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MS211000 | ***TASK*** the task is to summarize an input biomedical literature in 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 A subset of individuals with bulimia nervosa ( BN ) have borderline personality disorder ( BPD ) symptoms , including chronic negative affect and interpersonal problems . These symptoms predict poor BN treatment outcome in some studies . The broad version of Enhanced Cognitive Behavior Therapy ( CBT-E ) was developed to address co-occurring problems that interfere with treatment response . The current study investigated the relative effects , predictors , and moderators of CBT-E for BN with BPD and co-occurring mood/anxiety disorders . METHOD Fifty patients with BN and threshold or sub-threshold BPD and current or recent Axis I mood or anxiety disorders were r and omly assigned to receive focused CBT-E ( CBT-Ef ) or broad CBT-E ( CBT-Eb ) specifically including an interpersonal module and additional attention to mood intolerance . RESULTS Forty-two percent of the sample reported remission from binge eating and purging at termination . Significant changes across symptom domains were observed at termination and at 6-month follow-up . Though CBT-Ef predicted good outcomes in multivariate models , the severity of affective/interpersonal problems moderated treatment effects : participants with higher severity showed better ED outcomes in CBT-Eb , whereas those with lower severity showed better outcomes in CBT-Ef . Severity of affective/interpersonal BPD symptoms at baseline predicted negative outcomes overall . Follow-up BPD affective/interpersonal problems were predicted by baseline affective/interpersonal problems and by termination EDE score . DISCUSSION This study supports the utility of CBT-E for patients with BN and complex comorbidity . CBT-Ef appears to be more efficacious for patients with relatively less severe BPD symptoms , whereas CBT-Eb appears to be more efficacious for patients with more severe BPD symptoms Eating disorders may be viewed from a transdiagnostic perspective and there is evidence supporting a transdiagnostic form of cognitive behaviour therapy ( CBT-E ) . The aim of the present study was to compare CBT-E with interpersonal psychotherapy ( IPT ) , a leading alternative treatment for adults with an eating disorder . One hundred and thirty patients with any form of eating disorder ( body mass index > 17.5 to < 40.0 ) were r and omized to either CBT-E or IPT . Both treatments involved 20 sessions over 20 weeks followed by a 60-week closed follow-up period . Outcome was measured by independent blinded assessors . Twenty-nine participants ( 22.3 % ) did not complete treatment or were withdrawn . At post-treatment 65.5 % of the CBT-E participants met criteria for remission compared with 33.3 % of the IPT participants ( p < 0.001 ) . Over follow-up the proportion of participants meeting criteria for remission increased , particularly in the IPT condition , but the CBT-E remission rate remained higher ( CBT-E 69.4 % , IPT 49.0 % ; p = 0.028 ) . The response to CBT-E was very similar to that observed in an earlier study . The findings indicate that CBT-E is potent treatment for the majority of out patients with an eating disorder . IPT remains an alternative to CBT-E , but the response is less pronounced and slower to be expressed . Current controlled trials IS RCT N 15562271 OBJECTIVE The authors compared psychoanalytic psychotherapy and cognitive-behavioral therapy ( CBT ) in the treatment of bulimia nervosa . METHOD A r and omized controlled trial was conducted in which 70 patients with bulimia nervosa received either 2 years of weekly psychoanalytic psychotherapy or 20 sessions of CBT over 5 months . The main outcome measure was the Eating Disorder Examination interview , which was administered blind to treatment condition at baseline , after 5 months , and after 2 years . The primary outcome analyses were conducted using logistic regression analysis . RESULTS Both treatments result ed in improvement , but a marked difference was observed between CBT and psychoanalytic psychotherapy . After 5 months , 42 % of patients in CBT ( N=36 ) and 6 % of patients in psychoanalytic psychotherapy ( N=34 ) had stopped binge eating and purging ( odds ratio=13.40 , 95 % confidence interval [CI]=2.45 - 73.42 ; p<0.01 ) . At 2 years , 44 % in the CBT group and 15 % in the psychoanalytic psychotherapy group had stopped binge eating and purging ( odds ratio=4.34 , 95 % CI=1.33 - 14.21 ; p=0.02 ) . By the end of both treatments , substantial improvements in eating disorder features and general psychopathology were observed , but in general these changes took place more rapidly in CBT . CONCLUSIONS Despite the marked disparity in the number of treatment sessions and the duration of treatment , CBT was more effective in relieving binging and purging than psychoanalytic psychotherapy and was generally faster in alleviating eating disorder features and general psychopathology . The findings indicate the need to develop and test a more structured and symptom-focused version of psychoanalytic psychotherapy for bulimia nervosa OBJECTIVE The aim of this study was to compare two cognitive-behavioral treatments for out patients with eating disorders , one focusing solely on eating disorder features and the other a more complex treatment that also addresses mood intolerance , clinical perfectionism , low self-esteem , or interpersonal difficulties . METHOD A total of 154 patients who had a DSM-IV eating disorder but were not markedly underweight ( body mass index over 17.5 ) , were enrolled in a two-site r and omized controlled trial involving 20 weeks of treatment and a 60-week closed period of follow-up . The control condition was an 8-week waiting list period preceding treatment . Outcomes were measured by independent assessors who were blind to treatment condition . RESULTS Patients in the waiting list control condition exhibited little change in symptom severity , whereas those in the two treatment conditions exhibited substantial and equivalent change , which was well maintained during follow-up . At the 60-week follow-up assessment , 51.3 % of the sample had a level of eating disorder features less than one st and ard deviation above the community mean . Treatment outcome did not depend on eating disorder diagnosis . Patients with marked mood intolerance , clinical perfectionism , low self-esteem , or interpersonal difficulties appeared to respond better to the more complex treatment , with the reverse pattern evident among the remaining patients . CONCLUSIONS These two transdiagnostic treatments appear to be suitable for the majority of out patients with an eating disorder . The simpler treatment may best be viewed as the default version , with the more complex treatment reserved for patients with marked additional psychopathology of the type targeted by the treatment Anorexia nervosa is difficult to treat and no treatment is supported by robust evidence . As it is uncommon , it has been recommended that new treatments should undergo extensive preliminary testing before being evaluated in r and omized controlled trials . The aim of the present study was to establish the immediate and longer-term outcome following “ enhanced ” cognitive behaviour therapy ( CBT-E ) . Ninety-nine adult patients with marked anorexia nervosa ( body mass index ≤ 17.5 ) were recruited from consecutive referrals to clinics in the UK and Italy . Each was offered 40 sessions of CBT-E over 40 weeks with no concurrent treatment . Sixty-four percent of the patients were able to complete this outpatient treatment and in these patients there was a substantial increase in weight ( 7.47 kg , SD 4.93 ) and BMI ( 2.77 , SD 1.81 ) . Eating disorder features also improved markedly . Over the 60-week follow-up period there was little deterioration despite minimal additional treatment . These findings provide strong preliminary support for this use of CBT-E and justify its further evaluation in r and omized controlled trials . As CBT-E has already been established as a treatment for bulimia nervosa and eating disorder not otherwise specified , the findings also confirm that CBT-E is transdiagnostic in its scope OBJECTIVE This r and omized control trial is an evaluation of the effectiveness of enhanced cognitive behavioral treatment ( CBT-E ) for eating disorders adapted for a group setting . The study aim ed to examine the effects of group CBT-E on eating disorder psychopathology and additional maintaining pathology . METHOD A transdiagnostic sample of individuals with eating disorders with a BMI ≥ 18 kg/m2 ( N = 40 ) were r and omized to an immediate-start or delayed-start condition so as to compare therapeutic effects of group CBT-E with a waitlist control . Global Eating Disorder Examination Question naire ( EDE-Q ) scores , BMI , and measures of Clinical Perfectionism , Self-Esteem , Interpersonal Difficulties , and Mood Intolerance were measured across the 8-week control period , throughout the group treatment and at 3-months post-treatment . RESULTS Over 70 % of those who entered the trial completed treatment . The first eight weeks of group CBT-E were more effective at reducing Global EDE-Q scores than no treatment ( waitlist control ) . By post-treatment , good outcome ( a Global EDE-Q within 1 SD of Australian community norms plus BMI ≥ 18.5 ) was achieved by 67.9 % of treatment completers and 66.7 % of the total sample . Symptom abstinence within the previous month was reported by 14.3 % of treatment completers and 10.3 % of the total sample . Significant reductions in Clinical Perfectionism , Self-Esteem , Interpersonal Difficulties , and Mood Intolerance were also observed . DISCUSSION This study demonstrated that a group version of CBT-E can be effective at reducing eating disorder psychopathology in a transdiagnostic sample of individuals with eating disorders . Group CBT-E could provide a means of increasing availability of evidence -based treatment for eating disorders OBJECTIVE There is a paucity of r and omized clinical trials ( RCTs ) for adolescents with bulimia nervosa ( BN ) . Prior studies suggest cognitive-behavioral therapy adapted for adolescents ( CBT-A ) and family-based treatment for adolescent bulimia nervosa ( FBT-BN ) could be effective for this patient population . The objective of this study was to compare the relative efficacy of these 2 specific therapies , FBT-BN and CBT-A. In addition , a smaller participant group was r and omized to a nonspecific treatment ( supportive psychotherapy [ SPT ] ) , whose data were to be used if there were no differences between FBT-BN and CBT-A at end of treatment . METHOD This 2-site ( Chicago and Stanford ) r and omized controlled trial included 130 participants ( aged 12 - 18 years ) meeting DSM-IV criteria for BN or partial BN ( binge eating and purging once or more per week for 6 months ) . Outcomes were assessed at baseline , end of treatment , and 6 and 12 months posttreatment . Treatments involved 18 outpatient sessions over 6 months . The primary outcome was defined as abstinence from binge eating and purging for 4 weeks before assessment , using the Eating Disorder Examination . RESULTS Participants in FBT-BN achieved higher abstinence rates than in CBT-A at end of treatment ( 39 % versus 20 % ; p = .040 , number needed to treat [ NNT ] = 5 ) and at 6-month follow-up ( 44 % versus 25 % ; p = .030 , NNT = 5 ) . Abstinence rates between these 2 groups did not differ statistically at 12-month follow-up ( 49 % versus 32 % ; p = .130 , NNT = 6 ) . CONCLUSION In this study , FBT-BN was more effective in promoting abstinence from binge eating and purging than CBT-A in adolescent BN at end of treatment and 6-month follow-up . By 12-month follow-up , there were no statistically significant differences between the 2 treatments . CLINICAL TRIAL REGISTRATION INFORMATION Study of Treatment for Adolescents With Bulimia Nervosa ; http:// clinical trials.gov/ ; NCT00879151 BACKGROUND Anorexia nervosa ( AN ) is a serious illness leading to substantial morbidity and mortality . The treatment of AN very often is protracted ; repeated hospitalizations and lost productivity generate substantial economic costs in the health care system . Therefore , this study aim ed to determine the differential cost-effectiveness of out-patient focal psychodynamic psychotherapy ( FPT ) , enhanced cognitive-behavioural therapy ( CBT-E ) , and optimized treatment as usual ( TAU-O ) in the treatment of adult women with AN . METHOD The analysis was conducted alongside the r and omized controlled Anorexia Nervosa Treatment of Out Patients ( ANTOP ) study . Cost-effectiveness was determined using direct costs per recovery at 22 months post-r and omization ( n = 156 ) . Unadjusted incremental cost-effectiveness ratios ( ICERs ) were calculated . To derive cost-effectiveness acceptability curves ( CEACs ) adjusted net-benefit regressions were applied assuming different values for the maximum willingness to pay ( WTP ) per additional recovery . Cost-utility and assumptions underlying the base case were investigated in exploratory analyses . RESULTS Costs of in-patient treatment and the percentage of patients who required in-patient treatment were considerably lower in both inter
Output:
| Summary There is robust evidence that CBT-E is an effective treatment for patients with an eating disorder . |
MS211001 | ***TASK*** the task is to summarize an input biomedical literature in 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 identify predictors of unintentional injury to school-age children seen in pediatric primary care . METHODS Members of a managed health care system ( 295 children ages 5 - 11 years and their mothers ) participated . We used Time 1 measures of child , maternal , and family functioning and health care utilization to predict rates of unintentional child injury for the following year . Multiple regression analyses were performed to identify variables contributing to prospect i ve injury rates . RESULTS The final regression model included eight Time 1 variables and accounted for 21 % of the variance in Time 2 injury rates . Significant predictors of increased injury liability were younger child age , more children at home , child behavior problems , child social competence , three indices of reduced child health , and maternal anxiety . CONCLUSIONS We discuss the utility of these predictors for pediatric psychologists in targeting primary care preventive interventions to families at risk for unintentional child injury Abstract The accident risk to the children of a r and om sample of 458 women living in a former Inner London borough was associated with both a working-class status and the presence of psychiatric disturbance ( usually depression ) in the mother . The time of onset of the psychiatric disorder in these women and in another sample of women treated for depression by psychiatrists and general practitioners indicates that the mother 's psychiatric disorder greatly increases the risk of accidents to children The objective of this study was to evaluate the efficacy of a home-based intervention targeted to parents with intellectual disability to promote child health and home safety in the preschool years . A total of 63 parents were recruited for the study with 45 parents ( 40 mothers and 5 fathers ) from 40 families completing the project . The research design permitted comparison between the intervention and three alternative conditions with all parents receiving the intervention in an alternating sequence over the life of the project . The intervention consisted of 10 weekly lessons carried out in the parent 's home focusing on child health and home safety . The program was adapted to suit the Australian context from the UCLA Parent -- Child Health and Wellness Project ( Tymchuk , Groen , & Dolyniuk , 2000 ) . Outcome measures assessed parental health and safety behaviours . St and ard measures included parental health , intelligence and literacy . The intervention improved parents ' ability to recognize home dangers , to identify pre caution s to deal with these dangers and result ed in a significant increase in the number of safety pre caution s parents implemented in their homes with all gains being maintained at 3 months post-intervention . Parents ' health behaviours including improved underst and ing of health and symptoms of illness , knowledge of and skills needed to manage life-threatening emergencies , knowledge about visiting the doctor , knowing when to call , what information to provide and what questions to ask , and how to use medicines safely significantly increased . Again , all gains were maintained 3 months post-intervention . The intervention was effective regardless of parental health , literacy skills , and IQ . This form of home-based intervention promotes a healthy and safe environment which is a prerequisite to continuing parental custody Objective . To evaluate the extent to which a program of home visitation ( Early Start ) , targeted at families who are facing stress and difficulty , had beneficial consequences for child health , preschool education , service utilization , parenting , child abuse and neglect , and behavioral adjustment . Methods . The study used a r and omized , controlled trial design in which 220 families who were participating in the Early Start program were contrasted with a control series of 223 families who were not participating in the program . Families were enrolled in the program after population screening that was conducted by community health nurses . Families were enrolled in the program for up to 36 months . Outcomes were assessed at 6 , 12 , 24 , and 36 months after trial entry . Results . Families in the Early Start series received a mean of 24 months of service . Comparisons between the Early Start and control series over the 36-month follow-up period revealed that families in the Early Start program showed significant benefits in the areas of improved utilization of child health services , reduced rates of hospital attendance for injury/poisoning , increased preschool education , increased positive and nonpunitive parenting , reduced rates of severe parent/child assaults , and reduced rates of early problem behaviors . Effect sizes ( Cohen 's “ d ” ) were found to be in the small to moderate range , with d ranging from .03 to .31 ( median : .22 ) . Conclusions . The Early Start program was associated with small to moderate benefits in a wide range of areas relating to child health , preschool education , parenting , child abuse , and early behavioral adjustment . Comparisons with other studies are made , and threats to validity are considered BACKGROUND Healthy Steps ( HS ) was design ed to address , prospect ively , behavioral and developmental support needs of young families in pediatric clinical care setting s. PrePare ( PP ) initiates these services prenatally , whereas HS begins services in the postnatal period . Both interventions have universal and risk-directed components . Intervention effects in the first 3 months after birth are reported here . METHODS A quasi-experimental design was used to allocate 439 participants to intervention or usual care conditions . Within the intervention group , enrollees were r and omly assigned to receive HS or PP+HS services . Early outcomes were assessed by telephone survey at 1 week and 3 months postpartum . RESULTS Mothers in either intervention condition were less likely to report depressive symptoms and more likely to describe themselves as pleased in their role as parents . Intervention families were more likely to continue breastfeeding and more likely to read to their 3-month-old . Knowledge of infant development and recognition of appropriate discipline was greater among intervention recipients . Satisfaction with pediatric care was higher among intervention recipients and the rate of health plan disenrollment was 75 % lower at 3 months among those enrolled in the prenatal intervention . No other outcome difference emerged between HS and PP+HS enrollees . CONCLUSIONS Receipt of either intervention was associated with positive effects on health , safety , and developmentally appropriate parenting , as assessed in early infancy . There were positive effects on health plan disenrollment . No additional benefit could be ascribed to prenatal institution of services . A combination of universal and risk-based support for new parents is recommended , rather than the provision of risk-based services alone OBJECTIVE --To see whether non-professional volunteer community mothers could deliver a child development programme to disadvantaged first time mothers for children aged up to 1 year . DESIGN --R and omised controlled trial . SETTING --A regional health authority in Dublin . SUBJECTS--262 first time mothers who were delivered during six months in 1989 and who lived in a deprived area of Dublin ; 30 experienced mothers from the same community recruited as community mothers . INTERVENTIONS --All the first time mothers received st and ard support from the public health nurse . In addition , those in the intervention group received the services of a community mother , who was scheduled to visit monthly during the first year of the child 's life . RESULTS --232 ( 89 % ) first time mothers completed the study --127 in the intervention group , 105 controls . At the end of the study children in the intervention group were more likely to have received all of their primary immunisations , to be read to , and to be read to daily , played more cognitive games ; and were exposed to more nursery rhymes . They were less likely to begin cows ' milk before 26 weeks and to receive an inappropriate energy intake and inappropriate amounts of animal protein , non-animal protein , wholefoods , vegetables , fruit , and milk . Mothers in the intervention group also had a better diet than controls . At the end of the study they were less likely to be tired , feel miserable , and want to stay indoors ; had more positive feelings ; and were less likely to display negative feelings . CONCLUSION --Non-professionals can deliver a health promotion programme on child development effectively . Whether they can do so as effectively as professionals requires further study OBJECTIVES Two factors were considered as predictors of children 's risk for unintentional injury : ( a ) children 's temperamentally difficult behavior patterns and ( b ) parenting . Along with hypotheses to replicate previous univariate effects , it was hypothesized that active , involved parents with sufficient time re sources might reduce injury risk among temperamentally at-risk children . METHODS Study 1 used a retrospective design with a diverse sample of over 10,000 5-year-olds . Study 2 replicated Study 1 using a prospect i ve design and behavioral data from a sample of over 1,000 children followed from 6 to 36 months of age . RESULTS In Study 1 , male gender , child hyperactivity , and family poverty predicted injury in a univariate manner . In Study 2 , male gender and lack of positive parenting predicted injury in a univariate manner . Interaction effects also emerged : in Study 1 the interaction between child hyperactivity and parental time re sources protected children from injury , and in Study 2 the interaction between child 's difficult temperament and positive parenting protected children from injury . CONCLUSIONS Children at increased risk for injury , i.e. , those with hyperactive and difficult behavior patterns , might be protected in the environment of positive parenting . Theoretically , results suggest that research ers should consider Temperament x Environment interactions along with univariate predictors of outcome behavior . From an applied perspective , results have implication s for the design of injury prevention campaigns : Parents who spend positive time with temperamentally difficult children might protect them from injury Aims : To assess outcomes in families who received the First Parent Health Visitor Scheme ( FPHVS ) , in comparison with families who received conventional ( “ generic ” ) health visiting . Methods : Retrospective data on 2113 families were collected during 1986–92 as part of National Health Service ( NHS ) service provision . Prospect i ve data were collected during 1993–98 on 459 mothers and their children , with outcomes assessed at one year ( 93 % follow up ) and two years ( 80 % follow up ) . Results : There were no differences between the groups of mothers in self esteem , locus of control , or depression rates . The women who received the FPHVS were more likely to have changed partners , but they also had a wider support network than comparison women , and consulted their general practitioner ( GP ) less often . Breast feeding rates were higher in the FPHVS mothers , who also gave their infants more fruit juice drinks than the comparison group . No differences were apparent in developmental outcome using the Bayley Scales at 1 and 2 years of age . Both height and weight Z scores at 2 years of age were lower in the FPHVS children than the comparison children . Receipt of the FPHVS was associated with increased use of electric socket covers and lower accident rates in the second year of life . No differences were seen in immunisation rates , uptake of child health surveillance , or use of hospital services . A higher proportion of families who received the FPHVS were registered on the local child protection register compared with comparison families . Conclusion : Clustering effects dominated the analysis , but overall this evaluation could not show a clear advantage for the FPHVS over conventional health visiting Abstract Objective : To assess the effectiveness of safety advice at child health surveillance consultations , provision of low cost safety equipment to families receiving means tested state benefits , home safety checks , and first aid training on frequency and severity of unintentional injuries in children at home . Design : Cluster r and omised controlled trial . Setting : 36 general practice s in Nottingham . Subjects : All children aged 3 - 12 months registered with participating practice s. Interventions : A package of safety advice at child health surveillance consultations at 6 - 9 , 12 - 15 , and 18 - 24 months;provision of low cost safety equipment to families on means tested state benefits ; and home safety checks and first aid training by health visitors . Outcome measures : Primary outcomes measures were frequency and severity of medically attended injuries . Secondary outcome measures were self reported safety practice s , possession and use of safety equipment , knowledge and confidence in dealing with first aid , and perceptions of risk of injury and risk of hazards assessed by postal question naire at baseline and follow up at 25 months . Results : At baseline , both groups had similar risk factors for injury , sociodemographic characteristics , safety practice s , possession and use of safety equipment , knowledge and confidence in dealing with first aid , and perceptions of risk . No significant difference was found in frequency of at least one medically attended injury ( odds ratio 0.97 , 95 % confidence interval 0.72 to1.30 ) , at least one attendance at an accident and emergency department for injury ( , 0.76 to 1.37 ) , at least one primary care attendance for injury ( 0.75 , 0.48 to 1.17 ) , or at least one hospital admission for injury ( 0.69 , 0.42 to 1.12 ) . No significant difference in the secondary outcome measures was found between the intervention and control groups . Conclusions : The intervention package was not effective in reducing the frequency of minor unintentional injuries in children at home , and larger trials are required to assess the effect on more severe injuries The behavior of 10,394 British children was related prospect ively to their injury history between ages 5 and 10 years , obtained from parents . Aggressive and overactive behaviors at age 5 years were measured by subscales of the Rutter Child Behavior Question naire completed by the parents . Multivariate techniques were used to assess the association between behavior and injuries while controlling for social , demographic , and psychological characteristics . Boys ' behavior at age 5 years was more strongly predictive of injuries in the subsequent five years than was girls ' behavior . The odds of experiencing injuries result ing in hospitalization in boys with high aggression scores was 2.4 times that of boys with low aggression scores . The identification of high-risk children provides the foundation for underst and ing the behavioral mechanisms that contribute to injuries and for developing preventive strategies tailored to the needs of these children Physicians are often faced with conflicting recommendations from therapeutic studies . An evaluation form is proposed to facilitate the evaluation of the quality of therapeutic studies and the result ing treatment or management recommendations in any area of medicine . Twelve major topics for evaluation include sample size determination , r and omization , selection of control group(s )
Output:
| Parenting interventions , most commonly provided within the home , using multi-faceted interventions appear to be effective in reducing unintentional child injury . |
MS211002 | ***TASK*** the task is to summarize an input biomedical literature in 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 employed a self-report question naire in a Solomon four-groups design to assess the efficacy of suicide intervention classes in achieving their instructional objectives . Because adolescents are often the first to know of a peer 's suicidal thoughts or plans , the goal of the classes was to increase the likelihood that students who come into contact with potentially suicidal peers can more readily identify them and will be consistently inclined to take responsible action on their behalf . Students who participated in the classes as compared to controls showed significant gains in relevant knowledge about suicidal peers and significantly more positive attitudes toward help seeking and intervening with troubled peers . Results of this study will be used to strengthen components of the lessons aim ed at enhancing the likelihood of performance of responsible interventions Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts . Yet , currently available measures lack conceptual clarity and have largely unknown reliability and validity . This study developed and psychometrically assessed three new measures : the Acceptability of Intervention Measure ( AIM ) , Intervention Appropriateness Measure ( IAM ) , and Feasibility of Intervention Measure ( FIM ) . Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments . The Wilcoxon one- sample signed rank test was used to assess substantive and discriminant content validity . Exploratory and confirmatory factor analysis ( EFA and CFA ) and Cronbach alphas were used to assess the validity of the conceptual model . Three hundred twenty-six mental health counselors read one of six r and omly assigned vignettes depicting a therapist contemplating adopting an evidence -based practice ( EBP ) . Participants used 15 items to rate the therapist ’s perceptions of the acceptability , appropriateness , and feasibility of adopting the EBP . CFA and Cronbach alphas were used to refine the scales , assess structural validity , and assess reliability . Analysis of variance ( ANOVA ) was used to assess known-groups validity . Finally , half of the counselors were r and omly assigned to receive the same vignette and the other half the opposite vignette ; and all were asked to re-rate acceptability , appropriateness , and feasibility . Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change . Results All but five items exhibited substantive and discriminant content validity . A trimmed CFA with five items per construct exhibited acceptable model fit ( CFI = 0.98 , RMSEA = 0.08 ) and high factor loadings ( 0.79 to 0.94 ) . The alphas for 5-item scales were between 0.87 and 0.89 . Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales ( α ’s from 0.85 to 0.91 ) . A three-factor CFA exhibited acceptable fit ( CFI = 0.96 , RMSEA = 0.08 ) and high factor loadings ( 0.75 to 0.89 ) , indicating structural validity . ANOVA showed significant main effects , indicating known-groups validity . Test-retest reliability coefficients ranged from 0.73 to 0.88 . Regression analysis indicated each measure was sensitive to change in both directions . Conclusions The AIM , IAM , and FIM demonstrate promising psychometric properties . Predictive validity assessment is planned CONTEXT Universal screening for mental health problems and suicide risk is at the forefront of the national agenda for youth suicide prevention , yet no study has directly addressed the potential harm of suicide screening . OBJECTIVE To examine whether asking about suicidal ideation or behavior during a screening program creates distress or increases suicidal ideation among high school students generally or among high-risk students reporting depressive symptoms , substance use problems , or suicide attempts . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled study conducted within the context of a 2-day screening strategy . Participants were 2342 students in 6 high schools in New York State in 2002 - 2004 . Classes were r and omized to an experimental group ( n = 1172 ) , which received the first survey with suicide questions , or to a control group ( n = 1170 ) , which did not receive suicide questions . MAIN OUTCOME MEASURES Distress measured at the end of the first survey and at the beginning of the second survey 2 days after the first measured on the Profile of Mood States adolescent version ( POMS-A ) instrument . Suicidal ideation assessed in the second survey . RESULTS Experimental and control groups did not differ on distress levels immediately after the first survey ( mean [ SD ] POMS-A score , 5.5 [ 9.7 ] in the experimental group and 5.1 [ 10.0 ] in the control group ; P = .66 ) or 2 days later ( mean [ SD ] POMS-A score , 4.3 [ 9.0 ] in the experimental group and 3.9 [ 9.4 ] in the control group ; P = .41 ) , nor did rates of depressive feelings differ ( 13.3 % and 11.0 % , respectively ; P = .19 ) . Students exposed to suicide questions were no more likely to report suicidal ideation after the survey than unexposed students ( 4.7 % and 3.9 % , respectively ; P = .49 ) . High-risk students ( defined as those with depression symptoms , substance use problems , or any previous suicide attempt ) in the experimental group were neither more suicidal nor distressed than high-risk youth in the control group ; on the contrary , depressed students and previous suicide attempters in the experimental group appeared less distressed ( P = .01 ) and suicidal ( P = .02 ) , respectively , than high-risk control students . CONCLUSIONS No evidence of iatrogenic effects of suicide screening emerged . Screening in high schools is a safe component of youth suicide prevention efforts High school principals ' acceptability ratings of three school-based programs for the prevention of adolescent suicide were examined . From a r and om sample of members from the 1994 - 1995 membership directory of the National Association of Secondary School Principals ( NASSP ) , a total of 185 ( 40 % ) respondents completed the Suicide Prevention Program Rating Profile ( SPPRP ) , a measure design ed to evaluate the acceptability of suicide prevention programs , after reading a description of a particular prevention program . Programs evaluated for their acceptability included ( 1 ) curriculum-based programs presented to students , ( 2 ) in-service presentations to school staff , and ( 3 ) student self-report screening measures . The results indicated that the curriculum-based and staff in-service programs were significantly more acceptable to principals than was the schoolwide student screening program . No significant differences between the acceptability of curriculum-based and inservice programs were found . Limitations of the study and implication s for practice and research are discussed School-based depression screening and education programs are recommended for addressing the high rates of children ’s mental illness . The objectives of this study were to ( 1 ) identify Minnesota parent attitudes regarding the provision of school-based depression and suicide screening and education and ( 2 ) identify predictors of parent support for these school-based programs . A r and om sample of 1,300 Minnesota households with children ages 5–18 years was surveyed by mail . Chi-square tests and regression analyses were used to detect differences in parent support for depression and suicide screening and education across demographic categories , and parent beliefs and knowledge about depression and suicide . The response rate of eligible households was 43 % ( N = 511 ) . Overall , 84–89 % of parents supported school-based depression and suicide screening and education . After adjusting for all variables , parent support for depression screening was associated with greater knowledge [ OR 8.48 , CI(1.30–55.21 ) ] and fewer stigmatizing beliefs [ OR 0.03 , CI(0.01–0.12 ) ] . Support for suicide screening was associated with fewer stigmatizing beliefs [ OR 0.03 , CI(0.01 - 0.10 ) ] . Support for depression education was associated with fewer stigmatizing beliefs [ OR 0.32 , CI(0.10–1.00 ) ] and lower educational attainment [ OR 0.59 , CI(0.40–0.89 ) ] . Support for suicide education was associated with greater knowledge [ OR 7.99 , CI(1.02–62.68 ) ] , fewer stigmatizing beliefs [ OR 0.26 , CI(0.07–0.92 ) ] , and lower educational attainment [ OR 0.60 , CI(0.38–0.94 ) ] . Parent support for school-based depression and suicide screening and education was high . Parent education to decrease stigmatizing beliefs and increase knowledge about depression and suicide may increase support among the minority of parents who do not endorse such programs From a r and om sample of members of the 2000 - 2001 membership directory of the American Association of School Administrators ( AASA ) , public school administrators ' acceptability ratings of three school-based programs for the prevention of adolescent suicide were examined . A total of 210 ( 46 % ) respondents examined a description of a suicide prevention program and completed a measure design ed to evaluate the acceptability of suicide prevention programs . Three suicide prevention programs were evaluated for their acceptability , and included : ( a ) school-wide curriculum-based programs presented to students ; ( b ) in-service presentations to school staff ; and ( c ) self-report screening programs for students . The results indicated that superintendents rated the staff in-service training and curriculum-based programs as significantly more acceptable than the school-wide screening program . In addition , the school-wide screening program was rated as significantly more intrusive by school psychologists than the staff in-service training or curriculum-based prevention programs . Limitations of the study and future research directions are discussed 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 . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Attendance and grade point average ( GPA ) data are universally maintained in school records and can potentially aid in identifying students with concealed behavioral problems , such as substance use . Research ers evaluated attendance ( truancy ) and GPA as a means to identify high school students at risk for substance use , suicide behaviors , and delinquency in 10 high schools in San Antonio , Texas , and San Francisco , California , during the spring and fall of 2002 . A screening protocol identified students as “ high risk ” if ( 1 ) in the top quartile for absences and below the median GPA or ( 2 ) teacher referred . Survey responses of 930 high-risk students were compared with those from a r and om sample of 393 “ typical ” students not meeting the protocol . Bivariate and multivariate analyses assessed associations between the screening protocol variables and demographics , risk and protective factors , and problem outcomes . The individual contribution of each of the variables was also assessed . Students identified as high risk were significantly more likely than typical students to use cigarettes , alcohol , and marijuana , evidence suicide risk factors , and engage in delinquent behavior . Norms varied between the two districts ; nevertheless , high-risk students showed consistent differences in risk and protective factors , as well as problem behaviors , compared with typical students . Because of site differences in data collection and teacher participation , the comprehensive protocol is recommended , rather than individual indicators alone ( e.g. , truancy ) . Strengths of the screening protocol are the ready availability of school record data , the ease of use of the adapted protocol , and the option of including teacher referral . More research is recommended to test the generalizability of the protocol and to ensure that there are no unintended negative effects associated with identification of students as high risk BACKGROUND Although school-based programmes for the identification of children and young people ( CYP ) with mental health difficulties ( MHD ) have the potential to improve short- and long-term outcomes across a range of mental disorders , the evidence -base on the effectiveness of these programmes is underdeveloped . In this systematic review , we sought to identify and synthesis e evidence on the effectiveness and cost-effectiveness of school-based methods to identify students experiencing MHD , as measured by accurate identification , referral rates , and service uptake . METHOD Electronic bibliographic data bases : MEDLINE , Embase , PsycINFO , ERIC , British Education Index and ASSIA were search ed . Comparative studies were included if they assessed the effectiveness or cost-effectiveness of strategies to identify students in formal education aged 3 - 18 years
Output:
| The majority focused on behavioural and socioemotional problems or suicide risk , examined universal screening models , and used cross-sectional design s. In general , school-based programmes for identifying MHD aligned with schools ’ priorities , but their appropriateness for students varied by condition .
Time , re source , and cost concerns were the most common barriers to feasibility across models and conditions . |
MS211003 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background Cognitive remediation ( CR ) is an effective treatment for several psychiatric disorders . To date , there have been no published studies examining solely first-episode psychiatric cohorts , despite the merits demonstrated by early intervention CR studies . The current study aim ed to assess the effectiveness of CR in patients with a first-episode of either major depression or psychosis . Method Fifty-five patients ( mean age = 22.8 years , s.d . = 4.3 ) were r and omly assigned to either CR ( n = 28 ) or treatment as usual ( TAU ; n = 27 ) . CR involved once-weekly 2-h sessions for a total of 10 weeks . Patients were comprehensively assessed before and after treatment . Thirty-six patients completed the study , and analyses were conducted using an intent-to-treat ( ITT ) approach with all available data . Results In comparison to TAU , CR was associated with improved immediate learning and memory controlling for diagnosis and baseline differences . Similarly , CR patients demonstrated greater improvements than TAU patients in psychosocial functioning irrespective of diagnosis . Delayed learning and memory improvements mediated the effect of treatment on psychosocial functioning at a marginal level . Conclusions CR improves memory and psychosocial outcome in first-episode psychiatric out- patients for both depression and psychosis . Memory potentially mediated the functional gains observed . Future studies need to build on the current findings in larger sample s using blinded allocation and should incorporate longitudinal follow-up and assessment of potential moderators ( e.g. social cognition , self-efficacy ) to examine sustainability and the precise mechanisms of CR effects respectively Rationale Cognitive impairments are important determinants of functional outcome in psychosis , which are inadequately treated by antipsychotic medication . Modafinil is a wake-promoting drug that has been shown to improve attention , memory and executive function in the healthy population and in patients with schizophrenia . Objectives We aim ed to establish modafinil ’s role in the adjunctive treatment of cognitive impairments in the first episode of psychosis , a time when symptoms may be more malleable than at chronic stages of the disease . Methods Forty patients with a first episode of psychosis participated in a r and omised , double-blind , placebo-controlled crossover design study assessing the effects of a single dose of 200 mg modafinil on measures of executive functioning , memory , learning , impulsivity and attention . Results Modafinil improved verbal working memory ( d = 0.24 , p = 0.04 ) , spatial working memory errors ( d = 0.30 , p = 0.0004 ) and strategy use ( d = 0.23 , p = 0.03 ) . It also reduced discrimination errors in a task testing impulsivity . Modafinil showed no effect on impulsivity measures , sustained attention , attentional set-shifting , learning or fluency . Conclusions Modafinil selectively enhances working memory in first episode psychosis patients , which could have downstream effects on patients ’ social and occupational functioning First-episode schizophrenia ( FES ) spectrum disorders are associated with pronounced cognitive dysfunction across all domains . However , less is known about the course of cognitive functioning , following the first presentation of psychosis , and the relationship of cognition to clinical course during initial treatment . The present longitudinal study examined the magnitude of neurocognitive impairment , using the MATRICS Consensus Cognitive Battery , in patients experiencing their first episode of psychosis at baseline and after 12 weeks of r and omized antipsychotic treatment with either aripiprazole or risperidone . At baseline , FES patients evidence d marked impairments in cognitive functioning . Notably , performance on the mazes task of planning and reasoning significantly predicted the likelihood of meeting stringent criteria for positive symptom remission during the first 12 weeks of the trial . Performance on indices of general cognitive function , working memory , and verbal learning improved over time , but these improvements were mediated by improvements in both positive and negative symptoms . We did not detect any differential effects of antipsychotic medication assignment ( aripiprazole vs risperidone ) on cognitive functioning . Our results suggest that a brief paper- and -pencil measure reflecting planning/reasoning abilities may index responsivity to antipsychotic medication . However , improvements in cognitive functioning over time were related to clinical symptom improvement , reflecting " pseudospecificity . BACKGROUND Disturbed functional connectivity is assumed to underlie neurocognitive deficits in patients with schizophrenia . As neurocognitive deficits are already present in the high-risk state , identification of the neural networks involved in this core feature of schizophrenia is essential to our underst and ing of the disorder . Resting-state studies enable such investigations , while at the same time avoiding the known confounder of impaired task performance in patients . The aim of the present study was to investigate EEG resting-state connectivity in high-risk individuals ( HR ) compared to first episode patients with schizophrenia ( SZ ) and to healthy controls ( HC ) , and its association with cognitive deficits . METHODS 64-channel resting-state EEG recordings ( eyes closed ) were obtained for 28 HR , 19 stable SZ , and 23 HC , matched for age , education , and parental education . The imaginary coherence-based multivariate interaction measure ( MIM ) was used as a measure of connectivity across 80 cortical regions and six frequency b and s. Mean connectivity at each region was compared across groups using the non-parametric r and omization approach . Additionally , the network-based statistic was applied to identify affected networks in patients . RESULTS SZ displayed increased theta-b and resting-state MIM connectivity across midline , sensorimotor , orbitofrontal regions and the left temporoparietal junction . HR displayed intermediate theta-b and connectivity patterns that did not differ from either SZ or HC . Mean theta-b and connectivity within the above network partially mediated verbal memory deficits in SZ and HR . CONCLUSIONS Aberrant theta-b and connectivity may represent a trait characteristic of schizophrenia associated with neurocognitive deficits . As such , it might constitute a promising target for novel treatment applications OBJECTIVE Cognitive deficits that characterize schizophrenia are present in the prodrome , worsen with illness onset , and predict functional outcome . Cognitive dysfunction is thus a critical target for early intervention in young individuals with recent onset schizophrenia . METHOD This 2-site double-blind r and omized controlled trial investigated cognitive training of auditory processing/verbal learning in 86 subjects with recent onset schizophrenia ( mean age of 21 years ) . Subjects were given laptop computers to take home and were asked to perform 40 hours of training or 40 hours of commercial computer games over 8 weeks . We examined cognitive measures recommended by the Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative ( MATRICS ) , symptoms , and functioning . We also assessed baseline reward anticipation to index motivational system functioning and measured changes in auditory processing speed after 20 hours of training to assess target engagement . RESULTS Auditory training subjects demonstrated significant improvements in global cognition , verbal memory , and problem solving compared with those of computer games control subjects . Both groups showed a slight but significant decrease in symptoms and no change in functional outcome measures . Training-induced cognitive gains at posttraining showed significant associations with reward anticipation at baseline and with improvement in auditory processing speed at 20 hours . CONCLUSION Neuroscience-informed cognitive training via laptop computer represents a promising treatment approach for cognitive dysfunction in early schizophrenia . An individual 's baseline motivational system functioning ( reward anticipation ) , and ability to engage in auditory processing speed improvement , may represent important predictors of treatment outcome . Future studies must investigate whether cognitive training improves functioning and how best to integrate it into critical psychosocial interventions AIM To examine whether baseline neurocognition predicts vocational outcomes over 18 months in patients with first-episode psychosis enrolled in a r and omized controlled trial of Individual Placement and Support or treatment as usual . METHODS One-hundred and thirty-four first-episode psychosis participants completed an extensive neurocognitive battery . Principal axis factor analysis using PROMAX rotation was used to determine the underlying structure of the battery . Setwise ( hierarchical ) multiple linear and logistic regressions were used to examine predictors of ( 1 ) total hours employed over 18 months and ( 2 ) employment status , respectively . Neurocognition factors were entered in the models after accounting for age , gender , premorbid IQ , negative symptoms , treatment group allocation and employment status at baseline . RESULTS Five neurocognitive factors were extracted : ( 1 ) processing speed , ( 2 ) verbal learning and memory , ( 3 ) knowledge and reasoning , ( 4 ) attention and working memory and ( 5 ) visual organization and memory . Employment status over 18 months was not significantly predicted by any of the predictors in the final model . Total hours employed over 18 months were significantly predicted by gender ( P = .027 ) , negative symptoms ( P = .032 ) and verbal learning and memory ( P = .040 ) . Every step of the regression model was a significant predictor of total hours worked overall ( final model : P = .013 ) . CONCLUSION Verbal learning and memory , negative symptoms and gender were implicated in duration of employment in first-episode psychosis . The other neurocognitive domains did not significantly contribute to the prediction of vocational outcomes over 18 months . Interventions targeting verbal memory may improve vocational outcomes in early psychosis Background Verbal learning and memory are impaired not only in patients with a first episode of psychosis ( FEP ) but also – to a lower extent – in those with an at-risk mental state for psychosis ( ARMS ) . However , little is known about the specific nature of these impairments . Hence , we aim ed to study learning and memory processes in ARMS and FEP patients by making use of structural equation modelling . Methods Verbal learning was assessed with the California Verbal Learning Test ( CVLT ) in 98 FEP patients , 126 ARMS patients and 68 healthy controls ( HC ) as part of the Basel early detection of psychosis ( FePsy ) study . The four-factorial CFA model of Donders was used to estimate test performance on latent variables of the CVLT and growth curve analysis was used to model the learning curve . The latter allows disentangling initial recall , which is strongly determined by attentional processes , from the learning rate . Results The CFA model revealed that ARMS and FEP patients were impaired in Attention Span , Learning Efficiency and Delayed Memory and that FEP patients were additionally impaired in Inaccurate Memory . Additionally , ARMS-NT , but not ARMS-T , performed significantly worse than HC on Learning Efficiency . The growth curve model indicated that FEP patients were impaired in both initial recall and learning rate and that ARMS patients were only impaired in the learning rate . Conclusions Since impairments were more pronounced in the learning rate than the initial recall , our results suggest that the lower scores in the CVLT reported in previous studies are more strongly driven by impairments in the rate of learning than by attentional processes Cognitive deficits have an important role in the neurodevelopment of schizophrenia and other psychotic disorders . However , there is a continuing debate as to whether cognitive impairments in the psychosis prodrome are stable predictors of eventual psychosis or undergo a decline due to the onset of psychosis . In the present study , to determine how cognition changes as illness emerges , we examined baseline neurocognitive performance in a large sample of helping-seeking youth ranging in clinical state from low-risk for psychosis through individuals at clinical high-risk ( CHR ) for illness to early first-episode patients ( EFEP ) . At baseline , the MATRICS Cognitive Consensus battery was administered to 322 individuals ( 205 CHRs , 28 EFEPs , and 89 help-seeking controls , HSC ) that were part of the larger Early Detection , Intervention and Prevention of Psychosis Program study . CHR individuals were further divided into those who did ( CHR-T ; n = 12 , 6.8 % ) and did not ( CHR-NT , n = 163 ) convert to psychosis over follow-up ( Mean = 99.20 weeks , SD = 21.54 ) . ANCOVAs revealed that there were significant overall group differences ( CHR , EFEP , HSC ) in processing speed , verbal learning , and overall neurocognition , relative to healthy controls ( CNTL ) . In addition , the CHR-NTs performed similarly to the HSC group , with mild to moderate cognitive deficits relative to the CTRL group . The CHR-Ts mirrored the EFEP group , with large deficits in processing speed , working memory , attention/vigilance , and verbal learning ( > 1 SD below CNTLs ) . Interestingly , only verbal learning impairments predicted transition to psychosis , when adjusting for age , education , symptoms , antipsychotic medication , and neurocognitive performance in the other domains . Our findings suggest that large neurocognitive deficits are present prior to illness onset and represent vulnerability markers for psychosis . The results of this study further reinforce that verbal learning should be specifically targeted for preventive intervention for psychosis INTRODUCTION There is substantial evidence for Theory of Mind ( ToM ) deficits in patients with schizophrenia . Many psychotic symptoms may best be understood in light of an impaired capacity to infer one 's own and other persons ' mental states and to relate those to executing behavior . The aim of our study was to investigate ToM abilities in first-episode schizophrenia patients and to analyze them in relation to neuropsychological and psychopathological functioning . MATERIAL S AND METHODS A modified Moving Shapes paradigm was used to assess ToM abilities in 23 first-episode patients with schizophrenia and 23 matched healthy controls . Participants had to describe animated triangles which moved ( 1 ) r and omly , (
Output:
| Discussion While many scales are commonly used to measure verbal memory in first episode psychosis , they are not often administered via digital technology . |
MS211004 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Summary We studied the intubating conditions , haemodynamic and endocrine changes following tracheal intubation during sevoflurane anaesthesia guided by Bispectral Index ( BIS ) monitoring in 40 children who received either remifentanil 1 µg.kg−1 ( group R ) or saline 1 ml.kg−1 ( group S ) . Acceptable intubating conditions were found in all patients in group R ( n = 20 ) , compared to only 12 patients in group S ( p = 0.002 ) . There were no intergroup differences in heart rate , systolic blood pressure and plasma concentrations of epinephrine and norepinephrine at any time point and changes in haemodynamic variables throughout the study period were moderate . Titration of sevoflurane delivery to a target BIS of 35 ± 5 led to almost equal end‐tidal sevoflurane concentrations in either group and remifentanil did not affect the BIS . There were no side‐effects in either group that required intervention . Intubating conditions during sevoflurane anaesthesia in children were found to be improved by a single bolus dose of remifentanil 1 µg.kg−1 BACKGROUND We studied 120 children aged 2 - 7 yr in a prospect i ve , r and omized , assessor-blinded fashion to define the optimal rocuronium dose which provides a 95 % probability of acceptable intubation conditions ( ED95TI ) during inhalation induction with sevoflurane . METHODS After inhalation induction with 8 % sevoflurane in 60 % nitrous oxide and 40 % oxygen , and loss of the eyelash reflex , we administered rocuronium ( 0.1 , 0.15 , 0.22 , 0.3 , or 0.6 mg kg-1 ) or placebo . We quantified neuromuscular function by stimulation of the ulnar nerve at 0.1 Hz to produce contraction of the adductor pollicis muscle using accelerometry . Intubation conditions were assessed 2 min after test drug injection . The optimal rocuronium dose was defined as the lowest dose , which allowed acceptable intubation conditions in 95 % of children ( ED95TI ) . RESULTS Two minutes after injection of placebo or rocuronium , intubation conditions were acceptable in 35 , 45 , 80 , 90 , 95 , and 100 % of children , respectively . Rocuronium 0.07 [ CI 0.02 - 0.11 ] , 0.24 [ 0.19 - 0.31 ] , and 0.29 [ 0.23 - 0.38 ] mg kg-1 provided 50 , 90 , and 95 % probability of acceptable intubating conditions . When thumb acceleration was depressed by 50 % or more , intubating conditions were considered acceptable in 97 % of children . Recovery of the train-of-four ratio to 0.8 averaged 12 ( 7 ) , 16 ( 7 ) , 24 ( 7 ) , 24 ( 8) , and 50 ( 22 ) min after the respective dose of rocuronium . CONCLUSIONS During inhalation induction with 8 % sevoflurane in 60 % nitrous oxide , rocuronium 0.29 mg kg-1 ( ED95 ) optimizes intubation conditions for surgery of short duration BACKGROUND : Intubation without the use of muscle relaxants in children is frequently done before IV access is secured . In this r and omized controlled trial , we compared intubating conditions and airway response to intubation ( coughing and /or movement ) after sevoflurane induction in children at 2 and 3 min after the administration of intranasal remifentanil ( 4 mcg/kg ) or saline . METHODS : One hundred eighty-eight children , 1–7-yr old , were studied . Nasal remifentanil ( 4 mcg/kg ) or saline was administered 1 min after an 8 % sevoflurane N2O induction . The sevoflurane concentration was then reduced to 5 % in oxygen , and ventilation assisted/controlled . An anesthesiologist blinded to treatment assignment used a vali date d score to evaluate the conditions for laryngoscopy and response to intubation . Blood sample s for determination of remifentanil blood concentrations were collected from 17 children at baseline , 2 , 3 , 4 , and 10 min after nasal administration of remifentanil . RESULTS : Good or excellent intubating conditions were achieved at 2 min ( after the remifentanil bolus ) in 68.2 % and at 3 min in 91.7 % of the children who received intranasal remifentanil versus 37 % and 23 % in children who received placebo ( P < 0.01 ) . The mean remifentanil plasma concentrations ( ±sd ) at 2 , 3 , 4 , and 10 min were 1.0 ( 0.60 ) , 1.47 ( 0.52 ) , 1.70 ( 0.46 ) , and 1.16 ( 0.36 ) ng/mL , respectively . Peak plasma concentration was observed at 3.47 min . There were no complications associated with the use of nasal remifentanil . CONCLUSIONS : Nasal administration of remifentanil produces good-to-excellent intubating conditions in 2–3 min after sevoflurane induction of anesthesia Tracheal intubating conditions were assessed in 112 children after induction of anaesthesia with propofol and remifentanil 1.0 , 2.0 or 3.0 µg.kg−1 . Subjects in a control group were given propofol and mivacurium 0.2 mg.kg−1 . Haemodynamic and respiratory parameters were recorded . Plasma catecholamine levels were measured in a subgroup of 40 children . Intubating conditions were acceptable in 14/28 ( 50 % ) , 18/26 ( 69 % ) and 22/27 ( 82 % ) in those subjects given remifentanil 1.0 , 2.0 or 3.0 µg.kg−1 , respectively , and in 27/28 ( 96 % ) of the control group . Intubating conditions in subjects given remifentanil 3.0 µg.kg−1 were better than in those given remifentanil 1.0 µg.kg−1 ( p < 0.05 ) . There were no significant differences in intubating conditions between those given remifentanil 3.0 µg.kg−1 and the control group . Systolic blood pressure and heart rate increased in response to tracheal intubation in subjects given remifentanil 1.0 µg.kg−1 and in the control group ( p < 0.05 ) . Time to resumption of spontaneous respiration was prolonged in subjects given remifentanil 3.0 µg.kg−1 ( p < 0.001 ) . In conclusion , remifentanil 2 µg.kg−1 provides acceptable intubating conditions and haemodynamic stability without prolonging the return of spontaneous respiration Background : Sevoflurane inhalation induction of anaesthesia is widely used in paediatric anaesthesia . We have found that this method is frequently associated with epileptiform electroencephalogram ( EEG ) in adults , especially if controlled hyperventilation is used IMPLICATION S Supplementing a sevoflurane induction of anesthesia in children with IV lidocaine 2 mg/kg can suppress cough after tracheal intubation and thus improve intubating conditions . In addition , lidocaine minimizes blood pressure fluctuations after tracheal intubation BACKGROUND Remifentanil is known to cause bradycardia and hypotension . We aim ed to characterize the haemodynamic profile of remifentanil during sevoflurane anaesthesia in children with or without atropine . METHODS Forty children who required elective surgery received inhalational induction of anaesthesia using 8 % sevoflurane . They were allocated r and omly to receive either atropine , 20 microg kg(-1 ) ( atropine group ) or Ringer 's lactate ( control group ) after 10 min of steady-state 1 MAC sevoflurane anaesthesia ( baseline ) . Three minutes later ( T0 ) , all children received remifentanil 1 microg kg(-1 ) injected over a 60 s period , followed by an infusion of 0.25 microg kg(-1 ) min(-1 ) for 10 min then 0.5 microg kg(-1 ) min(-1 ) for 10 min . Haemodynamic variables and echocardiographic data were determined at baseline , T0 , T5 , T10 , T15 and T20 min . RESULTS Remifentanil caused a significant decrease in heart rate compared with the T0 value , which was greater at T20 than T10 in the two groups : however , the values at T10 and T20 were not significantly different from baseline in the atropine group . In comparison with T0 , there was a significant fall in blood pressure in the two groups . Remifentanil caused a significant decrease in the cardiac index with or without atropine . Remifentanil did not cause variation in stroke volume ( SV ) . In both groups , a significant increase in systemic vascular resistance occurred after administration of remifentanil . Contractility decreased significantly in the two groups , but this decrease remained moderate ( between -2 and + 2 sd ) . CONCLUSION Remifentanil produced a fall in blood pressure and cardiac index , mainly as a result of a fall in heart rate . Although atropine was able to reduce the fall in heart rate , it did not completely prevent the reduction in cardiac index BACKGROUND The aim of our study was to determine the optimal dose of propofol preceded by fentanyl for successful tracheal intubation and to see its effectiveness in blunting pressor response in children aged 3 - 10 years . METHODS This prospect i ve , double blind , r and omized study was conducted on 60 ASA grade I and II children , between 3 and 10 years undergoing elective surgery who were divided into three groups of 20 each . The children received different doses of propofol ( group I , 2.5 mg x kg(-1 ) ; group II , 3.0 mg x kg(-1 ) ; group III , 3.5 mg x kg(-1 ) ) preceded by a fixed dose of fentanyl ( 3.0 microg x kg(-1 ) ) 3 min earlier . The tracheal intubating conditions were grade d based on scoring system devised by Helbo-Hensen et al. with Steyn modification which includes five criteria ; ease of laryngoscopy , degree of coughing , position of vocal cords , jaw relaxation , and limb movement and grade d on a 4-point scale . Heart rate ( HR ) , mean arterial pressure ( MAP ) , and oxygen saturation changes were also noted . RESULTS Tracheal intubating conditions were acceptable in 25 % of the patients in group I , while significantly higher ( P < 0.001 ) in group II ( 80 % ) and in group III ( 90 % ) . The pressor response was not effectively blunted in group I ( 17 % increase in HR ) , while effectively blunted in groups II and III . A fall in cardiac output was seen in group III indicated by a decrease in MAP ( 16 % ) and HR ( 11 % ) . No airway complications were noted . CONCLUSIONS Propofol 3 mg x kg(-1 ) ( group II ) preceded by fentanyl 3 microg x kg(-1 ) is the optimal dose combination in our study . It provides acceptable intubating conditions in 80 % patients , blunts pressor response to intubation without significant cardiovascular depression BACKGROUND Drug effect lags behind the blood concentration . The goal of this investigation was to determine the time course of plasma concentration and the effects of propofol demonstrated by electroencephalogram or blood pressure changes and to compare them between elderly and young or middle-aged patients . METHODS A target-controlled infusion was used to rapidly attain and maintain four sequentially increasing , r and omly selected plasma propofol concentrations from 1 to 12 microg/ml in 41 patients aged 20 - 85 yr . The target concentration was maintained for about 30 min . Bispectral index ( BIS ) , spectral edge frequency , and systolic blood pressure ( SBP ) were used as measures of propofol effect . Because the time courses of these measures following the started drug infusion showed an exponential pattern , the first-order rate constant for equilibration of the effect site with the plasma concentration ( k(eO ) ) was estimated by fitting a monoexponential model to the effect versus time data result ing from the pseudo-steady-state propofol plasma concentration profile . RESULTS The half-times for the plasma-effect-site equilibration for BIS were 2.31 , 2.30 , 2.29 , and 2.37 min in patients aged 20 - 39 , 40 - 59 , 60 - 69 , and 70 - 85 yr , respectively ( n = 10 or 11 each ) . The half-times for SBP were 5.68 , 5.92 , 8.87 , and 10.22 min in the respective age groups . All were significantly longer than for BIS ( P < 0.05 ) . The propofol concentration at half of the maximal decrease of SBP was significantly greater ( P < 0.05 ) in the elderly than in the younger patients . CONCLUSIONS The effect of propofol on BIS occurs more
Output:
| No serious adverse events were reported with these combinations |
MS211005 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background —Whether cardiac rehabilitation ( CR ) is effective in patients older than 75 years , who have been excluded from most trials , remains unclear . We enrolled patients 46 to 86 years old in a r and omized trial and assessed the effects of 2 months of post-myocardial infa rct ion ( MI ) CR on total work capacity ( TWC , in kilograms per meter ) and health-related quality of life ( HRQL ) . Methods and Results —Of 773 screened patients , 270 without cardiac failure , dementia , disability , or contraindications to exercise were r and omized to outpatient , hospital-based CR ( Hosp-CR ) , home-based CR ( Home-CR ) , or no CR within 3 predefined age groups ( middle-aged , 45 to 65 years ; old , 66 to 75 years ; and very old , > 75 years ) of 90 patients each . TWC and HRQL were determined with cycle ergometry and Sickness Impact Profile at baseline , after CR , and 6 and 12 months later . Within each age group , TWC improved with Hosp-CR and Home-CR and was unchanged with no CR . The improvement was similar in middle-aged and old persons but smaller , although still significant , in very old patients . TWC reverted toward baseline by 12 months with Hosp-CR but not with Home-CR . HRQL improved in middle-aged and old CR and control patients but only with CR in very old patients . Complications were similar across treatment and age groups . Costs were lower for Home-CR than for Hosp-CR . Conclusions —Post-MI Hosp-CR and Home-CR are similarly effective in the short term and improve TWC and HRQL in each age group . However , with lower costs and more prolonged positive effects , Home-CR may be the treatment of choice in low-risk older patients BACKGROUND Increases in life stress have been linked to poor prognosis , after myocardial infa rct ion ( MI ) . Previous research suggested that a programme of monthly screening for psychological distress , combined with supportive and educational home nursing interventions for distressed patients , may improve post-MI survival among men . Our study assessed this approach for both men and women . We aim ed to find out whether the programme would reduce 1-year cardiac mortality for women and men . METHODS We carried out a r and omised , controlled trial of 1376 post-MI patients ( 903 men , 473 women ) assigned to the intervention programme ( n = 692 ) or usual care ( n = 684 ) for 1 year . All patients completed a baseline interview that included assessment of depression and anxiety . Survivors were also interviewed at 1 year . FINDINGS The programme had no overall survival impact . Preplanned analyses showed higher cardiac ( 9.4 vs 5.0 % , p = 0.064 ) and all-cause mortality ( 10.3 vs 5.4 % , p = 0.051 ) among women in the intervention group . There was no evidence of either benefit or harm among men ( cardiac mortality 2.4 vs 2.5 % , p = 0.94 ; all-cause mortality 3.1 vs 3.1 % , p = 0.93 ) . The programme 's impact on depression and anxiety among survivors was small . INTERPRETATION Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI . The poorer overall outcome for women , and the possible harmful impact of the intervention on women , underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials BACKGROUND Participation in cardiac rehabilitation after acute myocardial infa rct ion is sub-optimal . Offering home-based rehabilitation may improve uptake . We report the first r and omized study of cardiac rehabilitation to include patient preference . AIM To compare the clinical effectiveness of a home-based rehabilitation with hospital-based rehabilitation after myocardial infa rct ion and to determine whether patient choice affects clinical outcomes . DESIGN Pragmatic r and omized controlled trial with patient preference arms . SETTING Rural South West Engl and . METHODS Patients admitted with uncomplicated myocardial infa rct ion were offered hospital-based rehabilitation classes over 8 - 10 weeks or a self-help package of six weeks ' duration ( the Heart Manual ) supported by a nurse . Primary outcomes at 9 months were mean depression and anxiety scores on the Hospital Anxiety Depression scale , quality of life after myocardial infa rct ion ( MacNew ) score and serum total cholesterol . RESULTS Of the 230 patients who agreed to participate , 104 ( 45 % ) consented to r and omization and 126 ( 55 % ) chose their rehabilitation programme . Nine month follow-up data were available for 84/104 ( 81 % ) r and omized and 100/126 ( 79 % ) preference patients . At follow-up no difference was seen in the change in mean depression scores between the r and omized home and hospital-based groups ( mean difference : 0 ; 95 % confidence interval , -1.12 to 1.12 ) nor mean anxiety score ( -0.07 ; -1.42 to 1.28 ) , mean global MacNew score ( 0.14 ; -0.35 to 0.62 ) and mean total cholesterol levels ( -0.18 ; -0.62 to 0.27 ) . Neither were there any significant differences in outcomes between the preference groups . CONCLUSIONS Home-based cardiac rehabilitation with the Heart Manual was as effective as hospital-based rehabilitation for patients after myocardial infa rct ion . Choosing a rehabilitation programme did not significantly affect clinical outcomes BACKGROUND Disease management programs ( DMPs ) that use multidisciplinary teams and specialized clinics reduce hospital admissions and improve quality of life and functional status . Evaluations of cardiac DMPs delivered by home health nurses are required . METHODS Between August 1999 and August 2000 we identified consecutive patients admitted to hospital with elevated cardiac enzymes . Patients who agreed were r and omly assigned to participate in a DMP or to receive usual care . The DMP included 6 home visits by a cardiac-trained nurse , a st and ardized nurses ' checklist , referral criteria for specialty care , communication with the family physician and patient education . We measured readmission days per 1000 follow-up days for angina , congestive heart failure ( CHF ) and chronic obstructive pulmonary disease ( COPD ) ; all-cause readmission days ; and provincial cl aims for emergency department visits , physician visits , diagnostic or therapeutic services and laboratory services . RESULTS We screened 715 consecutive patients admitted with elevated cardiac markers between August 1999 and August 2000 . Of those screened 71 DMP and 75 usual care patients met the diagnostic criteria for myocardial infa rct ion , were eligible for visits from a home health nurse and consented to participate in the study . Readmission days for angina , CHF and COPD per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( incidence density ratio [ IDR ] = 1.59 , 95 % confidence interval [ CI ] 1.27 - 2.00 , p < 0.001 ) . All-cause readmission days per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( IDR = 1.53 , 95 % CI 1.37 - 1.71 , p < 0.001 ) . The difference in emergency department encounters per 1000 follow-up days was significant ( IDR = 2.08 , 95 % CI 1.56 - 2.77 , p < 0.001 ) . During the first 25 days after discharge , there were significantly fewer provincial cl aims su bmi tted for DMP patients than for usual care patients for emergency department visits ( p = 0.007 ) , diagnostic or therapeutic services ( p = 0.012 ) and laboratory services ( p = 0.007 ) . INTERPRETATION The results provide evidence that an appropriately developed and implemented community-based inner-city DMP delivered by home health nurses has a positive impact on patient outcomes Background : Psychological morbidity after an acute myocardial infa rct ion ( AMI ) is known to be common , but can be addressed by appropriate rehabilitation . The area in which this research was conducted experiences high rates of deprivation and of coronary heart disease and limited access to hospital-based rehabilitation . Responding to concern about psychological needs of AMI patients , a self-help package was introduced and evaluated alongside st and ard hospital-based cardiac rehabilitation . Aims : To evaluate the impact of a home-based self-help package ( the Heart Manual ) , alongside existing cardiac rehabilitation provision , on psychological morbidity and health status after AMI . A secondary aim was to assess the suitability of the Heart Manual for older patients aged over 80 years . Methods : A controlled observational study , comparing two cohorts of patients discharged from hospital after AMI . The intervention group was given the self-help package in addition to st and ard care . The control group received st and ard care alone . Outcome measures used were the Hospital Anxiety and Depression Scale and the EuroQol . Results : The intervention group showed significant improvement in anxiety and depression scores after 3 months and nonsignificant improvement in general health status . Patients who attended hospital-based rehabilitation classes , and those aged over 80 years , also benefited from the intervention . Conclusion : A home-based self-help rehabilitation package is an effective tool alongside hospital-based rehabilitation classes and can be given to all age groups This prospect i ve study evaluated the effect of an individualized , comprehensive , home-based cardiac rehabilitation program combining exercise training with risk factor modification and psychosocial counseling on risk factors , psychological well-being , functional capacity , and work resumption in 99 post-percutaneous coronary interventions ( PCI ) patients r and omized to control ( st and ard care plus telephone follow-up , n=49 ) or intervention ( individualized , comprehensive , home-based cardiac rehabilitation , n=50 ) groups . Data were collected at time 1 ( T(1 ) ) during hospital admission , time 2 ( T(2 ) ) approximately 2 months post-PCI , and time 3 ( T(3 ) ) approximately 12 months post-PCI . Results suggest that the allocation to an individualized , comprehensive , home-based cardiac rehabilitation program provided more advantageous outcomes . At both follow-ups , the intervention group showed within-group improvement in serum cholesterol levels ( P<0.02 ; P<0.01 ) and exercise participation ( P<0.001 ; P<0.001 ) with differences in exercise participation favoring the intervention group ( P<0.01 ) at T(2 ) . Repeated measures ANOVA showed significant improvements over time in body mass index ( BMI ) ( P<0.01 ) , psychological well-being ( P<0.001 ) , and functional capacity ( P<0.001 ) for both groups . More patients in the intervention group had returned to work at T(2 ) ( P<0.001 ) and did so more quickly ( P<0.01 ) . These findings suggest that an individualized , comprehensive , home-based cardiac rehabilitation program improves risk factor profiles and work resumption patterns for patients following PCI BACKGROUND Previous reports indicate risk factors and lifestyle behaviors may deteriorate early after completion of a cardiac rehabilitation program ( CRP ) . We hypothesized that a modest risk factor and lifestyle management intervention after a CRP would significantly reduce overall cardiovascular risk using the Framingham risk score compared with usual care after 4 years . METHODS Patients with ischemic heart disease ( n = 302 ) were r and omized after a CRP to either usual care or intervention ( exercise sessions , telephone follow-ups , counseling sessions , and reports to the participants ' family physicians ) . The Framingham risk score , risk factors , and lifestyle behaviors were compared after 4 years . RESULTS Data were available for 130 intervention and 119 usual care participants . The intervention result ed in 15.5 hours of direct participant contact . Framingham score , total cholesterol , low-density lipoprotein cholesterol , and systolic blood pressure were significantly improved in the intervention group after adjusting for baseline factors . There were no significant differences with respect to lifestyle factors between the groups . CONCLUSIONS A modest risk factor and lifestyle management intervention result ed in a significant reduction to global risk compared with usual care and should be considered after CRP Background Home-based cardiac rehabilitation ( CR ) has been demonstrated to be as effective as institution-based CR in post-coronary artery bypass graft surgery ( CABG ) patients in terms of short-term physical and psychosocial outcomes . The sustainability of these effects is less well studied . The aim of this study was to examine the sustainability of observed changes in physical , quality of life ( HRQL ) , and social support ( SS ) outcomes in patients 12 months after discharge from a r and omized controlled trial ( RCT ) of 6 months of monitored home-based versus supervised hospital-based CR . Design Two-hundred and twenty-two ( n = 222 ) patients were followed-up 12 months after discharge from a RCT of 6 months of monitored ‘ Home ' versus supervised ‘ Hospital ' CR after CABG . Methods At discharge from the 6-month RCT , participants who consented to the 12-month follow-up study , were given individualized guidelines for ongoing exercise , and
Output:
| Comprehensive cardiac rehabilitation has positive effects on many cardiac risk factors ( physical activity , smoking status , cholesterol , anxiety and depression ) and can lead to improvements in mortality , morbidity and quality of life .
While there have been fewer studies of home-based cardiac rehabilitation , the available data suggest that it has comparable results to hospital-based programs .
Many of these studies are small and heterogeneous in terms of interventions but home-based cardiac rehabilitation appears both safe and effective .
Available evidence suggests that it results in longer lasting maintenance of physical activity levels compared with hospital-based rehabilitation and is equally effective in improving cardiac risk factors .
Furthermore , it has the potential to be a more cost-effective intervention for patients who can not easily access their local centre or hospital .
Currently home-based cardiac rehabilitation is not offered routinely to all patients but it appears to have the potential to increase uptake in patients who are unable , or less likely , to attend more traditional hospital-based cardiac rehabilitation programs |
MS211006 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background The study aim ed to determine the prognostic impact of clinical and pathological factors on survival among patients with small cell neuroendocrine carcinoma ( SNEC ) , adenocarcinoma ( ADC ) , and squamous cell carcinoma ( SCC ) . Methods Eligible participants were all patients with histologically confirmed cervical cancer treated at Chiang Mai University Hospital between 1995 and 2011 . We included all patients with SNEC and r and omly enrolled patients with ADC and SCC . We used competing-risk regression analysis to examine the risk of cancer-related death by histological type . Results We included 130 ( 6.2 % ) women with SNEC , 346 ( 16.4 % ) with ADC , and 1,632 ( 77.4 % ) with SCC . Age > 60 years ( hazard ratio [ HR ] 4.9 , 95 % confidence interval [ CI ] 2.0–12.0 ) and lymph node involvement ( HR 3.0 , 95 % CI 1.2–7.4 ) were prognostic factors among surgically-treated patients with SNEC . Deeper stromal invasion ( HR 3.6 , 95 % CI 1.6–8.3 ) was a prognostic factor in patients with SCC . In patients with advanced SNEC , age > 60 years had a strong prognostic impact ( HR 2.6 , 95 % CI 1.0–6.5 ) while the International Federation of Gynecology and Obstetrics stages III and IV were prognostic factors for patients with advanced stage ADC ( HR 2.9 , 95 % CI 2.0–4.4 and HR 4.5 , 95 % CI 2.6–7.9 , respectively ) and SCC ( HR 1.7 , 95 % CI 1.4–2.0 and HR 3.7 , 95 % CI 2.8–4.9 , respectively ) compared with the International Federation of Gynecology and Obstetrics stage IIB . Conclusion Clinical and pathological prognostic factors in cervical cancer differed according to histological type . Taking the important prognostic factors for each histological type into consideration may be beneficial for tailored treatment and follow-up planning BACKGROUND Clarifying the prognostic impact of histological type is an essential issue that may influence the treatment and follow-up planning of newly diagnosed cervical cancer cases . This study aim ed to evaluate the prognostic impact of histological type on survival and mortality in patients with cervical squamous cell carcinoma ( SCC ) , adenocarcinoma ( ADC ) and small cell neuroendocrine carcinoma ( SNEC ) . MATERIAL S AND METHODS All patients with cervical cancer diagnosed and treated at Chiang Mai University Hospital between January 1995 and October 2011 were eligible . We included all patients with SNEC and a r and om weighted sample of patients with SCC and ADC . We used competing-risks regression analysis to evaluate the association between histological type and cancer-specific survival and mortality . RESULTS Of all 2,108 patients , 1,632 ( 77.4 % ) had SCC , 346 ( 16.4 % ) had ADC and 130 ( 6.2 % ) had SNEC . Overall , five-year cancer-specific survival was 60.0 % , 54.7 % , and 48.4 % in patients with SCC , ADC and SNEC , respectively . After adjusting for other clinical and pathological factors , patients with SNEC and ADC had higher risk of cancer-related death compared with SCC patients ( hazard ratio [ HR ] 2.6 ; 95 % CI , 1.9 - 3.5 and HR 1.3 ; 95 % CI , 1.1 - 1.5 , respectively ) . Patients with SNEC were younger and had higher risk of cancer-related death in both early and advanced stages compared with SCC patients ( HR 4.9 ; 95 % CI , 2.7 - 9.1 and HR 2.5 ; 95 % CI , 1.7 - 3.5 , respectively ) . Those with advanced-stage ADC had a greater risk of cancer-related death ( HR 1.4 ; 95 % CI , 1.2 - 1.7 ) compared with those with advanced-stage SCC , while no significant difference was observed in patients with early stage lesions . CONCLUSION Histological type is an important prognostic factor among patients with cervical cancer in Thail and . Though patients with SNEC were younger and more often had a diagnosis of early stage compared with ADC and SCC , SNEC was associated with poorest survival . ADC was associated with poorer survival compared with SCC in advanced stages , while no difference was observed at early stages . Further tailored treatment-strategies and follow-up planning among patients with different histological types should be considered
Output:
| The effect of low TSR on poor OS was observed among various cancer types , but not in the early stage of cervical caner .
Subgroup analyses indicated that cancer type , clinical stage , study region , blinding status , and NOS score did not affect the prognostic value of TSR for DFS .
Moreover , low TSR was significantly correlated with the serious clinical stage , advanced depth of invasion , and positive lymph node metastasis .
These findings indicate that a high proportion of stroma in cancer tissue is associated with poor clinical outcomes in cancer patients , and TSR may serve as an independent prognostic factor for solid tumors |
MS211007 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVES This study aim ed to investigate the lifestyle habits-physical activity ( PA ) , eating habits ( EH ) , and sleep duration (SD)-of Omani adolescents , and to examine gender differences in such variables . METHODS 802 Omani adolescents ( 442 females and 360 males ) , aged 15 - 18 years were r and omly recruited . Anthropometric indices , PA level , and EH and SD were evaluated by the Arab Teenage Lifestyle question naire . A semi-quantitative food frequency question naire for dietary assessment was also administered . RESULTS The results showed that although the study subjects had a sedentary lifestyle ( lack of PA , average of 6.7 hours sleep , and consumption of high calorie foods ) , they maintained a normal body mass ( less than 25 Kg/m(2 ) ) . Males were more than twice as active as females . With respect to EH , there were few gender differences , except in dairy and meat consumption where 62.5 % and 55.5 % of males consumed more than 3 servings , respectively , compared to 18.78 % and 35.2 % of females , respectively . In addition , waist/height ratio , height , reasons for being active , energy drinks , potato consumption , eating sweets , vigorous PA and breakfast EHs were statistically significant independent predictors for BMI , P < 0.05 for both males and females . CONCLUSION This study revealed a high prevalence of sedentary behaviors and a low level of physical activity , especially among females . Unhealthy dietary habits were also widely found among both genders . There is an urgent need for more research as well as a national policy promoting active living and healthy eating and discouraging sedentary behaviour among Omani adolescents The aim of present study was to determine the prevalence of prehypertension and associated risk factors among young adult females in Dammam , Saudi Arabia . A cross-sectional study was conducted on a sample of about one-third of female students enrolled in 4 colleges of the University of Dammam . They were screened for high blood pressure and associated cardiovascular risk factors by an interview question naire . Weight and height , waist and hip and blood pressure measurements and r and om blood glucose testing were done . The results revealed that 13.5 % of the 370 students were prehypertensive . The most prevalent risk factor for cardiovascular diseases was physical inactivity ( 53.2 % ) , followed by overweight/obesity ( 29.1 % ) ; 16.3 % of prehypertensive students had 3 or more risk factors . Logistic regression analysis revealed that overweight/ obesity was the strongest predictor of prehypertension . Our study indicates a need for routine blood pressure measurements and risk assessment in young adult females in Saudi Arabia Background A better underst and ing of the relationships between obesity and lifestyle factors is necessary for effective prevention and management of obesity in youth . Therefore , the objective of this study was to evaluate the associations between obesity measures and several lifestyle factors , including physical activity , sedentary behaviors and dietary habits among Saudi adolescents aged 14–19 years . Methods This was a school-based cross-sectional study that was conducted in three cities in Saudi Arabia ( Al-Khobar , Jeddah and Riyadh ) . The participants were 2906 secondary school males ( 1400 ) and females ( 1506 ) aged 14–19 years , who were r and omly selected using a multistage stratified cluster sampling technique . Measurements included weight , height , body mass index ( BMI ) , waist circumference , waist/height ratio ( WHtR ) , screen time ( television viewing , video games and computer use ) , physical activity ( determined using a vali date d question naire ) , and dietary habits ( intake frequency per week ) . Logistic regression was used to examine the associations between obesity and lifestyle factors . Results Compared with non-obese , obese males and females were significantly less active , especially in terms of vigorous activity , had less favorable dietary habits ( e.g. , lower intake of breakfast , fruits and milk ) , but had lower intake of sugar-sweetened drinks and sweets/chocolates . Logistic regression analysis showed that overweight/obesity ( based on BMI categories ) or abdominal obesity ( based on WHtR categories ) were significantly and inversely associated with vigorous physical activity levels ( aOR for high level = 0.69 , 95 % CI 0.41–0.92 for BMI and 0.63 , 95 % CI 0.45–0.89 for WHtR ) and frequency of breakfast ( aOR for < 3 days/week = 1.44 ; 95 % CI 1.20–1.71 for BMI and 1.47 ; 95 % CI 1.22–1.76 for WHtR ) and vegetable ( aOR for < 3 days/week = 1.29 ; 95 % CI 1.03–1.59 for WHtR ) intakes , and consumption of sugar-sweetened beverages ( aOR for < 3 days/week = 1.32 ; 95 % CI 1.08–1.62 for BMI and 1.42 ; 95 % CI 1.16–1.75 for WHtR ) . Conclusions The present study identified several lifestyle factors associated with obesity that may represent valid targets for the prevention and management of obesity among Saudi adolescents . Primary prevention of obesity by promoting active lifestyles and healthy diets should be a national public health priority OBJECTIVE To investigate the virtual importance of identified barriers to preventive interventions and to explore the association between physicians ' characteristics and their attitudes towards prevention . METHODS We conducted a cross-sectional survey of 182 r and omly selected family and general physicians ( 164/182=90 % response rate ) from total of 385 general physicians from 5 health sectors of Riyadh , Kingdom of Saudi Arabia in 2005 . A pre-tested question naire asking physicians to rate the general importance of 8 preventive health strategies was used . RESULTS The ranking of different preventive intervention varies from 124 ( 75.6 % ) for colorectal cancer screening to 155 ( 94.5 % ) for blood pressure control . Lack of time was rated an important barrier by 100 ( 61 % ) physicians , and lack of patient interest by 125 ( 76.2 % ) of physicians . There were 4 characteristics of physicians , which predicted negative attitudes toward prevention , sedentary lifestyle ( odds ratio [ OR ] = 3.4 , 95 % confidence interval [ CI ] , 1.1 - 11.1 ) , lack of awareness of their own blood pressure ( OR = 2.0 , 95 % CI , 1.0 - 3.9 ) , lack of training ( OR=2.2 , 95 % CI , 1.5 - 2.9 ) , and lack of evidence of benefits ( OR=1.98 , 95 % CI , 1.7 - 3.9 ) . CONCLUSION The influence of physicians ' own health behaviors and the importance of preventive intervention barriers , indicates a need for development of an approach to reduce the dominance of risky behavior OBJECTIVES To describe the physical activity profile of Saudi adults living in Riyadh , using the International Physical Activity Question naire ( IPAQ ) short-version telephone format . METHODS Physical activity was assessed using the official Arabic short form of IPAQ , intended for use in telephone interview . The instrument asks for times spent in walking , moderate- and vigorous-intensity physical activity of at least 10 min duration . The sample consisted of 1616 Saudis , between 15 and 78 years of age , living in Riyadh . Participants were drawn from a list of names in the telephone book using a simple r and om method . Telephone interviews were administered during the spring of 2003 by trained male interviewers . RESULTS The final sample size was 1064 Saudi males and females ( response rate of 66 % ) , with males comprising about 66 % of the respondents . Over 43 % of Saudis did not participate in any type of moderate-intensity physical activity lasting for at least 10 min . More than 72 % of the sample did not engage in any type of vigorous-intensity physical activity lasting for at least 10 min . The proportion of Saudis who walked for 150 min or more per week was 33.3 % . Females were engaged more in moderate physical activity than males , whereas males participated more in vigorous activity compared with females . Activity levels did not show significant relationships with education level or job hours per week . Based on the three activity categories established by IPAQ , 40.6 % of Saudis were inactive , 34.3 % were minimally active and 25.1 % were physically active . Physical inactivity increased with advancing age . CONCLUSION The data suggest that the prevalence of physical inactivity among Saudis adults is relatively high . Efforts are needed to encourage Saudis to be more physically active , with the goal of increasing the proportion of Saudis engaging in health-enhancing physical activity OBJECTIVE To assess the patterns and determinants of physical activity among Saudi adult males living in Riyadh . METHODS Self-administered question naires were filled out by 1333 r and omly selected Saudi males 19 years and older , during the Fall of 1996 . RESULTS Over 53 % of Saudi males were totally physically inactive , and another 27.5 % were irregularly active . Only 19 % of the entire sample were active on a regular basis . A curvilinear relationship was found between age and inactivity , with the middle age group the least active . Physical activity was lower among those who were married , work in the private sectors , working 2 shifts , less educated , or who had only one day off during the week . Time constraint seems to be the major contributing factor to inactivity , while maintaining health and losing weight were the most important reason for being physically active among Saudi males . CONCLUSION The proportion of Saudi males who are at risk for inactivity is very high . Indeed , it is exceedingly higher than those who are at risk for hypertension , hypercholesterolemia , obesity , or cigarette smoking . Public policies are needed to encourage active living and discourage sedentary habits . Health care providers have an important role in promoting physical activity among the population Background : The high prevalence of physical inactivity in Saudi Arabia is a growing challenge to public health . This study aim ed to examine the prevalence of physical activity ( PA ) and associated factors among female university students . Methods : This cross-sectional study involved 663 r and omly selected female university students who completed the Arab Teens Life Style question naire . Data included measurements of anthropometric , socioeconomic and environmental factors , as well as self-reported PA . Ordinal regression was used to identify associated factors with low , moderate and high PA levels . Results : The mean age of participants was 20.4 years ( SD 1.5 ) . Mean BMI of the students in relation to PA were 23.0 , 22.9 , 22.1 for high , moderate and low levels of activity , respectively . The analysis revealed significantly higher PA levels among married students , those with high educated mothers , and those who lived far from parks , and lower activity levels among underweight students . Conclusions : This study raises four important determinants for female university students ’ PA levels . These factors could be of great importance in the endeavor to prevent the health-threatening increase in physical inactivity patterns and thus non-communicable diseases and obesity where the focus should be on the specific situation and needs of women in Saudi Arabia 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 This study investigated the cross-cultural differences and similarity in health behaviors between Saudi and British adolescents . A school-based cross-sectional study was conducted at four cities in Saudi Arabia ( Riyadh and Al-Khobar ; N = 1,648 ) and Britain ( Birmingham and Coventry ; N = 1,158 ) . The participants ( 14–18 year-olds ) were r and omly selected using a multistage stratified cluster sampling technique . Measurements included anthropometric , screen time , vali date d physical activity ( PA ) question naire and dietary habits . The overweight/obesity prevalence among Saudi adolescents ( 38.3 % ) was significantly ( p < 0.001 ) higher than that found among British adolescents ( 24.1 % ) . The British adolescents demonstrated higher total PA energy expenditure than Saudi adolescents ( means ± SE = 3,804.8 ± 81.5 vs. 2,219.9 ± 65.5 METs-min/week ) . Inactivity prevalence was significantly ( p < 0.001 ) higher among Saudi adolescents ( 64 % ) compared with that of British adolescents ( 25.5 % ) . The proportions of adolescents exceeding 2 h of daily screen time were high ( 88.0 % and 90.8 % among Saudis and British , respectively ) . The majority of Saudi and British adolescents did not have daily intakes of breakfast , fruit , vegetables and milk . MANCOVA showed significant ( p < 0.05 ) gender by country interactions in several lifestyle factors . There was a significant ( p < 0.001 ) gender differences in the ratio of physical activity to sedentary behaviors . In conclusion , Saudi and British adolescents demonstrated some similarities and differences in their PA levels , sedentary behaviors
Output:
| Correlates demonstrated expected associations with health outcomes , low levels of physical activity ( particularly among young people ) , high levels of sedentary behaviour ( particularly among men and young people ) and expected associations of known correlates ( e.g. gender , age , education , time , self-motivation , social support , and access ) . |
MS211008 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Active participation in the medical consultation has been demonstrated to benefit aspects of patients ’ subsequent psychological well-being . We investigated two interventions promoting patient question -asking behaviour . The first was a question prompt sheet provided before the consultation , which was endorsed and worked through by the clinician . The second was a face to face coaching session exploring the benefits of , and barriers to , question -asking , followed by coaching in question -asking behaviour employing rehearsal techniques . Sixty patients with heterogeneous cancers , seeing two medical oncologists for the first time , were r and omly assigned to one of three groups : two intervention groups and one control group . Sociodemographic variables and anxiety were assessed prior to the intervention which preceded the consultation . The consultations were audiotaped and subsequently analysed for question -asking behaviour . Anxiety was assessed again immediately following the consultation . Question naires to assess patient satisfaction , anxiety and psychological adjustment were sent by mail 2 weeks following the consultation . Presentation and discussion of the prompt sheet significantly increased the total number of questions asked and the number of questions asked regarding tests and treatment . Coaching did not add significantly to the effects of the prompt sheet . Psychological outcomes were not different among the groups . We conclude that a question prompt sheet addressed by the doctor is a simple , inexpensive and effective means of promoting patient question asking in the cancer consultation Patient participation in medical consultations has been demonstrated to benefit their subsequent psychological well being . Question asking is one way in which patients can be active . We investigated 2 means of promoting cancer patient question asking . One was the provision of a question prompt sheet to patients prior to their initial consultation with their oncologist . The second was the active endorsement and systematic review of the question prompt sheet by their oncologist . 318 patients with heterogeneous cancers , seeing one of 5 medical and 4 radiation oncologists for the first time , were r and omised to either receive or not receive a question prompt sheet . Doctors were r and omised to either proactively address or passively respond to the question prompt sheet in the subsequent consultation . Anxiety was assessed prior to the consultation . Consultations were audiotaped and content analysed . Anxiety was assessed again immediately following the consultation . Within the next 10 days patients completed question naires assessing information needs , anxiety and satisfaction and were given a structured telephone interview assessing information recall . Patients provided with a question prompt sheet asked more questions about prognosis compared with controls and oncologists gave significantly more prognostic information to these patients . Provision of the question prompt sheet prolonged consultations and increased patient anxiety ; however , when oncologists specifically addressed the prompt sheet , anxiety levels were significantly reduced , consultation duration was decreased and recall was significantly improved . A patient question prompt sheet , used proactively by the doctor , is a powerful addition to the oncology consultation . © 2001 Cancer Research Campaign BACKGROUND The aims of this study were to ( i ) conceptualize dimensions of a good death in Japanese cancer care , ( ii ) clarify the relative importance of each component of a good death and ( iii ) explore factors related to an individual 's perception of the domains of a good death . METHODS The general population was sample d using a stratified r and om sampling method ( n = 2548 ; response rate , 51 % ) and bereaved families from 12 certified palliative care units were surveyed as well ( n = 513 ; 70 % ) . We asked the subjects about the relative importance of 57 components of a good death . RESULTS Explanatory factor analysis demonstrated 18 domains contributing to a good death . Ten domains were classified as ' consistently important domains ' , including ' physical and psychological comfort ' , ' dying in a favorite place ' , ' good relationship with medical staff ' , ' maintaining hope and pleasure ' , ' not being a burden to others ' , ' good relationship with family ' , ' physical and cognitive control ' , ' environmental comfort ' , ' being respected as an individual ' and ' life completion ' . CONCLUSIONS We quantitatively identified 18 important domains that contribute to a good death in Japanese cancer care . The next step of our work should be to conduct a national survey to identify what is required to achieve a good death BACKGROUND Active participation and asking questions are important ways in which patients can ensure they underst and what the doctor has said . This study evaluated a question prompt sheet design ed to encourage patients to ask questions in the cancer consultation . PATIENTS AND METHODS Patients ( n = 142 ) were r and omised to receive ( i ) a question prompt sheet or ( ii ) a general sheet informing patients of services available through the regional Cancer Council . Recall of information was assessed in a structured interview 4 - 20 days after the consultation . Question naires to assess patient satisfaction and adjustment to cancer were sent by mail . RESULTS The question prompt sheet had a significant effect in one content area : prognosis . Thirty-five percent of patients who received the question h and out asked questions about prognosis compared to 16 % of those receiving the information h and out . The prompt sheet did not increase the mean number of questions asked overall . Age , in/out-patient status , gender and involvement preference were predictive of both number and duration of patient questions . CONCLUSIONS A question prompt sheet has a limited but important effect on patient question asking behaviour in the cancer consultation PURPOSE This study evaluated a cancer consultation preparation package ( CCPP ) design ed to facilitate patient involvement in the oncology consultation . PATIENTS AND METHODS A total of 164 cancer patients ( 67 % response rate ) were r and omly assigned to receive the CCPP or a control booklet at least 48 hours before their first oncology appointment . The CCPP included a question prompt sheet , booklets on clinical decision making and patient rights , and an introduction to the clinic . The control booklet contained only the introduction to the clinic . Physicians were blinded to which intervention patients received . Patients completed question naires immediately after the consultation and 1 month later . Consultations were audiotaped , transcribed verbatim , and coded . RESULTS All but one patient read the information . Before the consultation , intervention patients were significantly more anxious than were controls ( mean , 42 v 38 ; P = .04 ) ; however anxiety was equivalent at follow-up . The CCPP was reported as being significantly more useful to family members than the control booklet ( P = .004 ) . Patients receiving the intervention asked significantly more questions ( 11 v seven questions ; P = .005 ) , tended to interrupt the physician more ( 1.01 v 0.71 interruptions ; P = .08 ) , and challenged information significantly more often ( twice v once ; P = .05 ) . Patients receiving the CCPP were less likely to achieve their preferred decision making style ( 22 % ) than were controls ( 35 % ; P = .06 ) . CONCLUSION This CCPP influences patients ' consultation behavior and does not increase anxiety in the long-term . However , this intervention , without physician endorsement , reduced the percentage of patients whose preferred involvement in decision making was achieved
Output:
| The findings in this review suggest that patient preferences with regard to the communication of bad news by physicians consist of four components : setting , manner of communicating bad news , what and how much information is provided and emotional support , and that patients ' preferences are associated with demographic factors .
Younger patients , female patients and more highly educated patients consistently expressed a desire to receive as much detailed information as possible and to receive emotional support .
