . MATERIAL S AND METHODS : A total of 45 type 2 DM patients with generalized periodontitis were selected for the study . The selected patients were r and omly assigned to three groups ( groups A , B , and C ) comprising 15 patients each : • Group A received treatment with scaling and root planing only . • Group B received treatment with scaling and root planing followed by systemic doxycycline . • Group C received no treatment ( control group ) . The periodontal parameters recorded included plaque index , gingival index , probing pocket depth , and clinical attachment level . These parameters were recorded at baseline ( day zero ) , at 1 month , and at the end of 3 months . The following metabolic parameters were recorded : fasting blood glucose ( FBG ) , postpr and ial blood glucose ( PPBG ) , and glycated hemoglobin . These were recorded at baseline ( day zero ) and at the end of 3 months . STATISTICAL ANALYSIS : All the parameters were subjected to repeated- measures ANOVA and Scheffe 's post hoc test . RESULTS : A statistically significant effect could be demonstrated for periodontal parameters for both group A and group B ( treatment groups ) . Glycated hemoglobin values showed statistically significant decrease in treatment groups compared to the control group , with group B showing more significant decrease than group A. CONCLUSIONS : The results of this study showed that nonsurgical periodontal treatment is associated with improved glycemic control in type 2 DM patients BACKGROUND , AIMS This study was design ed to explore the effect of periodontal therapy on glycemic control in persons with type 2 diabetes mellitus ( DM ) . METHODS 36 patients with type 2 DM ( treatment group ) received therapy for adult periodontitis during an 18-month period . A 36-person control group was r and omly selected from the same population of persons with type 2 DM who did not receive periodontal treatment . RESULTS These groups were well matched for most of the parameters investigated . During the nine-month observation period , there was a 6.7 % improvement in glycemic control in the control group when compared to a 17.1 % improvement in the treatment group , a statistically significant difference . Several parameters that could confound or moderate this glycemic control were explored . These included the treatment of non-dental infections , weight and medication changes . No moderating effect was associated with any of these variables . However , there were too few subjects in the study to have the statistical power necessary to assess these possible moderators of glycemic control . CONCLUSIONS We interpret the data in the study to suggest that periodontal therapy was associated with improved glycemic control in persons with type 2 DM AIM the purpose of the present study was to assess the effect of non-surgical periodontal therapy on glycaemic control of type 2 diabetes patients with moderate-to-severe periodontitis . MATERIAL S AND METHODS this was a r and omized , controlled clinical trial of patients with type 2 diabetes . A total of 60 patients with moderate-to-severe periodontal disease were assigned to either a periodontal treatment arm , consisting of scaling and root planing ( intervention group [ IG ] ) , or a delayed treatment arm that received periodontal care after 6 months ( control group [ CG ] ) . Periodontal parameters and glycosylated haemoglobin ( A1C ) were evaluated at 1 , 3 and 6 months . RESULTS all periodontal parameters improved significantly in the IG . A1C levels decreased statistically significantly more in the IG versus the CG ( 0.72%versus 0.13 % ; p<0.01 ) independently of other confounders . CONCLUSIONS this study provides evidence that periodontal treatment contributes to improved glycaemic control in type 2 diabetes mellitus patients . Larger controlled trials are needed to confirm if this finding is generalizable to other population s of patients with type 2 diabetes UNLABELLED The AIM of this study was to evaluate the effect of non-surgical therapy on clinical variables and glycemic control on type 2 diabetics with chronic periodontitis . PATIENTS AND METHODS Forty six type 2 diabetics with chronic periodontitis were r and omized into two groups ( group A and group B ) . Treatment included scaling and root planning for group A plus systematic use of doxycycline in both groups . Assessment was made prior to and 16 weeks following the therapy . RESULTS Analysis of data showed that both groups had clinical and glycated hemoglobin ( HbAlc ) improvement after the treatment . Group A had a statistically significant reduction of plaque index and bleeding on probing scores compared with controls ( P < 0.05 ) at 16 weeks . CONCLUSION These results suggest that non-surgical therapy is of value in maintaining periodontal health and may be beneficial in reducing blood glucose level in type 2 diabetics with chronic periodontitis OBJECTIVES Report results of a r and omized- clinical trial of the efficacy of periodontal care in the improvement of glycemic control in 165 veterans with poorly controlled diabetes over 4 months . METHODS Outcomes were change in Haemoglobin A1c ( HbA1c ) in the Early Treatment versus untreated ( Usual Care ) groups and percent of participants with decreases in HbA1c . Analyses included simple/multiple variable linear/logistic regressions , adjusted for baseline HbA1c , age , and duration of diabetes . RESULTS Unadjusted analyses showed no differences between groups . After adjustment for baseline HbA1c , age , and diabetes duration , the mean absolute HbA1c change in the Early Treatment group was -0.65 % versus -0.51 % in the Usual Care group ( p=0.47 ) . Adjusted odds for improvement by 0.5 % in the Early Treatment group was 1.67 ( 95 % confidence interval : 0.84 , 3.34 , p=0.14 ) . Usual Care subjects were twice as likely to increase insulin from baseline to 4 months ( 20 % versus 11 % , p=0.12 ) and less likely to decrease insulin ( 1 % versus 6 % , p=0.21 ) than Early Treatment subjects . Among insulin users at baseline , more increased insulin in the Usual Care group ( 40 % versus 21 % , p=0.06 ) . CONCLUSIONS No significant benefit was found for periodontal therapy after 4 months in this study ; trends in some results were in favour of periodontal treatment Output:	We can conclude that there is a significant effect of periodontal treatment on improvement of HbA1c in diabetes patients , although the effect size is extremely small .
MS21136	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To evaluate urethral catheter ( UC ) versus suprapubic tube ( SPT ) without stenting the anastomosis at robot-assisted radical prostatectomy ( RALP ) regarding surgical outcome and catheter-associated discomfort . One year after surgery , continence and patient satisfaction were evaluated . Material s and methods Sixty-two patients undergoing RALP were prospect ively r and omized to urinary drainage with UC or with SPT . Functional results were assessed with st and ardized question naires ( IPSS , IPSS Bother Score , IIEF and Visual Analogue Scale ) preoperatively , after catheter removal and 1 year after surgery . Moreover , bother by the catheter as well as pain due to the catheter was assessed . Results At personal hygiene , SPT was significantly less bothersome on the day of surgery as well as POD 1–6 . Pain caused by the catheter did not differ significantly between the two groups except for POD 5 and 6 , when the SPT performed significantly better . Differences regarding voiding parameters after catheter removal did not reach statistical significance . One year after surgery , no significant difference between the two groups was found regarding urinary function and IPSS . Though not statistically significant either , the need for the incision of bladder neck contracture ( BNC ) in two patients in the UC group is of note , as in the SPT group , no BNC occurred . Conclusion Draining the bladder with SPT only is a feasible option in patients undergoing RALP . Patients with SPT are significantly less bothered by the catheter at personal and genital hygiene compared to UC . The risk of BNC seems to be reduced in the SPT group BACKGROUND Robot-assisted radical prostatectomy ( RARP ) is a widespread option for the treatment of patients with clinical ly localised prostate cancer . Modifications in the surgical technique may help to further improve functional outcomes . OBJECTIVE To assess the outcome of early catheter removal 48h after surgery , as opposed to st and ard catheter removal 6 d after surgery following RARP , using a newly developed surgical technique for posterior reconstruction and anastomosis ( Aalst technique ) . DESIGN , SETTING , AND PARTICIPANTS Patients scheduled for RARP were prospect ively scheduled for early catheter removal at postoperative d 2 ( group A , n=37 ) and st and ard catheter removal at postoperative d 6 ( group B , n=37 ) . SURGICAL PROCEDURE RARP was performed using the Da Vinci Si system . The Aalst technique for the urethro-vesical anastomosis including posterior reconstruction was used as previously described . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary endpoint was spontaneous voiding after catheter removal . Secondary endpoints were rate of anastomotic urinary leakage after catheter removal , presence and severity of urethral , perineal , and abdominal pain , as well as patient 's bother after catheter removal using visual analogue scale ( VAS ) scores . Rate and severity of urinary incontinence after catheter removal were assessed using the International Consultation on Incontinence Question naire-Male Lower Urinary Tract Symptoms Module ( ICIQ-MLUTS ) question naire . RESULTS AND LIMITATIONS There was no significant difference between the groups with regard to baseline and perioperative parameters , as well as pathological features ; however , significantly more patients underwent bilateral nerve-sparing procedures in group A ( 34 vs 23 , p=0.008 ) . After catheter removal , patients in both groups showed spontaneous voiding , whereas only 11 % and 8 % of the patients in group A and group B experienced urinary retention after catheter removal ( p=0.7 ) . Patients in group B had significantly higher maximum flow rates , but lower voided volumes after catheter removal in comparison with patients in group A ( 21ml/s vs 10ml/s , p≤0.001 and 170ml vs 200ml , p≤0.001 , respectively ) . ICIQ-MLUTS question naire and VAS scores showed no significant differences between the groups at any time point . CONCLUSIONS The Aalst technique allows the removal of catheters 2 d after RARP and results in spontaneous voiding . Early removal showed no increased rate of urinary leakage , no negative impact on short-term continence and on perineal , urethral or penile pain , and no increase in urinary retention rates . Future studies have to confirm these results with longer follow-up including detailed parameters on return to daily activity . PATIENT SUMMARY We provide evidence that it is possible to remove the bladder catheter as early as 2 d after robot-assisted radical prostatectomy without any negative effects on voiding and pain parameters . Thus , leaving the hospital early without a catheter in place could represent a significant and relevant benefit for the patient PURPOSE Retrospective single institution data suggest that postoperative pain after robot-assisted laparoscopic radical prostatectomy is decreased by early removal of the urethral catheter with suprapubic tube drainage . In a r and omized patient population we determined whether suprapubic tube drainage with early urethral catheter removal would improve postoperative pain compared with urethral catheter drainage alone . MATERIAL S AND METHODS Men with a body mass index of less than 40 kg/m(2 ) who had newly diagnosed prostate cancer and elected robot-assisted laparoscopic radical prostatectomy were included in analysis . Block r and omization by surgeon was used and r and omization assignment was done after completing the urethrovesical anastomosis . In patients assigned to suprapubic tube drainage the urethral catheter was removed on postoperative day 1 and all catheters were removed on postoperative day 7 . Visual analog pain scale and satisfaction question naires were administered on postoperative days 0 , 1 and 7 . RESULTS A total of 29 patients were r and omized to the urethral catheter vs 29 to the suprapubic tube plus early urethral catheter removal at the time of interim futility analysis . Mean visual analog pain scale scores did not differ between the groups at any time point and a similar percent of patients cited the catheter as the greatest bother with nonsignificant differences in treatment related satisfaction . Complications during postoperative week 1 did not vary between the groups . Based on interim results the trial was terminated due to lack of effect . CONCLUSIONS Patients r and omized to suprapubic tube vs urethral catheter drainage for the week after prostatectomy had similar pain , catheter related bother and treatment related satisfaction in the perioperative period . We no longer routinely offer suprapubic tube drainage with early urethral catheter removal at our institution BACKGROUND The literature is lacking r and omised controlled trials comparing robot-assisted ( RARP ) and laparoscopic ( LRP ) radical prostatectomy , especially for follow-up > 1 yr . OBJECTIVE To report 5-yr outcomes for our previously published prospect i ve r and omised study comparing RARP and LRP . DESIGN , SETTING , AND PARTICIPANTS From January 2010 to January 2011 , 120 patients with organ-confined prostate cancer were enrolled and r and omly assigned to RARP or LRP . INTERVENTION A single surgeon performed all interventions using the same transperitoneal antero grade technique . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Continence , potency , and serum prostate-specific antigen were assessed postoperatively at 1 , 3 , 6 , and 12 mo , and then every 6 mo until 60 mo . At the end of the follow-up period , patients were administered questions 1 and 46 of the Exp and ed Prostate Cancer Index Composite question naire to assess their satisfaction with the intervention and general health status . A generalised estimating equations model was used to compare time series data for functional results , and Kaplan-Meier and Cox models were used to analyse oncologic outcomes . RESULTS AND LIMITATIONS The probability of achieving continence ( odds ratio [ OR ] 2.47 , p<0.021 ) and potency ( OR 2.35 , p<0.028 ) over time was more than doubled for the RARP compared to the LRP group . There was no difference between the two approaches in terms of patient survival . Pathologic Gleason score , positive surgical margins , and pT stage were associated with significantly higher biochemical recurrence in Cox multivariate models . Patient satisfaction with the intervention and their general health status was significantly higher in the RARP group . CONCLUSIONS Throughout the 5-yr follow-up , RARP yielded better functional results compared to LRP , without compromising oncologic outcomes . PATIENT SUMMARY In this report we looked at 5-yr outcomes for a study comparing robot-assisted radical prostatectomy ( RARP ) and laparascopic radical prostatectomy for the treatment of prostate cancer . We found that continence and potency are better among patients treated with RARP , while oncologic results are comparable BACKGROUND More than a decade since its inception , the benefits and cost efficiency of robot-assisted radical prostatectomy ( RARP ) continue to elicit controversy . OBJECTIVE To compare outcomes and costs between RARP and open RP ( ORP ) . DESIGN , SETTING , AND PARTICIPANTS A cohort study of 629 593 men who underwent RP for localized prostate cancer at 449 hospitals in the USA from 2003 to 2013 , using the Premier Hospital Data base . INTERVENTION RARP was ascertained through a review of the hospital charge description master for robotic supplies . OUTCOME MEASURES AND STATISTICAL ANALYSIS Outcomes were 90-d postoperative complications ( Clavien ) , blood product transfusions , operating room time ( ORT ) , length of stay ( LOS ) , and direct hospital costs . Propensity-weighted regression analyses accounting for clustering by hospitals and survey weighting ensured nationally representative estimates . RESULTS AND LIMITATIONS RARP utilization rapidly increased from 1.8 % in 2003 to 85 % in 2013 ( p<0.001 ) . RARP patients ( n=311 135 ) were less likely to experience any complications ( odds ratio [ OR ] 0.68 , p<0.001 ) or prolonged LOS ( OR 0.28 , p<0.001 ) , or to receive blood products ( OR 0.33 , p=0.002 ) compared to ORP patients ( n=318 458 ) . The adjusted mean ORT was 131min longer for RARP ( p=0.002 ) . The 90-d direct hospital costs were higher for RARP ( + $ 4528 , p<0.001 ) , primarily attributed to operating room and supplies costs . Costs were no longer signficantly different between ORP and RARP among the highest-volume surgeons ( ≥104 cases/yr ; + $ 1990 , p=0.40 ) and highest-volume hospitals ( ≥318 cases/yr ; + $ 1225 , p=0.39 ) . Limitations include the lack of oncologic characteristics and the retrospective nature of the study . CONCLUSIONS Our contemporary analysis reveals that RARP confers a perioperative morbidity advantage at higher cost . In the absence of large r and omized trials because of the widespread adoption of RARP , this retrospective study represents the best available evidence for the morbidity and cost profile of RARP versus ORP . PATIENT SUMMARY In this large study of men with prostate cancer who underwent either open or robotic radical prostatectomy , we found that robotic surgery has a better morbidity profile but costs more The purpose of this work was to assess the feasibility of urethral catheter removal 3 days after radical retropubic prostatectomy ( RRP ) . Twenty-two patients who underwent RRP with a watertight eight-suture vesicourethral anastomosis had their urethral catheter removed usually on postoperative day ( POD ) 3 . The average day of urethral catheter removal was POD 3.2 . At 3 months , 56 % of patients required no or one protective pad to stay dry and 68.4 % of patients ‘ never leaked ’ or ‘ leaked occasionally ’ . Following RRP , the urethral catheter can be removed as early as POD 3 if the intraoperative anastomosis is watertight without compromising urinary continence Purpose To evaluate the impact of the type of urinary diversion ( suprapubic vs. transurethral catheterization ) on patients ’ postoperative pain after radical prostatectomy , development of bacteriuria and long-term functional results . Methods A r and omized , prospect i ve clinical trial was performed including 160 patients who underwent robot-assisted radical prostatectomy after r and omization into two groups : intraoperatively , a transurethral catheter ( control group ) or an additional suprapubic tube ( with removal of the transurethral catheter in the morning of postoperative day 1 ; intervention group ) was placed . Primary study endpoint was postoperative pain objectified by the numeric rating scale question naire . Secondary endpoints were bacteriuria after catheter removal and functional outcomes after up to 2 years of follow-up . Results There were no significant differences in demographic and perioperative data . Starting on postoperative day 2 , patients in the suprapubic diversion group had significantly less pain on every time point preceding the removal of the catheter compared to the control cohort with a median overall numeric rating score on postoperative day 1–4 of 2.4 points in the transure Output:	Conclusions Available evidence suggests that the use of SPC can be a viable option for postoperative urine drainage after RARP , as it can translate into decreased postoperative pain without carrying a significant higher risk of catheter-related complications .
MS21137	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: UNLABELLED Pseudoephedrine is an over-the-counter drug to relieve nasal and sinus congestion . Although it has been suggested that pseudoephedrine could be a stimulant and ergogenic aid , pseudoephedrine was recently removed from the banned substance list by the International Olympic Committee and placed on the monitoring program ( from January 2004 ) . It was felt that evidence was lacking for an ergogenic effect , although few studies have investigated the effects of pseudoephedrine on exercise performance . This study , therefore , aim ed to investigate the effects of pseudoephedrine on 1500-m running performance . METHODS In a double-blind , r and omized crossover design , seven male athletes completed two 1500-m running trials on an outdoor track after having completed a familiarization trial . All trials were 7 d apart . After a 12-h overnight fast , subjects reported to the laboratory and received a st and ardized breakfast ( energy asymptotically equal to 500 kcal 50 % CHO ) . Subjects were given either 2.5 mg.kg(-1 ) bw pseudoephedrine or 2.5 mg.kg(-1 ) bw maltodextrins ( placebo ) in gelatin capsules 70 min before the start of the warm-up , which started 20 min before they ran 1500 m all-out . Pre- and postexercise blood sample s were collected and analyzed for lactate and glucose concentrations , partial pressure of oxygen ( PO2 ) and carbon dioxide ( PCO2 ) , and percent oxygen saturation . RESULTS Pseudoephedrine significantly decreased time to completion of 1500-m time trials in the present study by 2.1 % ( from 279.65 + /- 4.36 s with placebo to 273.86 + /- 4.36 s with pseudoephedrine ) with no reported side effects . No changes in the measured blood parameters were found , suggesting a central effect of pseudoephedrine rather than a metabolic effect . CONCLUSION The finding was that 2.5 mg.kg(-1 ) bw pseudoephedrine ingested 90 min preexercise improves 1500-m running performance The aim of the study was to assess the effect of maximal therapeutic dosing of sympathomimetic amines found in over-the-counter ( OTC ) decongestant preparations on endurance running . Following familiarisation and a grade d exercise test to determine maximal oxygen uptake ( VO2 max ) , trained male runners ( n = 8) completed four exercise sessions each separated by a minimum of one week . Each session was comprised of 20 min of sub-maximal treadmill running ( 70 % VO2 max ) followed by a 5,000-m time trial on the treadmill under drug , placebo or control conditions . Drugs were administered in their commercial format over the 36-hour period prior to testing in the manufacturer 's recommended maximal doses ( i. e. 25 mg of phenylpropanolamine and 60 mg of pseudoephedrine four times daily ) . During sub-maximal endurance running no statistical differences were observed in heart rate , VO2 , minute ventilation , respiratory exchange ratio , blood lactate , glucose or non-esterified fatty acids ( NEFA ) or ratings of perceived exertion with respect to the treatment administered . Similarly there were no statistical differences according to the condition during the 5,000-m running time trial , in terms of heart rate , ratings of perceived exertion , time of completion and pre and post exercise blood lactate , glucose or NEFA . The results indicate that in maximal , multiple therapeutic doses both pseudoephedrine or phenylpropanolamine as present in common OTC decongestant formulations do not affect , nor possess any ergogenic properties with regard to , endurance running OBJECTIVES The purpose of the present study was to examine a possible dose-response between pre-exercise pseudoephedrine intake and cycling time trial performance . DESIGN R and omised , double-blind , crossover trial . METHODS Ten trained male endurance cyclists ( 26.5 ± 6.2 years , 75.1 ± 5.9 kg , 70.6 ± 6.8 mL kg(-1)min(-1 ) ) undertook three cycling time trials in which a fixed amount of work ( 7 kJ kg(-1 ) body mass ) was completed in the shortest possible time . Sixty minutes before the start of exercise , subjects orally ingested either 2.3 mg kg(-1 ) or 2.8 mg kg(-1 ) body mass of pseudoephedrine or a placebo in a r and omised and double-blind manner . Venous blood was sample d at baseline , pre- and post-warm up and post-exercise for the analysis of pH and lactate and glucose concentrations ; plasma catecholamine and pseudoephedrine concentrations were measured at all times except post-warm up . RESULTS Cycling time trial performance ( ∼ 30 min ) was not enhanced by pseudoephedrine ingestion . Plasma pseudoephedrine concentration increased from pre-warm up to post-exercise in both treatment conditions , with the 2.8 mg kg(-1 ) body mass dose producing the highest concentration at both time points ( 2.8 mg kg(-1)>2.3 mg kg(-1)>placebo ; p<0.001 ) . CONCLUSIONS There was large individual variation in plasma pseudoephedrine concentration between subjects following pseudoephedrine administration . A number of factors clearly influence the uptake and appearance of pseudoephedrine in the blood and these are not yet fully understood . Combined with subsequent differences in plasma pseudoephedrine between individuals , this may partially explain the present findings and also the inconsistencies in performance following pseudoephedrine administration in previous studies The ingestion of a combination of caffeine ( C ) and ephedrine ( E ) has been reported to prolong exercise time to exhaustion during cycle ergometry at 85 % VO2max . The present study was undertaken to investigate whether this enhancement would occur in a field setting and if drug ingestion on 1 d would affect performance 1 d later . Two hours after ingesting either a combination of 375 mg of C and 75 mg E ( C+E ) , or a placebo ( P ) , 9 healthy male recreational runners completed six balanced and double-blind trials of the Canadian Forces Warrior Test ( WT ) , a 3.2 km run wearing " fighting order " which weighed about 11 kg . The trials were performed in sets of two runs , i.e. , two runs were done 24 h apart , and these sets were separated by a minimum of 7 d. The sets were : C+E trial on day 1 ( D1 ) , placebo on day 2 ( P2 ) ; placebo first ( P1 ) , C+E second ( D2 ) ; and placebo first ( P3 ) , placebo second ( P4 ) . In addition , 1 wk before the treatment trials the subjects performed a control trial WT . During the WT , heart rates ( HR ) were recorded every minute . Plasma C and E levels immediately before the WT were similar for both C+E trials , but were undetectable for all P trials . Run times ( mean+/-SD ) were 15.3+/-0.6 , 15.4+/-0.9 , 15.5+/-1.2 , 15.4+/-0.9 , 15.4+/-0.9 , 14.8+/-0.7 , and 14.6+/-0.8 min for control , P1 , P2 , P3 , P4 , D1 , D2 trials , respectively . The two C+E trial run times were similar and both were significantly faster ( p < 0.05 ) than control and all placebo trials . HR during the WT was significantly higher ( p < 0.05 ) for the C+E trials compared with the other trials . WT performance was not impaired by C+E ingestion 24 h earlier . In conclusion , performance of the WT was improved by ingestion of Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objective To investigate the effect of an acute oral administration of pseudoephedrine ( PSE ) on muscle function , fatigue , and anaerobic power output . Design and Material sHealthy males ( N = 10 ) and females ( N = 10 ) were allocated to receive both a placebo and PSE ( 120 mg ) using a r and omized , double-blind , crossover experimental design . Each subject had their maximal voluntary contraction strength and fatigability measured for both h and grip and ankle dorsi-flexion . Following the strength measurements , a 30-second maximal cycle test was performed to determine lower extremity anaerobic power and fatigue . Plasma lactate was measured before and after exercise . Results There were no significant differences in any of the outcome variables between the placebo and PSE trials . Conclusions These results demonstrated that a 120 mg dose of PSE did not enhance force production , time to fatigue , fatigue index , or power output in young men or women . Therefore , there does not appear to be an ergogenic benefit from the ingestion of 120 mg PSE in high-intensity exercise performance In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies , most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted This study was design ed to measure whether a single dose of 120 mg pseudoephedrine ingested 120 min before exercise influences performance during 1 h of high-intensity exercise . The effects of exercise on urinary excretion of the drug were also studied . Ten healthy male cyclists were tested on two occasions , separated by at least 7 days , by using a r and omly assigned , double-blind , placebo-controlled , crossover design . Exercise performance was tested during a 40-km trial on a laboratory cycle ergometer , and skeletal muscle function was measured during isometric contractions . On a third occasion , subjects ingested 120 mg pseudoephedrine but did not exercise [ control ( C ) ] . Pseudoephedrine did not influence either time trial performance [ drug ( D ) vs. placebo : 58.1 + /- 1.4 ( SE ) vs. 58.7 + /- 1.5 min ] or isometric muscle function . Urinary pseudoephedrine concentrations were significantly increased 1 h after exercise ( D vs. C : 114.3 + /- 27.2 vs. 35.4 + /- 13.1 micrograms/ml ; P < 0.05 ) . Peak plasma pseudoephedrine concentrations ( P < 0.05 ) but not time taken to reach peak plasma concentrations or the area under the plasma pseudoephedrine concentration vs. time curve was significantly increased in the total group with exercise ( D vs. C ) . In three subjects , plasma pseudoephedrine concentrations were not influenced by exercise . Only these subjects showed increased urinary pseudoephedrine excretion during exercise . We conclude that a single therapeutic dose of pseudoephedrine did not have a measurable ergogenic effect during high-intensity exercise of 1-h duration , but plasma drug concentrations and urinary excretion were altered by exercise . These findings have practical relevance to doping control regulations in international sporting competitions Objective To study the effects of over-the-counter dosages of the pure α1–agonists pseudoephedrine ( PSE ) and phenylpropanolamine ( PPA ) on selected parameters of exercise performance , and to establish a range of corresponding drug levels in the urine of the athletes who use these drugs . Design Placebo-controlled , r and omized , double-blinded , multiple-dose trial . Setting The National Institute of Fitness and Sport , the Department of Family Medicine , Indiana University , and the Sports Medicine Lab , Department of Pathology , Indiana University , Indianapolis , Indiana . Participants A convenience sample of 20 male cyclists , aged 18–35 , from the local cycling community . Inclusion criteria required cycling at least 50 miles a week , no chronic medical problems , and not taking any medications . Subjects were recruited by local ads and word of mouth . Intervention Patients were r and omized to one of two groups of 10 subjects . Each subject in both groups performed three separate bicycle ergometer tests after ingestion of varying dosages of α1–agonists . One group performed tests after receiving placebo , 0.33 mg/kg PPA , and 0.66 mg/kg PPA , whereas the other group received placebo , 1 mg/kg PSE , and 2 mg/kg PSE . A minimum 1-week washout period was required between tests . Urine for drug testing was collected 1 h before , immediately afterward , and the next morning after testing . Drug testing was performed by gas GC/MCD at a facility approved by the International Olympic Committee . Main outcome measures Maximum oxygen uptake ( VO2max ) , time to exhaustion , urine drug levels of PSE and PPA , peak blood pressures ( BPs ) , peak pulse , and Borg scale ( rating of perceived exertion or RPE ) . Main Results Output:	Results Overall , the review showed that the ergogenic effect of pseudoephedrine is dose-dependent . It is evident that there is a correlation between the dose administered and its ergogenic effects , but it is also evident that the side effects of using above the therapeutic dose outweigh the possible benefits of using pseudoephedrine in sport .
MS21138	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Postal surveys are a frequently used method of data collection in health services research . Low response rates increase the potential for bias and threaten study validity . The objectives of this study were to estimate current response rates , to assess whether response rates are falling , to explore factors that might enhance response rates and to examine the potential for non-response bias in surveys mailed to healthcare professionals . Methods A r and om sample of postal or electronic surveys of healthcare workers ( 1996 - 2005 ) was identified from Medline , Embase or Psycinfo data bases or Biomed Central . Outcome measures were survey response rate and non response analysis . Multilevel , multivariable logistic regression examined the relationship between response rate and publication type , healthcare profession , country and number of survey participants , question naire length and use of reminders . Results The analysis included 350 studies . Average response rate in doctors was 57.5 % ( 95%CI : 55.2 % to 59.8 % ) and significantly lower than the estimate for the prior 10 year period . Response rates were higher when reminders were sent ( adjusted OR 1.3 ; 95%CI 1.1 - 1.6 ) but only half the studies did this . Response rates were also higher in studies with fewer than 1000 participants and in countries other than US , Canada , Australia and New Zeal and . They were not significantly affected by publication type or healthcare profession ( p > 0.05 ) . Only 17 % of studies attempted assessment of possible non-response bias . Conclusion Response rates to postal surveys of healthcare professionals are low and probably declining , almost certainly leading to unknown levels of bias . To improve the informativeness of postal survey findings , research ers should routinely consider the use of reminders and assess potential for non-response bias Background Monetary incentives in survey research may provide important gains from a method ological perspective in the control and reduction of survey error associated with potential nonresponse of participants . However , few studies have systematic ally investigated the use of monetary incentives or other methods to improve the response rates in the nonphysician clinician population . Objective To investigate differences in response rates to a mailed self-administered survey of nonphysician clinicians who were r and omized to receive a prepaid monetary incentive , a postsurvey prize drawing , or no incentive . Methods A r and omized controlled trial of financial incentives was conducted from November 2002 to February 2003 . Nonphysician clinicians ( nurse practitioners [ NPs ] and physician assistants [ PAs ] ; N = 3,900 ) r and omly selected to participate in a national ethics-related study were assigned r and omly in equal allocations ( n = 1,300 [ 650 NPs , 650 PAs ] ) to three incentive groups : ( a ) no incentive ; ( b ) a $ 5 prepaid token incentive in the initial mailing ; or ( c ) a chance to win one of ten $ 100 prize drawings upon completion and return of a self-administered survey . Results A $ 5 cash incentive increased survey response rates to an adjusted 64.2 % : a 19.5 percentage point increase over the lottery group ( 44.7 % response rate ) , and a 22 percentage point increase over the control group ( 42.2 % response rate ) . Discussion A nominal cash incentive of $ 5 yields a significantly higher response rate from nonphysician providers than receiving either a lottery option or no incentive Background Given the increasingly stressful environment due to manpower shortages in the healthcare system in general , substance induced impairment among some healthcare professions is anticipated to grow . Though recent studies suggest that the prevalence of substance abuse is no higher in healthcare professionals ( HPs ) than the general population , given the responsibility to the public , any impairment could place the public at increased risk for errors . Few studies have ever reported predictors or risk factors for alcohol and other drug use ( AOD ) across a sample of HPs . Methods The study used a cross-sectional , descriptive self-report survey in a small northeastern state . A 7-page survey was mailed to a stratified r and om sample of 697 dentists , nurses , pharmacists and physicians registered in a northeastern state . The main outcome measures were demographic characteristics , lifetime , past year and past month prevalence of AOD use , the frequency of use , drug related dysfunctions , drug misuse and abuse potential . Six contacts during the summer of 2002 result ed in a 68.7 % response rate ( 479/697 ) . Results Risk factors contributing to any reported past year AOD use , as well as significant ( defined as the amount of AOD use by the top 25 % of respondents ) past year AOD use by HPs were examined using logistic regression . Risk factors of any self-reported past year AOD use included moderate or more frequency of alcohol use , being in situations when offered AODs , feeling immune to the addictive effects of drugs ( pharmaceutical invincibility ) and socializing with substance abusers . Risk factors of significant past year AOD use were HPs with younger licensees , a moderate pattern of alcohol use and not socializing with substance abusers . Conclusion National and state organizations need to develop policies that focus on prevention , treatment , and rehabilitation of alcohol and other drug-using healthcare professionals . The results of this study may help to delineate the characteristics of HPs abusing drugs , leading to the development of more effective policies design ed to protect the public , and move toward more tailored and effective intervention strategies for HPs The purpose of this research was to study the effect of various direct mail techniques on professional nurses ' response rates to question naires . A r and om sample of 700 registered professional nurses consisting of five groups who were members of New York State Nurses Association ( NYSNA ) were mailed a question naire with 22 items . The study demonstrated that the response rates were directly attributable to techniques used . Providing information about the association was related to significantly decreased response rates and monetary incentives with significantly increased response rates . A combined direct mailing for question naire completion and membership solicitation was not effective for either purpose The purpose was to examine the effectiveness of a modest monetary incentive ( $ 1 ) and none in increasing the response rate of a mail survey to 600 nurse practitioners . The response rate in the incentive group was 81 % and 66 % in the control group , significant by chi-square test . The most cost effective survey technique for increasing the response rate of nurse practitioners was to code the envelopes and eliminate the monetary incentive The past 20 years have seen an overall decline in survey response rates and an even more pronounced decline in sample s of health care professionals . The authors tested the use of a “ thank you ” or “ reminder ” postcard as a method by which to stem the tide of declining response rates . The authors conducted a mail and telephone survey of 49,605 registered nurses for the 2000 National Sample Survey of Registered Nurses and sent an extra mailing to a r and om sub sample ( n= 4,968 ) . They then compared response rates for both groups . Contrary to prior research , this study found that reminder postcards did not improve response rates or rates of return . There may be several reasons for this finding , including the general familiarity with , and high saliency of , this research project for the nursing community . These results suggest that even widely accepted best practice s for survey methods deserve scrutiny when applied to special sub population OBJECTIVE To examine response rate information from mailed physician question naires reported in published articles . DATA SOURCES / STUDY SETTING Citations for articles published between 1985 and 1995 were obtained using a key word search of the Medline , PsychLit , and Sociofile data bases . STUDY DESIGN A 5 percent r and om sample of relevant citations was selected from each year . DATA COLLECTION / EXTRACTION METHODS Citations found to be other than physician surveys were discarded and replaced with the next r and omly assigned article . Selected articles were abstract ed using a st and ardized variable list . PRINCIPAL FINDINGS The average response rate for mailed physician question naires was 61 percent . The average response rate for large sample surveys ( > 1,000 observations ) was 52 percent . In addition , only 44 percent of the abstract ed articles reported a discussion of response bias , and only 54 percent reported any type of follow-up . CONCLUSIONS ( 1 ) Response rates have remained somewhat constant over time , and ( 2 ) research ers need to document the efforts used to increase response rates to mailed physician question naires Background : Achieving acceptable response rates from health care providers via postal question naires is an ongoing challenge . The use of monetary incentives is one of the most effective strategies for increasing response rates . However , the effect and cost of such an incentive on retail pharmacists ’ response rates has not been well studied . Methods : A sample of 700 pharmacies was selected at r and om from the electronic Yellow Pages in NSW Australia and mailed a brief survey regarding pharmacotherapies and advice for smoking cessation . Half of the sample was r and omly allocated to receive an offer of an US$ 14 gift voucher . Results : The response rates were 65.9 % for the voucher group and 53.5 % for the no-voucher group . The odds of response from the voucher group was 1.68 ( 95%CI = 1.23 , 2.30 ) times greater than for the no-voucher group . The cost per additional respondent was US$ 67.95 . The incentive also reduced follow up costs by 10 % . Conclusions : A moderately sized monetary incentive is able to achieve a significant increase in response rates for retail pharmacists , thereby reducing potential bias in the sample Two major obstacles encountered when surveying nursing practice in institutional setting s are obtaining a representative sample and collecting an adequate number of observations at a reasonable cost . Past efforts to deal with these problems are review ed briefly , and results are reported from a two-stage mail survey of a national sample of critical-care nurses . The first stage involved attempts to procure a list of staff nurses from head nurses of critical-care units at 240 r and omly selected institutions . An 86 % response rate was obtained . The second stage involved mailing question naires to a r and om sample of 600 critical-care nurses listed . Completed , mailed question naires were obtained from 87 % . Little evidence of bias due to administrative selection and /or volunteerism was found in the lists of staff nurses . An analysis of membership in professional nursing organizations indicates that more than one half of the nurses who responded to this survey would not have been included had the sample been selected from organizational membership lists Background : Recent experiences of survey research ers suggest that physicians are becoming less willing to complete surveys . Objective : To compare response rates to a mailed physician survey with a prepaid check incentive of $ 20 versus $ 50 . Research Design : R and omized controlled trial . Subjects : Five hundred seventy-eight physicians caring for patients with lung or colorectal cancer in northern California . Measures : Proportion of physicians responding to the survey . Results : Overall , 60.0 % of physicians responded to the survey . The response rate was 52.1 % for physicians who received a $ 20 check versus 67.8 % for physicians who received a $ 50 check ( P < 0.001 ) . Similar differences in response rates were seen in strata by physician sex , year graduated from medical school , and survey version ( all P < 0.001 ) . More than 42 % of physicians who received a $ 50 check responded to the first mailing , compared with only 30.8 % of those who received a $ 20 check ( P < 0.001 ) . Conclusions : Among physicians caring for patients with lung cancer or colorectal cancer in northern California , a $ 50 check incentive was much more effective than a $ 20 check incentive at increasing response rates to a mailed survey . As physicians become increasingly burdened with surveys , larger incentives may be necessary to engage potential respondents and thus maximize response rates We conducted a pilot study to determine the most efficient mailing strategy for a postal question naire study among nurses in Ontario , Canada . Five mailing strategies involving types of stamps on the return envelopes were considered : no stamp , business-reply stamp , metered stamp , small regular stamp , and large commemorative stamp . We found that paper stamps , especially large commemorative stamps , on return envelopes increased the response rate and reduced the response time , as compared with other mailing strategies . Business-reply stamps had the lowest cost per response received and a low total cost This study assessed differences in response rates to a series of three-wave mail surveys when amiable or insistently worded postcards were the third wave of the mailing . Three studies were conducted ; one with a sample of 600 health commissioners , one with a sample of 680 vascular nurses , and one with 600 elementary school secretaries . The combined response rates for the first and second wave mailings were 65.8 % , 67.6 % , and 62.4 % , respectively . A total of 308 amiable and 308 insistent postcards were sent r and omly to nonrespondents as the third wave mailing . Overall , there were 41 amiable and 52 insistent postcards returned , not significantly different by chi-square test . However , a separate chi-square test for one of the three studies , the nurses ' study , did find a significant difference in favor of the insistently worded postcards To determine whether academic physicians ' response rates to a mail survey depend on the envelope used to mail the survey , we r and omized 901 internists affiliated with a university department of medicine to receive a survey in either a university envelope or a Veterans Affairs envelope . The response rate among those receiving the Veterans Affairs envelope ( 41 % ) was 20 % higher than the response rate among those receiving the university envelope ( 34 % ) . We conclude that the packaging of a mail survey can influence the response rate Background : More patients are receiving health Output:	Even small financial incentives were found to be effective in improving nurse survey participation . Token nonmonetary incentives , in contrast , were much less effective . In terms of design strategies , postal and telephone strategies have generally been more successful than have fax or web-based approaches , with evidence also supporting use of mixed-mode surveys in this population . In addition , use of first-class stamps on return envelopes as well as question naires personalized and endorsed by legitimizing professional associations were also more likely to be successful .
MS21139	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract 5′-Methyltetrahydrofolic acid ( 5′- MTHF ) in addition to st and ard psychotropic medication significantly improved clinical recovery in depressed patients with borderline or definite folate deficiency , and significantly reduced depressive symptoms in elderly normofolatemic patients after 3 weeks of treatment . In this equivalence study the effect of 5′- MTHF on depressive symptoms and cognitive status was compared to Trazodone ( TRZ ) in normofolatemic elderly patients with mild to moderate dementia and depression . Ninety-six patients with dementia , scoring 12–23 at the Mini Mental State Examination ( MMSE ) and ≥18 at the Hamilton Depression Rating Scale ( HDRS ) after a 2-week placebo run-in , were r and omized to receive either 5′-MTHF ( 50 mg/day p.o . ) ( 47 patients ) or TRZ ( 100 mg/day p.o . ) ( 49 patients ) in a double-blind design for 8 weeks . HDRS was assessed before , after 4 weeks and at the end of treatment ; Rey ’s Verbal Memory ( RVM ) test for immediate and delayed recall was evaluated before and after treatment . After 4 weeks of treatment HDRS score was reduced from 23±5 to 20±6 in the 5′-MTHF ( p<0.05 vs baseline ) , and from 23±3 to 21±4 in the TRZ group ( p<0.05 vs baseline ) . p]A further significant decrease to 18±6 and 19±5 respectively was obtained at the end of the treatment period ( p<0.05 vs week 4 ) with 5′-MTHF and TRZ . HDRS was administered again after a 4-week , drug-free , follow-up period : no change vs the post treatment scores was observed either in the 5′-MTHF or in the TRZ group ( 18±7 and 19±5 respectively ) . RVM test for immediate recall was significantly improved ( p<0.05 ) at week 8 vs baseline in the 5′-MTHF group whereas no significant change occurred in the TRZ group . No change in delayed recall was observed after treatment in either group . Tolerability was good for both treatments . This study shows that 5′-MTHF and TRZ are equally effective in improving depressive symptoms in patients with mild to moderate dementia and suggests that pharmacological doses of 5′-MTHF may exert psychotropic effects irrespective of folate status . ( Aging Clin . Exp . Res . 1 : 63–71 , 1993 Based on research demonstrating associations between folate , B-12 and B-6 vitamins and cognition and mood , we investigated the effects of short-term supplementation in 211 healthy younger , middle-aged and older women who took either 750 microg of folate , 15 microg of vitamin B-12 , 75 mg of vitamin B-6 or a placebo daily for 35 d. In addition , we examined associations between dietary intake of these vitamins and cognition and mood . Usual dietary intake status was estimated using a retrospective , self-report , quantified food frequency question naire . Participants completed alternate forms of st and ardized tests of cognitive processing re sources , memory , executive function , verbal ability and self-report mood measures before and after supplementation . Supplementation had a significant positive effect on some measures of memory performance only , and no effect on mood . Dietary intake status was associated with speed of processing , recall and recognition and verbal ability BACKGROUND Frail elders are at risk of suboptimal micronutrient status , functional decline , and neurologic disorders . The influence of oral multimicronutrients in physiologic doses and of moderately intense physical exercise on homocysteine ( Hcy ) , methylmalonic acid ( MMA ) , and neurologic functioning have not yet been investigated . OBJECTIVE Our goal was to determine the effects of enriched foods and exercise on blood vitamins , Hcy , MMA , and neuropsychological functioning in the frail . DESIGN A 17-wk r and omized controlled intervention trial was used to study 1 ) enriched foods plus a social program , 2 ) regular foods plus exercise , 3 ) enriched foods plus exercise , and 4 ) regular foods plus a social program . Enriched foods contained multiple micronutrients ( 25 - 100 % of the Dutch recommended dietary allowances ) ; exercises focused on strength , coordination , flexibility , and endurance . Vitamin ( cobalamin , red blood cell folate , and pyridoxal 5'-phosphate ) , Hcy , and MMA concentrations were measured and 2 neuropsychological tests were conducted . RESULTS Vitamin concentrations were higher in the supplemented groups than in the unsupplemented groups ( P < 0.001 ; total n = 130 ) . Compared with baseline , cobalamin in the supplemented groups was increased by 22 % , plasma folate by 101 % , red blood cell folate by 87 % , and pyridoxal 5'-phosphate by 68 % . Concentrations in the unsupplemented groups changed by -2 % , -6 % , 1 % , and -13 % , respectively . Hcy decreased by 25 % and MMA by 30 % in the supplemented groups , compared with a small increase in Hcy ( 2 % ) and decrease in MMA ( 9 % ) in the unsupplemented groups . Exercise did not significantly affect vitamin , Hcy , or MMA concentrations . No significant effect of either intervention was observed on the neuropsychological tests . CONCLUSIONS The decrease in Hcy and MMA in frail elders confirms a sub clinical metabolic deficiency state . Enriched foods containing physiologic amounts of micronutrients have a beneficial effect on these metabolites . No effects of B vitamins on mental health were identified OBJECTIVE The main hypothesis was that subtle vitamin B12 deficiencies occur more commonly in senile dementia of Alzheimer type ( SDAT ) that in healthy elderly individuals , and may be revealed by elevated total serum homocysteine ( tHcy ) . A subsidiary hypothesis was that such deficiencies would be nutritionally independent as determined by retinol binding protein ( RBP ) . DESIGN A prospect i ve case-controlled survey . SETTING A Welsh urban psychogeriatric assessment centre and local general practice . PATIENTS Thirty patients , aged 65 or over , seen consecutively in 1994 with features compatible with DSM-III-R criteria for primary degenerative dementia of Alzheimer type and 30 cognitively intact age-matched control subjects . MEASURES Diagnosis was assessed using the CAMDEX . Cognitive scores were evaluated with the CAMCOG scale for patients and MMSE scores for control subjects . THcy was measured using high performance liquid chromatography ( HPLC ) , and RBP assayed by a radial immunodiffusion method . RESULTS Patients had a highly significant elevation of tHcy compared with control ( p < 0.0001 ) . Multiple regression highlighted the interrelated effects of tHcy and total serum cobalamin on cognitive scores . RBP did not differ between groups . Macrocytosis was absent , and neutrophil hypersegmentation uncommon , in hyperhomocysteinaemic patients . CONCLUSIONS SDAT patients have significantly elevated tHcy . This is independent of RBP determined nutritional status . ' Classical ' haematological changes of cobalamin or folate deficiency are poor predictors of tHcy in these patients . Aberrant cobalamin tissue delivery appears to contribute to SDAT cognitive decline . Relative contributions of other tHcy determinants require further investigation Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration OBJECTIVES To examine the association of cognitive impairment with platelet activation and reactive oxygen species and total homocysteine levels ; and to assess the biochemical efficacy of treatment with aspirin and vitamin supplements in people at high risk of dementia . SUBJECTS People with dementia or mild cognitive impairment . DESIGN AND INTERVENTION In a 2 x 2 x 2 factorial design trial , 149 people at high-risk of dementia were r and omized to receive either low-dose aspirin ( 81 mg ) or placebo ; and folic acid ( 2 mg ) plus vitamin B12 ( 1 mg ) or placebo ; and vitamins E ( 500 mg ) plus C ( 200 mg ) or placebo . Participants were seen twice before and once after 12 weeks of treatment . MAIN OUTCOME MEASURES At each visit , participants had their cognitive function assessed and had blood collected for homocysteine , folate and vitamin B12 determination and urine collected for markers of platelet activation ( 11-dehydro-thromboxane B2 ) and reactive oxygen species ( 8-epi-PGF2 alpha ) . RESULTS Prior to treatment , cognitive function was inversely related with homocysteine and with urinary thromboxane and isoprostane , and these associations were independent of age . Aspirin was associated with a median reduction in 11-dehydrothromboxane B2 of 73 % ( P < 0.001 ) . B-vitamins lowered plasma homocysteine concentration by 30 % ( P < 0.0001 ) and antioxidant vitamins lowered isoprostane excretion by 26 % ( P < 0.1 ) . No effect of treatment on cognitive function was detected . CONCLUSIONS Aspirin and B-vitamins were effective in reducing biochemical factors associated with cognitive impairment in people at risk of dementia . Large-scale trials are now required to assess the relevance of aspirin and B-vitamins for the maintenance of cognitive function in people at risk of dementia Moderate hyperhomocysteinaemia is common in the general population and has been linked with cardiovascular disease . However , there are no data from prospect i ve , population -based studies . We examined the association between serum total homocysteine ( tHcy ) concentration and stroke in a nested case-control study within the British Regional Heart Study cohort . Between 1978 and 1980 serum was saved from 5661 men , aged 40 - 59 years , r and omly selected from the population of one general practice in each of 18 towns in the UK . During follow-up to December , 1991 , there were 141 incident cases of stroke among men with no history of stroke at screening . Serum tHcy was measured in 107 cases and 118 control men ( matched for age-group and town , without a history of stroke at screening , who did not develop a stroke or myocardial infa rct ion during follow-up ) . tHcy concentrations were significantly higher in cases than controls ( geometric mean 13.7 [ 95 % CI 12.7 - 14.8 ] vs 11.9 [ 11.3 - 12.6 ] mumol/L ; p = 0.004 ) . There was a grade d increase in the relative risk of stroke in the second , third , and fourth quarters of the tHcy distribution ( odds ratios 1.3 , 1.9 , 2.8 ; trend p = 0.005 ) relative to the first . Adjustment for age-group , town , social class , body-mass index , hypertensive status , cigarette smoking , forced expiratory volume , packed-cell volume , alcohol intake , diabetes , high-density-lipoprotein cholesterol , and serum creatinine did not attenuate the association . These findings suggest that tHcy is a strong and independent risk factor for stroke BACKGROUND Elevated plasma homocysteine levels are a risk factor for coronary heart disease , but the prognostic value of homocysteine levels in patients with established coronary artery disease has not been defined . METHODS We prospect ively investigated the relation between plasma total homocysteine levels and mortality among 587 patients with angiographically confirmed coronary artery disease . At the time of angiography in 1991 or 1992 , risk factors for coronary disease , including homocysteine levels , were evaluated . The majority of the patients subsequently underwent coronary-artery bypass grafting ( 318 patients ) or percutaneous transluminal coronary angioplasty ( 120 patients ) ; the remaining 149 were treated medically . RESULTS After a median follow-up of 4.6 years , 64 patients ( 10.9 Output:	Vitamin B12 deficiency produces both an anaemia identical to that of folate deficiency but also causes irreversible damage to the central and peripheral nervous systems . Folic acid will correct the anaemia of vitamin B12 deficiency and so delay diagnosis but will not prevent progression to neurological damage . REVIEW ER 'S CONCLUSIONS There was no beneficial effect of 750 mcg of folic acid per day on measures of cognition or mood in older healthy women . In patients with mild to moderate cognitive decline and different forms of dementia there was no benefit from folic acid on measures of cognition or mood . Folic acid plus vitamin B12 was effective in reducing the serum homocysteine concentrations . Folic acid was well tolerated and no adverse effects were reported .
MS21140	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Brief interventions for problem drinking in medical setting s are effective but rarely conducted , mainly due to insufficient time . A stepped care approach ( starting with a very brief intervention and intensifying efforts in case of no success ) could save re sources and enlarge effectiveness ; however , research is lacking . The present study compares a full care brief intervention for patients with at-risk drinking , alcohol abuse or dependence with a stepped care approach in a r and omized controlled trial . METHODS Participants were proactively recruited from general practice s in two northern German cities . In total , 10,803 screenings were conducted ( refusal rate : 5 % ) . Alcohol use disorders according to DSM-IV were assessed with the Munich-Composite International Diagnostic Interview ( M-CIDI ) . Eligible participants were r and omly assigned to one of three conditions : ( 1 ) stepped care ( SC ) : a computerized intervention plus up to three 40-min telephone-based interventions depending on the success of the previous intervention ; ( 2 ) full-care ( FC ) : a computerized intervention plus a fixed number of four 30-min telephone-based interventions that equals the maximum of the stepped care intervention ; ( 3 ) an untreated control group ( CG ) . Counseling effort in the intervention conditions and quantity/frequency of drinking were assessed at 12-month follow-up . RESULTS SC participants received roughly half of the amount of intervention in minutes compared to FC participants . Both groups did not differ in drinking outcomes . Compared to CG , intervention showed small to medium effect size for at-risk drinkers . CONCLUSIONS Study results reveal that a stepped care approach can be expected to increase cost-effectiveness of brief interventions for individuals with at-risk drinking Background Alcohol screening and brief intervention for unhealthy alcohol use has not been consistently delivered in primary care as part of preventive healthcare . Objective To explore whether telephone-based intervention delivered by a health educator is efficacious in reducing at-risk drinking among older adults in primary care setting s. Design Secondary analyses of data from a r and omized controlled trial . Participants Subjects r and omized to the intervention arm of the trial ( n = 310 ) . Interventions Personalized risk reports , advice from physicians , booklet about alcohol and aging , and up to three telephone calls from a health educator . All interventions were completed before the three-month follow-up . Measurements Risk outcomes ( at-risk or not at-risk ) at 3 and 12 months after enrollment . Main results In univariate analyses , compared to those who remained at risk , those who achieved not at-risk outcome at 3 months were more likely to be women , Hispanic or non-white , have lower levels of education , consume less alcohol , drink less frequently , and have lower baseline number of risks . In mixed-effects logistic regression models , completing all three health educator calls increased the odds of achieving not at-risk outcome compared to not completing any calls at 3 months ( OR 5.31 ; 95 % CI 1.92–14.7 ; p = 0.001 ) , but not at 12 months ( OR 2.01 ; 95 % CI 0.71–5.67 ; p = 0.18 ) . Conclusions Telephone-based intervention delivered by a health educator was moderately efficacious in reducing at-risk drinking at 3 months after enrollment among older adults receiving a multi-faceted intervention in primary care setting s ; however , the effect was not sustained at 12 months OBJECTIVE : To test the effectiveness of a brief intervention in the reduction of prenatal alcohol consumption by women when a partner is included . METHODS : R and omized trial of a single session brief intervention given by the study nurse or principal investigator for 304 pregnant women and their partners . The women had positive T-ACE ( Tolerance , Annoyed , Cut down , Eye-opener , an alcohol screening test ) results and were at risk for alcohol consumption while pregnant . All completed initial diagnostic and postpartum interviews . RESULTS : Fewer than 20 % of participants ( median 11.5 weeks of gestation ) were abstinent at study enrollment , averaging more than 1.5 drinks per episode . Nearly 30 % had 2 or more drinks at a time while pregnant . Prenatal alcohol use declined in both the treatment and control groups after study enrollment , based on a 95 % follow-up rate . Factors associated with increased prenatal alcohol use after r and omization included more years of education , extent of previous alcohol consumption , and temptation to drink in social situations . Brief interventions for prenatal alcohol reduced subsequent consumption most significantly for the women with the highest consumption initially ( regression coefficient , b = −0.163 , st and ard error ( b ) = 0.063 , P < .01 ) . Moreover , the effects of the brief intervention were significantly enhanced when a partner participated ( b = −0.932 , st and ard error ( b ) = 0.468 ) , P < .05 ) . CONCLUSION : Pregnant women with the highest levels of alcohol use reduced their drinking most after a brief intervention that included their partners . Recommendations include consistent screening for prenatal alcohol use followed by diagnostic assessment when indicated , and if confirmed by other studies , a patient-partner brief intervention for the heaviest drinkers . LEVEL OF EVIDENCE : Purpose The purpose of this study is to determine the effect at 48 months of a screening and brief patient-centered physician- and nurse practitioner-delivered intervention implemented during a routine primary care visit on the reduction of alcohol consumption by high-risk drinkers . Methods Participants seen in primary care practice s previously r and omized to special intervention ( SI ) or usual care ( UC ) were reconsented for long-term follow-up . From the initial cohort , 63 % reconsented to participate and provided follow-up at 48 months between November 1996 and March 2002 . The data for this paper were analyzed in June 2004 . Results At 48 months , SI participants maintained significant reductions in drinks per week seen at 6 and 12 months . However , there were no longer significant differences in drinks per week , binges per month , percentage of low-risk drinking , relapse rates , and new quits between the SI and UC groups at 48 months that had been seen at earlier follow-up . There was a significant effect of prior low-risk drinking status at 12 months ; those who were low-risk drinkers at 12 months were more likely to stay low-risk drinkers at 48 months regardless of treatment group . Conclusions With a single brief intervention , SI participants had significantly greater reductions in their drinking levels at 6 and 12 months compared to UC participants and maintained the lower-risk levels at 48 months result ing in a reduction in health risk exposure time . However , the significant group differences in treatment effect seen in earlier follow-ups were not maintained Seventy two women drinking 21 units ( 210 g ) or more of alcohol per week were recruited from an opportunistic screening programme in eight English general practice s. The women were r and omized into control and treatment groups . Women in the treatment group received ten minutes advice from their general practitioner to reduce alcohol consumption . At one year follow-up , when analyzed by intention to treat , women in the treatment group had reduced their alcohol consumption from an average of 35 - 24 units per week . Similar reductions were found in the control group ( from 37 - 27 units per week ) . The lack of evidence for a treatment effect may be explained by contamination of the control group by informal interventions In a controlled evaluation of general practitioner (GP)-based brief intervention , 378 excessive drinkers identified opportunistically by screening in 40 group practice s in metropolitan Sydney were assigned to groups receiving : ( i ) a five-session intervention by the GP ( the Alcoholscreen Program ) ; ( ii ) a single session of 5 minutes ' advice by the GP plus a self-help manual ( minimal intervention ) ; ( iii ) an alcohol-related assessment but no intervention ; ( iv ) neither intervention nor assessment . Among all patients allocated to receive it , the Alcoholscreen Program did not result in a significantly greater reduction in consumption at follow-up than control conditions but patients offered Alcoholscreen reported a significantly greater reduction in alcohol-related problems in the period to 6 months follow-up . A greater proportion of patients who returned for the second Alcoholscreen visit were drinking below recommended levels at follow-up than in the remainder of the sample . There was no evidence that minimal intervention or alcohol-related assessment were effective in reducing alcohol consumption or problems . Implication s for further research into GP-based brief interventions are discussed Home visitation interventions show promise for helping at-risk mothers , yet few programs have been developed and evaluated specifically for alcohol and drug-abusing pregnant women . This study examines outcomes among 216 women enrolled in the Washington State Parent-Child Assistance Program , a three-year intervention program for women who abuse alcohol and drugs during an index pregnancy . Pretest-posttest comparison was made across three sites : the original demonstration ( 1991–1995 ) , and the Seattle and Tacoma replications ( 1996–2003 ) . In the original demonstration , the client group performed significantly better than controls . Compared to the original demonstration , outcomes at replication sites were maintained ( for regular use of contraception and use of reliable method ; and number of subsequent deliveries ) , or improved ( for alcohol/drug treatment completed ; alcohol/drug abstinence ; subsequent delivery unexposed to alcohol/drugs ) . Improved outcomes at replication sites are not attributable to enrolling lower-risk women . Public policies and programs initiated over the study period may have had a positive effect on outcomes . Study findings suggest that this community-based intervention model is effective over time and across venues OBJECTIVE : To determine effectiveness of advice from general practitioners to heavy drinkers to reduce their excessive alcohol consumption ( 35 U or more a week for men , 21 U or more for women ) . DESIGN : R and omised , controlled double blind trial over 12 months with interim assessment at six months . SETTING : Group practice s ( n = 47 ; list size averaging 10,000 ) recruited from Medical Research Council 's general practice research framework , mostly in rural or small urban setting s. PATIENTS : Patients recruited after question naire survey . Of total of 2571 ( 61.2 % ) of 4203 patients invited for interview who attended , 909 ( 35.4 % ) stated that in past seven days they had drunk above the limits set for study and had not received advice ; they were r and omised to control and treatment groups . INTERVENTIONS : Patients in treatment group were interviewed by general practitioner ( who had had a training session ) and received advice and information about how to reduce consumption and also given a drinking diary . END POINT : Study aim ed at detecting a reduction in proportion of men with excessive alcohol consumption of 30 % in treatment group and 20 % in control group ( for women 40 % and 20 % , respectively ) with a power of 90 % at 5 % level of significance . In addition , corroborative measures such as estimation of gamma-glutamyltransferase activity were included . MEASUREMENTS AND MAIN RESULTS : At one year a mean reduction in consumption of alcohol of 18.2 ( SE 1.5 ) U/week had occurred in treated men compared with a reduction of 8.1 ( 1.6 ) U/week in controls ( p less than 0.001 ) . The proportion of men with excessive consumption at interview had dropped by 43.7 % in the treatment group compared with 25.5 % in controls ( p less than 0.001 ) . A mean reduction in weekly consumption of 11.5 ( 1.6 ) U occurred in treated women compared with 6.3 ( 2.0 ) U in controls ( p less than 0.05 ) , with proportionate reductions of excessive drinkers in treatment and control groups of 47.7 % and 29.2 % respectively . Reduction in consumption increased significantly with number of general practitioner interventions . At one year the mean value for gamma-glutamyltransferase activity had dropped significantly more in treated men ( -2.4 (0.9)IU/l ) than in controls ( + 1.1(1.0)IU/l ; t = 2.7 , p less than 0.01 ) . Reduction in gamma-glutamyltransferase activity tended to increase with number of intervention sessions in men . Changes in gamma-glutamyltransferase activity in women and changes in other indicators in both sexes did not differ significantly between treatment and control groups . CONCLUSIONS : If the results of this study were applied to the United Kingdom intervention by general practitioners could each year reduce to moderate levels the alcohol consumption of some 250000 men and 67500 women who currently drink to excess . General practitioners and other members of the primary health care team should therefore be encouraged to include counselling about alcohol consumption in their preventive activities AIM To analyse gender differences in the efficacy of stepped care brief interventions for general practice patients with alcohol problems . METHODS Data are part of " Stepped Interventions for Problem Drinkers , " in which 10,803 patients from 85 general practitioners were screened using alcohol related question naires ; 408 patients were r and omized ( 32 % were female ) to a control ( booklet only ) or two different intervention groups : stepped care ( feedback , manual , and up to three counselling sessions depending on the success of the previous intervention ) and fixed care ( four sessions ) . Response rate for the 12 months follow-up was 91.7 % . RESULTS Regression analysis revealed a significant effect size only in women ( P = 0.039 ) . After excluding alcohol dependents and binge drinkers , an effect size ( R(2 ) ) of 0.031 ( P Output:	The best evidence was for brief ( 10- to 15-minute ) multicontact interventions . Evidence was insufficient to draw conclusions about accidents , injuries , or alcohol-related liver problems . Trials enrolling young adults or college students showed reduced consumption and fewer heavy drinking episodes ( moderate strength of evidence ) . Little or no evidence of harms was found . CONCLUSION Behavioral counseling interventions improve behavioral outcomes for adults with risky drinking .
MS21141	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Over 650 million people globally are at risk of schistosomiasis infection , while more than 200 million people are infected of which the higher disease rates occur in children . Eighty three students between 6 - 20 years ( mean 12.45 ± 3.2 ) from Quran School for boys in Radwan village , Gezira state were recruited to investigate for the relationship between the genetic diversity of Schistosoma haematobium strains and the severity of the disease . MethodS chistosoma haematobium infection was detected by filtration of urine . Ultrasonography was done on each study subject , while PCR technique was used for genotyping via r and om amplified polymorphic DNA ( RAPD ) with A01 , A02 , A12 , Y20 and A13 primers . A01 primer gave three different genotypes ( A01 - 1 , A01 - 2 and A01 - 3 ) . Results About 54.2 % ( 45/83 ) were S. haematobium egg positive by urine filtration . On assessment of the upper and lower urinary tract by ultrasound technique , 61.4 % ( 51/83 ) were positive and 73.3 % ( 60/83 ) sample s were PCR positive . No significant difference was found when comparing the three different genotypes with severity of the disease . Conclusion This study concludes that no association was found between the different genotypes of S.haemtobium and the severity of the disease . Examination of more sample s from different areas to identify any possible differences between the parasites genes and disease severity was recommended Background Morbidity due to schistosomiasis is currently controlled by treatment of schistosome infected people with the antihelminthic drug praziquantel ( PZQ ) . Children aged up to 5 years are currently excluded from schistosome control programmes largely due to the lack of PZQ safety data in this age group . This study investigated the safety and efficacy of PZQ treatment in such children . Methods Zimbabwean children aged 1–5 years ( n = 104 ) were treated with PZQ tablets and side effects were assessed by question naire administered to their caregivers within 24 hours of taking PZQ . Treatment efficacy was determined 6 weeks after PZQ administration through schistosome egg counts in urine . The change in infection levels in the children 1–5 years old ( n = 100 ) was compared to that in 6–10 year old children ( n = 435 ) . Principal Findings Pre-treatment S. haematobium infection intensity in 1–5 year olds was 14.6 eggs/10 ml urine and prevalence was 21 % . Of the 104 children , 3.8 % reported side effects within 24 hours of taking PZQ treatment . These were stomach ache , loss of appetite , lethargy and inflammation of the face and body . PZQ treatment significantly reduced schistosome infection levels in 1–5 year olds with an egg reduction rate ( ERR ) of 99 % and cure rate ( CR ) of 92 % . This was comparable to the efficacy of praziquantel in 6–10 year olds where ERR was 96 % and CR was 67 % . Interpretation/ Significance PZQ treatment is as safe and efficacious in children aged 1–5 years as it is in older children aged 6–10 years in whom PZQ is the drug of choice for control of schistosome infections Background Schistosoma mansoni infection is proven to be a major health problem of preschool-age children in sub-Saharan Africa , yet this age category is not part of the schistosomiasis control program . The objective of this study was to compare the impact of single and double dose praziquantel ( PZQ ) treatment on cure rates ( CRs ) , egg reduction rates ( ERRs ) and re-infection rates 8 months later , in children aged 1 - 5 years living along Lake Victoria , Ug and a. Methodology /Principal Findings Infected children ( n= 1017 ) were r and omized to receive either a single or double dose of PZQ . Initially all children were treated with a single st and ard oral dose 40 mg/kg body weight of PZQ . Two weeks later a second dose was administered to children in the double dose treatment arm . Side effects were monitored at 30 minutes to 24 hours after each treatment . Efficacy in terms of CRs and ERRs for the two treatments was assessed and compared 1 month after the second treatment . Re-infection with S. mansoni was assessed in the same children 8 months following the second treatment . CRs were non-significantly higher in children treated with two 40 mg/kg PZQ doses ( 85.5 % ; 290/339 ) compared to a single dose ( 83.2 % ; 297/357 ) . ERRs were significantly higher in the double dose with 99.3 ( 95%CI : 99.2 - 99.5 ) compared with 98.9 ( 95%CI : 98.7 - 99.1 ) using a single dose , ( P = 0.01 ) . Side effects occurred more frequently during the first round of drug administration and were mild and short-lived ; these included vomiting , abdominal pain and bloody diarrhea . Overall re-infection rate 8 months post treatment was 44.5 % . Conclusions PZQ is efficacious and relatively safe to use in preschool-age children but there is still an unmet need to improve its formulation to suit small children . Two PZQ doses lead to significant reduction in egg excretion compared to a single dose . Re-infection rates with S. mansoni 8 months post treatment is the same among children irrespective of the treatment regimen OBJECTIVE To evaluate the efficacy and side effects of praziquantel ( PZQ ) in the treatment of schistosomiasis in Ethiopia . METHODS In a cross-sectional study , stool specimens were collected from r and omly selected 299 school children in Shesha Kekele Elementary School , Wondo Genet , Southern Ethiopia , in April 2010 . Stool specimens were examined using a single Kato-Katz thick smear for Schistosoma mansoni ( S. mansoni ) ova . Children who were found positive for S. mansoni were treated with a single oral dose of PZQ at 40 mg/kg bw and interviewed for treatment-related symptoms 24 hours after drug administration . Four weeks post-treatment , stool specimens were collected from the same children and examined following the same procedure as in the pre-treatment . Drug efficacy was determined based on cure and egg reduction rates . RESULTS Pre-treatment prevalence of S. mansoni infection was 74.9 % with geometric mean egg count of 268 . The evaluated generic PZQ produced an overall cure rate of 73.6 % ( P<0.000 1 , OR : 8.33 , CI : 5.3 - 13.1 ) and egg reduction rate of 68.2 % ( P=0.03 , F=0.64 ) . The cure rate showed significant association with age ( χ(2)=11 , P=0.004 ) , the highest rate being observed in the 15 - 22 age group . 83 % of S. mansoni infected children showed various treatment-related symptoms , the most frequent being headache , nausea , and abdominal pain . These symptoms were associated with age ( P<0.001 ) and pre-treatment intensity of infection ( P<0.05 ) . CONCLUSIONS The present observations revealed relatively lower cure and egg reduction rates of the PZQ evaluated as compared to previous reports for other PZQ br and s in Ethiopia . Hence , in depth studies are recommended to clarify whether the present relatively lower cure rate is the actual cure rate of the praziquantel evaluated , treatment failure , or reduced susceptibility of the parasite . Treatment-related side effects observed were transient and tolerable Background In 2012 the WHO formally recognised that infants and preschool children are at significant risk of schistosomiasis and qualify for treatment with praziquantel ( PZQ ) . Targeted surveys determining both the performance and safety of this drug are now needed in endemic areas . We have formally assessed parasitological cure and putative side-effects in a prospect i ve cohort of Schistosoma mansoni-infected children ( aged 5 months–7 years old ) in lakeshore setting s of Ug and a. Methodology /Principal Findings From a total of 369 children found to be egg-patent for intestinal schistosomiasis , 305 were followed-up three to four weeks after PZQ treatment and infection status re-assessed . Separately , a previously tested side-effect question naire was employed before and 24 hours after PZQ treatment to assess incidence and amelioration of symptoms in young children and their mothers . While the overall observed parasitological cure was 56.4 % , a significant difference was found between a sub-set of children who had a history of multiple PZQ treatments ( between one and four in an 18 month period ) , where cure rate was 41.7 % , and those who had never received treatment ( cure rate was 77·6 % ) . PZQ proved to be safe , with only mild reported side effects which cleared within a month after treatment . Prevalence of reported symptoms was significantly lower in children than in mothers , and fewer side-effects were reported upon subsequent rounds of PZQ treatment . Conclusion / Significance Our findings show that PZQ treatment of young children result ed in satisfactory cure rates , and marked reduction in egg-output , with only mild and transient reported side-effects . However , the cure rate is clearly lower in younger children and those with history of previous treatment . Cure rate , but not egg reduction rate , was also lower in children with heavier pre-intervention infection intensity . With chemotherapy now recommended as a long-term strategy for disease control in young children , research into optimising the periodicity of targeted treatment strategies is now crucial BACKGROUND The current recommended control strategy for schistosomiasis is annual treatment using 40 mg/kg of praziquantel . However , praziquantel is only effective on adult worms and giving a second dose may increase its efficacy . We assessed the effect of one versus two doses of praziquantel on cure rate and re-infection with Schistosoma mansoni in a high endemic community along Lake Victoria , Ug and a. METHODOLOGY To investigate the effect of the two regimens , 395 infected people were r and omised into two groups ; one received a single st and ard dose of praziquantel ( Distocide ® 600 mg , Shin Poong Pharmaceuticals , Seoul , Republic of Korea ) , 40mg/kg body weight , while the other group received a second dose 2 weeks later . Cure rate and infection intensity were assessed 9 weeks after the first treatment using st and ard parasitological procedures . Re-infection levels were monitored 8 and 24 months after treatment . RESULTS Those who received two doses were more likely to be cured ( 69.7 % ) compared to those who received a single dose ( 47.9 % ) ( χ(2 ) = 18.5 , p < 0.001 ) . Geometric mean intensity ( GMI ) of infection at 9 weeks ( eggs per gram of faeces [ epg ] ) was 12.0 epg ( CI95 : 8.9 - 16.1 ) for individuals who received 2 doses and 22.1 epg ( CI95 : 16.9 - 28.8 ) for those in the single dose arm . Eight months after treatment , prevalence of re-infection for individuals in the double dose arm ( 61.6 % , CI95 : 50.2 - 73.1 ) was not significantly different from that of those in a single dose arm ( 68.3 % , CI95 : 59.9 - 76.8 ) . The difference in GMI of re-infection for individuals in the single dose arm ( 33.8 epg , CI95 : 23.2 - 49.3 ) and those in the double dose arm ( 34.5 epg , CI95 : 24.7 - 48.1 ) was not significant . Twenty four months after treatment , prevalence of re-infection was not significantly different . The difference in GMI of re-infection for those in the single dose arm ( 57.5 epg , CI95 : 33.9 - 97.5 ) and those in the double dose arm ( 42.2 epg , CI95 : 29.9 - 59.6 ) was also insignificant . CONCLUSION Our results suggest that a second dose of praziquantel given 2 weeks after the first dose improves cure rate and reduces S. mansoni infection intensity . However , there is no added advantage on reduction of S. mansoni re-infection by administering two doses of praziquantel . CLINICAL TRIALS.GOV IDENTIFIER : NCT00215267 Disease outcome in persons infected with Schistosoma haematobium varies dramatically , ranging from mild symptoms to severe damage of the kidneys and /or bladder . We used ultrasonography to characterize the extent of urinary tract pathology of infected children in Zimbabwe , and r and om genetic markers to examine the relationship between genetic diversity of S. haematobium and clinical outcome . One hundred thirty-three parasite isolates from 12 students with mild lesions and 13 with severe lesions were compared . Using four r and omly amplified polymorphic DNA ( RAPD ) markers , we scored parasite allelic frequencies at 53 loci . Although parasite heterogene Output:	However , findings on efficacy of repeated doses in co-infection of S. mansoni and S. haematobium were not conclusive . Praziquantel administrated at 60 mg/kg was slightly more efficacious than the 40 mg/kg st and ard dose . Minor and transitory side-effects were reported for both regimens .
MS21142	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The aim of this study was to investigate the association between red blood cell ( RBC ) transfusion and haematocrit values with outcomes in infants with univentricular physiology undergoing surgery for a modified Blalock-Taussig shunt . MATERIAL AND METHODS This study included infants ≤ 2 months of age who underwent modified Blalock-Taussig shunt surgery at the Arkansas Children 's Hospital ( 2006 - 2012 ) . Infants undergoing a Norwood operation or Damus-Kaye-Stansel operation with modified Blalock-Taussig shunt were excluded . Demographics , pre-operative , operative , daily laboratory data , and post-operative variables were collected . We studied the association between haematocrit and blood transfusion with a composite clinical outcome . Multivariable logistic regression models were fitted to study the probability of study outcomes as a function of haematocrit values and RBC transfusions after operation . RESULTS Seventy-three patients qualified for inclusion . All study patients received blood transfusion within the first 48 hours after heart surgery . The median haematocrit was 44.3 ( interquartile range [ IQR ] 42.5 - 46.2 ) , and the median volume of RBC transfused was 28 mL/kg ( IQR , 10 - 125 ) in the first 14 days after surgery . The overall in-hospital mortality rate was 13.6 % ( 10 patients ) . A multivariable analysis adjusted for risk factors , including weight , prematurity , cardiopulmonary bypass and postoperative need for nitric oxide and dialysis , revealed no association between haematocrit values and RBC transfusion with the composite clinical outcome . DISCUSSION We did not find an association between higher haematocrit values and increasing RBC transfusions with improved outcomes in infants with shunt-dependent pulmonary blood flow and univentricular physiology . The power of our study was small , which prevents any strong statement on this lack of association . Future multi-centre , r and omised controlled trials are needed to investigate this topic in further detail Objective : To determine the impact of a restrictive vs. a liberal transfusion strategy on new or progressive multiple organ dysfunction syndrome in children post cardiac surgery . The optimal transfusion threshold after cardiac surgery in children is unknown . Design : R and omized , controlled trial . Setting : Tertiary pediatric intensive care units . Patients : Participants are a subgroup of pediatric patients post cardiac surgery from the TRIPICU ( Transfusion Requirements in Pediatric Intensive Care Units ) study . Exclusion criteria specific to the cardiac surgery subgroup included : age < 28 days and patients remaining cyanotic . Intervention : Critically ill children with a hemoglobin ≤95 g/L within 7 days of pediatric intensive care unit admission were r and omized to receive prestorage leukocyte-reduced red-cell transfusion if their hemoglobin dropped either < 70 g/L ( restrictive ) or 95 g/L ( liberal ) . Measurements and Main Results : Postoperative cardiac patients ( n = 125 ) from seven centers were enrolled . The restrictive ( n = 63 ) and liberal ( n = 62 ) groups were similar at baseline in age ( mean ± st and ard deviation = 31.4 ± 38.1 mos vs. 26.4 ± 39.1 mos ) , surgical procedure , severity of illness ( Pediatric Risk of Mortality score = 3.4 ± 3.2 vs. 3.2 ± 3.2 ) , multiple organ dysfunction syndrome ( 46 % vs. 44 % ) , mechanical ventilation ( 62 % vs. 60 % ) , and hemoglobin ( 83 vs. 80 g/L ) . Mean hemoglobin remained 21 g/L lower in the restrictive group after r and omization . No significant difference was found in new or progressive multiple organ dysfunction syndrome ( primary outcome ) in the restrictive group vs. liberal group ( 12.7 % vs. 6.5 % ; p = .36 ) , pediatric intensive care unit length of stay ( 7.0 ± 5.0 days vs. 7.4 ± 6.4 days ) or 28-day mortality ( 3.2 % vs. 3.2 % ) . Conclusion : In this subgroup analysis of cardiac surgery patients , a restrictive red-cell transfusion strategy , as compared with a liberal one , was not associated with any significant difference in new or progressive multiple organ dysfunction syndrome , but this evidence is not definitive Objective : Perioperative transfusion has adverse effects in adults undergoing cardiac surgery . We sought to investigate whether greater use of blood and blood products might be an independent predictor of prolonged postoperative recovery , indicated by duration of mechanical ventilation ( DMV ) , after reparative infant heart surgery . Design : Secondary analysis of prospect ively collected data from two r and omized trials of hematocrit strategy during cardiopulmonary bypass in infant heart surgery to explore the association of DMV with perioperative transfusion and other variables . Setting : Tertiary pediatric hospital . Patients : Two hundred seventy infants undergoing two ventricle corrective cardiac surgery without aortic arch reconstruction . Measurements and Main Results : In univariable analyses , longer DMV was associated with younger age and lower weight at surgery , diagnostic group , and higher intraoperative and postoperative blood product transfusion ( each p < .001 ) . In multivariable proportional hazard regression , longer total support time and greater intraoperative and early postoperative blood products per kg were the strongest predictors of longer DMV . Patients in the highest tertile of intraoperative blood products per kg had an instantaneous risk of being extubated approximately half that of patients in the lowest tertile ( hazard ratio , 0.51 ; 95 % confidence interval , 0.35 , 0.73 ) . Patients who received any blood products on postoperative day 1 , compared with those who did not , had a hazard ratio for extubation of 0.65 ( 95 % confidence interval , 0.50 , 0.85 ) . Conclusions : In this exploratory secondary analysis of infants undergoing two ventricular repair of congenital heart disease without aortic arch obstruction , greater intraoperative and early postoperative blood transfusion emerged as potential important risk factors for longer DMV . Future prospect i ve clinical trials are needed to determine whether reduction in blood product administration hastens postoperative recovery after infant heart surgery BACKGROUND Blood transfusion in adults is associated with increased mortality and morbidity after cardiac operations . The aim of this study was to identify the main predictors of blood transfusion and explore the relationship between blood transfusion and adverse outcomes in a pediatric population . METHODS We retrospectively analyzed a prospect ively collected data base ( January 2002 to December 2003 ) of 657 consecutive pediatric patients undergoing open heart procedures in a tertiary pediatric cardiac center . Risk models were calculated for each blood product and for the total amount of blood transfused during the operation and in the first 24 hours . Postoperative adverse events were investigated after propensity score adjustment . RESULTS During the postoperative period , 30 patients ( 4.6 % ) died , 80 ( 12.2 % ) sustained nonvascular pulmonary complications , and 113 ( 17.2 % ) had infection . The risk model for the total amount of blood transfusion included weight , preoperative creatinine clearance , preoperative mechanical ventilation , duration of operation and cross-clamp , surgeon , delayed chest closure , inotropic dose , and nitric oxide administration . Univariate analyses demonstrated significant associations between blood transfusion and occurrence of every complication except of neurologic events . After adjustment for propensity score and disease severity , the total amount of blood transfusion was independently associated with an increased risk for infections ( odds ratio , 1.01 ; 95 % confidence interval , 1.002 to 1.02 ; p = 0.01 ) . Transfusion of platelets was associated with lower incidence of nonvascular pulmonary complications ( odds ratio , 0.89 ; 95 % confidence interval , 0.79 to 0.99 ; p = 0.049 ) . CONCLUSIONS The amount of blood transfusion is independently associated with infections but not with mortality The importance and variability of pre‐operative anaemia in cardiac surgical patients across the UK is not known , and there is debate about its association with patient outcomes . The Association of Cardiothoracic Anaesthetists carried out its first national audit on anaemia and transfusion , and analysed data from 19,033 patients operated on in 12 cardiac surgical centres between 2010 and 2012 ; 5895 ( 31 % ) had pre‐operative anaemia . Centre‐specific prevalence of anaemia varied from 23 % to 45 % ; anaemia was associated with older patients , diabetes and surgical risk ( EuroSCORE ) . Nevertheless , controlling for these factors , regional variation remained an independent effect ( p < 0.001 ) . Multivariable analysis demonstrated an independent association of anaemia with transfusion ( odds ratio ( 95 % confidence interval ) 2.75 ( 2.55–2.95 ) , p < 0.001 ) , mortality ( 1.42 ( 1.18–1.71 ) , p < 0.001 ) and hospital stay ( geometric mean ratio ( 95 % confidence interval ) 1.15 ( 1.13–1.17 ) , p < 0.001 ) . Haemoglobin concentration per se was also independently associated with worse outcomes ; a 10 g.l−1 decrease in haemoglobin was associated with a 43 % increase ( 95 % confidence interval 40–46 % ) in the odds of transfusion and a 16 % increase ( 95 % confidence interval 10–22 % ) in the odds of mortality ( both p < 0.001 ) . This large UK‐wide audit has demonstrated marked regional variation in both anaemia and transfusion , with a consistently high incidence of both . The independent association between pre‐operative anaemia and worse outcomes in UK practice has also been confirmed , and robust prospect i ve study of anaemia treatment before cardiac surgery is required ; these data will assist in design ing such trials BACKGROUND Red blood cell ( RBC ) transfusions are common in the pediatric intensive care unit ( PICU ) . However , there are no recent data on transfusion practice s in the PICU . Our objective was to determine transfusion practice in the PICU , to compare this practice with that observed 10 years earlier , and to estimate the compliance to the recommendation of a large r and omized clinical trial , the Transfusion Requirements in Pediatric Intensive Care Unit ( TRIPICU ) study . STUDY DESIGN AND METHODS This was a single-center prospect i ve observational study over a 1-year period . Information was abstract ed from medical charts . Determinants of transfusion were search ed for daily until the first transfusion in transfused cases or until PICU discharge in nontransfused cases . The justifications for transfusions were assessed using a question naire . RESULTS Of 913 consecutive admissions , 842 were included . At least one RBC transfusion was given in 144 patients ( 17.1 % ) . The mean hemoglobin ( Hb ) level before the first transfusion was 77.3 ± 27.2 g/L. The determinants of a first transfusion event retained in the multivariate analysis were young age ( < 12 months ) , congenital cardiopathy , lowest Hb level of not more than 70 g/L , severity of illness , and some organ dysfunctions . The three most frequently quoted justifications for RBC transfusion were a low Hb level , intent to improve oxygen delivery , and hemodynamic instability . The main recommendation of the TRIPICU study was applied in 96.4 % of the first transfusion events . CONCLUSIONS RBC transfusions are frequent in the PICU . Young age , congenital heart disease , low Hb level , severity of illness , and some organ dysfunctions are significant determinants of RBC transfusions in the PICU . Most first transfusion events were prescribed according to recent recommendations Objective : To examine the impact of a restrictive vs. liberal transfusion strategy on arterial lactate and oxygen content differences in children with single-ventricle physiology post cavopulmonary connection . Children with single-ventricle physiology are routinely transfused postoperatively to increase systemic oxygen delivery , and transfusion thresholds in this population have not been studied . Design : Prospect i ve , r and omized , controlled , clinical trial . Setting : Pediatric cardiac intensive care unit in a teaching hospital . Patients : Infants and children ( n = 60 ) with variations of single-ventricle physiology presenting for cavopulmonary connection . Interventions : Subjects were r and omized to a restrictive ( hemoglobin of < 9.0 g/dL ) , or liberal ( hemoglobin of ≥13.0 g/dL ) transfusion strategy for 48 hrs post operation . Primary outcome measures were mean and peak arterial lactate . Secondary end points were arteriovenous ( C(a-v)o2 ) and arteriocerebral oxygen content ( C(a-c)o2 ) differences and clinical outcomes . Measurements and Main Results : A total of 30 children were in each group . There were no significant preoperative differences . Mean hemoglobin in the restrictive and liberal groups were 11 ± 1.3 g/dL and 13.9 ± 0.5 g/dL , respectively ( Output:	Conclusion : Evidence from RCTs in pediatric cardiac surgery , though limited , showed non-inferiority of restrictive thresholds over liberal thresholds in length of ICU stay and other outcomes following red blood cell transfusion .
MS21143	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose : To investigate the perceived clinical outcome and parents ’ satisfaction after dental rehabilitation under general anesthesia over a follow-up period of 2 years . Material s and Methods : A prospect i ve study of question naire data obtained from 352 pediatric patients before and after treatment of early childhood caries with full dental rehabilitation under general anesthesia . Question naires focused on oral symptoms , functional limitations , and emotional and social well-being before and after dental treatment . Cases were followed up for 2 years postoperatively . Results : A dramatic disappearance of symptoms was reported from parents ’ perspective . There was a high satisfaction rate ( 99.14 % ) also among parents of the children included in the study . Conclusion : Children with early childhood caries do not necessarily express it verbally as pain . The disease has a lot of other expressions affecting children 's behavior and habits , including the ability to sleep , thrive , and socialize . This study contributes to the existing literature that full dental rehabilitation under general anesthesia [ dental general anesthesia ( DGA ) ] has an immediate positive impact on the physical and social quality of life of children suffering from early childhood caries as well as on their families . Postoperative preventive care , early diagnosis , and treatment of recurrent caries are key factors to maintain postoperative outcome of DGA OBJECTIVE To compare subjective pain experience and oral health-related quality of life ( OH-QoL ) in treated and untreated subjects over the first 3 months of fixed appliance therapy . SETTING AND SAMPLE POPULATION The Department of Orthodontics , School of Medicine and Dentistry . One hundred and twenty-four subjects aged between 11 and 14 years either commencing or awaiting fixed appliance treatment . MATERIAL & METHODS A prospect i ve controlled longitudinal study design was applied to subjects , over a 3-month observation period , following the placement of fixed appliances . Socio-economic status , OH-QoL , pain experience and analgesic consumption were recorded on question naires at baseline ( T0 ) , 6 weeks ( T1 ) and 3 months ( T2 ) . RESULTS Oral symptoms and functional limitation domains of OH-QoL were found to worsen , during the follow-up period , in the test group ( p = 0.001 and p = 0.002 , respectively ) . In the treated group , pain intensity declined significantly on days 3 and 2 at T1 and T2 , respectively ( p < 0.001 ) . Analgesia was required during both periods in a total of 13 participants ( 24.5 % ) undergoing orthodontic treatment . CONCLUSION Based on this prospect i ve controlled study , the initial stages of fixed appliance treatment results in subjective pain experience , with subsequent reduction , and a significant impact on oral symptoms and functional limitation domains of Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Abstract Our goal was to evaluate how dental treatments under general anesthesia ( GA ) affect the quality of life by a prospect i ve pair-matched design . Pediatric patients , who had received dental treatments under GA , were enrolled and were asked to complete the Early Childhood Oral Health Impact Scale ( ECOHIS ) before the treatment and 1 month after the treatment . To shield the observed impacts , a pair-matched control group was performed . Patients in the control group were also required to complete the ECOHIS at these different points in time . In both groups , the items of troubled sleep and oral/dental pain scored highest , whereas avoiding smiling or laughing and avoiding talking scored lowest before the treatment . The total mean score in the 2 groups was 13.1 and 13.7 , respectively , and there was no significant statistical difference ( P > 0.05 ) . However , the total mean score was 1.9 in the experimental group after the treatment and smaller compared with the control group ( 1.9 vs. 4.7 , P < 0.001 ) . The majority of the items in both groups had an apparent effect size and the total mean effect in the experimental group was greater than that in the control group ( 85.5 % vs. 65.7 % , P < 0.001 ) . Therefore , dental treatment under GA could provide better quality of life restoration compared with treatment over multiple visits We present data from two studies which clarify the relationship between the responsiveness and validity of instruments design ed to measure health status in clinical trials . In a controlled trial of long vs short duration adjuvant chemotherapy for women with Stage II breast cancer , the Breast Cancer Chemotherapy Question naire ( BCQ ) proved valid as a measure of subjective health status and was able to distinguish long vs short arms . Well vali date d measures of physical and emotional function developed by the R and Corporation were unable to distinguish between the two groups . The Eastern Co-operative Oncology Group Criteria ( ECOG ) distinguished the two groups , but failed criteria of clinical sensibility as a measure of subjective health status . In a study of patients with Crohn 's disease and ulcerative colitis , the Inflammatory Bowel Disease Question naire ( IBDQ ) showed small intrasubject variability over time . Gobal ratings of change showed moderate to high correlations with changes in IBDQ score , and patients who reported overall improvement or deterioration showed large changes in IBDQ score . Each of these findings support , in different ways , the reproducibility , validity , and responsiveness of the question naire . While the same data can at times bear on both validity and responsiveness , when assessing evaluative instruments it is useful to make a conceptual distinction between the two OBJECTIVES This study examined the responsiveness of the Early Childhood Oral Health Impact Scale ( ECOHIS ) to dental treatment of early childhood caries ( ECC ) in a primary dental care setting . METHODS Parents of children participating in a r and omized controlled trial completed the ECOHIS at baseline and follow-up , and rated the global oral health transition of their child at follow-up ( ' worsened ' , ' no change ' , ' improved ' ) . Change scores were calculated and longitudinal construct validity assessed by examining the association between change scores and global oral health transition groups . ECOHIS changes from baseline to follow-up within global transition groups were also evaluated . Effect sizes , minimally important difference , and Guyatt 's responsiveness index were calculated to examine the scale 's sensitivity and responsiveness . RESULTS After 11.3 months , complete question naire data were available for 189 participants ; 59 % reported ' improved ' oral health . The follow-up scores were significantly lower in the child psychology , parental distress and family impact section , P < 0.001 , and in the child social interaction , family function and the total ECOHIS scores , P < 0.05 , Wilcoxon signed-rank test . There was a significant difference in changed scores among the global transition groups , P < 0.05 , Kruskal-Wallis test , and the difference was significant between ' worsened ' and ' improved ' groups for the family impact and the total ECOHIS scores , Dunn test , P < 0.05 . Effect sizes were small , 0.17 , 0.33 , 0.30 for the child impact , family impact and total ECOHIS scores , respectively , for those reporting ' improved ' oral health . CONCLUSIONS The responsiveness of the ECOHIS to the treatment of ECC in primary dental care setting s was modest , and its use to measure treatment effects in primary care setting s requires further investigations AIM To assess changes over time and determine the minimally important difference ( MID ) in the Oral Impact on Daily Performances ( OIDP ) index for patients with severe generalized periodontitis receiving periodontal treatment . METHODS This study was nested in a larger r and omized controlled trial and consisted of 45 consecutive subjects of the larger trial ( 17 receiving intensive and 28 receiving conservative periodontal care ) . The OIDP index assessed impacts on quality of life ( QoL ) at baseline and 1 month after treatment . Repeated- measures ANOVA was used for comparison over time and between treatment groups . To estimate the MID , two subjective global transition scales , related to periodontal and oral health , respectively , were used as anchors , whereas the effect size ( ES ) , st and ardized response mean and st and ard error of measurement were also calculated . RESULTS The mean OIDP score after treatment was significantly lower than at baseline , indicating improvement in QoL , but there were no differences between treatment groups . Based on an agreement between different methods , the MID of the OIDP index was around five scale points and corresponded to a moderate ES . CONCLUSION The MID for the OIDP index among patients treated for severe generalized periodontitis provides meaning to change scores and facilitates interpretation of findings This study aim ed to evaluate the impact of dental caries treatment on oral health-related quality of life ( OHRQoL ) among schoolchildren and the responsiveness of the Child Perceptions Question naire ( CPQ8 - 10 ) instrument . Brazilian schoolchildren , 8 - 10 yr of age , were r and omly selected and assigned to two groups -- dental caries treatment ( DCT ) and caries-free (CF)--according to their caries experience [ decayed , missing , or filled primary teeth ( dmft ) and decayed , missing or filled secondary teeth ( DMFT ) values of ≥ 0 ] . The CPQ8 - 10 instrument was administered at baseline and at 4 wk of follow-up ( i.e. 4 wk after completion of dental treatment ) . In the DCT group , increases in CPQ8 - 10 scores were observed between the baseline and follow-up results . However , longitudinal evaluation of the CF group demonstrated no statistically significant difference in CPQ8 - 10 scores . Responsiveness of the CPQ8 - 10 instrument ( magnitude of change in CPQ8 - 10 scores ) in the DCT group was greater ( effect size > 0.7 ) than in the CF group . The findings of this study show that dental caries treatment has an important impact on OHRQoL of children . The CPQ8 - 10 was considered an acceptable instrument for longitudinal measurement of changes in Abstract Objective : Our aim was to analyze longitudinally the impact of young children ’s dental general anaesthesia ( DGA ) treatment on their OHRQoL and to determine their post-operative oral health status at the six-month follow-up together with parental ratings of their children ’s oral health . Material and methods : We conducted a prospect i ve follow-up study of OHRQoL among Lithuanian child patients treated under general anaesthesia ( n = 144 ) . The study consisted of clinical dental examinations performed by two examiners at the time of DGA and at the six-month recall , along with OHRQoL surveys and data collected from the patients ’ files . The dmft index and Silness – Löe plaque index served as clinical measures . The survey tool for assessing the children ’s OHRQoL was the previously tested Lithuanian version of the ECOHIS . The Wilcoxon signed-rank test served for the statistical analysis ( p < 0.05 ) . Results : The ECOHIS scores clearly decreased post-operatively , indicating a significant ( p < 0.001 ) improvement in the children ’s OHRQoL after the DGA treatment . The ECOHIS scores were lower immediately after the DGA treatment and remained low at the six-month recall . Parents rated their child ’s oral health as higher after the DGA treatment ( p < 0.001 ) . The majority ( 75 % ) of the patients had poor or satisfactory oral hygiene at follow-up . Conclusions : This longitudinal study showed a sustained improvement in the children ’s OHRQoL six months after their DGA treatment . Post-operative parental ratings of their child ’s oral health were higher after the DGA treatment , but the children exhibited insufficient oral hygiene and new caries lesions . An appropriate follow-up system for children receiving DGA treatment with special focus on preventive care is needed BACKGROUND The aim of this study was to compare changes in child oral health-related quality of life ( COHRQoL ) after treatment for early childhood caries ( ECC ) using two alternative treatment approaches . METHODS A r and omized control trial with r and om allocation of parent/child dyads with ECC to test ( minimum intervention ) or control ( st and ard care ) . Participating parents completed the Early Childhood Oral Health Impact Scale ( ECOHIS ) at baseline and follow-up . Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups , Wilcoxon 's rank-sum test , and matched-pairs signed-rank test . RESULTS Two hundred and fifty-four children were r and omized ( test = 127 ; control = 127 ) . At baseline , mean ECOHIS score 11.1 , sd 8.2 ; mean age = 3.8 years , sd 0.90 ; mean dmft = 4.9 , sd 4.0 ; and 59 % male . After a mean interval of 11.4 months , 210 children were followed-up and returned a completed question naire ( test = 111 ; control = 99 ) . There was no significant difference in COHRQoL changes between test and control . For all the children combined , there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS , Wilcoxon signed-rank test , p < 0.05 . CONCLUSIONS COHRQoL improved with primary dental care for ECC , and there was no statistically significant difference between test and control in the extent of the improvement BACKGROUND Oral health-related quality of life ( OHRQoL ) Output:	In conclusion , there is evidence that the OHRQoL of children and adolescents improved following caries intervention procedures , but the quality of the evidence was very low . In spite of that , caries interventions are highly recommended as abstaining from treatment is likely to result in a deterioration of
MS21144	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) achieve similar type 2 diabetes mellitus ( T2DM ) remission rates . Since a great variability exists in defining T2DM remission , an expert panel proposed partial and complete remission criteria that include the maintenance of fasting plasma glucose ( FPG ) and glycosylated hemoglobin ( A1c ) objectives for at least 1 year . The 2-year T2DM remission rate and time needed to reach it after LSG or LRYGB were compared using different remission criteria . Methods This was a prospect i ve cohort study of 55 T2DM subjects operated on with LSG ( n = 21 ) or LRYGB ( n = 34 ) . Four models for defining remission were used : Buchwald criteria ( FPG < 100 mg/dl or A1c < 6 % ) , American Diabetes Association ( ADA ) complete ( FPG < 100 mg/dl plus A1c < 6 % maintained for at least 1 year ) , ADA partial ( FPG < 125 mg/dl with A1c < 6.5 % maintained for at least 1 year ) , and ADA complete without time requirement . Results Both groups were comparable , except for higher A1c levels in the LSG group . The remission rate ranged from 43.6 % using ADA complete remission to 92.7 % with Buchwald criteria , with no differences between surgical procedures . Differences were found in the time to achieve remission only when ADA complete remission criteria ( 5.1 ± 2.9 months LRYGB and 9.0 ± 3.8 months LSG , p = 0.014 ) and ADA without time requirement criteria ( 4.9 ± 2.7 months LRYGB and 8.4 ± 3.9 months LSG , p = 0.005 ) were used . Conclusions T2DM remission rate varies widely depending on the criteria used for its definition . Remission occurred sooner after LRYGB when the strictest criteria to define remission were used Objective : To present long-term results of a large series of patients su bmi tted to laparoscopic Roux-en-Y gastric bypass ( RYGBP ) for morbid obesity . Background : Reports on long-term results of RYGBP are scarce and focus primarily on weight loss . Our aim is to provide mid- to long-term data of RYGBP , with detailed results on weight loss , evolution of comorbidities and quality of life , also using the BAROS score . Methods : All patients who underwent a primary RYGBP for morbid obesity in our 2 hospitals between 1999 and August 2008 were included . Data were collected prospect ively in a computerized data base , and review ed for the purpose of this study . Results : A total of 379 patients were included in the analysis of long-term results , 282 women , and 97 men , with a mean BMI of 46.3 kg/m2 . After 5 years , 74.9 % of the patients achieved an excess weight loss of at least 50 % , with a mean of 62.7 % and 76.8 % achieved a BMI < 35 kg/m2 . The corresponding figures after 7 years were 64.9 , 58.1 , and 71.9 , respectively . There was a small but significant long-term weight regain . All comorbidities improved markedly in the vast majority of patients , with no significant difference between the 3- and 5-year terms . Quality of life also improved markedly , and more than 95 % of the patients had a good to excellent 5-year overall result according to the BAROS score . Conclusions : Laparoscopic RYGBP for morbid obesity results in good and maintained weight loss up to 7 years in the majority of patients , improves quality of life and markedly improves all the evaluated comorbidities , result ing in good to excellent overall 5-year results in 97 % of the patients according to the BAROS score BACKGROUND Obesity not only increases the chances of developing diabetes-one of the top causes of death in the United States-but it also results in further medical complications . OBJECTIVE To compare the 6-month and 1-year postoperative remission rates of type 2 diabetic ( T2D ) patients after bariatric surgery based on preoperative glycosylated hemoglobin ( A1C ) stratification and pharmacologic therapy : insulin-dependent diabetic ( IDD ) versus noninsulin-dependent diabetic ( NIDD ) . SETTING Academic hospital , United States . METHODS We retrospectively analyzed a prospect ively maintained data base of 186 obese patients with a diagnosis T2D who had undergone either a sleeve gastrectomy or a Roux-en-Y gastric bypass surgery at our hospital . RESULTS At 6 months ( n = 180 ) , patients who were stratified by preoperative A1C levels ( < 6.5 ; ≥6.5 to<8 ; ≥8 ) had 70.5 % , 51.7 % , and 30.0 % remission rates ( P<.001 ) and at 1 year ( n = 118 ) patients had 72.0 % , 54.0 % , and 42.8 % remission rates ( P = .053 ) , respectively . When patients were substratified by preoperative pharmacologic therapy , IDD and NIDD patients had different remission rates within the same A1C level . At 6-months follow-up within A1C ≥6.5 to<8 ( IDD versus NIDD ) , the remission rate was 23.5 % versus 64.1 % ( odds ratio [ OR ] : .173 , confidence interval [ CI ] : .0471 , .6308 , P = .0079 ) , and within A1C ≥8 the remission was 24.0 % versus 37.5 % ( OR : .5263 , CI : .2115 , 1.3096 , P = .1676 ) , respectively . At 1-year follow-up within A1C ≥6.5 to<8 , the remission rate was 30.0 % versus 62.9 % ( OR : .2521 , CI : .0529 , 1.2019 , P = .0838 ) , and within A1C ≥8 the remission was 31.4 % versus 61.9 % ( OR : .2821 , CI : .0908 , .8762 , P = .0286 ) , respectively . Furthermore , when IDD patients were compared between A1C ≥6.5 to<8 and A1C ≥8 the remission rates were nearly identical , and for NIDD patients A1C was not significantly associated with remission regardless of the level , except at 6 months . CONCLUSION While a difference was observed between overall A1C levels-the lower the A1C level , the higher the remission rate-IDD patients had lower remission rates than NIDD patients irrespective of A1C levels ; further , IDD patients performed similarly across A1C levels Importance Sleeve gastrectomy is increasingly used in the treatment of morbid obesity , but its long-term outcome vs the st and ard Roux-en-Y gastric bypass procedure is unknown . Objective To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss , changes in comorbidities , increase in quality of life , and adverse events . Design , Setting , and Participants The Swiss Multicenter Bypass or Sleeve Study ( SM-BOSS ) , a 2-group r and omized trial , was conducted from January 2007 until November 2011 ( last follow-up in March 2017 ) . Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers , 217 patients were enrolled and r and omly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period . Interventions Patients were r and omly assigned to undergo laparoscopic sleeve gastrectomy ( n = 107 ) or laparoscopic Roux-en-Y gastric bypass ( n = 110 ) . Main Outcomes and Measures The primary end point was weight loss , expressed as percentage excess body mass index ( BMI ) loss . Exploratory end points were changes in comorbidities and adverse events . Results Among the 217 patients ( mean age , 45.5 years ; 72 % women ; mean BMI , 43.9 ) 205 ( 94.5 % ) completed the trial . Excess BMI loss was not significantly different at 5 years : for sleeve gastrectomy , 61.1 % , vs Roux-en-Y gastric bypass , 68.3 % ( absolute difference , −7.18 % ; 95 % CI , −14.30 % to −0.06 % ; P = .22 after adjustment for multiple comparisons ) . Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass ( 60.4 % ) than after sleeve gastrectomy ( 25.0 % ) . Gastric reflux worsened ( more symptoms or increase in therapy ) more often after sleeve gastrectomy ( 31.8 % ) than after Roux-en-Y gastric bypass ( 6.3 % ) . The number of patients with reoperations or interventions was 16/101 ( 15.8 % ) after sleeve gastrectomy and 23/104 ( 22.1 % ) after Roux-en-Y gastric bypass . Conclusions and Relevance Among patients with morbid obesity , there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery . Trial Registration clinical trials.gov Identifier : Introduction Bariatric surgery is considered the most effective treatment for obesity . A recent worldwide survey demonstrated that Laparoscopic Sleeve Gastrectomy ( LSG ) is the most commonly performed bariatric procedure , while Laparoscopic Adjustable Gastric B and ing ( LAGB ) has been almost ab and oned . Objectives The aim of this retrospective study was to compare 5-year results of LSG and LAGB at our Institution . Material s and Methods Prospect i ve maintained data base of our Institution was review ed to find all patients who had undergone LSG between January 2009 and December 2011 . Inclusion criteria were BMI of 40–50 kg/m2 and age of 18–60 years old . Patients with Class I and II obesity , superobese subjects , and patients with previous history of bariatric surgery were excluded . Data on sex , age , pre-operative BMI , obesity-related diseases ( diabetes , hypertension , dyslipidemia ) , and early and late complications were collected . Each subject who underwent LSG was matched one-to-one with a patient that had undergone LAGB . Outcomes were analyzed at 1 , 3 , and 5 years of follow-up . Results A total number of 122 patients were included in this study , 61 in each group . Better % EWL was observed in the LSG group at 1 , 3 , and 5 years . Both procedures induced improvements of obesity-related diseases without significant difference . In the LAGB group , ten patients underwent uneventful b and removal . In the LSG group , two patients had serious postoperative complications . Conclusion LSG achieves better % EWL than LAGB within 5 years , but comorbidities improvement is not significantly different . Severity of complication is higher after LSG . LAGB is still a good option for selected patients Background Bariatric surgery is currently the most effective treatment for morbid obesity . It provides not only substantial weight loss , but also resolution of obesity-related comorbidities . Laparoscopic sleeve gastrectomy ( LSG ) has rapidly been gaining in popularity . However , there are limited data on the reduction of obesity-related comorbidities for LSG compared to laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . The aim of this study was to assess the effectiveness of laparoscopic LSG versus LRYGB for the treatment of obesity-related comorbidities . Methods A total of 558 patients who underwent either LSG or LRYGB for morbid obesity at the Westchester Medical Center between April 2008 and September 2010 were included . Data were collected prospect ively into a computerized data base and review ed for this study . Fisher ’s exact test analyses compared 30-day , 6-month , and 1-year outcomes of obesity-related comorbidities . Results A total of 558 patients were included in the analysis of obesity-related comorbidity resolution ; 200 underwent LSG and 358 underwent LRYGB . After 1 year , 86.2 % of the LSG patients had one or more comorbidities in remission compared to 83.1 % LRYGB patients ( P = 0.688 ) . With the exception of GERD ( −0.09 vs. 50 % ; P < 0.001 ) , similar comorbidity remission rates were observed between LSG and LRYGB for sleep apnea ( 91.2 vs. 82.8 % ; P = 0.338 ) , hyperlipidemia ( 63 vs. 55.8 % ; P = 0.633 ) , hypertension ( 38.8 vs. 52.9 % ; P = 0.062 ) , diabetes Output:	After stratifying for different criteria for remission , RYGB still tended to result in higher remission rates , but the difference was not statistically significant . This review demonstrates important remission of T2DM following SG . Nevertheless , as remission was significantly more often observed following RYGB surgery , the latter procedure remains the gold st and ard for reaching T2DM remission in patients with concurrent obesity
MS21145	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Complications of intravenous therapy with steel needles and small-bore Teflon catheters were compared in a r and omized study of 954 cannula insertions . Cannulas were inserted and cared for by an intravenous team following a st and ard protocol . There were no cases of cannula-related septicemia and only one case of local infection , a cellulitis in the group in which Teflon catheters were used . There was a low incidence of positive semiquantitative cannula cultures in both treatment groups ( steel needles 1.5 percent , Teflon catheters 1.4 percent ) . The risk of phlebitis was significantly greater with Teflon catheters ( 18.8 percent with Teflon catheters , 8.8 percent with steel needles , adjusted odds ratio 1.87 ) . Steel needles were significantly associated with infiltration ( 17.9 percent with Teflon catheters , 40.1 percent with steel needles , adjusted odds ratio 0.39 ) . The over-all rate of complications was significantly greater for the group in which steel needles were used ( 53.8 versus 64.0 percent , adjusted odds ratio 0.72 ) , principally due to the increased risk of infiltration with steel needles . Analysis of the per day risk of infiltration and phlebitis revealed that these relationships were present for each day the cannulas remained in place . We conclude ( 1 ) that steel needles and small-bore Teflon catheters can both be used with low risk of infection and ( 2 ) that Teflon catheters more frequently cause phlebitis , whereas steel needles infiltrate more readily OBJECTIVE An examination glove that delivers aloe vera ( AV ) gel to the gloved h and was studied in 30 adult females with bilateral occupational dry skin with or without irritant contact dermatitis ( with or without erythema , fissures , and excoriations ) . METHODS All participants were factory assembly-line workers with repeated superficial skin trauma who attributed their dry , irritated , emollient-dependent skin to a common cause ( occupational exposure ) . Participants were sequentially enrolled ( after written informed consent , n = 29 evaluable participants ) into an open , contralateral comparison study to evaluate efficacy of AV glove use 8 h/day to one h and versus no use to the opposite h and for 30 days , followed by 30 days rest , followed by 10 days of repeated use . Participant 's dorsal h and s were documented by st and ardized photos at baseline , during , and at the end of study . RESULTS Unblinded investigator baseline assessment rated dry skin as mild to moderate ( n = 27 ) , or moderate to severe ( n = 2 ) . Mean time to noticeable improvement for the AV glove h and was 3.5 days ( range : 2 - 6 days ) whereas marked improvement was 10.4 days ( range : 7 - 17 days ) for the AV glove h and . No improvement was detected for nonglove h and s. Blinded photo assessment was rated independently by dermatology research staff . End-of- study mean global assessment of AV glove h and s versus nonglove h and s was 1.3 for AV glove h and ( 0 = no change , 1 = good [ 10%-89 % global improvement ] , 2 = marked improvement [ 90%-100 % global improvement ] ) versus 0 for nonglove h and ( P < .0001 ) . Mean global end-of- study assessment s by the participants = 2.0 for AV glove h and versus 0 for nonglove h and . CONCLUSION Dry-coated AV gloves that provide for gradual delivery of AV gel to skin produced a uniformly positive outcome of improved skin integrity , decreased appearance of fine wrinkling , and decreased erythema in the management of occupational dry skin and irritant contact dermatitis OBJECTIVE To identify risk factors for infusion-related phlebitis with peripheral intravenous catheters . DESIGN A r and omized trial of two catheter material s , with consideration of 21 potential risk factors . SETTING A university hospital . PATIENTS Hospitalized adults without granulocytopenia who received a peripheral intravenous catheter . INTERVENTIONS House officers or ward nurses inserted the catheters , and each insertion was r and omized to a catheter made of tetrafluoroethylene-hexafluoropropylene ( FEP-Teflon ) or a novel polyetherurethane without leachable additives ( PEU-Vialon ) . MEASUREMENTS Research nurses scored insertion sites each day for inflammation and cultured catheters at removal . RESULTS The Kaplan-Meier risk for phlebitis exceeded 50 % by day 4 after catheterization . intravenous antibiotics ( relative risk , 2.00 ) , female sex ( relative risk , 1.88 ) , prolonged ( greater than 48 hours ) catheterization ( relative risk , 1.79 ) , and catheter material ( PEU-Vialon : FEP-Teflon ) ( relative risk , 0.73 ) strongly predicted phlebitis in a Cox proportional hazards model ( each , P less than 0.003 ) . The best-fit model for severe phlebitis identified the same predictors plus catheter-related infection ( relative risk , 6.19 ) , phlebitis with a previous catheter ( relative risk , 1.54 ) , and anatomic site ( h and : forearm , relative risk , 0.71 ; wrist : forearm , relative risk , 0.60 ) . The low incidence of local catheter-related infection was comparable with the two catheter material s ( 5.4 % [ 95 % CI , 3.8 % to 7.6 % ] and 6.9 % [ CI , 4.9 % to 9.6 % ] ) ; none of the 1054 catheters prospect ively studied caused bacteremia . CONCLUSIONS Multiple factors , including the infusate and the duration of cannulation , contribute to the development of infusion-related phlebitis . The use of peripheral intravenous catheters made of PEU-Vialon appears to pose the same risk for catheter-related infection as the use of catheters made of FEP-Teflon , and PEU-Vialon can permit longer cannulation with less risk for phlebitis . The risk for catheter-related bacteremia with FEP-Teflon and PEU-Vialon catheters is sufficiently low that it no longer seems justifiable to recommend the use of small steel needles for most peripheral intravenous therapy STUDY OBJECTIVES To prospect ively assess the relative risk for phlebitis in a series of consecutive patients with pneumonia and to identify risk factors that predict an increased risk for phlebitis . SETTING Internal medicine department of a tertiary teaching hospital . PATIENTS Seven hundred sixty-six consecutive patients with acute pneumonia receiving IV therapy . INTERVENTIONS Only the first catheter was taken into account . There were 308 short lines ( a 51-mm , 18-gauge Teflon catheter ) ; 307 midsized lines ( a 28-cm , 16-gauge polyvinyl chloride catheter ) ; and 151 long lines ( 71-cm , 14-gauge plain polyurethane catheter ) . Eighteen variables were prospect ively evaluated in an open , nonr and omized study for their contribution to the occurrence of phlebitis . RESULTS The overall phlebitis rate was 39 % . Phlebitis developed in 53 % of patients with short lines , in 41 % of patients with midsized lines , and in 10 % of patients with long lines , and these catheters remained in place an average ( + /- SD ) of 3.0+/-2.4 days , 4.6+/-3.4 days , and 7.8+/-6.6 days , respectively . The variables that influenced the development of phlebitis , as determined by multivariate analysis , were the following : type of catheter ; blood hemoglobin levels ; and IV therapy with either corticosteroids or erythromycin . CONCLUSIONS According to our data , when the use of a catheter is expected to be required for < or = 36 h , a short line can be used . If a longer duration is expected , a longer line is warranted . Ours is the first study in which the relationship between blood hemoglobin levels and phlebitis has been reported . Because the use of intravascular devices is increasingly common , a more complete knowledge of the factors that influence their acceptance has become essential Vinorelbine is a moderate vesicant that is well known to cause local venous toxicity such as drug induced-phlebitis . We conducted a prospect i ve r and omized trial to determine whether a 1-min bolus injection ( 1 min bolus ) of vinorelbine reduced the incidence of local venous toxicity compared with a 6-min drip infusion ( 6 min infusion ) . Non-small cell lung cancer patients who were to receive chemotherapy containing vinorelbine were r and omly assigned to receive either 6 min infusion or 1 min bolus of the drug . All infusions were administered through a peripheral vein . Local venous toxicity was evaluated at each infusion up to two cycles . Eighty-three patients were r and omized into the study and 81 of them assessable for analysis . One hundred thirty-eight infusions to 40 patients in 6 min infusion and 135 infusions to 41 patients in 1 min bolus were delivered . Vinorelbine induced-local venous toxicity was observed in 33 % of patients in 6 min infusion and 24 % in 1 min bolus . There was no statistically significant difference between the two arms ( P=0.41 ) . The incidence of local venous toxicity per infusions was 16 % ( 22 of 138 infusions ) in 6 min infusion and 11 % ( 15 of 135 infusions ) in 1 min bolus ( P=0.47 ) . No severe local venous toxicity was seen in either arm . In this study , the administration of in 1 min bolus of vinorelbine did not significantly reduce the incidence of local venous toxicity compared with 6 min infusion . Further studies for the control of local venous toxicity of vinorelbine are warranted Background : The herbal preparation , aloe vera , has been cl aim ed to have anti‐inflammatory effects and , despite a lack of evidence of its therapeutic efficacy , is widely used by patients with inflammatory bowel disease As part of a st and ardized , multi-hospital prospect i ve surveillance system for nosocomial infections in Rhode Isl and , an analysis was undertaken in March 1980-February 1982 to determine the interplay of factors that contribute to the risk of phlebitis in peripheral , non-steel , non-butterfly intravenous catheters . The authors studied 3094 patients with 5161 total episodes of peripheral intravenous catheters from day of admission until day of discharge . The overall rate of phlebitis was 2.3 % ( 118 episodes ) , and the rate of intravenous catheter-associated bacteremia was 0.08 % ( 1 definite episode , 3 possible episodes ) . Factors significantly associated with the occurrence of phlebitis were : underlying risk for any nosocomial infection , duration of the catheter episode , chronological order of the episode and an interaction between the latter two variables . Analysis of day-specific risk of phlebitis indicated that , for patients with low risk diagnoses , initial peripheral intravenous catheters might be left in place with relative safety for up to 96 hours . Over this time period , the day-specific risk for such patients ranged between 0.8 % and 1.4 % , exclusive of the first day . In all other circumstances , the current recommendation of 48 - 72 hours seems appropriate Output:	Aloe vera , either alone or in combination with routine treatment , was more effective than routine treatment alone for improving the symptoms of phlebitis including shortening the time of elimination of red swelling symptoms , time of pain relief at the location of the infusion vein and time of resolution of phlebitis . There is no strong evidence for preventing or treating infusion phlebitis with external application of Aloe vera .
MS21146	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: As the population of older Latinos in the U.S. increases , availability of culturally adapted geriatric psychiatry services is becoming a growing concern . This issue is exacerbated for rural Latino population s. In this study , we assessed whether neurocognitive assessment via telepsychiatry ( TP ) using a Spanish- language battery would be comparable to in-person ( IP ) testing using the same battery in a sample of Spanish-speaking older adults in a rural setting . Patients ( N = 22 ) received IP and TP testing 2 weeks apart . The order of IP and TP test administrations in individual subjects was determined r and omly . Comparison of scores indicated that there were no significant differences between IP and TP test performance though both groups scored non-significantly higher at the second visit . This study demonstrates feasibility and utility of neurocognitive testing in Spanish using TP among older rural Latinos Background It is possible that cross-over studies included in current systematic review s are being inadequately assessed , because the current risk of bias tools do not consider possible biases specific to cross-over design . We performed this study to evaluate whether this was being done in cross-over studies included in Cochrane Systematic Review s ( CSRs ) . Methods We search ed the Cochrane Library ( up to 2013 issue 5 ) for CSRs that included at least one cross-over trial . Two authors independently undertook the study selection and data extraction . A r and om sample of the CSRs was selected and we evaluated whether the cross-over trials in these CSRs were assessed according to criteria suggested by the Cochrane h and book . In addition we reassessed the risk of bias of these cross-over trials by a checklist developed form the Cochrane h and book . Results We identified 688 CSRs that included one or more cross-over studies . We chose a r and om sample of 60 CSRs and these included 139 cross-over studies . None of these CSRs undertook a risk of bias assessment specific for cross-over studies . In fact items specific for cross-over studies were seldom considered anywhere in quality assessment of these CSRs . When we reassessed the risk of bias , including the 3 items specific to cross-over trials , of these 139 studies , a low risk of bias was judged for appropriate cross-over design in 110(79 % ) , carry-over effects in 48(34 % ) and for reporting data in all stages of the trial in 114(82 % ) . Assessment of biases in cross-over trials could affect the GRADE assessment of a review ’s findings . Conclusion The current Cochrane risk of bias tool is not adequate to assess cross-over studies . Items specific to cross-over trials leading to potential risk of bias are generally neglected in CSRs . A proposed check list for the evaluation of cross-over trials is provided Accurate underst and ing of practice characteristics , performance stability , and error on neuropsychological tests is essential to both valid clinical assessment and maximization of signal detection for clinical trials of cognitive enhancing drugs . We examined practice effects in 28 healthy adults . As part of a larger study using donepezil and simulating a Phase I trial , participants were r and omized into : placebo , no-treatment and donepezil . Donepezil results are presented elsewhere . Neuropsychological tests were administered in a fixed order for 6 weeks , with alternate forms available for most tests . Despite alternate forms , ANOVAs revealed significant improvements for the pooled control group ( placebo and no-treatment ) on all tests except Letter Number Sequencing and Trails B. Learning occurred principally in the first three to four sessions . PASAT and Stroop interference showed the greatest learning . Thus , serial assessment with alternate forms may attenuate retest effects on some tests , but continued learning occurs on novel tests or those in which an advantageous test-taking strategy can be identified . Alternate forms and baseline practice sessions may help control early , rapid improvements in clinical trials Objectives : To compare in-person versus telehealth ( TH ) assessment of discourse ability in adults with chronic traumatic brain injury ( TBI ) . Design : Repeated- measures design with r and om order of conditions . Participants : Twenty adults with moderate-to-severe TBI . Method : Participants completed conversation , picture description , story-generation , and procedural description tasks . Sessions were video-recorded and transcribed . Measures : Measures of productivity and quality of discourse . Results : Significant differences between conditions were not detected in this sample , and feedback from participants was positive . Conclusions : These preliminary results support the use of TH for the assessment of discourse ability in adults with TBI , at least for individuals with sufficient cognitive skills to follow TH procedures OBJECTIVE Combat veterans returning to society with impairing mental health conditions such as PTSD and major depression ( MD ) report significant barriers to care related to aspects of traditional psychotherapy service delivery ( e.g. , stigma , travel time , and cost ) . Hence , alternate treatment delivery methods are needed . Home-based telehealth ( HBT ) is one such option ; however , this delivery mode has not been compared to in person , clinic-based care for PTSD in adequately powered trials . The present study was design ed to compare relative noninferiority of evidence -based psychotherapies for PTSD and MD , specifically Behavioral Activation and Therapeutic Exposure ( BA-TE ) , when delivered via HBT versus in person , in clinic delivery . METHOD A repeated measures ( i.e. , baseline , posttreatment , 3- , 6-month follow-up ) r and omized controlled design powered for noninferiority analyses was used to compare PTSD and MD symptom improvement in response to BA-TE delivered via HBT versus in person , in clinic conditions . Participants were 232 veterans diagnosed with full criteria or predefined subthreshold PTSD . RESULTS PTSD and MD symptom improvement following BA-TE delivered by HBT was comparable to that of BA-TE delivered in person at posttreatment and at 3- and 12-month follow-up . CONCLUSION Evidence -based psychotherapy for PTSD and depression can be safely and effectively delivered via HBT with clinical outcomes paralleling those of clinic-based care delivered in person . HBT , thereby , addresses barriers to care related to both logistics and stigma OBJECTIVE This study aims to assess the current utilisation of a real-time teleophthalmology service for rural Western Australia ( WA ) . DESIGN Service evaluation by prospect i ve audit . SETTING Includes general practice s , optometrists , hospitals in rural WA and the Lions Eye Institute in Perth . PARTICIPANTS Eighty-five patients from rural WA participating . INTERVENTIONS Video consultation ( VC ) with a general ophthalmologist . MAIN OUTCOME MEASURES Number of referring practitioners and their locations , software and imaging equipment used as well as the presentation , working diagnosis and follow-up plan for each consultation . RESULTS Eighty-five participants took part in a total of 100 VCs in the 5-month data collection period . There were 49 men ( 58 % ) ; age range 7 - 92 years ; 31 identified as Indigenous Australian ( 37 % ) . Participants were referred by optometrists ( 59 % ) , hospital district medical officers ( 23 % ) and GPs ( 18 % ) . Karratha ( 41 % ) , Albany ( 20 % ) and Broome ( 14 % ) were the main VC locations . There were 31 different eye conditions managed ; red eye , acute vision loss , known glaucoma and abnormal retinal photographs were the main presentations . Skype was the commonly used software ( 71 % ) . Images were provided in 63 % of all VCs . The main equipment used included digital retinal cameras ( 56 % ) , smartphones ( 25 % ) and digital slit lamps ( 13 % ) . An outpatient appointment with the ophthalmologist was recommended following 35 VCs . CONCLUSIONS Optometrists used this service most frequently , despite a lack of financial incentive . Digital retinal cameras and smartphones were the most commonly used imaging modalities . Overall , real-time teleophthalmology was used in the management of a broad range of eye conditions and was a useful supplement to outreach ophthalmology services BACKGROUND Dementia is a common but frequently undiagnosed problem in aging . Barriers to early diagnosis include a lack of routine screening for dementia and a lack of access to specialty consultative services . We conducted a pilot study to see if telemedicine could provide reliable , accurate geriatric consultative services to evaluate patients for dementia who were residing at remote sites . METHODS This was a prospect i ve cohort study that compared the diagnostic reliability of telemedicine to an in-person examination for dementia . Eligible subjects were residents of a Washington State Veterans ' Home , age 60 years or older , with no prior diagnosis of dementia . Eligible subjects were screened for dementia using the 7-Minute Screen . Veterans who screened positive and consented to participate in the study received an in-person neuropsychiatric evaluation at baseline , and then both telemedicine and in-person examinations for dementia conducted by experienced geriatric psychiatrists . The accuracy of the telemedicine diagnosis was estimated by comparing it to the diagnosis from the clinical examination . Three geriatric psychiatrists who were blinded to the results of the clinical examination conducted the telemedicine and in-person examinations . We also assessed attitudes of the subjects and geriatric psychiatrists towards the telemedicine sessions . RESULTS Eighteen of 85 subjects screened were ' positive ' for dementia on the 7 Minute Screen . Of these , 16 consented to participate in the telemedicine study . Twelve of the 16 subjects were subsequently diagnosed with dementia by the telemedicine examination . The telemedicine diagnoses were in 100 % agreement with the diagnoses from the in-person clinical examinations . Moreover , the subjects reported a high degree of satisfaction with the telemedicine experience and that they would like to have further care through telemedicine in the future . The geriatric psychiatrists reported technical difficulties with the audio-visual quality of telemedicine in the initial phases of the project that resolved as familiarity with the telemedicine equipment increased . None of these problems had an adverse impact on the diagnostic accuracy of telemedicine . CONCLUSIONS We found that telemedicine was as accurate as an in-person clinical examination in establishing the diagnosis of dementia . In addition , subjects reported a high degree of satisfaction with telemedicine and a willingness to participate in telemedicine clinical care in the future . Given the large increase in the aging population and the shortage of geriatric psychiatrists nationally , it appears that telemedicine may be a promising means to exp and the availability of geriatric psychiatric consultation to remote areas BACKGROUND Recent advances in telehealth have improved access to health care for those in rural areas . It is important that examinations conducted via telehealth are comparable to in-person testing . A rural and remote memory clinic in Saskatoon provided an opportunity to compare scores on the Mini-Mental State Examination ( MMSE ) administered in-person and via telehealth . METHODS After an initial one day assessment in Saskatoon , patients were seen in follow-up at 6 and 12 weeks . Individual patients were r and omly assigned to either in-person follow-up assessment in Saskatoon or telehealth assessment in their home community . Patients who initially received in-person assessment s were seen by telehealth for their next follow-up visit and vice-versa . The same neurologist administered MMSEs at all visits . The first 71 patients with both 6 and 12 week follow-up assessment s were included in this study . The scores of in-person and telehealth MMSE administrations were compared using the methods of Bl and and Altman as well as a paired t-test . RESULTS MMSE scores did not differ significantly between telehealth ( 22.34 + /- 6.35 ) and in-person ( 22.70 + /- 6.51 ) assessment s. CONCLUSION Telehealth provides an acceptable means of assessing mental status of patients in remote areas Mini-Mental State Examination scores were compared in an adult psychiatric population when the test was performed face to face and over a Low-Cost VideoConferencing System ( LCVC ) . The minor changes to the instrument that are required to make it compatible with the LCVC are described . The high correlations achieved between the test scores in the two conditions suggests that this cognitive screening test may be reliably performed in this group of patients over the LCVC Output:	Test specific analyses indicated that verbally-mediated tasks including digit span , verbal fluency , and list learning were not affected by videoconference administration .
MS21147	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Transcatheter arterial chemoembolization ( TACE ) offers a survival benefit to patients with intermediate hepatocellular carcinoma ( HCC ) . A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge — conventional TACE . Recently , a drug-eluting bead ( DC Bead ® ) has been developed to enhance tumor drug delivery and reduce systemic availability . This r and omized trial compares conventional TACE ( cTACE ) with TACE with DC Bead for the treatment of cirrhotic patients with HCC . Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and /or multinodular , unresectable , N0 , M0 HCCs were r and omized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin . R and omization was stratified according to Child-Pugh status ( A/B ) , performance status ( ECOG 0/1 ) , bilobar disease ( yes/no ) , and prior curative treatment ( yes/no ) . The primary endpoint was tumor response ( EASL ) at 6 months following independent , blinded review of MRI studies . The drug-eluting bead group showed higher rates of complete response , objective response , and disease control compared with the cTACE group ( 27 % vs. 22 % , 52 % vs. 44 % , and 63 % vs. 52 % , respectively ) . The hypothesis of superiority was not met ( one-sided P = 0.11 ) . However , patients with Child-Pugh B , ECOG 1 , bilobar disease , and recurrent disease showed a significant increase in objective response ( P = 0.038 ) compared to cTACE . DC Bead was associated with improved tolerability , with a significant reduction in serious liver toxicity ( P < 0.001 ) and a significantly lower rate of doxorubicin-related side effects ( P = 0.0001 ) . TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease BACKGROUND / AIMS Lipiodol chemoembolization is a widely used method of treatment in patients with unresectable hepatocellular carcinoma , but its efficacy is still debated . The aim of our study was to assess the efficacy of lipiodol chemoembolization in patients with unresectable hepatocellular carcinoma . METHODS Seventy-three patients with unresectable hepatocellular carcinoma , but without severe liver disease or portal vein occlusion , were r and omly assigned to receive either repeated lipiodol chemoembolization ( lipiodol , cisplatin ( 2 mg/kg ) , lecithin , and gelatin sponge injected into the hepatic artery ) plus tamoxifen ( 40 mg ) or tamoxifen alone . The main end-point was survival . RESULTS The 37 patients in the lipiodol chemoembolization group received 104 courses ( median 3 per patient ) . By 1 September 1996 , 58 patients had died : 30 in the lipiodol chemoembolization group and 28 in the tamoxifen group . There was no difference in survival between the two groups ( p=0.77 ) . The relative risk of death in the lipiodol chemoembolization plus tamoxifen group as compared to the tamoxifen group was 0.92 ( 95 % confidence interval 0.55 to 1.56 ) . At 1 year , survival was 51 % and 55 % , respectively . An objective tumoral response was more frequently observed in the lipiodol chemoembolization group than in the tamoxifen group ( 24 versus 5.5 % , respectively , p=0.046 ) . Lipiodol chemoembolization caused two deaths and induced signs of liver failure in 51 % of the patients assigned to this treatment . CONCLUSION In our r and omized study , lipiodol chemoembolization did not improve the survival of patients with unresectable hepatocellular carcinoma treated with tamoxifen A r and omized trial of hepatic arterial chemoembolization was conducted in 42 patients with unresectable hepatocellular carcinoma . These patients represented 41 % of patients with hepatocellular carcinoma seen during the inclusion period . In the remaining 59 % , 9 % had resectable tumours and 50 % had unresectable tumours with contraindication for chemoembolization . Patients received either repeated chemoembolization with gelfoam powder and doxorubicin ( group 1 ) or symptomatic treatment ( group 2 ) . There was no difference in age , prevalence of cirrhosis or staging according to Okuda between the two groups of patients . A complete tumour response ( assessed by arteriography , ultrasonography and serum alphafetoprotein ) was observed in four patients , and a partial response in three other patients from group 1 . Actuarial survival rates were 33 and 24 % in group 1 and 52 and 31 % in group 2 at 6 and 12 months , respectively ( differences were not significant -- logrank test ) . With the treatment used in our study , chemoembolization did not prolong the survival time of patients with unresectable hepatocellular carcinoma . There were , however , some complete or partial responses . The high spontaneous 1-year survival rate of untreated patients was probably due to the exclusion of the most severely ill patients . Our results do not support the use of this method of chemoembolization in the treatment of hepatocellular carcinoma This r and omized , controlled trial assessed the efficacy of transarterial Lipiodol ( Lipiodol Ultrafluide , Laboratoire Guerbet , Aulnay-Sous-Bois , France ) chemoembolization in patients with unresectable hepatocellular carcinoma . From March 1996 to October 1997 , 80 out of 279 Asian patients with newly diagnosed unresectable hepatocellular carcinoma fulfilled the entry criteria and r and omly were assigned to treatment with chemoembolization using a variable dose of an emulsion of cisplatin in Lipiodol and gelatin-sponge particles injected through the hepatic artery ( chemoembolization group , 40 patients ) or symptomatic treatment ( control group , 40 patients ) . One patient assigned to the control group secondarily was excluded because of unrecognized systemic metastasis . Chemoembolization was repeated every 2 to 3 months unless there was evidence of contraindications or progressive disease . Survival was the main end point . The chemoembolization group received a total of 192 courses of chemoembolization with a median of 4.5 ( range , 1 - 15 ) courses per patient . Chemoembolization result ed in a marked tumor response , and the actuarial survival was significantly better in the chemoembolization group ( 1 year , 57 % ; 2 years , 31 % ; 3 years , 26 % ) than in the control group ( 1 year , 32 % ; 2 years , 11 % ; 3 years , 3 % ; P = .002 ) . When adjustments for baseline variables that were prognostic on univariate analysis were made with a multivariate Cox model , the survival benefit of chemoembolization remained significant ( relative risk of death , 0.49 ; 95 % CI , 0.29 - 0.81 ; P = .006 ) . Although death from liver failure was more frequent in patients who received chemoembolization , the liver functions of the survivors were not significantly different . In conclusion , in Asian patients with unresectable hepatocellular carcinoma , transarterial Lipiodol chemoembolization significantly improves survival and is an effective form of treatment BACKGROUND The aim of our study was to compare the efficacy and safety of : 1 ) transarterial chemolipiodolization with gelatin sponge embolization vs chemolipiodolization without embolization , and 2 ) chemolipiodolization with triple chemotherapeutic agents vs epirubicin alone . METHODS A single-blind , three parallel arm , r and omized trial was conducted at three clinical centers with patients with biopsy-confirmed unresectable hepatocellular carcinoma . Arm 1 received triple-drug chemolipiodolization and sponge embolization , whereas Arm 2 received triple-drug chemolipiodolization only . Patients in arm 3 were treated with single-drug chemolipiodolization and sponge embolization . We compared overall survival and time to progression . Event-time distributions were estimated by the Kaplan-Meier method . All statistical tests were two-sided . RESULTS From July 2007 to November 2009 , 365 patients ( Arm 1 : n = 122 ; Arm 2 : n = 121 ; Arm 3 : n = 122 ) were recruited . The median tumor size was 10.9 cm ( range = 7 - 22 cm ) , and 34.5 % had macrovascular invasion . The median survivals and time to progression in Arm 1 , Arm 2 , and Arm 3 were 10.5 and 3.6 months , 10.1 and 3.1 months , and 5.9 and 3.1 months , respectively . Survival was statistically significantly better in Arm 1 than in Arm 3 ( P < .001 ) , whereas there was no statistically significant difference between Arm 1 and Arm 2 ( P = .20 ) . Objective response rates were 45.9 % , 29.7 % , and 18.9 % for Arm 1 , Arm 2 , and Arm 3 , respectively . CONCLUSIONS Chemolipiodolization played an important role in transarterial chemoembolization , and the choice of chemotherapy regimen may largely affect survival outcomes . However , the removal of embolization from chemoembolization might not statistically significantly decrease survival This r and omized , controlled trial assessed the effect of transarterial embolization ( TAE ) ( without associated chemotherapy ) on the survival of patients with nonsurgical hepatocellular carcinoma ( HCC ) . Eighty consecutive patients were r and omized to treatment with embolization ( Group A , n = 40 ) , or to symptomatic treatment ( Group B , n = 40 ) , there being no differences between both groups regarding the degree of liver function impairment and tumor stage . Eighty‐two percent of the patients presented a self‐limited postembolization syndrome , without treatment‐related mortality . Fifty‐five percent of the treated cases exhibited a partial response , which result ed in a lower probability of tumor progression during follow‐up ( 57 % vs. 77 % at 1 year ; P < .005 ) . However , after a median follow‐up of 24 months ( 30 deaths in each group ) , there are no differences in survival ( Group A : 49 % and 13 % ; Group B : 50 % and 27 % , at 2 and 4 years , respectively ; P = .72 ) . The absence of differences was maintained even when dividing patients according to Child‐Pugh 's grade , Okuda stage , or performance status test ( PST ) . Furthermore , there were no differences in the probability of complications or in the need of hospital admissions . In conclusion , TAE has a marked antitumoral effect associated to a slower growth of the tumor , but it does not improve the survival of patients with nonsurgical HCC Background Stimulation of vascular endothelial growth factor ( VEGF ) has been observed following transarterial chemoembolization ( TACE ) in hepatocellular cancer ( HCC ) and may contribute to tumor regrowth . This pilot study examined whether intravenous ( IV ) bevacizumab , a monoclonal antibody against VEGF , could inhibit neovessel formation after TACE . Methods 30 subjects with HCC undergoing TACE at a single academic institution were r and omized with a computer-generated allocation in a one to one ratio to either bevacizumab at a dose of 10 mg/kg IV every 14 days beginning 1 week prior to TACE ( TACE-BEV arm ) or observation ( TACE-O arm ) . Angiography was performed with TACE at day 8 , and again at weeks 10 and 14 . Repeat TACE was performed at week 14 if indicated . TACE-BEV subjects were allowed to continue bevacizumab beyond week 16 . TACE-O subjects were allowed to cross-over to bevacizumab at week 16 in the setting of progressive disease . The main outcome measure was a comparison of neovessel formation by serial angiography . Secondary outcome measures were progression free survival ( PFS ) at 16 weeks , overall survival ( OS ) , bevacizumab safety , and an analysis of VEGF levels before and after TACE with and without bevacizumab . Results Among the 30 subjects enrolled , 9 of 15 r and omized to the TACE-O arm and 14 of 15 r and omized to the TACE-BEV arm completed all 3 angiograms . At week 14 , 3 of 9 ( 33 % ) TACE-O subjects and 2 of 14 ( 14 % ) TACE-BEV subjects demonstrated neovascularity . The PFS at 16 weeks was 0.19 in the TACE-O arm and 0.79 in the TACE-BEV arm ( p = 0.021 ) . The median OS was 61 months in the TACE-O arm and 49 months in the TACE-BEV arm ( p = 0.21 ) . No life-threatening bevacizumab-related toxicities were observed . There were no substantial differences in bevacizumab pharmacokinetics compared to historical controls . Bevacizumab attenuated the increase in VEGF observed post-TACE . Conclusions IV beva Output:	Liver enzyme abnormalities were the most commonly observed AE , followed by the symptoms associated with postembolization syndrome .
MS21148	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement ( SAVR ) or transcatheter aortic valve replacement ( TAVR ) in high-risk patients with severe aortic stenosis . BACKGROUND The PARTNER ( Placement of Aortic Transcatheter Valve ) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients , but sex-specific outcomes are unknown . METHODS In all , 699 patients ( 300 female ) were r and omly assigned 1:1 to either SAVR or TAVR with a balloon exp and able pericardial tissue valve . Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females . RESULTS Baseline characteristics differed between the sexes . Despite higher Society of Thoracic Surgeons mortality risk scores ( 11.9 vs. 11.6 ; p = 0.05 ) , female patients had lower prevalence of coronary artery disease ( 64.4 % vs. 83.7 % ) , prior coronary artery bypass graft surgery ( 19.8 % vs. 61.2 % ) , peripheral vascular disease ( 36.4 % vs. 46.9 % ) , diabetes mellitus ( 35.6 % vs. 45.6 % ) , and elevated creatinine ( 11.7 % vs. 23.9 % ) . Among female patients , procedural mortality trended lower with TAVR versus SAVR ( 6.8 % vs. 13.1 % ; p = 0.07 ) and was maintained throughout follow-up ( hazard ratio [ HR ] : 0.67 ; 95 % confidence interval [ CI ] : 0.44 to 1.00 ; p = 0.049 ) , driven by the transfemoral arm ( HR : 0.55 ; 95 % CI : 0.32 to 0.93 ; p = 0.02 ) . Among male patients , although procedural mortality was lower with TAVR ( 6 % vs. 12.1 % ; p = 0.03 ) , there was no overall survival benefit ( HR : 1.15 ; 95 % CI : 0.82 to 1.61 ; p = 0.42 ) . CONCLUSIONS In this retrospective sub analysis of high-risk , symptomatic aortic stenosis patients in the PARTNER trial , female subjects had lower late mortality with TAVR versus SAVR . This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients . A r and omized , controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities . ( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) BACKGROUND The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not c and i date s for surgical replacement . However , the two procedures have not been compared in a r and omized trial involving high-risk patients who are still c and i date s for surgical replacement . METHODS At 25 centers , we r and omly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-exp and able bovine pericardial valve ( either a transfemoral or a transapical approach ) or surgical replacement . The primary end point was death from any cause at 1 year . The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement . RESULTS The rates of death from any cause were 3.4 % in the transcatheter group and 6.5 % in the surgical group at 30 days ( P=0.07 ) and 24.2 % and 26.8 % , respectively , at 1 year ( P=0.44 ) , a reduction of 2.6 percentage points in the transcatheter group ( upper limit of the 95 % confidence interval , 3.0 percentage points ; predefined margin , 7.5 percentage points ; P=0.001 for noninferiority ) . The rates of major stroke were 3.8 % in the transcatheter group and 2.1 % in the surgical group at 30 days ( P=0.20 ) and 5.1 % and 2.4 % , respectively , at 1 year ( P=0.07 ) . At 30 days , major vascular complications were significantly more frequent with transcatheter replacement ( 11.0 % vs. 3.2 % , P<0.001 ) ; adverse events that were more frequent after surgical replacement included major bleeding ( 9.3 % vs. 19.5 % , P<0.001 ) and new-onset atrial fibrillation ( 8.6 % vs. 16.0 % , P=0.006 ) . More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days , but by 1 year , there was not a significant between-group difference . CONCLUSIONS In high-risk patients with severe aortic stenosis , transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year , although there were important differences in periprocedural risks . ( Funded by Edwards Lifesciences ; Clinical Trials.gov number , NCT00530894 . ) OBJECTIVES We compared the incidence of prosthesis-patient mismatch ( PPM ) between transcatheter aortic valve replacement ( TAVR ) using a self-exp and ing bioprosthesis and surgical aortic valve replacement ( SAVR ) in the CoreValve US High Risk Pivotal Trial . We sought to determine the influence of PPM on clinical outcomes . METHODS Patients with severe aortic stenosis and at increased risk for surgery were r and omized 1:1 to TAVR or SAVR . Postoperative PPM was defined by the effective orifice area index ( EOAi ) as severe PPM ( EOAi ≤ 0.65 cm(2)/m(2 ) ) and no severe PPM ( EOAi > 0.65 cm(2)/m(2 ) ) ; clinical outcomes were analyzed in the TAVR arm ( n = 389 ) and SAVR arm ( n = 353 ) . Left ventricular mass index and regression were analyzed at baseline and 1 year . RESULTS The incidence of severe PPM in the SAVR group at 1 year was 25.7 % versus 6.2 % in the TAVR group ( P < .0001 ) . Left ventricular mass index regression at 1 year was 6.8 % for TAVR and 15.1 % for SAVR in patients with severe PPM . At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients ( TAVR + SAVR ) with severe PPM compared with no severe PPM ( 20.6 % vs 12.0 % [ P = .0145 ] for death and 19.2 % vs 8.5 % [ P = .0008 ] for acute kidney injury ) . CONCLUSIONS In patients with high surgical risk and severe aortic stenosis , severe PPM is more common in patients treated with SAVR than those treated with TAVR . Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM OBJECTIVES This study sought to compare health status and quality -of-life outcomes for patients with severe aortic stenosis ( AS ) and high surgical risk treated with either transcatheter aortic valve replacement ( TAVR ) or surgical aortic valve replacement ( AVR ) . BACKGROUND For high-risk patients with severe AS , TAVR has been shown to result in similar 12-month survival but differing adverse events compared with AVR . METHODS We evaluated the health status of 628 patients with severe , symptomatic AS at high risk of surgical complications who were r and omized to either TAVR or AVR in the PARTNER Trial . Health status was assessed at baseline and 1 , 6 , and 12 months using the Kansas City Cardiomyopathy Question naire , the Short Form-12 , and the EuroQol-5D . RESULTS The primary outcome , the Kansas City Cardiomyopathy Question naire summary score , improved more rapidly with TAVR , but was similar for the 2 groups at 6 and 12 months . However , there was a significant interaction between the benefit of TAVR and access site ( transapical vs. transfemoral ) . Patients eligible for transfemoral TAVR demonstrated significant health status benefits with TAVR versus AVR at 1 month ( difference , 9.9 points ; 95 % confidence interval : 4.9 to 14.9 ; p < 0.001 ) , whereas patients treated via the TA approach demonstrated no benefits with TAVR compared with AVR at any time point . Results for Kansas City Cardiomyopathy Question naire subscales and generic measures demonstrated similar patterns . CONCLUSIONS In high-risk patients with severe AS , health status improved substantially between baseline and 1 year after either TAVR or AVR . TAVR via the transfemoral , but not the transapical route , was associated with a short-term advantage compared with surgery . ( Placement of AoRTic TraNscathetER Valve [ PARTNER ] trial ; NCT00530894 ) BACKGROUND We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-exp and ing transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery . METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center . Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors . Eligible patients were r and omly assigned in a 1:1 ratio to TAVR with the self-exp and ing transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) . The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing . RESULTS A total of 795 patients underwent r and omization at 45 centers in the United States . In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P<0.001 for noninferiority ; P = 0.04 for superiority ) . The results were similar in the intention-to-treat analysis . In a hierarchical testing procedure , TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life . Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke . CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-exp and ing transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement . ( Funded by Medtronic ; U.S. CoreValve High Risk Study Clinical Trials.gov number , NCT01240902 . ) Background —The Placement of Aortic Transcatheter Valves ( PARTNER ) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement ( TAVR and SAVR , respectively ) in high-risk patients with symptomatic , severe aortic stenosis . The aim of this study was to evaluate the effect of left ventricular ( LV ) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function . Methods and Results —The PARTNER trial r and omized high-risk patients with severe aortic stenosis to TAVR or SAVR . Patients were stratified by the presence of LV ejection fraction ( LVEF ) < 50 % . All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique . In patients with LV dysfunction , mean LVEF increased from 35.7±8.5 % to 48.6±11.3 % ( P<0.0001 ) 1 year after TAVR and from 38.0±8.0 % to 50.1±10.8 % after SAVR ( P<0.0001 ) . Higher baseline LVEF ( odds ratio , 0.90 [ 95 % confidence interval , 0.86 , 0.95 ] ; P<0.0001 ) and previous permanent pacemaker ( odds ratio , 0.34 [ 95 % confidence interval , 0.15 , 0.81 ] ) were independently associated with reduced likelihood of ≥10 % absolute LVEF improvement by 30 days ; higher mean aortic valve gradient was associated with increased odds of LVEF improvement ( odds ratio , 1.04 per 1 mm Hg [ 95 % confidence interval , 1.01 , 1.08 ] ) . Failure to improve LVEF by 3 Output:	Conclusions Symptomatic aortic stenosis can be lethal without intervention but surgical resection is contraindicated for some patients and high risk for others . We found that all-cause mortality up to 5 years of follow-up did not differ significantly between TAVI and SAVR in patients surgically operable at a high risk , but favoured TAVI over medical therapy in patients surgically inoperable . TAVI is a viable life-extending treatment option in these surgical high risk groups
MS21149	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND / AIMS The effect of vitamin E administration on clinical and laboratory parameters of liver function and on markers of fibrogenesis was assessed in patients with mild to moderate alcoholic hepatitis in a double blind placebo controlled r and omized trial . METHODS Twenty-five patients received 1000 I.U. of vitamin E per day , while 26 patients received placebo for 3 months . The patients were followed for 1 year after entry into the trial . RESULTS Vitamin E did not result in significant greater decreases in serum aminotransferases and serum bilirubin or in greater increases in serum albumin as compared with placebo . Prothrombin time did not change , while serum creatinine remained in the normal range . Monocyte nuclear nuclear factor-kappa B binding activity decreased in patients who remained abstinent , regardless of whether they received vitamin E. As regards markers of hepatic fibrogenesis , vitamin E treatment decreased serum hyaluronic acid ( P<0.05 ) while serum aminoterminal peptide of type III procollagen did not change in either group . Four patients in the treatment group and five in the placebo group died during the 1-year study . CONCLUSIONS Vitamin E treatment improves serum hyaluronic acid but has no beneficial effects on tests of liver function in patients with mild to moderate alcoholic hepatitis Ageing is associated with impaired immune responses and increased infection-related morbidity . This study assessed the effect of physiological amounts of vitamins and trace elements on immunocompetence and occurrence of infection-related illness . 96 independently living , healthy elderly individuals were r and omly assigned to receive nutrient supplementation or placebo . Nutrient status and immunological variables were assessed at baseline and at 12 months , and the frequency of illness due to infection was ascertained . Subjects in the supplement group had higher numbers of certain T-cell subsets and natural killer cells , enhanced proliferation response to mitogen , increased interleukin-2 production , and higher antibody response and natural killer cell activity . These subjects were less likely than those in the placebo group to have illness due to infections ( mean [ SD ] 23 [ 5 ] vs 48 [ 7 ] days per year , p = 0.002 ) . Supplementation with a modest physiological amount of micronutrients improves immunity and decreases the risk of infection in old age BACKGROUND There is conflicting evidence on the benefits of foods rich in vitamin E ( alpha-tocopherol ) , n-3 polyunsaturated fatty acids ( PUFA ) , and their pharmacological substitutes . We investigated the effects of these substances as supplements in patients who had myocardial infa rct ion . METHODS From October , 1993 , to September , 1995 , 11,324 patients surviving recent ( < or = 3 months ) myocardial infa rct ion were r and omly assigned supplements of n-3 PUFA ( 1 g daily , n=2836 ) , vitamin E ( 300 mg daily , n=2830 ) , both ( n=2830 ) , or none ( control , n=2828 ) for 3.5 years . The primary combined efficacy endpoint was death , non-fatal myocardial infa rct ion , and stroke . Intention-to-treat analyses were done according to a factorial design ( two-way ) and by treatment group ( four-way ) . FINDINGS Treatment with n-3 PUFA , but not vitamin E , significantly lowered the risk of the primary endpoint ( relative-risk decrease 10 % [ 95 % CI 1 - 18 ] by two-way analysis , 15 % [ 2 - 26 ] by four-way analysis ) . Benefit was attributable to a decrease in the risk of death ( 14 % [ 3 - 24 ] two-way , 20 % [ 6 - 33 ] four-way ) and cardiovascular death ( 17 % [ 3 - 29 ] two-way , 30 % [ 13 - 44 ] four-way ) . The effect of the combined treatment was similar to that for n-3 PUFA for the primary endpoint ( 14 % [ 1 - 26 ] ) and for fatal events ( 20 % [ 5 - 33 ] ) . INTERPRETATION Dietary supplementation with n-3 PUFA led to a clinical ly important and statistically significant benefit . Vitamin E had no benefit . Its effects on fatal cardiovascular events require further exploration BACKGROUND The Beta-Carotene and Retinol Efficacy Trial ( CARET ) tested the effect of daily beta-carotene ( 30 mg ) and retinyl palmitate ( 25,000 IU ) on the incidence of lung cancer , other cancers , and death in 18,314 participants who were at high risk for lung cancer because of a history of smoking or asbestos exposure . CARET was stopped ahead of schedule in January 1996 because participants who were r and omly assigned to receive the active intervention were found to have a 28 % increase in incidence of lung cancer , a 17 % increase in incidence of death and a higher rate of cardiovascular disease mortality compared with participants in the placebo group . METHODS After the intervention ended , CARET participants returned the study vitamins to their study center and provided a final blood sample . They continue to be followed annually by telephone and mail self-report . Self-reported cancer endpoints were confirmed by review of pathology reports , and death endpoints were confirmed by review of death certificates . All statistical tests were two-sided . RESULTS With follow-up through December 31 , 2001 , the post-intervention relative risks of lung cancer and all-cause mortality for the active intervention group compared with the placebo group were 1.12 ( 95 % confidence interval [ CI ] = 0.97 to 1.31 ) and 1.08 ( 95 % CI = 0.99 to 1.17 ) , respectively . Smoothed relative risk curves for lung cancer incidence and all-cause mortality indicated that relative risks remained above 1.0 throughout the post-intervention follow-up . By contrast , the relative risk of cardiovascular disease mortality decreased rapidly to 1.0 after the intervention was stopped . During the post-intervention phase , females had larger relative risks of lung cancer mortality ( 1.33 versus 1.14 ; P = .36 ) , cardiovascular disease mortality ( 1.44 versus 0.93 ; P = .03 ) , and all-cause mortality ( 1.37 versus 0.98 ; P = .001 ) than males . CONCLUSIONS The previously reported adverse effects of beta-carotene and retinyl palmitate on lung cancer incidence and all-cause mortality in cigarette smokers and individuals with occupational exposure to asbestos persisted after drug administration was stopped although they are no longer statistically significant . Planned subgroup analyses suggest that the excess risks of lung cancer were restricted primarily to females , and cardiovascular disease mortality primarily to females and to former smokers Patients with chronic hepatitis C virus ( HCV ) infection often develop liver cirrhosis and hepatocellular carcinoma ( HCC ) . The purpose of this study was to test the chemopreventive effect of alpha-tocopherol on hepatocarcinogenesis in patients with liver cirrhosis and a history of HCV infection . Eighty-three patients with liver cirrhosis and with positive history of HCV infection were divided at r and om into two groups . Forty-four patients were treated with alpha-tocopherol ( Vit E group ) while the other 39 were followed as controls . The clinical background ( gender , age , and laboratory data ) was similar in the two groups . Serum levels of alpha-tocopherol , albumin , alanine aminotransferase ( ALT ) , and total cholesterol and platelet count were measured serially over a period of five years . The mean serum concentration of alpha-tocopherol was low in both groups at entry and was significantly higher in the Vit E group than in the control group one month after treatment . Platelet count , serum albumin , ALT , and total cholesterol were not different between the two groups during the five-year period . Cumulative tumor-free survival and cumulative survival rate tended to be higher in the Vit E group than in controls , albeit statistically insignificant . The serum level of alpha-tocopherol was low in patients with liver cirrhosis and positive for HCV . Although the administration of alpha-tocopherol normalized the level one month later , it could neither improve liver function , suppress hepatocarcinogenesis , nor improve cumulative survival . Patients treated with alpha-tocopherol tended to live longer without development of HCC but the difference was not statistically significant BACKGROUND It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer . To date , however , the published results of r and omized , placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect . We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population . METHODS The Supplementation en Vitamines et Mineraux Antioxydants ( SU.VI.MAX ) study is a r and omized , double-blind , placebo-controlled primary prevention trial . A total of 13 017 French adults ( 7876 women aged 35 - 60 years and 5141 men aged 45 - 60 years ) were included . All participants took a single daily capsule of a combination of 120 mg of ascorbic acid , 30 mg of vitamin E , 6 mg of beta carotene , 100 mug of selenium , and 20 mg of zinc , or a placebo . Median follow-up time was 7.5 years . RESULTS No major differences were detected between the groups in total cancer incidence ( 267 [ 4.1 % ] for the study group vs 295 [ 4.5 % ] for the placebo group ) , ischemic cardiovascular disease incidence ( 134 [ 2.1 % ] vs 137[2.1 % ] ) , or all-cause mortality ( 76 [ 1.2 % ] vs 98 [ 1.5 % ] ) . However , a significant interaction between sex and group effects on cancer incidence was found ( P = .004 ) . Sex-stratified analysis showed a protective effect of antioxidants in men ( relative risk , 0.69 [ 95 % confidence interval [ CI ] , 0.53 - 0.91 ] ) but not in women ( relative risk , 1.04 [ 95 % CI , 0.85 - 1.29 ] ) . A similar trend was observed for all-cause mortality ( relative risk , 0.63 [ 95 % CI , 0.42 - 0.93 ] in men vs 1.03 [ 95 % CI , 0.64 - 1.63 ] in women ; P = .11 for interaction ) . CONCLUSIONS After 7.5 years , low-dose antioxidant supplementation lowered total cancer incidence and all-cause mortality in men but not in women . Supplementation may be effective in men only because of their lower baseline status of certain antioxidants , especially of beta carotene Background —Epidemiological studies have demonstrated an inverse relationship between vitamin E intake and cardiovascular disease ( CVD ) risk . In contrast , r and omized controlled trials have reported conflicting results as to whether vitamin E supplementation reduces atherosclerosis progression and CVD events . Methods and Results —The study population consisted of men and women ≥40 years old with an LDL cholesterol level ≥3.37 mmol/L ( 130 mg/dL ) and no clinical signs or symptoms of CVD . Eligible participants were r and omized to DL-&agr;-tocopherol 400 IU per day or placebo and followed every 3 months for an average of 3 years . The primary trial end point was the rate of change in the common carotid artery far-wall intima-media thickness ( IMT ) assessed by computer image-processed B-mode ultrasonograms . A mixed effects model using all determinations of IMT was used to test the hypothesis of treatment differences in IMT change rates . Compared with placebo , & agr;-tocopherol supplementation significantly raised plasma vitamin E levels ( P < 0.0001 ) , reduced circulating oxidized LDL ( P = 0.03 ) , and reduced LDL oxidative susceptibility ( P < 0.01 ) . However , vitamin E supplementation did not reduce the progression of IMT over a 3-year period compared with subjects r and omized to placebo . Conclusions —The results are consistent with previous r and omized controlled trials and extend the null results of vitamin E supplementation to the progression of IMT in healthy men and women at low risk for CVD OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases Output:	In low-bias risk trials , after exclusion of selenium trials , beta carotene ( RR , 1.07 ; 95 % CI , 1.02 - 1.11 ) , vitamin A ( RR , 1.16 ; 95 % CI , 1.10 - 1.24 ) , and vitamin E ( RR , 1.04 ; 95 % CI , 1.01 - 1.07 ) , singly or combined , significantly increased mortality . Vitamin C and selenium had no significant effect on mortality . CONCLUSIONS Treatment with beta carotene , vitamin A , and vitamin E may increase mortality .
MS21150	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Systematic Review Series Series Editors : Cynthia Mulrow , MD , MSc Deborah Cook , MD , MSc The last article in this series outlined methods with which to search the literature for studies on the clinical question that generates a systematic review [ 1 ] . Herein , we discuss the subsequent steps of selecting and appraising studies for a review . Both of these steps involve important judgments that can influence the results of a review . In selecting studies , review ers judge the relevance of the studies to the review question . In appraising studies , review ers judge numerous features of design and analysis . Some of these judgments are easy to make ; others are more difficult and prone to error . To be confident in their decisions , review ers should use methods that are reliable ( the results do not change if the procedure is repeated ) , impartial ( not influenced by the study results ) , and explicit ( unambiguous ) [ 2 ] . These strategies for selection and appraisal are sensible , and they distinguish most systematic review s from most narrative review s. However , evidence to support the importance of some of the methods we suggest is either scant or conflicting ; readers are referred to the original research on these approaches for more details . Selecting Studies for Systematic Review s If review ers perform a comprehensive search of the literature using the methods described previously in this series [ 1 ] , they will probably have assembled a large sample of articles . This sample will include most ( ideally , all ) studies that are relevant to the review question ( that is , the sensitivity of the search will be high ) . Inevitably , because such a wide net is cast , articles not pertinent to the clinical question will be retrieved ( that is , the specificity of the search will be modest ) . Thus , the review ers ' next task is to sort through all of the potentially relevant articles and select those that will be included in the review . To do so , review ers adopt several of the tactics listed in Table 1 and Table 2 for planning and executing the selection process ( in effect , improving the specificity of the search ) ; these tactics are described below . Table 1 . Planning Study Selection Table 2 . Strategies for Selecting and Appraising Studies Begin with a Well-Built Clinical Question Review ers should ensure that the question for review includes the four elements of a well-built clinical question [ 3 , 4 ] : the patients of interest , the main interventions under investigation , the comparison interventions , and the clinical outcomes of interest . By including these four elements , review ers can better focus the selection process . Choose Selection Criteria That Fit the Clinical Question Consider a systematic review of the effectiveness of a drug treatment ( for example , a proton-pump inhibitor ) for patients with a particular disorder ( such as esophageal reflux ) . Review ers need to decide whether to include studies of patients with any symptoms of reflux , only those with classic symptoms , or only those in whom definitive diagnostic tests have confirmed the presence of reflux . In addition , review ers might choose to include studies of patients with different comorbid conditions ; patients from different demographic or geographic or cultural background s ; or patients from different health systems , such as inpatient or community population s. Similarly , review ers should use selection criteria that reflect the main and comparison interventions of interest . In our esophageal reflux example , review ers would need to decide whether to include studies of a particular drug or studies of all agents in that drug 's class and whether to include studies of any dose and regimen or only studies with a specific regimen . For the comparison interventions , the review ers would decide whether to include studies that compare the experimental drug with alternate treatments ( such as antacids or histamine-2-receptor antagonists ) , with placebo , or with both . For the clinical outcomes , review ers have analogous tasks of defining the outcomes and translating them into criteria . In our example , the review ers would start by listing each clinical outcome ( for example , whether the outcome was endoscopic or clinical and whether it focused on cure or persistence ) and then decide whether to include studies that reported any outcome or only those with certain clinical ly important outcomes ( such as improvement in symptoms at 1 year ) . After thoroughly considering each element of the review question , review ers compile a set of explicit selection criteria . When these criteria are not explicit , the results of the review are more prone to error [ 5 , 6 ] . Reporting the selection criteria used in a review is extremely important to readers because the criteria indicate the relevance of the review to the readers ' clinical practice . Specify the Types of Study Design To Be Included After creating selection criteria that appropriately reflect the review question , review ers should consider which study design s to include . Ideally , review ers choose study design s that are most likely to produce valid results . For example , to answer questions about therapy or harm , review ers may want to include r and omized trials [ 7 ] because they provide more accurate estimates of benefit or harm than do cohort studies , casecontrol studies , and case series [ 8 ] . In reality , however , r and omized trials may not be conducted to address questions of harm [ 9 ] . Therefore , review ers need to consider which study design s are likely to be available to answer their question ; this information may necessitate modification of originally conceptualized selection criteria to incorporate observational ( nonexperimental ) studies . Specify Criteria Related to Type and Form of Publication Review ers also need to consider issues related to type and form of publication . Ideally , all of the relevant studies would be published as peer- review ed journal articles . However , some completed studies may be published only as abstract s , in non-peer- review ed form , or not at all . Review ers decide whether to include these incompletely reported studies when planning their literature search . By including all articles in various stages of publication and subjecting them to rigorous critical appraisal , review ers minimize the threat of publication bias ( the preferential reporting of studies with positive results ) [ 10 - 12 ] , which could generate misleading review s. Other studies may be reported more than once . To avoid over-representing duplicate studies in the review , investigators should plan to look for and exclude duplicate publications [ 13 ] . Finally , because studies may be published in different language s and because excluding studies published in different language s may bias the results of review s [ 14 , 15 ] , articles should be included , as appropriate , regardless of the language of publication ( translating as necessary ) . Limited time and re sources , however , may preclude such an approach . Construct and Pretest Selection Forms After deciding on selection criteria , review ers can prepare customized forms that contain checklists of the selection criteria ( Figure 1 ) . Using these forms can simplify the selection process , increase reliability , and provide a record of the judgments made about each study . After drafting form prototypes , review ers pretest these forms for clarity , ease of application , and reliability . To pretest the forms , two or more independent review ers typically apply them to a r and om sample of studies identified by the literature search . Review ers compare their results to identify sources of ambiguity and then revise the forms accordingly . If the revisions are substantial , this process may need to be repeated before the forms can be used . Figure 1 . Example of a form that might be developed for the selection of studies for a systematic review evaluating the efficacy of -blockers for secondary prevention of variceal bleeding . Write a Detailed Protocol Having a selection protocol as part of a larger protocol for the entire review helps review ers in two ways . First , it provides a document that explicitly states the review question and the selection criteria , making the process accountable . Review ers can later return to the protocol for guidance in resolving disagreements about article selection . Second , the selection protocol identifies what work will be done , by whom , in what manner , when , and for what reason ; thus , it provides a mode of communication within the review team . When review ers have a very large sample of studies from which to select , they can simplify this task by review ing all of the titles , then the abstract s , and then the full articles , excluding studies that do not meet one or more selection criteria at each step . In doing so , review ers should record ( on the selection forms ) the reasons for exclusion . After review ers have selected studies for the systematic review , they will move to the next task of critical appraisal . This procedure also requires careful planning . Appraising Studies for Systematic Review s Review ers appraise the studies selected for review with three objectives in mind : 1 ) to underst and the validity of the studies , 2 ) to uncover reasons for differences among study results other than chance , and 3 ) to provide readers with sufficient information with which to judge for themselves the applicability of the systematic review to their clinical practice . To achieve these goals , review ers use the strategies outlined in Table 2 and Table 3 to carefully reexamine many important features of the primary studies . Table 3 . Planning Study Appraisal Examine Important Clinical Features Although the selection criteria for a systematic review define the population , interventions , and outcomes of interest , the appraisal process involves a detailed assessment of the patients ( for example , high , medium , or low risk ) , the study interventions ( for example , frequency , degree , and duration ) , and the outcome measurements ( for example , definitions and degree of surveillance ) Cluster r and omized controlled trial ( RCT ) , in which groups or clusters of individuals rather than individuals themselves are r and omized , are increasingly common . Indeed , for the evaluation of certain types of intervention ( such as those used in health promotion and educational interventions ) a cluster r and omized trial is virtually the only valid approach . However , cluster trials are generally more difficult to design and execute than individually r and omized studies , and some design features of a cluster trial may make it particularly vulnerable to a range of threats that can introduce bias . In this paper we discuss the issues that can lead to bias in cluster r and omized trials and conclude with some suggestions for avoiding these problems The employment of unlicensed personnel in Canadian acute care hospitals has been undertaken without clear evidence of outcomes for patients , caregivers , and hospital organizations . This quasi-experimental evaluation study was completed in a metropolitan Toronto acute care hospital to examine the effects of a new nursing care delivery system which included unlicensed assistive personnel . Most of the expected benefits of the newly implemented nursing care delivery system did not material ize leading to the conclusion that the employment of unlicensed assistive personnel in acute care hospital systems may not offer additional benefits for patients , caregivers , or hospital organizations . The processes and results of this study provide useful information for nurse administrators who are seeking effective and innovative care delivery systems that are design ed to optimize patient , caregiver , and hospital outcomes BACKGROUND Many studies have examined predictors of nurses ' intention to work in their job , including desire to quit . Intent has been a good predictor of actual turnover . Few longitudinal studies exist that consider regional variables . OBJECTIVES To extend the conceptual framework of turnover research to the whole nursing workforce and determine : ( 1 ) how do demographics , region ( metropolitan statistical area : MSA ) , movement opportunities , and work setting variables affect registered nurses ' ( RNs ) intent to work and desire to quit ; and ( 2 ) how do demographics , MSA variables , movement opportunities , and work setting variables affect RNs ' work behavior at time 2 ? DESIGN Panel study using Dillman 's design method . SETTING S AND PARTICIPANTS R and omly selected national cluster sample from 40 urban geographic regions ( MSAs ) in 29 states of the United States . METHODS Four thous and surveys were sent . There were 1907 female RNs under 65 ( 48 % response rate ) from year 1 of which 1348 responded at year 2 ( 70 % response rate ) . RESULTS The first analyses used desire to quit ( explained 65 % of the variance ) and intent to work from year 1 as dependent variables . Satisfaction and organizational commitment were significant negative predictors of desire to quit . In the logistic regression on intent to work , the work motivation and work-family conflict were positive and significant as well as wages ( negative ) and three benefit variables . In year 2 , the dependent variable was working or not and if working , full-time or not . For this bivariate probit regression no attitudes influenced the work/not work decision , but MSA level variables , wages ( positive ) and benefits ( positive ) did . Organizational commitment and higher workload increased the probability of working FT . CONCLUSIONS Regional differences across markets need to be controlled and their influence investigated . In addition , attitudes as well as wages and benefits were important in certain decisions : these factors are clearly under the influence of employers Day Surgery ( DS ) and prehospitalization emerged in Italy -- as it had previously in the United States and other European countries -- as able to improve healthcare and reduce costs . The purpose of this study was to evaluate the impact of the Nurse Case Manager ( NCM ) Model on patients undergoing DS procedures . The study assessed the intensity of pain , anxiety , and stress factors , and the level of discomfort experienced . The quasi-experimental study design involved two groups of patients ( at two different DS hospital centers ) : one using the NCM model ( Ward A ) the other based on team nursing ( Ward B ) . All patients undergoing DS for ( a ) varicose veins , ( b ) inguinal hernia , ( c ) breast biopsy , and ( d ) hemorrhoids were included . A valid question naire interview based on 22 questions was used ( 1 ) the morning before surgery , ( 2 ) the evening after surgery , and ( 3 ) 48 hr after the operation , by telephone . Of the 145 patients that were involved , 66 were from Ward A ( 45.5 % ) and 79 from Ward B ( 54.5 % ) . When patient care was based on the NCM Model ( Ward A ) , it seemed that ( a ) the pathway before DS was more efficient ; ( b ) they perceived lower levels of perioperative anxiety and pain ; and ( c ) they recognized the DS center as a unique point of reference for all postoperative problems Output:	The results reveal that implementation of the team nursing model of care result ed in significantly decreased incidence of medication errors and adverse intravenous outcomes , as well as lower pain scores among patients ; however , there was no effect of this model of care on the incidence of falls . Wards that used a hybrid model demonstrated significant improvement in quality of patient care , but no difference in incidence of pressure areas or infection rates . There were no significant differences in nursing outcomes relating to role clarity , job satisfaction and nurse absenteeism rates between any of the models of care . Based on the available evidence , a predominance of team nursing within the comparisons is suggestive of its popularity . Patient outcomes , nurse satisfaction , absenteeism and role clarity/confusion did not differ across model comparisons . Little benefit was found within primary nursing comparisons and the cost effectiveness of team nursing over other models remains debatable . Nonetheless , team nursing does present a better model for inexperienced staff to develop , a key aspect in units where skill mix or experience is diverse
MS21151	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Objective : To assess if a school based intervention was effective in reducing risk factors for obesity . Design : Group r and omised controlled trial . Setting : 10 primary schools in Leeds . Participants : 634 children aged 7 - 11 years . Intervention : Teacher training , modification of school meals , and the development of school action plans targeting the curriculum , physical education , tuck shops , and playground activities . Main outcome measures : Body mass index , diet , physical activity , and psychological state . Results : Vegetable consumption by 24 hour recall was higher in children in the intervention group than the control group ( weighted mean difference 0.3 portions/day , 95 % confidence interval 0.2 to 0.4 ) , representing a difference equivalent to 50 % of baseline consumption . Fruit consumption was lower in obese children in the intervention group ( −1.0 , −1.8 to −0.2 ) than those in the control group . The three day diary showed higher consumption of high sugar foods ( 0.8 , 0.1 to 1.6 ) ) among overweight children in the intervention group than the control group . Sedentary behaviour was higher in overweight children in the intervention group ( 0.3 , 0.0 to 0.7 ) . Global self worth was higher in obese children in the intervention group ( 0.3 , 0.3 to 0.6 ) . There was no difference in body mass index , other psychological measures , or dieting behaviour between the groups . Focus groups indicated higher levels of self reported behaviour change , underst and ing , and knowledge among children who had received the intervention . Conclusion : Although it was successful in producing changes at school level , the programme had little effect on children 's behaviour other than a modest increase in consumption of vegetables . What is already known on this topic Obesity is increasing among school children and dem and s preventive strategies R and omised controlled trials of school based primary prevention programmes have all used a prescriptive approach What this study adds Behavioural changes were disappointing with this programme based on the health promoting schools philosophy , despite changes at school level The only positive outcome was a modest increase in vegetable consumption The discrepancy between changes achieved at the individual and school level raises issues regarding the problems inherent in such Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs A health education intervention was carried out for three consecutive years on primary school Cretan children . Baseline measures were obtained from 962 pupils ( 509 boys and 453 girls ) registered in first grade in 1992 . The health education intervention programme was directed at both the children of the intervention group and their parents , and has a projected duration of 6 years . After the completion of the 3 years of intervention and while pupils were in fourth grade , measures were obtained for evaluation purpose s on a r and om sub sample of 393 pupils of the original cohort . Statistically greater improvements in the intervention , as opposed to the control group , were observed for both children 's and parents ' health knowledge , and children 's st and ing broad jump , sit-ups ( SUP ) , sit- and -reach , h and grip and endurance run test ( ERT ) . Furthermore , time spent on moderate to vigorous physical activities out of school significantly increased for intervention group children compared to the control group . Statistically smaller increases in the intervention as opposed to the control group were observed in suprailiac skinfold and body mass index . The degree of improvement in both SUP and ERT related positively to parent 's baseline physical activity score . Finally , the parental attitude of health-related hedonism related negatively to SUP improvement OBJECTIVE To determine whether a multicomponent health promotion intervention for Dutch adolescents would be successful in influencing body composition and aerobic fitness . DESIGN R and omized controlled trial . SETTING Ten intervention and 8 control prevocational secondary schools . PARTICIPANTS A total of 978 adolescents ( mean age , 12.7 years ) . INTERVENTION An interdisciplinary multicomponent intervention program with an adapted curriculum for 11 biology and physical education lessons and environmental change options , including additional lessons on physical education and advice on the school canteen selection . MAIN OUTCOME MEASURES Body height and weight , hip and waist circumference , 4 skinfold thickness measurements , and aerobic fitness . RESULTS Multilevel analyses showed significant differences in changes after the 8-month intervention period in favor of the intervention group with regard to hip circumference ( mean difference , 0.53 cm ; 95 % confidence interval , 0.07 to 0.98 ) and sum of skinfolds among girls ( mean difference , -2.31 mm ; 95 % confidence interval , -4.34 to -0.28 ) . In boys , the intervention result ed in a significant difference in waist circumference ( mean difference , -0.57 cm ; 95 % confidence interval , -1.10 to -0.05 ) . No significant intervention effects were found related to aerobic fitness . CONCLUSIONS The multicomponent Dutch Obesity Intervention in Teenagers program positively influenced several measures of body composition among both girls and boys . Our results indicate that secondary prevocational school curriculum changes may contribute to excessive weight gain prevention among adolescents OBJECTIVE To examine the effects of a health and nutrition intervention , implemented in primary schools of Crete , on health knowledge , nutrient intakes and physical activity of the intervention population . METHODS The intervention group consisted of 24 schools while the control group consisted of 16 schools . The overall duration of the intervention was six years , while the topics of the intervention primarily focused on children ' dietary habits , physical activity and fitness . RESULTS After the completion of the intervention period , the changes observed in health knowledge , nutrient intakes and physical activity were in favour of the intervention group pupils . CONCLUSION The encouraging findings of the study indicate the potential of the programme in health promotion and disease prevention without involving substantial new school re sources and time The effectiveness of a health and nutrition education programme , in changing certain chronic disease risk factors , was assessed after the 6 years intervention period was completed . The school-based intervention programme was applied to all children registered in the first grade ( age 5.5 - 6.5 years ) in 1992 in two counties of Crete , while the children from a third county served as a control group . In order to assess the effectiveness of the intervention , a variety of biological and behavioural parameters were measured before and following completion of the intervention in a r and omly selected school-based sample of 602 intervention group ( IG ) and 444 control group ( CG ) pupils . At the end of the 6-year period , it was found that biochemical indices generally improved significantly more in the IG compared with the CG ( mean change for IG v. CG was -0.27 v. -0.12 mmol/l for total cholesterol ( TC ) ; -0.07 v. + 0.24 for TC : HDL and -0.13 v. + 0.14 for LDL : HDL ) . Similarly , the changes observed in the anthropometric variables in the two groups were in favour of the IG ( + 3.68 v. + 4.28 kg/m2 for BMI ; + 2.97 v. + 4.47 mm for biceps skinfold ) . Total energy intake and consumption of total fat and saturated fat increased significantly less in the IG compared with the CG ( + 747.7 v. 1534.7 kJ ( + 178.7 v. + 366.8 kcal ) ; + 5.9 v. + 18.8 g and + 0.8 v. + 5.1 g respectively ) , while time devoted to leisure time physical activity and cardiovascular run test performance increased significantly more in the IG ( + 281 v. + 174 min/week and + 2.5 v. + 1.2 stages respectively ) . The findings of the present study underline the importance of such programmes in health promotion and disease prevention . Although the long-term effects of these programmes can only be assessed by tracking this population through to adolescence and adulthood , these programmes seem to have the potential to lead to a healthier lifestyle and thus a reduction in risk factor levels OBJECTIVES To evaluate the effects of a middle-school healthy eating promotion intervention combining environmental changes and computer-tailored feedback , with and without an explicit parent involvement component . DESIGN Clustered r and omised controlled trial . SETTING Fifteen West-Flemish ( Belgian ) middle schools . SUBJECTS A r and om sample of 15 schools with 2991 pupils in 7th and 8th grade s was r and omly assigned to an intervention group with parental support ( n = 5 ) , an intervention group without parental support ( n = 5 ) and a control group ( n = 5 ) . In these 15 schools an intervention combining environmental changes with computer-tailored feedback was implemented . Fat and fruit intake , water and soft drinks consumption were measured with food-frequency question naires in the total sample of children . RESULTS In girls , fat intake and percentage of energy from fat decreased significantly more in the intervention group with parental support , compared with the intervention alone group ( all F>3.9 , P < 0.05 ) and the control group ( all F>16.7 , P < 0.001 ) . In boys , there were no significant decreases in fat intake ( F = 1.4 , not significant ( NS ) ) or percentage of energy from fat ( F = 0.7 , NS ) as a result of the intervention . No intervention effects were found in boys or in girls for fruit ( F = 0.5 , NS ) , soft drinks ( F = 2.6 , NS ) and water consumption ( F = 0.3 , NS ) . CONCLUSIONS Combining physical and social environmental changes with computer-tailored feedback in girls and their parents can induce lower fat intake in middle-school girls . However , to have an impact on the consumption of soft drinks and water , governmental laws that restrict the at-school availability of low-nutritive products may be necessary Background Only limited data are available on the development , implementation , and evaluation processes of weight gain prevention programs in adolescents . To be able to learn from successes and failures of such interventions , integral written and published reports are needed . Methods Applying the Intervention Mapping ( IM ) protocol , this paper describes the development , implementation , and evaluation of the Dutch Obesity Intervention in Teenagers ( DOiT ) , a school-based intervention program aim ed at the prevention of excessive weight gain . The intervention focussed on the following health behaviours : ( 1 ) reduction of the consumption of sugar-sweetened beverages , ( 2 ) reduction of energy intake derived from snacks , ( 3 ) decrease of levels of sedentary behaviour , and ( 4 ) increase of levels of physical activity ( i.e. active transport behaviour and sports participation).The intervention program consisted of an individual classroom-based component ( i.e. an educational program , covering 11 lessons of both biology and physical education classes ) , and an environmental component ( i.e. encouraging and supporting changes at the school canteens , as well as offering additional physical education classes).We evaluated the effectiveness of the intervention program using a r and omised controlled trial design . We assessed the effects of the intervention on body composition ( primary outcome measure ) , as well as on behaviour , behavioural determinants , and aerobic fitness ( secondary outcome measures ) . Furthermore , we conducted a process evaluation . Output:	The results suggest that combining educational and environmental components that focus on both sides of the energy balance give better and more relevant effects . Furthermore , computer-tailored personalized education in the classroom showed better results than a generic classroom curriculum .