Asian patients were shown to prefer that relatives be present when receiving bad news more than Westerners do and to prefer to discuss their life expectancy less than Westerners . |
MS211009 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Part of a series of studies into early detection in adolescent suicide , this study investigated relationships between parenting style and suicidal thoughts , acts and depression . Students ( mean age 15 years ) from 4 r and omly chosen high schools completed self‐report question naires containing the Parental Bonding Instrument ( PBI ) and the Youth Self Report , which provided information about suicide ideation , deliberate self‐harm and depression . Significant differences for mean scores on the PBI subscales were noted between cases and noncases of depression , suicidal thoughts and deliberate self‐harm . Assignment by adolescents of their parents to the “ affectionless control ” quadrant of the PBI doubles the relative risk for suicidal thoughts , increases the relative risk for deliberate self‐harm 3‐fold and increases the relative risk for depression 5‐fold . It seems that the PBI may play a role in identification of vulnerable adolescents ; further , it both eluci date s aspects of adolescent‐parent interaction and points toward areas for intervention with at‐risk adolescents . We recommend the use of the PBI in early detection studies of adolescent suicide 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 OBJECTIVE To investigate the prospect i ve influence of individual adolescents ' sensation seeking tendency and the sensation seeking tendency of named peers on the use of alcohol and marijuana , controlling for a variety of interpersonal and attitudinal risk and protective factors . METHOD Data were collected from a cohort of adolescents ( N = 428 ; 60 % female ) at three points in time , starting in the eighth grade . Respondents provided information about sensation seeking , the positivity of family relations , attitudes toward alcohol and drug use , perceptions of their friends ' use of alcohol and marijuana , perceptions of influence by their friends to use alcohol and marijuana , and their own use of alcohol and marijuana . In addition , they named up to three peers , whose sensation seeking and use data were integrated with respondents ' data to allow for tests of hypotheses about peer clustering and substance use . RESULTS Structural equation modeling analyses revealed direct effects of peers ' sensation seeking on adolescents ' own use of both marijuana and alcohol 2 years later . An unexpected finding was that the individual 's own sensation seeking had indirect ( not direct ) effects on drug use 2 years later . CONCLUSIONS These findings indicate the potential importance of sensation seeking as a characteristic on which adolescent peers cluster . Furthermore , the findings indicate that , beyond the influence of a variety of other risk factors , peer sensation seeking contributes to adolescents ' substance use OBJECTIVE To identify which specific parenting behaviors are associated with the onset of alcohol and tobacco use and how they are associated . DESIGN Prospect i ve cohort study of two groups of preadolescents surveyed annually , the first group for 4 years , the second for 3 years . SETTING Two public school districts in Southern California . SUBJECTS 1034 fifth grade rs and 1266 seventh grade rs began the study after obtaining parental consent to complete surveys in a classroom setting . By the last measurement , attrition was 37 and 38 % for the two cohorts , respectively . MAIN OUTCOME MEASURES The onset of tobacco or alcohol use in the last month . RESULTS Children who reported that parents spent more time with them and communicated with them more frequently had lower onset rates of using alcohol and tobacco in the last month . These parental interactions lead to more positive relationships with their children . Parental monitoring and positive relations were protective factors for disruptive behavior and the selection of substance-using friends . Disruptive behavior increased the odds of adolescents drinking in the last month approximately twofold and of smoking in the last month two to fourfold . CONCLUSIONS This study provides further evidence that parenting behaviors are significant precursors to adolescent disruptive behavior , vulnerability to peer pressure , and subsequent substance use . Parents should be targeted in future substance use prevention programs , before their children reach adolescence OBJECTIVE Various studies reported associations between age
Output:
| Conclusions We found weak evidence for a prospect i ve association between the PCR and adolescent alcohol use . |
MS211010 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE : To compare the risks of short-term and long-term use of an etonogestrel-containing and ethinylestradiol-containing vaginal ring and combined oral contraceptive pills ( OCPs ) in a routine clinical study population . METHODS : This was a prospect i ve , controlled , noninterventional cohort study performed in the United States and five European countries with the following two cohorts : new users of the vaginal ring and new users of combined OCPs ( starters , switchers , or restarters ) . The study population included 33,295 users of the vaginal ring or combined OCPs recruited by 1,661 study centers . Follow-up of study participants occurred for 2 to 4 years . Main clinical outcomes of interest were cardiovascular outcomes , particularly venous and arterial thromboembolism . These outcomes were vali date d by attending physicians and further adjudicated by an independent board . Comprehensive follow-up ensured low loss to follow-up . Statistical analyses were based on Cox regression models . Primary statistical variable was the venous thromboembolic hazard ratio ( HR ) for the vaginal ring compared with combined OCPs . RESULTS : Study participants were followed-up for 66,489 woman-years . Loss to follow-up was 2.9 % . The venous thromboembolism incidence rates for the vaginal ring users and combined OCPs users were 8.3 and 9.2 per 10,000 woman-years , respectively . Cox regression analysis yielded crude and adjusted HRs for the vaginal ring users compared with combined OCPs users of 0.9 and 0.8 for venous thromboembolism ( 95 % confidence intervals [ CIs ] 0.5–1.6 and 0.5–1.5 ) and 0.8 and 0.7 ( 95 % CIs 0.2–2.5 and 0.2–2.3 ) for arterial thromboembolism , respectively . CONCLUSION : Vaginal ring use and combined OCP use were associated with a similar venous and arterial thromboembolic risk during routine clinical use . LEVEL OF EVIDENCE : OBJECTIVE The antidiabetic properties of metformin are mediated through its ability to activate the AMP-activated protein kinase ( AMPK ) . Activation of AMPK can suppress tumor formation and inhibit cell growth in addition to lowering blood glucose levels . We tested the hypothesis that metformin reduces the risk of cancer in people with type 2 diabetes . RESEARCH DESIGN AND METHODS In an observational cohort study using record-linkage data bases and based in Tayside , Scotl and , U.K. , we identified people with type 2 diabetes who were new users of metformin in 1994–2003 . We also identified a set of diabetic comparators , individually matched to the metformin users by year of diabetes diagnosis , who had never used metformin . In a survival analysis we calculated hazard ratios for diagnosis of cancer , adjusted for baseline characteristics of the two groups using Cox regression . RESULTS Cancer was diagnosed among 7.3 % of 4,085 metformin users compared with 11.6 % of 4,085 comparators , with median times to cancer of 3.5 and 2.6 years , respectively ( P < 0.001 ) . The unadjusted hazard ratio ( 95 % CI ) for cancer was 0.46 ( 0.40–0.53 ) . After adjusting for sex , age , BMI , A1C , deprivation , smoking , and other drug use , there was still a significantly reduced risk of cancer associated with metformin : 0.63 ( 0.53–0.75 ) . CONCLUSIONS These results suggest that metformin use may be associated with a reduced risk of cancer . A r and omized trial is needed to assess whether metformin is protective in a population at high risk for cancer There is growing evidence that patients with type 2 diabetes mellitus have increased cancer risk . We examined the association between diabetes , cancer , and cancer-related mortality and hypothesized that insulin sensitizers lower cancer-related mortality . Participants in the Diabetes Cardiovascular Risk and Evaluation : Targets and Essential Data for Commitment of Treatment study , a nationwide cross-sectional and prospect i ve epidemiological study , were recruited from German primary care practice s. In the cross-sectional study , subjects with type 2 diabetes mellitus had a higher prevalence of malignancies ( 66/1308 , 5.1 % ) compared to nondiabetic subjects ( 185/6211 , 3.0 % ) ( odds ratio , 1.64 ; 95 % confidence interval , 1.12 - 2.41 ) before and after adjustment for age , sex , hemoglobin A(1c ) , smoking status , and body mass index . Patients on metformin had a lower prevalence of malignancies , comparable with that among nondiabetic patients , whereas those on any other oral combination treatment had a 2-fold higher risk for malignancies even after adjusting for possible confounders ; inclusion of metformin in these regimens decreased the prevalence of malignancies . In the prospect i ve analyses , diabetic patients in general and diabetic patients treated with insulin ( either as monotherapy or in combination with other treatments ) had a 2- and 4-fold , respectively , higher mortality rate than nondiabetic patients , even after adjustment for potential confounders ( incidence of cancer deaths in patients with type 2 diabetes mellitus [ 2.6 % ] vs the incidence of cancer deaths in patients without type 2 diabetes mellitus [ 1.2 % ] ) . Our results suggest that diabetes and medications for diabetes , with the exception of the insulin sensitizer metformin , increase cancer risk and mortality Background : Experimental studies have suggested that metformin may decrease the incidence of colorectal cancer in patients with type II diabetes . However , previous observational studies have reported contradictory results , which are likely due to important method ologic limitations . Thus , the objective of this study was to assess whether the use of metformin is associated with the incidence of colorectal cancer in patients with type II diabetes . Methods : A cohort study of patients newly treated with non-insulin antidiabetic agents was assembled using the United Kingdom Clinical Practice Research Data link . A nested case – control analysis was conducted , where all incident cases of colorectal cancer occurring during follow-up were identified and r and omly matched with up to 10 controls . Conditional logistic regression was used to estimate adjusted rate ratios ( RR ) of colorectal cancer associated with ever use , and cumulative duration of use of metformin . All models accounted for latency and were adjusted for relevant potential confounding factors . Results : Overall , ever use of metformin was not associated with the incidence of colorectal cancer [ RR : 0.93 ; 95 % confidence interval ( CI ) , 0.73–1.18 ] . Similarly , no dose – response relationship was observed in terms of cumulative duration of use . Conclusions : The use of metformin was not associated with the incidence of colorectal cancer in patients with type II diabetes . Impact : The results of this study do not support the launch of metformin r and omized controlled trials for the chemoprevention of colorectal cancer . Cancer Epidemiol Biomarkers Prev ; 22(10 ) ; 1877–83 . © 2013 AACR Aims /hypothesis Studies on the link between diabetes and bladder cancer in Asians are rare . We investigated the association between diabetes and incidence of bladder cancer by using a large national insurance data base . Methods A r and om sample of 1,000,000 individuals covered by the National Health Insurance was recruited . A total of 495,199 men and 503,748 women for all ages and 187,609 men and 189,762 women ≥40 years old and without bladder cancer at recruitment were followed from 2003 to 2005 . Cox regression evaluated the adjusted relative risk for all ages and for age ≥40 years old . Results The results were similar for all ages and for age ≥40 years . In Cox models , patients with diabetes consistently showed a significantly higher relative risk ranging from 1.36 to 1.51 after adjustment for age , sex and other potential confounders . Age , male sex , nephropathy , urinary tract diseases ( infection and stone ) and statin use were associated with bladder cancer , but occupation , hypertension , stroke , ischaemic heart disease , peripheral arterial disease , eye disease , dyslipidaemia and medications ( oral glucose-lowering agents including sulfonylurea , metformin , acarbose and thiazolidinediones , insulin , fibrates , ACE inhibitors/angiotensin receptor blockers and calcium channel blockers ) were not . Chronic obstructive pulmonary disease and living in regions other than Metropolitan Taipei were associated with lower risk . Conclusions Patients with diabetes have a higher risk of bladder cancer . The association with urinary tract diseases suggests a complex scenario in the link between bladder cancer and diabetes at different disease stages INTRODUCTION The prevalence of type 2 diabetes in Thail and is 9.8 percent which is double the number forecast by World Health Organization . There is inadequate information to statistically represent all Thai diabetic patients for their causes of death . OBJECTIVE To determine the clinical characteristics that predicted death and causes of death in Thai diabetic patients . MATERIAL AND METHOD This prospect i ve cohort was a 3-year follow-up study of the Thai Diabetes Registry project done between April , 2003 , and February , 2006 , which registered 9,419 diabetic patients attending 11 diabetic clinics in tertiary medical centers in Bangkok and major provinces of Thail and . The dead or alive status ( 99.5 % ) was determined . The causes of death were defined by review ing the medical records . RESULTS Of the 9,370 diabetic patients registered , 425 patients died , 1.84 percent per year . There was an increased risk of death associated with age , type of healthcare plan , lower education , insulin use , smoking , history of coronary artery disease and cerebrovascular disease , serum creatinine and high HbA1c . Lipid-lowering medication and metformin decreased the risk of death . Cardiovascular disease , infection and cancer were the prevalent causes of death . CONCLUSION The present study showed risk factors that influenced death and causes of death in Thai diabetics BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases
Output:
| The apparent reductions in all-cause mortality and diseases of ageing associated with metformin use suggest that metformin could be extending life and healthspans by acting as a geroprotective agent |
MS211011 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE Little is known about the effectiveness of advance care planning in the United Kingdom , although policy documents recommend that it should be available to all those with life-limiting illness . METHOD An exploratory patient preference r and omized controlled trial of advance care planning discussion s with an independent mediator ( maximum three sessions ) was conducted in London outpatient oncology clinics and a nearby hospice . Seventy-seven patients ( mean age 62 years , 39 male ) with various forms of recurrent progressive cancer participated , and 68 ( 88 % ) completed follow-up at 8 weeks . Patients completed visual analogue scales assessing perceived ability to discuss end-of-life planning with healthcare professionals or family and friends ( primary outcome ) , happiness with the level of communication , and satisfaction with care , as well as a st and ardized measure of anxiety and depression . RESULTS Thirty-eight patients ( 51 % ) showed preference for the intervention . Discussion s with professionals or family and friends about the future increased in the intervention arms , whether r and omized or preference , but happiness with communication was unchanged or worse , and satisfaction with services decreased . Trial participation did not cause significant anxiety or depression and attrition was low . SIGNIFICANCE OF RESULTS A r and omized trial of advance care planning is possible . This study provides new evidence on its acceptability and effectiveness for patients with advanced cancer PURPOSE Decision making regarding cardiopulmonary resuscitation ( CPR ) is challenging . This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer . PATIENTS AND METHODS We performed a r and omized controlled trial of 150 patients with advanced cancer from four oncology centers . Participants in the control arm ( n = 80 ) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation . Participants in the intervention arm ( n = 70 ) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient . The primary outcome was participants ' preference for or against CPR measured immediately after exposure to either modality . Secondary outcomes were participants ' knowledge of CPR ( score range of 0 to 4 , with higher score indicating more knowledge ) and comfort with video . RESULTS The mean age of participants was 62 years ( st and ard deviation , 11 years ) ; 49 % were women , 44 % were African American or Latino , and 47 % had lung or colon cancer . After the verbal narrative , in the control arm , 38 participants ( 48 % ) wanted CPR , 41 ( 51 % ) wanted no CPR , and one ( 1 % ) was uncertain . In contrast , in the intervention arm , 14 participants ( 20 % ) wanted CPR , 55 ( 79 % ) wanted no CPR , and 1 ( 1 % ) was uncertain ( unadjusted odds ratio , 3.5 ; 95 % CI , 1.7 to 7.2 ; P < .001 ) . Mean knowledge scores were higher in the intervention arm than in the control arm ( 3.3 ± 1.0 v 2.6 ± 1.3 , respectively ; P < .001 ) , and 65 participants ( 93 % ) in the intervention arm were comfortable watching the video . CONCLUSION Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative Background The Medical Research Councils ’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation . Although the framework does include broad guidance on the use of theory , it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach . A prospect i ve , theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective , sustainable and scalable . Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool , Theory of Change ( ToC ) , into the MRC framework for complex interventions . We provide a guide to what ToC is , how to construct one , and how to integrate its use into research projects seeking to design , implement and evaluate complex interventions using the MRC framework . We test this approach by using ToC within two r and omized controlled trials and one non-r and omized evaluation of complex interventions . Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework . It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly design ing an intervention that is embedded in the local context . For the feasibility and piloting stage , ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design . ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact , combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework . Conclusions Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions , thereby increasing the likelihood that the intervention will be ultimately effective , sustainable and scalable . We urge research ers developing and evaluating complex interventions to consider using this approach , to evaluate its usefulness and to build an evidence base to further refine the methodology .Trial registration Clinical trials.gov : PURPOSE To determine whether the use of a goals -of-care video to supplement a verbal description can improve end-of-life decision making for patients with cancer . METHODS Fifty participants with malignant glioma were r and omly assigned to either a verbal narrative of goals -of-care options at the end of life ( control ) , or a video after the same verbal narrative ( intervention ) in this r and omized controlled trial . The video depicts three levels of medical care : life-prolonging care ( cardiopulmonary resuscitation [ CPR ] , ventilation ) , basic care ( hospitalization , no CPR ) , and comfort care ( symptom relief ) . The primary study outcome was participants ' preferences for end-of-life care . The secondary outcome was participants ' uncertainty regarding decision making ( score range , 3 to 15 ; higher score indicating less uncertainty ) . Participants ' comfort level with the video was also measured . RESULTS Fifty participants were r and omly assigned to either the verbal narrative ( n = 27 ) or video ( n = 23 ) . After the verbal description , 25.9 % of participants preferred life-prolonging care , 51.9 % basic care , and 22.2 % comfort care . In the video arm , no participants preferred life-prolonging care , 4.4 % preferred basic care , 91.3 % preferred comfort care , and 4.4 % were uncertain ( P < .0001 ) . The mean uncertainty score was higher in the video group than in the verbal group ( 13.7 v 11.5 , respectively ; P < .002 ) . In the intervention arm , 82.6 % of participants reported being very comfortable watching the video . CONCLUSION Compared with participants who only heard a verbal description , participants who viewed a goals -of-care video were more likely to prefer comfort care and avoid CPR , and were more certain of their end-of-life decision making . Participants reported feeling comfortable watching the video Objective To investigate the impact of advance care planning on end of life care in elderly patients . Design Prospect i ve r and omised controlled trial . Setting Single centre study in a university hospital in Melbourne , Australia . Participants 309 legally competent medical in patients aged 80 or more and followed for six months or until death . Interventions Participants were r and omised to receive usual care or usual care plus facilitated advance care planning . Advance care planning aim ed to assist patients to reflect on their goals , values , and beliefs ; to consider future medical treatment preferences ; to appoint a surrogate ; and to document their wishes . Main outcome measures The primary outcome was whether a patient ’s end of life wishes were known and respected . Other outcomes included patient and family satisfaction with hospital stay and levels of stress , anxiety , and depression in relatives of patients who died . Results 154 of the 309 patients were r and omised to advance care planning , 125 ( 81 % ) received advance care planning , and 108 ( 84 % ) expressed wishes or appointed a surrogate , or both . Of the 56 patients who died by six months , end of life wishes were much more likely to be known and followed in the intervention group ( 25/29 , 86 % ) compared with the control group ( 8/27 , 30 % ; P<0.001 ) . In the intervention group , family members of patients who died had significantly less stress ( intervention 5 , control 15 ; P<0.001 ) , anxiety ( intervention 0 , control 3 ; P=0.02 ) , and depression ( intervention 0 , control 5 ; P=0.002 ) than those of the control patients . Patient and family satisfaction was higher in the intervention group . Conclusions Advance care planning improves end of life care and patient and family satisfaction and reduces stress , anxiety , and depression in surviving relatives . Trial registration Australian New Zeal and clinical trials registry ACTRN12608000539336 BACKGROUND Cardiopulmonary resuscitation ( CPR ) is an important advance directive ( AD ) topic in patients with progressive cancer ; however such discussion s are challenging . OBJECTIVE This study investigates whether video educational information about CPR engenders broader advance care planning ( ACP ) discourse . METHODS Patients with progressive pancreas or hepatobiliary cancer were r and omized to an educational CPR video or a similar CPR narrative . The primary end-point was the difference in ACP documentation one month posttest between arms . Secondary end-points included study impressions ; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation ; and longitudinal patient outcomes . RESULTS Fifty-six subjects were consented and analyzed . Rates of ACP documentation ( either formal ADs or documented discussion s ) were 40 % in the video arm ( 12/30 ) compared to 15 % in the narrative arm ( 4/26 ) , OR=3.6 [ 95 % CI : 0.9 - 18.0 ] , p=0.07 . Post-intervention knowledge was higher in both arms . Posttest , preferences for CPR had changed in the video arm but not in the narrative arm . Preferences regarding mechanical ventilation did not change in either arm . The majority of subjects in both arms reported the information as helpful and comfortable to discuss , and they recommended it to others . More deaths occurred in the video arm compared to the narrative arm , and more subjects died in hospice setting s in the video arm . CONCLUSIONS This pilot r and omized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects . This trend , as well as other video effects , is the subject of ongoing study BACKGROUND Advance Care Planning ( ACP ) is a systematic approach to ensure that effective advance directives ( ADs ) are developed and respected . We studied the effects of implementing a regional ACP program in Germany . METHODS In a prospect i ve , inter-regionally controlled trial focusing on nursing homes ( n/hs ) , we compared the number , relevance and validity of new ADs completed in the intervention region versus the control region . Intervention n/h residents and their families were offered professional facilitation including st and ardized documentation . RESULTS Data from 136 residents of three intervention n/hs were compared with data from 439 residents of 10 control n/hs over a study period of 16.5 months . In the intervention region , 49 ( 36.0 % ) participating residents completed a new AD over the period of the study , compared to 18 ( 4.1 % ) in the control region ; these ADs included 30 ADs by proxy in the intervention region versus 10 in the control region . Proxies were design ated in 94.7 % versus 50.0 % of cases , the AD was signed by a physician in 93.9 % versus 16.7 % , and an emergency order was included in 98.0 % versus 44.4 % . Resuscitation status was addressed in 95.9 % versus 38.9 % of cases ( p<0.01 for all of the differences mentioned above ) . In the intervention region , new ADs were preceded by an average of 2.5 facilitated conversations ( range , 2–5 ) with a mean total duration of 100 minutes ( range , 60–240 minutes ) . CONCLUSION The implementation of an ACP program in German nursing homes led , much more frequently than previously reported , to the creation of advance directives with potential relevance to medical decision-making . Future research should assess the effect of such programs on clinical and structural outcomes Purpose To build on results of a cluster r and omized controlled trial ( RCT ) of a combined patient-oncologist intervention to improve communication in advanced cancer , we conducted a post hoc analysis of the patient intervention component , a previsit patient coaching session that used a question prompt list ( QPL ) . We hypothesized that intervention-group participants would bring up more QPL-related topics , particularly prognosis-related topics , during the subsequent oncologist visit . Patients and Methods This cluster RCT with 170 patients who had advanced nonhematologic cancer ( and their caregivers ) recruited from practice s of 24 participating oncologists in western New York . Intervention-group oncologists ( n = 12 ) received individualized communication training ; up to 10 of their patients ( n = 84 ) received a previsit individualized communication coaching session that incorporated a QPL . Control-group oncologists ( n = 12 ) and patients ( n = 86 ) received no interventions . Topics of interest identified by patients during the coaching session were summarized from coaching notes ; one office visit after the coaching session was audio recorded , transcribed , and analyzed by using linear regression modeling for group differences . Results Compared with controls , more than twice as many intervention-group participants brought up QPL-related topics during their office visits ( 70.2 % v 32
Output:
| Conclusion : The use of conceptual models underpinning the development of advance care planning is uncommon .
When used , they identify the individual behavioural change .
Strengthening patients ’ motivation and competence in participating advance care planning discussion s are key mechanisms of change . |
MS211012 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Introduction Virtual environments offer a variety of benefits and may be a powerful medium with which to provide nursing education . The objective of this study was to compare the achievement of learning outcomes of undergraduate nursing students when a virtual patient trainer or a traditional lecture was used to teach pediatric respiratory content . Methods This was a r and omized , controlled , posttest design . A virtual pediatric hospital unit was populated with four virtual pediatric patients having different respiratory diseases that were design ed to meet the same learning objectives as a traditional lecture . The study began in Spring 2010 with 93 Senior I , baccalaureate nursing students . Students were r and omized to receive either a traditional lecture or an experience with a virtual patient trainer . Students ’ knowledge acquisition was evaluated using multiple-choice questions , and knowledge application was measured as timeliness of care in two simulated clinical scenarios using high-fidelity mannequins and st and ardized patients . Results Ninety-three students participated in the study , of which 46 were in the experimental group that received content using the virtual patient trainer . After the intervention , students in the experimental group had significantly higher knowledge acquisition ( P = 0.004 ) and better knowledge application ( P = 0.001 ) for each of the two scenarios than students in the control group . Conclusions The purpose of this project was to compare a virtual patient trainer to a traditional lecture for the achievement of learning outcomes for pediatric respiratory content . Although the virtual patient trainer experience produced statistically better outcomes , the differences may not be clinical ly significant . The results suggest that a virtual patient trainer may be an effective substitute for the achievement of learning outcomes that are typically met using a traditional lecture format . Further research is needed to underst and how best to integrate a virtual patient trainer into undergraduate nursing education BACKGROUND An important facet of laparoscopic surgery is its psychomotor component . As this aspect of surgery gains attention , lessons from other psychomotor-intense fields such as athletics have led to an investigation of the benefits of " warming up " prior to entering the operating room . Practical implementation of established methods of warm-up is hampered by a reliance on special equipment and instrumentations that are not readily available . In light of emerging evidence of translatability between video-game play and operative performance , we sought to find if laparoscopic task performance improved after warming up on a mobile device balance game . MATERIAL S AND METHODS Laparoscopic novices were r and omized into either the intervention group ( n = 20 ) or the control group ( n = 20 ) . The intervention group played a mobile device balance game for 10 min while the control group did no warm-up whatsoever . Assessment was performed using two tasks on the ProMIS laparoscopic simulation system : " object positioning " ( where small beads are transferred between four cups ) and " tissue manipulation " ( where pieces of plastic are stretched over pegs ) . Metrics measured were time to task completion , path length , smoothness , h and dominance , and errors . RESULTS The intervention group made fewer errors : object positioning task 0.20 versus 0.70 , P = 0.01 , tissue manipulation task 0.15 versus 0.55 , P = 0.05 , total errors 0.35 versus 1.25 , P = 0.002 . The two groups performed similarly on the other metrics . CONCLUSIONS Warm-up using a mobile device balance game decreases errors on basic tasks performed on a laparoscopic surgery simulator , suggesting a practical way to warm-up prior to cases in the operating room OBJECTIVE The aim of this study was to assess , using a Web-based format , third-year medical students ' pediatric knowledge and perceptions of game playing with faculty facilitation compared with self- study computerized flash cards . METHODS This study used a repeated- measures experimental design with r and om assignment to a game group or self- study group . Pediatric knowledge was tested using multiple choice exams at baseline , week 6 of the clerkship following a 4-week intervention , and 6 weeks later . Perceptions about game playing and self- study were evaluated using a question naire at week 6 . RESULTS The groups did not differ on content mastery , perceptions about content , or time involved in game playing or self- study . Perceptions about game playing versus self- study as a pedagogical method appeared to favor game playing in underst and ing content ( P<.001 ) , perceived help with learning ( P<.05 ) , and enjoyment of learning ( P<.008 ) . An important difference was increased game group willingness to continue participating in the intervention . CONCLUSIONS Games can be an enjoyable and motivating method for learning pediatric content , enhanced by group interactions , competition , and fun . Computerized , Web-based tools can facilitate access to educational re sources and are feasible to apply as an adjunct to teaching clinical medicine Background Most patients with diabetes mellitus ( DM ) are followed by primary care physicians , who often lack knowledge or confidence to prescribe insulin properly . This contributes to clinical inertia and poor glycemic control . Effectiveness of traditional continuing medical education ( CME ) to solve that is limited , so new approaches are required . Electronic games are a good option , as they can be very effective and easily disseminated . Objective The objective of our study was to assess applicability , user acceptance , and educational effectiveness of InsuOnline , an electronic serious game for medical education on insulin therapy for DM , compared with a traditional CME activity . Methods Primary care physicians ( PCPs ) from South of Brazil were invited by phone or email to participate in an unblinded r and omized controlled trial and r and omly allocated to play the game InsuOnline , installed as an app in their own computers , at the time of their choice , with minimal or no external guidance , or to participate in a traditional CME session , composed by onsite lectures and cases discussion . Both interventions had the same content and duration ( ~4 h ) . Applicability was assessed by the number of subjects who completed the assigned intervention in each group . Insulin-prescribing competence ( factual knowledge , problem-solving skills , and attitudes ) was self-assessed through a question naire applied before , immediately after , and 3 months after the interventions . Acceptance of the intervention ( satisfaction and perceived importance for clinical practice ) was also assessed immediately after and 3 months after the interventions , respectively . Results Subjects ’ characteristics were similar between groups ( mean age 38 , 51.4 % [ 69/134 ] male ) . In the game group , 69 of 88 ( 78 % ) completed the intervention , compared with 65 of 73 ( 89 % ) in the control group , with no difference in applicability . Percentage of right answers in the competence subscale , which was 52 % at the baseline in both groups , significantly improved immediately after both interventions to 92 % in the game group and to 85 % in control ( P<.001 ) . After 3 months , it remained significantly higher than that at the baseline in both groups ( 80 % in game , and 76 % in control ; P<.001 ) . Absolute increase in competence score was better with the game ( 40 % ) than with traditional CME ( 34 % ; P=.01 ) . Insulin-related attitudes were improved both after the game ( significant improvement in 4 of 9 items ) and after control activity ( 3 of 9 ) . Both interventions were very well accepted , with most subjects rating them as “ fun or pleasant , ” “ useful , ” and “ practice -changing . ” Conclusions The game InsuOnline was applicable , very well accepted , and highly effective for medical education on insulin therapy . In view of its flexibility and easy dissemination , it is a valid option for large-scale CME , potentially helping to reduce clinical inertia and to improve quality of care for DM patients . Trial Registration Clinical trials.gov NCT001759953 ; https:// clinical trials.gov/ct2/show/NCT01759953 ( Archived by WebCite at http://www.webcitation.org/6oeHoTrBf Background Video-games have become an integral part of the new multimedia culture . Several studies assessed video-gaming enhancement of spatial attention and eye-h and coordination . Considering the technical difficulty of laparoscopic procedures , legal issues and time limitations , the validation of appropriate training even outside of the operating rooms is ongoing . We investigated the influence of a four-week structured Nintendo ® Wii ™ training on laparoscopic skills by analyzing performance metrics with a vali date d simulator ( Lap Mentor ™ , Simbionix ™ ) . Methodology /Principal Findings We performed a prospect i ve r and omized study on 42 post-graduate I – II year residents in General , Vascular and Endoscopic Surgery . All participants were tested on a vali date d laparoscopic simulator and then r and omized to group 1 ( Controls , no training with the Nintendo ® Wii ™ ) , and group 2 ( training with the Nintendo ® Wii ™ ) with 21 subjects in each group , according to a computer-generated list . After four weeks , all residents underwent a testing session on the laparoscopic simulator of the same tasks as in the first session . All 42 subjects in both groups improved significantly from session 1 to session 2 . Compared to controls , the Wii group showed a significant improvement in performance ( p<0.05 ) for 13 of the 16 considered performance metrics . Conclusions / Significance The Nintendo ® Wii ™ might be helpful , inexpensive and entertaining part of the training of young laparoscopists , in addition to a st and ard surgical education based on simulators and the operating room Written and clinical tests compared the change in clinical knowledge and practical clinical skill of first-year dental students watching a clinical video recording of the three-step etch- and -rinse resin bonding system to those using an interactive dental video game teaching the same procedure . The research design was a r and omized controlled trial with eighty first-year dental students enrolled in the pre clinical operative dentistry course . Students ' change in knowledge was measured through written examination using a pre-test and a post-test , as well as clinical tests in the form of a benchtop shear bond strength test . There was no statistically significant difference between teaching methods in regards to change in either knowledge or clinical skills , with one minor exception relating to the wetness of dentin following etching . Students expressed their preference for an interactive self-paced method of teaching We investigated if engagement modes and perceived self-efficacy differed in surgical novices before and after r and omized training in two different video games during five weeks , and a control group with no training . The control group expressed to a higher extent negative engagement modes during training in MIST-VR and GI Mentor II than the experimental groups . No statistically significant differences in self-efficacy were identified between groups . Both engagement modes and self-efficacy showed a positive correlation with previous and present video game experience . It is suggested that videogame training could have a framing effect on surgical simulator performance . EM and SE might be important intermediate variables between the strength of relationship between current videogame experience and simulator performance Cardiopulmonary resuscitation ( CPR ) is a first aid key survival technique used to stimulate breathing and keep blood flowing to the heart . Its effective administration can significantly increase the chances of survival for victims of cardiac arrest . LISSA is a serious game design ed to complement CPR teaching and also to refresh CPR skills in an enjoyable way . The game presents an emergency situation in a 3D virtual environment and the player has to save the victim applying the CPR actions . In this paper , we describe LISSA and its evaluation in a population composed of 109 nursing undergraduate students enrolled in the Nursing degree of our university . To evaluate LISSA we performed a r and omized controlled trial that compares the classical teaching methodology , composed of self-directed learning for theory plus laboratory sessions with a mannequin for practice , with the one that uses LISSA after self-directed learning for theory and before laboratory sessions with a mannequin . From our evaluation we observed that students using LISSA ( Group 2 and 3 ) gave significantly better learning acquisition scores than those following traditional classes ( Group 1 ) . To evaluate the differences between students of these groups we performed a paired sample s t-test between Group 1 and 2 ( μ1=35 , 67 , μ2=47 , 50 and p<0.05 ) and between students of Group 1 and 3 ( μ1=35 , 67 , μ3=50 , 58 and p<0.05 ) . From these tests we observed that there are significant differences in both cases . We also evaluated student performance of main steps of CPR protocol . Students that use LISSA performed better than the ones that did not use it Background —Many patients with high blood pressure ( BP ) do not have antihypertensive medications appropriately intensified at clinician visits . We investigated whether an online spaced-education ( SE ) game among primary care clinicians can decrease time to BP target among their hypertensive patients . Methods and Results —A 2-arm r and omized trial was conducted over 52 weeks among primary care clinicians at 8 hospitals . Educational content consisted of 32 vali date d multiple-choice questions with explanations on hypertension management . Providers were r and omized into 2 groups : SE clinicians were enrolled in the game , whereas control clinicians received identical educational content in an online posting . SE game clinicians were e-mailed 1 question every 3 days . Adaptive game mechanics resent questions in 12 or 24 days if answered incorrectly or correctly , respectively . Clinicians retired questions by answering each correctly twice consecutively . Posting of relative performance among peers fostered competition . Primary outcome measure was time to BP target ( < 140/90 mm Hg ) . One hundred eleven clinicians enrolled . The SE game was completed by 87 % of clinicians ( 48/55 ) , whereas 84 % of control clinicians ( 47/56 ) read the online posting . In multivariable analysis of 17 866 hypertensive periods among 14 336 patients , the hazard ratio for time to BP target in the SE game cohort was 1.043
Output:
| Evidence suggested that serious gaming was at least as effective as other digital education modalities for these outcomes .
There was insufficient evidence to conclude whether one type of serious gaming/gamification intervention is more effective than any other .
There was limited evidence for the effects of serious gaming/gamification on professional attitudes .
Serious gaming/gamification appears to be at least as effective as controls , and in many studies , more effective for improving knowledge , skills , and satisfaction . |
MS211013 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: STUDY OBJECTIVE To compare percutaneous nonangiographic insertion of a venous access device with a st and ard surgical cutdown insertion technique . DESIGN Prospect i ve , controlled , r and omized study . SETTING Operating room and anesthesia induction room of a university hospital . PATIENTS 100 consecutive oncology patients scheduled for intravenous chemotherapy . INTERVENTIONS Patients were r and omized to two groups : ( 1 ) The percutaneous group received implantation through the internal jugular vein by experienced anesthesiologists , whereas ( 2 ) the surgical group received venous cutdown insertion through the cephalic or subclavian vein by surgeons ( n = 50 for each group ) . MEASUREMENTS Duration of procedure , long-term device function , complications such as hematoma formation , infection , hemothorax , pneumothorax , and patients ' satisfaction with the placement procedure at two months of follow-up were all measured and recorded . MAIN RESULTS The percutaneous technique was found to have several advantages , including reduced time for insertion and greater patient satisfaction with procedure . The percutaneously implanted devices also had fewer insertion-associated complications . CONCLUSION The simplified , percutaneous , nonangiographic technique is as effective as the traditional venous cutdown technique and can be safely done by surgeons as well as by experienced physicians who are not surgeons BACKGROUND Central venous access is extensively used in oncology , though practical information from r and omized trials on the most convenient insertion modality and site is unavailable . METHODS Four hundred and three patients eligible for receiving i.v . chemotherapy for solid tumors were r and omly assigned to implantation of a single type of port ( Bard Port , Bard Inc. , Salt Lake City , UT ) , through a percutaneous l and mark access to the internal jugular , a ultrasound (US)-guided access to the subclavian or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove . Early and late complications were prospect ively recorded until removal of the device , patient 's death or ending of the study . RESULTS Four hundred and one patients ( 99.9 % ) were assessable : 132 with the internal jugular , 136 with the subclavian and 133 with the cephalic vein access . The median follow-up was 356.5 days ( range 0 - 1087 ) . No differences were found for early complication rate in the three groups { internal jugular : 0 % [ 95 % confidence interval ( CI ) 0.0 % to 2.7 % ] , subclavian : 0 % ( 95 % CI 0.0 % to 2.7 % ) , cephalic : 1.5 % ( 95 % CI 0.1 % to 5.3%)}. US-guided subclavian insertion site had significantly lower failures ( e.g. failed attempts to place the catheter in agreement with the original arm of r and omization , P = 0.001 ) . Infections occurred in one , three and one patients ( internal jugular , subclavian and cephalic access , respectively , P = 0.464 ) , whereas venous thrombosis was observed in 15 , 8 and 11 patients ( P = 0.272 ) . CONCLUSIONS Central venous insertion modality and sites had no impact on either early or late complication rates , but US-guided subclavian insertion showed the lowest proportion of failures Background The insertion of central venous access devices , such as totally implantable venous access ports ( TIVAPs ) , is routine in patients who need a safe and permanent venous access . The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies . Currently , two different strategies are being routinely used : surgical cut-down of the cephalic vein ( vena section ) and direct puncture of the subclavian vein . The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax . Methods / Design The PORTAS-3 trial is design ed as a multicentre , r and omised controlled trial to compare two implantation strategies . A total of 1,154 patients will be r and omised after giving written informed consent . Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the design ated side . The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies . The experimental intervention is as follows : open strategy , defined as surgical cut-down of the cephalic vein , supported by a rescue technique if necessary , and in the case of failure , direct puncture of the subclavian vein . The control intervention is as follows : direct puncture of the subclavian vein using the Seldinger technique guided by sonography , fluoroscopy or l and mark technique . The trial duration is approximately 36 months , with a recruitment period of 18 months and a follow-up period of 30 days . Discussion The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax . Since TIVAP implantation is one of the most common procedures in general surgery , the results will be of interest for a large community of surgeons as well as oncologists and general practitioners . The pragmatic trial design ensures that the results will be generalizable to a wide range of patients .Trial registration The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register ( DRKS00004900 ) . The World Health Organization ’s Universal Trial Number is U1111 - 1142 - 4420 The aim of this r and omized controlled study was to compare the primary success rate between venous cutdown and the Seldinger technique for placement of the totally implantable venous access port ( TIVAP ) Permanent central venous access devices ( PCVAD ) are used widely in the management of chronically ill patients , particularly in neoplastic diseases . The st and ard approach consists of positioning the catheter in the superior vena cava ( SVC ) either using subclavian or internal jugular vein puncture , or cephalic or external jugular vein cut-down , with the port implanted in a subcutaneous pouch of the thoracic region . Alternative insertion sites could be used in selected cases . In our experience , consisting of 158 PCVAD , 12 cases required a different insertion site : six cases of an SVC catheter and port on the forearm using a basilic vein cut-down , and six cases of an inferior vena cava ( IVC ) catheter and port in the abdominal region using a great saphenous vein cut-down . Comparing st and ard to alternative approaches , we observed a total morbidity rate of 8.9 % and 8.3 % , respectively ( P = NS ) , while the explant rate was 5.4 % vs 8.3 % ( P=0.1 ) . Our data show non-significant differences in morbidity and explant rates between the two groups of patients . Alternative insertion sites for the PCVAD implant seem to be a valid possibility in the management of chronically ill patients BACKGROUND This prospect i ve r and omized study evaluated complications related to long-term totally implantable catheters in oncologic children and adolescents by comparing venopunction performed either in the jugular or subclavian vein . METHODS A total of 83 catheters were implanted from January 2004 to April 2006 and followed-up until March 2008 . Patients were r and omly allocated to the subclavian or jugular vein group . The endpoint was complications that led to catheter revision or catheter removal . RESULTS Six patients were excluded , 43 had the catheter implanted in the subclavian and 34 in the jugular vein . Subclavian catheters were used for up to 12.6 months , while jugular catheters were kept in place for up to 14.8 months ( P = 0.38 ) . No statistical differences were found between the groups concerning age , sex , leukocyte count , platelet count , type of admission ( in or outpatient ) , or previous chemotherapy regimens . When analyzed individually , long-term complications did not present statistically significant differences either . Infection occurred in 20 and 11 % ( P = 0.44 ) , while catheter embolism took place in 23 and 8 % ( P = 0.11 ) of patients with subclavian and jugular catheters , respectively . A statistical difference was seen in the total number of complications , which occurred in 48 and 23 % ( P = 0.02 ) of patients in the subclavian and in the jugular groups , respectively . CONCLUSIONS Catheters implanted by puncture in the subclavian vein were more prone to late complications than those implanted in the jugular vein Totally implantable venous access ports are valuable instruments for long-term intravenous treatment of patients with cancer , but implantation and use of these devices may be associated with complications . The aim of our study was to compare two implantation techniques in order to establish which one is better for the patient and the surgeon as regards morbidity , surgical time , tolerability , and costs . A prospect i ve study was conducted on a series of 99 patients undergoing implantation of totally implantable venous access ports with surgical cut-down or percutaneous access from January 2000 to June 2004 at the Department of Surgical Sciences , Organ Transplantation and Advanced Technologies . Our experience shows that there are no statistically significant differences between these two techniques in terms of associated morbidity , technical failure , operative time and patient acceptance PURPOSE To examine the safety , efficacy , costs , and impact on quality of life of venous access ports implanted at the outset of a course of intravenous cancer chemotherapy . PATIENTS AND METHODS Adults beginning a course of intravenous chemotherapy at two university-affiliated hospitals were r and omly allocated to have venous access using a surgically implanted venous access port ( Port-a-Cath ; Pharmacia , Canada Inc , Montreal , Québec , Canada ) or using st and ard peripheral venous access . All accesses were documented by number , route , purpose , and procedure duration . Outcome measurements included port complications , access strategy failure , access-related anxiety and pain , quality of life ( Functional Living Index-Cancer [ FLI-C ] ) , and costs . RESULTS Port complication rates were low ( 0.23/1,000 days ) . Failure occurred in two ( 3.4 % ) of 59 port subjects and 16 ( 26.7 % ) of 60 controls ( P = . 0004 ) at a median period of 26 days after r and omization ( 95 % confidence interval , 8 to 92 ) . Peripheral accesses in port subjects took less time , had less access-related anxiety and pain , and were less costly to perform than in controls . Allocation had no effect on FLI-C scores . Peripheral access failure correlated with allocation to the control group ( P = .007 ) , higher pain scores with intravenous ( IV ) starts ( P = .003 ) , and anxiety with IV starts ( P = .01 ) . Venous accessing overall in port patients was four times more costly than that in controls ( $ 2,178/patient v $ 530/patient , respectively ) . CONCLUSION Ports were safe and effective but had no detectable impact on functional quality of life , despite less access-related anxiety , pain , and discomfort . Because only approximately one quarter of control patients ultimately required central venous access , economic considerations suggest that port-use policies should be based upon defined criteria of need Objective : Comparison of two different insertion techniques for implantation of totally implantable access ports ( TIAP ) . Background : TIAP are introduced through different open and closed cannulation strategies and by various medical experts . The aim of this expertise-based r and omized trial was to compare venous cutdown approach with puncture of subclavian vein . Methods : One hundred and ten patients scheduled for primary implantation of a TIAP were r and omly assigned to either open insertion technique performed by surgeons or puncture of the subclavian vein under fluoroscopic guidance by radiologists at an outpatient single university center . The primary endpoint was the primary success rate of the cannulation strategy . A logistic regression model was used for analysis adjusting for age , Karnofsky index , body mass index and surgeons ' , and the radiologists ' experience . Results : Percutaneus cannulation was not superior to surgical venous cutdown in the intention-to-treat analysis ( odds ratio , 0.37 ; 95 % CI , 0.07 ; 2.15 ) and the as-treated analysis ( odds ratio , 0.16 ; 95 % CI , 0 ; 1.28 ) . The procedure was shorter with surgery ( median , 21 minutes ; 95 % CI , 14 ; 30 ) than with radiology ( median , 45 minutes ; 95 % CI , 43 ; 50 ) ( P < 0.001 ) , and the dose of radiation was lower with surgery ( median , 37 cGy/cm2 ; 95 % CI , 26 ; 49 ) than with radiology ( 200 cGy/cm2 ; 95 % CI , 200 ; 300 ) ( P < 0.001 ) . Conclusion : Central venous cannulation for insertion of TIAPs can be performed safely and effectively with both approaches . The open direct surgical access requires further strategies for successful placement of a TIAP , and percutaneous Seldinger technique requires more time and a higher dose of radiation and is associated with risk of pneumothorax
Output:
| Moderate- quality evidence showed that the Seldinger technique has a higher primary implantation success rate compared with the venous cutdown technique .
Moderate- quality evidence showed no difference in the overall complication rate between the Seldinger and venous cutdown techniques .
However , when the Seldinger technique with subclavian vein access was compared with the venous cutdown group , there was a higher reported incidence of catheter complications .
The rates of pneumothorax and infection did not differ between the Seldinger and venous cutdown group . |
MS211014 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIM This paper is a report of a study to explore the effects of psychosocial group nursing intervention on older people 's feelings of loneliness , social activity and psychological well-being . BACKGROUND Older people 's loneliness is associated with low quality of life , and impaired health , increased use of health and social services and increased mortality . Previous intervention studies have achieved quite modest results . METHOD A r and omized controlled trial was conducted between 2003 and 2006 using a group intervention aim ed at empowering older people , and promoting peer support and social integration . A total of 235 people ( > 74 years ) suffering from loneliness met 12 times with professional leaders in groups . The UCLA Loneliness Scale and Lubben 's Social Network Scale were used at entry , after 3 and 6 months . Psychological well-being was charted using a six-dimensional question naire at baseline and 12 months later . FINDINGS A statistically significantly larger proportion of intervention group participants had found new friends during the follow-up year ( 45 % vs. 32 % , P = 0.048 ) , and 40 % of intervention group participants continued their group meetings for 1 year . However , no differences were found in loneliness or social networks between the groups . Psychological well-being score improved statistically significantly in the intervention groups [ + 0.11 , 95 % confidence interval ( CI ) : + 0.04 to + 0.13 ] , compared with the controls ( + 0.01 , 95 % CI : -0.05 to + 0.07 , P = 0.045 ) . Feeling needed was statistically significantly more common in the intervention groups ( 66 % ) than in controls ( 49 % , P = 0.019 ) . CONCLUSION New sensitive measurements of loneliness and social isolation are needed to measure fluctuations in feelings of loneliness and in social isolation BACKGROUND Animal-assisted therapy ( AAT ) is cl aim ed to have a variety of benefits , but almost all published results are anecdotal . We characterized the resident population in long-term care facilities desiring AAT and determined whether AAT can objective ly improve loneliness . METHODS Of 62 residents , 45 met inclusion criteria for the study . These 45 residents were administered the Demographic and Pet History Question naire ( DPHQ ) and Version 3 of the UCLA Loneliness Scale ( UCLA-LS ) . They were then r and omized into three groups ( no AAT ; AAT once/week ; AAT three times/week ; n = 15/group ) and retested with the UCLA-LS near the end of the 6-week study . RESULTS Use of the DPHQ showed residents volunteering for the study had a strong life-history of emotional intimacy with pets and wished that they currently had a pet . AAT was shown by analysis of covariance followed by pairwise comparison to have significantly reduced loneliness scores in comparison with the no AAT group . CONCLUSIONS The desire for AAT strongly correlates with previous pet ownership . AAT reduces loneliness in residents of long-term care facilities Background Social isolation affects a significant proportion of older people and is associated with poor health outcomes . The current evidence base regarding the effectiveness of interventions targeting social isolation is poor , and the potential utility of mentoring for this purpose has not previously been rigorously evaluated . The purpose of this study was to examine the effectiveness of a community-based mentoring service for improving mental health , social engagement and physical health for socially isolated older people . Methods This prospect i ve controlled trial compared a sample of mentoring service clients ( intervention group ) with a matched control group recruited through general practice . One hundred and ninety five participants from each group were matched on mental wellbeing and social activity scores . Assessment s were conducted at baseline and at six month follow-up . The primary outcome was the Short Form Health Survey v2 ( SF-12 ) mental health component score ( MCS ) . Secondary outcomes included the SF-12 physical health component score ( PCS ) , EuroQol EQ-5D , Geriatric Depression Score ( GDS-10 ) , social activity , social support and morbidities . Results We found no evidence that mentoring was beneficial across a wide range of participant outcomes measuring health status , social activity and depression . No statistically significant between-group differences were observed at follow-up in the primary outcome ( p = 0.48 ) and in most secondary outcomes . Identifying suitable matched pairs of intervention and control group participants proved challenging . Conclusions The results of this trial provide no substantial evidence supporting the use of community mentoring as an effective means of alleviating social isolation in older people . Further evidence is needed on the effectiveness of community-based interventions targeting social isolation . When using non-r and omised design s , there are considerable challenges in the recruitment of suitable matches from a community sample .Trial registration SCIE Research Register for Social Care OBJECTIVE The impact of depression and perceived loneliness in the oldest old is largely unknown . The authors studied the relationship between the presence of depressive symptoms and all-cause mortality in old age , especially the potential distorting effect of perceived loneliness . METHOD Within a prospect i ve population -based study of 85-year-olds , the 15-item Geriatric Depression Scale and the Loneliness Scale were annually applied in all 476 participants with a Mini-Mental State Examination score of 18 points or more . RESULTS Depression was present in 23 % and associated with marital state , institutionalization , and perceived loneliness . When depression and perceived loneliness were assessed during follow-up , neither depression nor perceived loneliness had a significant effect on mortality . However , those who suffered from both depression and feelings of loneliness had a 2.1 times higher mortality risk . CONCLUSIONS The data suggest that the increased mortality risk attributable to depression in the presence of perceived loneliness may result from motivational depletion In the present r and omized controlled trial ( RCT ) it was investigated whether single women , 55 years of age and older , improved with regard to self-management ability , well-being , and social and emotional loneliness after having participated in a newly design ed self-management group intervention based on the Self-Management of Well-being ( SMW ) theory . The expected mediating effect of self-management ability on well-being was not found . Although self-management ability , well-being and loneliness improved significantly in the intervention group immediately after the intervention , and also remained at this improved level after six months , there was also improvement in the control group after six months , rendering the longer-term differences between the groups non-significant . It can , however , be concluded that , although the longer-term effectiveness could not be proven , this SMW theory-based intervention seems to be useful in supporting older women to improve their self-management ability and well-being The aim of the study was to examine the prevalence and self-reported causes of loneliness among Finnish older population . The data were collected with a postal question naire from a r and om sample of 6,786 elderly people ( > or=75 years of age ) . The response rate was 71.8 % from community-dwelling sample . Of the respondents , 39 % suffered from loneliness , 5 % often or always . Loneliness was more common among rural elderly people than those living in cities . It was associated with advancing age , living alone or in a residential home , widowhood , low level of education and poor income . In addition , poor health status , poor functional status , poor vision and loss of hearing increased the prevalence of loneliness . The most common subjective causes for loneliness were illnesses , death of a spouse and lack of friends . Loneliness seems to derive from societal life changes as well as from natural life events and hardships originating from aging Background : Seniors aged 75 and above have the highest suicide rates of all age groups in most industrialized countries . However , research concerning risk factors for suicide in the old elderly is sparse . Objective : The purpose was to determine predictors for suicide among the old elderly ( 75 + ) . Data concerning the young elderly ( 65–74 years ) are shown for comparison . Methods : 85 consecutive cases of suicide that occurred in western Sweden and 153 control persons with the same sex , birth year , and zip code as the suicide cases were r and omly selected from the tax register . The old elderly group included 38 cases and 71 controls ; the young elderly group included 47 cases and 82 controls . Data concerning the suicide cases were collected through interviews with close informants ; controls were interviewed in person . The interview included questions on past-year life events and mental and physical health . Medical records were review ed for cases and controls . The Cumulative Illness Rating Scale – Geriatrics was used to rate illness burden . Results : Family conflict , serious physical illness , loneliness , and both major and minor depressions were associated with suicide in the 75 + group . Economic problems predicted suicide in the younger but not in the older elderly . Old elderly suicide victims with depression ( major or minor ) were less likely to have received depression treatment than their younger counterparts . Conclusions : Better recognition and treatment of both major and minor depression should constitute an important target for the prevention of suicide in the old elderly . Intervention studies with large numbers of senior participants are sorely needed Objective : The objective of this trial , the Leiden 85-Plus Occupational Therapy Intervention Study ( LOTIS ) , was to assess whether unsolicited occupational therapy , as compared to no therapy , can decelerate the increase in disability in high-risk elderly people . Design : This was a r and omised controlled trial with 2-y follow-up . Setting : The study took place in the municipality of Leiden in the Netherl and s. Participants : The participants were 402 community-dwelling 85-y-old people , with a Mini-Mental State Examination score of > 18 points at baseline . Interventions : Participants in the intervention group were visited by an occupational therapist who provided training and education about assistive devices that were already present and who gave recommendations and information about procedures , possibilities , and costs of assistive devices and community-based services . Control participants were not visited by an occupational therapist . Outcome Measures : The primary outcome measure was the score achieved on the Groningen Activity Restriction Scale . Secondary outcome measures included self-evaluations of well-being and feelings of loneliness . Results : The participants were evenly divided between the two groups : 202 participants were allocated to the intervention group and 200 participants to the control group . Of the 202 participants r and omised to occupational therapy , 55 participants declined the proposed intervention . An occupational therapist indicated that of the remaining 147 participants , 66 ( 45 % ) needed an occupational therapy intervention . A total of 44 new assistive devices and five community-based services were implemented . During follow-up there was a progressive increase in disability in the intervention group ( mean annual increase , 2.0 points ; SE 0.2 ; p < 0.001 ) and control group ( mean annual increase , 2.1 points ; SE 0.2 ; p < 0.001 ) . The increase in disability was not significantly different between study groups ( 0.08 points ; 95 % CI , −1.1–1.2 ; p = 0.75 ) . There was also no difference between study groups for any of the secondary outcome measures . Conclusion : Unsolicited occupational therapy in high-risk elderly participants does not decelerate the increase in disability over time Objectives : This study examined relations between social isolation , loneliness , and social support to health outcomes in a sample of New Mexico seniors . Method : We used r and om-digit dialing to obtain a r and om sample of 755 southern New Mexico seniors . Participants answered questions pertaining to demographics , social isolation and loneliness , social support , and disease diagnosis including diabetes , hypertension , heart disease , liver disease , arthritis , emphysema , tuberculosis , kidney disease , cancer , asthma , and stroke . The sample allowed for comparison of Caucasian and Hispanic participants . Results : Correlational and logistic analyses indicated that belongingness support related most consistently to health outcomes . Ethnic subgroup analysis revealed similarities and differences in the pattern of associations among the predictor and outcome variables . Discussion : The results demonstrate the importance of social variables for predicting disease outcomes in the elderly and across ethnic groups Seniors are most vulnerable to conjugal bereavement . Although social support buffers the effects of bereavement , widows and widowers have lower levels of social support than married individuals . Self-help/support groups can supplement support from their depleted natural networks . Accordingly , the aim of this demonstration project was to examine the impact of support groups on widowed seniors ' loneliness , affect , and perceived support . Four face-to-face support groups for widowed seniors were conducted weekly for a maximum of 20 weeks . Participants completed pretest , posttest , and delayed posttest measures of support need and support satisfaction , positive and negative affect , and loneliness/isolation . The statistically significant impacts of the intervention were enhanced support satisfaction , diminished support needs , and increased positive affect . There was a trend toward decreased social isolation and emotional loneliness . In postintervention semistructured interviews , bereaved seniors reported increased hope , improved skills in developing social relationships , enhanced coping , new role identities , and less loneliness . Community health nurse research ers could conduct r and omized controlled trials of face-to-face and telephone support groups for bereaved people of all ages . Community health nurse practitioners could benefit from lessons learned about timing , duration , and selection of sensitive outcomes Background : Emotional loneliness and social isolation are major problems in old age . These concepts are interrelated and often used interchangeably , but few studies have investigated them simultaneously thus trying to clarify their relationship . Objectives : To describe the prevalence of loneliness among aged Finns and to study the relationship of loneliness with the frequency of social contacts , with older people ’s expectations and satisfaction of their human relationships . Especially , we wanted to clarify whether emotional loneliness is a separate concept from social isolation . Methods : The data were collected with a postal question naire . Background information , feelings of loneliness ,
Output:
| The findings suggest that it is possible to reduce loneliness by using educational interventions focused on social networks maintenance and enhancement .
Multiple approaches show promise , although flawed design often prevents proper evaluation of efficacy . |
MS211015 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Treatment goals for patients with CKD are often unrealized for many reasons , but support by nurse practitioners may improve risk factor levels in these patients . Here , we analyzed renal endpoints of the Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse Practitioners ( MASTERPLAN ) study after extended follow-up to determine whether strict implementation of current CKD guidelines through the aid of nurse practitioners improves renal outcome . In total , 788 patients with moderate to severe CKD were r and omized to receive nurse practitioner support added to physician care ( intervention group ) or physician care alone ( control group ) . Median follow-up was 5.7 years . Renal outcome was a secondary endpoint of the MASTERPLAN study . We used a composite renal endpoint of death , ESRD , and 50 % increase in serum creatinine . Event rates were compared with adjustment for baseline serum creatinine concentration and changes in estimated GFR were determined . During the r and omized phase , there were small but significant differences between the groups in BP , proteinuria , LDL cholesterol , and use of aspirin , statins , active vitamin D , and antihypertensive medications , in favor of the intervention group . The intervention reduced the incidence of the composite renal endpoint by 20 % ( hazard ratio , 0.80 ; 95 % confidence interval , 0.66 to 0.98 ; P=0.03 ) . In the intervention group , the decrease in estimated GFR was 0.45 ml/min per 1.73 m(2 ) per year less than in the control group ( P=0.01 ) . In conclusion , additional support by nurse practitioners attenuated the decline of kidney function and improved renal outcome in patients with CKD PURPOSE Though case management has been recommended to improve the outcomes of patients with costly or morbid conditions , it has seldom been studied in controlled trials . We performed a r and omized , controlled clinical trial of an intensive , multidisciplinary case management program for patients with chronic renal insufficiency and followed patients for 5 years . PATIENTS AND METHODS We enrolled 437 primary -care patients ( 73 % of those eligible ) with chronic renal insufficiency ( estimated creatinine clearance consistently < 50 mL/min with the last serum creatinine level > 1.4 mg/dL ) who were attending an urban academic general internal medicine practice . The intensive case management , administered during the first 2 years after enrollment , consisted of m and atory repeated consultations in a nephrology case management clinic staffed by two nephrologists , a renal nurse , a renal dietitian , and a social worker . Control patients received usual care . Primary outcome measurements included serum creatinine level , estimated creatinine clearance , health services use , and mortality in the 5 years after enrollment . Secondary measures included use of renal sparing and potentially nephrotoxic drugs . RESULTS There were no differences in renal function , health services use , or mortality in the first , second , or third through fifth years after enrollment . There were significantly more outpatient visits among intervention patients , mainly because of the added visits to the nephrology case management clinic . There were also no significant differences in the use of renal sparing or selected potentially nephrotoxic drugs . The annual direct costs of the intervention were $ 89,355 ( $ 484 per intervention patient ) . CONCLUSION This intensive , multidisciplinary case-management intervention had no effect on the outcomes of care among primary -care patients with established chronic renal insufficiency . Such expensive and intrusive interventions , despite representing state-of-the-art care , should be tested prospect ively before being widely introduced into practice BACKGROUND AND OBJECTIVES It is unclear how to optimally care for chronic kidney disease ( CKD ) . This study compares a new coordinated model to usual care for CKD . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS A r and omized trial in nephrology clinics and the community included 474 patients with median estimated GFR ( eGFR ) 42 ml/min per 1.73 m(2 ) identified by laboratory-based case finding compared care coordinated by a general practitioner ( controls ) with care by a nurse-coordinated team including a nephrologist ( intervention ) for a median ( interquartile range [ IQR ] ) of 742 days . 32 % were diabetic , 60 % had cardiovascular disease , and proteinuria was minimal . Guided by protocol s , the intervention team targeted risk factors for adverse kidney and cardiovascular outcomes . Serial eGFR and clinical events were tracked . RESULTS The average decline in eGFR over 20 months was -1.9 ml/min per 1.73 m(2 ) . eGFR declined by ≥4 ml/min per 1.73 m(2 ) within 20 months in 28 ( 17 % ) intervention patients versus 23 ( 13.9 % ) control patients . Control of BP , LDL , and diabetes were comparable across groups . In the intervention group there was a trend to greater use of renin-angiotensin blockers and more use of statins in those with initial LDL > 2.5 mmol/L. Treatment was rarely required for anemia , acidosis , or disordered mineral metabolism . Clinical events occurred in 5.2 % per year . CONCLUSIONS Patients with stage 3/4 CKD identified through community laboratories largely had nonprogressive kidney disease but had cardiovascular risk . Over a median of 24 months , the nurse-coordinated team did not affect rate of GFR decline or control of most risk factors compared with usual care Background The multidisciplinary pre-dialysis education ( MPE ) retards renal progression , reduce incidence of dialysis and mortality of CKD patients . However , the financial benefit of this intervention on patients starting hemodialysis has not yet been evaluated in prospect i ve and r and omized trial . Methods We studied the medical expenditure and utilization incurred in the first 6 months of dialysis initiation in 425 incident hemodialysis patients who were r and omized into MPE and non-MPE groups before reaching end-stage renal disease . The content of the MPE was st and ardized in accordance with the National Kidney Foundation Dialysis Outcomes Quality Initiative guidelines . Results The mean age of study patients was 63.8±13.2 years , and 221 ( 49.7 % ) of them were men . The mean serum creatinine level and estimated glomerular filtration rate was 6.1±4.0 mg/dL and 7.6±2.9 mL⋅min−1⋅1.73 m−2 , respectively , at dialysis initiation . MPE patients tended to have lower total medical cost in the first 6 months after hemodialysis initiation ( 9147.6±0.1 USD/patient vs. 11190.6±0.1 USD/patient , p = 0.003 ) , fewer in numbers [ 0 ( 1 ) vs. 1 ( 2 ) , p<0.001 ] and length of hospitalization [ 0 ( 15 ) vs. 8 ( 27 ) days , p<0.001 ] , and also lower inpatient cost [ 0 ( 2617.4 ) vs. 1559,4 ( 5019.6 ) USD/patient , p<0.001 ] than non-MPE patients , principally owing to reduced cardiovascular hospitalization and vascular access – related surgeries . The decreased inpatient and total medical cost associated with MPE were independent of patients ' demographic characteristics , concomitant disease , baseline biochemistry and use of double-lumen catheter at initiation of hemodialysis . Conclusions Participation of multidisciplinary education in pre-dialysis period was independently associated with reduction in the inpatient and total medical expenditures of the first 6 months post-dialysis owing to decreased inpatient service utilization secondary to cardiovascular causes and vascular access – related surgeries . Trial Registration Clinical Trials.gov Background . A well-functioning vascular access ( VA ) is essential to efficient dialysis therapy . Guidelines have been implemented improving care , yet access use varies widely across countries and VA complications remain a problem . This study took advantage of the unique opportunity to utilize data from the Dialysis Outcomes and Practice Patterns Study ( DOPPS ) to examine international trends in VA use and trends in patient characteristics and practice s associated with VA use from 1996 to 2007 . DOPPS is a prospect i ve , observational study of haemodialysis ( HD ) practice s and patient outcomes at > 300 HD units from 12 countries and has collected data thus far from > 35 000 r and omly selected patients . Methods . VA data were collected for each patient at study entry ( 1996–2007 ) . Practice pattern data from the facility medical director , nurse manager and VA surgeon were also analysed . Results . Since 2005 , a native arteriovenous fistula ( AVF ) was used by 67–91 % of prevalent patients in Japan , Italy , Germany , France , Spain , the UK , Australia and New Zeal and , and 50–59 % in Belgium , Sweden and Canada . From 1996 to 2007 , AVF use rose from 24 % to 47 % in the USA but declined in Italy , Germany and Spain . Moreover , graft use fell by 50 % in the USA from 58 % use in 1996 to 28 % by 2007 . Across three phases of data collection , patients consistently were less likely to use an AVF versus other VA types if female , of older age , having greater body mass index , diabetes , peripheral vascular disease or recurrent cellulitis/gangrene . In addition , countries with a greater prevalence of diabetes in HD patients had a significantly lower percentage of patients using an AVF . Despite poorer outcomes for central vein catheters , catheter use rose 1.5- to 3-fold among prevalent patients in many countries from 1996 to 2007 , even among non-diabetic patients 18–70 years old . Furthermore , 58–73 % of patients new to end-stage renal disease ( ESRD ) used a catheter for the initiation of HD in five countries despite 60–79 % of patients having been seen by a nephrologist > 4 months prior to ESRD . Patients were significantly ( P < 0.05 ) less likely to start dialysis with a permanent VA if treated in a faciity that ( 1 ) had a longer time from referral to access surgery evaluation or from evaluation to access creation and ( 2 ) had longer time from access creation until first AVF cannulation . The median time from referral until access creation varied from 5–6 days in Italy , Japan and Germany to 40–43 days in the UK and Canada . Compared to patients using an AVF , patients with a catheter displayed significantly lower mean Kt/V levels . Conclusions . Most countries meet the contemporary National Kidney Foundation 's Kidney Disease Outcomes Quality Initiative goal for AVF use ; however , there is still a wide variation in VA preference . Delays between the creation and cannulation must be improved to enhance the chances of a future permanent VA . Native arteriovenous fistula is the VA of choice ensuring dialysis adequacy and better patient outcomes . Graft is , however , a better alternative than catheter for patients where the creation of an attempted AVF failed or could not be created for different reasons A 1993 National Institutes of Health Consensus statement stressed the importance of early medical intervention in predialysis population s. Given the need for evidence -based practice , we report the outcomes of predialysis programs in two major Canadian cities . The purpose of this report was to determine whether the institution of a multidisciplinary predialysis program is of benefit to patients , and to analyze those factors that are important in actualizing those benefits . Data from two different studies is presented : ( 1 ) a prospect i ve , nonr and omized cohort study comparing patients who were or were not exposed to an ongoing multidisciplinary predialysis team ( St Paul 's Hospital ) and ( 2 ) a retrospective review of outcomes before and after the institution of a predialysis program ( The Toronto Hospital ) . Although created independently in major academic centers in Canada , the programs both aim ed to reduce urgent dialysis starts , improve preparedness for dialysis , and improve re source utilization . The Vancouver study was able to demonstrate significantly fewer urgent dialysis starts ( 13 % v 35 % ; P < 0.05 ) , more outpatient training ( 76 % v 43 % ; P < 0.05 ) , and less hospital days in the first month of dialysis ( 6.5 days v 13.5 days ; P < 0.05 ) . Cost savings of the program patients in 1993 are conservatively estimated to be $ 173,000 ( Canadian dollars ) or over $ 4,000 per patient . The Toronto study demonstrated success in predialysis access creation ( 86.3 % of patients ) , but could not realize any benefit in terms of elective dialysis initiation due to well-documented hemodialysis re source constraints . We conclude that an approach to predialysis patients involving a multidisciplinary team can have a positive impact on quantitative outcomes , but essential elements for success include ( 1 ) early referral to a nephrology center , ( 2 ) adequate re sources for dedicated predialysis program staff and infrastructure , and ( 3 ) available re sources for patients with end-stage renal disease ( ESRD ) ( dialysis stations ) . In times of economic constraints , objective data are necessary to justify re source
Output:
| Compared with the non-MDC group , MDC was associated with a lower risk of all-cause mortality and lower hospitalization rates for patients with CKD .
In addition , MDC also result ed in a slower eGFR decline and reduced temporary catheterization for patients receiving dialysis .
However , according to the subgroup analysis , the lower rates of all-cause mortality in the MDC group were observed only in patients in stage 4–5 and when the staff of the MDC consisted of nephrologists , nurse specialists and professionals from other fields .
The most prominent effect of reducing the hospitalization rates was also observed in patients with stage 4–5 but not in patients with stage 4–5 CKD .
Conclusions MDC can lower the all-cause mortality of patients with CKD , reduce temporary catheterization for patients receiving dialysis , decrease the hospitalization rate , and slow the eGFR decline .
Moreover , the reduction in all-cause mortality crucially depends on the professionals comprising the MDC staff and the stage of CKD in patients .
In addition , the CKD stage influences the hospitalization rates |
MS211016 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background One of the main strategies to control tuberculosis ( TB ) is to find and treat people with active disease . Unfortunately , the case detection rates remain low in many countries . Thus , we need interventions to find and treat sufficient number of patients to control TB . We investigated whether involving health extension workers ( HEWs : trained community health workers ) in TB control improved smear-positive case detection and treatment success rates in southern Ethiopia . Methodology /Principal Finding We carried out a community-r and omized trial in southern Ethiopia from September 2006 to April 2008 . Fifty-one kebeles ( with a total population of 296 , 811 ) were r and omly allocated to intervention and control groups . We trained HEWs in the intervention kebeles on how to identify suspects , collect sputum , and provide directly observed treatment . The HEWs in the intervention kebeles advised people with productive cough of 2 weeks or more duration to attend the health posts . Two hundred and thirty smear-positive patients were identified from the intervention and 88 patients from the control kebeles . The mean case detection rate was higher in the intervention than in the control kebeles ( 122.2 % vs 69.4 % , p<0.001 ) . In addition , more females patients were identified in the intervention kebeles ( 149.0 vs 91.6 , p<0.001 ) . The mean treatment success rate was higher in the intervention than in the control kebeles ( 89.3 % vs 83.1 % , p = 0.012 ) and more for females patients ( 89.8 % vs 81.3 % , p = 0.05 ) . Conclusions / Significance The involvement of HEWs in sputum collection and treatment improved smear-positive case detection and treatment success rate , possibly because of an improved service access . This could be applied in setting s with low health service coverage and a shortage of health workers . Trial Registration Clinical Trials.gov Background Lay health workers ( LHWs ) play a pivotal role in addressing the high TB burden in Malawi . LHWs report lack of training to be a key barrier to their role as TB care providers . Given the cost of traditional off-site training , an alternative approach is needed . Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs . Methods The study design is a pragmatic cluster r and omized trial . The study was embedded within a larger trial , PALMPLUS , and compared three arms which included 28 health centers in Zomba district , Malawi . The control arm included 14 health centers r and omized as controls in the larger trial and maintained as control sites . Seven of 14 PALMPLUS intervention sites were r and omized to the LHW intervention ( PALM/LHW intervention arm ) , and the remaining 7 PALMPLUS sites maintained as a PALM only arm . PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers . LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs . Control sites received no intervention . The main outcome measure is the proportion of treatment successes . Results Among the 28 sites , there were 178 incident TB cases with 46/80 ( 0.58 ) successes in the control group , 44/68 ( 0.65 ) successes in the PALMPLUS group , and 21/30 ( 0.70 ) successes in the PALM/LHW intervention group . There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster r and omization ( p = 0.578 ) or multivariate analysis controlling for covariates with significant model effects ( p = 0.760 ) . The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance ( p = 0.056 ) , with the interaction significant only in the control arm [ RR of treatment success for pulmonary TB relative to non-pulmonary TB , 1.18 , 95 % CI 1.05–1.31 ] . Conclusions We found no significant treatment effect of our intervention . Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training , further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted . Trial registration Clinical Trials.gov NCT01356095 OBJECTIVE To investigate the effects of nutritional supplementation on the outcome and nutritional status of south Indian patients with tuberculosis ( TB ) with and without human immunodeficiency virus ( HIV ) coinfection on anti-tuberculous therapy . METHOD R and omized controlled trial on the effect of a locally prepared cereal-lentil mixture providing 930 kcal and a multivitamin micronutrient supplement during anti-tuberculous therapy in 81 newly diagnosed TB alone and 22 TB-HIV-coinfected patients , among whom 51 received and 52 did not receive the supplement . The primary outcome evaluated at completion of TB therapy was outcome of TB treatment , as classified by the national programme . Secondary outcomes were body composition , compliance and condition on follow-up 1 year after cessation of TB therapy and supplementation . RESULTS There was no significant difference in TB outcomes at the end of treatment , but HIV-TB coinfected individuals had four times greater odds of poor outcome than those with TB alone . Among patients with TB , 1/35 ( 2.9 % ) supplemented and 5/42(12 % ) of those not supplemented had poor outcomes , while among TB-HIV-coinfected individuals , 4/13 ( 31 % ) supplemented and 3/7 ( 42.8 % ) non-supplemented patients had poor outcomes at the end of treatment , and the differences were more marked after 1 year of follow-up . Although there was some trend of benefit for both TB alone and TB-HIV coinfection , the results were not statistically significant at the end of TB treatment , possibly because of limited sample size . CONCLUSION Nutritional supplements in patients are a potentially feasible , low-cost intervention , which could impact patients with TB and TB-HIV . The public health importance of these diseases in re source -limited setting s suggests the need for large , multi-centre r and omized control trials on nutritional supplementation 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 SETTING Farms in the Bol and health district , Western Cape Province , South Africa . OBJECTIVE To evaluate the effect of lay health workers ( LHWs ) on tuberculosis ( TB ) control among permanent farm workers and farm dwellers in an area with particularly high TB prevalence . DESIGN Pragmatic , unblinded cluster r and omised control trial . METHODS This trial measured successful treatment completion rates among new smear-positive ( NSP ) adult TB patients on 106 intervention farms , and compared them with outcomes in patients on 105 control farms . Farms were the unit of r and omisation , and analysis was by intention to treat . RESULTS A total of 164 adult TB patients were recruited into the study , 89 of whom were NSP . The successful treatment completion rate in NSP adult TB patients was 18.7 % higher ( P = 0.042 , 95%CI 0.9 - 36.4 ) on farms in the intervention group than on farms in the control group . Case finding for adult NSP TB cases was 8 % higher ( P = 0.2671 ) on farms in the intervention group compared to the control group . CONCLUSION Trained LHWs were able to improve the successful TB treatment rate among adult NSP TB patients in a well-established health service , despite reduction of services 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 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 4
Output:
| We did not detect effects of SPS on the outcomes treatment failure and death .
These findings revealed that SPS might improve TB treatment outcomes in lower-middle-income economies or countries with high burden of this disease . |
MS211017 | ***TASK*** the task is to summarize an input biomedical literature in 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 recent clinical trial of sodium monofluorophosphate dentifrices , oral rinsing habits were found to influence dental caries . Thus an oral fluoride clearance study has been undertaken which was design ed to test a possible mechanism for the observed effects . Eight subjects brushed with one of the trial dentifrices and then rinsed using 1 of 8 procedures of varying thoroughness . The salivary fluoride concentration measured 5 min after dentifrice application decreased significantly with increasing rinse volume , rinse duration , and rinse frequency ( p less than 0.01 , analysis of variance ) . The area under the clearance curve determined over a further 3 h was significantly higher ( 300 % ; p less than 0.01 ) following use of the least thorough rinsing procedure ( 5 ml x 2 s once ) as compared with the corresponding area under the clearance curve following the most thorough procedure ( 20 ml x 10 s twice ) . These findings indicate that rinsing habits may play an important role in the oral retention of fluoride from dentifrices which may , in turn , affect their clinical efficacy The aim of the study was to determine whether rinsing with a mouthwash after brushing with a fluori date d toothpaste affected oral fluoride ( F ) retention and clearance compared with an oral hygiene regime without mouthwash . In this supervised , single-blind study , 3 regimes were compared : ( A ) brushing for 1 min with 1 g of 1,450 μg F/g NaF toothpaste followed by rinsing for 5 s with 10 ml water ; ( B ) as A but followed by rinsing for 30 s with 20 ml of 100 mg F/l NaF mouthwash , and ( C ) as B but rinsing for 30 s with a non-fluori date d mouthwash . Twenty-three adults applied each treatment once in a r and omised order , separated by 1-week washout periods , and used a non-fluori date d toothpaste at home prior to and during the study . Whole saliva sample s ( 2 ml ) , collected before each treatment commenced and 10 , 20 , 30 , 60 , 90 and 120 min afterwards , were subsequently analysed for fluoride by ion-specific electrode . The mean ( SD ) back-transformed log ( area under salivary F clearance curve ) values were : A = 2.36 ( + 3.37 , –1.39 ) , B = 2.54 ( + 2.72 , –1.31 ) and C = 1.19 ( + 1.10 , –0.57 ) mmol F/l × min , respectively . The values for regimes A and B were statistically significantly greater than that for regime C ( p < 0.001 ; paired t test ) . These findings suggest that use of a non-F mouthwash after toothbrushing with a F toothpaste may reduce the anticaries protection provided by toothbrushing with a F toothpaste alone . The use of a mouthwash with at least 100 mg F/l should minimise this risk The preventive effect of a modified fluoride ( F ) toothpaste technique was investigated . Both the incidence and progression of approximal caries among Saudi adults with a high caries prevalence were evaluated after 2 years . A total of 175 adults were r and omly assigned to a test group and a control group and 106 completed the study . In the test group ( n = 54 ) , the patients were asked to use the provided F toothpaste twice a day . They were instructed to use the " modified F toothpaste technique " as follows : ( 1 ) to use 2 cm of the toothpaste , ( 2 ) to brush for 2 min , ( 3 ) to swish the toothpaste slurry around the dentition with active movements of the cheeks , lips and tongue , forcing the slurry into the approximal area for about half a minute , before spitting it out , and ( 4 ) no post-brushing rinsing and no eating/drinking for 2 hr . The patients in the control group ( n = 52 ) were instructed to continue using their regular F toothpaste twice a day without any further instructions . Approximal caries and filled surfaces were scored on bitewing radiographs at baseline and after 2 years . The mean ( SD ) total caries incidence for the test and control group was 1.15 ( 1.49 ) and 3.37 ( 2.57 ) respectively ( p < 0.001 ) . In general , the control group displayed a higher progression rate than the test group with regard to enamel lesions to dentine ( NS ) , enamel lesions to filled surfaces ( p < 0.05 ) and filled surfaces that had recurrent caries ( NS ) . To conclude , the " modified fluoride toothpaste technique " , as practised over the 2 years in a Saudi population with a high caries prevalence , had a caries preventive effect on the incidence of approximal caries , but not on the progression This study compared the ability of two sodium fluoride dentifrices , one containing 5,000 ppm fluoride ( Prevident 5000 Plus ) and the other 1,100 ppm fluoride ( Winterfresh Gel ) , to reverse primary root caries lesions ( PRCLs ) . A total of 201 subjects with at least one PRCL each entered the study and were r and omly allocated to use one of the dentifrices . After 6 months , 186 subjects were included in statistical analyses . At baseline and after 3 and 6 months , the lesions were clinical ly assessed and their electrical resistance measured using an electrical caries monitor . After 3 months , 39 ( 38.2 % ) of the 102 subjects in the 5,000 ppm F– group and 9 ( 10.7 % ) of 84 subjects using the 1,100 ppm F– dentifrice , had one or more PRCLs which had hardened ( p = 0.005 ) . Between baseline and 3 months , the log10 mean ± SD resistance values of lesions for subjects in the 1,100 ppm F– group had decreased by 0.06±0.55 , whereas those in the 5,000 ppm F– group had increased by 0.40±0.64 ( p<0.001 ) . After 6 months , 58 ( 56.9 % ) of the subjects in the 5,000 ppm F– group and 24 ( 28.6 % ) in the 1,100 ppm F– group had one or more PRCLs that had become hard ( p = 0.002 ) . Between baseline and 6 months , the log10 mean ± SD resistance values of lesions for subjects in the 1,100 ppm F– group decreased by 0.004±0.70 , whereas in the 5,000 ppm F– group , they increased by 0.56±0.76 ( p<0.001 ) . After 3 and 6 months , the distance from the apical border of the root caries lesions to the gingival margin increased significantly in the 5,000 ppm F– group when compared with the 1,100 ppm F– group . The plaque index in the 5,000 ppm F– group was also significantly reduced when compared with the 1,100 ppm F– group . The colour of the lesions remained unchanged . It was concluded that the dentifrice containing 5,000 ppm F– was significantly better at remineralising PRCLs than the one containing 1,100 ppm It is now well-accepted that the primary anti-caries activity of fluoride ( F ) is via topical action . The retention of F in the mouth after topical fluoride treatment is considered to be an important factor in the clinical efficacy of F. The purpose of this study was to evaluate F levels in ductal saliva , whole saliva , and pooled plaque after treatment with topical F agents intended for home use . Ten consenting adults , mean ( SD ) age 31.0 ( 8.2 ) years , participated in all aspects of the study . Two days before each test , subjects received a professional tooth cleaning and subsequently abstained from all oral hygiene procedures to permit plaque to accumulate , and from the use of F-containing dental products . Treatments consisted of a placebo dentifrice ( PD ) , fluoride dentifrice ( FD ; 0.24 % NaF ) , fluoride rinse ( FR ; 0.05 % NaF ) , and fluoride gel ( FG ; 1.1 % NaF ) . Unstimulated whole saliva and pooled plaque were sample d at multiple points over a 24-hour period . In a separate experimental series , stimulated parotid saliva was sample d over a two-hour period after treatment . Fluoride levels generally followed the same pattern in whole saliva and pooled plaque sample s , with FG > FR > FD > PD . Night-time F application result ed in prolonged F retention in whole saliva but not in plaque . Fluoride levels in parotid saliva were only slightly higher after F treatment and returned to baseline levels within two h. The results of this study indicate that the method of F delivery , the F concentration of the agent , and the time of application ( daytime vs. night-time ) are important factors influencing F levels in the mouth . The recycling of F in ductal saliva as a consequence of the inadvertent ingestion of home-use fluoride products does not appear to make a clinical ly significant contribution to F levels in the mouth Recent evidence has suggested that the cariostatic effects of topical fluoride ( F ) are related to the presence of low concentrations of ionic F in the oral environment . The purpose of this study was to compare the retention of F in the oral environment over 24-hour periods after the use of a F dentifrice or a F rinse . Groups of ten consenting adult subjects ( age 18 - 52 years ) brushed and /or rinsed ( B/R ) in a st and ardized manner twice per day in the morning ( AM ) and before bed ( PM ) with either a placebo dentifrice ( 8 ppm F ) , NaF dentifrice ( 1100 ppm F ) , or NaF rinse ( 225 ppm F ) . Experiments were performed with placebo dentifrice only ( PD ) ; F dentifrice only ( FD ) ; F dentifizce followed by F rinse ( FD/FR ) ; placebo dentifrice followed by F rinse ( PD/FR ) ; and F rinse followed by placebo dentifrice ( FR/PD ) . Unstimulated whole saliva sample s were collected at baseline and then at 0 , 15 , 30 , and 45 min , 1 , 2 , and 8 hr after B/R in the AM , after B/R in the PM and upon rising the following morning . Salivary flow rate and F were determined for each sampling interval . The results of this study suggest that : ( 1 ) F rinse may be a more effective way of delivering topical F than F dentifrice ; ( 2 ) based on F retention , the combination of FD/FR was not more effective than FR only ( PD/FR ) ; ( 3 ) older individuals with gingival recession retained higher F levels ; and ( 4 ) bedtime F application result ed in longer F retention than did daytime application , which may have important implication s for enamel remineralization A total of 26 healthy volunteers participated in this r and omized 4-leg crossover study design ed to measure fluoride ( F ) retention in interdental plaque and saliva . Two NaF dentifrices ( 5,000 and 1,450 ppm F ) were used , with and without postbrushing water rinsing . The 4 tooth brushing methods were carried out twice a day during 2 weeks . Interdental plaque was collected from all proximal sites after each method , using dental floss . Immediately after the plaque sampling , the subjects were asked to brush their teeth with the same toothpaste and use the postbrushing water rinsing procedure as previously . Proximal saliva was collected from 4 interdental sites , using small paper points , before and up to 60 min after the brushing . The present study showed that the 5,000 ppm F toothpaste without postbrushing water rinsing result ed in the highest F concentration in both plaque and saliva and the 1,450 ppm F toothpaste with water rinsing in the lowest . The difference in the area under the curve of saliva F concentration versus time between the 2 methods was 4.2 times ( p < 0.001 ) . The corresponding difference in F concentration per unit weight of plaque ( n = 16 ) was 2.75 times ( p < 0.05 ) . Water rinsing immediately after tooth brushing with 5,000 ppm reduced the F concentration in saliva by 2.4 times ( p < 0.001 ) . The difference in F values in saliva between 5,000/rinsing and 1,450/no rinsing was minor and not significant . The increase of F in both proximal saliva and plaque , using a dentifrice with 5,000 ppm F without postbrushing water rinsing , may be of clinical importance OBJECTIVES To develop a st and ardized method for measuring the variables affecting fluoride ingestion from toothpaste in young children between the ages of 1.5 and 3.5 years , and to use the method at seven European sites . METHODS R and om sample s of children were invited to take part in the study . Parents who gave consent were visited at home . The children brushed their teeth using the toothpaste br and and toothbrush type currently in use . The difference between the fluoride dispensed onto the toothbrush and the fluoride recovered after accounting for losses was deemed to be the fluoride ingested . Details of other oral health-care habits were collected by question naire . For each child , the fluoride concentration of the toothpaste used was measured in the laboratory , from which an estimate of total daily fluoride ingestion was made . R
Output:
| Fluoride mouthrinses have simpler formulations and can have better oral fluoride retention profiles than fluoride toothpastes , depending on post-brushing rinsing behaviors . |
MS211018 | ***TASK*** the task is to summarize an input biomedical literature in 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 assess the safety and efficacy of two , single-tablet regimens for the initial treatment of HIV infection . Design : Phase 2 , r and omized , double-blind , double-dummy , multicenter , active-controlled study . Methods : Antiretroviral treatment-naive adults with a screening HIV-1 RNA at least 5000 copies/ml and a CD4 cell count more than 50 cells/μl were r and omized 2 : 1 to receive fixed-dose combination tablets of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate ( EVG/COBI/FTC/TDF ; N = 48 ) or efavirenz/emtricitabine/tenofovir disoproxil fumarate ( EFV/FTC/TDF ; n = 23 ) for 48 weeks . The primary endpoint was proportion of participants with HIV-1 RNA less than 50 copies/ml at week 24 . Results : Participants receiving EVG/COBI/FTC/TDF exhibited a more rapid decline in HIV-1 RNA and a greater proportion suppressed viral load to less than 50 copies/ml than participants receiving EFV/FTC/TDF . Both EVG/COBI/FTC/TDF and EFV/FTC/TDF result ed in high rates of viral suppression and increases in CD4 cell count . Ninety and 83 % of participants suppressed HIV-1 RNA to less than 50 copies/ml both at the 24-week and 48-week visits for EVG/COBI/FTC/TDF and EFV/FTC/TDF , respectively . Once-daily administration of EVG/COBI/FTC/TDF provided a mean EVG trough concentration 10-fold over its protein binding-adjusted IC95 across study visits . EVG/FTC/TDF/GS-9350 was generally well tolerated with a lower rate of drug-related central nervous system ( 17 % ) and psychiatric ( 10 % ) adverse events versus EFV/FTC/TDF ( 26 and 44 % , respectively ) . Decreases in estimated glomerular filtration rate occurred within the first few weeks of dosing in participants receiving EVG/COBI/FTC/TDF , remained within the normal range and did not progress at week 24 or 48 ; no participant experienced a clinical adverse event or discontinued study drug due to changes in serum creatinine or renal function . Conclusion : Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current st and ard-of-care regimen of EFV/FTC/TDF Background Rates of cardiovascular disease are higher among HIV-infected patients as a result of the complex interplay between traditional risk factors , HIV-related inflammatory and immunologic changes , and effects of antiretroviral therapy ( ART ) . This study prospect ively evaluated changes in cardiovascular biomarkers in an underrepresented , racially diverse , HIV-1-infected population receiving abacavir/lamivudine as backbone therapy . Methods This 96-week , open-label , r and omized , multicenter study compared once-daily fosamprenavir/ritonavir 1400/100 mg and efavirenz 600 mg , both with ABC/3TC 600 mg/300 mg , in antiretroviral-naïve , HLA-B*5701-negative adults without major resistance mutations to study drugs . We evaluated changes from baseline to weeks 4 , 12 , 24 , 48 , and 96 in interleukin-6 ( IL-6 ) , high-sensitivity C-reactive protein ( hs-CRP ) , soluble vascular adhesion molecule-1 ( sVCAM-1 ) , d-dimer , plasminogen , and fibrinogen . Biomarker data were log-transformed before analysis , and changes from baseline were described using geometric mean ratios . Results This study enrolled 101 patients ( 51 receiving fosamprenavir/ritonavir ; 50 receiving efavirenz ) : 32 % female , 60 % African American , and 38 % Hispanic/Latino ; 66 % ( 67/101 ) completed 96 weeks on study . At week 96 , levels of IL-6 , sVCAM-1 , d-dimer , fibrinogen , and plasminogen were lower than baseline in both treatment groups , and the decrease was statistically significant for sVCAM-1 ( fosamprenavir/ritonavir and efavirenz ) , d-dimer ( fosamprenavir/ritonavir and efavirenz ) , fibrinogen ( efavirenz ) , and plasminogen ( efavirenz ) . Values of hs-CRP varied over time in both groups , with a significant increase over baseline at Weeks 4 and 24 in the efavirenz group . At week 96 , there was no difference between the groups in the percentage of patients with HIV-1 RNA < 50 copies/mL ( fosamprenavir/ritonavir 63 % ; efavirenz 66 % ) by ITT missing-equals-failure analysis . Treatment-related grade 2–4 adverse events were more common with efavirenz ( 32 % ) compared with fosamprenavir/ritonavir ( 20 % ) , and median lipid concentrations increased in both groups over 96 weeks of treatment . Conclusions In this study of underrepresented patients , treatment with abacavir/lamivudine combined with either fosamprenavir/ritonavir or efavirenz over 96 weeks , produced stable or declining biomarker levels except for hs-CRP , including significant and favorable decreases in thrombotic activity ( reflected by d-dimer ) and endothelial activation ( reflected by sVCAM-1 ) . Our study adds to the emerging data that some cardiovascular biomarkers are decreased with initiation of ART and control of HIV viremia . Trial registration Clinical Trials.gov identifier Initial viral decay rate may be useful when comparing the relative potency of antiretroviral regimens . Two hundred twenty-seven ART-naïve patients were r and omized to receive efavirenz ( EFV ) ( n = 74 ) , lopinavir/ritonavir ( LPV/r ) ( n = 77 ) , or atazanavir/ritonavir ( ATV/r ) ( n = 79 ) in combination with two NRTIs . The most frequently used NRTI combinations in the EFV and ATV/r groups were the nonthymidine analogues tenofovir and emtricitabine or lamivudine ( 70 % and 68 % , respectively ) and , in the LPV/r group , lamivudine and the thymidine analogue zidovudine ( 89 % ) . HIV-1 RNA was monitored during the first 28 days after treatment initiation . Phase 1 and 2 decay rate was estimated in a subset of 157 patients by RNA decrease from days 0 to 7 , and days 14 to 28 . One-way ANOVA and subsequent Tukey 's post hoc tests were used for groupwise comparisons . Mean ( 95 % CI ) HIV-1 RNA reductions from days 0 to 28 were 2.59 ( 2.45 - 2.73 ) , 2.42 ( 2.27 - 2.57 ) , and 2.13 ( 2.01 - 2.25 ) log(10 ) copies/ml for the EFV- , LPV/r- , and ATV/r-based treatment groups , respectively , with a significantly larger decrease in the EFV-based group at all time points compared with ATV/r ( p < 0.0001 ) , and with LPV/r at days 7 - 21 ( p < 0.0001 - 0.03 ) . LPV/r gave a greater RNA decrease compared with ATV/r from day 14 ( p = 0.02 ) . Phase 1 decay rate was significantly higher in the EFV group compared with LPV/r ( p = 0.003 ) or ATV/r ( p < 0.0001 ) . No difference was found in phase 2 decrease . EFV-based treatment gave a more rapid decline in HIV-1 RNA than did either of the boosted protease inhibitor-based regimens . The observed differences may reflect different inherent regimen potencies Background : Raltegravir is an HIV-1 integrase str and -transfer inhibitor with potent in vitro activity . This study explored the antiretroviral activity and safety of raltegravir in treatment-naive patients with plasma HIV-1 RNA levels ≥5000 copies/mL and CD4 + T-cell counts ≥100 cells/mm3 . Methods : Multicenter , double-blind , r and omized , controlled study of raltegravir at doses of 100 , 200 , 400 , and 600 mg twice daily versus efavirenz at a dose of 600 mg/d , all in combination with tenofovir at a dose of 300 mg/d and lamivudine at a dose of 300 mg/d ( clinical trials.gov identifier : NCT00100048 ) . Results : In the 198 patients treated ( 160 on raltegravir and 38 on efavirenz ) , the mean HIV-1 RNA level ranged from 4.6 to 4.8 log10 copies/mL at baseline . At weeks 2 , 4 , and 8 , the proportion of patients achieving an HIV-1 RNA level < 50 copies/mL was greater in each of the raltegravir treatment groups than in the efavirenz group . By week 24 , all treatment groups appeared similar , with plasma HIV-1 RNA levels < 400 copies/mL in 85 % to 98 % of patients and < 50 copies/mL in 85 % to 95 % of patients . These reductions were maintained through week 48 in 85 % to 98 % of patients and in 83 % to 88 % of patients , respectively . Five ( 3 % ) patients on raltegravir and 1 ( 3 % ) on efavirenz experienced virologic failure before week 48 . Drug-related clinical adverse events were less common with raltegravir than with efavirenz . After 24 and 48 weeks of treatment , raltegravir did not result in increased serum levels of total cholesterol , low-density lipoprotein cholesterol , or triglycerides . Conclusions : Raltegravir at all doses studied was generally well tolerated in combination with tenofovir and lamivudine . Raltegravir exhibited potent and durable antiretroviral activity similar to that of efavirenz at 24 and 48 weeks but achieved HIV-1 RNA levels below detection at a more rapid rate BACKGROUND The MERIT ( Maraviroc versus Efavirenz in Treatment-Naive Patients ) study compared maraviroc and efavirenz , both with zidovudine-lamivudine , in antiretroviral-naive patients with R5 human immunodeficiency virus type 1 ( HIV-1 ) infection . METHODS Patients screened for R5 HIV-1 were r and omized to receive efavirenz ( 600 mg once daily ) or maraviroc ( 300 mg once or twice daily ) with zidovudine-lamivudine . Co primary end points were proportions of patients with a viral load < 400 and < 50 copies/mL at week 48 ; the noninferiority of maraviroc was assessed . RESULTS The once-daily maraviroc arm was discontinued for not meeting prespecified noninferiority criteria . In the primary 48-week analysis ( n = 721 ) , maraviroc was noninferior for < 400 copies/mL ( 70.6 % for maraviroc vs 73.1 % for efavirenz ) but not for < 50 copies/mL ( 65.3 % vs 69.3 % ) at a threshold of -10 % . More maraviroc patients discontinued for lack of efficacy ( 11.9 % vs 4.2 % ) , but fewer discontinued for adverse events ( 4.2 % vs 13.6 % ) . In a post hoc re analysis excluding 107 patients ( 15 % ) with non-R5 screening virus by the current , more sensitive tropism assay , the lower bound of the 1-sided 97.5 % confidence interval for the difference between treatment groups was above -10 % for each end point . CONCLUSIONS Twice-daily maraviroc was not noninferior to efavirenz at < 50 copies/mL in the primary analysis . However , 15 % of patients would have been ineligible for inclusion by a more sensitive screening assay . Their retrospective exclusion result ed in similar response rates in both arms Trial registration . Clinical Trials.gov identifier : ( NCT00098293 ) BACKGROUND Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1 . Rilpiv
Output:
| In comparison with both InSTI-based and CCR5-based therapy , efavirenz-based treatment was associated with a higher risk of therapy discontinuation due to adverse events .