MS21152	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: STUDY OBJECTIVE To determine whether the pain and discomfort of routine hysteroscopy with endometrial biopsy to diagnose infertility and endometrial pathology can be minimized by topical application of mepivacaine . DESIGN Prospect i ve , r and omized , double-blind study . SETTING The Department of Obstetrics and Gynecology at a teaching hospital in Rome , Italy . PATIENTS Eighteen women undergoing diagnostic hysteroscopy . INTERVENTIONS Hysteroscopy and endometrial biopsy were performed after transcervical injection of 5 ml 2 % mepivacaine or 5 ml saline solution into the uterine cavity . MEASUREMENTS AND MAIN RESULTS Difficulty introducing the hysteroscope was rated by the operator on a scale of 1 to 3 . An observer scored visible signs of each woman 's distress using a three-point scale . The patients reported their pain 15 , 30 , 60 , 120 minutes after the procedure on a visual analog scale . Mepivacaine was more effective than placebo according to all measurements . CONCLUSIONS Topical mepivacaine reduced the pain experienced during and after hysteroscopy and endometrial biopsy BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences Outpatient hysteroscopy is now regarded as the investigation of choice for abnormal uterine bleeding as there is no longer any doubt that hysteroscopy is more effective than conventional curettage at identifying intrauterine pathology ( Gimpelson , 1984 ; Goldrath & Sherman , 1985 ; Gimpelson & Rappold , 1988 ; Loffer 1989 ) as it allows direct inspection of the uterine cavity , directed biopsy and appropriate therapeutic management . Another important advantage of hysteroscopy is that it can be performed without general anaesthesia and , in our experience , only 28.5 % of patients required local anaesthesia ; this was significantly associated with the need to dilate the cervix ( Hill et al. 1992 ) . In order to assess the role and efficacy of local anaesthesia before hysteroscopy , a r and omized placebo controlled double blind trial was performed comparing intracervical lignocaine with saline Objective To compare saline with and without added lignocaine and carbon dioxide distension for out patient hysteroscopy with regards to patient discomfort and hysteroscopic view OBJECTIVE To assess the efficacy of lignocaine spray during outpatient hysteroscopy in reducing the need for additional anesthesia and reducing the discomfort of the procedure . DESIGN A r and omized double-blind , placebo-controlled trial . SETTING An undergraduate university teaching hospital in London . PATIENT(S ) One hundred twenty patients undergoing outpatient hysteroscopy . INTERVENTION(S ) Application of lignocaine spray to the cervix , cervical canal , and uterine cavity during outpatient hysteroscopy . MAIN OUTCOME MEASURE(S ) The need to use additional anesthesia and the pain experienced at various steps of the procedure . RESULT ( S ) Women treated with active spray experienced significantly less pain when the cervix was grasped with a tenaculum at the start of hysteroscopy . There were no other significant differences in the outcome of hysteroscopy between the placebo and lignocaine groups , although there was a significant reduction in the use of additional anesthesia in both groups compared with historical controls . CONCLUSION ( S ) Lignocaine spray has beneficial effects on cervical but not uterine sensation . Pretreatment with either lignocaine or placebo seems to reduce the need for additional intracervical anesthesia during hysteroscopy OBJECTIVE : To compare a “ no touch ” approach to diagnostic hysteroscopy without anesthesia with traditional diagnostic hysteroscopy after intracervical injection of mepivacaine hydrochloride 3 % . METHODS : A total of 130 women undergoing diagnostic hysteroscopy were included in the study and were r and omized , using a computer-generated r and omization list to one of two treatment groups in a ratio of 2:1 . Eighty-three women underwent hysteroscopy without speculum , tenaculum , or anesthesia . Forty-seven women received intracervical anesthesia with 10 mL of 3 % mepivacaine hydrochloride solution injected at two sites ( 3:00 and 9:00 positions ) and underwent traditional hysteroscopy . Hysteroscopy was performed using a rigid 3.7-mm hysteroscope and a medium of 0.9 % saline , and the image was transmitted to a screen visible to the patient . A visual analog scale ( VAS ) consisting of a 10-cm line was used to assess the intensity of pain experienced during and after the procedure . Overall patient satisfaction was assessed during , immediately after , 15 minutes later , and 3 days after hysteroscopy . RESULTS : The mean pain score was significantly lower in the group without the use of speculum , tenaculum , or anesthesia ( VAS1 : 3.8±2.7 versus 5.34±3.23 , P=.01 ; VAS2 : 3.02±2.50 versus 4.57±3.30 , P=.008 ) . Patient satisfaction rate was similar in both groups . CONCLUSION : Patients reported significantly less pain with the altered approach to diagnostic hysteroscopy compared with patients undergoing the traditional procedure with anesthesia . This new approach can therefore be considered as a useful hysteroscopic technique . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00319410 LEVEL OF EVIDENCE : BACKGROUND The study was design ed to compare local anaesthesia and conscious sedation for outpatient bipolar operative hysteroscopy in terms of pain control and patients ' satisfaction . METHODS A prospect i ve multicentre r and omized study was carried out in university hospitals and in a private endoscopy unit . A total of 166 women with surgically treatable lesions associated with infertility or abnormal uterine bleeding was considered eligible for the study . Patients were r and omized , using a computer-generated r and omization list , into two groups . Group A ( 82 patients ) underwent operative hysteroscopy with local anaesthesia . Group B ( 84 patients ) received conscious sedation . Operative hysteroscopy was performed with a bipolar electrosurgical device to cut , vaporize and coagulate . Main outcome measures were pain control during the procedure , the post-operative pain score at 15 and 60 min , and at 24 h after the procedure , and patients ' satisfaction rate . RESULTS All procedures were completed within 35 min , the amount of saline used varied from 400 - 1200 ml . There were no significant differences between local anaesthesia and conscious sedation in terms of pain control during the procedure and in postoperative pain at different intervals . Satisfaction rate was similar in the two groups . CONCLUSIONS Both local anaesthesia and conscious sedation can be used for operative hysteroscopy using a bipolar electrosurgical system without significant differences in terms of pain control and patients ' satisfaction STUDY OBJECTIVE To evaluate the amount of pain during office hysteroscopy and endometrial biopsy with and without intrauterine anesthesia . DESIGN Prospect i ve r and omized study ( Canadian Task Force classification I ) . SETTING Academic teaching center . PATIENTS A total of 82 women underwent outpatient hysteroscopy for evaluation of their uterine cavity . INTERVENTIONS R and omization to local cervical or combined cervical and intrauterine anesthesia . MEASUREMENTS AND MAIN RESULTS Amount of pain experienced during the procedure ; 10 , 30 , and 60 minutes after the procedure ; and during endometrial biopsy . We used a visual analog scale ranging from 0 to 10 ( 0 : no pain , 10 : excruciating pain ) . Of 82 patients , 4 patients were excluded , 36 patients underwent hysteroscopy using local cervical anesthesia , and 42 others with combined cervical and intrauterine anesthesia . The mean age of the patients in the local group was 37.4 + /- 0.8 years and in the combined group was 38.3 + /- 0.7 years . In both groups , patients experienced significantly more pain during and 10 minutes after the procedure than 30 and 60 minutes after . No significant differences occurred in the pain scores during the hysteroscopy , and 10 , 30 , and 60 minutes after between the 2 anesthesia groups . The pain score in the local group during endometrial biopsy was significantly higher than during ( p < .05 ) , 10 minutes after ( p < .001 ) , 30 minutes after ( p < .001 ) , and 60 minutes after ( p < .001 ) the procedure , respectively . In the combined group , compared with the pain score during endometrial biopsy , the scores during the hysteroscopy ( p < .05 ) , 10 minutes after ( p < .01 ) , 30 minutes after ( p < .001 ) , and 60 minutes after ( p < .001 ) the procedure were also less , respectively . CONCLUSION Intrauterine anesthesia with medicated saline as a distending medium is ineffective . Endometrial biopsy is associated with more pain than hysteroscopy OBJECTIVE To determine the feasibility and patient satisfaction of female sterilisation using the Essure system in an outpatient hysteroscopy clinic without conscious sedation or general anaesthesia . DESIGN Prospect i ve cohort study . SETTING Outpatient hysteroscopy clinic in a large teaching hospital . POPULATION Women undergoing outpatient hysteroscopic sterilisation using the Essure system for permanent fertility control . METHODS Demographic and procedural data were prospect ively collected from 112 consecutive women undergoing outpatient hysteroscopic sterilisation without sedation or general anaesthesia . A hysterosalpingogram ( HSG ) was performed routinely in all women 3 months after the procedure to confirm bilateral tubal occlusion . Postal question naires were sent at this time enquiring about patient satisfaction and experience with the outpatient procedure . Multivariable logistic regression was used to identify factors independently predictive of successful completion of the procedure . MAIN OUTCOME MEASURES Technical feasibility , predictive factors for technical success ( operator , body mass index , uterine size , axis , menstrual phase and cervical stenosis ) , complications , tubal occlusion on HSG , patient satisfaction and procedure-related experience . RESULTS Successful bilateral tubal placement of the Essure microinserts was achieved in 103/112 ( 92 % , 95 % CI 85 - 96 % ) women . Nonsecretory phase of the menstrual cycle ( P = 0.04 ) and a clinical ly normal-sized uterus ( P = 0.003 ) were independently predictive for successful completion of the outpatient procedure on multivariable modelling . There were no major procedure-related complications recorded , but transient vasovagal reactions occurred in 5/112 ( 5 % ) women . Of the original cohort of 112 women with successful procedures , 84 women were 3 months postprocedure and had undergone a HSG . Bilateral tubal occlusion was confirmed in 83/84 ( 99 % , 95 % CI 94 - 100 % ) women at 3 months and in 100 % at 6 months . Seventy-six of 84 ( 91 % ) had returned the question naires , and 70/73 ( 96 % , 95 % CI 88 - 99 % ) were satisfied with their overall experience of the procedure including radiological follow up , with most reporting being ' very satisfied ' ( 64/73 , 88 % , 95 % CI 78 - 94 % ) . CONCLUSIONS Outpatient hysteroscopic sterilisation using the Essure system without sedation or general anaesthesia is a successful and safe procedure associated with high rates of patient satisfaction . If practical , women should be scheduled to have their procedures in the proliferative phase of the menstrual cycle to optimise successful placement of Essure devices , especially if the uterus is clinical ly enlarged OBJECTIVE To evaluate the efficiency of par Output:	Paracervical local anaesthetic injection is the best method of pain control for women undergoing hysteroscopy as out patients
MS21153	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Fluoroscopy-guided bronchoscopy is usually performed for the diagnosis of peripheral pulmonary lesions ( PPL ) , but the diagnostic yield varies widely among studies . Endobronchial ultrasound ( EBUS ) can increase the diagnostic yield of bronchoscopic diagnosis of PPL . OBJECTIVE To compare the diagnostic yield of fluoroscopy-guided bronchoscopy and EBUS with fluoroscopy-guided bronchoscopy in the study of PPL . METHODS All patients who underwent bronchoscopy to study PPL from January 2009 to December 2012 were prospect ively included . 145 consecutive patients were r and omly distributed in two groups : EBUS and fluoroscopy ( 50 patients , 71.3 ± 8.2 years ) or fluoroscopy alone ( 95 patients , 68 ± 10.5 years ) . The mean diameter of the lesions was 41.97 ± 19.22 mm . Cytological brushing and transbronchial biopsies were obtained . All procedures were performed under fluoroscopic guidance with intravenous conscious sedation . EBUS was performed using an endoscopic ultrasound system equipped with a 20-MHz radial miniprobe introduced via a guide-sheath . Bronchoscopist , cytologist , study protocol , techniques and tools were the same throughout the whole study . RESULTS 129 ( 89 % ) patients had malignant disease . A diagnosis with bronchoscopy was established in 105 ( 72.4 % ) patients . EBUS plus fluoroscopy obtained a diagnostic yield in 78 % of patients and fluoroscopy alone in 69.5 % ( non-significant ) . In contrast , for lesions smaller than 30 mm , EBUS plus fluoroscopy guidance provided significantly greater diagnostic performance than fluoroscopy alone ( 90 vs. 52 % ; P=.05 ) . CONCLUSIONS Bronchoscopy under EBUS plus fluoroscopy guidance is a technique that has become useful for the diagnostic of LPPs , especially those smaller than 30 mm in diameter STUDY OBJECTIVE To assess the ability of endobronchial ultrasonography ( EBUS ) using a guide sheath ( EBUS-GS ) to diagnose peripheral pulmonary lesions . METHOD We devised a technique for EBUS-GS covering a miniature probe , and 150 lesions were evaluated in a prospect i ve open study . In this procedure , the probe covered by a guide sheath is introduced into the lesion via the working channel of a bronchoscope . The probe is withdrawn , while the guide sheath is left in situ . A brush or biopsy forceps is introduced through the guide sheath into the lesion . RESULTS One hundred sixteen of 150 EBUS-GS procedures ( 77 % ) were diagnostic . Cases in which the probe was located within the lesion had a significantly higher diagnostic yield ( 105 of 121 cases , 87 % ) than when the probe was located adjacent to it ( 8 of 19 cases , 42 % ) [ p < 0.0001 , chi(2 ) ] . The diagnostic yield from EBUS-GS in lesions < /= 10 mm ( 16 of 21 lesions , 76 % ) , > 10 to < /= 15 mm ( 19 of 25 lesions , 76 % ; p = 0.99 , chi(2 ) ) , > 15 to < /= 20 mm ( 23 of 35 lesions , 66 % ; p = 0.41 , chi(2 ) ) , and > 20 to < /= 30 mm ( 33 of 43 lesions , 77 % ; p = 0.96 , chi(2 ) ) were similar , demonstrating the efficacy of EBUS-GS even in lesions < /= 10 mm in diameter . In 54 of 81 lesions < /= 20 mm , fluoroscopy was not able to confirm whether the forceps reached the lesion . However , the yield was the same with ( 67 % , 18 of 27 lesions ) and without ( 74 % , 40 of 54 lesions ) successful fluoroscopy ( p = 0.96 , chi(2 ) ) . Moderate bleeding occurred in two patients ( 1 % ) ; there were no other complications . CONCLUSIONS EBUS-GS is a useful method for collecting sample s from peripheral pulmonary lesions , even those too small to be visualized under fluoroscopy Transbronchial biopsy ( TBBX ) for peripheral lung lesions is usually performed with the help of fluoroscopy , but the yield varies widely . This feasibility study aim ed to assess the ability of endobronchial ultrasound ( EBUS ) to provide imaging guidance for TBBX . In a prospect i ve study , 50 consecutive patients referred for TBBX for peripheral lesions underwent fluoroscopy-guided and EBUS-guided TBBX in r and om order . Diagnostic yields were compared for both modalities and feasibility was assessed for EBUS . Diagnostic material was obtained in 80 % of patients with EBUS and 76 % of patients with fluoroscopy . There was a nonsignificant trend for EBUS to be better than fluoroscopy for lesions <3 cm in diameter . Four lesions could not be visualised with EBUS . There were no significant complications associated with the use of EBUS . Endobronchial ultrasound-guided transbronchial biopsy is feasible . It appears to be at least equivalent to fluoroscopy without the accompanying radiation exposure . Further large-scale studies are indicated to assess the possible role of endobronchial ultrasound as a potential imaging method of choice for the biopsy of peripheral lung lesions RATIONALE Endobronchial ultrasound ( EBUS ) and electromagnetic navigation bronchoscopy ( ENB ) have increased the diagnostic yield of bronchoscopic diagnosis of peripheral lung lesions . However , the role of combining these modalities to overcome each individual technique 's limitations and , consequently , to further increase the diagnostic yield remains untested . OBJECTIVES A prospect i ve r and omized controlled trial involving three diagnostic arms : EBUS only , ENB only , and a combined procedure . METHODS All procedures were performed via flexible bronchoscopy and transbronchial forceps biopsies were obtained without fluoroscopic guidance . In the combined group , after electromagnetic navigation , the ultrasound probe was passed through an extended working channel to visualize the lesion . Biopsies were taken if ultrasound visualization showed that the extended working channel was within the target . Primary outcome was diagnostic yield . The reference " gold st and ard " was a surgical biopsy if bronchoscopic biopsy did not reveal a definite histological diagnosis compatible with the clinical presentation . Secondary outcomes were yields by size , lobar distribution , and lesion pathology . Complication rates were also documented . MEASUREMENTS AND MAIN RESULTS Of the 120 patients recruited , 118 had a definitive histological diagnosis and were included in the final analysis . The diagnostic yield of the combined procedure ( 88 % ) was greater than EBUS ( 69 % ) or ENB alone ( 59 % ; p = 0.02 ) . The combined procedure 's yield was independent of lesion size or lobar distribution . The pneumothorax rates ranged from 5 to 8 % , with no significant differences between the groups . CONCLUSIONS Combined EBUS and ENB improves the diagnostic yield of flexible bronchoscopy in peripheral lung lesions without compromising safety RATIONALE Advanced bronchoscopy techniques such as electromagnetic navigation ( EMN ) have been studied in clinical trials , but there are no r and omized studies comparing EMN with st and ard bronchoscopy . OBJECTIVES To measure and identify the determinants of diagnostic yield for bronchoscopy in patients with peripheral lung lesions . Secondary outcomes included diagnostic yield of different sampling techniques , complications , and practice pattern variations . METHODS We used the AQuIRE ( ACCP Quality Improvement Registry , Evaluation , and Education ) registry to conduct a multicenter study of consecutive patients who underwent transbronchial biopsy ( TBBx ) for evaluation of peripheral lesions . MEASUREMENTS AND MAIN RESULTS Fifteen centers with 22 physicians enrolled 581 patients . Of the 581 patients , 312 ( 53.7 % ) had a diagnostic bronchoscopy . Unadjusted for other factors , the diagnostic yield was 63.7 % when no radial endobronchial ultrasound ( r-EBUS ) and no EMN were used , 57.0 % with r-EBUS alone , 38.5 % with EMN alone , and 47.1 % with EMN combined with r-EBUS . In multivariate analysis , peripheral transbronchial needle aspiration ( TBNA ) , larger lesion size , nonupper lobe location , and tobacco use were associated with increased diagnostic yield , whereas EMN was associated with lower diagnostic yield . Peripheral TBNA was used in 16.4 % of cases . TBNA was diagnostic , whereas TBBx was nondiagnostic in 9.5 % of cases in which both were performed . Complications occurred in 13 ( 2.2 % ) patients , and pneumothorax occurred in 10 ( 1.7 % ) patients . There were significant differences between centers and physicians in terms of case selection , sampling methods , and anesthesia . Medical center diagnostic yields ranged from 33 to 73 % ( P = 0.16 ) . CONCLUSIONS Peripheral TBNA improved diagnostic yield for peripheral lesions but was underused . The diagnostic yields of EMN and r-EBUS were lower than expected , even after adjustment AIM To determine diagnostic rate , complications and patient tolerability of endobronchial ultrasound-guide sheath ( EBUS-GS ) and computed tomography (CT)-guided percutaneous core biopsy for peripheral lung lesions . METHODS Lesions > 1 cm diameter on CT were r and omised to either EBUS-GS or CT-guided biopsy . Excluded were patients with severe chronic obstructive airway disease , lesions touching visceral pleura or hilum , and patients with symptoms needing bronchoscopic evaluation . Patients completed preprocedure and postprocedure question naires on tolerability . RESULTS Of 64 participants ( mean lesion size 29 ± 16 mm ) , 57 completed the study . Diagnostic sensitivity was 67 % for EBUS-GS and 78 % for CT-guided biopsy ( P = not significant ) . In those with negative results , in the EBUS group , nine had a CT-guided biopsy as a cross-over , seven of which were positive . In the CT group , four had cross-over EBUS-GS of which three were diagnostic . Sensitivity for malignancy was 17/23 for EBUS-GS ( 74 % ) and 23/26 ( 88 % , P = not significant ) . For lesions < 2 cm , CT-guided biopsy had a significantly better diagnostic yield ( 80 % vs 50 % , P = 0.05 ) . In EBUS-GS cases , for lesions with an air bronchogram , sensitivity was 89 % . Pneumothorax and intercostal catheter insertion occurred in three and two cases , respectively , for EBUS , and 10 and 3 cases for CT-guided biopsy ( P = 0.02 for pneumothorax ) . Nine unexpected admissions occurred after CT-guided biopsy compared with three after EBUS-GS . Overall , tolerability was high for both groups ; however three patients had moderate-to-severe pain after CT-guided biopsy . CONCLUSIONS In lesions < 2 cm , CT-guided biopsy had higher yields ; however , EBUS-GS had better tolerability and fewer complications Background : Peripheral lung lesions are increasing in numbers . Endoscopic diagnosis is essential for the prevention of unnecessary operations . Conventional diagnostic procedures have limitations in availability and results . Objectives : Endobronchial ultrasonography ( EBUS ) was investigated as a means to guide transbronchial lung biopsy , to reduce the discomfort during the procedure and to improve diagnostic accuracy . Methods : In 50 cases , we performed transbronchial lung biopsy combined with EBUS and fluoroscopic guidance . The results were compared to 42 controls assessed by fluoroscopy only . Results : In 38 cases ( 76 % ) , EBUS could describe the peripheral lesion ( 33 from inside , including 9 cases with difficulties in fluoroscopic observation , and 5 from an adjacent bronchus , indicating the correct location of the lesion ) . If successfully placed inside , a change in the patient ’s position was not required , which helped to reduce patient discomfort . Lung cancer was diagnosed in 24 patients and benign disease in 25 patients ; in 1 case diagnosis remained unknown . When the EBUS probe could be introduced inside the lesion , the sensitivity for cancer diagnosis and specificity for cancer exclusion were 100 % , respectively ( 15/15 , 18/18 ) . Compared to the controls in whom the biopsy site was determined by fluoroscopy only , the sensitivity tended to be superior by EBUS , although it did not reach statistical significance ( p = 0.06 ) . However , specificity and accuracy were statistically significant ( both p = 0.02 ) . Conclusions : When the lesion can be correctly described by EBUS from inside the lesion , EBUS is useful to guide transbronchial lung biopsy , can contribute to a reduction in patient discomfort and improves the accuracy of diagnosis . Additional navigation tools to increase correct positioning of the EBUS probe are desirable Output:	Conclusion : Obtaining TBB sample s for histopathological diagnosis is enhanced by the addition of EBUS to conventional fluoroscopic guidance ; this is , especially important for patients with small peripheral lung lesions who benefit greatly from early diagnosis
MS21154	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIM To investigate the prognostic role of thymidylate synthase ( TS ) and thymidine phosphorylase ( TP ) mRNA levels in T3 or T4 gastric cancer treated with 5-fluorouracil-based adjuvant chemotherapy . METHODS Fifty-one patients with T3 or T4 gastric cancer received systemic 5-fluorouracil-based adjuvant chemotherapy , and intratumoral expression of TS and TP in 51 gastric cancer tissue sample s was tested by real-time quantitative PCR . RESULTS The median disease-free survival ( DFS ) time was 10.2 mo in the patients . There were no significant differences in DFS between the groups with high and low levels of TP . However , the group with low level of TS had a longer DFS ( 14.4 mo vs 8.3 mo , P = 0.017 ) . The median overall survival ( OS ) time was 18.5 mo , and there were significant differences in OS between the groups with high and low levels of TS or TP ( for TS , 17.0 mo vs 21.3 mo , P = 0.010 ; for TP , 16.6 mo vs 22.5 mo , P = 0.009 ) . Moreover , the coupled low expression of these two genes was strongly associated with a longer survival time of patients as compared with that of a single gene . CONCLUSION Expression of TS and TP mRNA is a useful predictive parameter for the survival of postoperative gastric cancer patients after 5-fluorouracil-based adjuvant chemotherapy Purpose : We evaluated the expression of seven therapy-related genes to predict the clinical outcome of advanced gastric cancer patients treated with a neoadjuvant chemotherapeutic protocol . Experimental Design : Pretherapeutic , formalin-fixed , and paraffin-embedded biopsies of 61 patients , who received a 5-fluorouracil (5-FU)– and cisplatin-based chemotherapy were studied . The expressions of the 5-FU – related genes TS , DPD , and TP and of the cisplatin-related genes ERCC1 , ERCC4 , KU80 , and GADD45A were analyzed by quantitative real-time PCR . The expression levels of single genes and of various combinations were tested for an association with response and overall survival . Results : High DPD levels were more frequently found in nonresponding patients and were associated with worse survival . GADD45A and TP levels showed weak associations with response , but GADD45A expression correlated with survival . There was no association with response for TS expression , but tumors with a high TS level were associated with worse survival . The combination of GADD45A and TP revealed the strongest predictive effect . High expression values of TP and /or GADD45A were exclusively found in nonresponding patients ( P = 0.002 ) and were associated with a significantly poorer survival ( P = 0.04 ) . Conclusions : Combined gene expression levels of TP and GADD45A represent a new variable to predict the clinical outcome after neoadjuvant chemotherapy in gastric cancer . The association of DPD expression with response and survival underlines a predominant role of DPD to predict 5-FU sensitivity . The association of TS expression levels with survival but not with response suggests an importance of this gene for tumor progression We evaluated the expression of thymidylate synthase ( TS ) in locally advanced gastric cancer patients treated with adjuvant chemotherapy after curative resection and investigated the association between TS expression and clinicopathologic characteristics including prognosis of the patients . TS expression was evaluated by immunohistochemical staining using TS106 monoclonal antibody in 103 locally advanced gastric cancer patients ( stage IB – IV ) who underwent 5-fluorouracil ( 5-FU ) and doxorubicin-based adjuvant chemotherapy after curative resection . 65 patients ( 63 % ) had primary tumours with high TS expression ( ≥ 25 % of tumour cells positive ) , and 38 patients ( 37 % ) demonstrated low TS expression ( < 25 % of tumour cells positive or no staining ) . High TS expression was associated with male gender ( P=0.002 ) , poorly differentiated histology ( P=0.015 ) , and mixed type in Lauren 's classification ( P=0.027 ) . There were no statistically significant differences in 4-year disease-free survival ( 60.0 % vs 57.2 % , P=0.548 ) and overall survival ( 59.6 % vs 59.3 % , P=0.792 ) between high-TS group and low-TS group . In conclusion , although high TS expression was associated with poorly differentiated histology and mixed type in Lauren 's classification , it did not predict poor disease-free and overall survival in gastric cancer patients treated with 5-FU and doxorubicin-based adjuvant chemotherapy after curative resection . Further prospect i ve studies including the evaluation of other biological markers associated with the resistance to 5-FU and doxorubicin are necessary . © 2001 Cancer Research Campaign The predictive values of thymidylate synthase ( TS ) and dihydropyrimidine dehydrogenase ( DPD ) gene expressions were retrospectively evaluated in patients with gastric cancer treated by a regimen containing S-1 . The study population consisted of 53 patients registered into different two phase II studies for metastatic gastric cancer ; 27 patients treated by S-1-alone study : 26 patients treated with S-1 combined with irinotecan ( CPT-11 ) . TS and DPD gene expressions in primary tumours were measured by the real-time reverse transcription PCR method . There was no statistical difference in DPD gene expression in terms of response in cases treated with S-1 alone and those treated with S-1 plus CPT-11 . TS mRNA of responding tumours was lower than that of nonresponding ones when treated with S-1 ( P<0.005 ) . In the S-1-alone group , taking TS cutoff as the median values , the response rate in the low TS group was 50 % , but only 8 % in the high TS group ( P<0.05 ) . Patients with low TS gene expression survived longer than those with high TS gene expression ( P<0.0001 ) . However , there was no statistically significant difference in response rate and survival between patients with low TS tumours and those with high TS tumours , when the cutoff was taken as the median value of TS gene expression in the group treated with S-1 plus CPT-11 . In conclusion , treatment effects of S-1 monotherapy for gastric cancer were determined by the status of TS gene expression , regardless of DPD gene expression . TS predictive power was overcome by CPT-11 combination therapy with S-1 We investigated the utility of examining biological markers to predict chemoresponse and survival . The subjects consisted of 39 unresectable gastric cancer patients treated with a combination of 5-fluorouracil and cis-platinum . The expression of p53 , bcl-2 , thymidylate synthase ( TS ) , glutathione S-transferase pi ( GST-pi ) , and vascular endothelial growth factor ( VEGF ) in the formalin-fixed biopsy sample s of primary tumors before chemotherapy was examined immunohistochemically . The positive rate for VEGF , bcl-2 , TS , p53 , and GST-pi was 51 , 10 , 46 , 38 , and 69 % , respectively . VEGF-positive cases showed a higher response rate than did negative cases ( 11 of 20 versus 2 of 19 cases ; P = 0.0057 ) . The cases that were negative for p53 , TS , bcl-2 , and GST-pi were more likely to respond to chemotherapy than the cases that were positive for these markers . The 10 cases having 4 or 5 favorable phenotypes ( VEGF positive , p53 negative , bcl-2 negative , TS negative , and GST-pi negative ) survived longer than the remaining 29 cases ( P = 0.0069 ) . Multivariate analysis revealed that the number of favorable phenotypes ( > or = 4 versus < or = 3 ) had a greater impact on survival than performance status ( 0 versus 1 or 2 ) , age ( > 60 years versus < or = 60 years ) , macroscopic type ( scirrhous versus nonscirrhous ) , histological type ( intestinal versus diffuse ) , or tumor extent ( locally advanced versus metastatic ) . Immunohistochemical examination of biological markers in biopsy sample s may be useful in predicting the clinical outcome of unresectable gastric cancer patients treated with 5-fluorouracil and cis-platinum PURPOSE We have previously shown that relative thymidylate synthase ( TS ) mRNA levels in primary gastric adenocarcinomas treated with fluorouracil ( 5-FU ) and cisplatin are inversely associated with response and survival . This is a presumed function of TS as a target for 5-FU activity . We now test the hypotheses that the relative mRNA level of the excision repair cross-complementing ( ERCC1 ) gene is inversely associated with response and survival as an independent function of cisplatin efficacy . PATIENTS AND METHODS Patients had intact , untreated , primary gastric adenocarcinoma cancer and were evaluated for eligibility on a preoperative cisplatin infusion-5-FU protocol . cDNA , derived from primary gastric tumors before chemotherapy , was used to determine ERCC1 mRNA levels , expressed as the ratio of polymerase chain reaction ( PCR ) product of the ERCC1 gene and the beta-actin gene . RESULTS The median ERCC1 mRNA level from 38 primary gastric cancers ( 33 assessable for response ) was 5.8 x 10(-3 ) ( range , 1.8 x 10(-3 ) to 19.5 x 10(-3 ) ) . Of 17 responding patients , 13 ( 76 % ) were less than or equal to 5.8 x 10(-3 ) and four were greater than 5.8 x 10(-3 ) ( P = .003 ) . The median survival for patients with ERCC1 mRNA levels less than or equal to 5.8 x 10(-3 ) has not been reached , whereas for those greater than 5.8 x 10(-3 ) it was 5.4 months ( P = .034 ) . The median TS mRNA level , 3.7 x 10(-3 ) ( range , 0.9 to 18.9 ) also segregated responsive versus resistant tumors ( P = .024 ) . With both ERCC1 and TS mRNA levels below their medians , 11 of 13 patients ( 85 % ) responded ; with both ERCC1 and TS mRNA levels above their medians , two of 10 patients ( 20 % ) responded ( P = .003 ) . CONCLUSION Considered separately , either ERCC1 or TS mRNA levels in a primary gastric adenocarcinoma has a statistically significant relationship to response . ERCC1 mRNA levels have a statistically significant association with survival ; in this cohort TS mRNA levels did not reach statistically significant association with survival as in our previous publication . Whether these molecular parameters are independent of each other as predictors of outcome remains to be determined In the past 4 years , the weekly 24‐hour infusion of high dose 5‐fluorouracil ( 5‐FU ) and leucovorin in the treatment of patients with advanced gastric carcinoma has been prospect ively studied at the authors ' institution . This has enabled them to explore the possibility that the level of expression of thymidylate synthase ( TS ) , the target enzyme of 5‐FU , is related to the drug sensitivity of gastric carcinoma to 5‐FU‐based chemotherapy Purpose We investigated whether the intensity of thymidylate synthase ( TS ) staining in tissue sample s obtained from gastric cancer ( GC ) patients undergoing gastrectomy could predict response to 5-FU-based adjuvant chemotherapy after gastrectomy . Method and material sClinicopathological features of 124 patients with histologically proven GC who underwent radical gastrectomy were retrospectively review ed . Tissue sample s obtained from these patients were immunohistochemically stained for assessing TS expression . We arbitrarily classified the TS staining results as low ( < 20 % cytoplasmic immunostaining ) and high ( ≥20 % cytoplasmic immunostaining ) TS expression . Results The clinicopathological features of the low TS expression group patients were typically similar to those of the high TS expression group patients . However , multivariate forward stepwise logistic regression analysis revealed that low TS expression was independently associated with females and responders to 5-FU-based adjuvant chemotherapy . The median follow-up duration for the 124 GC patients who had undergone curative resection was 41.3 months . The GC patients who showed poor tumor differentiation and high TS expression had short disease-free survival ( DFS ) and overall survival ( OS ) . Conclusions Low TS expression is significantly associated with female GC patients and responders to 5-FU-based adjuvant chemotherapy . It predicts longer DFS and OS in selected GC patients treated with 5-FU-based adjuvant chemotherapy after curative resection . The results suggest that prospect i ve assessment of TS staining intensity in tissue sample s obtained from GC patients undergoing gastrectomy would be useful to predict the patients who would be benefited from 5-FU-based adjuvant chemotherapy after gastrectomy Output:	High levels of TS expression were associated with a poorer OS for advanced GC patients compared with low levels . In the adjuvant setting , high TS expression was also associated with a worse EFS .
MS21155	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE To evaluate the safety and efficacy of laser in situ keratomileusis ( LASIK ) compared to photorefractive keratectomy ( PRK ) for the correction of low or moderate myopia ( -0.50 to -6.00 D ) at 6 months after surgery . METHODS The study population comprised a non-r and omized consecutive series of 622 eyes of 392 patients who were treated with the Nidek EC-5000 excimer laser . LASIK was performed using the ACS Chiron microkeratome on 314 eyes and surface PRK on 308 eyes . All patients were treated using a st and ard protocol , then assessed at 1 , 3 , and 6 months postoperatively . RESULTS Forty-four percent of the LASIK group and 67 % of the PRK group attended their 6-month examination . Eighty percent of patients ( 111 eyes ) after LASIK and 65 % ( 136 eyes ) after PRK had an uncorrected visual acuity of 20/20 or better . Spherical equivalent refraction was within + /-0.50 D of intended refraction in 78 % ( 109 eyes ) for LASIK and 82 % ( 170 eyes ) for PRK . Loss of two more lines of best spectacle-corrected visual acuity at 6 months occurred in 1.4 % ( 2 eyes ) of the LASIK group and 1.0 % ( 2 eyes ) of the PRK group . CONCLUSION At 1 month follow-up , the percentage of eyes that achieved 20/20 uncorrected visual acuity was greater in the LASIK group than in the PRK group . At 6 months , visual and refractive outcomes of LASIK and PRK were similar . Although flap related complications occurred only after LASIK , the overall risk of loss of best spectacle-corrected visual acuity was not significantly greater than for PRK OBJECTIVE This report presents patient-reported optical symptoms after photorefractive keratectomy ( PRK ) and laser in situ keratomileusis ( LASIK ) . DESIGN Preoperative and postoperative patient surveys in a prospect i ve , multicenter , r and omized clinical trial . PARTICIPANTS Two hundred twenty eyes of 220 patients entered the study ; 105 were r and omized to PRK and 115 were r and omized to LASIK . INTERVENTION All patients received a one-pass , multizone excimer laser ablation as part of either a PRK or LASIK procedure . Attempted corrections ranged from 6.00 to 15.00 diopters ( D ) . MAIN OUTCOME MEASURES Glare , halo , and monocular diplopia symptoms as reported by patients on question naires before surgery and at the 6-month follow-up . Comparison was made between symptoms when using optical correction before surgery and symptoms without correction after surgery . RESULTS For both the PRK and LASIK groups analyzed individually , the difference in average glare index before surgery and after surgery was not statistically significant ( P = 0.54 for PRK ; P = 0.15 for LASIK ; t test ) . Twenty-four PRK patients ( 41.4 % ) reported worsening of glare symptoms from baseline compared with 11 LASIK patients ( 21.6 % ) ; however , the difference between the two groups was not statistically significant ( P = 0.086 , chi-square test ) . Within the PRK group , the difference in average halo index before and after surgery was statistically significant ( P = 0.0003 , t test ) ; in the LASIK group , it was not statistically significant ( P = 0.1 1 , t test ) . Thirty-four PRK patients ( 58.6 % ) reported worsening of halo symptoms from baseline compared with 26 LASIK patients ( 50.0 % ) ; this difference was not statistically significant ( P = 0.086 , chi-square test ) . For both the PRK and LASIK groups , the difference in average diplopia index before and after surgery was statistically significant ( P < 0.0001 for PRK ; 0.047 for LASIK ; t test ) . Twenty-six PRK patients ( 44.8 % ) reported a worsening of monocular diplopia symptoms from baseline compared with 19 LASIK patients ( 35.8 % ) ; this difference was not statistically significant ( P = 0.39 , chi-square test ) . When changes in glare and halo from before surgery to after surgery were pooled as a glare-halo index , however , the PRK group did show a significantly greater likelihood of demonstrating an increase in symptoms compared with the LASIK group ( P = 0.048 , chi-square test ) . CONCLUSIONS Optical sequelae of glare , halo , and monocular diplopia may occur in some patients after either both PRK or LASIK for moderate to high myopia ; in contradistinction , many other patients ' preoperative symptoms improve after surgery . On average , PRK patients show an increase in halo and diplopia symptoms , but not glare , after surgery , and LASIK patients show an increase in diplopia , but not glare and halo symptoms . There is a suggestion of a somewhat lesser tendency toward postoperative optical symptoms in LASIK compared with PRK treated eyes OBJECTIVE Determine the outcomes of single-zone photorefractive keratectomy ( SZPRK ) , aspherical photorefractive keratectomy ( ASPRK ) , and laser in-situ keratomileusis ( LASIK ) for the correction of myopia between -6 and -12 diopters . DESIGN Two simultaneous prospect i ve , r and omized , multi-center clinical trials . PARTICIPANTS 286 first-treated eyes of 286 patients enrolled in one of two studies . In Study I , 134 eyes were r and omized to SZPRK ( 58 eyes ) or ASPRK ( 76 eyes ) . In Study II , 152 eyes were r and omized to ASPRK ( 76 eyes ) or to LASIK ( 76 eyes ) . INTERVENTION All eyes received spherical one-pass excimer laser ablation as part of PRK or LASIK performed with the Summit Technologies Apex laser under an investigational device exemption , with attempted corrections between -6 and -12 diopters . MAIN OUTCOME MEASURES Data on uncorrected and best spectacle-corrected visual acuity , predictability and stability of refraction , and complications were analyzed . Follow-up was 12 months . RESULTS At 1 month postoperatively , more eyes in the LASIK group achieved 20/20 and 20/25 or better uncorrected visual acuity than PRK-treated eyes ; at the 20/25 or better level , the difference was significant for LASIK ( 29/76 eyes , 38 % ) over SZPRK ( 10/58 eyes , 17 % ) ( P = .0064 ) . At all subsequent postoperative intervals , no difference was seen between treatment groups . Similarly , best corrected visual acuities were better for LASIK than all PRK eyes at 1 month postoperatively , and LASIK was better than SZPRK at 3 months follow-up ( e.g. , for 20/20 or better at 1 month , LASIK 50/76 eyes ( 66 % ) versus SZPRK 24/57 eyes ( 42 % ) , P = .0066 ) . PRK eyes had a mean loss of BCVA through 6 months , while LASIK eyes had a slight gain of mean BCVA through month 6 ; at 12 months , both ASPRK groups but not SZPRK continued to have a small mean loss of BCVA ( e.g. , compared to preoperative , mean BCVA at 12 months for SZPRK was + 0.3 , LASIK was + .21 , ASPRK I was -0.11 , and ASPRK II -0.31 ( SZPRK versus ASPRK II , P = .0116 ) . Predictability was better for PRK than LASIK at all follow-up intervals ( e.g. , for manifest refraction spherical equivalent + /- 1.0 diopters at 6 months , ASPRK I 42/62 eyes ( 68 % ) versus LASIK 29/72 eyes ( 40 % ) , P = .0014 % ) . Stability was slightly but insignificantly less in the LASIK eyes compared to PRK eyes . All visual outcome measures were better for eyes with preoperative myopia between -6 and -8.9 D compared with eyes with myopia between -9 and -12 D. No consistent differences in refractive outcomes or postoperative corneal haze were seen between aspherical and single-zone ablations ; haze diminished over 12 months and was judged to be vision-impairing in only one ASPRK eye . Microkeratome and flap complications occurred in 4 eyes , result ing in delay of completion of the procedure in 3 eyes but not causing long-term impairment . CONCLUSIONS Improvement in uncorrected visual acuity and return of best corrected visual acuity was more rapid for LASIK than PRK , but efficacy outcomes in the longer term through 12 months were similar for all treatment groups . LASIK eyes tended toward undercorrection with the nomogram employed in this study compared to PRK , but the scatter was similar , suggesting little difference between these procedures for most patients by 6 months and thereafter . No consistent advantage was demonstrated between aspherical and single-zone ablation patterns . Predictability was much better for all procedures for corrections of -6 to -8.9 D compared with -9 to -12 D. Sporadic loss of best corrected vision in the PRK eyes not found in the LASIK eyes and other measures of visual function require further study PURPOSE To review cases of corneal ectasia after laser in situ keratomileusis ( LASIK ) , identify preoperative risk factors , and evaluate methods and success rates of visual rehabilitation for these cases . DESIGN Retrospective nonr and omized comparative trial . PARTICIPANTS Ten eyes from seven patients identified as developing corneal ectasia after LASIK , 33 previously reported ectasia cases , and two control groups with uneventful LASIK and normal postoperative courses : 100 consecutive cases ( first control group ) , and 100 consecutive cases with high myopia ( > 8 diopters [ D ] ) preoperatively ( second control group ) . METHODS Retrospective review of preoperative and postoperative data for each case compared with that of previously reported cases and cases with uneventful postoperative courses . MAIN OUTCOME MEASURES Preoperative refraction , topographic features , residual stromal bed thickness ( RSB ) , time to the development of ectasia , number of enhancements , final best-corrected visual acuity ( BCVA ) , and method of final correction . RESULTS Length of follow-up averaged 23.4 months ( range , 6 - 48 months ) after LASIK . Mean time to the development of ectasia averaged 16.3 months ( range , 1 - 45 months ) . Preoperative refraction averaged -8.69 D compared with -5.37 D for the first control group ( P = 0.005 ) . Preoperatively , 88 % of ectasia cases met criteria for forme fruste keratoconus , compared with 2 % of the first control group ( P < 0.0000001 ) and 4 % of the second control group ( P = 0.0000001 ) . Seven eyes ( 70 % ) had RSB < 250 microm , as did 16 % of eyes in the first control group and 46 % of the second control group . The mean RSB for ectasia cases ( 222.8 microm ) was significantly less than that for the first control group ( 293.6 micro m , P = 0.0004 ) and the second control group ( 256.5 microm ; P = 0.04 ) . Seven eyes ( 70 % ) had enhancements . Only 10 % of eyes lost more than one line of BCVA , and all patients eventually achieved corrected vision of 20/30 or better . One case required penetrating keratoplasty ( 10 % ) , while all others required rigid gas-permeable contact lenses for correction . CONCLUSIONS Significant risk factors for the development of ectasia after LASIK include high myopia , forme fruste keratoconus , and low RSB . All patients had at least one risk factor other than high myopia , and significant differences remained even when controlling for myopia . Multiple enhancements were common among affected cases , but their causative role remains unknown . We did not identify any patients who developed ectasia without recognizable preoperative risk factors Purpose : To compare differences in visual acuity , contrast sensitivity , complications , and higher-order ocular aberrations ( HOAs ) in eyes with stable myopia undergoing either photo-refractive keratectomy ( PRK ) or thin-flap laser in situ keratomileusis ( LASIK ) ( intended flap thickness of 90 μm ) using the VISX Star S4 CustomVue excimer laser and the IntraLase FS60 femtosecond laser at 1 , 3 , and 6 months postoperatively . Methods : In this prospect i ve , masked , and r and omized pilot study , refractive surgery was performed contralaterally on 52 eyes : 26 with PRK and 26 with thin-flap LASIK . Primary outcome measures were uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity ( CDVA ) , contrast sensitivity , and complications . Results : At 6 months , mean values for UDVA ( logMAR ) were −0.043 ± 0.668 Output:	There was evidence that LASIK gives a faster visual recovery than PRK and is a less painful technique . Results at one year after surgery were comparable : most analyses favoured LASIK but they were not statistically significant . LASIK gives a faster visual recovery and is a less painful technique than PRK . The two techniques appear to give similar outcomes one year after surgery .
MS21156	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT Cardiovascular disease is increased in patients with human immunodeficiency virus ( HIV ) , but the specific mechanisms are unknown . OBJECTIVE To assess arterial wall inflammation in HIV , using 18fluorine-2-deoxy-D-glucose positron emission tomography ( 18F-FDG-PET ) , in relationship to traditional and nontraditional risk markers , including soluble CD163 ( sCD163 ) , a marker of monocyte and macrophage activation . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional study of 81 participants investigated between November 2009 and July 2011 at the Massachusetts General Hospital . Twenty-seven participants with HIV without known cardiac disease underwent cardiac 18F-FDG-PET for assessment of arterial wall inflammation and coronary computed tomography scanning for coronary artery calcium . The HIV group was compared with 2 separate non-HIV control groups . One control group ( n = 27 ) was matched to the HIV group for age , sex , and Framingham risk score ( FRS ) and had no known atherosclerotic disease ( non-HIV FRS-matched controls ) . The second control group ( n = 27 ) was matched on sex and selected based on the presence of known atherosclerotic disease ( non-HIV atherosclerotic controls ) . MAIN OUTCOME MEASURE Arterial inflammation was prospect ively determined as the ratio of FDG uptake in the arterial wall of the ascending aorta to venous background as the target-to- background ratio ( TBR ) . RESULTS Participants with HIV demonstrated well-controlled HIV disease ( mean [ SD ] CD4 cell count , 641 [ 288 ] cells/μL ; median [ interquartile range ] HIV-RNA level , < 48 [ < 48 to < 48 ] copies/mL ) . All were receiving antiretroviral therapy ( mean [ SD ] duration , 12.3 [ 4.3 ] years ) . The mean FRS was low in both HIV and non-HIV FRS-matched control participants ( 6.4 ; 95 % CI , 4.8 - 8.0 vs 6.6 ; 95 % CI , 4.9 - 8.2 ; P = .87 ) . Arterial inflammation in the aorta ( aortic TBR ) was higher in the HIV group vs the non-HIV FRS-matched control group ( 2.23 ; 95 % CI , 2.07 - 2.40 vs 1.89 ; 95 % CI , 1.80 - 1.97 ; P < .001 ) , but was similar compared with the non-HIV atherosclerotic control group ( 2.23 ; 95 % CI , 2.07 - 2.40 vs 2.13 ; 95 % CI , 2.03 - 2.23 ; P = .29 ) . Aortic TBR remained significantly higher in the HIV group vs the non-HIV FRS-matched control group after adjusting for traditional cardiovascular risk factors ( P = .002 ) and in stratified analyses among participants with undetectable viral load , zero calcium , FRS of less than 10 , a low-density lipoprotein cholesterol level of less than 100 mg/dL ( < 2.59 mmol/L ) , no statin use , and no smoking ( all P ≤ .01 ) . Aortic TBR was associated with sCD163 level ( P = .04 ) but not with C-reactive protein ( P = .65 ) or D-dimer ( P = .08 ) among patients with HIV . CONCLUSION Participants infected with HIV vs noninfected control participants with similar cardiac risk factors had signs of increased arterial inflammation , which was associated with a circulating marker of monocyte and macrophage activation BACKGROUND The objective of this study was to examine the association of Joint National Committee ( JNC-V ) blood pressure and National Cholesterol Education Program ( NCEP ) cholesterol categories with coronary heart disease ( CHD ) risk , to incorporate them into coronary prediction algorithms , and to compare the discrimination properties of this approach with other noncategorical prediction functions . METHODS AND RESULTS This work was design ed as a prospect i ve , single-center study in the setting of a community-based cohort . The patients were 2489 men and 2856 women 30 to 74 years old at baseline with 12 years of follow-up . During the 12 years of follow-up , a total of 383 men and 227 women developed CHD , which was significantly associated with categories of blood pressure , total cholesterol , LDL cholesterol , and HDL cholesterol ( all P<.001 ) . Sex-specific prediction equations were formulated to predict CHD risk according to age , diabetes , smoking , JNC-V blood pressure categories , and NCEP total cholesterol and LDL cholesterol categories . The accuracy of this categorical approach was found to be comparable to CHD prediction when the continuous variables themselves were used . After adjustment for other factors , approximately 28 % of CHD events in men and 29 % in women were attributable to blood pressure levels that exceeded high normal ( > or = 130/85 ) . The corresponding multivariable-adjusted attributable risk percent associated with elevated total cholesterol ( > or = 200 mg/dL ) was 27 % in men and 34 % in women . CONCLUSIONS Recommended guidelines of blood pressure , total cholesterol , and LDL cholesterol effectively predict CHD risk in a middle-aged white population sample . A simple coronary disease prediction algorithm was developed using categorical variables , which allows physicians to predict multivariate CHD risk in patients without overt CHD Background Therapy with a HIV protease inhibitor is associated with elevations in cholesterol and triglycerides . HMG-CoA reductase inhibitors ( ` statins ' ) are the established therapy for persons with primary hypercholesterolaemia . Because of drug interactions , pravastatin may represent the preferred choice in those taking HIV protease inhibitors . Design A r and omized , open-label comparative 24 week trial of dietary advice alone or with pravastatin in 31 male patients established on protease inhibitor-based regimens for greater than 12 weeks with viral load < 500 copies/ml and cholesterol > 6.5 mmol/l . Results There were no significant clinical or laboratory events and no patient discontinuation secondary to adverse effects . Viral rebound did not occur . Relative to baseline , total cholesterol at week 24 fell significantly in the pravastatin ( 1.2 mmol/l ; 17.3 % ) ( P < 0.05 ) but not in the dietary advice ( 0.3 mmol/l ; 4 % ) group . The difference between the two groups approached significance at week 24 ( P = 0.051 ) . This fall was accounted for entirely by a reduction in low density lipoprotein [ calculated change 1.24 mmol/l ( 19 % ) and 0.07 mmol ( 5.5 % ) in pravastatin and dietary advice groups , respectively ] as high density lipoprotein rose non-significantly by 0.6 mmol/l in both groups . Weight , basal metabolic rate , fasting glucose and triglycerides did not change significantly in either group . Conclusions Dietary advice plus pravastatin significantly reduced total cholesterol in HIV-positive individuals taking protease inhibitors , without significant adverse effects . The inclusion of pravastatin substantially increases the magnitude of the change , which is comparable with changes achieved in endogenous hyperlipidaemia Background : The effect of specific antiretrovirals on inflammation is unclear . Methods : A5224s was a sub study of A5202 , which r and omized HIV-infected treatment-naïve patients to blinded abacavir/lamivudine ( ABC/3TC ) or tenofovir/emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or atazanavir/ritonavir ( ATV/r ) in a factorial design . Our analysis compared changes in inflammation markers from baseline to week 24 between ABC/3TC and TDF/FTC . Secondary analyses included changes at week 96 and comparisons of EFV vs. ATV/r . Results : Analyses included 244 patients ( 85 % male , 48 % white non-Hispanic ) , median age 39 years , HIV-1 RNA 4.6 log10 copies/ml , CD4 240 cells/&mgr;l . TNF-&agr ; , soluble receptors of TNF-&agr ; (sTNFR)-I and II , soluble vascular cellular adhesion molecule (sVCAM)-1 and soluble intercellular adhesion molecule (sICAM)-1 decreased significantly at weeks 24 and 96 , without significant differences between components ( P ≥ 0.44 ) . At week 24 , ABC/3TC had a greater high-sensitivity C-reactive protein ( hsCRP ) mean fold change than TDF/FTC { 1.43 vs. 0.88 , estimated mean fold change percentage difference [ & Dgr ; ] 61.5 % [ 95 % confidence interval ( CI ) 13.6 % , 129.5 % ] ; P = 0.008}. Similar results were seen at week 96 ( P = 0.021 ) . At week 24 ( but not 96 ) , EFV had a greater hsCRP mean fold change than ATV/r [ 1.41 vs. 0.88 ; & Dgr ; = 60.2 % ( 12.6 % , 127.7 % ) ; P = 0.009 ] . IL-6 decreased significantly at week 24 with TDF/FTC but not with ABC/3TC ( between-components P = 0.019 ) . At week 96 , IL-6 decreased significantly in both nucleoside reverse transcriptase inhibitor components ( between-components P = 0.11 ) . IL-6 changes were not significantly different between ATV/r and EFV at either time point ( P ≥ 0.89 ) . Conclusions : Soluble TNF-receptors and adhesion molecules decreased following treatment initiation and did not differ by regimens . Differences were seen on hsCRP and IL-6 changes with ABC/3TC vs. TDF/FTC and on hsCRP with EFV vs. ATV/r Objectives : To evaluate simplified protease inhibitor (PI)-sparing antiretroviral treatment versus lipid-lowering therapy for the management of highly active antiretroviral therapy (HAART)-induced hyperlipidaemia . Design : R and omized , open-label clinical trial assessing the efficacy on hyperlipidaemia of a switching therapy from PI to non-nucleoside reverse transcriptase inhibitor ( NNRTI ) nevirapine or efavirenz versus a hypolipidaemic treatment ( with pravastatin or bezafibrate ) added to current , unchanged antiretroviral combination . Methods : All HIV-infected patients on their first HAART regimen , with stable immuno-virological features , naive to all NNRTIs , and with mixed hyperlipidaemia , were r and omized to replace PI with nevirapine ( arm A ) or efavirenz ( arm B ) , or to receive pravastatin ( arm C ) or bezafibrate ( arm D ) with unchanged HAART regimen , and were followed-up for 12 months . Results : One hundred and thirty patients were evaluated : 29 patients were r and omized to arm A , 34 to arm B , 36 to arm C , and 31 to arm D. At the end of the 12-month follow-up , a reduction of 25.2 , 9.4 , 41.2 and 46.6 % in mean triglyceridaemia versus respective baseline values was reported in groups A , B , C and D , respectively , with statistically significant difference between arms A – B and C – D ( P < 0.01 ) . Similar results were reported for total and low-density lipoprotein cholesterol levels . Viro-immunological efficacy and tolerability profile were comparable in all considered arms . Conclusion : Pravastatin and bezafibrate proved significantly more effective in the management of HAART-related hyperlipidaemia than the switching therapy from PI to nevirapine or efavirenz CONTEXT A syndrome of lipodystrophy , characterized by fat redistribution and insulin resistance , has been estimated to affect the majority of human immunodeficiency virus (HIV)-infected individuals who are treated with combination antiretroviral therapy . There are no proven therapies for the metabolic disturbances associated with HIV lipodystrophy syndrome . OBJECTIVE To determine the safety and efficacy of metformin therapy in HIV-infected patients with fat redistribution and abnormal glucose homeostasis . DESIGN AND SETTING R and omized , double-blind , placebo-controlled pilot study conducted in a university hospital between December 1998 and January 2000 . PATIENTS Twenty-six HIV-infected , nondiabetic patients with fat redistribution and abnormal oral glucose tolerance test ( OGTT ) results , hyperinsulinemia , or both . INTERVENTIONS Patients were r and omly assigned to receive metformin , 500 mg twice daily ( n = 14 ) , or identical placebo ( n = 12 ) , for 3 months . MAIN OUTCOME MEASURES Insulin area under the curve ( AUC ) , calculated 12 Output:	Among HIV-infected individuals , the prevalence of CVD risk factors and the risk for CVD is higher compared with HIV negatives . Antiretroviral drugs may induce dyslipidaemia , reduce insulin sensitivity , and promote body fat redistribution that additionally contributes to CVD risk . Some antiretroviral drugs may increase risk for CVD events , but the absolute risk increase is moderate and has to be put into perspective with the massive HIV-related benefits . Sustained HIV suppression reduces systemic inflammatory markers and is associated with a moderate reduction in CVD events . Statins are effective for the treatment of dyslipidaemia in HIV infection , but drug interactions with ART need to be considered . Human immunodeficiency virus-infected individuals are at increased risk for CVD . Timely initiation of ART with consequent viral suppression is likely to reduce CVD events and to offset potential side effects from ART-induced metabolic changes .
MS21157	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND AND PURPOSE Safinamide is an α-aminoamide with both dopaminergic and non-dopaminergic mechanisms of action in Phase III clinical development as a once-daily add-on to dopamine agonist ( DA ) therapy for early Parkinson 's disease ( PD ) . METHODS Study 017 was a 12-month , r and omized , double-blind , placebo-controlled pre-planned extension study to the previously reported Study 015 . Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD . The primary efficacy endpoint was the time from baseline ( Study 015 r and omization ) to ' intervention ' , defined as increase in DA dose ; addition of another DA , levodopa or other PD treatment ; or discontinuation due to lack of efficacy . Safinamide groups were pooled for the primary efficacy endpoint analysis ; post hoc analyses were performed on each separate dose group . RESULTS Of the 269 patients r and omized in Study 015 , 227 ( 84 % ) enrolled in Study 017 and 187/227 ( 82 % ) patients completed the extension study . Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups , respectively ( log-rank test ; P = 0.3342 ) . In post hoc analyses , patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo ( 25 % vs. 51 % , respectively ) and a delay in median time to intervention of 9 days ( P < 0.05 ; 240- to 540-day analysis ) . CONCLUSIONS The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention . Post hoc analyses indicate that safinamide 100 mg/day may be effective as add-on treatment to DA in PD CONTEXT Monotherapy with rasagiline mesylate may be useful in early Parkinson disease ( PD ) . OBJECTIVE To evaluate the safety and efficacy of the selective monoamine oxidase type B inhibitor rasagiline . DESIGN Multicenter , 26-week , parallel-group , r and omized , double-blind , placebo-controlled clinical trial . SETTING Academically based movement disorders clinics . PATIENTS Patients with early PD not requiring dopaminergic therapy ( n = 404 ) . INTERVENTION Research participants were r and omized to rasagiline mesylate at dosages of 1 mg or 2 mg per day or matching placebo . A 1-week escalation period was followed by a 25-week maintenance period . MAIN OUTCOME MEASURE The primary prespecified measure of efficacy was the change in the total Unified Parkinson 's Disease Rating Scal score between baseline and 26 weeks of treatment , comparing each active treatment group with the placebo group . RESULTS Monotherapy with rasagiline was effective in this 26-week study . The adjusted effect size for the total Unified Parkinson 's Disease Rating Scale was -4.20 units comparing 1 mg of rasagiline and placebo ( 95 % confidence interval , -5.66 to -2.73 units ; P<.001 ) and -3.56 units comparing a 2-mg dosage and placebo ( 95 % confidence interval , -5.04 to -2.08 units ; P<.001 ) . There were no meaningful differences in the frequency of adverse events or premature withdrawals among the treatment groups . CONCLUSIONS Rasagiline is effective as monotherapy for patients with early PD . The 2 dosages in this trial were both effective relative to placebo . Further study is warranted to evaluate the longer-term effects of rasagiline in PD Background and purpose Depressed mood is a common psychiatric problem associated with Parkinson ’s disease ( PD ) , and studies have suggested a benefit of rasagiline treatment . Methods ACCORDO ( see the 1 ) was a 12-week , double-blind , placebo-controlled trial to evaluate the effects of rasagiline 1 mg/day on depressive symptoms and cognition in non-demented PD patients with depressive symptoms . The primary efficacy variable was the change from baseline to week 12 in depressive symptoms measured by the Beck Depression Inventory ( BDI-IA ) total score . Secondary outcomes included change from baseline to week 12 in cognitive function as assessed by a comprehensive neuropsychological battery ; Parkinson ’s disease quality of life question naire ( PDQ-39 ) scores ; Apathy Scale scores ; and Unified Parkinson ’s Disease Rating Scale ( UPDRS ) subscores . Results One hundred and twenty-three patients were r and omized . At week 12 there was no significant difference between groups for the reduction in total BDI-IA score ( primary efficacy variable ) . However , analysis at week 4 did show a significant difference in favour of rasagiline ( marginal means difference ± SE : rasagiline −5.46 ± 0.73 vs. placebo −3.22 ± 0.67 ; P = 0.026 ) . There were no significant differences between groups on any cognitive test . Rasagiline significantly improved UPDRS Parts I ( P = 0.03 ) and II ( P = 0.003 ) scores versus placebo at week 12 . Post hoc analyses showed the statistical superiority of rasagiline versus placebo in the UPDRS Part I depression item ( P = 0.04 ) and PDQ-39 mobility ( P = 0.007 ) and cognition domains ( P = 0.026 ) . Conclusions Treatment with rasagiline did not have significant effects versus placebo on depressive symptoms or cognition in PD patients with moderate depressive symptoms . Although limited by lack of correction for multiple comparisons , post hoc analyses signalled some improvement in patient-rated cognitive and depression outcomes A median safinamide ( SAF ) dose of 70 mg/day ( range 40 to 90 mg/day ) increased the percentage of parkinsonian patients improving their motor scores by ≥30 % from baseline ( responders ) after 3 months from 21.4 % ( placebo ) to 37.5 % ( p < 0.05 , calculated by logistic regression analysis ) . In a subgroup of 101 patients under stable treatment with a single dopamine agonist , addition of SAF magnified the response ( 47.1 % responders , mean 4.7-point motor score decrease ; p ≥ 0.05 ) . These results suggest that doses of SAF exerting ion channel block and glutamate release inhibition add to its symptomatic effect and warrant exploration of higher doses Dopamine agonists ( DA ) are often used as first-line monotherapy for the symptomatic control of Parkinson 's disease ( PD ) . However , DA monotherapy typically becomes inadequate within a few years , at which time the DA dosage must be increased or other antiparkinsonian medications added . Adding a monoamine oxidase-B ( MAO-B ) inhibitor to DA monotherapy might improve symptomatic control while maintaining good safety and tolerability . We conducted an 18-week , r and omized , double-blind , placebo-controlled trial of rasagiline 1 mg/d as an add-on to DA therapy ( ropinirole ≥ 6 mg/d or pramipexole ≥ 1.0 mg/d ) in early PD patients whose conditions were not adequately controlled on their current treatment regimen . The primary efficacy variable was the change in total Unified Parkinson Disease Rating Scale ( UPDRS ) score ( sum of parts I , II , and III ) from baseline to week 18 , comparing rasagiline and placebo groups . The modified intent-to-treat ( ITT ) population included 321 subjects whose mean ± SD age was 62.6 ± 9.7 , and duration of PD was 2.1 ± 2.1 years . Results demonstrated a significantly greater improvement in total UPDRS scores from baseline to week 18 in the rasagiline group compared with the placebo group ( least squares [ LS ] mean difference ± SE , -2.4 ± 0.95 ; 95 % confidence interval [ CI ] , -4.3 , -0.5 ; P = 0.012 ) . Mean improvement ( LS mean ± SE ) was -3.6 ± 0.68 in the rasagiline group and -1.2 ± 0.68 in the placebo group . Rasagiline was well tolerated , and the most common adverse events ( AEs ; rasagiline vs. placebo ) were dizziness ( 7.4 % vs. 6.1 % ) , somnolence ( 6.8 % vs. 6.7 % ) , and headache ( 6.2 % vs. 4.3 % ) . Rasagiline 1 mg/d provided statistically significant improvement when added to dopamine agonist therapy and was well tolerated In a 6-month double-blind , placebo-controlled study of Parkinson 's disease patients with motor fluctuations , safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia . Further long-term safinamide use in these patients was evaluated over an additional 18 months . Patients continued on their r and omized placebo , 50 , or 100 mg/d safinamide . The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months . Other efficacy endpoints included change in ON-time without troublesome dyskinesia , changes in individual diary categories , depressive symptoms , and quality of life measures . Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups , despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo . Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline ( 36 % of patients ) showed a decrease with safinamide 100 mg/d compared with placebo ( P = 0.0317 ) . Improvements in motor function , activities of daily living , depressive symptoms , clinical status , and quality of life at 6 months remained significant at 24 months . Adverse events and discontinuation rates were similar with safinamide and placebo . This 2-year , controlled study of add-on safinamide in mid-to-late Parkinson 's disease with motor fluctuations , although not demonstrating an overall difference in dyskinesias between patients and controls , showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline . The study additionally demonstrated significant clinical benefits in ON-time ( without troublesome dyskinesia ) , OFF-time , activities of daily living , motor symptoms , quality of life , and symptoms of depression To confirm the clinical utility of selegiline ( L-deprenyl ) , a selective inhibitor of monoamine oxidase B , as an anti-Parkinson 's disease ( PD ) agent , the first Japanese multi-center , double-blind comparative study of this drug was conducted . The subjects were patients who had responded poorly or suffered with other problems related to L-dopa treatment . A total of 112 patients in two groups , one given selegiline at a dose of 7.5 mg/day ( Group D , n = 60 ) and another given a placebo ( Group P , n = 52 ) , were compared over an 8-week treatment period . The percentage patients showing " moderate improvement " or better was 34.5 % in Group D , while that in Group P was 11.5 % ( P < 0.01 ) . In the assessment of overall safety , 66.7 % in Group D showed no adverse reactions , which was not significantly different from the result of 78.9 % for Group Rasagiline ( N-propargyl-1(R)-aminoindan ) mesylate is a potent , selective , and irreversible monoamine oxidase-B inhibitor . This study was design ed to evaluate the safety , tolerability , and preliminary efficacy of rasagiline monotherapy in early Parkinson 's disease ( PD ) patients not receiving levodopa . The study was performed as a multicenter , parallel-group , double-blind , r and omized , placebo-controlled , 10-week study . Fifty-six PD patients were r and omly assigned to rasagiline mesylate 1 , 2 , or 4 mg once daily , or placebo . A 3-week dose-escalation period was followed by a 7-week maintenance phase . At week 10 , the mean ( + /-SE ) changes from baseline in total Unified Parkinson 's Disease Rating Scale ( UPDRS ) score were -1.8 ( + /-1.3 ) , -3.6 ( + /-1.7 ) , -3.6 ( + /-1.2 ) , and -0.5 ( + /-0.8 ) in the rasagiline 1 , 2 , and 4 mg/day and placebo groups , respectively . Analysis of responders showed that 28 % of patients ( 12 of 43 ) receiving rasagiline had an improvement in total UPDRS score of greater than 30 % , compared with none of the patients receiving placebo ( P < 0.05 , Fisher 's exact test ) . The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar . These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD Levodopa is effective for the motor symptoms of Parkinson 's disease ( PD ) , but is associated with motor fluctuations and dy Output:	When ranking the MAO-B inhibitors given in combination with levodopa , selegiline was the most effective and rasagiline was the second best . All of the included MAO-B inhibitors were effective compared to placebo when given as monotherapy . Combination therapy with MAO-B inhibitors and levodopa showed that all three MAO-B inhibitors were effective compared to placebo , but selegiline was the most effective drug
MS21158	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background —Recovery of function is possible in patients with ischemic cardiomyopathy when left ventricular dysfunction is caused by stunning or hibernation . It is plausible that recovery of function after revascularization may take a longer time in hibernating myocardium compared with stunned myocardium . Accordingly , the time courses of functional recovery in hibernating and stunned myocardium were compared . Methods and Results — Patients ( n=26 ) with ischemic cardiomyopathy undergoing surgical revascularization were studied ; regional perfusion ( resting 201Tl single-photon emission CT ) , glucose utilization ( 18F-2-deoxyglucose single-photon emission CT ) , and contractile function ( 2D echocardiography ) were assessed before revascularization . Dysfunctional segments with normal perfusion/glucose utilization were considered to be stunned , and dysfunctional segments with reduced perfusion/preserved glucose utilization were considered to be hibernating . Contractile function was reevaluated 3 months ( early ) and 14 months ( late ) after revascularization . Of the 266 dysfunctional segments , 57 ( 22 % ) were stunned , 62 ( 23 % ) were hibernating , and 147 ( 55 % ) were scar tissue . In stunned myocardium , contractile function improved significantly at 3 months , without further improvement at 14 months ; 61 % of the stunned segments improved at 3 months , and 9 % improved at 14 months . In hibernating myocardium , contractile function improved at 3 months , with a further improvement at 14 months ; 31 % of the hibernating segments improved at 3 months , and 61 % showed ( additional ) recovery at 14 months . Conclusions —Stunned myocardium is likely to demonstrate early recovery of function , whereas hibernating myocardium may take a longer time to ( fully ) recover in function after revascularization BACKGROUND In 10 % to 15 % of patients with ST-segment elevation myocardial infa rct ion ( STEMI ) , concurrent coronary chronic total occlusion ( CTO ) in a non-infa rct -related artery is present and is associated with increased morbidity and mortality . OBJECTIVES The EXPLORE ( Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on Occlusions After ST-Elevation Myocardial Infa rct ion ) trial evaluated whether patients with STEMI and concurrent CTO in a non-infa rct -related artery benefit from additional percutaneous coronary intervention ( PCI ) of CTO shortly after primary PCI . METHODS From November 2007 through April 2015 , we enrolled 304 patients with acute STEMI who underwent primary PCI and had concurrent CTO in 14 centers in Europe and Canada . A total of 150 patients were r and omly assigned to early PCI of the CTO ( CTO PCI ) , and 154 patients were assigned to conservative treatment without PCI of the CTO ( no CTO PCI ) . Primary outcomes were left ventricular ejection fraction ( LVEF ) and left ventricular end diastolic volume ( LVEDV ) on cardiac magnetic resonance imaging after 4 months . RESULTS The investigator-reported procedural success rate in the CTO PCI arm of the trial was 77 % , and the adjudicated success rate was 73 % . At 4 months , mean LVEF did not differ between the 2 groups ( 44.1 ± 12.2 % vs. 44.8 ± 11.9 % , respectively ; p = 0.60 ) . Mean LVEDV at 4 months was 215.6 ± 62.5 ml in the CTO PCI arm versus 212.8 ± 60.3 ml in the no-CTO PCI arm ( p = 0.70 ) . Subgroup analysis revealed that patients with CTO located in the left anterior descending coronary artery who were r and omized to the CTO PCI strategy had significantly higher LVEF compared with patients r and omized to the no-CTO PCI strategy ( 47.2 ± 12.3 % vs. 40.4 ± 11.9 % ; p = 0.02 ) . There were no differences in terms of 4-month major adverse coronary events ( 5.4 % vs. 2.6 % ; p = 0.25 ) . CONCLUSIONS Additional CTO PCI within 1 week after primary PCI for STEMI was feasible and safe . In patients with STEMI and concurrent CTO , we did not find an overall benefit for CTO PCI in terms of LVEF or LVEDV . The finding that early CTO PCI in the left anterior descending coronary artery subgroup was beneficial warrants further investigation . ( Evaluating Xience and Left Ventricular Function in Percutaneous Coronary Intervention on Occlusions After ST-Segment Elevation Myocardial Infa rct ion ; NTR1108 ) OBJECTIVES This study explored whether cardiac magnetic resonance ( CMR ) could help select patients who could benefit from revascularization by identifying inducible myocardial ischemia and viability in the perfusion territory of the artery with chronic total occlusion ( CTO ) . BACKGROUND The benefit of revascularization using percutaneous coronary intervention ( PCI ) in CTO is controversial . CMR offers incomparable left ventricular ( LV ) systolic function assessment in addition to potent ischemic burden quantification and reliable myocardial viability analysis . Whether CMR guided CTO revascularization would be helpful to such patients has not yet been explored fully . METHODS A prospect i ve study of 50 consecutive CTO patients was conducted . Of 50 patients undergoing baseline stress CMR , 32 ( 64 % ) were selected for recanalization based on the presence of significant inducible perfusion deficit and myocardial viability within the CTO arterial territory . Patients were rescanned 3 months after successful CTO recanalization . RESULTS At baseline , myocardial perfusion reserve ( MPR ) in the CTO territory was significantly reduced compared with the remote region ( 1.8 ± 0.72 vs. 2.2 ± 0.7 ; p = 0.01 ) . MPR in the CTO region improved significantly after PCI ( to 2.3 ± 0.9 ; p = 0.02 vs. baseline ) with complete or near-complete resolution of CTO related perfusion defect in 90 % of patients . Remote territory MPR was unchanged after PCI ( 2.5 ± 1.2 ; p = NS vs. baseline ) . The LV ejection fraction increased from 63 ± 13 % to 67 ± 12 % ( p < 0.0001 ) and end-systolic volume decreased from 65 ± 38 to 56 ± 38 ml ( p < 0.001 ) 3 months after CTO PCI . Importantly , despite minimal post-procedural infa rct ion due to distal embolization and side branch occlusion in 8 of 32 patients ( 25 % ) , the total Seattle Angina Question naire score improved from a median of 54 ( range 45 to 74 ) at baseline to 89 ( range 77 to 98 ) after CTO recanalization ( p < 0.0001 ) . CONCLUSIONS In this small group of patients showing CMR evidence of significant myocardial inducible perfusion defect and viability , CTO recanalization reduces ischemic burden , favors reverse remodeling , and ameliorates quality of life AIMS The aim of the present study was to investigate the effects of successful PCI CTO on absolute myocardial blood flow ( MBF ) and functional recovery . METHODS AND RESULTS Patients with a documented CTO were prospect ively examined for ischaemia and viability with [15O]H2O positron emission tomography ( PET ) and late gadolinium enhancement cardiac magnetic resonance imaging ( LGE-CMR ) . Sixty-nine consecutive patients , in whom PCI was successful , underwent follow-up PET and CMR after approximately 12 weeks to evaluate potential improvement of MBF as well as systolic function . After PCI , stress MBF in the CTO area increased from 1.22±0.36 to 2.40±0.90 mL·min-1·g-1 ( p<0.001 ) , whilst stress MBF in the remote area also increased significantly between baseline and follow-up PET ( 2.58±0.68 to 2.77±0.77 mL·min-1·g-1 , p=0.01 ) . The ratio of stress MBF between CTO and remote area was 0.49±0.13 at baseline and increased to 0.87±0.24 at follow-up ( p<0.001 ) . The MBF defect size of the CTO area decreased from 5.12±1.69 to 1.91±1.75 myocardial segments after PCI ( p<0.001 ) . Left ventricular ejection fraction ( LVEF ) increased significantly ( 46.4±11.0 vs. 47.5±11.4 % , p=0.01 ) at follow-up . CONCLUSIONS The vast majority of CTO patients with documented ischaemia and viability showed significant improvement in stress MBF and a reduction of ischaemic burden after successful percutaneous revascularisation with only minimal effect on LVEF The present study aim ed to assess the mechanisms of effects of percutaneous coronary intervention ( PCI ) for chronic total occlusion ( CTO ) from two different aspects : left ventricular ( LV ) systolic function assessed by two-dimensional speckle tracking echocardiography ( 2D-STE ) and electrical stability evaluated by late potential on signal-averaged electrocardiogram ( SAECG ) . We conducted a prospect i ve observational study with consecutive CTO-PCI patients . 2D-STE and SAECG were performed before PCI , and after 1-day and 3-months of procedure . 2D-STE computed global longitudinal strain ( GLS ) and regional longitudinal strain ( RLS ) in CTO area , collateral blood-supplying donor artery area , and non-CTO/non-donor area . A total of 37 patients ( 66 ± 11 years , 78 % male ) were analyzed . RLS in CTO and donor areas and GLS were significantly improved 1-day after the procedure , but these improvements diminished during 3 months . The improvement of RLS in donor area remained significant after 3-months the index procedure ( pre-PCI −13.4 ± 4.8 % vs. post-3 M −15.1 ± 4.5 % , P = 0.034 ) . RLS in non-CTO/non-donor area and LV ejection fraction were not influenced . Mitral annulus velocity was improved at 3-month follow-up ( 5.0 ± 1.4 vs. 5.6 ± 1.7 cm/s , P = 0.049 ) . Before the procedure , 12 patients ( 35 % ) had a late potential . All components of the late potential ( filtered QRS duration , root-mean-square voltage in the terminal 40 ms , and duration of the low amplitude signal < 40 μV ) were not improved . CTO-PCI improved RLS in the donor area at 3-month follow-up without changes of LV ejection fraction . Although higher prevalence of late potential in the current population compared to healthy population was observed , late potential as a surrogate of arrhythmogenic substrate was not influenced by CTO-PCI Background In congestive heart failure patients , a single measurement of left ventricular ejection fraction ( LVEF ) provides important prognostic information . The importance , if any , of improvement or worsening in serial LVEF has not been defined . The Department of Veterans Affairs Cooperative Vasodilator-Heart Failure Trials ( V-HeFT ) data base was analyzed to determine the prognostic importance of LVEF changes . Methods and Results The data bases for V-HeFT I ( n = 642 ) and V-HeFT II ( n=804 ) were analyzed . All patients had heart failure with documented exercise intolerance and abnormal LVEF or cardiac dilatation by chest x-ray or echocardiography . Radionuclide LVEF was obtained at baseline , within 6 months , and at least yearly after r and omization to treatment . Cumulative survival subsequent to LVEF follow-up measurements was calculated for strata defined by LVEF change from baseline . In V-HeFT I , patients treated with hydralazine/isosorbide dinitrate ( H-I ) experienced a significant ( P < O.OOl ) increase in LVEF and a survival advantage over those treated with placebo and prazosin . In V-HeFT II , both treatment groups showed significant improvements in LVEF , with the increase with H-I greater than that with enalapril , and enalapril provided a significant survival advantage overH-L. Change ( > 5 ) in LVEF from baseline at 6 months ( V-HeFT I ) and 1 year ( V-HeFT II ) were the strongest predictors of mortality among the serial measurements and were significant after adjustment for therapy and baseline LVEF . Baseline clinical variables were not helpfulin predicting the patients who would experience an improvement in LVEF . Conclusions In patients with heart failure , serial measurements of LVEF provide additional important prognostic information . Vasodilator therapy with H-I is associated with an improvement in LVEF and prognosis . Vasodilator therapy with enalapril improves LVEF less than H-I but provides an additional survival benefit In recent years , several clinical trials conducted on selected middle-aged patients have documented the positive effects of new pharm Output:	Successful CTO PCI is associated with a statistically significant improvement in LV ejection fraction and decrease in LV end-systolic volume , that may reflect a beneficial effect of CTO recanalization on LV remodeling .
MS21159	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Early detection of pulmonary hypertension ( PH ) in patients with systemic sclerosis ( SSc ) is essential as it leads to substantial morbidity and mortality irrespective of its etiology . The aim of our study was to determine whether noninvasive biochemical and /or echocardiographic indices can predict the presence of PH in these patients . We prospect ively studied 66 patients ( mean age of 57.7 ± 12.1 years , 63 women ) with SSc without clinical manifestations of heart failure . All patients underwent st and ard and tissue Doppler echocardiography . Plasma N-terminal pro-B type natriuretic peptide ( NT-proBNP ) and asymmetric dimethylarginine ( ADMA ) levels were also measured . In 24 ( 36 % ) patients , the diagnosis of PH was established by echocardiography ( systolic pulmonary artery pressure value ≥40 mmHg ) . Left atrial ( LA ) volume , NT-proBNP , ADMA , ratio of early transmitral filling velocity to early diastolic velocity of the mitral annulus ( mitral E/Em ) , and right ventricular myocardial performance index ( MPI ) were univariate predictors of PH . In multivariate analysis , NT-proBNP , LA volume , and right ventricular MPI were independent predictors of PH in SSc patients . LA volume and NT-proBNP may be useful noninvasive markers for the prediction of elevated pulmonary artery pressure in patients with SSc . These parameters should be considered when assessing this population for risk stratification and for identification of patients dem and ing further investigation and institution of specific therapy for the disease at the time when it is most likely to be effective This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer BACKGROUND Asymmetric dimethylarginine ( ADMA ) is associated with endothelial injury . Increased ADMA levels are found in rheumatoid arthritis ( RA ) and ankylosing spondylitis ( AS ) . We set out to assess the ADMA and symmetric dimethylarginine ( SDMA ) levels in AS , RA , and healthy controls , and in the anti-TNF treated patients with active AS . METHODS In 78AS patients and 29 RA patients who were anti-TNF treatment naive at baseline , along with 23 healthy control subjects , we assessed erythrocyte sedimentation rate ( ESR ) , high-sensitivity C-reactive protein ( hsCRP ) , ADMA , and SDMA . For AS patients , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , back pain VAS and patient 's global activity of disease were calculated . After 6 months , we repeated the assessment in 30 out of the 78 AS patients in whom the anti-TNF treatment was initiated . RESULTS The baseline mean ( SD ) plasma ADMA concentration of AS patients was 0.64 ( 0.19 ) μmol/l and did not differ from controls ( 0.65 [ 0.19 ] μmol/l , p > 0.05 ) . In the RA group , ADMA concentration was higher than in controls ( 0.77 vs. 0.65 μmol/l , p < 0.05 ) . Both at baseline and at follow-up , ADMA levels correlated positively with BASDAI ( R = 0.52 , p = 0.02 , and R = 0.47 , p = 0.04 , baseline and follow-up , respectively ) . Six months of anti-TNF treatment did not influence ADMA concentration ( 0.51 [ 0.12 ] vs. 0.51 [ 0.11 ] μmol/l , p = 0.70 ) . CONCLUSION An absence of changes in plasma ADMA levels in the anti-TNF treated AS group despite the improvement in disease activity ( BASDAI ) and inflammation ( ESR , CRP ) may suggest either a lack of effect , or , even if such an effect were to take place , it needs not imply measurable changes in blood ADMA We explored the role of asymmetrical dimethylarginine ( ADMA ) as a cause of endothelial dysfunction induced by systemic inflammation . In vitro data suggest that ADMA bioavailability is regulated by proinflammatory stimuli , but it is unclear whether ADMA is a link between inflammation and endothelial dysfunction in humans . In study 1 we recruited 351 patients with coronary artery disease ( CAD ) and 87 healthy controls . In study 2 we recruited 69 CAD , 69 healthy , and 10 patients with rheumatoid arthritis , whereas in study 3 , 22 healthy and 70 CAD subjects were r and omly assigned to Salmonella typhii vaccination ( n=11 healthy and n=60 CAD ) or placebo ( n=11 healthy and n=10 CAD ) . Circulating interleukin 6/ADMA and flow-mediated dilation ( FMD ) were measured at 0 and 8 hours . In study 1 , ADMA was inversely correlated with FMD in healthy individuals and CAD patients ( P<0.0001 for both ) . However , interleukin 6 was inversely correlated with FMD ( P<0.0001 ) in healthy subjects but not in CAD patients . The positive correlation between ADMA and interleukin 6 was stronger in healthy ( r=0.515 ; P<0.0001 ) compared with CAD ( r=0.289 ; P=0.0001 ) subjects . In study 2 , both patients with rheumatoid arthritis and CAD had higher interleukin 6 ( P<0.0001 ) and ADMA ( P=0.004 ) but lower FMD ( P=0.001 ) versus healthy subjects . In study 3 , vaccination increased interleukin 6 in healthy ( P<0.001 ) and CAD ( P<0.001 ) subjects . FMD was reduced in healthy subjects ( P<0.05 ) , but its reduction in CAD was borderline . Vaccination increased ADMA only in healthy subjects ( P<0.001 ) . Systemic , low- grade inflammation leads to increased ADMA that may induce endothelial dysfunction . This study demonstrated that ADMA may be a link between inflammation and endothelial dysfunction in humans BACKGROUND Asymmetric dimethylarginine ( ADMA ) is an endogenous competitive inhibitor of nitric oxide ( NO ) synthase . Because endothelial NO elaboration is impaired in hypercholesterolemia , we investigated whether plasma concentrations of ADMA are elevated in young , clinical ly asymptomatic hypercholesterolemic adults . We further studied whether such elevation of ADMA levels was correlated with impaired endothelium-dependent , NO-mediated vasodilation and urinary nitrate excretion . In a r and omized , double-blind , placebo-controlled study , we investigated whether these changes could be reversed with exogenous L-arginine . METHODS AND RESULTS We measured plasma levels of L-arginine , ADMA , and symmetrical dimethylarginine ( SDMA ) by high-performance liquid chromatography in 49 hypercholesterolemic ( HC ) and 31 normocholesterolemic ( NC ) humans . In 8 HC subjects , endothelium-dependent forearm vasodilation was assessed before and after an intravenous infusion of L-arginine or placebo and compared with 8 NC control subjects . ADMA levels were significantly elevated by > 100 % ( 2.17+/-0.15 versus 1.03+/-0.09 micromol/L ; P<0.05 ) in HC subjects compared with NC adults . L-Arginine levels were similar , result ing in a significantly decreased L-arginine/ADMA ratio in HC subjects ( 27.7+/-2.4 versus 55 . 7+/-5.4 ; P<0.05 ) . In 8 HC subjects , intravenous infusion of L-arginine significantly increased the L-arginine/ADMA ratio and normalized endothelium-dependent vasodilation and urinary nitrate excretion . ADMA levels were inversely correlated with endothelium-mediated vasodilation ( R=0.762 , P<0.01 ) and urinary nitrate excretion rates ( R=0.534 , P<0.01 ) . CONCLUSIONS We find that ADMA is elevated in young HC individuals . Elevation of ADMA is associated with impaired endothelium-dependent vasodilation and reduced urinary nitrate excretion . This abnormality is reversed by administration of L-arginine . ADMA may be a novel risk factor for endothelial dysfunction in humans Objectives . Impaired endothelial function represents the early stage of atherosclerosis , which is typically associated with systemic inflammatory diseases like rheumatoid arthritis ( RA ) . As modulators of endothelial nitric oxide synthase expression , asymmetric-dimethylarginine ( ADMA ) and apelin might be measured in the blood of RA patients to detect early atherosclerotic changes . We conducted a prospect i ve , case-control study to investigate serum ADMA and apelin profiles of patients with early-stage RA ( ERA ) before and after disease-modifying antirheumatic drug ( DMARD ) therapy . Methods . We enrolled 20 consecutively diagnosed , treatment-naïve patients with ERA and 20 matched healthy controls . Serum ADMA and apelin levels and the 28-joint disease activity scores ( DAS28 ) were assessed before and after 12 months of DMARDs treatment . All patients underwent ultrasonographic assessment for intima-media tickness ( IMT ) evaluation . Results . In the ERA group , ADMA serum levels were significantly higher than controls at baseline ( P = 0.007 ) and significantly decreased after treatment ( P = 0.012 versus controls ) . Baseline serum apelin levels were significantly decreased in this group ( P = 0.0001 versus controls ) , but they were not significantly altered by treatment . IMT did not show significant changes . Conclusions . ERA is associated with alterations of serum ADMA and apelin levels , which might be used as biomarkers to detect early endothelial dysfunction in these patients Background Heart and pulmonary involvement is a leading cause of systemic sclerosis (SSc)-related deaths . Objectives The aim of our study was to assess if biochemical markers of right ventricular ( RV ) overload , endothelial function and collagen metabolism can predict RV dysfunction assessed by Doppler echocardiography in SSc patients . Methods We prospect ively studied 111 consecutive patients ( 101 F , 10 M , age 54.2 ± 13.8 years ) with diagnosed SSc ( mean disease duration 9.4 ± 11.4 years ) and a group of 21 age-matched subjects ( 18 F , 3 M , age 49.3 + 10.5 years ) . We performed transthoracic echocardiography ( Phillips iE 33 ) and measured serum endothelin-1 ( ET-1 ) , N-terminal pro-brain natriuretic peptide ( NT-proBNP ) , asymmetric dimethylarginine ( ADMA ) , endoglin and human tissue inhibitor of matrix metalloproteinase ( TIMP-1 ) concentration . Results Median serum NT-proBNP level in SSc patients was 133.5 ( range 21.86–17,670 pg/ml ) and was significantly higher than in controls ( p = 0.0002 ) . Moreover , the median serum ET-1 level of 1.49 ( range 0.26–8.75 pg/ml ) was higher in SSc patients ( p = 0.002 ) . However , no significant differences in ADMA , TIMP-1 and endoglin serum concentration between SSc patients and controls were observed . Serum NT-proBNP concentration correlated positively with echocardiographic signs of RV overload : tricuspid regurgitation pressure gradient ( r = 0.38 , p = 0.0004 ) and RV Tei index ( r = 0.25 , p = 0.01 ) . ET-1 serum level correlated negatively with tricuspid annular plane systolic excursion ( r = −0.4 , p = 0.01 ) and positively with inferior vena cava diameter measured at expiration ( r = 0.38 , p = 0.0002 ) . The echocardiographic signs of RV overload were significantly more pronounced in the highest NT-proBNP tertile ( > 195 pg/ml ) group than in the lowest one ( < 88 pg/ml ) . Conclusions Serum ET-1 and NT-proBNP , but not endoglin , ADMA and TIMP-1 levels correlating with the echocardiographic parameters of Output:	Differences in ADMA concentrations between controls and RDs patients were not significantly associated with inflammatory markers , increasing age , lipid concentrations , body mass index , blood pressure , or methodology used to assess ADMA . This meta- analysis showed that , in the context of significant between- study heterogeneity , circulating concentrations of ADMA are positively related to RDs
MS21160	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Hospital-acquired delirium is a known risk factor for negative outcomes in patients admitted to the surgical intensive care unit ( SICU ) . Outcomes worsen as the duration of delirium increases . The purpose of this study was to evaluate the efficacy of a delirium prevention program and determine whether it decreased the incidence and duration of hospital-acquired delirium in older adults ( age>50 y ) admitted to the SICU . METHODS A prospect i ve pre- or post-intervention cohort study was done at an academic level I trauma center . Older adults admitted to the SICU were enrolled in a delirium prevention program . Those with traumatic brain injury , dementia , or 0 d of obtainable delirium status were excluded from analysis . The intervention consisted of multidisciplinary education , a pharmacologic protocol to limit medications associated with delirium , and a nonpharmacologic sleep enhancement protocol . Primary outcomes were incidence of delirium and delirium-free days/30 . Secondary outcomes were ventilator-free days/30 , SICU length of stay ( LOS ) , daily and cumulative doses of opioids ( milligram , morphine equivalents ) and benzodiazepines ( milligram , lorazepam equivalents ) , and time spent in severe pain ( greater than or equal to 6 on a scale of 1 - 10 ) . Delirium was measured using the Confusion Assessment Method for the ICU . Data were analyzed using Chi-squared and Wilcoxon rank sum analysis . RESULTS Of 624 patients admitted to the SICU , 123 met inclusion criteria : 57 preintervention ( 3/12 - 6/12 ) and 66 postintervention ( 7/12 - 3/13 ) . Cohorts were similar in age , gender , ratio of trauma patients , and Injury Severity Score . Postintervention , older adults experienced delirium at the same incidence ( pre 47 % versus 58 % , P=0.26 ) , but for a significantly decreased duration as indicated by an increase in delirium-free days/30 ( pre 24 versus 27 , P=0.002 ) . After intervention , older adults with delirium had more vent-free days ( pre 21 versus 25 , P=0.03 ) , shorter SICU LOS ( pre 13 [ median 12 ] versus 7 [ median 6 ] , P=0.01 ) and were less likely to be treated with benzodiazepines ( pre 85 % versus 63 % , P=0.05 ) with a lower daily dose when prescribed ( pre 5.7 versus 3.6 mg , P=0.04 ) . After intervention , all older adults spent less time in pain ( pre 4.7 versus 3.1 h , P=0.02 ) , received less total opioids ( pre 401 versus 260 mg , P=0.01 ) , and had shorter SICU LOS ( pre 9 [ median 5 ] versus 6 [ median 4 ] , P=0.04 ) . CONCLUSIONS Although delirium prevention continues to be a challenge , this study successfully decreased the duration of delirium for older adults admitted to the SICU . Our simple , cost-effective program led to improved pain and sedation outcomes . Older adults with delirium spent less time on the ventilator and all patients spent less time in the SICU Background : Delirium after acute stroke is a serious complication . Numerous studies support a benefit of multicomponent interventions in minimizing delirium-related complications in at-risk patients , but this has not been reported in acute stroke patients . The purpose of this study was to explore the feasibility of conducting a r and omized ( delirium care ) versus usual st and ardized stroke care ( usual care ) in reducing delirium in acute stroke . Objective : This pilot study assessed the feasibility of ( 1 ) enrollment within the 48-hour window when delirium risk is greatest , ( 2 ) measuring cognitive function using the Montreal Cognitive Assessment , ( 3 ) delivering interventions 7 days per week , and ( 4 ) determining delirium incidence in stroke-related cognitive dysfunction . Methods : A 2-group r and omized controlled trial was conducted . Patients admitted with ischemic and hemorrhagic strokes and 50 years or older , English speaking , and without delirium on admit were recruited , consented , and r and omized to usual care or delirium care groups . Results : Data from 125 subjects ( delirium care , n = 59 ; usual care , n = 66 ) were analyzed . All Montreal Cognitive Assessment subscales were completed by 86 % of subjects ( delirium care , mean [ SD ] , 18.14 [ 6.03 ] ; usual care , mean [ SD ] , 17.61 [ 6.29 ] ) . Subjects in the delirium care group received a mean of 6.10 therapeutic activities ( range , 2–23 ) and daily medication review by a clinical pharmacist using anticholinergic drug calculations . Delirium incidence was 8 % ( 10/125 ) , 3 in the delirium care group and 7 in the usual care group . Conclusion : Findings support the feasibility of delivering a multicomponent delirium prevention intervention in acute stroke and warrants testing intervention effects on delirium outcomes and anticholinergic medication administration OBJECTIVE To develop and vali date a new st and ardized confusion assessment method ( CAM ) that enables nonpsychiatric clinicians to detect delirium quickly in high-risk setting s. DESIGN Prospect i ve validation study . SETTING Conducted in general medicine wards and in an outpatient geriatric assessment center at Yale University ( site 1 ) and in general medicine wards at the University of Chicago ( site 2 ) . PATIENTS The study included 56 subjects , ranging in age from 65 to 98 years . At site 1 , 10 patients with and 20 without delirium participated ; at site 2 , 16 patients with and 10 without delirium participated . MEASUREMENTS AND MAIN RESULTS An expert panel developed the CAM through a consensus building process . The CAM instrument , which can be completed in less than 5 minutes , consists of nine operationalized criteria from the Diagnostic and Statistical Manual of Mental Disorders ( DSM-III-R ) . An a priori hypothesis was established for the diagnostic value of four criteria : acute onset and fluctuating course , inattention , disorganized thinking , and altered level of consciousness . The CAM algorithm for diagnosis of delirium required the presence of both the first and the second criteria and of either the third or the fourth criterion . At both sites , the diagnoses made by the CAM were concurrently vali date d against the diagnoses made by psychiatrists . At sites 1 and 2 values for sensitivity were 100 % and 94 % , respectively ; values for specificity were 95 % and 90 % ; values for positive predictive accuracy were 91 % and 94 % ; and values for negative predictive accuracy were 100 % and 90 % . The CAM algorithm had the highest predictive accuracy for all possible combinations of the nine features of delirium . The CAM was shown to have convergent agreement with four other mental status tests , including the Mini-Mental State Examination . The interobserver reliability of the CAM was high ( kappa = 0.81 - 1.0 ) . CONCLUSIONS The CAM is sensitive , specific , reliable , and easy to use for identification of delirium OBJECTIVE To determine the long-term effects on total healthcare costs of the Improving Mood : Promoting Access to Collaborative Treatment ( IMPACT ) program for late-life depression compared with usual care . STUDY DESIGN R and omized controlled trial with enrollment from July 1999 through August 2001 . The IMPACT trial , conducted in primary care practice s in 8 delivery organizations across the United States , enrolled 1801 depressed primary care patients 60 years or older . Data are from the 2 IMPACT sites for which 4-year cost data were available . Trial enrollment across these 2 health maintenance organizations was 551 patients . METHODS Participants were r and omly assigned to the IMPACT intervention ( n = 279 ) or to usual primary care ( n = 272 ) . Intervention patients had access to a depression care manager who provided education , behavioral activation , support of antidepressant medication management prescribed by their regular primary care provider , and problem-solving treatment in primary care for up to 12 months . Care managers were supervised by a psychiatrist and a primary care provider . The main outcome measures were healthcare costs during 4 years . RESULTS IMPACT participants had lower mean total healthcare costs ( $ 29 422 ; 95 % confidence interval , $ 26 479-$32 365 ) than usual care patients ( $ 32 785 ; 95 % confidence interval , $ 27 648-$37 921 ) during 4 years . Results of a bootstrap analysis suggested an 87 % probability that the IMPACT program was associated with lower healthcare costs than usual care . CONCLUSION Compared with usual primary care , the IMPACT program is associated with a high probability of lower total healthcare costs during a 4-year period Background and objectives : delirium is a distressing but potentially preventable condition common in older people in long-term care . It is associated with increased morbidity , mortality , functional decline , hospitalization and significant healthcare costs . Multicomponent interventions , addressing delirium risk factors , have been shown to reduce delirium by one-third in hospitals . It is not known whether this approach is also effective in long-term care . In previous work , we design ed a bespoke delirium prevention intervention , called ‘ Stop Delirium ! ’ In preparation for a definitive trial of Stop Delirium , we sought to address key aspects of trial design for the particular circumstances of care homes . Design : a cluster r and omized feasibility study with an embedded process evaluation . Setting and participants : residents of 14 care homes for older people in one metropolitan district in the UK . Intervention : Stop Delirium ! : a 16-month-enhanced educational package to support care home staff to address key delirium risk factors . Control homes received usual care . Measurements : we collected data to determine the following : recruitment and attrition ; delirium rates and variability between homes ; feasibility of measuring delirium , re source use , quality of life , hospital admissions and falls ; and intervention implementation and adherence . Results : two-thirds ( 215 ) of eligible care home residents were recruited . One-month delirium prevalence was 4.0 % in intervention and 7.1 % in control homes . Proposed outcome measurements were feasible , although our approach appeared to underestimate delirium . Health economic evaluation was feasible using routinely collected data . Conclusion : a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work OBJECTIVE Delirium is a highly prevalent and deleterious disorder in terminally ill cancer patients . We assessed whether a multicomponent preventive intervention was effective in decreasing delirium incidence and severity among cancer patients receiving end-of-life care . METHODS A cohort of 1516 patients was followed from admission to death at seven Canadian palliative care centers . In two of these centers , routine care included a delirium preventive intervention targeting physicians ( written notice on selective delirium risk factors and inquest on intended medication changes ) , patients , and their family ( orientation to time and place , information about early delirium symptoms ) . Delirium frequency and severity were compared between patients at the intervention ( N = 674 ) and usual-care ( N = 842 ) centers based on thrice-daily symptom assessment s with the Confusion Rating Scale . RESULTS The overall rate of adherence to the intervention was 89.7 % . The incidence of delirium was 49.1 % in the intervention group , compared with 43.9 % in the usual-care group ( odds ratio [ OR ] 1.23 , P = 0.045 ) . When confounding variables were controlled for , no difference was observed between the intervention and the usual-care groups in delirium incidence ( OR 0.94 , P = 0.66 ) , delirium severity ( 1.83 vs. 1.92 ; P = 0.07 ) , total days in delirium ( 4.57 vs. 3.57 days ; P = 0.63 ) , or duration of first delirium episode ( 2.9 vs. 2.1 days ; P = 0.96 ) . Delirium-free survival was similar in the two groups . CONCLUSION A simple multicomponent preventive intervention was ineffective in reducing delirium incidence or severity among cancer patients receiving end-of-life care . Delirium prevention remains a difficult challenge in terminally ill cancer patients CONTEXT In the intensive care unit ( ICU ) , delirium is a common yet underdiagnosed form of organ dysfunction , and its contribution to patient outcomes is unclear . OBJECTIVE To determine if delirium is an independent predictor of clinical outcomes , including 6-month mortality and length of stay among ICU patients receiving mechanical ventilation . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study enrolling 275 consecutive mechanically ventilated patients admitted to adult medical and coronary ICUs of a US university-based medical center between February 2000 and May 2001 . Patients were followed up for development of delirium over 2158 ICU days using the Confusion Assessment Method for the ICU and the Richmond Agitation-Sedation Scale . MAIN OUTCOME MEASURES Primary outcomes included 6-month mortality , overall hospital length of stay , and length of stay in the post-IC Output:	Several models of care can prevent delirium . The diverse models of care included here explored interventions adapted to specific care setting s , especially by addressing setting -specific delirium risk factors .
MS21161	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : To determine , in a community-based sample of slow-to-talk toddlers , the extent to which specific maternal responsive behaviors at 24 months predict child language at 24 and 36 months . Methods : Mother-child dyads were recruited for this prospect i ve longitudinal study from 3 local government areas spanning low , middle , and high socioeconomic status in Melbourne , Australia . At child age 18 months , 1138 parents completed a 100-word expressive vocabulary checklist ; the 251 ( 22.1 % ) children scoring ⩽20th percentile were then followed up to comprise this study . Predictors : Six maternal responsive behaviors ( imitations , interpretations , labels , expansions , supportive directives and responsive questions ) were derived from mother-child free-play videos collected at 24 months of age and coded using the Observer XT system . Outcomes : Expressive and receptive language measured at 24 and 36 months of age ( Preschool Language Scale-4 ) , blind to maternal responsiveness ratings . Results : Two hundred and twenty-six of the 251 ( 90.0 % ) mother-child dyads were followed up at 36 months . In confounder-adjusted linear regression analyses , expansions , imitations , and responsive questions were strongly associated with better receptive and expressive language at 24 and 36 months . Labels unexpectedly predicted poorer expressive language at 36 months . Expansions were the only maternal behavior that predicted improvement in language between 24 and 36 months . Conclusions : Maternal responsive behaviors , particularly expansions , offer promise in enhancing early language learning in slow-to-talk toddlers . Parent-child interactions characterized by frequent use of maternal labels at 24 months could also be a predictive marker of those slow-to-talk toddlers at greater risk of persistent language problems PURPOSE The aim of this study was to investigate the language outcomes of 7-year-old children with and without a history of late language emergence at 24 months . METHOD One hundred twenty-eight children with a history of late language emergence ( LLE ) at 24 months and 109 children with a history of normal language emergence ( NLE ) at 24 months participated in direct behavioral assessment of multiple dimensions of language at 7 years . The children were recruited from a prospect i ve cohort study of 1,766 epidemiologically ascertained 24-month-old singleton children . RESULTS The group mean for the LLE children was within the typical range on an omnibus measure of general language ability and measures of specific dimensions of language . However , a greater percentage of LLE children , relative to NLE children , performed below normative expectations on a measure of general language ability ( 20 % versus 11 % ) , speech ( 7 % versus 2 % ) , syntax ( 18 % versus 8 % ) , and morphosyntax ( 9%-23 % versus 2%-14 % ) , but not vocabulary or semantics . CONCLUSION The results provide support for growth models of language impairment that predict that late onset of language foretells a protracted growth difference for some LLE children relative to NLE children , particularly for syntax and morphosyntax OBJECTIVE To examine psychosocial and obstetric outcomes at 1 year postpartum in first-time mothers who conceived after IVF . DESIGN Prospect i ve cohort study . SETTING University medical center in the United Kingdom . PATIENT(S ) One hundred twenty-nine mothers with a single naturally conceived birth , 95 mothers with a single IVF birth , and 36 mothers with a twin or triplet IVF birth . MAIN OUTCOME MEASURE(S ) General Health Question naire and Parenting Stress Index . RESULT ( S ) Twenty-two percent of mothers of multiples had Parenting Stress Index scores indicating severe parenting stress , compared with 5 % of mothers of IVF singletons ( odds ratio , 5.14 [ 95 % confidence interval ( CI ) , 1.55 - 16.99 ] ) and 9 % of mothers of naturally conceived singletons ( odds ratio , 2.76 [ 95 % CI , 1.03 - 7.4 ] ) . Mothers of multiple children conceived by IVF did not have poorer mental health but were less likely to be in paid employment at follow-up than were mothers of singletons conceived by IVF ( odds ratio , 0.3 [ 95 % CI , 0.13 - 0.67 ] ) or naturally ( odds ratio , 0.27 [ 95 % CI , 0.12 - 0.59 ] ) . Multiple births were more premature , had lower birth weights , and had more medical complications . They were more likely to have been admitted to special care than were singletons conceived by IVF ( odds ratio , 14.6 [ 95 % CI , 5.1 - 42.0 ) ] or those conceived naturally ( odds ratio , 10.59 [ 95 % CI , 3.67 - 30.57 ] ) CONCLUSION ( S ) Clinicians should ensure that couples making decisions about embryo transfer have considered the potential psychosocial burden of a multiple birth BACKGROUND The aim of the present study was to determine language levels in twins and singletons born after at least 34 weeks gestation and without identifiable neurological abnormality and to evaluate whether in vitro fertilization ( IVF ) affects language development in twin pregnancies . METHODS A prospect i ve study of a large cohort of all children born between 1 January 2001 and 31 December 2003 was carried out at Gazi University Hospital . All live-born twin pairs in which both twins survived were identified , and a comparable sample of families with pairs of singletons were chosen . The Stanford-Binet Intelligence Scale Form and the translated Turkish form of the Peabody Picture Vocabulary Test were completed at 60 months . RESULTS Even after excluding the most premature twins and those with diagnosable neurological damage , twins performed worse than singletons on language development tests . Twin girls had better scores than twin boys . A statistically significant difference was found between the scores of term and preterm twins . No significant difference was noted when compared according to birth order . Appropriate for gestational age ( AGA ) twins did better than small for gestational age ( SGA ) twins in the test scores . All twin girls did not differ from singleton girls , but all twin boys performed worse than singleton boys . Term twins had similar results with term singletons , but preterm twins had lower scores than preterm singletons . SGA singletons had better scores than SGA twins , while AGA twins and singletons did not differ . When the children were compared with regard to method of conception , IVF children had significantly lower scores on the tests than those in the spontaneous conception group . CONCLUSION It is hoped that the present findings could lead to a more precise assessment of children for speech impairment and , above all , to more efficient preventive intervention . Whatever mechanisms are involved , the present results indicate that twins born as a result of IVF , are at a disadvantage in terms of language development in comparison with spontaneously conceived twins OBJECTIVE To establish the nature and extent of difficulties in parenting and child development in families with twins conceived by assisted reproduction . DESIGN Comparisons were carried out between a representative sample of 344 families with 2- to 5-year-old twins conceived by IVF/intracytoplasmic sperm injection ( ICSI ) and a matched comparison group of 344 families with singletons from IVF/ICSI . One twin was r and omly selected for data analysis to avoid the bias associated with nonindependence of measures . SETTING A general population sample of IVF/ICSI families . PATIENT(S ) Mothers and children . INTERVENTION(S ) Mothers completed a question naire booklet . MAIN OUTCOME MEASURE(S ) St and ardized measures of the mother 's psychological well-being ( parenting stress , depression , and quality of marriage ) and st and ardized measures of the child 's psychological development ( emotional/behavioral problems and cognitive development ) . RESULT ( S ) Mothers of twins showed significantly higher levels of parenting stress and depression than mothers of singletons and were significantly more likely to find parenting difficult and significantly less likely to obtain pleasure from their child . Regarding the children , there was no difference in the level of emotional or behavioral problems between twins and singletons . However , twins showed significantly lower levels of cognitive functioning . CONCLUSION ( S ) Greater difficulties in parenting and child development were experienced by IVF/ICSI families with twins than by IVF/ICSI families with singletons Output:	Results : To our knowledge , this is the first systematic review focused on the comparison of twins ' and singletons ' linguistic environments . Differences between the groups were found in all of the included studies . Data against twins were generally identified regarding all the considered linguistic environment 's features . Conclusion : The disadvantaged linguistic environment of twins is likely due to limited parental re sources and dem and s associated with the management of two children of the same age . However , the limited and conflicting data found did not allow for a firm conclusion to be drawn on the differences in the twins ' and singletons ' linguistic environments .
MS21162	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIM Underst and ing predictors of long-term benefit with currently available melanoma therapies is the key for optimising individualised treatments . A prior pooled analysis of dabrafenib plus trametinib ( D + T)-r and omised trials ( median follow-up , 20.0 months ) identified baseline lactate dehydrogenase ( LDH ) and number of organ sites with metastasis as predictive factors for progression-free ( PFS ) and overall ( OS ) survival . However , longer-term follow-up analyses are needed to confirm which patients treated with D + T can achieve maximum benefit . METHODS Three-year l and mark data were retrospectively pooled for D + T patients in phase 3 trials ( COMBI-d [ NCT01584648 ] ; COMBI-v [ NCT01597908 ] ) . Univariate and multivariate analyses assessed prognostic values of predefined baseline factors ; regression tree analysis determined hierarchy and interactions between variables . RESULTS Long-term pooled outcomes were consistent with individual trial results ( N = 563 ; 3-year PFS , 23 % ; 3-year OS , 44 % ) . Baseline LDH level and number of organ sites remained strongly associated with and /or predictive of PFS and OS . In addition , baseline sum of lesion diameters ( SLD ) was identified as a predictor for progression . In the most favourable prognostic group ( normal LDH , SLD < 66 mm , <3 organ sites ; n = 183/563 [ 33 % ] ) , 3-year PFS was 42 % . Baseline number of organ sites was also predictive of outcomes in patients with PFS ≥ 6 months . CONCLUSION Using the largest phase 3 data set available for BRAF/MEK inhibitor combination therapy in melanoma , these results demonstrate that durable responses lasting ≥3 years are possible in subsets of patients with BRAF-mutant melanoma receiving D + T. Although the best predictive model evolved with longer follow-up , factors predicting clinical outcomes with the combination remained consistent with previous analyses BACKGROUND The combination of cobimetinib with vemurafenib improves progression-free survival compared with placebo and vemurafenib in previously untreated patients with BRAF(V600)-mutant advanced melanoma , as previously reported in the coBRIM study . In this Article , we report up date d efficacy results , including overall survival and safety after longer follow-up , and selected biomarker correlative studies . METHODS In this double-blind , r and omised , placebo-controlled , multicentre study , adult patients ( aged ≥18 years ) with histologically confirmed BRAF(V600 ) mutation-positive unresectable stage IIIC or stage IV melanoma were r and omly assigned ( 1:1 ) using an interactive response system to receive cobimetinib ( 60 mg once daily for 21 days followed by a 7-day rest period in each 28-day cycle ) or placebo , in combination with oral vemurafenib ( 960 mg twice daily ) . Progression-free and overall survival were primary and secondary endpoints , respectively ; all analyses were done on the intention-to-treat population . This study is registered with Clinical Trials.gov , number NCT01689519 , and is ongoing but no longer recruiting participants . FINDINGS Between Jan 8 , 2013 , and Jan 31 , 2014 , 495 eligible adult patients were enrolled and r and omly assigned to the cobimetinib plus vemurafenib group ( n=247 ) or placebo plus vemurafenib group ( n=248 ) . At a median follow-up of 14·2 months ( IQR 8·5 - 17·3 ) , the up date d investigator-assessed median progression-free survival was 12·3 months ( 95 % CI 9·5 - 13·4 ) for cobimetinib and vemurafenib versus 7·2 months ( 5·6 - 7·5 ) for placebo and vemurafenib ( HR 0·58 [ 95 % CI 0·46 - 0·72 ] , p<0·0001 ) . The final analysis for overall survival occurred when 255 ( 52 % ) patients had died ( Aug 28 , 2015 ) . Median overall survival was 22·3 months ( 95 % CI 20·3-not estimable ) for cobimetinib and vemurafenib versus 17·4 months ( 95 % CI 15·0 - 19·8 ) for placebo and vemurafenib ( HR 0·70 , 95 % CI 0·55 - 0·90 ; p=0·005 ) . The safety profile for cobimetinib and vemurafenib was tolerable and manageable , and no new safety signals were observed with longer follow-up . The most common grade 3 - 4 adverse events occurring at a higher frequency in patients in the cobimetinib and vemurafenib group compared with the vemurafenib group were γ-glutamyl transferase increase ( 36 [ 15 % ] in the cobimetinib and vemurafenib group vs 25 [ 10 % ] in the placebo and vemurafenib group ) , blood creatine phosphokinase increase ( 30 [ 12 % ] vs one [ < 1 % ] ) , and alanine transaminase increase ( 28 [ 11 % ] vs 15 [ 6 % ] ) . Serious adverse events occurred in 92 patients ( 37 % ) in the cobimetinib and vemurafenib group and 69 patients ( 28 % ) in the vemurafenib group . Pyrexia ( six patients [ 2 % ] ) and dehydration ( five patients [ 2 % ] ) were the most common serious adverse events reported in the cobimetinib and vemurafenib group . A total of 259 patients have died : 117 ( 47 % ) in the cobimetinib and vemurafenib group and 142 ( 58 % ) in the vemurafenib group . The primary cause of death was disease progression in most patients : 109 ( 93 % ) of 117 in the cobimetinib and vemurafenib group and 133 ( 94 % ) of 142 in the vemurafenib group . INTERPRETATION These data confirm the clinical benefit of cobimetinib combined with vemurafenib and support the use of the combination as a st and ard first-line approach to improve survival in patients with advanced BRAF(V600)-mutant melanoma . FUNDING F Hoffmann-La Roche-Genentech BACKGROUND Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib ( PLX4032 ) have shown response rates of more than 50 % in patients with metastatic melanoma with the BRAF V600E mutation . METHODS We conducted a phase 3 r and omized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated , metastatic melanoma with the BRAF V600E mutation . Patients were r and omly assigned to receive either vemurafenib ( 960 mg orally twice daily ) or dacarbazine ( 1000 mg per square meter of body-surface area intravenously every 3 weeks ) . Co primary end points were rates of overall and progression-free survival . Secondary end points included the response rate , response duration , and safety . A final analysis was planned after 196 deaths and an interim analysis after 98 deaths . RESULTS At 6 months , overall survival was 84 % ( 95 % confidence interval [ CI ] , 78 to 89 ) in the vemurafenib group and 64 % ( 95 % CI , 56 to 73 ) in the dacarbazine group . In the interim analysis for overall survival and final analysis for progression-free survival , vemurafenib was associated with a relative reduction of 63 % in the risk of death and of 74 % in the risk of either death or disease progression , as compared with dacarbazine ( P<0.001 for both comparisons ) . After review of the interim analysis by an independent data and safety monitoring board , crossover from dacarbazine to vemurafenib was recommended . Response rates were 48 % for vemurafenib and 5 % for dacarbazine . Common adverse events associated with vemurafenib were arthralgia , rash , fatigue , alopecia , keratoacanthoma or squamous-cell carcinoma , photosensitivity , nausea , and diarrhea ; 38 % of patients required dose modification because of toxic effects . CONCLUSIONS Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation . ( Funded by Hoffmann-La Roche ; BRIM-3 Clinical Trials.gov number , NCT01006980 . ) BACKGROUND Combined BRAF-MEK inhibitor therapy is the st and ard of care for BRAFV600-mutant advanced melanoma . We investigated encorafenib , a BRAF inhibitor with unique target-binding properties , alone or in combination with the MEK inhibitor binimetinib , versus vemurafenib in patients with advanced BRAFV600-mutant melanoma . METHODS COLUMBUS was conducted as a two-part , r and omised , open-label phase 3 study at 162 hospitals in 28 countries . Eligible patients were aged 18 years or older and had histologically confirmed locally advanced ( American Joint Committee on Cancer [ AJCC ] stage IIIB , IIIC , or IV ) , unresectable or metastatic cutaneous melanoma , or unknown primary melanoma ; a BRAFV600E or BRAFV600 K mutation ; an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 ; and were treatment naive or had progressed on or after previous first-line immunotherapy . In part 1 of the study , patients were r and omly assigned ( 1:1:1 ) via interactive response technology to receive either oral encorafenib 450 mg once daily plus oral binimetinib 45 mg twice daily ( encorafenib plus binimetinib group ) , oral encorafenib 300 mg once daily ( encorafenib group ) , or oral vemurafenib 960 mg twice daily ( vemurafenib group ) . The primary endpoint was progression-free survival by blinded independent central review for encorafenib plus binimetinib versus vemurafenib . Efficacy analyses were by intention-to-treat . Safety was analysed in patients who received at least one dose of study drug and one postbaseline safety assessment . The results of part 2 will be published separately . This study is registered with Clinical Trials.gov , number NCT01909453 , and EudraCT , number 2013 - 001176 - 38 . FINDINGS Between Dec 30 , 2013 , and April 10 , 2015 , 577 of 1345 screened patients were r and omly assigned to either the encorafenib plus binimetinib group ( n=192 ) , the encorafenib group ( n=194 ) , or the vemurafenib group ( n=191 ) . With a median follow-up of 16·6 months ( 95 % CI 14·8 - 16·9 ) , median progression-free survival was 14·9 months ( 95 % CI 11·0 - 18·5 ) in the encorafenib plus binimetinib group and 7·3 months ( 5·6 - 8·2 ) in the vemurafenib group ( hazard ratio [ HR ] 0·54 , 95 % CI 0·41 - 0·71 ; two-sided p<0·0001 ) . The most common grade 3 - 4 adverse events seen in more than 5 % of patients in the encorafenib plus binimetinib group were increased γ-glutamyltransferase ( 18 [ 9 % ] of 192 patients ) , increased creatine phosphokinase ( 13 [ 7 % ] ) , and hypertension ( 11 [ 6 % ] ) ; in the encorafenib group they were palmoplantar erythrodysaesthesia syndrome ( 26 [ 14 % ] of 192 patients ) , myalgia ( 19 [ 10 % ] ) , and arthralgia ( 18 [ 9 % ] ) ; and in the vemurafenib group it was arthralgia ( 11 [ 6 % ] of 186 patients ) . There were no treatment-related deaths except for one death in the combination group , which was considered possibly related to treatment by the investigator . INTERPRETATION Encorafenib plus binimetinib and encorafenib monotherapy showed favourable efficacy compared with vemurafenib . Overall , encorafenib plus binimetinib appears to have an improved tolerability profile compared with encorafenib or vemurafenib . Encorafenib plus binimetinib could represent a new treatment option for patients with BRAF-mutant melanoma . FUNDING Array BioPharma , Novartis BACKGROUND Combined BRAF and MEK inhibition , as compared with BRAF inhibition alone , delays the emergence of resistance and reduces toxic effects in patients who have Output:	The indirect comparison revealed no statistically differences for OS , PFS and ORR across trials , while safety profile differed between the three couples of agents . This indirect adjusted meta- analysis suggests a similar efficacy and a slightly different safety profile , related to specific molecular properties of the three different BRAF and MEK inhibitors currently approved in the management of advanced MM
MS21163	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE In previously well infants hospitalized with acute viral bronchiolitis , the effectiveness of repeated nebulized therapy with epinephrine ( EPI ) was compared with treatment with albuterol ( ALB ) or saline placebo ( PLAC ) . STUDY DESIGN In this r and omized , double-blind , parallel-group , controlled trial , infants received study nebulizations every 1 to 6 hours and were assessed twice daily by the research team . The primary outcome was length of hospital stay ( LOS ) . Secondary outcomes included the time from admission until the infant had normal hydration , oxygenation , and minimal respiratory distress . RESULTS A total of 149 infants were r and omized ; 50 were allocated to receive racemic EPI , 51 were given ALB , and 48 received PLAC . Baseline characteristics and pre-enrollment symptoms , signs , and therapy were similar between groups . There were no group differences in the primary outcome measure , mean LOS (hours)(+/- SD ) : EPI = 59.8 ( 62 ) , ALB = 61.4 ( 54 ) , and PLAC = 63.3 ( 47 ) ; P = .95 by intent-to-treat analysis . Group differences were not statistically significant in any of the secondary outcomes . CONCLUSIONS There were no group differences in the effectiveness of therapy for infants hospitalized with bronchiolitis . Based on these results , we do not recommend routine use of either nebulized EPI or ALB in this patient group Objective To compare the length of hospital stay ( primary ) and improvement in clinical severity scores ( secondary ) among children with bronchiolitis nebulized with 3 % hypertonic saline or 0.9 % saline . Design R and omized double blind controlled trial . Setting Tertiary care teaching hospital . Patients Hospitalized children ( 1–24 months ) with acute bronchiolitis of moderate severity . InterventionNebulization of 4 ml of 3 % hypertonic saline or 4 mL of 0.9 % saline , along with 2.5 mg salbutamol , at 4-hourly intervals till the patient was ready for discharge . Results Baseline characteristics were similar in two groups . Median clinical severity score at admission was 6 ( IQR-1 ) in both the groups . Clinical severity scores monitored afterwards 12-hourly till discharge ( 132 h ) did not show statistically significant differences in 3 % and 0.9 % saline groups . Mean length of hospital stay ( time to reach predefined clinical severity score<3 ) was 63.93 ± 22.43 h in 3 % saline group and 63.51 ± 21.27 h in 0.9 % saline group ( P=0.878 ) . No adverse events were reported by the parents , caregivers or treating medical attendants in both groups . Conclusion Nebulized 3 % saline is not superior to 0.9 % saline in infants with clinical ly diagnosed acute bronchiolitis Objective An appropriate treatment of acute viral bronchiolitis can reduce the symptoms , hospitalization duration and exorbitant costs which is imposed on the families and insurance organizations . This study was conducted to determine the efficacy of epinephrine in comparison with salbutamol in the treatment of the disease . Methods Forty infants aged one month to 2 years with acute bronchiolitis in Amin and Al-Zahra hospitals , during 2008 , were enrolled in this study . The participants were r and omized in two treatment groups to receive epinephrine 0.1 ml/kg or salbutamol 0.15 mg/kg . Three doses of each medication were prescribed at intervals of 20 minutes and continued every 10 minutes after the third dose . The patients in both groups were monitored and rated by RDAI , number of the hospitalized days in the hospital , level of oxygen saturation and vital signs . Findings Mean hospitalization duration was 3.3±1.1 and 3±0.9 in the patients receiving salbutamol and epinephrine , respectively ( P=0.03 ) . There was a significant difference in assessing RDAI index between the two groups ( P=0.03 ) . There were no differences in SPO2 , PR , or RR variables in the studied intervals in both groups ( P>0.05 ) . Conclusion Regarding the effect of epinephrine on reduction of hospitalization duration and the RDAI index in patients with acute bronchiolitis , it seems that using epinephrine instead of salbutamol could be more effective in the management of the disease OBJECTIVE To investigate whether nebulized racemic epinephrine or albuterol improves respiratory distress in infants with acute bronchiolitis . DESIGN A r and omized , placebo-controlled , double-blind study . SETTING A university hospital providing primary hospital care for all pediatric patients in a defined area . PATIENTS One hundred consecutive infants younger than 24 months treated in the hospital for acute bronchiolitis . INTERVENTION The patients received two inhalations at 30-minute intervals : racemic epinephrine followed by physiologic saline ( REP group ; n = 24 ) , albuterol followed by physiologic saline ( AP group ; n = 27 ) , physiologic saline followed by racemic epinephrine ( PRE group ; n = 24 ) , and physiologic saline followed by albuterol ( PA group ; n = 25 ) . All patients received intramuscular epinephrine 60 minutes after the beginning of the study . MAIN OUTCOME MEASURES Oxygen saturation , respiratory rate , and two clinical scores were used : one based on wheezing and retractions ( Respiratory Distress Assessment Instrument ) and the other based on changes in wheezing , retractions , and respiratory rate ( Respiratory Assessment Change Score ) . MAIN RESULTS During the study , there were no significant differences among the four groups in clinical scores , oxygen saturations , and respiratory rates . Mean Respiratory Distress Assessment Instrument scores improved significantly within the REP , PRE , and AP groups 15 minutes after the first inhalation . In only the REP group , which received racemic epinephrine , the confidence limits did not overlap . A comparison of paired data of each patient revealed that the difference in Respiratory Assessment Change Score was significant between racemic epinephrine and physiologic saline , but not between albuterol and physiologic saline . Intramuscular epinephrine significantly improved Respiratory Distress Assessment Index scores in those groups treated earlier with racemic epinephrine ( REP and PRE groups ) . No significant adverse effects were seen in any group or at any phase of the study . CONCLUSIONS Elimination of hypoxia by supplemental oxygen and moistening of inspired air relieve the symptoms of acute bronchiolitis . Nebulized racemic epinephrine and albuterol are safe and useful in the treatment of acute bronchiolitis . Improvements in symptom scores at 15 minutes favor the use of racemic epinephrine . As the action of epinephrine is short , the effect can be increased by repeated inhalations To evaluate combination therapy of mild to moderate bronchiolitis with bronchiodilators and corticosteroids , we treated 51 young children with first-time wheezing and symptoms of respiratory tract infection with albuterol plus either prednisolone or placebo for 5 days . Disease severity was scored on days 0 , 2 , 3 , and 6 . On day 2 , prednisolone result ed in significantly lower scores ( 2.7 ±1.4 vs. 4.0 ±1.5 in all patients evaluated , p<0.05 ) than placebo , whereas there was no detectable difference on day 6 , suggesting that addition of prednisolone to albuterol transiently accelerates recovery from bronchiolitis . The clinical significance of this effect needs to be evaluated in further studies OBJECTIVE To determine the utility of inhaled hypertonic saline solution to treat ambulatory infants with viral bronchiolitis . DESIGN R and omized , double-blind , controlled trial . Sixty-five ambulatory infants ( mean + /- SD age , 12.5 + /- 6 months ) with viral bronchiolitis received either of the following : inhalation of 0.5 mL ( 5 mg ) terbutaline added to 2 mL of 0.9 % saline solution as a wet nebulized aerosol ( control ; group 1 ; n = 32 ) or 0.5 mL ( 5 mg ) terbutaline added to 2 mL of 3 % saline solution administered in the same manner as above ( treatment ; group 2 ; n = 33 ) . This therapy was repeated three times every day for 5 days . RESULTS The clinical severity ( CS ) scores at baseline on the first day of treatment were 6.4 + /- 1.8 in group 1 and 6.6 + /- 1.5 in group 2 ( not significant ) . After the first day , the CS score was significantly lower ( better ) in group 2 as compared to group 1 on each of the treatment days ( p < 0.005 ; Fig 1 ) . On the first day , the percentage decrease in the CS score after inhalation therapy was significantly better for group 2 ( 33 % ) than for group 1 ( 13 % ) [ p < 0.005 ; Fig 1 ] . On the second day , the percentage improvement was better in the hypertonic saline solution-treated patients ( group 2 ) as compared to the 0.9 % saline solution-treated patients ( group 1 ) [ p = 0.01 ; Fig 1 ] . CONCLUSIONS We conclude that in nonasthmatic , nonseverely ill ambulatory infants with viral bronchiolitis , aerosolized 3 % saline solution plus 5 mg terbutaline is effective in decreasing symptoms as compared to 0.9 % saline solution plus 5 mg terbutaline OBJECTIVE To determine the utility of inhaled hypertonic saline solution to treat infants hospitalized with viral bronchiolitis . DESIGN R and omized , double-blind , controlled trial . Fifty-two hospitalized infants ( mean + /- SD age , 2.9 + /- 2.1 months ) with viral bronchiolitis received either inhalation of epinephrine , 1.5 mg , in 4 mL of 0.9 % saline solution ( group 1 ; n = 25 ) or inhalation of epinephrine , 1.5 mg , in 4 mL of 3 % saline solution ( group 2 ; n = 27 ) . This therapy was repeated three times every hospitalization day until discharge . RESULTS The percentage improvement in the clinical severity scores after inhalation therapy was not significant in group 1 on the first , second , and third days after hospital admission ( 3.5 % , 2 % , and 4 % , respectively ) . In group 2 , significant improvement was observed on these days ( 7.3 % , 8.9 % , and 10 % , respectively ; p < 0.001 ) . Also , the improvement in clinical severity scores differed significantly on each of these days between the two groups . Using 3 % saline solution decreased the hospitalization stay by 25 % : from 4 + /- 1.9 days in group 1 to 3 + /- 1.2 days in group 2 ( p < 0.05 ) . CONCLUSIONS We conclude that in nonasthmatic , nonseverely ill infants hospitalized with viral bronchiolitis , aerosolized 3 % saline solution/1.5 mg epinephrine decreases symptoms and length of hospitalization as compared to 0.9 % saline solution/1.5 mg epinephrine OBJECTIVES Bronchiolitis is the most common disease of the lower respiratory tract in the first year of life . Treatment is controversial , with studies giving conflicting views on the benefits of bronchodilators and steroids . The objectives of this study were 1 ) to characterize the management of bronchiolitis in pediatric emergency departments ( PEDs ) in Canada , 2 ) to determine patient outcomes following emergency department ( ED ) visits , and 3 ) to provide descriptive data regarding bronchiolitis symptoms and family/personal medical history of these patients . METHODS A prospect i ve consecutive cohort of children with bronchiolitis presenting to seven Canadian PEDs was enrolled during a seven-to-21-day period . St and ardized interviews with parents provided data regarding symptoms , previous treatment , and past history . Charts were review ed for treatment , investigations , and disposition . Telephone follow-up at two to three weeks collected information regarding duration of illness and return visits . RESULTS Two hundred thirty-seven ( 91 % ) of 260 eligible patients were enrolled . One hundred eighty-nine patients ( 80 % ) had both an interview and chart review , and 48 ( 20 % ) had only chart review s ; follow-up was completed for 163 ( 69 % ) patients . One hundred fifteen ( 63 % ) had seen their primary care provider during their illness prior to the ED visit . Seventy-three percent of patients ( range per site 59 - 100 % ) were treated in the ED with bronchodilators ( usually salbutamol or epinephrine ) and 5 % ( range per site 0 - 14 % ) with oral steroids . Twenty-four percent ( 58/237 ) were prescribed bronchodilators on discharge , 3 % ( 7/237 ) inhaled steroids , and 2 % ( 5/237 ) oral steroids . Chi-square tests indicated significant practice variation by site in ED bronchodilator use ( p < 0.001 ) and bronchodilator use at discharge ( p = 0.0003 ) . Admission rate was 31 % ( range by site 22 - 43 % ) , 17 % of Output:	Including only studies with low risk of bias reduced the heterogeneity but had little impact on the overall effect size of average clinical score ( SMD -0.22 , 95 % CI -0.41 to -0.03).Sub-analyses limited to nebulized albuterol or salbutamol among out patients ( nine studies ) showed no effect on oxygen saturation ( MD -0.19 , 95 % CI -0.59 to 0.21 , n = 572 ) , average clinical score ( SMD -0.36 , 95 % CI -0.83 to 0.11 , n = 532 ) or hospital admission after treatment ( OR 0.77 , 95 % CI 0.44 to 1.33 , n = 404).Adverse effects included tachycardia , oxygen desaturation and tremors . AUTHORS ' CONCLUSIONS Bronchodilators such as albuterol or salbutamol do not improve oxygen saturation , do not reduce hospital admission after outpatient treatment , do not shorten the duration of hospitalization and do not reduce the time to resolution of illness at home .
MS21164	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background The aims of this prospect i ve study were to analyze the predictors of postoperative sleep disturbance after esophagectomy for cancer and to identify patients at risk for postoperative hypnotic administration . Methods Sixty two consecutive patients who underwent cancer-related esophagectomy were enrolled in this study from May 2011 to February 2012 . Data about perioperative management , postoperative complications , ICU stay , and vasopressor , hypnotic , and painkiller administration were retrieved . The EORTC QLQ-C30 was used and global quality of life ( QL2 item ) and sleep disturbance ( SL item ) were the primary endpoints . Univariate and multivariate analyses were performed . Results Postoperative request of hypnotics independently predicted bad quality of life outcome . Sleep disturbance after esophagectomy was independently predicted by the duration of dopamine infusion in the ICU and the daily request of benzodiazepines . Even in this case , only sleep disturbance at diagnosis revealed to be an independent predictor of hypnotic administration need . ROC curve analysis showed that sleep disturbance at diagnosis was a good predictor of benzodiazepine request ( AUC = 73 % , P = 0.02 ) . Conclusions The use of vasopressors in the ICU affects sleep in the following postoperative period and the use of hypnotics is neither completely successful nor lacking in possible consequences . Sleep disturbance at diagnosis can successfully predict patients who can develop sleep disturbance during the postoperative period Background In patients with esophageal cancer , evidence for prognostic significance of preoperative quality of life ( QoL ) is limited , while the prognostic significance of postoperative QoL has not been investigated at all . Aim To determine whether preoperative and postoperative QoL measurements can predict survival independently from clinical and pathological factors , in patients with potentially curable esophageal adenocarcinoma . Methods A r and omized controlled trial was performed from 1994 to 2000 in two academic medical centres , comparing transthoracic and transhiatal esophagectomy . QoL question naires were sent before and 3 months after surgery ( Medical Outcome Study Short Form-20 and Rotterdam Symptom Checklist ) . Uni- and multivariate Cox regression analyses were used to examine firstly the prognostic value of preoperative QoL and several clinical factors , and secondly of postoperative QoL , several clinical factors , and pathological staging . Results Out of 220 r and omized patients , 199 participated in the QoL- study . In the multivariate preoperative model physical symptom scale ( p = 0.021 ) , tumor length ( p = 0.034 ) , and endosonographic T-stage ( p = 0.003 ) were predictive for overall survival . In the postoperative multivariate analysis , social functioning ( p = 0.035 ) , pain ( p = 0.026 ) , and activity level ( p = 0.037 ) predicted survival , besides pathological T-stage ( p < 0.001 ) and N-stage ( p < 0.001 ) . Conclusion In the present paper the first large consecutive series of potentially curable esophageal cancer patients is presented in whom prospect ively collected QoL data before and after potentially curative surgical resection were used to predict survival . Both preoperative ( physical symptoms ) and postoperative ( social functioning , pain , and activity level ) QoL subscales are independent predictors of survival in potentially curable patients with esophageal adenocarcinoma Background For patients undergoing oncologic surgery , the quality of life ( QoL ) is generally accepted as an important outcome parameter in addition to long-term survival , mortality , and complication rates . Our study focused on outcome in terms of QoL in patients with esophageal cancer , comparing the sites of anastomosis ( cervical versus thoracic anastomosis ) . Methods In a prospect i ve longitudinal single-center study from 1998 to 2005 , 105 patients underwent surgery for esophageal cancer . To assess QoL the EORTC-QLQ-C-30 and a tumor-specific module were administered before surgery , at discharge , and three , six , 12 , and 24 months after surgery . Clinical data were collected prospect ively and follow-up was performed every six months . Results The histological type was squamous cell carcinoma in 51.4 % of the cases , adenocarcinoma in 41.9 % , and some other type in 6.7 % . There was no significant difference between cervical and thoracic anastomosis with regard to morbidity , mortality , and survival rates ( 30 % five-year survival rate ) , whereas tumor stage was a significant ( p < 0.001 ) prognostic factor . Most QoL scores dropped significantly below baseline in the early postoperative period . Even though they recovered slowly during the follow-up period , they never reached preoperative levels again . There was no statistically significant difference in any of the QoL scales between patients with a cervical or a thoracic anastomosis . Conclusions Esophageal resections are associated with significant deterioration of QoL , which persists during the follow-up period . The surgical technique and position of the esophagogastrostomy did not affect QoL deterioration Although several studies have reported the impact of oesophagectomy on health-related quality of life ( HRQOL ) , none has objective ly assessed its impact on physical fitness . This study aim ed to evaluate the impact of oesophagectomy on physical fitness and HRQOL in patients with oesophageal cancer . In this prospect i ve study , we investigated 30 consecutive patients with newly diagnosed resectable oesophageal cancer who were scheduled to receive either neoadjuvant chemotherapy followed by surgery or surgery alone . The primary end-points were change from baseline in two measures of physical fitness ( knee-extensor muscle strength and 6-min walking distance ) after oesophagectomy . The secondary end-point was change from baseline in HRQOL measured with the European Organization for the Research and Treatment of Cancer Quality of Life Core Question naire with 30 items ( EORTC QLQ-C30 ) . Physical fitness was significantly lower after oesophagectomy than before oesophagectomy ( P < 0.001 ) . With regard to HRQOL , there was a significant pre- to post-oesophagectomy change in most of the scales . In the multiple regression analysis , the change in 6-min walking distance was the only significant variable affecting the change in physical functional score on the EORTC QLQ-C30 ( P = 0.032 ) . In conclusion , oesophagectomy adversely affects physical fitness and HRQOL in patients with oesophageal cancer . Six-minute walking distance may be a good indicator of HRQOL shortly after oesophagectomy Objective : The aim of this study was to compare the 2-year functional performance and quality of life in patients with operable squamous cell carcinoma of the esophagus , who have received either surgery or definitive chemoradiation ( CRT ) . Summary Background Data : The functional outcomes and quality of life in patients receiving esophagectomy or definitive CRT is uncertain . Methods : Data were extracted from the data base of a prospect i ve r and omized controlled trial that included patients with resectable mid or lower thoracic esophageal cancers . The patients were r and omized to either st and ard esophagectomy or definitive CRT . Quality of life assessment s were performed using the EORTC QLQ-C30 and QLQ-OES24 modules . Other functional assessment s included pulmonary and eating functions . Results : From July 2000 to December 2004 , a total of 81 patients were enrolled into the study . No significant longitudinal changes were detected in the global health status in both groups upon available follow-up . Surgery was associated with worsened physical functioning and fatigue symptoms up to 6 months after treatment ( P < 0.001 and P = 0.021 , respectively ) and these scales improved at 2 years . In terms of pulmonary function , dyspnoic and coughing symptoms were significantly worsened 3 months after surgery ( P = 0.024 and P = 0.036 , respectively ) whereas symptoms in the CRT group progressively deteriorated over time . Concerning the eating function , both groups had improvements in dysphagia but there were frequent need for endoscopic intervention . This study has been registered with clinical trials.gov and the clinical trials.gov ID number is NCT01032967 . Conclusion : Neither surgery nor definitive CRT significantly impaired the global health status of patients . Surgery was associated with a short-term negative impact in some aspects of health related quality of life assessment s but these changes became insignificant 2 years after treatment . However , CRT was associated with progressive deteriorations in pulmonary function in the longer term PURPOSE To assess 3 years of quality of life in patients with esophageal cancer in a r and omized trial comparing limited transhiatal resection with extended transthoracic resection . PATIENTS AND METHODS Quality -of-life question naires were sent at baseline and at 5 weeks ; 3 , 6 , 9 , and 12 months ; and 1.5 , 2 , 2.5 , and 3 years after surgery . Physical and psychological symptoms , activity level , and global quality of life were assessed with the disease-specific Rotterdam Symptom Checklist . Generic quality of life was measured with the Medical Outcomes Study Short Form-20 . RESULTS A total of 199 patients participated . Physical symptoms and activity level declined after the operation and gradually returned toward baseline within the first year ( P < .01 ) . Psychological well-being consistently improved after baseline ( P < .01 ) , whereas global quality of life showed a small initial decline followed by continuous gradual improvement ( P < .01 ) . Quality of life stabilized in the second and third year . Three months after the operation , patients in the transhiatal esophagectomy group ( n = 96 ) reported fewer physical symptoms ( P = .01 ) and better activity levels ( P < .01 ) than patients in the transthoracic group ( n = 103 ) , but no differences were found at any other measurement point . For psychological symptoms and global quality of life , no differences were found at any follow-up measurement . A similar pattern was found for generic quality of life . CONCLUSION No lasting differences in quality of life of patients who underwent either transhiatal or transthoracic resection were found . Compared with baseline , quality of life declined after the operation but was restored within a year in both groups Purpose Improving survival after esophagectomy is an important issue in treating patients with esophageal cancer ( EC ) . In addition to st and ard hospitalization management , periodic assessment of quality -of-life ( QOL ) measures may be useful to detect disease progression from patients ’ subjective reports . Therefore , this prospect i ve longitudinal study was undertaken to identify prognostic factors for 3-year survival of EC patients after esophagectomy and to evaluate the impact of QOL measures on these prognostic factors . Methods Patients with EC ( n = 67 ) who had a complete tumor resection and were alive 6 months after esophagectomy were followed in this study for 3 years . Data were collected on patients ’ sociodemographics , cancer characteristics , adjuvant therapy , general QOL and EC-specific QOL ( before esophagectomy and 6 months afterward ) , cancer recurrence , and death . Patients ’ independent risk factors for 3-year survival were investigated by multivariate Cox regression analysis . Results Of the 67 participants with EC , 26 had late mortality , with a median survival for the whole cohort of 38.2 months ( 95 % CI 31.97–44.35 ) . Independent predictors of early death were early cancer recurrence ( within 6 months after surgery ) , poor cognitive function ( 95 % CI 1.020–1.041 ) , and worse dyspnea ( 95 % CI 1.007–1.034 ) . Conclusions The most predictive factor for early death in EC patients after esophagectomy was cancer recurrence within 6 months after surgery . However , QOL measures could be a tool to provide clinical information from patients ’ perspective suggesting cancer recurrence Health‐related quality of life ( HRQL ) outcomes are important in assessing new approaches to the treatment of cancer . Neoadjuvant therapy is being used increasingly before surgery in patients with localized oesophageal cancer . This prospect i ve non‐r and omized study evaluated HRQL in patients treated by preoperative chemotherapy and radiation therapy followed by surgery ( multimodal therapy ) or by surgery alone Objective : The aim of this study was to assess long-term health-related quality of life ( HRQL ) in patients after thoracoscopic and open esophagectomy . Summary of Background Data : Trials comparing minimally invasive with open transthoracic esophagectomy have shown improved short-term outcomes ; however , long-term HRQL data are lacking . This prospect i ve nonr and omized study compared HRQL and survival after thoracoscopically assisted McKeown esophagectomy ( TAMK ) and open transthoracic Ivor Lewis esophagectomy ( TTIL ) for esophageal or gastroesophageal junction ( GEJ ) cancer . Methods : Patients with esophageal or GEJ cancer selected for TAMK or TTIL completed baseline and follow-up HRQL assessment s for up to 24 months using the EORTC generic and disease-specific measures , QLQ-C30 and QLQ-OES18 . Baseline clinical variables were examined between the treatment groups and changes in mean HRQL scores over time estimated and tested using generalised estimating equations with propensity score ( generated by boosted regression ) adjust Output:	We hypothesized that QoL is consistently better in patients treated with minimally invasive surgery than in those treated with a more traditional and invasive approach . Although global health , social function , and emotional function improved more commonly after minimally invasive surgery compared with open surgery , physical function and role function , as well as symptoms including choking , dysphagia , eating problems , and trouble swallowing saliva , declined for both surgery types . Cognitive function was equivocal across both groups .
MS21165	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES The aim of the study was to assess prevalence , incidence , recovery , and risk factors of irritable bowel syndrome according to different definitions in a large r and om population . DESIGN A 5 year follow-up study of a sex- and age-stratified r and om sample of 4581 Danes interviewed about abdominal symptoms . SETTING The Glostrup Population s Studies Unit at Glostrup County Hospital . MAIN OUTCOME MEASURES Prevalence , incidence , recovery , and the association of risk factors to irritable bowel syndrome ( IBS ) . The percentage of subjects common to the population s selected by the various definitions of IBS . RESULTS According to various definitions , the prevalence of IBS varied from 5 to 65 % and the incidence varied from 1 to 36 % . At the 5 year follow-up only 5 % of subjects with IBS were completely free of all symptoms . Psychological vulnerability and the experience of having problems were strongly associated with prevalence and incidence of IBS , whereas lifestyle factors only showed a very weak or no relationship to IBS . Population s defined as suffering from IBS according to the various definitions had less than 50 % of the subjects in common . CONCLUSIONS Irritable bowel syndrome is frequent but fluctuating in the general population . Psychological factors seem to be of greater aetiological importance to IBS than lifestyle factors . However , a generally accepted and precise definition is essential to make future studies comparable and to allow general conclusions to be drawn . Furthermore , it still needs to be verified whether the syndrome is a disease entity or just an acceptable , common life-condition Alosetron is a 5‐hydroxytryptamine‐3 receptor antagonist reducing symptoms in female patients with diarrhoea‐predominant irritable bowel syndrome , and is known to increase the colonic transit time Functional gastrointestinal disorders , including the irritable bowel syndrome , account for up to 40 % of referrals to gastroenterologists , but accurate data on the natural history of these disorders in the general population are lacking . Using a reliable and valid question naire , the authors estimated the onset and disappearance of symptoms consistent with functional gastrointestinal disorders . An age- and sex-stratified r and om sample of 1,021 eligible residents of Olmsted County , Minnesota , aged 30 - 64 years were initially mailed the question naire ; 82 % responded ( n = 835 ) . In a remailing to responders 12 - 20 months later , 83 % responded again ( n = 690 ) . The age- and sex-adjusted prevalence rates per 100 for irritable bowel syndrome , chronic constipation , chronic diarrhea , and frequent dyspepsia were 18.1 ( 95 % confidence interval ( CI ) 15.1 - 21.1 ) , 14.7 ( 95 % CI 11.9 - 17.4 ) , 7.3 ( 95 % CI 5.3 - 9.3 ) , and 14.1 ( 95 % CI 11.5 - 16.8 ) , respectively , on the second mailing . Symptoms were not significantly associated with nonresponse to the second mailing ; moreover , the estimated prevalence rates were not significantly different from the first mailing . Among the 582 subjects free of the irritable bowel syndrome on the first survey , 9 % developed symptoms during 795 person-years of follow-up , while 38 % of the 108 who initially had the irritable bowel syndrome did not meet the criteria after 146 person-years of follow-up . Similar onset and disappearance rates were observed for the other main symptom categories . While functional gastrointestinal symptoms are common in middle-aged persons and overall prevalence appears relatively stable over 12 - 20 months , substantial turnover is implied by the observed onset and disappearance rates ; several potential sources of bias do not seem to account for this variation Background Flatulence is a common symptom in patients with irritable bowel syndrome ( IBS ) . This may be due to production of hydrogen by intestinal flora . With the presence of methanogenic flora , 4 mol of hydrogen ( H2 ) are used with 1 mol of carbon dioxide ( CO2 ) to produce 1 mol of methane ( CH4 ) , a process greatly reducing the volume of gas in the colon . However , the prevalence of methanogenic flora has not yet been reported in healthy and IBS patients from North India . Therefore , this study was planned . Methods This study was conducted prospect ively and included 345 patients with irritable bowel syndrome ( fulfilling Rome II criteria ) and 254 age- and gender-matched apparently healthy controls . Each subject underwent a hydrogen breath test using 10 g lactulose after an overnight fast . An SC Microlyser from Quintron , USA , was used to measure methane and hydrogen at baseline and at every 30 min for 4 h. Subjects with fasting methane concentration < 10 p.p.m . were labeled as low methane producers ( LMPs ) and > 10 p.p.m . as predominant methane producers ( PMPs ) . Results The IBS and control groups included 66.78 % and 67.53 % men , respectively . Mean age in the two groups was 48.52 ± 30.54 years ( range 15–68 years ) and 45.67 ± 30.54 years ( range 15–78 years ) , respectively . Prevalence of predominant methanogenic flora in IBS and control groups was 14.5 % ( 50/345 ) and 34.6 % ( 88/254 ) , respectively ( P < 0.001 ) . Fifty-two out of 254 ( 20.6 % ) were PMPs and 36 out of 254 ( 14.0 % ) were LMPs in controls . In contrast to this , IBS patients had 17 out of 354 ( 4.9 % ) that were PMPs and 33 out of 345 ( 9.6 % ) that were LMPs . Conclusion Methanogenic flora was significantly lower in IBS patients from North India than in apparently healthy subjects . This may be one of the causes of flatulence in IBS patients & NA ; Visceral pain processing is abnormal in a majority of irritable bowel syndrome ( IBS ) patients . Aberrant endogenous nociceptive modulation and anticipation are possible underlying mechanisms investigated in the current study . Twelve IBS patients and 12 matched healthy controls underwent brain fMRI scanning during the following r and omised stimuli : sham and painful rectal distensions by barostat without and with simultaneous activation of endogenous descending nociceptive inhibition using ice water immersion of the foot for heterotopic stimulation . Heterotopic stimulation decreased rectal pain scores from 3.7 ± 0.2 to 3.1 ± 0.3 ( mean ± SE , scale 0–5 ) in controls ( p < 0.01 ) , but not significantly in IBS . Controls differed from IBS patients in showing significantly greater activation bilaterally in the anterior insula , SII and putamen during rectal stimulation alone compared to rectal plus heterotopic stimulation . Greater activation during rectal plus heterotopic versus rectal stimulation was seen bilaterally in SI and the right superior temporal gyrus in controls and in the right inferior lobule and bilaterally in the superior temporal gyrus in IBS . Rectal pain scores were similarly low during sham stimulation in both groups , but brain activation patterns differed . In conclusion , IBS patients showed dysfunctional endogenous inhibition of pain and concomitant aberrant activation of brain areas involved in pain processing and integration . Anticipation of rectal pain was associated with different brain activation patterns in IBS involving multiple interoceptive , homeostatic , associative and emotional areas , even though pain scores were similar during sham distension . The aberrant activation of endogenous pain inhibition appears to involve circuitry relating to anticipation as well as pain processing itself OBJECTIVE : Little is known about the natural history of functional GI symptoms , including what factors influence GI symptom patterns and health care seeking for them over the long term . We aim ed to determine whether psychological factors play a role in the development and long-term course of these symptoms . METHODS : A r and om sample of community subjects ( n = 361 ) who reported having unexplained abdominal pain for ≥1 month in a previous population survey were included in the study . Controls ( n = 120 ) were defined as not having abdominal pain for ≥1 month from this initial survey . Subjects were prospect ively followed up via a question naire every 4 months over a 12-month period . The question naire asked about the presence of GI symptoms over the past week and psychological distress over the past 3 wk ( psychological caseness being defined as a score of ≥2 of 12 on the General Health Question naire ) . The number of visits made to a physician or medical specialist over the past 4 months was evaluated . RESULTS : GI symptoms were common among community controls and subjects with abdominal pain . Similar onset and disappearance rates were observed for the majority of GI symptom categories , accounting for the stability of the prevalence rates over a 1-yr period . Changes in a state measure of psychological distress were not significantly associated with changes in GI symptom status between the 4- and 8-month ( r= 0.14 , p= 0.08 ) and 8- and 12-month ( r= 0.02 , p= 0.77 ) follow-ups . Baseline psychological distress , however , was an independent predictor of having persistent GI symptoms , including abdominal pain , bloating , and constipation , and frequently seeking health care for GI symptoms over 1 yr . CONCLUSIONS : Psychological distress levels do not seem to be important in explaining GI symptom change over a 1-yr period . Psychological distress , however , is linked to having persistent GI symptoms and frequently seeking health care for them over time . Clinicians should consider psychological factors in the treatment of this subset of irritable bowel syndrome patients BACKGROUND : While symptom question naires provide a snapshot of bowel habits , they may not reflect day-to-day variations or the relationship between bowel symptoms and stool form . AIM : To assess bowel habits by daily diaries in women with and without functional bowel disorders . METHOD : From a community-based survey among Olmsted County , MN , women , 278 r and omly selected subjects were interviewed by a gastroenterologist , who completed a bowel symptom question naire . Subjects also maintained bowel diaries for 2 wk . RESULTS : Among 278 subjects , question naires revealed diarrhea ( 26 % ) , constipation ( 21 % ) , or neither ( 53 % ) . Asymptomatic subjects reported bowel symptoms ( e.g. , urgency ) infrequently ( i.e. , < 25 % of the time ) and generally for hard or loose stools . Urgency for soft , formed stools ( i.e. , Bristol form = 4 ) was more prevalent in subjects with diarrhea ( 31 % ) and constipation ( 27 % ) than in normals ( 16 % ) . Stool form , straining to begin ( odds ratio [ OR ] 4.1 , 95 % confidence interval [ CI ] 1.7–10.2 ) and end ( OR 4.7 , 95 % CI 1.6–15.2 ) defecation increased the odds for constipation . Straining to end defecation ( OR 3.7 , 95 % CI 1.2–12.0 ) , increased stool frequency ( OR 1.9 , 95 % CI 1.02–3.7 ) , incomplete evacuation ( OR 2.2 , 95 % CI 1.04–4.6 ) , and rectal urgency ( OR 3.1 , 95 % CI 1.4–6.6 ) increased the odds for diarrhea . In contrast , variations in stool frequency and form were not useful for discriminating between health and disease . CONCLUSIONS : Bowel symptoms occur in association with , but are only partly explained by , stool form disturbances . These observations support a role for other pathophysiological mechanisms in functional bowel disorders Objectives The role of melatonin in regulating gut motility in human subjects is not clear . The aim of this study was to investigate the effects of exogenous melatonin on colonic transit time ( CTT ) in healthy subjects and in patients with irritable bowel syndrome ( IBS ) . Methods Colonic transit time was measured in 17 healthy controls using the radio-opaque , blue dye , and Bristol stool form score method before and after 30 days of melatonin treatment 3 mg daily . A double blind cross-over study aim ed at measuring CTT was also performed in 17 matched IBS patients using the blue dye and Bristol stool form score methods . The patients were r and omized and received either melatonin 3 mg or placebo daily for 8 weeks , followed by a 4-week washout , and then placebo or melatonin in the reverse order for a second 8-week period . Results The melatonin treatment of the control subjects caused an increase in CTT ( mean ± SD ) from 27.4 ± 10.5 to 37.4 ± 23.8 h ( P = 0.04 ) . Compared with the CTT of the controls ( 25.2 ± 7.7 ) , that of the constipation-predominant IBS patients appeared prolonged—65.2 ± 33.3 h ( P < 0.01 ) . The CTT did not change significantly in IBS patients after melatonin treatment . Conclusion Melatonin may be a promising c and i date for the future research of agents that can modulate bowel motility Modern methods of diagnosing diarrhe Output:	The definitions of healthy controls in studies of functional bowel diseases such as IBS are inconsistent .
MS21166	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Please cite this paper as : MacIntyre et al. ( 2011 ) A cluster r and omized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers . Influenza and Other Respiratory Viruses DOI : 10.1111/j.1750‐2659.2010.00198.x . Background We compared the efficacy of medical masks , N95 respirators ( fit tested and non fit tested ) , in health care workers ( HCWs ) . Methods A cluster r and omized clinical trial ( RCT ) of 1441 HCWs in 15 Beijing hospitals was performed during the 2008/2009 winter . Participants wore masks or respirators during the entire work shift for 4 weeks . Outcomes included clinical respiratory illness ( CRI ) , influenza‐like illness ( ILI ) , laboratory‐confirmed respiratory virus infection and influenza . A convenience no‐mask/respirator group of 481 health workers from nine hospitals was compared . Findings The rates of CRI ( 3·9 % versus 6·7 % ) , ILI ( 0·3 % versus 0·6 % ) , laboratory‐confirmed respiratory virus ( 1·4 % versus 2·6 % ) and influenza ( 0·3 % versus 1 % ) infection were consistently lower for the N95 group compared to medical masks . By intention‐to‐treat analysis , when P values were adjusted for clustering , non‐fit‐tested N95 respirators were significantly more protective than medical masks against CRI , but no other outcomes were significant . The rates of all outcomes were higher in the convenience no‐mask group compared to the intervention arms . There was no significant difference in outcomes between the N95 arms with and without fit testing . Rates of fit test failure were low . In a post hoc analysis adjusted for potential confounders , N95 masks and hospital level were significant , but medical masks , vaccination , h and washing and high‐risk procedures were not . Interpretation Rates of infection in the medical mask group were double that in the N95 group . A benefit of respirators is suggested but would need to be confirmed by a larger trial , as this study may have been underpowered . The finding on fit testing is specific to the type of respirator used in the study and can not be generalized to other respirators . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) , ACTRN : ACTRN12609000257268 ( http://www.anzctr.org.au ) Background Obesity has become a global public health problem , which also affects children . It has been proposed that the educational interventions during childhood could be a key strategy in the prevention of obesity . Objective To evaluate the efficacy of an intervention on food habits and physical activity in school children . Methods A 2-year cluster-r and omised prospect i ve study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling ( 5–6 years of age ) in schools in the city of Granollers . The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation , Vision , Action and Change ( IVAC ) . At the beginning and at the end of the study ( 2006 and 2008 ) the weight and height of each child was measured in situ , while the families were given a self-report physical activity question naire and the Krece Plus quick test . Results Two years after the beginning of the study , the body mass index of the children in the control group was 0.89 kg/m2 higher than that of the intervention schools . The intervention reduced by 62 % the prevalence of overweight children . Similarly , the proportion of children that ate a second piece of fruit and took part in an after-school physical activity increased in the intervention group . In the control group , the weekly consumption of fish was reduced . Conclusions The educational intervention in healthy eating habits and physical activity in the school could contribute to lessen the current increase in child obesity Background In the UK public concern about the safety of the combined measles , mumps and rubella [ MMR ] vaccine continues to impact on MMR coverage . Whilst the sharp decline in uptake has begun to level out , first and second dose uptake rates remain short of that required for population immunity . Furthermore , international research consistently shows that some parents lack confidence in making a decision about MMR vaccination for their children . Together , this work suggests that effective interventions are required to support parents to make informed decisions about MMR.This trial assessed the impact of a parent-centred , multi-component intervention ( balanced information , group discussion , coaching exercise ) on informed parental decision-making for MMR . Methods This was a two arm , cluster r and omised trial . One hundred and forty two UK parents of children eligible for MMR vaccination were recruited from six primary healthcare centres and six childcare organisations . The intervention arm received an MMR information leaflet and participated in the intervention ( parent meeting ) . The control arm received the leaflet only . The primary outcome was decisional conflict . Secondary outcomes were actual and intended MMR choice , knowledge , attitude , concern and necessity beliefs about MMR and anxiety . Results Decisional conflict decreased for both arms to a level where an ' effective ' MMR decision could be made one-week ( effect estimate = -0.54 , p < 0.001 ) and three-months ( effect estimate = -0.60 , p < 0.001 ) post-intervention . There was no significant difference between arms ( effect estimate = 0.07 , p = 0.215 ) . Heightened decisional conflict was evident for parents making the MMR decision for their first child ( effect estimate = -0.25 , p = 0.003 ) , who were concerned ( effect estimate = 0.07 , p < 0.001 ) , had less positive attitudes ( effect estimate = -0.20 , p < 0.001 ) yet stronger intentions ( effect estimate = 0.09 , p = 0.006 ) . Significantly more parents in the intervention arm reported vaccinating their child ( 93 % versus 73 % , p = 0.04 ) . Conclusions Whilst both the leaflet and the parent meeting reduced parents ' decisional conflict , the parent meeting appeared to enable parents to act upon their decision leading to vaccination uptake INTRODUCTION Majority of studies on evaluation of emergency management courses have focused on outcomes such as knowledge and skills demonstrated in non- clinical or traditional testing manner . Such surrogate outcomes may not necessarily reflect vital changes in practice . The aim of this study was to determine if and to what extent , specific training in the management of life threatening emergencies result ed in an increased in compliance with established care guidelines of doctors working in the emergency departments of public sector hospitals in Pakistan . METHODS A cluster r and omised controlled trial was conducted in three districts hospitals in three cities ( Khairpur , Vehari and Peshawar ) of Pakistan . Thirty-six doctors , 18 in intervention ( trained in ESS-EMNCH training ) and 18 in control ( untrained ) , were enrolled and 248 life threatening emergency events , 124 in each group , were observed for the correct use of the Airway , Breathing , Circulation ( ABC ) structured approach . The outcome measure was structured approach defined a priori . Data was analysed by using STATA software . RESULTS At individual level , 79 ( 63.7 % ) life threatening episodes were managed according to the structured approach in the intervention group and 46 ( 37.1 % ) were managed according to the structured approach in controls ( OR 2.98 , 95%CI 1.78 - 4.99 , p-value=0.0001 ) . At cluster level , the mean percentage ( 95 % CI ) of the structured approach used by doctors in the intervention group [ 62.9 % ( 50.4 - 75.3 % ) ] , was significantly higher than those in the control group , [ 36.3 % ( 26.3 - 46.4 ) ] ( p-value=0.001 ) . CONCLUSIONS 5-day training of ESS-EMNCH significantly increased the compliance with established care guidelines of doctors during their management of life threatening emergency episodes in the public sector hospitals in Pakistan OBJECTIVE The number of extremely thin young women has increased and education at school on maintaining an optimal weight has become important . The aim of the present study was to assess the effectiveness of a group-based home-collaborative dietary education ( HCDE ) programme to maintain appropriate dietary intake compared to conventional school classroom education . DESIGN Two-arm cluster r and omized controlled trial . Twelve classes were r and omly assigned as clusters to either the HCDE group or the control group . Each participant in the HCDE group received twelve sessions of group counselling aim ed at increasing energy intake at breakfast by modifying dietary intake and adopting appropriate habits . The hypothesis underlying the study was that after 6 months of HCDE the total energy intake would be increased by 627 kJ from baseline ( primary endpoint ) . Secondary outcomes were differences in intake of various nutrients from baseline . Outcome measures after log transformation were examined by t tests and linear mixed models ( crude and baseline-adjusted ) . SETTING Young women among Japanese female adolescents in Tokyo . SUBJECTS Four hundred and seventy-four participants aged 13 - 15 years . RESULTS Students in twelve classes were used for analysis ( n 459 ) . Energy intake was decreased in many of the classes during the 6-month period , especially for those in the control group . After adjustment for the baseline value , significant increases in energy intake and protein , calcium , magnesium and iron intakes at breakfast were observed ( P<0.05 ) CONCLUSIONS Although energy intake was increased in the HCDE group compared to the control group , further study of the HCDE is warranted BACKGROUND Intensive care units ( ICUs ) are high-risk setting s for the transmission of methicillin-resistant Staphylococcus aureus ( MRSA ) and vancomycin-resistant enterococcus ( VRE ) . METHODS In a cluster-r and omized trial , we evaluated the effect of surveillance for MRSA and VRE colonization and of the exp and ed use of barrier pre caution s ( intervention ) as compared with existing practice ( control ) on the incidence of MRSA or VRE colonization or infection in adult ICUs . Surveillance cultures were obtained from patients in all participating ICUs ; the results were reported only to ICUs assigned to the intervention . In intervention ICUs , patients who were colonized or infected with MRSA or VRE were assigned to care with contact pre caution s ; all the other patients were assigned to care with universal gloving until their discharge or until surveillance cultures obtained at admission were reported to be negative . RESULTS During a 6-month intervention period , there were 5434 admissions to 10 intervention ICUs , and 3705 admissions to 8 control ICUs . Patients who were colonized or infected with MRSA or VRE were assigned to barrier pre caution s more frequently in intervention ICUs than in control ICUs ( a median of 92 % of ICU days with either contact pre caution s or universal gloving [ 51 % with contact pre caution s and 43 % with universal gloving ] in intervention ICUs vs. a median of 38 % of ICU days with contact pre caution s in control ICUs , P<0.001 ) . In intervention ICUs , health care providers used clean gloves , gowns , and h and hygiene less frequently than required for contacts with patients assigned to barrier pre caution s ; when contact pre caution s were specified , gloves were used for a median of 82 % of contacts , gowns for 77 % of contacts , and h and hygiene after 69 % of contacts , and when universal gloving was specified , gloves were used for a median of 72 % of contacts and h and hygiene after 62 % of contacts . The mean ( ±SE ) ICU-level incidence of events of colonization or infection with MRSA or VRE per 1000 patient-days at risk , adjusted for baseline incidence , did not differ significantly between the intervention and control ICUs ( 40.4±3.3 and 35.6±3.7 in the two groups , respectively ; P=0.35 ) . CONCLUSIONS The intervention was not effective in reducing the transmission of MRSA or VRE , although the use of barrier pre caution s by providers was less than what was required . ( Funded by the National Institute of Allergy and Infectious Diseases and others ; STAR*ICU Clinical Trials.gov number , NCT00100386 . ) BACKGROUND We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence -based management of fever , hyperglycaemia , and swallowing dysfunction in acute stroke units ( ASUs ) . METHODS In the Quality in Acute Stroke Care ( QASC ) study , a single-blind cluster r and omised controlled trial , we r and omised ASUs ( clusters ) in New South Wales , Australia , with immediate access to CT and on-site high dependency units , to intervention or control group . Patients were eligible if they spoke English , were aged 18 years or older , had had an ischaemic stroke or intracerebral haemorrhage , and presented within 48 h of onset of symptoms . Intervention ASUs received treatment protocol s to manage fever , hyperglycaemia , and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers . Control ASUs received only an abridged version of existing guidelines . We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency ( modified Rankin scale [ mRS ] ≥2 ) , functional dependency ( Barthel index ) , and SF-36 physical and mental component summary scores . Research assistants , the Output:	Conclusion : Despite the recommendations of the Consoli date d St and ards of Reporting Trials statement extension to cluster r and omised trials , treatment adherence is under-reported . Among the trials providing adherence information , there was substantial variation in how adherence was defined , h and led and reported .
MS21167	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Total parenteral nutrition ( TPN ) supplemented with glutamine ( GLN ) has been reported to be effective for patients with bone marrow transplantation ( BMT ) . Our aim was to evaluate enteral and parenteral glutamine in patients undergoing BMT . METHODS For evaluation of GLN in BMT , 66 patients with 43 hematologic and 23 solid malignancies ( 21 breast carcinomas ) , were r and omized , double-blinded , to either oral GLN ( n = 35 ) or glycine-control ( GLY ) ( n = 31 ) , 10 g three times daily . When TPN became necessary , patients who received GLN orally were given TPN with GLN ( 0.57 g/kg ) . Those who received GLY received st and ard TPN , isocaloric and isonitrogenous . Patients with hematologic malignancies received high-dose chemotherapy , total body irradiation , and either allogeneic ( ALLO ) BMT ( n = 18 ) or autologous ( AUTO ) stem cell transplantation ( n = 25 ) . Patients with solid malignancies ( n = 23 ) received AUTO . RESULTS There were 14 in-hospital deaths without relationship to GLN administration . For respective comparisons of ALLO and AUTO transplants in the GLN and GLY hematologic groups and AUTO in the solid tumor groups , there were no significant differences in hospital stay , duration of stay after BMT , TPN days , neutrophil recovery > 500/mm3 , incidence of positive blood cultures , sepsis , mucositis , and diarrhea . Acute graft us host disease occurred in 1 of 10 hematologic patients receiving GLN and in 3 of 8 patients receiving GLY placebo ( p > .05 ) . Possible reduction in need for TPN and a suggestion of improved long-term survival were associated with GLN . CONCLUSIONS Oral and parenteral GLN seemed to be of limited benefit for patients having AUTO or ALLO BMT for hematologic or solid malignancies . Further study of long-term effects of GLN in BMT seems warranted Forty-four adult autologous transplant patients with hematological malignancies were r and omized to receive either prophylactic parenteral nutrition PN ( P group ) , or PN given ad hoc ( C group ) . In each group , they were further r and omized to receive st and ard PN ( B group ) , or PN with 0.5 g glutamine/kg as L-Ala-L-Gln ( A group ) . The overall survival ( OS ) , disease-free survival ( DFS ) and event-free survival ( EFS ) in groups C vs. P and A vs. B were compared during follow-up with median 38 months . The final outcome rates in C/P/A/B groups , respectively ( OS 65/81/63/85 % , EFS 45/53/33/65 % and DFS 56/50/35/77 % ) , were not significantly different , apart from A < B in DFS rate ( p=0.03 , Fisher 's exact test ) . Also in survival analysis ( logrank test ) , no significant difference between groups C and P was found but generally worse parameters were observed for A vs. B group : for DFS ( p=0.04 ) and EFS ( p=0.01 ) the difference was significant , and for OS ( p=0.09 ) it was borderline . In the three years ' follow-up , no clinical ly useful benefit of prophylactic PN in autologous transplant patients was proven . Also , glutamine supplementation was not helpful , and was even connected with apparently worse long-term outcome Objective : The purpose of this study was to determine the most appropriate dose of oral glutamine to use in a further clinical study in paediatric oncology patients . Design : This was a phase I , pharmokinetic study . Setting : The study was carried out at The Yorkshire Regional Centre for Paediatric Oncology and Haematology , St James 's University Hospital , Leeds , UK.Subjects : Thirteen patients undergoing treatment for paediatric malignancy participated in this study . All 13 completed the study . Interventions : The most appropriate dose was determined by patient acceptability and by plasma glutamine and ammonia levels measured at timed intervals after ingestion of a single glutamine dose . Results : Doses of 0.35 , 0.5 and 0.65 g/kg were well tolerated with no untoward plasma glutamine and ammonia levels . One patient was recruited to a higher dose of 0.75 g/kg , but the plasma glutamine and ammonia levels peaked at 2601 and 155 µmol/l , respectively . The ammonia level was greater than the acceptable upper limit . It was difficult to disperse the glutamine adequately at this dose , result ing in the suspension being found to be unpalatable and therefore no further patients were recruited at this dose . Conclusion : It was concluded that 0.65 g/kg is a safe dose of glutamine to use in a clinical study in paediatric oncology patients .Sponsorship : Scientific Hospital Supplies UK Ltd provided the L-glutamine and financial help for the biochemical analysis Painful oral mucositis is a common complication after bone marrow transplantation ( BMT ) . Glutamine is a nutrient for rapidly dividing cells and the major energy source for intestinal epithelium . This study tested whether an oral glutamine preparation could decrease the severity of oral mucositis in patients undergoing BMT . Glutamine or a placebo ( glycine ) were administered from admission until day + 28 in 193 BMT patients in a r and omized , double-blind , placebo-controlled study at a dose of 1.0 g amino acid/m2/dose swish and swallow four times a day . In autologous BMT patients ( n = 87 ) glutamine was associated with significantly less mouth pain by self report and by opiate use ( 5.0 ± 6.2 days of morphine for glutamine vs 10.3 ± 9.8 days for placebo ; P = 0.005 ) . Matched sibling BMT patients had no effect by self report and an increased duration of opiate use ( 23.2 ± 5.7 days for glutamine vs 16.3 ± 8.3 days for placebo ) ( P = 0.002 ) . However , day 28 survival of allogeneic patients was improved by glutamine . No significant differences in TPN use , rate of relapse or progression of malignancy , parenteral antibiotic use , acute or chronic GVHD , or days of hospitalization were observed in either autologous or allogeneic recipients . No toxicity of glutamine was observed . We conclude that oral glutamine can decrease the severity and duration of oropharyngeal mucositis in autologous BMT patients but not in allogeneic BMT patients , possibly due to interaction with methotrexate An oral glutamine load was administered to nine healthy subjects to determine the effect on plasma glutamine , bicarbonate , and circulating growth hormone concentrations . Two grams glutamine were dissolved in a cola drink and ingested over a 20-min period 45 min after a light breakfast . Forearm venous blood sample s were obtained at zero time and at 30-min intervals for 90 min and compared with time controls obtained 1 wk earlier . Eight of nine subjects responded to the oral glutamine load with an increase in plasma glutamine at 30 and 60 min before returning to the control value at 90 min . Ninety minutes after the glutamine administration load both plasma bicarbonate concentration and circulating plasma growth hormone concentration were elevated . These findings demonstrate that a surprisingly small oral glutamine load is capable of elevating alkaline reserves as well as plasma growth hormone UNLABELLED Bone marrow transplantation ( BMT ) is a therapy used for hematologic malignancies and solid tumors . Associated chemotherapy and radiotherapy to which these patients are su bmi tted induce secondary effects , with a high metabolic stress . Glutamine is considered a conditionally essential amino acid , and has been shown effective in severe catabolic states . The aim of the study was to assess the effect of parenteral nutrition ( PN ) therapy supplemented with glutamine on duration of nutritional support in a group of patients with BMT . We have also analyzed associated complications , the nutritional status , the clinical course at 6 months , differences as to type of transplantation , and oral ingestion capability . This is a phase IV , r and omized , double blind , and parallel clinical trial , done at a single center . The study was performed on 49 patients , 29 % male and 71 % female patients , with ages between 21 - 63 years , distributed in 3 diagnostic groups ( leukemia , lymphoma , and solid tumors ) , and admitted to the Hematology Department of our Hospital . Fifty percent of the patients in each group have received PN supplemented with glutamine ( 0.4 g/kg/day of L-alanine-L-glutamine ) , and the other 50 % have received st and ard PN . RESULTS we have not found significant differences nor at the beginning nor at the end of the study between both groups with regards to studied variables . CONCLUSIONS PN is and effective therapy for maintenance of the nutritional status in patients su bmi tted to a therapy with a , highly catabolic effect such as BMT . Although we have not been able to show the efficacy of glutamine supplementation in this study with the used dose , it does have been effective in other reports Glutamine ( Gln ) is an important nutrient substrate for lymphocytes and macrophages in vitro . This pilot study evaluated effects of Gln supplementation on circulating lymphocytes and lymphocyte subsets after allogeneic bone marrow transplantation ( BMT ) . Adult patients received either parenteral nutrition supplemented by L-Gln ( Gln-PN ) or st and ard Gln-free PN after BMT . Leukocyte and total lymphocyte counts were determined during hospitalization , and flow cytometry studies of peripheral mononuclear cells were performed 1 to 2 weeks after hospital discharge . The Gln-PN group demonstrated a higher percentage of blood lymphocytes during hospitalization . At flow cytometry , patients who received Gln-PN had an increased total lymphocyte count ( 332 + /- 50 versus 590 + /- 71 cells/microL , P = 0.010 ) ; greater numbers of total T lymphocytes ( 54 + /- 19 versus 229 + /- 70 cells/microL , P = 0.030 ) ; and higher CD4 + and CD8 + T-lymphocyte counts in peripheral blood compared with controls . Gln-PN may support lymphocyte recovery after BMT OBJECTIVE In a r and omized , double-blind , prospect i ve clinical trial , we evaluated the metabolic effects of glutamine-supplemented parenteral nutrition in patients with bone marrow transplants . We compared hospital charge and cost data for the two groups of patients in the trial . DESIGN Retrospective review . SETTING Bone Marrow Transplant Unit , Brigham and Women 's Hospital , Boston , Mass. SUBJECTS Forty-three patients admitted to the Bone Marrow Transplant Unit were assigned r and omly to receive either st and ard parenteral nutrition or an isocaloric , isonitrogenous parenteral nutrition solution containing glutamine starting on day 1 after bone marrow transplant . The two groups were well matched for diagnosis , antineoplastic treatment , and sex . MEASURES The primary clinical end points evaluated were nitrogen balance , length of hospitalization , incidence of infection , and results of microbial culture . After completion of the study , we compared the hospital charges for the categories of room and board , surgery , laboratory , pharmacy , radiology , ancillary , and miscellaneous between the two groups of patients . STATISTICAL ANALYSIS PERFORMED The two groups were compared using the unpaired t test or Mann-Whitney test for nonparametric measurements . A P value of < .05 was considered significant . RESULTS Nitrogen balance improved in the glutamine-supplemented group compared with control subjects ( -1.4 + /- 0.5 g/day vs 4.2 + /- 1.2 g/day , respectively ; P = .002 ) . Length of hospitalization was significantly shorter in the glutamine-supplemented group than in the control group ( 29 + /- 1 day vs 36 + /- 2 days , respectively ; P = .017 ) . The incidence of positive microbial cultures and clinical infection was also significantly lower with glutamine supplementation . Hospital charges were $ 21,095 per patient less in the glutamine-supplemented group compared with charges for patients who received st and ard therapy . Room and board charges were significantly different : $ 51,484 + /- 2,647 for the glutamine-supplemented group vs $ 61,591 + /- 3,588 in the control group ( P = .02 ) . CONCLUSION This intervention study using a new therapy demonstrated clinical and nutritional benefits to patients and cost savings to the hospital BACKGROUND / AIMS Long-term total parenteral nutrition is accompanied with mucosal atrophy and subsequent malabsorption syndrome . Current information attests the important role of glutamine in maintaining intestinal structure and function . The aim of this study was to investigate the effect of glutamine Output:	Glutamine ( i.v . ) There was no effect of oral or i.v .