Results of our meta- analysis support the present clinical guidelines for antiretroviral-naive , HIV-infected patients , in which efavirenz is one of the most preferred regimens in the analyzed population . |
MS211019 | ***TASK*** the task is to summarize an input biomedical literature in 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: Essential oil compounds such as found in thyme extract are established for the therapy of chronic and acute bronchitis . Various pharmacodynamic activities for thyme extract and the essential thyme oil , respectively , have been demonstrated in vitro , but availability of these compounds in the respective target organs has not been proven . Thus , investigation of absorption , distribution , metabolism , and excretion are necessary to provide the link between in vitro effects and in vivo studies . To determine the systemic availability and the pharmacokinetics of thymol after oral application to humans , a clinical trial was carried out in 12 healthy volunteers . Each subject received a single dose of a Bronchipret TP tablet , which is equivalent to 1.08 mg thymol . No thymol could be detected in plasma or urine . However , the metabolites thymol sulfate and thymol glucuronide were found in urine and identified by LC-MS/MS . Plasma and urine sample s were analyzed after enzymatic hydrolysis of the metabolites by headspace solid-phase micro extraction prior to GC analysis and flame ionization detection . Thymol sulfate , but not thymol glucuronide , was detectable in plasma . Peak plasma concentrations were 93.1+/-24.5 ng ml(-1 ) and were reached after 2.0+/-0.8 hours . The mean terminal elimination half-life was 10.2 hours . Thymol sulfate was detectable up to 41 hours after administration . Urinary excretion could be followed over 24 hours . The amount of both thymol sulfate and glucuronide excreted in 24-hour urine was 16.2%+/-4.5 % of the dose Essential oils of many plants have been previously tested in the treatment of oral diseases and other infections . This study was a r and omized , double-blind , in parallel with an active control study , which aim ed to evaluate the efficacy of three formulations of the Lippia sidoides Cham . essential oil ( LSO ) in the reduction of salivary Streptococcus mutans in children with caries . 81 volunteers , aged 6 - 12 years , both genders , with caries , were recruited to participate in this study , and r and omly assigned to either one of five different groups . Each group received topical treatment with either 1.4 % LSO toothpaste , 1.4 % LSO gel , 0.8 % LSO mouthwash , 1 % chlorhexidine gel , or 0.12 % chlorhexidine mouthwash . A 5-ml volume of each gel was placed inside disposable trays , and applied for 1 min , every 24h , for 5 consecutive days . The mouthwash groups used 5-ml volume of a mouthwash inside disposable syringes . In the toothpaste group , children brushed their teeth for 1 min , once a day for 5 days . Saliva was collected before and after treatment . MS colonies were counted , isolated and confirmed through biochemical tests . Differences in MS levels measured in different days within the same treatment group was only verified with LSO toothpaste , chlorhexidine gel and chlorhexidine mouthwash . Comparison between groups of LSO mouthwash , toothpaste and gel showed that the toothpaste group expressed significantly lower MS levels than the mouthwash and gel groups at day-30 . Chlorhexidine significantly reduced MS levels after 5 days of treatment , but these levels returned to baseline in other periods of the study . LSO toothpaste reduced MS levels after 5 days of treatment , and MS levels remained low and did not return to baseline during subsequent analysis . Hence , LSO toothpaste demonstrated the most long-lasting MS reduction in saliva , whereas other LSO formulations did not effectively reduce MS levels in children with dental caries Objectives : The antiplaque and antigingivitis effect of Lippia Sidoides ( LS ) was evaluated in this in vivo investigation . Material and Methods : Twenty-three subjects participated in a cross-over , double-blind clinical study , using 21-day partial-mouth experimental model of gingivitis . A toothshield was constructed for each volunteer , avoiding the brushing of the 4 experimental posterior teeth in the lower left quadrant . The subjects were r and omly assigned initially to use either the placebo gel ( control group ) or the test gel , containing 10 % LS ( test group ) . Results : The clinical results showed statistically significant differences for plaque index ( PLI ) ( p<0.01 ) between days 0 and 21 in both groups , however only the control group showed statistically significant difference ( p<0.01 ) for the bleeding ( IB ) and gingival ( GI ) index within the experimental period of 21 days . On day 21 , the test group presented significantly better results than the control group with regard to the GI ( p<0.05 ) . Conclusions : The test gel containing 10 % LS was effective in the control of gingivitis Several different plant extracts have been evaluated with respect to their antimicrobial effects against oral pathogens and for reduction of gingivitis . Given that a large number of these substances have been associated with significant side effects that contraindicate their long-term use , new compounds need to be tested . The aim of this study was to assess the short-term safety and efficacy of a Lippia sidoides ( " alecrim pimenta")-based essential oil mouthrinse on gingival inflammation and bacterial plaque . Fifty-five patients were enrolled into a pilot , double-blinded , r and omized , parallel-armed study . Patients were r and omly assigned to undergo a 7-day treatment regimen with either the L. sidoides-based mouthrinse or 0.12 % chlorhexidine mouthrinse . The results demonstrated decreased plaque index , gingival index and gingival bleeding index scores at 7 days , as compared to baseline . There was no statistically significance difference ( p>0.05 ) between test and control groups for any of the clinical parameters assessed throughout the study . Adverse events were mild and transient . The findings of this study demonstrated that the L. sidoides-based mouthrinse was safe and efficacious in reducing bacterial plaque and gingival inflammation BACKGROUND To investigate the method ological quality of r and omized controlled trials in three areas of complementary medicine . METHODS The method ological quality of 207 r and omized trials collected for five previously published systematic review s on homeopathy , herbal medicine ( Hypericum for depression , Echinacea for common cold ) , and acupuncture ( for asthma and chronic headache ) was assessed using a vali date d scale ( the Jadad scale ) and single quality items . RESULTS While the method ological quality of the trials was highly variable , the majority had important shortcomings in reporting and /or methodology . Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals . There were relevant differences in single quality components between the different complementary therapies : For example , acupuncture trials reported adequate allocation concealment less often ( 6 % versus 32 % of homeopathy and 26 % of herb trials ) , and trials on herbal extracts had better summary scores ( mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials ) . Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria . CONCLUSION Trials of complementary therapies often have relevant method ological weaknesses . The type of weaknesses varies considerably across interventions A novel mouthrinse ( IND 61,164 ) containing essential oils and extracts from four plant species ( Melaleuca alternifolia , Leptospermum scoparium , Calendula officinalis and Camellia sinensis ) were tested . This study aim ed to evaluate the safety , palatability and preliminary efficacy of the rinse . Fifteen subjects completed the Phase I safety study . Seventeen subjects completed the Phase II r and omized placebo-controlled study . Plaque was collected , gingival and plaque indices were recorded ( baseline , 6 weeks , and 12 weeks ) . The relative abundance of two periodontal pathogens ( Actinobacillus actinomycetemcomitans , Tanerella forsythensis ) was determined utilizing digoxigenin-labeled DNA probes . ANCOVA was used at the p = 0.05 level of significance . Two subjects reported a minor adverse event . One subject withdrew from the study . Several subjects objected to the taste of the test rinse but continued treatment . Differences between gingival index , plaque index or relative abundance of either bacterial species did not reach statistical significance when comparing nine placebo subjects with eight test rinse subjects . Subjects exposed to the test rinse experienced no abnormal oral lesions , altered vital signs , changes in liver , kidney , or bone marrow function . Larger scale studies would be necessary to determine the efficacy and oral health benefits of the test rinse BACKGROUND Gingivitis is a chronic inflammatory condition , result ing from gingival bacteria and bacterial byproducts . Antiplaque oral rinses reduce inflammation by removing or inhibiting plaque formation . The purpose of this pilot study was to examine the anti-inflammatory effects of HM-302 , a mouth rinse based on natural products , on gingival inflammation . METHODS A prospect i ve , double-blinded , r and omized parallel-group controlled trial involving 62 patients was conducted to assess efficacy and safety . During a 2-week period with no dental hygiene , subjects were r and omized to receive either the study rinse ( HM-302 ) ; a cetylpyridinium chloride ( CPC ) rinse ; an essential oils ( EO ) rinse ; or a water-only preparation . The gingival index ( GI ) , plaque index ( PI ) , and number of bleeding sites were measured at baseline and at the end of the study period . RESULTS Progression of gingival inflammation result ing from lack of dental hygiene was lowest in patients treated with the HM-302 rinse , and was significantly less marked than in patients treated with the water-only preparation . When compared to the CPC and EO treatments , HM-302 was the only mouth rinse that was significantlybetter than the control , with respect to both the change in absolute GI scores ( p = .006 ) and to the percent increase in GI scores ( p = .012 ) . No serious adverse effects were noted in any of the study groups . CONCLUSION HM-302 is a safe and effective treatment for preventing the development of gingival inflammation in an experimental gingivitis model . Further research is needed to evaluate its long-term effects R and omized , controlled trials ( RCTs ) of herbal interventions often inadequately describe important aspects of their methods ( 1 - 4 ) . Although the quality of reporting of these trials may be improving with time , many still lack important information , particularly about the composition of the herbal intervention ( 4 , 5 ) . Crude herbal drugs are natural products and their chemical composition varies depending on several factors , such as geographic source of the plant material , climate in which it was grown , and time of harvest . Commercially available herbal medicinal products also vary in their content and concentration of chemical constituents from batch to batch and when products containing the same herbal ingredient are compared among manufacturers ( 6 - 14 ) . Even when herbal products are st and ardized for content of known active or marker compounds to achieve more consistent pharmaceutical quality , there is variation in the concentrations of other constituents . These variations can result in differences in pharmacologic activity in vitro ( 15 ) and in bioavailability in humans ( 16 ) . Mindful of these issues , we elaborated on the 22-item checklist of the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement ( 17 ) to help authors and editors improve reporting of RCTs of herbal interventions . Methods We developed these reporting recommendations in 3 phases that included premeeting item generation , a consensus meeting , and postmeeting feedback . The individuals who participated are listed in the Appendix . To generate items , 1 investigator conducted telephone interviews of 16 participants with expertise in the method and reporting of RCTs ( 5 participants ) , pharmacognosy ( 4 participants ) , herbal medicinal products ( 5 participants ) , medical statistics ( 1 participant ) , and herbal product manufacturing ( 1 participant ) . The investigator asked participants to suggest revisions to existing CONSORT checklist items and also to additional items required for reporting trials of herbal interventions . He asked participants to nominate revisions or new items on the basis of empirical evidence that not reporting the item would bias estimates of treatment effect . When no empirical evidence was available , commonsense reasoning was acceptable . After completing all telephone calls , the investigator thematically grouped items and circulated them by e-mail to each participant for review . Fourteen participants attended the consensus meeting . The meeting began with a review of the premeeting checklist item suggestions . We emphasized minimizing item elaborations and additions and basing elaborations on evidence whenever possible . Each item suggestion was presented and followed by debate for its inclusion , deletion , or modification . This process was repeated until all items were review ed and a consensus emerged . After the consensus meeting , we circulated a draft summary report to all participants to ensure that it accurately represented decisions made during the consensus meeting . We then circulated the report to the wider CONSORT Group for input and revised it on the basis of their suggestions . Ethical approval was obtained from The University of Toronto Health Sciences Ethics Review Committee on 23 January 2004 . Financial support for the consensus meeting was provided by the Canadian Institutes of Health Research . The funding body had no role in the design , conduct , or analysis of this study and did not influence the decision to su bmi t the manuscript for publication . All research ers are independent of the funders . Results The group did not recommend any new CONSORT checklist items or modifications in the CONSORT flow diagram . We did , however , elaborate on 9 of the 22 CONSORT checklist items to enhance their relevance to trials of herbal interventions ( Table , Figure ; Appendix Table ) , including minor recommend
Output:
| The most promising species with antibacterial potential against cariogenic bacteria are : Achillea ligustica , Baccharis dracunculifolia , Croton cajucara , Cryptomeria japonica , Cori and rum sativum , Eugenia caryophyllata , Lippia sidoides , Ocimum americanum , and Rosmarinus officinalis .
In some cases , the major phytochemical compounds determine the biological properties of EOs .
Menthol and eugenol were considered outst and ing compounds demonstrating an antibacterial potential .
Only L. sidoides mouthwash ( 1 % ) has shown clinical antimicrobial effects against oral pathogens thus far . |
MS211020 | ***TASK*** the task is to summarize an input biomedical literature in 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 protective effects of ischemic preconditioning in a prospect i ve r and omized study involving a large population of unselected patients and to identify factors affecting the protective effects . Summary Background Data : Ischemic preconditioning is an effective protective strategy in several animal models . Protection has also been suggested in a small series of patients undergoing a hemihepatectomy with 30 minutes of inflow occlusion . Whether preconditioning confers protection in other types of liver resection and longer periods of ischemia is unknown . Therefore , we conducted a prospect i ve r and omized study to evaluate the impact of ischemic preconditioning in liver surgery . Methods : A total of 100 unselected patients undergoing major liver resection ( > bisegmentectomy ) under inflow occlusion for at least 30 minutes were r and omized during surgery to either receive or not receive an ischemic preconditioning protocol ( 10 minutes of ischemia followed by 10 minutes of reperfusion ) . Univariate and multivariate analyses were performed to identify independent factors affecting the protective effects of ischemic preconditioning . ATP contents in liver were measured as a possible mechanism of protection . Results : Both groups ( n = 50 in each ) were comparable regarding age , gender , duration of inflow occlusion , and resected liver volumes . Postoperative serum transaminase levels were significantly lower in preconditioned than in control patients ( median peak AST 364 U/L vs. 520 U/L , P = 0.028 ; ALT 406 vs. 519 U/L , P = 0.049 ) . Regression multivariate analysis revealed an increased benefit of ischemic preconditioning in younger patients , in patients with longer duration of inflow occlusion ( up to 60 minutes ) , and in cases of lower resected liver volume ( < 50 % ) . Patients with steatosis were also particularly protected by ischemic preconditioning . ATP content in liver tissue was preserved by ischemic preconditioning in young but not older patients . Conclusions : This study establishes ischemic preconditioning as a protective strategy against hepatic ischemia in humans . The strategy is particularly effective in young patients requiring a prolonged period of inflow occlusion , and in the presence of steatosis , and is possibly related to preservation of ATP content in liver tissue . Other strategies are needed in older patients BACKGROUND Clamping of the portal triad ( Pringle maneuver ) prevents blood loss during liver resection , but leads to liver injury upon reperfusion . Ischemic preconditioning ( IP ) has been shown to protect the liver against prolonged ischemic injury in animal models . However , the clinical value of this procedure has not yet been established . METHODS 61 Patients undergoing hepatic resection under inflow occlusion were r and omized to either to receive ( Group-A n = 30 ) or not to receive ( Group-B n = 31 ) an IP ( 10 minutes of ischemia followed 10 minutes of reperfusion ) . RESULTS Mean ( + /- SD)/ Group-A vs. Group-B. Pringle time of 34 + /- 14 and 33 + /- 12 minutes and the extent of resected liver tissue ( 2.7 + /- 1.3 vs. 2.7 + /- 1.1 segments ) were comparable in both groups . Complications , including death , severe liver dysfunction and biliary leakage occurred in 6 patients of Group-A vs. 14 patients of Group-B ( p<0.05 ) . Intraoperative blood loss was significantly lower in Group-A ( 1.28 + /- 0.91 l vs. 1.94 + /- 0.76 l ; p<0.001 ) with 5 vs. 15 patients requiring transfusions ( p<0.01 ) . In a multivariate analysis the duration of the Pringle maneuver ( p<0.05 ) and the absence of preconditioning ( p<0.05 ) were independent predictors for the occurrence of postoperative complications . CONCLUSIONS IP protects against reperfusion injury , reduces the incidence of complications after hepatic resection under inflow occlusion and is simple to use in clinical practice Background / Purpose Continuous inflow vascular occlusion during liver resections causes less severe ischemia and reperfusion injury ( IRI ) if it is preceded by ischemic preconditioning ( IP ) or if intermittent inflow occlusion is used during the resection . No previous clinical trial has studied the effects of adding IP to intermittent inflow occlusion . Methods Consecutive patients ( n = 32 ) with suspicion of malignant liver disease had liver resections ( minimum 2 segments ) performed with inflow occlusion ( intermittent clamping in a manner of 15 min of ischemia and 5 min of reperfusion repetitively ; 15/5 ) . Half of the patients were r and omized to receive IP ( 10 min of ischemia and 10 min of reperfusion before parenchymal transection ; 10/10 ) . The patients were stratified according to volume of resection and none had chronic liver disease . The patients were followed for 5 days with microdialysis ( μD ) . Results All patients completed the study and there were no deaths . No differences were seen between the groups regarding demographics or perioperative parameters ( bleeding , duration of ischemia , resection volume , complications , and serum laboratory tests ) . There were no differences in alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , bilirubin , or prothrombin time (PT)-INR levels , but μD revealed lower levels of lactate , pyruvate , and glucose in the IP group having major liver resections ( analysis of variance ; ANOVA ) . Nitrite and nitrate levels in μD decreased postoperatively , but no differences were seen between the groups . In one patient an elevated μD – glycerol curve was seen before the diagnosis of a stroke was made . Conclusions IP before intermittent vascular occlusion does not reduce the serum parameters used to assess IRI . IP seems to improve aerobic glucose metabolism , as the levels of glucose , pyruvate , and lactate locally in the liver were reduced , compared to controls , in patients having > 3 segments resected . μD may be used to monitor metabolism locally BACKGROUND / AIMS Liver pathology induced by chemotherapy ( steatosis or vascular injury ) is known to increase the liver 's sensitivity to ischemia/ reperfusion ( I/R ) injury , thereby increasing morbidity and mortality after liver resection . Our aim was to assess whether ischemic preconditioning ( IP ) reduces I/R injury to livers with chemotherapy-induced pathology . METHODS We analyzed a series of livers from patients treated with chemotherapy for colorectal cancer who underwent IP ( n=30 ) or not ( n=31 ) before hepatectomy . All but one of the livers exhibited chemotherapy-induced steatosis and / or peliosis before the I/R insult . RESULTS Necrosis was less frequent ( p=0.038 ) in livers with IP than in the others . IP had no influence on apoptosis as assessed by terminal transferase uridyl nick-end labeling ( TUNEL ) assay or caspase-3 , -8 and -9 expression . IP induced a twofold increase in B-cell leukemia/ lymphoma 2 ( Bcl-2 ; p<0.05 ) , which was localized to hepatocytes of centrolobular and peliotic areas and colocalized with the autophagy protein beclin-1 in livers with IP , suggesting their coordinated role in autophagy . Increased expression of the phosphorylated Bcl-2 was observed in preconditioned livers and was associated with a decreased immunoprecipitation of beclin-1 and the increased expression of light chain 3 type II ( LC3-II ) . The increased number of autophagic vacuoles seen by electron microscopy confirmed an association of autophagy in chemotherapy-injured livers following IP . However , the differences in protein expression were not reflected in postresection liver-injury tests or measure of patient morbidity . CONCLUSIONS IP is associated with a reduction in necrosis of hepatocytes already damaged by chemotherapy and an activation of autophagy . Bcl-2 and beclin-1 could be major targets in the regulation of cell death during I/R injury BACKGROUND Two r and omized prospect i ve studies suggested that ischemic preconditioning ( IP ) protects the human liver against ischemia-reperfusion injury after hepatectomy performed under continuous clamping of the portal triad . The primary goal of this study was to determine whether IP protects the human liver against ischemia-reperfusion injury after hepatectomy under continuous vascular exclusion with preservation of the caval flow . STUDY DESIGN Sixty patients were r and omly divided into two groups : with ( n=30 ; preconditioning group ) and without ( n=30 ; control group ) IP ( 10 minutes of portal triad clamping and 10 minutes of reperfusion ) before major hepatectomy under vascular exclusion of the liver preserving the caval flow . Serum concentrations of aspartate transferase , alanine transferase , glutathione-S-transferase , and bilirubin and prothrombin time were regularly determined until discharge and at 1 month . Morbidity and mortality were determined in both groups . RESULTS Peak postoperative concentrations of aspartate transferase were similar in the groups with and without IP ( 851 + /- 1,733 IU/L and 427 + /- 166 IU/L respectively , p=0.2 ) . A similar trend toward a higher peak concentration of alanine transferase and glutathione-S-transferase was indeed observed in the preconditioning group compared with the control group . Morbidity and mortality rates and lengths of ICU and hospitalization stays were similar in both groups . CONCLUSIONS IP does not improve liver tolerance to ischemia-reperfusion after hepatectomy under vascular exclusion of the liver with preservation of the caval flow . This maneuver does not improve postoperative liver function and does not affect morbidity or mortality rates . The clinical use of IP through 10 minutes of warm ischemia in this technique of hepatectomy is not currently recommended Hepatic pedicle clamping ( HPC ) is widely used to control intraoperative bleeding during hepatectomy ; intermittent HPC is better tolerated but is associated with blood loss during each period of reperfusion . Recently , it has been shown that ischemic preconditioning ( IP ) reduces the ischemia-reperfusion damage for up to 30 minutes of continuous clamping in healthy liver . We evaluated the safety of IP for more prolonged periods of continuous clamping in 42 consecutive patients with healthy liver su bmi tted to hepatectomy . IP was used in 21 patients ( group A ) ; mean + /- SD of liver ischemia was 54 + /- 19 minutes ( range , 27 - 110 ; in 7 cases > 60 minutes ) . In the other 21 patients , continuous clamping alone was used ( Group B ) ; liver ischemia lasted 36 + /- 14 minutes ( range , 13 - 70 ; in 2 cases > 60 minutes ) . Two patients in Group A ( 9.5 % ) and 3 in Group B ( 14.2 % ) received blood transfusions . In spite of the longer duration of ischemia ( P=.001 ) , patients with IP had lower aspartate aminotransferase ( AST ; P=.03 ) and alanine aminotransferase ( ALT ; P = not significant ) at postoperative day 1 , with a similar trend at postoperative day 3 . This was reconfirmed by multiple regression analysis , which showed that although postoperative transaminases increased with increasing duration of ischemia and of the operation in both groups , the increases were significantly smaller ( P<.001 ) with the use of preconditioning . In conclusion , the present study confirms that IP is safe and effective for liver resection in healthy liver and is also better tolerated than continuous clamping alone for prolonged periods of ischemia . This technique should be preferred to continuous clamping alone in healthy liver . Additional studies are needed to assess the role of IP in cirrhotic liver and to compare IP with intermittent clamping BACKGROUND The Pringle manoeuvre and ischaemic preconditioning are applied to prevent blood loss and ischaemia-reperfusion injury , respectively , during liver surgery . In this prospect i ve clinical trial we report on the intraoperative haemodynamic effects of the Pringle manoeuvre alone or in combination with ischaemic preconditioning . METHODS Patients ( n=68 ) were assigned r and omly to three groups : ( i ) resection with the Pringle manoeuvre ; ( ii ) with ischaemic preconditioning before the Pringle manoeuvre for resection ; ( iii ) without pedicle clamping . RESULTS Following the Pringle manoeuvre the mean arterial pressure increased transiently , but significantly decreased after unclamping as a result of peripheral vasodilation . Ischaemic preconditioning improved cardiovascular stability by lowering the need for catecholamines after liver reperfusion without affecting the blood sparing benefits of the Pringle manoeuvre . In addition , ischaemic preconditioning protected against reperfusion-induced tissue injury . CONCLUSIONS Ischaemic preconditioning provides both better intraoperative haemodynamic stability and anti-ischaemic effects thereby allowing us to take full advantage of blood loss reduction by the Pringle manoeuvre Ischemic preconditioning ( IPC ) has the potential to decrease graft injury and morbidity
Output:
| IPC decreases hepatocellular damage in liver surgery as determined by transaminases but does not translate to any significant clinical benefit in orthotopic liver transplant or liver resection .
Available clinical evidence does not support routine use of IPC in liver surgery as it does not offer any apparent benefit in perioperative outcome . |
MS211021 | ***TASK*** the task is to summarize an input biomedical literature in 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 ability of Amino-Cerv to promote healing of the cervix following loop electrical excision procedure ( LEEP ) of the cervix for cervical intraepithelial neoplasia . STUDY DESIGN A r and omized study was conducted on 48 women in a private office setting . Patients were divided into two groups , to use or not use Amino-Cerv intravaginally for two weeks after the procedure . Statistical analysis of the findings were performed using the chi 2 test . RESULTS Twenty of 24 ( 83 % ) of women using Amino-Cerv had completely healed tissue at four weeks , whereas 12 of 24 ( 50 % ) in the untreated group had healed tissue at four weeks . Findings were not statistically significant at two weeks but were statistically significant ( P < .005 , power = .55 ) at four weeks after the procedure . CONCLUSION Amino-Cerv after LEEP of the cervix promotes healing Summary . Fifty women undergoing laser vaporization of the cervix for cervical intraepithelial neoplasia were r and omly allocated to one of two groups . In one group the patients received no anaesthesia , in the other the ectocervix was infiltrated with 2 ml of Citanest with Octapressin ( prilocaine 3 % with 0.03 i.u./ml . of felypressin ) immediately before the procedure . The pain experienced by each group was assessed immediately after treatment by visual analogue and verbal rating scales . The pain experienced by those women receiving local anaesthesia was significantly reduced as assessed by the visual analogue scale ( P = 0.011 ) and this reduction was not quite significant by the verbal rating scale ( P = 0.06 ) . The Citanest group had less troublesome bleeding but the difference in bleeding between the two groups was not significant Objective To test the hypothesis that prilocaine with felypressin causes fewer side effects than lignocaine with adrenaline when performing large loop excision of the transformation zone of the cervix Abstract . Laser Conization of the cervix was performed in both inpatient and outpatient setting s with either local or general anesthesia . All of the patients included had abnormal cervical smears , abnormal colposcopic findings and were allocated to one of two groups , A and B. Patients in group A had general anesthesia while patients in group B had only local anesthesia . A st and ard operative technique , was used and all patients had estimation of blood loss , recording of operative time , surgical suite time , anesthesia induction time , and assessment of postoperative pain and morbidity . Statistical analysis was performed using the student t-test . We concluded that laser conization of the cervix can be performed more cheaply with local anesthesia than with general anesthesia and with little discomfort , less nausea , and vomitting OBJECTIVE The purpose of this study was to compare Monsel 's paste with fulguration with ball electrode for hemostasis after loop electrosurgical excision procedure . STUDY DESIGN One hundred healthy women were assigned r and omly by computer-generated r and om numbers to ball electrode or thickened Monsel 's paste for hemostasis after loop electrosurgical excision procedure . Patients rated pain during hemostasis using a visual analog scale . At 2 weeks , postprocedural vaginal discharge was rated on a Likert scale . Pathology was review ed for dysplasia grade and margin status . Recurrent dysplasia on repeat Papanicolaou tests was noted . RESULTS Six patients ( 2 Monsel 's and 4 fulguration ) required an alternate method of hemostasis . Patient demographics , postprocedural discharge , and recurrent dysplasia were comparable between the 2 groups . Visual analog scale scores and hemostasis time were significantly higher in the fulguration group . Estimated blood loss , although higher in the fulguration group , was not significant between groups . CONCLUSION Monsel 's paste and fulguration with ball electrode appear be equally effective as hemostatic agents after loop electrosurgical excision procedure Objective To investigate whether central diathermy ball cauterization after loop excision affects satisfactory colposcopy at follow-up . Methods One hundred one consecutive women with the squamocolumnar junction visible at the ectocervix scheduled for loop excision were assigned alternately into two groups . In group A , diathermy ball cauterization was applied to the entire crater following excision . In group B , cauterization was avoided in a 2–3-mm zone around the new os . The women were re-examined 4 months postoperatively by colposcopy and microcolpohysteroscopy with specific intention to identify the location of the squamocolumnar junction . The examiners performing colposcopy and microcolpohysteroscopy were not aware of each other 's interpretation , or of the method of cauterization used . Results Follow-up colposcopy was satisfactory in 12 women in group A ( 24 % ) and 47 women in group B ( 92.2 % ) ( P < .001 ) . Forty-three women ( 86 % ) in group A and ten in group B ( 19.6 % ) had the squamocolumnar junction partly or fully located within the cervical canal ( P < .001 ) . Microcolpohysteroscopy located the squamocolumnar junction at a mean depth of 4.5 ± 2.4 mm ( ± st and ard deviation [ SD ] ) in the women in group A and 1 ± 0.9 mm in group B ( P < .001 ) . Microcolpohysteroscopy could not be performed in 13 women in group A ( 26 % ) and one woman in group B ( 2 % ) ( P < .001 ) . Conclusion Diathermy ball cauterization at the new cervical os after loop excision results in a shift of the squamocolumnar junction toward the endocervical canal , and predisposes to cervical stenosis , thereby decreasing satisfactory colposcopy rates One hundred forty patients who underwent laser conization and 220 patients who underwent laser miniconizations were prospect ively r and omized into two study groups . One treatment group was given antifibrinolytic therapy in the form of tranexamic acid ( Cyklokapron , KabiVitrum , Sweden ) intraoperatively and for 14 days postoperatively . The other group did not receive antifibrinolytic therapy . In the group of 68 patients with laser conizations who were given antifibrinolytic therapy , no postoperative hemorrhages occurred , whereas there were eight such hemorrhages in 72 conizations ( 11 % ) in the untreated patients . This difference is statistically significant ( P = .004 , Fisher exact test for two proportions ) . Also , for laser miniconization , the frequency of postoperative hemorrhage was almost halved , from 9.1 % in 110 patients not receiving antifibrinolytic therapy to 5.5 % in the 110 treated patients . The use of lateral cervical sutures did not reduce the frequency of postoperative hemorrhage at laser conization in the present study Two methods of obtaining hemostasis after cold knife cone biopsy were compared in a prospect i ve r and omized trial involving 200 patients . One method relied primarily on hemostatic sutures , and the other involved the use of a styptic solution ( Monsel 's solution ) and vaginal pack , thus avoiding the use of sutures altogether . The short- and long-term morbidity in these two groups were compared and 12-month follow-up was completed . The use of sutures did not reduce the incidence of primary hemorrhage . Secondary hemorrhage was twice as frequent in the suture group , although this trend did not quite reach statistical significance . During long-term follow-up , significantly more patients in the suture group developed menstrual symptoms , cervical stenosis , and unsatisfactory colposcopy , requiring further operative intervention as a result Since its initial description by Prendiville et al. ( 1989 ) , loop diathermy excision of the transformation zone has become a common method for the local treatment of colposcopically detected abnormalities of the transformation zone . A number of studies including Luesley et al. ( 1990,1992 ) , have analysed patient symptoms retrospectively and noted that these were in the main related to vaginal discharge and bleeding of short duration . We report here a prospect i ve study objective ly documenting patient bleeding and discharge following loop diathermy . Monsel ’s solution has been shown to be an effective haemostat at cone biopsy ( Gilbert etal . 1989 ) ; we determined to see if Monsel ’s solution applied following loop diathermy would reduce vaginal discharge A double blind r and omized trial was made to ascertain the effect of tranexamic acid ( AMCA ) ( Cyklo‐kapron ® ) on the postoperative blood loss after conization . The case material consisted of 50 women referred to the clinic because of dysplasia or non‐invasive cancer of the cervix . Five patients were excluded for various reasons . The treatment started in the evening of the day of operation and was continued for another 12 days , the dose being three tablets every 8 hours , corresponding to 4.5 g of tranexamic acid daily when the active drug was given . During the first 7 postoperative days , when the patients were in hospital , the blood losses were determined quantitatively . Prophylactic treatment with tranexamic acid reduced the postoperative blood loss as compared with the placebo group , the blood losses being 23 ± 3.2 ml and 79 ± 20.4 ml respectively . Sudden profuse bleeding postoperatively , requiring remedial measures , occurred in 7 patients , all in the placebo group . With the exception of 1 patient in the placebo group , who complained of nausea , no side effects were recorded Objective To evaluate whether routinely giving an antibiotic after loop diathermy excision of the cervical transformation zone reduced post‐operative vaginal loss OBJECTIVE To estimate the perioperative or postoperative bleeding rates after treatment of cervical intraepithelial neoplasia by loop electrosurgical excision procedure in either the follicular or luteal phase of the menstrual cycle . METHODS A r and omized controlled trial was carried out to compare the outcomes in terms of primary and secondary hemorrhage between patients treated by loop electro‐surgical excision procedure during either the follicular ( 30 women ) or luteal phase ( 30 women ) of the menstrual cycle . The two groups did not differ in terms of mean age , grade of cervical intraepithelial neoplasia , depth of excision , parity , and duration of menses . Primary outcome measures included the objective and subjective assessment of intra‐operative and postoperative bleeding . RESULTS Women treated during the luteal phase of the menstrual cycle experienced significantly more postoperative bleeding than women treated during the follicular phase , as assessed by the fall in hematocrit levels ( P < .001 ) and subjective reports . Intraoperative bleeding was judged to be more severe in women treated during the luteal phase of the cycle by a single , blinded colposcopist ( P = .02 ) . These women also experienced higher levels of anxiety postoperatively , which result ed in more consultations with medical staff ( P = .007 ) . CONCLUSION The use of loop electrosurgical excision procedure to treat cervical intraepithelial neoplasia results in less bleeding if performed during the follicular phase of the menstrual cycle Abstract . To evaluate the inhibitory effect of tranexamic acid ( AMCA ) on increased fibrinolyctical activity in connection with conisatio colli uteri we have carried out a r and omized , double‐blind study with patients operated upon partly with an open method of operation ( 80 patients ) and partly with modified Sturmdorff sutures ( 150 patients ) . In connection with the open method the frequency of late bleeding decreased from . 17.5 % to 2.5 % , which is significant . The corresponding decrease in connection with the other method was from 10.7 % to 4.1 % . This material was not sufficiently large to verify significance . The side effects of the prophylactic treatment with AMCA were few
Output:
| Bleeding associated with surgery of the cervix appears to be reduced by vasopressin , used in combination with local anaesthetic .
Tranexamic acid appears to be beneficial after knife and laser cone biopsy .
There is some evidence that haemostatic suturing has an adverse effect on blood loss , cervical stenosis and satisfactory colposcopy |
MS211022 | ***TASK*** the task is to summarize an input biomedical literature in 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 The Institute of Medicine report that caused concern about adverse events in hospitals relied on studies that used medical record review to identify adverse events . Many people question whether medical record review s can accurately identify negligent adverse events . Contribution The following changes in the review process markedly reduced the rates of negligent adverse events : 1 ) increasing the number of review ers from one to three and 2 ) requiring review ers to be highly confident that an event was due to negligence . Implication s Because review criteria can affect adverse event rates , the estimates cited by the Institute of Medicine could be inaccurate . The Editors Implicit judgments , based on medical record review , about adverse events caused by medical care have moderate to poor inter-rater reliability ( 1 - 7 ) . However , the influential report on medical errors issued by the U.S. Institute of Medicine ( IOM ) in 2000 ( 8) relied on studies based on medical record review to estimate that 44 000 ( 9 ) to 98 000 ( 10 ) Americans die each year because of medical errors . These studies used one ( 9 ) or up to three ( 10 ) physician review ers per record to detect adverse events . The IOM estimates are important because they have prompted health care providers and administrators to reduce errors and have influenced the U.S. research budget . We report details on the reliability of physician judgments about adverse events and negligent adverse events in the study from which the IOM derived its estimate of 44 000 error-related deaths per year ( 9 ) . We also report the effects of varying criteria for review er confidence in and review er agreement about the presence of adverse events . Methods Data Sources This study was conducted as part of the Utah and Colorado Medical Practice Study ( UCMPS ) ( 5 ) . In UCMPS , trained nurses review ed medical records to identify 1 of 19 screening criteria that could indicate the presence of an adverse event . A trained physician then review ed flagged records by using a structured chart abstract ion form . Previously , the nurse review process was found to be a good screening tool , with a sensitivity of 84 % ( 1 ) . We began the current study with all 2868 records referred for physician review by nurse screeners from the original 15 000-record sample ( 5000 from Utah and 10 000 from Colorado ) ( Appendix Figure ) . Two physician investigators confirmed all adverse events detected during this initial review . As a result of this confirmation process , we eliminated 13 false-positive cases . We eliminated cases only if they failed to meet explicit criteria for an adverse event , not if there was a concern about the review er 's judgment regarding whether medical management caused the adverse event . Next , we r and omly selected 500 of the 2868 records referred for physician review by nurse screeners ( 167 from Utah and 333 from Colorado ) , maintaining the original 1 to 2 ratio of Utah to Colorado records ( Appendix Figure ) . The general characteristics of this sample are described elsewhere ( 5 ) . Of these 500 records , 400 were r and omly sample d from referred records that a single physician review er had previously judged to show no adverse events . Fifty records were r and omly sample d from records initially found to show nonnegligent adverse events , and the remaining 50 were sample d from records initially judged to show negligent adverse events . This mix provided a sample similar to the one originally review ed by the physicians . Record Review We completed three independent physician review s of the original 500 medical records ( not photocopies ) . The first was the original review for the UCMPS . The two subsequent physician review s were conducted by physicians from the original UCMPS and by newly recruited physician review ers who were trained in the same manner as the original UCMPS physician review ers ( 5 ) . Physicians could participate in more than one review ; however , all review ers were blinded to the purpose of these additional review s , and none of them review ed a record that they had previously review ed . All physician review ers used the same data form , which included the same definition of adverse event : an injury caused by medical management ( rather than the disease process ) that result ed in prolonged hospital stay or disability at discharge . Negligence was defined as care that fell below the st and ard expected of physicians in the community . Because judgments about adverse events may be complex , review ers used a six-point confidence scale that has been used in previous studies ( 5 , 6 ) . We required a confidence score of at least four ( > 50 % chance that medical management caused the adverse event ) to indicate the presence of adverse events or negligent adverse events . For each of the three review s , two investigators independently review ed all detected adverse events to confirm that they met the study criteria . Statistical Analysis We calculated the rates of adverse events and negligent adverse events detected during each review . We report statistics for adverse events and negligent adverse events as the measure of inter-rater reliability . For all statistical analyses , we used SAS software , release 6.12 ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source contributed to the design of the study but had no role in conducting the study or in reporting its results . Results The first independent review of the study sample detected 64 adverse events ; the second , 95 ; and the third , 86 . Table 1 shows the agreement and disagreement among the three review s. Comparisons between sets of review s ( review 1 compared with review 2 , review 1 compared with review 3 , and review 2 compared with review 3 ) demonstrated similar reliability . The statistics ranged from 0.40 to 0.41 ( the lowest bound of the three 95 % CIs was 0.30 , and the highest was 0.51 ) for adverse events and from 0.19 to 0.24 ( the lowest bound of the 95 % CIs was 0.05 , and the highest was 0.37 ) for negligent adverse events . The former is considered moderate ; the latter is considered poor ( 11 ) . We had hypothesized that reliability would increase as the review er confidence score required to indicate an adverse event decreased . However , when adverse events were defined as having a confidence score of two or greater instead of four or greater , the overall statistic for adverse events decreased slightly , from 0.41 to 0.37 ( P = 0.19 ) . Table 1 . Number of Cases Result ing in Agreement and Disagreement among Three Sets of Review s Different review strategies produced different estimates of the total number of adverse events and negligent adverse events . Increasing the confidence score to indicate the presence of an adverse event and increasing the degree of consensus between independent review ers ( agreement of one , two , or three review ers ) substantially affected adverse event rates in this sample of 500 records ( Table 2 ) . For example , if all three review ers had a confidence score of four or greater , the adverse event rate would be 7.58 % and the negligent adverse event rate would be 0.82 % . If we required a score of four or greater on only one of three review s to confirm the presence of an adverse event , the adverse event rate would be 37.68 % and the negligent adverse event rate would be 15.13 % . When the required confidence score was decreased to two , estimates among the three review ers varied even more . Table 2 . Adverse Event Rates Using Different Thresholds Discussion We found moderate to poor inter-rater reliability among physicians trying to identify adverse events and negligent adverse events by medical record review . Increasing the required levels of review er confidence to indicate the presence of an event or increasing the number of physician review ers who detected an event result ed in markedly different event rates . Similar studies of medical record review have found almost identical reliability ( statistics of approximately 0.4 for both studies ) ( 6 , 7 ) . Our study is limited because our data come from hospital records in two states that may not be generalizable to other geographic locations . Furthermore , we could not measure the validity of chart review because there is no true gold st and ard that avoids some type of implicit assessment . Despite the poor to moderate reliability of medical record review , each of the adverse events identified represents a potential opportunity for quality improvement ( 12 , 13 ) . Each case involving an adverse event may contain valuable information for improving patient safety . However , research ers should use caution when estimating incidence and prevalence of errors solely on the basis of these data . For example , the IOM used data from our larger study ( 9 ) , which used medical record review , to estimate that 44 000 Americans die each year of preventable adverse events ( or , to use the IOM term , medical errors ) ( 8) . Our results suggest that these estimates are sensitive to the review er consensus and confidence required to indicate the presence of adverse events . The estimate of 44 000 deaths could be approximately 50 % lower if the study used to estimate that figure required independent agreement by two physician review ers and could be 30 % higher if the required review er confidence about the presence of an adverse event was lower ( Table 2 ) . We can not quantify the reduction more precisely because the IOM figures are based on judgments about the number of preventable adverse events and our results are based on judgments about adverse events and negligent adverse events . The figures for error-related death reported by the IOM are imprecise . However , it is shortsighted to focus on the exact number of deaths and thereby ignore the vast additional research on errors and adverse events cited by the IOM ( 8 , 14 ) . Regardless of whether the number of annual U.S. deaths due to medical error is 30 000 or 300 000 , the need to test interventions to reduce errors and adverse events is clear . Our findings suggest that persons and institutions Patient injuries are thought to have a substantial financial impact on the health care system , but recent studies have been limited to estimating the costs of adverse drug events in teaching hospitals . This analysis estimated the costs of all types of patient injuries from a representative sample of hospitals in Utah and Colorado . We detected 459 adverse events ( of which 265 were preventable ) by review ing the medical records of 14,732 r and omly selected 1992 discharges from 28 hospitals . The total costs ( all results are discounted 1996 dollars ) were $ 661,889,000 for adverse events , and $ 308,382,000 for preventable adverse events . Health care costs totaled $ 348,081,000 for all adverse events and $ 159,245,000 for the preventable adverse events . Fifty-seven percent of the adverse event health care costs , and 46 % of the preventable adverse event costs were attributed to outpatient medical care . Surgical complications , adverse drug events , and delayed or incorrect diagnoses and therapies were the most expensive types of adverse events . The costs of adverse events were similar to the national costs of caring for people with HIV/AIDS , and totaled 4.8 % of per capita health care expenditures in these states Background : An unplanned admission to the intensive care unit within 24 h of a procedure ( UIA ) is a recommended clinical indicator in surgical patients . Often regarded as a surrogate marker of adverse events , it has potential as a direct measure of patient safety . Its true validity for such use is currently unknown . Methods : The authors vali date d UIA as an indicator of safety in surgical patients in a prospect i ve cohort study of 44,130 patients admitted to their hospital . They assessed the association of UIA with intraoperative incidents and near misses , increased hospital length of stay , and 30-day mortality as three constructs of patient safety . Results : The authors identified 201 patients with a UIA ; 104 ( 52.2 % ) had at least one incident or near miss . After adjusting for confounders , these incidents were significantly associated with UIA in all categories of surgical procedures analyzed ; odds ratios were 12.21 ( 95 % confidence interval [ CI ] , 6.33–23.58 ) , 4.06 ( 95 % CI , 2.74–6.03 ) , and 2.13 ( 95 % CI , 1.02–4.42 ) , respectively . The 30-day mortality for patients with UIA was 10.9 % , compared with 1.1 % in non-UIA patients . After risk adjustment , UIA was associated with excess mortality in several types of surgical procedures ( odds ratio , 3.89 ; 95 % CI , 2.14–7.04 ) . The median length of stay was increased if UIA occurred : 16 days ( interquartile range , 10–31 ) versus 2 days ( interquartile range , 0.5–9 ) ( P < 0.001 ) . For patients with a UIA , the likelihood of discharge from hospital was significantly decreased in most surgical categories analyzed , with adjusted hazard ratios of 0.41 ( 95 % CI , 0.23–0.77 ) to 0.58 ( 95 % CI , 0.37–0.93 ) . Conclusions : These findings provide strong support for the construct validity of UIA as a measure of patient safety AIM To identify the effect of an ICU Liaison Nurse ( LN ) on major adverse events in patients recently discharged from the ICU . METHODS Case-control study using a chart audit protocol to assess controls retrospectively and cases prospect ively . Controls did not receive ICU-based follow-up care . Cases received at least three visits over 3 days from the ICU LN . The LN service operated 7 days/week 0800 - 1800 . Data on a range of predictors and three major adverse events ( unexpected death , surgical procedure needed , and transfer to a higher level of care ) were collected using a purpose built audit form . RESULTS A total of 388 patients ( 201 controls and 187 cases ) were included in the study . Demographic and clinical characteristics were similar for both groups . A total of 165 major adverse
Output:
| Adverse events are a persistent and an important reason for admission to the ICU .
However , there is relatively weak evidence to estimate an overall incidence and preventability rate of these events .
IMPLICATION S FOR PRACTICE Unplanned intensive care admission within 24 hours of a procedure with an anesthetist in attendance ( UIA ) is a recommended clinical indicator in surgical patients . |
MS211023 | ***TASK*** the task is to summarize an input biomedical literature in 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 There is growing evidence supporting the reactive oxygen species ( ROS ) in the pathogenesis of psoriasis . Propylthiouracil(PTU ) , an antithyroid drug , has been shown to have beneficial effects on psoriasis . The aim of this study was to investigate both disturbances in oxidant/antioxidant system in psoriasis and whether PTU , shown to have immunomodulatory effects and antioxidant potential , has effects on oxidant/antioxidant system and clinical improvement in psoriatics . DESIGN AND METHODS Malondialdehyde ( MDA ) , end product of lipid peroxidation , superoxide dismutase ( SOD ) and glutathione peroxidase ( GSH-Px ) , and antioxidant enzymes were measured in plasma , erythrocytes and skin biopsies of psoriatics who were resistant to conventional therapy before and after 8 weeks of oral treatment with PTU ( 300 mg/day ) or PTU/thyroxine ( 25 microg/day- to prevent possible hypothyroidism ) . The same parameters were also studied in healthy controls . Psoriasis Area and Severity Index ( PASI ) scores were used to evaluate the severity of the disease , and routine analyses and thyroid function tests were measured during the study . RESULTS Increased baseline MDA in all sample s were found to be lower . In addition baseline SOD and GSH-Px in skin and erythrocytes were also lower . The increased plasma SOD levels in skin and erythrocytes of the study groups was found to be higher and lower , respectively in all patients after the treatment . No tissue parameters or erythrocyte GSH-Px were different from control levels at the end of the study . Significant clinical improvement and decreased PASI scores were observed in all patients . Post treatment TSH levels were higher in all patients , but these levels were within the reference range and none had clinical hypothyroidism . CONCLUSION These findings may provide some evidence for a potential role of increased lipid peroxidation and decreased antioxidant activity in psoriasis . PTU may be considered as treatment model in psoriasis , in particular for resistant cases , because of its antioxidant potential , and also antiproliferative and immunomodulatory effects BACKGROUND Psoriasis is a common , an inflammatory skin disease . Trace elements may play an active role in the pathogenesis of psoriasis . OBJECTIVE The aim of this study was to estimate the concentration of selenium ( Se ) , zinc ( Zn ) , copper ( Cu ) and Cu/Zn ratio as well as total antioxidant status ( TAS ) and c-reactive protein ( CRP ) in the serum of patients with psoriasis . METHODS In this case-control study sixty patients with psoriasis and fifty-eight healthy people were examined . Serum levels of Se , Zn and Cu were determined by atomic absorption spectrometry . Cu/Zn ratio was calculated . TAS was measured spectrophotometrically . CRP was analyzed by immunoturbidimetric method . Clinical activity of psoriasis was evaluated using Psoriasis Area and Severity Index ( PASI ) . RESULTS Serum concentration of Se in patients with psoriasis ( 71.89±16.90μg/L ) was lower as compared to the control group ( 79.42±18.97μg/L ) and after NB-UVB . Cu level of patients was higher ( 1.151±0.320mg/L ) as compared to controls ( 1.038±0.336mg/L ) , but Zn level did not differ . We observed higher Cu/Zn ratio ( p<0.05 ) in examined patients than in the control group and after NB-UVB . We found decrease TAS before and after NB-UVB . CRP levels was found to be normal range . A significant correlation coefficient between CRP and Cu/Zn was observed . CONCLUSIONS The study showed some disturbances in the serum levels of trace elements and TAS in psoriatic patients Background Psoriasis is a chronic , inflammatory skin condition associated with a high frequency of cardiovascular events . Modifications of plasma lipids , and an increase in the levels of biochemical markers of inflammation and lipid peroxidation have been reported in subjects with psoriasis , suggesting a relationship between psoriasis , inflammation and oxidative damage The aim of this research was to determine levels in blood of vitamin E , beta carotene , lipid peroxidation as malondialdehyde ( MDA ) , reduced glutathione ( GSH ) and glutathione peroxidase ( GSH-Px ) activity in patients with psoriasis . Studies were carried out on 34 patients with moderate and severe psoriases and healthy age-matched controls . Red blood cell ( RBC ) and plasma sample s from healthy and patient subjects were taken . Levels of GSH and the activity of GSH-Px in both plasma and RBC sample s were significantly ( P<0.001 ) lower in patients with psoriasis than in controls , whereas beta carotene levels in plasma and MDA levels in RBC sample s were significantly ( P<0.01 , P<0.001 ) higher in patients with psoriasis than in controls . However , vitamin E and MDA levels in plasma did not differ statistically . Although being far from conclusive , these results provide some evidence for a potential role of increased lipid peroxidation and decreased antioxidants in psoriasis
Output:
| Moreover , the combined results showed a significant difference in the TAS , MDA , and CAT levels in patients with mild vs. moderate psoriasis and moderate vs. severe psoriasis .
TAS and CAT levels in psoriasis patients were significantly lower than in healthy controls , whereas the TOS and MDA levels were significantly higher .
Furthermore , the TAS , MDA , and CAT levels are associated with the severity of disease .
These results indicate that redox imbalances play a major role in the pathogenesis of psoriasis |
MS211024 | ***TASK*** the task is to summarize an input biomedical literature in 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 : Tinnitus is experienced by up to 15 % of the population and can lead to significant disability and distress . There is rarely a medical or surgical target and psychological therapies are recommended . We investigated whether mindfulness-based cognitive therapy ( MBCT ) could offer an effective new therapy for tinnitus . Methods : This single-site r and omized controlled trial compared MBCT to intensive relaxation training ( RT ) for chronic , distressing tinnitus in adults . Both treatments involved 8 weekly , 120-min sessions focused on either relaxation ( RT ) or mindfulness meditation ( MBCT ) . Assessment s were completed at baseline and at treatment commencement 8 weeks later . The primary outcomes were tinnitus severity ( Tinnitus Question naire ) and psychological distress ( Clinical Outcomes in Routine Evaluation - Non-Risk , CORE-NR ) , 16 weeks after baseline . The analysis utilized a modified intention-to-treat approach . Results : A total of 75 patients were r and omly allocated to MBCT ( n = 39 ) or RT ( n = 36 ) . Both groups showed significant reductions in tinnitus severity and loudness , psychological distress , anxiety , depression , and disability . MBCT led to a significantly greater reduction in tinnitus severity than RT , with a mean difference of 6.3 ( 95 % CI 1.3 - 11.4 , p = 0.016 ) . Effects persisted 6 months later , with a mean difference of 7.2 ( 95 % CI 2.1 - 2.3 , p = 0.006 ) and a st and ardized effect size of 0.56 ( 95 % CI 0.16 - 0.96 ) . Treatment was effective regardless of initial tinnitus severity , duration , or hearing loss . Conclusions : MBCT is effective in reducing tinnitus severity in chronic tinnitus patients compared to intensive RT . It also reduces psychological distress and disability . Future studies should explore the generalizability of this approach and how outcome relates to different aspects of the intervention The Tinnitus Research Consortium ( TRC ) issued a Request for Proposals in 2003 to develop a new tinnitus outcome measure that would : ( 1 ) be highly sensitive to treatment effects ( vali date d for " responsiveness " ) ; ( 2 ) address all major dimensions of tinnitus impact ; and ( 3 ) be vali date d for scaling the negative impact of tinnitus . A grant was received by M. Meikle to conduct the study . In that observational study , all of the TRC objectives were met , with the final 25-item Tinnitus Functional Index ( TFI ) containing eight subscales . The study was published in 2012 , and since then the TFI has received increasing international use and is being translated into at least 14 language s. The present study utilized data from a r and omized controlled trial ( RCT ) that involved testing the efficacy of " telephone tinnitus education " as intervention for bothersome tinnitus . These data were used to confirm results from the original TFI study . Overall , the TFI performed well in the RCT with Cohen 's d being 1.23 . There were large differences between the eight different subscales , ranging from a mean 13.2-point reduction ( for the Auditory subscale ) to a mean 26.7-point reduction ( for the Relaxation subscale ) . Comparison of TFI performance was made with the Tinnitus H and icap Inventory . All of the results confirmed sensitivity of the TFI along with its subscales . This article is part of a Special Issue entitled Objectives Research suggests that an 8-week Mindfulness-Based Stress Reduction ( MBSR ) program ( a structured form of meditation ) might be effective in the treatment of various health problems including chronic pain . Our objective was to compare the clinical effectiveness of the MBSR program with a multidisciplinary pain intervention ( MPI ) program in terms of pain intensity , pain-related distress , quality of life , and mood in patients with chronic pain . Methods A r and omized , comparative clinical trial was conducted , including 6-month posttreatment follow-up . Ninety-nine participants , aged 24 to 64 years , with pain for a minimum of 3 months , were recruited from community-based clinics , hospitals , and community service centers . Participants were r and omly allocated to either the MBSR program ( 51 participants ) or a MPI program ( 48 participants ) . The study used vali date d Chinese versions of self-reported question naires measuring pain , mood symptoms , and health-related quality of life . Results Thirty-nine participants ( 77 % ) completed the MBSR program and 44 ( 90 % ) completed the MPI program . Patients in both the groups were comparable with regard to demographical characteristics , pain intensity , mood symptoms , and health-related quality -of-life measures before intervention . In both the groups , patients who completed the trial demonstrated statistically significant improvements in pain intensity and pain-related distress . However , no statistically significant differences were observed in overall results between the MBSR and MPI groups . Conclusions This r and omized , clinical trial showed that both MBSR and MPI programs reduced pain intensity and pain-related distress although no statistically significant differences were observed between the 2 groups and the improvements were small Background Tinnitus , the perception of sound in absence of an external acoustic source , impairs the quality of life in 2 % of the population . Since in most cases causal treatment is not possible , the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies . Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders . Here we conducted a r and omized , controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus . Methods Thirty-six patients were enrolled in this pilot study . The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy . Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks ( eleven hours/weekend ) and in four further two-hour sessions ( week 2 , 9 , 18 and 22 ) . Patients were r and omized to receive treatment either immediately or after waiting time , which served as a control condition . The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Question naire ( TQ ) . Results ANOVA testing for the primary outcome showed a significant interaction effect time by group ( F = 7.4 ; df = 1,33 ; p = 0.010 ) . Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups ( intervention group : t = 6.2 ; df = 17 ; p < 0.001 ; control group : t = 2.5 ; df = 16 ; p = 0.023 ) , but the intervention group improved more than the control group . Groups differed at week 7 and 9 , but not at week 24 as far as the TQ score was concerned . Conclusions Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes . The study is registered with clinical trials.gov ( NCT01540357 ) UNLABELLED We conducted a r and omized clinical trial to examine the relative effectiveness of two psychological interventions for treating tinnitus . People with tinnitus were initially offered a single session of psychoeducation about tinnitus , followed 2 months later by six weekly sessions of either mindfulness or relaxation training . Results indicated benefits from psychoeducation in reducing negative emotions , rumination and psychological difficulties of living with tinnitus . These effects were maintained or enhanced by mindfulness training that also emphasized acceptance , although they were eroded in the relaxation condition over the follow-up . Mediating processes are discussed , and suggestions for refining clinical interventions for this population are offered . KEY PRACTITIONER MESSAGE The present results suggest that mindfulness training might constitute a useful addition to psychoeducation for interventions targeting the psychological consequences of tinnitus BACKGROUND Chronic tinnitus is a frequent symptom presentation in clinical practice . No drug treatment to date has shown itself to be effective . The aim of the present study was to investigate the effects of cognitive behavioural therapy and meditation in tinnitus sufferers . METHODOLOGY Patients were selected from a dedicated tinnitus clinic in the Welsh Hearing Institute . A waiting list control design was used . Twenty-five chronic tinnitus sufferers were consecutively allocated to two groups , one receiving a cognitive behavioural therapy/meditation intervention of four one hour sessions with the other group waiting three months and subsequently treated in the same way , thereby acting as their own control . The main outcome was measured using the Hallam tinnitus question naire . A four to six month follow up was conducted . RESULTS These showed significant statistical reductions in tinnitus variables both in the active and also in the control group . Post-therapy , no significant change was found after the waiting list period . The improvement was maintained at the four to six month period . CONCLUSION The positive findings give support for the use of cognitive behavioural therapy/meditation for chronic tinnitus sufferers Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument & NA ; The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight‐session mindfulness meditation program for community‐dwelling older adults with chronic low back pain ( CLBP ) and to develop initial estimates of treatment effects . It was design ed as a r and omized , controlled clinical trial . Participants were 37 community‐dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day . Participants were r and omized to an 8‐week mindfulness‐based meditation program or to a wait‐list control group . Baseline , 8‐week and 3‐month follow‐up measures of pain , physical function , and quality of life were assessed . Eighty‐nine older adults were screened and 37 found to be eligible and r and omized within a 6‐month period . The mean age of the sample was 74.9 years , 21/37 ( 57 % ) of participants were female and 33/37 ( 89 % ) were white . At the end of the intervention 30/37 ( 81 % ) participants completed 8‐week assessment s. Average class attendance of the intervention arm was 6.7 out of 8 . They meditated an average of 4.3 days a week and the average minutes per day was 31.6 . Compared to the control group , the intervention group displayed significant improvement in the Chronic Pain Acceptance Question naire Total Score and Activities Engagement subscale ( P = .008 , P = .004 ) and SF‐36 Physical Function ( P = .03 ) . An 8‐week mindfulness‐based meditation program is feasible for older adults with CLBP . The program may lead to improvement in pain acceptance and physical function OBJECTIVE Psychotherapeutic interventions have been adopted effectively in the management of tinnitus for a long time . This study compared mindfulness meditation and relaxation therapy for management of tinnitus . METHODS In this r and omised controlled trial , patients were recruited for five sessions of mindfulness meditation or five sessions of relaxation therapy . Patients ' responses were evaluated using the Tinnitus Reaction Question naire as a primary outcome measure , and the Hospital Anxiety and Depression Scale , visual analogue scale and a health status indicator as secondary outcome measures . RESULTS A total of 86 patients were recruited . Thirty-four patients completed mindfulness meditation and 27 patients completed relaxation therapy . Statistically significant improvement was seen in all outcome measures except the health status indicator in both treatment groups . The change in treatment scores was greater in the mindfulness meditation group than in the relaxation therapy group . CONCLUSION This study suggests that although both mindfulness meditation and relaxation therapy are effective in the management of tinnitus , mindfulness meditation is superior to relaxation therapy OBJECTIVES Tinnitus is a very common experience , and although usually mild , in a significant proportion of people , it is intrusive , persistent , and disabling . This paper explores the lived experience of chronic disabling tinnitus , with the aim of underst and ing how distress and chronicity occur , and what might help to reduce this . DESIGN Nine individuals were interviewed 6 months after completing mindfulness-based cognitive therapy ( MBCT ) as part of a r and omized controlled trial . The results reported here focus on their experiences of tinnitus before receiving MBCT . METHODS Data were collected through semi-structured , face-to-face interviews with a clinical psychologist , and an interpretative phenomenological analysis approach was used . RESULTS Two supraordinate themes emerged . ' Living with tinnitus ' describes a range of significant and profound life changes that result from the condition . Tinnitus can be a life-altering condition affecting thoughts , emotions , attention , behaviour , and the social world . ' The health care journey ' shows how chronic distress was intensified by unhelpful health communications and alleviated by helpful consultations . CONCLUSIONS Tinnitus is a biopsychosocial condition , and associated distress is affected by cognitive , behavioural , attentional , and social factors . The individuals ' initial reactions to tinnitus interact with the responses of others , including health care professionals . The burden of tinnitus could be reduced by developing early interventions that
Output:
| Conclusions : A decrease of tinnitus distress scores in MBIs can be observed directly post-therapy based on moderate to high quality studies .
This was found regardless of the heterogeneity of patients , study design , type of MBI and outcome assessment .
No effect of MBIs was observed for depression and anxiety in tinnitus patients .
Long term effects remain uncertain . |
MS211025 | ***TASK*** the task is to summarize an input biomedical literature in 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 Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results OBJECTIVE To test the hypothesis that a custom-fit valgus knee brace and custom-made lateral wedge foot orthotic will have greatest effects on decreasing the external knee adduction moment during gait when used concurrently . DESIGN Proof-of-concept , single test session , crossover trial . SETTING Biomechanics laboratory within a tertiary care center . PARTICIPANTS Patients ( n=16 ) with varus alignment and knee osteoarthritis ( OA ) primarily affecting the medial compartment of the tibiofemoral joint ( varus gonarthrosis ) . INTERVENTIONS Custom-fit valgus knee brace and custom-made full-length lateral wedge foot orthotic . Amounts of valgus angulation and wedge height were tailored to each patient to ensure comfort . MAIN OUTCOME MEASURES The external knee adduction moment ( % body weight [BW]*height [ Ht ] ) , frontal plane lever arm ( cm ) , and ground reaction force ( N/kg ) , determined from 3-dimensional gait analysis completed under 4 r and omized conditions : ( 1 ) control ( no knee brace , no foot orthotic ) , ( 2 ) knee brace , ( 3 ) foot orthotic , and ( 4 ) knee brace and foot orthotic . RESULTS The reduction in knee adduction moment was greatest when concurrently using the knee brace and foot orthotic ( effect sizes ranged from 0.3 to 0.4 ) . The mean decrease in first peak knee adduction moment compared with control was .36 % BW*Ht ( 95 % confidence interval [ CI ] , -.66 to -.07 ) . This was accompanied by a mean decrease in frontal plane lever arm of .59 cm ( 95 % CI , -.94 to -.25 ) . CONCLUSIONS These findings suggest that using a custom-fit knee brace and custom-made foot orthotic concurrently can produce a greater overall reduction in the knee adduction moment , through combined effects in decreasing the frontal plane lever arm We examined if a subject-specific amount of lateral wedge added to a foot orthosis could alter knee mechanics to potentially reduce the progression of knee osteoarthritis in patients with medial knee osteoarthritis . Twenty individuals with medial knee osteoarthritis ( > /=2 Kellgren Lawrence grade ) were prescribed a custom laterally wedged foot orthotic device . The prescribed wedge amount was the minimal wedge amount that provided the maximum amount of pain reduction during a lateral step-down test . Following an accommodation period , all subjects returned to the laboratory for a gait analysis . Knee mechanics were collected as the subjects walked at an intentional walking speed . Walking in the laterally wedged orthotic device significantly reduced the peak adduction moment during early stance ( p < 0.01 ) compared to the nonwedged device . Similarly , the wedged orthotic device significantly reduced the knee adduction excursion from heel strike to peak adduction ( p < 0.01 ) compared to the nonwedged device . No differences in the peak adduction moment during propulsion or peak adduction during stance were observed between the orthotic conditions . A subject-specific laterally wedged orthotic device was able to reduce the peak knee adduction moment during early stance , which is thought to be associated with the progression of knee osteoarthritis . Previous studies on this device have reported issues associated with foot discomfort when using wedge amounts > 7 degrees ; however , no such issues were reported in this study . Therefore , providing a custom laterally wedged orthotic device may potentially increase compliance while still potentially reducing disease progression OBJECTIVE To compare the clinical effects of laterally wedged insoles and neutrally wedged insoles ( used as control ) in patients with medial femoro-tibial knee osteoarthritis ( OA ) . DESIGN 6-month prospect i ve r and omized controlled study . PATIENTS out patients with painful medial femoro-tibial knee OA . OUTCOME MEASURES patient 's overall assessment of disease activity ( 5 grade scale ) , WOMAC index subscales and concomitant treatments . STATISTICAL ANALYSIS Performed as an intention-to-treat analysis . Main criterion : improvement in the patient 's assessment of activity ( defined as a reduction of 1 grade or more at month 6 compared to baseline , and no intraarticular injection or lavage during the study ) . Secondary criteria for assessment : ( a ) improvement in the patient 's assessment of activity at months 1 and 3 compared to baseline , ( b ) improvement in the WOMAC subscales at months 1 , 3 and 6 , compared to baseline ( defined as an improvement of at least 30 % , and no intraarticular injection or lavage during the study ) and ( c ) concomitant therapies ( analgesics and NSAIDs ) . RESULTS The baseline characteristics of the 156 recruited patients ( 41 males , 115 females , mean age 64.8 years ) were not different in the two treatment groups . At months 1 , 3 and 6 the percentages of patients with improvement in assessment of disease activity , in WOMAC pain , joint stiffness , and physical functioning subscales were similar in the two groups . The number of days with NSAIDs intake during the previous 3 months was decreased at month 6 compared with baseline in the group furnished with laterally wedged insoles ( 14.1 days+/-28 vs 9.9 days+/-27 , P=0.04 , Wilcoxon paired test ) , while it remained unchanged in the other group ( 15.5 days+/-24 vs 15+/-28 , P=0.56 ) . Compliance and tolerance were satisfactory . Compliance was different between the two groups at month 6 , with a greater frequency of patients who wore insoles permanently in the laterally wedged insole group than in the other group ( 87.8 % vs 74.3%;P=0.032 ) . CONCLUSION This study failed to demonstrate a relevant short-term symptomatic effect of laterally-wedged insoles in medial femoro-tibial OA . However , the decrease in NSAIDs consumption together with better compliance in the treated group are in favor of a beneficial effect of laterally-wedged insoles in medial femoro-tibial OA Objective This study aim ed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis ( OA ) declined after one month of wear , and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month . Methods Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i ) no insoles and ; ii ) insoles wedged laterally 5 ° in r and om order . Testing occurred at baseline and after one month of use of the insoles . Participants recorded daily use of insoles in a log-book . Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse , compared across conditions and time with repeated measures general linear models . Correlations were obtained between total insole use and change in gait parameters with used insoles at one month , and change scores were compared between high and low users of insoles using general linear models . Results There was a significant main effect for condition , whereby insoles significantly reduced the adduction moment ( all p < 0.001 ) . However there was no significant main effect for time , nor was an interaction effect evident . No significant associations were observed between total insole use and change in gait parameters with used insoles at one month , nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time . Conclusion Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use , suggesting that significant wedge degradation does not occur over the short-term 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 Pronated foot posture is associated with many clinical and biomechanical outcomes unique to medial compartment knee osteoarthritis ( OA ) . Though shoe-worn insole treatment , including lateral wedges , is commonly studied in this patient population , their effects on the specific subgroup of people with medial knee OA and concomitant pronated feet are unknown . The purpose of this study was to evaluate whether lateral wedge insoles with custom arch support are more beneficial than lateral wedge insoles alone for knee and foot symptoms in people with medial tibiofemoral knee osteoarthritis ( OA ) and pronated feet . Methods Twenty-six people with pronated feet and symptomatic medial knee OA participated in a r and omized crossover study comparing five degree lateral wedge foot insoles with and without custom foot arch support . Each intervention was worn for two months , separated by a two-month washout period of no insoles wear . Main outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain and physical function subscales , the revised short-form Foot Function Index ( FFI-R ) pain and stiffness subscales , and the timed stair climb test . Regression modeling was conducted to examine treatment , period , and interaction effects . Results Twenty-two participants completed the study , and no carryover or interaction effects were observed for any outcome . Significant treatment effects were observed for the timed stair climb , with greater improvements seen with the lateral wedges with arch support . Within-condition significant improvements were observed for WOMAC pain and physical function , as well as FFI-R pain and stiffness with lateral wedges with arch support use . More adverse effects were reported with the lateral wedges alone , while more people preferred the lateral wedges with arch support overall . Conclusions Addition of custom arch support to a st and ard lateral wedge insole may improve foot and knee symptoms in people with knee OA and concomitant pronated feet . These preliminary findings suggest further research evaluating the role of shoe-worn insoles for treatment of this specific sub-group of people with knee OA is warranted . Trial registration Clinical trials.gov identifier : NCT02234895 Background The results of conservative treatment of knee osteoarthritis ( OA ) are generally evaluated in epidemiological studies with clinical outcome measures as primary outcomes . Biomechanical evaluation of orthoses shows that there are potentially beneficial biomechanical changes to joint loading ; however , evaluation in relation to clinical outcome measures in longitudinal studies is needed . Questions / purpose sWe asked ( 1 ) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace ; ( 2 ) is there a late ( 6 weeks ) effect ; and ( 3 ) is there a difference between subgroups within each group with respect to patient compliance , body mass index , and OA status ? Methods This was a secondary analysis of data from a previous r and omized controlled trial of patients with early medial knee OA . A total of 91 patients were enrolled in that trial , and 73 ( 80 % ) completed it after 6 months . Of the enrolled patients , 80 ( 88 % ) met prespecified inclusion criteria for analysis in the present study . The patients were r and omized to an insole or brace . Gait was analyzed with and without wearing the orthosis ( insole or brace ) at baseline and after 6 weeks . Measurements were taken of the knee adduction moment , ground reaction force , moment arm , walking speed , and toe-out angle . Data were analyzed with regression analyses based on an intention-to-treat principle . Results A mean reduction of 4 % ( ± 10 ) ( 95 % confidence interval [ CI ] , −0.147 to −0.03 , p = 0.003 ) of the peak knee adduction moment and 4 % ( ± 13 ) ( 95 % CI , −0.009 to −0.001 , p = 0.01 ) of the moment arm
Output:
| ConclusionS ystematic review and meta- analysis suggests that lateral wedge insoles cause an overall slight reduction in the biomechanical parameters .
Higher degrees do not show higher reductions than lower degrees . |
MS211026 | ***TASK*** the task is to summarize an input biomedical literature in 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 Currently available pharmacological and non-pharmacological treatments have shown only modest effects in slowing the progression of dementia . Our objective was to assess the impact of a long-term non-pharmacological group intervention on cognitive function in dementia patients and on their ability to carry out activities of daily living compared to a control group receiving the usual care . Methods A r and omized , controlled , single-blind longitudinal trial was conducted with 98 patients ( follow-up : n = 61 ) with primary degenerative dementia in five nursing homes in Bavaria , Germany . The highly st and ardized intervention consisted of motor stimulation , practice in activities of daily living , and cognitive stimulation ( acronym MAKS ) . It was conducted in groups of ten patients led by two therapists for 2 hours , 6 days a week for 12 months . Control patients received treatment as usual . Cognitive function was assessed using the cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-Cog ) , and the ability to carry out activities of daily living using the Erlangen Test of Activities of Daily Living ( E-ADL test ) at baseline and after 12 months . Results Of the 553 individuals screened , 119 ( 21.5 % ) were eligible and 98 ( 17.7 % ) were ultimately included in the study . At 12 months , the results of the per protocol analysis ( n = 61 ) showed that cognitive function and the ability to carry out activities of daily living had remained stable in the intervention group but had decreased in the control patients ( ADAS-Cog : adjusted mean difference : -7.7 , 95 % CI -14.0 to -1.4 , P = 0.018 , Cohen 's d = 0.45 ; E-ADL test : adjusted mean difference : 3.6 , 95 % CI 0.7 to 6.4 , P = 0.015 , Cohen 's d = 0.50 ) . The effect sizes for the intervention were greater in the subgroup of patients ( n = 50 ) with mild to moderate disease ( ADAS-Cog : Cohen 's d = 0.67 ; E-ADL test : Cohen 's d = 0.69 ) . Conclusions A highly st and ardized , non-pharmacological , multicomponent group intervention conducted in a nursing-home setting was able to postpone a decline in cognitive function in dementia patients and in their ability to carry out activities of daily living for at least 12 months . Trial Registration http://www.is rct n.com Identifier : IS RCT BACKGROUND Reality orientation therapy combined with cholinesterase inhibitors has not been evaluated in patients with Alzheimer 's disease . AIMS To perform such an evaluation . METHOD We r and omly assigned 79 of 156 patients treated with donepezil to receive a reality orientation programme . Caregivers of the treatment group were trained to offer the programme at home 3 days a week , 30 min/day , for 25 consecutive weeks , and were invited to stimulate and involve patients in reality-based communication . RESULTS The treatment group showed a slight improvement in Mini-Mental State Examination ( MMSE ) scores ( mean change + 0.2 , s.e.=0.4 ) compared with a decline in the control group ( mean change -1.1 , s.e.=0.4 ; P=0.02 ) . Similarly for the Alzheimer 's Disease Assessment Scale -- Cognition ( treatment group mean change + 0.4 , s.e.=0.8 ; control group -2.5 , s.e.=0.8 ; P=0.01 ) . The intervention had an equal effect on cognition in those with mild ( MMSE score > or = 20 ) and moderate ( score < 20 ) dementia . No significant effect was observed for behavioural and functional outcomes . CONCLUSIONS Reality orientation enhances the effects of donepezil on cognition in Alzheimer 's disease We compared reality orientation with reminiscence therapy for elderly people in a large residential home , using a controlled cross-over design . Both kinds of therapy group were enjoyed by both staff and residents , and enabled staff to get to know moderately and severely confused residents . The group that received reality orientation followed by reminiscence therapy showed improvement in cognitive and behavioural measures which was not found in the other two groups . It may be important to use reality orientation techniques with confused residents before involving them in a reminiscence group Background The Promoting Action on Research Implementation in Health Services framework , or PARIHS , is a conceptual framework that posits key , interacting elements that influence successful implementation of evidence -based practice s. It has been widely cited and used as the basis for empirical work ; however , there has not yet been a literature review to examine how the framework has been used in implementation projects and research . The purpose of the present article was to critically review and synthesize the literature on PARIHS to underst and how it has been used and operationalized , and to highlight its strengths and limitations . Methods We conducted a qualitative , critical synthesis of peer- review ed PARIHS literature published through March 2009 . We synthesized findings through a three-step process using semi-structured data abstract ion tools and group consensus . Results Twenty-four articles met our inclusion criteria : six core concept articles from original PARIHS authors , and eighteen empirical articles ranging from case reports to quantitative studies . Empirical articles generally used PARIHS as an organizing framework for analyses . No studies used PARIHS prospect ively to design implementation strategies , and there was generally a lack of detail about how variables were measured or mapped , or how conclusions were derived . Several studies used findings to comment on the framework in ways that could help refine or vali date it . The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships . Strengths identified included its flexibility , intuitive appeal , explicit acknowledgement of the outcome of ' successful implementation , ' and a more expansive view of what can and should constitute ' evidence . ' Conclusions While we found studies reporting empirical support for PARIHS , the single greatest need for this and other implementation models is rigorous , prospect i ve use of the framework to guide implementation projects . There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements ; greater conceptual discrimination among sub-elements may be necessary first . In general , it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies Several data suggest that physical activity and cognitive stimulation have a positive effect on the quality of life ( QoL ) of people with Alzheimer ’s disease ( AD ) , slowing the decline due to the disease . A pilot project was undertaken to assess the effect of cognitive stimulation , physical activity , and socialization on patients with AD and their informal caregiver ’s QoL and mood . Fourteen patients with AD were r and omly divided into active treatment group and control group . At the end of treatment , a significant improvement in apathy , anxiety , depression , and QoL in the active treatment group was found . Considering caregivers , those of the active treatment group exhibited a significant improvement in their mood and in their perception of patients ’ QoL. This study provides evidence that a combined approach based on cognitive stimulation , physical activity , and socialization is a feasible tool to improve mood and QoL in patients with AD and their caregivers BACKGROUND Psychological therapy groups for people with dementia are widely used , but their cost-effectiveness has not been explored . AIMS To investigate the cost-effectiveness of an evidence -based cognitive stimulation therapy ( CST ) programme for people with dementia as part of a r and omised controlled trial . METHOD A total of 91 people with dementia , living in care homes or the community , received a CST group intervention twice weekly for 8 weeks ; 70 participants with dementia received treatment as usual . Service use was recorded 8 weeks before and during the 8-week intervention and costs were calculated . A cost-effectiveness analysis was conducted with cognition as the primary outcome , and quality of life as the secondary outcome . Cost-effectiveness acceptability curves were plotted . RESULTS Cognitive stimulation therapy has benefits for cognition and quality of life in dementia , and costs were not different between the groups . Under reasonable assumptions , there is a high probability that CST is more cost-effective than treatment as usual , with regard to both outcome measures . CONCLUSIONS Cognitive stimulation therapy for people with dementia has effectiveness advantages over , and may be more cost-effective than , treatment as usual Current methodology has made popular the pragmatic r and omized trial ( Foster & Little , 2012 ) and has led to an acknowledged growth of high- quality research in the ‘ new generation ’ of psychosocial interventions in dementia care ( Orrell , 2012 ) . However , many trials of psychosocial interventions in dementia lack impact . It is not clear whether this reflects a genuine ineffectiveness , since the methodology used in dementia care research is at present weak in addressing the important distinction between genuine ineffectiveness and an implementation error . Therefore , potentially effective dementia care interventions that may have a positive impact on patient experience can fail to show effectiveness , thereby reducing treatment options and wasting research money . Method ological discussion s about the success and failure of interventions in dementia care within the European INTERDEM group of multi-professional research ers on psychosocial dementia care ( www.interdem.org/ ) led to a critical analysis of the suitability of the current methodology . This has often relied on the Medical Research Council ’s ( MRC ) Framework for complex interventions and its iterations ( Campbell et al. , 2000 ; Craig et al. , 2008 ; Craig & Petticrew , 2013 ) . Foster and Little ( 2012 ) pinpoint an important obstacle to improving clinical practice as the legacy of ‘ simple ’ drug therapy evaluations which are engrained in the design and conduct of the pragmatic trial , a view that can also be extended more generally to the interpretation and conduct of the MRC framework for complex interventions and its method ologies . The advantage of pragmatic trials is their proximity to daily practice in routine health care setting s. This has particular implication s for the design and conduct of psychosocial intervention research in dementia , where the important distinction between poor attention to implementation and genuine ineffectiveness is often overlooked . Furthermore , better attention to the implication s of this proximity in the design and conduct of psychosocial intervention research trials may reduce the need for a separate large-scale implementation study phase in the way that this is currently conceived within the MRC approach to complex interventions ( Craig et al. , 2008 ; Craig & Petticrew , 2013 ) . This is an urgent issue for psychosocial intervention research in dementia care as today 35.6 million people and families worldwide live with dementia ( Prince et al. , 2013 ) , whilst major pharmaceutical advances in prevention and cure remain elusive ( Miller , 2012 ) . The predicted future growth of dementia cases over the next decade will undoubtedly raise the already high costs of care , estimated at US$ 604 billion in 2010 ( Wimo et al. , 2013 ) , in an illness that is most feared people over the age of 55 years ( Le Couteur , Doust , Creasey , & Brayne , 2013 ) , since it can undermine core human capacities result ing in decline in quality of life ( Selkoe , 2012 ) . Although cure for dementia is not available for dementia patients , we are not empty h and ed . Psychosocial intervention research has emerged as today ’s forerunner , given its aim to improve daily practice among professionals who provide support to people and families living with dementia . Psychosocial interventions in dementia involve interactions between people to improve psychological and social functioning ( Moniz-Cook , Vernooij-Dassen , Woods , & Orrell , 2011 ; Rabins et al. , 2007 ) , such as cognitive stimulation therapy ( Woods , Aguirre , Spector , & Orrell , 2012 ) , occupational therapy ( Graff et al. , 2006 ) and support programmes for family carers ( Vernooij-Dassen , Draskovic , McCleery , & Downs , 2011 ) . This paper outlines the rationale for a paradigm shift in the design and methodology for evaluation of complex interventions in applied dementia care research . We use psychosocial intervention research as an exemplar of how research ers and their funders may achieve better value for money This r and omized study evaluated the combined effect of a cognitive-communication program plus an acetylcholinesterase inhibitor ( donepezil ; donepezil-plus-stimulation group ; n = 26 ) , as compared with donepezil alone ( donepezil-only group ; n = 28 ) in 54 patients with mild to moderate Alzheimer 's disease ( AD ; Mini-Mental Status Examination score of 12- 28 ) ranging in age from 54 to 91 years . It was hypothesized that cognitive-communication stimulation in combination with donepezil would positively affect the following : ( a ) relevance of discourse , ( b ) performance of functional abilities , ( c ) emotional symptoms , ( d ) quality of life , and ( e ) overall global function , as measured by caregiver and participant report and st and ardized measures . Cognitive-communication , neuropsychiatric , functional performance , and quality of life evaluations were conducted at baseline and Month 4 , the month after the 2-month active stimulation period . Follow-up evaluations were performed at Months 8 and 12 . The stimulation program consisted of 12 hr of intervention over an 8-week period and involved participant-led discussion s requiring homework , interactive sessions about AD , and discussion s using salient life stories . Additive effects of active stimulation with donepezil were examined in 2 ways : ( 1 ) comparing mean group performance over time and ( 2 ) evaluating change scores from baseline . A Group x Time interaction was found for the donepezil-plus-
Output:
| According to the checklist the most comprehensive and ready to implement version of cognitive stimulation was Cognitive Stimulation Therapy .
Conclusions Reports of interventions rarely include consideration of implementation in practice .
This study was able to show that the ImpRess checklist was feasible in practice and reliable .