MS21168	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To investigate the significance of N-terminal proBrain natriuretic peptide ( NT-proBNP ) in predicting the outcome of acute stroke in relation to other cardiovascular variables and stroke severity . DESIGN Prospect i ve study of previously independent acute ischemic and hemorrhagic stroke patients admitted to the acute stroke ward . METHODS Measurements of NT-proBNP in acute phase in addition to st and ard assessment of cardiovascular and neurological details . MAIN OUTCOME MEASURES Concentrations and significance of NT-proBNP in patients who were dead versus alive at 120 days after acute stroke and Cox regression analysis with stroke severity measured as Sc and inavian Stroke Scale ( SSS ) and other cardiovascular disease to predict mortality . RESULTS One hundred fourteen patients were recruited , median age 74 years . At 120 days , 13 patients had died . Deceased patients had a significantly higher concentration of NT-proBNP as compared to alive patients ( P < .001 ) . All patients who had died had NT-proBNP concentration above the median for the whole group . Cox regression analysis revealed that NT-proBNP was the most significant independent variable predicting mortality ( odds ratio [ OR ] 2.4 , 95 % confidence interval [ CI ] 1.35 to 4.41 , P = .003 ) followed by the SSS ( OR 0.95 , 95 % CI 0.90 to 0.98 , P = .005 ) . Higher NT-proBNP and lower SSS predicted mortality . There was a significant negative correlation of NT-proBNP with SSS score ( r = -0.24 , P = .02 ) . There were no significant difference in NT-proBNP concentrations between ischemic and hemorrhagic strokes ( P < .346 ) . At 6 weeks , the dependent patients had higher concentrations of NT-proBNP than independent patients . CONCLUSION NT-proBNP , an index of cardiac impairment , has an independent prognostic value in acute stroke patients over other cardiovascular variables and stroke severity . This may provide a channel for interventional therapy in acute stroke Background and Purpose — Because there is no biologic marker offering precise information about stroke etiology , many patients receive a diagnosis of undetermined stroke even after all available diagnostic tests are done , precluding correct treatment . Methods — To examine the diagnostic value of a panel of biochemical markers to differentiate stroke etiologies , consecutive acute stroke patients were prospect ively evaluated . Brain computed tomography , ultrasonography , cardiac evaluations , and other tests were done to identify an etiologic diagnosis according to TOAST classification . Blood sample s were drawn on Emergency Department arrival ( < 24 hours ) to test selected biomarkers : C-reactive protein , D-dimer , soluble receptor for advanced glycation end products , matrix metalloproteinase-9 , S-100b , brain natriuretic peptide ( BNP ) , neurotrophin-3 , caspase-3 , chimerin , and secretagogin ( assayed by ELISA ) . Results — Of 707 ischemic stroke patients included , 36.6 % were cardioembolic , 21.4 % atherothrombotic , 18.1 % lacunar , and 23.9 % of undetermined origin . High levels of BNP , soluble receptor for advanced glycation end products , and D-dimer ( P<0.0001 ) were observed in patients with cardioembolic stroke . Independent predictors ( odds ratios with CIs are given ) of cardioembolic stroke were as follows : atrial fibrillation 15.3 ( 8.4–27.7 , P<0.001 ) ; other embolic cardiopathies 14.7 ( 4.7–46 , P<0.001 ) ; total anterior circulation infa rct ion 4 ( 2.3–6.8 , P<0.001 ) ; BNP > 76 pg/mL 2.3 ( 1.4–3.7 , P=0.001 ) ; and D-dimer > 0.96 & mgr;g/mL 2.2 ( 1.4–3.7 , P=0.001 ) . Even among patients with transient symptoms ( n=155 ) , a high BNP level identified cardioembolic etiology ( 6.7 , 2.4–18.9 ; P<0.001 ) . A model combining clinical and biochemical data had a sensitivity of 66.5 % and a specificity of 91.3 % for predicting cardioembolism . Conclusions — Using a combination of biomarkers may be a feasible strategy to improve the diagnosis of cardioembolic stroke in the acute phase , thus rapidly guiding other diagnostic tests and accelerating the start of optimal secondary prevention OBJECTIVE To determine the value of the use of plasma B-type natriuretic peptide ( BNP ) among acute ischemic stroke patients in a Chinese emergency department ( ED ) . MATERIAL S AND METHODS In our ED , the emergency physicians prospect ively assessed consecutive adult patients with acute phase of ischemic stroke and measured plasma BNP by Biosite Triage( ® )BNP POCT platform on admission , then followed up these patients . And the stroke neurologists evaluated patients ' functional outcome at hospital discharge , and also made discharge diagnosis and stroke etiologic subtypes according to TOAST criteria : large-artery atherosclerosis ( LAA ) , cardioembolism ( CE ) , small-artery occlusion ( SAO ) , stroke of other determined etiology ( SOE ) and stroke of other undetermined etiology ( SUE ) . RESULTS In this study , 142 of 238 acute ischemic stroke patients met the study criteria [ mean age 70.84 ± 11.48 years , 74 ( 52.11 % ) female ] . Of the 142 patients , 35.92 % were diagnosed with LAA at discharge , 25.35 % with CE , 27.46 % with SAO , 11.27 % with SOE or SUE . Age , previous cardiac disease , atrial fibrillation , the length of hospital stays , SSS score on admission ≤ 25 and mRS ≥ 3 or death at discharge were all significantly higher in the CE patients compared to other subtypes ( p<0.01 ) . And the mean BNP concentration was significantly higher in the CE group than in other three subtypes ( p<0.001 ) . The optimal cut-off concentration , sensitivity and specificity of the plasma BNP concentration suitable to distinguish CE from non-CE were 66.50 pg/ml , 75.0 % and 88.7 % , respectively . CONCLUSIONS Plasma BNP level is significantly higher in CE patients than in other TOAST subtypes , and by using Biosite Triage( ® )BNP POCT platform , emergency physicians should strongly consider CE subtype with the plasma BNP level of over 66.50 pg/ml . However , the single BNP biomarker panel can not be used to confidently rule out or identify stroke subtypes as a diagnosis and must be taken in context with clinical assessment and judgment before making management decisions in the ED Background and Purpose — A new clinical construct termed embolic stroke of undetermined source ( ESUS ) was recently introduced , but no such population has been described yet . Our aim is to provide a detailed descriptive analysis of an ESUS population derived from a large prospect i ve ischemic stroke registry using the proposed diagnostic criteria . Methods — The criteria proposed by the Cryptogenic Stroke/ESUS International Working Group were applied to the Athens Stroke Registry to identify all ESUS patients . ESUS was defined as a radiologically confirmed nonlacunar brain infa rct in the absence of ( a ) extracranial or intracranial atherosclerosis causing ≥50 % luminal stenosis in arteries supplying the ischemic area , ( b ) major-risk cardioembolic source , and ( c ) any other specific cause of stroke . Results — Among 2735 patients admitted between 1992 and 2011 , 275 ( 10.0 % ) were classified as ESUS . In the majority of ESUS ( 74.2 % ) , symptoms were maximal at onset . ESUS were of moderate severity ( median National Institute Health Stroke Scale score , 5 ) . The most prevalent risk factor was arterial hypertension ( 64.7 % ) , and 50.9 % of patients were dyslipidemic . Among potential causes of the ESUS , covert atrial fibrillation ( AF ) was the most prevalent : in 30 ( 10.9 % ) patients , AF was diagnosed during hospitalization for stroke recurrence , whereas in 50 ( 18.2 % ) patients AF was detected after repeated ECG monitoring during follow-up . Also , covert AF was strongly suggested in 38 patients ( 13.8 % ) but never recorded . Conclusions — About 10 % of patients with first-ever ischemic stroke met criteria for ESUS ; covert paroxysmal AF seems to be a frequent cause of ESUS Background and Purpose The etiology of ischemic stroke affects prognosis , outcome , and management . Trials of therapies for patients with acute stroke should include measurements of responses as influenced by subtype of ischemic stroke . A system for categorization of subtypes of ischemic stroke mainly based on etiology has been developed for the Trial of Org 10172 in Acute Stroke Treatment ( TOAST ) . Methods A classification of subtypes was prepared using clinical features and the results of ancillary diagnostic studies . “ Possible ” and “ probable ” diagnoses can be made based on the physician 's certainty of diagnosis . The usefulness and interrater agreement of the classification were tested by two neurologists who had not participated in the writing of the criteria . The neurologists independently used the TOAST classification system in their bedside evaluation of 20 patients , first based only on clinical features and then after review ing the results of diagnostic tests . Results The TOAST classification denotes five subtypes of ischemic stroke : 1 ) large-artery atherosclerosis , 2 ) cardioembolism , 3 ) small-vessel occlusion , 4 ) stroke of other determined etiology , and 5 ) stroke of undetermined etiology . Using this rating system , interphysician agreement was very high . The two physicians disagreed in only one patient . They were both able to reach a specific etiologic diagnosis in 11 patients , whereas the cause of stroke was not determined in nine . Conclusions The TOAST stroke subtype classification system is easy to use and has good interobserver agreement . This system should allow investigators to report responses to treatment among important subgroups of patients with ischemic stroke . Clinical trials testing treatments for acute ischemic stroke should include similar methods to diagnose subtypes of stroke Background and Purpose : Our previous retrospective study demonstrated that a brain natriuretic peptide ( BNP ) level of > 140 pg/ml on admission was useful to distinguish cardioembolism ( CE ) from non-CE . The aim of the present study was to prospect ively investigate the utility of this predefined threshold . Method : Two hundred and twenty-one consecutive patients were prospect ively enrolled . On admission , the BNP levels of the patients were measured and classified according to low BNP ( ≤140.0 pg/ml ) or high BNP ( > 140.0 pg/ml ) levels . Final diagnosis of stroke subtype on discharge was made using the TOAST criteria . Measured parameters included the sensitivity , specificity , positive predictive value , and negative predictive value for CE in the high BNP group . Results : There were 81 patients in the high BNP group and 140 patients in the low BNP group . A total of 76 ( 34.4 % ) patients were diagnosed with CE , including 59 ( 72.8 % ) patients in the high BNP group and 17 ( 12.1 % ) patients in the low BNP group ( p < 0.001 ) . A BNP level > 140.0 pg/ml corresponded to a sensitivity of 77.6 % , specificity of 84.8 % , positive predictive value of 72.8 % , and negative predictive value of 87.9 % for a diagnosis of CE . Conclusion : A BNP level of > 140.0 pg/ml on admission in patients with acute ischemic stroke is a strong biochemical predictor for CE Objective : Antiplatelets are recommended for secondary prevention in patients with cryptogenic stroke ; however , some patients may present with a cardioembolic source that has not been detected , which may modify the treatment . Because high pro – brain natriuretic peptide ( BNP ) levels are associated with cardioembolic stroke , our objective was to determine whether pro-BNP levels in the acute phase of stroke predict the development of atrial fibrillation ( AF ) in patients with cryptogenic stroke . Methods : A prospect i ve study including patients with cryptogenic stroke was conducted . Demographic data , medical history , and stroke characteristics were assessed at admission . A blood sample was obtained within the first 24 hours from stroke onset to determine pro-BNP levels . Patients were followed by a neurologist at 3 and 6 months and later by a primary care physician for 2 years to evaluate the development of AF . Results : One thous and fifty patients with ischemic stroke were evaluated . Three hundred seventy-two patients ( 35 % ) had cryptogenic stroke . One hundred eight patients were excluded from the study , so 264 patients were valid for the analysis . AF was detected in 15 patients ( 5.6 % ) during the follow-up . Patients who developed AF were older , had hypertension more frequently , and showed higher levels of pro-BNP . In the logistic regression model , we found that pro-BNP ≥360 pg/mL was the only variable independently associated with the risk of developing AF ( odd Output:	Both peptides also increased significantly the area under the curve and integrated discrimination improvement index compared with clinical models . Natriuretic peptides are strongly increased in cardioembolic strokes .
MS21169	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The purpose of this study was to evaluate the effects of a brief intervention programme on STD knowledge , condom use and gonorrhoea incidence among sex workers in Singapore . A controlled before- and -after study design with non-r and om assignment of sex workers was used , supplemented by multivariate analysis to adjust for baseline differences . Control ( n = 221 , denoted C1 ) and experimental ( n = 221 , denoted E1 ) groups were interviewed on 2 occasions 3 months apart . Two supplementary groups were interviewed once each at the end of the 3-month period ( n = 145 who had received the intervention and n = 151 who had not ) . Basic knowledge of STD symptoms and HIV transmission was high in all groups . There were misconceptions about casual transmission of HIV which improved dramatically at the second interview for group El ( from 37–56 % correct responses to 82–90 % ) . Overall condom use was high ( about 75 % ) and did not change after the intervention . Gonorrhoea rates were correspondingly low ( 0.4 episodes/worker/year ) and also did not change . This brief intervention improved the STD knowledge of sex workers . However , behaviour as measured by reported condom use and gonorrhoea incidence did not change . Implication s for future intervention programmes are discussed Objective : To describe the impact of a repeating behavioural intervention focused on preventive education and provision of STD testing and treatment services to female sex workers . Methods : A prospect i ve cohort study of 966 sex workers ( first of its kind in China ) was conducted in Guangzhou from March 1998 to October 1999 . At each visit information was collected on sexual behaviour , condom use and knowledge about HIV transmission and condom use , education was given , STD were diagnosed , and treatment was provided free of charge . We evaluated trends in condom use , knowledge about HIV transmission and condom use , and STD incidences . Generalised estimating equations were applied to control for repeated measurements . Results : The proportion of consistent condom use increased from the intake through the third follow up visit ( from 30 % to 81 % ) , as well as the proportion of having good knowledge on HIV transmission ( 4.3 % to 98.6 % ) and condom use ( 23.6 % to 79.3 % ) . The incidence of gonorrhoea , trichomoniasis , and chlamydia decreased over each follow up visit ; from 17.5/100 person years ( PY ) , 22.4/100PY , 65.9/100PY at the first follow up visit to 5.1/100PY , 3.0/100PY , 16.1/100PY at the third follow up visit , for each STD respectively . Conclusions : STD care and prevention programmes targeting sex workers are feasible in China and , more importantly , intervention consisting of prevention education and STD care is likely to reduce unprotected sexual behaviour and STD incidence in this group at high risk for HIV and other STD infection OBJECTIVE To determine the efficacy of the nonoxynol 9 contraceptive sponge in preventing sexual acquisition of the human immunodeficiency virus ( HIV ) . DESIGN Prospect i ve , r and omized placebo-controlled trial . SETTING Research clinic for prostitutes in Nairobi , Kenya . PATIENTS AND INTERVENTIONS One hundred thirty-eight HIV-seronegative women were enrolled , of whom 74 were assigned to nonoxynol 9 sponge use and 64 to placebo use . These two groups did not significantly differ with respect to demographic characteristics , sexual practice s , or prevalence of genital infections at enrollment , except for a lower number of sex partners per week and a higher initial prevalence of genital ulcers among women assigned to nonoxynol 9 sponge use . Among the 116 women who returned for follow-up , the mean duration s of follow-up were 14 and 17 months for the two groups , respectively . MAIN OUTCOME MEASURE HIV seroconversion . RESULTS Nonoxynol 9 sponge use was associated with an increased frequency of genital ulcers ( relative risk [ RR ] , 3.3 ; P less than .0001 ) and vulvitis ( RR , 3.3 ; P less than .0001 ) and a reduced risk of gonococcal cervicitis ( RR , 0.4 ; P less than .0001 ) . Twenty-seven ( 45 % ) of 60 women in the nonoxynol 9 sponge group and 20 ( 36 % ) of 56 women in the placebo group developed HIV antibodies . The hazard ratio for the association between nonoxynol 9 sponge use and HIV seroconversion was 1.7 ( 95 % confidence interval [ CI ] , 0.9 to 3.0 ) . Using multivariate analysis to control for the presence of genital ulcers at enrollment , the adjusted hazard ratio for the association between nonoxynol 9 sponge use and seroconversion was 1.6 ( 95 % CI , 0.8 to 2.8 ) . CONCLUSIONS Genital ulcers and vulvitis occurred with increased frequency in nonoxynol 9 sponge users . We were unable to demonstrate that nonoxynol 9 sponge use was effective in reducing the risk of HIV infection among highly exposed women Background and Objective : The Sonagachi Project in Calcutta , India , organized sex workers to improve working conditions . Goal : To compare rates of sexually transmitted diseases between the Sonagachi Project and other areas in which only the National AIDS Control Organization ( NACO ) interventions were implemented . Study : A cross-sectional survey of r and omly selected female sex workers . Results : There was no difference in the prevalence of all STDs between the 2 areas ; both were lower than reported in other surveys in 1992 . Analysis using propensity scores also failed to demonstrate any difference . The number of preventive activities was similar in the Sonagachi and NACO-only areas but was more prevalent than in 1992 . Sex workers in the Sonagachi area had better treatment-seeking behavior and attitudes . Both the Sonagachi and NACO strategies have result ed in lower STD rates , but the Sonagachi Project also increased the proportion who had an optimistic attitude and increased prevention and treatment-seeking behavior Objective To assess the short- and long-term impact of a 6-month pilot intervention program on condom use among prostitutes in Accra , Ghana . Design The 4-year prospect i ve study follows-up cohorts enrolled in the intervention in 1987 and 1988 , comparing condom use in 1991 with that among a comparison group not enrolled in the intervention . Setting The community-based intervention was initiated in Accra , Ghana in 1987 . Participants Self-identified female prostitutes who volunteered participation . InterventionThe educational intervention used local health workers to train and support selected prostitutes to be health educators and condom distributers to their peers . Outcome measures Self-reported condom use with clients . Results Reported condom use increased dramatically between 1987 and 1988 during the first 6 months of the intervention . In 1991 , after 3 years of program relapse , 107 ( 43 % ) of the 248 women who had enrolled in 1987 or 1988 were still in prostitution and located for interview . Their level of condom use in 1991 was higher than pre-enrollment but similar to use among prostitutes never enrolled . Sixty-four per cent of those followed-up reported always using condoms with clients in 1991 . These ‘ always users ' were more likely to have maintained informal contact with project staff , know that HIV can be transmitted by healthy clients , and report that clients frequently initiate condom use . Conclusions Findings support the development of long-range educational strategies that recognize the career longevity of prostitutes , available channels for informal program diffusion , individual changes in condom use over time , and the role of clients in condom negotiation BACKGROUND Nonoxynol-9 ( rINN , nonoxinol-9 ) is an over-the-counter spermicide that has in-vitro anti-HIV-1 activity . Results of studies of its effectiveness in prevention of HIV-1 infection in women have been inconclusive . We aim ed to assess effectiveness of this vaginal gel . METHODS We did a r and omised , placebo-controlled , triple-blinded , phase 2/3 trial with COL-1492 , a nonoxynol-9 vaginal gel , in 892 female sex workers in four countries : Benin , Côte d'Ivoire , South Africa , and Thail and . 449 women were r and omly allocated nonoxynol-9 and 443 placebo . Primary endpoint was incident HIV-1 infection . Secondary endpoints included Neisseria gonorrhoeae and Chlamydia trachomatis infections . Analysis was by intention to treat . FINDINGS 765 women were included in the primary analysis . HIV-1 frequency in nonoxynol-9 users was 59 ( 16 % ) of 376 compared with 45 ( 12 % ) [ corrected ] of 389 in placebo users ( 402.5 vs 435.0 woman-years ; hazard ratio adjusted for centre 1.5 ; 95 % CI 1.0 - 2.2 ; p=0.047 ) . 239 ( 32 % ) women reported use of a mean of more than 3.5 applicators per working day , and in these women , risk of HIV-1 infection in nonoxynol-9 users was almost twice that in placebo users ( hazard ratio 1.8 ; 95 % CI 1.0 - 3.2 ) . 516 ( 68 % ) women used the gel less frequently than 3.5 times a day , and in these , risk did not differ between the two treatments . No significant effect of nonoxynol-9 on N gonorrhoeae ( 1.2 ; 0.9 - 1.6 ) or C trachomatis ( 1.2 ; 0.8 - 1.6 ) infections was reported . INTERPRETATION This study did not show a protective effect of COL-1492 on HIV-1 transmission in high-risk women . Multiple use of nonoxynol-9 could cause toxic effects enhancing HIV-1 infection . This drug can no longer be deemed a potential HIV-1-prevention method . Assessment of other microbicides should continue Summary : To test the efficacy of a sustainable community-level HIV intervention among sex workers , the Sonagachi Project was replicated , including community organizing and advocacy , peer education , condom social marketing , and establishment of a health clinic . Sex workers were r and omly selected in 2 small urban communities in northeastern India ( n = 100 each ) and assessed every 5–6 months over 15 months ( 85 % retention ) . Overall condom use increased significantly in the intervention community ( 39 % ) compared with the control community ( 11 % ) , and the proportion of consistent condom users increased 25 % in the intervention community compared with a 16 % decrease in the control community . This study supports the efficacy of the Sonagachi model intervention in increasing condom use and maintaining low HIV prevalence among sex workers A community based sample survey of sexually transmitted diseases and Human Immuno deficiency Virus infection was carried out among commercial sex workers of a red-light area in Calcutta . In this paper socio-demographic aspects of sex workers are discussed . For the survey , 450 sex workers were selected by r and om sampling method . Among the sex workers surveyed , 84.89 per cent were in the age group 15 - 29 years . Lowest age was 13 years and mean age was 23.12 years . Large number of sex workers were from Nepal ( 15.11 per cent ) and Bangladesh ( 11.78 per cent ) . About 38 per cent were from three districts of West Bengal bordering Bangladesh . About 84.44 per cent of the sex workers were illiterate . Extreme poverty forced 49.10 per cent to choose this profession and family disturbances led 21.56 per cent to this profession . Almost all sex workers ( 448 ) had addiction , alcohol being taken regularly by 81.11 per cent . Number of clients of sex workers varied from 2 to 10 , average being 3 . About 67.33 per cent gave history of pregnancy , 46 per cent had abortion and 41.11 per cent had living children . About 27.11 per cent took pre caution against pregnancy regularly . Use of oral pills was found to be the most common practice against pregnancy ( 13.65 per cent ) , followed by ligation ( 11.56 per cent ) . Only 1.11 per cent reported that their clients used condom regularly Our objectives were to describe the baseline findings of a trial of antibiotic prophylaxis to prevent sexually transmitted infections ( STIs ) and HIV-1 in a cohort of Nairobi female sex workers ( FSWs ) . A question naire was administered and a medical examination was performed . HIV-negative women were r and omly assigned to either one gram azithromycin or placebo monthly . Mean age of the 318 women was 32 years , mean duration of sex work 7 years and mean number of clients was 4 per day . High-risk behaviour was frequent : 14 % practised anal intercourse , 23 % sex during menses , and 3 % used intravenous drugs . While 20 % reported condom use with all clients , 37 % never use condoms . However , STI prevalence was relatively low : HIV-1 27 % , bacterial vaginosis 46 % , Trichomonas vaginalis 13 % , Neisser Output:	Despite method ological limitations , the evidence suggested that combining sexual risk reduction , condom promotion and improved access to STI treatment reduces HIV and STI acquisition in sex workers receiving the intervention . Strong evidence that regular STI screening or periodic treatment of STIs confers additional protection against HIV was lacking . It appears that structural interventions , policy change or empowerment of sex workers , reduce the prevalence of STIs and HIV . There is some evidence for the efficacy of multi-component interventions , and /or structural interventions .
MS21170	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To determine whether community-based health workers in a rural region of Ethiopia can provide injectable contraceptives to women with similar levels of safety , effectiveness and acceptability as health extension workers ( HEWs ) . METHODS This was a prospect i ve non-r and omized community intervention trial design ed to test the provision of injectable contraceptives by community-based reproductive health agents ( CBRHAs ) . Effectiveness , safety , acceptability and continuation rates were the outcomes of interest . The outcomes observed when injectable contraceptives were administered by HEWs in health posts and when they were administered by CBRHAs were compared by means of χ(2 ) tests for association among categorical variables and t-tests for independent sample s to determine differences between group means . FINDINGS A total of 1062 women participated in the study . Compared with health post clients , the clients of CBRHAs were , on average , slightly older , less likely to be married and less educated , and they had significantly more living children . Women seeking services from CBRHAs were also significantly more likely to be using injectable contraceptives for the first time ; health post clients were more likely to have used them in the past . In addition , clients of CBRHAs were less likely to discontinue using injectable contraceptives over three injection cycles than health post clients . CONCLUSION Receiving injectable contraceptives from CBRHAs proved as safe and acceptable to this sample of Ethiopian women as receiving them in health posts from HEWs . These findings add to the growing body of evidence supporting the development , introduction and scale up of programmes to train community-based health workers such as CBRHAs to safely administer injectable contraceptives OBJECTIVE To compare the safety and quality of contraceptive injections by community-based health workers with those of clinic-based nurses in a rural African setting . METHODS A nonr and omized community trial tested provision of injectable Depo Provera ( DMPA ) by community reproductive health workers and compared it with routine DPMA provision at health units in Nakasongola District , Ug and a. The primary outcome measures were safety , acceptability and continuation rates . FINDINGS A total of 945 new DMPA users were recruited by community workers , clinic-based nurses and midwives . Research ers successfully followed 777 ( 82 % follow-up ) : 449 community worker clients and 328 clinic-based clients . Ninety-five percent of community-worker clients were " satisfied " or " highly satisfied " with services , and 85 % reported receiving information on side-effects . There were no serious injection site problems in either group . Similarly , there was no significant difference between continuation to second injection ( 88 % among clients of community-based workers , 85 % among clinic-going clients ) , nor were there significant differences in other measures of safety , acceptability and quality . CONCLUSION Community-based distribution ( CBD ) of injectable contraceptives is now routine in some countries in Asia and Latin America , but is practically unknown in Africa , where arguably the need for this practice is greatest . This research reinforces experience from other regions suggesting that well-trained community health workers can safely provide contraceptive injections CONTEXT Contraceptive use among young couples in India is low , and early childbearing and short birth intervals are common . The PRACHAR Project , an ongoing intervention in Bihar , seeks to increase contraceptive use for delaying and spacing births through communication interventions . METHODS R and om sample s of married women younger than 25 with no more than one child were surveyed in 2002 - 2003 , before PRACHAR was implemented ( N=1,995 ) , and in 2004 , 21 - 27 months after implementation ( N=2,080 ) . Contraceptive dem and and use , and related attitudes and knowledge , were assessed in the two surveys in both intervention areas and comparison areas . Logistic regression was used to assess the effect of the interventions on these indicators . RESULTS Contraceptive use was very low ( 2 - 6 % ) at baseline in both comparison and intervention areas . Dem and for contraception increased from 25 % at baseline to 40 % at follow-up in intervention areas , but remained virtually unchanged in comparison areas . At follow-up , contraceptive use had risen in both areas , but the adjusted odds of use in intervention areas were 3.8 times those in comparison areas . Women in intervention areas had elevated odds of knowing that fertility varies during the menstrual cycle , and of agreeing that early childbirth can be harmful and that contraceptive use is necessary and safe for delaying first births ( odds ratios , 1.6 - 3.0 ) . CONCLUSION Culturally appropriate , community-based communication programs that target youth and those who influence their decisions can create dem and for contraception among young couples and lead to increased contraceptive use A r and omized community trial of a family planning outreach program was conducted in Rakai District , Ug and a. Five communities received st and ard services ; six intervention communities received additional family planning information , counseling , and contraceptive methods from government service providers and community-based volunteer agents using social marketing and other strategies . Condom use was promoted in all of the communities . The community-based family planning outreach program was implemented in two phases--1999 - 2000 ( early ) and 2001(late)-- and its impact was evaluated by means of population surveys in 2002 - 03 . At follow-up , hormonal contraceptive prevalence was 23 percent in the intervention communities , compared with 20 percent in the control communities . The differential was greater in the early-intervention communities than the late-intervention communities . Pregnancy rates at follow-up were 15 percent in the control and 13 percent in the intervention communities . No differentials in condom use were found between study arms . Family planning outreach via social marketing can significantly increase hormonal contraceptive use and decrease pregnancy rates , but the impact of this outreach program was modest The impact of community-based family planning programs and access to credit on contraceptive use , fertility , and family size preferences has not been established conclusively in the literature . We provide additional evidence on the possible effect of such programs by describing the results of a r and omized field experiment whose main purpose was to increase the use of contraceptive methods in rural areas of Ethiopia . In the experiment , administrative areas were r and omly allocated to one of three intervention groups or to a fourth control group . In the first intervention group , both credit and family planning services were provided and the credit officers also provided information on family planning . Only credit or family planning services , but not both , were provided in the other two intervention groups , while areas in the control group received neither type of service . Using pre- and post-intervention surveys , we find that neither type of program , combined or in isolation , led to an increase in contraceptive use that is significantly greater than that observed in the control group . We conjecture that the lack of impact has much to do with the mismatch between women ’s preferred contraceptive method ( injectibles ) and the contraceptives provided by community-based agents ( pills and condoms ) Objective Despite the availability of free contraception from family planning clinics , the rate of unwanted pregnancy in Iran is still high . The effectiveness of other methods for contraceptive supply should , therefore , be evaluated . The aim of this study was to determine the effects of community-based distribution ( CBD ) on contraceptive usage in Iran . Methods This controlled field trial study involved 297 individuals ( 100 subjects in the CBD group and 197 subjects in the control group ) from four major remote areas of Hamedan , Iran . Stratified r and om sampling was used . Results Data analysis suggested that using CBD has four major effects : ( 1 ) it increases the level of contraceptive knowledge ( p<0.0001 ) , ( 2 ) it enhances correct contraceptive choice by couples ( p<0.0001 ) , ( 3 ) it improves contraceptive usage ( p<0.0001 ) and ( 4 ) it improves contraceptive continuation rates ( p<0.0001 ) . Conclusions CBD facilitates better knowledge , proper choice , and correct and continuous usage of contraception . This method should , therefore , be adopted for family planning services in remote areas of Iran Output:	Based on these findings , strong evidence exists for promoting CHW programs to improve access to FP services .
MS21171	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A common rehabilitation strategy for patellofemoral pain syndrome ( PFPS ) , which lacks scientific evidence , includes pulling the patella medially with tape to reduce pain and increase the vastus medialis oblique ( VMO ) muscle activity . The purpose of this study was to examine the effect of various patellar taping procedures on force production , EMG activity of the VMO and vastus lateralis ( VL ) muscles , and perceived pain experienced by 30 women ( 27.3 + /- 1.53 ) , half diagnosed with PFPS . The perceived pain , force , and EMG of the VMO and VL , were recorded while subjects performed maximal isokinetic leg presses at 30 degrees /s for each of the following patellar taping conditions : no tape ( control ) , no glide ( placebo ) , medial and lateral glide ( experimental ) . The medial and placebo procedures significantly ( P < 0.01 ) reduced perceived pain ( 70 - 80 % ) in PFPS subjects . Although patellar taping did not influence leg press force ( P > 0.05 ) , it increased the VMO activity and decreased the VL activity in PFPS subjects but had the opposite effect in healthy subjects . The findings suggest that taping the patella medially can contribute positively to PFPS rehabilitation . Because the medial glide and placebo taping conditions had similar effects , it is proposed that the benefits of patellar taping are not due to a change in patellar position but rather due to enhanced support of the patellofemoral ligaments and /or pain modulation via cutaneous stimulation BACKGROUND AND PURPOSE Quadriceps strengthening , quadriceps stretching and patellar taping are commonly prescribed together for patellofemoral pain patients . This study aim ed to examine the effectiveness of each of these techniques in isolation for one week and in combination for one week . METHODS A prospect i ve double-blind r and omized control study was design ed involving 41 subjects with 60 knees diagnosed with patellofemoral pain . The knees were r and omized in onto one of four groups ( n = 15 ) : infrapatellar taping , quadriceps strengthening , quadriceps stretching and control . The taping was worn continually for the week ; the strengthening group followed a programme of non-weight-bearing terminal range quadriceps exercises , the stretching group performed rectus femoris stretches . The control group did not receive treatment . All subjects received advice . Seven pre- and post-treatment measures included isokinetic quadriceps strength , quadriceps length , pain measured during four activities and maximum eccentric , posturally controlled , pain-free knee flexion angle during a step-down . Results showed significant changes over time ( p < 0.01 ) in two out of seven measures for the taping group , in five out of seven for the strengthening group and five out of seven for the stretching group and none in the control group . When the three modalities were combined for one week , ( n = 60 ) all seven measures improved significantly ( p < 0.01 ) . CONCLUSION In isolation , quadriceps stretching and quadriceps strengthening result ed in more improvements than taping . Combining these treatments is recommended as the initial approach to treating patellofemoral pain but further individualized more functional , global treatment is essential OBJECTIVE To compare a commercially available electric muscle stimulation regimen with a novel form of stimulation for the rehabilitation of the quadriceps muscle , in patients with patellofemoral pain syndrome . DESIGN Double-blinded r and omized trial with a parallel control group and stratified r and omization . SETTING Home-based rehabilitation program assessed in research center . PARTICIPANTS Eighty patients ( 47 women , 33 men ) with patellofemoral pain syndrome . INTERVENTIONS One group ( EMPI ) received 1 uniform constant frequency component of 35Hz . The other ( EXPER ) group received an experimental form of stimulation that contained 5 simultaneously delivered frequency components of 125 , 83 , 50 , 2.5 , and 2Hz . Stimulation was applied to the quadriceps muscles of the affected leg for 1 hour daily for 6 weeks , a total of 42 treatments . MAIN OUTCOME MEASURES Lower-limb isometric and isokinetic torque , quadriceps fatigue , knee flexion , patellar pain , a step test , quadriceps cross-sectional area , and Kujala patellofemoral score for pain before and after treatment . RESULTS Seventy-four patients ( 43 women , 31 men ) completed the trial . Patients in both groups showed significant improvements in all outcomes ( P<.05 ) . No significant differences existed between the 2 stimulators in any outcome ( P>.05 ) except for quadriceps cross-sectional area ( P=.023 ) . CONCLUSIONS One form of stimulation was just as efficacious as the other in improving subjective and objective measures Objective To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy , and to investigate the effectiveness of foot orthoses plus physiotherapy . Design Prospect i ve , single blind , r and omised clinical trial . Setting Single centre trial within a community setting in Brisbane , Australia . Participants 179 participants ( 100 women ) aged 18 to 40 years , with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks ’ duration , who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months . Interventions Six weeks of physiotherapist intervention with off the shelf foot orthoses , flat inserts , multimodal physiotherapy ( patellofemoral joint mobilisation , patellar taping , quadriceps muscle retraining , and education ) , or foot orthoses plus physiotherapy . Main outcome measures Global improvement , severity of usual and worst pain over the preceding week , anterior knee pain scale , and functional index question naire measured at 6 , 12 , and 52 weeks . Results Foot orthoses produced improvement beyond that of flat inserts in the short term , notably at six weeks ( relative risk reduction 0.66 , 99 % confidence interval 0.05 to 1.17 ; NNT 4 ( 99 % confidence interval 2 to 51 ) . No significant differences were found between foot orthoses and physiotherapy , or between physiotherapy and physiotherapy plus orthoses . All groups showed clinical ly meaningful improvements in primary outcomes over 52 weeks . Conclusion While foot orthoses are superior to flat inserts according to participants ’ overall perception , they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain . Given the long term improvement observed in all treatment groups , general practitioners may seek to hasten recovery by prescribing prefabricated orthoses . Trial registration Australian Clinical Trials Registry ACTRN012605000463673 and Clinical Trials.gov NCT00118521 Background : McConnell recommended that patellar tape be kept on all day , until patients learn how to activate their vastus medialis obliquus ( VMO ) during an exercise program . This application may pose problems because prolonged taping may be inadvisable for some patients or even contraindicated owing to skin discomfort , irritation , or allergic reaction . Hypothesis : Wearing patellofemoral tape for a shorter duration during an exercise program would be just as beneficial as a prolonged taping application . Study Design : Prospect i ve cohort . Methods : Twelve patients and 16 healthy people participated . Patients underwent short-period patellar taping plus an exercise program for 3 months . Numeric pain rating , muscle strength of the knee extensors , and electromyogram activity of the vastus lateralis and VMO were evaluated . Results : There were significant differences in electromyogram activity ( P = .04 ) and knee extensor muscle strength ( P = .03 ) between involved and uninvolved sides before treatment . After treatment , pain scores decreased , and there were no significant differences between involved and uninvolved sides in electromyogram activity ( P = .68 ) and knee extensor strength ( P = .62 ) . Before treatment , mean VMO activation started significantly later than that of vastus lateralis , as compared with the matched healthy control group ( P = .01 ) . After treatment , these differences were nonsignificant ( P = .08 ) . Conclusion : Short-period patellar taping plus an exercise program improves VMO and vastus lateralis activation . Clinical Relevance : A shorter period of taping for the exercise program may be as beneficial as a prolonged taping application STUDY DESIGN A r and omized controlled trial . OBJECTIVES To investigate the effectiveness of daily patella taping and exercise on pain and function in individuals with patellofemoral pain syndrome . BACKGROUND Patella taping and muscle-strengthening programs are commonly used to treat patellofemoral pain syndrome . There is , however , little evidence for the effectiveness of these approaches . METHODS AND MEASURES Twenty-four men and 6 women aged 17 to 25 years ( mean + /- SD , 18.7 + /- 1.2 years ) participated in the study . Subjects were r and omly and exclusively assigned to 1 of 3 treatment groups : patella taping combined with a st and ardized exercise program , placebo patella taping and exercise program , or exercise program alone ( n = 10 in each group ) . Taping was applied and exercises performed on a daily basis for 4 weeks . Outcome measures were visual analog scales for pain and the functional index question naire , recorded at weekly intervals by a therapist who was blinded to group allocation . RESULTS Separate mixed-model ANOVAs , with repeated measures on time , indicated statistically significant improvements in pain and function over time for all groups ( P<.01 ) and also significant differences between groups for all measures ( P<.01 ) . Separate independent sample s t tests showed that the group receiving taping and exercises had better pain and function scores following treatment than the placebo taping- and -exercise group and the exercise-alone group . There were no significant differences between the placebo taping- and -exercise group and exercise-alone group at any time point . CONCLUSIONS These findings indicate that over a period of 4 weeks a combination of daily patella taping and exercises was successful in improving pain and function in individuals with patellofemoral pain syndrome . The combination of patella taping and exercise was superior to the use of exercise alone STUDY DESIGN A multicenter , single-masked study of patients with patellofemoral pain syndrome ( PFPS ) using a repeated- measures design . OBJECTIVE To compare 3 different methods of patellar taping for individuals with PFPS . BACKGROUND Patellar taping is commonly used as a treatment for PFPS . It is commonly thought that taping works by medially realigning the patella . However , comparisons have been rarely made with other methods of taping which attempt to realign the patella in different directions . METHODS AND MEASURES Seventy-one patients with PFPS ( 39 men , 32 women ; average age + /- SD , 34 + /- 10 years ) from 3 different treatment centers were tested . Each patient performed 4 single step-downs from a st and ard 8-inch ( 20.3-cm ) platform , initially with the patella untaped and then with the patella taped in a medial , neutral , and lateral direction . Pain was recorded on a st and ard 11-point numerical pain rating scale . The sequence of taping was r and omly allocated and patients were masked to the method used . The methods of taping were compared using repeated- measures generalized linear model analysis . RESULTS All methods of taping significantly decreased pain when compared to the untaped condition ( P<.0001 ) . Neutral- and lateral-glide techniques produced a significantly greater degree of pain relief ( P<.0001 ) than the medial-glide technique . CONCLUSION In this study , patellar taping produced an immediate decrease in pain in patients with PFPS , irrespective of how taping was applied . These data raise questions as to the mechanism of action of patellar taping . Furthermore , these results suggest that it is unlikely that taping works by altering patellar position Background Patellar taping is widely used clinical ly to treat patients with patellofemoral pain syndrome ( PFPS ) . Although patellar taping has been demonstrated to reduce patellofemoral pain in patients with PFPS , the kinematic source for this pain reduction has not been identified . Objective The purpose of this study was to quantify the changes in the 6-degrees-of-freedom patellofemoral kinematics due to taping in patients with PFPS . Design A within-subject design and a sample of convenience were used . Participants Fourteen volunteers ( 19 knees ) who were diagnosed with patellofemoral pain that was present for a year or longer were included . Each knee had to meet at least 1 of the following inclusion criteria : Q-angle of ≥15 degrees , a positive apprehension test , patellar lateral hypermobility ( ≥10 mm ) , or a positive “ J sign . ” Methods Each knee underwent 2 r and omly ordered testing conditions ( untaped and taped ) . A full fast-phase contrast ( PC ) magnetic resonance image set was acquired for each condition while the participants volitionally extended and flexed their knee . Three-dimensional displacements and rotations were calculated through integration of the fast-PC velocity data . Statistical comparisons between baseline patellofemoral kinematics and the change in kinematics due to taping were performed using a 2-tailed paired Student t test . Correlations between baseline patellofemoral kinematics and the change in kinematics due to taping also were quantified . Results Patellar taping result ed in a significant patellofemoral inferior shift . The strongest correlation existed between the change in lateral-medial displacement with taping and baseline ( r=−.60 ) . Conclusions The inferior shift in patellar displacement with taping partially explains the previously documented decrease in pain due to increases in contact area . The lack of alteration Output:	The currently available evidence from trials reporting clinical ly relevant outcomes is low quality and insufficient to draw conclusions on the effects of taping , whether used on its own or as part of a treatment programme .
MS21172	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We present statistical considerations for the design of the Community Intervention Trial for Smoking Cessation ( COMMIT ) . One outcome measurement , the quit rate in r and omly selected cohorts of smokers , is compared with another outcome measurement , the decrease in smoking prevalence , in terms of statistical efficiency and interpretability . The COMMIT study uses both types of outcome measurements . The merits of pair-matching the communities are considered , and sample size calculations take into account heterogeneity among pair-matched communities . In addition to significance tests based on the permutational ( r and omization ) distribution , we also describe approaches for covariate adjustment . The COMMIT design includes 11 pair-matched communities , which should provide good power to detect a 10 % or greater difference in quit rates between the intervention and control communities in cohorts of heavy smokers and in cohorts of light or moderate smokers . The power is only moderate to detect intervention effects on the decreases in overall smoking prevalence or in the prevalence of heavy smoking PURPOSE Toward developing attractive and effective means to reduce cancer risks faced by Native American people , this study developed and tested interactive computer software to improve dietary choices and prevent tobacco use among Native American adolescents . METHODS Based on a legend of the Seneca Nation , a cancer prevention lesson was developed and programmed for software . A sample of 368 Native American adolescents were divided r and omly into intervention and control arms . Youths in both arms were pre-tested , youths in the intervention arm interacted with the software , and all youths were post-tested . Pre-test and post-test measures covered information and attitudes about cancer risks from dietary practice s and tobacco use . RESULTS Pre-test scores differed between the two arms on youths ' age and on one outcome variable . Relative to their counterparts in the control arm , youths in the intervention arm increased their post-test scores on 8 of 12 outcome measurement variables . Process data gathered during intervention delivery indicated that nearly all youths were involved with the interactive software and lesson . CONCLUSION Interactive computer software holds promise for delivering cancer risk reduction intervention aim ed at modifying dietary habits and preventing tobacco use among Native American youth BACKGROUND This article discusses the development , implementation , and preliminary testing of an intervention to reduce cancer risks through tobacco use prevention and dietary modification among Native American youth in the Northeastern United States . METHODS The intervention outcome study includes a research design and outcome measurement instruments . In collaboration with Native American communities , reservations , and organizations in the Northeastern United States , implementation of the design quantifies the separate and combined effects of a tobacco use prevention and a dietary modification intervention . RESULTS Native American youths in the tobacco prevention intervention and in the combined tobacco and dietary intervention increased their knowledge of tobacco facts and their awareness of the motives of tobacco advertising , and showed higher ratings for an ability to resist peer pressure and to refuse offers of tobacco use between pretest and posttest . Youths in the combined intervention were significantly less apt to report smoking of any kind . Youths in the tobacco use prevention-only condition reported significantly less smoking than their counterparts in the dietary modification-only condition and control condition on 4 of 8 measurement items . As for dietary variables , pretest to posttest measurement scores showed that , after receiving the curriculum , youths in the dietary modification intervention and in the combined intervention improved their knowledge of the health implication s of consuming dietary fat , fiber , fruits , and vegetables . Youths in the dietary modification and combined intervention also improved their scores of knowledge related to cancer risk-reducing nutritional practice s , cultural dietary habits , and healthy food choices available for Native American cultures . Youths in the dietary modification-only condition report significantly increasing their consumption of complex carbohydrates and significantly decreasing their fat intake between pretest and posttest occasions . CONCLUSIONS Data from this longitudinal study suggest the value of the FACETS curriculum for helping Native American youth reduce their risks for cancer associated with tobacco use and dietary preference and consumption patterns . In particular , results indicate the enhanced effects of the combined tobacco use prevention and dietary modification intervention for preventing tobacco use and for improving youths ' knowledge and attitudes with regard to tobacco use and diet . Further , the study demonstrates the value of collaborating with Native American organizations to design a cancer risk-reducing curriculum and to implement tests of that curriculum A smoking prevention project in six European countries ( European Smoking prevention Framework Approach ) was developed , featuring activities for adolescents , schools and parents , including out-of-school activities . Consensus meetings result ed in agreement between the countries on goals , objectives and theoretical methods . Countries ' specific objectives were also included . National diversities required country-specific methods to realize the goals and objectives . The community intervention trial was used as the research design . Since interventions took place at the community level , communities or regions were allocated at r and om to the experimental or control conditions . Complete r and omization was achieved in four countries . At baseline , smoking prevalence among 23 125 adolescents at the start of the project was 5.6 % for regular smoking and 4.0 % for daily smoking . Smoking prevalence rates were higher among girls than boys in all countries as far as weekly smoking was concerned . Process evaluations revealed that the project 's ambitions were high , but were limited by various constraints including time and delays in receiving funds . Future smoking prevention projects should aim to identify the effective components within the social influence approach as well as within broader approaches and on reaching sustained effects This study developed and tested skills- and community-based approaches to prevent substance abuse among Native American youth . After completing pretest measurements , 1,396 third- through fifth- grade Native American students from 27 elementary schools in five states were divided r and omly by school into two intervention arms and one control arm . Following intervention delivery , youths in all arms completed posttest measurements and three annual follow-up measurements . Youths in schools assigned to the intervention arms learned cognitive and behavioral skills for substance abuse prevention . One intervention arm additionally engaged local community residents in efforts to prevent substance use among Native American youth . Outcome assessment batteries measured youths ' reported use of smoked and smokeless tobacco , alcohol , and marijuana . Over the course of the 3.5-year study , increased rates of tobacco , alcohol , and marijuana use were reported by youths across the three arms of the study . Though cigarette use was unaffected by intervention , follow up rates of smokeless tobacco , alcohol , and marijuana use were lower for youths who received skills intervention than for youths in the control arm . Community intervention components appeared to exert no added beneficial influence on youths ' substance use , beyond the impact of skills intervention components alone . Finally , gender differences were apparent across substances , measurements , and study arms , with girls smoking more cigarettes and boys using more smokeless tobacco , alcohol , and marijuana Output:	Based on the available evidence , a conclusion can not be drawn as to the efficacy of tobacco prevention initiatives tailored for Indigenous youth . Smoking prevalence in Indigenous youth is twice that of the non-Indigenous population , with tobacco experimentation commencing at an early age . As such , a significant health disparity exists where Indigenous population s , a minority , are over-represented in the burden of smoking-related morbidity and mortality .
MS21173	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The long‐term effects of abdominal aortic aneurysm ( AAA ) screening were investigated in extended follow‐up from the UK Multicentre Aneurysm Screening Study ( MASS ) r and omized trial Context Is it cost-effective to screen older adults for abdominal aortic aneurysm ( AAA ) ? Contribution This 7-year follow-up report of a large r and omized trial in the United Kingdom found that men age 65 to 74 years who were invited to have ultrasonography and surveillance for AAA had lower mortality rates than did those who were not invited ( hazard ratio , 0.53 [ CI , 0.42 to 0.68 ] ) . Cost-effectiveness for AAA-related deaths , based on costs applied to the events experienced by the men , was estimated at $ 19500 ( CI , $ 12400 to $ 39800 ) per life-year gained . Caution s Only men were studied . Actual costs of screening and surveillance may vary substantially in different setting s. The Editors A fast-growing body of literature is providing evidence in favor of screening men for abdominal aortic aneurysm ( AAA ) . Several large , r and omized trials published in the past few years ( 14 ) have consistently shown that screening reduces AAA-related mortality . A few observational studies of programs under way in localized areas have established the feasibility of systematic screening and have explored its practical implementation ( 57 ) . In addition to the mortality benefit , evidence indicating that screening is highly cost-effective is increasing ( 811 ) . In light of this evidence , national screening programs are now being considered in many countries ( 1214 ) . However , there is little evidence regarding long-term outcomes after AAA screening ; almost all of the evidence from r and omized trials is limited to the first 4 years after screening ( 14 ) . Moreover , long-term cost-effectiveness has been estimated only through health economic modeling ( 10 ) . We describe cost-effectiveness based on 7-year follow-up from the largest of the 4 trials of AAA screeningthe Multicentre Aneurysm Screening Study ( MASS ) ( 2 ) . The trial r and omly assigned approximately 67800 men age 65 to 74 years to receive an invitation to screening or to not receive an invitation . At 4-year follow-up , the trial reported a substantial relative reduction of 42 % ( 95 % CI , 22 % to 58 % ) in AAA-related mortality and an incremental cost-effectiveness ratio of $ 44900 ( CI , $ 24000 to $ 231000 ) per life-year gained ( 9 ) , which is at the borderline of the commonly accepted threshold for interventions . All values are reported in U.S. dollars ( U.K. 1 = U.S. $ 1.58 ) ( 15 ) . The costs of AAA screening are primarily incurred at the start of the program , but benefits continue to accrue in terms of life-years gained in patients in whom AAA rupture is avoided through elective surgery . It is therefore expected that cost-effectiveness of screening will improve over time . The mid-term results of MASS provide reliable , trial-based information regarding clinical outcomes and cost-effectiveness over a longer period . Methods The details of the MASS protocol were described previously ( 2 ) , but a brief summary is provided ( Figure 1 ) . Between 1997 and 1999 , a population -based sample of 70495 men age 65 to 74 years from 4 centers in the United Kingdom was identified by obtaining records for every man in this age range who was registered with a family physician ( registered persons account for approximately 98 % of the population ) . Persons who were ineligible for the trial ( incorrect details , known AAA , previous AAA surgery , or terminal illness ) were excluded before r and omization . The remaining 67770 men were r and omly assigned to receive an invitation to ultrasonography for AAA or to not receive an invitation to ultrasonography . At screening , men with an aortic diameter of 3.0 cm or greater were defined as having an AAA and were subsequently invited for recall scans to monitor growth of the aneurysm . Men with an aortic diameter of 3.0 to 4.4 cm were rescreened every year , and those with an aortic diameter of 4.5 to 5.4 cm were rescreened every 3 months . Participants were considered for elective surgery when the aortic diameter reached 5.5 cm , aortic expansion was 1.0 cm or more in 1 year , or they experienced symptoms attributable to the aneurysm . Men with an aortic diameter less than 3.0 cm on the initial scan were not rescreened . Blood pressure was also measured ; although family physicians were informed of these measurements , no further intervention was provided through the screening program . We obtained approval from local ethics committees at each center , and all patients who had screening provided signed informed consent . Figure 1 . Study flow diagram . Additional data on follow-up scans and AAA surgeries were collected from hospital records . Deaths up to 31 March 2005 were confirmed by the U.K. Office of National Statistics after matching of the unique National Health Service number for each person . Follow-up ranged from 5.9 to 8.2 years ( mean , 7.1 years ) . The primary outcome of interest , AAA-related mortality , is defined as all deaths within 30 days of any AAA surgery ( elective or emergency ) plus all deaths with International Classification of Diseases , Ninth Revision , codes 441.3 ( ruptured abdominal aortic aneurysm ) , 441.4 ( abdominal aortic aneurysm without mention of rupture ) , 441.5 ( ruptured aortic aneurysm at unspecified site ) , or 441.6 ( aortic aneurysm at unspecified site without mention of rupture ) . The use of codes 441.5 and 441.6 may result in inclusion of some thoracic aortic aneurysm deaths . Investigation of the accuracy of cause-of-death coding on the death certificates was done by an independent mortality working party that was blinded to group allocation . The results of this analysis showed that inaccuracies in coding did not have an important impact on study outcomes ( 2 ) . Statistical Analysis All analyses were done by using Stata , version 9 ( Stata Corp. , College Station , Texas ) . Deaths related to AAA ( primary analysis ) and all-cause mortality ( secondary analysis ) were compared between the 2 r and omized groups by using unadjusted Cox regression by intention-to-treat analysis . Adjustment for age at baseline did not influence the results . The proportional hazards assumption was tested by using Schoenfeld residuals . An unbiased r and omization-based estimate of the benefit of screening was also obtained ( 16 ) . This estimate is calculated by subtracting from the control group a subgroup that is equivalent in terms of survival to the nonadherent subgroup in the invited group . Thus , the remaining controls are comparable to the group of invited patients who attended screening . Life-years gained are estimated as the area between the KaplanMeier curves for both groups ( 17 ) . The cost-effectiveness of screening is estimated from a health service perspective for follow-up truncated at 7 years , with adjustment for censoring ( 18 ) . Details of the costing exercise in the trial at 20002001 prices were reported previously ( 9 ) . The unit costs obtained ( U.K. 1 = U.S. $ 1.58 for the year 2000 [ 15 ] ) are inflated to the 20042005 financial-year level by using annual hospital and community health services pay and price inflation indices ( 19 ) . Costs are applied to the following events on the basis of individual re source use : invitation to screening ( $ 2.46 ) , reinvitation after nonresponse ( $ 2.42 ) , initial scan ( $ 35.95 ) , recall scan ( $ 86.74 ; done in the hospital rather than in the community and including costs for periodic routine meetings with a consultant ) , consultation for elective surgery ( $ 583.79 ) , elective AAA surgery ( $ 13015.74 ) , and emergency AAA surgery ( $ 21054.32 ) . Costs relating to scans of incidentally detected AAAs in the control group are not included ( data not available ) , but costs relating from result ant AAA repair surgery are included . Sensitivity analyses were done by using 1 ) costs retained at the 20002001 financial-year level for comparison with previous publications , 2 ) quality -adjusted life-years based on age-related reductions , 3 ) U.S.-based unit cost estimates for scans and surgeries , 4 ) an increase of 50 % in the cost of a consultation ( a U.S.-based estimate was not available , but this analysis reflects possible additional assessment s ) , 5 ) 3 and 4 combined . Quality -of-life adjustments are made only on the basis of age , with an adjustment of 0.78 for life-years gained between the ages 65 and 74 years and an adjustment of 0.75 for life-years gained at ages older than 75 years ( 20 ) . The U.S.-specific estimates for scans ( initial and recall ) are based on Medicare reimbursement for AAA screening at $ 90.95 ( Current Procedural Terminology code G0389 ) ( 21 ) , and U.S.-specific costs for surgeries are based on previously published estimates ( 22 , 23 ) that were inflated to 2004 prices ( 24 ) : $ 18160 for elective procedures and $ 31106 for emergency procedures . Discounting is applied at the current recommended values of 3 % per annum for costs and effects ( 25 ) . Estimates of AAA-related costs and effects take into account the rate of nonAAA-related deaths across both groups over time . The Fieller method is used to calculate bounds for the CI for cost-effectiveness ( 26 , 27 ) . Role of the Funding Source This study was funded by the Medical Research Council . The funding source had no role in the design , implementation , or analysis of the study . Results Figure 1 shows the flow of participants through the trial . Numbers differ slightly from earlier publications because of identification of a few duplicate records in the data base . Of 67770 r and omly assigned men , 33883 were invited to be screened : 27204 ( 80 % ) attended and 1334 ( 4.9 % ) AAAs were identified . The mean age at r and omization was 69.2 years in both groups . Loss to follow-up because of death was 2.1 % overall ( 2.2 % in the control group and 2.1 % in the invited group ) . Loss to clinical follow-up ( nonattendance at recall scans ) was 19 % at 4 years and 24 % at 7 years . The Appendix Table shows surgeries and deaths within 30 days in each of the r and omly assigned groups . A few endovascular operations are included in these figures6 in the control group and 14 in the invited group . As expected , the total number of elective procedures is greater in the invited group than in the control group BACKGROUND At present , several regions and countries are considering screening for abdominal aortic aneurysm ( AAA ) . However , The Chichester Aneurysms Screening Trial has reported poor long term benefit of screening for AAA . We therefore supplement previously published data with a preliminary analysis of the ten-year mortality from AAA , based upon population -based data until 2002 ( 7 years ) and incomplete hospital-based information on deaths until 2005 ( 10 years ) . METHODS AND MATERIAL In 1994 we started a r and omised screening trial of 12,639 64 - 73 year-old males ; 6,306 were controls , and 6,333 were invited to an abdominal ultrasound scan at their district hospital . Information on all deaths until 15.3.2005 was obtained from the Office of Civil Registration . Information on AAA related deaths was obtained from the national registry of Causes of Deaths from 1.4.1994 to 31.12.2001 , and supplemented with AAA deaths known to the Danish National Patient Registry until 15.3.2005 . Operations were obtained from the Danish National Vascular Registry from 1.4.1994 to 15.3.2005 . Death certificates and medical records were review ed by two independent assessors . The analyses were based on " intention to treat " from the date of r and omisation . RESULTS The attendance rate was 76.6 % and 191 ( 4.0 % ) had an AAA . The median observation time was 9.58 years . In the invited group 13 subjects were acutely operated on compared to 40 in the control group ( Risk ratio : 0.32 ( 95 % C.I. 0.17 - 0.60 , P<0.001 ) ) , and 14 died due to AAA compared to 51 in the control group ( Hazard ratio : 0.27 ( 95 % C.I. : 0.15 - 0.49 , P<0.001 ) . CONCLUSION Over ten years , screening reduced mortality from AAA by 73 % , and the frequency of emergency operations by 68 % Screening for abdominal aortic aneurysm ( AAA ) is commonly restricted to men . Recent studies have indicated a possible increase in deaths due to ruptured AAA in women , and a higher rate of rupture in women than in men . The present report details results from a r and omized controlled trial that assessed the effects of screening women for AAA B Output:	Conclusions : Population ‐based one‐time screening for AAA with ultrasound in asymptomatic men aged 65 years and older remains beneficial during the longer term after screening has ceased , with significant reductions in AAA mortality and AAA rupture rate , and hence avoids unnecessary AAA‐related deaths . The sensitivity analyses also showed that the benefits of AAA screening were more pronounced in men at a mean age of < 70 years with a relatively lower prevalence of AAA than in men at a mean age of > 70 years with a relatively higher prevalence of AAA .
MS21174	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND AND OBJECTIVES Several temporary venous catheterizations are sometimes required for acute renal replacement therapy ( RRT ) in the intensive care unit ( ICU ) . This study compares first and second catheterizations in the femoral and jugular veins in terms of patient safety . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS A crossover study from the catheter-dialysis r and omized study ( Cathedia ) , which was conducted among 736 critically ill adults requiring RRT , was performed . Catheter insertion complications , catheter-tip colonization , catheter dysfunction and urea reduction ratio ( URR ) were analyzed considering the crossover and longitudinal design s. RESULTS This study analyzed 134 patients who underwent two different sites of catheterization , 57 and 77 of whom were initially r and omized in the femoral and jugular site , respectively . Using anatomic l and marks , time to insert a femoral catheter was shorter ( P=0.01 ) and more successful ( P=0.003 ) compared with catheterization in the jugular site . Time to catheter-tip colonization at removal was not significantly different between the two sites of insertion ( median , 14 days in both groups ; hazard ratio , 0.99 ; 95 % confidence interval , 0.61 - 1.59 ; P=0.96 ) , as well as time to dysfunction . URRs were analyzed from 395 dialysis sessions ( n=48 patients ) . No significant difference ( P=0.49 ) in mean URR was detected between sessions performed through femoral ( n=213 ; 50.9 % ) and jugular ( n=182 ; 49.5 % ) dialysis catheters . CONCLUSIONS These results vali date prior results of this study group and extend external validity to the second catheter used for RRT in the ICU . Femoral and internal jugular acute vascular access sites are both acceptable for RRT therapy in the ICU BACKGROUND Intravascular-catheter-related infections are frequent life-threatening events in health care , but incidence can be decreased by improvements in the quality of care . Optimisation of skin antisepsis is essential to prevent short-term catheter-related infections . We hypothesised that chlorhexidine-alcohol would be more effective than povidone iodine-alcohol as a skin antiseptic to prevent intravascular-catheter-related infections . METHODS In this open-label , r and omised controlled trial with a two-by-two factorial design , we enrolled consecutive adults ( age ≥18 years ) admitted to one of 11 French intensive-care units and requiring at least one of central -venous , haemodialysis , or arterial catheters . Before catheter insertion , we r and omly assigned ( 1:1:1:1 ) patients via a secure web-based r and om-number generator ( permuted blocks of eight , stratified by centre ) to have all intravascular catheters prepared with 2 % chlorhexidine-70 % isopropyl alcohol ( chlorhexidine-alcohol ) or 5 % povidone iodine-69 % ethanol ( povidone iodine-alcohol ) , with or without scrubbing of the skin with detergent before antiseptic application . Physicians and nurses were not masked to group assignment but microbiologists and outcome assessors were . The primary outcome was the incidence of catheter-related infections with chlorhexidine-alcohol versus povidone iodine-alcohol in the intention-to-treat population . This study is registered with Clinical Trials.gov , number NCT01629550 and is closed to new participants . FINDINGS Between Oct 26 , 2012 , and Feb 12 , 2014 , 2546 patients were eligible to participate in the study . We r and omly assigned 1181 patients ( 2547 catheters ) to chlorhexidine-alcohol ( 594 patients with scrubbing , 587 without ) and 1168 ( 2612 catheters ) to povidone iodine-alcohol ( 580 patients with scrubbing , 588 without ) . Chlorhexidine-alcohol was associated with lower incidence of catheter-related infections ( 0·28 vs 1·77 per 1000 catheter-days with povidone iodine-alcohol ; hazard ratio 0·15 , 95 % CI 0·05 - 0·41 ; p=0·0002 ) . Scrubbing was not associated with a significant difference in catheter colonisation ( p=0·3877 ) . No systemic adverse events were reported , but severe skin reactions occurred more frequently in those assigned to chlorhexidine-alcohol ( 27 [ 3 % ] patients vs seven [ 1 % ] with povidone iodine-alcohol ; p=0·0017 ) and led to chlorhexidine discontinuation in two patients . INTERPRETATION For skin antisepsis , chlorhexidine-alcohol provides greater protection against short-term catheter-related infections than does povidone iodine-alcohol and should be included in all bundles for prevention of intravascular catheter-related infections . FUNDING University Hospital of Poitiers , CareFusion The low-flow method has been shown as a reliable evaluation of access recirculation . Few data is available on temporary central catheter blood recirculation ; results of 2 % and 4 % have been reported in subclavian , 10 % in 24 cm long femoral , and 18 % in 15 cm long femoral catheters , mostly in indwelling catheters for chronic hemodialysis . The purpose of this prospect i ve study was to evaluate blood recirculation in a larger number of recently inserted temporary intravenous catheters for acute hemodialysis , comparing subclavian and femoral sites . Fifty blood recirculation measurements were performed in 38 different temporary central venous dialysis catheters inserted in thirty-one critically ill patients from medical and surgical intensive care units presenting acute renal failure supported by intermittent hemodialysis . All the catheters used were well-functioning 11.5 French dual lumen Quinton of 13.5 or 19.5 cm length . Catheters presenting mechanical dysfunction , which did not allow a blood flow rate of 300 ml/min or for which lines had to be reversed were excluded from the analysis . Access blood recirculation was measured shortly after catheter insertion according to the low flow method applied after the first 30 minutes of hemodialysis at a blood flow rate of 300 ml/min . Mean blood recirculation for the 50 measurements was 10.3 + /- 9.2 % . It was significantly higher in the 26 femoral catheters than in the 24 subclavian catheters , reaching respective means of 16.1 + /- 9.1 % and 4.1 + /- 3.6 % ( p = 0.0001 ) . Blood recirculation rate was not different between 13.5 cm and 19.5 cm long subclavian catheters ( 3.0 + /- 2.6 % , n = 13 , versus 5.4 + /- 4.3 % , n = 11 , respectively ) , but was significantly higher in 13.5 cm long femoral catheters ( 22.8 + /- 9.1 % , n = 9 , versus 12.6 + /- 6.9 % , n = 17 ) ( p = 0.004 ) . Blood recirculation was measured on two separate occasions in 12 catheters r and omly selected ( 5 femoral and 7 subclavian catheters ) ; the obtained results were reproducible with a mean difference of only 2.1 + /- 1.8 % between the two measurements and a correlation of 0.96 . The mean time elapsed between catheter insertion and recirculation assessment was 2.2 + /- 3.1 days and was similar for femoral and subclavian catheters . No correlation was found between the percentage of recirculation and the arterial and venous resistances recorded during dialysis session or with the time from catheter insertion . Mean urea reduction ratio ( URR ) for the 50 dialysis sessions was 57.8 + /- 13.0 % . It was significantly higher for sessions performed with subclavian than with femoral catheters ( 62.5 + /- 10.9 % , n = 24 , versus 54.5 + /- 14.2 % , n = 26 ) ( p = 0.03 ) . In conclusion , the expected blood recirculation in well-functioning and recently inserted temporary dialysis catheters is under 5 % for subclavian , over 12 % in 19.5 cm femoral , and over 22 % in shorter 13.5 cm femoral catheters at a blood flow rate of 300 ml/min . The consequently reduced dialysis efficiency with femoral catheters is another factor to be considered in the choice of a site for temporary dialysis catheter insertion in acute renal failure patients , particularly when dialysis dose delivery is a priority , such as intoxication cases treated by extracorporeal therapy Background Intensive care unit ( ICU ) patients require dialysis catheters ( DCs ) for renal replacement therapy ( RRT ) . They carry a high risk of developing end-stage renal disease , and therefore their vascular access must be preserved . Guidewire exchange ( GWE ) is often used to avoid venipuncture insertion ( VPI ) at a new site . However , the impact of GWE on infection and dysfunction of DCs in the ICU is unknown . Our aim was to compare the effect of GWE and VPI on DC colonization and dysfunction in ICU patients . Methods Using data from the ELVIS r and omized controlled trial ( RCT ) ( 1496 ICU adults requiring DC for RRT or plasma exchange ) we performed a matched-cohort analysis . Cases were DCs inserted by GWE ( n = 178 ) . They were matched with DCs inserted by VPI . Matching criteria were participating centre , simplified acute physiology score ( SAPS ) II + /-10 , insertion site ( jugular or femoral ) , side for jugular site , and length of ICU stay before DC placement . We used a marginal Cox model to estimate the effect of DC insertion ( GWE vs. VPI ) on DC colonization and dysfunction . Results DC colonization rate was not different between GWE-DCs and VPI-DCs ( 10 ( 5.6 % ) for both groups ) but DC dysfunction was more frequent with GWE-DCs ( 67 ( 37.6 % ) vs. 28 ( 15.7 % ) ; hazard ratio ( HR ) , 3.67 ( 2.07–6.49 ) ; p < 0.01 ) . Results were similar if analysis was restricted to DCs changed for dysfunction . Conclusions GWE for DCs in ICU patients , compared with VPI did not contribute to DC colonization or infection but was associated with more than twofold increase in DC dysfunction . Trial registration This study is registered with Clinical Trials.gov , number NCT00563342 . Registered 2 April 2009 Aims : The study aims to describe the use of dialysis catheters in critically ill patients treated with continuous renal replacement therapy ( CRRT ) and to study the impact of femoral versus non-femoral access on CRRT dose . Methods : Statistical analysis and predictive modelling of data from the R and omized Evaluation of Normal vs. Augmented Level renal replacement therapy trial . Results : The femoral vein was the first access site in 937 ( 67 % ) of 1,399 patients . These patients had higher Acute Physiology and Chronic Health Evaluation and Sequential Organ Failure Assessment scores ( p = 0.009 ) and lower pH ( p < 0.001 ) but similar mortality to patients with non-femoral access ( 44 vs. 45 % ; p = 0.63 ) . Lower body weight was independently associated with femoral access placement ( OR 0.97 , 95 % CI 0.96 - 0.98 ) . Femoral access was associated with a 1.03 % lower CRRT dose ( p = 0.05 ) , but a 4.20 % higher dose was achieved with 13.5 Fr catheters ( p = 0.03 ) . Conclusions : Femoral access was preferred in lighter and sicker patients . Catheter gauge had greater impact than catheter site in CRRT dose delivery . Video Journal Club “ Cappuccino with Claudio Ronco ” at http://www.karger.com/?doi=439581 From January 1986 to December 1990 we studied angiographically the subclavian-brachiocephalic vein of 100 patients dialysed by subclavian catheter for 50 ( first group ) and by internal jugular catheter for the 50 others ( second group ) . These two groups were not statistically different as regards age ( 61.6 + /- 11.3 years in the first and 61 + /- 11.1 in the second ) , sex ( 48 % and 56 % were women ) , duration of catheter insertion ( 31 + /- 21.8 and 31.7 + /- 16 days ) , and the number of dialysis sessions ( 13.5 + /- 9.1 and 13.6 + /- 7.1 ) . The type of catheters , the frequency Output:	A diferencia de la terapia de reemplazo renal para pacientes con enfermedad renal crónica donde la fístula arteriovenosa es la primera opción , seguida del catéter tunelizado , en pacientes con lesión renal aguda el acceso vascular de elección es el catéter temporal . En pacientes que cuentan con fístula arteriovenosa preexistente , su punción en pacientes con inestabilidad hemodinámica conlleva riesgos y no puede ser recomendada . The length of the access should be evaluated according to the insertion site , while 20 cm catheters are usually suitable for right jugular puncture , the left jugular usually requires 25 cm for achieving the position inside the right atrium . On the other h and , the femoral access increases its performance with lengths of 25 - 35 cm . The low posterior jugular approach is considered a simple , safe technique that allows up to 5 cm further towards the right atrium . The use of heparin 1000 U/ml for sealing the ports reduces the risk of bleeding compared to heparin 5000 U/ml .
MS21175	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE Vascular targeted photodynamic therapy with WST11 ( TOOKAD ® Soluble ) is a form of tissue ablation that may be used therapeutically for localized prostate cancer . To study dosing parameters and associated treatment effects we performed a prospect i ve , multicenter , phase I/II trial of WST11 vascular targeted photodynamic therapy of prostate cancer . MATERIAL S AND METHODS A total of 30 men with unilateral , low volume , Gleason 3 + 3 prostate cancer were enrolled at 5 centers after local institutional review board approval . Light energy , fiber number and WST11 dose were escalated to identify optimal dosing parameters for vascular targeted photodynamic therapy hemi-ablation . Men were treated with photodynamic therapy and evaluated by posttreatment magnetic resonance imaging and biopsy . Prostate specific antigen , light dose index ( defined as fiber length/desired treatment volume ) , toxicity and quality of life parameters were recorded . RESULTS After dose escalation 21 men received optimized dosing of 4 mg/kg WST11 at 200 J energy . On posttreatment biopsy residual prostate cancer was found in the treated lobe in 10 men , the untreated lobe in 4 and both lobes in 1 . At a light dose index of 1 or greater with optimal dosing in 15 men 73.3 % had a negative biopsy in the treated lobe . Six men undergoing retreatment with the optimal dose and a light dose index of 1 or greater had a negative posttreatment biopsy . Minimal effects were observed on urinary and sexual function , and overall quality of life . CONCLUSIONS Hemi-ablation of the prostate with WST11 vascular targeted photodynamic therapy was well tolerated and result ed in a negative biopsy in the treated lobe in the majority of men . Dosing parameters and the light dose index appear related to tissue response as determined by magnetic resonance imaging and biopsy . These parameters may serve as the basis for further prospect i ve studies Purpose : We assessed the midterm oncologic outcomes of vascular targeted photodynamic therapy with padeliporfin for low risk prostate cancer treatment . Material s and Methods : We prospect ively assessed all patients treated with vascular targeted photodynamic therapy for low risk prostate cancer at our center . Patients were followed every 6 months . All patients underwent prostate biopsies 6 months after treatment or when there was biological or clinical progression . The primary end point was progression‐free survival . Secondary end points were absent clinical ly significant cancer in the treated lobes , radical therapy and the prostate specific antigen rate . Variables were compared with the chi‐square , Mann‐Whitney or Wilcoxon test . Progression‐free survival is reported with Kaplan‐Meier curves . Results : A total of 82 men were treated with vascular targeted photodynamic therapy . Median followup was 68 months ( range 6 to 89 ) . Median progression‐free survival was 86 months ( 95 % CI 82–90 ) . Median prostate specific antigen decreased significantly by 41 % 6 months after treatment and it remained stable during followup ( p < 0.001 ) . A total of 115 lobes were treated and absent clinical ly significant cancer was achieved in 94 ( 82 % ) . Of the 82 patients 20 ( 24 % ) underwent radical therapy , including radical prostatectomy in 18 and brachytherapy in 2 , at a median of 22 months ( range 6 to 86 ) . Study limitations include a single arm design , small population size and midterm followup . Conclusions : Padeliporfin vascular targeted photodynamic therapy for low risk prostate cancer achieved an 82 % rate of absent clinical ly significant cancer in treated lobes and 76 % of patients avoided radical therapy at a median followup of 68 months . However , longer followup is required to determine long‐term outcomes Low-risk prostate adenocarcinoma is classically managed either with active surveillance or radical therapy ( such as external radiotherapy or radical prostatectomy ) , but both have significant side effects . Vascular-targeted photodynamic therapy ( VTP ) is a focal therapy proposed as an alternative approach for localized , low-volume , and low-Gleason score ( ≤6 ) carcinomas . We report histological modifications observed in prostate biopsies of 56 patients , performed 6 months after VTP using the photosensitizer TOOKAD ® Soluble ( WST11 ) and low-energy laser administered in the tumor area transperineally by optic fibers . In 53 patients , we observed sharply demarcated hyaline fibrotic scars , with or without rare atrophic gl and s , sometimes reduced to corpora amylacea surrounded by giant multinuclear macrophages . Mild chronic inflammation , hemosiderin , and coagulative necrosis were also observed . When residual cancer was present in a treated lobe ( 17 patients ) , it was always located outside the scar , most often close to the prostate capsule , and it showed no therapy-related modification . Histopathological interpretation of post-WST11 VTP prostate biopsies was straightforward , in contrast with that of prostate biopsies after radio or hormonal therapy , which introduces lesions difficult to interpret . VTP result ed in complete ablation of cancer in the targeted area To report on the efficacy of TOOKAD ® ( WST 09 ; NegmaLerads , Magny‐Les‐Hameaux , France ) vascular‐targeted photodynamic therapy ( VTP ) as a method of whole‐prostate ablation in patients with recurrent localized prostate cancer after the failure of external beam radiotherapy ( EBRT ) BACKGROUND AND OBJECTIVES Interstitial photodynamic therapy ( PDT ) is an emerging modality for the treatment of solid organ disease . Our group at the University of Pennsylvania has performed extensive studies that demonstrate the feasibility of interstitial PDT for prostate cancer . Our pre clinical and clinical experience is herein detailed . STUDY DESIGN / MATERIAL S AND METHODS We have treated 16 canines in pre clinical studies , and 16 human subjects in a Phase I study , using motexafin lutetium-mediated PDT for recurrent prostate adenocarcinoma . Dosimetry of light fluence , drug level and oxygen distribution for these patients were performed . RESULTS We demonstrate the safe and comprehensive treatment of the prostate using PDT . However , there is significant variability in the dose distribution and the subsequent tissue necrosis throughout the prostate . CONCLUSIONS PDT is an attractive option for the treatment of prostate adenocarcinoma . However , the observed variation in PDT dose distribution translates into uncertain therapeutic reproducibility . Our future focus will be on the development of an integrated system that is able to both detect and compensate for dose variations in real-time , in order to deliver a consistent overall PDT dose distribution BACKGROUND AND OBJECTIVES Prostate cancer is increasing in incidence , but current treatments including surgery and radiotherapy have significant side effects . This pilot study was design ed to assess the potential of photodynamic therapy ( PDT ) using meso tetra hydroxy phenyl chlorin ( mTHPC ) for organ confined prostate cancer . STUDY DESIGN / PATIENTS AND METHODS Six men with organ confined prostate cancer were photosensitised with mTHPC ( 0.15 mg/kg ) . Between 2 and 5 days later , red light ( 652 nm ) was delivered to areas of biopsy proven cancer via fibres inserted through transperineal needles ( 50 - 100 J per site ) . RESULTS After 8 of 10 PDT sessions , the prostate specific antigen ( PSA ) fell by up to 67 % . Early MRI scans showed oedema and patchy necrosis , which resolved over 2 months . Biopsies of treated areas revealed necrosis and fibrosis at 1 - 2 months . CONCLUSIONS PDT for primary prostate cancer appears safe and can reduce PSA levels . As this was a phase I study , no attempt was made to treat the whole prostate ; this or targeted tumour ablation could be attempted in a phase II study with an increased number of fibres . This technique merits further investigation in early prostate cancer To determine the optimal drug and light dose for prostate ablation using WST11 ( TOOKAD ® Soluble ) for vascular‐targeted photodynamic ( VTP ) therapy in men with low‐risk prostate cancer It is desirable to quantify the distribution of the light fluence rate , the optical properties , the drug concentration , and the tissue oxygenation for photodynamic therapy ( PDT ) of prostate cancer . We have developed an integrated system to determine these quantities before and after PDT treatment using motorized probes . The optical properties ( absorption ( micro(a ) ) , transport scattering ( micro(s ' ) , and effective attenuation ( micro(eff ) ) coefficients ) of cancerous human prostate were measured in-vivo using interstitial isotropic detectors . Measurements were made at 732 nm before and after motexafin lutetium ( MLu ) mediated PDT at different locations along each catheter . The light fluence rate distribution was also measured along the catheters during PDT . Diffuse absorption spectroscopy measurement using a white light source allows extrapolation of the distribution of oxygen saturation StO2 , total blood volume ( [Hb]t ) , and MLu concentration . The distribution of drug concentration was also studied using fluorescence from a single optical fiber , and was found to be in good agreement with the values determined by absorption spectroscopy . This study shows significant inter- and intra-prostatic variations in the tissue optical properties and MLu drug distribution , suggesting that a real-time dosimetry measurement and feedback system for monitoring these values during treatment should be considered in future PDT studies Locally recurrent prostate cancer after treatment with radiation therapy is a clinical problem with few acceptable treatments . One potential treatment , photodynamic therapy ( PDT ) , is a modality that uses laser light , drug photosensitizer , and oxygen to kill tumor cells through direct cellular cytotoxicity and /or through destruction of tumor vasculature . A Phase I trial of interstitial PDT with the photosensitizer Motexafin lutetium was initiated in men with locally recurrent prostate cancer . In this ongoing trial , the primary objective is to determine the maximally tolerated dose of Motexafin lutetium-mediated PDT . Other objectives include evaluation of Motexafin lutetium uptake from prostate tissue using a spectrofluorometric assay and evaluation of optical properties in the human prostate . Fifteen men with biopsy-proven locally recurrent prostate cancer and no evidence of distant metastatic disease have been enrolled and 14 have been treated . Treatment plans were developed using transrectal ultrasound images . The PDT dose was escalated by increasing the Motexafin lutetium dose , increasing the 732 ran light dose , and decreasing the drug-light interval . Motexafin lutetium doses ranged from 0.5 to 2 mg/kg administered IV 24 , 6 , or 3 hr prior to 732 ran light delivery . The light dose , measured in real time with in situ spherical detectors was 25 - 100 J/cm2 . Light was delivered via optical fibers inserted through a transperineal brachytherapy template in the operating room . Optical property measurements were made before and after light therapy . Prostate biopsies were obtained before and after light delivery for spectrofluorometric measurements of photosensitizer uptake . Fourteen patients have completed protocol treatment on eight dose levels without dose-limiting toxicity . Grade I genitourinary symptoms that are PDT related have been observed . One patient had Grade II urinary urgency that was urinary catheter related . No rectal or other gastrointestinal PDT-related tox-icities have been observed to date . Measurements of Motexafin lutetium demonstrated the presence of photosensitizer in prostate tissue from all patients . Optical property measurements demonstrated substantial heterogeneity in the optical properties of the human prostate gl and which supports the use of individualized treatment planning for prostate PDT PURPOSE Photodynamic therapy , using a photosensitizing drug activated by red light , can destroy localized areas of cancer with safe healing and without the cumulative toxicity associated with ionizing radiation . We used photodynamic therapy in a phase I-II study to treat patients with locally recurrent prostate cancer after radiotherapy . MATERIAL S AND METHODS Patients with an increasing prostate specific antigen ( PSA ) and biopsy proven local recurrence after radiotherapy were offered photodynamic therapy . Three days after intravenous administration of the photosensitizer meso-tetrahydroxyphenyl chlorin , light was applied using optical fibers inserted percutaneously through perineal needles positioned in the prostate with imaging guidance . Patients were followed with PSA measurements , prostate biopsies , computerized tomography or magnetic resonance imaging and question naires on urinary and sexual function . RESULTS Photodynamic therapy was given to 14 men using high light doses in 13 . Treatment was well tolerated . PSA decreased in 9 patients ( to undetectable levels in 2 ) and 5 had no viable tumor on posttreatment biopsies . After photodynamic therapy , contrast enhanced computerized tomography or magnetic resonance imaging showed necrosis involving up to 91 % of the prostate cross section . In 4 men stress incontinence developed ( troublesome in 2 and mild in 2 ) which is slowly improving . Sexual potency was impaired in 4 of the 7 men able to have intercourse before photodynamic therapy , which did not improve . There were no rectal complications directly related to photodynamic therapy , but in 1 patient a urethrorectal fistula developed following an ill-advised rectal biopsy 1 month after therapy . CONCLUSIONS Photodynamic therapy is a new option that could Output:	Conclusions The meta- analysis results shows that PDT for patients with prostate cancer can be considered as effective based on single-arm clinical trials . Meanwhile , this study reveals that there are not only low levels of side effect rates but also insignificant effect on both urinary and erectile function .