The checklist may be useful in evaluating readiness for implementation for other manualised interventions |
MS211027 | ***TASK*** the task is to summarize an input biomedical literature in 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 restricted sequential design multicentre controlled trial of yttrium-90 against triamcinolone intra-articularly was undertaken in patients with rheumatoid arthritis with knee involvement . The trial had to be discontinued because of dwindling recruitment over time . The reasons for this and other features contributing to an inconclusive outcome are noted . This experience lends little encouragement to the idea that yttrium-90 therapy is more or less advantageous than triamcinolone hexacetonide The use of irradiation of the synovium in the treatment of rheumatoid arthritis is presented . A colloidal resin of radioactive yttrium ( 90Y ) or saline was injected intra-articularly into 44 knee joints under double blind conditions . Patients selected for treatment had chronic effusions which were resistant to all forms of therapy , other than surgical synovectomy . All patients were followed up for one year . There was a sustained improvement in joint range in 13 cases ( 57 per cent ) and of knee circumference in eight cases ( 35 per cent ) ( P < 0.005 and < 0.05 respectively ) compared with the control . In seven patients ( 30 per cent ) the joint effusion had completely resolved . Intra-articular yttrium had no advantage over saline for the prevention of radiological deterioration of the joint . Irradiation of the synovium produced a significant reduction in the acid phosphatase concentration of the synovial fluid . One-third of the patients developed general and local reactions to the 90Y injection Irradiation of the synovium for the treatment of chronic knee effusions associated with rheumatoid arthritis and allied conditions is being increasingly used as an alternative to surgical synovectomy . Intraarticular injections of a colloidal solution of radioactive gold ( 19"8Au ) has been tried with some success ( Ansell , Crook , Mallard , and Bywaters , 1963 ; Virkkunen , Krusius , and Heiskanen , 1967 ; Makin and Robin , 1968 ; Grahame , Ramsey , and Scott , 1970 ) . However , as 198Au has a beta-particle maximum range in tissue of only 4 mm . and as the synovium in these chronic knee effusions can attain a thickness of greater than 1 cm . , a complete synovial ablation is not produced . A serious disadvantage of intraarticular 198Au is that there may be marked leakage from the joint to the regional lymph nodes , the liver , and spleen in as many as 36 per cent . of patients so treated ( Virkkunnen and others , 1967 ) . Moreover , radioactive gold possesses a significant gamma-ray component and this gives an unwanted whole body radiation to the patient . Because of these disadvantages it has been suggested that radioactive yttrium ( 90Y ) may be a more suitable agent ( Ansell and others , 1963 ; Grahame and others , 1970 ) . 90Y is a pure beta-emitter with a maximum range in tissue of 10 mm . It has a higher maximum energy than gold , 2 26 MeV compared with 0 9 MeV , and it has a half-life of 2 - 7 days . The whole body distribution of 90Y silicate and 90Y resin after intraarticular injections has been compared ( Prichard , Bridgman , and Bleehen , 1970 ) . It was found that silicate preparations were associated with an appreciable leakage from the joint , but that the resin remained localized . It has also been shown that the 90Y resin was taken up more or less evenly in both normal and inflamed rabbit synovia ( Webb , Lowe , and Bluestone , 1969 ) . We have therefore undertaken a controlled double-blind trial , using intra-articular 90Y resin in the treatment of chronic knee effusions . The preliminary results after assessment of all cases 6 months after the intra-articular injections are presented In 66 patients with rheumatoid knee joint synovitis and hydrops and with only slight radiological destruction , local treatment of the knee was r and omly performed either with osmic acid , radioactive yttrium or surgical synovectomy . After a one-year follow-up the clinical and radiological results were slightly better in patients who underwent surgical synovectomy than in other treatment groups . However , radiological osteoarthrosis had progressed more in synovectomized patients than in others . In 2 patients with radioactive yttrium a relapse requiring surgical synovectomy was seen . Because osmic acid is almost as effective as surgical synovectomy , is very cheap and easy to perform , it can be recommended as the first choice for local therapy in patients with corticosteroid-restant knee joint synovitis , in the early stage of the disease Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists In an open , controlled trial , radioactive 90Yttrium was injected in doses of 3 - 6 mCi into 40 joints with chronic effusions in patients suffering from rheumatoid arthritis and other rheumatoid diseases . The processing in a computer was carried out by the punch card method . Intra-articular administration of 90Y result ed in a significant improvement of five objective criteria . In our study we have paid particular attention to the clinical and statistical differentiation of the effects of systemic , and especially of basic therapy , from the effects of topical intra-articular therapy . At the time of the last check-up examination , 43 % of the patients were free of any effusion . The treatment was well tolerated . Skin necrosis occurred in only one single case . Intra-articular treatment with radioactive 90Yttrium represents a valuable contribution to the therapeutic arsenal for the treatment of the chronic articular effusions when all other methods of treatment failed The effectiveness of osmic acid and yttrium-90 in the treatment of synovitis of the knee in rheumatoid arthritis is compared in 126 patients followed-up for 3 years . Ninety-one knees were injected with osmic acid and eighty-four knees with yttrium-90 . Osmic acid appeared to be more effective than yttrium-90 throughout the period of the follow-up but the difference only reached statistical significance ( p less than 0.05 ) at 3 years . Both therapies were well tolerated by patients and should be considered as an alternative to operative synovectomy
Output:
| CONCLUSION From the point of view of evidence based medicine it should be seriously question ed whether yttrium synovectomy deserves a place in clinical practice |
MS211028 | ***TASK*** the task is to summarize an input biomedical literature in 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 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 Background Bipolar disorder is highly recurrent and rates of comorbidity are high . Studies have pointed to anxiety comorbidity as one factor associated with risk of suicide attempts and poor overall outcome . This study aim ed to explore the feasibility and potential benefits of a new psychological treatment ( Mindfulness-based Cognitive Therapy : MBCT ) for people with bipolar disorder focusing on between-episode anxiety and depressive symptoms . Methods The study used data from a pilot r and omized trial of MBCT for people with bipolar disorder in remission , focusing on between-episode anxiety and depressive symptoms . Immediate effects of MBCT versus waitlist on levels of anxiety and depression were compared between unipolar and bipolar participants . Results The results suggest that MBCT led to improved immediate outcomes in terms of anxiety which were specific to the bipolar group . Both bipolar and unipolar participants allocated to MBCT showed reductions in residual depressive symptoms relative to those allocated to the waitlist condition . Limitations Analyses were based on a small sample , limiting power . Additionally the study recruited participants with suicidal ideation or behaviour so the findings can not immediately be generalized to individuals without these symptoms . Conclusions The study , although preliminary , suggests an immediate effect of MBCT on anxiety and depressive symptoms among bipolar participants with suicidal ideation or behaviour , and indicates that further research into the use of MBCT with bipolar patients may be warranted Weekly affective symptom severity and polarity were compared in 135 bipolar I ( BP I ) and 71 bipolar II ( BP II ) patients during up to 20 yr of prospect i ve symptomatic follow-up . The course of BP I and BP II was chronic ; patients were symptomatic approximately half of all follow-up weeks ( BP I 46.6 % and BP II 55.8 % of weeks ) . Most bipolar disorder research has concentrated on episodes of MDD and mania and yet minor and subsyndromal symptoms are three times more common during the long-term course . Weeks with depressive symptoms predominated over manichypomanic symptoms in both disorders ( 31 ) in BP I and BP II at 371 in a largely depressive course ( depressive symptoms=59.1 % of weeks vs. hypomanic=1.9 % of weeks ) . BP I patients had more weeks of cyclingmixed polarity , hypomanic and subsyndromal hypomanic symptoms . Weekly symptom severity and polarity fluctuated frequently within the same bipolar patient , in which the longitudinal symptomatic expression of BP I and BP II is dimensional in nature involving all levels of affective symptom severity of mania and depression . Although BP I is more severe , BP II with its intensely chronic depressive features is not simply the lesser of the bipolar disorders ; it is also a serious illness , more so than previously thought ( for instance , as described in DSM-IV and ICP-10 ) . It is likely that this conventional view is the reason why BP II patients were prescribed pharmacological treatments significantly less often when acutely symptomatic and during intervals between episodes . Taken together with previous research by us on the long-term structure of unipolar depression , we su bmi t that the thrust of our work during the past decade supports classic notions of a broader affective disorder spectrum , bringing bipolarity and recurrent unipolarity closer together . However the genetic variation underlying such a putative spectrum remains to be clarified OBJECTIVES People in the late stage of bipolar disorder ( BD ) experience elevated relapse rates and poorer quality of life ( QoL ) compared with those in the early stages . Existing psychological interventions also appear less effective in this group . To address this need , we developed a new online mindfulness-based intervention targeting quality of life ( QoL ) in late stage BD . Here , we report on an open pilot trial of ORBIT ( online , recovery-focused , bipolar individual therapy ) . METHODS Inclusion criteria were : self-reported primary diagnosis of BD , six or more episodes of BD , under the care of a medical practitioner , access to the internet , proficient in English , 18 - 65 years of age . Primary outcome was change ( baseline - post-treatment ) on the Brief QoL.BD ( Michalak and Murray , 2010 ) . Secondary outcomes were depression , anxiety , and stress measured on the DASS scales ( Lovibond and Lovibond , 1993 ) . RESULTS Twenty-six people consented to participate ( Age M=46.6 years , SD=12.9 , and 75 % female ) . Ten participants were lost to follow-up ( 38.5 % attrition ) . Statistically significant improvement in QoL was found for the completers , t(15)=2.88 , 95 % CI:.89 - 5.98 , p=.011 , ( Cohen׳s dz=.72 , partial η(2)=.36 ) , and the intent-to-treat sample t(25)=2.65 , 95 % CI:.47 - 3.76 , ( Cohen׳s dz=.52 ; partial η(2)=.22 ) . A non-significant trend towards improvement was found on the DASS anxiety scale ( p=.06 ) in both completer and intent-to-treat sample s , but change on depression and stress did not approach significance . LIMITATIONS This was an open trial with no comparison group , so measured improvements may not be due to specific elements of the intervention . Structured diagnostic assessment s were not conducted , and interpretation of effectiveness was limited by substantial attrition . CONCLUSION Online delivery of mindfulness-based psychological therapy for late stage BD appears feasible and effective , and ORBIT warrants full development . Modifications suggested by the pilot study include increasing the 3 weeks duration of the intervention , adding caution s about the impact of extended meditations , and addition of coaching support/monitoring to optimise engagement In many clinical setting s , there is a high comorbidity between substance use disorders , psychiatric disorders , and traumatic stress . Novel therapies are needed to address these co-occurring issues efficiently . The aim of the present study was to conduct a pragmatic r and omized controlled trial comparing Mindfulness-Oriented Recovery Enhancement ( MORE ) to group Cognitive-Behavioral Therapy ( CBT ) and treatment-as-usual ( TAU ) for previously homeless men residing in a therapeutic community . Men with co-occurring substance use and psychiatric disorders , as well as extensive trauma histories , were r and omly assigned to 10 weeks of group treatment with MORE ( n = 64 ) , CBT ( n = 64 ) , or TAU ( n = 52 ) . Study findings indicated that from pre-to post-treatment MORE was associated with modest yet significantly greater improvements in substance craving , post-traumatic stress , and negative affect than CBT , and greater improvements in post-traumatic stress and positive affect than TAU . A significant indirect effect of MORE on decreasing craving and post-traumatic stress by increasing dispositional mindfulness was observed , suggesting that MORE may target these issues via enhancing mindful awareness in everyday life . This pragmatic trial represents the first head-to-head comparison of MORE against an empirically-supported treatment for co-occurring disorders . Results suggest that MORE , as an integrative therapy design ed to bolster self-regulatory capacity , may hold promise as a treatment for intersecting clinical conditions This study evaluated mindfulness-based cognitive therapy ( MBCT ) , a group intervention design ed to train recovered recurrently depressed patients to disengage from dysphoria-activated depressogenic thinking that may mediate relapse/recurrence . Recovered recurrently depressed patients ( n = 145 ) were r and omized to continue with treatment as usual or , in addition , to receive MBCT . Relapse/recurrence to major depression was assessed over a 60-week study period . For patients with 3 or more previous episodes of depression ( 77 % of the sample ) , MBCT significantly reduced risk of relapse/recurrence . For patients with only 2 previous episodes , MBCT did not reduce relapse/recurrence . MBCT offers a promising cost-efficient psychological approach to preventing relapse/recurrence in recovered recurrently depressed patients BACKGROUND Bipolar disorder ( BD ) is a chronic and disabling psychiatric disorder characterized by recurrent episodes of mania/hypomania and depression . Dialectical behavior therapy ( DBT ) techniques have been shown to effectively treat borderline personality disorder , a condition also marked by prominent affective disturbances . The utility of DBT techniques in treating BD has been largely unexplored . The purpose of this research was to conduct a pilot study of a DBT-based psychoeducational group ( BDG ) in treating euthymic , depressed , or hypomanic Bipolar I or II patients . METHODS In this experiment , 26 adults with bipolar I or II were r and omized to intervention or wait-list control groups and completed the Beck depression inventory II , mindfulness-based self-efficacy scale , and affective control scale at baseline and 12 weeks . The BDG intervention consisted of 12 weekly 90-min sessions which taught DBT skills , mindfulness techniques , and general BD psychoeducation . RESULTS Using RM-ANOVA , subjects in BDG demonstrated a trend toward reduced depressive symptoms , and significant improvement in several MSES subscales indicating greater mindful awareness , and less fear toward and more control of emotional states ( ACS ) . These findings were supported with a larger sample of patients who completed the BDG . Furthermore , group attendees had reduced emergency room visits and mental health related admissions in the six months following BDG . LIMITATIONS The small sample size in RCT affects power to detect between group differences . How well improvements after the12-week BDG were maintained is unknown . CONCLUSIONS There is preliminary evidence that DBT skills reduce depressive symptoms , improve affective control , and improve mindfulness self-efficacy in BD . Its application warrants further evaluation in larger studies Introduction : Bipolar disorder is characterized by recurrent episodes of depression and /or mania along with interepisodic mood symptoms that interfere with psychosocial functioning . Despite periods of symptomatic recovery , many individuals with bipolar disorder continue to experience substantial residual mood symptoms that often lead to the recurrence of mood episodes BACKGROUND The present open study investigates the feasibility of Mindfulness-based cognitive therapy ( MBCT ) in groups solely composed of bipolar patients of various subtypes . MBCT has been mostly evaluated with remitted unipolar depressed patients and little is known about this treatment in bipolar disorder . METHODS Bipolar out patients ( type I , II and NOS ) were included and evaluated for depressive and hypomanic symptoms , as well as mindfulness skills before and after MBCT . Patients ' expectations before the program , perceived benefit after completion and frequency of mindfulness practice were also recorded . RESULTS Of 23 included patients , 15 attended at least four MBCT sessions . Most participants reported having durably , moderately to very much benefited from the program , although mindfulness practice decreased over time . Whereas no significant increase of mindfulness skills was detected during the trial , change of mindfulness skills was significantly associated with change of depressive symptoms between pre- and post-MBCT assessment s. CONCLUSIONS MBCT is feasible and well perceived among bipolar patients . Larger and r and omized controlled studies are required to further evaluate its efficacy , in particular regarding depressive and (hypo)manic relapse prevention . The mediating role of mindfulness on clinical outcome needs further examination and efforts should be provided to enhance the persistence of meditation practice with time
Output:
| Our meta- analysis showed significantly beneficial effects on depressive and anxiety symptoms of BD patients in within-group analysis .
However , this significance was not observed in comparison with the control groups . |
MS211029 | ***TASK*** the task is to summarize an input biomedical literature in 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: Article abstract —We examined the pattern of neuroanatomic abnormalities in adults with Down 's syndrome ( DS ) and the cognitive correlates of these abnormalities . Specifically , we compared this pattern with what would be predicted by the hypotheses attributing DS pathology to either premature aging or Alzheimer 's disease . We measured a number of brain regions on MRIs of 25 subjects : 13 persons with the DS phenotype and 12 age- and sex-matched healthy volunteers . Study participants had no history of cardiovascular disease , diabetes , thyroid dysfunction , or seizure disorder . After statistical adjustment for differences in body size , we found that , in comparison with controls , DS subjects had substantially smaller cerebral and cerebellar hemispheres , ventral pons , mammillary bodies , and hip-pocampal formations . In the cerebellar vermis of DS subjects , we observed smaller lobules VI to VIII without appreciable differences in other regions . In addition , we noted trends for shrinkage of the dorsolateral prefrontal cortex , anterior cingulate gyrus , inferior temporal and parietal cortices , parietal white matter , and pericalcarine cortex in DS subjects compared with normal controls . The parahippocampal gyrus was larger in DS subjects . We found no significant group differences in the volumes of the prefiontal white matter , the orbitofiontal cortex , the pre- and post central gyri , or the basal ganglia . We conclude that the pattern of selective cerebral damage in DS does not clearly fit the predictions of the premature aging or Alzheimer 's disease hypotheses . To examine the relationship between brain abnormalities and cognitive deficits observed in DS , we correlated the size of brain regions that were significantly reduced in DS with performance on tests of intelligence and language . The correlational analysis suggested age-related decline in the DS subjects in general intelligence and basic linguistic skills . General intelligence and mastery of linguistic concepts correlated negatively with the volume of the parahippocampal gyrus . There was no relationship between total brain size and the cognitive variables BACKGROUND While neuropathological studies indicate a high risk for Alzheimer 's disease in adults with Down 's syndrome , neuropsychological studies suggest a lower prevalence of dementia . In this study , cognitive deterioration in adults with Down 's syndrome was examined prospect ively over 4 years to establish rates and profiles of cognitive deterioration . METHODS Fifty-seven people with Down 's syndrome aged 30 years or older were assessed using a battery of neuropsychological tests on five occasions across 50 months . Assessment s of domains of cognitive function known to change with the onset of Alzheimer related dementia were employed . These included tests of learning , memory , orientation , agnosia , apraxia and aphasia . The individual growth trajectory methodology was used to analyse change over time . RESULTS Severe cognitive deterioration , such as acquired , apraxia and agnosia , was evident in 28.3 % of those aged over 30 and a higher prevalence of these impairments was associated with older age . The rate of cognitive deterioration also increased with age and degree of pre-existing cognitive impairment . Additionally , deterioration in memory , learning and orientation preceded the acquisition of aphasia , agnosia and apraxia . CONCLUSIONS The prevalence of cognitive impairments consistent with the presence of Alzheimer 's disease is lower than that suggested by neuropathological studies . The pattern of the acquisition of cognitive impairments in adults with Down 's syndrome is similar to that seen in individuals with Alzheimer 's disease who do not have Down 's syndrome Frontotemporal dementia ( FTD ) is often misdiagnosed as Alzheimer ’s disease ( AD ) . We hypothesized that the first symptoms associated with FTD would be different from those seen in AD and that the first symptoms in FTD would reflect loss of function in the frontal region with the greatest degree of degeneration . The objective of the study was to compare the earliest symptoms in patients with FTD and AD , and to delineate the symptoms that were associated with right , left or bilateral frontotemporal degeneration in FTD . The first symptoms in 52 FTD and 101 AD patients were determined in retrospect . Based on functional imaging studies , the FTD patients were divided into those with predominantly bilateral ( n = 15 ) , left-sided ( n = 19 ) and right-sided ( n = 18 ) patterns of atrophy . The results showed that disinhibition , social awkwardness , passivity and loss of executive function were more common in FTD , while memory loss was more common in AD . Disinhibition was greatest in the asymmetric right-sided group , language dysfunction was commonest in the asymmetric left-sided group and loss of executive function was most frequent in the bilateral group . In summary , different first symptoms appeared in FTD and AD , which may help distinguish between the diseases . The anatomic site for FTD largely determined the kind of first symptoms BACKGROUND The clinical and neuropathological features associated with dementia in Down 's syndrome ( DS ) are not well established . Aims To examine clinico-pathological correlations and the incidence of cognitive decline in a cohort of adults with DS . METHOD A total of 92 hospitalized persons with DS were followed up from 1985 to December 2000 . At outset , 87 participants were dementia-free , with a median age of 38 years . Assessment s included the Prudhoe Cognitive Function Test ( PCFT ) and the Adaptive Behavior Scale ( ABS ) , to measure cognitive and behavioural deterioration . Dementia was diagnosed from case records and caregivers ' reports . RESULTS Eighteen ( 21 % ) patients developed dementia during follow-up , with a median age of onset 55.5 years ( range 45 - 74 ) . The PCFT demonstrated cognitive decline among those with a less severe intellectual disability ( mild and moderate ) but not among the profoundly disabled people ( severe and profound ) . Clinical dementia was associated with neuropathological features of Alzheimer 's disease , and correlated with neocortical neurofibrillary tangle densities . At the age of 60 years and above , a little more than 50 % of patients still alive had clinical evidence of dementia . CONCLUSIONS Clinical dementia associated with measurable cognitive and functional decline is frequent in people with DS after middle age , and can be readily diagnosed among less severely intellectually disabled persons using measures of cognitive function such as the PCFT and behavioural scales such as the ABS . In the more profoundly disabled people , the diagnosis of dementia is facilitated by the use of behavioural and neurological criteria . In this study , the largest prospect i ve DS series including neuropathology on deceased patients , the density of neurofibrillary tangles related more closely to the dementia of DS than senile plaques . In people with DS surviving to middle and old age , the development of dementia of Alzheimer type is frequent but not inevitable , and some people with DS reach old age without clinical features of dementia CYP17 and CYP19 are involved in the peripheral synthesis of estrogens , and polymorphisms in CYP17 and CYP19 have been associated with increased risk of estrogen-related disorders . Women with Down syndrome ( DS ) have early onset and high risk for Alzheimer 's disease ( AD ) . We conducted a prospect i ve community-based cohort study to examine the relationship between SNPs in CYP17 and CYP19 and cumulative incidence of AD , hormone levels and sex hormone binding globulin in women with DS . Two hundred and thirty-five women with DS , 31 to 67 years of age and nondemented at initial examination , were assessed for cognitive and functional abilities , behavioral/psychiatric conditions , and health status at 14 - 20 month intervals over five assessment cycles . We genotyped these individuals for single-nucleotide polymorphisms ( SNPs ) in CYP17 and CYP19 . Four SNPs in CYP17 were associated with a two and one half-fold increased risk of AD , independent of APOE genotype . Four SNPs in CYP19 were associated with a two-fold increased risk of AD , although three were significant only in those without an APOE ε4 allele . Further , carrying high risk alleles in both CYP17 and CYP19 was associated with an almost four-fold increased risk of AD ( OR = 3.8 , 95 % CI , 1.6 - 9.5 ) and elevated sex hormone binding globulin in postmenopausal women . The main effect of the CYP17 and CYP19 variants was to decrease the age at onset . These findings suggest that genes contributing to estrogen bioavailability influence risk of AD in women with DS Research based on retrospective reports by carers suggests that the presentation of dementia in people with Down 's syndrome may differ from that typical of Alzheimer 's disease ( AD ) in the general population , with the earliest changes tending to be in personality or behaviour rather than in memory . This is the first long‐term prospect i ve study to test the hypothesis that such changes , which are more typical of dementia of frontal type ( DFT ) in the general population , mark the pre clinical stage of AD in DS BACKGROUND Recent research has suggested a specific impairment in frontal-lobe functioning in the pre clinical stages of Alzheimer 's disease ( AD ) in people with Down 's syndrome ( DS ) , characterised by prominent changes in personality or behaviour . The aim of the current paper is to explore whether particular kinds of change ( namely executive dysfunction ( EDF ) , disinhibition and apathy ) , associated in the literature with disruption of different underlying frontal-subcortical circuits , are a ) more or less frequently reported than others and b ) related to poor performance on tasks involving different cognitive processes . METHOD Seventy-eight participants ( mean age 47 years , range 36 - 72 ) with DS and mild to moderate intellectual disability ( based on ICD-10 criteria ) , without a diagnosis of dementia of Alzheimer 's type ( DAT ) or other psychiatric disorders , were selected from a larger sample of older adults with DS ( n = 122 ) . Dementia diagnosis was based on the CAMDEX informant interview , conducted with each participant 's main carer . Informant-reported changes in personality/behaviour and memory were recorded . Participants were scored based on symptoms falling into three behavioural domains and completed five executive function ( EF ) tasks , six memory tasks ( two of which also had a strong executive component ) and the BPVS ( as a measure of general intellectual ability ) . Multiple regression analyses were conducted to determine the degree to which the behavioural variables of ' EDF ' , ' disinhibition ' and ' apathy ' , along with informant-reported memory decline and antidepressant medication use , predicted performance on the cognitive tasks ( whilst controlling for the effects of age and general intellectual ability ) . RESULTS Strikingly , disinhibited behaviour was reported for 95.7 % of participants with one or more behavioural change ( n = 47 ) compared to 57.4 % with reported apathy and 36.2 % with reported EDF . ' Disinhibition ' score significantly predicted performance on three EF tasks ( design ed to measure planning , response inhibition and working memory ) and an object memory task , ( also thought to place high dem and s on working memory ) , while ' apathy ' score significantly predicted performance on two different tasks , those measuring spatial reversal and prospect i ve memory ( p < 0.05 ) . Informant reported memory decline was associated only with performance on a delayed recall task while antidepressant medication use was associated with better performance on a working memory task ( p < 0.05 ) . CONCLUSION Observed dissociation between performance on cognitive tasks associated with reported apathy and disinhibition is in keeping with proposed differences underlying neural circuitry and supports the involvement of multiple frontal-subcortical circuits in the early stages of DAT in DS . However , the prominence of disinhibition in the behavioural profile ( which more closely resembles that of disinhibited subtype of DFT than that of AD in the general population ) leads us to postulate that the serotonergically mediated orbitofrontal circuit may be disproportionately affected . A speculative theory is developed regarding the biological basis for observed changes and discussion is focused on how this underst and ing may aid us in the development of treatments directly targeting underlying abnormalities BACKGROUND Prevalence of Alzheimer 's disease in people with Down 's syndrome is very high , and many such individuals who are older than 40 years have pathological changes characteristic of Alzheimer 's disease . Evidence to support treatment with Alzheimer 's drugs is inadequate , although memantine is beneficial in transgenic mice . We aim ed to assess safety and efficacy of memantine on cognition and function in individuals with Down 's syndrome . METHODS In our prospect i ve r and omised double-blind trial , we enrolled adults ( > 40 years ) with karyotypic or clinical ly diagnosed Down 's syndrome , with and without dementia , at four learning disability centres in the UK and Norway . We r and omly allocated participants ( 1:1 ) to receive memantine or placebo for 52 weeks by use of a computer-generated sequence and a minimisation algorithm to ensure balanced allocation for five prognostic factors ( sex , dementia , age group , total Down 's syndrome attention , memory , and executive function scales [ DAMES ] score , and centre ) . The primary outcome was change in cognition and function , measured with DAMES scores and the adaptive behaviour scale ( ABS ) parts I and II . We analysed differences in DAMES and ABS scores between groups with analyses of covariance or quantile regression in all patients who completed the 52 week assessment and had available follow-up data . This study is registered , number IS RCT N47562898 .
Output:
| We conducted a systematic review selecting studies employing cognitive assessment s. Summary : We identified few studies using objective measurements to determine whether cognitive aspects associated with the frontal lobe correlate with dementia in this population .
We observed a tendency toward such correlations . |
MS211030 | ***TASK*** the task is to summarize an input biomedical literature in 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 a double-blind trial in which a pulsed infrared beam was compared with a placebo in the treatment of myofascial pain in the cervical region . The patients were su bmi tted to 12 sessions on alternate days to a total energy dose of 5 J each . At each session , the four most painful muscular trigger points and five bilateral homometameric acupuncture points were irradiated . Those in the placebo group su bmi tted to the same number of sessions following an identical procedure , the only difference being that the laser apparatus was nonoperational . Pain was monitored using the Italian version of the McGill pain question naire and the Scott-Huskisson visual analogue scale . The results show a pain attenuation in the treated group and a statistically significant difference between the two groups of patients , both at the end of therapy and at the 3-month follow-up examination OBJECTIVE The objective of the study was to investigate clinical effects of low-level laser therapy ( LLLT ) in patients with acute neck pain with radiculopathy . DESIGN Double-blind , r and omized , placebo-controlled study . SETTING The study was carried out between January 2005 and September 2007 at the Clinic for Rehabilitation at the Medical School , University of Bel grade , Serbia . PATIENTS AND INTERVENTION Sixty subjects received a course of 15 treatments over 3 weeks with active or an inactivated laser as a placebo procedure . LLLT was applied to the skin projection at the anatomical site of the spinal segment involved with the following parameters : wavelength 905 nm , frequency 5,000 Hz , power density of 12 mW/cm(2 ) , and dose of 2 J/cm(2 ) , treatment time 120 seconds , at whole doses 12 J/cm(2 ) . OUTCOME MEASURES The primary outcome measure was pain intensity as measured by a visual analog scale . Secondary outcome measures were neck movement , neck disability index , and quality of life . Measurements were taken before treatment and at the end of the 3-week treatment period . RESULTS Statistically significant differences between groups were found for intensity of arm pain ( P = 0.003 , with high effect size d = 0.92 ) and for neck extension ( P = 0.003 with high effect size d = 0.94 ) . CONCLUSION LLLT gave more effective short-term relief of arm pain and increased range of neck extension in patients with acute neck pain with radiculopathy in comparison to the placebo procedure OBJECTIVE We aim ed to evaluate the effectiveness of laser therapy in myofascial pain syndrome treatment . BACKGROUND DATA Myofascial pain syndrome is a disease that is characterized by hypersensitive points called trigger points found in one or more muscles and /or connective tissues . It can cause pain , muscle spasm , sensitivity , stiffness , weakness , limitation of range of motion and rarely autonomic dysfunction . Physical therapy modalities and exercise are used in the treatment of this frequently encountered disease . METHODS The placebo controlled , prospect i ve , long-term follow up study was planned with 60 patients who had trigger points in their upper trapezius muscles . The patients were divided into three groups r and omly . Stretching exercises were taught to each group and they were asked to exercise at home . Treatment duration was 4 weeks . Placebo laser was applied to group 1 , dry needling to group 2 and laser to group 3 . He-Ne laser was applied to three trigger points in the upper trapezius muscles on both sides with 632.8 nm . The patients were assessed at before , post-treatment , and 6 months after-treatment for pain , cervical range of motion and functional status . RESULTS We observed a significant decrease in pain at rest , at activity , and increase in pain threshold in the laser group compared to other groups . Improvement according to Nottingham Health Profile gave the superiority of the laser treatment . However , those differences among the groups were not observed at 6-month follow up . CONCLUSIONS Laser therapy could be useful as a treatment modality in myofascial pain syndrome because of its noninvasiveness , ease , and short-term application Abstract A r and omized , double‐blind , placebo‐controlled study of low‐level laser therapy ( LLLT ) in 90 subjects with chronic neck pain was conducted with the aim of determining the efficacy of 300 mW , 830 nm laser in the management of chronic neck pain . Subjects were r and omized to receive a course of 14 treatments over 7 weeks with either active or sham laser to tender areas in the neck . The primary outcome measure was change in a 10 cm Visual Analogue Scale ( VAS ) for pain . Secondary outcome measures included Short‐Form 36 Quality ‐of‐Life question naire ( SF‐36 ) , Northwick Park Neck Pain Question naire ( NPNQ ) , Neck Pain and Disability Scale ( NPAD ) , the McGill Pain Question naire ( MPQ ) and Self‐Assessed Improvement ( SAI ) in pain measured by VAS . Measurements were taken at baseline , at the end of 7 weeks ' treatment and 12 weeks from baseline . The mean VAS pain scores improved by 2.7 in the treated group and worsened by 0.3 in the control group ( difference 3.0 , 95 % CI 3.8–2.1 ) . Significant improvements were seen in the active group compared to placebo for SF‐36‐Physical Score ( SF36 PCS ) , NPNQ , NPAD , MPQVAS and SAI . The results of the SF‐36 – Mental Score ( SF36 MCS ) and other MPQ component scores ( afferent and sensory ) did not differ significantly between the two groups . Low‐level laser therapy ( LLLT ) , at the parameters used in this study , was efficacious in providing pain relief for patients with chronic neck pain over a period of 3 months Low-energy laser therapy has been applied in several rheumatoid and soft tissue disorders with varying rates of success . The objective of our study was to investigate the effect of laser therapy on cervical myofascial pain syndrome with a placebo-controlled double-blind prospect i ve study model . It was performed with a total of 53 patients ( 35 females and 18 males ) with cervical myofascial pain syndrome . In group 1 ( n=23 ) , GaAs laser treatment was applied over three trigger points bilaterally and also one point in the taut b and s in trapezius muscle bilaterally with a frequency of 1000 Hz for 2 min over each point once a day for 10 days during a period of 2 weeks . In group 2 ( n=25 ) , the same treatment protocol was given , but the laser instrument was switched off during applications . All patients in both groups were instructed to perform daily isometric exercises and stretching just short of pain for 2 weeks at home . Evaluations were performed just before treatment ( week 0 ) , immediately after ( week 2 ) , and 12 weeks later ( week 14 ) . Evaluation parameters included pain , algometric measurements , and cervical lateral flexion . Statistical analysis was done on data collected from three evaluation stages . The results were evaluated in 48 patients ( 32 females , 16 males ) . Week 2 and week 14 results showed significant improvement in all parameters for both groups . However , comparison of the percentage changes both immediately and 12 weeks after treatment did not show a significant difference relative to pretreatment values . In conclusion , the results of our study have not shown the superiority of GaAs laser therapy over placebo in the treatment of cervical myofascial pain syndrome , but we suggest that further studies on this topic be done using different laser types and dosages in larger patient population & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies BACKGROUND AND OBJECTIVES A prospect i ve , double-blind , r and omized , and controlled trial was conducted in patients with chronic myofascial pain syndrome ( MPS ) in the neck to evaluate the effects of infrared low level 904 nm Gallium-Arsenide ( Ga-As ) laser therapy ( LLLT ) on clinical and quality of life ( QoL ) . STUDY DESIGN / PATIENTS AND METHODS The study group consisted of 60 MPS patients . Patients were r and omly assigned to two treatment groups : Group I ( actual laser ; 30 patients ) and Group II ( placebo laser ; 30 patients ) . LLLT continued daily for 2 weeks except weekends . Follow-up measures were evaluated at baseline , 2 , 3 , and 12 weeks . All patients were evaluated with respect to pain at rest , pain at movement , number of trigger points ( TP ) , the Neck Pain and Disability Visual Analog Scale ( NPAD ) , Beck depression Inventory ( BDI ) , and the Nottingham Health Profile ( NHP ) . RESULTS In active laser group , statistically significant improvements were detected in all outcome measures compared with baseline ( P < 0.01 ) while in the placebo laser group , significant improvements were detected in only pain score at rest at the 1 week later of the end of treatment . The score for self-assessed improvement of pain was significantly different between the active and placebo laser groups ( 63 vs. 19 % ) ( P < 0.01 ) . CONCLUSION This study revealed that short-period application of LLLT is effective in pain relief and in the improvement of functional ability and QoL in patients with MPS The efficacy of low-level laser therapy ( LLLT ) in myofascial pain syndrome ( MPS ) seems controversial . A prospect i ve , double-blind , r and omized controlled trial was conducted in patients with chronic MPS in the neck to evaluate the effects of low-level 830-nm gallium arsenide aluminum ( Ga – As – Al ) laser therapy . The study group consisted of 64 MPS patients . The patients were r and omly assigned into two groups . In group 1 ( n = 32 ) , Ga – As – Al laser treatment was applied over three trigger points bilaterally for 2 min over each point once a day for 15 days during a period of 3 weeks . In group 2 ( n = 32 ) , the same treatment protocol was given , but the laser instrument was switched off during applications . All patients in both groups performed daily isometric exercise and stretching exercises for cervical region . Parameters were measured at baseline and after 4 weeks . All patients were evaluated with respect to pain ( at rest , movement , and night ) and assessed by visual analog scale , measurement of active range of motion using an inclinometer and a goniometer , and the neck disability index . In both groups , statistically significant improvements were detected in all outcome measures compared with baseline ( p < 0.05 ) . However , no significant differences were obtained between the two groups ( p > 0.05 ) . In conclusion , although the laser therapy has no superiority over placebo groups in this study , we can not exclude the possibility of effectivity with another treatment regimen including different laser wavelengths and dosages ( different intensity and density and /or treatment interval ) Abstract : Pain is a major symptom in cervical osteoarthritis ( COA ) . Low-power laser ( LPL ) therapy has been cl aim ed to reduce pain in musculoskeletal pathologies , but there have been concerns about this point . The aim of this study was to evaluate the analgesic efficacy of LPL therapy and related functional changes in COA . Sixty patients between 20 and 65 years of age with clinical ly and radiologically diagnosed COA were included in the study . They were r and omised into two equal groups according to the therapies applied , either with LPL or placebo laser . Patients in each group were investigated blindly in terms of pain and pain-related physical findings , such as increased paravertebral muscle spasm , loss of lordosis and range of neck motion restriction before and after therapy . Functional improvements were also evaluated . Pain , paravertebral muscle spasm , lordosis angle , the range of neck motion and function were observed to improve significantly in the LPL group , but no improvement was found in the placebo group . LPL seems to be successful in relieving pain and improving function in osteoarthritic
Output:
| The benefit seen in the use of LLLT , although statistically significant , does not constitute the threshold of minimally important clinical difference |
MS211031 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND African Americans have a disproportionate burden of hypertension and comorbid disease . Pharmacogenetic markers of blood pressure response have yet to be defined clearly . This study explores the association between G-protein-coupled receptor kinase type 4 ( GRK4 ) variants and blood pressure response to metoprolol among African Americans with early hypertensive nephrosclerosis . METHODS Participants from the African American Study of Kidney Disease and Hypertension ( AASK ) trial were genotyped at three GRK4 polymorphisms : R65L , A142V , and A486V . A Cox proportional hazards model , stratified by gender , was used to determine the relationship between GRK4 variants and time to reach a mean arterial pressure ( MAP ) of 107 mm Hg , adjusted for other predictors of blood pressure response . Potential interactions between the three polymorphisms were explored by analyzing the effects of gene haplotypes and by stratifying the analysis by neighboring sites . RESULTS The hazard ratio with 95 % confidence interval by A142V among men r and omized to a usual MAP ( 102 - 107 mm Hg ) was 1.54 ( 1.11 - 2.44 ; P = 0.0009 ) . The hazard ratio by A142V with R65/L65 or L65/L65 was 2.14 ( 1.35 - 3.39 ; P = 0.001 ) . Haplotype analyses were consistent but inconclusive . There was no association between A142V and blood pressure response among women . CONCLUSIONS Results suggest a sex-specific relationship between GRK4 A142V and blood pressure response among African-American men with early hypertensive nephrosclerosis . Men with a GRK4 A142 were less responsive to metoprolol if they had a GRK4 L65 variant . The effect of GRK4 variants and blood pressure response to metoprolol should be studied in larger clinical trials A single-blind , placebo-controlled study was conducted to compare the inhibitory effects of intravenous propranolol on exercise-induced tachycardia in eight matched pairs of healthy black and white volunteers , consisting of equal numbers of men and women . At the beginning of each test session , subjects were exercised on a bicycle ergometer -- the load predetermined to increase their heart rates to 160 - 190 beats/min . Exactly 30 min after having received an intravenous injection of placebo or propranolol ( the dose varying from 0.0125 to 0.15 mg/kg ) , they were subjected to the same exercise load . Heart rates were continuously recorded throughout exercise periods , and readings at 6 , 8 , and 10 min were compared for pre- and postinjection periods . A washout period of at least 3 days was allowed to elapse between sessions . Postinjection reductions of heart rate in blacks were compared with postinjection reductions in their white counterparts . Analysis of results indicated that the dose-response curve for the heart rate reduction result ing from propranolol for blacks was shifted to the right with respect to that for whites . In clinical terms , this means that to achieve the same degree of beta-blockade in blacks , a larger dose of propranolol is required than for whites , but that the same maximum is attainable In a double-blind , outcome trial conducted in hypertensive patients r and omized to chlorthalidone ( C ) , amlodipine ( A ) , lisinopril ( L ) , or doxazosin ( D ) , the α-adducin Gly460Trp polymorphism was typed ( n=36 913 ) . Mean follow-up was 4.9 years . Relative risks ( RRs ) of chlorthalidone versus other treatments were compared between genotypes ( Gly/Gly+Gly/Trp versus Trp/Trp ) . Primary outcome was coronary heart disease ( CHD ) . Coronary heart disease incidence did not differ among treatments or genotypes nor was there any interaction between treatment and genotype ( P=0.660 ) . Subgroup analyses indicated that Trp allele carriers had greater CHD risk with C versus A+L in women ( RR=1.31 ) but not men ( RR=0.91 ) with no RR gender differences for non-carriers ( gender – gene – treatment interaction , P=0.002 ) . The α-adducin gene is not an important modifier of antihypertensive treatment on cardiovascular risk , but women Trp allele carriers may have increased CHD risk if treated with C versus A or L. This must be confirmed to have implication s for hypertension treatment Purpose : To explore the association between CYP3A4 and CYP3A5 gene polymorphisms and blood pressure response to amlodipine among participants from the African-American Study of Kidney Disease and Hypertension Trial r and omized to amlodipine ( n = 164 ) . Methods : Cox proportional hazards models were used to determine the risk of reaching a target mean arterial pressure ( MAP ) of ≤107 mm Hg by CYP3A4 ( A–392 G and T16090C ) and CYP3A5 ( A6986 G ) gene polymorphisms , stratified by MAP r and omization group ( low or usual ) and controlling for other predictors for blood pressure response . Results : Women r and omized to a usual MAP goal with an A allele at CYP3A4 A–392 G were more likely to reach a target MAP of 107 mm Hg . The adjusted hazard ratio ( AA/AG compared to GG ) with 95 % confidence interval was 3.41 ( 1.20–9.64 ; p = 0.020 ) . Among participants r and omized to a lower MAP goal , those with the C allele at CYP3A4 T16090C were more likely to reach target MAP : The adjusted hazard ratio was 2.04 ( 1.17–3.56 ; p = 0.010 ) . After adjustment for multiple testing using a threshold significance level of p = 0.016 , only the CYP3A4 T16090C SNP remained significant . CYP3A5 A6986 G was not associated with blood pressure response . Conclusions : Our findings suggest that blood pressure response to amlodipine among high-risk African-Americans appears to be determined by CYP3A4 genotypes , and sex specificity may be an important consideration . Clinical applications of CYP3A4 genotype testing for individualized treatment regimens warrant further study OBJECTIVES The purpose of this study was to evaluate the efficacy and tolerability of monotherapy with the selective aldosterone blocker eplerenone in both black and white patients with hypertension . BACKGROUND Essential hypertension and cardiovascular-renal-target organ damage is more prevalent in black than white adults in the U.S. METHODS Black ( n = 348 ) and white ( n = 203 ) patients with mild-to-moderate hypertension were r and omized to double-blind treatment with eplerenone 50 mg , the angiotensin II receptor antagonist losartan 50 mg , or placebo once daily . Doses were increased if blood pressure remained uncontrolled . The primary end point was change in mean diastolic blood pressure ( DBP ) after 16 weeks of therapy . RESULTS Adjusted mean changes from baseline in DBP were -5.3 + /- 0.7 , -10.3 + /- 0.7 , and -6.9 + /- 0.6 mm Hg in the placebo , eplerenone-treated , and losartan-treated groups , respectively ( mean + /- SE , p < 0.001 eplerenone vs. placebo , p < 0.001 eplerenone vs. losartan ) . In black patients , DBP decreased by -4.8 + /- 1.0 , -10.2 + /- 0.9 , and -6.0 + /- 0.9 mm Hg for the placebo , eplerenone-treated , and losartan-treated groups , respectively ( mean + /- SE , p < 0.001 eplerenone vs. placebo , p < 0.001 eplerenone vs. losartan ) , whereas in white patients , DBP decreased by -6.4 + /- 1.0 , -11.1 + /- 1.1 , and -8.4 + /- 1.0 mm Hg , respectively ( p = 0.001 eplerenone vs. placebo , p = 0.068 for eplerenone vs. losartan ) . For reduction of systolic blood pressure ( SBP ) , eplerenone was superior to placebo and losartan in all patients combined and in black patients , and was superior to placebo in white patients . Eplerenone was as effective as losartan in reducing SBP and DBP in the high renin patient , but more effective than losartan in the low renin patient . Similarly , eplerenone was at least as effective as losartan in patients with differing baseline levels of aldosterone . Both eplerenone and losartan were well tolerated . CONCLUSIONS The antihypertensive effect of eplerenone was equal in black and white patients and was superior to losartan in black patients Background — We previously hypothesized that high activity of creatine kinase , the central regulatory enzyme of energy metabolism , facilitates the development of high blood pressure . Creatine kinase rapidly provides adenosine triphosphate to highly energy-dem and ing processes , including cardiovascular contraction , and antagonizes nitric oxide – mediated functions . Relatively high activity of the enzyme , particularly in resistance arteries , is thought to enhance pressor responses and increase blood pressure . Tissue creatine kinase activity is reported to be high in black people , a population subgroup with greater hypertension risk ; the proposed effects of high creatine kinase activity , however , are not “ race dependent . ” We therefore assessed whether creatine kinase is associated with blood pressure in a multiethnic population . Methods and Results — We analyzed a stratified r and om sample of the population of Amsterdam , the Netherl and s , consisting of 1444 citizens ( 503 white European , 292 South Asian , 580 black , and 69 of other ethnicity ) aged 34 to 60 years . We used linear regression analysis to investigate the association between blood pressure and normal serum creatine kinase after rest , as a substitute measure of tissue activity . Creatine kinase was independently associated with blood pressure , with an increase in systolic and diastolic pressure , respectively , of 8.0 ( 95 % CI , 3.3 to 12.7 ) and 4.7 ( 95 % CI , 1.9 to 7.5 ) mm Hg per log creatine kinase increase after adjustment for age , sex , body mass index , and ethnicity . Conclusions — Creatine kinase is associated with blood pressure . Further studies are needed to explore the nature of this association , including how variation in cardiovascular creatine kinase activity may affect pressor responses Objectives In the vast majority of cases the cause for hypertension is not known . On the basis of observations from black and multiethnic population s , it has been hypothesized that a genetically high tissue creatine kinase activity may be an independent factor responsible for primary hypertension . If the relation between creatine kinase and blood pressure is causal , it is reasonable to believe that it will be independent of ethnicity and present in different population s. In this cross-sectional study , we examined whether creatine kinase was associated with blood pressure in a large Caucasian normal population . Methods and results Data on creatine kinase and blood pressure were analyzed in a r and om sample of 12 776 men and women ( 65 % of those eligible ) , aged 30–87 years from a normal population in the municipality of Tromsø , Norway . We used linear regression to model the association between creatine kinase and blood pressure . Creatine kinase was independently associated with blood pressure . A one unit increase in log CK was associated with a 3.3 ( 95 % CI 1.4–5.2 ) mmHg increase in systolic blood pressure and a 1.3 ( 95 % CI 0.3–2.3 ) mmHg increase in diastolic blood pressure , after adjustment for age , sex , body mass index , s-glucose , s-creatinine , physical activity and alcohol consumption . The creatine kinase effect on blood pressure was independent of antihypertensive medication , and no difference in creatine kinase level was found between those with controlled and uncontrolled hypertension ( geometric mean 101 vs. 104 IU/l , P = 0.1 ) . Conclusion Creatine kinase was associated with blood pressure in this population BACKGROUND Age and race categories or renin profiling have been recommended to predict blood pressure responses to monotherapy with a beta-blocker or thiazide diuretic . Whether these or other characteristics predict blood pressure responses when the drugs are administered as add-on therapy is uncertain . METHODS We evaluated predictors of blood pressure response in 363 men and women < or = 65 years of age with primary hypertension ( 152 blacks , 211 whites ) , 86 of whom ( 24 % ) were untreated and 277 of whom ( 76 % ) were withdrawn from previous antihypertensive drugs before r and omization to either atenolol followed by addition of hydrochlorothiazide ( N = 180 ) or hydrochlorothiazide followed by addition of atenolol ( N = 183 ) . Responses were determined by home blood pressure averages before and after each drug administration . Race , age , plasma renin activity , and other characteristics including pretreatment blood pressure levels were incorporated into linear
Output:
| Pharmacokinetics , plasma renin and genetic polymorphisms did notwell predict the response of patients of African ancestry toantihypertensive drugs .
Conclusion Available data are inconclusive regarding why patients of African ancestrydisplay the typical response to antihypertensive drugs .
In lieu ofbiochemical or pharmacogenomic parameters , self-defined African ancestryseems the best available predictor of individual responses toantihypertensive drugs |
MS211032 | ***TASK*** the task is to summarize an input biomedical literature in 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 —Recent clinical studies have demonstrated that hypothermia to 32 ° to 34 ° C provides significant clinical benefit when induced after resuscitation from cardiac arrest . However , cooling during the postresuscitation period was slow , requiring 4 to 8 hours to achieve target temperatures after return of spontaneous circulation ( ROSC ) . Whether more rapid cooling would further improve survival remains unclear . We sought to determine whether cooling during cardiac arrest before ROSC ( ie , “ intra-arrest ” hypothermia ) has survival benefit over more delayed post-ROSC cooling , using a murine cardiac arrest model . Methods and Results —A model of potassium-induced cardiac arrest was established in C57BL/6 mice . After 8 minutes of untreated cardiac arrest , resuscitation was attempted with chest compression , ventilation , and intravenous fluid . Mice were r and omized to 3 treatment groups ( n=10 each ) : an intra-arrest hypothermia group , in which mice were cooled to 30 ° C just before attempted resuscitation , and then rewarmed after 1 hour ; a post-ROSC hypothermia group , in which mice were kept at 37 ° C for 20 minutes after successful ROSC and then were cooled to 30 ° C for 1 hour ; and a normothermic control group , in which mice were kept at 37 ° C . The intra-arrest hypothermia group demonstrated better 72-hour survival than delayed hypothermia and normothermia groups ( 6/10 versus 1/10 and 1/10 survivors , respectively , P < 0.05 ) , with similar differences seen at 6-hour survival and on neurological scoring . Conclusions —Timing of hypothermia is a crucial determinant of survival in the murine arrest model . Early intra-arrest cooling appears to be significantly better than delayed post-ROSC cooling or normothermic resuscitation Background — Therapeutic hypothermia is recommended for the treatment of neurological injury after resuscitation from out-of-hospital cardiac arrest . Laboratory studies have suggested that earlier cooling may be associated with improved neurological outcomes . We hypothesized that induction of therapeutic hypothermia by paramedics before hospital arrival would improve outcome . Methods and Results — In a prospect i ve , r and omized controlled trial , we assigned adults who had been resuscitated from out-of-hospital cardiac arrest with an initial cardiac rhythm of ventricular fibrillation to either prehospital cooling with a rapid infusion of 2 L of ice-cold lactated Ringer 's solution or cooling after hospital admission . The primary outcome measure was functional status at hospital discharge , with a favorable outcome defined as discharge either to home or to a rehabilitation facility . A total of 234 patients were r and omly assigned to either paramedic cooling ( 118 patients ) or hospital cooling ( 116 patients ) . Patients allocated to paramedic cooling received a median of 1900 mL ( first quartile 1000 mL , third quartile 2000 mL ) of ice-cold fluid . This result ed in a mean decrease in core temperature of 0.8 ° C ( P=0.01 ) . In the paramedic-cooled group , 47.5 % patients had a favorable outcome at hospital discharge compared with 52.6 % in the hospital-cooled group ( risk ratio 0.90 , 95 % confidence interval 0.70 to 1.17 , P=0.43 ) . Conclusions — In adults who have been resuscitated from out-of-hospital cardiac arrest with an initial cardiac rhythm of ventricular fibrillation , paramedic cooling with a rapid infusion of large-volume , ice-cold intravenous fluid decreased core temperature at hospital arrival but was not shown to improve outcome at hospital discharge compared with cooling commenced in the hospital . Clinical Trial Registration — URL : http://www.anzctr.org.au . Unique identifier : ACTRN12605000179639 Background — Although delayed hospital cooling has been demonstrated to improve outcome after cardiac arrest , in-field cooling started immediately after the return of spontaneous circulation may be more beneficial . The aims of the present pilot study were to assess the feasibility , safety , and effectiveness of in-field cooling . Methods and Results — We determined the effect on esophageal temperature , before hospital arrival , of infusing up to 2 L of 4 ° C normal saline as soon as possible after resuscitation from out-of-hospital cardiac arrest . A total of 125 such patients were r and omized to receive st and ard care with or without intravenous cooling . Of the 63 patients r and omized to cooling , 49 ( 78 % ) received an infusion of 500 to 2000 mL of 4 ° C normal saline before hospital arrival . These 63 patients experienced a mean temperature decrease of 1.24±1 ° C with a hospital arrival temperature of 34.7 ° C , whereas the 62 patients not r and omized to cooling experienced a mean temperature increase of 0.10±0.94 ° C ( P<0.0001 ) with a hospital arrival temperature of 35.7 ° C . In-field cooling was not associated with adverse consequences in terms of blood pressure , heart rate , arterial oxygenation , evidence for pulmonary edema on initial chest x-ray , or rearrest . Secondary end points of awakening and discharged alive from hospital trended toward improvement in ventricular fibrillation patients r and omized to in-field cooling . Conclusions — These pilot data suggest that infusion of up to 2 L of 4 ° C normal saline in the field is feasible , safe , and effective in lowering temperature . We propose that the effect of this cooling method on neurological outcome after cardiac arrest be studied in larger numbers of patients , especially those whose initial rhythm is ventricular fibrillation Background The International Liaison Committee on Resuscitation ( ILCOR ) now recommends therapeutic hypothermia ( TH ) ( 33 ° C for 12 - 24 hours ) as soon as possible for patients who remain comatose after resuscitation from shockable rhythm in out-of-hospital cardiac arrest and that it be considered for non shockable rhythms . The optimal timing of TH is still uncertain . Laboratory data have suggested that there is significantly decreased neurological injury if cooling is initiated during CPR . In addition , peri-arrest cooling may increase the rate of successful defibrillation . This study aims to determine whether paramedic cooling during CPR improves outcome compared st and ard treatment in patients who are being resuscitated from out-of-hospital cardiac arrest . Methods / Design This paper describes the methodology for a definitive multi-centre , r and omised , controlled trial of paramedic cooling during CPR compared with st and ard treatment . Paramedic cooling during CPR will be achieved using a rapid infusion of large volume ( 20 - 40 mL/kg to a maximum of 2 litres ) ice-cold ( 4 ° C ) normal saline . The primary outcome measure is survival at hospital discharge . Secondary outcome measures are rates of return of spontaneous circulation , rate of survival to hospital admission , temperature on arrival at hospital , and 12 month quality of life of survivors . Discussion This trial will test the effect of the administration of ice cold saline during CPR on survival outcomes . If this simple treatment is found to improve outcomes , it will have generalisability to prehospital services globally . Trial Registration Clinical Trials.gov : Objective : Accurate measurement of temperature is vital in the intensive care setting . A prospect i ve trial was performed to compare the accuracy of tympanic , urinary , and axillary temperatures with that of pulmonary artery ( PA ) core temperature measurements . Design : A total of 110 patients were enrolled in a prospect i ve observational cohort study . Setting : Multidisciplinary intensive care unit of a university teaching hospital . Patients : The cohort was ( mean ± sd ) 65 ± 16 yrs of age , Acute Physiology and Chronic Health Evaluation ( APACHE ) II score was 25 ± 9 , 58 % of the patients were men , and 76 % were mechanically ventilated . The accuracy of tympanic ( averaged over both ears ) , axillary ( averaged over both sides ) , and urinary temperatures was referenced ( as mean difference , & Dgr ; degrees centi grade ) to PA temperatures as st and ard in 6,703 recordings . Lin concordance correlation ( pc ) and Bl and –Altman 95 % limits of agreement ( degrees centi grade ) described the relationship between paired measurements . Regression analysis ( linear mixed model ) assessed covariate confounding with respect to temperature modes and reliability formulated as an intraclass correlation coefficient . Measurements and Main Results : Concordance of PA temperatures with tympanic , urinary , and axillary was 0.77 , 0.92 , and 0.83 , respectively . Compared with PA temperatures , & Dgr ; ( limits of agreement ) were 0.36 ° C ( −0.56 ° C , 1.28 ° C ) , −0.05 ° C ( −0.69 ° C , 0.59 ° C ) , and 0.30 ° C ( −0.42 ° C , 1.01 ° C ) for tympanic , urinary , and axillary temperatures , respectively . Temperature measurement mode effect , estimated via regression analysis , was consistent with concordance and & Dgr ; ( PA vs. urinary , p = .98 ) . Patient age ( p = .03 ) , sedation score ( p = .0001 ) , and dialysis ( p = .0001 ) had modest negative relations with temperature ; quadratic relationships were identified with adrenaline and dobutamine . No interactions with particular temperature modes were identified ( p ≥ .12 for all comparisons ) and no relationship was identified with either mean arterial pressure or APACHE II score ( p ≥ .64 ) . The average temperature mode intraclass correlation coefficient for test – retest reliability was 0.72 . Conclusion : Agreement of tympanic with pulmonary temperature was inferior to that of urinary temperature , which , on overall assessment , seemed more likely to reflect PA core temperature Background — Transnasal evaporative cooling has sufficient heat transfer capacity for effective intra-arrest cooling and improves survival in swine . The aim of this study was to determine the safety , feasibility , and cooling efficacy of prehospital transnasal cooling in humans and to explore its effects on neurologically intact survival to hospital discharge . Methods and Results — Witnessed cardiac arrest patients with a treatment interval ≤20 minutes were r and omized to intra-arrest cooling with a RhinoChill device ( treatment group , n=96 ) versus st and ard care ( control group , n=104 ) . The final analysis included 93 versus 101 patients , respectively . Both groups were cooled after hospital arrival . The patients had similar demographics , initial rhythms , rates of byst and er cardiopulmonary resuscitation , and intervals to cardiopulmonary resuscitation and arrival of advanced life support personnel . Eighteen device-related adverse events ( 1 periorbital emphysema , 3 epistaxis , 1 perioral bleed , and 13 nasal discolorations ) were reported . Time to target temperature of 34 ° C was shorter in the treatment group for both tympanic ( 102 versus 282 minutes , P=0.03 ) and core ( 155 versus 284 minutes , P=0.13 ) temperature . There were no significant differences in rates of return of spontaneous circulation between the groups ( 38 % in treated subjects versus 43 % in control subjects , P=0.48 ) , in overall survival of those admitted alive ( 44 % versus 31 % , respectively , P=0.26 ) , or in neurologically intact survival to discharge ( Pittsburgh cerebral performance category scale 1 to 2 , 34 % versus 21 % , P=0.21 ) , although the study was not adequately powered to detect changes in these outcomes . Conclusions — Prehospital intra-arrest transnasal cooling is safe and feasible and is associated with a significant improvement in the time intervals required to cool patients . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00808236 BACKGROUND Therapeutic hypothermia ( TH ) represents an important method to attenuate post-resuscitation injury after cardiac arrest . Laboratory investigations have suggested that induction of hypothermia before return of spontaneous circulation ( ROSC ) may confer the greatest benefit . We hypothesized that a short delay in resuscitation to induce hypothermia before ROSC , even at the expense of more prolonged ischemia , may yield both physiological and survival advantages . METHODS Cardiac arrest was induced in C57BL/6 mice using intravenous potassium chloride ; resuscitation was attempted with CPR and fluid administration . Animals were r and omized into three groups ( n=15 each ) : a normothermic control group , in which 8 min of arrest at 37 degrees C was followed by resuscitation ; an early intra-arrest hypothermia group , in which 6.5 min of 37 degrees C arrest were followed by 90s of cooling , with resuscitation attempted at 30 degrees C ( 8 min total ischemia ) ; and a delayed intra-arrest hypothermia group , with 90s cooling begun after 8 min of 37 degrees C ischemia , so that animals underwent resuscitation at 9.5 min . RESULTS Animals treated with TH demonstrated improved hemodynamic variables and survival compared to normothermic controls . This was the case even when comparing the delayed intra-arrest hypothermia group with prolonged ischemia time against normothermic controls with shorter ischemia time ( 7-day survival , 4/15 vs. 0/15 , p<0.001 ) . CONCLUSIONS Short res
Output:
| However , no significant differences were observed in the survival to the hospital discharge , favorable neurological outcome at hospital discharge , and rearrest .
This review demonstrates that prehospital therapeutic hypothermia after cardiac arrest can decrease temperature on hospital admission .
On the other h and , regarding the survival to hospital discharge , favorable neurological outcome at hospital discharge , and rearrest , our meta- analysis and review produces non-significant results . |
MS211033 | ***TASK*** the task is to summarize an input biomedical literature in 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: Sumatriptan , a 5-hydroxytryptamine1 ( 5-HT1 ) receptor agonist at enteric neuronal 5-HT receptors , causes a relaxation of the gastric fundus and inhibition of antral contractile activity . The present study examined the effect of sumatriptan on gastric emptying of solids and liquids in humans . In eight healthy subjects the gastric emptying rate for liquids and solids was measured using the carbon-labeled glycine and octanoic acid breath test after subcutaneous administration of placebo or sumatriptan . Sumatriptan increased the gastric half-emptying time of liquids ( P < 0.0005 ) and induced a prolonged lag phase for liquids ( P < 0.0005 ) in all subjects . Sumatriptan increased gastric half-emptying time ( P < 0.005 ) and the lag phase of solids ( P < 0.05 ) in all subjects . In two healthy subjects gastric emptying of liquids and solids after subcutaneous administration of sumatriptan was studied by radioscintigraphy . Radioscintigraphy confirmed the delayed emptying and the prolonged lag phases after sumatriptan . In conclusion , sumatriptan delays gastric emptying of solids and liquids in healthy subjects . Moreover , sumatriptan induces a lag phase for liquids . The mechanism by which sumatriptan alters gastric emptying remains to be studied To verify the influence of food consistency on satiety mechanisms we evaluated the effects of the same meal in solid-liquid ( SM ) and homogenized ( HM ) form on satiety sensation , gastric emptying rate and plasma cholecystokinin ( CCK ) concentration . Eight healthy men , aged 21 - 28 ( mean 24.5 ) years were given two meals ( cooked vegetables 250 g , cheese 35 g , croutons 50 g and olive oil 25 g , total energy 2573 kJ , with water 300 ml ) differing only in physical state : SM and HM . The subjects consumed the meals in r and omized order on non-consecutive days . The sensations of fullness , satiety and desire to eat were evaluated by means of a question naire , gastric emptying was assessed by ultrasonographic measurement of antral area , and plasma CCK concentration was measured by radioimmunoassay . The vegetable-rich meal was significantly more satiating ( P < 0.05 ) when in the HM form than when eaten in a SM state . Furthermore , the overall gastric emptying time was significantly slowed ( 255 ( SEM 11 ) min after HM v. 214 ( SEM 12 ) min after SM ; P < 0.05 ) and CCK peak occurred later ( 94 ( SEM 12 ) min after HM v. 62 ( SEM 11 ) min after SM ; NS ) when the food was consumed in the HM form . Independently of the type of meal , antral area was significantly related to fullness sensations ( r2 0.46 , P = 0.004 ) . These results demonstrate that meal consistency is an important physical food characteristic which influences both gastric emptying rate and satiety sensation . Moreover , the relationship observed between antral area and fullness sensation confirms that antral distension plays a part in the regulation of eating behaviour To ascertain the effect of gastric emptying on the symptoms of non-ulcer dyspepsia ( NUD ) patients , we r and omly selected 60 NUD patients and , as control , 26 dyspepsia-free volunteers . We measured the gastric emptying time of mixed food ( 270 kcal ) , using real-time ultrasonography in two ways . NUD patients were divided r and omly into two groups and given domperidone or placebo in a double-blind trial . Of the NUD patients 48 % had delayed gastric emptying times and associated epigastric pain , bloating , early satiety , and regurgitation . A prokinetic agent not only improved emptying time but also relieved some of the symptoms of the NUD patients . Real-time ultrasonography proved a useful method for evaluating gastric emptying Duodenal lipid exacerbates gastrointestinal sensations during gastric distension . Using luminal application of the local anesthetic benzocaine , we investigated the role of intestinal receptors in the induction of these sensations . Nine healthy subjects were studied on five occasions , during which isotonic saline or 20 % lipid ( 2 kcal/min ) , combined with ( duodenal or jejunal ) 0.75 % benzocaine or vehicle at 2.5 ml/min , was infused intraduodenally before and during gastric distension . Intragastric pressures and volumes , gastrointestinal sensations , and plasma CCK levels were determined . Duodenal lipid combined with vehicle increased gastric volume ( in ml : saline , -10 + /- 18 ; lipid/vehicle , 237 + /- 30 ) and plasma CCK [ mean levels ( pmol/l ) : saline , 2.0 + /- 0 . 2 ; lipid/vehicle , 8.0 + /- 1.6 ] and , during distensions , induced nausea ( scores : saline , 3 + /- 2 : lipid/vehicle , 58 + /- 19 ) and decreased pressures at which fullness and discomfort occurred . Duodenal but not jejunal benzocaine attenuated the effect of lipid on gastric volume , plasma CCK , and nausea during distension ( 135 + /- 38 and 216 + /- 40 ml , 4.6 + /- 0.6 pmol/l and not assessed , and 37 + /- 12 and 64 + /- 21 for lipid + duodenal benzocaine and lipid + jejunal benzocaine , respectively ) and on pressures for sensations . In conclusion , intestinal receptors modulate gastrointestinal sensations associated with duodenal lipid and gastric distension . There is also the potential for local neural mechanisms to regulate CCK release and thereby reduce afferent activation indirectly Sumatriptan , a 5HT1 receptor agonist , inhibits antral motor activity , delays gastric emptying and relaxes the gastric fundus . The aim of this study was to characterize the effect of sumatriptan on transpyloric flow and gastric accommodation during and immediately after ingestion of a liquid meal using duplex sonography . Ten healthy subjects were investigated twice on separate days . In r and om order either sumatriptan 6 mg ( Imigran 0.5 mL ) or a placebo were given s.c . 15 min before ingesting 500 mL of a meat soup . The subjects were examined during the 3-min period before ingestion of the liquid meal , the 3-min spent drinking the meal and 10 min postpr and ially . Sumatriptan caused a significant widening of both the gastric antrum ( P=0.02 ) and the proximal stomach ( P=0.01 ) 10 min postpr and ially as compared with placebo . It caused no significant differences in time to initial gastric emptying ( P=0.2 ) , but significantly delayed commencement of peristaltic-related transpyloric flow ( P=0.04 ) . Sumatriptan had no significant effect on mean abdominal symptom scores , but after sumatriptan there was a significant negative correlation between width of postpr and ial antral area and postpr and ial nausea and between width of postpr and ial antral area and postpr and ial bloating . We therefore conclude that sumatriptan causes a postpr and ial dilatation of both the distal and the proximal stomach with no change in dyspeptic symptoms nor in length of time to first gastric emptying . Time to commencement of peristaltic-related emptying is delayed The role of cholecystokinin ( CCK ) in the regulation of gastric emptying and pancreatic enzyme secretion was evaluated by infusing the CCK-receptor antagonist loxiglumide . Gastric emptying rates and pancreatic secretory outputs were measured in five healthy volunteers by the double-indicator perfusion technique using a multiple-lumen tube in the duodenum . Placebo or loxiglumide ( 22 mumol.kg-1.h-1 ) was infused throughout each experiment . Five hundred-milliliter liquid intragastric meals of ( a ) fat , protein , and glucose ( Ensure ; Abbott , Chicago , IL ) ; ( b ) glucose , 20 g/dL ; and ( c ) guar gum , 1.1 g/dL , were given in r and om order . In addition , the effect of a physiologic CCK-8 dose ( 20 pmol.kg-1.h-1 ) after an intragastric 500-mL saline meal ( 0.154 mol/L ) was tested . Intravenous CCK-8 induced a marked retardation of the gastric emptying rate of the saline solution ( P less than 0.05 ) while stimulating pancreatic secretory outputs ; both effects were completely abolished by the infusion of loxiglumide . Loxiglumide markedly accelerated the gastric emptying rates ( by approximately 40 % ) and simultaneously diminished lipase ( by approximately 75 % ) and trypsin ( by approximately 50 % ) outputs of both the mixed meal ( P less than 0.01 ) and the pure glucose meal ( P less than 0.05 ) . Additional experiments using gamma camera scintigraphy confirmed the accelerating effect of loxiglumide on gastric emptying of the mixed meal ( P less than 0.01 ) . The gastric emptying rate of the guar meal , which did not release CCK , was not influenced by the infusion of loxiglumide . Loxiglumide distinctly augmented plasma CCK levels after the mixed ( 2.6 times ) and the pure glucose ( 2.1 times ) meals while markedly reducing ( approximately 76 % ) pancreatic polypeptide release ( P less than 0.02 ) . It is concluded that endogeneous CCK exerts a major role in the regulation of both gastric liquid emptying and pancreatic secretion in humans The factors influencing appetite in humans are poorly understood . There is a weak relation between appetite and gastric emptying in normal subjects . Recent studies have shown that fasting and postpr and ial antral areas increase in patients with functional dyspepsia compared with normal subjects . We evaluated the hypothesis that antral area , and hence antral distention , is a significant determinant of postpr and ial fullness . Fourteen normal subjects had simultaneous measurements of gastric emptying by scintigraphy and antral area by ultrasound after ingestion of 350 mL 20 % glucose . Fullness and hunger were assessed by visual analog scales . Measurements of the gastric-emptying half time ( t1/2 ) by scintigraphy and ultrasound were not significantly different ( 129.6 + /- 11.8 min compared with 115.6 + /- 11.4 min ) . Fullness increased ( P < 0.001 ) and hunger decreased ( P < 0.001 ) after the drink . Both fullness and the magnitude of the increase in fullness after the drink were related to antral area ( r > 0.56 , P < 0.05 ) , the increase in antral area ( r > 0.59 , P < 0.05 ) , and the scintigraphic content of the distal stomach ( r > 0.57 , P < 0.05 ) , but not to the ultrasound or scintigraphic t1/2 values . In contrast , hunger and the magnitude of the decrease in hunger after the drink were not related to either antral area , the increase in antral area , or the rate of gastric emptying . We conclude that postpr and ial fullness , but not hunger , was closely related to antral distention in normal subjects BACKGROUND : Peripheral administration of glucagon-like peptide-1 ( GLP-1 ) for four hours , to normal weight and obese humans , decreases food intake and suppresses appetite . OBJECTIVE : The aim of this study was to assess the effect of an eight hour infusion of GLP-1 on appetite and energy intake at lunch and dinner in obese subjects . DESIGN : R and omised , blinded cross-over design with intravenous infusion of GLP-1 ( 0.75 pmol·kg−1·min−1 ) or saline . SUBJECTS : Eight obese ( body mass index , BMI , 45.5±2.3 kg/m2 ) male subjects . MEASUREMENTS : Ad libitum energy intake at lunch ( 12.00 h ) and dinner ( 16.00 h ) after an energy fixed breakfast ( 2.4 MJ ) at 08.00 h. Appetite sensations using visual analogue scales , ( VAS ) immediately before and after meals and hourly in-between . Blood sample s for the analysis of glucose , insulin , C-peptide , GLP-1 and peptide YY . Gastric emptying after breakfast and lunch using a paracetamol absorption technique . RESULTS : Hunger ratings were significantly lower with GLP-1 infusion . The summed ad libitum energy intake at lunch and dinner was reduced by 1.7±0.5 MJ ( 21±6 % ) by GLP-1 infusion ( P=0.01 ) . Gastric emptying was delayed by GLP-1 infusion , and plasma glucose concentrations decreased ( baseline : 6.6±0.35 mmol/L ; nad
Output:
| Dietary assessment s have frequently implicated fatty foods in symptom induction , and these findings are supported by laboratory-based studies , particularly the demonstration that FD patients more often experience symptoms after intraduodenal infusions of fat , than glucose . |
MS211034 | ***TASK*** the task is to summarize an input biomedical literature in 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 Recent guidelines recommend regular exercise in the management of patients with chronic heart failure ( CHF ) . This study was design ed to compare the safety and efficacy of conventional bicycle exercise and functional electrical stimulation ( FES ) of the legs as forms of home-based exercise training for patients with stable CHF . METHODS AND RESULTS Forty-six patients ( 38 male ) with stable NYHA Class II/III heart failure underwent a 6-week training programme using either a bicycle ergometer or electrical stimulation of the quadriceps and gastrocnemius muscles . In the bike group , significant increases were seen in 6-min walk ( 44.6 m , 95 % confidence interval ( CI ) 29.3 - 60.9 m ) , treadmill exercise time ( 110 s , 95 % CI 72.2 - 148.0 s ) , maximum leg strength ( 5.32 kg , 95 % CI 3.18 - 7.45 kg ) , and quadriceps fatigue index ( 0.08 , 95 % CI 0.04 - 0.12 ) following training . In the stimulator group , similar significant increases were seen following training for 6-min walk ( 40.6 m , 95 % CI 28.2 - 53.0 m ) , treadmill exercise time ( 67 s , 95 % CI 11.8 - 121.8s ) , maximum leg strength ( 5.35 kg , 95 % CI 1.53 - 9.17 kg ) , and quadriceps fatigue index ( 0.10 , 95 % CI 0.04 - 0.17 ) . Peak VO(2)did not change in either group following training , indicating a low-intensity regime . Quality of life scores improved following training when the bicycle and stimulator groups were considered together , but not when considered separately ( -0.43 , 95 % CI -8.13 to -0.56 ) . CONCLUSIONS FES produces beneficial changes in muscle performance and exercise capacity in patients with CHF . Within this study , the benefits were similar to those observed following bicycle training . FES could be offered to patients with heart failure as an alternative to bicycle training as part of a home-based rehabilitation programme Systemic arterial compliance ( SAC ) makes an important contribution to cardiac afterload , and thus is a significant determinant of left ventricular work . Previous studies have suggested that arterial compliance may be reduced in patients with congestive heart failure ( CHF ) , and that SAC is increased after a 4-week exercise training programme in healthy , sedentary individuals . The present study aim ed to investigate the effects of an 8-week exercise training programme on arterial mechanical properties , left ventricular performance and quality of life in CHF patients . A total of 21 patients with NYHA class II or III CHF ( mean+/-S.D. age 55+/-13 years ) were r and omly allocated to either an 8-week exercise training group or a " usual lifestyle " control group . SAC , as determined non-invasively using applanation tonometry and Doppler aortic velocimetry , increased from 0.57+/-0.11 to 0.77+/-0.14 arbitrary compliance units ( mean+/-S.E.M. ; P=0.01 ) in the exercise group , while no change occurred in the control group . Left ventricular structure and function was assessed by echocardiography , and these parameters were unchanged over the 8-week study period . Exercise training significantly increased exercise capacity , measured by a 6-min walking test ( 474+/-27 to 547+/-34 m ; P=0.008 ) . Quality of life , as assessed using the Minnesota Living with Heart Failure Evaluation , demonstrated a decrease in heart failure symptoms from 46+/-7 to 24+/-5 units ( P=0.01 ) following the exercise training programme . These data show that exercise training improves SAC in patients with CHF . The accompanying improvement in exercise capacity may be due , in part , to an improvement in arterial function AIM To assess changes in quality of life ( QoL ) and oxygen consumption produced by two different patterns of physical training in patients with congestive heart failure ( CHF ) . MATERIAL AND METHODS 42 men ( mean age 55.9+/-8.1 years ) with ischaemic CHF lasting 3.1+/-1.0 years . Patients were r and omised into three groups each consisting of 14 men : group A -- with constant workload , group B-with progressive/increasing workload , each trained up to 6 months and group C -- not trained . QoL was assessed at baseline and at 6 months by means of the Psychological General Well-being Index ( PGWB ) and the Subjective Symptoms Assessment Profile ( SSA-P ) . Cardiopulmonary exercise test and echocardiography were performed twice . RESULTS At 6 months improvement in PGWB total index was observed , both in groups A and B ( p<0.01 ) . Men from groups A and B reported less cardiac symptoms ( p<0.01 ) , emotional distress ( p<0.01 ) , peripheral circulatory symptoms ( p<0.01 ) and dizziness ( p<0.01 ) in SSA-P. Improvement in sexual life was observed only in group B ( p<0.01 ) . Overall improvement of QoL was greater in group B than in group A as well as oxygen uptake ( p<0.01 ) . Higher QoL correlated positively with peak VO2 only in group B ( r=0.56 , p<0.05 ) . CONCLUSIONS Physical training improves QoL in men with CHF , but only progressive/increasing workload seems to markedly improve oxygen uptake . Improvement of QoL is related to psychological well-being and physical complaints associated with CHF Background Heart rate recovery ( HRR1 ) immediately after exercise reflects parasympathetic activity , which is markedly attenuated in chronic heart failure ( CHF ) patients . The aim of our study was to examine both continuous and interval exercise training effects on HRR1 in these patients . Design The population study consisted of 29 stable CHF patients that participated at a rehabilitation program of 36 sessions , three times per week . Of the 29 patients , 24 completed the program . Patients were r and omly assigned to interval { n = 10 [ 100 % peak work rate ( WRp ) for 30 s , alternating with rest for 30 s ] } and to continuous training [ n = 14 ( 50%WRp ) ] . Methods All patients performed a symptom-limited cardiopulmonary exercise test on a cycle ergometer before and after the completion of the program . Measurements included peak oxygen uptake ( VO2p ) , anaerobic threshold ( AT ) , WRp , first degree slope of VO2 during the first minute of recovery ( VO2/t-slope ) , chronotropic response [ % chronotropic reserve ( CR ) = ( peak HR - resting HR ) × 100/(220 - age - resting HR ) ] , HRR1 ( HR difference from peak exercise to one minute after ) . Results After the completion of the rehabilitation program there was a significant increase of WRp , VO2p , AT and VO2/t-slope ( by 30 % , P=0.01 ; 6 % , P=0.01 ; 10 % , P=0.02 ; and 27 % , P=0.03 respectively for continuous training and by 21 % , P≤0.05 ; 8 % , P=0.01 ; 6 % , P = NS ; and 48 % , P=0.02 respectively for interval training ) . However , only patients exercised under the continuous training regime had a significant increase in HRR1 ( 15.0±9.0 to 24.0±12bpm ; P=0.02 ) and CR ( 57±19 to 72±21 % , P=0.02 ) , in contrast with those assigned to interval training ( HRR1 : 21 ± 11 to 21 ± 8 bpm ; P = NS and CR : 57 ± 18 to 59 ± 21 % , P = NS ) . Conclusions Both continuous and interval exercise training program improves exercise capacity in CHF patients . However , continuous rather than interval exercise training improves early HRR1 , a marker of parasympathetic activity , suggesting a greater contribution to the autonomic nervous system AIMS Hydrotherapy , i.e. exercise in warm water , as a rehabilitation program has been considered potentially dangerous in patients with chronic heart failure ( CHF ) due to the increased venous return caused by the hydrostatic pressure . However , hydrotherapy has advantages compared to conventional training . We studied the applicability of an exercise programme in a temperature-controlled swimming pool , with specific reference to exercise capacity , muscle function , quality of life and safety . METHODS AND RESULTS Twenty-five patients with CHF ( NYHA II-III , age 72.1+/-6.1 ) were r and omised into either 8 weeks of hydrotherapy ( n=15 ) , or into a control group ( n=10 ) . The training program was well tolerated with no adverse events . Patients in the hydrotherapy group improved their maximal exercise capacity ( + 6.5 vs.-5.9 W , P=0.001 ) , isometric endurance in knee extension ( + 4 vs.-9 s , P=0.01 ) together with an improvement in the performance of heel-lift ( + 4 vs. -3 n.o . , P=<0.01 ) , shoulder abduction ( + 12 vs. -8 s , P=0.01 ) and shoulder flexion ( + 6 vs. + 4 , P=0.01 ) in comparison to patients in the control group . CONCLUSION Physical training in warm water was well tolerated and seems to improve exercise capacity as well as muscle function in small muscle groups in patients with CHF . This new approach broadens the variety of training regimes for older patients with CHF BACKGROUND Heart failure , a condition predominantly affecting the elderly , represents an ever-increasing clinical and financial burden for the NHS . Cardiac rehabilitation , a service that incorporates patient education , exercise training and lifestyle modification , requires further evaluation in heart failure management . AIM The aim of this study was to determine whether a cardiac rehabilitation programme improved on the outcomes of an outpatient heart failure clinic ( st and ard care ) for patients , over 60 years of age , with chronic heart failure . METHODS Two hundred patients ( 60 - 89 years , 66 % male ) with New York Heart Association ( NYHA ) II or III heart failure confirmed by echocardiography were r and omised . Both st and ard care and experimental groups attended clinic with a cardiologist and specialist nurse every 8 weeks . Interventions included exercise prescription , education , dietetics , occupational therapy and psychosocial counselling . The main outcome measures were functional status ( NYHA , 6-min walk ) , health-related quality of life ( MLHF and EuroQol ) and hospital admissions . RESULTS There were significant improvements in MLHF and EuroQol scores , NYHA classification and 6-min walking distance ( meters ) at 24 weeks between the groups ( p<0.001 ) . The experimental group had fewer admissions ( 11 vs. 33 , p<0.01 ) and spent fewer days in hospital ( 41 vs. 187 , p<0.001 ) . CONCLUSIONS Cardiac rehabilitation , already widely established in the UK , offers an effective model of care for older patients with heart failure AIMS Patients with chronic heart failure ( CHF ) exhibit detrimental changes in skeletal muscle that contribute to their impaired physical performance . This study investigates the possibility of counteracting these changes by chronic low-frequency electrical stimulation ( CLFS ) of left and right thigh muscles . METHODS AND RESULTS ( mean+/-SD ) 32 CHF patients ( 53+/-10 years ) with an LVEF of 22+/-5 % , NYHA II-IV , undergoing optimized drug therapy , were r and omized in a CLFS group ( CLFSG ) or a control group ( controls ) . The groups differed in terms of the intensity of stimulation , which elicited strong muscle contractions only in the CLFSG , whereas the controls received current input up to the sensory threshold without muscle contractions . Functional capacity was assessed by peak VO(2 ) , work capacity , and a 6-min-walk ( 6-MW ) . Muscle biopsies were analyzed for myosin heavy chain ( MHC ) isoforms , citrate synthase ( CS ) and glyceraldehydephosphate dehydrogenase ( GAPDH ) activities . Peak VO(2)(mlmin(-1)kg -1 ) increased from 9.6+/-3.5 to 11.6+/-2.8 ( P<0.001 ) in the CLFSG , and decreased from 10.6+/-2.8 to 9.4+/-3.2 ( P<0.05 ) in the controls . The increase in the CLFSG was paralleled by increases in maximal workload ( P<0.05 ) and oxygen uptake at the anaerobic threshold ( P<0.01 ) . The corresponding values of the controls were unchanged , as also the 6-MW values , the MHC isoform distribution , and both CS and GAPDH activities . In the CLFSG , the 6-MW values increased ( P<0.001 ) , CS activity was elevated ( P<0.05 ) , GAPDH activity decreased ( P<0.01 ) , and the MHC isoforms were shifted in the slow direction with increases in MHCI at the expense of MHCIId/x ( P<0.01 ) . CONCLUSIONS Our results suggest that CLFS is a suitable treatment to counteract detrimental changes in skelet
Output:
| Study findings suggest that the favorable physiological responses to exercise might slow some of the pathophysiological progression of HF . |
MS211035 | ***TASK*** the task is to summarize an input biomedical literature in 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 VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company Summary Purpose . This phase II , open-label , multicenter study assessed the oral , multitargeted , tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received prior chemotherapy . Experimental design . Patients received sunitinib 50 mg/day on Schedule 4/2 ( 4 weeks on treatment , followed by 2 weeks off treatment ) . The primary endpoint was objective response rate ; secondary endpoints included clinical benefit rate , duration of response , progression-free survival ( PFS ) , overall survival ( OS ) , pharmacokinetics , pharmacodynamics , safety and tolerability , and quality of life . Results . Of 78 patients enrolled , most had gastric adenocarcinoma ( 93.6 % ) and metastatic disease ( 93.6 % ) . All were evaluable for safety and efficacy . Two patients ( 2.6 % ) had partial responses and 25 patients ( 32.1 % ) had a best response of stable disease for ≥6 weeks . Median PFS was 2.3 months ( 95 % confidence interval [ CI ] , 1.6–2.6 months ) and median OS was 6.8 months ( 95 % CI , 4.4–9.6 months ) . Grade ≥3 thrombocytopenia and neutropenia were reported in 34.6 % and 29.4 % of patients , respectively , and the most common non-hematologic adverse events were fatigue , anorexia , nausea , diarrhea , and stomatitis . Pharmacokinetics of sunitinib and its active metabolite were consistent with previous reports . There were no marked associations between baseline soluble protein levels , or changes from baseline , and measures of clinical outcome . Conclusions . The progression-delaying effect and manageable toxicity observed with sunitinib in this study suggest that although single-agent sunitinib has insufficient clinical value as second-line treatment for advanced gastric cancer , its role in combination with chemotherapy merits further study Background YN968D1 ( Apatinib ) selectively inhibits phosphorylation of VEGFR-2 and tumor angiogenesis in mice model . The study was conducted to determine the maximum tolerated dose ( MTD ) , safety profile , pharmacokinetic variables , and antitumor activity in advanced solid malignancies . Methods This dose-escalation study was conducted according to the Chinese State Food and Drug Administration ( S FDA ) recommendations in patients with advanced solid tumors to determine the MTD for orally administered apatinib . Doses of continuously administered apatinib were escalated from 250 mg . Treatment continued after dose-escalation phase until withdrawal of consent , intolerable toxicities , disease progression or death . Results Forty-six patients were enrolled . Hypertension and h and -foot syndrome were the two dose-limiting toxicities noted at dose level of 1000 mg . MTD was determined to be 850 mg once daily . Pharmacokinetic analysis showed early absorption with a half-life of 9 hours . The mean half-life was constant over all dose groups . Steady-state conditions analysis suggested no accumulation during 56 days of once-daily administration . The most frequently observed drug-related adverse events were hypertension ( 69.5 % , 29 grade 1 - 2 and 3 grade 3 - 4 ) , proteinuria ( 47.8 % , 16 grade 1 - 2 and 6 grade 3 - 4 ) , and h and -foot syndrome ( 45.6 % , 15 grade 1 - 2 and 6 grade 3 - 4 ) . Among the thirty-seven evaluable patients , PR was noted in seven patients ( 18.9 % ) , SD 24 ( 64.9 % ) , with a disease control rate of 83.8 % at 8 weeks . Conclusions The recommended dose of 750 mg once daily was well tolerated . Encouraging antitumor activity across a broad range of malignancies warrants further evaluation in selected population s . Trial registration Clinical Trials.gov unique identifier : PURPOSE The first planned interim analysis ( median follow-up , 3 years ) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival , the primary end point . The results were therefore opened at the recommendation of an independent data and safety monitoring committee . We report 5-year follow-up data on patients enrolled onto the ACTS-GC study . PATIENTS AND METHODS Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were r and omly assigned to receive S-1 after surgery or surgery only . S-1 ( 80 to 120 mg per day ) was given for 4 weeks , followed by 2 weeks of rest . This 6-week cycle was repeated for 1 year . The primary end point was overall survival , and the secondary end points were relapse-free survival and safety . RESULTS The overall survival rate at 5 years was 71.7 % in the S-1 group and 61.1 % in the surgery-only group ( hazard ratio [ HR ] , 0.669 ; 95 % CI , 0.540 to 0.828 ) . The relapse-free survival rate at 5 years was 65.4 % in the S-1 group and 53.1 % in the surgery-only group ( HR , 0.653 ; 95 % CI , 0.537 to 0.793 ) . Subgroup analyses according to principal demographic factors such as sex , age , disease stage , and histologic type showed no interaction between treatment and any characteristic . CONCLUSION On the basis of 5-year follow-up data , postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy Angiogenesis is an important process in cell development , especially in cancer . Vascular endothelial growth factor ( VEGF ) signaling is an important regulator of angiogenesis . Several therapies that act against VEGF signal transduction have been developed , including YN968D1 , which is a potent inhibitor of the VEGF signaling pathway . This study investigated the antitumor activity of YN968D1 ( apatinib mesylate ) in vitro and in vivo . YN968D1 potently suppressed the kinase activities of VEGFR‐2 , c‐kit and c‐src , and inhibited cellular phosphorylation of VEGFR‐2 , c‐kit and PDGFRβ . YN968D1 effectively inhibited proliferation , migration and tube formation of human umbilical vein endothelial cells induced by FBS , and blocked the budding of rat aortic ring . In vivo , YN968D1 alone and in combination with chemotherapeutic agents effectively inhibited the growth of several established human tumor xenograft models with little toxicity . A phase I study of YN968D1 has shown encouraging antitumor activity and a manageable toxicity profile . These findings suggest that YN968D1 has promise as an antitumor drug and might have clinical benefits . ( Cancer Sci 2011 ; 102 : 1374–1380 BACKGROUND A regimen of epirubicin , cisplatin , and infused fluorouracil ( ECF ) improves survival among patients with incurable locally advanced or metastatic gastric adenocarcinoma . We assessed whether the addition of a perioperative regimen of ECF to surgery improves outcomes among patients with potentially curable gastric cancer . METHODS We r and omly assigned patients with resectable adenocarcinoma of the stomach , esophagogastric junction , or lower esophagus to either perioperative chemotherapy and surgery ( 250 patients ) or surgery alone ( 253 patients ) . Chemotherapy consisted of three preoperative and three postoperative cycles of intravenous epirubicin ( 50 mg per square meter of body-surface area ) and cisplatin ( 60 mg per square meter ) on day 1 , and a continuous intravenous infusion of fluorouracil ( 200 mg per square meter per day ) for 21 days . The primary end point was overall survival . RESULTS ECF-related adverse effects were similar to those previously reported among patients with advanced gastric cancer . Rates of postoperative complications were similar in the perioperative-chemotherapy group and the surgery group ( 46 percent and 45 percent , respectively ) , as were the numbers of deaths within 30 days after surgery . The resected tumors were significantly smaller and less advanced in the perioperative-chemotherapy group . With a median follow-up of four years , 149 patients in the perioperative-chemotherapy group and 170 in the surgery group had died . As compared with the surgery group , the perioperative-chemotherapy group had a higher likelihood of overall survival ( hazard ratio for death , 0.75 ; 95 percent confidence interval , 0.60 to 0.93 ; P=0.009 ; five-year survival rate , 36 percent vs. 23 percent ) and of progression-free survival ( hazard ratio for progression , 0.66 ; 95 percent confidence interval , 0.53 to 0.81 ; P<0.001 ) . CONCLUSIONS In patients with operable gastric or lower esophageal adenocarcinomas , a perioperative regimen of ECF decreased tumor size and stage and significantly improved progression-free and overall survival . ( Current Controlled Trials number , IS RCT N93793971 [ controlled-trials.com ] . )
Output:
| Compare ramucirumab and bevacizumab in combination with traditional chemotherapy ; ramucirumab has shown to improve progression-free survival and overall survival .
Apatinib tyrosine kinase inhibitor combined with traditional chemotherapy has shown to improve overall response rate and progression-free survival with marginal improvements in overall survival .
Chemotherapy , in combination with anti-VEGF drugs , in the management of advanced gastric cancer significantly improves the outcome of overall response rate , progression-free survival and overall survival when compared to chemotherapy alone . |
MS211036 | ***TASK*** the task is to summarize an input biomedical literature in 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: Abbreviations ACCORD Action to Control Cardiovascular Risk in Diabetes ADVANCE Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation AGI α-Glucosidase inhibitor CAD Coronary artery disease CKD Chronic kidney disease CVD Cardiovascular disease DPP-4 Dipeptidyl peptidase IV GIP Glucose-dependent insulinotropic peptide GLP-1 Glucagon-like peptide 1 NPH Neutral protamine Hagedorn TZD Thiazolidinedione UKPDS UK Prospect i ve Diabetes Study VADT Veterans Affairs Diabetes OBJECTIVE To evaluate the effects of canagliflozin , a sodium-glucose cotransporter 2 inhibitor , in type 2 diabetes mellitus inadequately controlled with metformin monotherapy . RESEARCH DESIGN AND METHODS This was a double-blind , placebo-controlled , parallel-group , multicenter , dose-ranging study in 451 subjects r and omized to canagliflozin 50 , 100 , 200 , or 300 mg once daily ( QD ) or 300 mg twice daily ( BID ) , sitagliptin 100 mg QD , or placebo . Primary end point was change in A1C from baseline through week 12 . Secondary end points included change in fasting plasma glucose ( FPG ) , body weight , and overnight urinary glucose-to-creatinine ratio . Safety and tolerability were also assessed . RESULTS Canagliflozin was associated with significant reductions in A1C from baseline ( 7.6–8.0 % ) to week 12 : −0.79 , −0.76 , −0.70 , −0.92 , and −0.95 % for canagliflozin 50 , 100 , 200 , 300 mg QD and 300 mg BID , respectively , versus −0.22 % for placebo ( all P < 0.001 ) and −0.74 % for sitagliptin . FPG was reduced by −16 to −27 mg/dL , and body weight was reduced by −2.3 to −3.4 % , with significant increases in urinary glucose-to-creatinine ratio . Adverse events were transient , mild to moderate , and balanced across arms except for a non – dose-dependent increase in symptomatic genital infections with canagliflozin ( 3–8 % ) versus placebo and sitagliptin ( 2 % ) . Urinary tract infections were reported without dose dependency in 3–9 % of canagliflozin , 6 % of placebo , and 2 % of sitagliptin arms . Overall incidence of hypoglycemia was low . CONCLUSIONS Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss . The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females CONTEXT Dapagliflozin , a selective sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor , reduces hyperglycemia in patients with type 2 diabetes mellitus ( T2DM ) by increasing urinary glucose excretion , and weight loss is a consistent associated finding . OBJECTIVES Our objectives were to confirm weight loss with dapagliflozin and establish through body composition measurements whether weight loss is accounted for by changes in fat or fluid components . DESIGN AND SETTING This was a 24-wk , international , multicenter , r and omized , parallel-group , double-blind , placebo-controlled study with ongoing 78-wk site- and patient-blinded extension period at 40 sites in five countries . PATIENTS Included were 182 patients with T2DM ( mean values : women 63.3 and men 58.6 yr of age ; hemoglobin A1c 7.17 % , body mass index 31.9 kg/m2 , and body weight 91.5 kg ) inadequately controlled on metformin . INTERVENTION Dapagliflozin 10 mg/d or placebo was added to open-label metformin for 24 wk . MAIN OUTCOME MEASURES Primary endpoint was total body weight ( TBW ) change from baseline at wk 24 . Key secondary endpoints were waist circumference and dual-energy x-ray absorptiometry total-body fat mass ( FM ) changes from baseline at wk 24 , and patient proportion achieving body weight reduction of at least 5 % at wk 24 . In a subset of patients , magnetic resonance assessment of visceral adipose tissue ( VAT ) and sc adipose tissue ( SAT ) volume and hepatic lipid content were also evaluated . RESULTS At wk 24 , placebo-corrected changes with dapagliflozin were as follows : TBW , -2.08 kg [ 95 % confidence interval (CI)=-2.84 to -1.31 ; P<0.0001 ] ; waist circumference , -1.52 cm ( 95 % CI=-2.74 to -0.31 ; P=0.0143 ) ; FM , -1.48 kg ( 95 % CI=-2.22 to -0.74 ; P=0.0001 ) ; proportion of patients achieving weight reduction of at least 5 % , + 26.2 % ( 95 % CI=15.5 to 36.7 ; P<0.0001 ) ; VAT , -258.4 cm3 ( 95 % CI=-448.1 to -68.6 ; nominal P=0.0084 ) ; SAT , -184.9 cm3 ( 95 % CI=-359.7 to -10.1 ; nominal P=0.0385 ) . In the dapagliflozin vs. placebo groups , respectively , serious adverse events were reported in 6.6 vs. 1.1 % ; events suggestive of vulvovaginitis , balanitis , and related genital infection in 3.3 vs. 0 % ; and lower urinary tract infections in 6.6 vs. 2.2 % . CONCLUSIONS Dapagliflozin reduces TBW , predominantly by reducing FM , VAT and SAT in T2DM inadequately controlled with metformin OBJECTIVE Dapagliflozin , a highly selective inhibitor of the renal sodium-glucose cotransporter-2 , increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner . We evaluated the efficacy and safety of dapagliflozin in treatment-naive patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This was a 24-week parallel-group , double-blind , placebo-controlled phase 3 trial . Patients with A1C 7.0–10 % ( n = 485 ) were r and omly assigned to one of seven arms to receive once-daily placebo or 2.5 , 5 , or 10 mg dapagliflozin once daily in the morning ( main cohort ) or evening ( exploratory cohort ) . Patients with A1C 10.1–12 % ( high-A1C exploratory cohort ; n = 73 ) were r and omly assigned 1:1 to receive blinded treatment with a morning dose of 5 or 10 mg/day dapagliflozin . The primary end point was change from baseline in A1C in the main cohort , statistically tested using an ANCOVA . RESULTS In the main cohort , mean A1C changes from baseline at week 24 were −0.23 % with placebo and −0.58 , −0.77 ( P = 0.0005 vs. placebo ) , and −0.89 % ( P < 0.0001 vs. placebo ) with 2.5 , 5 , and 10 mg dapagliflozin , respectively . Signs , symptoms , and other reports suggestive of urinary tract infections and genital infection were more frequently noted in the dapagliflozin arms . There were no major episodes of hypoglycemia . Data from exploratory cohorts were consistent with these results . CONCLUSIONS Dapagliflozin lowered hyperglycemia in treatment-naive patients with newly diagnosed type 2 diabetes . The near absence of hypoglycemia and an insulin-independent mechanism of action make dapagliflozin a unique addition to existing treatment options for type 2 diabetes 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 OBJECTIVE To examine the safety and efficacy of dapagliflozin , a sodium-glucose cotransporter-2 inhibitor , added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone . RESEARCH DESIGN AND METHODS Treatment-naive patients or those receiving metformin , sulfonylurea , or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone . They were then r and omized , along with patients previously receiving pioglitazone ≥30 mg , to 48 weeks of double-blind dapagliflozin 5 ( n = 141 ) or 10 mg ( n = 140 ) or placebo ( n = 139 ) every day plus open-label pioglitazone . The primary objective compared HbA1c change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24 . Primary analysis was based on ANCOVA model using last observation carried forward ; all remaining analyses used repeated- measures analysis . RESULTS At week 24 , the mean reduction from baseline in HbA1c was −0.42 % for placebo versus −0.82 and −0.97 % for dapagliflozin 5 and 10 mg groups , respectively ( P = 0.0007 and P < 0.0001 versus placebo ) . Patients receiving pioglitazone alone had greater weight gain ( 3 kg ) than those receiving dapagliflozin plus pioglitazone ( 0.7–1.4 kg ) at week 48 . Through 48 weeks : hypoglycemia was rare ; more events suggestive of genital infection were reported with dapagliflozin ( 8.6–9.2 % ) than placebo ( 2.9 % ) ; events suggestive of urinary tract infection showed no clear drug effect ( 5.0–8.5 % for dapagliflozin and 7.9 % for placebo ) ; dapagliflozin plus pioglitazone groups had less edema ( 2.1–4.3 % ) compared with placebo plus pioglitazone ( 6.5 % ) ; and congestive heart failure and fractures were rare . CONCLUSIONS In patients with type 2 diabetes inadequately controlled on pioglitazone , the addition of dapagliflozin further reduced HbA1c levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk Background Despite the number of medications for type 2 diabetes , many people with the condition do not achieve good glycaemic control . Some existing glucose-lowering agents have adverse effects such as weight gain or hypoglycaemia . Type 2 diabetes tends to be a progressive disease , and most patients require treatment with combinations of glucose-lowering agents . The sod
Output:
| Hypoglycemic risk was similar to that of other agents .
Results for cardiovascular outcomes and death were inconclusive .
An imbalance in incidence of bladder and breast cancer was noted with dapagliflozin compared with control .
Sodium-glucose cotransporter 2 inhibitors may improve short-term outcomes in adults with type 2 diabetes , but effects on long-term outcomes and safety are unclear . |
MS211037 | ***TASK*** the task is to summarize an input biomedical literature in 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 Self-reported knee pain is highly prevalent among adolescents . As much as 50 % of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome ( PFPS ) . In the short term , exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment . But the long-term effect of exercise therapy compared with patient education is conflicting . The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents . Methods / Design This study is a single blind pragmatic cluster r and omised controlled trial . Four upper secondary schools have been invited to participate in the study ( approximately 2500 students , aged 15 - 19 years ) . Students are asked to answer an online question naire regarding musculoskeletal pain . The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist . Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study . A minimum of 102 students with PFPS are then cluster-r and omised into two intervention groups based on which school they attend . Both intervention groups receive written information and education . In addition to patient education , one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot , knee and hip and home exercises . The students with PFPS fill out self-reported question naires at baseline , 3 , 6 , 12 and 24 months after inclusion in the study . The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from " completely recovered " to " worse than ever " at 12 months . Discussion This study is design ed to investigate the effectiveness of patient education compared with patient education combined with multimodal physiotherapy . If patient education and multimodal physiotherapy applied at an early stage of Patellofemoral Pain Syndrome proves effective , it may serve as a basis for optimising the clinical pathway for those suffering from the condition , where specific emphasis can be placed on early diagnosis and early treatment . Trial Registration clinical trials.gov reference : Objectives Describe proportions of individuals with patellofemoral pain ( PFP ) with an unfavourable recovery over 12 months ; identify clinical predictors of poor recovery at 3 and 12 months ; and determine baseline values of predictors that identify those with poor 12-month prognosis . Methods An observational analysis utilised data from 310 individuals with PFP enrolled in two r and omised clinical trials . Thirteen baseline variables ( participant , PFP , study characteristics ) were investigated for their prognostic ability . Pain , function and global recovery were measured at 3 and 12 months . Multivariate backward stepwise regression analyses ( treatment-adjusted , p<0.10 ) were performed for each follow-up measure . Receiver operator characteristic curves identified cut-points associated with unfavourable recovery at 12 months . Results 55 % and 40 % of participants had an unfavourable recovery at 3 and 12 months , respectively . Longer baseline pain duration was significantly associated with poor 3-month and 12-month recovery on measures of pain severity ( β 11.36 to 24.94 ) , Anterior Knee Pain ( AKP ) Scale ( −4.44 to −11.33 ) and global recovery ( OR : 2.32 to 6.11 ) . Greater baseline pain severity and lower AKP Scale score were significantly associated with poor recovery on multiple measures ( p<0.05 ) . Baseline duration > 2 months and AKP Scale score < 70/100 were associated with unfavourable 12-month recovery . Conclusions A substantial number of individuals with PFP have an unfavourable recovery over 12 months , irrespective of intervention . Knee pain duration > 2 months is the most consistent prognostic indicator , followed by AKP Scale score < 70 . Sports medicine practitioners should utilise interventions with known efficacy in reducing PFP , and promote early intervention to maximise prognosis . Trial registration Australian study : Australian Clinical Trials Registry ( ACTRN012605000463673 ) , Clinical Trials.gov ( NCT00118521 ) ; Dutch study : International St and ard R and omised Controlled Trial Number Register ( IS RCT N83938749 OBJECTIVE To determine the effects of electromyographic biofeedback treatment in patients with patellofemoral pain syndrome . DESIGN R and omized controlled trial . SETTING A physical medicine and rehabilitation department in a research hospital of a university referral center . PATIENTS Sixty patients with patellofemoral pain syndrome . Patients were r and omly placed into 2 groups : biofeedback group ( n = 30 ) and a control group ( n = 30 ) . INTERVENTION The biofeedback group received electromyographic biofeedback training and a conventional exercise program , whereas the control group received a conventional exercise program only . MAIN OUTCOME MEASURES Maximum and mean contraction values of the vastus medialis and the vastus lateralis muscles were assessed with the biofeedback device . Pain and functional status of the patients were measured by a visual analog scale ( VAS ) and the Functional Index Question naire ( FIQ ) , respectively . RESULTS Contraction values improved significantly at the end of the first month , compared with the pretreatment values in both groups . Mean contraction values in the biofeedback group of the vastus medialis muscles in all 3 monthly measurements , and the vastus lateralis muscles at the end of the first month , were significantly higher than those of the control group . Significant improvements were shown for both the VAS and the FIQ in both groups . Monthly follow-ups showed no VAS and FIQ differences between the groups . CONCLUSION Electromyographic biofeedback treatment did not result in further clinical improvement when compared with a conventional exercise program in patients with patellofemoral pain syndrome Purpose Neuromuscular electrical stimulation ( NMES ) with large electrodes and multiple current pathways ( m-NMES ) has recently been proposed as a valid alternative to conventional NMES ( c-NMES ) for quadriceps muscle (re)training . The main aim of this study was to compare discomfort , evoked force and fatigue between m-NMES and c-NMES of the quadriceps femoris muscle in healthy subjects . Methods Ten healthy subjects completed two experimental sessions ( c-NMES and m-NMES ) , that were r and omly presented in a cross-over design . Maximal electrically evoked force at pain threshold , self-reported discomfort at different levels of evoked force , and fatigue-induced force declines during and following a series of 20 NMES contractions were compared between c-NMES and m-NMES . Results m-NMES result ed in greater evoked force ( P < 0.05 ) and lower discomfort in comparison to c-NMES ( P < 0.05–0.001 ) , but fatigue time course and magnitude did not differ between the two conditions . Conclusions The use of quadriceps m-NMES appears legitimate for (re)training purpose s because it generated stronger contractions and was less discomfortable than c-NMES ( due to multiple current pathways and /or lower current density with larger electrodes ) Abstract Traditional conservative treatment for patellar disorders is successful in about 80 percents of cases . We introduced two new conservative treatment protocol s for patellar pathology in order to further improve the success rate . The first protocol consisted of high load/low repetition quadriceps femoris training ( 10 patients ) while the second enclosed selective electrostimulation of vastus medialis muscle ( 7 patients ) . Results were evaluated clinical ly and neurophysiologically . High load/low repetition training result ed in significant increase of maximal voluntary contraction of quadriceps muscle ( P < 0.001 ) . Significant gain of Activity ( P = 0.017 ) and Kujala scores ( P = 0.07 ) was observed in group with high load/low repetition quadriceps training compared to patients with electrostimulation . There was no significant change in neurophysiological or clinical status between the beginning and the end of treatment with electrostimulation . Our results indicate that high load/low repetition quadriceps femoris training poses an important alternative to traditional conservative treatment protocol for patellar disorders 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 A linear analogue for rating pain with 10 , 15 and 20 cm lines is significantly less variable than a 5 cm line ( mean error of 15 cm line is 0 - 19 % , 95 % confidence limits for the group + /- 2 % and an inood correlation between repeated ratins of a recalled pain distant in time . The variance of the rating is significantly less than the repeated rating of a r and om mark . The linear analogue rating of a constant pain stimulus is reproducible and changes in rating are likely to be real changes of opinion . Pethidine 150 mg intramuscularly had no significant effect , tested 30 minutes after the administration , on the accuracy or reproducibility of the analogue rating . A linear analogue seems a suitable method of recording the patient 's opion of a severe pain such as that of labour The aim of this study was to assess the clinical efficacy and safety of NMES program applied in male soccer players ( after ACL reconstruction ) on the quadriceps muscle . The 80 participants ( NMES = 40 , control = 40 ) received an exercise program , including three sessions weekly . The individuals in NMES group additionally received neuromuscular electrical stimulation procedures on both right and left quadriceps ( biphasic symmetric rectangular pulses , frequency of impulses : 2500 Hz , and train of pulses frequency : 50 Hz ) three times daily ( 3 hours of break between treatments ) , 3 days a week , for one month . The tensometry , muscle circumference , and goniometry pendulum test ( follow-up after 1 and 3 months ) were applied . The results of this study show that NMES ( in presented parameters in experiment ) is useful for strengthening the quadriceps muscle in soccer athletes . There is an evidence of the benefit of the NMES in restoring quadriceps muscle mass and strength of soccer players . In our study the neuromuscular electrical stimulation appeared to be safe for biomechanics of knee joint . The pathological changes in knee function were not observed . This trial is registered with Australian and New Zeal and Clinical Trials Registry ACTRN12613001168741 PURPOSE Although physical therapy is known to be effective in treating patellofemoral pain ( PFP ) , there is considerable individual variation in the treatment response . It is unclear why some patients benefit from a specific treatment while others do not experience improvement . This study , using a prospect i ve study design , aims to identify factors that could predict the short-term functional outcome and account for the variation frequently seen in the outcome after conservative treatment of PFP . METHODS Thirty-six patients ( 20 female and 16 male with a mean age of 23.8 ± 6.7 yr ) followed a physical therapy rehabilitation program of 7 wk . Before this treatment , all patients were evaluated on subjective symptoms ( pain on visual analog scales in millimeters ) and functional performance ( step test expressed as highest level , single-legged hop test in centimeters , and triple-hop test in centimeters ) . The concentric and eccentric knee extensor strength at 60 ° .s(-1 ) and 240 ° .s(-1 ) ( N.m ) were measured as well as the quadriceps muscle size by calculating the cross-sectional area ( cm(2 ) ) with magnetic resonance imaging . The success of the treatment was evaluated by the functional Kujala anterior knee pain scale . A linear regression model was used to identify predisposing factors for the functional outcome . RESULTS The total quadriceps cross-sectional area ( P = 0.010 ) , the eccentric average peak torque at 60 ° .s(-1 ) ( P = 0.015 ) , and the frequency of pain at baseline ( P = 0.012 ) have been indicated as predisposing variables in the short-term functional outcome after a physical therapy rehabilitation program for PFP ( adjusted R(2 ) = 0.46 ) . CONCLUSION Patients with a greater quadriceps
Output:
| The very low- quality evidence available means that we are uncertain whether or not a multiple-session programme of NMES combined with exercise over several weeks versus exercise alone results in clinical ly important differences in knee pain and function at the end of the treatment period or at one year .
There were no data on adverse effects such as muscle fatigue and discomfort . |
MS211038 | ***TASK*** the task is to summarize an input biomedical literature in 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 r and omized controlled trial of an information and medical record booklet design ed to improve patient underst and ing and participation in the management of hypertension was conducted in six inner London general practice s. After one year there were no significant differences between the group who had received the booklets and the control group in mean systolic or diastolic blood pressure , but the study group scored significantly higher on knowledge about hypertension and its management . However , the difference between the two groups was small , possibly because both groups started with a high level of underst and ing about hypertension and its management . In addition , the mean diastolic blood pressure in the control group showed that the treatment provided was already satisfactory , and that there was little need for improvement . Nevertheless , the information booklet evaluated in this study provides health professionals with a highly acceptable method of informing the patient about hypertension and its management and could be used both in hospital and general practice Background Hypertension is one of the key factors causing cardiovascular diseases which make up the most frequent cause of death in industrialised nations . However about 60 % of hypertensive patients in Germany treated with antihypertensives do not reach the recommended target blood pressure . The involvement of patients in medical decision making fulfils not only an ethical imperative but , furthermore , has the potential of higher treatment success . One concept to enhance the active role of patients is shared decision making . Until now there exists little information on the effects of shared decision making trainings for general practitioners on patient participation and on lowering blood pressure in hypertensive patients . Methods / Design In a cluster-r and omised controlled trial 1800 patients receiving antihypertensives will be screened with 24 h ambulatory blood pressure monitoring in their general practitioners ’ practice s. Only patients who have not reached their blood pressure target ( approximately 1200 ) will remain in the study ( T1 – T3 ) . General practitioners of the intervention group will take part in a shared decision making-training after baseline assessment ( T0 ) . General practitioners of the control group will treat their patients as usual . Primary endpoints are change of systolic blood pressure and change of patients ’ perceived participation . Secondary endpoints are changes of diastolic blood pressure , knowledge , medical adherence and cardiovascular risk . Data analysis will be performed with mixed effects models . Discussion The hypothesis underlying this study is that shared decision making , realised by a shared decision making training for general practitioners , activates patients , facilitates patients ’ empowerment and contributes to a better hypertension control . This study is the first one that tests this hypothesis with a ( cluster- ) r and omised trial and a large sample size . Trial registration WHO International Clinical Trials : http://apps.who.int/trial search /Trial.aspx?TrialID = Background To improve risk factor management in diabetes , we need to support effective interactions between patients and healthcare providers . Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes , and is intended to empower patients in taking a proactive role in their disease management . Important features are : ( 1 ) involving patients in setting goals together with their provider ; ( 2 ) encourage them to prioritise on treatments that maximise relevant outcomes ; and ( 3 ) integration of the decision aid in the practice setting and workflow . As secondary aim , we want to evaluate the impact of different presentation formats , and learn more from the experiences of the healthcare providers and patients with the decision aid . Methods and design We will conduct a r and omised trial comparing four formats of the decision aid in a 2 × 2 factorial design with a control group . Patients with type 2 diabetes managed in 18 to 20 primary care practice s in The Netherl and s will be recruited . Excluded are patients with a recent myocardial infa rct ion , stroke , heart failure , angina pectoris , terminal illness , cognitive deficits , > 65 years at diagnosis , or not able to read Dutch . The decision aid is offered to the patients immediately before their quarterly practice consultation . The same decision information will be available to the healthcare provider for use during consultation . In addition , the providers receive a set of treatment cards , which they can use to discuss the benefits and risks of different options . Patients in the control group will receive care as usual . We will measure the effect of the intervention on patient empowerment , satisfaction with care , beliefs about medication , negative emotions , health status , prescribed medication , and predicted cardiovascular risk . Data will be collected with question naires and automated extraction from medical records in 6 months before and after the intervention . Discussion This decision aid is innovative in supporting patients and their healthcare providers to make shared decisions about multiple treatments , using the patient ’s data from electronic medical records . The results can contribute to the further development and implementation of electronic decision support tools for the management of chronic diseases . Trial registration Dutch Trial register NTR1942 CONTEXT Decision aids can increase patient involvement in treatment decision making . However , questions remain regarding their effects and cost implication s. OBJECTIVE To evaluate the effects of information , with and without a structured preference elicitation interview , on treatment choices , health outcomes , and costs . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial with 2 years of follow-up . Between October 1996 and February 1998 , 894 women with uncomplicated menorrhagia were recruited from 6 hospitals in southwest Engl and . Women were r and omized to the control group , information alone group ( information ) , or information plus interview group ( interview ) . INTERVENTIONS Women in both intervention groups were sent an information pack ( a booklet and complementary videotape ) 6 weeks before their specialist consultation . Immediately before their consultation , women in the interview group underwent structured interview , to clarify and elicit their preferences . MAIN OUTCOME MEASURES Self-reported health status was the main outcome ; secondary outcomes included treatments received and costs . Cost analyses adopted a UK health service ( payer ) perspective , and were based on patient-reported re source use data and are reported in 1999 - 2000 US dollars . RESULTS The interventions had no consistent effect on health status . Hysterectomy rates were lower for women in the interview group ( 38 % ) ( adjusted odds ratio [ OR ] , 0.60 ; 95 % confidence interval [ CI ] , 0.38 - 0.96 ) than in the control group ( 48 % ) and women who received the information alone ( 48 % ) ( adjusted OR , 0.52 ; 95 % CI , 0.33 - 0.82 ) . The interview group had lower mean costs ( $ 1566 ) than the control group ( $ 2751 ) ( mean difference , $ 1184 ; 95 % CI , $ 684-$2110 ) and the information group $ 2026 ( mean difference , $ 461 ; 95 % CI , $ 236-$696 ) . CONCLUSIONS Neither intervention had an effect on health status . Providing women with information alone did not affect treatment choices ; however , the addition of an interview to clarify values and elicit preferences had a significant effect on women 's management and result ed in reduced costs The authors assessed whether patient empowerment in the management of hypertension improved more with the practice of shared decision making ( SDM ) than by education programs . In a prospect i ve controlled clinical study , 15 general practitioners in Nuremberg , Germany who were specially trained to conduct SDM consultations participated in a 12-month study . Hypertensive patients ( N=86 ) were included ; N=40 were in the SDM group and N=46 were in the control group , if blood pressures were > or = 135 / 85 mm Hg ( self measurement ) and patients had no signs of cardiovascular complications or severe hypertension . All participants in the SDM group and the control group were enrolled in an education program on hypertension in small groups . The SDM group participants also had 4 special consultations to share medical decisions . The main outcome measures were the effect of SDM on blood pressure control . After 1 year blood pressure had decreased in all participants : Delta-9.26 + /- 10.2 mm Hg/Delta-5.33 + /- 9.5 mm Hg in the SDM group ( P<0.001 ) compared to Delta-6.0 + /- 11.8 mm Hg/Delta-3.0 + /- 8.3 mm Hg in the control group . There was no significant difference between the 2 groups . The study group practice d more SDM than controls , but blood pressure control was not significantly better . Patient empowerment by means of an education program in small groups and creating awareness of hypertensive disease helps to improve the outcome of hypertension treatment . SDM , however , did not improve management when compared to an education program , which is much easier to implement in general practice Concordance -- that is , shared decision-making between doctors and patients --is nowadays accepted as an integral part of good clinical practice . It is of particular importance in the case of treatments with only marginal benefits such as those recommended in guidelines for the management of common , chronic diseases . However , the implementation of guideline -based medicine conflicts with that of concordance . Studies indicate that patients are not adequately informed about their treatment . Clinical guidelines for conditions such as cardiovascular disease are based on large-scale r and omized trials and the complex nature of the data limits effective communication especially in an environment characterized by time constraints . But other factors may be more relevant , notably pressures to comply with guidelines and financial rewards for meeting targets : it is simply not in the interests of doctors to disclose accurate information . Studies show that patients are far from impressed by the small benefits derived from large scale trials . Indeed , faced with absolute risk reductions , patients decline treatment promoted by guidelines . To participate in clinical decisions , patients require unbiased information concerning outcomes with and without treatment , and the absolute risk reduction ; they should be told that most patients receiving long-term medication obtain no benefit despite being exposed to adverse drug reactions ; furthermore , they should be made aware of the question able validity of large-scale trials and that these studies may be influenced by those with a vested interest . Genuine concordance will inevitably lead to many patients rejecting the recommendations of guidelines and encourage a more critical approach to clinical research and guideline -based medicine Background Hypertension is one of the key factors causing cardiovascular diseases . A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values . Shared decision making ( SDM ) is to enhance the active role of patients . As until now there exists little information on the effects of SDM training in antihypertensive therapy , we tested the effect of an SDM training programme for general practitioners ( GPs ) . Our hypotheses are that this SDM training ( 1 ) enhances the participation of patients and ( 2 ) leads to an enhanced decrease in blood pressure ( BP ) values , compared to patients receiving usual care without prior SDM training for GPs . Methods The study was conducted as a cluster r and omised controlled trial ( c RCT ) with GP practice s in Southwest Germany . Each GP practice included patients with treated but uncontrolled hypertension and /or with relevant comorbidity . After baseline assessment ( T0 ) GP practice s were r and omly allocated into an intervention and a control arm . GPs of the intervention group took part in the SDM training . GPs of the control group treated their patients as usual . The intervention was blinded to the patients . Primary endpoints on patient level were ( 1 ) change of patients ’ perceived participation ( SDM-Q-9 ) and ( 2 ) change of systolic BP ( 24h-mean ) . Secondary endpoints were changes of ( 1 ) diastolic BP ( 24h-mean ) , ( 2 ) patients ’ knowledge about hypertension , ( 3 ) adherence ( MARS-D ) , and ( 4 ) cardiovascular risk score ( CVR ) . Results In total 1357 patients from 36 general practice s were screened for blood pressure control by ambulatory blood pressure monitoring ( ABPM ) . Thereof 1120 patients remained in the study because of uncontrolled ( but treated ) hypertension and /or a relevant comorbidity . At T0 the intervention group involved 17 GP practice s with 552 patients and the control group 19 GP practice s with 568 patients . The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints . Conclusion The study hypothesis that the SDM training enhanced patients ’ perceived participation and lowered their BP could not be confirmed . Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care . Trial registration German Clinical Trials Register ( DRKS ) : Background Disparities in health and healthcare are extensively documented across clinical conditions , setting s , and dimensions of healthcare quality . In particular , studies show that ethnic minorities and persons with low socioeconomic status receive poorer quality of interpersonal or patient-centered care than whites and persons with higher socioeconomic status . Strong evidence links patient-centered care to improvements in patient adherence and health outcomes ; therefore , interventions that enhance this dimension of care are promising strategies to improve adherence and overcome disparities in outcomes for ethnic minorities and poor persons . Objective This paper describes the design of the Patient-Physician Partnership ( Triple P ) Study . The goal of the study is to compare the relative effectiveness of the patient and physician intensive interventions , separately , and in combination with one another , with the effectiveness of minimal interventions . The main hypothesis is that patients in the intensive intervention groups will have better adherence to appointments , medication , and lifestyle recommendations at three and twelve months than patients in minimal intervention groups . The study also examines other process and outcome measures , including patient-physician communication behaviors , patient ratings of care , health service utilization , and blood pressure control . Methods A total of 50 primary care physicians and 279 of their ethnic minority or poor patients with hypertension were recruited into a r and omized controlled trial with a two by two factorial design . The study used a patient-centered , culturally tailored , education and activation intervention for patients with active follow-up delivered by a community health worker in the clinic . It also included a computerized , self- study communication skills training program for physicians , delivered via an interactive CD-ROM , with tailored feedback to address their individual communication skills needs . Conclusion The Triple P study will provide new knowledge about
Output:
| Conclusions Despite widespread calls for shared decision making to be embedded in health care , there is little evidence to inform shared decision making for hypertension , one of the most common conditions managed in primary care |
MS211039 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background The use of mobile apps for health and well being promotion has grown exponentially in recent years . Yet , there is currently no app- quality assessment tool beyond “ star”-ratings . Objective The objective of this study was to develop a reliable , multidimensional measure for trialling , classifying , and rating the quality of mobile health apps . Methods A literature search was conducted to identify articles containing explicit Web or app quality rating criteria published between January 2000 and January 2013 . Existing criteria for the assessment of app quality were categorized by an expert panel to develop the new Mobile App Rating Scale ( MARS ) subscales , items , descriptors , and anchors . There were sixty well being apps that were r and omly selected using an iTunes search for MARS rating . There were ten that were used to pilot the rating procedure , and the remaining 50 provided data on interrater reliability . Results There were 372 explicit criteria for assessing Web or app quality that were extracted from 25 published papers , conference proceedings , and Internet re sources . There were five broad categories of criteria that were identified including four objective quality scales : engagement , functionality , aesthetics , and information quality ; and one subjective quality scale ; which were refined into the 23-item MARS . The MARS demonstrated excellent internal consistency ( alpha = .90 ) and interrater reliability intraclass correlation coefficient ( ICC = .79 ) . Conclusions The MARS is a simple , objective , and reliable tool for classifying and assessing the quality of mobile health apps . It can also be used to provide a checklist for the design and development of new high quality health apps Purpose Patients undergoing radiotherapy for prostate cancer suffer from a variety of symptoms which influence health-related quality of life . We have developed an application ( Interaktor ) for smartphones and tablets for early detection , reporting and management of symptoms , and concerns during treatment for prostate cancer . The study evaluates the effect on symptom burden and quality of life when using the application for real-time symptom assessment and management during radiotherapy for localized prostate cancer . Methods A non-r and omized controlled study was used at two university hospitals in Sweden where 64 patients constituted a control group and 66 patients made up an intervention group . The intervention group was asked to report symptoms via the application daily during the treatment as well as 3 weeks after . The EORTC QLQ-C30 and its module PR25 and the Sense of Coherence question naire were administered at three time points in both groups . Results The intervention group rated significantly lower levels of fatigue and nausea at the end of radiotherapy . Moreover , they had significantly less burden in emotional functioning , insomnia , and urinary-related symptoms at the end of treatment as well as 3 months later compared with the control group . In the multivariate analyses , with education and sense of coherence as covariates , the intervention group still significantly rated emotional functioning ( p = 0.007 ) , insomnia ( p = 0.017 ) , and urinary-related symptoms ( p = 0.008 ) as better than the control group at T2 . ConclusionS tudy findings suggest that Interaktor could be an efficient mHealth tool for facilitating supportive care needs during cancer treatment Background Mobile health apps for diabetes self-management have different functions . However , the efficacy and safety of each function are not well studied , and no classification is available for these functions . Objective The aims of this study were to ( 1 ) develop and vali date a taxonomy of apps for diabetes self-management , ( 2 ) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of r and omized controlled trials ( RCTs ) , and ( 3 ) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy . Methods We developed a 3-axis taxonomy with columns of clinical modules , rows of functional modules and cells of functions with risk assessment s. This taxonomy was vali date d by review ing and classifying commercially available diabetes apps . We search ed MEDLINE , EMBASE , the Cochrane Central Register of Controlled Trials , the Chinese Biomedical Literature Data base , and Clinical Trials.gov from January 2007 to May 2016 . We included RCTs of adult out patients with diabetes that compared using mobile app-based interventions with usual care alone . The mean differences ( MDs ) in hemoglobin A1c ( HbA1c ) concentrations and risk ratios of adverse events were pooled using a r and om-effects meta- analysis . After taxonomic classification , we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions . Results Across 12 included trials involving 974 participants , using app-based interventions was associated with a clinical ly significant reduction of HbA1c ( MD 0.48 % , 95 % CI 0.19%-0.78 % ) without excess adverse events . Larger HbA1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes ( MD 0.67 % , 95 % CI 0.30%-1.03 % vs MD 0.37 % , 95 % CI –0.12%-0.86 % ) . Having a complication prevention module in app-based interventions was associated with a greater HbA1c reduction ( with complication prevention : MD 1.31 % , 95 % CI 0.66%-1.96 % vs without : MD 0.38 % , 95 % CI 0.09%-0.67 % ; intersubgroup P=.01 ) , as was having a structured display ( with structured display : MD 0.69 % , 95 % CI 0.32%-1.06 % vs without : MD 0.69 % , 95 % CI –0.18%-0.53 % ; intersubgroup P=.03 ) . However , having a clinical decision-making function was not associated with a larger HbA1c reduction ( with clinical decision making : MD 0.19 % , 95 % CI –0.24%-0.63 % vs without : MD 0.61 % , 95 % CI 0.27%-0.95 % ; intersubgroup P=.14 ) . Conclusions The use of mobile app-based interventions yields a clinical ly significant HbA1c reduction among adult out patients with diabetes , especially among those with type 2 diabetes . Our study suggests that the clinical decision-making function needs further improvement and evaluation before being added to apps Background Brief interventions via the internet have been shown to reduce university students ’ alcohol intake . This study tested two smartphone applications ( apps ) targeting drinking choices on party occasions , with the goal of reducing problematic alcohol intake among Swedish university students . Methods Students were recruited via e-mails sent to student union members at two universities . Those who gave informed consent , had a smartphone , and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test ( AUDIT ) were r and omized into three groups . Group 1 had access to the Swedish government alcohol monopoly ’s app , Promillekoll , offering real-time estimated blood alcohol concentration ( eBAC ) calculation ; Group 2 had access to a web-based app , PartyPlanner , developed by the research group , offering real-time eBAC calculation with planning and follow-up functions ; and Group 3 participants were controls . Follow-up was conducted at 7 weeks . Results Among 28574 students offered participation , 4823 agreed to join ; 415 were excluded due to incomplete data , and 1932 fulfilled eligibility criteria for r and omization . Attrition was 22.7–39.3 percent , higher among heavier drinkers and highest in Group 2 . Self-reported app use was higher in Group 1 ( 74 % ) compared to Group 2 ( 41 % ) . Per- protocol analyses revealed only one significant time-by-group interaction , where Group 1 participants increased the frequency of their drinking occasions compared to controls ( p = 0.001 ) . Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week ( p = 0.001 ) , but not among women . Among all participants , 29 percent showed high-risk drinking , over the recommended weekly drinking levels of 9 ( women ) and 14 ( men ) st and ard glasses . Conclusions Smartphone apps can make brief interventions available to large numbers of university students . The apps studied using eBAC calculation did not , however , seem to affect alcohol consumption among university students and one app may have led to a negative effect among men . Future research should : 1 ) explore ways to increase user retention , 2 ) include apps facilitating technical manipulation for evaluation of added components , 3 ) explore the effects of adapting app content to possible gender differences , and 4 ) offer additional interventions to high-risk users . Trial registration clinical trials.gov : NCT01958398 BACKGROUND Nonpharmacological intervention for individuals with mild cognitive impairment ( MCI ) needs further investigation . OBJECTIVE Test efficacy of an eight-week Chinese calligraphy writing training course in improving attentional control and working memory . METHODS Ninety-nine participants with MCI were r and omized into the eight-week calligraphy writing ( n = 48 ) or control ( tablet computer ) training ( n = 51 ) . Outcomes of the interventions were attentional control , working memory , visual scan and processing speed . They were measured at baseline , post-training , and six-month follow-up . RESULTS Calligraphy writing , when compared with control , significantly improved working memory as reflected from DST-Backward sequence ( p = 0.009 ) and span scores ( p = 0.002 ) , and divided attention as reflected from CTT2 ( p < 0.001 ) , and at the post-training . The unique improvement in working memory ( span : p < 0.001 ; sequence : p = 0.008 ) of the intervention group was also found at follow-up when comparing with those at baseline . Changes in the other outcome measures were not statistically significant . CONCLUSION The findings provide support that Chinese calligraphy writing training for eight weeks using a cognitive approach would improve working memory and to a lesser extent attentional control functions of patients with early MCI . They also demonstrate the usefulness of using mind- and -body practice for improving specific cognitive functions BACKGROUND AND OBJECTIVES Patient self-management has been shown to improve health outcomes . We developed a smartphone-based system to boost self-care by patients with CKD and integrated its use into usual CKD care . We determined its acceptability and examined changes in several clinical parameters . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS We recruited patients with stage 4 or 5 CKD attending outpatient renal clinics who responded to a general information newsletter about this 6-month proof-of-principle study . The smartphone application targeted four behavioral elements : monitoring BP , medication management , symptom assessment , and tracking laboratory results . Prebuilt customizable algorithms provided real-time personalized patient feedback and alerts to providers when predefined treatment thresholds were crossed or critical changes occurred . Those who died or started RRT within the first 2 months were replaced . Only participants followed for 6 months after recruitment were included in assessing changes in clinical measures . RESULTS In total , 47 patients ( 26 men ; mean age = 59 years old ; 33 % were ≥65 years old ) were enrolled ; 60 % had never used a smartphone . User adherence was high ( > 80 % performed ≥80 % of recommended assessment s ) and sustained . The mean reductions in home BP readings between baseline and exit were statistically significant ( systolic BP , -3.4 mmHg ; 95 % confidence interval , -5.0 to -1.8 and diastolic BP , -2.1 mmHg ; 95 % confidence interval , -2.9 to -1.2 ) ; 27 % with normal clinic BP readings had newly identified masked hypertension . One hundred twenty-seven medication discrepancies were identified ; 59 % were medication errors that required an intervention to prevent harm . In exit interviews , patients indicated feeling more confident and in control of their condition ; clinicians perceived patients to be better informed and more engaged . CONCLUSIONS Integrating a smartphone-based self-management system into usual care of patients with advanced CKD proved feasible and acceptable , and it appeared to be clinical ly useful . The results provide a strong rationale for a r and omized , controlled trial We performed a pilot r and omized , controlled trial of intensive , computer-based cognitive training in 47 subjects with mild cognitive impairment . The intervention group performed exercises specifically design ed to improve auditory processing speed and accuracy for 100 min/d , 5 d/wk for 6 weeks ; the control group performed more passive computer activities ( reading , listening , visuospatial game ) for similar amounts of time . Subjects had a mean age of 74 years and 60 % were men ; 77 % successfully completed training . On our primary outcome , Repeatable Battery for Assessment of Neuropsychological Status total scores improved 0.36 st and ard deviations ( SD ) in the intervention group ( P=0.097 ) compared with 0.03 SD in the control group ( P=0.88 ) for a nonsignificant difference between the groups of 0.33 SD ( P=0.26 ) . On 12 secondary outcome measures , most differences between the groups were not statistically significant . However , we observed a pattern in which effect sizes for verbal learning and memory measures tended to favor the intervention group whereas effect sizes for language and visuospatial function measures tended to favor the control group , which raises the possibility that these training programs may have domain-specific effects . We conclude that intensive , computer-based mental activity is feasible in subjects with mild cognitive impairment and that larger trials are warranted Objective To determine whether mobile phone based monitoring improves asthma control compared with st and ard paper based monitoring strategies . Design Mult
Output:
| Results Of 13 review s and six single studies assessing efficacy , consistent evidence of benefit was seen only with apps for diabetes , as measured by decreased glycosylated haemoglobin levels ( HbA1c ) .
Some , but not all , studies showed benefit in asthma , low back pain , alcohol addiction , heart failure , ischaemic heart disease and cancer .
There was no evidence of benefit in COPD , cognitive impairment or CKD .
In all studies , benefits were clinical ly marginal and none related to morbid events or hospitalisation .
Conclusion Evidence of clinical benefit of most available apps is very limited .
Design features that enhance usability and maximise efficacy were identified .
This paper presents a comprehensive review of evidence relating to the efficacy , usability and evaluation of apps for 11 common diseases aim ed at assisting patients in self-management .
Consistent evidence of benefit was only seen for diabetes apps ; there was absent or conflicting evidence of benefit for apps for the remaining 10 diseases .
Benefits that were detected were of marginal clinical importance , with no reporting of hard clinical end-points , such as mortality or hospitalisations .
Many apps lacked design features that the literature identified as enhancing usability and potential to confer benefit . |
MS211040 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES We sought to determine whether structured exercise training ( ET ) improves maximal exercise capacity , left ventricular diastolic function , and quality of life ( QoL ) in patients with heart failure with preserved ejection fraction ( HFpEF ) . BACKGROUND Nearly one-half of patients with heart failure experience HFpEF , but effective therapeutic strategies are sparse . METHODS A total of 64 patients ( age 65 ± 7 years , 56 % female ) with HFpEF were prospect ively r and omized ( 2:1 ) to supervised endurance/resistance training in addition to usual care ( ET , n = 44 ) or to usual care alone ( UC ) ( n = 20 ) . The primary endpoint was the change in peak Vo(2 ) after 3 months . Secondary endpoints included effects on cardiac structure , diastolic function , and QoL. RESULTS Peak Vo(2 ) increased ( 16.1 ± 4.9 ml/min/kg to 18.7 ± 5.4 ml/min/kg ; p < 0.001 ) with ET and remained unchanged ( 16.7 ± 4.7 ml/min/kg to 16.0 ± 6.0 ml/min/kg ; p = NS ) with UC . The mean benefit of ET was 3.3 ml/min/kg ( 95 % confidence interval [ CI ] : 1.8 to 4.8 , p < 0.001 ) . E/e ' ( mean difference of changes : -3.2 , 95 % CI : -4.3 to -2.1 , p < 0.001 ) and left atrial volume index ( milliliters per square meter ) decreased with ET and remained unchanged with UC ( -4.0 , 95 % CI : -5.9 to -2.2 , p < 0.001 ) . The physical functioning score ( 36-Item Short-Form Health Survey ) improved with ET and remained unchanged with UC ( 15 , 95 % CI : 7 to 24 , p < 0.001 ) . The ET-induced decrease of E/e ' was associated with 38 % gain in peak Vo(2 ) and 50 % of the improvement in physical functioning score . CONCLUSIONS Exercise training improves exercise capacity and physical dimensions of QoL in HFpEF . This benefit is associated with atrial reverse remodeling and improved left ventricular diastolic function . ( Exercise Training in Diastolic Heart Failure-Pilot Study : A Prospect i ve , R and omised , Controlled Study to Determine the Effects of Physical Training on Exercise Capacity and Quality of Life [ Ex-DHF-P ] ; IS RCT N42524037 ) Background —Heart failure ( HF ) with preserved left ventricular ejection fraction ( HFPEF ) is the most common form of HF in the older population . Exercise intolerance is the primary chronic symptom in patients with HFPEF and is a strong determinant of their reduced quality of life ( QOL ) . Exercise training ( ET ) improves exercise intolerance and QOL in patients with HF with reduced ejection fraction ( EF ) . However , the effect of ET in HFPEF has not been examined in a r and omized controlled trial . Methods and Results —This 16-week investigation was a r and omized , attention-controlled , single-blind study of medically supervised ET ( 3 days per week ) on exercise intolerance and QOL in 53 elderly patients ( mean age , 70±6 years ; range , 60 to 82 years ; women , 46 ) with isolated HFPEF ( EF ≥50 % and no significant coronary , valvular , or pulmonary disease ) . Attention controls received biweekly follow-up telephone calls . Forty-six patients completed the study ( 24 ET , 22 controls ) . Attendance at exercise sessions in the ET group was excellent ( 88 % ; range , 64 % to 100 % ) . There were no trial-related adverse events . The primary outcome of peak exercise oxygen uptake increased significantly in the ET group compared to the control group ( 13.8±2.5 to 16.1±2.6 mL/kg per minute [ change , 2.3±2.2 mL/kg per minute ] versus 12.8±2.6 to 12.5±3.4 mL/kg per minute [ change , −0.3±2.1 mL/kg per minute ] ; P=0.0002 ) . There were significant improvements in peak power output , exercise time , 6-minute walk distance , and ventilatory anaerobic threshold ( all P<0.002 ) . There was improvement in the physical QOL score ( P=0.03 ) but not in the total score ( P=0.11 ) . Conclusions —ET improves peak and submaximal exercise capacity in older patients with HFPEF . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01113840 BACKGROUND The health benefits of leisure-time physical activity are well known , but whether less exercise than the recommended 150 min a week can have life expectancy benefits is unclear . We assessed the health benefits of a range of volumes of physical activity in a Taiwanese population . METHODS In this prospect i ve cohort study , 416,175 individuals ( 199,265 men and 216,910 women ) participated in a st and ard medical screening programme in Taiwan between 1996 and 2008 , with an average follow-up of 8·05 years ( SD 4·21 ) . On the basis of the amount of weekly exercise indicated in a self-administered question naire , participants were placed into one of five categories of exercise volumes : inactive , or low , medium , high , or very high activity . We calculated hazard ratios ( HR ) for mortality risks for every group compared with the inactive group , and calculated life expectancy for every group . FINDINGS Compared with individuals in the inactive group , those in the low-volume activity group , who exercised for an average of 92 min per week ( 95 % CI 71 - 112 ) or 15 min a day ( SD 1·8 ) , had a 14 % reduced risk of all-cause mortality ( 0·86 , 0·81 - 0·91 ) , and had a 3 year longer life expectancy . Every additional 15 min of daily exercise beyond the minimum amount of 15 min a day further reduced all-cause mortality by 4 % ( 95 % CI 2·5 - 7·0 ) and all-cancer mortality by 1 % ( 0·3 - 4·5 ) . These benefits were applicable to all age groups and both sexes , and to those with cardiovascular disease risks . Individuals who were inactive had a 17 % ( HR 1·17 , 95 % CI 1·10 - 1·24 ) increased risk of mortality compared with individuals in the low-volume group . INTERPRETATION 15 min a day or 90 min a week of moderate-intensity exercise might be of benefit , even for individuals at risk of cardiovascular disease . FUNDING Taiwan Department of Health Clinical Trial and Research Center of Excellence and National Health Research Institutes Exercise training improves functional capacity in patients with exercise limitation attributed to systolic dysfunction ( SD ) , but exercise training effects in patients with diastolic dysfunction is unclear . The authors determined the functional capacity , quality of life , and echocardiography responses of heart failure with preserved ejection fraction ( HFpEF ) patients to 16 weeks exercise training . Thirty patients with HFpEF were r and omized to an exercise training or non-exercising control group . The patients had a baseline mean age of 64 ± 8 years , left ventricular ejection fraction 57 % ± 10 % , and peak oxygen consumption ( peak VO(2 ) ) of 13.3 ± 3.8 mL O(2 ) /kg/min . Minnesota Living With Heart Failure and Hare-Davis scores and echocardiographic measures ( ejection fraction , systolic and diastolic tissue velocity and filling pressure [ E/E ' ] ) were performed at baseline and after 16 weeks of exercise training . The exercise training and non-exercising control groups showed similar baseline VO(2 ) ( 12.2 ± 3.6 mL/kg/min vs 14.1 ± 4.1 mL/kg/min ) , ejection fraction ( 58 % ± 13 % vs 57 % ± 8 % ) , and systolic and diastolic function . After exercise training the increment in peak VO(2 ) in the exercise training group was ( 24.6 % , P=.02 ) , and the non-exercising control group ( 5.1 % , P=.19 ) . V(E ) /VCO(2 ) slope was reduced by 12.7 % in the exercise training group ( P=.02 ) but was unchanged in the non-exercising control group ( P=.03 ) . No significant changes in diastolic or systolic function were noted in either group . Quality -of-life and depression scores were unchanged with exercise training . Changes in peak VO(2 ) and V(E ) /VCO(2 ) slope were unrelated to measures of diastolic and systolic function . In patients with exercise limitation attributed to HFpEF , the improvement in peak VO(2 ) with exercise training was not clearly related to changes in cardiac function 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 Heart failure with preserved ejection fraction ( HFpEF ) is a major cause of morbidity and mortality . Exercise training is an established adjuvant therapy in heart failure ; however , the effects of high-intensity interval training ( HIIT ) in HFpEF are unknown . We compared the effects of HIIT vs. moderate-intensity aerobic continuous training ( MI-ACT ) on peak oxygen uptake ( V̇o₂peak ) , left ventricular diastolic dysfunction , and endothelial function in patients with HFpEF . Nineteen patients with HFpEF ( age 70 ± 8.3 yr ) were r and omized to either HIIT ( 4 × 4 min at 85 - 90 % peak heart rate , with 3 min active recovery ) or MI-ACT ( 30 min at 70 % peak heart rate ) . Fifteen patients completed exercise training ( HIIT : n = 9 ; MI-ACT : n = 6 ) . Patients trained 3 days/wk for 4 wk . Before and after training patients underwent a treadmill test for V̇o₂peak determination , 2D-echocardiography for assessment of left ventricular diastolic dysfunction , and brachial artery flow-mediated dilation ( FMD ) for assessment of endothelial function . HIIT improved V̇o₂peak ( pre = 19.2 ± 5.2 ml·kg(-1)·min(-1 ) ; post = 21.0 ± 5.2 ml·kg(-1)·min(-1 ) ; P = 0.04 ) and left ventricular diastolic dysfunction grade ( pre = 2.1 ± 0.3 ; post = 1.3 ± 0.7 ; P = 0.02 ) , but FMD was unchanged ( pre = 6.9 ± 3.7 % ; post = 7.0 ± 4.2 % ) . No changes were observed following MI-ACT . A trend for reduced left atrial volume index was observed following HIIT compared with MI-ACT ( -3.3 ± 6.6 vs. + 5.8 ± 10.7 ml/m(2
Output:
| There were significant improvements in peak oxygen uptake , 6-min walking test distance , and ventilatory threshold , whereas quality of life and echocardiographic parameters improved only in some studies .
Endothelial function/arterial stiffness remained unchanged .
No adverse events were reported .
Appropriate exercise programs are able to get a favorable cardiovascular outcome in patients with HFpEF .
This could also benefit in terms of quality of life , even if more controversial . |
MS211041 | ***TASK*** the task is to summarize an input biomedical literature in 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 prospect i ve r and omized double-blind study was performed to determine the effects of three colloids , Haemaccel , Gelofusine and albumin , and also saline on platelet activation , platelet aggregation ( induced by adenosine diphosphate ( ADP ) , epinephrine , collagen ) platelet agglutination by ristocetin and other hemostatic variables in 55 patients undergoing primary unilateral total hip replacement . The fluids were administered according to normal clinical practice and assessment s were made immediately before , at the end , and 2 h after the end of surgery . Surgery was accompanied by thrombin generation ( increases in thrombin/antithrombin III complex , prothrombin F1 + 2 fragment ) platelet activation ( betaTG ) and compromised coagulation . Generally , the platelet activation appeared to result in platelet desensitization and brought about a persistent reduction in platelet aggregation to ADP and epinephrine , irrespective of the fluid used . Additionally , Haemaccel and Gelofusine inhibited ristocetin-induced platelet agglutination and albumin inhibited collagen-induced platelet aggregation . Gross inhibitory effects of Haemaccel that had been predicted from an earlier in vitro study did not occur . Particular fluids had selective additional effects on the hemostatic system . Albumin infusion served to maintain plasma albumin at normal concentrations postsurgery . The two gelatin preparations , Haemaccel and Gelofusine , maintained plasma viscosity . All three colloids led to a transient increase in activated partial thromboplastin time postsurgery and also a transient fall in the concentration of factor VIII , which were accompanied by a transient increase in bleeding time , but there was no measurable increase in blood loss . Inhibition of platelet aggregation by certain colloids may provide additional protection against the increased thrombotic risk in patients following major surgery Metabolic acidosis and changes in serum osmolarity are consequences of 0.9 % normal saline ( NS ) solution administration . We sought to determine if these physiologic changes influence patient outcome . Patients undergoing aortic reconstructive surgery were enrolled and were r and omly assigned to receive lactated Ringer ’s ( LR ) solution ( n = 33 ) or NS ( n = 33 ) in a double-blinded fashion . Anesthetic and fluid management were st and ardized . Multiple measures of outcome were monitored . The NS patients developed a hyperchloremic acidosis and received more bicarbonate therapy ( 30 ± 62 mL in the NS group versus 4 ± 16 mL in the LR group ; mean ± sd ) , which was given if the base deficit was greater than −5 mEq/L. The NS patients also received a larger volume of platelet transfusion ( 478 ± 302 mL in the NS group versus 223 ± 24 mL in the LR group ; mean ± sd ) . When all blood products were summed , the NS group received significantly more blood products ( P = 0.02 ) . There were no differences in duration of mechanical ventilation , intensive care unit stay , hospital stay , and incidence of complications . When NS was used as the primary intraoperative solution , significantly more acidosis was seen on completion of surgery . This acidosis result ed in no apparent change in outcome but required larger amounts of bicarbonate to achieve predetermined measurements of base deficit and was associated with the use of larger amounts of blood products . These changes should be considered when choosing fluids for surgical procedures involving extensive blood loss and requiring extensive fluid administration Study Design . Prospect i ve , r and omized , double blind , clinical study . Objective . To compare the hemostatic and electrolyte effects of 2 commonly administered hydroxyethyl starches ( HES ) in patients undergoing posterior lumbar interbody fusion ( PLIF ) . Summary of Background Data . HES are commonly administered colloid solutions to restore and maintain intravascular volume before transfusion is initiated . However , infusion of HES itself can impair coagulation . HES-induced coagulopathy could be a serious problem in PLIF which involves continuous bone bleeding and oozing . Voluven ( Fresenius Kabi , Germany ) , previously regarded as the least coagulopathic due to its low molecular weight ( MW ) and degree of substitution ( DS ) , is a saline-based HES . Hextend ( Biotime , United States ) is a new type of HES with physiologic pH and balanced electrolytes , including calcium , which is beneficial to coagulation . Studies comparing the coagulopathy of Hextend and Voluven are rare . Therefore , coagulation , pH/electrolyte changes , and blood loss using Hextend and Voluven in patients undergoing PLIF were compared . Methods . Fifty-four patients scheduled for PLIF involving 3 vertebrae or less were r and omly assigned to the Voluven or the Hextend group . Of each solution 15 mL/kg was administered during surgery . Blood loss , coagulation , and electrolyte profiles were checked before infusion and 5 minutes , 3 hours , and 24 hours after the end of infusion . Results . The Hextend group showed slightly better electrolyte balance , however , more coagulation impairment and postoperative transfusion ( 37 % vs. 11 % ) compared with the Voluven group . The effect of Hextend on coagulation lasted until 24 hours after infusion . Conclusion . If coagulopathy is a concern during PLIF , then , a HES with low MW/DS in a saline-based medium ( Voluven ) may be a better alternative than a HES with high MW/DS in a balanced salt medium ( Hextend ) OBJECTIVES To compare the effects of lactated Ringer 's solution ( LR ) , 6 % hetastarch in a balanced-saline vehicle ( HS-BS ) , and 6 % hetastarch in normal saline ( HS-NS ) on coagulation using thromboelastography . DESIGN Prospect i ve , r and omized double-blinded evaluation of previously published clinical trial . SETTING Tertiary-care medical center . PARTICIPANTS Patients undergoing elective noncardiac surgery with an anticipated blood loss > 500 mL. A total of 90 patients were enrolled with 30 patients in each group . INTERVENTIONS Patients received a st and ardized anesthetic . LR , HS-BS , and HS-NS were administered intraoperatively based on a fluid administration algorithm . Hemodynamic targets included maintenance of arterial blood pressure , heart rate , and urine output within a predefined range . MEASUREMENTS AND MAIN RESULTS Thromboelastography variables for r time , k time , maximum amplitude , and alpha angle ( mean + /- SD ) were recorded at induction of anesthesia , at the end of surgery , and 24 hours postoperatively . Patients in the LR group showed a state of hypercoagulation at the end of surgery with reductions ( p < 0.005 ) in r time ( -3.8 + /- 6.7 mm ) and k time ( -1.7 + /- 2.5 mm ) . This state of hypercoagulation continued into the postoperative period . Patients in the HS-NS group showed a state of hypocoagulation with increases ( p < 0.05 ) in r time ( + 6.2 + /- 8.5 mm ) and k time ( + 1.7 + /- 3.9 mm ) and a reduction in maximum amplitude ( -8.0 + /- 9.8 mm ) at the end of surgery . This state of hypocoagulation was reduced in the postoperative period . Patients in the HS-BS group showed no significant changes in coagulation status at end of surgery , with the smallest changes in r time ( -0.3 + /- 4.1 mm ) , k time ( + 0.1 + /- 3.1 mm ) , maximum amplitude ( -5.4 + /- 12.3 mm ) , and alpha angle ( 0.3 + /- 12.5 degrees ) . CONCLUSION LR-treated patients exhibited a hypercoagulative profile that persisted into the postoperative period . HS-BS administration was associated with a lesser change in the coagulation profile compared with HS-NS , which was associated with a hypocoagulative state Normal saline ( NS ; 0.9 % NaCl ) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids . Recent evidence suggests that NS may be associated with adverse effects that are not seen with balanced-salt fluids , e.g. , lactated Ringer ’s solution ( LR ) . We hypothesized that NS is detrimental to renal function in kidney transplant recipients . Adults undergoing kidney transplantation were enrolled in a prospect i ve , r and omized , double-blind clinical trial of NS versus LR for intraoperative IV fluid therapy . The primary outcome measure was creatinine concentration on postoperative Day 3 . The study was terminated for safety reasons after interim analysis of data from 51 patients . Forty-eight patients underwent living donor kidney transplants , and three patients underwent cadaveric donor transplants . Twenty-six patients received NS , and 25 patients received LR . There was no difference between groups in the primary outcome measure . Five ( 19 % ) patients in the NS group versus zero ( 0 % ) patients in the LR group had potassium concentrations > 6 mEq/L and were treated for hyperkalemia ( P = 0.05 ) . Eight ( 31 % ) patients in the NS group versus zero ( 0 % ) patients in the LR group were treated for metabolic acidosis ( P = 0.004 ) . NS did not adversely affect renal function . LR was associated with less hyperkalemia and acidosis compared with NS . LR may be a safe choice for IV fluid therapy in patients undergoing kidney transplantation Purpose A balanced fluid replacement strategy appears to be promising for correcting hypovolemia . The benefits of a balanced fluid replacement regimen were studied in elderly cardiac surgery patients . Methods In a r and omized clinical trial , 50 patients aged > 75 years undergoing cardiac surgery received a balanced 6 % HES 130/0.42 plus a balanced crystalloid solution ( n = 25 ) or a non-balanced HES in saline plus saline solution ( n = 25 ) to keep pulmonary capillary wedge pressure/ central venous pressure between 12–14 mmHg . Acid-base status , inflammation , endothelial activation ( soluble intercellular adhesion molecule-1 , kidney integrity ( kidney-specific proteins glutathione transferase-alpha ; neutrophil gelatinase-associated lipocalin ) were studied after induction of anesthesia , 5 h after surgery , 1 and 2 days thereafter . Serum creatinine ( sCr ) was measured approximately 60 days after discharge . Results A total of 2,750 ± 640 mL of balanced and 2,820 ± 550 mL of unbalanced HES were given until the second POD . Base excess ( BE ) was significantly reduced in the unbalanced ( from + 1.21 ± 0.3 to −4.39 ± 1.0 mmol L−1 5 h after surgery ; P < 0.001 ) and remained unchanged in the balanced group ( from 1.04 ± 0.3 to −0.81 ± 0.3 mmol L−1 5 h after surgery ) . Evolution of the BE was significantly different . Inflammatory response and endothelial activation were significantly less pronounced in the balanced than the unbalanced group . Concentrations of kidney-specific proteins after surgery indicated less alterations of kidney integrity in the balanced than in the unbalanced group . Conclusions A total balanced volume replacement strategy including a balanced HES and a balanced crystalloid solution result ed in moderate beneficial effects on acid-base status , inflammation , endothelial activation , and kidney integrity compared to a conventional unbalanced volume replacement regimen The IV administration of sodium chloride solutions may produce a metabolic acidosis and gastrointestinal dysfunction . We design ed this trial to determine whether , in elderly surgical patients , crystalloid and colloid solutions with a more physiologically balanced electrolyte formulation , such as Hartmann ’s solution and Hextend ® , can provide a superior metabolic environment and improved indices of organ perfusion when compared with saline-based fluids . Forty-seven elderly patients undergoing major surgery were r and omly allocated to one of two study groups . Patients in the Balanced Fluid group received an intraoperative fluid regimen that consisted of Hartmann ’s solution and 6 % hetastarch in balanced electrolyte and glucose injection ( Hextend ) . Patients in the Saline group were given 0.9 % sodium chloride solution and 6 % hetastarch in 0.9 % sodium chloride solution ( Hespan ® ) . Biochemical indices and acid-base balance were determined . Gastric tonometry was used as a reflection of splanchnic perfusion . Postoperative chloride levels demonstrated a larger increase in the Saline group than the Balanced Fluid group ( 9.8 vs 3.3 mmol/L , P = 0.0001 ) . Postoperative st and ard base excess showed a larger decline in the Saline group than the Balanced Fluid group ( −5.5 vs −0.9 mmol/L , P = 0.0001 ) . Two-thirds of patients in the Saline group , but none in the Balanced Fluid group , developed postoperative hyperchloremic metabolic acidosis ( P = 0.0001 ) . Gastric tonometry indicated a larger increase in the CO2 gap during surgery in the Saline group compared with the Balanced Fluid group ( 1.7 vs 0.9 kPa , P = 0.0394 ) . In this study , the use
Output:
| There was no difference in intraoperative blood loss nor the volumes of intraoperative red cell or fresh frozen plasma transfused between groups .
The non-buffered fluid group also had significantly greater base deficit , serum sodium and chloride levels .
There was no difference demonstrated in length of hospital stay and no data were reported on cost or quality of life .
AUTHORS ' CONCLUSIONS The administration of buffered fluids to adult patients during surgery is equally safe and effective as the administration of non-buffered saline-based fluids .
The use of buffered fluids is associated with less metabolic derangement , in particular hyperchloraemia and metabolic acidosis . |
MS211042 | ***TASK*** the task is to summarize an input biomedical literature in 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 : To test the effects of pregabalin on the induction of neurogenic claudication . Methods : This study was a r and omized , double-blind , active placebo-controlled , 2-period , crossover trial . Twenty-nine subjects were r and omized to receive pregabalin followed by active placebo ( i.e. , diphenhydramine ) or active placebo followed by pregabalin . Each treatment period lasted 10 days , including a 2-step titration . Periods were separated by a 10-day washout period , including a 3-day taper phase after the first period . The primary outcome variable was the time to first moderate pain symptom ( Numeric Rating Scale score ≥4 ) during a 15-minute treadmill test ( Tfirst ) . Secondary outcome measures included pain intensity at rest , pain intensity at the end of the treadmill test , distance walked , and vali date d self-report measures of pain and functional limitation including the Rol and -Morris Disability Question naire , modified Brief Pain Inventory – Short Form , Oswestry Disability Index , and Swiss Spinal Stenosis Question naire . Results : No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom ( difference in median Tfirst = −1.08 [ 95 % confidence interval −2.25 to 0.08 ] , p = 0.61 ) . In addition , none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo . Conclusions : Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis . Classification of evidence : This study provides Class I evidence that for patients with neurogenic claudication , compared with diphenhydramine , pregabalin does not increase the time to moderate pain during a treadmill test Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain . The efficacy and tolerability of the combination have not yet been established . The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain . This double-blind , double-dummy , r and omized , comparative , multicentric , parallel group study enrolled 197 patients of either sex in the age range of 18–70 years with acute low back pain . The patients were r and omized to receive either aceclofenac ( 100 mg)–tizanidine ( 2 mg ) b.i.d or aceclofenac ( 100 mg ) alone b.i.d for 7 days . The primary efficacy outcomes were pain intensity ( on movement , at rest and at night ; on VAS scale ) and pain relief ( on a 5-point verbal rating scale ) . The secondary efficacy outcomes measures included functional impairment ( modified Schober ’s test and lateral body bending test ) and patient ’s and investigator ’s global efficacy assessment . aceclofenac – tizanidine was significantly superior to aceclofenac for pain intensity ( on movement , at rest and at night ; P < 0.05 ) and pain relief ( P = 0.00 ) on days 3 and 7 . There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group ( P < 0.05 ) . There were significantly more number of patients with excellent to good response for the aceclofenac – tizanidine treatment as compared to aceclofenac alone ( P = 0.00 ) . Both the treatments were well tolerated . In this study , aceclofenac – tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain This large , open-label , r and omized , parallel-group , multicenter study compared two oral sustained-release opioids (SROs)--AVINZA ( A-MQD ) , morphine sulfate extended-release capsules given once a day , and OxyContin ( O-ER ) , oxycodone modified-release tablets given twice a day -- in SRO-naive subjects ages 30 to 70 with chronic , moderate to severe low back pain . Of the 392 subjects enrolled and r and omized , 266 ( 132 in the A-MQD group and 134 in the O-ER group ) completed the opioid dose titration phase and entered an eight-week evaluation phase . During the evaluation phase , A-MQD achieved significantly better pain control than O-ER , as demonstrated by a greater decrease from baseline in pain scores obtained four times daily during weeks one , four , and eight ( p = 0.002 ) . The number of breakthrough-pain rescue medication doses adjusted for the number of patient days was significantly lower in the A-MQD group ( p < 0.0001 ) . Better pain control with A-MQD was achieved with a significantly lower daily opioid dose than with O-ER ( mean 69.9 mg and 91 mg morphine equivalents , respectively ; p = 0.0125 ) . Quality of sleep was significantly better with A-MQD for the entire evaluation phase ( p = 0.0026 ) . The incidence and severity of elicited opioid side effects were similar in the two groups . This trial demonstrated that once-daily A-MQD provides consistent around-the-clock pain relief in patients with low back pain . In patients who completed opioid dose titration , A-MQD was significantly better than O-ER for reducing pain and improving sleep , while requiring a lower daily opioid dose & NA ; We evaluated the efficacy of pregabalin in patients with chronic lumbosacral radiculopathy . This r and omized , controlled , withdrawal trial included five phases : screening ( 4–18 days ) ; run‐in ( 4–10 days ) to screen out placebo responders ; single‐blind ( 28 days ) to identify pregabalin responders ; double‐blind to r and omize responders to pregabalin or placebo ( 35 days ) ; and final study medication taper ( 7 days ) . The primary endpoint was time to loss of response ( LOR ) during the double‐blind phase ( ≥1‐point increase in pain , discontinuation , or rescue‐medication use ) . In the single‐blind phase , 58 % of patients had ≥30 % pain reduction . In the double‐blind phase , pregabalin ( n = 110 ) and placebo ( n = 107 ) groups did not differ significantly in time to LOR . Adverse events caused the discontinuation of 9.9 % and 5.6 % of pregabalin‐treated and placebo‐treated patients , respectively . Most patients with chronic lumbosacral radiculopathy responded to pregabalin therapy ; however , time to LOR did not significantly differ between pregabalin and placebo . Considering the results of all phases of the study , it is difficult to draw definitive conclusions from it , suggesting a need for further work to underst and the clinical potential of pregabalin treatment for lumbosacral radiculopathy Background Corticoids have potent anti-inflammatory effects , which may help in relieving pain and dysfunction associated with lumbar canal stenosis . We assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospect i ve , double-blind , r and omized , placebo-controlled trial . Results Sixty-one patients with lumbar canal stenosis ( 50–75 years ; canal area < 100 mm2 at L3/L4 , L4/L5 , and /or L5/S1on magnetic resonance imaging ; and claudication within 100 m were electronically r and omized to an oral corticoid group ( n = 31 ) or a placebo group ( n = 30 ) . The treatment group received 1 mg/kg of oral corticoids daily , with a dose reduction of one-third per week for 3 weeks . Patients and controls were assessed by the Short Form 36 Health Survey , Rol and –Morris Question naire , 6-min walk test , visual analog scale , and a Likert scale . All instruments showed similar outcomes for the corticoid and placebo groups ( P > 0.05 ) . Obese patients exhibited more severe symptoms compared with non-obese patients . L4/L5 stenosis was associated with more severe symptoms compared with stenosis at other levels . Conclusion The oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis Study Design . Two replicate , 4-week , r and omized , double-blind , placebo-controlled , trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain . Objectives . To determine the efficacy and safety of two doses of rofecoxib compared to placebo in the treatment of chronic low back pain . Summary of Background Data . Although nonsteroidal anti-inflammatory drugs are commonly prescribed for chronic low back pain , their efficacy is unproven and toxicity can be serious . These studies evaluated the efficacy and tolerability of rofecoxib , a selective COX-2 inhibitor , in the treatment of chronic low back pain . Methods . Patients with chronic low back pain were r and omized 1:1:1 to rofecoxib 25 mg , 50 mg , or placebo once daily . Primary endpoint : Low Back Pain Intensity . Secondary endpoints : Pain Bothersomeness , Global Assessment s of Response to Therapy , Global Assessment of Disease Status , Rol and -Morris Disability Question naire , SF-12 Health Survey , Use of Rescue Acetaminophen , and Discontinuations Due to Lack of Efficacy . Results . Combining both studies , 690 patients were r and omized to placebo ( N = 228 ) , rofecoxib 25 mg ( N = 233 ) , or rofecoxib 50 mg ( N = 229 ) . Mean ( ± SD ) age was 53.4 ( ± 12.9 ) years , pain duration 12.1 ( ± 11.8 ) years , 62.3 % female . Both rofecoxib groups improved significantly . Mean differences from placebo in pain intensity were −13.50 mm , −13.81 mm ( 25 , 50 mg doses ) respectively ( P < 0.001 ) . Both regimens were superior to placebo
Output:
| Three trials in this review found no differences between an NSAID and |
MS211043 | ***TASK*** the task is to summarize an input biomedical literature in 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 Changes in gut microbiota induced by bariatric surgery have been associated with metabolic benefits . OBJECTIVES Our aim was to identify specific gut microbiota that may contribute to the improvement of type 2 diabetes ( T2D ) after Roux-en-Y gastric bypass ( RYGB ) . SETTING Laboratories of Shanghai Diabetes Institute and Shanghai Sixth People 's Hospital . METHODS Diabetic rats induced via a high-fat diet and low-dose streptozotocin administration were r and omized to RYGB or sham surgery , and stool sample s were collected at baseline and at postoperative week 8 . The fecal microbiota was profiled using 16S ribosomal RNA gene sequencing . Additionally , we performed a case-control study of the gut microbial community profiles of T2D patients compared with those of healthy individuals via 16S ribosomal RNA gene sequencing of mucosal-luminal interface sample s collected from the ascending colon during colonoscopy . RESULTS RYGB significantly reduced the weight and improved glucose tolerance and insulin sensitivity in diabetic rats . Principal coordinate analysis showed that RYGB caused marked alterations in the gut microbiota . The RYGB group was postoperatively enriched for Bacteroidetes , Proteobacteria , Fusobacteria , and Actinobacteria , whereas the sham surgery group was enriched for Firmicutes and Verrucomicrobia . Based on the gut microbial patterns in the T2D patients , we found that the family Coriobacteriaceae within Actinobacteria might contribute to the beneficial effects of RYGB on T2D . CONCLUSIONS RYGB significantly improves glucose metabolism and alters the gut microbiota . Moreover , the family Coriobacteriaceae may partly mediate the beneficial effects of RYGB on T2D and thus possibly contribute to the development of novel bacteria-based therapeutic approaches Background and Objectives Bariatric surgery improves metabolic diseases and alters the intestinal microbiota in animals and humans , but different procedures reportedly have different impacts on the intestinal microbiota . We developed laparoscopic sleeve gastrectomy with duodenojejunal bypass ( LSG-DJB ) as an alternative to laparoscopic Roux-en-Y gastric bypass ( LRYGB ) in addition to laparoscopic sleeve gastrectomy ( LSG ) for Japanese patients with obesity . We investigated the precise change in the intestinal microbiota induced by these procedures in the present study . Methods A prospect i ve observational study of 44 Japanese patients with obesity was conducted [ 22 patients underwent LSG , 18 underwent LSG-DJB , and 4 underwent laparoscopic adjustable gastric b and ing ( LAGB ) ] . The patients ’ clinical parameters and intestinal microbiota were investigated before and for 6 months after surgery . The microbiota was analyzed by a 16S rDNA method . Results LSG and LSG-DJB significantly improved the metabolic disorders in the patients with obesity . The proportion of the phylum Bacteroidetes and order Lactobacillales increased significantly in the LSG group , and that of the order Enterobacteriales increased significantly in the LSG-DJB group . Conclusions LSG and LSG-DJB improved obesity and type 2 diabetes in Japanese patients with obesity , but the impact of LSG-DJB on the intestinal microbiota differed from that of LSG . This difference in the impact on the intestinal environment could explain the different efficacies of LSG and LSG-DJB in terms of their ability to resolve metabolic disorders in the clinical setting BACKGROUND Changes in the gut microbiome following bariatric surgery have been causally linked to metabolic benefits . OBJECTIVES We sought to characterize and assess the stability of gut microbiome shifts following sleeve gastrectomy ( SG ) . SETTING University laboratories . METHODS Diet-induced obese mice were r and omized to SG or sham surgery . Mice were housed individually or cohoused such that one SG mouse was housed with one weight-matched , sham-operated mouse . Fecal sample s were collected before and on postoperative days 7 and 28 . Bacterial composition in feces was characterized by using next-generation Illumina sequencing of 16 S rRNA . RESULTS SG mice lost more weight and were more insulin sensitive than sham mice independent of housing status ( P<.05 ) . One week following surgery , fecal sample s from all mice showed shifts in the microbiome that only persisted in SG-operated mice . Cohousing did not alter the microbial composition of SG-operated mice . Cohoused sham-operated mice showed a unique shift in microbial composition on postoperative day 28 that differed from individually housed , sham-operated mice ( P<.001 ) . Cohousing did not affect metabolic outcomes of either SG or sham surgeries . CONCLUSION SG results in acute and sustained shifts in the gut microbiome . SG associated shifts are not altered by reexposure to obesity-associated gut microbiota Background Roux-en-Y gastric bypass ( RYGB ) is an effective means to achieve sustained weight loss for morbidly obese individuals . Besides rapid weight reduction , patients achieve major improvements of insulin sensitivity and glucose homeostasis . Dysbiosis of gut microbiota has been associated with obesity and some of its co-morbidities , like type 2 diabetes , and major changes of gut microbial communities have been hypothesized to mediate part of the beneficial metabolic effects observed after RYGB . Here we describe changes in gut microbial taxonomic composition and functional potential following RYGB . Methods We recruited 13 morbidly obese patients who underwent RYGB , carefully phenotyped them , and had their gut microbiomes quantified before ( n = 13 ) and 3 months ( n = 12 ) and 12 months ( n = 8) after RYGB . Following shotgun metagenomic sequencing of the fecal microbial DNA purified from stools , we characterized the gut microbial composition at species and gene levels followed by functional annotation . Results In parallel with the weight loss and metabolic improvements , gut microbial diversity increased within the first 3 months after RYGB and remained high 1 year later . RYGB led to altered relative abundances of 31 species ( P < 0.05 , q < 0.15 ) within the first 3 months , including those of Escherichia coli , Klebsiella pneumoniae , Veillonella spp . , Streptococcus spp . , Alistipes spp . , and Akkermansia muciniphila . Sixteen of these species maintained their altered relative abundances during the following 9 months . Interestingly , Faecalibacterium prausnitzii was the only species that decreased in relative abundance . Fifty-three microbial functional modules increased their relative abundance between baseline and 3 months ( P < 0.05 , q < 0.17 ) . These functional changes included increased potential ( i ) to assimilate multiple energy sources using transporters and phosphotransferase systems , ( ii ) to use aerobic respiration , ( iii ) to shift from protein degradation to putrefaction , and ( iv ) to use amino acids and fatty acids as energy sources . Conclusions Within 3 months after morbidly obese individuals had undergone RYGB , their gut microbiota featured an increased diversity , an altered composition , an increased potential for oxygen tolerance , and an increased potential for microbial utilization of macro- and micro-nutrients . These changes were maintained for the first year post-RYGB.Trial registration Current controlled trials ( ID NCT00810823 , NCT01579981 , and NCT01993511 ) Background The role of the gut microbiome in arresting pathogen colonization and growth is important for protection against Clostridium difficile infection ( CDI ) . Observational studies associate proton pump inhibitor ( PPI ) use and CDI incidence . We hypothesized that PPI use affected the distal gut microbiome over time , an effect that would be best explored by time-longitudinal study of healthy subjects on PPI in comparison to treatment-naïve CDI subjects . This study enrolled nine healthy human subjects and five subjects with treatment-naïve CDI . After r and om assignment to a low ( 20 mg/day ) or high ( 2 × 20 mg/day ) dose group , fecal sample s were collected from the nine healthy subjects before , during , and after 28 days of PPI use . This was done in conjunction with pre-treatment fecal collection from CDI subjects . High-throughput sequencing ( 16S rRNA ) was performed on time-longitudinal sample s to assess changes to the healthy gut microbiome associated with prolonged PPI usage . The healthy sample s were then compared to the CDI subjects to explore changes over time to the gut microbiome associated with PPI use and potentially related to CDI . Results We report that PPI usage at low and high dosages , administered for 28 days , result ed in decreases to observed operational taxonomic unit ( OTU ) counts after both 1 week and 1 month . This decrease result ed in observed OTU levels that were similar to those found in treatment-naïve CDI patients , which was partly reversible after a 1 month recovery period . We did not detect a dose-dependent difference in OTU levels nor did we detect significant changes in taxa previously reported to be affected by PPI treatment . Conclusion While our observation of diminishing observed OTU counts during PPI therapy is a preliminary finding in a small cohort , our hypothesis that PPIs disrupt the healthy human gut microbiome is supported in this group . We conclude that decreases in observed species counts were reversible after cessation of PPI usage within 1 month . This finding may be a potential explanation for the association between prolonged PPI usage and CDI incidence Summary Bariatric surgery is currently the most effective procedure for the treatment of obesity . Given the role of the gut microbiota in regulating host metabolism and adiposity , we investigated the long-term effects of bariatric surgery on the microbiome of patients r and omized to Roux-en-Y gastric bypass or vertical b and ed gastroplasty and matched for weight and fat mass loss . The two surgical procedures induced similar and durable changes on the gut microbiome that were not dependent on body mass index and result ed in altered levels of fecal and circulating metabolites compared with obese controls . By colonizing germ-free mice with stools from the patients , we demonstrated that the surgically altered microbiota promoted reduced fat deposition in recipient mice . These mice also had a lower respiratory quotient , indicating decreased utilization of carbohydrates as fuel . Our results suggest that the gut microbiota may play a direct role in the reduction of adiposity observed after bariatric surgery Despite substantial research efforts , the mechanisms proposed to explain weight loss after gastric bypass ( RYGB ) and sleeve gastrectomy ( SL ) do not explain the large individual variation seen after these treatments . A complex set of factors are involved in the onset and development of obesity and these may also be relevant for the underst and ing of why success with treatments vary considerably between individuals . This calls for explanatory models that take into account not only biological determinants but also behavioral , affective and context ual factors . In this prospect i ve study , we recruited 47 women and 8 men , aged 25–56 years old , with a BMI of 45.8 ± 7.1 kg/m2 from the waiting list for RYGB and SL at Køge hospital , Denmark . Pre-surgery and 1.5 , 6 and 18 months after surgery we assessed various endpoints spanning multiple domains . Endpoints were selected on basis of previous studies and include : physiological measures : anthropometrics , vital signs , biochemical measures and appetite hormones , genetics , gut microbiota , appetite sensation , food and taste preferences , neural sensitivity , sensory perception and movement behaviors ; psychological measures : general psychiatric symptom-load , depression , eating disorders , ADHD , personality disorder , impulsivity , emotion regulation , attachment pattern , general self-efficacy , alexithymia , internalization of weight bias , addiction , quality of life and trauma ; and sociological and anthropological measures : sociodemographic measures , eating behavior , weight control practice s and psycho-social factors . Joining these many endpoints and method ologies from different scientific disciplines and creating a multi-dimensional predictive model has not previously been attempted . Data on the primary endpoint are expected to be published in 2018 . Trial registration Clinical trials . gov ID NCT02070081 Background : Probiotics are commonly used after bariatric surgery ; however , uncertainty remains regarding their efficacy . Our aim was to compare the effect of probiotics vs placebo on hepatic , inflammatory and clinical outcomes following laparoscopic sleeve gastrectomy ( LSG ) . Methods : This r and omized , double-blind , placebo-controlled , trial of 6-month treatment with probiotics ( Bio-25 ; Supherb ) vs placebo and 6 months of additional follow-up was conducted among 100 morbidly obese nonalcoholic fatty liver disease ( NAFLD ) patients who underwent LSG surgery . The primary outcome was a reduction in liver fat content , measured by abdominal ultrasound , and secondary outcomes were improvement of fibrosis , measured by shear-wave elastography , metabolic and inflammatory parameters , anthropometrics and quality of life ( QOL ) . Fecal sample s were collected and analyzed for microbial composition . Results : One hundred patients ( 60 % women , mean age of 41.9±9.8 years and body mass index of
Output:
| Roux-n-Y gastric bypass caused more alterations in gut microbial composition in comparison with sleeve gastrectomy . |
MS211044 | ***TASK*** the task is to summarize an input biomedical literature in 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 Inferior scapular notching following reverse shoulder arthroplasty is due to mechanical impingement and , in some studies , has been associated with poorer functional scores , lower patient satisfaction , and more limited shoulder motion . We aim ed to test the hypothesis that inferior positioning of the center of rotation with eccentric glenosphere design s decreases the adduction deficit before impingement occurs and improves clinical outcome . METHODS A r and omized , controlled , double-blinded trial was performed . According to the results of a power analysis , fifty patients undergoing reverse shoulder arthroplasty for the diagnosis of cuff tear arthropathy were r and omized intraoperatively to receive either a concentric or eccentric glenosphere . The glenoid baseplate was positioned flush to the inferior border of the glenoid before the glenosphere was then attached . Notching was assessed using an anteroposterior radiograph , and clinical outcome was assessed using the visual analog pain scale score , shoulder function rating , American Shoulder and Elbow Surgeons score , and Oxford shoulder score . Active forward elevation and external rotation were assessed . The outcome assessor was blinded to the treatment group . The mean follow-up period for the groups was forty-three and forty-seven months . RESULTS Patient demographics and preoperative scores were similar between the groups . At the time of the final follow-up , four patients ( 14.8 % ) in the concentric group had developed inferior scapular notching ( two with Nerot grade I and two with Nerot grade II ) , ranging in size from 1.1 to 7.4 mm , compared with one patient ( 4.3 % ; Nerot grade I ) in the eccentric group ( p = 0.36 ) . No notching occurred in any patient with glenoid overhang of > 3.5 mm . No significant difference between the groups was seen with respect to functional outcome scores , patient satisfaction , or shoulder motion . CONCLUSIONS There were no differences in notching rates or clinical outcomes between concentric and eccentric glenospheres following reverse shoulder arthroplasty . Inferior glenosphere overhang of > 3.5 mm , however , prevented notching . This may be achieved with a modified surgical technique , but eccentric glenospheres provide an additional option . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence The choice is not clear cut and patients ’ expectations and preferences may affect the outcome In this issue Hay et al 1 report the results of a r and omised clinical trial evaluating the effectiveness of physiotherapy and corticosteroid injection for patients with unilateral shoulder pain . Shoulder pain is a common complaint ; estimates of the annual incidence in general practice vary from 6.6 to 25 cases per 1000 patients .2–4 Most patients are treated in primary care . If treatment with analgesics or non-steroidal anti-inflammatory drugs ( NSAIDs ) is not successful , patients with persistent symptoms are often referred for physiotherapy or treated with local infiltration of a corticosteroid.4 Until recently , evidence on the effectiveness of these interventions was scarce , particularly for primary care patients . Over the past few years two r and omised trials have been published that directly compared the effects of physiotherapy with corticosteroid injections.5,6 Both trials were carried out in Dutch general practice . The trial by Hay et al adds important and relevant information to this existing evidence . The trial is characterised by a thorough design , enrolled a relatively large number of patients , used relevant outcome measures , and achieved a nearly complete six months ’ follow up of participants . When examining the results of these three primary care trials , three issues arise for discussion . Firstly , the short term findings are rather different , with the Dutch trials clearly showing better effects of corticosteroid injections , whereas the English trial reports similar outcomes for the two interventions . Secondly , all three trials show minor and non-significant differences at long term follow up.1,6,7 Thirdly , the somewhat ambiguous overall evidence may leave substantial room for considering patient preferences and expectations when applying the results in clinical practice . Figure 1a shows the self reported change of symptoms at 5–7 weeks of follow up for BACKGROUND Glenoid component loosening remains a significant issue after anatomic shoulder arthroplasty . Pegged glenoid components have shown better lucency rates than keeled components in the short term ; however , midterm to long-term results have not fully been determined . We previously reported early outcomes of the current r and omized controlled group of patients , with higher glenoid lucency rates in those with a keeled glenoid . The purpose of this study was to evaluate the radiographic and clinical outcomes of these components at minimum 5-year follow-up . METHODS Fifty-nine total shoulder arthroplasties were performed in patients with primary glenohumeral osteoarthritis . Patients were r and omized to receive either a pegged or keeled glenoid component . Three raters grade d radiographic glenoid lucencies . Clinical outcome scores and active mobility outcomes were collected preoperatively and at yearly postoperative appointments . RESULTS Of the 46 shoulders meeting the inclusion criteria , 38 ( 82.6 % ) were available for minimum 5-year radiographic follow-up . After an average of 7.9 years , radiographic lucency was present in 100 % of pegged and 91 % of keeled components ( P = .617 ) . Grade 4 or 5 lucency was present in 44 % of pegged and 36 % of keeled components ( P = .743 ) . There were no differences in clinical outcome scores or active mobility outcomes between shoulders with pegged and keeled components at last follow-up . Within the initial cohort , 20 % of the keeled shoulders ( 6 of 30 ) and 7 % of the pegged shoulders ( 2 of 29 ) underwent revision surgery ( P = .263 ) . Kaplan-Meier analysis showed no significant difference in survival rates between groups ( P = .560 ) . CONCLUSION At an average 7.9-year follow-up , non-ingrowth , all-polyethylene pegged glenoid implants are equivalent to keeled implants with respect to radiolucency , clinical outcomes , and need for revision surgery BACKGROUND Presently , there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain . Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain result ing from various etiologies . The present study evaluated the efficacy and safety of sodium hyaluronate ( Hyalgan ; molecular weight , 500 to 730 kDa ) for these patients . METHODS Six hundred and sixty patients with persistent shoulder pain and limitation result ing from glenohumeral joint osteoarthritis , rotator cuff tear , and /or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind , r and omized , phosphate-buffered saline solution-controlled study , and 456 patients completed twenty-six weeks of follow-up . Patients were r and omized to receive either five weekly intra-articular injections of sodium hyaluronate , three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution , or five weekly intra-articular injections of saline solution . The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment ( as assessed with use of a 100-mm visual analog scale ) and the treatment effect throughout twenty-six weeks . RESULTS For the overall intent-to-treat population , patients who were managed with sodium hyaluronate had greater pain relief than controls did ; significant differences were noted at Week 7 ( for the five-injection hyaluronate group ) , Week 17 ( for the three and five-injection hyaluronate groups ) , and Week 26 ( for the three-injection hyaluronate group ) . Analysis of the stratified population s clearly established that this effect was due to benefits experienced by the patients with osteoarthritis . The treatment effect through twenty-six weeks was significant in patients with osteoarthritis in the three-injection ( p = 0.003 ) and five-injection ( p = 0.002 ) groups , with no significant difference for either regimen in patients without osteoarthritis . The safety profile was very favorable , with no product-related serious adverse effects and no between-group differences for any reported adverse event . CONCLUSIONS Although the primary end point of this study ( that is , improvement in terms of shoulder pain at thirteen weeks ) was not achieved , the overall findings , including secondary end points , indicate that sodium hyaluronate ( 500 to 730 kDa ) is effective and well tolerated for the treatment of osteoarthritis and persistent shoulder pain that is refractory to other st and ard nonoperative interventions BACKGROUND Controversy exists regarding the optimal technique of subscapularis mobilization during shoulder arthroplasty . The purpose of this study was to compare healing rates and subscapularis fatty infiltration in patients undergoing a lesser tuberosity osteotomy ( LTO ) versus subscapularis peel for exposure during shoulder arthroplasty . MATERIAL S AND METHODS Eighty-seven patients , with a mean age of 67.8 ± 10.9 years , undergoing shoulder arthroplasty , were r and omized to receive either an LTO ( n = 43 ) or peel ( n = 44 ) . Computed tomography scans were conducted preoperatively and at 12 months postoperatively . Outcome variables included healing rates and subscapularis Goutallier fatty infiltration grade , as well as subscapularis strength and Western Ontario Osteoarthritis of the Shoulder Index and American Shoulder and Elbow Surgeons outcome scores . RESULTS Computed tomography imaging was available in 91 % ( n = 79 ) of the cohort . The healing rates for the peel ( 100 % ) and for the LTO ( 95 % ) did not differ significantly ( P = .493 ) . Preoperatively , the mean fatty infiltration grade for the peel ( mean , 0.53 ) was not significantly different ( P = .925 ) from the LTO ( mean , 0.54 ) . Postoperatively , the Goutallier mean fatty infiltration grade for the peel ( mean , 0.95 ) did not differ significantly ( P = .803 ) from the LTO ( mean , 0.9 ) . A significant increase in subscapularis fatty infiltration grade occurred postoperatively from the preoperative status ( peel , P = .003 ; LTO , P = .0002 ) . No statistically significant associations were observed between postoperative fatty infiltration grade s and subscapularis strength , Western Ontario Osteoarthritis of the Shoulder Index scores , or American Shoulder and Elbow Surgeons scores . DISCUSSION No statistically significant differences were observed in the healing rates or subscapularis fatty infiltration grade s between the peel and the LTO . This trial does not show any clear difference in radiologic and clinical outcomes of one subscapularis management technique over the other BACKGROUND Both total shoulder arthroplasty and hemiarthroplasty have been used commonly to treat severe osteoarthritis of the shoulder ; however , their effect on disease-specific quality -of-life outcome is unknown . The purpose of this study was to compare the quality -of-life outcome following hemiarthroplasty with that following total shoulder arthroplasty in patients with osteoarthritis of the shoulder . METHODS Forty-two patients with a diagnosis of osteoarthritis of the shoulder were r and omized to receive a hemiarthroplasty or a total shoulder arthroplasty . One patient died , and all others were evaluated preoperatively and at six weeks and three , six , twelve , eighteen , and twenty-four months postoperatively with use of a st and ardized format including a disease-specific quality -of-life measurement tool ( Western Ontario Osteoarthritis of the Shoulder [ WOOS ] index ) , general shoulder rating scales ( University of California at Los Angeles [ UCLA ] shoulder scale , Constant score , and American Shoulder and Elbow Surgeons [ ASES ] evaluation form ) , general pain scales ( McGill pain score and visual analogue scale ) , and a global health measure ( Short Form-36 [ SF-36 ] ) . When a patient required revision of a hemiarthroplasty to a total shoulder arthroplasty , the last score before he or she " crossed over " was used for the analysis . RESULTS Significant improvements in disease-specific quality of life were seen two years after both the total shoulder arthroplasties and the hemiarthroplasties . There were no significant differences in quality of life ( WOOS score ) between the group treated with total shoulder arthroplasty and that treated with hemiarthroplasty ( 90.6 + /- 13.2 and 81.5 + /- 24.1 points , respectively ; p = 0.18 ) . The other outcome measures demonstrated similar findings . Two patients in the hemiarthroplasty group crossed over to the other group by undergoing a revision to a total shoulder arthroplasty because of glenoid arthrosis . CONCLUSIONS Both total shoulder arthroplasty and hemiarthroplasty improve disease-specific and general quality -of-life measurements . With the small number of patients in our study , we found no significant differences in these measurements between the two treatment groups . LEVEL OF EVIDENCE Therapeutic Level OBJECTIVES : To determine , in a population based study , the influence of occupational factors on the occurrence of shoulder pain and disability . METHODS : A r and om sample of patients was selected from the register of a general practice in the Greater Manchester area of the United Kingdom . Information was collected by a posted question naire with specific
Output:
| At two years , low- quality evidence from two trials ( down grade d for bias and imprecision ) suggested there may be a small but clinical ly uncertain improvement in pain and function .