MS21176	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE -Impaired endothelial function of resistance and conduit arteries can be detected in patients with type 1 diabetes . We studied whether a persistent improvement of endothelial function can be achieved by regular physical training . RESEARCH DESIGN AND METHODS -The study included 26 patients with type 1 diabetes of 20 + /- 10 years ' duration and no overt angiopathy ; 18 patients ( 42 + /- 10 years old ) participated in a bicycle exercise training program , and 8 patients with type 1 diabetes ( 33 + /- 11 years old ) served as control subjects . Vascular function of conduit arteries was assessed by flow-mediated and endothelium-independent dilation of the brachial artery and of resistance vessels by the response of ocular fundus pulsation amplitudes to intravenous N(G)-monomethyl-L-arginine ( L-NMMA ) at baseline , after 2 and 4 months of training , and 8 months after cessation of regular exercise . RESULTS -Training increased peak oxygen uptake ( VO(2max ) ) by 13 % after 2 months and by 27 % after 4 months ( P = 0.04 ) . Flow-mediated dilation ( FMD ) of the brachial artery increased from 6.5 + /- 1.1 to 9.8 + /- 1.1 % ( P = 0.04 ) by training . L-NMMA administration decreased fundus pulsation amplitude ( FPA ) by 9.1 + /- 0.9 % before training and by 13.4 + /- 1.5 % after 4 months of training ( P = 0.02 ) . VO(2max ) , FMD , and FPA were unchanged in the control group . Vascular effects from training were abrogated 8 months after cessation of exercise . CONCLUSIONS -Our study demonstrates that aerobic exercise training can improve endothelial function in different vascular beds in patients with long-st and ing type 1 diabetes , who are at considerable risk for diabetic angiopathy . However , the beneficial effect on vascular function is not maintained in the absence of exercise OBJECTIVES This study aim ed to identify clinical features associated with premature mortality in a large contemporary cohort of adults with type 1 diabetes . RESEARCH DESIGN AND METHODS The Finnish Diabetic Nephropathy ( FinnDiane ) study is a national multicenter prospect i ve follow-up study of 4,201 adults with type 1 diabetes from 21 university and central hospitals , 33 district hospitals , and 26 primary health care centers across Finl and . RESULTS During a median 7 years of follow-up , there were 291 deaths ( 7 % ) , 3.6-fold ( 95 % CI 3.2–4.0 ) more than that observed in the age- and sex-matched general population . Excess mortality was only observed in individuals with chronic kidney disease . Individuals with normoalbuminuria showed no excess mortality beyond the general population ( st and ardized mortality ratio [ SMR ] 0.8 , 95 % CI 0.5–1.1 ) , independent of the duration of diabetes . The presence of microalbuminuria , macroalbuminuria , and end-stage kidney disease was associated with 2.8 , 9.2 , and 18.3 times higher SMR , respectively . The increase in mortality across each stage of albuminuria was equivalent to the risk conferred by preexisting macrovascular disease . In addition , the glomerular filtration rate was independently associated with mortality , such that individuals with impaired kidney function , as well as those demonstrating hyperfiltration , had an increased risk of death . CONCLUSIONS An independent grade d association was observed between the presence and severity of kidney disease and mortality in a large contemporary cohort of individuals with type 1 diabetes . These findings highlight the clinical and public health importance of chronic kidney disease and its prevention in the management of type 1 diabetes Objective : To investigate the impact of intensive lifestyle education on dietary practice s , exercise and metabolic measurements in people with insulin-dependent diabetes mellitus ( IDDM ) . Design : Sixty-one volunteer subjects with IDDM were r and omised to intensive ( Group 1 ) or st and ard ( Group 2 ) education programmes for six months . During a second six month period of observation Group 1 subjects received routine surveillance for their condition and those in Group 2 were given intensive advice ( phase 2 ) . Current insulin regimens were modified to optimise glycaemic control before the start of the intervention phase . Nutrient intakes , weight , blood pressure , glycated haemoglobin ( HbA ) , plasma lipids , lipoproteins and maximal oxygen consumption ( VO max ) were measured at the time of recruitment and at three monthly intervals during the trial and phase 2 . Setting : Department of Human Nutrition at the University of Otago . Results : Glycated haemoglobin decreased significantly in both groups between recruitment and r and omisation , the improvement being sustained during the six months of the r and omised trial and for group 1 during the six months of post trial observation . A further decrease was seen in Group 2 during the second six month period when they were given intensive advice . Comparable changes were seen with total and low density lipoprotein ( LDL ) cholesterol in Group 1 during the trial , but significant decreases were only seen in Group 2 in association with intensive intervention ( phase 2 ) . These changes occurred in parallel with increases in intakes of carbohydrate and monounsaturated fatty acids , a reduction in intakes of total and saturated fat , and an improvement in maximum oxygen consumption . Conclusions : A lifestyle programme for people with IDDM results in modest changes in diet and exercise habits sufficient to improve measures of glycaemic control and lipoprotein mediated risk of coronary heart disease independent of changes in insulin regime . More innovative approaches to achieve lifestyle changes are required to meet current recommendations which in turn are likely to produce even greater beneficial changes than those observed here . Sponsorship : This study was supported by the Eli Lilly Research Grant ( Eli Lilly and Company ( New Zeal and ) Ltd ) , The Deans Research Grant ( Otago Medical School , New Zeal and ) and The New Zeal and Dietetic Association ( Abbott Award ) Physical inactivity is highly common in adults with type 1 diabetes ( T1D ) as specific barriers ( i.e. , hypoglycemia ) may prevent them from being active . The objective of this study was to examine the efficacy of the Physical Exercise Promotion program in type 1 diabetes ( PEP-1 ) program , a group program of physical activity ( PA ) promotion ( intervention ) compared with an information leaflet ( control ) , to improve total energy expenditure ( TEE ) in adults with T1D after 12 weeks . TEE was measured with a motion sensor over a 7-day period at inclusion , after the program ( 12 weeks ) and 1-year after inclusion . The 12 weekly sessions of the program included a 30-min information session ( glycemic control and PA ) and 60 min of PA . A total of 48 adults , aged 18 to 65 years with a reported PA practice < 150 min per week , were recruited ( 45.8 % men ; aged 44.6 ± 13.3 years ; 8.0 % ± 1.1 % glycated hemoglobin ( A1c ) ) and r and omized in this pilot trial . Ninety percent of participants completed the program and 88 % completed the 1-year follow-up . No change was observed for TEE and A1c in both groups . After the 12-week program , the mean peak oxygen uptake increased ( 14 % ; p = 0.003 ) in the intervention group ; however , at the 1-year follow-up , it was no longer different from baseline . In the control group , no difference was observed for the peak oxygen uptake . These results suggest that the PEP-1 pilot program could increase cardiorespiratory fitness . However , this benefit is not sustained over a long-term period . The PEP-1 program did not increase TEE in patients with T1D and other strategies remain necessary to counteract physical inactivity in this population Summary No objective evidence has been presented to support the beneficial effect of physical training on glycaemic control in Type 1 ( insulin-dependent ) diabetic patients trained two to three times a week for several months . In the present study we examined the possibility that a daily exercise programme would be more suitable for improving glycaemic control . Thirteen patients completed a 5-month study ; 6 were r and omized to exercise training ( 20 min daily bicycle exercise ) and 7 served as non-exercising controls . The training result ed in an 8 % increase in maximal oxygen uptake ( p < 0.05 ) . No change in glycaemic control occurred during the study period in either group . In addition , serum lipid and lipoprotein levels were followed . Total cholesterol decreased during the study period irrespective of training . No effect was noted on the levels of LDL , VLDL , HDL and HDL2 cholesterol . A significant training effect was obtained in the HDL3 subfraction ( −10%,p < 0.05 ) . Total triglycerides were unchanged , but a decrease in the level of LDL triglycerides was observed with training ( −12%,p < 0.01 ) . It is concluded that , in female Type 1 diabetic patients , daily physical training for several months does not improve glycaemic control and results only in minor changes in serum lipoprotein profiles BACKGROUND Intensive diabetes therapy aim ed at achieving near normoglycemia reduces the risk of microvascular and neurologic complications of type 1 diabetes . We studied whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial ( DCCT ) affected the long-term incidence of cardiovascular disease . METHODS The DCCT r and omly assigned 1441 patients with type 1 diabetes to intensive or conventional therapy , treating them for a mean of 6.5 years between 1983 and 1993 . Ninety-three percent were subsequently followed until February 1 , 2005 , during the observational Epidemiology of Diabetes Interventions and Complications study . Cardiovascular disease ( defined as nonfatal myocardial infa rct ion , stroke , death from cardiovascular disease , confirmed angina , or the need for coronary-artery revascularization ) was assessed with st and ardized measures and classified by an independent committee . RESULTS During the mean 17 years of follow-up , 46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT , as compared with 98 events in 52 patients who had received conventional treatment . Intensive treatment reduced the risk of any cardiovascular disease event by 42 percent ( 95 percent confidence interval , 9 to 63 percent ; P=0.02 ) and the risk of nonfatal myocardial infa rct ion , stroke , or death from cardiovascular disease by 57 percent ( 95 percent confidence interval , 12 to 79 percent ; P=0.02 ) . The decrease in glycosylated hemoglobin values during the DCCT was significantly associated with most of the positive effects of intensive treatment on the risk of cardiovascular disease . Microalbuminuria and albuminuria were associated with a significant increase in the risk of cardiovascular disease , but differences between treatment groups remained significant ( P < or = 0.05 ) after adjusting for these factors . CONCLUSIONS Intensive diabetes therapy has long-term beneficial effects on the risk of cardiovascular disease in patients with type 1 diabetes BACKGROUND Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention . We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes . METHODS We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes , using Cox proportional-hazards models with adjustment for covariates measured at baseline and after r and omization . RESULTS During a median follow-up period of 5 years , 231 patients ( 2.1 % ) had at least one severe hypoglycemic episode ; 150 had been assigned to intensive glucose control ( 2.7 % of the 5571 patients in that group ) , and 81 had been assigned to st and ard glucose control ( 1.5 % of the 5569 patients in that group ) . The median times from the onset of severe hypoglycemia to the first major macrovascular event , the first major microvascular event , and death were 1.56 years ( interquartile range , 0.84 to 2.41 ) , 0.99 years ( interquartile range , 0.40 to 2.17 ) , and 1.05 years ( interquartile range , 0.34 to 2.41 ) , respectively . During follow-up , severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events ( hazard ratio , 2.88 ; 95 % confidence interval [ CI ] , 2.01 to 4.12 ) , major microvascular events ( hazard ratio , 1.81 ; 95 % CI , 1.19 to 2.74 ) , death from a cardiovascular cause ( hazard ratio , 2.68 ; 95 % CI , 1.72 to 4.19 ) , and death from any cause ( hazard ratio , 2.69 ; 95 % Output:	Exercise training did not lead to consistent changes in body mass index ( BMI ) , blood pressure , triglycerides , high-density lipoprotein cholesterol ( HDL-C ) , or low-density lipoprotein cholesterol ( LDL-C ) . In persons living with T1D , exercise training is associated with a beneficial cardiovascular profile , including improvements in lipid profile , glycemic control ( decreased daily insulin dosage and HbA1c ) , and aerobic fitness
MS21177	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective The Pragmatic Ischaemic Thrombectomy Evaluation ( PISTE ) trial was a multicentre , r and omised , controlled clinical trial comparing intravenous thrombolysis ( IVT ) alone with IVT and adjunctive intra-arterial mechanical thrombectomy ( MT ) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography ( CTA ) . Design Eligible patients had IVT started within 4.5 hours of stroke symptom onset . Those r and omised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device , with target interval times for IVT start to arterial puncture of < 90 min . The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale ( mRS ) score of 0–2 at day 90 . Results Ten UK centres enrolled 65 patients between April 2013 and April 2015 . Median National Institutes of Health Stroke Scale score was 16 ( IQR 13–21 ) . Median stroke onset to IVT start was 120 min . In the intention-to-treat analysis , there was no significant difference in disability-free survival at day 90 with MT ( absolute difference 11 % , adjusted OR 2.12 , 95 % CI 0.65 to 6.94 , p=0.20 ) . Secondary analyses showed significantly greater likelihood of full neurological recovery ( mRS 0–1 ) at day 90 ( OR 7.6 , 95 % CI 1.6 to 37.2 , p=0.010 ) . In the per- protocol population ( n=58 ) , the primary and most secondary clinical outcomes significantly favoured MT ( absolute difference in mRS 0–2 of 22 % and adjusted OR 4.9 , 95 % CI 1.2 to 19.7 , p=0.021 ) . Conclusions The trial did not find a significant difference between treatment groups for the primary end point . However , the effect size was consistent with published data and across primary and secondary end points . Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe , improves excellent clinical outcomes and , in the per- protocol population , improves disability-free survival . Trial registration number NCT01745692 ; Results Background and Purpose — Imaging findings can predict outcomes in patients with acute stroke . Relationships between imaging findings and clinical and imaging outcomes in patients r and omized to intravenous tissue-type plasminogen activator – alone versus tissue-type plasminogen activator plus endovascular therapy ( Solitaire device ) in the Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke ( SWIFT PRIME ) study were assessed . Methods — We evaluated associations between imaging assessment s ( baseline mismatch profiles/ischemic core volumes and successful reperfusion ) with imaging outcomes ( 27-hour infa rct volume/growth ) and clinical outcomes ( modified Rankin Scale scores at 90 days ) . Imaging variables that predict favorable clinical outcomes were assessed in both univariate and multivariate models . Results — One hundred and ninety-five patients were included . Successful reperfusion and infa rct volume ( assessed at 27 hours ) were powerful independent predictors of favorable clinical outcomes ( modified Rankin Scale score of 0–2 at 90 days ) . Patients with the target mismatch profile at baseline had a higher rate of reperfusion , lesser infa rct growth , smaller infa rct volumes , and better clinical outcomes in the Solitaire plus tissue-type plasminogen activator ( intervention ) group than those in the tissue-type plasminogen activator – alone ( control ) group . Patients with larger mismatch volumes at baseline had a trend toward better treatment response in the intervention group than patients who had smaller ( < 50 mL ) mismatch volumes . Conclusions — Patients who achieved reperfusion had substantially more favorable clinical and imaging outcomes in both the intervention and the control groups . Infa rct volume at 27 hours strongly correlated with clinical outcome at 90 days in both treatment groups . SWIFT PRIME patients with the target mismatch profile had a highly favorable response to endovascular therapy on both clinical and imaging outcomes . Both reperfusion and infa rct volumes at 27 hours were powerful and independent predictors of 90-day clinical outcomes . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01657461 Introduction The minimal stroke severity justifying endovascular intervention remains elusive ; however , a significant proportion of patients presenting with large vessel occlusion ( LVO ) and mild symptoms subsequently decline and face poor outcomes . Objective To evaluate our experience with these patients by comparing best medical therapy with thrombectomy in an intention-to-treat analysis . Methods Analysis of prospect ively collected data of all consecutive patients with National Institutes of Health Stroke Scale ( NIHSS ) score ≤5 , LVO on CT angiography , and baseline modified Rankin Scale ( mRS ) score 0–2 from November 2014 to May 2016 . After careful discussion with patients /family , a decision to pursue medical or interventional therapy was made . Deterioration ( development of aphasia , neglect , and /or significant weakness ) triggered reconsideration of thrombectomy . The primary outcome measure was NIHSS shift ( discharge NIHSS score minus admission NIHSS score ) . Results Of the 32 patients qualifying for the study , 22 ( 69 % ) were primarily treated with medical therapy and 10 ( 31 % ) intervention . Baseline characteristics were comparable . Nine ( 41 % ) medically treated patients had subsequent deterioration requiring thrombectomy . Median time from arrival to deterioration was 5.2 hours ( 2.0–25.0 ) . Successful reperfusion ( modified Treatment in Cerebral Infa rct ion 2b−3 ) was achieved in all 19 thrombectomy patients . The NIHSS shift significantly favored thrombectomy ( −2.5 vs 0 ; p<0.01 ) . The median NIHSS score at discharge was low with both thrombectomy ( 1 ( 0–3 ) ) and medical therapy ( 2 ( 0.5–4.5 ) ) . 90-Day mRS 0–2 rates were 100 % and 77 % , respectively ( p=0.15 ) . Multivariable linear regression indicated that thrombectomy was independently associated with a beneficial NIHSS shift ( unst and ardized β −4.2 ( 95 % CI −8.2 to −0.1 ) ; p=0.04 ) . Conclusions Thrombectomy led to a shift towards a lower NIHSS in patients with LVO presenting with minimal stroke symptoms . Despite the overall perception that this condition is benign , nearly a quarter of patients primarily treated with medical therapy did not achieve independence at 90 days Background and objective Acute ischemic stroke is a potentially devastating condition and leading cause of morbidity and mortality , affecting an estimated 800 000 people per year in the USA . The natural history of untreated or unrevascularized large vessel occlusions in acute stroke patients results in mortality rates approaching 30 % , with only 25 % achieving good neurologic outcomes at 90 days . Recently , data have demonstrated that early endovascular recanalization of large vessel occlusions results in better outcomes than medical therapy alone . However , the majority of patients in these studies were treated with a stent retriever based approach . The purpose of COMPASS is to evaluate whether patients treated with a direct aspiration first pass ( ADAPT ) approach have non-inferior functional outcomes to those treated with a stent retriever as the firstline ( SRFL ) approach . Material s and methods All patients who meet the inclusion and exclusion criteria and consent to participate will be enrolled at participating centers . Treatment will be r and omly assigned by a central web based system in a 1:1 manner to treatment with either ADAPT or SRFL thrombectomy . Statistical methodology is prespecified with details available in the statistical analysis plan . Results The trial recently completed enrollment , and data collection /verification is ongoing . The final results will be made available on completion of enrollment and follow-up . Conclusions This paper details the design of the COMPASS trial , a r and omized , blinded adjudicator , concurrent , controlled trial of patients treated with either ADAPT or SRFL approaches in order to evaluate whether ADAPT results in non-inferior functional outcome . Trial registration number NCT02466893 , Results Background and Purpose — In acute ischemic stroke , fast and complete recanalization of the occluded vessel is associated with improved outcomes . We describe a novel measure for newer generation devices : the first pass effect ( FPE ) . FPE is defined as achieving a complete recanalization with a single thrombectomy device pass . Methods — The North American Solitaire Acute Stroke Registry data base was used to identify a FPE subgroup . Their baseline features and clinical outcomes were compared with non-FPE patients . Clinical outcome measures included 90-days modified Rankin Scale score , National Institutes of Health Stroke Scale score , mortality , and symptomatic intracranial hemorrhage . Multivariate analyses were performed to determine whether FPE independently result ed in improved outcomes and to identify predictors of FPE . Results — A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry . FPE was achieved in 89 out of 354 ( 25.1 % ) . More middle cerebral artery occlusions ( 64 % versus 52.5 % ) and fewer internal carotid artery occlusions ( 10.1 % versus 27.7 % ) were present in the FPE group . Balloon guide catheters were used more frequently with FPE ( 64.0 % versus 34.7 % ) . Median time to revascularization was significantly faster in the FPE group ( median 34 versus 60 minutes ; P=0.0003 ) . FPE was an independent predictor of good clinical outcome ( modified Rankin Scale score ⩽2 was seen in 61.3 % in FPE versus 35.3 % in non-FPE cohort ; P=0.013 ; odds ratio , 1.7 ; 95 % confidence interval , 1.1–2.7 ) . The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion . Conclusions — The achievement of complete revascularization from a single Solitaire thrombectomy device pass ( FPE ) is associated with significantly higher rates of good clinical outcome . The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion Background and Purpose — The Los Angeles Motor Scale ( LAMS ) is a 3-item , 0- to 10-point motor stroke-deficit scale developed for prehospital use . We assessed the convergent , divergent , and predictive validity of the LAMS when performed by paramedics in the field at multiple sites in a large and diverse geographic region . Methods — We analyzed early assessment and outcome data prospect ively gathered in the FAST-MAG trial ( Field Administration of Stroke Therapy – Magnesium phase 3 ) among patients with acute cerebrovascular disease ( cerebral ischemia and intracranial hemorrhage ) within 2 hours of onset , transported by 315 ambulances to 60 receiving hospitals . Results — Among 1632 acute cerebrovascular disease patients ( age 70±13 years , male 57.5 % ) , time from onset to prehospital LAMS was median 30 minutes ( interquartile range 20–50 ) , onset to early postarrival ( EPA ) LAMS was 145 minutes ( interquartile range 119–180 ) , and onset to EPA National Institutes of Health Stroke Scale was 150 minutes ( interquartile range 120–180 ) . Between the prehospital and EPA assessment s , LAMS scores were stable in 40.5 % , improved in 37.6 % , and worsened in 21.9 % . In tests of convergent validity , against the EPA National Institutes of Health Stroke Scale , correlations were r=0.49 for the prehospital LAMS and r=0.89 for the EPA LAMS . Prehospital LAMS scores did diverge from the prehospital Glasgow Coma Scale , r=−0.22 . Predictive accuracy ( adjusted C statistics ) for nondisabled 3-month outcome was as follows : prehospital LAMS , 0.76 ( 95 % confidence interval 0.74–0.78 ) ; EPA LAMS , 0.85 ( 95 % confidence interval 0.83–0.87 ) ; and EPA National Institutes of Health Stroke Scale , 0.87 ( 95 % confidence interval 0.85–0.88 ) . Conclusions — In this multicenter , prospect i ve , prehospital study , the LAMS showed good to excellent convergent , divergent , and predictive validity , further establishing it as a vali date d instrument to characterize stroke severity in the field Importance Intravenous thrombolysis ( IVT ) followed by mechanical thrombectomy ( MT ) is recommended to treat acute ischemic stroke ( AIS ) with a large vessel occlusion ( LVO ) . Most hospitals do not have on-site MT facilities , and most patients need to be transferred secondarily after IVT ( drip and ship ) , which may Output:	RESULTS We found high- quality evidence to recommend MT plus best medical management ( BMM , including intravenous thrombolysis whenever indicated ) to improve functional outcome in patients with LVO-related acute ischemic stroke within 6 hours after symptom onset . MT is the st and ard of care in patients with LVO-related acute stroke .
MS21178	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose Concurrent chemoradiotherapy ( CCRT ) is recommended for the management of patients with unresectable non-small cell lung cancer ( NSCLC ) . This prospect i ve study aim ed to compare the efficacy of concurrently delivered cisplatin doublets with paclitaxel , or docetaxel , or gemcitabine . Methods The main eligibility criteria consisted of previously untreated stage IIIB NSCLC . The subjects were r and omized into three arms : paclitaxel 45 mg/m2/week ( TP ) , docetaxel 20 mg/m2/week ( DP ) , and gemcitabine 350 mg/m2/week ( GP ) in addition to cisplatin 20 mg/m2/week . Three-dimensional conformal radiotherapy was given once daily , weekly 5 fractions and the total prescription dose was 60–66 Gy . The primary endpoint was response rate , and the secondary endpoints were survival and toxicity . Results A total of 101 patients were recruited into this trial of whom 93 ( TP : 33 , DP : 29 , GP : 31 ) patients were treated with CCRT from March 2005 to July 2007 . Similar response rates were observed across arms : TP : 63.6 % , DP : 72.4 % , GP : 61.3 % ( p = 0.679 ) . There was no statistically significant difference of median survival ( TP : 27.3 , DP : 27.6 , GP : 16.5 months , p = 0.771 ) . In subgroup analysis , a survival benefit of consolidation chemotherapy was not seen , but leucopenia ( 63.2 % ) and neutropenia ( 68.4 % ) more than grade 3 were significantly high in DP arm . The grade ≥3 radiation esophagitis was more frequent in the GP arm ( 22.6 % , p = 0.163 ) . Conclusions Among the three arms , no statistically significant difference in response rate , survival , and toxicity was observed . However , clinical ly significant radiation toxicity was more frequent in the GP arm PURPOSE The phase III PROCL AIM study evaluated overall survival ( OS ) of concurrent pemetrexed-cisplatin and thoracic radiation therapy ( TRT ) followed by consolidation pemetrexed , versus etoposide-cisplatin and TRT followed by nonpemetrexed doublet consolidation therapy . PATIENTS AND METHODS Patients with stage IIIA/B unresectable nonsquamous non-small-cell lung cancer r and omly received ( 1:1 ) pemetrexed 500 mg/m(2 ) and cisplatin 75 mg/m(2 ) intravenously every 3 weeks for three cycles plus concurrent TRT ( 60 to 66 Gy ) followed by pemetrexed consolidation every 3 weeks for four cycles ( arm A ) , or st and ard therapy with etoposide 50 mg/m(2 ) and cisplatin 50 mg/m(2 ) intravenously , every 4 weeks for two cycles plus concurrent TRT ( 60 to 66 Gy ) followed by two cycles of consolidation platinum-based doublet chemotherapy ( arm B ) . The primary objective was OS . The study was design ed as a superiority trial with 80 % power to detect an OS hazard ratio of 0.74 with a type 1 error of .05 . RESULTS Enrollment was stopped early because of futility . Five hundred ninety-eight patients were r and omly assigned ( 301 to arm A , 297 to arm B ) and 555 patients ( 283 in arm A , 272 in arm B ) were treated . Arm A was not superior to arm B in terms of OS ( hazard ratio , 0.98 ; 95 % CI , 0.79 to 1.20 ; median , 26.8 v 25.0 months ; P = .831 ) . Arm A had a significantly lower incidence of any drug-related grade 3 to 4 adverse events ( 64.0 % v 76.8 % ; P = .001 ) , including neutropenia ( 24.4 % v 44.5 % ; P < .001 ) , during the overall treatment period . CONCLUSION Pemetrexed-cisplatin combined with TRT followed by consolidation pemetrexed was not superior to st and ard chemoradiotherapy for stage III unresectable nonsquamous non-small-cell lung cancer Purpose The purpose of this phase I/II study was to evaluate the feasibility and efficacy of S-1 plus cisplatin at the recommended schedule with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer ( LA-NSCLC ) . Methods Eligible patients with LA-NSCLC were treated with cisplatin intravenously at a dose of 60 mg/m2 on day 8 plus oral S-1 at a dosage of 40 mg/m2 twice per day for two different treatment schedules for up to 4 cycles . Patients also concurrently received 60 Gy of thoracic radiation in 30 fractions . The primary endpoint of the phase II study was the proportion of patients who survived for more than 2 years . Results Between August 2005 and October 2010 , a total of 45 patients were enrolled in this phase I/II study ; their long-term survival was then followed for a median period of 5.8 years . Nineteen of the 39 patients in the phase II study survived for more than 2 years and met the primary endpoint of the study . The median overall survival period was 24.9 months [ 95 % confidence interval ( CI ) 17.4–74.5 months ] , and the 2- and 5-year overall survival rates were 51.0 and 43.0 % , respectively . The response rate was 85 % , and the median progression-free survival period was 13.8 months ( 95 % CI 9.5–27.1 months ) . Hematological toxicity was mild . Grade 3 febrile neutropenia and pneumonitis was observed in 5 and 5 % , respectively . Conclusion Our study indicated that S-1 plus cisplatin with concurrent thoracic radiotherapy yielded encouraging survival outcomes and an acceptable safety profile for LA-NSCLC Background The optimal chemotherapy regimen administered currently with radiation in patients with stage III non-small cell lung cancer ( NSCLC ) remains unclear . A multicenter phase III trial was conducted to compare the efficacy of concurrent thoracic radiation therapy with either etoposide/cisplatin ( EP ) or carboplatin/paclitaxel ( PC ) in patients with stage III NSCLC . Patients and methods Patients were r and omly received 60–66 Gy of thoracic radiation therapy concurrent with either etoposide 50 mg/m2 on days 1–5 and cisplatin 50 mg/m2 on days 1 and 8 every 4 weeks for two cycles ( EP arm ) , or paclitaxel 45 mg/m2 and carboplatin ( AUC 2 ) on day 1 weekly ( PC arm ) . The primary end point was overall survival ( OS ) . The study was design ed with 80 % power to detect a 17 % superiority in 3-year OS with a type I error rate of 0.05 . Results A total of 200 patients were r and omized and 191 patients were treated ( 95 in the EP arm and 96 in the PC arm ) . With a median follow-up time of 73 months , the 3-year OS was significantly higher in the EP arm than that of the PC arm . The estimated difference was 15.0 % ( 95 % CI 2.0%–28.0 % ) and P value of 0.024 . Median survival times were 23.3 months in the EP arm and 20.7 months in the PC arm ( log-rank test P = 0.095 , HR 0.76 , 95%CI 0.55–1.05 ) . The incidence of Grade ≥2 radiation pneumonitis was higher in the PC arm ( 33.3 % versus 18.9 % , P = 0.036 ) , while the incidence of Grade ≥3 esophagitis was higher in the EP arm ( 20.0 % versus 6.3 % , P = 0.009 ) . Conclusion EP might be superior to weekly PC in terms of OS in the setting of concurrent chemoradiation for unresectable stage III NSCLC . Trial registration ID NCT01494558 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Our aim was to evaluate the efficacy and safety of cisplatin with pemtrexed or vinorelbine and concurrent late course accelerated hyperfractionated radiotherapy ( LCAHRT ) . Patients with unresectable stage III non-small-cell lung cancer ( NSCLC ) were r and omly assigned to two regimens . The experimental ( PP ) arm included cisplatin , pemtrexed and concurrent LCAHRT based on bilateral lung V20 = 33 % . The control ( NP ) arm used cisplatin , vinorelbine with the same radiotherapy protocol . The primary endpoint was overall survival . Median survival times were 26.0 months ( 95 % CI 23.2 to 28.7 months ) and 28.5 months ( 95 % CI 17.1 to 39.9 months ) for the NP and PP arms , respectively ( P = 0.26 ) . Median progression-free survival was 12.5 months and 17.5 months in the NP and PP arms ( P = 0.07 ) . In both arms of the study , there were no differences in overall survival between patients with squamous and nonsquamous NSCLC . The incidences of grade 3 or 4 toxicity were higher in NP than PP arm . With concurrent LCAHRT , pemetrexed/cisplatin was equally as efficacious as vinorelbine/cisplatin , but showed a more favorable toxicity profile OBJECTIVE To evaluate the activity and safety of concurrent thoracic radiotherapy ( TRT ) plus weekly paclitaxel/carboplatin ( PC ) regimen compared with widely used cisplatin/etoposide ( PE ) regimen in patients with unresectable stage III non-small cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients were r and omly assigned to receive the following treatments : PE arm , cisplatin ( 50mg/m(2 ) ) on days 1 , 8 , 29 , and 36 and etoposide ( 50 mg/m(2 ) ) on days 1 - 5 and 29 - 33 plus 60 Gy of TRT ; PC arm , weekly concurrent carboplatin ( AUC = 2 ) and paclitaxel ( 45 mg/m(2 ) ) plus 60 Gy of TRT . RESULTS A total of 65 patients were r and omized ( PE arm , n = 33 ; PC arm , n = 32 ) . The 3-year overall survival ( OS ) was significantly better in the PE arm than in the PC arm ( 33.1 % vs. 13 % , P = .04 ) . The incidence of Grade 3/4 neutropenia was 78.1 % in the PE arm and 51.5 % in the PC arm ( P = .05 ) . The rate of Grade 2 or greater radiation pneumonitis was 25 % in the PE arm and 48.5 % in the PC arm ( P = .09 ) . CONCLUSIONS Compared to PE regimen , weekly PC regimen can not be recommended since it failed to achieve an improvement in either OS or PFS INTRODUCTION The optimal chemotherapy with thoracic radiotherapy ( TRT ) for locally advanced non-small-cell lung cancer ( NSCLC ) remains to be established . This r and omized phase II study of concurrent chemoradiotherapy was conducted to compare uracil/tegafur ( UFT ) and cisplatin with vinorelbine and cisplatin for stage III NSCLC . PATIENTS AND METHODS Patients with unresectable stage III NSCLC were r and omized to receive UP ( 400 mg/m(2 ) UFT on days 1 - 14 and 29 - 42 and 80 mg/m(2 ) cisplatin on days 8 and 36 ) or NP ( 20 mg/m(2 ) vinorelbine on days 1 , 8 , 29 , and 36 and 80 mg/m(2 ) cisplatin on days 1 and 29 ) . TRT began on day 1 ( total 60 Gy in 30 fractions ) . RESULTS Of 70 enrolled patients , 66 were evaluable for efficacy and safety . The overall response rates were 80 % ( 95 % CI : 67 - 93 % ) and 71 % ( 95 % CI : 55 - 87 % ) for the UP arm and the NP arm . With a median follow-up of 20.2 months , the progression-free survival and median survival time were 8.8 and 26.9 months in the UP arm , and 6.8 and 21.7 months in the NP arm . The 2-/3-year survival rates were 51.0/34.3 % and 46.9/33.4 % for the UP arm and the NP arm , respectively . Grade 3/4 neutropenia occurred in 20 % and 58 % of patients in the UP and NP arms , respectively . CONCLUSION Combined Output:	In network meta- analysis , all regimen comparisons did not produce statistically significant differences in survival . Based on treatment ranking of OS and the benefit-risk ratio , S-1-cisplatin ( SP ) was likely to be the most preferable regimen for its best efficacy and low risk of causing SAEs . Gemcitabine-cisplatin ( GP ) and PC + Cetuximab ( PC-Cet ) appeared to be the worst and second-worst regimens for their poor efficacy and poor tolerability . Conclusions Based on efficacy and tolerability , SP is likely to be the most preferable regimen used concurrently with thoracic radiation for locally advanced NSCLC , followed by UP and PP .
MS21179	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Cigarette smoking is a tough addiction to break . Therefore , improved approaches to smoking cessation are necessary . The electronic-cigarette ( e-Cigarette ) , a battery-powered electronic nicotine delivery device ( ENDD ) resembling a cigarette , may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated . Methods In this prospect i ve proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers ( unwilling to quit ) experimenting the ' Categoria ' e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend a total of five study visits : at baseline , week-4 , week-8 , week-12 and week-24 . Product use , number of cigarettes smoked , and exhaled carbon monoxide ( eCO ) levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Sustained 50 % reduction in the number of cig/day at week-24 was shown in 13/40(32.5 % ) participants ; their median of 25 cigs/day decreasing to 6 cigs/day ( p < 0.001 ) . Sustained 80 % reduction was shown in 5/40(12.5 % ) participants ; their median of 30 cigs/day decreasing to 3 cigs/day ( p = 0.043 ) . Sustained smoking abstinence at week-24 was observed in 9/40(22.5 % ) participants , with 6/9 still using the e-Cigarette by the end of the study . Combined sustained 50 % reduction and smoking abstinence was shown in 22/40 ( 55 % ) participants , with an overall 88 % fall in cigs/day . Mouth ( 20.6 % ) and throat ( 32.4 % ) irritation , and dry cough ( 32.4 % ) were common , but diminished substantially by week-24 . Overall , 2 to 3 cartridges/day were used throughout the study . Participants ' perception and acceptance of the product was good . Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit ( http:// Clinical Trials.gov number NCT01195597 ) Electronic cigarettes ( e-Cigarette ) are battery-operated devices design ed to vaporise nicotine that may aid smokers to quit or reduce their cigarette consumption . Research on e-Cigarettes is urgently needed to ensure that the decisions of regulators , healthcare providers and consumers are evidence based . Here we assessed long-term effectiveness and tolerability of e-Cigarette used in a ‘ naturalistic ’ setting . This prospect i ve observational study evaluated smoking reduction/abstinence in smokers not intending to quit using an e-Cigarette ( ‘ Categoria ’ ; Arbi Group , Italy ) . After an intervention phase of 6 months , during which e-Cigarette use was provided on a regular basis , cigarettes per day ( cig/day ) and exhaled carbon monoxide ( eCO ) levels were followed up in an observation phase at 18 and 24 months . Efficacy measures included : ( a ) ≥50 % reduction in the number of cig/day from baseline , defined as self-reported reduction in the number of cig/day ( ≥50 % ) compared to baseline ; ( b ) ≥80 % reduction in the number of cig/day from baseline , defined as self-reported reduction in the number of cig/day ( ≥80 % ) compared to baseline ; ( c ) abstinence from smoking , defined as complete self-reported abstinence from tobacco smoking ( together with an eCO concentration of ≤10 ppm ) . Smoking reduction and abstinence rates were computed , and adverse events review ed . Of the 40 subjects , 17 were lost to follow-up at 24 months . A > 50 % reduction in the number of cig/day at 24 months was shown in 11/40 ( 27.5 % ) participants with a median of 24 cig/day use at baseline decreasing significantly to 4 cig/day ( p = 0.003 ) . Smoking abstinence was reported in 5/40 ( 12.5 % ) participants while combined > 50 % reduction and smoking abstinence was observed in 16/40 ( 40 % ) participants at 24 months . Five subjects stopped e-Cigarette use ( and stayed quit ) , three relapsed back to tobacco smoking and four up grade d to more performing products by 24 months . Only some mouth irritation , throat irritation , and dry cough were reported . Withdrawal symptoms were uncommon . Long-term e-Cigarette use can substantially decrease cigarette consumption in smokers not willing to quit and is well tolerated . ( http:// Clinical Trials.govnumberNCT01195597 ) Background Electronic cigarettes ( e-cigarettes or electronic nicotine delivery systems [ ENDS ] ) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and /or glycerol mist to the airway of users when drawing on the mouthpiece . Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device . People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids . However , to date there have been no adequately powered r and omised trials investigating their cessation efficacy or safety . This paper outlines the protocol for this study . Methods / design Design : Parallel group , 3-arm , r and omised controlled trial . Participants : People aged ≥18 years resident in Auckl and , New Zeal and ( NZ ) who want to quit smoking . Intervention : Stratified blocked r and omisation to allocate participants to either Elusion ™ e-cigarettes with nicotine cartridges ( 16 mg ) or with placebo cartridges ( i.e. no nicotine ) , or to nicotine patch ( 21 mg ) alone . Participants r and omised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day , while participants r and omised to patches will be told to use them daily for the same period . All participants will be offered behavioural support to quit from the NZ Quitline . Primary outcome : Biochemically verified ( exhaled carbon monoxide ) continuous abstinence at six months after quit day . Sample size : 657 people ( 292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group ) will provide 80 % power at p = 0.05 to detect an absolute difference of 10 % in abstinence between the nicotine e-cigarette and nicotine patch groups , and 15 % between the nicotine and placebo e-cigarette groups . Discussion This trial will inform international debate and policy on the regulation and availability of e-cigarettes . If shown to be efficacious and safe , these devices could help many smokers as an alternative smoking cessation aid to st and ard nicotine products . Trial registration Australian NZ Clinical Trials Registry ( ACTRN12610000866000 ) Background While electronic cigarettes are forbidden in several countries , their sales are exploding in many others . Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation , very scarce data are available on their efficacy and safety . We describe the protocol of a 5-year multicentric prospect i ve study aim ed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and /or quitting traditional cigarette smoking . The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking . Methods / design From June to December 2013 , we will enroll adult smokers of : ( EC ) e-cigarettes ( self-reported inhaling ≥ 50 puffs per week since ≥ 6 months ) ; ( TC ) traditional cigarettes ( ≥ 1 per day since ≥ 6 m ) ; ( Mixed ) both electronic and traditional cigarettes ( ≥1 per day since ≥ 6 m ) . Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops . Each subject will have to compile a structured question naire at enrolment and after 6 , 12 , 24 , 36 and 60 months . The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase , using portable carbon monoxide analyzers . The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes . Secondary outcomes include adherence to e-cigarettes , self-reported adverse events , quality of life , and time to hospital admission for one among cardiovascular diseases , chronic obstructive pulmonary diseases , cancer of the lung , esophagus , larynx , oral cavity , bladder , pancreas , kidney , stomach , cervix , and myeloid leukemia . Admissions will be checked using official discharge data of the Abruzzo Region . A minimum of 500 subjects in each group will be enrolled , for a total of 1500 participants . Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable . Discussion Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes . Trial registration The protocol has been registered ( NCT01785537 ) and approved by the Ethics Committee of the University of Chieti ( Record n. 6 ; 25 - 03 - 2013 ) Background and Aims Electronic cigarettes ( e-cigarettes ) are rapidly increasing in popularity . Two r and omized controlled trials have suggested that e-cigarettes can aid smoking cessation , but there are many factors that could influence their real-world effectiveness . This study aim ed to assess , using an established methodology , the effectiveness of e-cigarettes when used to aid smoking cessation compared with nicotine replacement therapy ( NRT ) bought over-the-counter and with unaided quitting in the general population . Design and Setting A large cross-sectional survey of a representative sample of the English population . Participants The study included 5863 adults who had smoked within the previous 12 months and made at least one quit attempt during that period with either an e-cigarette only ( n = 464 ) , NRT bought over-the-counter only ( n = 1922 ) or no aid in their most recent quit attempt ( n = 3477 ) . Measurements The primary outcome was self-reported abstinence up to the time of the survey , adjusted for key potential confounders including nicotine dependence . Findings E-cigarette users were more likely to report abstinence than either those who used NRT bought over-the-counter [ odds ratio ( OR ) = 2.23 , 95 % confidence interval ( CI ) = 1.70–2.93 , 20.0 versus 10.1 % ] or no aid ( OR = 1.38 , 95 % CI = 1.08–1.76 , 20.0 versus 15.4 % ) . The adjusted odds of non-smoking in users of e-cigarettes were 1.63 ( 95 % CI = 1.17–2.27 ) times higher compared with users of NRT bought over-the-counter and 1.61 ( 95 % CI = 1.19–2.18 ) times higher compared with those using no aid . Conclusions Among smokers who have attempted to stop without professional support , those who use e-cigarettes are more likely to report continued abstinence than those who used a licensed NRT product bought over-the-counter or no aid to cessation . This difference persists after adjusting for a range of smoker characteristics such as nicotine dependence Smoking cessation treatment is now integrated into many health-care systems and a major research effort is under way to improve current success rates . Until now results from r and omized clinical trials have been reported in many different ways , leading to problems of interpretation . We propose six st and ard criteria comprising the ' Russell St and ard ' ( RS ) . These criteria are applicable to trials of cessation aids where participants have a defined target quit date and there is face-to-face contact with research ers or clinic staff , as follows . ( 1 ) Follow-up for 6 months ( RS6 ) or 12 months ( RS12 ) from the target quit date or the end of a predefined ' grace period ' ; ( 2 ) self-report of smoking abstinence over the whole follow-up period allowing up to five cigarettes in total ; ( 3 ) biochemical verification of abstinence at least at the 6-month or 12-month follow-up point ; ( 4 ) use of an ' intention-to-treat ' approach in which data from all r and omized smokers are included in the analysis unless they have died or moved to an untraceable address ( participants who are included in the analysis are counted as smokers if their smoking status at the final follow-up can not be determined ) ; ( 5 ) following-up ' protocol violators ' and using their true smoking status in the analysis ; and ( 6 ) collecting follow-up data blind to sm Output:	A ' low ' grade means that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate . No evidence emerged that short-term EC use is associated with health risk
MS21180	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background — Diabetes mellitus and heart failure frequently coexist . However , few diabetes mellitus trials have prospect ively evaluated and adjudicated heart failure as an end point . Methods and Results — A total of 16 492 patients with type 2 diabetes mellitus and a history of , or at risk of , cardiovascular events were r and omized to saxagliptin or placebo ( mean follow-up , 2.1 years ) . The primary end point was the composite of cardiovascular death , myocardial infa rct ion , or ischemic stroke . Hospitalization for heart failure was a predefined component of the secondary end point . Baseline N-terminal pro B-type natriuretic peptide was measured in 12 301 patients . More patients treated with saxagliptin ( 289 , 3.5 % ) were hospitalized for heart failure compared with placebo ( 228 , 2.8 % ; hazard ratio , 1.27 ; 95 % confidence intercal , 1.07–1.51 ; P=0.007 ) . Corresponding rates at 12 months were 1.9 % versus 1.3 % ( hazard ratio , 1.46 ; 95 % confidence interval , 1.15–1.88 ; P=0.002 ) , with no significant difference thereafter ( time-varying interaction , P=0.017 ) . Subjects at greatest risk of hospitalization for heart failure had previous heart failure , an estimated glomerular filtration rate ⩽60 mL/min , or elevated baseline levels of N-terminal pro B-type natriuretic peptide . There was no evidence of heterogeneity between N-terminal pro B-type natriuretic peptide and saxagliptin ( P for interaction=0.46 ) , although the absolute risk excess for heart failure with saxagliptin was greatest in the highest N-terminal pro B-type natriuretic peptide quartile ( 2.1 % ) . Even in patients at high risk of hospitalization for heart failure , the risk of the primary and secondary end points were similar between treatment groups . Conclusions — In the context of balanced primary and secondary end points , saxagliptin treatment was associated with an increased risk or hospitalization for heart failure . This increase in risk was highest among patients with elevated levels of natriuretic peptides , previous heart failure , or chronic kidney disease . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01107886 Abstract Background Diabetes is associated closely with an increased risk of cardiovascular events , including diastolic dysfunction and heart failure that leads to a shortening of life expectancy . It is therefore extremely valuable to evaluate the impact of antidiabetic agents on cardiac function . However , the influence of dipeptidyl peptidase 4 inhibitors on cardiac function is controversial and a major matter of clinical concern . We therefore evaluated the effect of sitagliptin on echocardiographic parameters of diastolic function in patients with type 2 diabetes as a sub- analysis of the PROLOGUE study . Methods Patients in the PROLOGUE study were assigned r and omly to either add-on sitagliptin treatment or conventional antidiabetic treatment . Of the 463 patients in the overall study , 115 patients ( 55 in the sitagliptin group and 60 in the conventional group ) who had complete echocardiographic data of the ratio of peak early diastolic transmitral flow velocity ( E ) to peak early diastolic mitral annular velocity ( e′ ) at baseline and after 12 and 24 months were included in this study . The primary endpoint of this post hoc sub- analysis was a comparison of the changes in the ratio of E to e′ ( E/e′ ) between the two groups from baseline to 24 months . Results The baseline-adjusted change in E/e′ during 24 months was significantly lower in the sitagliptin group than in the conventional group ( −0.18 ± 0.55 vs. 1.91 ± 0.53 , p = 0.008 ) , irrespective of a higher E/e′ value at baseline in the sitagliptin group . In analysis of covariance , sitagliptin treatment was significantly associated with change in E/e′ over 24 months ( β = −9.959 , p = 0.001 ) , independent of other clinical variables at baseline such as blood pressure , HbA1c , and medications for diabetes . Changes in other clinical variables including blood pressure and glycemic parameters , and echocardiographic parameters , such as cardiac structure and systolic function , were comparable between the two groups . There was also no significant difference in the serum levels of N-terminal-pro brain natriuretic peptide and high-sensitive C-reactive protein between the two groups during the study period . Conclusions Adding sitagliptin to conventional antidiabetic regimens in patients with T2DM for 24 months attenuated the annual exacerbation in the echocardiographic parameter of diastolic dysfunction ( E/e′ ) independent of other clinical variables such as blood pressure and glycemic control . Trial registration UMIN000004490 ( University Hospital Medical Information Network Clinical Trials ) . https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005356 ; registered November 1 , BACKGROUND An association between dipeptidyl peptidase-IV ( DPP-IV ) inhibitors with worse prognosis in HF has been suggested . We aim ed to assess the serum DPP-IV levels in chronic stable HF patients and determine their association with prognosis . METHODS AND RESULTS Chronic stable HF patients with optimized prognostic-modifying therapy were prospect ively recruited . EXCLUSION CRITERIA 1 ) ejection fraction>50 % , 2 ) hospitalizations or therapeutic adjustments in the previous 2months ; 3 ) patients on renal replacement therapy , and 4 ) use of DPP-IV inhibitors . A fasting venous blood sample was collected and DPP-IV was measured . Patients were followed-up for 3years and the endpoint studied was all-cause death . Patients ' characteristics were compared according to DPP-IV quartiles . A Cox regression analysis was performed and multivariate models were built . The 3rd DPP-IV quartile was the reference category . We studied 264 patients . Mean age : 69 (±13)years , 70.5 % were male and 33.7 % diabetic . Median ( IQR ) serum DPP-IV levels were 455.6 (350.0 - 625.5)ng/mL. DPP-IV had an inverse relationship with age . Patients in 3rd DPP-IV quartile were in lower NYHA classes and had the lowest 3years all-cause mortality . Patients in the 1st DPP-IV quartile had a multivariate adjusted HR of 3-year mortality of 2.62 ( 95%CI : 1.15 - 5.95 ) when compared with reference category and the HR for the 4th quartile was of 3.79 ( 95%CI : 1.68 - 8.54 ) . CONCLUSIONS There is a U-shaped association of serum DPP-IV with mortality in chronic systolic HF patients . Patients in the 3rd DPP-IV quartile have the best multivariate adjusted 3-year survival . DPP-IV inhibition might be harmful in patients with low DPP-IV BACKGROUND The cardiovascular safety and efficacy of many current antihyperglycemic agents , including saxagliptin , a dipeptidyl peptidase 4 ( DPP-4 ) inhibitor , are unclear . METHODS We r and omly assigned 16,492 patients with type 2 diabetes who had a history of , or were at risk for , cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years . Physicians were permitted to adjust other medications , including antihyperglycemic agents . The primary end point was a composite of cardiovascular death , myocardial infa rct ion , or ischemic stroke . RESULTS A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group ( 7.3 % and 7.2 % , respectively , according to 2-year Kaplan-Meier estimates ; hazard ratio with saxagliptin , 1.00 ; 95 % confidence interval [ CI ] , 0.89 to 1.12 ; P=0.99 for superiority ; P<0.001 for noninferiority ) ; the results were similar in the " on-treatment " analysis ( hazard ratio , 1.03 ; 95 % CI , 0.91 to 1.17 ) . The major secondary end point of a composite of cardiovascular death , myocardial infa rct ion , stroke , hospitalization for unstable angina , coronary revascularization , or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group ( 12.8 % and 12.4 % , respectively , according to 2-year Kaplan-Meier estimates ; hazard ratio , 1.02 ; 95 % CI , 0.94 to 1.11 ; P=0.66 ) . More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure ( 3.5 % vs. 2.8 % ; hazard ratio , 1.27 ; 95 % CI , 1.07 to 1.51 ; P=0.007 ) . Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups ( acute pancreatitis , 0.3 % in the saxagliptin group and 0.2 % in the placebo group ; chronic pancreatitis , < 0.1 % and 0.1 % in the two groups , respectively ) . CONCLUSIONS DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events , though the rate of hospitalization for heart failure was increased . Although saxagliptin improves glycemic control , other approaches are necessary to reduce cardiovascular risk in patients with diabetes . ( Funded by AstraZeneca and Bristol-Myers Squibb ; SAVOR-TIMI 53 Clinical Trials.gov number , NCT01107886 . ) IMPORTANCE Abnormal cardiac metabolism contributes to the pathophysiology of advanced heart failure with reduced left ventricular ejection fraction ( LVEF ) . Glucagon-like peptide 1 ( GLP-1 ) agonists have shown cardioprotective effects in early clinical studies of patients with advanced heart failure , irrespective of type 2 diabetes status . OBJECTIVE To test whether therapy with a GLP-1 agonist improves clinical stability following hospitalization for acute heart failure . DESIGN , SETTING , AND PARTICIPANTS Phase 2 , double-blind , placebo-controlled r and omized clinical trial of patients with established heart failure and reduced LVEF who were recently hospitalized . Patients were enrolled between August 2013 and March 2015 at 24 US sites . INTERVENTIONS The GLP-1 agonist liraglutide ( n = 154 ) or placebo ( n = 146 ) via a daily subcutaneous injection ; study drug was advanced to a dosage of 1.8 mg/d during the first 30 days as tolerated and continued for 180 days . MAIN OUTCOMES AND MEASURES The primary end point was a global rank score in which all patients , regardless of treatment assignment , were ranked across 3 hierarchical tiers : time to death , time to rehospitalization for heart failure , and time-averaged proportional change in N-terminal pro-B-type natriuretic peptide level from baseline to 180 days . Higher values indicate better health ( stability ) . Exploratory secondary outcomes included primary end point components , cardiac structure and function , 6-minute walk distance , quality of life , and combined events . RESULTS Among the 300 patients who were r and omized ( median age , 61 years [ interquartile range { IQR } , 52 - 68 years ] ; 64 [ 21 % ] women ; 178 [ 59 % ] with type 2 diabetes ; median LVEF of 25 % [ IQR , 19%-33 % ] ; median N-terminal pro-B-type natriuretic peptide level of 2049 pg/mL [ IQR , 1054 - 4235 pg/mL ] ) , 271 completed the study . Compared with placebo , liraglutide had no significant effect on the primary end point ( mean rank of 146 for the liraglutide group vs 156 for the placebo group , P = .31 ) . There were no significant between-group differences in the number of deaths ( 19 [ 12 % ] in the liraglutide group vs 16 [ 11 % ] in the placebo group ; hazard ratio , 1.10 [ 95 % CI , 0.57 - 2.14 ] ; P = .78 ) or rehospitalizations for heart failure ( 63 [ 41 % ] vs 50 [ 34 % ] , respectively ; hazard ratio , 1.30 [ 95 % CI , 0.89 - 1.88 ] ; P = .17 ) or for the exploratory secondary end points . Prespecified subgroup analyses in patients with diabetes Output:	The results suggested that targeting the DPP-4-GLP-1 pathway can improve exercise tolerance in heart failure patients [ MD 24.88 ( 95 % CI 5.45 , 44.31 ) , P = 0.01 ] without decreasing QoL [ SMD -0.51 ( 95 % CI -1.13 , 0.10 ) , P = 0.10 ] ; additionally , targeting the DPP-4-GLP-1 pathway did not show signs of increasing the incidence of serious AEs or mortality . Conclusion Our results suggest that DPP-4 inhibitors or GLP-1 RAs improve exercise tolerance in heart failure patients . Although the use of these drugs for heart failure has not been approved by any organization , they may be a better choice for type 2 diabetes mellitus patients with heart failure .
MS21181	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Chronic intensive exercise is associated with a greater induction of oxidative stress and with an excess of endogenous advanced glycation end-products ( AGEs ) . Curcumin can reduce the accumulation of AGEs in vitro and in animal models . We examined whether supplementation with curcumin and Boswellia serrata ( BSE ) gum resin for 3 months could affect plasma levels of markers of oxidative stress , inflammation , and glycation in healthy master cyclists . Methods . Forty-seven healthy male athletes were r and omly assigned to Group 1 , consisting of 22 subjects given a Mediterranean diet ( MD ) alone ( MD group ) , and Group 2 consisted of 25 subjects given a MD plus curcumin and BSE ( curcumin/BSE group ) . Interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNFα ) , high-sensitivity c-reactive protein ( hs-CRP ) , total AGE , soluble receptor for AGE ( sRAGE ) , malondialdehyde ( MDA ) , plasma phospholipid fatty acid ( PPFA ) composition , and non-esterified fatty acids ( NEFA ) were tested at baseline and after 12 weeks . Results : sRAGE , NEFA , and MDA decreased significantly in both groups , while only the curcumin/BSE group showed a significant decline in total AGE . Only the changes in total AGE and MDA differed significantly between the curcumin/BSE and MD groups . Conclusions . Our data suggest a positive effect of supplementation with curcumin and BSE on glycoxidation and lipid peroxidation in chronically exercising master athletes LI73014F2 is a novel composition prepared from extracts of Terminalia chebula fruit , Curcuma longa rhizome , and Boswellia serrata gum resin with synergistic benefit in 5-Lipoxygenase ( 5-LOX ) inhibition . This herbal composition with strong anti-5-LOX activity exhibited significant pain relief as indicated through improvements in weight-bearing capacity in a monosodium iodoacetate-induced osteoarthritis ( OA ) model of Sprague-Dawley rats . A 90-day r and omized , placebo-controlled double-blind study evaluates the clinical efficacy and tolerability of LI73014F2 in the management of symptoms of OA of the knee ( Clinical Trial Registration No. CTRI/2014/01/004338 ) . Subjects , ( n = 105 ) , were r and omized into three groups : placebo ( n = 35 ) , 200 mg/day of LI73014F2 ( n = 35 ) , and 400 mg/day of LI73014F2 ( n = 35 ) . All study participants were evaluated for pain and physical function by using st and ard tools , that is , Visual Analog Scale , Lequesne 's Functional Index , and Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) at the baseline ( day 0 ) and on day 14 ± 3 , 30 ± 3 , 60 ± 3 , and at the end of the study ( day 90 ± 3 ) . In addition , routine examinations on biochemical parameters in serum , urine , and hematological parameters were conducted on each visit to assess the safety of the study material . At the end of the trial period , LI73014F2 conferred significant pain relief , improved physical function , and quality of life in OA patients . In conclusion , pre clinical and clinical data together strongly suggest that the herbal formulation LI73014F2 is a safe and effective intervention for management of joint discomfort , demonstrating efficacy as early as 14 days Introduction Oral curcumin decreases inflammatory cytokines and increases muscle regeneration in mice . Purpose To determine effects of curcumin on muscle damage , inflammation and delayed onset muscle soreness ( DOMS ) in humans . MethodS eventeen men completed a double-blind r and omized-controlled crossover trial to estimate the effects of oral curcumin supplementation ( 2.5 g twice daily ) versus placebo on single-leg jump performance and DOMS following unaccustomed heavy eccentric exercise . Curcumin or placebo was taken 2 d before to 3 d after eccentric single-leg press exercise , separated by 14-d washout . Measurements were made at baseline , and 0 , 24 and 48-h post-exercise comprising : ( a ) limb pain ( 1–10 cm visual analogue scale ; VAS ) , ( b ) muscle swelling , ( c ) single-leg jump height , and ( d ) serum markers of muscle damage and inflammation . St and ardized magnitude-based inference was used to define outcomes . Results At 24 and 48-h post-exercise , curcumin caused moderate-large reductions in pain during single-leg squat ( VAS scale −1.4 to −1.7 ; 90 % CL : ±1.0 ) , gluteal stretch ( −1.0 to −1.9 ; ±0.9 ) , squat jump ( −1.5 to −1.1 ; ± 1.2 ) and small reductions in creatine kinase activity ( −22–29 % ; ±21–22 % ) . Associated with the pain reduction was a small increase in single-leg jump performance ( 15 % ; 90 % CL ± 12 % ) . Curcumin increased interleukin-6 concentrations at 0-h ( 31 % ; ±29 % ) and 48-h ( 32 % ; ±29 % ) relative to baseline , but decreased IL-6 at 24-h relative to post-exercise ( −20 % ; ±18 % ) . Conclusions Oral curcumin likely reduces pain associated with DOMS with some evidence for enhanced recovery of muscle performance . Further study is required on mechanisms and translational effects on sport or vocational performance Background Curcumin is the major yellow pigment extracted from turmeric , a commonly-used spice in India and Southeast Asia that has broad anticarcinogenic and cancer chemopreventive potential . However , few systematic studies of curcumin 's pharmacology and toxicology in humans have been performed . Methods A dose escalation study was conducted to determine the maximum tolerated dose and safety of a single dose of st and ardized powder extract , uniformly milled curcumin ( C3Complex ™ , Sabinsa Corporation ) . Healthy volunteers were administered escalating doses from 500 to 12,000 mg . Results Seven of twenty-four subjects ( 30 % ) experienced only minimal toxicity that did not appear to be dose-related . No curcumin was detected in the serum of subjects administered 500 , 1,000 , 2,000 , 4,000 , 6,000 or 8,000 mg . Low levels of curcumin were detected in two subjects administered 10,000 or 12,000 mg . Conclusion The tolerance of curcumin in high single oral doses appears to be excellent . Given that achieving systemic bioavailability of curcumin or its metabolites may not be essential for colorectal cancer chemoprevention , these findings warrant further investigation for its utility as a long-term chemopreventive agent Background Exercise-Induced Muscle Damage ( EIMD ) and delayed onset muscle soreness ( DOMS ) impact subsequent training sessions and activities of daily living ( ADL ) even in active individuals . In sedentary or diseased individuals , EIMD and DOMS may be even more pronounced and present even in the absence of structured exercise . Methods The purpose of this study was to determine the effects of oral curcumin supplementation ( Longvida ® 400 mg/days ) on muscle & ADL soreness , creatine kinase ( CK ) , and inflammatory cytokines ( TNF-α , IL-6 , IL-8 , IL-10 ) following EMID ( eccentric-only dual-leg press exercise ) . Subjects ( N = 28 ) were r and omly assigned to either curcumin ( 400 mg/day ) or placebo ( rice flour ) and supplemented 2 days before to 4 days after EMID . Blood sample s were collected prior to ( PRE ) , and 1 , 2 , 3 , and 4 days after EIMD to measure CK and inflammatory cytokines . Data were analyzed by ANOVA with P < 0.05 . Results Curcumin supplementation result ed in significantly smaller increases in CK ( − 48 % ) , TNF-α ( − 25 % ) , and IL-8 ( − 21 % ) following EIMD compared to placebo . We observed no significant differences in IL-6 , IL-10 , or quadriceps muscle soreness between conditions for this sample size . Conclusions Collectively , the findings demonstrated that consumption of curcumin reduced biological inflammation , but not quadriceps muscle soreness , during recovery after EIMD . The observed improvements in biological inflammation may translate to faster recovery and improved functional capacity during subsequent exercise sessions . General significance These findings support the use of oral curcumin supplementation to reduce the symptoms of EIMD . The next logical step is to evaluate further the efficacy of an inflammatory clinical disease model We hypothesized that curcumin would improve resistance and conduit artery endothelial function and large elastic artery stiffness in healthy middle-aged and older adults . Thirty-nine healthy men and postmenopausal women ( 45 - 74 yrs ) were r and omized to 12 weeks of curcumin ( 2000 mg/day Longvida ® ; n=20 ) or placebo ( n=19 ) supplementation . Forearm blood flow response to acetylcholine infusions ( FBFACh ; resistance artery endothelial function ) increased 37 % following curcumin supplementation ( 107±13 vs. 84±11 AUC at baseline , P=0.03 ) , but not placebo ( P=0.2 ) . Curcumin treatment augmented the acute reduction in FBFACh induced by the nitric oxide synthase inhibitor NG monomethyl-L-arginine ( L-NMMA ; P=0.03 ) , and reduced the acute increase in FBFACh to the antioxidant vitamin C ( P=0.02 ) , whereas placebo had no effect ( both P>0.6 ) . Similarly , brachial artery flow-mediated dilation ( conduit artery endothelial function ) increased 36 % in the curcumin group ( 5.7±0.4 vs. 4.4±0.4 % at baseline , P=0.001 ) , with no change in placebo ( P=0.1 ) . Neither curcumin nor placebo influenced large elastic artery stiffness ( aortic pulse wave velocity or carotid artery compliance ) or circulating biomarkers of oxidative stress and inflammation ( all P>0.1 ) . In healthy middle-aged and older adults , 12 weeks of curcumin supplementation improves resistance artery endothelial function by increasing vascular nitric oxide bioavailability and reducing oxidative stress , while also improving conduit artery endothelial function The aim of this study was to analyze the effects of oral consumption of curcumin and piperine in combination on the recovery kinetics after exercise-induced muscle damage . Forty-eight hours before and following exercise-induced muscle damage , ten elite rugby players consumed curcumin and piperine ( experimental condition ) or placebo . A r and omized cross-over design was performed . Concentric and isometric peak torque for the knee extensors , one leg 6 seconds sprint performance on a non-motorized treadmill , counter movement jump performance , blood creatine kinase concentration and muscle soreness were assessed immediately after exercise , then at 24h , 48h and 72h post-exercise . There were moderate to large effects of the exercise on the concentric peak torque for the knee extensors ( Effect size ( ES ) = -1.12 ; Confidence interval at 90 % ( CI90 % ) : -2.17 to -0.06 ) , the one leg 6 seconds sprint performance ( ES=-1.65 ; CI90 % = -2.51to -0.80 ) and the counter movement jump performance ( ES = -0.56 ; CI90 % = -0.81 to -0.32 ) in the 48h following the exercise . There was also a large effect of the exercise on the creatine kinase level 72h after the exercise in the control group ( ES = 3.61 ; CI90 % : 0.24 to 6.98 ) . This decrease in muscle function and this elevation in creatine kinase indicate that the exercise implemented was efficient to induce muscle damage . Twenty four hours post-exercise , the reduction ( from baseline ) in sprint mean power output was moderately lower in the experimental condition ( -1.77 ± 7.25 % ; 1277 ± 153W ) in comparison with the placebo condition ( -13.6 ± 13.0 % ; 1130 ± 241W ) ( Effect Size = -1.12 ; Confidence Interval 90%=-1.86 to -0.86 ) . However , no other effect was found between the two conditions . Curcumin and piperine supplementation before and after exercise can attenuate some , but not all , aspects of muscle damage BACKGROUND In response to physiologic stressors , skeletal muscle has the potential to elicit wide variety of adaptive responses , such as biogenesis of mitochondria and clearance of damaged mitochondria to promote healthy muscle . The polyphenol curcumin , derived from the rhizome Curcuma long Output:	Most of the studies displayed positive effects of the curcumin supplementation for athletes and physical exercise practitioners , and no side effects were reported . Participants supplemented with curcumin displayed reduced inflammation and oxidative stress , decreased pain and muscle damage , superior recovery and muscle performance , better psychological and physiological responses ( thermal and cardiovascular ) during training and improved gastrointestinal function . Curcumin supplementation appears to be safe and beneficial for sport and physical exercise in human beings .
MS21182	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Diet is an important factor in colorectal carcinogenesis ; thus , dietary supplements may have a role in colorectal cancer prevention . OBJECTIVE The objective was to establish the relative luminal , epithelial , and epigenetic consequences of prebiotic , probiotic , and synbiotic dietary supplementation in humans . DESIGN This was a r and omized , double-blind , placebo-controlled , 4-wk crossover trial of resistant starch and Bifidobacterium lactis , either alone or as a combined synbiotic preparation , in 20 human volunteers . Rectal biopsy , feces , and serum sample s were collected . The rectal mucosal endpoints were DNA methylation at 16 CpG isl and loci and LINE-1 , epithelial proliferation ( Ki67 immunohistochemistry ) , and crypt cellularity . The fecal endpoints were short-chain fatty acid concentrations , pH , ammonia , and microbiological profiles ( by denaturing gradient gel electrophoresis and sequencing ) . Serum endpoints were a panel of cytokines and high-sensitivity C-reactive protein . RESULTS Seventeen subjects completed the entire study . The synbiotic intervention fostered a significantly different fecal stream bacterial community than did either the prebiotic ( P = 0.032 ) or the probiotic ( P = 0.001 ) intervention alone , in part because of a greater proportion of patients harboring fecal Lachnospiraceae spp . These changes developed in the absence of any significant differences in fecal chemistry . There were no differences in epithelial kinetics . CONCLUSIONS This synbiotic supplementation with B. lactis and resistant starch , in the doses used , induced unique changes in fecal microflora but did not significantly alter any other fecal , serum , or epithelial variables . This trial was registered in the Australian New Zeal and Clinical Trials Registry at www.anzctr.org.au as ACTRN012606000115538 Objective : This study investigated the effects of oral supplementation of resistant starch ( RS ) on tumour cell and colonic mucosal cell kinetics and on gene expression in patients with colorectal cancer ( CRC ) , and its potential role in colon cancer prevention . Methods : 65 patients with CRC were r and omised to treatment with RS or ordinary starch ( OS ) and were given starch treatment for up to 4 weeks . Pretreatment and post-treatment biopsies were obtained from the tumour and colonic mucosa , and the effects of the starch treatment on cell proliferation and expression of the cell cycle regulatory genes CDK4 ( cyclin-dependent kinase 4 ) and GADD45A ( growth arrest and DNA damage-inducible , alpha ) were investigated . Results : The proportion of mitotic cells in the top half of the colonic crypt was significantly lower following RS treatment ( 3.1 ( 1.5 ) , mean ( SEM ) ) as compared with OS treatment ( 13.7 ( 3.2 ) ) ( p = 0.028 ) . However , there was no effect of RS treatment on crypt dimensions and tumour cell proliferation index . There was significant upregulation in expression of CDK4 ( p<0.01 ) and downregulation in expression of GADD45A ( p<0.001 ) in the tumour tissue when compared with macroscopically normal mucosa . Following RS treatment , CDK4 expression in tumours ( 0.88 ( 0.15 ) ) was twofold higher than that in the OS group ( 0.37 ( 0.16 ) ) ( p = 0.02 ) . The expression of GADD45A , which was downregulated in the presence of cancer , was significantly upregulated ( p = 0.048 ) following RS treatment ( 1.41 ( 0.26 ) ) as compared with OS treatment ( 0.56 ( 0.3 ) ) . However , there were no significant differences in the expression of these genes in the normal mucosa following starch treatment . Conclusions : Cell proliferation in the upper part of colonic crypts is a premalignant marker and its reduction by RS supplementation is consistent with an antineoplastic action of this food component . Differential expression of the key cell cycle regulatory genes may contribute to the molecular mechanisms underlying these antineoplastic effects of RS . Trial registration number : IS RCT N93586244 BACKGROUND Animal studies suggest that prebiotics and probiotics exert protective effects against tumor development in the colon , but human data supporting this suggestion are weak . OBJECTIVE The objective was to verify whether the prebiotic concept ( selective interaction with colonic flora of nondigested carbohydrates ) as induced by a synbiotic preparation-oligofructose-enriched inulin ( SYN1 ) + Lactobacillus rhamnosus GG ( LGG ) and Bifidobacterium lactis Bb12 (BB12)-is able to reduce the risk of colon cancer in humans . DESIGN The 12-wk r and omized , double-blind , placebo-controlled trial of a synbiotic food composed of the prebiotic SYN1 and probiotics LGG and BB12 was conducted in 37 colon cancer patients and 43 polypectomized patients . Fecal and blood sample s were obtained before , during , and after the intervention , and colorectal biopsy sample s were obtained before and after the intervention . The effect of synbiotic consumption on a battery of intermediate bio-markers for colon cancer was examined . RESULTS Synbiotic intervention result ed in significant changes in fecal flora : Bifidobacterium and Lactobacillus increased and Clostridium perfringens decreased . The intervention significantly reduced colorectal proliferation and the capacity of fecal water to induce necrosis in colonic cells and improve epithelial barrier function in polypectomized patients . Genotoxicity assays of colonic biopsy sample s indicated a decreased exposure to genotoxins in polypectomized patients at the end of the intervention period . Synbiotic consumption prevented an increased secretion of interleukin 2 by peripheral blood mononuclear cells in the polypectomized patients and increased the production of interferon gamma in the cancer patients . CONCLUSIONS Several colorectal cancer biomarkers can be altered favorably by synbiotic intervention Background To systematic ally develop dietary strategies based on resistant starch ( RS ) that modulate the human gut microbiome , detailed in vivo studies that evaluate the effects of different forms of RS on the community structure and population dynamics of the gut microbiota are necessary . The aim of the present study was to gain a community wide perspective of the effects of RS types 2 ( RS2 ) and 4 ( RS4 ) on the fecal microbiota in human individuals . Methods and Findings Ten human subjects consumed crackers for three weeks each containing either RS2 , RS4 , or native starch in a double-blind , crossover design . Multiplex sequencing of 16S rRNA tags revealed that both types of RS induced several significant compositional alterations in the fecal microbial population s , with differential effects on community structure . RS4 but not RS2 induced phylum-level changes , significantly increasing Actinobacteria and Bacteroidetes while decreasing Firmicutes . At the species level , the changes evoked by RS4 were increases in Bifidobacterium adolescentis and Parabacteroides distasonis , while RS2 significantly raised the proportions of Ruminococcus bromii and Eubacterium rectale when compared to RS4 . The population shifts caused by RS4 were numerically substantial for several taxa , leading for example , to a ten-fold increase in bifidobacteria in three of the subjects , enriching them to 18–30 % of the fecal microbial community . The responses to RS and their magnitudes varied between individuals , and they were reversible and tightly associated with the consumption of RS . Conclusion Our results demonstrate that RS2 and RS4 show functional differences in their effect on human fecal microbiota composition , indicating that the chemical structure of RS determines its accessibility by groups of colonic bacteria . The findings imply that specific bacterial population s could be selectively targeted by well design ed functional carbohydrates , but the inter-subject variations in the response to RS indicates that such strategies might benefit from more personalized approaches The potential ' nutritional advantages ' of probiotics and prebiotics consist of preventive , and sometimes curative , effects against certain diseases . The evidence supporting such advantages , which requires r and omised controlled trials and consistency of results from study to study , is rapidly increasing . This article summarizes the effects against diseases of intestinal origin . There is a high level of evidence for positive effects of some prebiotics to alleviate constipation and treat hepatic encephalopathy . Interesting aspects , but with a lower level of evidence at the present time , include prevention of colon cancer , intestinal infection , and recurrence of inflammatory bowel disease . There is a high level of evidence for positive effects of some probiotics in the alleviation of lactose intolerance , antibiotic-associated intestinal disorders and gastroenteritis . Evidence is rapidly growing regarding the prevention of recurrence of inflammatory bowel diseases . Positive trials have suggested preventive effects against intestinal colonization with specific gut pathogens including Clostridium difficile and Helicobacter pylori Certain nondigestible oligosaccharides can be selectively utilized by probiotics and reduce the risk of colon cancer . However , the inhibitory effects of xylooligosaccharides ( XOS ) on colon cancer are not well documented . This study evaluated the effects of xylooligosaccharides and fructooligosaccharides ( FOS ) on the alteration of cecal microbiota , cecal pH , cecal weight , and serum lipid levels , and also their inhibitory effect on precancerous colon lesions in male Sprague-Dawley rats . The rats were r and omly assigned to 4 groups : control , treatment with 1,2-dimethylhydrazine ( DMH ) [ 15 mg/(kg body wt.wk ) for 2 wk ] , treatment with DMH + 60 g XOS/kg diet , and treatment with DMH + 60 g FOS/kg diet . Rats were fed the experimental diets for 35 d , beginning 1 wk after the second dose of DMH . Both XOS and FOS markedly decreased the cecal pH and serum triglyceride concentration , and increased the total cecal weight and bifidobacteria population . XOS had a greater effect on the bacterial population than did FOS . Moreover , both XOS and FOS markedly reduced the number of aberrant crypt foci in the colon of DMH-treated rats . These results suggest that XOS and FOS dietary supplementation may be beneficial to gastrointestinal health , and indicate that XOS is more effective than FOS BACKGROUND Nondigestible oligosaccharides have been cl aim ed to benefit the health of the colon by selectively stimulating the growth of bifidobacteria and by decreasing the toxicity of the colon contents . OBJECTIVE We compared the effect of 2 doses of transgalactooligosaccharides and a placebo on the composition and activity of the intestinal microflora in 18 women and 22 men . DESIGN Strictly controlled experimental diets were supplied to 3 intervention groups in a parallel design . The study was divided into 2 consecutive 3-wk periods during which each participant consumed a run-in diet followed by an intervention diet that differed only in the amount of transgalactooligosaccharides : 0 ( placebo ) , 7.5 , and 15 g/d . Breath sample s and fecal sample s were collected at the end of both the run-in and intervention periods . RESULTS Apparent fermentability of transgalactooligosaccharides was 100 % . The highest dose of transgalactooligosaccharides significantly increased the concentration of breath hydrogen by 130 % ( P < 0.01 ) and the nitrogen density of the feces by 8.5 % ( P < 0.05 ) . The number of bifidobacteria increased after both placebo and transgalactooligosaccharides ingestion , but the differences between these increases were not significantly different . Transgalactooligosaccharides did not significantly affect bowel habits ; stool composition ; the concentration of short-chain fatty acids or bile acids in fecal water ; the concentration of ammonia , indoles , or skatoles in feces ; fecal pH ; or the composition of the intestinal microflora . CONCLUSION We conclude that transgalactooligosaccharides are completely fermented in the human colon , but do not beneficially change the composition of the intestinal microflora , the amount of protein fermentation products in feces , or the profile of bile acids in fecal water 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 b Output:	Lactulose reduced adenoma recurrence , while resistant starch had no effect on adenoma or CRC development . Crypt mitotic location , gene expression , and DNA methylation were somewhat improved after resistant starch consumption . No changes in cell proliferation and apoptosis , crypt morphology , or aberrant crypt foci were found .
MS21183	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In a double-blind , r and omized , controlled study , the effectiveness of treatment with a combination of Benfotiamine ( an Allithiamine , a lipid-soluble derivative of vitamin B1 with high bioavailability ) plus vitamin B6/B12 on objective parameters of neuropathy was studied over a period of 12 weeks on 24 diabetic patients with diabetic polyneuropathy . The results showed a significant improvement ( p = 0.006 ) of nerve conduction velocity in the peroneal nerve and a statistical trend toward improvement of the vibration perception threshold . Long-term observation of 9 patients with verum over a period of 9 months support the results . Therapy-specific adverse effects were not seen . The results of this double-blind investigation , of the long-term observation and of the reports in the literature support the contention that the neurotropic benfotiamine-vitamin B combination represents a starting point in the treatment of diabetic polyneuropathy Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND Diabetes is the most important cause of peripheral neuropathy ( DPN ) . No definitive treatment for DPN has been established , and very few data on the role of exercise training on DPN have been reported . AIM OF THE STUDY We sought to examine the effects of long-term exercise training on the development of DPN in both Types 1 and 2 diabetic patients . PARTICIPANTS AND METHODS Seventy-eight diabetic patients without signs and symptoms of peripheral DPN were enrolled , r and omized , and subdivided in two groups : 31 diabetic participants [ 15 f , 16 m ; 49+/-15.5 years old ; body mass index ( BMI ) = 27.9+/-4.7 ] , who performed a prescribed and supervised 4 h/week brisk walking on a treadmill at 50 % to 85 % of the heart rate reserve ( exercise group : EXE ) , and a control group of 47 diabetic participants ( CON ; 24 f , 23 m ; 52.9+/-13.4 years old ; BMI = 30.9+/-8.4 ) . Vibration perception threshold ( VPT ) , nerve distal latency ( DL ) , nerve conduction velocity ( NCV ) , and nerve action potential amplitude ( NAPA ) in the lower limbs were measured . RESULTS We found significant differences on Delta ( delta ) in NCV for both peroneal and sural motor nerve between the EXE and CON groups during the study period ( P<.001 , for both ) . The percentage of diabetic patients that developed motor neuropathy and sensory neuropathy during the 4 years of the study was significantly higher in the CON than the EXE group ( 17 % vs. 0.0 % , P<.05 , and 29.8 % vs. 6.45 % , P<.05 , respectively ) . In addition , the percentage of diabetic patients who developed increased VPT ( 25 V ) during the study was significantly higher in the CON than the EXE group ( 21.3 % vs. 12.9 % , P<.05 ) . Change on Hallux VPT from baseline to the end of the study was significantly different between the EXE and CON groups ( P<.05 ) ; no significant change in Malleolus VPT between the two groups occurred . CONCLUSIONS This study suggests , for the first time , that long-term aerobic exercise training can prevent the onset or modify the natural history of DPN BACKGROUND Improved blood-glucose control decreases the progression of diabetic microvascular disease , but the effect on macrovascular complications is unknown . There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation . We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a r and omised controlled trial . METHODS 3867 newly diagnosed patients with type 2 diabetes , median age 54 years ( IQR 48 - 60 years ) , who after 3 months ' diet treatment had a mean of two fasting plasma glucose ( FPG ) concentrations of 6.1 - 15.0 mmol/L were r and omly assigned intensive policy with a sulphonylurea ( chlorpropamide , glibenclamide , or glipizide ) or with insulin , or conventional policy with diet . The aim in the intensive group was FPG less than 6 mmol/L. In the conventional group , the aim was the best achievable FPG with diet alone ; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment : any diabetes-related endpoint ( sudden death , death from hyperglycaemia or hypoglycaemia , fatal or non-fatal myocardial infa rct ion , angina , heart failure , stroke , renal failure , amputation [ of at least one digit ] , vitreous haemorrhage , retinopathy requiring photocoagulation , blindness in one eye , or cataract extraction ) ; diabetes-related death ( death from myocardial infa rct ion , stroke , peripheral vascular disease , renal disease , hyperglycaemia or hypoglycaemia , and sudden death ) ; all-cause mortality . Single clinical endpoints and surrogate sub clinical endpoints were also assessed . All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy . FINDINGS Over 10 years , haemoglobin A1c ( HbA1c ) was 7.0 % ( 6.2 - 8.2 ) in the intensive group compared with 7.9 % ( 6.9 - 8.8 ) in the conventional group -- an 11 % reduction . There was no difference in HbA1c among agents in the intensive group . Compared with the conventional group , the risk in the intensive group was 12 % lower ( 95 % CI 1 - 21 , p=0.029 ) for any diabetes-related endpoint ; 10 % lower ( -11 to 27 , p=0.34 ) for any diabetes-related death ; and 6 % lower ( -10 to 20 , p=0.44 ) for all-cause mortality . Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25 % risk reduction ( 7 - 40 , p=0.0099 ) in microvascular endpoints , including the need for retinal photocoagulation . There was no difference for any of the three aggregate endpoints between the three intensive agents ( chlorpropamide , glibenclamide , or insulin ) . Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis ( both p<0.0001 ) . The rates of major hypoglycaemic episodes per year were 0.7 % with conventional treatment , 1.0 % with chlorpropamide , 1.4 % with glibenclamide , and 1.8 % with insulin . Weight gain was significantly higher in the intensive group ( mean 2.9 kg ) than in the conventional group ( p<0.001 ) , and patients assigned insulin had a greater gain in weight ( 4.0 kg ) than those assigned chlorpropamide ( 2.6 kg ) or glibenclamide ( 1.7 kg ) . INTERPRETATION Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications , but not macrovascular disease , in patients with type 2 diabetes . ( ABSTRACT TRUNCATED We studied the clinical and neurophysiological effects of methylcobalamin on patients with diabetic neuropathy . In a double-blind study , the active group showed statistical improvement in the somatic and autonomic symptoms with regression of signs of diabetic neuropathy . Motor and sensory nerve conduction studies showed no statistical improvement after 4 months . The drug was easily tolerated by the patients and no side effects were encountered The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Forty five insulin dependent diabetics were r and omised to treatment with continuous subcutaneous insulin infusion ( CSII ) , multiple insulin injections ( five or six daily ) , or conventional twice daily insulin injections . Near normoglycaemia was obtained with CSII and multiple injections but not with conventional treatment ( p less than 0.01 ) . Hypoglycaemic coma was observed less frequently with CSII than with multiple injections and conventional treatment ( p less than 0.001 ) , but blood glucose concentrations below 2.5 mmol/l ( 45 mg/100 ml ) were more common . After two years fewer retinal microaneurysms and haemorrhages had developed in the patients given CSII and multiple injections compared with those given conventional treatment , in whom the number had increased significantly ( p less than 0.01 ) . Motor nerve conduction velocity deteriorated in the patients given conventional treatment ; in those given CSII it was unchanged during the first year but had improved after two years ( p less than 0.01 ) . Glomerular hyperfiltration was reduced with CSII , but no change occurred in urine albumin excretion rates . Long term near normoglycaemia may prevent the progression of early stages of late diabetic complications OBJECTIVE To evaluate the effects of Shenmai Huoxue Decoction ( SMHXD ) on early diabetic peripheral neuropathy ( DPN ) in rats . METHODS The rats were r and omly divided into 3 groups : normal group , diabetic model group and SMHXD-treated diabetic group . The diabetic rats were induced by streptozotocin ( STZ ) intraperitoneally . After the treatment , sensory nerve conduction velocity ( SNCV ) of caudal nerve was detected with evoked electromyography , and the activity of aldose reductase ( AR ) in erythrocytes and the concentration of endothelin ( ET ) in plasma were measured . RESULTS It was showed that the SNCV reduced significantly and the activity of AR in erythrocytes and the concentration of ET in plasma were increased significantly in diabetic group as compared with those in the normal group . The SNCV was increased , and the activity of AR in erythrocytes and the concentration of ET in plasma were improved significantly in SMHXD-treated diabetic group after the treatment . CONCLUSION The results indicate that SMHXD can alleviate the lesion of DPN in the early stage of diabetic rats BACKGROUND Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus ( IDDM ) . We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications . METHODS A total of 1441 patients with IDDM--726 with no retinopathy at base line ( the primary -prevention cohort ) and 715 with mild retinopathy ( the secondary -intervention cohort ) were r and omly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections . The patients were followed for a mean of 6.5 years , and the appearance and progression of retinopathy and other complications were assessed regularly . RES Output:	Adverse effects were reported in all of the ten included studies , and well tolerated in all patients with DPN . Despite of the apparently positive findings and low risk of bias , it is premature to conclude the efficacy of CHMs for the treatment of DPN because of the high clinical heterogeneity and small sample sizes of the included studies . However , CHM therapy was safe for DPN .