Although it is an established procedure , no high- quality r and omised trials have been conducted to determine whether shoulder replacement might be more effective than other treatments for osteoarthritis or rotator cuff tear arthropathy of the shoulder .
We remain uncertain about which type or technique of shoulder replacement surgery is most effective in different situations .
When humeral hemiarthroplasty was compared to TSR surgery for osteoarthritis , low- quality evidence led to uncertainty about whether there is a clinical ly important benefit for patient-reported pain or function and suggested there may be little or no difference in quality of life .
Evidence is insufficient to show whether TSR is associated with greater or less risk of harm than humeral hemiarthroplasty .
Although reverse TSR is now the most commonly performed type of shoulder replacement , we found no studies comparing reverse TSR to any other type of treatment |
MS211045 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Introduction . Laparoendoscopic single-site surgery ( LESS ) uses a multiple-entry portal in a single 3.0- to 4.0-cm incision in a natural scar , the umbilicus . The present study aim ed to compare the inflammatory impact of classic video laparoscopic cholecystectomy ( LC ) versus LESS cholecystectomy . Methods . A prospect i ve r and omized controlled study was conducted from January to June 2011 at 2 university hospitals in Rio de Janeiro , Brazil . Fifty-seven patients ( 53 women , 4 men ; mean age = 48.7 years ) were r and omly assigned to receive LC ( n = 29 ) or LESS ( n = 28 ) cholecystectomy . C-reactive protein ( CRP ) and interleukin 6 ( IL-6 ) were measured from blood sample s collected during induction of anesthesia and at 3 and 24 hours postoperatively . Results . Median IL-6 levels in the LESS and LC groups , respectively , were 2.96 and 4.5 pg/mL preoperatively , 11.6 and 28.05 pg/mL at 3 hours postoperatively ( P = .029 ) , and 13.18 and 15.1 pg/mL at 24 hours postoperatively ( P = .52 ) . Median CRP levels in the LESS and LC groups , respectively , were 0.33 and 0.44 mg/mL preoperatively , 0.40 and 0.45 mg/mL ( P = .73 ) at 3 hours postoperatively , and 1.7 and 1.82 mg/mL ( P = .84 ) at 24 hours postoperatively . We did not find a significant association between IL-6 ( and CRP ) and body mass index in the LESS group . Conclusions . LESS cholecystectomy requires a larger size incision than LC . We found a tendency of less postoperative pain following LESS cholecystectomy than LC . There was also a tendency toward lower early inflammatory impact following LESS cholecystectomy versus LC Purpose : To evaluate the safety and feasibility of single-incision laparoscopic cholecystectomy ( SILS-C ) compared with conventional laparoscopic cholecystectomy ( CLC ) . Methods : Sixty-five patients ( SILS-C : 35 , CLC : 30 ) were prospect ively enrolled and operated with conventional straight instruments . The postoperative pain scores at 6 , 24 hours , and 1 week , nausea , vomiting , commencement of oral intake , hospital stay , resumption of normal activities and work and satisfaction levels were noted . Results : Twenty-eight percent ( 10/35 ) SILS-C patients required introduction of additional trocars to complete the procedure . No patient required conversion to open . All the morbidity parameters were similar in both the groups , except that the seroma formation in the wound was significantly higher in the SILS-C group [ SILS-C : 17 % (6/35)/CLC : 0 % , P=0.038 ] . One patient in SILS-C had a major bile duct injury . Conclusions : SILS-C is safe and feasible with conventional instruments . However , caution needs to be exercised in view of a major bile duct injury and a higher rate of seroma formation in the wound Background : Two-port laparoscopic cholecystectomy has been reported to be safe and feasible . However , whether it offers any additional advantages remains controversial . This study reports a r and omized trial that compared the clinical outcomes of two-port laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy . Methods : One hundred and twenty consecutive patients who underwent elective laparoscopic cholecystectomy were r and omized to receive either the two-port or the four-port technique . All patients were blinded to the type of operation they underwent . Four surgical tapes were applied to st and ard four-port sites in both groups at the end of the operation . All dressings were kept intact until the first follow-up 1 week after surgery . Postoperative pain at the four sites was assessed on the first day after surgery using a 10-cm unscaled visual analog scale ( VAS ) . Other outcome measures included analgesia requirements , length and difficulty of the operation , postoperative stay , and patient satisfaction score on surgery and scars . Results : Demographic data were comparable for both groups . Patients in the two-port group had shorter mean operative time ( 54.6 ± 24.7 min vs 66.9 ± 33.1 min for the four-post group ; p = 0.03 ) and less pain at individual subcostal port sites [ mean score using 10-cm unscaled VAS : 1.5 vs 2.8 ( p = 0.01 ) at the midsubcostal port site and 1.3 vs 2.3 ( p = 0.02 ) at the lateral subcostal port site ] . Overall pain score , analgesia requirements , hospital stay , and patient satisfaction score on surgery and scars were similar between the two groups . Conclusion : Two-port laparoscopic cholecystectomy result ed in less individual port-site pain and similar clinical outcomes but fewer surgical scars compared to four-port laparoscopic cholecystectomy . Thus , it can be recommended as a routine procedure in elective laparoscopic cholecystectomy Objective : To compare short-term surgical outcomes and quality of life ( QOL ) between single-port laparoscopic cholecystectomy ( SPLC ) and classic 4-port laparoscopic cholecystectomy ( CLC ) . Background : There is significant interest in further reducing the trauma associated with surgical procedures . Although a number of observational studies have suggested that SPLC is a feasible alternative to CLC , there is a lack of data from r and omized studies validating any benefit over CLC . Methods : Eligible patients were r and omized to receive SPLC or CLC . Operative and perioperative outcomes , including cosmesis and QOL were analyzed . Results : Forty-three patients were r and omized to SPLC ( n = 21 ) or CLC ( n = 22 ) . There were no significant differences between groups for most preoperative demographics , American Society of Anesthesiology score , gallstone characteristics , local inflammation , blood loss , or length of stay . Patients undergoing SPLC were older than those receiving CLC ( 57.3 years vs. 45.8 years , P < 0.05 ) . Operative times for SPLC were greater than CLC ( 88.5 minutes vs. 44.8 minutes , P < 0.05 ) . Overall and cosmetic satisfaction , QOL as determined by the SF-36 survey , postoperative complications , and post-operative pain scores between discharge and 2-week postoperative visit were not significantly different between groups . Wound infection rates were similar in both groups . The SPLC group contained 1 retained bile duct stone , 1-port site hernia , and 1 postoperative port site hemorrhage . Conclusions : SPLC procedure time was longer and incurred more complications than CLC without significant benefits in patient satisfaction , postoperative pain and QOL . SPLC may be offered in carefully selected patients . Larger r and omized trials performed later in the learning curve with SPLC may identify more subtle advantages of one method over another Purpose : We report the outcomes of a r and omized clinical trial of single-port laparoscopic cholecystectomy ( SPLC ) and multiport laparoscopic cholecystectomy ( MPLC ) . Methods : Fifty-four patients ( 27 in each group ) were r and omized . A visual analog scale was used with a 10-point scale for an objective assessment of incisional pain and incisional cosmesis on postoperative days 1 , 3 , and 14 . Results : The mean operating time was significantly longer in the SPLC . The mean cosmesis scores on postoperative days 3 ( 9.7 vs. 8.9 , P=0.01 ) and 14 ( 9.9 vs. 9.2 , P<0.01 ) were significantly greater in the SPLC group than in the MPLC group . The group ’s mean visual analog scale scores for incisional pain , and their requirements for analgesics , did not differ significantly . Conclusions : Although SPLC takes longer than MPLC , experienced laparoscopic surgeons can perform SPLC safely with results comparable with those for MPLC . SPLC is superior to MPLC in terms of short-term cosmetic outcomes Although laparoscopic cholecystectomy has rapidly developed in the treatment of gall bladder disease in the absence of controlled clinical trial data its outcome parameters compared with open cholecystectomy remain unclear . A prospect i ve audit of the introduction of laparoscopic cholecystectomy in the west of Scotl and over a two year period was carried out to attempt to assess this new procedure . A total of 45 surgeons in 19 hospitals performing laparoscopic cholecystectomy su bmi tted prospect i ve data from September 1990 - 1992 . A total of 2285 cholecystectomies were audited ( a completed data collection rate of 99 % ) . Laparoscopic cholecystectomy was attempted in 1683 ( 74 % ) patients and completed in 1448 patients ( median conversion rate to the open procedure 17 % ) . The median operation time in the completed laparoscopic cholecystectomy patients was 100 minutes ( range 30 - 330 ) and overall hospital stay three days ( 1 - 33 ) . There were nine deaths ( 0.5 % ) after laparoscopic cholecystectomy although only two were directly attributable to the laparoscopic procedure . In the laparoscopic cholecystectomy group there were 99 complications ( 5.9 % ) , 53 ( 3 % ) of these were major requiring further invasive intervention . Forty patients ( 2.4 % ) required early or delayed laparotomy for major complications such as bleeding or bile duct injuries . There were 11 ( 0.7 % ) bile duct injuries in the laparoscopic cholecystectomy series , five were noted during the initial procedure and six were recognised later result ing from jaundice or bile leaks . Ductal injuries occurred after a median of 20 laparoscopic cholecystectomies . In conclusion laparoscopic cholecystectomy has rapidly replaced open cholecystectomy in the treatment of gall bladder disease . Although the overall death and complication rate associated with laparoscopic cholecystectomy is similar to open cholecystectomy , the bile duct injury rate is higher The main objectives of minisite cholecystectomy ( MC ) are to have smaller incisions , better cosmetic results , less trauma , and a lower morbidity rate . This prospect i ve r and omized study compares MC with conventional laparoscopic cholecystectomy ( CLC ) in terms of surgical trauma and cosmetic results in 44 patients . Conversion from MC to CLC was required in five patients . No conversion to open surgery was needed in the CLC group . The average operating time was slightly longer in the MC group , but the difference was not statistically significant ( 81 minutes versus 72 minutes , p=0.22 ) . The population characteristics , postoperative respiratory function measurements , pain scores , and analgesic requirements were similar in the two groups . The average score for scar tissue was significantly lower in the MC group ( 0.73 versus 1.93 , p=0.0045 ) . Only the cosmetic results of MC were superior to CLC . This technique could be a feasible alternative procedure in patients seeking better cosmetic results . However , further studies with larger sample sizes are needed to evaluate the postoperative morbidity of MC.RésuméLes objectifs principaux de la cholécystectomie laparoscopique minime ( CM ) ( par mini-trocars ) sont de réaliser de plus petites incisions , d’obtenir un meilleur résultat esthétique , de provoquer moins de trauma et d’avoir un taux plus bas de morbidité que la cholécystectomie par laparoscopic classique . Cette étude prospect i ve r and omisée a comparé la CM à la cholécystectomie par laparoscopic ( CL ) traditionnelle en termes de traumatisme chirurgical et de résultat esthétique chez 44 patients . On a du convertir la CM en CL chez cinq patients . Aucune conversion vers la chirurgie ouverte n’a été nécessaire dans le groupe de CL traditionnelle . Le temps moyen d’intervention a été plus long dans le groupe CM mais cette différence n’était pas statistiquement significative ( 81 min vs. 72 min , p=0.22 ) . Les caractéristiques de la population , les fonctions respiratoires , les scores de la douleur et les besoins en analgésiques étaient similaires dans les deux groupes . Les scores moyens d’évaluation de la cicatrice ont été significativement plus bas dans le groupe CM ( 0.73 vs. 1.93 , p=0.0045 ) . Seuls les résultats esthétiques de la CM étaient supérieurs à la CL . Cette technique pourrait être une alternative valable chez les patients cherchant une amélioration des résultats esthétiques . Cependant , d’autres études avec des échantillons plus larges sont nécessaires pour évaluer la morbidité postopératoire de la CM.ResumenEl propósito principal de la colecistectomía de invasión mínima ( CIM ) es lograr una cicatriz pequeña , mejor apariencia estética , menos trauma y morbilidad reducida . El présente estudio prospect i ve y aleatorizado compara la CIM con la coleciste
Output:
| There is very low quality evidence that is insufficient to determine whether there is any significant clinical benefit in using fewer-than-four-ports laparoscopic cholecystectomy compared with four-port laparoscopic cholecystectomy . |
MS211046 | ***TASK*** the task is to summarize an input biomedical literature in 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 Recently , a number of studies using intra-articular application of tranexamic acid ( IA-TXA ) , with different dosage and techniques , successfully reduced postoperative blood loss in total knee replacement ( TKR ) . However , best of our knowledge , the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied . This study aim ed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss and blood transfusion reduction . Methods Between 2010 and 2011 , a triple-blinded r and omized controlled study was conducted in 135 patients undergoing conventional TKR . The patients were allocated into three groups according to intra-articular solution received : Control group ( physiologic saline ) , TXA-250 group ( TXA 250 mg ) , and TXA-500 group ( TXA 500 mg ) . The solution was injected after wound closure followed by drain clamping for 2 hours . Blood loss and transfusion were recorded . Duplex ultrasound was performed . Functional outcome and complication were followed for one year . Results There were forty-five patients per groups . The mean total hemoglobin loss was 2.9 g/dL in control group compared with 2.2 g/dL in both TXA groups ( p > 0.001 ) . Ten patients ( 22 % , control ) , six patients ( 13 % , TXA-250 ) and none ( TXA-500 ) required transfusion ( p = 0.005 ) . Thromboembolic events were detected in 7 patients ( 4 controls , 1 TXA-250 , and 2 TXA-500 ) . Functional outcome was non-significant difference between groups . Conclusions Combined low-dose IA-TXA , as 500 mg , with 2-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional TKR without significant difference in postoperative knee function or complication . Trial registration Clinical Trials.gov NCT01850394 Abstract Purpose To compare the blood loss and the blood transfusion between a control group and a group of patients following either a local administration of tranexamic acid or a mechanical post-operative knee flexion , a controlled r and omized study was performed . Methods Sixty patients affected by primary knee osteoarthritis and c and i date s to receive a primary unilateral total knee arthroplasty were enrolled in a prospect i ve , r and omized , controlled study . Exclusion criteria were the following : tranexamic acid allergy , the use of pharmacological anticoagulant therapy , previous knee surgery and renal failure . For each patient , the following parameters were investigated : the blood loss volume , the haemoglobin and haematocrit concentrations and the blood transfusion needs . Results Compared to the control group , the administration of systemic tranexamic acid significantly reduces ( p < 0.05 ) both the blood loss ( average reduction 39.8 % ) and the blood transfusion needs ( 64 % ) . Furthermore , the tranexamic acid group shows a significant reduction ( p < 0.05 ) compared to the knee flexion group of the blood loss ( average reduction 31.8 % ) and the transfusion needs ( 65 % ) . However , even if the knee flexion technique slightly reduces the blood loss ( average reduction 11.6 % ) compared to the control group , this difference is not statistically significant ( n.s . ) . Moreover , this treatment did not reduce the transfusion needs compared to the control group ( n.s . ) . Incidence of complications was not influenced by any of the treatments . Conclusions The use of tranexamic acid compared to knee flexion and to control group significantly reduces blood loss and transfusion needs , without wound complications or symptomatic deep vein thrombosis . Level of evidence Prospect i ve therapeutic study , Level The aim of the present study was to investigate aspects of coagulation and fibrinolysis during knee arthroplasties in order to find out . 1 . whether an increased fibrinolysis is correlated to an increased blood loss 2 . whether there is a difference in markers for coagulation and fibrinolysis in peripheral venous blood compared to those in blood from the wounds 3 . whether the administration of tranexamic acid modifies the fibrinolytic response . Twenty-four patients were included . Twelve patients were given tranexamic acid intravenously at the end of the operation . The dose was repeated three hours later . The other 12 patients were given an equivalent amount of placebo . The administration was r and omised and double-blind . Levels of prothrombin fragments 1 + 2 , D-dimers , plasminogen , alpha 2-antiplasmin , tissue plasminogen activator ( tPA ) , and plasminogen activator inhibitor ( PAI-1 ) in venous blood were investigated just before the operation , at the end of the operation and three hours later . At the end of the operation blood for analysis was also drawn from the wound . Coagulation and fibrinolysis was activated during and after surgery . The activation was significantly higher in blood from the wounds than in peripheral venous blood . We found no direct correlation between the degree of fibrinolysis and blood loss . The administration of tranexamic acid reduced fibrinolysis in the wounds but not in peripheral venous blood . The postoperative blood loss was reduced by half The ideal method of providing tranexamic acid ( TXA ) for decreasing hemoglobin drop after TKA is still controversial . In this clinical trial , 200 patients were r and omly allocated to four groups . In group 1,500 mg TXA was administered intravenously . In group 2 , the joint irrigated with 3 g of TXA in 100 cc of saline . In group 3 , 1.5 g of TXA was injected through the drain . Group 4 did not take TXA . Albeit all methods had a statistical effect on hemoglobin drop , drainage and number of transfused units when compared to controls , but intravenous injection of TXA seems to be much more effective in terms of reducing hemoglobin drop and transfused units ; and what 's more TXA injection by drain is more effective regarding to reducing postoperative drainage BACKGROUND Total knee arthroplasty ( TKA ) is often carried out using a tourniquet and shed blood is collected in drains . Tranexamic acid decreases the external blood loss . Some blood loss may be concealed , and the overall effect of tranexamic acid on the haemoglobin ( Hb ) balance is not known . METHODS Patients with osteoarthrosis had unilateral cemented TKA using spinal anaesthesia . In a double-blind fashion , they received either placebo ( n=24 ) or tranexamic acid 10 mg kg(-1 ) ( n=27 ) i.v . just before tourniquet release and 3 h later . The decrease in circulating Hb on the fifth day after surgery , after correction for Hb transfused , was used to calculate the loss of Hb in grams . This value was then expressed as ml of blood loss . RESULTS The groups had similar characteristics . The median volume of drainage fluid after placebo was 845 ( interquartile range 523 - 990 ) ml and after tranexamic acid was 385 ( 331 - 586 ) ml ( P<0.001 ) . Placebo patients received 2 ( 0 - 2 ) units and tranexamic acid patients 0 ( 0 - 0 ) units of packed red cells ( P<0.001 ) . The estimated blood loss was 1426 ( 1135 - 1977 ) ml and 1045 ( 792 - 1292 ) ml , respectively ( P<0.001 ) . The hidden loss of blood ( calculated as loss minus drainage volume ) was 618 ( 330 - 1347 ) ml and 524 ( 330 - 9620 ) ml , respectively ( P=0.41 ) . Two patients in each group developed deep vein thrombosis . CONCLUSIONS Tranexamic acid decreased total blood loss by nearly 30 % , drainage volume by approximately 50 % and drastically reduced transfusion . However , concealed loss was only marginally influenced by tranexamic acid and was at least as large as the drainage volume Purpose The surgical stress of total knee arthroplasty ( TKA ) procedure and the application of intra-operative pneumatic thigh tourniquet increases local fibrinolytic activity , which contributes significantly to post-operative blood loss . Tranexamic acid , an antifibrinolytic drug , is commonly used to control post-operative blood loss . The recommended mode of administration of tranexamic acid is either oral or intravenous . However , the mechanism of action of the tranexamic acid points towards the possible effectiveness it may have following local/intra-articular application . This prospect i ve , double-blinded , r and omized preliminary study evaluated the efficacy of intra-articular tranexamic acid in reducing TKA-associated post-operative blood loss . Methods Fifty consenting patients with osteoarthritis of the knee scheduled for primary unilateral cemented-TKA were r and omly allocated to one of the two groups : Tranexamic Acid ( TA ) group ( n = 25 , 500 mg/5 ml tranexamic acid ) and the control group ( n = 25 , 5 ml 0.9 % saline ) . The drug and control solution were administered intra-articularly through the drain tube immediately after the wound closure . Parameters related to blood loss ( drop in haemoglobin , haematocrit differential ) and the drain output [ volume ( ml ) ] were compared between the two groups . Results On a comparative basis , TA-group obtained significant reduction in the drain output [ 95 % CI : 360.41–539.59 , p < 0.001 ] at 48 h post-operatively . Even though the control group received sixfold more blood transfusion than TA-group , it showed a greater drop in haemoglobin and haematocrit ( p < 0.05 ) . Conclusions Local application of tranexamic acid seems to be effective in reducing post-TKA blood loss as well as blood transfusion requirements . Level of evidence Therapeutic study , Level II Background The antifibrinolytic tranexamic acid reduces surgical blood loss , but studies have not identified an optimal regimen . Questions / purpose sWe studied different dosages , timings , and modes of administration to identify the most effective regimen of tranexamic acid in achieving maximum reduction of blood loss in TKA . Methods We prospect ively studied five regimens ( four intravenous , one local ; 40 patients each ) with a control group ( no tranexamic acid ) . The four intravenous ( 10-mg/kg dose ) regimens included ( 1 ) intraoperative dose ( IO ) given before tourniquet deflation , ( 2 ) additional preoperative dose ( POIO ) , ( 3 ) additional postoperative dose ( IOPO ) , and ( 4 ) all three doses ( POIOPO ) . The fifth regimen was a single local application ( LA ) . Two independent parameters of drain loss and total blood loss , calculated by the hemoglobin balance method , were evaluated statistically . Results Both parameters were reduced in all five regimens as against the control . A significant reduction in drain loss was seen in the POIO , IOPO , and POIOPO groups whereas total blood loss was significantly reduced in the POIO , POIOPO , and LA groups . The POIOPO group had the least drain loss ( 303 mL ) and least total blood loss ( 688 mL ) . The IO group had the greatest drain loss and the IOPO group the greatest total blood loss . Conclusions Single-dose tranexamic acid did not give effective results . The two-dose regimen of POIO was the least amount necessary for effective results . When compared against the control , this regimen produced reduction of drain loss and total blood loss , whereas the IOPO regimen did not . The three-dose regimen of POIOPO produced maximum effective reduction of drain loss and total blood loss . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence A high-dose local tranexamic acid has been introduced in total knee arthroplasty for bleeding control . We are not sure about the systemic absorption and side effects . The aim of this study was to evaluate the effect of low dosage of intra-articular tranexamic acid injection combined with 2-hour clamp drain in minimally bleeding computer-assisted surgery total knee replacement ( CAS-TKR ) . A prospect i ve r and omized controlled trial was conducted in a total of 48 patients underwent CAS-TKR . The patients were r and omly assigned to receive either of a mixed intra-articular solution of tranexamic acid 250 mg with physiologic saline ( TXA group ) , or physiologic saline ( control group ) and then followed by clamp drain for 2 hours . Postoperative blood loss was measured by three different methods as drainage volume , total hemoglobin loss and calculated total blood loss . Transfusion requirement and postoperative complications were recorded . All patients were screened for deep vein thrombosis and the functional outcomes were evaluated at 6 months after surgery . The mean postoperative drainage volume , total hemoglobin loss and calculated total blood loss in TXA group were 308.8 mL , 2.1 g/dL and 206.3 mL compared to 529.0 mL , 3.0 g/dL and 385.1 mL in the control group
Output:
| The authors found a statistically significant reduction in blood loss and transfusion rates when using topical tranexamic acid in primary TKA .
Furthermore , the currently available evidence does not support an increased risk of deep venous thrombosis or pulmonary embolism due to tranexamic acid administration .
Topical tranexamic acid was effective for reducing postoperative blood loss and transfusion requirements without increasing the prevalence of thromboembolic complications |
MS211047 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND For coronary surgery we often use the radial artery ( RA ) instead of the saphenous vein , trying to exploit the advantages offered by this conduit . To eliminate the problems regarding alteration of upper-extremity function after RA procurement related to the st and ard conventional harvesting technique , we started using the less invasive harvesting technique with surprisingly good preliminary results . To compare the outcomes of open versus less invasive harvesting procedures , a prospect i ve , nonr and omized study was developed by 2 centers . METHODS From January 2001 to March 2003 , there were 87 consecutive patients in the less invasive radial artery harvesting ( LIRAH ) group and 90 patients in the conventional radial artery harvesting ( CRAH ) group . Patient characteristics and demographics were similar in the groups . Data collection was made to evaluate possible benefits of the LIRAH technique in terms of fewer forearm and h and complications , better aesthetics , and improved patient satisfaction . RESULTS Between January 11 , 2001 , and March 30 , 2003 , 177 patients underwent either primary or redo coronary artery revascularizations with procurement of the RA for use as a conduit with the less invasive harvesting technique . The mean follow-up was 2 months . Four patients died , and overall mortality was 2.26 % . One hundred seventy-three patients were successfully examined during the first postoperative control , 85 in the LIRAH group and 88 patients in the CRAH group . Objective and subjective data were collected from the consultant . The overall average age was 60.5 years ( range , 40 - 77 years ) . In the LIRAH group , the mean overall incision length ( when 2 incisions were necessary , both incision lengths were measured ) was 5.6 cm ( range , 4 - 10 cm ) , and the mean vessel length was 16 cm ( range , 10 - 19 cm ) . Eighteen patients ( 20.6 % ) necessitated double incision . Mean harvesting time ( from incision to skin closure ) was 43.3 min ( range , 25 - 70 min ) . Fourteen patients ( 16.4 % ) presented some kind of complication during the study . There were no cases with acute ischemia , bleeding , or re-exploration . Seventy-five patients ( 88.2 % ) found the cosmetic result excellent . Ten patients ( 11.8 % ) found it good , and none considered it mediocre . In the CRAH group , the mean incision length was 20 cm ( range , 18 - 22 cm ) , and the mean vessel length was 18 cm ( range , 17 - 20 cm ) . Mean harvesting time ( from incision to skin closure ) was 30.8 min ( range , 14 - 45 min ) . Thirty-four patients ( 38.6 % ) presented some kind of complication during the study . Three patients ( 3.5 % ) found the cosmetic result excellent . Forty-three ( 48.8 % ) found it good , and 42 ( 47.7 % ) considered it mediocre . CONCLUSIONS A potential of fewer neurological forearm postoperative complications , better aesthetics , and improved patient satisfaction can be achieved by the LIRAH technique OBJECTIVE To compare the endothelial integrity of radial artery grafts harvested by minimally invasive surgery and arteries harvested conventionally for coronary artery bypass surgery ( CABG ) in 200 participants , who were assigned to interventions by using r and om allocation . METHODS An immunohistochemical procedure with monoclonal antibodies was employed to estimate CD31 antigen and endothelial nitric oxide synthase ( eNOS ) expressions - markers defining endothelial integrity . RESULTS The CD31 immunostaining revealed that the endothelial cell integrity of the minimally invasive harvested arteries was preserved in 76.1±7.4 % of the circumference of luminal endothelium , which was similar to results obtained in conventionally harvested grafts ( 77.2±9.8 % ; not significant ) . On the other h and , eNOS immunostaining indicated that the endothelial integrity of the minimally invasive harvested grafts was preserved in 75.4±10.5 % while in conventionally harvested grafts it was reduced to 42.4±14.5 % of the total luminal endothelium circumference ( P<0.05 ) . CONCLUSIONS The endothelial integrity of radial artery grafts harvested by minimally invasive surgery is better preserved than in the grafts obtained by the conventional manner . This could play an important role in improving graft patency and might represent a preliminary condition of stable functioning in coronary arterial bypasses OBJECTIVES The purpose of this study was to present radial and saphenous vein graft ( SVG ) occlusion results more than 5 years following coronary artery bypass surgery . BACKGROUND In the RAPS ( Radial Artery Patency Study ) study , complete graft occlusion was less frequent in radial artery compared with SVG 1 year post-operatively while functional occlusion ( Thrombolysis In Myocardial Infa rct ion flow grade 0 , 1 , 2 ) was similar . METHODS A total of 510 patients < 80 years of age undergoing primary isolated nonemergent coronary artery bypass grafting with 3-vessel disease were initially enrolled in 9 Canadian centers . Target vessels for the radial artery and study SVG were the right and circumflex coronary arteries , which had > 70 % proximal stenosis . Within-patient r and omization was performed ; the radial artery was r and omized to either the right or circumflex territory and the study SVG was used for the other territory . The primary endpoint was functional graft occlusion by invasive angiography at least 5 years following surgery . Complete graft occlusion by invasive angiography or computed tomography angiography was a secondary endpoint . RESULTS A total of 269 patients underwent late angiography ( 234 invasive angiography , 35 computed tomography angiography ) at a mean of 7.7 ± 1.5 years after surgery . The frequency of functional graft occlusion was lower in radial arteries compared with SVGs ( 28 of 234 [ 12.0 % ] vs. 46 of 234 [ 19.7 % ] ; p = 0.03 by McNemar 's test ) . The frequency of complete graft occlusion was also significantly lower in radial compared with SVGs ( 24 of 269 [ 8.9 % ] vs. 50 of 269 [ 18.6 % ] ; p = 0.002 ) . CONCLUSIONS Radial arteries are associated with reduced rates of functional and complete graft occlusion compared with SVGs more than 5 years following surgery . ( Multicentre Radial Artery Patency Study : 5 Year Results ; NCT00187356 ) BACKGROUND Endoscopic radial artery harvest provides better cosmetic result without compromising the quality of the graft . We sought to compare postoperative harvesting site neurologic and vascular outcome . METHODS From 10/2002 until 10/2004 , 50 patients were r and omized to have their radial artery harvested for coronary bypass either endoscopically ( group A , n = 25 ) or conventionally ( group B , n = 25 ) . Radial arteries were preoperatively evaluated by Doppler echocardiography . Neurologic and functional status was assessed by a self reporting question naire with a semiquantitative ( 1 - 5 ) scale . Vascular status of the forearm was assessed by control echocardiography . RESULTS At an average follow-up of 37 + /- 7 months , patients undergoing endoscopic radial artery harvesting had less overall neurologic complications ( 11 versus 17 patients , P = .023 ) and they were less severe ( 0.8 + /- 1.1 versus 2.2 + /- 1.2 ; P < .001 ) . Ulnar flow increase was similar among the groups : 13.1 + /- 5.43 cm/s in group A versus 15.9 + /- 4.9 cm/s in group B ( P = .147 ) as well as ulnar artery diameter increase 0.29 + /- 0.16 mm in group A versus 0.29 + /- 0.26 cm in group B ( P = .914 ) . CONCLUSION Endoscopic radial artery is safe and does not compromise graft quality or forearm and h and circulation postoperatively . Along with providing a better cosmetic result , endoscopic artery harvesting reduces postoperative harvesting site pain and neurologic complications BACKGROUND We report the 5-year results of the SYNTAX trial , which compared coronary artery bypass graft surgery ( CABG ) with percutaneous coronary intervention ( PCI ) for the treatment of patients with left main coronary disease or three-vessel disease , to confirm findings at 1 and 3 years . METHODS The r and omised , clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe . A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments . Eligible patients suitable for either treatment were r and omly assigned ( 1:1 ) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG . Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries . We analysed a composite rate of major adverse cardiac and cerebrovascular events ( MACCE ) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis . This study is registered with Clinical Trials.gov , number NCT00114972 . FINDINGS 1800 patients were r and omly assigned to CABG ( n=897 ) or PCI ( n=903 ) . More patients who were assigned to CABG withdrew consent than did those assigned to PCI ( 50 vs 11 ) . After 5 years ' follow-up , Kaplan-Meier estimates of MACCE were 26·9 % in the CABG group and 37·3 % in the PCI group ( p<0·0001 ) . Estimates of myocardial infa rct ion ( 3·8 % in the CABG group vs 9·7 % in the PCI group ; p<0·0001 ) and repeat revascularisation ( 13·7%vs 25·9 % ; p<0·0001 ) were significantly increased with PCI versus CABG . All-cause death ( 11·4 % in the CABG group vs 13·9 % in the PCI group ; p=0·10 ) and stroke ( 3·7%vs 2·4 % ; p=0·09 ) were not significantly different between groups . 28·6 % of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1 % of patients in the PCI group ( p=0·43 ) and 31·0 % in the CABG group with left main coronary disease had MACCE versus 36·9 % in the PCI group ( p=0·12 ) ; however , in patients with intermediate or high SYNTAX scores , MACCE was significantly increased with PCI ( intermediate score , 25·8 % of the CABG group vs 36·0 % of the PCI group ; p=0·008 ; high score , 26·8%vs 44·0 % ; p<0·0001 ) . INTERPRETATION CABG should remain the st and ard of care for patients with complex lesions ( high or intermediate SYNTAX scores ) . For patients with less complex disease ( low SYNTAX scores ) or left main coronary disease ( low or intermediate SYNTAX scores ) , PCI is an acceptable alternative . All patients with complex multivessel coronary artery disease should be review ed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment . FUNDING Boston Scientific We present a less traumatic surgical technique for harvesting the radial artery as a coronary artery bypass graft that does not require any special equipment or skills . We prospect ively r and omized 40 patients undergoing coronary artery bypass grafting with the radial artery into two groups on the basis of harvest techniques : tunneling excision and conventional open method . The less-invasive tunneling technique is safe , easily applicable , and preferred by patients because of the superior cosmetic result BACKGROUND In the past decade , the radial artery has frequently been used for coronary bypass surgery despite concern regarding the possibility of graft spasm . Graft patency is a key predictor of long-term survival . We therefore sought to determine the relative patency rate of radial-artery and saphenous-vein grafts in a r and omized trial in which we controlled for bias in the selection of patients and vessels . METHODS We enrolled 561 patients at 13 centers . The left internal thoracic artery was used to bypass the anterior circulation . The radial-artery graft was r and omly assigned to bypass the major vessel in either the inferior ( right coronary ) territory or the lateral ( circumflex ) territory , with the saphenous-vein graft used for the opposing territory ( control ) . The primary end point was graft occlusion , determined by angiography 8 to 12 months postoperatively . RESULTS Angiography was performed at one year in 440 patients :
Output:
| There were no statistically significant differences in overall mortality , recurrent myocardial infa rct ion , or graft patency between the two surgical techniques .
However , patients who underwent endoscopic harvesting were found to have significantly lower incidences of wound infection , hematoma formation , and paresthesia .
However , the available evidence suggests that the endoscopic approach is associated with superior perioperative outcomes without clear evidence demonstrating compromised patency or survival outcomes |
MS211048 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Functional outcome after rectal excision with coloanal anastomosis is improved by construction of a colonic J pouch . Present prospect i ve r and omized studies lack follow‐up beyond 1 year . The aim of this study was to assess the clinical outcome at both short‐ and long‐term follow‐UP Objective To assess the efficacy of a novel coloplasty colonic pouch design in optimizing bowel function after ultralow anterior resection . Summary Background Data A colonic J-pouch may reduce excessive stool frequency and incontinence after anterior resection , but at the risk of evacuation problems . Experimental surgery on pigs has suggested that a coloplasty pouch ( CP ) may be a useful alternative . Although CP has recently been shown to be feasible in patients , there is no r and omized controlled trial comparing bowel function with the J-pouch . Methods After anterior resection for cancer , patients were allocated to either J-pouch or CP-anal anastomoses . Continence scoring , anorectal manometry , and endoanal ultrasound assessment s were made before surgery . All complications were recorded , and these preoperative assessment s were repeated at 4 months . The assessment s were repeated again at 1 year , and a quality of life question naire was added . Results Eighty-eight patients were recruited from October 1998 to April 2000 . Both groups were well matched for age , gender , staging , adjuvant therapy , and mean follow-up . There were no differences in the intraoperative time and hospital stay . CP result ed in more anastomotic leaks . At 4 months , J-pouch patients had 10.3 % less stool fragmentation but poorer stool deferment and more nocturnal leakage . However , there were no differences in the bowel function , continence score , and quality of life at 1 year . There were no differences in the anorectal manometry and endoanal ultrasound findings . Conclusions Coloplasty pouches result ed in more anastomotic leaks and minimal differences in bowel function . At present , the J-pouch remains the benchmark for routine clinical practice , and due care ( including defunctioning stoma ) should be exercised in situations requiring CP Objectives To compare a colonic J-pouch or a side-to-end anastomosis after low-anterior resection for rectal cancer with regard to functional and surgical outcome . Summary Background Data A complication after restorative rectal surgery with a straight anastomosis is low-anterior resection syndrome with a postoperatively deteriorated anorectal function . The colonic J-reservoir is sometimes used with the purpose of reducing these symptoms . An alternative method is to use a simple side-to-end anastomosis . Methods One-hundred patients with rectal cancer undergoing total mesorectal excision and colo-anal anastomosis were r and omized to receive either a colonic pouch or a side-to-end anastomosis using the descending colon . Surgical results and complications were recorded . Patients were followed with a functional evaluation at 6 and 12 months postoperatively . Results Fifty patients were r and omized to each group . Patient characteristics in both groups were very similar regarding age , gender , tumor level , and Dukes ’ stages . A large proportion of the patients received short-term preoperative radiotherapy ( 78 % ) . There was no significant difference in surgical outcome between the 2 techniques with respect to anastomotic height ( 4 cm ) , perioperative blood loss ( 500 ml ) , hospital stay ( 11 days ) , postoperative complications , reoperations or pelvic sepsis rates . Comparing functional results in the 2 study groups , only the ability to evacuate the bowel in < 15 minutes at 6 months reached a significant difference in favor of the pouch procedure . Conclusions The data from this study show that either a colonic J-pouch or a side-to-end anastomosis performed on the descending colon in low-anterior resection with total mesorectal excision are methods that can be used with similar expected functional and surgical results The efficacy of colon-J-pouch anal anastomosis ( CPAA ) in reducing defecatory frequency and urgency and the incidence of anastomotic fistulas has been proved by several studies but only as compared to straight colo-anal anastomosis ( CAA ) of the end-to-end type . We investigated the role played by the colon pouch in the strict sense , without the influence of a different CAA model , in a r and omised prospect i ve study comparing CPAA and straight side-to-end CAA . Over the period from 1994 to 1998 we selected 66 of 118 patients operated on for rectal cancer : a CPAA was constructed in 35 ( group P ) and a direct side-to-end CAA in 31 ( group D ) . The two groups were well matched for surgeon , type of patient , stage of disease and incidence of radiotherapy and presented no differences in operative mortality , general and anastomotic morbidity , or need for reoperation . Functional results : after 3 , 12 and 36 months , defecatory frequency > or = 4 movements/day was observed in 93.4 , 67.7 and 41.6 % of cases , respectively , in group D as against 25.7 , 14.2 and 13 % , respectively , in group P ( P < 0.05 ) , while defecatory urgency was recorded in 77.4 , 35.4 and 27.9 % of cases , respectively , in group D as against 34.2 , 17.1 and 9 % , respectively , in group P ( p < 0.05 ) . In the long term , incontinence was also significantly lower in group P. The colon pouch improves sphincter rehabilitation after anal recanalization compared to straight side-to-end CAA . It does not affect anastomotic morbidity but affords a protective effect on function in irradiated patients . CPAA proves to be the optimal reconstruction option after excision of the rectum 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 : Colonic pouches have been used for 20 years to provide reservoir function after reconstructive proctectomy for rectal cancer . More recently coloplasty has been advocated as an alternative to a colonic pouch . However there have been no long-term r and omized , controlled trials to compare functional outcomes of coloplasty , colonic J-Pouch ( JP ) , or a straight anastomosis ( SA ) after the treatment of low rectal cancer . Aim : To compare the complications , long-term functional outcome , and quality of life ( QOL ) of patients undergoing a coloplasty , JP , or an SA in reconstruction of the lower gastrointestinal tract after proctectomy for low rectal cancer . Methods : A multicenter study enrolled patients with low rectal cancer , who were r and omized intraoperatively to coloplasty ( CP-1 ) or SA if JP was not feasible , or JP or coloplasty ( CP-2 ) if a JP was feasible . Patients were followed for 24 months with SF-36 surveys to evaluate the QOL . Bowel function was measured quantitatively and using Fecal Incontinence Severity Index ( FISI ) . Urinary function and sexual function were also assessed . Results : Three hundred sixty-four patients were r and omized . All patients were evaluated for complications and recurrence . Mean age was 60 ±12 years , 71 % were male . Twenty-three ( 7.4 % ) died within 24 months of surgery . No significant difference was observed in the complications among the 4 groups . Two hundred ninety-seven of 364 were evaluated for functional outcome at 24 months . There was no difference in bowel function between the CP-1 and SA groups . JP patients had fewer bowel movements , less clustering , used fewer pads and had a lower FISI than the CP-2 group . Other parameters were not statistically different . QOL scores at 24 months were similar for each of the 4 groups . Conclusions : In patients undergoing a restorative resection for low rectal cancer , a colonic JP offers significant advantages in function over an SA or a coloplasty . In patients who can not have a pouch , coloplasty seems not to improve the bowel function of patients over that with an SA Objectives The introduction of the colonic J‐pouch has markedly improved the functional outcome of restorative rectal cancer surgery . However colonic J‐pouch surgery can be problematic and may present some late evacuatory problems . To overcome these limitations a novel pouch has been proposed : the transverse coloplasty pouch . The purpose of our study was to compare the functional outcomes of these two different types of pouches – the transverse coloplasty pouch ( TCP ) and the colonic J‐pouch ( CJP ) – during the first 12 months postoperatively OBJECTIVE The authors compared clinical bowel function and complications of a low anterior resection with either a straight or colonic J pouch anastomosis . SUMMARY BACKGROUND DATA Urgency and frequent bowel movements after rectal resection with a low anastomosis have been related to the loss of rectal reservoir function . Reconstruction with a colonic J pouch possibly can obviate some of this dysfunction . Earlier reports have been favorable , but they must be verified in r and omized trials . METHOD One hundred patients with rectal cancer in whom a sphincter-saving procedure was appropriate were r and omized to reconstruction with either a straight or a colonic J pouch anastomosis . RESULTS The incidence of symptomatic anastomotic leakage was lower in the pouch group ( 2 % vs. 15 % , p = 0.03 ) . Eighty-nine patients could be evaluated after 1 year . The pouch patients had significantly fewer bowel movements per 24 hours , and less nocturnal evacuations , urgency , and incontinence . Overall well-being owing to the bowel function was rated significantly higher by the pouch patients . CONCLUSION Reconstruction with a colonic J pouch was associated with a lower incidence of anastomotic leakage and better clinical bowel function when compared with the traditional straight anastomosis . Functional superiority was especially evident during the first 2 months Twenty patients ( 13 men ) with low rectal cancer , median ( range ) age 64.5 ( 38–83 ) years were prospect ively r and omized to undergo ultra‐low anterior resection with a J colonic pouch‐anal anastomosis ( median ( range ) distance of anastomosis from the anal verge 3 ( 1–4 ) cm ) . Another 20 patients ( 15 men ) , median ( range ) age 62.5 ( 44–86 ) years ) with low rectal cancer were r and omized to a straight coloanal anastomosis ( median ( range ) distance of anastomosis from the anal verge 3.25 ( 2–5 ) cm ) . There were no significant differences in operative time or complications between the two groups . There was significantly better postoperative anal function in patients who underwent pouch‐anal anastomosis at 1 , 6 and 12 months after ileostomy closure . At 12 months all patients ( 19 of 19 ) with a pouch reconstruction had regained normal continence compared with 14 of 20 of those who had a straight coloanal anastomosis . No patient complained of severe constipation requiring enema or intubation to evacuate Abstract BACKGROUND : Low anterior resection with coloanal anastomosis prevents a definitive stoma in patients with distal rectal cancer . However , imperative stool urge , stool fragmentation , prolonged stooling sessions , and minor problems of incontinence are frequently observed in the postoperative situation and negatively affect quality of life . Therefore , the colonic J-pouch was originally constructed to create a stool reservoir . In a r and omized , prospect i ve study , the short ( 5 cm ) colonic J-pouch was tested for function and continence vs. straight coloanal anastomosis . METHODS : Over a period of 30 months , 74 consecutive patients ( 55 males ) with rectal cancer in the lower and middle third of the rectum were included and r and omized into two groups . Anastomosis was performed either as a coloanal or a colon-pouch-anal anastomosis . The st and ardized surgical procedure included mobilization of the left hemicolon , central ligation of the inferior mesenteric artery and vein , preaortal lymph node dissection , autonomic nerve preservation , and total mesorectal excision . The anastomosis was performed at the upper anal canal or at the intersphincteric level . All patients were evaluated preoperatively and six months postoperatively for fecal continence , including sphincter manometry and defecation habits . In addition , quality of life was determined by use of a st and ardized question naire ( European Organization for Research and Treatment of Cancer , EORTC-QLQ-C30 ) . RESULTS : Thirty-seven patients were r and omized into each group . In general , problems with continence for liquids or gas occurred less frequently in the colonic J-pouch group 6 months after surgery . The frequency of bowel movements was lower in the J-pouch group ( 2.5 per day ) than in the coloanal group ( 4.7 per day ) . Importantly , in a manometric study at the same postoperative point , neorectal capacity was decreased to a similar degree in both groups compared with the preoperative rectal volume . Thus , the expected and postulated reservoir effect could not be achieved by forming a 5-cm colonic J-pouch . CONCLUSION : The colonic J-pouch was superior with regard to continence for gas and liquids compared with a straight coloanal anastomosis . Furthermore , stool frequency was significantly lower in the J-pouch group than in the coloanal reconstruction group . However , because neorectal capacity decreased equally in both groups , we speculate that the advantage of the colonic
Output:
| Colonic J pouch was associated with lower stool frequency and antidiarrhoeal medication use for up to 1 year after surgery compared with straight CAA .
Transverse coloplasty and side-to-end CAA had similar functional outcomes to the colonic J pouch .
No superiority was found for any of the techniques in terms of anastomotic leak rate .
CONCLUSION Colonic J pouch and side-to-end CAA or transverse coloplasty lead to a better functional outcome than straight CAA for the first year after surgery |
MS211049 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective : To use an ecological systems approach to examine individual- , family- , community- and area-level risk factors for overweight ( including obesity ) in 3-year-old children . Methods : A prospect i ve nationally representative cohort study conducted in Engl and , Wales , Scotl and , Northern Irel and . Participants included 13 188 singleton children aged 3 years in the Millennium Cohort Study , born between 2000 and 2002 , who had complete height/weight data . The main outcome measure was childhood overweight ( including obesity ) defined by the International Obesity TaskForce cut-offs for body mass index . Results : 23.0 % of 3-year-old children were overweight or obese . In the fully adjusted model , primarily individual- and family-level factors were associated with early childhood overweight : birthweight z-score ( adjusted odds ratio , 1.36 , 95 % CI 1.30 to 1.42 ) , black ethnicity ( 1.41 , 1.11 to 1.80 ) ( compared with white ) , introduction to solid foods < 4 months ( 1.12 , 1.02 to 1.23 ) , lone motherhood ( 1.32 , 1.15 to 1.51 ) , smoking during pregnancy ( 1–9 cigarettes daily : 1.34 , 1.17 to 1.54 ; 10–19 : 1.49 , 1.26 to 1.75 ; 20 + : 1.34 , 1.05 to 1.70 ) , parental overweight ( both : 1.89 , 1.63 to 2.19 ; father only : 1.45 , 1.28 to 1.63 ; mother only : 1.37 , 1.18 to 1.58 ) , prepregnancy overweight ( 1.28 , 1.14 to 1.45 ) and maternal employment ⩾21 hours/week ( 1.23 , 1.10 to 1.37 ) ( compared with never worked ) . Breastfeeding ⩾4 months ( 0.86 , 0.76 to 0.97 ) ( compared with none ) and Indian ethnicity ( 0.63 , 0.42 to 0.94 ) were associated with a decreased risk of early childhood overweight . Children from Wales were also more likely to be overweight than children from Engl and . Conclusions : Most risk factors for early childhood overweight are modifiable or would allow at-risk groups to be identified . Policies and interventions should focus on parents and providing them with an environment to support healthy behaviours for themselves and their children OBJECTIVE To investigate the predictive association between preschool childcare arrangements and overweight/obesity in childhood . STUDY DESIGN Children were enrolled in a prospect i ve birth cohort in Quebec , Canada ( n = 1649 ) . Information about childcare obtained via question naires to the mothers at ages 1.5 , 2.5 , 3.5 , and 4 years was used to compute a main childcare arrangement exposure variable ( center-based/family-based/care by a relative/nanny ) . Body mass index was derived from measured weights and heights at ages 4 , 6 , 7 , 8 , and 10 years and children were classified as overweight/obese versus normal weight . Generalized estimating equations were used to model the effect of main childcare arrangement ( center-based/family-based/relative/nanny ) ( vs parental care ) on overweight/obesity adjusting for several potential confounding factors . RESULTS Compared with parental care , children who attended a center-based childcare ( OR : 1.65 , 95 % CI : 1.13 - 2.41 ) or were cared for by a relative ( OR : 1.50 ; 95 % CI : 0.95 - 2.38 , although with greater uncertainty ) had higher odds of being overweight/obese in childhood ( 4 - 10 years ) . Analyses of number of hours additionally suggested that each increment of 5 hours spent in either center-based or relative childcare increased the odds of overweight/obesity in the first decade of life by 9 % . Associations were not explained by a wide range of confounding factors , including socioeconomic position , breastfeeding , maternal employment , and maternal body mass index . CONCLUSION Overweight/obesity was more frequently observed in children who received non-parental care in center-based setting s or care by a relative other than the parent . " Obesogeonic " features of these childcare arrangements should be investigated in future studies Background : In young children , the eating environment is an important social context within which eating behaviors develop . Among many low-income young children , the responsibility for feeding may have shifted from family members to child care providers because these children spend the majority of their day in child care setting s. Methods : To examine the influence of feeding among low-income children in child care setting s , feeding behaviors of child care providers in Head Start were observed and food consumption was assessed . Head Start , a comprehensive child development program that serves children from ages 3 to 5 , was chosen because of the large percentage of minorities , the low-income status of the families , and the age of the children . Fifty child care providers ( 25 African-American ; 25 Hispanic ) r and omly selected from Head Start centers in a large , urban southwestern city were observed on three mealtime occasions and self-reported feeding styles were assessed . Observed feeding behaviors were categorized into four feeding patterns based on their conceptual similarity to a general parenting typology ( i.e. , authoritarian , authoritative , indulgent , and uninvolved ) . Measures of food consumption were assessed on 549 children sitting with the child care providers during lunch at the Head Start centers . Results : Indulgent feeding behaviors were positively related to children ’s consumption of vegetables , dairy , entrée , and starch ; authoritative feeding behaviors were positively related to dairy consumption . Conclusion : This research highlights the important influence that child care providers have in the development of healthy and unhealthy eating behaviors in minority children . Implication s for intervention training for child care providers to promote healthy eating among Head Start children are discussed Background Low levels of physical activity are characteristic in preschoolers . To effectively promote physical activity , it is necessary to underst and factors that influence young children 's physical activity . The present study aim ed to investigate how physical activity levels are influenced by environmental factors during recess in preschool . Methods Preschool playground observations and pedometry during recess were carried out in 39 r and omly selected preschools ( 415 boys and 368 girls ; 5.3 ± 0.4 years old ) . In order to examine the contribution of playground variables to physical activity levels , taking adjustment for clustering of subjects within preschools into account , multilevel analyses were conducted . Results During recess boys took significantly more steps per minute than girls ( 65 ± 36 versus 54 ± 28 steps/min ) . In both genders higher step counts per minute were significantly associated with less children per m2 and with shorter recess times . Only in boys a hard playground surface was a borderline significant predictor for higher physical activity levels . In girls higher step counts were associated with the presence of less supervising teachers . Playground markings , access to toys , the number of playing or aim ing equipment pieces and the presence of vegetation or height differences were not significant physical activity predictors in both genders . Conclusion In preschool children physical activity during outdoor play is associated with modifiable playground factors . Further study is recommended to evaluate if the provision of more play space , the promotion of continued activity by supervisors and the modification of playground characteristics can increase physical activity levels in preschoolers BACKGROUND : The majority of infants in the United States are in nonparental child care , yet little is known about the effect of child care on development of obesity . OBJECTIVE : To examine the relationship between child care attendance from birth to 6 months and adiposity at 1 and 3 years of age . METHODS : We studied 1138 children from a prospect i ve cohort of pregnant women and their offspring . The main exposure was time in child care from birth to 6 months of age , overall and by type of care : ( 1 ) child care center ; ( 2 ) someone else 's home ; and ( 3 ) child 's own home by nonparent . The main outcomes were weight-for-length ( WFL ) z score at 1 year and BMI z score at 3 years of age . RESULTS : A total of 649 ( 57 % ) infants attended child care ; 17 % were cared for in a center , 27 % in someone else 's home , and 21 % in their own home by a nonparent . After adjustment for confounders , overall time in child care was associated with an increased WFL z score at 1 year and BMI z score at 3 years of age but not skinfold thicknesses . Center and own home care were not associated with the outcomes , but care in someone else 's home was associated with an increase in both the 1- and 3-year outcomes . CONCLUSION : Child care in the first 6 months of life , especially in someone else 's home , was associated with an increased WFL z score at 1 year and BMI z score at 3 years of age BACKGROUND Previous research has shown that children in child-care do not comply with dietary intake recommendations ( i.e. either exceeding or not meeting recommendations ) , which may be attributable to specific features of the child-care environment . The present study explored the relationship between the social and physical child-care ( day-care ) environment and dietary intake of 2- and 3-year-olds in Dutch child-care centres . METHODS The dietary intake of 135 children , aged 2 and 3 years , who were in child-care was assessed by observing r and omly selected children at three meals ( morning snack , lunch and afternoon snack ) to determine dietary intake ( i.e. saturated fat , dietary fibre and energy intake ) . The environment was observed using the Environment and Policy Assessment and Observation checklist , a structured instrument assessing the physical and social environment . RESULTS Children consumed a mean of 486 kJ ( 116 kcal ) during the morning snack , 2043 kJ ( 488 kcal ) during lunch and 708 kJ ( 169 kcal ) during the afternoon snack . There were some gender and age differences in dietary intake . Several environmental factors ( e.g. serving style and staff 's model dietary behaviour ) were significantly associated with the children 's dietary intake . CONCLUSIONS Overall , energy intake was in the upper range of recommended intake for children in child-care . The associations of several environmental factors with dietary intake stress the importance of the child-care environment for children 's dietary behaviour . Intervening in this setting could possibly contribute to the comprehensive prevention of childhood obesity OBJECTIVE A r and omized controlled pilot study to test the hypothesis that increasing preschool children 's outdoor free play time increases their daily physical activity levels . METHODS Physical activity was assessed by accelerometers for four consecutive school days in thirty-two Latino children ( 3.6+/-0.5 years ) attending a preschool for low-income families . After two days of baseline physical activity assessment , participants were r and omly assigned to an intervention ( RECESS ; n = 17 ) or control ( CON ; n = 15 ) group . The RECESS group received two additional 30-minute periods of outdoor free play time per day for two days . The CON group followed their normal classroom schedule . Between group differences in physical activity variables were tested with a Wilcoxon rank-sum test . RESULTS There were no statistically significant differences between groups in changes from baseline in average total daily ( CON , 48.2+/-114.5 ; RECESS , 58.2+/-74.6 ) and during school day ( CON , 64.6+/-181.9 ; RECESS , 59.7+/-79.1 ) counts per minute , or total daily ( CON , 0.4+/-1.3 ; RECESS , 0.3+/-0.8 ) and during school day ( CON , 0.6+/-2.1 ; RECESS , 0.5+/-0.8 ) percent of time spent in moderate to vigorous physical activity . CONCLUSIONS Substantially increasing preschoolers ' outdoor free play time did not increase their physical activity levels OBJECTIVES We aim ed to investigate the effects of providing play equipment and markings at the pre-school playground on physical activity engagement levels . METHODS We performed a cluster r and omised control trial . In November and December 2007 , a convenience sample of 40 public pre-schools in Fl and ers , Belgium , was r and omly assigned to one of the following conditions : 1 ) in 10 pre-schools play equipment was provided , 2 ) in 10 pre-schools markings were painted on the playground , 3 ) in 10 schools play equipment was provided and markings were painted , 4 ) 10 schools served as a control condition . Accelerometer-based physical activity levels during recess were evaluated at baseline and 4 to 6 weeks after the implementation of the intervention in 583 children ( 52 % boys ; mean age 5.3 years , SD 0.4 ) . RESULTS At baseline pre-schoolers spent only 11.2 % ( average : 4.7 min ) of recess time in moderate to vigorous activity , while 61.3 % ( average : 25.7 min ) was spent in sedentary activity . The interventions were not effective in increasing the average activity levels or the percentages of engagement in moderate or vigorous activity , or in decreasing sedentary time . CONCLUSION Providing playground markings or play equipment is not sufficient to increase activity levels and decrease levels of sedentary activity during pre-school recess . More activating supervision and the inclusion of more structured physical activity seem needed Objective : We evaluated the effects of a preschool
Output:
| Discussion Several studies support the hypothesis that the influence of the childcare environment on children ’s physical activity and diet is moderated by child characteristics ( age , gender ) , but interaction between environmental types as well as between micro-systems is hardly examined in the field of behavioral nutrition and physical activity . |
MS211050 | ***TASK*** the task is to summarize an input biomedical literature in 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 Energy drink consumption has continued to gain in popularity since the 1997 debut of Red Bull , the current leader in the energy drink market . Although energy drinks are targeted to young adult consumers , there has been little research regarding energy drink consumption patterns among college students in the United States . The purpose of this study was to determine energy drink consumption patterns among college students , prevalence and frequency of energy drink use for six situations , namely for insufficient sleep , to increase energy ( in general ) , while study ing , driving long periods of time , drinking with alcohol while partying , and to treat a hangover , and prevalence of adverse side effects and energy drink use dose effects among college energy drink users . Methods Based on the responses from a 32 member college student focus group and a field test , a 19 item survey was used to assess energy drink consumption patterns of 496 r and omly surveyed college students attending a state university in the Central Atlantic region of the United States . Results Fifty one percent of participants ( n = 253 ) reported consuming greater than one energy drink each month in an average month for the current semester ( defined as energy drink user ) . The majority of users consumed energy drinks for insufficient sleep ( 67 % ) , to increase energy ( 65 % ) , and to drink with alcohol while partying ( 54 % ) . The majority of users consumed one energy drink to treat most situations although using three or more was a common practice to drink with alcohol while partying ( 49 % ) . Weekly jolt and crash episodes were experienced by 29 % of users , 22 % reported ever having headaches , and 19 % heart palpitations from consuming energy drinks . There was a significant dose effect only for jolt and crash episodes . Conclusion Using energy drinks is a popular practice among college students for a variety of situations . Although for the majority of situations assessed , users consumed one energy drink with a reported frequency of 1 – 4 days per month , many users consumed three or more when combining with alcohol while partying . Further , side effects from consuming energy drinks are fairly common , and a significant dose effect was found with jolt and crash episodes . Future research should identify if college students recognize the amounts of caffeine that are present in the wide variety of caffeine-containing products that they are consuming , the amounts of caffeine that they are consuming in various situations , and the physical side effects associated with caffeine consumption Energy drinks containing caffeine , taurine , and glucose may improve mood and cognitive performance . However , there are no studies assessing the individual and interactive effects of these ingredients . We evaluated the effects of caffeine , taurine , and glucose alone and in combination on cognitive performance and mood in 24-hour caffeine-abstained habitual caffeine consumers . Using a r and omized , double-blind , mixed design , 48 habitual caffeine consumers ( 18 male , 30 female ) who were 24-hour caffeine deprived received one of four treatments ( 200 mg caffeine/0 mg taurine , 0 mg caffeine/2000 mg taurine , 200 mg caffeine/2000 mg taurine , 0 mg caffeine/0 mg taurine ) , on each of four separate days , separated by a 3-day wash-out period . Between- participants treatment was a glucose drink ( 50 g glucose , placebo ) . Salivary cortisol , mood and heart rate were measured . An attention task was administered 30-minutes post-treatment , followed by a working memory and reaction time task 60-minutes post-treatment . Caffeine enhanced executive control and working memory , and reduced simple and choice reaction time . Taurine increased choice reaction time but reduced reaction time in the working memory tasks . Glucose alone slowed choice reaction time . Glucose in combination with caffeine , enhanced object working memory and in combination with taurine , enhanced orienting attention . Limited glucose effects may reflect low task difficulty relative to subjects ' cognitive ability . Caffeine reduced feelings of fatigue and increased tension and vigor . Taurine reversed the effects of caffeine on vigor and caffeine-withdrawal symptoms . No effects were found for salivary cortisol or heart rate . Caffeine , not taurine or glucose , is likely responsible for reported changes in cognitive performance following consumption of energy drinks , especially in caffeine-withdrawn habitual caffeine consumers BACKGROUND There has been a significant growth in the energy drink ( ED ) market in Australia and around the world ; however , most research investigating the popularity of ED and alcohol and energy drink ( AED ) use has focused on specific sub population s such as university students . The aim of this study was to estimate the prevalence , consumption patterns , and sociodemographic correlates of ED and combined AED use among a representative Australian population sample . METHODS A computer-assisted telephone interview survey ( n = 2,000 ) was undertaken in March-April 2013 of persons aged 18 years and over . Half of the interviews were obtained through r and omly generated l and line telephone numbers and half through mobile phones . Approximately half of the sample was female ( 55.5 % ; n = 1,110 ) and the mean age of participants was 45.9 ( range 18 to 95 , SD 20.0 ) . RESULTS Less than 1 in 6 Australians reported ED use ( 13.4 % , n = 268 ) and 4.6 % ( n = 91 ) reported AED use in the past 3 months . Majority of ED and AED users consumed these beverages monthly or less . ED and AED users are more likely to be aged 18 to 24 years , live in a metropolitan area , and be moderate risk or problem gamblers . AED consumers are more likely to report moderate levels of psychological distress . CONCLUSIONS Our findings in relation to problem gambling and psychological distress are novel and require further targeted investigation . Health promotion strategies directed toward reducing ED and AED use should focus on young people living in metropolitan areas and potentially be disseminated through locations where gambling takes place Rationale Combining alcohol and caffeine is associated with increased alcohol consumption , but no prospect i ve experimental studies have examined whether added caffeine increases alcohol consumption . Objectives This study examined how caffeine alters alcohol self-administration and subjective reinforcing effects in healthy adults . Methods Thirty-one participants completed six double-blind alcohol self-administration sessions : three sessions with alcohol only ( e.g. , beverage A ) and three sessions with alcohol and caffeine ( e.g. , beverage B ) . Participants chose which beverage to consume on a subsequent session ( e.g. , beverage A or B ) . The effects of caffeine on overall beverage choice , number of self-administered drinks , subjective ratings ( e.g. , Biphasic Alcohol Effects Scale ) , and psychomotor performance were examined . Results A majority of participants ( 65 % ) chose to drink the alcohol beverage containing caffeine on their final self-administration session . Caffeine did not increase the number of self-administered drinks . Caffeine significantly increased stimulant effects , decreased sedative effects , and attenuated decreases in psychomotor performance attributable to alcohol . Relative to nonchoosers , caffeine choosers reported overall lower stimulant ratings and reported greater drinking behavior prior to the study . Conclusions Although caffeine did not increase the number of self-administered drinks , most participants chose the alcohol beverage containing caffeine . Given the differences in subjective ratings and pre-existing differences in self-reported alcohol consumption for caffeine choosers and nonchoosers , these data suggest that decreased stimulant effects of alcohol and heavier self-reported drinking may predict subsequent choice of combined caffeine and alcohol beverages . These predictors may identify individuals who would benefit from efforts to reduce risk behaviors associated with combining alcohol and caffeine BACKGROUND Well-known reports suggest that the use of energy drinks might reduce the intensity of the depressant effects of alcohol . However , there is little scientific evidence to support this hypothesis . OBJECTIVE AND METHODS The present study aim ed at evaluating the effects of the simultaneous ingestion of an alcohol ( vodka(37.5%v/v ) ) and an energy drink ( Red Bull-3.57 mL/kg ) , compared with those presented after the ingestion of an alcohol or an energy drink alone . Twenty-six young healthy volunteers were r and omly assigned to 2 groups that received 0.6 or 1.0 g/kg alcohol , respectively . They all completed 3 experimental sessions in r and om order , 7 days apart : alcohol alone , energy drink alone , or alcohol plus energy drink . We evaluated the volunteers ' breath alcohol concentration , subjective sensations of intoxication , objective effects on their motor coordination , and visual reaction time . RESULTS When compared with the ingestion of alcohol alone , the ingestion of alcohol plus energy drink significantly reduced subjects ' perception of headache , weakness , dry mouth , and impairment of motor coordination . However , the ingestion of the energy drink did not significantly reduce the deficits caused by alcohol on objective motor coordination and visual reaction time . The ingestion of the energy drink did not alter the breath alcohol concentration in either group . CONCLUSIONS Even though the subjective perceptions of some symptoms of alcohol intoxication were less intense after the combined ingestion of the alcohol plus energy drink , these effects were not detected in objective measures of motor coordination and visual reaction time , as well as on the breath alcohol concentration BACKGROUND Recently , Marczinski and colleagues ( 2013 ) showed that energy drinks combined with alcohol augment a person 's desire to drink more alcohol relative to drinking alcohol alone . The current study replicates the findings of Marczinski and colleagues ( 2013 ) using a robust measure of alcohol craving . METHODS Seventy-five participants aged 18 to 30 years were assigned to an alcohol only or alcohol+energy drink condition in a double-blind r and omized pre- versus posttest experiment . Participants received a cocktail containing either 60 ml of vodka and a Red Bull ( ® ) Silver Edition energy drink ( alcohol+energy drink condition ) or 60 ml of vodka with a soda water vehicle ( alcohol-only condition ) ; both cocktails contained 200 ml of fruit drink . The primary outcome measure was the Alcohol Urge Question naire taken at pretest and at 20 minutes ( posttest ) . Other measures taken at posttest were the Biphasic Alcohol Effects Question naire , the Drug Effects Question naire , and breath alcohol concentration ( BAC ) . RESULTS The alcohol+energy drink condition showed a greater pre- versus posttest increase in urge to drink alcohol compared with the alcohol-only condition ( B = 3.24 , p = 0.021 , d = 0.44 ) . Participants in the alcohol+energy drink condition had significantly higher ratings on liking the cocktail and wanting to drink more of the cocktail , and lower BACs , than the alcohol-only condition . When examined at specific BACs , the effect of the energy drink on the pre- to posttest increase in urge to drink was largest and only significant at BACs of 0.04 - 0.05 ( cf . < 0.04 g/dl).There were no significant differences in stimulation , sedation , feeling the effects of the cocktail , or feeling high . CONCLUSIONS Combining energy drinks with alcohol increased the urge to drink alcohol relative to drinking alcohol alone . More research is needed to underst and what factors mediate this effect and whether it increases subsequent alcohol consumption OBJECTIVES The consumption of alcohol mixed with energy drinks ( AmED ) is popular on college campuses in the United States . Limited research suggests that energy drink consumption lessens subjective intoxication in persons who also have consumed alcohol . This study examines the relationship between energy drink use , high-risk drinking behavior , and alcohol-related consequences . METHODS In Fall 2006 , a Web-based survey was conducted in a stratified r and om sample of 4,271 college students from 10 universities in North Carolina . RESULTS A total of 697 students ( 24 % of past 30-day drinkers ) reported consuming AmED in the past 30 days . Students who were male , white , intramural athletes , fraternity or sorority members or pledges , and younger were significantly more likely to consume AmED . In multivariable analyses , consumption of AmED was associated with increased heavy episodic drinking ( 6.4 days vs. 3.4 days on average ; p < 0.001 ) and twice as many episodes of weekly drunkenness ( 1.4 days/week vs. 0.73 days/week ; p < 0.001 ) . Students who reported consuming AmED had significantly higher prevalence of alcohol-related consequences , including being taken advantage of sexually , taking advantage of another sexually , riding with an intoxicated driver , being physically hurt or injured , and requiring medical treatment ( p < 0.05 ) . The effect of consuming AmED on driving while intoxicated depended on a student 's reported typical alcohol consumption ( interaction p = 0.027 ) . CONCLUSIONS Almost one-quarter of college student current drinkers reported mixing alcohol with energy drinks . These students are at increased risk for alcohol-related consequences , even after adjusting for the amount of alcohol consumed . Further research is necessary to underst and this association and to develop targeted interventions to reduce risk OBJECTIVE This study examines the use of alcohol mixed with energy drinks ( AmED ) as a predictor of alcohol problems and alcohol-related consequences and accidents two years later in a college student sample . METHOD Longitudinal data on AmED use , alcohol consequences , and alcohol problems were collected from the fall of students ' second year of college to the fall of their fourth year ( N = 620 , 49 % male ) . RESULTS After we controlled for demographic indicators and
Output:
| Within-subject comparisons restricted to AMED consumers revealed that alcohol consumption does not significantly differ between typical AMED and AO occasions .
On past month heaviest drinking occasions , AMED users consume significantly less alcohol on AMED occasions when compared to AO occasions .
AMED consumers experience significantly fewer negative consequences and risk-taking behavior on AMED occasions compared with AO occasions .
Meta-analyses of subjective intoxication studies suggest that AMED consumption does not differentially affect subjective intoxication when compared to AO consumption .
In conclusion , when compared to AO consumption , mixing alcohol with energy drink does not affect subjective intoxication and seems unlikely to increase total alcohol consumption , associated risk-taking behavior , nor other negative alcohol-related consequences . |
MS211051 | ***TASK*** the task is to summarize an input biomedical literature in 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 the effects of ' ' Playstation EyeToy Games ' ' on upper extremity motor recovery and upper extremity-related motor functioning of patients with subacute stroke . METHODS The authors design ed a r and omized , controlled , assessor-blinded , 4-week trial , with follow-up at 3 months . A total of 20 hemiparetic in patients ( mean age 61.1 years ) , all within 12 months post-stroke , received 30 minutes of treatment with ' ' Playstation EyeToy Games ' ' per day , consisting of flexion and extension of the paretic shoulder , elbow and wrist as well as abduction of the paretic shoulder or placebo therapy ( watching the games for the same duration without physical involvement into the games ) in addition to conventional program , 5 days a week , 2 - 5 hours/day for 4 weeks . Brunnstrom 's staging and self-care sub-items of the functional independence measure ( FIM ) were performed at 0 month ( baseline ) , 4 weeks ( post-treatment ) , and 3 months ( follow-up ) after the treatment . RESULTS The mean change score ( 95 % confidence interval ) of the FIM self-care score ( 5.5 [ 2.9 - 8.0 ] vs 1.8 [ 0.1 - 3.7 ] , P=0.018 ) showed significantly more improvement in the EyeToy group compared to the control group . No significant differences were found between the groups for the Brunnstrom stages for h and and upper extremity . CONCLUSION ' ' Playstation EyeToy Games ' ' combined with a conventional stroke rehabilitation program have a potential to enhance upper extremity-related motor functioning in subacute stroke patients In a multiple-object tracking ( MOT ) task , young and older adults attentively tracked a subset of 10 identical , r and omly moving disks for several seconds , and then tried to identify those disks that had comprised the subset . Young adults who habitually played video games performed significantly better than those who did not . Compared to young subjects ( mean age = 20.6 years ) with whom they were matched for video game experience , older subjects ( mean age = 75.3 years ) showed much reduced ability to track multiple moving objects , particularly with faster movement or longer tracking times . Control measurements with stationary disks show that the age-related decline in MOT was not caused by a general change in memory per se . To generate an item-wise performance measure , we examined older subjects ' proportion correct according to the serial order in which individual disks were identified . Correct identification of target disks declined with the order in which targets were reported , suggesting that attentional tracking produced grade d , rather than all-or-none , outcomes Background Evidence suggests that increasing intensity of rehabilitation results in better motor recovery . Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation . EVREST was design ed to evaluate feasibility , safety and efficacy of using the Nintendo Wii gaming virtual reality ( VRWii ) technology to improve arm recovery in stroke patients . Methods Pilot r and omized study comparing , VRWii versus recreational therapy ( RT ) in patients receiving st and ard rehabilitation within six months of stroke with a motor deficit of ≥3 on the Chedoke-McMaster Scale ( arm ) . In this study we expect to r and omize 20 patients . All participants ( age 18–85 ) will receive customary rehabilitative treatment consistent of a st and ardized protocol ( eight sessions , 60 min each , over a two-week period ) . Outcome measures The primary feasibility outcome is the total time receiving the intervention . The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period . Efficacy , a secondary outcome measure , will be measured by the Wolf Motor Function Test , Box and Block Test , and Stroke Impact Scale at the four-week follow-up visit . From November , 2008 to September , 2009 21 patients were r and omized to VRWii or RT . Mean age , 61 ( range 41–83 ) years . Mean time from stroke onset 25 ( range 10–56 ) days . Conclusions EVREST is the first r and omized parallel controlled trial assessing the feasibility , safety , and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation . The results of this study will serve as the basis for a larger multicentre trial . Clinical Trials.gov registration # Objective . To investigate the effectiveness of computerized virtual reality ( VR ) training of the hemiparetic h and of patients poststroke using a system that provides repetitive motor reeducation and skill reacquisition . Methods . Eight subjects in the chronic phase poststroke participated in a 3-week program using their hemiparetic h and in a series of interactive computer games for 13 days of training , weekend breaks , and pretests and posttests . Each subject trained for about 2 to 2.5 h per day . Outcome measures consisted of changes in the computerized measures of thumb and finger range of motion , thumb and finger velocity , fractionation ( the ability to move fingers independently ) , thumb and finger strength , the Jebsen Test of H and Function , and a Kinematic reach to grasp test . Results . Subjects as a group improved in fractionation of the fingers , thumb and finger range of motion , and thumb and finger speed , retaining those gains at the 1-week retention test . Transfer of these improvements was demonstrated through changes in the Jebsen Test of H and Function and a decrease after the therapy in the overall time from h and peak velocity to the moment when an object was lifted from the table . Conclusions . It is difficult in current service delivery models to provide the intensity of practice that appears to be needed to effect neural reorganization and functional changes poststroke . Computerized exercise systems may be a way to maximize both the patients ’ and the clinicians ’ time . The data in this study add support to the proposal to explore novel technologies for incorporation into current practice The combination of active video gaming and exercise ( exergaming ) is suggested to improve elderly people 's balance , thereby decreasing fall risk . Exergaming has been shown to increase motivation during exercise therapy , due to the enjoyable and challenging nature , which could support long-term adherence for exercising balance . However , scarce evidence is available of the direct effects of exergaming on postural control . Therefore , the aim of the study was to assess the effect of a six-week videogame-based exercise program aim ed at improving balance in elderly people . Task performance and postural control were examined using an interrupted time series design . Results of multilevel analyses showed that performance on the dot task improved within the first two weeks of training . Postural control improved during the intervention . After the intervention period task performance and balance were better than before the intervention . Results of this study show that healthy elderly can benefit from a videogame-based exercise program to improve balance and that all subjects were highly motivated to exercise balance because they found gaming challenging and enjoyable The aims of this r and omized , single-blind crossover trial were to investigate the effect of adding a simulated bowling video game via the Nintendo Wii ® gaming system to the st and ard exercise regimen of cognitively intact residents of long-term care ( LTC ) with upper extremity dysfunction and to identify individual characteristics that might predict improvement . Residents ( n=34 ) were recruited through two LTC facilities in southwestern Ontario and were r and omized into a st and ard exercise ( SG ) or st and ard exercise plus Wii bowling ( Wii ) arm . After 4 weeks of intervention , the groups were crossed over to the opposite arm . Outcomes included measures of pain intensity and bothersomeness , physical activity enjoyment , and a six-item measure of functional capacity design ed specifically for residents of LTC . Results suggest that subjects improved on all outcomes from pre- to postintervention but that only enjoyment of activity showed a significant difference between the SG and Wii groups . Effect sizes ( Cohen 's d ) ranged from small ( 0.30 for bothersomeness ) to large ( 1.77 for functional capacity ) . Responders , defined as those subjects who reported any degree of improvement following the Wii intervention , were less likely to complain of stiffness or shoulder symptoms and were more likely to complain of h and symptoms than non-responders . Limitations in interpretation and recommendations for future research are presented Background Physical activity promotes health in older adults but participation rates are low . Interactive video dance games can increase activity in young persons but have not been design ed for use with older adults . The purpose of this research was to evaluate healthy older adults ’ interest and participation in a dance game adapted for an older user . Methods Healthy older adults were recruited from 3 senior living setting s and offered three months of training and supervision using a video dance game design ed for older people . Before and after the program , data was collected on vital signs , physical function and self reported quality of life . Feedback was obtained during and after training . Results Of 36 persons who entered ( mean age 80.1 + 5.4 years , 83 % female ) , 25 completed the study . Completers were healthier than noncompleters . Completers showed gains in narrow walk time , self-reported balance confidence and mental health . While there were no serious adverse events , 4 of 11 noncompleters withdrew due to musculoskeletal complaints . Conclusions Adapted Interactive video dance is feasible for some healthy older adults and may help achieve physical activity goals The objective of this study was to investigate the potential of using a low-cost video-capture virtual reality ( VR ) platform , the Sony PlayStation II EyeToy , for the rehabilitation of older adults with disabilities . This article presents three studies that were carried out to provide information about the EyeToy 's potential for use in rehabilitation . The first study included the testing of healthy young adults ( N = 34 ) and compared their experiences using the EyeToy with those using GestureTek 's IREX VR system in terms of a sense of presence , level of enjoyment , control , success , and perceived exertion . The second study aim ed to characterize the VR experience of healthy older adults ( N = 10 ) and to determine the suitability and usability of the EyeToy for this population and the third study aim ed to determine the feasibility of the EyeToy for use by individuals ( N = 12 ) with stroke at different stages . The implication s of these three studies for applying the system to rehabilitation are discussed Background Due to the many problems associated with reduced balance and mobility , providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills . Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging , interactive video game paradigm . The intervention focused on performing targeted dynamic tasks , which included reactive balance controls and environmental interaction . Design This study was a r and omized controlled trial . Setting The study was conducted in a geriatric day hospital . Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study . Interventions Participants were r and omly assigned to either a control group or an experimental group . The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital . The experimental group received a program of dynamic balance exercises coupled with video game play , using a center-of-pressure position signal as the computer mouse . The tasks were performed while st and ing on a fixed floor surface , with progression to a compliant sponge pad . Each group received 16 sessions , scheduled 2 per week , with each session lasting 45 minutes . Measurements Data for the following measures were obtained before and after treatment : Berg Balance Scale , Timed “ Up & Go ” Test , Activities-specific Balance Confidence Scale , modified Clinical Test of Sensory Interaction and Balance , and spatiotemporal gait variables assessed in an instrumented carpet system test . Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups , and change scores were significantly greater in the experimental group compared with the control group . No significant treatment effect was observed in either group for the Timed “ Up & Go ” Test or spatiotemporal gait variables . Limitations The sample size was small , and there were group differences at baseline in some performance measures . Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise . This coupling , in turn , result ed in a greater improvement in dynamic st and ing balance control compared with the typical exercise program . However , there was no transfer of effect to gait function OBJECTIVE To determine whether a dance mat test of choice stepping reaction time ( CSRT ) is reliable and can detect differences in fall risk in older adults . DESIGN R and omized order , crossover comparison . SETTING Balance laboratory , medical research institute , and retirement village . PARTICIPANTS Older ( mean age , 78.87±5.90y ; range , 65 - 90y ) independent-living people ( N=47 ) able to walk in place without assistance . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Reaction ( RT ) , movement , and response times of dance pad -- based stepping tests , Physiological Profile Assessment ( PPA ) score , Digit Symbol Substitution Test ( DSST ) score , time to complete the Trail Making Test ( TMT ) A+B , Fall Efficacy Scale International ( FES-I ) score , Activities-specific Balance Confidence ( ABC ) Scale score , and Incidental and Planned Exercise Question naire ( IPEQ ) incidental IPEQ activity subscore . RESULTS Test-retest reliability of the dance mat CSRT response time was high ( intraclass correlation coefficient model 3,k=.90 ; 95 % confidence interval [ CI ] , .82-.94 ; P<.001 ) and correlated highly with the existing laboratory-based measure ( r=.86 ; 95 % CI , .75-.92 ; P<.001 ) . Concurrent validity was shown by significant correlations between response time and measures of fall risk ( PPA : r=.42 ; 95 % CI , .15-.63 ; P<.01 ; TMT A : r=.61 ; 95 % CI , .39-.77 ; TMT B : r=.55 ; 95 % CI , .31-.72 ; DSST : r=-.
Output:
| A majority of the studies revealed significant positive effects on health outcomes associated with digital videogame play among older adults . |
MS211052 | ***TASK*** the task is to summarize an input biomedical literature in 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 examine whether and how improvement of glycemic control by long-term insulin therapy decreases endothelial activation as measured by serum levels of the soluble adhesion molecules sE-selectin and vascular cell adhesion molecule ( VCAM-1 ) and whether the drug used to lower blood glucose in addition to insulin influences such a response . RESEARCH DESIGN AND METHODS Circulating adhesion molecules were measured before and after 3 and 12 months of therapy in 81 patients with type 2 diabetes and 41 subjects without diabetes . The patients were treated with bedtime administration of NPH insulin combined with either glibenclamide ( n = 19 ) , metformin ( n = 17 ) , glibenclamide and metformin ( n = 17 ) , or morning administration of NPH insulin ( n = 23 ) . RESULTS Before insulin therapy , serum sE-selectin level was 71 % higher in the patients with type 2 diabetes ( 77 + /- 4 ng/ml ) than in the normal subjects ( 45 + /- 3 ng/ml , P < 0.001 ) , whereas levels of sVCAM-1 were comparable ( 420 + /- 25 vs. 400 + /- 11 ng/ml , respectively ) . Glycemic control in all patients improved as judged from a decrease in HbA1c from 9.7 + /- 0.2 to 7.6 + /- 0.1 % ( P < 0.001 ) . sE-selectin decreased to 67 + /- 4 ng/ml by 3 months ( P < 0.001 vs. 0 months ) and then remained unchanged until 12 months ( 70 + /- 4 ng/ml P < 0.001 vs 0 months ) . sVCnM-1 levels at 12 months was similar to those at 0 months ( 416 + /- 25 ng/ml ) . The change in glycemic control , measured by HbA1c , but not in other parameters , was correlated with the change of sE-selectin ( r = 0.41 , P < 0.001 ) within the patients with type 2 diabetes . The decreases in sE-selectin were not different between the various treatment groups . CONCLUSIONS We conclude that improvement in glycemic control by administration of insulin alone or insulin combined with either glibenclamide , metformin , or both agents induces a sustained decrease in sE-selectin , the magnitude of which seems to be dependent on the degree of improvement in glycemia . These data suggest that sE-selectin might provide a marker of effects of treatment of chronic hyperglycemia on endothelial activation OBJECTIVE —The efficacy and safety of adding liraglutide ( a glucagon-like peptide-1 receptor agonist ) to metformin were compared with addition of placebo or glimepiride to metformin in subjects previously treated with oral antidiabetes ( OAD ) therapy . RESEARCH DESIGN AND METHODS —In this 26-week , double-blind , double-dummy , placebo- and active-controlled , parallel-group trial , 1,091 subjects were r and omly assigned ( 2:2:2:1:2 ) to once-daily liraglutide ( either 0.6 , 1.2 , or 1.8 mg/day injected subcutaneously ) , to placebo , or to glimepiride ( 4 mg once daily ) . All treatments were in combination therapy with metformin ( 1 g twice daily ) . Enrolled subjects ( aged 25–79 years ) had type 2 diabetes , A1C of 7–11 % ( previous OAD monotherapy for ≥3 months ) or 7–10 % ( previous OAD combination therapy for ≥3 months ) , and BMI ≤40 kg/m2 . RESULTS —A1C values were significantly reduced in all liraglutide groups versus the placebo group ( P < 0.0001 ) with mean decreases of 1.0 % for 1.8 mg liraglutide , 1.2 mg liraglutide , and glimepiride and 0.7 % for 0.6 mg liraglutide and an increase of 0.1 % for placebo . Body weight decreased in all liraglutide groups ( 1.8–2.8 kg ) compared with an increase in the glimepiride group ( 1.0 kg ; P < 0.0001 ) . The incidence of minor hypoglycemia with liraglutide ( ∼3 % ) was comparable to that with placebo but less than that with glimepiride ( 17 % ; P < 0.001 ) . Nausea was reported by 11–19 % of the liraglutide-treated subjects versus 3–4 % in the placebo and glimepiride groups . The incidence of nausea declined over time . CONCLUSIONS —In subjects with type 2 diabetes , once-daily liraglutide induced similar glycemic control , reduced body weight , and lowered the occurrence of hypoglycemia compared with glimepiride , when both had background therapy of metformin We conducted a double-blind crossover study to determine which patient characteristics best predict a beneficial response to combined insulin-glyburide therapy . Glyburide ( 15 mg/day ) or placebo was added to the treatment regimen of 31 insulin-treated type II ( non-insulin-dependent ) diabetic subjects . During glyburide therapy , there was a significant improvement in glycemic control with a reduction in glycosylated hemoglobin from 9.9 ± 1.3 to 9.1 ± 1.3 % ( P < .001 ) . Patients who responded had higher fasting C-peptide levels ( P < .001 ) and shorter duration s of insulin therapy ( P < .01 ) than those who did not respond . Glyburide withdrawal was associated with a > expected deterioration in glycemic control . Patients on insulin therapy for > 8 yr are unlikely to benefit significantly from the addition of glyburide to their treatment regimen To assess the effect of Glipizide on glycaemic control and peripheral insulin sensitivity , 9 type 1 ( insulin dependent ) diabetic patients with normal BMI , mean age 42.1 + /- 11.0 years , diabetes duration 16.3 + /- 9.2 years were studied . They were treated by continuous subcutaneous insulin infusion for a mean duration of 32.2 + /- 11.0 months , they were in good glycaemic control ( mean HbA1 7.9 + /- 1.2 % , upper limit of normal value 7.5 % ) . In a double blind r and omized control study they were successively allocated for a three month period to 15 mg of Glipizide daily or a Placebo . At the end of each period the following parameters were recorded : HbA1 , mean plasma glucose levels , daily insulin dosage : basal rate and pre pr and ial bolus , peripheral insulin sensitivity assessed by euglycaemic hyperinsulinic clamp technique , the addition of Glipizide did not induce any statistically significant modification of HbA1 , glycaemic values , and daily insulin dosage : basal rate 18.2 + /- 8.7 vs. 17.9 + /- 7.3 IU/24 hours and pre pr and ial bolus 18.6 + /- 7.0 vs 17.6 + /- 6.3 IU/24 hours . During the glucose clamp , glucose uptake was similar under Glipizide or Placebo with the 3 levels of insulin infused . These results suggest that in type 1 diabetic patients the addition of Glipizide to insulin therapy does not alter glycaemic control and peripheral insulin sensitivity BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 : metformin and glyburide vs. metformin vs. glyburide ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.6 + /- 0.2 percent , P < 0.001 ) . In protocol 2 , the 213 patients given metformin and glyburide , as compared with the 210 patients treated with glyburide alone , had lower mean fasting plasma glucose concentrations ( 187 + /- 4 vs. 261 + /- 4 mg per deciliter [ 10.5 + /- 0.2 vs. 14.6 + /- 0.2 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.7 + /- 0.1 percent , P < 0.001 ) . The effect of metformin alone was similar to that of glyburide alone . Eighteen percent of the patients given metformin and glyburide had symptoms compatible with hypoglycemia , as compared with 3 percent in the glyburide group and 2 percent in the metformin group . In both protocol s the patients given metformin had statistically significant decreases in plasma total and low-density lipoprotein cholesterol and triglyceride concentrations , whereas the values in the respective control groups did not change . There were no significant changes in fasting plasma lactate concentrations in any of the groups . CONCLUSIONS Metformin monotherapy and combination therapy with metformin and sulfonylurea are well tolerated and improve glycemic control and lipid concentrations in patients with NIDDM whose diabetes is poorly controlled with diet or sulfonylurea therapy alone Abstract Objective : To determine the relation between systolic blood pressure over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4801 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any complications or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , lower extremity amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photocoagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 10 mm Hg decrease in up date d mean systolic blood pressure adjusted for specific confounders Results : The incidence of clinical complications was significantly associated with systolic blood pressure , except for cataract extraction . Each 10 mm Hg decrease in up date d mean systolic blood pressure was associated with reductions in risk of 12 % for any complication related to diabetes ( 95 % confidence interval 10 % to 14 % , P<0.0001 ) , 15 % for deaths related to diabetes ( 12 % to 18 % , P<0.0001 ) , 11 % for myocardial infa rct ion ( 7 % to 14 % , P<0.0001 ) , and 13 % for microvascular complications ( 10 % to 16 % , P<0.0001 ) . No threshold of risk was observed for any end point . Conclusions : In patients with type 2 diabetes the risk of diabetic complications was strongly associated with raised blood pressure . Any reduction in blood pressure is likely to reduce the risk of complications , with the lowest risk being in those with systolic blood pressure less than 120 mm Hg OBJECTIVE To assess the efficacy , safety , and dose-response relationship of glimepiride in patients with NIDDM . RESEARCH DESIGN AND METHODS After a 21-day placebo washout period , 304 patients were r and omized to receive either placebo or glimepiride , 1 , 4 , or 8 mg once daily . Fasting plasma glucose ( FPG ) , 2-h postpr and ial glucose ( PPG ) , and HbA1c
Output:
| Higher sulfonylurea doses did not reduce HbA1c more than lower doses .