MS21184	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We recently published the results of a r and omised controlled trial of a nurse telephone consultation service in primary care out of hours.1 The new service , operating at evenings and weekends , significantly reduced general practitioners ’ workload and was at least as safe as the existing out of hours service . Contacts diminish sharply after about 10 pm,2 and , anecdotally , a higher proportion of night calls necessitate consultation with a general practitioner . We report here a parallel trial aim ed at establishing whether nurse telephone consultation was equally effective in managing workload at night Objective : To investigate the potential impact for ambulance services of telephone assessment and triage for callers who present with non-serious problems ( Category C calls ) as classified by ambulance service call takers . Design : Pragmatic controlled trial . Calls identified using priority dispatch protocol s as non-serious were allocated to intervention and control groups according to time of call . Ambulance dispatch occurred according to existing procedures . During intervention sessions , nurses or paramedics within the control room used a computerised decision support system to provide telephone assessment , triage and , if appropriate , offer advice to permit estimation of the potential impact on ambulance dispatch . Setting : Ambulance services in London and the West Midl and s. Subjects : Patients for whom emergency calls were made to the ambulance services between April 1998 and May 1999 during four hour sessions sample d across all days of the week between 0700 and 2300 . Main outcome measures : Triage decision , ambulance cancellation , attendance at an emergency department . Results : In total , there were 635 intervention calls and 611 controls . Of those in the intervention group , 330 ( 52.0 % ) were triaged as not requiring an emergency ambulance , and 119 ( 36.6 % ) of these did not attend an emergency department . This compares with 55 ( 18.1 % ) of those triaged by a nurse or paramedic as requiring an ambulance ( odds ratio 2.62 ; 95 % CI 1.78 to 3.85 ) . Patients triaged as not requiring an emergency ambulance were less likely to be admitted to an inpatient bed ( odds ratio 0.55 ; 95 % CI 0.33 to 0.93 ) , but even so 30 ( 9.2 % ) were admitted . Nurses were more likely than paramedics to triage calls into the groups classified as not requiring an ambulance . After controlling for age , case mix , time of day , day of week , season , and ambulance service , the results of a logistic regression analysis revealed that this difference was significant with an odds ratio for nurses : paramedics of 1.28 ( 95 % CI 1.12 to 1.47 ) . Conclusions : The findings indicate that telephone assessment of Category C calls identifies patients who are less likely to require emergency department care and that this could have a significant impact on emergency ambulance dispatch rates . Nurses were more likely than paramedics to assess calls as requiring an alternative response to emergency ambulance despatch , but the extent to which this relates to aspects of training and professional perspective is unclear . However , consideration should be given to the acceptability , reliability , and cost consequences of this intervention before it can be recommended for full evaluation OBJECTIVE To determine the safety and effectiveness of nurse telephone consultation in out of hours primary care by investigating adverse events and the management of calls . DESIGN Block r and omised controlled trial over a year of 156 matched pairs of days and weekends in 26 blocks . One of each matched pair was r and omised to receive the intervention . SETTING One 55 member general practice cooperative serving 97 000 registered patients in Wiltshire . SUBJECTS All patients contacting the out of hours service or about whom contact was made during specified times over the trial year . INTERVENTION A nurse telephone consultation service integrated within a general practice cooperative . The out of hours period was 615 pm to 1115 pm from Monday to Friday , 1100 am to 1115 pm on Saturday , and 800 am to 1115 pm on Sunday . Experienced and specially trained nurses received , assessed , and managed calls from patients or their carers . Management options included telephone advice ; referral to the general practitioner on duty ( for telephone advice , an appointment at a primary care centre , or a home visit ) ; referral to the emergency service or advice to attend accident and emergency . Calls were managed with the help of decision support software . MAIN OUTCOME MEASURES Deaths within seven days of a contact with the out of hours service ; emergency hospital admissions within 24 hours and within three days of contact ; attendance at accident and emergency within three days of a contact ; number and management of calls in each arm of the trial . RESULTS 14 492 calls were received during the specified times in the trial year ( 7308 in the control arm and 7184 in the intervention arm ) concerning 10 134 patients ( 10.4 % of the registered population ) . There were no substantial differences in the age and sex of patients in the intervention and control groups , though male patients were underrepresented overall . Reasons for calling the service were consistent with previous studies . Nurses managed 49.8 % of calls during intervention periods without referral to a general practitioner . A 69 % reduction in telephone advice from a general practitioner , together with a 38 % reduction in patient attendance at primary care centres and a 23 % reduction in home visits was observed during intervention periods . Statistical equivalence was observed in the number of deaths within seven days , in the number of emergency hospital admissions , and in the number of attendances at accident and emergency departments . Conclusions Nurse telephone consultation produced substantial changes in call management , reducing overall workload of general practitioners by 50 % while allowing callers faster access to health information and advice . It was not associated with an increase in the number of adverse events . This model of out of hours primary care is safe and effective The authors examined the effect of after-hours telephone access to physicians and physician access to computerized medical records on hospitalizations and emergency room ( ER ) visits in an inner-city , adult , general medicine clinic . Patients were r and omly assigned to a control ( C ) and two study groups ( S1 and S2 ) . Patients in study groups S1 and S2 had after-hours telephone access to physicians . Computerized medical records were accessible to physicians only for callers in study group S2 . During the initial 18 months of study , only 7.6 % of eligible patients called the after-hours service , a rate of 6 calls/1,000 patients / month ( 200 calls/1,849 patients /18 months ) . Repeated promotion of the service was subsequently undertaken , and 19.4 % of the patients used the service during the final 12 months of study , a rate of 24.1 calls/1,000 patients /month ( 467 calls/1,616 patients /12 months ) . There were no significant differences in hospitalizations or ER visits among the control and two study groups A r and omized clinical trial of pediatric protocol s administered by health assistants demonstrated an alternate method of h and ling telephone complaints in a large emergency room . The new system advised a higher medical examination rate than the current system in the emergency room probably bacause the current system has deficits with respect to collecting necessary information and making explicit decisions . This higher rate of recommended visits demonstrated in the emergency room was not confirmed in the two pediatric primary -care setting s in which the protocol system was also tested . In addition to this use , the telephone protocol s may also be useful in training medical and nursing students , in h and ling telephone complaints similar to a poison control center , in triaging problems in a rural or emergency medical service , and in providing a record of the telephone call BACKGROUND After-hours telephone calls are a stressful and frustrating aspect of pediatric practice . At the request of private practice pediatricians in Denver , a metropolitan area-wide system was created to manage after-hours pediatric telephone calls and after-hours patient care . This system , the After-Hours Program ( AHP ) , uses specially trained pediatric nurses with st and ardized protocol s to provide after-hours telephone triage and advice for the patients of 92 Denver pediatricians , representing 56 practice s. OBJECTIVES This report describes the AHP , presents data from 4 years ' experience with the program , and describes results of our evaluation of the following aspects of the program : subscribing physician satisfaction , parent satisfaction , the accuracy and appropriateness of telephone triage , and program costs . METHODS After-Hours Program records ( including quality assurance data ) for all 4 years of operation were retrospectively review ed , tabulated , and analyzed . The results of two subscribing physician surveys and one parent caller satisfaction survey are presented . A retrospective review of after-hours patient care encounter forms assessed the necessity for after-hours visits triaged by the AHP . An analysis of the total cost of this program to 10 r and omly selected subscribing physicians was conducted using current AHP data and a survey of the 10 physicians . RESULTS In 4 years , 107,938 calls have been successfully managed without an adverse clinical outcome . Minor errors in using protocol s occurred in one call out of 1450 after-hours calls . After-hours phoen calls necessitated an after-hours patient visit 20 % of the time and generated one after-hours hospital admission out of every 88 calls . Just over half of the patients were managed with home care advice only , and 28 % were given home care advice after-hours and seen the next day in the primary physician 's office . Of all patients directed by the telephone triage nurses to be seen after hours , 78 % were determined to have a condition necessitating after-hours care . Data are presented regarding call volumes by time of day , day of week , patient age , and patient 's initial complaint . The 6 most common complaints accounted for more than one half of the calls , and 38 complaints accounted for more than 95 % of all after-hours calls . Utilization by subscribing physicians is described . Satisfaction among subscribing pediatricians was 100 % , and among parents was 96 % to 99 % on a variety of issues . The total cost to participating Denver pediatricians ( which includes revenues " given up " as a result of not seeing patients after hours ) ranged from 1 % to 12 % of their annual net income , depending on a variety of factors . CONCLUSIONS Large-scale after-hours telephone coverage systems can be effective and well-received by patients , parents , and primary physicians . Data presented in this report can assist in planning the training of personnel who provide after-hours telephone advice and triage . Controversies associated with this type of program are discussed . Suggestions are made regarding the direction of future programs and research The purpose of this research was to determine whether a specialized telephone service could cut down on unscheduled visits to ambulatory care and improve satisfaction with care . Patients who were to receive care ( N=561 ) were assigned r and omly to a specialized telephone service or a control group . They were measured with regard to satisfaction with care before being assigned and 6 months later . The number of scheduled and unscheduled visits also were monitored for a 1-year follow-up period . The telephone service , which provided a triage system for referrals as well as a source of central contact for scheduling or for complaints , helped to improve satisfaction and reduce the number of unscheduled visits within 6 months . Such a service also may have application in other problem areas in the delivery of quality ambulatory care STUDY OBJECTIVES We sought to compare triage design ations derived from in-person and telephone interviews and systematic ally examine the effect of visual cues , vital signs , and complaint-based protocol s on the triage process . METHODS We conducted a 2-phase , prospect i ve , observational study employing a r and omized , crossover design in a university teaching hospital emergency department . In both phases , every eligible patient underwent sequential in-person and telephone triage interviews conducted by certified ED triage nurses . After taking a history , each nurse chose 1 of 5 hypothetical triage design ations and , after being told the patient 's vital signs , again selected a design ation . Phase 1 design ations were based solely on nurses ' clinical expertise . In phase 2 , both nurses used complaint-based protocol s. RESULTS Agreement between telephone and in-person design ations was poor ( percent agreement , 43.1 % to 48.8 % ; kappa,.19 to.26 ; taub,.34 to.45 for the 4 primary comparisons ) . Knowledge of vital signs and use of protocol s did not improve agreement or increase identification of patients requiring admission to hospital . CONCLUSION These data establish that telephone and in-person triage are not equivalent and suggest that visual cues may play an important role in the triage process . It is unclear whether telephone triage is an adequate method of assigning patients to an appropriate level of care Output:	Although telephone consultation appears to have the potential to reduce GP workload , questions remain about its effect on service use .
MS21185	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective Small food store interventions show promise to increase healthy food access in under-re source d areas . However , none have tested the impact of price discounts on healthy food supply and dem and . We tested the impact of store-directed price discounts and communications strategies , separately and combined , on the stocking , sales and prices of healthier foods and on storeowner psychosocial factors . Design Factorial design r and omized controlled trial . Setting Twenty-four corner stores in low-income neighbourhoods of Baltimore City , MD , USA . Subjects Stores were r and omized to pricing intervention , communications intervention , combined pricing and communications intervention , or control . Stores that received the pricing intervention were given a 10–30 % price discount by wholesalers on selected healthier food items during the 6-month trial . Communications stores received visual and interactive material s to promote healthy items , including signage , taste tests and refrigerators . Results All interventions showed significantly increased stock of promoted foods υ . control . There was a significant treatment effect for daily unit sales of healthy snacks ( β = 6·4 , 95 % CI 0·9 , 11·9 ) and prices of healthy staple foods ( β = −0·49 , 95 % CI −0·90 , −0·03 ) for the combined group υ . control , but not for other intervention groups . There were no significant intervention effects on storeowner psychosocial factors . Conclusions All interventions led to increased stock of healthier foods . The combined intervention was effective in increasing sales of healthier snacks , even though discounts on snacks were not passed to the consumer . Experimental research in small stores is needed to underst and the mechanisms by which store-directed price promotions can increase healthy food supply and dem and Objectives This study examined associations between high school students ' lunch patterns and vending machine purchases and the school food environment and policies . Methods A r and omly selected sample of 1088 high school students from 20 schools completed surveys about their lunch practice s and vending machine purchases . School food policies were assessed by principal and food director surveys . The number of vending machines and their hours of operation were assessed by trained research staff . Results Students at schools with open campus policies during lunchtime were significantly more likely to eat lunch at a fast food restaurant than students at schools with closed campus policies ( 0.7 days/week vs. 0.2 days/week , p < .001 ) . Student snack food purchases at school were significantly associated with the number of snack machines at schools ( p < .001 ) and policies about the types of food that can be sold . In schools with policies , students reported making snack food purchases an average of 0.5 ± 1.1 days/week as compared to an average of 0.9 ± 1.3 days/week in schools without policies ( p < .001 ) . In schools in which soft drink machines were turned off during lunch time , students purchased soft drinks from vending machines 1.4 ± 1.6 days/week as compared to 1.9 ± 1.8 days/week in schools in which soft drink machines were turned on during lunch ( p = .040 ) . ConclusionS chool food policies that decrease access to foods high in fats and sugars are associated with less frequent purchase of these items in school among high school students . Schools should examine their food-related policies and decrease access to foods that are low in nutrients and high in fats and sugars OBJECTIVES Financial constraint is the underpinning determinant of household food insecurity ; however , there has been little research examining the impact that increasing the ‘ money available ’ to food-insecure households could have on food purchasing . The main objective of the present study was to examine the effect of additional money ( in the form of supermarket vouchers ) on food expenditure in food-insecure households with children . DESIGN A parallel r and omized controlled trial with a 4-week baseline phase followed by a 4-week intervention phase . Households were r and omized to either receive vouchers ( coupons ) for 4 weeks or a control group that did not receive any vouchers . SETTING Dunedin , New Zeal and . SUBJECTS Low-income households with children ≥ 18 years ) reporting food insecurity ( n 214 ) . RESULTS The mean monetary value of the vouchers received by households was $ NZ 17?00 per week . The voucher group spent ≥ NZ 15.20 ( 95 % CI 1.46 , 28.94 ) more per week on food during the intervention phase compared with the control group ( P50.030 ) . There were no differences in expenditure between the voucher and the control group for the food groups ‘ fruit and vegetables ’ ( mean difference : ≥ NZ 0?46 ; 95 % CI 21.97 , 2.89 ; P50.709 ) , ‘ meat and poultry ’ ( mean difference : ≥ NZ 0.29 ; 95 % CI 23.07 , 3.64 ; P50.866 ) and ‘ dairy ’ ( mean difference : ≥ NZ 0.82 ; 95 % CI 20.75 , 2.42 ; P50.302 ) . CONCLUSIONS Providing money via supermarket vouchers to food-insecure result ed in an increase in overall expenditure on food Importance Strategies to improve the nutritional status of those participating in the Supplemental Nutrition Assistance Program ( SNAP ) are of interest to policymakers . Objective To evaluate whether the proposed policy of incentivizing the purchase of fruits and vegetables and prohibiting the purchase of less nutritious foods in a food benefit program improves the nutritional quality of participants ' diets . Design , Setting , and Participants Lower income participants ( n = 279 ) not currently enrolled in SNAP were r and omized to 1 of 4 experimental financial food benefit conditions : ( 1 ) incentive ( 30 % financial incentive for fruits and vegetables purchased using food benefits ) ; ( 2 ) restriction ( not allowed to buy sugar sweetened beverages , sweet baked goods , or c and ies with food benefits ) ; ( 3 ) incentive plus restriction ( 30 % financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages , sweet baked goods , or c and y with food benefits ) ; or ( 4 ) control ( no incentive or restrictions on foods purchased with food benefits ) . Participants in all conditions were given a study -specific debit card where funds were added every 4 weeks for a 12-week period . Outcome measures were collected at baseline and in the final 4 weeks of the experimental period . Main Outcomes and Measures Primary outcomes ( from 24-hour dietary recalls ) included intake of energy , discretionary calories , and overall diet quality . Results A number of favorable changes were observed in the incentive plus restriction condition that were significantly different from changes in the control condition . These included ( 1 ) reduced intake of energy ( -96 kcal/d , st and ard error [ SE ] , 59.9 ) ; ( 2 ) reduced intake of discretionary calories ( -64 kcal/d , SE 26.3 ) ; ( 3 ) reduced intake of sugar sweetened beverages , sweet baked goods , and c and ies ( -0.6 servings/d , SE 0.2 ) ; ( 4 ) increased intake of solid fruit ( 0.2 servings/d , SE 0.1 ) ; and ( 5 ) improved Healthy Eating Index score ( 4.1 points , SE 1.4 ) . Fewer improvements were observed in the incentive only and restriction only arms . Conclusions and Relevance A food benefit program that pairs incentives for purchasing more fruits and vegetables with restrictions on the purchase of less nutritious foods may reduce energy intake and improve the nutritional quality of the diet of participants compared with a program that does not include incentives or restrictions . Clinical Trial Registration clinical trials.gov Identifier : NCT02643576 Background Amateur sporting clubs represent an attractive setting for health promotion . This study assesses the impact of a multi-component intervention on the availability , promotion and purchase of fruit and vegetable and non sugar -sweetened drink products from community sporting club canteens . We also assessed the impact the intervention on sporting club revenue from the sale of food and beverages . Method A repeat cross-sectional , parallel group , cluster r and omized controlled trial was undertaken with amateur community football clubs in New South Wales , Australia . The intervention was conducted over 2.5 winter sporting seasons and sought to improve the availability and promotion of fruit and vegetables and non sugar-sweetened drinks in sporting club canteens . Trial outcomes were assessed via telephone surveys of sporting club representatives and members . Results Eighty five sporting clubs and 1143 club members participated in the study . Relative to the control group , at follow-up , clubs allocated to the intervention were significantly more likely to have fruit and vegetable products available at the club canteen ( OR = 5.13 ; 95 % CI 1.70 - 15.38 ) , were more likely to promote fruit and vegetable selection using reduced pricing and meal deals ( OR = 34.48 ; 95 % CI 4.18 - 250.00 ) and members of intervention clubs were more likely to report purchase of fruit and vegetable ( OR = 2.58 95 % CI ; 1.08 - 6.18 ) and non sugar -sweetened drink ( OR = 1.56 ; 95 % CI 1.09 - 2.25 ) products . There was no significant difference between groups in the annual club revenue from food and non-alcoholic beverage sales . Conclusion The findings demonstrate that the intervention can improve the nutrition environment of sporting clubs and the purchasing behaviour of members . Trial registration Australian New Zeal and Clinical Trials Registry : ACTRN12609000224224 Background U.S. adults are at unprecedented risk of becoming overweight or obese , and most scientists believe the primary cause is an obesogenic environment . Worksites provide an opportunity to shape the environments of adults to reduce obesity risk . The goal of this group-r and omized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period . Environmental components focused on food availability and price , physical activity promotion , scale access , and media enhancements . Methods Six worksites in a U.S. metropolitan area were recruited and r and omized in pairs at the worksite level to either a two-year intervention or a no-contact control . Evaluations at baseline and two years included : 1 ) measured height and weight ; 2 ) online surveys of individual dietary intake and physical activity behaviors ; and 3 ) detailed worksite environment assessment . Results Mean participant age was 42.9 years ( range 18 - 75 ) , 62.6 % were women , 68.5 % were married or cohabiting , 88.6 % were white , 2.1 % Hispanic . Mean baseline BMI was 28.5 kg/m2 ( range 16.9 - 61.2 kg/m2 ) . A majority of intervention components were successfully implemented . However , there were no differences between sites in the key outcome of weight change over the two-year study period ( p = .36 ) . Conclusions Body mass was not significantly affected by environmental changes implemented for the trial . Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention . Trial Registration Clinical Trials.gov : Peer education has become a popular strategy for health promotion interventions with adolescents , but it has not been used widely in school-based nutrition education . This paper describes and reports on the feasibility of the peer leader component of a school-based nutrition intervention for young adolescents design ed to increase fruit and vegetable intakes and lower fat foods . About 1,000 seventh- grade students in eight schools received the nutrition intervention . Of these , 272 were trained as peer leaders to assist the teacher in implementing the activities . Results from a multicomponent process evaluation based on peer leader and classroom student feedback , direct classroom observation , and teacher ratings and interviews are presented . Results show that peer-led nutrition education approaches in schools are feasible and have high acceptability among peer leaders , classroom students , and teachers OBJECTIVE To examine the effectiveness of two methods of increasing fruit and fruit juice intake in pregnancy : midwives ' advice and vouchers exchangeable for juice . DESIGN Pregnant women were r and omly allocated to three groups : a control group , who received usual care ; an advice group , given advice and leaflets promoting fruit and fruit juice consumption ; and a voucher group , given vouchers exchangeable for fruit juice from a milk delivery firm . Dietary question naires were administered at ~16 , 20 and 32 weeks of pregnancy . Serum beta-carotene was measured at 16 and 32 weeks . SETTING An antenatal clinic in a deprived area . SUBJECTS Pregnant women aged 17 years and over . RESULTS The study comprised 190 women . Frequency of fruit consumption declined during pregnancy in all groups , but that of fruit juice increased substantially in the voucher group . Serum beta-carotene concentration increased in the voucher group , from 106.2 to 141.8 micromol l(-1 ) in women with measurements on both occasions ( P = 0.003 ) , decreased from 120.0 to 99.8 micromol l(-1 ) in the control group ( P = 0.005 ) , and was unchanged in the advice group . CONCLUSIONS Pregnant women drink more fruit juice if they receive vouchers exchangeable for juice supplied by the milk delivery service . Midwives ' advice to eat more fruit has no great effect . Providing vouchers for fruit juice is a simple method of increasing its intake in a deprived population and may be useful for other sections of the community OBJECTIVE To pilot the design and methodology for a large r and omised controlled trial ( RCT ) of two interventions to Output:	Most studies assessed promotions of fresh fruits and vegetables ( n = 20 ) ; however , these foods may be hard to source , have high perishability , and raise concerns about safety and h and ling . Pricing interventions generally increased stocking , sales , purchasing , and consumption of promoted foods and beverages .
MS21186	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND We assessed the efficacy and safety of programmed cell death 1 ( PD-1 ) inhibition with pembrolizumab in patients with advanced non-small-cell lung cancer enrolled in a phase 1 study . We also sought to define and vali date an expression level of the PD-1 lig and 1 ( PD-L1 ) that is associated with the likelihood of clinical benefit . METHODS We assigned 495 patients receiving pembrolizumab ( at a dose of either 2 mg or 10 mg per kilogram of body weight every 3 weeks or 10 mg per kilogram every 2 weeks ) to either a training group ( 182 patients ) or a validation group ( 313 patients ) . We assessed PD-L1 expression in tumor sample s using immunohistochemical analysis , with results reported as the percentage of neoplastic cells with staining for membranous PD-L1 ( proportion score ) . Response was assessed every 9 weeks by central review . RESULTS Common side effects that were attributed to pembrolizumab were fatigue , pruritus , and decreased appetite , with no clear difference according to dose or schedule . Among all the patients , the objective response rate was 19.4 % , and the median duration of response was 12.5 months . The median duration of progression-free survival was 3.7 months , and the median duration of overall survival was 12.0 months . PD-L1 expression in at least 50 % of tumor cells was selected as the cutoff from the training group . Among patients with a proportion score of at least 50 % in the validation group , the response rate was 45.2 % . Among all the patients with a proportion score of at least 50 % , median progression-free survival was 6.3 months ; median overall survival was not reached . CONCLUSIONS Pembrolizumab had an acceptable side-effect profile and showed antitumor activity in patients with advanced non-small-cell lung cancer . PD-L1 expression in at least 50 % of tumor cells correlated with improved efficacy of pembrolizumab . ( Funded by Merck ; KEYNOTE-001 Clinical Trials.gov number , NCT01295827 . ) BACKGROUND Previous , uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer . METHODS In this phase 3 , open-label study , we r and omly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib ( 250 mg per day ) ( 609 patients ) or carboplatin ( at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute ) plus paclitaxel ( 200 mg per square meter of body-surface area ) ( 608 patients ) . The primary end point was progression-free survival . RESULTS The 12-month rates of progression-free survival were 24.9 % with gefitinib and 6.7 % with carboplatin-paclitaxel . The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority , as compared with carboplatin-paclitaxel , with respect to progression-free survival in the intention-to-treat population ( hazard ratio for progression or death , 0.74 ; 95 % confidence interval [ CI ] , 0.65 to 0.85 ; P<0.001 ) . In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene ( EGFR ) mutation , progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel ( hazard ratio for progression or death , 0.48 ; 95 % CI , 0.36 to 0.64 ; P<0.001 ) , whereas in the subgroup of 176 patients who were negative for the mutation , progression-free survival was significantly longer among those who received carboplatin-paclitaxel ( hazard ratio for progression or death with gefitinib , 2.85 ; 95 % CI , 2.05 to 3.98 ; P<0.001 ) . The most common adverse events were rash or acne ( in 66.2 % of patients ) and diarrhea ( 46.6 % ) in the gefitinib group and neurotoxic effects ( 69.9 % ) , neutropenia ( 67.1 % ) , and alopecia ( 58.4 % ) in the carboplatin-paclitaxel group . CONCLUSIONS Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib . ( Clinical Trials.gov number , NCT00322452 . BACKGROUND This trial was design ed to evaluate the activity and safety of ganetespib in combination with docetaxel in advanced non-small cell lung cancer ( NSCLC ) and to identify patient population s most likely to benefit from the combination . PATIENTS AND METHODS Patients with one prior systemic therapy for advanced disease were eligible . Docetaxel ( 75 mg/m(2 ) on day 1 ) was administered alone or with ganetespib ( 150 mg/m(2 ) on days 1 and 15 ) every 3 weeks . The primary end points were progression-free survival ( PFS ) in two subgroups of the adenocarcinoma population : patients with elevated lactate dehydrogenase ( eLDH ) and mutated KRAS ( mKRAS ) . RESULTS Of 385 patients enrolled , 381 were treated . Early in the trial , increased hemoptysis and lack of efficacy were observed in nonadenocarcinoma patients ( n = 71 ) ; therefore , only patients with adenocarcinoma histology were subsequently enrolled . Neutropenia was the most common grade ≥3 adverse event : 41 % in the combination arm versus 42 % in docetaxel alone . There was no improvement in PFS for the combination arm in the eLDH ( N = 114 , adjusted hazard ratio ( HR ) = 0.77 , P = 0.1134 ) or mKRAS ( N = 89 , adjusted HR = 1.11 , P = 0.3384 ) subgroups . In the intent-to-treat adenocarcinoma population , there was a trend in favor of the combination , with PFS ( N = 253 , adjusted HR = 0.82 , P = 0.0784 ) and overall survival ( OS ) ( adjusted HR = 0.84 , P = 0.1139 ) . Exploratory analyses showed significant benefit of the ganetespib combination in the prespecified subgroup of adenocarcinoma patients diagnosed with advanced disease > 6 months before study entry ( N = 177 ) : PFS ( adjusted HR = 0.74 , P = 0.0417 ) ; OS ( adjusted HR = 0.69 , P = 0.0191 ) . CONCLUSION Advanced lung adenocarcinoma patients treated with ganetespib in combination with docetaxel had an acceptable safety profile . While the study 's primary end points were not met , significant prolongation of PFS and OS was observed in patients > 6 months from diagnosis of advanced disease , a subgroup chosen as the target population for the phase III study BACKGROUND Nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , disrupts PD-1-mediated signaling and may restore antitumor immunity . METHODS In this r and omized , open-label , international phase 3 study , we assigned patients with nonsquamous non-small-cell lung cancer ( NSCLC ) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks . The primary end point was overall survival . RESULTS Overall survival was longer with nivolumab than with docetaxel . The median overall survival was 12.2 months ( 95 % confidence interval [ CI ] , 9.7 to 15.0 ) among 292 patients in the nivolumab group and 9.4 months ( 95 % CI , 8.1 to 10.7 ) among 290 patients in the docetaxel group ( hazard ratio for death , 0.73 ; 96 % CI , 0.59 to 0.89 ; P=0.002 ) . At 1 year , the overall survival rate was 51 % ( 95 % CI , 45 to 56 ) with nivolumab versus 39 % ( 95 % CI , 33 to 45 ) with docetaxel . With additional follow-up , the overall survival rate at 18 months was 39 % ( 95 % CI , 34 to 45 ) with nivolumab versus 23 % ( 95 % CI , 19 to 28 ) with docetaxel . The response rate was 19 % with nivolumab versus 12 % with docetaxel ( P=0.02 ) . Although progression-free survival did not favor nivolumab over docetaxel ( median , 2.3 months and 4.2 months , respectively ) , the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel ( 19 % and 8 % , respectively ) . Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression ( ≥1 % , ≥5 % , and ≥10 % ) of the PD-1 lig and . Treatment-related adverse events of grade 3 or 4 were reported in 10 % of the patients in the nivolumab group , as compared with 54 % of those in the docetaxel group . CONCLUSIONS Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy , overall survival was longer with nivolumab than with docetaxel . ( Funded by Bristol-Myers Squibb ; CheckMate 057 Clinical Trials.gov number , NCT01673867 . ) BACKGROUND Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2 . We aim ed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer ( NSCLC ) after platinum-based therapy . METHODS In this multicentre , double-blind , r and omised phase 3 trial ( REVEL ) , we enrolled patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen . Patients were r and omly allocated ( 1:1 ) with a central ised , interactive voice-response system ( stratified by sex , region , performance status , and previous maintenance therapy [ yes vs no ] ) to receive docetaxel 75 mg/m(2 ) and either ramucirumab ( 10 mg/kg ) or placebo on day 1 of a 21 day cycle until disease progression , unacceptable toxicity , withdrawal , or death . The primary endpoint was overall survival in all patients allocated to treatment . We assessed adverse events according to treatment received . This study is registered with Clinical Trials.gov , number NCT01168973 . FINDINGS Between Dec 3 , 2010 , and Jan 24 , 2013 , we screened 1825 patients , of whom 1253 patients were r and omly allocated to treatment . Median overall survival was 10·5 months ( IQR 5·1 - 21·2 ) for 628 patients allocated ramucirumab plus docetaxel and 9·1 months ( 4·2 - 18·0 ) for 625 patients who received placebo plus docetaxel ( hazard ratio 0·86 , 95 % CI 0·75 - 0·98 ; p=0·023 ) . Median progression-free survival was 4·5 months ( IQR 2·3 - 8·3 ) for the ramucirumab group compared with 3·0 months ( 1·4 - 6·9 ) for the control group ( 0·76 , 0·68 - 0·86 ; p<0·0001 ) . We noted treatment-emergent adverse events in 613 ( 98 % ) of 627 patients in the ramucirumab safety population and 594 ( 95 % ) of 618 patients in the control safety population . The most common grade 3 or worse adverse events were neutropenia ( 306 patients [ 49 % ] in the ramucirumab group vs 246 [ 40 % ] in the control group ) , febrile neutropenia ( 100 [ 16 % ] vs 62 [ 10 % ] ) , fatigue ( 88 [ 14 % ] vs 65 [ 10 % ] ) , leucopenia ( 86 [ Output:	Both disease control ( PR plus stable disease status ) and l and mark progression-free survival were correlated with OS , with the longer interval l and mark PFS being the best predictor of survival in patients with NSCLC treated with anti-PD-1/PD-L1 antibodies
MS21187	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : To evaluate the viability and effectiveness of a simulation-based pediatric mock code program on patient outcomes , as well as residents ' confidence in performing resuscitations . A resident 's leadership ability is integral to accurate and efficient clinical response in the successful management of cardiopulmonary arrest ( CPA ) . Direct experience is a contributing factor to a resident 's code team leadership ability ; however , opportunities to gain experience are limited by relative infrequency of pediatric arrests and code occurrences when residents are on service . Design : Longitudinal , mixed- methods research design . Setting : Children 's hospital at an tertiary care academic medical center . Patients : Pediatric . Interventions : Clinicians responsible for pediatric resuscitations responded to mock codes r and omly called at increasing rates over a 48-month period , just as they would an actual CPA event . Events were recorded and used for immediate debriefing facilitated by clinical faculty to provide residents feedback about their performance . Measurements : Self- assessment data were collected from all team members . Hospital records for pediatric CPA survival rates were examined for the study duration . Results : Survival rates increased to approximately 50 % ( p = .000 ) , correlating with the increased number of mock codes ( r = .87 ) . These results are significantly above the average national pediatric CPA survival rates and held steady for 3 consecutive years , demonstrating the stability of the program 's outcomes . Conclusions : This study suggests that a simulation-based mock code program may significantly benefit pediatric patient CPA outcomes —applied clinical outcomes —not simply learner perceived value , increased confidence , or simulation-based outcomes . The use of mock codes as an integral part of residency programs could provide residents with the resuscitation training they require to become proficient in their practice . Future programs that incorporate transport scenarios , ambulatory care , and other outpatient setting s could further benefit pediatric patients in prehospital context Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement AIM Advanced simulation tools are increasingly being incorporated into cardiopulmonary resuscitation ( CPR ) training . These educational methods have been shown to improve trainee performance in simulated setting s , but translation into clinical practice remains unknown for many aspects of CPR quality . This study attempts to measure the impact of simulation-based training for resuscitation team leaders on some measures of CPR quality during actual in-hospital resuscitation attempts . METHODS In this prospect i ve , r and omized interventional cluster trial , internal medicine resident physicians ( post-graduate year 2 ) were r and omized using a r and om number generator to participate in a 4-h , immersive simulation course in cardiopulmonary resuscitation leadership using a high-fidelity simulator with video debriefing prior to serving as resuscitation team leaders at an academic medical center . Objective metrics of actual resuscitation performance were obtained from a CPR-sensing monitor/defibrillator . RESULTS Thirty-two residents were r and omized to receive simulation training or no additional training between April and July 2007 and data were collected following 98 actual resuscitations between July 2007 and June 2008 . CPR quality from resuscitations led by 14 simulation-trained and 16 control group residents was similar in terms of mean compression depth ( 48 vs 49 mm ; p = 0.53 ) ; compression rate ( 107 vs 104 min⁻¹ ; p = 0.30 ) ; ventilation rate ( 12 vs 12 min⁻¹ ; p = 0.45 ) and no-flow fraction ( 0.08 vs 0.07 ; p = 0.34 ) . CONCLUSIONS Although we failed to detect any significant differences in objective measures of CPR quality , we have demonstrated that CPR-sensing technology has the potential for use in assessing the impact of a simulation curriculum on some aspects of actual resuscitation performance . A larger study , performed in a setting with lower baseline performance , would be required to assess the specific simulation curriculum This study examines effectiveness of a donated Laerdal Virtual I.V. simulator when compared with traditional methods of teaching intravenous ( IV ) cannulation to third year medical students in the Philippines . Forty novice Filipino medical students viewed an instructional video on how to start intravenous lines and were then r and omly divided into two groups of twenty . The " Traditional " group observed an IV insertion on an actual patient performed by an experienced practitioner , and then subsequently performed an IV on an actual patient which was videotaped . The " Simulation " group practice d the Virtual I.V. simulator until they successfully completed level three using the " doctor " setting . These students then performed an IV on an actual patient which was videotaped . The videotapes for both groups were review ed by two pre-trained ( Inter-rater reliability of > or = 0.84 ) observers who were blinded to the group using a previously vali date d checklist for IV insertion . Students trained on the Virtual I.V. showed significantly greater success in successfully starting an IV on an actual patient ( 40 % VS . 15 % , p<0.05 ) , decreased constrictive b and time ( p<.05 ) , increased raw score on the check list ( p<.03 ) , and decreased overall time to start an IV ( p<.05 ) . The technology was well received but wider application in the non western world is limited by lack of in country company support and the relative expense Background With increasing pressure to use operating room time efficiently , opportunities for residents to learn fiberoptic orotracheal intubation in the operating room have declined . The purpose of this study was to determine whether fiberoptic orotracheal intubation skills learned outside the operating room on a simple model could be transferred into the clinical setting . Methods First-year anesthesiology residents and first- and second-year internal medicine residents were recruited . Subjects were r and omized to a didactic-teaching-only group ( n = 12 ) or a model-training group ( n = 12 ) . The didactic-teaching group received a detailed lecture from an expert bronchoscopist . The model-training group was guided , by experts , through tasks performed on a simple model design ed to refine fiberoptic manipulation skills . After the training session , subjects performed a fiberoptic orotracheal intubation on healthy , consenting , anesthetized , paralyzed female patients undergoing elective surgery with predicted “ easy ” laryngoscopic intubations . Two blinded anesthesiologists evaluated each subject . Results After the training session , the model group significantly outperformed the didactic group in the operating room when evaluated with a global rating scale ( P < 0.01 ) and checklist ( P < 0.05 ) . Model-trained subjects completed the fiberoptic orotracheal intubation significantly faster than didactic-trained subjects ( P < 0.01 ) . Model-trained subjects were also more successful at achieving tracheal intubation than the didactic group ( P < 0.005 ) . Conclusion Fiberoptic orotracheal intubation skills training on a simple model is more effective than conventional didactic instruction for transfer to the clinical setting . Incorporating an extraoperative model into the training of fiberoptic orotracheal intubation may greatly reduce the time and pressures that accompany teaching this skill in the operating room BACKGROUND We studied the reasons why patients undergoing thoracenteses performed in our outpatient pulmonary clinic had a higher frequency of iatrogenic pneumothorax compared to that in the concurrent radiology practice in our institution , which utilizes ultrasound guidance . We review ed our practice model and implemented a unique experiential training paradigm in a zero-risk simulation environment to improve efficacy , timeliness , service orientation , and safety . METHODS We retrospectively determined the rate of clinical ly significant pneumothoraces in our practice ( phase I , July 1 , 2001 , to June 30 , 2002 ) . The training system re design included the following : ( 1 ) a design ated group of pulmonologist instructors dedicated to treating pleural disease and reducing the number of iatrogenic complications ; ( 2 ) the use of ultrasound image guidance for all thoracenteses ; and ( 3 ) structured proficiency and competency st and ards for proceduralists . Postintervention ( phase II ) data were prospect ively collected ( January 2005 to December 2006 ) and compared with our baseline data . RESULTS The baseline rate of pneumothorax was 8.6 % ( 5 of 58 patients ) in our pulmonary practice . Following intervention ( phase II ) , the rate of pneumothorax declined to 1.1 % ( p = 0.0034 ) . During phase II , the number of thoracenteses performed increased ( 186 vs 58 per year , respectively ; p < 0.05 ) . The iatrogenic pneumothorax rate was stable in the 2 years following intervention ( 2005 , 0.7 % [ 1 of 137 pneumothoraces ] ; 2006 , 1.3 % [ 3 of 226 pneumothoraces ] ; p > 0.9 ) . Postintervention complications included procedure-related pain ( n = 19 ) , cough ( n = 4 ) , and hypotension ( n = 10 ) . CONCLUSIONS An improvement program that included simulation , ultrasound guidance , competency testing , and performance feedback reduced iatrogenic risk to patients . We recommend application of this process to procedural practice Purpose To determine whether simulation training of ultrasound (US)-guided central venous catheter ( CVC ) insertion skills on a partial task trainer improves cannulation and insertion success rates in clinical practice . Method This prospect i ve , r and omized , controlled , single-blind study of first- and second-year residents occurred at a tertiary care teaching hospital from January 2007 to September 2008 . The intervention group ( n = 90 ) received a didactic and h and s-on , competency-based simulation training course in US-guided CVC insertion , whereas the control group ( n = 95 ) received training through a traditional , bedside apprenticeship model . Success at first cannulation and successful CVC insertion served as the primary outcomes . Secondary outcomes included reduction in technical errors and decreased mechanical complications . Results Blinded independent raters observed 495 CVC insertions by 115 residents over a 21-month period . Successful first cannulation occurred in 51 % of the intervention group versus 37 % of the control group ( P = .03 ) . CVC insertion success occurred for 78 % of the intervention group versus 67 % of the control group ( P = .02 ) . Simulation training was independently and significantly associated with success at first cannulation ( odds ratio : 1.7 ; 95 % confidence interval : 1.1–2.8 ) and with successful CVC insertion ( odds ratio : 1.7 ; 95 % confidence interval : 1.1–2.8)—both independent of US use , patient comorbidities , or resident specialty . No significant differences related to technical errors or mechanical complications existed between the two groups . Conclusions Simulation training was associated with improved in-hospital performance of CVC insertion . Procedural simulation was associated with improved residents ' skills and was more effective than traditional training BACKGROUND AND STUDY AIM As for any manual procedure , the learning curves for medical interventions can have undesirable phases , occurring mostly in the early experience of applying a technique . There have been impressive advances in endoscopic procedures during recent years , and there is an emerging trend that the number of procedures is increasing in parallel with these . In addition , the introduction of screening programs for colorectal cancer will also increase the numbers of procedures needed . Recent developments in medical simulation seem promising with regard to the possibility of " training out " undesirable parts of the learning curve outside the operating room . The aim of this study was to investigate whether the use of the AccuTouch flexible endoscopy simulator improves the early part of the learning curve in colonoscopy training . METHOD 12 endoscopy trainees , 10 surgeons and two medical gastroenterologists , all with experience in gastroscopy but with no specific colonoscopy experience , were r and omly assigned to either simulator training or to a control group . They all received the same theoretical study package and the training group practice d with the AccuTouch colonoscopy simulator until a predefined expert level of performance was reached . All trainees performed their first ten individual colonoscopies described in detail in a separate protocol . RESULTS Trainees in the simulator-trained group performed significantly better ( P=0.0011 ) and managed to reach the cecum in 52 % of their cases ( vs. 19 % in the control group ) , and were 4.53 times more likely to succeed compared with the controls . Additionally , there was a significantly shorter procedure time and less patient discomfort in the h and s of the simulator-trained group . Output:	CONCLUSIONS Simulation-based education was associated with small-moderate patient benefits in comparison with no intervention and non-simulation instruction , although the latter did not reach statistical significance .
MS21188	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective . To investigate over a 1-year period in dogs that underwent extracapsular stabilization surgery ( ECS ) following anterior cruciate ligament ( ACL ) transection : whether reconstructive surgery could prevent osteoarthritis ( OA ) progression and whether treatment with the bisphosphonate tiludronic acid ( TA ) could improve the chronic evolution of OA structural changes . Methods . ACL transection was performed on dogs on Day 0 and ECS on Day 28 . Dogs were r and omly divided into 2 groups : 15 received placebo and 16 were treated with TA ( 2 mg/kg subcutaneous injection ) on Days 14 , 28 , 56 , and 84 . Magnetic resonance images were acquired on Days −10 , 26 , 91 , 210 , and 357 , and cartilage volume was quantified . At sacrifice ( Day 364 ) , cartilage from femoral condyles and tibial plateaus was macroscopically and histologically evaluated . Expression levels of MMP-1 , -3 , -13 , ADAMTS-4 , -5 , BMP-2 , FGF-2 , IGF-1 , TGF-ß1 , collagen type II , and aggrecan were determined using real-time RT-PCR . Results . The loss of cartilage volume observed after ACL transection stabilized following ECS . Thereafter , a gradual gain occurred , with the cartilage volume loss on the tibial plateaus reduced at Day 91 ( p < 0.02 ) and Day 210 ( p < 0.001 ) in the TA-treated dogs . At sacrifice , TA-treated dogs presented a reduction in the severity of macroscopic ( p = 0.03 for plateaus ) and histologic ( p = 0.07 for plateaus ) cartilage lesions , had a better preserved collagen network , and showed decreased MMP-13 ( p = 0.04 ) , MMP-1 and MMP-3 levels . Conclusion . Our findings indicate that in dogs with ACL transection , ECS greatly prevents development of cartilage volume loss . Treatment with TA provided an additional benefit of reducing the development of OA lesions OBJECTIVES To investigate changes in the knee during the first year after acute rupture of the anterior cruciate ligament ( ACL ) of volumes of joint fluid ( JF ) , bone marrow lesions ( BMLs ) , and cartilage volume ( VC ) , and cartilage thickness ( ThCcAB ) and cartilage surface area ( AC ) . To identify factors associated with these changes . METHODS Fifty-eight subjects ( mean age 26 years , 16 women ) with an ACL rupture to a previously un-injured knee were followed prospect ively using a 1.5 T MR imager at baseline ( within 5 weeks from injury ) , 3 months , 6 months , and 1 year . Thirty-four subjects were treated with ACL reconstruction followed by a structured rehabilitation program and 24 subjects were treated with structured rehabilitation only . Morphometric data were acquired from computer-assisted segmentation of MR images . Morphometric cartilage change was reported as mean change divided by the st and ard deviation of change ( st and ard response mean , SRM ) . RESULTS JF and BML volumes gradually decreased over the first year , although BML persisted in 62 % of the knees after 1 year . One year after the ACL injury , a reduction of VC , AC and ThCcAB ( SRM -0.440 or greater ) was found in the trochlea femur ( TrF ) , while an increase of VC and ThCcAB was found in the central medial femur ( cMF ) ( SRM greater than 0.477 ) . ACL reconstruction was directly and significantly related to increased JF volume at 3 and 6 months ( P<0.001 ) , BML volume at 6 months ( P=0.031 ) , VC and ThCcAB in cMF ( P<0.002 ) and decreased cartilage area in TrF ( P=0.010 ) at 12 months . CONCLUSION Following an acute ACL tear , cMF and TrF showed the greatest consistent changes of cartilage morphometry . An ACL reconstruction performed within a mean of 6 weeks from injury was associated with increased ThCcAB and VC in cMF and decreased AC in TrF , compared to knees treated without reconstruction . This may suggest a delayed structural restitution in ACL reconstructed knees Background Bone marrow lesions ( BMLs ) , common osteoarthritis-related magnetic resonance imaging findings , are associated with osteoarthritis progression and pain . However , there are no articles describing the use of 3-dimensional quantitative assessment s to explore the longitudinal relationship between BMLs and hyaline cartilage loss . The purpose of this study was to assess the cross-sectional and longitudinal descriptive characteristics of BMLs with a simple measurement of approximate BML volume , and describe the cross-sectional and longitudinal relationships between BML size and the extent of hyaline cartilage damage . Methods 107 participants with baseline and 24-month follow-up magnetic resonance images from a clinical trial were included with symptomatic knee osteoarthritis . An ' index ' compartment was identified for each knee defined as the tibiofemoral compartment with greater disease severity . Subsequently , each knee was evaluated in four regions : index femur , index tibia , non-index femur , and non-index tibia . Approximate BML volume , the product of three linear measurements , was calculated for each BML within a region . Cartilage parameters in the index tibia and femur were measured based on manual segmentation . Results BML volume changes by region were : index femur ( median [ 95 % confidence interval of the median ] ) 0.1 cm3 ( -0.5 to 0.9 cm3 ) , index tibia 0.5 cm3 ( -0.3 to 1.7 cm3 ) , non-index femur 0.4 cm3 ( -0.2 to 1.6 cm3 ) , and non-index tibia 0.2 cm3 ( -0.1 to 1.2 cm3 ) . Among 44 knees with full thickness cartilage loss , baseline tibia BML volume correlated with baseline tibia full thickness cartilage lesion area ( r = 0.63 , p < 0.002 ) and baseline femur BML volume with longitudinal change in femoral full thickness cartilage lesion area ( r = 0.48 p < 0.002 ) . Conclusions Many regions had no or small longitudinal changes in approximate BML volume but some knees experienced large changes . Baseline BML size was associated to longitudinal changes in area of full thickness cartilage loss One of the primary goals of physiotherapy after anterior cruciate ligament ( ACL ) reconstruction is to restore of the patient 's normal gait patterns . However , to date , only a limited number of studies have examined gait during physiotherapeutic procedures following ACL reconstruction . Thus , the objective of the present study was to evaluate gait kinematics and symmetry in male patients after ACL reconstruction during the first two stages of their physiotherapy programme . Ninety-seven males , including 53 patients after primary ACL reconstruction in one limb and 44 healthy controls , participated in the study . The patients were examined using a movement analysis system during their physiotherapeutic programme ( from the 2nd to the 12th week following reconstruction ) . Some selected parameters of gait kinematics , a dynamic range of movement in the knee joint and gait asymmetry coefficients were evaluated . During the 12th week of physiotherapy , a mean gait velocity increased by more than 0.97 m/s compared to that obtained during the 2nd week of physiotherapy . A statistically significant increase in the relative length of stance phase was observed in the involved extremity , from 36.1 % to 62.7 % ( P = 0.01 ) ; the range of movement significantly improved from 25.8 degrees during the 2nd week to 63.7 degrees during the 12th week of physiotherapy . At the same time , the stance time asymmetry coefficient decreased from 68.5 % to -0.4 % . We observed a significant improvement in most of the gait parameters from the 2nd to the 12th week of physiotherapy after reconstruction and also in comparison to the results obtained for the control group BACKGROUND The optimal management of a torn anterior cruciate ligament ( ACL ) of the knee is unknown . METHODS We conducted a r and omized , controlled trial involving 121 young , active adults with acute ACL injury in which we compared two strategies : structured rehabilitation plus early ACL reconstruction and structured rehabilitation with the option of later ACL reconstruction if needed . The primary outcome was the change from baseline to 2 years in the average score on four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS)--pain , symptoms , function in sports and recreation , and knee-related quality of life ( KOOS(4 ) ; range of scores , 0 [ worst ] to 100 [ best ] ) . Secondary outcomes included results on all five KOOS subscales , the Medical Outcomes Study 36-Item Short-Form Health Survey , and the score on the Tegner Activity Scale . RESULTS Of 62 subjects assigned to rehabilitation plus early ACL reconstruction , 1 did not undergo surgery . Of 59 assigned to rehabilitation plus optional delayed ACL reconstruction , 23 underwent delayed ACL reconstruction ; the other 36 underwent rehabilitation alone . The absolute change in the mean KOOS(4 ) score from baseline to 2 years was 39.2 points for those assigned to rehabilitation plus early ACL reconstruction and 39.4 for those assigned to rehabilitation plus optional delayed reconstruction ( absolute between-group difference , 0.2 points ; 95 % confidence interval , -6.5 to 6.8 ; P=0.96 after adjustment for the baseline score ) . There were no significant differences between the two treatment groups with respect to secondary outcomes . Adverse events were common in both groups . The results were similar when the data were analyzed according to the treatment actually received . CONCLUSIONS In young , active adults with acute ACL tears , a strategy of rehabilitation plus early ACL reconstruction was not superior to a strategy of rehabilitation plus optional delayed ACL reconstruction . The latter strategy substantially reduced the frequency of surgical reconstructions . ( Funded by the Swedish Research Council and the Medical Faculty of Lund University and others ; Current Controlled Trials number , IS RCT N84752559 . OBJECTIVE Prevalence and clinical relevance of patellofemoral ( PF ) osteoarthritis ( OA ) after anterior cruciate ligament ( ACL ) injury . METHOD Prospect ively we studied 94 out of 100 consecutive patients 15 years after acute ACL injury . ACL reconstructions were only performed late if recurrent " give way " persisted or a secondary meniscal injury suitable for repair occurred . The subjects , mean age 42 years , had knee radiographs including skyline PF view taken , which were grade d according to the atlas of the Osteoarthritis Research Society International . Knee-related symptoms and function were assessed by question naires . RESULTS PF OA was present in 12/75 knees ( 16 % ) . Of 94 patients 22 ( 23 % ) have had their ACL reconstructed during follow-up . Meniscal injury and ACL reconstruction had occurred more often in knees with PF OA than in knees without PF OA ( P=0.004 and P=0.002 , respectively ) . Seven of 15 ACL reconstructed knees showed radiographic PF OA at follow-up . Knees with PF OA had more extension and flexion deficit than knees without PF OA . Subjects with PF OA maintained a higher activity level from injury to follow-up , but did not differ significantly from those without PF OA regarding patient-relevant symptoms and knee function . However , there was a trend for worse outcome in subjects with PF OA . CONCLUSION We found a relatively low prevalence of mild PF OA after ACL injury treated non-operatively , and it had limited impact on knee symptoms and patient-relevant knee function . At follow-up PF OA was associated with higher activity level , meniscal injury , extension and flexion deficit , and ACL reconstruction OBJECTIVE To evaluate the effects of a modified shoe that incorporates both lateral wedging and a variable-stiffness sole on knee joint loading in 3 population s : individuals with symptomatic and radiographic knee osteoarthritis ( OA ) , asymptomatic overweight individuals , and asymptomatic healthy weight individuals . METHODS Ninety participants ( 30 per group ) underwent a 3-dimensional gait analysis across 3 test conditions : modified shoes , st and ard control shoes , and barefoot . For each condition , the first peak knee adduction moment ( KAM ) and knee flexion moment ( KFM ) ( both expressed as Nm/[body weight × height]% ) as well as the KAM impulse ( expressed as Nm.s/[body weight × height]% ) were determined . RESULTS The modified shoes significantly reduced the peak KAM as compared to the control shoes in both the OA ( P = 0.002 ) and the overweight ( P = 0.03 ) groups . In the OA group , there was no significant difference in peak KAM when walking in the modified shoe as compared to walking barefoot . In the overweight and the healthy weight groups , the peak KAM when walking in the modified shoe was significantly higher than that when walking barefoot ( P < 0.001 ) . Irrespective of group , the KAM impulse was significantly reduced when walking in the modified shoe as compared to the control shoe ( P < 0.001 ) and was significantly higher during both shoe conditions as compared to walking barefoot ( P < 0.001 ) . There was no change Output:	Moderate-to-strong evidence was presented for meniscal lesion or meniscectomy , presence of bone marrow lesions ( BMLs ) , time from injury , and persisting altered biomechanics , possibly affecting cartilage change after ACL reconstruction . First-year morphological change was more aggravated in ACL reconstruction compared to non-surgical treatment .
MS21189	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Introduction This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium . Two research questions were formulated . First , does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU ? Second , does the use of earplugs during the night improve the quality of sleep in the ICU ? Methods A r and omized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night . The research ers were blinded during data collection . Assignment was performed by an independent nurse research er using a computer program . Eligible patients had an expected length of stay in the ICU of more than 24 hours , were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10 . Delirium was assessed using the vali date d NEECHAM scale , sleep perception was reported by the patient in response to five questions . Results The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients . A vast improvement was shown by a Hazard Ratio of 0.47 ( 95 % confidence interval ( CI ) 0.27 to 0.82 ) . Also , patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs . After the first night in the ICU , patients sleeping with earplugs reported a better sleep perception . Conclusions Earplugs may be a useful instrument in the prevention of confusion or delirium . The beneficial effects seem to be strongest within 48 hours after admission . The relation between sleep , sound and delirium , however , needs further research .Trial registration Current Controlled Trials IS RCT OBJECTIVE To develop and vali date a new st and ardized confusion assessment method ( CAM ) that enables nonpsychiatric clinicians to detect delirium quickly in high-risk setting s. DESIGN Prospect i ve validation study . SETTING Conducted in general medicine wards and in an outpatient geriatric assessment center at Yale University ( site 1 ) and in general medicine wards at the University of Chicago ( site 2 ) . PATIENTS The study included 56 subjects , ranging in age from 65 to 98 years . At site 1 , 10 patients with and 20 without delirium participated ; at site 2 , 16 patients with and 10 without delirium participated . MEASUREMENTS AND MAIN RESULTS An expert panel developed the CAM through a consensus building process . The CAM instrument , which can be completed in less than 5 minutes , consists of nine operationalized criteria from the Diagnostic and Statistical Manual of Mental Disorders ( DSM-III-R ) . An a priori hypothesis was established for the diagnostic value of four criteria : acute onset and fluctuating course , inattention , disorganized thinking , and altered level of consciousness . The CAM algorithm for diagnosis of delirium required the presence of both the first and the second criteria and of either the third or the fourth criterion . At both sites , the diagnoses made by the CAM were concurrently vali date d against the diagnoses made by psychiatrists . At sites 1 and 2 values for sensitivity were 100 % and 94 % , respectively ; values for specificity were 95 % and 90 % ; values for positive predictive accuracy were 91 % and 94 % ; and values for negative predictive accuracy were 100 % and 90 % . The CAM algorithm had the highest predictive accuracy for all possible combinations of the nine features of delirium . The CAM was shown to have convergent agreement with four other mental status tests , including the Mini-Mental State Examination . The interobserver reliability of the CAM was high ( kappa = 0.81 - 1.0 ) . CONCLUSIONS The CAM is sensitive , specific , reliable , and easy to use for identification of delirium Background : Major depression is a frequent and serious disorder in older medical in patients . Because the condition goes undetected and untreated in most of these patients , we conducted a r and omized clinical trial to evaluate the effectiveness of a strategy of systematic detection and multidisciplinary treatment of depression in this population . Methods : Consecutive patients aged 65 years or more admitted to general medical services in a primary care hospital between October 1999 and November 2002 were screened for depression with the Diagnostic Interview Schedule ( DIS ) within 48 hours after admission . Patients found to have major depression were r and omly allocated to receive the intervention or usual care . The intervention involved consultation and treatment by a psychiatrist and follow-up by a research nurse and the patient 's family physician . Research assistants , blind to group allocation , collected data from the patients at enrolment and at 3 and 6 months later using the Hamilton Depression Rating Scale ( HAMD ) , the Medical Outcomes 36-item Short Form ( SF-36 ) , the DIS , the Mini-Mental State Examination ( MMSE ) , the Older Americans Re sources and Services ( OARS ) question naire to assess basic and instrumental activities of daily living ( OARS-ADL and OARS-IADL ) and the Rating Scale for Side Effects . Data on the severity of illness , length of hospital stay , health services and medication use , mortality and process of care were also collected . The primary outcome measures were the HAMD and SF-36 . Results : Of 1500 eligible patients who were screened , 157 were found to have major depression and consented to participate ( 78 in the intervention group and 79 in the usual care group ) . At r and omization , there were no clinical ly or statistically significant differences between the 2 groups . Sixty-four patients completed follow-up to 6 months , 57 withdrew , and 36 died . At 6 months , there were no clinical ly or statistically significant differences the 2 groups in HAMD or SF-36 scores or any of the secondary outcome measures . Interpretation : We were unable to demonstrate that systematic detection and multidisciplinary care of depression was more beneficial than usual care for elderly medical in patients BACKGROUND delirium is a frequent adverse consequence of hospitalisation for older patients , but there has been little research into its prevention . A recent study of Hospital in the Home ( admission substitution ) noted less delirium in the home-treated group . SETTING a tertiary referral teaching hospital in Sydney , Australia . METHODS we r and omised 104 consecutive patients referred for geriatric rehabilitation to be treated in one of two ways , either in Hospital in the Home ( early discharge ) or in hospital , in a rehabilitation ward . We compared the occurrence of delirium measured by the confusion assessment method . Secondary outcome measures were length of stay , hospital bed days , cost of acute care and rehabilitation , functional independence measure ( FIM ) , Mini-Mental State Examination ( MMSE ) and geriatric depression score ( GDS ) assessed on discharge and at 1- and 6-month follow-up and patient satisfaction . RESULTS the home group had lower odds of developing delirium during rehabilitation [ odds ratio ( OR ) = 0.17 ; 95 % confidence interval 0.03 - 0.65 ] , shorter duration of rehabilitation ( 15.97 versus 23.09 days ; P = 0.0164 ) and used less hospital bed days ( 20.31 versus 40.09 , P < or = 0.0001 ) . The cost was lower for the acute plus rehabilitation phases ( 7,680 pounds versus 10,598 pounds ; P = 0.0109 ) and the rehabilitation phase alone ( 2,523 pounds versus 6,100 pounds ; P < or = 0.0001 ) . There was no difference in FIM , MMSE or GDS scores . the home group was more satisfied ( P = 0.0057 ) . CONCLUSIONS home rehabilitation for frail elderly after acute hospitalisation is a viable option for selected patients and is associated with a lower risk of delirium , greater patient satisfaction , lower cost and more efficient hospital bed use The purpose of this r and omized controlled study was to determine the effects of music listening on acute confusion that is common in older adults after hip or knee surgery . A control group demonstrated greater decreases in cognition on the first postoperative day compared to a music-listening group ( F = 8.448 , p = .009 ) . In the 3-day postoperative period , the cognitive status of the control group improved ; on the third postoperative day , there was no significant difference between the two groups ( F = 3.52 , p = .075 ) . The music-listening group had higher scores on the NEECHAM Acute Confusion Scale across the 3-day postoperative period ( F = 7.28 , p = .014 ) OBJECTIVES Delirium ( or acute confusional state ) affects 35 % to 65 % of patients after hip-fracture repair , and has been independently associated with poor functional recovery . We performed a r and omized trial in an orthopedic surgery service at an academic hospital to determine whether proactive geriatrics consultation can reduce delirium after hip fracture . DESIGN Prospect i ve , r and omized , blinded . SETTING Inpatient academic tertiary medical center . PARTICIPANTS 126 consenting patients 65 and older ( mean age 79 + /- 8 years , 79 % women ) admitted emergently for surgical repair of hip fracture . MEASUREMENTS Detailed assessment through interviews with patients and design ated proxies and review of medical records was performed at enrollment to ascertain prefracture status . Subjects were then r and omized to proactive geriatrics consultation , which began preoperatively or within 24 hours of surgery , or " usual care . " A geriatrician made daily visits for the duration of the hospitalization and made targeted recommendations based on a structured protocol . To ascertain study outcomes , all subjects underwent daily , blinded interviews for the duration of their hospitalization , including the Mini-Mental State Examination ( MMSE ) , the Delirium Symptom Interview ( DSI ) , and the Memorial Delirium Assessment Scale ( MDAS ) . Delirium was diagnosed using the Confusion Assessment Method ( CAM ) algorithm . RESULTS The 62 patients r and omized to geriatrics consultation were not significantly different ( P>.1 ) from the 64 usual-care patients in terms of age , gender , prefracture dementia , comorbidity , type of hip fracture , or type of surgical repair . Sixty-one percent of geriatrics consultation patients were seen preoperatively and all were seen within 24 hours postoperatively . A mean of 10 recommendations were made throughout the duration of the hospitalization , with 77 % adherence by the orthopedics team . Delirium occurred in 20 /62 ( 32 % ) intervention patients , versus 32 / 64 ( 50 % ) usual-care patients ( P = .04 ) , representing a relative risk of 0.64 ( 95 % confidence interval ( CI ) = 0.37 - 0.98 ) for the consultation group . One case of delirium was prevented for every 5.6 patients in the geriatrics consultation group . There was an even greater reduction in cases of severe delirium , occurring in 7/ 60 ( 12 % ) of intervention patients and 18 / 62 ( 29 % ) of usual-care patients , with a relative risk of 0.40 ( 95 % CI = 0.18 - 0.89 ) . Despite this reduction in delirium , length of stay did not significantly differ between intervention and usual-care groups ( median + /- interquartile range = 5 + /- 2 days in both groups ) , likely because protocol s and pathways predetermined length of stay . In subgroup analyses , geriatrics consultation was most effective in reducing delirium in patients without prefracture dementia or activities of daily living ( ADL ) functional impairment . CONCLUSIONS Proactive geriatrics consultation was successfully implemented with good adherence after hip-fracture repair . Geriatrics consultation reduced delirium by over one-third , and reduced severe delirium by over one-half . Our trial provides strong preliminary evidence that proactive geriatrics consultation may play an important role in the acute hospital management of hip-fracture patients BACKGROUND delirium is a clinical syndrome associated with multiple short and long-term complications and therefore prevention is an essential part of its management . This study was design ed to assess the efficacy of multicomponent intervention in delirium prevention . METHODS a total of 287 hospitalised patients at intermediate or high risk of developing delirium were r and omised to receive a non-pharmacological intervention delivered by family members ( 144 patients ) or st and ard management ( 143 patients ) . The primary efficacy outcome was the occurrence of delirium at any time during the course of hospitalisation . Three vali date d observers performed the event adjudication by using the confusion assessment method screening instrument . RESULTS there were no significant differences in the baseline characteristics between the two groups . The primary outcome occurred in 5.6 % of the patients in the intervention group and in 13.3 % of the patients in the control group ( relative risk : 0.41 ; confidence interval : 0.19 - 0.92 ; P = 0.027 ) . CONCLUSION the results of this study show that there is a benefit in the non-pharmacological prevention of delirium using family members , when compared with st and ard management of patients at risk of developing this condition BACKGROUND Delirium is a common syndrome with poor prognosis affecting elderly in patients . Treatment is mainly based on common sense with wide variations in practice . We investigated whether intensified , multicomponent geriatric treatment could improve the prognosis of delirious patients . METHODS We performed a r and omized , controlled trial of 174 patients with delirium in six general medicine units from an acute hospital Output:	Strong recommendations in favor of multicomponent interventions to prevent delirium , in surgical or medicals wards , were formulated . In the latter case the evidence applied to older patients at intermediate - high risk of developing delirium . Weak recommendations , to prevent delirium , were formulated for multicomponent interventions provided by family members ( medical ward ) , staff education ( medical ward ) , ear plugs ( intensive care unit ) , reorientation protocol ( intensive care unit ) , and the use of a software to perform drug review . Weak recommendations were provided for the use of multicomponent interventions to prevent delirium in medical wards in patients not selected according to the risk of delirium . Strong recommendations not to use bright light therapy to prevent delirium in intensive care unit setting s were articulated . Moreover , weak recommendations were provided for the use of multicomponent interventions to treat delirium of older patients ( medical wards ) . Conclusions Overall , the panel developed 12 recommendations for the delivery of non-pharmacological interventions to older patients at risk of developing or , with delirium
MS21190	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design OBJECTIVE Numerous studies has shown that regular physical exercise can reduce musculoskeletal pain , but the optimal setting to achieve high adherence and effectiveness remains unknown . This study investigated the effect of workplace versus home-based physical exercise on musculoskeletal pain among healthcare workers . METHODS The r and omized controlled trial ( RCT ) comprised 200 female healthcare workers from 18 departments at 3 hospitals . Participants were r and omly allocated at the cluster level to ten weeks of : ( i ) workplace physical exercise ( WORK ) performed during working hours for 5 × 10 minutes per week and up to 5 group-based coaching sessions on motivation for regular physical exercise , or ( ii ) home-based physical exercise ( HOME ) performed during leisure time for 5 × 10 minutes per week . Both groups received ergonomic counseling on patient h and ling and use of lifting aides . Average pain intensity ( 0 - 10 scale ) in the low back and neck/shoulder was the primary outcome . RESULTS Per week , 2.2 ( SD 1.1 ) and 1.0 ( SD 1.2 ) training sessions were performed in WORK and HOME groups , respectively . Pain intensity , back muscle strength and use of analgesics improved more following WORK than HOME ( P<0.05 ) . Between-group differences at follow-up ( WORK versus HOME ) was -0.7 points for pain intensity [ 95 % confidence interval ( 95 % CI ) -1.0- -0.3 ] , 5.5 Nm for back muscle strength ( 95 % CI 2.0 - 9.0 ) , and -0.4 days per week for use of analgesics ( 95 % CI -0.7- -0.2 ) . The effect size for between-group differences in pain intensity was small ( Cohen 's d=0.31 ) . CONCLUSIONS Workplace physical exercise is more effective than home-based exercise in reducing musculoskeletal pain , increasing muscle strength and reducing the use of analgesics among healthcare workers Purpose To evaluate whether information and reassurance about low back pain ( LBP ) given to employees at the workplace could reduce sick leave . Methods A Cluster r and omized controlled trial with 135 work units of about 3,500 public sector employees in two Norwegian municipalities , r and omized into two intervention groups ; Education and peer support ( EPS ) ( n = 45 units ) , education and “ peer support and access to an outpatient clinic ” ( EPSOC ) ( n = 48 units ) , and a control group ( n = 42 units ) . Both interventions consisted of educational meetings based on a “ non-injury model ” and a “ peer adviser ” appointed by colleagues . Employees in the EPSOC group had access to an outpatient clinic for medical examination and further education . The control group received no intervention . The main outcome was sick leave based on municipal records . Secondary outcomes were self-reported pain , pain related fear of movement , coping , and beliefs about LBP from survey data of 1,746 employees ( response rate about 50 % ) . Results EPS reduced sick leave by 7 % and EPSOC reduced sick leave by 4 % during the intervention year , while sick leave in the control group was increased by 7 % during the same period . Overall , Rate Ratios ( RR ) were statistically significant for EPSOC ( RR = .84 ( C.I = 0.71–.99 ) but not EPS ( RR = .92 ( C.I = 0.78–1.09 ) ) in a mixed Poisson regression analysis . Faulty beliefs about LBP were reduced in both intervention groups . Conclusions Educational meetings , combined with peer support and access to an outpatient clinic , were effective in reducing sick leave in public sector employees The aim of the present study was to compare the effect of increased aerobic capacity versus muscle strength rehabilitation of female hospital staff with long-lasting musculoskeletal back pain . Seventy-nine women agreed to participate in the intervention study . After a medical examination , 65 individuals were assigned to one of three balanced groups : Endurance training ( aerobic capacity promoting training : ET : n = 22 ) , strength promotion exercise ( SP : n = 24 ) or a control group ( CON : n = 19 ) . The active groups met twice a week for 60 minutes of exercise over 15 weeks . Aerobic capacity ( VO2max ) and musculoskeletal pain were measured immediately before ( T1 ) and after the intervention period ( T2 ) . Aerobic capacity significantly increased in the ET group , whereas no change was observed in the SP group , and a significant reduction was found in the CON group from T1 to T2 . Musculoskeletal pain was significantly reduced in both intervention groups , whereas minor changes were observed in the control group . Results from a 7-month follow-up ( T3 ) survey confirmed the beneficial effects of interventions on musculoskeletal pain . In conclusion , improved aerobic capacity appeared not to be a necessary mechanism in musculoskeletal back pain reduction Purpose . To report findings from Treatwell 5-a-Day process tracking . Design . Worksites were r and omly assigned to a minimal intervention control , worksite-only condition , or worksite-plus-family condition . Setting . Twenty-two small community health centers in Massachusetts . Subjects . Employees of the community health centers . Intervention . Both intervention conditions included the formation of employee advisory boards ; activities such as nutrition discussion s and taste tests targeting individual behavior change ; and point-of-purchase labeling as an environmental strategy . Worksite-plus-family sites incorporated activities such as family contests , campaigns , and picnics . Measures . Documentation of the number and type of activities for extent of implementation ; number of participants in activities for reach ; program awareness and participation from the follow-up employee survey ( n = 1306 , representing 76 % [ range , 56%–100 % ] of the sample ) ; change in fruit and vegetable consumption from a comparison between the follow-up and baseline surveys ( n = 1359 , representing 87 % [ range , 75%–100 % ] of the sample ) . Results . A higher number of activities per employee was significantly correlated with greater program awareness ( . 68 ; p = . 006 ) and greater change in fruit and vegetable consumption ( .55 ; p = .04 ) . Greater participation in activities was significantly correlated with greater awareness ( .67 ; p = .007 ) , higher participation ( .61 ; p = .02 ) , and increase in fruit and vegetable consumption . ( .55 ; p = .04 ) . Conclusions . These results provide quantitative indicators of a dose-response relationship between the number of intervention activities per employee and higher percentage of employee participation and observed increases in fruit and vegetable consumption OBJECTIVE Shift work is associated with adverse health outcomes , and an unhealthy diet may be a contributing factor . We compared diet quantity and quality between day and shift workers , and studied exposure-response relationships regarding frequency of night shifts and years of shift work . METHODS Cross-sectional general population data from the European Prospect i ve Investigation into Cancer and Nutrition-Netherl and s ( EPIC-NL ) cohort was used . Dietary intake was assessed in 1993 - 1997 among adults aged 20 - 70 years using a food frequency question naire . We calculated energy intake , the Mediterranean Diet Score ( MDS ) and WHO-based Healthy Diet Indicator ( HDI ) . In 2011 - 2014 , we retrospectively identified 683 shift workers and 7173 day workers in 1993 - 1997 . Using multivariable-adjusted linear regression analysis , we estimated regression coefficients ( β ) and 95 % confidence intervals ( 95 % CI ) of the differences in dietary intake between day and shift workers . RESULTS Shift workers had a higher energy intake than day workers ( β:56 kcal/d , 95 % CI 10 - 101 ) , and a higher consumption of grains , dairy products , meat and fish ( P<0.05 ) . The difference in energy intake was largest for shift workers with ≥5 night shifts/month . They consumed 103 kcal/d ( 95 % CI 29 - 176 ) more than day workers . No associations were found with MDS and HDI . CONCLUSION Shift workers and particularly those with a high frequency of night shifts had a higher energy intake than day workers . Regardless of number of night shifts and years of shift work , shift workers had similar diet quality as day workers . This suggests that increased energy intake among shift workers may contribute to shift work-induced adverse health outcomes Background Increased physical activity levels benefit both an individuals ' health and productivity at work . The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention design ed to increase physical activity levels . Methods A total of 1260 participants from 44 UK worksites ( based within 5 organizations ) were recruited to a cluster r and omized controlled trial with worksites r and omly allocated to an intervention or control condition . Measurement of physical activity and other variables occurred at baseline , and at 0 months , 3 months and 9 months post-intervention . Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention . The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior , delivered in-house by nominated facilitators . Self-reported physical activity ( measured using the IPAQ short-form ) and health outcomes were assessed . Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity ( from the IPAQ ) at any of the follow-up time points controlling for baseline activity . However , the intervention did significantly reduce systolic blood pressure ( B = -1.79 mm/Hg ) and resting heart rate ( B = -2.08 beats ) and significantly increased body mass index ( B = .18 units ) compared to control . The intervention was found not to be cost-effective , however the substantial variability round this estimate suggested that further research is warranted . Conclusions The current study found mixed support for this worksite physical activity intervention . The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale r and omized controlled trials in real-world setting s . Trial registration Current controlled trials IS RCT Background Dietary behaviour interventions have the potential to reduce diet-related disease . Ample opportunity exists to implement these interventions in the workplace . The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace setting s. Methods / design A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted . The complex intervention design has been developed using the Medical Research Council ’s framework and the National Institute for Health and Clinical Excellence ( NICE ) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-r and omized design s. It will draw on a soft paternalistic “ nudge ” theoretical perspective . Nutrition education will include three elements : group presentations , individual nutrition consultations and detailed nutrition information . Environmental dietary modification will consist of five elements : ( a ) restriction of fat , saturated fat , sugar and salt , ( b ) increase in fibre , fruit and vegetables , ( c ) price discounts for whole fresh fruit , ( d ) strategic positioning of healthier alternatives and ( e ) portion size control . No intervention will be offered in workplace A ( control ) . Workplace B will receive nutrition education . Workplace C will receive nutrition education and environmental dietary modification . Workplace D will receive environmental dietary modification alone . A total of 448 participants aged 18 to 64 years will be selected r and omly . All permanent , full-time employees , purchasing at least one main meal in the workplace daily , will be eligible . Changes in dietary behaviours , nutrition knowledge , health status with measurements obtained at baseline and at intervals of 3 to 4 months , 7 to 9 months and 13 to 16 months will be recorded . A process evaluation and cost-effectiveness economic evaluation will be undertaken . Discussion A ' Food Choice at Work ’ toolbox ( concise teaching kit to replicate the intervention ) will be developed to inform and guide future research ers , workplace stakeholders , policy makers and the food industry . Trial registration Current Controlled Trials , IS RCT Background The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers , allegedly due to high physical work dem and s of healthcare work . Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups , but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise . Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence . On the other h and , physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend . Thus , it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain . This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers . Methods / Design This study was design ed Output:	There was moderate evidence for effectiveness on weight and physical activity outcomes , but insufficient evidence for healthy eating outcomes . Conclusion Current evidence demonstrates that group-based workplace interventions can be effective for supporting shift workers to lose weight and increase physical activity , while further research is needed to change healthy eating and sedentary behaviors .
MS21191	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Forty patients undergoing elective and emergency Caesarean section ( excluding severe fetal distress ) were divided into four groups to receive 50 % oxygen , 50 % nitrous oxide , and 0.5 % halothane ( group 1 , controls ) or 100 % oxygen supplemented by 1.5 x MAC of halothane , enflurane or isoflurane ( groups 2,3,4 , respectively ) reducing to 1.0 x MAC 5 min after induction . The umbilical venous PO2 in the oxygen-only groups was higher than in the oxygen-nitrous oxide groups , this difference reaching statistical significance when the patients in the oxygen-only groups were combined . Blood loss and uterine contractility were unaffected by the increased concentrations of volatile agents , and awareness did not occur . Improved cardiovascular stability was demonstrated in the elective high-oxygen groups . The technique is safe and warrants further study , since there are no important ethical objections To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results The use of supplemental oxygen in uncomplicated cesarean deliveries under spinal anesthesia has been thoroughly investigated during recent decades . The aim of this study was to determine the benefits for both mother and infant of administering supplemental , low-dose oxygen via a nasal cannula versus having no supplement ( i.e. , room air only ) . Healthy parturients at term undergoing elective cesarean section under spinal anesthesia were r and omly allocated into two groups : an oxygen group ( n = 170 ) , who received 3 LPM oxygen via a nasal cannula ; and a room-air group ( n = 170 ) , who were assigned to breathe room air . Maternal oxygen saturation was measured continuously by using pulse oximeter . The desaturation was determined by oxygen saturation < 94 % over 30 seconds . Umbilical cord gases and Apgar scores were collected followed delivery of the infant . All maternal desaturation events occurred in 12 parturients assigned to the room-air group . Most events were concurrent with hypotension . The umbilical venous partial pressure of oxygen was significantly higher in the oxygen group . The other blood gas measurements and Apgar scores were not significantly different between the two groups . Based on our findings , the use of supplemental oxygen could prevent maternal desaturation result ing from receiving sedation and intraoperative hypotension BACKGROUND Newborns exposed to oxygen suffer from an oxidative stress with significant alterations in the concentrations of superoxide dismutase ( SOD ) and glutathione ( GSSG ) . OBJECTIVE To investigate the biological and clinical effects of oxygen administration to delivering mothers . METHODS We conducted a r and omized , double-blinded , controlled trial on a cohort of delivering women ( n=56 ) with an uncomplicated term pregnancy . Women were r and omly assigned to one of two groups : Oxygen group or Room Air group . The Oxygen group received 100 % oxygen ( 2l/min ) via nasal cannula for at least 30 min before delivery . Subjects in the Room Air group were connected to a nasal cannula while on room air . Concentrations of SOD ( μg/g of Hb ) and GSSG ( μM/ml ) were measured in maternal and umbilical cord blood . Bivariate and multivariate analyses were used to compare the two groups using the SAS system . RESULTS Maternal SOD and GSSG did not differ between the two groups at baseline or after delivery . Concentrations of SOD and GSSG in umbilical cord blood did not differ between groups . More infants in Oxygen Group required delivery room resuscitation ( 20 % vs. 0 % , P=0.03 ) . This difference could not be explained by mode of delivery , infant sex , or other confounders . CONCLUSIONS Maternal exposure to oxygen during delivery is not associated with changes in umbilical cord SOD or GSSG . Further studies are needed to explore mechanisms responsible for the need of resuscitation in the oxygen group Spinal anesthesia recently has gained popularity for elective cesarean section . Our anesthesia service changed from epidural to spinal anesthesia for elective cesarean section in 1991 . To evaluate the significance of this change in terms of time management , costs , charges , and complication rates , we retrospectively review ed the charts of patients who had received epidural ( n = 47 ) or spinal ( n = 47 ) anesthesia for nonemergent cesarean section . Patients who received epidural anesthesia had significantly longer total operating room ( OR ) times than those who received spinal anesthesia ( 101 + /- 20 vs 83 + /- 16 min , [ mean + /- SD ] P < 0.001 ) ; this was caused by longer times spent in the OR until surgical incision ( 46 + /- 11 vs 29 + /- 6 min , P < 0.001 ) . Length of time spent in the postanesthesia recovery unit was similar in both groups . Supplemental intraoperative intravenous ( IV ) analgesics and anxiolytics were required more often in the epidural group ( 38 % ) than in the spinal group ( 17 % ) ( P < 0.05 ) . Complications were noted in six patients with epidural anesthesia and none with spinal anesthesia ( P < 0.05 ) . Average per-patient charges were more for the epidural group than for the spinal group . Although direct cost differences between the groups were negligible , there were more substantial indirect costs differences . We conclude that spinal block may provide better and more cost effective anesthesia for uncomplicated , elective cesarean sections . ( Anesth Analg 1995;80:709 - 12 Objective : To compare general , epidural and combined spinal-epidural anesthesia with respect to short-term outcome of newborns delivered by elective Cesarean section of healthy parturients with normal pregnancies . Study design : A total of 238 eight pregnant women admitted to our institution between January 1998 and July 2002 , for whom elective Cesarean section was planned after 38 weeks ' gestation , were grouped according to the kind of anesthesia used for the procedure . Maternal characteristics , birth weight , Apgar scores , and maternal and umbilical artery ( UA ) acid-base parameters were analyzed . Results : Maternal pH was significantly lower and pCO2 and pO2 were significantly higher in the general anesthetic group , compared to the other two groups ( 7.38 ± 0.03 vs. 7.43 ± 0.02 and 7.43 ± 0.05 , respectively ; 35.03 ± 3.88 mmHg vs. 29.25 ± 5.05 mmHg and 29.64 ± 4.16 mmHg , respectively ; and 224.56 ± 86.77 mmHg vs. 151.28 ± 38 mmHg and 157.36 ± 53.51 mmHg , respectively , p < 0.05 ) . The pH of the UA was higher in the general anesthetic group , compared to the spinal-epidural group ( 7.29 ± 0.02 vs. 7.26 ± 0.06 , p < 0.05 ) . The pO2 as well as O2 saturation of the UA were higher when general anesthetic was administered , compared to the two regional modalities ( 15.60 ± 5.48 mmHg vs. 9.29 ± 4.41 mmHg and 9.20 ± 4.06 mmHg , respectively ; and 17.37 ± 9.79 % vs. 7.87 ± 4.98 % and 6.90 ± 5.22 % , respectively , p < 0.05 ) . UA O2 saturation fell to zero in some cases in the combined spinal-epidural group , without an evident effect on fetal well-being . No fetal acidemia was noted in any group . Neonatal outcomes were similar in the three groups studied . Conclusions : Type of anesthesia does not influence short-term outcomes in infants born via elective Cesarean section , although differences in acid-base status of both the mother and especially the newborn recommend careful use of spinal anesthesia We investigated the necessity for administration of supplementary oxygen to mothers undergoing elective Caesarean section under spinal anaesthesia . Sixty‐nine women undergoing elective Caesarean section were r and omly allocated to one of three groups to be given either oxygen ( 40 % ) by facemask , air by facemask or oxygen at 2 l.min−1 by nasal cannulae . Umbilical arterial and venous blood sample s were taken and analysed immediately after delivery . The results showed that there were no significant differences in the umbilical arterial or venous pH , partial pressure of oxygen and partial pressure of carbon dioxide between any of the three groups . We also assessed the patient acceptability of oxygen administered by facemask vs. nasal cannulae should the need for supplementary oxygen arise . It was found that use of the facemask impeded communication BACKGROUND Oxygen supplementation is given routinely to parturients undergoing Caesarean section under regional anaesthesia . While the aim is to improve fetal oxygenation , inspiring a high oxygen fraction ( FIO2 ) can also increase free radical activity and lipid peroxidation in both the mother and baby . In this prospect i ve , r and omized , double-blind study , we investigated the effect of high inspired oxygen fraction ( FIO2 ) on maternal and fetal oxygenation and oxygen free radical activity in parturients having Caesarean section under spinal anaesthesia . METHODS Forty-four healthy parturients were r and omized to breathe either 21 % ( air group ) or 60 % oxygen ( oxygen group ) intraoperatively via a ventimask . Maternal arterial blood was collected at 5-min intervals from baseline until delivery , and umbilical arterial and venous blood was collected at delivery . We measured blood gases and the products of lipid peroxidation ( 8-isoprostane , malondialdehyde ( MDA ) , hydroperoxide ( OHP ) ) and purine metabolites . RESULTS At delivery , the oxygen group had greater maternal arterial PO2 [ mean 30.0 ( SD 6.3 ) vs 14.2 ( 1.9 ) kPa ; mean difference 15.8 kPa , 95 % confidence interval 12.9 - 18.7 kPa , P<0.001 ] and greater umbilical venous PO2 [ 4.8 ( 1.0 ) vs 4.0 ( 1.4 ) kPa ; mean difference 0.8 kPa , 95 % confidence interval 0.0 - 1.5 kPa , P=0.04 ] compared with the air group . Maternal and umbilical plasma concentrations of lipid peroxides ( 8-isoprostane , MDA , OHP ) were greater in the oxygen group than in the air group ( P<0.05 ) . CONCLUSIONS We conclude that breathing high FIO2 modestly increased fetal oxygenation but caused a concomitant increase in oxygen free radical activity in both mother and fetus We report the changes observed in a number of pulmonary function tests performed on 36 patients undergoing Caesarean section under spinal anaesthesia . The tests comprised peak expiratory flow , forced expiratory volume in one second , forced vital capacity , forced expiratory volume in one second to forced vital capacity ratio and the maximal mid‐expiratory flow . Significant changes occurred that are consistent with a restrictive ventilatory defect . These changes persisted for four hours after the induction of spinal anaesthesia . Administration of 35 % oxygen by facemask failed to change significantly fetal umbilical vein pH or partial pressure of oxygen Purpose The aim of this investigation was to determine whether supplementary oxygen provided by either nasal cannula or face mask versus room air might affect fetal oxygenation during elective cesarean section under spinal anesthesia by assessing maternal and neonatal regional cerebral oxygenation ( rSO2 ) with a cerebral oximeter . Methods Ninety parturients were r and omly allocated into three groups : two groups received 5 L/min oxygen by either nasal cannula ( Group NC , n = 30 ) or face mask ( Output:	Overall , we found no convincing evidence that giving supplementary oxygen to healthy term pregnant women during elective caesarean section under regional anaesthesia is either beneficial or harmful for either the mother or the foetus ' short-term clinical outcome as assessed by Apgar scores .