Conclusions /interpretationSulfonylurea monotherapy lowered HbA1c level more than previously reported , and we found no evidence that increasing sulfonylurea doses result ed in lower HbA1c .
HbA1c is a surrogate endpoint , and we were unable to examine long-term endpoints in these predominately short-term trials , but sulfonylureas appear to be associated with an increased risk of hypoglycaemic events |
MS211053 | ***TASK*** the task is to summarize an input biomedical literature in 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 goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice Background Tobacco remains a seemingly intractable problem for individuals living with severe and persistent mental illness . This study evaluated the implementation , technical assistance , and perceived impact of a model curriculum ( " Learning About Healthy Living " ) to promote wellness and motivation to quit tobacco use in psychosocial rehabilitation clubhouses . Methods We used semi-structured interviews ( n = 9 ) with clubhouse staff ( n = 12 ) and a survey of participating clubhouse members ( n = 271 ) in nine clubhouses . Results Fifty-eight percent of clubhouse participants completed surveys . Results showed tobacco users open to tobacco-free policies ( 62 % ) and perceiving more discussion s about quitting tobacco with healthcare providers ( 69 % ) . Analyses of staff interviews and member surveys revealed four key themes : ( 1 ) the curriculum was successfully implemented and appreciated ; ( 2 ) technical assistance kept implementation on track ; ( 3 ) adding wellness content and interactive components should enhance the curriculum ; and , ( 4 ) the curriculum advanced other healthful policies and practice s. Conclusions Mental health setting s are important locations for implementing programs to address tobacco use . In this real-world implementation of a model curriculum in psychosocial rehabilitation clubhouses , the curriculum tested well , was feasible and well-received , and suggests potential impact on tobacco use outcomes . Revision , dissemination , and a r and omized controlled trial evaluation of the model curriculum should now occur BACKGROUND Evidence -based public health decision-making depends on high quality and transparent accounts of what interventions are effective , for whom , how and at what cost . Improving the quality of reporting of r and omized and non-r and omized study design s through the CONSORT and TREND statements has had a marked impact on the quality of study design s. However , public health users of systematic review s have been concerned with the paucity of synthesized information on context , development and rationale , implementation processes and sustainability factors . METHODS This paper examines the existing reporting frameworks for research against information sought by users of systematic review s of public health interventions and suggests additional items that should be considered in future recommendations on the reporting of public health interventions . RESULTS Intervention model , theoretical and ethical considerations , study design choice , integrity of intervention/process evaluation , context , differential effects and inequalities and sustainability are often overlooked in reports of public health interventions . CONCLUSION Population health policy makers need synthesized , detailed and high quality a priori accounts of effective interventions in order to make better progress in tackling population morbidities and inequalities . Adding simple criteria to reporting st and ards will significantly improve the quality and usefulness of published evidence and increase its impact on public health program planning OBJECTIVES We examined the effect of community coalition network structure on the effectiveness of an intervention design ed to accelerate the adoption of evidence -based substance abuse prevention programs . METHODS At baseline , 24 cities were matched and r and omly assigned to 3 conditions ( control , satellite TV training , and training plus technical assistance ) . We surveyed 415 community leaders at baseline and 406 at 18-month follow-up about their attitudes and practice s toward substance abuse prevention programs . Network structure was measured by asking leaders whom in their coalition they turned to for advice about prevention programs . The outcome was a scale with 4 subscales : coalition function , planning , achievement of benchmarks , and progress in prevention activities . We used multiple linear regression and path analysis to test hypotheses . RESULTS Intervention had a significant effect on decreasing the density of coalition networks . The change in density subsequently increased adoption of evidence -based practice s. CONCLUSIONS Optimal community network structures for the adoption of public health programs are unknown , but it should not be assumed that increasing network density or central ization are appropriate goals . Lower-density networks may be more efficient for organizing evidence -based prevention programs in communities This article describes process evaluation methods for the Pool Cool diffusion trial across 4 years . Pool Cool is a skin cancer prevention program that was found to improve behaviors and environments for sun protection at swimming pools in a r and omized efficacy trial , which was followed by a national diffusion trial . The process evaluation focus shifted from measuring program satisfaction to assessing widespread program implementation , barriers and facilitators to implementation , and program maintenance and sustainability . Data collection methods include training surveys , data base tracking , field coordinator activity logs , e-mails , surveys of parents , lifeguards and pool managers , and process evaluation interviews and site visits . The data revealed high levels of implementation of major program components when disseminated in the diffusion trial , including sun safety lessons , sun safety signs , and sunscreen use . This article describes program features and participant factors that facilitated local implementation , maintenance and sustainability across dispersed pools such as linkage agents , a packaged program , and adaptations of program elements Background Studies have shown that communities have not always been able to implement evidence -based prevention programs with quality and achieve outcomes demonstrated by prevention science . Implementation support interventions are needed to bridge this gap between science and practice . The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes ( AGTO ) intervention in 12 Maine communities engaged in promoting Developmental Assets , a positive youth development approach to prevention . AGTO is an implementation support intervention that consists of : a manual of text and tools ; face-to-face training , and onsite technical assistance , focused on activities shown to be associated with obtaining positive results across any prevention program . Methods This study uses a nested and cross-sectional , cluster r and omized controlled design . Participants were coalition members and program staff from 12 communities in Maine . Each coalition nominated up to five prevention programs to participate . At r and om , six coalitions and their respective 30 programs received the two-year AGTO intervention and the other six maintained routine operations . The study assessed prevention practitioner capacity ( efficacy and behaviors ) , practitioner exposure to and use of AGTO , practitioner perceptions of AGTO , and prevention program performance . Capacity of coalition members and performance of their programs were compared between the two groups across the baseline , one- , and two-year time points . Results We found no significant differences between AGTO and control group ’s prevention capacity . However , within the AGTO group , significant differences were found between those with greater exposure to and use of AGTO . Programs that received the highest number of technical assistance hours showed the most program improvement . Conclusions This study is the first of its kind to show that use of an implementation support intervention-AGTO -yielded improvements in practitioner capacity and consequently in program performance on a large sample of practitioners and programs using a r and omized controlled design . Clinical Trials.gov Underage drinking is a significant problem facing US communities . Several environmental alcohol prevention ( EAP ) strategies ( laws , regulations , responsible beverage service training and practice s ) successfully address underage drinking . Communities , however , face challenges carrying out these EAP strategies effectively . This small-scale , 3-year , r and omized controlled trial assessed whether providing prevention coalitions with Getting To Outcomes –Underage Drinking ( GTO-UD ) , a tool kit and implementation support intervention , helped improve implementation of two common EAP strategies , responsible beverage service training ( RBS ) and compliance checks . Three coalitions in South Carolina and their RBS and compliance check programs received the 16-month GTO-UD intervention , including the GTO-UD manual , training , and onsite technical assistance , while another three in South Carolina maintained routine operations . The measures , collected at baseline and after the intervention , were a structured interview assessing how well coalitions carried out their work and a survey of merchant attitudes and practice s in the six counties served by the participating coalitions . Over time , the quality of some RBS and compliance check activities improved more in GTO-UD coalitions than in the control sites . No changes in merchant practice s or attitudes significantly differed between the GTO-UD and control groups , although merchants in the GTO-UD counties did significantly improve on refusing sales to minors while control merchants did not This paper describes the extent to which communities implementing the Communities That Care ( CTC ) prevention system adopt , replicate with fidelity , and sustain programs shown to be effective in reducing adolescent drug use , delinquency , and other problem behaviors . Data were collected from directors of community-based agencies and coalitions , school principals , service providers , and teachers , all of whom participated in a r and omized , controlled evaluation of CTC in 24 communities . The results indicated significantly increased use and sustainability of tested , effective prevention programs in the 12 CTC intervention communities compared to the 12 control communities , during the active phase of the research project when training , technical assistance , and funding were provided to intervention sites , and 2 years following provision of such re sources . At both time points , intervention communities also delivered prevention services to a significantly greater number of children and parents . The quality of implementation was high in both conditions , with only one significant difference : CTC sites were significantly more likely than control sites to monitor the quality of implementation during the sustainability phase of the project One of the important research issues in the emerging area of research on dissemination of prevention programs relates to the type and extent of training needed by program providers to prepare them to implement effective programs with fidelity . The present paper describes the immediate outcomes of a dissemination and implementation trial of Project Toward No Drug Abuse , an evidence -based prevention program for high school students . A total of 65 high schools in 14 school districts across the USA were recruited and r and omly assigned to one of three experimental conditions : comprehensive implementation support for teachers , regular workshop training only , or st and ard care control . The comprehensive intervention was comprised of on-site coaching , web-based support , and technical assistance , in addition to the regular workshop . Students ( n = 2,983 ) completed self-report surveys before and immediately after program implementation . Fidelity of implementation was assessed with a classroom observation procedure that focused on program process . Results indicated that relative to the controls , both intervention conditions produced effects on hypothesized program mediators , including greater gains in program-related knowledge ; greater reductions in cigarette , marijuana and hard drug use intentions ; and more positive changes in drug-related beliefs . There were stronger effects on implementation fidelity in the comprehensive , relative to the regular , training condition . However , seven of the ten immediate student outcome measures showed no significant differences between the two training conditions . The implication s of these findings for dissemination research and practice are discussed There continues to be a gap in prevention outcomes achieved in research trials versus those achieved in “ real-world ” practice . This article reports interim findings from a r and omized controlled trial evaluating Assets-Getting To Outcomes ( AGTO ) , a two-year intervention design ed to build prevention practitioners ’ capacity to implement positive youth development – oriented practice s in 12 community coalitions in Maine . A survey of coalition members was used to assess change on individual practitioners ’ prevention capacity between baseline and one year later . Structured interviews with 32 program directors ( 16 in the intervention group and 16 in the control group ) were used to assess changes in programs ’ prevention practice s during the same time period . Change in prevention capacity over time did not differ significantly between the intervention and control groups . However , in secondary analyses of only those assigned to the AGTO intervention , users showed greater improvement in their self-efficacy to conduct Assets – based programming and increases in the frequency with which they engaged in AGTO behaviors , whereas among non-users , self-efficacy to conduct Assets – based programming declined . Interview ratings showed improvement in several key areas of performance among intervention programs . Improvement was associated with the number of technical assistance hours received . These results suggest that , after one year , AGTO is beginning to improve the capacity of community practitioners who make use of it There has been relatively little research on effects of interventions aim ed directly at improving internal community coalition functioning , particularly in the area of planning for adoption of evidence -based prevention programs . The current study investigated the effect of Project STEP , a prevention diffusion trial , on three factors hypothesized to improve coalition prevention planning ( quality of coalition plans , extent of plan implementation , and committee internal functioning in meetings ) . Cities were r and omly assigned to one of three conditions ( televised training with limited technical assistance , televised training alone , or control ; n = 24 ) . Results demonstrated that at 1.5 year follow-up , coalitions in the two intervention groups showed more effective prevention plans , plan implementation , and functioning in meetings than control coalitions . Group differences were maintained at 3-year follow-up , albeit at decreased levels , for quality of planning and implementation . The findings suggest that building coalition capacity to diffuse evidence -based prevention programs works at least partially by increasing the effectiveness of coalition functioning , and that booster training may be warranted within 3 years after initial training OBJECTIVES AIDS service organizations ( ASOs ) rarely have access to the information needed to implement research -based HIV prevention interventions for their clients . We compared the effectiveness of 3 dissemination strategies for transferring HIV prevention models from the research arena to community providers of HIV prevention services . METHODS Interviews were conducted with the directors of 74 ASOs to assess current HIV prevention services . ASOs were r and omized to programs that provided ( 1 ) technical assistance manuals describing how to implement research -based HIV prevention interventions , ( 2 ) manuals plus a staff training workshop on how to conduct the implementation , or ( 3 ) manuals , the training
Output:
| Both the type and structure of capacity-building strategies may have influenced effectiveness .
The review also identified context ual factors that may require variations in the ways capacity-building interventions are design ed . |
MS211054 | ***TASK*** the task is to summarize an input biomedical literature in 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 performed a double-blind , placebo-controlled , r and omized 12-week trial of desipramine hydrochloride treatment of cocaine dependence among methadone-maintained patients . Fifty-nine patients completed the 12-week medication trial ( 36 received desipramine and 23 received placebo ) , and 94 % were recontacted 1 , 3 , and 6 months after treatment . There were significantly more dropouts in the desipramine than in the placebo group . Baseline to 12-week comparisons of Addiction Severity Index interview data indicated that both groups showed improvements . At 12 weeks , the desipramine group showed significantly better psychiatric status than the placebo group but did not differ from the placebo group on any of 21 other outcome measures , including cocaine use . During the 12-week medication phase and at the 1-month follow-up evaluation , urine toxicology screenings showed no significant difference between groups , but the placebo group had significantly less cocaine use at both the 3- and 6-month follow-up points . We conclude that desipramine has few benefits with regard to control of cocaine use in this population A 4-week , double-blind , placebo-controlled trial of amantadine was conducted in 61 cocaine dependent out patients . Subjects received 100 mg of amantadine 3 times daily . A follow-up visit was conducted at week 8 . There were no significant differences between groups in treatment retention , or in the number of benzoylecgonine positive urine sample s. Self-reported drug and alcohol use declined in both groups . At week 8 follow-up , self-reported drug use was significantly lower in the placebo group . Amantadine was not effective , and discontinuation of it may have been associated with an increase in cocaine use An open field trial was conducted comparing desipramine and an active placebo in separate population s of chronic cocaine and phencyclidine ( PCP ) abusers , who discontinued their abuse . Subjects who received desipramine showed a decrease in depressive symptoms after a 20 - 40 day period regardless of whether they abused PCP or cocaine Summary : Recent pre clinical studies suggest utility for voltage-sensitive calcium channel blockers ( VSCCBs ) in the treatment of cocaine addiction . The following double-blind placebo-controlled study examined the role of the VSCCB nimodipine in attenuating cocaine craving in 66 recently abstinent cocaine-dependent patients on an inpatient substance abuse treatment unit utilizing an intensive 12-step milieu-oriented psychosocial therapy . While the medication was well tolerated , the dose of nimodipine used in this study ( 90 mg q.d . ) was not superior to placebo in reducing background or cue-induced cocaine craving over the 3 weeks of the study . There was the suggestion that nimodipine might attenuate the severity of some cocaine-induced brain deficits , as detected by evaluation of smooth pursuit eye movement function . A rationale for evaluating higher doses of nimodipine for the treatment of cocaine addiction is presented . As nimodipine might have anticraving and moodstabilizing properties and cardio- and neuroprotective properties in the face of cocaine intoxication and might possibly even reverse some cocaine-induced brain deficits , further investigation of the role of nimodipine ( and other VSCCBs ) in cocaine addiction appears an attractive avenue of future medication development Three methods of analysis were used to determine the effects of the combination of counseling with fluoxetine ( 20 , 40 , or 60 mg ) and " active " placebo ( diphenhydramine , 12.5 mg ) r and omly assigned . Forty-five cocaine-only dependent subjects were treated as out patients with " interpersonal " counseling , medication , and drug use monitoring three times per week for up to 12 weeks . Treatment effects were analyzed : first , by comparing the three original assignments and placebo ; second , by comparing the placebo group to fluoxetine subjects with detectable fluoxetine/norfluoxetine blood levels and those with no detectable medication blood level ; third , by examining relapse prevention versus use cessation through stratifying the subjects into four groups according to fluoxetine or placebo assignment and initial urine cocaine positivity or negativity . All three analyses showed improvement on some measures over time regardless of group assignment . The 60-mg fluoxetine group showed least effectiveness , the group with detectable blood levels had less cravings , and the fluoxetine subjects who were abstinent at the start of treatment were somewhat less likely to avoid relapse than those on placebo BACKGROUND We examined the effects of disulfiram versus placebo on cocaine dependence in buprenorphine-maintained subjects . METHODS Opioid and cocaine dependent subjects ( n = 20 ) were induced onto buprenorphine maintenance , then r and omized to disulfiram ( 250 mg q.d . ; n = 11 ) or placebo ( n = 9 ) treatment for 12 weeks . RESULTS Groups were comparable at baseline on demographic measures and on baseline measures of drug-use severity . Fifteen subjects completed the study , including 8 subjects r and omized to disulfiram ( 72.7 % ) and 7 subjects r and omized to placebo ( 77.8 % ) . The total number of weeks abstinent from cocaine was significantly greater on disulfiram versus placebo ( mean + /- SD : 7.8 + /- 2.6 vs. 3.3 + /- 0.5 , p < .05 ) and the number of days to achieving 3 weeks ( 24.6 + /- 15.1 vs. 57.8 + /- 7.7 , p < .01 ) of continuous cocaine abstinence was significantly lower in disulfiram compared with placebo . The number of cocaine-negative urine tests during the trial were also higher on disulfiram ( 14.7 ) than on placebo ( 8.6 ) ; furthermore , subjects in the disulfiram group achieved consistently higher rates of cocaine-negative urine tests in each 3-week interval and the increase over time was faster in the disulfiram compared with placebo . CONCLUSIONS This preliminary study suggests the potential efficacy of disulfiram versus placebo for treatment of cocaine dependence in buprenorphine-maintained patients Thirty-six male cocaine abusers , in withdrawal , were studied for 99 days in a double-blind design . Treatment with bromocriptine was significantly more effective than placebo in alleviating withdrawal symptoms . Adding desipramine to the bromocriptine regimen was significantly more effective than either placebo or bromocriptine alone . The authors hypothesize that these results support a model of dopamine depletion and receptor supersensitivity in cocaine withdrawal A partial blockade of the multiple actions of cocaine is one strategy by which cocaine dependence may be treated . Risperidone , a 5-hydroxytryptamine and dopamine D2 antagonist , is an atypical antipsychotic and was a c and i date medication for the treatment of cocaine dependence . One hundred ninety-three cocaine-dependent subjects were enrolled in a 12-week , r and omized , double-blind , placebo-controlled trial . Subjects initially received either placebo or 4 or 8 mg of risperidone , with a subsequent change to active doses of 2 mg and 4 mg . Subjects attended the clinic twice each week , provided urine sample s , obtained medication , and underwent one behavioral therapy session per week . The study was terminated at the interim analysis . Retention was worse for the 4- and 8-mg active medication groups . Side effects were primarily associated with the 8-mg dose , although neither 2 mg nor 4 mg was well accepted by subjects . There was no reduction in cocaine use associated with risperidone . The results suggest that although antagonists might be a useful treatment approach , such as in the treatment of opiate dependence , risperidone is unlikely to find broad acceptance with the treatment-seeking population We conducted a multi-site , placebo-controlled , r and omized double-blind clinical trial comparing bupropion HCL ( 300 mg/day ) to placebo for the treatment of cocaine dependence in methadone-maintained subjects . A total of 149 subjects at three sites participated in a 12-week study . Outcome measures included cocaine use , level of depression , and psychosocial functioning . Results showed no significant differences between placebo and bupropion . Exploratory analyses suggested a medication effect for the subset of subjects depressed at study entry . The need to target subgroups of cocaine abusers in future pharmacotherapy trials and the possible role of treatment readiness are discussed This study was conducted to determine the effectiveness of carbamazepine ( CBZ ) for treatment of cocaine dependence . Sixty-two ( CBZ = 28 , placebo = 34 ) cocaine-dependent ( DSM-III-R criteria ) volunteers consented to be treated for eight weeks with st and ardized outpatient individual counseling twice a week plus double-blind CBZ or inactive placebo . During the 8-week trial , both groups showed increased number of urine sample s negative for cocaine , significantly ( P < 0.01 ) decreased self-reported cocaine use ( money spent and grams used ) , and decreased Beck Depression Inventory and Symptom Check List-90-Revised ( SCL-90-R ) total scores . However , there were no significant differences between CBZ and placebo . This study does not support the effectiveness of CBZ for outpatient treatment of cocaine dependence Twenty-four cocaine addicts who experienced withdrawal symptoms were studied for six weeks in a double-blind design . Half of the group received daily treatment with bromocriptine and the other half with placebo . Significant relief with bromocriptine was seen almost immediately and continued throughout the detoxification period . The authors speculate that the results are consistent with the " dopamine-depletion model " of cocaine withdrawal An interim analysis of 41 evaluable patients compared gepirone to placebo treatment in a r and omized , double-blind , 12-week study of cocaine dependence without opiate abuse . The response to gepirone at a mean dose of 16.25 mg/day did not differ from placebo by measures of time in study , positive urine cocaine screens ( greater than 6 weeks ) , Clinical Global Impressions ( CGI ) Global Improvements Scale , Cocaine Craving Scale ( CCS ) , Quantitative Cocaine Inventory ( QCI ) , Addiction Severity Index ( ASI ) , Global Assessment Scale ( GAS ) , Hamilton Rating Scale for Depression ( HAM-D ) , and Hamilton Anxiety Scale ( HAM-A ) . Both treatment groups showed similar modest , average improvements during the study in all treatment measures . Adverse events were not treatment limiting . The following demographic and study measures suggested favorable trends for study outcomes : older age , divorced status , higher pre-treatment cocaine use , lower CCS scores , and lower self-reports of cocaine use according to QCI Twenty male combinative cocaine free-base/phencyclidine ( space-base ) abusers were studied for forty-five days , in a double-blind design . Treatment with desipramine was significantly more effective than placebo in alleviating abstinence symptoms . This study tends to support the catecholamine-depletion hypothesis of cocaine and phencyclidine withdrawal A 12-week placebo-controlled , r and omized clinical trial was undertaken to evaluate imipramine as a treatment for cocaine abuse , and to examine whether its effect may be limited to subgroups defined by route of use or by diagnosis of depression . One-hundred thirteen patients were r and omized , stratified by route of use and depression . All patients received weekly individual counseling . Compared to placebo the imipramine group showed greater reductions in cocaine craving , cocaine euphoria , and depression , but the effect of imipramine on cocaine use was less clear . A favorable response , defined as at least 3 consecutive , urine-confirmed , cocaine-free weeks was achieved by 19 % ( 11/59 ) of patients on imipramine compared to 7 % ( 4/54 ) on placebo ( P < 0.09 ) . The imipramine effect was greater among nasal users--33 % ( 9/27 ) response on imipramine vs. 5 % ( 1/22 ) on placebo ( P < 0.02 ) . Response was also more frequent , but not significantly so , among depressed users on imipramine ( 26 % , 10/38 ) than on placebo ( 13 % , 4/31 ) ( P < 0.19 ) . Response rates were low in intravenous and freebase users and those without depression . Considered together with the literature on desipramine , these data suggest tricyclic antidepressants are not promising as a mainstay of treatment for unselected cocaine abusers . However , tricyclics may be useful for selected cocaine abusers with comorbid depression or intranasal use , or in conjunction with a more potent psychosocial intervention We conducted a single-blind , r and om assignment , placebo-controlled , 12-week comparison of desipramine hydrochloride and amantadine hydrochloride as adjunctive treatments to counseling for cocaine dependence . Subjects were 54 out patients who met DSM III-R criteria for active cocaine dependence and who completed a minimum of 2 weeks of treatment . Subjects treated with fixed doses of 200 mg/day desipramine ( N = 17 ) , 400 mg/day
Output:
| The main efficacy outcome reported in the studies was the presence of cocaine metabolites in the urine .
No significant results were found , regardless the type of drug or dose used for all relevant outcomes assessed .
There is no current evidence supporting the clinical use of CBZ , antidepressants , dopamine agonists , disulfiram , mazindol , phenytoin , nimodipine , lithium and NeuRecover-SA in the treatment of cocaine dependence . |
MS211055 | ***TASK*** the task is to summarize an input biomedical literature in 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 It is estimated that disease burden due to low fruit and vegetable consumption is higher in Central and Eastern Europe ( CEE ) and the former Soviet Union ( FSU ) than any other parts of the world . However , no large scale studies have investigated the association between fruit and vegetable ( F&V ) intake and mortality in these regions yet . Design The Health , Alcohol and Psychosocial Factors in Eastern Europe ( HAPIEE ) study is a prospect i ve cohort study with participants recruited from the Czech Republic , Pol and and Russia . Methods Dietary data was collected using food frequency question naire . Mortality data was ascertained through linkage with death registers . Multivariable adjusted hazard ratios were calculated by Cox regression models . Results Among 19,333 disease-free participants at baseline , 1314 died over the mean follow-up of 7.1 years . After multivariable adjustment , we found statistically significant inverse association between cohort-specific quartiles of F&V intake and stroke mortality : the highest vs lowest quartile hazard ratio ( HR ) was 0.52 ( 95 % confidence interval ( CI ) : 0.28–0.98 ) . For total mortality , significant interaction ( p = 0.008 ) between F&V intake and smoking was found . The associations were statistically significant in smokers , with HR 0.70 ( 0.53–0.91 , p for trend : 0.011 ) for total mortality , and 0.62 ( 0.40–0.97 , p for trend : 0.037 ) for cardiovascular disease ( CVD ) mortality . The association was appeared to be mediated by blood pressure , and F&V intake explained a considerable proportion of the mortality differences between the Czech and Russian cohorts . Conclusions Our results suggest that increasing F&V intake may reduce CVD mortality in CEE and FSU , particularly among smokers and hypertensive individuals BACKGROUND Red meat consumption has been associated with an increased risk of chronic diseases . However , its relationship with mortality remains uncertain . METHODS We prospect ively observed 37 698 men from the Health Professionals Follow-up Study ( 1986 - 2008 ) and 83 644 women from the Nurses ' Health Study ( 1980 - 2008 ) who were free of cardiovascular disease ( CVD ) and cancer at baseline . Diet was assessed by vali date d food frequency question naires and up date d every 4 years . RESULTS We documented 23 926 deaths ( including 5910 CVD and 9464 cancer deaths ) during 2.96 million person-years of follow-up . After multivariate adjustment for major lifestyle and dietary risk factors , the pooled hazard ratio ( HR ) ( 95 % CI ) of total mortality for a 1-serving-per-day increase was 1.13 ( 1.07 - 1.20 ) for unprocessed red meat and 1.20 ( 1.15 - 1.24 ) for processed red meat . The corresponding HRs ( 95 % CIs ) were 1.18 ( 1.13 - 1.23 ) and 1.21 ( 1.13 - 1.31 ) for CVD mortality and 1.10 ( 1.06 - 1.14 ) and 1.16 ( 1.09 - 1.23 ) for cancer mortality . We estimated that substitutions of 1 serving per day of other foods ( including fish , poultry , nuts , legumes , low-fat dairy , and whole grains ) for 1 serving per day of red meat were associated with a 7 % to 19 % lower mortality risk . We also estimated that 9.3 % of deaths in men and 7.6 % in women in these cohorts could be prevented at the end of follow-up if all the individuals consumed fewer than 0.5 servings per day ( approximately 42 g/d ) of red meat . CONCLUSIONS Red meat consumption is associated with an increased risk of total , CVD , and cancer mortality . Substitution of other healthy protein sources for red meat is associated with a lower mortality risk Despite a proposed protective effect of fish intake on the risk of cardiovascular disease , epidemiologic evidence on fish intake and mortality is inconsistent . We investigated associations of fish intake , assessed through a vali date d food frequency question naire , with risks of total and cause-specific mortality in 2 prospect i ve cohort studies of 134,296 Chinese men and women ( 1997 - 2009 ) . Vital status and date and cause of death were ascertained through annual linkage to the Shanghai Vital Statistics Registry data base and biennial home visits . Cox regression was used to calculate hazard ratios and corresponding 95 % confidence intervals . After excluding the first year of observation , the analysis included 3,666 deaths among women and 2,170 deaths among men . Fish intake was inversely associated with risks of total , ischemic stroke , and diabetes mortality ; the corresponding hazard ratios for the highest quintiles of intake compared with the lowest were 0.84 ( 95 % confidence interval ( CI ) : 0.76 , 0.92 ) , 0.63 ( 95 % CI : 0.41 , 0.94 ) , and 0.61 ( 95 % CI : 0.39 , 0.95 ) , respectively . No associations with cancer or ischemic heart disease mortality were observed . Further analyses suggested that the inverse associations with total , ischemic stroke , and diabetes mortality were primarily related to consumption of saltwater fish and intake of long-chain n-3 fatty acids . Overall , our findings support the postulated health benefits of fish consumption In the last 20 years , many prospect i ve cohort studies have assessed the relationships between food consumption and mortality . Result interpretation is mainly hindered by the limited adjustment for confounders and , to a lesser extent , the small sample sizes . The aim of this study was to investigate the association between dietary habits and all-cause mortality in a multicentre prospect i ve cohort that included non-institutionalised , community-based elderly individuals ( Three-City Study ) . A brief FFQ was administered at baseline . Hazard ratios ( HR ) and 95 % CI for all-cause mortality were estimated relative to the consumption frequency of several food groups , using Cox proportional hazards models adjusted for sex , centre , socio-demographic characteristics and health status indicators . Among the 8937 participants ( mean age : 74·2 years , 60·7 % women ) , 2016 deaths were recorded during an average follow-up of 9 years . The risk of death was significantly lower among subjects with the highest fruit and vegetable consumption ( HR 0·90 ; 95 % CI 0·82 , 0·99 , P=0·03 ) and with regular fish consumption ( HR 0·89 ; 95 % CI 0·81 , 0·97 , P=0·01 ) . The benefit of olive oil use was found only in women ( moderate olive oil use : HR 0·80 ; 95 % CI 0·68 , 0·94 , P=0·007 ; intensive use : HR 0·72 ; 95 % CI 0·60 , 0·85 , P=0·0002 ) . Conversely , daily meat consumption increased the mortality risk ( HR 1·12 ; 95 % CI , 1·01 , 1·24 , P=0·03 ) . No association was found between risk of death and diet diversity and use of various fats . These findings suggest that fruits/vegetables , olive oil and regular fish consumptions have a beneficial effect on the risk of death , independently of the socio-demographic features and the number of medical conditions Background A healthy diet , as defined by the US Dietary Guidelines for Americans ( DGA ) , has been associated with lower morbidity and mortality from major chronic diseases in studies conducted in predominantly non-Hispanic white individuals . It is unknown whether this association can be extrapolated to African-Americans and low-income population s. Methods and Findings We examined the associations of adherence to the DGA with total and cause-specific mortality in the Southern Community Cohort Study , a prospect i ve study that recruited 84,735 American adults , aged 40–79 y , from 12 southeastern US states during 2002–2009 , mostly through community health centers that serve low-income population s. The present analysis included 50,434 African-Americans , 24,054 white individuals , and 3,084 individuals of other racial/ethnic groups , among whom 42,759 participants had an annual household income less than US$ 15,000 . Usual dietary intakes were assessed using a vali date d food frequency question naire at baseline . Adherence to the DGA was measured by the Healthy Eating Index ( HEI ) , 2010 and 2005 editions ( HEI-2010 and HEI-2005 , respectively ) . During a mean follow-up of 6.2 y , 6,906 deaths were identified , including 2,244 from cardiovascular disease , 1,794 from cancer , and 2,550 from other diseases . A higher HEI-2010 score was associated with lower risks of disease death , with adjusted hazard ratios ( HRs ) of 0.80 ( 95 % CI , 0.73–0.86 ) for all-disease mortality , 0.81 ( 95 % CI , 0.70–0.94 ) for cardiovascular disease mortality , 0.81 ( 95 % CI , 0.69–0.95 ) for cancer mortality , and 0.77 ( 95 % CI , 0.67–0.88 ) for other disease mortality , when comparing the highest quintile with the lowest ( all p-values for trend < 0.05 ) . Similar inverse associations between HEI-2010 score and mortality were observed regardless of sex , race , and income ( all p-values for interaction > 0.50 ) . Several component scores in the HEI-2010 , including whole grains , dairy , seafood and plant proteins , and ratio of unsaturated to saturated fatty acids , showed significant inverse associations with total mortality . HEI-2005 score was also associated with lower disease mortality , with a HR of 0.86 ( 95 % CI , 0.79–0.93 ) when comparing extreme quintiles . Given the observational study design , however , residual confounding can not be completely ruled out . In addition , future studies are needed to evaluate the generalizability of these findings to African-Americans of other socioeconomic status . Conclusions Our results showed , to our knowledge for the first time , that adherence to the DGA was associated with lower total and cause-specific mortality in a low-income population , including a large proportion of African-Americans , living in the southeastern US BACKGROUND Because egg yolk has a high cholesterol concentration , limited egg consumption is often suggested to help prevent ischemic heart disease ( IHD ) . OBJECTIVE We epidemiologically examined the validity of this recommendation . DESIGN We analyzed the relations of egg consumption to serum cholesterol and cause-specific and all-cause mortality by using the NIPPON DATA 80 ( National Integrated Project for Prospect i ve Observation of Non-communicable Disease And its Trends in the Aged , 1980 ) data base . At the baseline examination in 1980 , a nutritional survey was performed by using the food-frequency method in Japanese subjects aged > or = 30 y. We followed 5186 women and 4077 men for 14 y. RESULTS The subjects were categorized into 5 egg consumption groups on the basis of their responses to a question naire ( > or = 2/d , 1/d , 1/2 d , 1 - 2/wk , and seldom ) . There were 69 , 1396 , 1667 , 1742 , and 315 women in each of the 5 groups , respectively . Age-adjusted total cholesterol ( 5.21 , 5.04 , 4.95 , 4.91 , and 4.92 mmol/L in the 5 egg consumption categories , respectively ) was related to egg consumption ( P < 0.0001 , analysis of covariance ) . In women , unadjusted IHD mortality and all-cause mortality differed significantly between the groups [ IHD mortality : 1.1 , 0.5 , 0.4 , 0.5 , and 2.0 per 1000 person-years , respectively ( P = 0.008 , chi-square test ) ; all-cause mortality : 14.8 , 8.0 , 7.5 , 7.5 , and 14.5 per 1000 person-years , respectively ( P < 0.0001 , chi-square test ) ] . In men , egg consumption was not related to age-adjusted total cholesterol . Cox analysis found that , in women , all-cause mortality in the 1 - 2-eggs/wk group was significantly lower than that in the 1-egg/d group , whereas no such relations were noted in men . CONCLUSION Limiting egg consumption may have some health benefits , at least in women in geographic areas where egg consumption makes a relatively large contribution to total dietary cholesterol intake BACKGROUND Prospect i ve studies suggested that substituting whole-grain products for refined-grain products lowers the risks of type 2 diabetes and cardiovascular disease ( CVD
Output:
| A clear indication of nonlinearity was seen for the relations between vegetables , fruits , nuts , and dairy and all-cause mortality .
Optimal consumption of risk-decreasing foods results in a 56 % reduction of all-cause mortality , whereas consumption of risk-increasing foods is associated with a 2-fold increased risk of all-cause mortality .
Conclusion : Selecting specific optimal intakes of the investigated food groups can lead to a considerable change in the risk of premature death |
MS211056 | ***TASK*** the task is to summarize an input biomedical literature in 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: Only a few papers have been published concerning the incidence and outcome of patients with a pathological complete response after cytotoxic treatment in breast cancer . The purpose of this retrospective study was to assess the outcome of patients found to have a pathological complete response in both the breast and axillary lymph nodes after neoadjuvant chemotherapy for operable breast cancer . Our goal was also to determine whether the residual pathological size of the tumour in breast could be correlated with pathological node status . Between 1982 and 2000 , 451 consecutive patients were registered into five prospect i ve phase II trials . After six cycles , 396 patients underwent surgery with axillary dissection for 277 patients ( 69.9 % ) . Pathological response was evaluated according to the Chevallier 's classification . At a median follow-up of 8 years , survival was analysed as a function of pathological response . A pathological complete response rate was obtained in 60 patients ( 15.2 % ) after induction chemotherapy . Breast tumour persistence was significantly related to positive axillary nodes ( P=5.10−6 ) . At 15 years , overall survival and disease-free survival rates were significantly higher in the group who had a pathological complete response than in the group who had less than a pathological complete response ( P=0.047 and P=0.024 , respectively ) . In the absence of pathological complete response and furthermore when there is a notable remaining pathological disease , axillary dissection is still important to determine a major prognostic factor and subsequently , a second non cross resistant adjuvant regimen or high dose chemotherapy could lead to a survival benefit On June 20 , 2006 , the U.S. Food and Drug Administration ( FDA ) approved bevacizumab ( Avastin ; Genentech , Inc. , South San Francisco , CA ) , administered in combination with FOLFOX4 ( 5-fluorouracil , leucovorin , and oxaliplatin ) for the second-line treatment of metastatic carcinoma of the colon or rectum . Efficacy and safety were demonstrated in one Eastern Cooperative Oncology Group ( ECOG ) open-label , multicenter , r and omized , three-arm , active-controlled trial enrolling 829 adult patients . Patients had received a fluoropyrimidine- and irinotecan-based regimen as initial therapy for metastatic disease ; or they had received prior adjuvant irinotecan-based chemotherapy and had recurred within 6 months of completing therapy . Treatments included bevacizumab , 10 mg/kg , as a 90-minute i.v . infusion on day 1 , every 2 weeks , either alone or in combination with FOLFOX4 , or FOLFOX4 alone . The bevacizumab monotherapy arm was closed to accrual after an interim efficacy analysis suggested a possibly shorter survival in that arm . Overall survival ( OS ) , the primary study endpoint , was significantly longer for patients receiving bevacizumab in combination with FOLFOX4 than for those receiving FOLFOX4 alone . The objective response rate was significantly higher in the FOLFOX4 plus bevacizumab arm than in the FOLFOX4 alone arm . The duration of response was approximately 6 months for both treatment arms . Patients treated with the bevacizumab combination were also reported , based on investigator assessment , to have significantly longer progression-free survival . There were no new bevacizumab safety signals . The most serious , and sometimes fatal , bevacizumab toxicities are gastrointestinal perforation , wound-healing complications , hemorrhage , arterial thromboembolic events , hypertensive crisis , nephrotic syndrome , and congestive heart failure PURPOSE The advantage of chemotherapy in asymptomatic patients with advanced colorectal cancer is debatable . Whether early chemotherapy improves survival and the length of the symptom-free period versus no therapy until symptoms appear was studied in a r and omized trial . PATIENTS AND METHODS A total of 183 patients with advanced , but asymptomatic colorectal cancer were r and omly allocated to receive either initial treatment with sequential methotrexate 250 mg/m2 during the first 2 hours , and fluorouracil ( 5-FU ) 500 mg/m2 at hours 3 and 23 followed by leucovorin rescue initiated at hour 24 ( MFL ) for 12 courses or to primary expectancy with chemotherapy not considered until symptoms appeared . One patient was ineligible and excluded from analysis . Nine patients did not fulfill the inclusion criteria and five patients refused treatment allocation ; these patients were not excluded from the study population so as not to introduce bias . So far , 51 of 90 ( 60 % ) patients in the expectancy group have received chemotherapy . RESULTS Overall survival was better in the MFL group than in the expectancy group ( Breslow-Gehan , P less than .02 ; log-rank , P = .13 ) with a difference in median survival of approximately 5 months . Also the symptom-free period and the time to disease progression were longer in the MFL group ( P less than .001 ) , with median differences of 8 and 4 months , respectively . Toxicity to MFL treatment was low ; however , three patients died because of toxicity -- none of them should have received therapy because of poor performance or S-creatinine elevation . The patients maintained an excellent performance throughout the MFL treatment unless the disease was progressive . CONCLUSION We concluded that early treatment with MFL in asymptomatic patients with advanced colorectal cancer prolongs survival , the asymptomatic period , and the time to disease progression by approximately 6 months over primary expectancy PURPOSE In this report , we up date survival ( OS ) and time-to-progression ( TTP ) data for the Intergroup trial N9741 after a median 5 years of follow-up by using risk-stratified and prognostic factor analyses to determine if treatment outcomes differ in specific patient subgroups . PATIENTS AND METHODS A total of 1,691 patients were r and omly assigned to one of seven fluorouracil- , oxaliplatin- , and irinotecan-containing regimens . OS and TTP were calculated by treatment arm and baseline risk group ( on the basis of WBC , performance status , number of sites of disease , and alkaline phosphatase ) . Multivariate prognostic factor analysis was used to assess clinical factors for their relationships to OS , TTP , response , and toxicity by using Cox and logistic regression models . RESULTS The observed 5-year survival with infusional fluorouracil , leucovorin , and oxaliplatin ( FOLFOX ) of 9.8 % was better than with irinotecan plus bolus fluorouracil and leucovorin ( IFL ; 3.7 % ; P = .04 ) or with bolus irinotecan/oxaliplatin ( IROX ; 5.1 % ; P = .128 ) . OS and TTP were significantly longer for FOLFOX ( 20.2 months and 8.9 months , respectively ) than for IFL ( 14.6 months and 6.1 months , respectively ; P < .001 for both ) or for IROX ( 17.3 months and 6.7 months , respectively ; P < .001 for both ) . OS differed by risk group : 20.7 months for low risk , 17.4 months for intermediate risk , and 9.4 months for high risk ( P < .001 ) . FOLFOX treatment was superior in all risk groups and was the most powerful prognostic factor for OS , TTP , response rate , and toxicity . CONCLUSION The 9.8 % 5-year OS in patients with metastatic colorectal cancer who were treated with first-line FOLFOX sets a new benchmark . Neither baseline risk group nor any prognostic factor examined was predictive of treatment-specific outcome . However , treatment efficacy and patient longevity varied as a function of risk group
Output:
| The CR is a rare event in advanced CRC ; however , the addition of MoAbs to first-line chemotherapy significantly increases the curative rate of metastatic disease compared with controls |
MS211057 | ***TASK*** the task is to summarize an input biomedical literature in 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 OF THE STUDY The aim of this work was to assess the usefulness of specialized rehabilitation sessions after anterior cruciate ligament reconstruction in high-level athletes participating in regional- , national- , or international-level sports . MATERIAL AND METHODS We conducted a retrospective comparison between two population s : in the first , rehabilitation was limited to the early postoperative period ( PO ) ; in the second , rehabilitation sessions were repeated , once in the early postoperative period and again 90 days later ( POR ) . The second rehabilitation period lasted two or three weeks and included an open and closed-chain muscle training program controlled by physical therapists using isokinetic devices . The sessions also included proprioceptive exercises and cardiovascular exercise reconditioning with a therapeutic project developed by the Physical Medicine and Rehabilitation physician in collaboration with other health professionals and taking into consideration the surgical recommendations and the patient 's clinical status . A question naire was addressed to all patients one year after the operation . The response rate was 55 % . Two groups were created at r and om : 74 patients were in the PO group and 75 in the POR group . The two population s were comparable in terms of gender ( 64 men , 10 women in PO versus 57 men and 18 women in POR ) , sports level ( regional , national , international ) , type of surgery ( 41 hamsting , 33 bone-patellar tendon-bone in PO and 43 hamstring and 32 bone-patellar tendon-bone in POR ) and sports ( generally rugby , soccer , h and ball or ski ) . RESULTS Our results were statistically in favor of the group POR in terms of resumption of sports activities : time to return to training ( 7.6 versus 8.7 months , p=0.03 ) and time to return to competition ( 9.06 versus 10.84 months , p=0.007 ) . They were also in favor of the group POR for resumption of sports activities at the former level ( 52.05 % versus 19.44 % , p=0.001 ) , pain ( numerical scale : 1.52 versus 2.03 , p=0.021 ) and subjective impression ( IKDC subjective score : 87.58 % versus 81.64 % , p=0.003 ) . There was no significant difference for resumption of training ( 90.50 % versus 81.69 % , p=0.2 ) or competition ( 71.80 % versus 56.76 % , p=0.1 ) at one year , but the results were close to the level of significance . DISCUSSION Adapted preparation before returning to sports activities using a scheme elaborated by specialists ( physicians , physical therapists , trainers ) provided a statistically significant improvement in time and quality of resumed activity ( return to prior level , pain , subjective IKDC score ) in this specific population of high-level competition athletes . A larger series would be interesting to check the statistical significance of return to training and competition at one year . Another follow-up beyond one year ( 1.5 or two years for example ) would also provide information on the percentage of definitive return to sports in these two population Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials A more sports-specific and detailed strength assessment has been advocated for patients after anterior cruciate ligament ( ACL ) injury and reconstruction . The purpose of this study was to develop a test battery of lower extremity strength tests with high ability to discriminate between leg power development on the injured and uninjured sides in patients after ACL injury and in patients who have undergone ACL reconstruction . Twenty-three patients were tested 6 months after ACL injury and 44 patients were tested 6 months after ACL reconstruction . Twenty-four of the 44 patients were operated on using a hamstrings graft and 20 patients were operated on using a patellar tendon graft . All the patients performed a test battery of three strength tests for each leg in a r and omised order . The three strength tests were chosen to reflect quadriceps and hamstring muscular power in a knee-extension and a knee-flexion test ( open kinetic chain ) and lower-extremity muscular power in a leg-press test ( closed kinetic chain ) . There was a higher sensitivity for the test battery to discriminate abnormal leg power compared with any of the three strength tests individually . Nine out of ten patients after ACL reconstruction and six out of ten of the patients after ACL injury exhibited abnormal leg power symmetry using the test battery . Thus , this test battery had high ability in terms of discriminating between the leg power performance on the injured and uninjured side , both in patients with an ACL injury and in patients who have undergone ACL reconstruction . It is concluded that a test battery consisting of a knee-extension , knee-flexion and leg-press muscle power test had high ability to determine deficits in leg power 6 months after ACL injury and reconstruction . Only a minority of the patients had restored leg muscle power . The clinical relevance is that the test battery may contribute to the decision-making process when deciding whether and when patients can safely return to strenuous physical activities after an ACL injury or reconstruction [ Purpose ] To compare outcomes of anterior cruciate ligament ( ACL ) reconstruction after open kinetic chain ( OKC ) exercises and closed kinetic chain ( CKC ) exercises . [ Subjects and Methods ] The subjects comprised 11 female and 47 male patients who are r and omly divided into two groups : which performed a CKC exercise program Group I and Group II which performed an OKC exercise program . Pain intensity was evaluated using visual analogue scale ( VAS ) . Knee flexion was evaluated using a universal goniometer , and thigh circumference measurements were taken with a tape measure at baseline and at 3 months and 6 months after the treatment . Lysholm scores were used to assess knee function . [ Results ] There were no significant differences between the two groups at baseline . Within each group , VAS values and knee flexion were improved after the surgery . These improvements were significantly higher in the CKC group than in the OKC group . There were increases in thigh circumference difference at the 3 and 6 month assessment s post-surgery . A greater improvement in the Lysholm score was observed in the CKC group at 6 months . [ Conclusion ] The CKC exercise program was more effective than OKC in improving the knee functions of patients with ACL reconstruction BACKGROUND AND PURPOSE Nondistally fixated ( ie , what is often referred to as " open kinetic chain " [ OKC ] ) knee extensor resistance training appears to have lost favor for some forms of rehabilitation due partly to concerns that this exercise will irritate the extensor mechanism . In this r and omized , single-blind clinical trial , nondistally fixated versus distally fixated ( ie , often called " closed kinetic chain " [ CKC ] ) leg extensor training were compared for their effects on knee pain . SUBJECTS Forty-three patients recovering from anterior cruciate ligament ( ACL ) reconstruction surgery ( 34 male , 9 female ; mean age=29 years , SD=7.9 , range=16 - 54 ) . METHODS Knee pain was measured at 2 and 6 weeks after ACL reconstruction surgery using visual analog scales in a self- assessment question naire and during maximal isometric contractions of the knee extensors . Between test sessions , subjects trained 3 times per week using either OKC or CKC resistance of their knee and hip extensors as part of their physical therapy . RESULTS No differences in knee pain were found between the treatment groups . DISCUSSION AND CONCLUSION Open kinetic chain and CKC leg extensor training in the early period after ACL reconstruction surgery do not differ in their immediate effects on anterior knee pain . Based on these findings , further studies are needed using different exercise dosages and patient groups BACKGROUND Subjective evaluation by patients has recently become an important adjunct to postoperative clinical assessment . Apart from st and ard physical examination , scales demonstrating patients ’ subjective outcome measures are used for assessing the efficacy of the treatment and rehabilitation of knee ligamentous injuries . The present work presents patients ’ subjective assessment of rehabilitation protocol s after ACL reconstruction . MATERIAL AND METHODS Forty individuals who had undergone ACL reconstruction were r and omised into two groups ( G1 , G2 ) and followed one of two rehabilitation protocol s ( A or B ) . The subjects assessed their knee function at baseline and after physical therapy using the Lysholm score and the IKDC form . The results were analysed with the Mann-Whitney U test . The subjects also completed a question naire at discharge . RESULTS Analysis of Lysholm and IKDC scores revealed significant differences between the mean pre- and postrehabilitation results in the groups ( p<0.05 ) . The greatest improvement was seen in G2 patients rehabilitated with protocol B , with significant mean improvements of 56.3 % and 46.7 % for the Lysholm and IKDC scores , respectively . Group G1 registered only half of this magnitude of change . Protocol B was also highly rated in the question naires . CONCLUSION According the patients opinion a rehabilitation protocol involving a larger number of open kinetic chain exercises may prove more effective in the rehabilitation of patients after ACL reconstruction compared to a programme basing mainly on closed kinetic chains The goal of this prospect i ve study was to determine the outcome -predictive role of various parameters in the nonoperative treatment of chronic anterior knee pain patients . Thirty patients followed a five-week treatment program , which consisted out of only closed kinetic chain exercises . Prior to this treatment all subjects were evaluated on muscular characteristics , subjective symptoms , weight , sex , duration of symptoms and functional performance . A multiple stepwise regression analysis revealed that the reflex response time of m. vastus medialis obliquus ( VMO ) ( P=0.041 ; 0.026 ) , and the duration of symptoms ( P=0.019 ; 0.045 ) were the only two parameters which were significantly associated with the outcome ( evaluated by the Kujala score ) at five weeks , and at three months . The shorter the duration of symptoms , or the faster the reflex response time of VMO prior to the treatment , the better the outcome after a closed kinetic chain exercise program . The statistical significance of these parameters in this study may be seen as an indication of the importance of these variables as predictors of the outcome of a closed kinetic chain strengthening program . Using this information , it seems clinical ly important to begin the treatment program before the anterior knee pain becomes more chronic and treatment results become less good We compared the diagnostic and predictive value of magnetic resonance imaging ( MRI ) and clinical findings with arthroscopy in 61 knees in a prospect i ve study . In meniscal tears , the accuracy and positive predictive value of MRI was found to be nearly twice that of clinical examination . The sensitivity , specificity , and negative predictive value of MRI were comparable to the figures found in other studies . We recommend MRI as a clarifying diagnostic tool when a clinical examination indicates a lesion of the meniscus . In our study , the clinical relevance of MRI in anterior cruciate ligament lesions and especially in cartilage lesions was more doubtful . The combination of clinical and MRI findings would reduce the number of blank arthroscopies to 5 % . MRI is a valuable diagnostic tool in planning the type of anesthesia and treatment , and could significantly reduce the need for a second arthroscopy Open kinetic chain ( OKC ) knee extensor resistance training has lost favour in ACLR rehabilitation due to concerns that this exercise is harmful to the graft and will be less effective in improving function . In this r and omized , single-blind clinical trial OKC and closed kinetic chain ( CKC ) knee extensor training were compared for their effects on knee laxity and function in the middle period of ACLR rehabilitation . The study subjects were 49 patients recovering from ACLR surgery ( 37 M , 12 F ; mean age=33 years ) . Tests were carried out at 8 and 14 weeks after ACLR with knee laxity measured using a ligament arthrometer and function with the Hughston Clinic knee self- assessment question naire and single leg , maximal effort jump testing ( post-test only ) . Between tests , subjects trained using either OKC or CKC resistance of their knee and hip extensors as part of formal physical therapy sessions three times per week . No statistically significant ( one-way ANOVA , p>0.05 ) differences were found between the treatment groups in knee laxity or leg function . OKC and CKC knee extensor training in the middle period of
Output:
| Conclusions While OKC and CKC may be beneficial during ACL surgical rehabilitation , there is insufficient evidence to suggest that either one is superior to the other |
MS211058 | ***TASK*** the task is to summarize an input biomedical literature in 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 The most popular method of stretching is static stretching . Vibration may provide a means of enhancing range of motion beyond that of static stretching alone . PURPOSE This study sought to observe the effects of vibration on static stretching to determine whether vibration-aided static stretching could enhance range of motion acquisition more than static stretching alone in the forward split position . METHODS Ten highly trained male volunteer gymnasts were r and omly assigned to experimental ( N = 5 ) and control ( N = 5 ) groups . The test was a forward split with the rear knee flexed to prevent pelvic misalignment . Height of the anterior iliac spine of the pelvis was measured at the lowest split position . Athletes stretched forward and rearward legs to the point of discomfort for 10 s followed by 5 s of rest , repeated four times on each leg and split position ( 4 min total ) . The experimental group stretched with the device turned on ; the control group stretched with the device turned off . A pretest was followed by an acute phase posttest , then a second posttest measurement was performed following 4 wk of treatment . Difference scores were analyzed . RESULTS The acute phase showed dramatic increases in forward split flexibility for both legs ( P < 0.05 ) , whereas the long-term test showed a statistically significant increase in range of motion on the right rear leg split only ( P < 0.05 ) . Effect sizes indicated large effects in all cases . CONCLUSION This study showed that vibration can be a promising means of increasing range of motion beyond that obtained with static stretching in highly trained male gymnasts The effects of hard squatting exercise with ( VbX+ ) and without ( VbX− ) vibration on neuromuscular function were tested in 19 healthy young volunteers . Before and after the exercise , three different tests were performed : maximum serial jumping for 30 s , electromyography during isometric knee extension at 70 % of the maximum voluntary torque , and the quantitative analysis of the patellar tendon reflex . Between VbX+ and VbX− values , there was no difference found under baseline conditions . Time to exhaustion was significantly shorter in VbX+ than in VbX− ( 349 ± 338 s versus 515 ± 338 s ) , but blood lactate ( 5·49 ± 2·73 mmol l−1 versus 5·00 ± 2·26 mmol l−1 ) and subjectively perceived exertion ( rate of perceived exertion values 18·1 ± 1·2 versus 18·6 ± 1·6 ) at the termination of exercise indicate comparable levels of fatigue . After the exercise , comparable effects were observed on jump height , ground contact time , and isometric torque . The vastus lateralis mean frequency during isometric torque , however , was higher after VbX+ than after VbX−. Likewise , the tendon reflex amplitude was significantly greater after VbX+ than after VbX− ( 4·34 ± 3·63 Nm versus 1·68 ± 1·32 Nm ) . It is followed that in exercise unto comparable degrees of exhaustion and muscular fatigue , superimposed 26 Hz vibration appears to elicit an alteration in neuromuscular recruitment patterns , which apparently enhance neuromuscular excitability . Possibly , this effect may be exploited for the design of future training regimes Purpose To examine the acute and short-term effect of a wearable vibration device following strenuous eccentric exercise of the elbow flexors . Methods Physically active males ( n = 13 ) performed vibration therapy ( VT ) and control following eccentric exercise . The arms were r and omised and counterbalanced , separated by 14 days . 15 min of VT ( 120 Hz ) was applied immediately and 24 , 48 , and 72 h after eccentric exercise while the contralateral arm performed no VT ( control ) . Muscle ( isometric and concentric ) strength , range of motion , electromyography ( EMG ) , muscle soreness and creatine kinase were taken pre-exercise , immediately and 24 , 48 , and 72 h post-eccentric exercise . Additionally , the acute effect of VT of muscle strength , range of motion , EMG , muscle soreness was also investigated immediately after VT . Results In the short-term VT was able to significantly reduce the level of biceps brachii pain at 24 h ( p < 0.05 ) and 72 h ( p < 0.01 ) , enhance pain threshold at 48 h ( p < 0.01 ) and 72 h ( p < 0.01 ) , improve range of motion at 24 h ( p < 0.05 ) , 48 h ( p < 0.01 ) and 72 h ( p < 0.01 ) and significantly ( p < 0.05 ) reduced creatine kinase at 72 h compared to control . Acutely , following VT treatment muscle pain and range of motion significantly improved ( p < 0.05 ) at 24 h post , 48 h post , and 72 h post but no significant changes in muscle strength and EMG were reported acutely or short-term . Conclusions Acute and short-term VT attenuated muscle soreness , creatine kinase and improved range of motion ; however , there was no improvement of muscle strength recovery compared to control following eccentric exercise of the elbow flexors Abstract The aim of this study was to assess the effects of a bout of whole body vibration ( WBV ) on muscle response and to determine whether this stimulus leads to muscle damage . Thirty healthy and physically active participants ( mean±SD ; age : 21.8±2.0 years ; height : 176.7±5.8 cm ; body mass : 76±6.8 kg and BMI : 23.1±3.7 kg·m−2 ) participated in this study . Participants were r and omly allocated in one of two groups , one of them performed a bout of 360 s WBV ( frequency : 30 Hz ; peak-to-peak displacement : 4 mm ) ( VIB ) and the other one adopted a sham position ( CON ) . Muscle contractile properties were analysed in the rectus femoris ( RF ) by using tensiomyography ( TMG ) 2 min before the warm-up and 2 min after intervention . Muscle damage was assessed by determining plasma creatine kinase ( CK ) and lactate dehydrogenase ( LDH ) levels at three time points ; 5 min before warm-up and 1 h and 48 h after the intervention . TMG results showed a significant decrease in maximal displacement ( p<0.05 ) and delay time ( p<0.05 ) in VIB and in delay time ( p<0.05 ) and relaxation time ( p<0.05 ) in CON . Muscle damage markers showed significant group differences ( p<0.05 ) for CK 1 h after the intervention . In addition , differences for CK 1 h after the intervention from baseline ( p<0.05 ) were also observed in VIB . In conclusion , a 6-min bout of WBV results in an increase of muscle stiffness in RF and increased CK levels 1 h after intervention ( returning to baseline within 48 h ) Objective : The purpose of this study was to determine if vibration therapy is more effective than the st and ard treatment of stretching and massage for improving recovery of muscle strength and reducing muscle soreness after muscle damage induced by eccentric exercise . Design : A r and omized , single-blinded parallel intervention trial design was used . Setting : Research laboratory . Participants : Fifty untrained men aged 18 to 30 years completed the study . Interventions : Participants performed 100 maximal eccentric muscle actions ( ECCmax ) of the right knee extensor muscles . For the next 7 days , 25 participants applied cycloidal vibration therapy to the knee extensors twice daily and 25 participants performed stretching and sports massage ( SSM ) twice daily . Main Outcome Measures : Changes in markers of muscle damage [ peak isometric torque ( PIT ) , serum creatine kinase ( CK ) , and serum myoglobin ( Mb ) ] , muscle soreness ( visual analog scale ) , and inflammation [ serum C-reactive protein ( CRP ) ] were assessed . Results : After ECCmax , there was no difference in recovery of PIT and muscle soreness or serum CK , Mb , and CRP levels between vibration and SSM groups ( P > 0.28 ) . Conclusions : Cycloidal vibration therapy is no more effective than the st and ard practice of stretching and massage to promote muscle recovery after the performance of muscle-damaging exercise . Clinical Relevance : Prescription of vibration therapy after maximal exercise involving eccentric muscle damage did not alleviate signs and symptoms of muscle damage faster than the st and ard prescription of stretching and massage [ Purpose ] To investigate the effects of pre-induced muscle damage vibration stimulation on the pressure-pain threshold and muscle-fatigue-related metabolites of exercise-induced muscle damage . [ Subjects and Methods ] Thirty healthy , adult male subjects were r and omly assigned to the pre-induced muscle damage vibration stimulation group , post-induced muscle damage vibration stimulation group , or control group ( n=10 per group ) . To investigate the effects of pre-induced muscle damage vibration stimulation , changes in the pressure-pain threshold ( lb ) , creatine kinase level ( U/L ) , and lactate dehydrogenase level ( U/L ) were measured and analyzed at baseline and at 24 hours , 48 hours , and 72 hours after exercise . [ Results ] The pressure-pain thresholds and concentrations of creatine kinase and lactate dehydrogenase varied significantly in each group and during each measurement period . There were interactions between the measurement periods and groups , and results of the post-hoc test showed that the pre-induced muscle damage vibration stimulation group had the highest efficacy among the groups . [ Conclusion ] Pre-induced muscle damage vibration stimulation is more effective than post-induced muscle damage vibration stimulation for preventing muscle damage Objective In this study , the effects of vibration therapy ( VT ) on delayed-onset muscle soreness ( DOMS ) and associated inflammatory markers after downhill running were determined . Methods 29 male recreational runners ( 33 ( 8) years ; Vo2peak 57 ( 6 ) ml kg−1 min−1 ) completed a 40-min downhill run and were r and omly allocated to a VT group or Control group . For 5 days post-run , the VT group underwent once-daily sessions of VT on the upper and lower legs . DOMS was assessed pre-run and for 5 days post-run by visual analogue scale . Immune cell subsets and plasma inflammatory markers were assessed pre-run , post-run , 24 and 120 h post-run by full differential cell count , and by ELISA and enzyme immunoassay , respectively . Data were analysed as per cent change from pre-run ( ANOVA ) and the magnitude of the treatment effect ( Cohen 's effect size statistics ) . Results VT significantly reduced calf pain 96 h post-run ( −50 % ( 40 % ) , 90 % confidence limits ) and gluteal pain 96 h ( −50 % ( 40 % ) ) and 120 h post-run ( −30 % ( 30 % ) ) ; decreased interleukin 6 ( IL6 ) 24 h ( −46 % ( 31 % ) ) and 120 h post-run ( −65 % ( 30 % ) ) ; substantially decreased histamine 24 h ( −40 % ( 50 % ) ) and 120 h post-run ( −37 % ( 48 % ) ) ; substantially increased neutrophils ( 8.6 % ( 8.1 % ) ) and significantly decreased lymphocytes ( −17 % ( 12 % ) ) 24 h post-run . There were no clear substantial effects of VT on other leukocyte subsets and inflammatory markers . Conclusion VT reduces muscle soreness and IL6 . It may stimulate lymphocyte and neutrophil responses and may be a useful modality in treating muscle inflammation The purpose of this study was to investigate the effects of a single bout of whole-body vibration on isometric squat ( IS ) and countermovement jump ( CMJ ) performance . Nine moderately resistance-trained men were tested for peak force ( PF ) during the IS and jump height ( JH ) and peak power ( PP ) during the CMJ . Average integrated electromyography ( IEMG ) was measured from the vastus medialis , vastus lateralis , and biceps femoris muscles . Subjects performed the 2 treatment conditions , vibration or sham , in a r and omized order . Subjects were tested for baseline performance variables in both the IS and CMJ , and were exposed to either a 30-second bout of whole-body vibration or sham intervention . Subjects were tested immediately following the vibration or sham treatment , as well as 5 , 15 , and 30 minutes posttreatment . Whole-body vibration result ed in a significantly higher ( p ≤ 0.05 ) JH during the CMJ immediately following vibration , as compared with the sham condition . No significant differences were observed in CMJ PP ; PF during IS or IEMG of the vastus medialis , vastus lateralis , or biceps femoris during the CMJ ; or IS between vibration and sham treaments . Whole-body vibration may be a potential warm-up procedure for increasing vertical JH . Future research is warranted addressing the influence of various protocol s of whole-body vibration ( i.e. , duration , amplitude , frequency ) on athletic performance CONTEXT Numerous recovery strategies have been used in an attempt to minimize the symptoms of delayed-onset muscle soreness ( DOMS ) . Whole-body vibration ( WBV ) has been suggested as a viable warm-up for
Output:
| The meta- analysis indicated that vibration significantly improved the VAS at 24 , 48 , and 72 hours after exercise , and significantly improved CK levels at 24 and 48 hours , but not at 72 hours .
Conclusion Vibration is a beneficial and useful form of physiotherapy for alleviating DOMS . |
MS211059 | ***TASK*** the task is to summarize an input biomedical literature in 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: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain Background It has been suggested that exercise training results in compensatory mechanisms that attenuate weight loss . However , this has only been examined with large doses of exercise . The goal of this analysis was to examine actual weight loss compared to predicted weight loss ( compensation ) across different doses of exercise in a controlled trial of sedentary , overweight or obese postmenopausal women ( n = 411 ) . Methodology /Principal Findings Participants were r and omized to a non-exercise control ( n = 94 ) or 1 of 3 exercise groups ; exercise energy expenditure of 4 ( n = 139 ) , 8 ( n = 85 ) , or 12 ( n = 93 ) kcal/kg/week ( KKW ) . Training intensity was set at the heart rate associated with 50 % of each woman 's peak VO2 and the intervention period was 6 months . All exercise was supervised . The main outcomes were actual weight loss , predicted weight loss ( exercise energy expenditure/ 7700 kcal per kg ) , compensation ( actual minus predicted weight loss ) and waist circumference . The study sample had a mean ( SD ) age 57.2 ( 6.3 ) years , BMI of 31.7 ( 3.8 ) kg/m2 , and was 63.5 % Caucasian . The adherence to the intervention was > 99 % in all exercise groups . The mean ( 95 % CI ) weight loss in the 4 , 8 and 12 KKW groups was −1.4 ( −2.0 , −0.8 ) , −2.1 ( −2.9 , −1.4 ) and −1.5 ( −2.2 , −0.8 ) kg , respectively . In the 4 and 8 KKW groups the actual weight loss closely matched the predicted weight loss of −1.0 and −2.0 kg , respectively , result ing in no significant compensation . In the 12 KKW group the actual weight loss was less than the predicted weight loss ( −2.7 kg ) result ing in 1.2 ( 0.5 , 1.9 ) kg of compensation ( P<0.05 compared to 4 and 8 KKW groups ) . All exercise groups had a significant reduction in waist circumference which was independent of changes in weight . Conclusion In this study of previously sedentary , overweight or obese , postmenopausal women we observed no difference in the actual and predicted weight loss with 4 and 8 KKW of exercise ( 72 and 136 minutes respectively ) , while the 12 KKW ( 194 minutes ) produced only about half of the predicted weight loss . However , all exercise groups had a significant reduction in waist circumference which was independent of changes in weight . Trial Registration Clinical Trials.gov NCT Keeping moderately active is the best way to boost total daily energy expenditure . BACKGROUND It is not clear how decreased activity quantitatively affects energy balance ( EB ) in subjects feeding ad libitum . OBJECTIVE We assessed the effect of an imposed sedentary routine on appetite , energy intake ( EI ) , EB , and nutrient balance in lean men for 7 d. DESIGN Six men with a mean ( + /-SD ) age of 23.0 + /- 2.3 y , weight of 69.2 + /- 11.4 kg , and height of 1.76 + /- 0.07 m were each studied twice during a sedentary [ 1.4 x resting metabolic rate ( RMR ) ] and a moderately active ( 1.8 x RMR ) regimen . During each treatment , they resided in the whole-body indirect calorimeter for the 7 d and had ad libitum access to a medium-fat diet of constant , measurable composition . Meal size , frequency , and composition were continually monitored . Motivation to eat was recorded during waking hours . Subjects were weighed in light clothing each morning , and their weight was corrected to nude . RESULTS Energy expenditure was 9.7 and 12.8 MJ/d [ P < 0.01 ; SE of the difference between means ( SED ) = 0.41 ] during the sedentary and active regimens , respectively . EI was 13.5 and 14.4 MJ/d ( P = 0.463 , SED = 1.06 ) , respectively . There was no regimen effect on hunger , appetite , or body weight . By day 7 , cumulative EB was 26.3 and 11.1 MJ , respectively . CONCLUSIONS Reducing a level of physical activity from 1.8 to 1.4 x RMR can markedly affect EB . A sedentary routine does not induce a compensatory reduction of EI and leads to a significantly positive EB , most of which is stored as fat 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 Recent r and omized controlled trials indicated that exercise training for elderly significantly increased their physical fitness . However , very few studies have examined changes in physical activity after exercise training . The purpose of this study was to investigate whether six-month exercise training for older adults can increase and maintain their physical activity in daily life . METHODS Sixty-two men and women aged 60 to 81 years ( mean age 67.1 years ) , living in communities , were r and omly allocated into an exercise group ( n = 32 ) or a control group ( n = 33 ) . The intervention started in April 1998 and lasted for 25 weeks . The exercise regimen consisted of endurance training and resistance exercises in a two-hour class conducted at least twice a week . The subjects completed a physical activity diary at each pre-intervention ( March 1998 ) , post-intervention ( September 1998 ) and follow-up ( April 1999 ) measurement of physical activity . Physical activity , expressed as total daily energy expenditure , was calculated by multiplying the amount of time spent in each activity and the corresponding METs . RESULTS Total daily energy expenditure significantly increased from 40.8 kcal/kg/day to 43.5 kcal/kg/day in the exercise group ( p = 0.03 ) , but did not change in the control group . At the follow-up measurement , the mean total daily energy expenditure in the exercise group remained significantly higher , by 1.7 kcal/kg/day , than that at the pre-intervention ( p = 0.05 ) . CONCLUSIONS This r and omized controlled trial indicated that exercise training for elderly was effective in increasing physical activity in daily life Exercise is recommended by public health agencies for weight management ; however , the role of exercise is generally considered secondary to energy restriction . Few studies exist that have verified completion of exercise , measured the energy expenditure of exercise , and prescribed exercise with equivalent energy expenditure across individuals and genders . Objective The objective of this study was to evaluate aerobic exercise , without energy restriction , on weight loss in sedentary overweight and obese men and women . Design and Methods This investigation was a r and omized , controlled , efficacy trial in 141 overweight and obese participants ( body mass index , 31.0 ± 4.6 kg/m2 ; age 22.6 ± 3.9 years ) . Participants were r and omized ( 2:2:1 ratio ) to exercise at either 400 kcal/session or 600 kcal/session or to a non-exercise control . Exercise was supervised , 5 days/week , for 10 months . All participants were instructed to maintain usual ad libitum diets . Due to the efficacy design , completion of ≥ 90 % of exercise sessions was an a priori definition of per protocol , and these participants were included in the analysis . Results Weight loss from baseline to 10 months for the 400 and 600 kcal/session groups was 3.9 ± 4.9 kg ( 4.3 % ) and 5.2 ± 5.6 kg ( 5.7 % ) , respectively compared to weight gain for controls of 0.5 ± 3.5 kg ( 0.5 % ) ( p<0.05 ) . Differences for weight loss from baseline to 10 months between the exercise groups and differences between men and women within groups were not statistically significant . Conclusions Supervised exercise , with equivalent energy expenditure , results in clinical ly significant weight loss with no significant difference between men and women BACKGROUND It is currently unclear how physical activity and diet interact within the ranges of activity seen in the general population . This study aim ed to establish whether a small , acute , increase in physical activity would lead to compensatory change in energy intake and nutrient balance , and to provide power analysis data for future research in this field . METHOD Twelve participants were studied over 7 days of habitual activity and 2 weeks after instruction to increase physical activity by 2000 steps per day . Physical activity was assessed using a diary , the ' activPAL ' activity monitor and a pedometer . Dietary analyses from prospect i ve food diaries were compared between the first and third weeks . RESULTS Participants increased step-counts ( + 2600 steps per day , P = 0.008 ) and estimated energy expenditure ( + 300 - 1000 kJ day(-1 ) , P = 0.002 ) but did not significantly change their energy intake , dietary composition or number of meals per day . From reverse power analysis 38 participants would be needed to exclude a change in energy intake of 400 kJ day(-1 ) with 90 % power at P < 0.05 ; 400 kJ day(-1 ) would compensate for a 2000 steps per day increase in physical activity . CONCLUSION These results did not demonstrate any compensatory increase in food consumption when physical activity was increased by walking an average of 2600 additional steps per day . Power analysis indicates that a larger study
Output:
| We found minimal evidence to support the hypothesis that prescribed physical activity/exercise training results in decreased non-exercise physical activity/energy expenditure in healthy adults . |
MS211060 | ***TASK*** the task is to summarize an input biomedical literature in 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 For patients with chronic pancreatitis and a dilated pancreatic duct , ductal decompression is recommended . We conducted a r and omized trial to compare endoscopic and surgical drainage of the pancreatic duct . METHODS All symptomatic patients with chronic pancreatitis and a distal obstruction of the pancreatic duct but without an inflammatory mass were eligible for the study . We r and omly assigned patients to undergo endoscopic transampullary drainage of the pancreatic duct or operative pancreaticojejunostomy . The primary end point was the average Izbicki pain score during 2 years of follow-up . The secondary end points were pain relief at the end of follow-up , physical and mental health , morbidity , mortality , length of hospital stay , number of procedures undergone , and changes in pancreatic function . RESULTS Thirty-nine patients underwent r and omization : 19 to endoscopic treatment ( 16 of whom underwent lithotripsy ) and 20 to operative pancreaticojejunostomy . During the 24 months of follow-up , patients who underwent surgery , as compared with those who were treated endoscopically , had lower Izbicki pain scores ( 25 vs. 51 , P<0.001 ) and better physical health summary scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey question naire ( P=0.003 ) . At the end of follow-up , complete or partial pain relief was achieved in 32 % of patients assigned to endoscopic drainage as compared with 75 % of patients assigned to surgical drainage ( P=0.007 ) . Rates of complications , length of hospital stay , and changes in pancreatic function were similar in the two treatment groups , but patients receiving endoscopic treatment required more procedures than did patients in the surgery group ( a median of eight vs. three , P<0.001 ) . CONCLUSIONS Surgical drainage of the pancreatic duct was more effective than endoscopic treatment in patients with obstruction of the pancreatic duct due to chronic pancreatitis . ( Current Controlled Trials number , IS RCT N04572410 [ controlled-trials.com ] . ) OBJECTIVE This study evaluated the effect of operative drainage of the main pancreatic duct ( MPD ) on functional derangements associated with chronic pancreatitis ( CP ) . SUMMARY BACKGROUND DATA The author previously reported delayed functional impairment in an evaluation of the impact of operative drainage in patients with CP . The author now reports on a prospect i ve study of 143 patients with this diagnosis . METHODS Each patient underwent 1 ) ERCP , 2 ) the Bentiromide PABA , 3 ) 72-hour fecal fat test , 4 ) oral glucose tolerance test ( OGTT ) and 5 ) fat meal (LIPOMUL)--stimulated pancreatic polypeptide release ( PP ) . All patients were stratified as mild/moderate ( M/M ) or severe CP on the basis of a 5-point system that was developed by the author . Patients were studied at 16-month intervals . RESULTS All 143 patients underwent initial and follow-up evaluations in a mean follow-up of 47.3 months ; 83 of 143 patients had M/M grade at initial evaluation . Eighty-seven patients underwent ( MPD ) decompression to relieve abdominal pain . In a separate prospect i ve 17 patients with a diagnosis of CP , a grade of M/M and non-disabling abdominal pain were r and omized to operative or non-operative treatment ; 9 of these r and omized patients were operated upon and 8 were not . No patient improved their grade during follow-up ; 47 of 83 M/M patients had operative drainage and 36 did not . This grade was preserved in 41 of 47 ( 87 % ) operated patients but in only 8 of the 36 non-operated patients ( 22 % ) . In the r and omized trial , seven of nine operated patients retained their functional status in follow-up , whereas only two of eight patients ( 25 % ) r and omized to non-operation preserved their functional grade . CONCLUSIONS These data in this large study as well as among a previous r and omized sample , support a policy of early operative drainage before the development of irreversible functional impairment in patients with chronic pancreatitis and associated dilation of the main pancreatic duct OBJECTIVE To analyze the efficacy of extended drainage -- that is , longitudinal pancreaticojejunostomy combined with local pancreatic head excision (LPJ-LPHE)- and pylorus-preserving pancreatoduodenectomy ( PPPD ) in terms of pain relief , control of complications arising from adjacent organs , and quality of life . SUMMARY BACKGROUND DATA Based on the hypotheses of pain origin ( ductal hypertension and perineural inflammatory infiltration ) , drainage and resection constitute the main principles of surgery for chronic pancreatitis . METHODS Sixty-one patients were r and omly allocated to either LPJ-LPHE ( n = 31 ) or PPPD ( n = 30 ) . The interval between symptoms and surgery ranged from 12 months to 10 years ( mean 5.1 years ) . In addition to routine pancreatic diagnostic workup , a multidimensional psychometric quality -of-life question naire and a pain score were used . Endocrine and exocrine functions were assessed in terms of oral glucose tolerance and serum concentrations of insulin , C-peptide , and HbA1c , as well as fecal chymotrypsin and pancreolauryl testing . During a median follow-up of 24 months ( range 12 to 36 ) , patients were reassessed in the outpatient clinic . RESULTS One patient died of cardiovascular failure in the LPJ-LPHE group ( 3.2 % ) ; there were no deaths in the PPPD group . Overall , the rate of in-hospital complications was 19.4 % in the LPJ-LPHE group and 53.3 % in the PPPD group , including delayed gastric emptying in 9 of 30 patients ( 30 % ; p < 0.05 ) . Complications of adjacent organs were definitively resolved in 93.5 % in the LPJ-LPHE group and in 100 % in the PPPD group . The pain score decreased by 94 % after LPJ-LPHE and by 95 % after PPPD . Global quality of life improved by 71 % in the LPJ-LPHE group and by 43 % in the PPPD group ( p < 0.01 ) . CONCLUSIONS Both procedures are equally effective in terms of pain relief and definitive control of complications affecting adjacent organs , but extended drainage by LPJ-LPHE provides a better quality of life Background This study aim ed to compare the outcomes of endoscopic treatment ( ET ) and surgical treatment ( ST ) for common bile duct ( CBD ) stricture in patients with chronic pancreatitis ( CP ) . Methods From 2004 to 2009 , 39 patients ( 35 men and 4 women ; median age , 52 years ; range , 38–66 years ) were referred for CBD stricture in CP . Of these 39 patients , 33 ( 85 % ) underwent primary ET , and 6 underwent primary ST . Treatment success was defined in both groups as the absence of signs denoting recurrence , with normal serum bilirubin and alkaline phosphatase levels after permanent stent removal in ET group . The follow-up period was longer than 12 months for all the patients . Results For the patients treated with ET , the mean number of biliary procedures was 3 ( range , 1–10 ) per patient including extractible metallic stents in 35 % and multiple plastic stents in 65 % of the patients . The mean duration of stent intubation was 11 months . The surgical procedure associated with biliary drainage ( 4 choledochoduodenostomies , 1 choledochojejunostomy , and 1 biliary decompression within the pancreatic head ) was a Frey procedure for five patients and a pancreaticojejunostomy for one patient . The overall morbidity rate was higher in the ST group . The total hospital length of stay was similar in the two groups ( 16 vs 24 days , respectively ; p = 0.21 ) . In terms of intention to treat , the success rates for ST and ET did not differ significantly ( 83 % vs 76 % ; p = 0.08 ) . Due to failure , 17 patients required ST after ET . Event-free survival was significantly longer in the ST group ( 16.9 vs 5.8 months ; p = 0.01 ) . The actuarial success rates were 74 % at 6 months , 74 % at 12 months , and 65 % at 24 months in the ST group and respectively 75 % , 69 % , and 12 % in the ET group ( p = 0.01 ) . After more than three endoscopic procedures , the success rates were 27 % at 6 months and 18 % at 18 months . Conclusion For bile duct stricture in CP , surgery is associated with better long-term outcomes than endoscopic therapy . After more than three endoscopic procedures , the success rate is low This paper discusses the various philosophies that influence the selection of patients for entry into r and omized controlled trials . Although a number of different and often competing issues have to be considered depending upon the trial , keeping entry criteria simple , wide and at times even flexible is usually preferable . Such a strategy can be a positive virtue by helping to attain the large numbers of patients that are usually needed to reliably detect the sorts of moderate benefits that are plausible , at a reasonable cost and by providing answers that are relevant to many different categories of patients with a particular condition Background A number of studies support the use of endoscopically placed pancreatic duct ( PD ) stents to decrease pain in chronic pancreatitis ( CP ) . Nevertheless , flaws in study design have prevented experts from reaching a consensus . Purpose ( 1 ) Evaluate the efficacy of PD stenting to ameliorate abdominal pain in patients with CP and ductal strictures ; ( 2 ) evaluate the placebo response rate from sham endoscopic therapy ; ( 3 ) compare pain medication usage , healthcare utilization , psychological distress , and quality of life before and after endoscopic stenting ; ( 4 ) prospect ively evaluate the durability of the response . Methods Patients with typical abdominal pain , imaging confirmation of CP and endoscopic retro grade cholangiopancreatography ( ERCP ) confirmation of PD stricture will complete question naires to assess quality of life , psychological distress , pain intensity/unpleasantness , pain medication usage , and healthcare utilization . Enrolled patients will be r and omized to ERCP with sphincterotomy and PD stenting versus sham procedure . Pain level and medication usage will be assessed weekly with telephone interviews . At 6—8 weeks , patients treated with stents will undergo stent removal ; those r and omized to the sham procedure without significant improvement ( < 50 % reduction in pain score ) will cross over to the treatment group ; and those r and omized to sham procedure who experienced improvement ( > 50 % reduction ) will be followed clinical ly . Patients will be followed in clinic or by phone biannually ( up to 3 years ) . The primary endpoint is improvement in abdominal pain . The secondary endpoints are reduction in narcotic use , healthcare utilization , and work days missed ; return to employment ; improvement in quality of life and weight gain . Results Proposed study . Limitations Strict inclusion criteria may limit enrollment . Conclusion The proposed study represents the first trial of endoscopic stenting for symptomatic CP and ductal strictures with a credible sham procedure , assessment of multiple dimensions of pain , and psychosocial factors . Clinical Trials 2009 ; 6 : 455—463 . Objective : To report on the long-term follow-up of a r and omized clinical trial comparing pancreatic head resection according to Beger and limited pancreatic head excision combined with longitudinal pancreatico-jejunostomy according to Frey for surgical treatment of chronic pancreatitis . Summary Background Data : Resection and drainage are the 2 basic surgical principles in surgical treatment of chronic pancreatitis . They are combined to various degrees by the classic duodenum preserving pancreatic head resection ( Beger ) and limited pancreatic head excision combined with longitudinal pancreatico-jejunostomy ( Frey ) . These procedures have been evaluated in a r and omized controlled trial by our group . Long-term follow up has not been reported so far . Methods : Seventy-four patients suffering from chronic pancreatitis were initially allocated to DPHR ( n = 38 ) or LE ( n = 36 ) . This postoperative follow-up included the following parameters : mortality , quality of life ( QL ) , pain ( vali date d pain score ) , and exocrine and endocrine function . Results : Median follow-up was 104 months ( 72 - 144 ) . Seven patients were not available for follow-up ( Beger = 4 ; Frey = 3 ) . There was no significant difference in late mortality ( 31 % [ 8/26 ] versus 32 % [ 8/25 ] ) . No significant differences were found regarding QL ( global QL 66.7 [ 0–100 ] versus 58.35 [ 0–100 ] ) , pain score ( 11.25 [ 0–75 ] versus 11.25 [ 0–99.75 ] ) , exocrine ( 88 % versus 78 % ) or endocrine insufficiency ( 56 % versus 60 % ) . Conclusions : After almost 9 years ’ long
Output:
| The trial showed that surgical intervention result ed in a higher percentage of participants with pain relief and better preservation of pancreatic function .
For patients with obstructive chronic pancreatitis and dilated pancreatic duct , this review shows that surgery is superior to endoscopy in terms of pain relief .