MS21192	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study was design ed as a test of the serum lipid response and dietary adaptation to recommended daily inclusion of instant oats in an otherwise regular diet . Hypercholesterolemic adults were r and omly assigned to a control or intervention group . Participants in the intervention group were given packages of instant oats and requested to eat two servings per day ( approximately two ounces dry weight ) , substituting the oats for other carbohydrate foods in order to maintain baseline calorie intake and keep weight stable . Serum lipids were measured in blood collected by venipuncture at baseline , four weeks , and eight weeks . Baseline mean total cholesterol ( TC ) levels were 6.56 mmol/L and 6.39 mmol/L for intervention and control groups , respectively . After eight weeks , mean serum total cholesterol of the intervention group was lower by -0.40 mmol/L , and mean net difference in TC between the two groups was 0.32 mmol/L ( 95 % CI : 0.09 , 0.54 ) . Low-density lipoprotein-cholesterol was similarly reduced with mean net difference of 0.25 mmol/L ( 95 % CI : 0.02 , 0.48 ) between the two groups . Mean soluble fiber intake increased along with slight self-imposed reductions in mean total fat , saturated fat , and dietary cholesterol intake in the intervention group . Neither group changed mean body weight . Daily inclusion of two ounces of oats appeared to facilitate reduction of serum total cholesterol and LDL-C in these hyperlipidemic individuals BACKGROUND Epidemiologic studies have found whole-grain intake to be inversely associated with the risk of type 2 diabetes and heart disease . OBJECTIVE We tested the hypothesis that whole-grain consumption improves insulin sensitivity in overweight and obese adults . DESIGN This controlled experiment compared insulin sensitivity between diets ( 55 % carbohydrate , 30 % fat ) including 6 - 10 servings/d of breakfast cereal , bread , rice , pasta , muffins , cookies , and snacks of either whole or refined grains . Total energy needs were estimated to maintain body weight . Eleven overweight or obese [ body mass index ( in kg/m(2 ) ) : 27 - 36 ] hyperinsulinemic adults aged 25 - 56 y participated in a r and omized crossover design . At the end of each 6-wk diet period , the subjects consumed 355 mL ( 12 oz ) of a liquid mixed meal , and blood sample s were taken over 2 h. The next day a euglycemic hyperinsulinemic clamp test was administered . RESULTS Fasting insulin was 10 % lower during consumption of the whole-grain than during consumption of the refined-grain diet ( mean difference : -15 + /- 5.5 pmol/L ; P = 0.03 ) . After the whole-grain diet , the area under the 2-h insulin curve tended to be lower ( -8832 pmol.min/L ; 95 % CI : -18720 , 1062 ) than after the refined-grain diet . The rate of glucose infusion during the final 30 min of the clamp test was higher after the whole-grain diet ( 0.07 x 10(-4 ) mmol.kg(-1).min(-1 ) per pmol/L ; 95 % CI : 0.003 x 10(-4 ) , 0.144 x 10(-4 ) ) . CONCLUSION Insulin sensitivity may be an important mechanism whereby whole-grain foods reduce the risk of type 2 diabetes and heart disease BACKGROUND Whole-grain cereal foods including rye have been identified as providing significant health benefits that do not occur when refined-cereal foods are ingested . OBJECTIVES Foods ( 90 g ) containing whole-grain rye flour and whole-grain wheat flour were compared with low-fiber refined-cereal foods for their effects on markers of bowel health and the metabolic markers insulin and glucose . DESIGN Three 4-wk interventions were undertaken in a r and omized crossover design with 28 overweight men aged 40 - 65 y who had no history of bowel disease . Against a background intake of 14 g dietary fiber ( DF ) , the men were fed low-fiber cereal grain foods providing 5 g DF for a total of 19 g DF/d . High-fiber wheat foods provided 18 g DF , and high-fiber rye foods provided 18 g DF , both giving a total of 32 g DF/d . Fecal sample s ( 48-h ) and fasting and postpr and ial blood sample s were collected at the end of each period and assayed . RESULTS Both high-fiber rye and wheat foods increased fecal output by 33 - 36 % ( P = 0.004 ) and reduced fecal beta-glucuronidase activity by 29 % ( P = 0.027 ) . Postpr and ial plasma insulin was decreased by 46 - 49 % ( P = 0.0001 ) and postpr and ial plasma glucose by 16 - 19 % ( P = 0.0005 ) . Rye foods were associated with significantly ( P = 0.0001 ) increased plasma enterolactone ( 47 % and 71 % ) and fecal butyrate ( 26 % and 36 % ) , relative to wheat and low-fiber options , respectively . CONCLUSIONS High-fiber rye and wheat food consumption improved several markers of bowel and metabolic health relative to that of low-fiber food . Fiber from rye appears more effective than that from wheat in overall improvement of biomarkers of bowel health Systematic review s ( SRs ) are an increasingly popular evidence -based tool and are often used to answer complex research questions across many different research domains . Early SR methodology was advanced by social scientists , and the term meta- analysis was coined by a social scientist who also conducted research in psychology . SRs have recently become popular in healthcare and are likely to be beneficial in any field . The aim of this report is to highlight issues in SR conduct with a focus on the field of nutrition and to make recommendations on improving SR conduct in this area . Development of the research question is probably the most important step in conducting an SR . The 4 main components of an answerable question are 1 ) the patient , population , or problem ; 2 ) the intervention , independent variable , or exposure ; 3 ) the comparators ; and 4 ) the dependent variables or outcomes of interest . The question will be used to determine the optimal methods for conducting the SR . SRs often include study design s beyond r and omized trials and do not always include a meta- analysis of the results . Other topics explored include underst and ing and interpreting discordant review s and the importance of reporting tools [ eg , QUality Of Reporting Of Meta-analyses ( QUOROM Statement ) or CONsoli date d St and ards Of Reporting of Trials ( CONSORT Statement ) ] . Recommendations are then provided , such as developing a capacity-building program , search ing the primary literature for research gaps , and extending reporting tools such as the QUOROM Statement to the field of nutrition BACKGROUND Epidemiologic studies that directly examine changes in whole-grain consumption in relation to weight gain are sparse , and characterization of this association has been obscured by method ologic inconsistencies in the assessment of whole grains . OBJECTIVE We aim ed to ascertain the associations between changes in new quantitative estimates of whole-grain intake and 8-y weight gain among US men . DESIGN The study was conducted in a prospect i ve cohort of 27 082 men aged 40 - 75 y at baseline in 1986 . Data on lifestyle factors were obtained periodically by using self-reported question naires , and participants measured and reported their body weight in 1986 and 1994 . RESULTS In multivariate analyses , an increase in whole-grain intake was inversely associated with long-term weight gain ( P for trend < 0.0001 ) . A dose-response relation was observed , and for every 40-g/d increment in whole-grain intake from all foods , weight gain was reduced by 0.49 kg . Bran that was added to the diet or obtained from fortified-grain foods further reduced the risk of weight gain ( P for trend = 0.01 ) , and , for every 20 g/d increase in intake , weight gain was reduced by 0.36 kg . Changes in cereal and fruit fiber were inversely related to weight gain . No associations were observed between changes in refined-grain or added germ consumption and body weight . CONCLUSIONS The increased consumption of whole grains was inversely related to weight gain , and the associations persisted after changes in added bran or fiber intakes were accounted for . This suggests that additional components in whole grains may contribute to favorable metabolic alterations that may reduce long-term weight gain High intakes of whole grain foods are inversely related to the incidence of coronary heart diseases and type 2 diabetes , but the mechanisms remain unclear . Our study aim ed to evaluate the effects of a diet rich in whole grains compared with a diet containing the same amount of refined grains on insulin sensitivity and markers of lipid peroxidation and inflammation . In a r and omized crossover study , 22 women and 8 men ( BMI 28 + /- 2 ) were given either whole-grain or refined-grain products ( 3 bread slices , 2 crisp bread slices , 1 portion muesli , and 1 portion pasta ) to include in their habitual daily diet for two 6-wk periods . Peripheral insulin sensitivity was determined by euglycemic hyperinsulinemic clamp tests . 8-Iso-prostagl and in F(2alpha ) ( 8-iso PGF(2alpha ) ) , an F(2)-isoprostane , was measured in the urine as a marker of lipid peroxidation , and highly sensitive C-reactive protein and IL-6 were analyzed in plasma as markers of inflammation . Peripheral insulin sensitivity [ mg glucose . kg body wt(-1 ) . min(-1 ) per unit plasma insulin ( mU/L ) x 100 ] did not improve when subjects consumed whole-grain products ( 6.8 + /- 3.0 at baseline and 6.5 + /- 2.7 after 6 wk ) or refined products ( 6.4 + /- 2.9 and 6.9 + /- 3.2 , respectively ) and there were no differences between the 2 periods . Whole-grain consumption also did not affect 8-iso-PGF(2alpha ) in urine , IL-6 and C-reactive protein in plasma , blood pressure , or serum lipid concentrations . In conclusion , substitution of whole grains ( mainly based on milled wheat ) for refined-grain products in the habitual daily diet of healthy moderately overweight adults for 6-wk did not affect insulin sensitivity or markers of lipid peroxidation and inflammation Hypertension , dyslipidemia and overweight contribute substantially to cardiovascular disease risk . One of the most effective methods for improving high blood pressure and lipid profiles is loss of excess weight . Other recommendations for reducing cardiovascular risk include changes in dietary micronutrient , macronutrient and fiber intakes . To better define a diet for reduction in cardiovascular risk , 43 adults ( body mass index 26.4 + /- 3.3 , range 20.5 - 33.9 kg/m(2 ) ) participated in an 8-wk study to determine the effects of two diets on weight , blood pressure , lipids and insulin sensitivity . For 2 wk , weight was maintained and all subjects consumed a control diet . For the next 6 wk , subjects consumed one of two hypocaloric diets ( maintenance energy minus 4.2 MJ/d ) : the control diet ( n = 21 ) or a diet containing oats [ 45 g/(4.2 MJ dietary energy . d ) , n = 22 ] . There was no significant difference between groups in changes in weight loss ( control -4.0 + /- 1.1 kg , oats -3.9 + /- 1.6 kg , P = 0.8 ) . The oats diet result ed in greater decreases in mean systolic blood pressure ( oats -6 + /- 7 mm Hg , control -1 + /- 10 mm Hg , P = 0.026 ) , whereas diastolic blood pressure change did not differ between the two groups ( oats -4 + /- 6 mm Hg , control -3 + /- 5 mm Hg , P = 0.8 ) . The oat diet result ed in significantly greater decreases in total cholesterol ( oats -0.87 + /- 0.47 mmol/L , control -0.34 + /- 0.5 mmol/L , P = 0.003 ) and LDL cholesterol ( oats -0.6 + /- 0.41 mmol/L , control -0.2 + /- 0.41mmol/L , P = 0.008 ) . In summary , a hypocaloric diet containing oats consumed over 6 wk result ed in greater improvements in systolic blood pressure and lipid profile than did a hypocaloric diet without oats The objective of this study was to determine the hypocholesterolemic effects of whole meal rye and white wheat breads in healthy humans with elevated serum cholesterol concentrations , and the changes in plasma glucose and insulin concentrations during r Output:	Whole-grain consumption does not decrease body weight compared with control consumption , but a small beneficial effect on body fat may be present . The relatively short duration of intervention studies ( ≤16 wk ) may explain the lack of difference in body weight and fat .
MS21193	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Human microbial communities are characterized by their taxonomic , metagenomic and metabolic diversity , which varies by distinct body sites and influences human physiology . However , when and how microbial communities within each body niche acquire unique taxonomical and functional signatures in early life remains underexplored . We thus sought to determine the taxonomic composition and potential metabolic function of the neonatal and early infant microbiota across multiple body sites and assess the effect of the mode of delivery and its potential confounders or modifiers . A cohort of pregnant women in their early third trimester ( n = 81 ) were prospect ively enrolled for longitudinal sampling through 6 weeks after delivery , and a second matched cross-sectional cohort ( n = 81 ) was additionally recruited for sampling once at the time of delivery . Sample s across multiple body sites , including stool , oral gingiva , nares , skin and vagina were collected for each maternal – infant dyad . Whole-genome shotgun sequencing and sequencing analysis of the gene encoding the 16S rRNA were performed to interrogate the composition and function of the neonatal and maternal microbiota . We found that the neonatal microbiota and its associated functional pathways were relatively homogeneous across all body sites at delivery , with the notable exception of the neonatal meconium . However , by 6 weeks after delivery , the infant microbiota structure and function had substantially exp and ed and diversified , with the body site serving as the primary determinant of the composition of the bacterial community and its functional capacity . Although minor variations in the neonatal ( immediately at birth ) microbiota community structure were associated with the cesarean mode of delivery in some body sites ( oral gingiva , nares and skin ; R2 = 0.038 ) , this was not true for neonatal stool ( meconium ; Mann – Whitney P > 0.05 ) , and there was no observable difference in community function regardless of delivery mode . For infants at 6 weeks of age , the microbiota structure and function had exp and ed and diversified with demonstrable body site specificity ( P < 0.001 , R2 = 0.189 ) but without discernable differences in community structure or function between infants delivered vaginally or by cesarean surgery ( P = 0.057 , R2 = 0.007 ) . We conclude that within the first 6 weeks of life , the infant microbiota undergoes substantial reorganization , which is primarily driven by body site and not by mode of delivery Importance Establishment of the infant microbiome has lifelong implication s on health and immunity . Gut microbiota of breastfed compared with nonbreastfed individuals differ during infancy as well as into adulthood . Breast milk contains a diverse population of bacteria , but little is known about the vertical transfer of bacteria from mother to infant by breastfeeding . Objective To determine the association between the maternal breast milk and areolar skin and infant gut bacterial communities . Design , Setting , and Participants In a prospect i ve , longitudinal study , bacterial composition was identified with sequencing of the 16S ribosomal RNA gene in breast milk , areolar skin , and infant stool sample s of 107 healthy mother-infant pairs . The study was conducted in Los Angeles , California , and St Petersburg , Florida , between January 1 , 2010 , and February 28 , 2015 . Exposures Amount and duration of daily breastfeeding and timing of solid food introduction . Main Outcomes and Measures Bacterial composition in maternal breast milk , areolar skin , and infant stool by sequencing of the 16S ribosomal RNA gene . Results In the 107 healthy mother and infant pairs ( median age at the time of specimen collection , 40 days ; range , 1 - 331 days ) , 52 ( 43.0 % ) of the infants were male . Bacterial communities were distinct in milk , areolar skin , and stool , differing in both composition and diversity . The infant gut microbial communities were more closely related to an infant ’s mother ’s milk and skin compared with a r and om mother ( mean difference in Bray-Curtis distances , 0.012 and 0.014 , respectively ; P < .001 for both ) . Source tracking analysis was used to estimate the contribution of the breast milk and areolar skin microbiomes to the infant gut microbiome . During the first 30 days of life , infants who breastfed to obtain 75 % or more of their daily milk intake received a mean ( SD ) of 27.7 % ( 15.2 % ) of the bacteria from breast milk and 10.3 % ( 6.0 % ) from areolar skin . Bacterial diversity ( Faith phylogenetic diversity , P = .003 ) and composition changes were associated with the proportion of daily breast milk intake in a dose-dependent manner , even after the introduction of solid foods . Conclusions and Relevance The results of this study indicate that bacteria in mother ’s breast milk seed the infant gut , underscoring the importance of breastfeeding in the development of the infant gut microbiome Infant microbiota is influenced by numerous factors , such as delivery mode , environment , prematurity and diet ( breast milk or formula ) . In addition to its nutritional value , breast milk contains bioactive substances that drive microbial colonisation and support immune system development , which are usually not present in infant formulas . Among these substances , polyamines have been described to be essential for intestinal and immune functions in newborns . However , their effect on the establishment of microbiota remains unclear . Therefore , the aim of the present study was to ascertain whether an infant formula supplemented with polyamines has an impact on microbial colonisation by modifying it to resemble that in breast-fed neonatal BALB/c mice . In a 4 d intervention , a total of sixty pups ( 14 d old ) were r and omly assigned to the following groups : ( 1 ) breast-fed group ; ( 2 ) non-enriched infant formula-fed group ; ( 3 ) three different groups fed an infant formula enriched with increasing concentrations of polyamines ( mixture of putrescine , spermidine and spermine ) , following the proportions found in human milk . Microbial composition in the contents of the oral cavity , stomach and small and large intestines was analysed by quantitative PCR targeted at fourteen bacterial genera and species . Significantly different ( P < 0·05 ) microbial colonisation patterns were observed in the entire gastrointestinal tract of the breast-fed and formula-fed mice . In addition , our findings demonstrate that supplementation of polyamines regulates the amounts of total bacteria , Akkermansia muciniphila , Lactobacillus , Bifidobacterium , Bacteroides-Prevotella and Clostridium groups to levels found in the breast-fed group . Such an effect requires further investigation in human infants , as supplementation of an infant formula with polyamines might contribute to healthy gastrointestinal tract development Background The fungi in the gastrointestinal tract , the gut mycobiota , are now recognised as a significant part of the gut microbiota , and they may be important to human health . In contrast to the adult gut mycobiota , the establishment of the early gut mycobiota has never been described , and there is little knowledge about the fungal transfer from mother to offspring . Methods In a prospect i ve cohort , we followed 298 pairs of healthy mothers and offspring from 36 weeks of gestation until 2 years of age ( 1516 sample s ) and explored the gut mycobiota in maternal and offspring sample s. Half of the pregnant mothers were r and omised into drinking probiotic milk during and after pregnancy . The probiotic bacteria included Lactobacillus rhamnosus GG ( LGG ) , Bifidobacterium animalis subsp . lactis Bb-12 and Lactobacillus acidophilus La-5 . We quantified the fungal abundance of all the sample s using qPCR of the fungal internal transcribed spacer (ITS)1 segment , and we sequenced the 18S rRNA gene ITS1 region of 90 high-quantity sample s using the MiSeq platform ( Illumina ) . Results The gut mycobiota was detected in most of the mothers and the majority of the offspring . The offspring showed increased odds of having detectable faecal fungal DNA if the mother had detectable fungal DNA as well ( OR = 1.54 , p = 0.04 ) . The fungal alpha diversity in the offspring gut increased from its lowest at 10 days after birth , which was the earliest sampling point . The fungal diversity and fungal species showed a succession towards the maternal mycobiota as the child aged , with Debaryomyces hansenii being the most abundant species during breast-feeding and Saccharomyces cerevisiae as the most abundant after weaning . Probiotic consumption increased the gut mycobiota abundance in pregnant mothers ( p = 0.01 ) . Conclusion This study provides the first insight into the early fungal establishment and the succession of fungal species in the gut mycobiota . The results support the idea that the fungal host phenotype is transferred from mother to offspring . Trial registration Clinical trials.gov Background In a recent study , supplementation of infant formula with milk fat globule membranes ( MFGM ) decreased the incidence of otitis media in infants < 6 months of age . Objectives The aim of the present study was to characterize the oral microbiota in infants fed MFGM-supplemented formula and compare it to that of infants fed st and ard formula or breast milk . Methods In a prospect i ve double-blinded r and omized controlled trial , exclusively formula-fed infants < 2 months of age were r and omized to be fed experimental formula ( EF , n = 80 ) with reduced energy and protein and supplemented with a bovine MFGM concentrate , or st and ard formula ( SF , n = 80 ) until 6 months of age . A breast-fed reference ( BFR , n = 80 ) group was also recruited . The oral microbiota was analyzed at 4 ( n = 124 ) and 12 ( n = 166 ) months of age using Illumina MiSeq multiplex sequencing and taxonomic resolution against the HOMD 16S rDNA data base of oral bacteria . Results Species richness in the oral sample s did not differ between the EF and SF groups , but partial least square modeling identified a few taxa that were significantly associated with being in either group , e.g. lower level of Moraxella catarrhalis in the EF group . Infants in the BFR group had significantly lower species richness at 4 months of age and their microbiota pattern differed markedly from the formula-fed groups . Conclusions Supplementation of infant formula with MFGM yielded moderate effects on the oral microbiome . Moraxella catarrhalis was less prevalent in infants fed EF than in those fed SF and may be associated with the decrease in otitis media seen in the same group A prospect i ve study was conducted to determine risk factors for fungal colonization , drug susceptibility , and association with invasive fungal infections ( IFIs ) in a neonatal unit . On admission and weekly thereafter , surveillance fungal cultures were taken from mouth , rectum , and trachea of neonates with expected stays of > 1 week . Fungal colonization was detected in 72 ( 12.1 % ) of 593 neonates during 12 months . C AND IDA ALBICANS was isolated from 42 % of colonized neonates . Although early colonization ( age 1.3 + /- 0.2 days ) was found in 2.5 % of the neonates , late colonization ( age 17.6 + /- 1.4 days ) was noted in 14.2 % of neonates hospitalized for > 5 days . Neonates born vaginally were at higher risk for early colonization than those delivered after cesarean section ( P = 0.01 ) . By multivariate logistic regression , very low birthweight was the only independent risk factor for late colonization . Ten IFIs ( nine c and idemias ) were diagnosed , yielding a rate of 1.1 % . These episodes occurred in 6.9 % of colonized neonates , compared with 0.76 % of noncolonized neonates ( P = 0.002 ) . C. ALBICANS was susceptible to azoles , but some non- ALBICANS C AND IDA spp . exhibited decreased susceptibility to these drugs In the neonate , fungal infections result in significant morbidity and mortality . For very low birth weight ( less than 1,500 g ) infants , we prospect ively determined the fungal colonization rate to be 26.7 % . In one third of infants with fungal colonies , mucocutaneous c and idiasis developed , and in 7.7 % , systemic disease developed . Two thirds of the infants had colonies in the first week of life . This colonization was probably acquired during labor and delivery , because those infants who had colonization were more often delivered vaginally than by cesarean section . Early colonization , commonly from the gastrointestinal or respiratory tract , featured C and ida albicans and C and ida tropicalis . Late colonization , occurring after 2 weeks of life ( 15.0 % of patients ) , was more likely to be cutaneous and was associated with either C and ida parapsilosis or such poor growth that the organism could not be identified . Infants with colonization only rarely had budding yeasts ( 6.1 % ) , whereas more than half of the infants with either a urinalysis showing budding yeasts or a urine culture growing fungi had invasive disease . Fungal contamination was not found on either thoracotomy tubes or catheter tips . In the low birth weight infant , fungal colonization represents a significant risk factor for cutaneous or systemic c and idiasis in these infants Abstract Background : Knowledge of fungal colonization patterns in very low birth weight infants ( VLBWI ) admitted to the neonatal intensive care unit ( NICU ) is essential in underst and ing the process of fungal infections in neonates . We analyz Output:	Our analysis revealed no significant differences between the oral mycobiome of breastfed and bottle-fed children . As for the delivery mode , the majority of studies found a relation between fungal colonization and vaginal delivery . Our analysis suggests that maternal breastfeeding does not seem to influence oral mycology , but vaginal delivery appears to promote oral yeast colonization in early life
MS21194	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background — Cardiac stress testing in patients at low risk for acute coronary syndrome is associated with increased false-positive test results , unnecessary downstream procedures , and increased cost . We judged it unlikely that patient preferences were driving the decision to obtain stress testing . Methods and Results — The Chest Pain Choice trial was a prospect i ve r and omized evaluation involving 204 patients who were r and omized to a decision aid or usual care and were followed for 30 days . The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options ( observation unit admission and stress testing or 24–72 hours outpatient follow-up ) . The primary outcome was patient knowledge measured by an immediate postvisit survey . Additional outcomes included patient engagement in decision making and the proportion of patients who decided to undergo observation unit admission and cardiac stress testing . Compared with usual care patients ( n=103 ) , decision aid patients ( n=101 ) had significantly greater knowledge ( 3.6 versus 3.0 questions correct ; mean difference , 0.67 ; 95 % CI , 0.34–1.0 ) , were more engaged in decision making as indicated by higher OPTION ( observing patient involvement ) scores ( 26.6 versus 7.0 ; mean difference , 19.6 ; 95 % CI , 1.6–21.6 ) , and decided less frequently to be admitted to the observation unit for stress testing ( 58 % versus 77 % ; absolute difference , 19 % ; 95 % CI , 6%–31 % ) . There were no major adverse cardiac events after discharge in either group . Conclusions — Use of a decision aid in patients with chest pain increased knowledge and engagement in decision making and decreased the rate of observation unit admission for stress testing . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01077037 Background While some research has examined general attitudes about efforts to reduce overutilization of services , such as the Choosing Wisely ® ( CW ) initiative , little data exists regarding primary care providers ’ attitudes regarding individual recommendations . Objective We sought to identify whether particular CW recommendations were perceived by primary care providers as difficult to follow , difficult for patients to accept , or both . Design Two national surveys , one by mail to a r and om sample of 2000 U.S. primary care physicians in November 2013 , and the second electronically to a r and om sample of 2500 VA primary care providers ( PCPs ) in October – December 2014 . Participants A total of 603 U.S. primary care physicians and 1173 VA primary care providers . Response rates were 34 and 48 % , respectively . Main Measures PCP ratings of whether 12 CW recommendations for screening , testing and treatments applicable to adult primary care were difficult to follow and difficult for patients to accept ; and ratings of potential barriers to reducing overutilization . Key Results For four recommendations regarding not screening or testing in asymptomatic patients , less than 20 % of PCPs found the CW recommendations difficult to accept ( range 7.2–16.6 % ) or difficult for patients to follow ( 12.2–19.3 % ) . For five recommendations regarding testing or treatment for symptomatic conditions , however , there was both variation in reported difficulty to follow ( 9.8–32 % ) and a high level of reported difficulty for patients to accept ( 35.7–87.1 % ) . The most frequently reported barriers to reducing overuse included mal practice concern , patient requests for services , lack of time for shared decision making , and the number of tests recommended by specialists . Conclusions While PCPs found many CW recommendations easy to follow , they felt that some , especially those for symptomatic conditions , would be difficult for patients to accept . Overcoming PCPs ’ perceptions of patient acceptability will require approaches beyond routine physician education , feedback and financial incentives Objective To establish whether an interactive booklet on respiratory tract infections in children reduces reconsultation for the same illness episode , reduces antibiotic use , and affects future consulting intentions , while maintaining parental satisfaction with care . Design Pragmatic cluster r and omised controlled trial . Setting 61 general practice s in Wales and Engl and . Participants 558 children ( 6 months to 14 years ) presenting to primary care with an acute respiratory tract infection ( 7 days or less ) . Children with suspected pneumonia , asthma or a serious concomitant illness , or needing immediate hospital admission were excluded . Three withdrew and 27 were lost to follow-up , leaving 528 ( 94.6 % ) with main outcome data . Interventions Clinicians in the intervention group were trained in the use of an interactive booklet on respiratory tract infections and asked to use the booklet during consultations with recruited patients ( and provide it as a take home re source ) . Clinicians in the control group conducted their consultations as usual . Main outcome measures The proportion of children who attended a face-to-face consultation about the same illness during the two week follow-up period . Secondary outcomes included antibiotic prescribing , antibiotic consumption , future consulting intentions , and parental satisfaction , reassurance , and enablement . Results Reconsultation occurred in 12.9 % of children in the intervention group and 16.2 % in the control group ( absolute risk reduction 3.3 % , 95 % confidence interval −2.7 % to 9.3 % , P=0.29 ) . Using multilevel modelling ( at the practice and individual level ) to account for clustering , no significant difference in reconsulting was noted ( odds ratio 0.75 ; 0.41 to 1.38 ) . Antibiotics were prescribed at the index consultation to 19.5 % of children in the intervention group and 40.8 % of children in the control group ( absolute risk reduction 21.3 % , 95 % confidence interval 13.7 to 28.9 ) , P<0.001 ) . A significant difference was still present after adjusting for clustering ( odds ratio 0.29 ; 0.14 to 0.60 ) . There was also a significant difference in the proportion of parents who said they would consult in the future if their child developed a similar illness ( odds ratio 0.34 ; 0.20 to 0.57 ) . Satisfaction , reassurance , and parental enablement scores were not significantly different between the two groups . Conclusions Use of a booklet on respiratory tract infections in children within primary care consultations led to important reductions in antibiotic prescribing and reduced intention to consult without reducing satisfaction with care . Trial registration Current Controlled Trials IS RCT Background : Few interventions have proven effective in reducing the overuse of antibiotics for acute respiratory infections . We evaluated the effect of DECISION+2 , a shared decision-making training program , on the percentage of patients who decided to take antibiotics after consultation with a physician or resident . Methods : We performed a r and omized trial , clustered at the level of family practice teaching unit , with 2 study arms : DECISION+2 and control . The DECISION+2 training program included a 2-hour online tutorial followed by a 2-hour interactive seminar about shared decision-making . The primary outcome was the proportion of patients who decided to use antibiotics immediately after consultation . We also recorded patients ’ perception that shared decision-making had occurred . Two weeks after the initial consultation , we assessed patients ’ adherence to the decision , repeat consultation , decisional regret and quality of life . Results : We compared outcomes among 181 patients who consulted 77 physicians in 5 family practice teaching units in the DECISION+2 group , and 178 patients who consulted 72 physicians in 4 family practice teaching units in the control group . The percentage of patients who decided to use antibiotics after consultation was 52.2 % in the control group and 27.2 % in the DECISION+2 group ( absolute difference 25.0 % , adjusted relative risk 0.48 , 95 % confidence interval 0.34–0.68 ) . DECISION+2 was associated with patients taking a more active role in decision-making ( Z = 3.9 , p < 0.001 ) . Patient outcomes 2 weeks after consultation were similar in both groups . Interpretation : The shared decision-making program DECISION+2 enhanced patient participation in decision-making and led to fewer patients deciding to use antibiotics for acute respiratory infections . This reduction did not have a negative effect on patient outcomes 2 weeks after consultation . Clinical Trials.gov trial register no. NCT01116076 Objective To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome . Design Multicenter pragmatic parallel r and omized controlled trial . Setting Six emergency departments in the United States . Participants 898 adults ( aged > 17 years ) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing ( 451 were allocated to the decision aid and 447 to usual care ) , and 361 emergency clinicians ( emergency physicians , nurse practitioners , and physician assistants ) caring for patients with chest pain . Interventions Patients were r and omly assigned ( 1:1 ) by an electronic , web based system to shared decision making facilitated by a decision aid or to usual care . The primary outcome , selected by patient and caregiver advisers , was patient knowledge of their risk for acute coronary syndrome and options for care ; secondary outcomes were involvement in the decision to be admitted , proportion of patients admitted for cardiac testing , and the 30 day rate of major adverse cardiac events . Results Compared with the usual care arm , patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care ( questions correct : decision aid , 4.2 v usual care , 3.6 ; mean difference 0.66 , 95 % confidence interval 0.46 to 0.86 ) , were more involved in the decision ( observing patient involvement scores : decision aid , 18.3 v usual care , 7.9 ; 10.3 , 9.1 to 11.5 ) , and less frequently decided with their clinician to be admitted for cardiac testing ( decision aid , 37 % v usual care , 52 % ; absolute difference 15 % ; P<0.001 ) . There were no major adverse cardiac events due to the intervention . Conclusions Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk , increased engagement , and safely decreased the rate of admission to an observation unit for cardiac testing . Trial registration Clinical Trials.gov NCT01969240 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more INTRODUCTION Antibiotic overuse promotes resistant strains of bacteria and puts patients at risk for adverse reactions . Given the use of educational posters in government-sponsored public health campaigns , this study examined the effectiveness of a waiting room poster in reducing excessive antibiotic use in clinical practice . METHODS Investigators conducted a 1-month trial of an educational poster with historical controls using three private pediatric group practice s in Westchester County , New York . Children between the ages of 6 months and 10 years at the time of a visit to diagnose and treat symptoms of respiratory illness were enrolled as subjects . Antibiotic prescriptions for children with respiratory illnesses seen during the poster month were compared with prescriptions written during three 1-month historical control periods . The proportion of visits that result ed in a prescription for an antibiotic served as the outcome measure . RESULTS Overall , 326 of the 720 patients ( 45.2 % ) enrolled in the study were treated with an antibiotic . Multiple logistic regression analysis revealed no statistically significant difference in the proportion of visits result ing in an antibiotic prescription among the 4 study months ( P = .79 ) , indicating that the educational poster had no effect on antibiotic use . DISCUSSION Public education in the form of a waiting room poster was not sufficient to decrease antibiotic prescriptions . This finding has implication s for current large-scale programs and for health care providers as they continue to attempt to educate patients on the appropriate use of antibiotics Decision aids are evidence -based sources of health information that can help patients make informed treatment decisions . However , little is known about how decision aids affect health care use when they are implemented outside of r and omized controlled clinical trials . We conducted an observational study to examine the associations between introducing decision aids for hip and knee osteoarthritis and rates of joint replacement surgery and costs in a large health system in Washington State . Consistent with prior r and omized trials , our introduction of decision aids was associated with 26 percent fewer hip replacement surgeries , 38 percent fewer knee replacements , and 12 - 21 percent lower costs over six months . These findings support the concept that patient decision aids for some health conditions , for which treatment decisions are highly sensitive to both patients ' and physicians ' preferences , may reduce rates of elective surgery and lower costs OBJECTIVES To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section . DESIGN R and omised trial , conducted from May 2004 to August 2006 . SETTING Four maternity units in south west Engl and , and Scotl and . PARTICIPANTS 742 pregnant women with one previous lower segment caesarean section and delivery expected at > or=37 weeks . Non-English speakers were excluded . INTERVENTIONS Usual care : st and ard care given by obstetric and midwifery staff . Information programme : women navigated through descriptions and probabilities of clin Output:	De-implementation interventions that engage patients within the patient-clinician interaction through patient-targeted educational material s or shared decision-making tools are effective in decreasing the use of low-value care .
MS21195	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Transcranial direct current stimulation ( tDCS ) of the human motor cortex results in polarity-specific shifts of cortical excitability during and after stimulation . Anodal tDCS enhances and cathodal stimulation reduces excitability . Animal experiments have demonstrated that the effect of anodal tDCS is caused by neuronal depolarisation , while cathodal tDCS hyperpolarises cortical neurones . However , not much is known about the ion channels and receptors involved in these effects . Thus , the impact of the sodium channel blocker carbamazepine , the calcium channel blocker flunarizine and the NMDA receptor antagonist dextromethorphane on tDCS-elicited motor cortical excitability changes of healthy human subjects were tested . tDCS- protocol s inducing excitability alterations ( 1 ) only during tDCS and ( 2 ) eliciting long-lasting after-effects were applied after drug administration . Carbamazepine selectively eliminated the excitability enhancement induced by anodal stimulation during and after tDCS . Flunarizine result ed in similar changes . Antagonising NMDA receptors did not alter current-generated excitability changes during a short stimulation , which elicits no after-effects , but prevented the induction of long-lasting after-effects independent of their direction . These results suggest that , like in other animals , cortical excitability shifts induced during tDCS in humans also depend on membrane polarisation , thus modulating the conductance of sodium and calcium channels . Moreover , they suggest that the after-effects may be NMDA receptor dependent . Since NMDA receptors are involved in neuroplastic changes , the results suggest a possible application of tDCS in the modulation or induction of these processes in a clinical setting . The selective elimination of tDCS-driven excitability enhancements by carbamazepine proposes a role for this drug in focussing the effects of cathodal tDCS , which may have important future clinical applications BACKGROUND Carefully design ed controlled studies are essential in further evaluating the therapeutic efficacy of transcranial magnetic stimulation ( TMS ) in psychiatric disorders . A major method ological concern is the design of the " sham " control for TMS . An ideal sham would produce negligible cortical stimulation in conjunction with a scalp sensation akin to real treatment . Strategies employed so far include alterations in the position of the stimulating coil , but there has been little systematic study of their validity . In this study , we investigated the effects of different coil positions on cortical activation and scalp sensation . METHODS In nine normal subjects , single TMS pulses were administered at a range of intensities with a " figure eight " coil held in various positions over the left primary motor cortex . Responses were measured as motor-evoked potentials in the right first dorsal interosseus muscle . Scalp sensation to TMS with the coil in various positions over the prefrontal area was also assessed . RESULTS None of the coil positions studied met the criteria for an ideal sham . Arrangements associated with a higher likelihood of scalp sensation were also more likely to stimulate the cortex . CONCLUSIONS The choice of a sham for TMS involves a trade-off between effective blinding and truly inactive " stimulation . " Further research is needed to develop the best sham condition for a range of applications OBJECTIVE Several studies have shown that repetitive transcranial magnetic stimulation ( rTMS ) over the dorsolateral prefrontal cortex ( DLPFC ) is effective in the treatment of depression in patients with Parkinson disease ( PD ) . However , since research into the effect of this type of rTMS regime on motor function is limited , we studied the effect of rTMS over the DLPFC on the motor functions in PD patients . METHODS Thirteen patients were r and omly assigned into 2 groups , one receiving real-rTMS ( 90 % of resting motor threshold , 10 Hz , 450 pulses-day for 10 consecutive days ) over the DLPFC contralateral to the more affected side , and the other group receiving sham-rTMS . Assessment included a clinical motor evaluation using part III of the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , and several motor tasks . The UPDRS was applied before and after 10 days of rTMS . Finger tapping , reach movement , grip movement and gait were measured in each session before and after the rTMS over the 10 day period . RESULTS Statistical analysis ( ANOVA for repeated measures ; group * day * side * rTMS ) only showed a significant effect for finger tapping , reach movement and gait for the factor day . No significant change was reported for the UPDRS in any group . CONCLUSIONS Application of rTMS over the DLPFC as a 10 day course had no significant effect on motor functions and clinical motor status , and the improvement in performance of motor tasks can be attributed to the effects of practice . SIGNIFICANCE rTMS over the DLPFC did not lead to any motor improvement in PD patients OBJECTIVE To investigate the dopamine-dependent effect of combining transcranial direct current stimulation ( tDCS ) with visually cued gait training on cortical excitability and functional mobility in individuals with Parkinson 's disease . DESIGN A pilot , r and omized , double-blind , controlled trial . METHODS Twenty-two patients with Parkinson 's disease were r and omly assigned to 2 groups : ( i ) active anodal tDCS over the supplementary motor area ( experimental group ) , or ( ii ) sham tDCS ( control group ) . After tDCS , both groups participated in a visually cued gait training . Functional mobility was evaluated with the Timed Up and Go test ( TUG ) . Cortical excitability was assessed by active motor threshold and motor-evoked potential amplitudes elicited by transcranial magnetic stimulation in patients in on and off medication states . RESULTS In the TUG test both groups achieved improvements either in on or off medication condition compared with baseline . However , for both medication conditions , these gains were maintained only in the experimental group during 1-month follow-up , compared with baseline . In the experimental group , enhancement of cortical excitability was observed at post-intervention and 1-month follow-up ( both only for the " on " phase ) compared with baseline . CONCLUSION These findings suggest that tDCS , independent of dopaminergic medication state , might prolong the positive effect induced by cued gait training on functional mobility PURPOSE The aim of this study was to investigate the site-specific effects of repetitive transcranial magnetic stimulation ( rTMS ) on freezing of gait ( FOG ) in patients with parkinsonism . METHODS Twenty patients with parkinsonism and FOG were included . A single session of 10 Hz rTMS was applied over three different cortical regions of the dominant hemisphere : the primary motor cortex of the lower leg ( M1-LL ) , the supplementary motor area ( SMA ) , and the dorsolateral prefrontal cortex ( DLPFC ) . We also performed sham stimulation as a control . The Timed Up and Go ( TUG ) test , Turn Steps and Turn Time in 180 ° turning , Unified Parkinson 's Disease Rating Scale ( UPDRS ) part III , FOG Question naire ( FOG-Q ) , and motor evoked potential ( MEP ) studies were performed before and after each intervention . RESULTS There were significant improvements in TUG test times after rTMS over the M1-LL and the DLPFC . Improvement was significantly greater after the M1-LL stimulation than sham condition . The M1-LL and DLPFC stimulation also result ed in significant improvements in both the number of Turn Steps and Turn Time . UPDRS-III scores were significantly decreased after the M1-LL and DLPFC stimulation . CONCLUSIONS Use of 10 Hz rTMS on the M1-LL and DLPFC is therapeutically effective for FOG in patients with parkinsonism Objective : To investigate the safety and efficacy of intermittent theta-burst stimulation ( iTBS ) in the treatment of motor symptoms in Parkinson disease ( PD ) . Background : Progression of PD is characterized by the emergence of motor deficits , which eventually respond less to dopaminergic therapy and pose a therapeutic challenge . Repetitive transcranial magnetic stimulation ( rTMS ) has shown promising results in improving gait , a major cause of disability , and may provide a therapeutic alternative . iTBS is a novel type of rTMS that may be more efficacious than conventional rTMS . Methods : In this r and omized , double-blind , sham-controlled study , we investigated safety and efficacy of iTBS of the motor and dorsolateral prefrontal cortices in 8 sessions over 2 weeks ( evidence Class I ) . Assessment of safety and clinical efficacy over a 1-month period included timed tests of gait and bradykinesia , Unified Parkinson 's Disease Rating Scale ( UPDRS ) , and additional clinical , neuropsychological , and neurophysiologic measures . Results : We investigated 26 patients with mild to moderate PD : 13 received iTBS and 13 sham stimulation . We found beneficial effects of iTBS on mood , but no improvement of gait , bradykinesia , UPDRS , and other measures . EEG/EMG monitoring recorded no pathologic increase of cortical excitability or epileptic activity . Few reported discomfort or pain and one experienced tinnitus during real stimulation . Conclusion : iTBS of the motor and prefrontal cortices appears safe and improves mood , but failed to improve motor performance and functional status in PD . Classification of evidence : This study provides Class I evidence that iTBS was not effective for gait , upper extremity bradykinesia , or other motor symptoms in PD Background Depression is one of the most common psychiatric illnesses worldwide , but is nevertheless preventable . Since the children of parents who have depression are at greatest risk of developing depression themselves , prevention programmes for this population are a major public health priority . Here we report the study protocol of a r and omised controlled trial of a group-based psychological intervention for families with i ) at least one parent who suffers ( or has suffered ) from depression and ii ) at least one child who has no current or previous psychiatric diagnosis . Methods / Design Eligible families will be r and omly allocated to receive either a German adaptation of the 12-session cognitive-behavioural Raising Healthy Children intervention ( Gesund und glücklich aufwachsen ; N = 50 ) , or no intervention ( usual care ; N = 50 ) . The primary outcome ( child diagnosis of an episode of depression ) will be assessed at 15-month follow-up . The secondary outcomes ( child psychopathological symptoms ) will be assessed immediately following completion of the intervention ( 6-months ) , as well as at 9- and 15-month follow-up . We hypothesise that children in the intervention condition , compared with those who do not receive the intervention , will show fewer symptoms of psychopathology , and be less likely to meet diagnostic criteria for a depressive episode , at follow-up . Discussion Despite their elevated risk of developing depression , there is little formal support available for the children of parents with depression . This study provides an important step in the development of more effective depression prevention measures , which are needed if the personal , social and economic burden of depression is to be reduced . Trial registration Clinical Trials NCT02115880 . Registered April 7 2014 Weak transcranial direct current stimulation ( tDCS ) induces persisting excitability changes in the human motor cortex . These plastic excitability changes are selectively controlled by the polarity , duration and current strength of stimulation . To reveal the underlying mechanisms of direct current (DC)-induced neuroplasticity , we combined tDCS of the motor cortex with the application of Na(+)-channel-blocking carbamazepine ( CBZ ) and the N-methyl-D-aspartate (NMDA)-receptor antagonist dextromethorphan ( DMO ) . Monitored by transcranial magnetic stimulation ( TMS ) , motor cortical excitability changes of up to 40 % were achieved in the drug-free condition . Increase of cortical excitability could be selected by anodal stimulation , and decrease by cathodal stimulation . Both types of excitability change lasted several minutes after cessation of current stimulation . DMO suppressed the post-stimulation effects of both anodal and cathodal DC stimulation , strongly suggesting the involvement of NMDA receptors in both types of DC-induced neuroplasticity . In contrast , CBZ selectively eliminated anodal effects . Since CBZ stabilizes the membrane potential voltage-dependently , the results reveal that after-effects of anodal tDCS require a depolarization of membrane potentials . Similar to the induction of established types of short- or long-term neuroplasticity , a combination of glutamatergic and membrane mechanisms is necessary to induce the after-effects of tDCS . On the basis of these results , we suggest that polarity-driven alterations of resting membrane potentials represent the crucial mechanisms of the DC-induced after-effects , leading to both an alteration of spontaneous discharge rates and to a change in NMDA-receptor activation Objective . To investigate the safety and efficacy of 50-Hz repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of motor symptoms in Parkinson disease ( PD ) . Background . Progression of PD is characterized by the emergence of motor deficits that gradually respond less to dopaminergic therapy . rTMS has shown promising results in improving gait , a major cause of disability , and may provide a therapeutic alternative . Prior controlled studies suggest that an increase in stimulation frequency might enhance therapeutic efficacy . Methods . In this r and omized , double blind , sham-controlled study , the authors investigated the safety and efficacy of 50-Hz rTMS of the motor cortices in 8 sessions over 2 weeks . Assessment of Output:	Neither rTMS nor TES improved cognition . No effects for stimulation parameters on motor or cognitive function were observed .
MS21196	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective : We compared mindfulness-based cognitive therapy ( MBCT ) with both cognitive psychological education ( CPE ) and treatment as usual ( TAU ) in preventing relapse to major depressive disorder ( MDD ) in people currently in remission following at least 3 previous episodes . Method : A r and omized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU , CPE plus TAU , and TAU alone , and data were analyzed for the 255 ( 93 % ; MBCT = 99 , CPE = 103 , TAU = 53 ) retained to follow-up . MBCT was delivered in accordance with its published manual , modified to address suicidal cognitions ; CPE was modeled on MBCT , but without training in meditation . Both treatments were delivered through 8 weekly classes . Results : Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up , hazard ratio for MBCT vs. CPE = 0.88 , 95 % CI [ 0.58 , 1.35 ] ; for MBCT vs. TAU = 0.69 , 95 % CI [ 0.42 , 1.12 ] . However , severity of childhood trauma affected relapse , hazard ratio for increase of 1 st and ard deviation = 1.26 ( 95 % CI [ 1.05 , 1.50 ] ) , and significantly interacted with allocated treatment . Among participants above median severity , the hazard ratio was 0.61 , 95 % CI [ 0.34 , 1.09 ] , for MBCT vs. CPE , and 0.43 , 95 % CI [ 0.22 , 0.87 ] , for MBCT vs. TAU . For those below median severity , there were no such differences between treatment groups . Conclusion : MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma , but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression Background : Social anxiety disorder ( SAD ) is characterized by distorted self-views . The goal of this study was to examine whether mindfulness-based stress reduction ( MBSR ) alters behavioral and brain measures of negative and positive self-views . Methods : Fifty-six adult patients with generalized SAD were r and omly assigned to MBSR or a comparison aerobic exercise ( AE ) program . A self-referential encoding task was administered at baseline and post-intervention to examine changes in behavioral and neural responses in the self-referential brain network during functional magnetic resonance imaging . Patients were cued to decide whether positive and negative social trait adjectives were self-descriptive or in upper case font . Results : Behaviorally , compared to AE , MBSR produced greater decreases in negative self-views , and equivalent increases in positive self-views . Neurally , during negative self versus case , compared to AE , MBSR led to increased brain responses in the posterior cingulate cortex ( PCC ) . There were no differential changes for positive self versus case . Secondary analyses showed that changes in endorsement of negative and positive self-views were associated with decreased social anxiety symptom severity for MBSR , but not AE . Additionally , MBSR-related increases in dorsomedial prefrontal cortex ( DMPFC ) activity during negative self-view versus case were associated with decreased social anxiety related disability and increased mindfulness . Analysis of neural temporal dynamics revealed MBSR-related changes in the timing of neural responses in the DMPFC and PCC for negative self-view versus case . Conclusion : These findings suggest that MBSR attenuates maladaptive habitual self-views by facilitating automatic ( i.e. , uninstructed ) recruitment of cognitive and attention regulation neural networks . This highlights potentially important links between self-referential and cognitive-attention regulation systems and suggests that MBSR may enhance more adaptive social self-referential processes in patients with SAD IMPORTANCE Currently , fewer than 40 % of patients treated for major depressive disorder achieve remission with initial treatment . Identification of a biological marker that might improve these odds could have significant health and economic impact . OBJECTIVE To identify a c and i date neuroimaging " treatment-specific biomarker " that predicts differential outcome to either medication or psychotherapy . DESIGN Brain glucose metabolism was measured with positron emission tomography prior to treatment r and omization to either escitalopram oxalate or cognitive behavior therapy for 12 weeks . Patients who did not remit on completion of their phase 1 treatment were offered enrollment in phase 2 comprising an additional 12 weeks of treatment with combination escitalopram and cognitive behavior therapy . SETTING Mood and anxiety disorders research program at an academic medical center . PARTICIPANTS Men and women aged 18 to 60 years with currently untreated major depressive disorder . INTERVENTION R and omized assignment to 12 weeks of treatment with either escitalopram oxalate ( 10 - 20 mg/d ) or 16 sessions of manual-based cognitive behavior therapy . MAIN OUTCOME AND MEASURE Remission , defined as a 17-item Hamilton depression rating scale score of 7 or less at both weeks 10 and 12 , as assessed by raters blinded to treatment . RESULTS Positive and negative predictors of remission were identified with a 2-way analysis of variance treatment ( escitalopram or cognitive behavior therapy ) × outcome ( remission or nonresponse ) interaction . Of 65 protocol completers , 38 patients with clear outcomes and usable positron emission tomography scans were included in the primary analysis : 12 remitters to cognitive behavior therapy , 11 remitters to escitalopram , 9 nonresponders to cognitive behavior therapy , and 6 nonresponders to escitalopram . Six limbic and cortical regions were identified , with the right anterior insula showing the most robust discriminant properties across groups ( effect size = 1.43 ) . Insula hypometabolism ( relative to whole-brain mean ) was associated with remission to cognitive behavior therapy and poor response to escitalopram , while insula hypermetabolism was associated with remission to escitalopram and poor response to cognitive behavior therapy . CONCLUSIONS AND RELEVANCE If verified with prospect i ve testing , the insula metabolism-based treatment-specific biomarker defined in this study provides the first objective marker , to our knowledge , to guide initial treatment selection for depression . TRIAL REGISTRATION Registered at clinical trials.gov ( NCT00367341 ) OBJECTIVE Military deployment can have profound effects on physical and mental health . Few studies have examined whether interventions prior to deployment can improve mechanisms underlying resilience . Mindfulness-based techniques have been shown to aid recovery from stress and may affect brain-behavior relationships prior to deployment . The authors examined the effect of mindfulness training on resilience mechanisms in active-duty Marines preparing for deployment . METHOD Eight Marine infantry platoons ( N=281 ) were r and omly selected . Four platoons were assigned to receive mindfulness training ( N=147 ) and four were assigned to a training-as-usual control condition ( N=134 ) . Platoons were assessed at baseline , 8 weeks after baseline , and during and after a stressful combat training session approximately 9 weeks after baseline . The mindfulness training condition was delivered in the form of 8 weeks of Mindfulness-Based Mind Fitness Training ( MMFT ) , a program comprising 20 hours of classroom instruction plus daily homework exercises . MMFT emphasizes interoceptive awareness , attentional control , and tolerance of present-moment experiences . The main outcome measures were heart rate , breathing rate , plasma neuropeptide Y concentration , score on the Response to Stressful Experiences Scale , and brain activation as measured by functional MRI . RESULTS Marines who received MMFT showed greater reactivity ( heart rate [ d=0.43 ] ) and enhanced recovery ( heart rate [ d=0.67 ] , breathing rate [ d=0.93 ] ) after stressful training ; lower plasma neuropeptide Y concentration after stressful training ( d=0.38 ) ; and attenuated blood-oxygen-level-dependent signal in the right insula and anterior cingulate . CONCLUSIONS The results show that mechanisms related to stress recovery can be modified in healthy individuals prior to stress exposure , with important implication s for evidence -based mental health research and treatment OBJECTIVE To examine whether mindfulness-based cognitive therapy ( MBCT ) increases momentary positive emotions and the ability to make use of natural rewards in daily life . METHOD Adults with a life-time history of depression and current residual depressive symptoms ( mean age = 43.9 years , SD = 9.6 ; 75 % female ; all Caucasian ) were r and omized to MBCT ( n = 64 ) or waitlist control ( CONTROL ; n = 66 ) in a parallel , open-label , r and omized controlled trial . The Experience Sampling Method was used to measure momentary positive emotions as well as appraisal of pleasant activities in daily life during 6 days before and after the intervention . Residual depressive symptoms were measured using the 17-item Hamilton Depression Rating Scale ( Hamilton , 1960 ) . RESULTS MBCT compared to CONTROL was associated with significant increases in appraisal s of positive emotion ( b * = .39 ) and activity pleasantness ( b * = .22 ) as well as enhanced ability to boost momentary positive emotions by engaging in pleasant activities ( b * = .08 ; all ps < .005 ) . Associations remained significant when corrected for reductions in depressive symptoms or for reductions in negative emotion , rumination , and worry . In the MBCT condition , increases in positive emotion variables were associated with reduction of residual depressive symptoms ( all ps < .05 ) . CONCLUSIONS MBCT is associated with increased experience of momentary positive emotions as well as greater appreciation of , and enhanced responsiveness to , pleasant daily-life activities . These changes were unlikely to be pure epiphenomena of decreased depression and , given the role of positive emotions in resilience against depression , may contribute to the protective effects of MBCT against depressive relapse BACKGROUND Preliminary research findings have shown that mindfulness-based cognitive therapy improves anxiety and depressive symptoms in bipolar disorder . In this study , we further investigated the effects of MBCT in bipolar disorder , in a controlled fMRI study . METHOD Twenty three patients with bipolar disorder underwent neuropsychological testing and functional MRI . Sixteen of these patients were tested before and after an eight-week MBCT intervention , and seven were wait listed for training and tested at the same intervals . The results were compared with 10 healthy controls . RESULTS Prior to MBCT , bipolar patients reported significantly higher levels of anxiety and symptoms of stress , scored significantly lower on a test of working memory , and showed significant BOLD signal decrease in the medial PFC during a mindfulness task , compared to healthy controls . Following MBCT , there were significant improvements in the bipolar treatment group , in measures of mindfulness , anxiety and emotion regulation , and in tests of working memory , spatial memory and verbal fluency compared to the bipolar wait list group . BOLD signal increases were noted in the medial PFC and posterior parietal lobe , in a repeat mindfulness task . A region of interest analysis revealed strong correlation between signal changes in medial PFC and increases in mindfulness . LIMITATIONS The small control group is a limitation in the study . CONCLUSION These data suggest that MBCT improves mindfulness and emotion regulation and reduces anxiety in bipolar disorder , corresponding to increased activations in the medial PFC , a region associated with cognitive flexibility and previously proposed as a key area of pathophysiology in the disorder The possibility of individualized treatment prediction has profound implication s for the development of personalized interventions for patients with anxiety disorders . Here we utilize r and om forest classification and pre-treatment functional magnetic resonance imaging ( fMRI ) data from individuals with generalized anxiety disorder ( GAD ) and panic disorder ( PD ) to generate individual subject treatment outcome predictions . Before cognitive behavioral therapy ( CBT ) , 48 adults ( 25 GAD and 23 PD ) reduced ( via cognitive re appraisal ) or maintained their emotional responses to negative images during fMRI scanning . CBT responder status was predicted using activations from 70 anatomically defined regions . The final r and om forest model included 10 predictors contributing most to classification accuracy . A similar analysis was conducted using the clinical and demographic variables . Activations in the hippocampus during maintenance and anterior insula , superior temporal , supramarginal , and superior frontal gyri during re appraisal were among the best predictors , with greater activation in responders than non-responders . The final fMRI-based model yielded 79 % accuracy , with good sensitivity ( 0.86 ) , specificity ( 0.68 ) , and positive and negative likelihood ratios ( 2.73 , 0.20 ) . Clinical and demographic variables yielded poorer accuracy ( 69 % ) , sensitivity ( 0.79 ) , specificity ( 0.53 ) , and likelihood ratios ( 1.67 , 0.39 ) . This is the first use of r and om forest models to predict treatment outcome from pre-treatment neuroimaging data in psychiatry . Together , r and om forest models and fMRI can provide single-subject predictions with good test characteristics . Moreover , activation patterns are consistent with the notion that greater activation in cortico-limbic circuitry predicts better CBT response in GAD and PD Output:	The most consistent longitudinal effect observed was increased insular cortex activity following mindfulness‐based interventions . In contrast to previous review s , we did not find robust evidence for increased activity in specific prefrontal cortex sub‐regions . These findings suggest that mindfulness interventions are associated with changes in functioning of the insula , plausibly impacting awareness of internal reactions ‘ in‐the‐moment ’ .
MS21197	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The effects of deep brain stimulation ( DBS ) on balance in people with Parkinson 's disease ( PD ) are not well established . This study examined whether DBS r and omized to the subthalamic nucleus ( STN ; n = 11 ) or globus pallidus interna ( GPi ; n = 10 ) improved compensatory stepping to recover balance after a perturbation . The st and ing surface translated backward , forcing subjects to take compensatory steps forward . Kinematic and kinetic responses were recorded . PD-DBS subjects were tested off and on their levodopa medication before bilateral DBS surgery and retested 6 mo later off and on DBS , combined with off and on levodopa medication . Responses were compared with PD-control subjects ( n = 8) tested over the same timescale and 17 healthy control subjects . Neither DBS nor levodopa improved the stepping response . Compensatory stepping in the best-treated state after surgery ( DBS+DOPA ) was similar to the best-treated state before surgery ( DOPA ) for the PD-GPi group and the PD-control group . For the PD-STN group , there were more lateral weight shifts , a delayed foot-off , and a greater number of steps required to recover balance in DBS+DOPA after surgery compared with DOPA before surgery . Within the STN group five subjects who did not fall during the experiment before surgery fell at least once after surgery , whereas the number of falls in the GPi and PD-control groups were unchanged . DBS did not improve the compensatory step response needed to recover from balance perturbations in the GPi group and caused delays in the preparation phase of the step in the STN group BACKGROUND Low-frequency , bilateral stimulation of the subthalamic nucleus can improve axial symptoms of advanced Parkinson 's disease ( PD ) , but it is not particularly effective for segmental symptoms . METHODS The optimal contacts for low-frequency ( 60 Hz ) and high-frequency ( 130 Hz ) single monopolar stimulation were determined . Then , in a r and omized , double-blind , prospect i ve crossover manner , 60-Hz and 130-Hz stimulations via the respective optimal contacts were compared for immediate efficacy in improving the motor function of patients with PD . RESULTS The optimal contacts for 60-Hz stimulation were situated more ventrally than those for 130-Hz stimulation ( P = 0.038 ) . Under the respective optimal , single monopolar stimulation , 60 Hz provided superior efficacy over 130 Hz in improving the total Unified Parkinson 's Disease Rating Scale motor score ( P < 0.001 ) and the akinesia ( P = 0.011 ) and axial motor signs ( P = 0.012 ) subscores without compromising the therapeutic effect on tremor and rigidity . CONCLUSIONS Low-frequency stimulation via the optimal contacts is effective in improving overall motor function of patients with PD OBJECT Difficulty with step initiation , called " start hesitation , " is related to gait bradykinesia and is an early hallmark of gait freezing in Parkinson disease ( PD ) . Authors of this study investigated the effects of deep brain stimulation ( DBS ) and levodopa on step initiation before and 6 months after DBS surgery in 29 patients with PD who were r and omized to either the bilateral subthalamic nucleus ( STN ) or globus pallidus internus ( GPi ) as the DBS site . METHODS The authors measured the amplitude and duration of anticipatory postural adjustments ( APAs ) , the feed-forward postural preparation that precedes the onset of voluntary step initiation , based on center-of-pressure displacements on a force plate . They also measured the length and velocity of the first step using a motion analysis system to study kinematics . Some of the patients ( 22 ) were from a large , multicenter , double-blind clinical trial , and all patients in the study ( 29 , PD-DBS group ) were r and omized to DBS in either the bilateral STN ( 15 patients ) or bilateral GPi ( 14 patients ) . Differences in step initiation were investigated in 2 conditions before surgery ( off/on levodopa ) and in 4 conditions after surgery ( off/on levodopa combined with off/on DBS ) . Twenty-eight elderly healthy control volunteers ( CTRL group ) were also tested , and 9 control volunteers with PD who met the criteria for DBS ( PD-C group ) were tested at baseline and 6 months later . RESULTS Patients in the PD-DBS group had smaller amplitudes and longer duration s of APAs compared with those in the 28 healthy control volunteers in all conditions . Before surgery , APAs improved with levodopa . After surgery , the APAs were significantly worse than in the best-treatment state before surgery ( DOPA condition ) , and responsiveness to levodopa decreased . No differences in APAs were detected between the STN and GPi groups . A comparison with PD control volunteers who did not undergo DBS surgery confirmed that a deterioration in step preparation was not related to disease progression . Step length and velocity were smaller in the PD-DBS group than in controls in all conditions . Before surgery , levodopa improved the length and velocity of the first step . Both step length and velocity were unchanged in the best-treatment state before surgery ( DOPA condition ) as compared with after surgery ( DBS+DOPA ) , with only step velocity in the STN group getting worse after surgery . CONCLUSIONS Six months of DBS in the STN or GPi impaired anticipatory postural preparation for step initiation , the opposite effect as with levodopa . Deep brain stimulation disrupted postural preparation more than step execution , suggesting independent motor pathways for preparation and execution of gait . Although turning the stimulators on after surgery combined with levodopa benefited the postural preparation to step , a comparison of pre- and postsurgery conditions suggests that either the surgery itself or 6 months of continuous stimulation may lead to an alteration of circuits or plastic changes that impair step initiation BACKGROUND High frequency stimulation ( HFS ) of the subthalamic nucleus ( STN-DBS ) has been shown to have little impact on postural control and gait improvements in Parkinson 's disease ( PD ) . There is a lack of consensus and quantitative evidence to suggest that stimulating STN at a lower frequency ( LFS ) as compared to HFS will be superior in improving symptoms . OBJECTIVE /HYPOTHESIS To determine if postural control and gait characteristics of persons with PD improve at an LFS ( 60 Hz ) compared to HFS ( > 100 Hz ) . We hypothesized that persons with PD would perform better on postural control and gait measures at LFS . METHODS Nineteen participants with bilateral STN-DBS underwent UPDRS , static and dynamic postural control using gait initiation , and gait evaluations in three stimulation conditions ( baseline voltage stable across conditions : OFF , LFS of 60 Hz , and HFS of > 100 Hz ) . Additionally 10/19 participants were also stimulated at 30 Hz and 60 Hz and at higher voltages . A one-way ANOVA was performed to compare the conditions . RESULTS Total UPDRS-III score , step length and velocity during gait initiation , and gait speed significantly improved during 60 Hz and > 100 Hz conditions when compared to the OFF condition ( P < 0.05 ) . There were no significant differences between 60 Hz and > 100 Hz conditions . Using LFS at higher voltage showed no improvement over > 100 Hz condition . CONCLUSIONS The positive effects of both LFS and HFS on postural control and gait were similar and clinical changes were relatively small . LFS may not help improve postural control , and gait particularly for persons with PD who do not develop gait-related disorders after HFS Postural instability is a sign of progression of Parkinson 's disease ( PD ) and often resistant to levodopa treatment . To explore the effect of bilateral deep brain stimulation ( DBS ) of the subthalamic nucleus ( STN ) on postural stability and gait , full body gait analyses were performed without medication , OFF and ON DBS in eight PD patients and 12 healthy age-matched controls . DBS setting was changed at least 3 hours before gait analysis . To describe asymmetry most and least affected sides ( MAS and LAS ) were rated with the Unified Parkinson 's Disease Rating Scale , motor part and quantitative gait analysis with the Vicon 612 gait analysis system . Stride length and gait velocity but not cadence improved ON DBS . The distances between the heel markers and center of mass ( COM ) were asymmetric and reduced OFF DBS . STN DBS increased the distances significantly and reduced asymmetry . The improvement in heel to COM distance was larger on the MAS compared with the LAS . OFF DBS knee momentum asymmetry was inversed so that LAS was more impaired than MAS . ON DBS asymmetry improved . PD patients OFF DBS place the heel too close to COM . The most affected body side has the most impaired swing and the result is a smaller knee moment on the opposite and least affected body side and an asymmetric gait pattern with disturbed balance OFF STN DBS . The asymmetry OFF DBS improved ON DBS . We suggest that DBS facilitates symmetric gait and thereby improves balance during gait Deep brain stimulation of the subthalamic nucleus represents the most important innovation for treatment of advanced Parkinson 's disease . Prospect i ve studies have shown that although the beneficial effects of this procedure are maintained at 5 years , axial motor features and cognitive decline may occur in the long term after the implants . In order to address some unsolved questions raised by previous studies , we evaluated a series of 20 consecutive patients who received continuous stimulation for 8 years . The overall motor improvement reported at 5 years ( 55.5 % at Unified Parkinson 's Disease Rating Scale-motor part , P < 0.001 compared with baseline ) was only partly retained 3 years later ( 39 % , P < 0.001 , compared with baseline ; -16.5 % , P < 0.01 , compared with 5 years ) , with differential effects on motor features : speech did not improve and postural stability worsened ( P < 0.05 ) . The preoperative levodopa equivalent daily dose was reduced by 58.2 % at 5 years and by 60.3 % at 8 years . In spite of subtle worsening of motor features , a dramatic impairment in functional state ( -56.6 % at Unified Parkinson 's Disease Rating Scale-Activities of Daily Living , P < 0.01 ) emerged after the fifth year of stimulation . The present study did not reveal a predictive value of preoperative levodopa response , whereas few single features at baseline ( such as gait and postural stability motor scores and the preoperative levodopa equivalent daily dose ) could predict long-term motor outcome . A decline in verbal fluency ( slightly more pronounced than after 5 years ) was detected after 8 years . A significant but slight decline in tasks of abstract reasoning , episodic memory and executive function was also found . One patient had developed dementia at 5 years with further progression at 8 years . Executive dysfunction correlated significantly with postural stability , suggesting interplay between axial motor deterioration and cognition . Eight years after surgery , no significant change was observed on scales assessing depression or anxiety when compared with baseline . At 8 years , there was no significant increase of side-effects when compared with 5-year follow-up . In conclusion , deep brain stimulation of the subthalamic nucleus is a safe procedure with regard to cognitive and behavioural morbidity over long-term follow-up . However , the global benefit partly decreases later in the course of the disease , due to progression of Parkinson 's disease and the appearance of medication- and stimulation-resistant symptoms Gait and balance disturbances typically emerge in advanced Parkinson ’s disease with generally limited response to dopaminergic medication and subthalamic nucleus deep brain stimulation . Therefore , advanced programming with interleaved pulses was put forward to introduce concomittant nigral stimulation on caudal contacts of a subthalamic lead . Here , we hypothesized that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata improves axial symptoms compared with st and ard subthalamic nucleus stimulation . Twelve patients were enrolled in this 2 × 2 cross-over double-blind r and omized controlled clinical trial and both the safety and efficacy of combined subthalamic nucleus and substantia nigra pars reticulata stimulation were evaluated compared with st and ard subthalamic nucleus stimulation . The primary outcome measure was the change of a broad-scaled cumulative axial Unified Parkinson ’s Disease Rating Scale score ( Scale II items 13–15 , Scale III items 27–31 ) at ‘ 3-week follow-up ’ . Secondary outcome measures specifically addressed freezing of gait , balance , quality of life , non-motor symptoms and neuropsychiatric symptoms . For the primary outcome measure no statistically significant improvement was observed for combined subthalamic nucleus and substantia nigra pars reticulata stimulation at the ‘ 3-week follow-up ’ . The secondary endpoints , however , revealed that the combined stimulation of subthalamic nucleus and substantia nigra pars reticulata might specifically improve freezing of gait , whereas balance impairment remained unchanged . The combined stimulation of subthalamic nucleus and substantia nigra pars reticulata was safe , and of note , no clinical ly relevant neuropsychiatric adverse effect was observed . Patients treated with subthalamic nucleus and substantia nigra pars reticulata stimulation revealed no ‘ global ’ effect on axial motor domains . However , this study opens the perspective that concomittant stimulation of Output:	This meta- analysis showed a robust improvement of gait and FOG by STN-DBS for more than 4 years in the Med-Off/Stim-On condition . No beneficial effect was found for the On state of medication . Pre-operative levodopa responsiveness of global motor performance ( UPDRS-III ) is the strongest predictor of the effect of deep brain stimulation on gait
MS21198	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The outcome of different treatment modalities after 7 years was investigated in a selected group of 50 patients with craniom and ibular disorders of muscular origin . To minimize the possible effects of selection on the clinical material , the selected treatment group was compared to a consecutive group of patients in terms of age , gender , intensity/ duration of pain , and socioeconomic profile . Both groups were comparable in most respects , but the selected group had a longer duration and a higher intensity of pain at baseline . There were more men in the consecutive group than in the selected group . A combined treatment approach result ed in a better outcome than single treatments . Sixty-five percent of all patients in the selected group reported improvement at the 7-year follow-up . All of the 19 patients who received counseling combined with different occlusal treatments improved . Forty-three percent of the patients treated otherwise showed improvement . Patients who were aware of stress responded better to treatment To assess the differential efficacy of two commonly used treatments for temporom and ibular disorders ( TMD ) , intraoral appliances ( IAs ) and biofeedback ( BF ) , separately and in combination , two studies were conducted . The first study directly compared IA treatment , a combination of biofeedback and stress management ( BF/SM ) , and a waiting list control group in a sample of 80 TMD patients . Both treatments were determined to be equally credible to patients , ruling out this potential threat to the validity of the results obtained . The results demonstrated that the IA treatment was more effective than the BF/SM treatment in reducing pain after treatment , but at a 6-month follow-up the IA group significantly relapsed , especially in depression , whereas the BF/SM maintained improvements on both pain and depression and continued to improve . The second study examined the combination of IA and BF/SM in a sample of 30 TMD patients . The results of this study demonstrated that the combined treatment approach was more effective than either of the single treatments alone , particularly in pain reduction , at the 6-month follow-up . These results support the importance of using both dental and psychologic treatments to successfully treat TMD patients if treatment gains are to be maintained BACKGROUND Treatment recommendations for patients with painful temporom and ibular disorders ( TMDs ) range from conservative treatments such as physiotherapy to aggressive and irreversible treatments such as restorative reconstruction and joint surgery . METHODS The authors r and omized 200 subjects diagnosed with TMD into three groups : usual conservative , dentist-prescribed self-care treatment without any intraoral splint appliance ( UT ) ; UT plus a conventional flat-plane hard acrylic splint ( HS ) ; and UT plus a soft vinyl ( a low-cost athletic mouth guard ) splint ( SS ) . Subjects completed question naires and clinical examinations at three , six and 12 months . RESULTS The authors observed no significant differences among the groups in TMD-related pain levels or other common signs and symptoms of TMD at baseline ( BL ) or at any follow-up . The changes from BL were comparable for all three groups . The authors did not note any significant differences at any follow-up for compliance with study protocol s or for occurrences of adverse effects from either splint type . For HS versus SS , there were significant differences in rates of splint use , but these differences were not accompanied by differences in either self-reported symptoms or in clinical findings . CONCLUSIONS All patients improved over time , and traditional splint therapy offered no benefit over the SS splint therapy . Neither splint therapy provided a greater benefit than did self-care treatment without splint therapy . CLINICAL IMPLICATION S These findings suggest that clinicians who treat patients with TMD should consider prescribing low-cost nonsplint self-care therapy for most patients & NA ; This paper reports the development of a scale for assessing the quality of reports of r and omised controlled trials for psychological treatments . The Delphi method was used in which a panel of 15–12 experts generated statements relating to treatment and design components of trials . After three rounds , statements with high consensus agreement were review ed by a second expert panel and rewritten as a scale . Evidence to support the reliability and validity of the scale is reported . Three expert and five novice raters assessed sets of 31 and 25 published trials to establish scale reliability ( ICC ranges from 0.91 to 0.41 for experts and novices , respectively ) and item reliability ( Kappa and inter‐rater agreement ) . The total scale score discriminated between trials globally judged as good and poor by experts , and trial quality was shown to be a function of year of publication . Uses for the scale are suggested In a r and omized trial the effects of occlusal appliance and relaxation therapy , each combined with brief information , were compared with brief information only , in adolescents with temporom and ibular disorder ( TMD ) pain . One-hundred- and -twenty-two adolescents ( 93 F and 29 M aged 12 - 18 years ) were r and omly assigned to one of the following 3 groups : brief information + occlusal appliance ( BI + OA ) , brief information + relaxation therapy ( BI + RT ) , or brief information ( BI ) . Included were subjects reporting pain once a week or more often , in addition to receiving a diagnosis of TMD according to the Research Diagnostic Criteria ( RDC/TMD ) . They were evaluated before and after treatment and at a 6-month follow-up by means of self-reports and clinical assessment . The result revealed a significantly higher reduction in frequency of pain , in pain intensity ( visual analog scale [ VAS ] ) , and in a composite pain index ( intensity x frequency ) for patients treated with BI + OA compared with those treated with BI alone . In the BI + OA group , 60 % of the patients attained a clinical ly significant improvement ( at least 50 % or more ) on the pain index , a significantly higher proportion compared to that obtained in the other 2 treatment groups . Analgesic consumption was also significantly more reduced in the BI + OA group compared to the BI group . However , no significant differences were found between the treatment groups in jaw opening or in muscle and TMJ tenderness scores . Occlusal appliance was found to be superior to both relaxation therapy and brief information regarding pain reduction and can therefore be recommended when treating adolescents with TMD pain & NA ; The course of pain associated with temporom and ibular disorders ( TMD ) and other chronic pain conditions is typically episodic . Its expression may influence when a person seeks treatment , for example , when the level of pain flares up or exceeds its characteristic severity . Improvement in pain status subsequent to entering treatment may be due to : ( 1 ) specific effects of treatment ; ( 2 ) non‐specific effects of treatment ( ‘ placebo effects ’ ) ; or ( 3 ) regression to the mean . Due to regression to the mean , uncontrolled evaluation of treatment in persons self‐selected by a pain flare‐up may lead to erroneous conclusions concerning effects of treatment by patients , providers , and /or research ers . For this report , the magnitude of regression to the mean due to self‐ selection for treatment is estimated by comparing subjects who sought treatment for TMD pain ( n = 147 ) to a r and om sample of subjects with TMD pain not seeking treatment ( n = 95 . Among subjects seeking treatment , a significant 14.7‐point reduction in VAS pain intensity was observed at 1‐year follow‐up . A control group of TMD subjects not seeking treatment showed no mean reduction in pain intensity but reported lower pain intensity at baseline than the group seeking care . When both groups of subjects were stratified on baseline VAS pain values , the reduction in pain increased as the baseline pain level increased , but no differences between comparable treated and untreated cases in the extent of improvement were observed . The before‐after differences in both groups may be attributed to regression to the mean . We conclude that before‐after differences in pain intensity can be large and that such improvement may be largely due to regression to the mean . This suggests the need for research which differentiates change due to regression to the mean ( due to homeostatic processes , r and om within‐subject variation , or measurement error ) from change due to specific and non‐specific effects of treatment . In clinical practice , the personal experience of patients and clinicians who observe improvement after initiation of treatment should be regarded as an unreliable guide to treatment efficacy due to regression to the mean . This phenomenon may contribute to the proliferation and continued use of treatments of unproven efficacy for pain management and suggests caution in the use of costly or risky pain treatments the efficacy of which is unknown AIMS To test the usefulness of tailoring cognitive-behavioral therapy ( CBT ) for patients with temporom and ibular disorders ( TMD ) who demonstrated poor psychosocial adaptation to their TMD condition , independent of physical diagnosis . METHODS A r and omized clinical trial compared a 6-session CBT intervention delivered in conjunction with the usual TMD treatment to the usual conservative treatment by TMD specialist dentists . For study inclusion , Research Diagnostic Criteria for Temporom and ibular Disorders ( RDC/TMD ) , Axis II criteria , were used to target patients with elevated levels of TMD pain-related interference with daily activities , independent of physical diagnosis ( i.e. , Axis I ) . RESULTS At the post-treatment assessment , about 4 months after the baseline evaluations , the comprehensive care group , when compared to the usual treatment group , showed significantly lower levels of characteristic pain intensity , significantly higher self-reported ability to control their TMD pain , and a strong trend ( P = .07 ) toward lower pain-related interference in daily activities . From post-intervention to 1-year follow-up , all subjects showed improvement . At the 1-year follow-up , the comprehensive care group , while not losing any of its early gains , was not significantly different from the usual care group with regard to reported levels of pain , ability to control pain , and levels of interference in activities . For many of these psychosocially disabled TMD patients , pain and interference 1 year after treatment remained at the same or higher levels than those observed at baseline among a group of patients selected for a separate r and omized clinical trial on the basis of better psychosocial adaptation . CONCLUSION The 6-session CBT intervention for patients with heightened psychologic and psychosocial disability was effective in improving pain-related variables over the course of the CBT in conjunction with usual treatment , but was too brief an intervention to result in further improvement after the sessions ended . Patient ratings of treatment satisfaction and helfulness were high for both groups , but they were significantly higher for the comprehensive care group OBJECTIVE The purpose of this study was to identify the appropriate treatment element for initial anterior disc displacement without reduction subjects . STUDY DESIGN Sixty-nine consecutive patients with temporom and ibular joint disc displacement without reduction confirmed on magnetic resonance images were r and omly divided into 3 experimental treatment groups . The treatment of group 1 consisted of short-term nonsteroidal anti-inflammatory drugs and self-care instructions ( palliative care group ) ; group 2 , nonsteroidal anti-inflammatory drugs , self-care instructions , and occlusal appliance and mobilization therapy ( physical medicine group ) ; and group 3 , no treatment ( control group ) . Outcomes were assessed by means of a 5-item question naire that evaluated ( 1 ) symptom improvement , ( 2 ) difficulty of treatment , and ( 3 ) satisfaction with treatment during the 8-week observation period . RESULTS Improvement scores in the palliative care group were significantly better than those in the physical medicine group or the no-treatment group . Satisfaction scores showed no significant difference among the 3 groups . Difficulty from treatment for the physical medicine group was significantly greater than that for other 2 groups . CONCLUSION These data suggest that palliative care would be more appropriate as the initial therapy to treat painful anterior disc displacement without reduction AIMS To compare the short-term efficacy of patient education only versus the combination of patient education and home exercises for the treatment of myofascial pain of the jaw muscles . MATERIAL S AND METHODS Seventy myogenous temporom and ibular disorder patients were assigned to 2 treatment groups . One group received patient education supplemented by general information about self-care of the jaw musculature . The other group received both education and a home physical therapy program . Treatment contrast , calculated from the mean normalized relative changes in anamnestic and clinical scores , was used to determine treatment success . Clinical outcome measures included pressure pain threshold ( PPT ) of the masseter , anterior temporalis , and Achilles tendon ; pain-free maximal jaw opening ; and pain on chewing , spontaneous muscle pain , and headache as rated on visual analog scales . RESULTS After 3 months the success rate was 57 % for the group that received education only and 77 % for the group that received both education and home physical therapy ( P = .157 ) . The patients were then redivided into 2 groups : successfully treated patients and unsuccessfully treated patients . In the unsuccessfully treated group , pain-free maximal jaw opening increased significantly more among those who had been in the education and physical therapy group than among those who had been in the education-only group ( P = .019 ) . The change in PPT was significantly greater in successfully treated patients than in unsuccessfully treated patients ( .009 < P < .039 ) , independent of the treatment modality , with higher PPTs among successful patients . There were no significant differences between the successfully and unsuccessfully treated groups or between treatment modalities for any other variable . CONCLUSION Over a period of 3 months , the combination of education and a home physical therapy regimen , as used in this protocol , is slightly more clinical ly effective than education alone for the treatment of myofascial pain of the jaw muscles Forty-eight dysfunctional patients ( i.e. , high levels of pain , interference , and affective distress and low levels of perceived control ) with temporom and ibular disorders ( TMDs ) were r and omly assigned either to a treatment consisting of an intraoral appliance ( IA ) and stress management with biofeedback ( SM ) plus nondirective , supportive counseling ( SC ) -- IA + SM + SC -- or to a customized treatment that included cognitive therapy ( CT ) with the IA and SM -- IA + SM + CT . Both treatment groups reported statistically significant reductions on a set of physical , psychosocial , and behavioral measures posttreatment and at a 6-month follow-up . However , the intervention that included CT demonstrated significantly greater reductions in pain , depression , and medication use . Only Output:	1 ) In the disc displacement group with pain , multimodal therapy was not superior to explanation and advice . There was no superiority of multimodal therapy including splints as compared with simple care . A slightly better outcome was reported for a combination of education and home physical therapy regimen than for patient education alone . ( 3 ) In temporom and ibular pain patients with major psychological disturbances , patients benefited more from a combined therapeutic approach compared with simple care . Current research suggests that individuals without major psychological symptoms do not require more than simple therapy . In contrast , patients with major psychological involvement need multimodal , interdisciplinary therapeutic strategies .
MS21199	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In 1973 the observation was published that in patients who had received non specific blood transfusions before kidney transplantation graft survival was improved . An immunosuppressive effect of blood transfusion was suggested . Indeed , modulation on the cellular and humoral immunologic system has been demonstrated during the last decade . But this immunomodulation effect might worsen the prognosis after cancer surgery . Whereas in several experimental studies in animals the negative influence was confirmed , clinical investigations on the other h and are contradictive . In our retrospective study we analysed the follow-up of 273 patients ( 158 men , 115 women ; average age 66 years ) on which we had performed a curative resection of their colorectal carcinoma . 182 patients had received nonspecific r and om blood transfusions . The survival rate for patients with blood transfusions was significantly worse in comparison to the non-transfused group ( 43 % versus 73 % , respectively ) . Even when we subdivided our patients into tumor stage , differentiation and localisation , the negative influence of transfused blood was confirmed . We conclude that beside the risk of transmitting hepatitis or HIV the immunosuppressive effect is a strong argument to restrict the indication for blood transfusion After curative resection of colorectal cancer , immediate short-term postoperative intraportal adjuvant chemotherapy reduces the relative risk of recurrence and death in the non-transfused patient significantly , when compared to transfused patients without chemotherapy . This is demonstrated in a multivariate analysis using the Cox model on a group of 469 patients who have been intraoperatively r and omized to receive either intraportal chemotherapy for 7 days or no further treatment . The transfused patients with chemotherapy and those receiving neither transfusions nor chemotherapy had a relative risk of recurrence and death situated in between the two groups mentioned above , not statistically different from either of them . In the setting of this study , 7 days postoperative intraportal chemotherapy seems particularly effective in the non-transfused patients BACKGROUND Benchmarking transfusion activity may help to eliminate inappropriate use of blood products . The goal of this study was to measure and to compare the current transfusion practice and to identify predictors of transfusion in public hospitals to develop strategies to optimize transfusion practice s. STUDY DESIGN AND METHODS This was a prospect i ve observational study in 18 r and omly selected public hospitals from April 2004 to February 2005 . Primary outcome measures were the amount of intra- and postoperative blood components transfused and intercenter variability of transfusion rate . Secondary outcome measures were prevalence of preoperative anemia , calculated perioperative blood loss , and lowest measured perioperative hemoglobin ( Hb ) level . RESULTS Adult patients undergoing primary unilateral total hip replacement ( THR , n = 1401 ) , primary unilateral knee replacement ( TKR , n = 1296 ) , hemicolectomy ( HECOC , n = 148 ) , and coronary artery bypass graft ( CABG ) surgery ( n = 777 ) were enrolled . Due to the small number , data of HECOC patients were not fully analyzed . In the remaining procedures , there was a large intercenter variability in the percentage of patients who received transfusions : THR 16 to 85 percent , TKR 12 to 87 percent , and CABG 37 to 63 percent . In the patients who received transfusions , the number of red blood cells ( RBC ) units transfused varied significantly . There was also a considerable intercenter variability in RBC loss . The prevalence of preoperative anemia was 19 percent and identical in both sexes . The incidence of preoperative anemia was three times higher in patients who received transfusions compared to those who did not . CONCLUSION This study demonstrates a high intercenter variability in RBC transfusions and RBC loss in st and ard surgical procedures . Whereas the variability in blood loss remains largely unexplained , the main predictors for allogeneic RBC transfusions are preoperative and nadir Hb and surgical RBC loss The aim of this prospect i ve study was to evaluate if there was a statistical correlation between allogeneic blood transfusion and postoperative infections , and if this could have a dose-dependent pattern . The evaluation was based on multiple logistic and receiver operating characteristics ( ROC ) curve analyses . On hospital admission the following parameters were determined in 267 consecutive patients with colorectal cancer : hemoglobin , serum albumin , serum cholinesterase activity , total iron binding capacity and weight loss . Duration of operation , operative blood loss , amount of transfused blood , Dukes ' cancer stage and occurrence of postoperative infections were also recorded . One hundred and thirty-two patients ( 49.4 % ) were given perioperatively allogeneic blood . Postoperative infections developed in 47 ( 17.6 % ) patients . Multivariate analysis identified allogeneic blood transfusion as the only variable related to the occurrence of postoperative infections ( p < 0.05 ) . ROC curve analysis showed that the risk for the occurrence of infection was significantly higher in patients transfused one unit of blood ( p < 0.01 ) . Moreover , a significant trend between increasing number of transfused blood units and susceptibility to infection was found ( p < 0.00019 ) R and om‐donor blood transfusions are deliberately given before cadaver renal allografting to improve allograft survival . Since host modifications that improve the outcome of an allograft might be associated with a decreased ability of the host to control cancer growth , the relationship between blood transfusions and the outcome of 146 Dukes ' stages A , B , and C colon cancers treated by resection during the years 1974 to 1979 was studied . It was found that 65 patients ( 45 % ) had been transfused and that at 5 years , overall survival was significantly better in the nontransfused patients compared to the transfused patients ( 0.68 and 0.51 5‐year product limit survival fractions respectively ; P = 0.03 for unadjusted log‐rank comparison of entire survival curves ) . Relative risk of death due to cancer in transfused patients versus nontransfused patients was 2.3 ( P = 0.05 ) when controlled for sex , age , stage , histologic differentiation , cancer location , and preresection hemoglobin level using Cox regression analysis . Thus , blood transfusion appears to be an additional important prognostic variable . The hypothesis suggested but not proven by these data that the outcome for some malignancies may be related to the immunomodulating effects of blood transfusions needs further study . Cancer 55:1195‐1201 , 1985 Clinical studies report reduced recurrence-free survival and increased cancer-related death after surgical treatment for cancer , when peri-operative blood transfusions were given . In this study we collected transfusion data of 212 patients who participated in a prospect i ve study of two different resection techniques for colorectal cancer . One hundred and fifty-eight patients were transfused and 54 were not . The follow-up period for almost all patients was 5 years . The 5-year survival rate was 52 % both for the transfused patients and the nontransfused patients . For subgroups of patients with Dukes ' B and Dukes ' C tumours no statistically significant differences were found . In the group of patients that were transfused the number of transfusions did not affect survival . In this study we could not confirm the deleterious effect of peri-operative blood transfusions on survival PURPOSE Allogeneic blood transfusions have reportedly been associated with a poor prognosis in patients with curatively resected cancer . To control for immunosuppression induced by a speculatively causal allogeneic blood transfusion , we design ed a r and omized study in which the control group received autologous blood transfusions not related to any condition of immunosuppression . PATIENTS AND METHODS One hundred twenty patients with potentially curative resectable colorectal cancer and the capability to predeposit autologous blood were r and omly selected to receive either st and ard allogeneic blood transfusion or predeposited autologous blood . RESULTS In curatively resected cancer patients , the number who needed allogeneic blood transfusions was reduced from 60 % in the allogeneic blood group to 33 % in the autologous blood group ( P = .009 ) . After a median follow-up duration of 22 months ( range , 8 to 48 ) tumor recurrence was observed in 28.9 % of the allogeneic blood group and 16.7 % of the autologous blood group . Life-table analysis established a tendency toward a shorter tumor-free survival for the allogeneic blood group ( log-rank P = .11 ) . The problem with this analysis was the strong association of allogeneic blood transfusions with tumor recurrence , which interfered in 33 % of patients in the autologous blood group who required additional allogeneic blood transfusions . Multivariate analysis of established risk factors for tumor recurrence and surgery-related variables reflecting potential immunosuppressive conditions showed that only pT stage ( relative risk , 6.61 ; 95 % confidence interval [ CI ] , 1.82 to 23.99 ; P = .004 ) , pN stage ( relative risk , 8.39 ; 95 % CI , 3.15 to 22.33 ; P < .001 ) , and the need for allogeneic blood ( relative risk , 6.18 ; 95 % CI , 2.20 to 17.37 ; P < .001 ) were independent predictors of tumor recurrence . Subgroup analysis of patients who received a transfusion of < or = 2 U blood found a significantly higher risk of tumor recurrence in the allogeneic blood group ( relative risk , 5.16 ; 95 % CI , 1.13 to 23.62 ; P = .034 ) , which was reduced to borderline significance ( relative risk , 3.54 ; 95 % CI , 0.76 to 16.51 ; P = .107 ) by adjustment for tumor ( T ) and node ( N ) stage . CONCLUSION As indicated by these first results , the blood transfusion modality has a significant effect on tumor recurrence after surgical treatment of colorectal cancer . A change in the practice of blood transfusion might thus potentially surpass the impact of any recent adjuvant treatment strategies The relationship between blood transfusion , disease-free survival , and other potential prognostic factors was prospect ively studied in 339 consecutive patients with colorectal cancer . Admission and discharge hematocrit , Dukes ' stage , and blood loss were significantly related to both blood transfusion and disease-free survival . Using Cox proportional hazards model , however , the association of transfusion with disease-free survival was significant ( p = 0.0196 ) after controlling for age , sex , blood loss , procedure , tumor differentiation , stage , admission hematocrit , duration of surgery , length of the specimen , and tumor size . Dukes ' stage ( p < 0.0001 ) and blood transfusion ( p < 0.0001 ) were the only variables independently related to disease-free survival . Forty per cent ( 44 ) of the 110 patients who received transfusions developed cancer recurrence , compared with 22 % ( 50 ) of the 229 patients who did not receive blood ( p < 0.0001 ) . Five-year disease-free survival of the transfused patients was 57 % , compared with 77 % for nontransfuscd patients . Patients who developed recurrence received an average of twice as much blood as patients without recurrence ( 1.26 versus 0.61 units , p = 0.0128 ) . Peri-operative blood transfusion is a significant independent prognostic factor for colorectal cancer BACKGROUND Previous studies on patients with hip fractures and in patients with colorectal cancer have documented that perioperative transfusion is associated with a significant increase in postoperative infection rate . Therefore , we sought to investigate the incidence of preoperative and postoperative anemia in noncardiac surgical patients and to determine if transfusion is an independent risk factor for infection and adverse outcome postoperatively . METHODS Prospect i ve data from the National Veterans Administration Surgical Quality Improvement Program ( NSQIP ) was collected on 6301 noncardiac surgical patients at the Veterans Affairs Maryl and Healthcare System from 1995 to 2000 . RESULTS The mean age of the study cohort was 61 + /- 13 . Descriptive data revealed 95 % were male , 44 % used tobacco , 19 % were diabetic , 9 % had COPD , 9 % used alcohol , 3 % used steroids , 1.7 % had a diagnosis of cancer , and 1.2 % had ascites . Preoperative anemia ( hematocrit less than 36 ) was found in 33.9 % and postoperative anemia was found in 84.1 % of the study cohort . In the postoperative period , 32.5 % of patients had a hematocrit of 26 - 30 , and 26.5 % had a hematocrit of 21 - 25 . Mean units of blood transfused in the perioperative period ranged from 0.1 + /- 0.9 in patients without anemia to 2.7 + /- 2.9 in those with anemia . Incidence of pneumonia increased from 2.6 to 5 % with increasing degree of anemia . Multiple logistic regression analysis documented that low preoperative hematocrit , low postoperative hematocrit , and increased blood transfusion rates were associated with increased mortality ( P < 0.01 ) , increased postoperative Output:	In patients with colorectal cancer ( CRC ) undergoing surgery , ABTs are associated with adverse clinical outcomes , including increased mortality .

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