Morbidity and mortality seem not to differ between the two intervention modalities , but the small trials identified do not provide sufficient power to detect the small differences expected in this outcome .Regarding the comparison of surgical intervention versus conservative treatment , this review has shown that surgical intervention in an early stage of chronic pancreatitis is a promising approach in terms of pain relief and pancreatic function . |
MS211061 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background . A recent Cochrane Review showed that early robotic training of the upper limb in stroke survivors can be more effective than other interventions when improving activities of daily living involving the arm function is the aim of therapy . Objective . We tested for efficacy of the study a protocol which involved the use of the NeReBot therapy in partial substitution of st and ard upper limb rehabilitation in post – acute stroke patients . Methods . In this dose-matched , r and omized controlled clinical trial , 34 hemiparetic participants with movement against gravity in shoulder , elbow , and wrist muscle groups were enrolled within 15 days of the onset of stroke . All participants received a total daily rehabilitation treatment for 120 minutes , 5 days per week for 5 weeks . The control group received st and ard therapy for the upper limb . The experimental group received st and ard therapy ( 65 % of exercise time ) associated with robotic training ( 35 % of exercise time ) . Muscle tone ( Modified Ashworth Scale ) , strength ( Medical Research Council ) , and synergism ( Fugl-Meyer motor scores ) were measured at impairment level , whereas dexterity ( Box and Block Test and Frenchay Arm Test ) and activities of daily living ( Functional Independence Measure ) were measured at activity level . All assessment s were performed at baseline , at the end of therapy ( time T1 ) , at 3 months ( time T2 ) , and at 7 months ( time T3 ) after entry . All between-group analyses were tested using nonparametric test with Bonferroni ’s adjustments for multiple testing . Results . No significant between-group differences were found with respect to demographic characteristics , motor , dexterity , and ADLs at baseline , postintervention ( T1 ) and at follow-up ( T2 and T3 ) . Conclusions . The robot therapy by NeReBot did not lead to better outcomes compared with conventional inpatient rehabilitation Background and Purpose — It is unknown whether one method of neuromuscular electrical stimulation for poststroke upper limb rehabilitation is more effective than another . Our aim was to compare the effects of contralaterally controlled functional electrical stimulation ( CCFES ) with cyclic neuromuscular electrical stimulation ( cNMES ) . Methods — Stroke patients with chronic ( > 6 months ) moderate to severe upper extremity hemiparesis ( n=80 ) were r and omized to receive 10 sessions/wk of CCFES- or cNMES-assisted h and opening exercise at home plus 20 sessions of functional task practice in the laboratory for 12 weeks . The task practice for the CCFES group was stimulation assisted . The primary outcome was change in Box and Block Test ( BBT ) score at 6 months post treatment . Upper extremity Fugl – Meyer and Arm Motor Abilities Test were also measured . Results — At 6 months post treatment , the CCFES group had greater improvement on the BBT , 4.6 ( 95 % confidence interval [ CI ] , 2.2–7.0 ) , than the cNMES group , 1.8 ( 95 % CI , 0.6–3.0 ) , between-group difference of 2.8 ( 95 % CI , 0.1–5.5 ) , P=0.045 . No significant between-group difference was found for the upper extremity Fugl – Meyer ( P=0.888 ) or Arm Motor Abilities Test ( P=0.096 ) . Participants who had the largest improvements on BBT were < 2 years post stroke with moderate ( ie , not severe ) h and impairment at baseline . Among these , the 6-month post-treatment BBT gains of the CCFES group , 9.6 ( 95 % CI , 5.6–13.6 ) , were greater than those of the cNMES group , 4.1 ( 95 % CI , 1.7–6.5 ) , between-group difference of 5.5 ( 95 % CI , 0.8–10.2 ) , P=0.023 . Conclusions — CCFES improved h and dexterity more than cNMES in chronic stroke survivors . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00891319 Background Effective poststroke motor rehabilitation depends on repeated limb practice with voluntary efforts . An electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robot arm was design ed for the multi-joint physical training on the elbow , the wrist , and the fingers . Objectives To investigate the training effects of the device-assisted approach on subacute stroke patients and to compare the effects with those achieved by the traditional physical treatments . Method This study was a pilot r and omized controlled trial with a 3-month follow-up . Subacute stroke participants were r and omly assigned into two groups , and then received 20-session upper limb training with the EMG-driven NMES-robotic arm ( NMES-robot group , n = 14 ) or the time-matched traditional therapy ( the control , n = 10 ) . For the evaluation of the training effects , clinical assessment s including Fugl-Meyer Assessment ( FMA ) , Modified Ashworth Score ( MAS ) , Action Research Arm Test ( ARAT ) , and Function Independence Measurement ( FIM ) were conducted before , after the rehabilitation training , and 3 months later . Session-by-session EMG parameters in the NMES-robot group , including normalized co-contraction Indexes ( CI ) and EMG activation level of target muscles , were used to monitor the progress in muscular coordination patterns . Results Significant improvements were obtained in FMA ( full score and shoulder/elbow ) , ARAT , and FIM [ P < 0.001 , effect sizes ( EFs ) > 0.279 ] for both groups . Significant improvement in FMA wrist/h and was only observed in the NMES-robot group ( P < 0.001 , EFs = 0.435 ) after the treatments . Significant reduction in MAS wrist was observed in the NMES-robot group after the training ( P < 0.05 , EFs = 0.145 ) and the effects were maintained for 3 months . MAS scores in the control group were elevated following training ( P < 0.05 , EFs > 0.24 ) , and remained at an elevated level when assessed 3 months later . The EMG parameters indicated a release of muscle co-contraction in the muscle pairs of biceps brachii and flexor carpi radialis and biceps brachii and triceps brachii , as well as a reduction of muscle activation level in the wrist flexor in the NMES-robot group . Conclusion The NMES-robot-assisted training was effective for early stroke upper limb rehabilitation and promoted independence in the daily living comparable to the traditional physical therapy . It could achieve higher motor outcomes at the distal joints and more effective release in muscle tones than the traditional therapy . Clinical Trial Registration Clinical Trials.gov , identifier NCT02117089 ; date of registration : April 10 , 2014 Background Most stroke survivors continue to experience motor impairments even after hospital discharge . Virtual reality-based techniques have shown potential for rehabilitative training of these motor impairments . Here we assess the impact of at-home VR-based motor training on functional motor recovery , corticospinal excitability and cortical reorganization . Objective The aim of this study was to identify the effects of home-based VR-based motor rehabilitation on ( 1 ) cortical reorganization , ( 2 ) corticospinal tract , and ( 3 ) functional recovery after stroke in comparison to home-based occupational therapy . Methods We conducted a parallel-group , controlled trial to compare the effectiveness of domiciliary VR-based therapy with occupational therapy in inducing motor recovery of the upper extremities . A total of 35 participants with chronic stroke underwent 3 weeks of home-based treatment . A group of subjects was trained using a VR-based system for motor rehabilitation , while the control group followed a conventional therapy . Motor function was evaluated at baseline , after the intervention , and at 12-weeks follow-up . In a subgroup of subjects , we used Navigated Brain Stimulation ( NBS ) procedures to measure the effect of the interventions on corticospinal excitability and cortical reorganization . Results Results from the system ’s recordings and clinical evaluation showed significantly greater functional recovery for the experimental group when compared with the control group ( 1.53 , SD 2.4 in Chedoke Arm and H and Activity Inventory ) . However , functional improvements did not reach clinical significance . After the therapy , physiological measures obtained from a subgroup of subjects revealed an increased corticospinal excitability for distal muscles driven by the pathological hemisphere , that is , abductor pollicis brevis . We also observed a displacement of the centroid of the cortical map for each tested muscle in the damaged hemisphere , which strongly correlated with improvements in clinical scales . Conclusions These findings suggest that , in chronic stages , remote delivery of customized VR-based motor training promotes functional gains that are accompanied by neuroplastic changes . Trial Registration International St and ard R and omized Controlled Trial Number NCT02699398 ( Archived by Clinical Trials.gov at https:// clinical trials.gov/ct2/show/NCT02699398?term=NCT02699398&rank=1 OBJECTIVE To investigate the effectiveness of neuromuscular electrical stimulation ( NMES ) with or without other interventions in improving lower limb activity after chronic stroke . DATA SOURCES Electronic data bases , including PubMed , EMBase , Cochrane Library , PEDro ( Physiotherapy Evidence Data base ) , and PsycINFO , were search ed from the inception to January 2017 . STUDY SELECTION We selected the r and omized controlled trials ( RCTs ) involving chronic stroke survivors with lower limb dysfunction and comparing NMES or combined with other interventions with a control group of no electrical stimulation treatment . DATA EXTRACTION The primary outcome was defined as lower limb motor function , and the secondary outcomes included gait speed , Berg Balance Scale , timed Up and Go , 6-minute walk test , Modified Ashworth Scale , and range of motion . DATA SYNTHESIS Twenty-one RCTs involving 1481 participants were identified from 5759 retrieved articles . Pooled analysis showed that NMES had a moderate but statistically significant benefit on lower limb motor function ( st and ard mean difference 0.42 , 95 % confidence interval 0.26 - 0.58 ) , especially when NMES was combined with other interventions or treatment time within either 6 or 12 weeks . NMES also had significant benefits on gait speed , balance , spasticity , and range of motion but had no significant difference in walking endurance after NMES . CONCLUSIONS NMES combined with or without other interventions has beneficial effects in lower limb motor function in chronic stroke survivors . These data suggest that NMES should be a promising therapy to apply in chronic stroke rehabilitation to improve the capability of lower extremity in performing activities Background Late-life depression is associated with high rates of morbidity , premature mortality , disability , functional decline , caregiver burden and increased health care costs . While clinical and public health approaches are focused on prevention or early intervention strategies , the ideal method of intervention remains unclear . No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older population s at risk of depression . Methods / Design Subjects with previously reported sub-threshold depressive symptoms , aged 60 to 74 years , will be screened to participate in a single-centre , double-blind , r and omised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride , compared with matching placebo . Subjects will be excluded if they have current depression or suicide ideation ; are taking antidepressants or any supplement containing omega-3 fatty acid ; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease , neurological disease , significant psychiatric disease ( other than depression ) or neurodegenerative disease . The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events . At three months , subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes . Additionally , proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions . The trial will be conducted in urban New South Wales , Australia , and will recruit a community-based sample of 450 adults . Using intention-to-treat methods , the primary endpoint is an absence of clinical ly relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition . Discussion The current health , social and economic costs of late-life depression make prevention imperative from a public health perspective . This innovative trial aims to address the long-neglected area of prevention of depression in older adults . The interventions are targeted to the pathophysiology of disease , and regardless of the effect size of treatment , the outcomes will offer major scientific advances regarding the neurobiological action of these agents . The main results are expected to be available in 2017.Trial Registration Australian and New Zeal and Clinical Trials Registry ACTRN12610000032055 ( 12 January 2010 Background . Timely provision of an ankle-foot orthosis ( AFO ) orthotist customized for individuals early after stroke can be problematic . Objective . To evaluate the efficacy of a therapist-made AFO ( SWIFT Cast ) for walking recovery . Methods . This was a r and omized controlled , observer-blind trial . Participants ( n = 105 ) were recruited 3 to 42 days poststroke . All received conventional physical therapy ( CPT
Output:
| Other Interventions for Motor Therapy The remaining studies compared various interventions for rehabilitation of motor deficits with control |
MS211062 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine the effect of frequency of resistive training on gain in muscle strength and neuromuscular performance in healthy older adults . DESIGN A r and omized controlled trial with subjects assigned either to high-intensity resistance training 1 ( EX1 ) , 2 ( EX2 ) , or 3 ( EX3 ) days per week for 24 weeks or to a control group ( CO ) . SETTING An exercise facility at an academic medical center . SUBJECTS Forty-six community-dwelling healthy men ( n = 29 ) and women ( n = 17 ) aged 65 to 79 years . INTERVENTION Progressive resistance training consisting of three sets of eight exercises targeting major muscle groups of the upper and lower body , at 80 % of one-repetition maximum ( 1-RM ) for eight repetitions , either 1 , 2 , or 3 days per week . MEASURES Dynamic muscle strength ( 1-RM ) using isotonic equipment every 4 weeks , bone mineral density and body composition by dual energy X-ray absorptiometry ( DXA ) , and neuromuscular performance by timed chair rise and 6-meter backward t and em walk . RESULTS For each of the eight exercises , muscle strength increased in the exercise groups relative to CO ( P < .01 ) , with no difference among EX1 , EX2 and EX3 groups at any measurement interval . Percent change averaged 3.9 + /- 2.4 ( CO ) , 37.0 + /- 15.2 ( EX1 ) , 41.9 + /- 18.2 ( EX2 ) , and 39.7 + /- 9.8 ( EX3 ) . The time to rise successfully from the chair 5 times decreased significantly ( P < .01 ) at 24 weeks , whereas improvement in the 6-meter backward t and em walk approached significance ( P = .10 ) in the three exercise groups compared with CO . Changes in chair rise ability were correlated to percent changes in quadriceps strength ( r = -0.40 , P < .01 ) and lean mass ( r = -0.40 , P < .01 ) . CONCLUSIONS A program of once or twice weekly resistance exercise achieves muscle strength gains similar to 3 days per week training in older adults and is associated with improved neuromuscular performance . Such improvement could potentially reduce the risk of falls and fracture in older adults Abstract Fisher , G , McCarthy , JP , Zuckerman , PA , Bryan , DR , Bickel , CS , and Hunter , GR . Frequency of combined resistance and aerobic training in older women . J Strength Cond Res 27(7 ) : 1868–1876 , 2013—The aim of this study was to determine the optimal frequency of combined aerobic and resistance training for improving muscular strength ( MS ) , cardiovascular fitness ( CF ) , and functional tasks ( FTs ) in women older than 60 years . Sixty-three women were r and omly assigned to 1 of 3 exercise training groups . Group 1 performed 1 resistance exercise training ( RET ) and 1 aerobic exercise training ( AET ) session per week ( AET/RET 1 × wk−1 ) ; group 2 performed 2 RET and 2 AET sessions per week ( AET/RET 2 × wk−1 ) ; and group 3 performed 3 RET and 3 AET sessions per week ( AET/RET 3 × wk−1 ) . MS , CF , and FT measurements were made pretraining and 16 weeks posttraining . Repeated- measures analysis of variance indicated a significant time effect for changes in MS , CF , and FT , such that all improved after training . However , there were no significant training group or training group × time interactions . Sixteen weeks of combined AET/RET ( 1 × wk−1 , 2 × wk−1 , or 3 × wk−1 ) lead to significant improvements in MS , CF , exercise economy , and FT . However , there were no significant differences for MS , CF , or FT outcomes between groups PURPOSE The purpose of this study was to compare changes in maximal strength , power , and muscular endurance after 12 wk of periodized heavy-resistance training directly supervised by a personal trainer ( SUP ) versus unsupervised training ( UNSUP ) . METHODS Twenty moderately trained men aged 24.6 + /- 1.0 yr ( mean + /- SE ) were r and omly assigned to either the SUP group ( N = 10 ) or the UNSUP group ( N = 8) . Both groups performed identical linear periodized resistance training programs consisting of preparatory ( 10 - 12 repetitions maximum ( RM ) ) , hypertrophy ( 8 to 10-RM ) , strength ( 5 to 8-RM ) , and peaking phases ( 3 to 6-RM ) using free-weight and variable-resistance machine exercises . Subjects were tested for maximal squat and bench press strength ( 1-RM ) , squat jump power output , bench press muscular endurance , and body composition at week 0 and after 12 wk of training . RESULTS Mean training loads ( kg per set ) per week were significantly ( P < 0.05 ) greater in the SUP group than the UNSUP group at weeks 7 through 11 for the squat , and weeks 3 and 7 through 12 for the bench press exercises . The rates of increase ( slope ) of squat and bench press kg per set were significantly greater in the SUP group . Maximal squat and bench press strength were significantly greater at week 12 in the SUP group . Squat and bench press 1-RM , and mean and peak power output increased significantly after training in both groups . Relative local muscular endurance ( 80 % of 1-RM ) was not compromised in either group despite significantly greater loads utilized in bench press muscular endurance testing after training . Body mass , fat mass , and fat-free mass increased significantly after training in the SUP group . CONCLUSION Directly supervised , heavy-resistance training in moderately trained men result ed in a greater rate of training load increase and magnitude which result ed in greater maximal strength gains compared with unsupervised training Abstract Seventeen subjects performed resistance training of the leg extensor and flexor muscle groups two ( 2/wk ) or three ( 3/wk ) times per week . Changes in the relative myosin heavy chain ( MHC ) isoform contents ( I , IIa and IIx ) of the vastus lateralis and isometric , isokinetic and squat-lift one-repetition maximum ( 1RM ) strength were compared between conditions after both a common training period ( 6 weeks ) and number of training sessions ( 18 ) . After 6 weeks and 18 sessions ( 9 weeks for the 2/wk group ) , increments in 1RM strength for the 3/wk and 2/wk groups were similar [ effect size ( ES ) differences ≈0.3 , 3/wk > 2/wk ] , whereas the 2/wk group presented greater isokinetic ( ES differences = 0.3–1.2 ) and isometric ( ES differences ≈0.7 ) strength increases than the 3/wk condition . A significant ( P < 0.05 ) increase in MHC IIa percentage was evident for the 2/wk group after 18 sessions . Both training groups exhibited a trend towards a reduction in the relative MHC IIx and an increase in MHC IIa contents ( ES range = 0.5–1.24 ) . However , correlations between changes in the strength and MHC profiles were weak ( r2 : 0.0–0.5 ) . Thus , isometric and isokinetic strength responses to variations in training frequency differed from 1RM strength responses , and changes in strength were not strongly related to alterations in relative MHC content Background : Strength training has been shown to benefit the health and function of older adults . Objective : To investigate whether one set of exercises performed once a week was as effective in increasing muscle strength as training twice a week . Methods : 18 subjects ( 7 women and 11 men ) aged 65–79 years were r and omly assigned to two groups . Both groups performed one set of exercises to muscular fatigue ; group 1 trained 1 day/week and group 2 trained 2 days/week on three lower and three upper body exercises for 9 weeks . The data were analysed using a mixed model 2 × 2 analysis of variance . Results : A significant main effect of time ( p<0.001 ) , but not group , on one-repetition maximum scores was observed . No significant interaction was observed between time and group and therefore no difference in strength changes between training once a week versus twice a week after 9 weeks . Conclusions : One set of exercises performed once weekly to muscle fatigue improved strength as well as twice a week in the older adult . Our results provide information that will assist in design ing strength-training programmes that are more time and cost efficient in producing health and fitness benefits for older adults Abstract Schoenfeld , BJ , Ratamess , NA , Peterson , MD , Contreras , B , and Tiryaki-Sonmez , G. Influence of resistance training frequency on muscular adaptations in well-trained men . J Strength Cond Res 29(7 ) : 1821–1829 , 2015—The purpose of this study was to investigate the effects of training muscle groups 1 day per week using a split-body routine ( SPLIT ) vs. 3 days per week using a total-body routine ( TOTAL ) on muscular adaptations in well-trained men . Subjects were 20 male volunteers ( height = 1.76 ± 0.05 m ; body mass = 78.0 ± 10.7 kg ; age = 23.5 ± 2.9 years ) recruited from a university population . Participants were pair matched according to baseline strength and then r and omly assigned to 1 of the 2 experimental groups : a SPLIT , where multiple exercises were performed for a specific muscle group in a session with 2–3 muscle groups trained per session ( n = 10 ) or a TOTAL , where 1 exercise was performed per muscle group in a session with all muscle groups trained in each session ( n = 10 ) . Subjects were tested pre- and post study for 1 repetition maximum strength in the bench press and squat , and muscle thickness ( MT ) of forearm flexors , forearm extensors , and vastus lateralis . Results showed significantly greater increases in forearm flexor MT for TOTAL compared with SPLIT . No significant differences were noted in maximal strength measures . The findings suggest a potentially superior hypertrophic benefit to higher weekly resistance training frequencies PURPOSE To compare the effects of the 16-wk training period ( 2 d.wk(-1 ) ) of resistance training alone ( S ) , endurance training alone ( E ) , or combined resistance ( once weekly ) and endurance ( once weekly ) training ( SE ) on muscle mass , maximal strength and power of the leg and arm extensor muscles , and maximal workload ( Wmax ) by using a incremental cycling test in older men . METHODS Thirty-one healthy men ( 65 - 74 yr ) were divided into three treatment groups to train 2x wk(-1 ) for 16 wk : S ( N = 10 ) , E ( N = 11 ) , or SE ( N = 10 ; 1x wk(-1 ) S + 1x wk(-1 ) E ) . The subjects were tested at 8-wk intervals ( i.e. , weeks 8 and 16 ) . RESULTS There were no significant differences between S- and SE-induced muscle hypertrophy ( 11 % and 11 % ) and maximal strength ( 41 % and 38 % ) gains of the legs as well as between E- and SE-induced Wmax ( 28 % and 23 % ) gains . The increase in arm strength in S ( 36 % ) was greater than that recorded in SE ( 22 % ) and greater than that recorded in E ( 0 % ) . CONCLUSIONS Prolonged combined resistance and endurance training in older men seemed to lead to similar gains in muscle mass , maximal strength , and power of the legs as resistance training alone and to similar gains in maximal peak power output measured in an incremental cycling test as endurance training alone . These findings may have an effect on how resistance exercise is prescribed to older adults Purpose To determine if muscle growth is important for increasing muscle strength or if changes in strength can be entirely explained from practicing the strength test . Methods Thirty-eight untrained individuals performed knee extension and chest press exercise for 8 wk . Individuals were r and omly assigned to either a high-volume training group ( HYPER ) or a group just performing the one repetition maximum ( 1RM ) strength test ( TEST ) . The HYPER group performed four sets to volitional failure ( ~8RM–12RM ) , whereas the TEST group performed up to five attempts to lift as much weight as possible one time each visit . Results Data are presented as mean ( 90 % confidence interval ) . The change in muscle size was greater in the HYPER group for both the upper and lower bodies at most but not all sites . The change in 1RM strength for both the upper body ( difference of −1.1 [ −4.8 , 2.4 ] kg ) and lower body ( difference of 1.0 [ −0.7 , 2.8 ] kg for dominant leg ) was not different between groups ( similar for nondominant ) . Changes in isometric and isokinetic torque were not different between groups . The HYPER group observed a greater change in muscular endurance ( difference of 2 [ 1,4 ] repetitions ) only in the dominant leg . There were no differences in the change between groups in upper body endurance . There were between-group differences for exercise volume ( mean [ 95 % confidence interval ] ) of the dominant ( difference of 11,049.3 [ 9254.6–12,844.0 ] kg ) leg ( similar for nondominant ) and chest press with the HYPER group completing significantly more total volume ( difference of 13259.9 [ 9632.0–16,887.8 ] kg ) . Conclusions These findings suggest that neither exercise volume nor the change in muscle size from training contributed to greater strength gains compared with just practicing the
Output:
| Conclusions The results of the present systematic review and meta- analysis suggest a significant effect of RT frequency as higher training frequencies are translated into greater muscular strength gains .
However , these effects seem to be primarily driven by training volume because when the volume is equated , there was no significant effect of RT frequency on muscular strength gains .
Thus , from a practical st and point , greater training frequencies can be used for additional RT volume , which is then likely to result in greater muscular strength gains .
However , it remains unclear whether RT frequency on its own has significant effects on strength gain .
It seems that higher RT frequencies result in greater gains in muscular strength on multi-joint exercises in the upper body and in women , and , finally , in contrast to older adults , young individuals seem to respond more positively to greater RT frequencies . |
MS211063 | ***TASK*** the task is to summarize an input biomedical literature in 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: Inspiring a hyperoxic ( H ) gas permits subjects to exercise at higher power outputs while training , but there is controversy as to whether this improves skeletal muscle oxidative capacity , maximal O(2 ) consumption ( Vo(2 max ) ) , and endurance performance to a greater extent than training in normoxia ( N ) . To determine whether the higher power output during H training leads to a greater increase in these parameters , nine recreationally active subjects were r and omly assigned in a single-blind fashion to train in H ( 60 % O(2 ) ) or N for 6 wk ( 3 sessions/wk of 10 x 4 min at 90 % Vo(2 max ) ) . Training heart rate ( HR ) was maintained during the study by increasing power output . After at least 6 wk of detraining , a second 6-wk training protocol was completed with the other breathing condition . Vo(2 max ) and cycle time to exhaustion at 90 % of pretraining Vo(2 max ) were tested in room air pre- and posttraining . Muscle biopsies were sample d pre- and posttraining for citrate synthase ( CS ) , beta-hydroxyacyl-coenzyme A dehydrogenase ( beta-HAD ) , and mitochondrial aspartate aminotransferase ( m-AsAT ) activity measurements . Training power outputs were 8 % higher ( 17 W ) in H vs. N. However , both conditions produced similar improvements in Vo(2 max ) ( 11 - 12 % ) ; time to exhaustion ( approximately 100 % ) ; and CS ( H , 30 % ; N , 32 % ) , beta-HAD ( H , 23 % ; N , 21 % ) , and m-AsAT ( H , 21 % ; N , 26 % ) activities . We conclude that the additional training stimulus provided by training in H was not sufficient to produce greater increases in the aerobic capacity of skeletal muscle and whole body Vo(2 max ) and exercise performance compared with training in UNLABELLED Both time-to-exhaustion ( TTE ) and time-trial ( TT ) exercise tests are commonly used to assess exercise performance , but no study has directly examined the reliability of comparable tests in the same subjects . PURPOSE To evaluate the reliability of comparable TTE and TT treadmill running tests of high and moderately high exercise intensity in endurance-trained male distance runners , and to vali date Hinckson and Hopkins TT prediction methods using log-log modeling from TTE results . METHODS After familiarization tests , eight endurance-trained male distance runners performed , in a r and omized , counterbalanced order , eight trials consisting of two 5-km TT and two 1500-m TT , and four TTE tests run at a speed equivalent to the average speed attained during both the 5-km and 1500-m TT distances . RESULTS Typical error of the estimate ( TEE ) expressed as a coefficient of variation for the 5-km TT , 5-km TTE , 1500-m TT , and 1500-m TTE were 2.0 , 15.1 , 3.3 , and 13.2 % , respectively . The st and ard error of the estimate for predicted TT running speed using log-log modeling from TTE results was 0.67 % , and the predicted versus criterion reliability of this method revealed TEE values of 1.6 % and 2.5 % for the prediction of 5-km and 1500-m TT , respectively . CONCLUSION The variability of 5-km and 1500-m TT tests was significantly less than for similar TTE treadmill protocol s. Despite the greater variability of the TTE tests , log-log modeling using the TTE test results reliably predicted actual TT performance The combined effects of hyperventilation and arterial desaturation on cerebral oxygenation ( [ Formula : see text ] ) were determined using near-infrared spectroscopy . Eleven competitive oarsmen were evaluated during a 6-min maximal ergometer row . The study was r and omized in a double-blind fashion with an inspired O2 fraction of 0.21 or 0.30 in a crossover design . During exercise with an inspired O2 fraction of 0.21 , the arterial CO2 pressure ( 35 ± 1 mmHg ; mean ± SE ) and O2 pressure ( 77 ± 2 mmHg ) as well as the hemoglobin saturation ( 91.9 ± 0.7 % ) were reduced ( P < 0.05).[Formula : see text ] was reduced from 80 ± 2 to 63 ± 2 % ( P < 0.05 ) , and the near-infrared spectroscopy-determined concentration changes in deoxy- ( ΔHb ) and oxyhemoglobin ( ΔHbO2 ) of the vastus lateralis muscle increased 22 ± 3 μM and decreased 14 ± 3 μM , respectively ( P < 0.05 ) . Increasing the inspired O2fraction to 0.30 did not affect ventilation ( 174 ± 4 l/min ) , but arterial CO2 pressure ( 37 ± 2 mmHg ) , O2 pressure ( 165 ± 5 mmHg ) , and hemoglobin O2saturation ( 99 ± 0.1 % ) increased ( P < 0.05).[Formula : see text ] remained close to the resting level during exercise ( 79 ± 2 vs. 81 ± 2 % ) , and although the muscle ΔHb ( 18 ± 2 μM ) and ΔHbO2 ( -12 ± 3 μM ) were similar to those established without O2 supplementation , work capacity increased from 389 ± 11 to 413 ± 10 W ( P < 0.05 ) . These results indicate that an elevated inspiratory O2fraction increases exercise performance related to maintained cerebral oxygenation rather than to an effect on the working muscles The aim of this study was to determine whether the decreased muscle and blood lactate during exercise with hyperoxia ( 60 % inspired O2 ) vs. room air is due to decreased muscle glycogenolysis , leading to decreased pyruvate and lactate production and efflux . We measured pyruvate oxidation via PDH , muscle pyruvate and lactate accumulation , and lactate and pyruvate efflux to estimate total pyruvate and lactate production during exercise . We hypothesized that 60 % O2 would decrease muscle glycogenolysis , result ing in decreased pyruvate and lactate contents , leading to decreased muscle pyruvate and lactate release with no change in PDH activity . Seven active male subjects cycled for 40 min at 70 % VO2 peak on two occasions when breathing 21 or 60 % O2 . Arterial and femoral venous blood sample s and blood flow measurements were obtained throughout exercise , and muscle biopsies were taken at rest and after 10 , 20 , and 40 min of exercise . Hyperoxia had no effect on leg O2 delivery , O2 uptake , or RQ during exercise . Muscle glycogenolysis was reduced by 16 % with hyperoxia ( 267 + /- 19 vs. 317 + /- 21 mmol/kg dry wt ) , translating into a significant , 15 % reduction in total pyruvate production over the 40-min exercise period . Decreased pyruvate production during hyperoxia had no effect on PDH activity ( pyruvate oxidation ) but significantly decreased lactate accumulation ( 60 % : 22.6 + /- 6.4 vs. 21 % : 31.3 + /- 8.7 mmol/kg dry wt ) , lactate efflux , and total lactate production over 40 min of cycling . Decreased glycogenolysis in hyperoxia was related to an approximately 44 % lower epinephrine concentration and an attenuated accumulation of potent phosphorylase activators ADPf and AMPf during exercise . Greater phosphorylation potential during hyperoxia was related to a significantly diminished rate of PCr utilization . The tighter metabolic match between pyruvate production and oxidation result ed in a decrease in total lactate production and efflux over 40 min of exercise during hyperoxia Abstract Six male rowers rowed maximally for 2500 m in ergometer tests during normoxia ( fractional concentration of oxygen in inspired air , FIO2 0.209 ) , in hyperoxia ( FIO2 0.622 ) and in hypoxia ( FIO2 0.158 ) in a r and omized single-blind fashion . Oxygen consumption ( V˙O2 ) , force production of strokes as well as integrated electromyographs ( iEMG ) and mean power frequency ( MPF ) from seven muscles were measured in 500-m intervals . The iEMG signals from individual muscles were summed to represent overall electrical activity of these muscles ( sum-iEMG ) . Maximal force of a stroke ( Fmax ) decreased from the 100 % pre-exercise maximal value to 67 ( SD 12)% , 63 ( SD 15)% and 76 ( SD 13)% ( P<0.05 to normoxia , ANOVA ) and impulse to 78 ( SD 4)% , 75 ( SD 14)% and 84 ( SD 7)% ( P<0.05 ) in normoxia , hypoxia and hyperoxia , respectively . A strong correlation between Fmax and V˙O2 was found in normoxia but not in hypoxia and hyperoxia . The mean sum-iEMG tended to be lower ( P<0.05 ) in hypoxia than in normoxia but hyperoxia had no significant effect on it . In general , FIO2 did not affect MPF of individual muscles . In conclusion , it was found that force output during ergometer rowing was impaired during hypoxia and improved during hyperoxia when compared with normoxia . Moreover , the changes in force output were only partly accompanied by changes in muscle electrical activity as sum-iEMG was affected by hypoxic but not by hyperoxic gas . The lack of a significant correlation between Fmax and V˙O2 during hypoxia and hyperoxia may suggest a partial uncoupling of these processes and the existence of other limiting factors in addition to V˙O2 This investigation explored the influence of supplemental oxygen administered during the recovery periods of an interval-based running session on the post-exercise markers of reactive oxygen species ( ROS ) and inflammation . Ten well-trained male endurance athletes completed two sessions of 10 × 3 min running intervals at 85 % of the maximal oxygen consumption velocity ( vVO2peak ) on a motorised treadmill . A 90-s recovery period was given between each interval , during which time the participants were administered either a hyperoxic ( HYP ) ( Fraction of Inspired Oxygen ( FIO2 ) 99.5 % ) or normoxic ( NORM ) ( FIO2 21 % ) gas , in a r and omized , single-blind fashion . Pulse oximetry ( SpO2 ) , heart rate ( HR ) , blood lactate ( BLa ) , perceived exertion ( RPE ) , and perceived recovery ( TQRper ) were recorded during each trial . Venous blood sample s were taken pre-exercise , post-exercise and 1 h post-exercise to measure Interleukin-6 ( IL-6 ) and Isoprostanes ( F2-IsoP ) . The SpO2 was significantly lower than baseline following all interval repetitions in both experimental trials ( p < 0.05 ) . The SpO2 recovery time was significantly quicker in the HYP when compared to the NORM ( p < 0.05 ) , with a trend for improved perceptual recovery . The IL-6 and F2-IsoP were significantly elevated immediately post-exercise , but had significantly decreased by 1 h post-exercise in both trials ( p < 0.05 ) . There were no differences in IL-6 or F2-IsoP levels between trials . Supplemental oxygen provided during the recovery periods of interval based exercise improves the recovery time of SPO2 but has no effect on post-exercise ROS or inflammatory responses It has been shown that peak oxygen uptake ( % MathType!MTEF!2!1!+- % feaafaart1ev1aqatCvAUfeBSn0BKvguHDwzZbqefeKCPfgBGuLBPn % 2BKvginnfarmWu51MyVXgatuuDJXwAK1uy0HwmaeHbfv3ySLgzG0uy % 0Hgip5wzaebbnrfifHhDYfgasaacH8srps0lbbf9q8WrFfeuY-Hhbb % f9v8qqaqFr0xc9pk0xbba9q8WqFfea0-yr0RYxir-Jbba9q8aq0-yq % -He9q8qqQ8frFve9Fve9Ff0dmeaabaqaceGacaGaaeqabaWaaeWaea % aakeaaceWGwbGbaiaaaaa!3A5B ! $ $ { \dot{V}}$$ O2peak ) during leg exercise is enhanced by an increased inspiratory oxygen fraction ( FiO2 ) , indicating that oxygen supply is the limiting factor . Whether oxygen supply is a limiting factor in arm exercise performance is unknown . The purpose of this study , therefore , was to examine the effect of different levels of FiO2 on % MathType!MTEF!2!1!+- % feaafaart1ev1aqatCvAUfeBSn0BKvguHDwzZbqefeKCPfgBGuLBPn % 2BKvginnfarmW
Output:
| Conclusion Acute exercise performance is increased with hyperoxia .
An FiO2 ≥ 0.30 appears to be beneficial for performance , with a higher FiO2 being correlated to greater performance improvement in TTs , TTE , and dynamic muscle function tests .
Exercise training and recovery supplemented with hyperoxic gas appears to have a beneficial effect on subsequent exercise performance , but small sample size and wide disparity in experimental protocol s preclude definitive conclusions |
MS211064 | ***TASK*** the task is to summarize an input biomedical literature in 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 provide clinicians with a brief screening tool to predict accurately which individuals may develop aberrant behaviors when prescribed opioids for chronic pain . DESIGN One hundred and eighty-five consecutive new patients treated in one pain clinic took the self-administered Opioid Risk Tool ( ORT ) . The ORT measured the following risk factors associated in scientific literature with substance abuse : personal and family history of substance abuse ; age ; history of preadolescent sexual abuse ; and certain psychological diseases . Patients received scores of 0 - 3 ( low risk ) , 4 - 7 ( moderate risk ) , or > or= 8 ( high risk ) , indicating the probability of their displaying opioid-related aberrant behaviors . All patients were monitored for aberrant behaviors for 12 months after their initial visits . RESULTS For those patients with a risk category of low , 17 out of 18 ( 94.4 % ) did not display an aberrant behavior . For those patients with a risk category of high , 40 out of 44 ( 90.9 % ) did display an aberrant behavior . The authors used the c statistic to vali date the ORT , because it simultaneously assesses sensitivity and specificity . The ORT displayed excellent discrimination for both the male ( c = 0.82 ) and the female ( c = 0.85 ) prognostic models . CONCLUSION In a preliminary study , among patients prescribed opioids for chronic pain , the ORT exhibited a high degree of sensitivity and specificity for determining which individuals are at risk for opioid-related , aberrant behaviors . Further studies in a variety of pain and nonpain setting s are needed to determine the ORT 's universal applicability Assessing for the presence of addiction in the chronic pain patient receiving chronic opioid analgesia is a challenging clinical task . This paper presents a recently developed screening tool for addictive disease in chronic pain patients , and pilot efficacy data describing its ability to do so . In a small sample of patients ( n = 52 ) referred from a multidisciplinary pain center for " problematic " medication use , responses to the screening question naire were compared between patients who met combined diagnostic criteria for a substance use disorder and those who did not , as assessed by a trained addiction medicine specialist . Responses of addicted patients significantly differed from those of nonaddicted patients on multiple screening items , with the two groups easily differentiated by total question naire score . Further , three key screening indicators were identified as excellent predictors for the presence of addictive disease in this sample of chronic pain patients The Prescription Drug Use Question naire ( PDUQ ) is one of several published tools developed to help clinicians better identify the presence of opioid abuse or dependence in patients with chronic pain . This paper introduces a patient version of the PDUQ ( PDUQp ) , a 31-item question naire derived from the items of the original tool design ed for self-administration , and describes evidence for its validity and reliability in a sample of patients with chronic nonmalignant pain and on opioid therapy . Further , this study examines instances of discontinuation from opioid medication treatment related to violation of the medication agreement in this population , and the relationship of these with problematic opioid misuse behaviors , PDUQ and PDUQp scores . A sample of 135 consecutive patients with chronic nonmalignant pain was recruited from a multidisciplinary Veterans Affairs chronic pain clinic , and prospect ively followed over one year of opioid therapy . Using the PDUQ as a criterion measure , moderate to good concurrent and predictive validity data for the PDUQp are presented , as well as item-by-item comparison of the two formats . Reliability data indicate moderate test stability over time . Of those patients whose opioid treatment was discontinued due to medication agreement violation-related discontinuation ( MAVRD ) ( n=38 or 28 % of sample ) , 40 % of these ( n=11 ) were due to specific problematic opioid misuse behaviors . Based upon specificity and sensitivity analyses , a suggested cutoff PDUQp score for predicting MAVRD is provided . This study supports the PDUQp as a useful tool for assessing and predicting problematic opioid medication use in a chronic pain patient sample BACKGROUND : We recently described a method to identify drug diversion in the operating room ( OR ) from automated drug dispensing carts by anesthesia care providers , based on a retrospective outlier analysis of atypical transactions . Such transactions included those occurring on patients after their exit from the OR and on patients whose drugs were not dispensed at the location where the case was performed . In this report , we demonstrate prospect ively the utility of our methodology to detect diversion by unsuspected individuals . METHODS : Each month , all transactions involving scheduled drugs by anesthesia care providers are downloaded from the pharmacy data base and matched to case records from the anesthesia information management system . The frequency of atypical transactions is determined for each provider , normalized by the number of days they worked in the OR . For individuals who are > 2 SDs above the mean for the month for any of the screening queries , a manual examination of their drug transaction logs is performed . Anesthesia records for such providers are examined manually to help determine the likelihood that diversion is taking place , and evidence of escalating activity is considered . Actions taken depend on an assessment of the strength of the evidence that diversion has been occurring . RESULTS : Two unsuspected individuals were identified prospect ively as diverting drugs . Two individuals identified as abusing drugs recreationally outside the workplace showed no evidence of drug diversion through examination of the screening reports and transaction logs , and their rehabilitation treatment teams concurred that there was a very low probability of diversion . A final individual who demonstrated suspicious activity by the screening process was determined to have been careless in documentation practice s , rather than diverting . CONCLUSIONS : The drug diversion screening methodology previously developed is valid for the prospect i ve detection of unsuspected individuals diverting drugs from the OR . The system also provides material useful in the evaluation of possible diversion by anesthesia providers determined to be abusing drugs outside the workplace
Output:
| Discussion Automated algorithms can facilitate population -level surveillance .
However , there is no true gold st and ard for determining nonmedical opioid use .
Few algorithms have been applied in real-world setting s. Conclusion Automated algorithms may facilitate identification of patients and /or providers most likely to need more intensive screening and /or intervention for nonmedical opioid use . |
MS211065 | ***TASK*** the task is to summarize an input biomedical literature in 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 / PURPOSE It is reported that the main mechanism responsible for gastroesophageal reflux ( GER ) is transient lower esophageal sphincter ( LES ) relaxation in children . However , the effect of Nissen fundoplication on transient LES relaxation has not been investigated in children . This study examined the effect of Nissen fundoplication on motor patterns of the LES in children with pathological GER . METHODS Esophageal manometry and pH were recorded concurrently for 2 hours after administration of apple juice ( 10 mL/kg ) . In seven children documented to have pathological GER by prolonged esophageal pH monitoring ( % time pH less than 4.0>5.0 ) , studies were performed preoperatively and 1 to 3 months after surgery . RESULTS Nissen fundoplication virtually eliminated reflux in all patients . Percentage of time pH was less than 4.0 reduced from 15+/-9 to 0+/-0 . Basal LES pressure did not change significantly ( pre , 21+/-10 mm Hg v post , 27+/-9 mm Hg ) . The number of transient LES relaxation reduced significantly from 13+/-4 to 7+/-7 , and the mean nadir LES pressures during swallow-induced LES relaxation and transient LES relaxation increased significantly from 1+/-1 mm Hg to 13+/-5 mm Hg and from 0+/-0 mm Hg to 11+/-7 mm Hg , respectively . CONCLUSIONS Our findings suggest the antireflux effects of Nissen fundoplication may be based on changes of LES motor patterns that result in incomplete LES relaxation and reduction of the number of transient LES relaxation OBJECTIVES To study the effect of Nissen fundoplication and gastrostomy in severely neurologically impaired children . DESIGN Prospect i ve observational study . SETTING Developmental Disabilities Unit of a regional medical centre in Hong Kong . PATIENTS Children with severe neurological impairment and gastroesophageal reflux who were institutionalised between 1999 and 2004 inclusive . MAIN OUTCOME MEASURES Incidence of vomiting , gastro-intestinal bleeding , and pneumonia in the baseline year and consecutive years following surgery ; 24-hour oesophageal pH monitoring ; recurrence rate ( determined by 24-hour oesophageal monitoring ) ; body weight ; complications of surgery ; and mortality . RESULTS Twenty children , with a mean age at surgery of 8.5 ( st and ard deviation , 3.5 ) years , were recruited . Nissen fundoplication was performed in nine children and 11 children underwent laparoscopic fundoplication . Children were monitored for 1.3 to 5.7 years ( median , 3.5 years ) after surgery . The incidence of vomiting and gastro-intestinal bleeding was significantly decreased following surgery ( P < 0.001 and P = 0.001 , respectively ; Friedman 's test ) . There was no difference between the preoperative and postoperative incidence of pneumonia ( P = 0.973 , Friedman 's test ) . The median reflux index was reduced from 5.7 % to 0.15 % after surgery but six ( 30 % ) patients had recurrent gastroesophageal reflux . The mean body weight was 17.4 kg ( st and ard deviation , 4.7 kg ) at baseline and 22.8 kg ( st and ard deviation , 4.4 kg ) at the end of follow-up ( P < 0.05 , Student 's t test ) . One patient had mild dumping syndrome soon after fundoplication . One patient had one episode of intestinal obstruction . Four patients died 1.9 to 5.0 years following surgery due to respiratory disease . CONCLUSION Our results indicate that in severely neurologically impaired children with gastroesophageal reflux , vomiting , gastro-intestinal bleeding , and reflux indices based on 24-hour oesophageal pH monitoring were significantly reduced following fundoplication and gastrostomy . The incidence of pneumonia was unchanged . The recurrence rate of reflux was 30 % and mortality rate was 20 % Background : Skepticism is still present today about the laparoscopic treatment of gastro-esophageal reflux ( GER ) in children . We present the prospect i ve experience and short-term results of eight Italian pediatric surgical units . Methods : We included all the children with complicated GER , operated after January 1998 by single surgeons from eight different centers . Diagnostic aspects , type of fundoplication , and complications were considered . All the patients were followed for a minimum period of 6 months in order to detect complications or recurrences . Results : 288 children were prospect ively included . Mean age was 4.8 years ( 3 m–14 y ) . Nissen fundoplication was done in 25 % , floppy Nissen in 63 % , Toupet in 1.7 % , and anterior procedures ( Lortat Jacob , Thal ) in 10 % . Gastrostomy was associated , if neurological impairment or feeding disorders were present . Mean follow-up was 15 months and reoperation was necessary in 3.8 % of cases . Conclusions : This experience underlines that minimal invasive access surgery in children is safe and that the laparoscopic approach is considered in eight centers the golden st and ard for surgical repair of gastro-esophageal reflux disease maintaining the same indications and techniques of the open approach Laparoscopic antireflux surgery has been performed in neurologically impaired and scoliotic children . We aim ed to assess the effectiveness of laparoscopic fundoplication in mentally normal children with gastroesophageal reflux disease that failed to respond to medical therapy . Data were prospect ively collected ( symptoms , medical therapy , endoscopies ' findings ) on 12 children ( nine boys , three girls ) aged 9 - 15 years with gastroesophageal reflux disease . Pre- and postoperative ambulatory 24-h pH and DeMeester and Johnson scores were also recorded . Effectiveness of surgery was assessed by comparison of pre- and postoperative total acid exposure time , Visick grade , need for antireflux medication and symptom scores . In total , 11 children underwent a laparoscopic Nissen fundoplication and one underwent a Toupet procedure . Median length of stay was 2 ( 2 - 3 ) nights . The median preoperative pH acid exposure time ( AET ) was 4.7 ( 0.8 - 16.4 ) percent compared with postoperative AET of 0.4 ( 0 - 3 ) percent . Early postoperative dysphagia occurred in four out of 12 patients , requiring a total of six dilatations . Postoperative Visick scores were : grade I=7 and grade II=5 . Laparoscopic fundoplication can be safely performed and is effective in children with GERD who have failed to respond to medical therapy Aim : We investigated the impact of laparoscopic anterior hemifundoplication on gastric emptying ( GE ) and specific symptoms in children with and children without neurodevelopmental delays gastroesophageal reflux . Scintigraphic and ultrasonographic GE measurements were correlated . Patients and Methods : Twenty-six children ( mean age 7 ± 6.1 years ) , of whom 14 were neurodevelopmentally delayed , were evaluated prospect ively before 3 and 6 months after laparoscopic anterior hemifundoplication . All of the patients underwent clinical assessment s , interviews , and 24-hour pH monitoring . Key symptoms were evaluated using a 5-point Likert scale . Gastric emptying was assessed by Tc-99m-DTPA-scintigraphy and ultrasonography . Results : All of the children had significant catch-up growth after fundoplication , which was more pronounced in the neurologically normal children ( P < 0.05 vs impaired ) , in line with a decrease in the use of omeprazol ( mean 0.93 ± 0.7 mg · kg−1 · day−1 before and 0.06 ± 0.18 mg · kg−1 · day−1 at 6 months after operation ; P < 0.001 ) . The 24-hour pH monitoring normalized in all of the children , and the mean severity of the key symptoms such as vomiting , choking , and pain was significantly reduced ( P < 0.001 ) . Scintigraphic GE parameters , such as the elimination rate/minute , gastric half-emptying time ( t1/2 ) , gastric residual activity ( RA ) , and duration of the initial merging time , were not altered significantly by the operation ( P > 0.05 ) . Ultrasonographic evaluations confirmed these results [ positive correlation with scintigraphy for t1/2 ( P = 0.006 ) and RA ( P = 0.01 ) ] . The symptoms evolution and GE were uncorrelated ( P > 0.01 ) . There were no significant differences between children with and children without neurodevelopmental delays . Conclusions : Laparoscopic anterior hemifundoplication achieves an excellent symptomatic outcome without affecting GE in children with and children without neurodevelopmental delays Objectives : Bloating , abdominal pain , and early satiety have been reported in up to 30 % of patients after Nissen fundoplication . We hypothesized that these postsurgical complications in children and young adults are linked to either the effects of surgery on gastric sensation , compliance or motor function or to preexisting physiological abnormalities . Methods : We prospect ively evaluated the effect of Nissen fundoplication on gastric sensory and motor functions in 13 children with gastroesophageal reflux . Gastric barostat and mixed meal gastric emptying studies were performed before surgery in all patients and were repeated after surgery in 8 and 9 children , respectively . Results : Thirteen patients ( median age , 7 years ; range , 6 months to 18 years ) underwent open Nissen ( n = 6 ) or laparoscopic Nissen fundoplication ( n = 7 ) . After fundoplication , patients had significantly higher minimal distending pressure values ( 10 mm Hg vs 3 mm Hg pre-Nissen , respectively ; P < 0.001 ) , reduced gastric compliance ( slope values of 8.39 mm Hg vs 9.15 mm Hg , respectively , P < 0.001 ) and significantly higher pain scores ( P < 0.001 ) . Presurgery and postsurgery gastric emptying at 60 , 90 and 120 minutes after feeding showed no significant changes . Conclusions : After Nissen fundoplication , children with gastroesophageal reflux manifest the following : ( 1 ) reduction in gastric compliance , ( 2 ) increase in minimal gastric distending pressure , ( 3 ) exacerbation of the sensations discomfort with gastric distension and ( 4 ) no effect on gastric emptying Background The laparoscopic approach has become increasingly popular for fundoplication over the last few years ; however many surgeons are skeptical about its real advantages . Methods We conducted a prospect i ve comparative study of children operated on for gastroesophageal reflux ( GER ) . Exclusion criteria included age < 1 year and > 14 years , previous surgery on the esophagus or stomach , and neurologic impairment . We compared two groups of patients who met the same inclusion /exclusion criteria . One group was treated via a laparotomic approach between January 1993 and December 1997 ; the other was treated via a laparoscopic approach between September 1998 and December 2000 . A 360 ° wrap was performed in each group . Results Group 1 ( laparotomic approach ) included 17 patients ; mean operative time was 100 min and postoperative time was 7 days . Group 2 comprised 49 children operated on via a laparoscopic approach ; mean operative time was 78 min and postoperative time was 48 hours . No major complications were encountered in either group . In postoperative period , two patients in group 1 had complications . One had a prolonged bout of gastroplegia , which required nasogastric drainage , and then recovered spontaneously after 20 days ; the other had stenosis of the wrap , which required dilation . No relapses occurred during a follow-up of 6 months . Longterm follow-up data are not presented . Comparative analysis of the short-term functional results indicated that there were no differences between the two groups . Conclusion This study confirms that the minimally invasive approach is safe and effective for the treatment of primary gastroesophageal reflux disease in children CONTEXT AND OBJECTIVE Association between neurological lesions and gastroesophageal reflux disease ( GERD ) in children is very common . When surgical treatment is indicated , the consensus favors the fundoplication technique recommended by Nissen , despite its high morbidity and relapse rates . Vertical gastric plication is a procedure that may have advantages over Nissen fundoplication , since it is less aggressive and more adequately meets anatomical principles . The authors proposed to compare the results from the Nissen and vertical gastric plication techniques . DESIGN AND SETTING R and omized prospect i ve study within the Postgraduate Surgery and Experimentation Program of UNIFESP-EPM , at Hospital do Servidor Público Estadual ( IAMSPE ) and Hospital Municipal Infantil Menino Jesus . METHODS Fourteen consecutive children with cerebral palsy attended between November 2003 and July 2004 were r and omized into two groups for surgical treatment of GERD : NF , Nissen fundoplication ( n = 7 ) ; and VGP , vertical gastric plication ( n = 7 ) . These were clinical ly assessed by scoring for signs and symptoms
Output:
| However , less postoperative dysphagia was observed after partial fundoplication and laparoscopic ARS was associated with less pain medication and a shorter hospital stay .
Complications of ARS varied from minimal postoperative complications to severe dysphagia and gas bloating .
Conclusion ARS in children shows a good overall success rate ( median 86 % ) in terms of complete relief of symptoms .
Efficacy of ARS in neurologically impaired children may be similar to normally developed children .
The outcome of ARS does not seem to be influenced by different surgical techniques , although postoperative dysphagia may occur less after partial fundoplication . |
MS211066 | ***TASK*** the task is to summarize an input biomedical literature in 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 ( 1 ) whether telephone follow-up using a st and ardized telemonitoring tool can influence the nature and extent to which antidepressant users provide feedback to pharmacists , ( 2 ) whether patient characteristics are associated with the extent of patient feedback , and ( 3 ) how patient feedback affects subsequent outcomes after controlling for patient characteristics . DESIGN R and omized , controlled , experimental design . SETTING Eight Wisconsin community pharmacies within a large managed care organization . PATIENTS 60 patients presenting new antidepressant prescriptions . INTERVENTIONS Three monthly telephone calls from pharmacists providing structured education and monitoring . MAIN OUTCOME MEASURES Frequency of patient feedback to pharmacists , antidepressant knowledge , beliefs , percentage of missed doses , depression symptom scores , and perceptions of progress . RESULTS Compared with usual care patients ( n=32 ) , pharmacist-guided education and monitoring ( PGEM ) patients ( n=28 ) provided significantly more feedback to pharmacists regarding different aspects of their antidepressant therapy even after controlling for patient characteristics . Regression results also showed that patient feedback was significantly associated with greater antidepressant knowledge , positive antidepressant beliefs , and perceptions of progress after 3 months . Patient feedback was unrelated to nonadherence and depressive symptoms . CONCLUSION Structured education and monitoring by pharmacists significantly improves the level of patient feedback to pharmacists , and such feedback may help pharmacists identify and address their patients ' misconceptions , concerns , and progress with antidepressant therapy Among a sample of 119 distressed high-utilizers of primary care , 45 % of patients evaluated by a psychiatrist as needing antidepressant treatment had been treated in the year before the examination . However , only 11 % of the patients needing antidepressants had received adequate dosage and duration of pharmacotherapy . In the year following the intervention , study patients whose physicians were advised regarding treatment during a psychiatric consultation were more likely to receive antidepressant medications ( 52.7 % ) relative to a r and omized control group ( 36.1 % ) . However , the intervention did not significantly increase the provision of adequate antidepressant therapy ( 37.1 % vs 27.9 % ) . Among study patients using antidepressants , patient characteristics did not differentiate patients who received adequate dosage and duration of antidepressant medications from those who did not . Analysis of data on the duration of antidepressant therapy for all health maintenance organization enrollees initiating use of antidepressants showed that only 20 % of patients who had been given prescriptions for first-generation antidepressants ( amitriptyline , imipramine , or doxepin ) filled four or more prescriptions in the following six months , compared to 34 % of patients who had prescriptions for newer antidepressants ( nortriptyline , desipramine , trazodone and fluoxetine ) . Experimental research evaluating whether these newer medications ( with more favorable side effect profiles ) improve adherence , and thereby patient outcome , is needed OBJECTIVE The most common ways of assessing adherence to oral antipsychotic medications in research and in clinical practice are self-report and physician report . This prospect i ve study examined the agreement among measures of adherence to oral antipsychotic medications among 52 out patients with schizophrenia . METHODS Participants were assessed at baseline during a visit to their outpatient clinic and followed for 12 weeks . Adherence was assessed by using subjective measures ( self-report and physician report ) and objective measures ( pill counts conducted in the home , electronic monitoring , and blood plasma concentrations ) . Electronic monitoring was used as an imperfect st and ard against which other methods were judged . RESULTS Data from pill counts and from electronic monitoring were strongly correlated ( r(k)=.61 ) . Self-report and physicians ' ratings of compliance were weakly correlated with pill count and electronic monitoring when compliance scores were examined with rank-order correlations ( r(k)=.18-.32 ) . When the sample was dichotomized into adherent and nonadherent groups on the basis of electronic monitoring or pill count ( at least 80 % adherent ) , neither physicians nor patients identified adherent behavior ( kappa < or=20 ) . Blood plasma concentrations were not correlated with any other measures of adherence ( kappa < or=20 ) . Self-report and physician report were best correlated with clinical state ( r(k)=-.27 , r(k)=-.25 ) , suggesting that patients and treating professionals may use clinical state to estimate adherence . CONCLUSIONS Patients and physicians were not able to identify adherence . The inability of physicians to accurately identify adherent individuals is likely to have important consequences for prescribing behavior , health care costs , and patient outcomes The object of the study was to evaluate outcomes of a r and omized clinical trial ( RCT ) of a pharmacist intervention for depressed patients in primary care ( PC ) . We report antidepressant ( AD ) use and depression severity outcomes at 6-months . The RCT was conducted between 1998 and 2000 in 9 eastern Massachusetts PC practice s. We studied 533 patients with major depression and /or dysthymia as determined by a screening test done at the time of a routine PC office visit . The majority of participants had recurrent depressive episodes ( 63.5 % with > /=4 lifetime episodes ) , and 49.5 % were taking AD medications at enrollment . Consultation in person and by telephone was performed by a clinical pharmacist who assisted the primary care practitioner ( PCP ) and patient in medication choice , dose , and regimen , in accordance with AHCPR depression guidelines . Six-month AD use rates for intervention patients exceeded controls ( 57.5 % vs. 46.2 % , P = .03 ) . Furthermore , the intervention was effective in improving AD use rates for patients not on ADs at enrollment ( 32.3 % vs. 10.9 % , P = .001 ) . The pharmacist intervention proved equally effective in subgroups traditionally considered difficult to treat : those with chronic depression and dysthymia . Patients taking ADs had better modified Beck Depression Inventory ( mBDI ) outcomes than patients not taking ADs , ( -6.3 points change , vs. -2.8 , P = .01 ) but the outcome differences between intervention and control patients were not statistically significant ( 17.7 BDI points vs. 19.4 BDI points , P = .16 ) . Pharmacists significantly improved rates of AD use in PC patients , especially for those not on ADs at enrollment , but outcome differences were too small to be statistically significant . Difficult-to-treat subgroups may benefit from pharmacists ' care The objective of this systematic review was to evaluate the impact of pharmacist delivered community-based services to optimise the use of medications for mental illness . Twenty-two controlled ( r and omised and non-r and omised ) studies of pharmacists ' interventions in community and residential aged care setting s identified in international scientific literature were included for review . Papers were assessed for study design , service recipient , country of origin , intervention type , number of participating pharmacists , method ological quality and outcome measurement . Three studies showed that pharmacists ' medication counselling and treatment monitoring can improve adherence to antidepressant medications among those commencing treatment when calculated using an intention-to-treat analysis . Four trials demonstrated that pharmacist conducted medication review s may reduce the number of potentially inappropriate medications prescribed to those at high risk of medication misadventure . The results of this review provide some evidence that pharmacists can contribute to optimising the use of medications for mental illness in the community setting . However , more well design ed studies are needed to assess the impact of pharmacists as members of community mental health teams and as providers of comprehensive medicines information to people with schizophrenia and bipolar BACKGROUND The prevalence , long-term temporal consistency and factors influencing negative attitudes and poor treatment adherence among psychiatric patients with major depressive disorder ( MDD ) are not well known . METHODS In the Vantaa Depression Study ( VDS ) , a prospect i ve 5-year study of psychiatric patients with DSM-IV MDD , 238 ( 88.5 % ) patients ' attitudes towards and adherence to both antidepressants and psychotherapeutic treatments at baseline , 6 months , 18 months and 5 years was investigated . RESULTS Throughout the follow-up , most patients reported positive attitudes towards pharmacotherapy and psychosocial treatments , and good adherence . While attitudes became more critical over time , adherence to psychosocial treatment improved , but remained unchanged for pharmacotherapy . Employment predicted positive attitude ( OR=1.97 , 95 % CI 1.01 - 3.83 , P=0.046 ) , and larger social network good adherence ( OR=1.11 , 95 % CI 1.00 - 1.23 , P=0.042 ) to pharmacotherapy at the last follow-up . Cluster B personality disorder symptoms predicted negative attitude ( OR=0.82 , 95 % CI 0.70 - 0.96 , P=0.012 ) and poor adherence ( OR=0.83 , 95 % CI 0.72 - 0.95 , P=0.007 ) , but cluster C symptoms positive attitude ( OR=1.30 , 95 % CI 1.09 - 1.54 , P=0.003 ) , and living alone good adherence ( OR=3.13 , 95 % CI 1.10 - 9.09 , P=0.032 ) to psychosocial treatment . LIMITATIONS Patients may exaggerate their adherence to treatments . Attrition from follow-up may occur due to undetected negative change in treatment attitude or adherence . CONCLUSIONS Among psychiatric MDD patients in long-term follow-up , treatment attitudes and adherence to pharmaco- and psychotherapy were and remained mostly positive . They were significantly predicted by personality features and social support . Attention to adherence of those with cluster B personality disorders , or poor social support , may be needed Introduction The efficacy of antidepressants in the treatment of depression has been convincingly demonstrated in r and omised trials . However , non-adherence to antidepressant treatment is common . Objective To evaluate , from a societal perspective , the cost effectiveness of a pharmacy-based intervention to improve adherence to antidepressant therapy in adult patients receiving treatment in primary care . Methods An economic evaluation was performed alongside a 6-month r and omised controlled trial in The Netherl and s. Patients who came to 19 pharmacies with a new prescription for a non-tricyclic antidepressant , i.e. those who had not received any prescription for an antidepressant in the past 6 months , were invited to participate . They were then r and omly allocated to education and coaching by the pharmacist or to usual care . The coaching programme consisted of three contacts with the pharmacist , with a mean duration of between 13 and 20 minutes , and a take-home video review ing important facts on depression and antidepressant treatment . The clinical outcome measures were adherence to antidepressant treatment measured using an electronic pill container ( eDEM ) and improvement in depressive symptoms measured using the Hopkins Symptom Checklist ( SCL ) . Re source use was measured by means of question naires . The uncertainty around differences in costs and cost effectiveness between the treatment groups was evaluated using bootstrapping . Results Seventy patients were r and omised to the intervention group and 81 to the usual care group ; of these , 40 in the intervention group and 48 in the control group completed all of the follow-up question naires . There were no significant differences in adherence , improvements in the SCL depression mean item score and costs over 6 months between the two treatment groups . Mean total costs ( 2002 values ) were € 3275 in the intervention group and € 2961 in the control group ( mean difference € 315 ; 95 % CI —1922 , 2416 ) . The incremental cost-effectiveness ratio associated with the pharmacist intervention was € 149 per 1 % improvement in adherence and € 2550 per point improvement in the SCL depression mean item score . Cost-effectiveness planes and acceptability curves indicated that the pharmacist intervention was not likely to be cost effective compared with usual care . Conclusion In patients starting treatment with antidepressants , there were no significant differences in adherence , severity of depression , costs and cost effectiveness between patients receiving coaching by a pharmacist and patients receiving usual care after 6 months . Considering the re sources needed to implement an intervention like this in clinical practice , based on these results , the continuation of usual care is recommended OBJECTIVE Documentation and evaluation of patient outcomes in a pilot study into the role of rural community pharmacists in the management of depression . DESIGN Parallel groups design with a control and intervention group . SETTING Thirty-two community pharmacies in rural and remote New South Wales , Australia . PARTICIPANTS One hundred and six patient participants , mean age of 46 years , predominantly female , not currently employed , recruited by participating pharmacists . INTERVENTIONS Intervention pharmacists were given video-conference training on the nature and management of depression by a psychiatrist , psychologist and general practitioner and asked to dispense medication with extra advice and support . Control pharmacists were asked to provide usual care . MAIN OUTCOME MEASURES Adherence by self-report , K10 , Drug Attitude Index . RESULTS The results indicated that adherence to medications was high in both groups ( 95 % versus 96 % ) and that both groups had improved significantly in wellbeing ( a reduction K10 score of 4 ( control ) versus 4.7 ( intervention ) ) . No significant
Output:
| The most common intervention strategy that pharmacists utilized was a combination of patient education and drug monitoring .
This review suggests that pharmacist intervention is effective in the improvement of patient adherence to antidepressants . |
MS211067 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE We sought to develop a valid , reliable assessment of intraoperative judgment by residents during gynecologic surgery based on Script Concordance Theory . STUDY DESIGN This was a multicenter prospect i ve study involving 5 obstetrics and gynecology residency programs . Surgeons from each site generated case scenarios based on common gynecologic procedures . Construct validity was evaluated by correlating scores to training level , in-service examinations , and surgical skill and experience using a Global Rating Scale of Operative Performance and case volumes . RESULTS A final test that included 42 case scenarios was administered to 75 residents . Internal consistency ( Cronbach alpha = 0.73 ) and test-retest reliability ( Lin correlation coefficient = 0.76 ) were good . There were significant differences between test scores and training levels ( P = .002 ) and test scores correlated with in-service examination scores ( r = 0.38 ; P = .001 ) . There was no association between test scores and total number of cases or technical skills . CONCLUSION The Script Concordance Test appears to be a reliable , valid assessment tool for intraoperative decision-making during gynecologic surgery Aim : To examine which response options children prefer and which they find easiest to use , and to study the relative reliability of the different response options . Methods : A consecutive group of unselected children ( n= 120 ) filled out three question naires in a paediatric outpatient clinic . Each question naire included seven similar questions , but had different response options : the Likert scale , the Visual Analogue Scale ( VAS ) and the numeric VAS . In general , the questions were not related to the children 's particular diseases , but dealt with the frequency of simple activities , their feelings and opinions . The pages with the three different response options were offered in r and om order . Afterwards , the children rated their preference and ease of use of the different response options on a scale from one to 10 . Results : Children preferred the Likert scale ( median mark 9.0 ) over the numeric VAS ( median mark 8.0 ) and the simple VAS ( median 6.0 ) . They considered the Likert scale easiest to fill out ( median mark 10 vs 9 and 7.5 for the numeric and simple VAS , respectively ) . Results of the different response options correlated strongly with each other ( rho = 0.67–0.90 , p < 0.05 ) Many controlled trials rely on subjective measures of symptoms or quality of life as primary outcomes . The relative merits of different response options for these measures is an important , but largely unexplored , issue . Therefore , we compared the responsiveness of seven-point Likert vs visual analogue scales ( VAS ) in a question naire measuring quality of life in chronic lung disease . The VAS and seven-point scale versions of the question naire were administered to 28 patients before and after completing an inpatient respiratory rehabilitation program of known benefit . For all four dimensions of the question naire ( dyspnea , fatigue , emotional function , and mastery ) the VAS showed a larger improvement than the seven-point scale when both were st and ardized on a scale of 0 - 10 . However , in each case the variability of the improvement was greater using the VAS . The difference in improvement between the two scales was not statistically significant . We conclude that the two methods of presenting response options show comparable responsiveness . The ease of administration and interpretation of the seven-point scale recommend its use in clinical trials OBJECTIVE To report on the creation and administration of an online Script Concordance Test ( SCT ) for ear , nose , and throat ( ENT ) , the ENT-SCT . DESIGN Prospect i ve study . SETTING Two tertiary care university centers . PARTICIPANTS In total , 132 individuals were asked to test an ENT-SCT of 20 cases and 94 questions based on the major educational objectives of the ENT residency program . MAIN OUTCOME MEASURES Three levels of experience were tested : medical students , ENT residents , and board-certified otorhinolaryngologists as the expert panel . The test 's construct validity-whether scores were related to clinical experience-was statistically analyzed . Reliability was estimated by the Cronbach α internal consistency coefficient . Participants ' perception of the test was assessed with the use of a question naire . RESULTS The 65 respondents with usable data were medical students ( n = 21 ) , ENT residents ( n = 22 ) , and experts ( n = 22 ) . Total mean ( SD ) test scores differed significantly : 76.81 ( 3.31 ) for the expert panel , 69.05 ( 4.35 ) for residents , and 58.29 ( 5.86 ) for students . The Cronbach α coefficient was 0.95 . More than two-thirds of the participants found the test to be realistic and relevant for assessing clinical reasoning . The test was also considered fun , interesting , and intuitive . CONCLUSIONS The Web-based ENT-SCT is feasible , reliable , and useful for assessing clinical reasoning . This online assessment tool may have applications for residency programs and continuing medical education
Output:
| Conclusions Although SCT is an interesting test to evaluate clinical decision-making in emergency medicine , our results raise concerns regarding whether the judgments of an expert panel are sufficiently valid as the reference st and ard for this test |
MS211068 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: We present the preliminary toxicity data from the MRC COIN trial , a phase III r and omised controlled trial of first-line therapy in advanced colorectal cancer , with particular reference to the addition of cetuximab to an oxaliplatin – fluoropyrimidine combination . A total of 804 patients were r and omised between March 2005 and July 2006 from 78 centres throughout the United Kingdom . Patients were allocated to oxaliplatin plus fluoropyrimidine chemotherapy with or without the addition of weekly cetuximab . The choice of fluoropyrimidine ( either 5-fluorouracil ( 5FU ) or capecitabine ) was decided by the treating physician and patient before r and omisation . Toxicity data were collected from all patients . Two hundred and three patients received 5FU plus oxaliplatin ( OxMdG , 25 % ) , 333 oxaliplatin+capecitabine ( Xelox , 41 % ) , 102 received OxMdG+cetuximab ( OxMdG+C , 13 % ) and 166 Xelox+cetuximab ( 21 % ) . Percent grade 3/4 toxicities included diarrhoea 6 , 15 , 13 and 25 % , nausea/vomiting 3 , 7 , 7 and 14 % for OxMdG , Xelox , OxMdG+C and Xelox+C , respectively . Sixty-day all-cause mortality was 6 , 5 , 5 and 7 % . Statistically significant differences were evident for patients receiving Xelox+cetuximab vs Xelox alone : diarrhoea relative risk ( RR ) 1.69 ( 1.17 , 2.43 , P=0.005 ) and nausea/vomiting RR 2.01 ( 1.16 , 3.47 , P=0.012 ) . The excess toxicity observed in the oxaliplatin- , capecitabine- , cetuximab-treated patients led the trial management group to conclude that a capecitabine dose adjustment was required to maintain safety levels when using this regimen BACKGROUND Targeting the vascular endothelial growth factor or the epidermal growth factor receptor ( EGFR ) has shown efficacy in advanced colorectal cancer ( ACC ) , but no data are available on the combination of these strategies with chemotherapy in the first-line treatment . The CAIRO2 study evaluates the effect of adding cetuximab , a chimeric mAb against EGFR , to capecitabine , oxaliplatin and bevacizumab in the first-line treatment of ACC . PATIENTS AND METHODS In all , 755 patients were r and omly assigned between treatment with capecitabine , oxaliplatin and bevacizumab with or without cetuximab . The primary end point is progression-free survival . We here present the toxicity results in the first 400 patients that entered the study . RESULTS The incidence of overall grade 3 - 4 toxicity was significantly higher in arm B compared with arm A ( 81 % versus 72 % , P = 0.03 ) . This difference is fully attributed to cetuximab-related skin toxicity . The addition of cetuximab did not result in an increase of gastrointestinal toxicity or treatment-related mortality . CONCLUSIONS The addition of cetuximab to capecitabine , oxaliplatin and bevacizumab in the first-line treatment of ACC appears to be safe and feasible . No excessive or unexpected toxicity in the cetuximab-containing treatment arm was observed Summary Background In the Medical Research Council ( MRC ) COIN trial , the epidermal growth factor receptor (EGFR)-targeted antibody cetuximab was added to st and ard chemotherapy in first-line treatment of advanced colorectal cancer with the aim of assessing effect on overall survival . Methods In this r and omised controlled trial , patients who were fit for but had not received previous chemotherapy for advanced colorectal cancer were r and omly assigned to oxaliplatin and fluoropyrimidine chemotherapy ( arm A ) , the same combination plus cetuximab ( arm B ) , or intermittent chemotherapy ( arm C ) . The choice of fluoropyrimidine therapy ( capecitabine or infused fluouroracil plus leucovorin ) was decided before r and omisation . R and omisation was done central ly ( via telephone ) by the MRC Clinical Trials Unit using minimisation . Treatment allocation was not masked . The comparison of arms A and C is described in a companion paper . Here , we present the comparison of arm A and B , for which the primary outcome was overall survival in patients with KRAS wild-type tumours . Analysis was by intention to treat . Further analyses with respect to NRAS , BRAF , and EGFR status were done . The trial is registered , IS RCT N27286448 . Findings 1630 patients were r and omly assigned to treatment groups ( 815 to st and ard therapy and 815 to addition of cetuximab ) . Tumour sample s from 1316 ( 81 % ) patients were used for somatic molecular analyses ; 565 ( 43 % ) had KRAS mutations . In patients with KRAS wild-type tumours ( arm A , n=367 ; arm B , n=362 ) , overall survival did not differ between treatment groups ( median survival 17·9 months [ IQR 10·3–29·2 ] in the control group vs 17·0 months [ 9·4–30·1 ] in the cetuximab group ; HR 1·04 , 95 % CI 0·87–1·23 , p=0·67 ) . Similarly , there was no effect on progression-free survival ( 8·6 months [ IQR 5·0–12·5 ] in the control group vs 8·6 months [ 5·1–13·8 ] in the cetuximab group ; HR 0·96 , 0·82–1·12 , p=0·60 ) . Overall response rate increased from 57 % ( n=209 ) with chemotherapy alone to 64 % ( n=232 ) with addition of cetuximab ( p=0·049 ) . Grade 3 and higher skin and gastrointestinal toxic effects were increased with cetuximab ( 14 vs 114 and 67 vs 97 patients in the control group vs the cetuximab group with KRAS wild-type tumours , respectively ) . Overall survival differs by somatic mutation status irrespective of treatment received : BRAF mutant , 8·8 months ( IQR 4·5–27·4 ) ; KRAS mutant , 14·4 months ( 8·5–24·0 ) ; all wild-type , 20·1 months ( 11·5–31·7 ) . Interpretation This trial has not confirmed a benefit of addition of cetuximab to oxaliplatin-based chemotherapy in first-line treatment of patients with advanced colorectal cancer . Cetuximab increases response rate , with no evidence of benefit in progression-free or overall survival in KRAS wild-type patients or even in patients selected by additional mutational analysis of their tumours . The use of cetuximab in combination with oxaliplatin and capecitabine in first-line chemotherapy in patients with widespread metastases can not be recommended . Funding Cancer Research UK , Cancer Research Wales , UK Medical Research Council , Merck BACKGROUND Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics : both tumour shrinkage ( objective response ) and disease progression are useful endpoints in clinical trials . Since RECIST was published in 2000 , many investigators , cooperative groups , industry and government authorities have adopted these criteria in the assessment of treatment outcomes . However , a number of questions and issues have arisen which have led to the development of a revised RECIST guideline ( version 1.1 ) . Evidence for changes , summarised in separate papers in this special issue , has come from assessment of a large data warehouse ( > 6500 patients ) , simulation studies and literature review s. HIGHLIGHTS OF REVISED RECIST 1.1 : Major changes include : Number of lesions to be assessed : based on evidence from numerous trial data bases merged into a data warehouse for analysis purpose s , the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total ( and from five to two per organ , maximum ) . Assessment of pathological lymph nodes is now incorporated : nodes with a short axis of 15 mm are considered measurable and assessable as target lesions . The short axis measurement should be included in the sum of lesions in calculation of tumour response . Nodes that shrink to < 10 mm short axis are considered normal . Confirmation of response is required for trials with response primary endpoint but is no longer required in r and omised studies since the control arm serves as appropriate means of interpretation of data . Disease progression is clarified in several aspects : in addition to the previous definition of progression in target disease of 20 % increase in sum , a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small . Furthermore , there is guidance offered on what constitutes ' unequivocal progression ' of non-measurable/non-target disease , a source of confusion in the original RECIST guideline . Finally , a section on detection of new lesions , including the interpretation of FDG-PET scan assessment is included . Imaging guidance : the revised RECIST includes a new imaging appendix with up date d recommendations on the optimal anatomical assessment of lesions . FUTURE WORK A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI . It was concluded that , at present , there is not sufficient st and ardisation or evidence to ab and on anatomical assessment of tumour burden . The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression . As is detailed in the final paper in this special issue , the use of these promising newer approaches requires appropriate clinical validation studies BACKGROUND The growing availability of active agents makes the development of novel therapies increasingly complex and the choice of end points critical . We assessed the frequency of use of efficacy end points in advanced breast cancer . METHODS We search ed PubMed for r and omized trials published between 2000 and 2007 in 10 leading medical journals . We abstract ed data on progression-free survival ( PFS ) , time to tumor progression ( TTP ) , response rate ( RR ) and overall survival . RESULTS A total of 58 studies enrolled 23,371 assessable patients in 122 treatment arms . The primary end points most frequently used were RR and TTP ( n=21 each ) , followed by PFS ( n=14 ) . In five of the trials using TTP as the primary end point , no definition of TTP was reported ; in 13 of the other 16 cases , death was counted as an event , making TTP indistinguishable from PFS . Trials having PFS , TTP or time to treatment failure as the primary end point ( n=36 ) had a higher mean number of patients than those using RR ( P=0.061 ) . CONCLUSION Investigators seem to be frequently using PFS and TTP interchangeably in advanced breast cancer . Such use of terms may lead to confusion when results of different trials are compared , and uniform use of definitions seems in order PURPOSE To compare the efficacy of cediranib ( a vascular endothelial growth factor receptor tyrosine kinase inhibitor [ VEGFR TKI ] ) with that of bevacizumab ( anti-VEGF-A monoclonal antibody ) in combination with chemotherapy as first-line treatment for advanced metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS HORIZON III [ Cediranib Plus FOLFOX6 Versus Bevacizumab Plus FOLFOX6 in Patients With Untreated Metastatic Colorectal Cancer ] had an adaptive phase II/III design . Patients r and omly assigned 1:1:1 received mFOLFOX6 [ oxaliplatin 85 mg/m(2 ) and leucovorin 400 mg/m(2 ) intravenously followed by fluorouracil 400 mg/m(2 ) intravenously on day 1 and then continuous infusion of 2,400 mg/m(2 ) over the next 46 hours every 2 weeks ] with cediranib ( 20 or 30 mg per day ) or bevacizumab ( 5 mg/kg every 14 days ) . An independent end-of-phase II analysis concluded that mFOLFOX6/cediranib 20 mg met predefined criteria for continuation ; subsequent patients received mFOLFOX6/cediranib 20 mg or mFOLFOX6/bevacizumab ( r and omly assigned 1:1 ) . The primary objective was to compare progression-free survival ( PFS ) . RESULTS In all , 1,422 patients received mFOLFOX6/cediranib 20 mg ( n = 709 ) or mFOLFOX6/bevacizumab ( n = 713 ) . Primary analysis revealed no significant difference between arms for PFS ( hazard ratio [ HR ] , 1.10 ; 95 % CI , 0.97 to 1.25 ; P = .119 ) , overall survival ( OS ; HR , 0.9
Output:
| The addition of MA to CT for patients with metastatic colorectal cancer does not prolong GS and PFS |
MS211069 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Topical glucocorticoids are the medical treatment of choice in a majority of patients suffering from nasal polyposis . Fluticasone propionate is a fluorinated steroid reported to be highly effective when used topically in the nose for seasonal and perennial allergic and nonallergic rhinitis . OBJECTIVES To evaluate the efficacy and tolerability of intranasal fluticasone propionate in the treatment of long-st and ing polyposis . METHODS Fifty-five patients with long-st and ing nasal polyposis were treated over a 26-week period with fluticasone propionate aqueous nasal spray 200 micrograms bid , beclomethasone dipropionate aqueous nasal spray 200 micrograms bid or placebo , administered intranasally in an aqueous spray in a double-blind , placebo-controlled parallel-group design at a single center . The primary efficacy endpoint was the physicians ' assessment of symptoms and polyp score . Peak nasal inspiratory flow was performed twice daily and on every visit to evaluate the effect of the corticosteroids on nasal air flow . RESULTS A significant difference in the primary efficacy endpoint between fluticasone propionate aqueous nasal spray and beclomethasone dipropionate aqueous nasal spray compared with placebo was seen after 14 weeks of treatment . This was further verified by the peak nasal inspiratory flow results . There was some evidence of earlier onset in the fluticasone propionate aqueous nasal spray group compared with the beclomethasone dipropionate aqueous nasal spray group after 4 weeks in terms of the primary efficacy endpoint . From the daily record cards patients receiving fluticasone propionate aqueous nasal spray had a significantly higher percentage of days on which they required no rescue medication ( P < .009 ) and a higher percentage of days with an overall nasal blockage score on waking of < 2 ( P < .013 ) when compared with placebo-treated patients . No other statistically significant results were found between the two active compounds . CONCLUSION Fluticasone propionate aqueous nasal spray 200 micrograms bid and beclomethasone dipropionate aqueous nasal spray 200 micrograms bid are effective in treating the symptoms of nasal polyps , with some evidence that fluticasone propionate aqueous nasal spray has a faster onset of action and is tolerated at least as well as beclomethasone dipropionate aqueous nasal spray at the same dose BACKGROUND : Topical nasal steroids such as beclomethasone dipropionate and fluticasone propionate have been widely used in the treatment of rhinitis and polyposis . An increase in infection has occurred with the use of fluticasone propionate after endoscopic polypectomy . OBJECTIVE : The purpose of this study was to determine the prevalence of nasal and paranasal infections with the use of topic nasal steroids after endoscopic polypectomy and to compare the recurrence rates of the polyposis . DESIGN AND SETTING : We conducted a prospect i ve , comparative , open , experimental , longitudinal study at an academic tertiary referral medical center . METHODS : One hundred sixty-two patients in whom endoscopic polypectomy had been indicated were r and omly divided into 3 groups of 54 patients each . The patients from the first group were treated with saline lavage only . Patients from the second group also received fluticasone propionate 400 μg/day in nasal spray after lavage . Patients from the third group received beclomethasone dipropionate 600 μg/day after lavage . The prevalence of infections and recurrence of polyposis was compared in the 3 groups . RESULTS : Three patients , 2 in the placebo group and 1 in the beclomethasone group , developed infections during the first 3 months after surgical procedure . The recurrence of polyps in the group without steroids was 44 % . In contrast , 15 % from the patients treated with fluticasone showed recurrence of polyposis ; furthermore , 26 % of the patients treated with beclomethasone showed recurrence of polypsosis , with a minimum follow-up of 12 months . CONCLUSIONS : The use of nasal steroids does not seem to increase the prevalence of infections after endoscopic polypectomy . ( Otolaryngol Head Neck Surg 2004;130:319–22 . BACKGROUND There is little scientific evidence to support the current practice of using oral glucocorticosteroids and antibiotics to treat patients with chronic rhinosinusitis and nasal polyps . OBJECTIVE We evaluated the effects of oral glucocorticoids and doxycycline on symptoms and objective clinical and biological parameters in patients with chronic rhinosinusitis and nasal polyps . METHODS In a double-blind , placebo-controlled , multicenter trial , we r and omly assigned 47 participants with bilateral nasal polyps to receive either methylprednisolone in decreasing doses ( 32 - 8 mg once daily ) , doxycycline ( 200 mg on the first day , followed by 100 mg once daily ) , or placebo for 20 days . Participants were followed for 12 weeks . Patients were assessed for nasal peak inspiratory flow and symptoms and by nasal endoscopy . Markers of inflammation such as eosinophilic cationic protein ( ECP ) , IL-5 , myeloperoxidase , matrix metalloproteinase 9 , and IgE were measured in nasal secretions . Concentrations of eosinophils , ECP , and soluble IL-5 receptor alpha were measured in peripheral blood sample s. RESULTS Methylprednisolone and doxycycline each significantly decreased nasal polyp size compared with placebo . The effect of methylprednisolone was maximal at week 3 and lasted until week 8 , whereas the effect of doxycycline was moderate but present for 12 weeks . Methylprednisolone significantly reduced levels of ECP , IL-5 , and IgE in nasal secretions , whereas doxycycline significantly reduced levels of myeloperoxidase , ECP , and matrix metalloproteinase 9 in nasal secretions . CONCLUSION This is the first double-blind , placebo-controlled study to show a significant effect of oral methylprednisolone and doxycycline on size of nasal polyps , nasal symptoms , and mucosal and systemic markers of inflammation This double-blind parallel-group study compared the effect of budesonide with placebo , in the prophylaxis of nasal polyp recurrence after evulsion . Seventy-three patients with first time or recurrent polypectomy were enrolled . At revisits 3 and 6 months after evulsion , the budesonide-treated patients had significantly lower polyp scores than the placebo-treated patients . Only patients with recurrent nasal polyposis benefited from the budesonide treatment , whereas no effect was evident in patients with first time evulsion 60 patients , aged 15 - 51 years , with chronic allergic or bacterial maxillary sinusitis , were entered in a controlled , double-blind study comparing the efficacy of endonasal irrigations of tixocortol pivalate (Pivalone)-neomycin and neomycin . The treatment lasted 11 days and was administered once daily . A ventilometric measurement of sinus pressure was performed every two endonasal irrigations to assess treatment efficacy . The percentage of nasal deobstruction was significantly higher with tixocortol pivalate-neomycin than with neomycin alone by the fifth examination ( 9th day ) regardless of the etiology of the sinusitis ( allergic or bacterial ) . After 11 days of treatment , significantly better results were obtained in cases of bacterial sinusitis ( 94 % deobstruction with tixocortol pivalate-neomycin versus 74 % with neomycin ) than in cases of allergic sinusitis ( 69 % deobstruction with tixocortol pivalate-neomycin versus 36 % with neomycin ) OBJECTIVES To investigate the effect of intranasal corticosteroids in the treatment of polyps in patients with severe polyposis listed for surgical treatment and to determine the treatment effect on the progression of the disease . DESIGN A double-blind , r and omized , parallel-group , placebo-controlled , 12-week study at a single center . SETTING A tertiary referral center in London , Engl and . PATIENTS Thirty-four patients with severe polyposis listed for endoscopic surgical treatment . INTERVENTION By r and om allocation , fluticasone propionate aqueous nasal spray ( FPANS ) , 200 microg twice a day ; beclomethasone dipropionate aqueous nasal spray , 200 microg twice a day ; or placebo nasal spray twice a day was administered . Patients received 2 actuations to each nostril in the morning and in the evening . MAIN OUTCOME MEASURES Efficacy end points were the need for polypectomy at the end of treatment , the results of acoustic rhinometry , the polyp score , the peak nasal inspiratory flow rate , and an assessment of symptoms . RESULTS The polyp score was significantly decreased in the FPANS-treated group ( P < or = .01 ) . The nasal cavity volume was significantly increased in both the FPANS-treated group and the group receiving beclomethasone compared with placebo ( P < or = .01 ) at the end of treatment . The percentage change in the mean morning peak nasal inspiratory flow rate was greater in the FPANS-treated group , with a significant effect observed at week 2 ( P = .01 ) . Nasal blockage was significantly decreased in both active groups compared with the group receiving placebo . No significant difference was observed between the treatment groups in the number of patients requiring polypectomy . CONCLUSIONS Fluticasone and beclomethasone aqueous nasal sprays are effective in treating the symptoms of severe nasal polyps . There was some evidence that the group treated with FPANS responded more quickly to intervention and that the magnitude of the response was greater than in the group receiving beclomethasone Background The failure rate for frontal sinusotomy is higher than that of overall endoscopic sinus surgery ( ESS ) . To prevent frontal sinus obstruction , systemic or topical steroids are commonly used , but systemic steroid therapy can cause significant morbidity and topical sprays can not be distributed to the frontal ostium . This study was design ed to determine the efficacy of anatomically directed topical steroid drops in reducing frontal ostium stenosis compared with topical steroid sprays after ESS . Methods A prospect i ve , r and omized , single-blind study was conducted in 43 patients ( 77 nasal cavities ) who had undergone ESS , including frontal sinusotomy . Twenty-one patients ( 39 nasal cavities ) used steroid drops applied with the Mygind technique , and 22 patient 8 nasal cavities ) used steroid sprays for 8 weeks postoperatively . The patency of the frontal ostium was evaluated endoscopically 3 months postoperatively . Results The study included 29 men and 14 women ( mean age , 48.2 years ; range , 19–62 years ) . Endoscopic scores in terms of polypoid change , edema , and scar in the middle meatus and frontal recess were not significantly different between the groups , although the drop group showed a tendency to superior scores when compared with the spray group ( p > 0.05 ) . The frontal sinus patency of the drop group was significantly higher than of the spray group ( p < 0.05 ) . Conclusion Topical steroid drops using the Mygind technique led to a 16 % improvement in frontal sinus patency rates in 3 month after ESS in this study compared with postoperative topical steroid use OBJECTIVE To assess the efficacy and safety of fluticasone propionate administered using OptiNose 's novel delivery device ( Opt-FP ) in subjects with bilateral mild-to-moderate nasal polyposis . METHODS A prospect i ve , multicentre , r and omized , double-blind , placebo-controlled , parallel group study was conducted in adult subjects ( n = 109 ) with mild-to-moderate bilateral nasal polyposis . Subjects received Opt-FP 400 microg or placebo twice daily for 12 weeks . Endpoints included endoscopic assessment of polyp size using Lildholdt 's Scale , peak nasal inspiratory flow ( PNIF ) , symptom scores and use of rescue medication . RESULTS The proportion of subjects with improvement in summed polyp score > or= 1 ( Lildholdt\ 's Scale ) was significantly higher with Opt-FP compared with placebo at 4 , 8 and 12 weeks ( 22 % vs 7 % , p = 0.011 , 43 % vs 7 % , p < 0.001 , 57 % vs 9 % , p < 0.001 ) . After 12 weeks the summed polyp score was reduced by 35 % ( -0.98 vs + 0.23 , p < 0.001 ) . PNIF increased progressively during Opt-FP treatment ( p < 0.05 ) . Combined symptom score , nasal blockage , discomfort , rhinitis symptoms and sense of smell were all significantly improved . Rescue medication use was lower ( 3.1 % vs 22.4 % , p < 0.001 ) . Opt-FP was well tolerated . CONCLUSIONS Fluticasone propionate ( 400 microg b
Output:
| Conclusion INCS is effective for CRS .
Prior sinus surgery and direct sinus delivery enhance the effectiveness of INCS in CRS |
MS211070 | ***TASK*** the task is to summarize an input biomedical literature in 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 Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention , including the prevention of mother-to-child transmission . We aim ed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing . Methods and Findings We conducted a r and omized trial in Kisumu , Kenya , between June 11 , 2015 , and January 15 , 2016 . Six hundred antenatal and postpartum women aged 18–39 y were r and omized to an HIV self-testing ( HIVST ) group or a comparison group . Participants in the HIVST group were given two oral-fluid-based HIV test kits , instructed on how to use them , and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple . Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner , a routine practice in many health clinics . The primary outcome was partner testing within 3 mo of enrollment . Among 570 participants analyzed , partner HIV testing was more likely in the HIVST group ( 90.8 % , 258/284 ) than the comparison group ( 51.7 % , 148/286 ; difference = 39.1 % , 95 % CI 32.4 % to 45.8 % , p < 0.001 ) . Couples testing was also more likely in the HIVST group than the comparison group ( 75.4 % versus 33.2 % , difference = 42.1 % , 95 % CI 34.7 % to 49.6 % , p < 0.001 ) . No participants reported intimate partner violence due to HIV testing . This study was limited by self-reported outcomes , a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used . Conclusions Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing . This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing . Trial Registration Clinical Trials.gov NCT02386215 BACKGROUND Frequent testing of individuals at high risk of HIV is central to current prevention strategies . We aim ed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men , with a particular focus on men who delayed testing or had never been tested before . METHODS In this r and omised trial , HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia . Enrolled participants were r and omly assigned ( 1:1 ) to the intervention ( free HIV self-testing plus facility-based testing ) or st and ard care ( facility-based testing only ) . Participants completed a brief online question naire every 3 months , which collected the number of self-tests used and the number and location of facility-based tests , and HIV testing was subsequently source d from clinical records . The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata : recent ( last test ≤2 years ago ) and non-recent ( > 2 years ago or never tested ) testers . A statistician who was masked to group allocation analysed the data ; analyses included all participants who completed at least one follow-up question naire . After the 12 month follow-up , men in the st and ard care group were offered free self-testing kits for a year . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12613001236785 . FINDINGS Between Dec 1 , 2013 , and Feb 5 , 2015 , 182 men were r and omly assigned to self-testing , and 180 to st and ard care . The analysis population included 178 ( 98 % ) men in the self-testing group ( 174 person-years ) and 165 ( 92 % ) in the st and ard care group ( 162 person-years ) . Overall , men in the self-testing group had 701 HIV tests ( 410 self-tests ; mean 4·0 tests per year ) , and men in the st and ard care group had 313 HIV tests ( mean 1·9 tests per year ) ; rate ratio ( RR ) 2·08 ( 95 % CI 1·82 - 2·38 ; p<0·0001 ) . Among recent testers , men in the self-testing group had 627 tests ( 356 self-tests ; mean 4·2 per year ) , and men in the st and ard care group had 297 tests ( mean 2·1 per year ) ; RR 1·99 ( 1·73 - 2·29 ; p<0·0001 ) . Among non-recent testers , men in the self-testing group had 74 tests ( 54 self-tests ; mean 2·8 per year ) , and men in the st and ard care group had 16 tests ( mean 0·7 per year ) ; RR 3·95 ( 2·30 - 6·78 ; p<0·0001 ) . The mean number of facility-based HIV tests per year was similar in the self-testing and st and ard care groups ( mean 1·7 vs 1·9 per year , respectively ; RR 0·86 , 0·74 - 1·01 ; p=0·074 ) . No serious adverse events were reported during follow-up . INTERPRETATION HIV self-testing result ed in a two times increase in frequency of testing in gay and bisexual men at high risk of infection , and a nearly four times increase in non-recent testers , compared with st and ard care , without reducing the frequency of facility-based HIV testing . HIV self-testing should be made more widely available to help increase testing and earlier diagnosis . FUNDING The National Health and Medical Research Council , Australia 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 Reaching universal HIV-status awareness is crucial to ensure all HIV-infected patients access antiretroviral treatment ( ART ) and achieve virological suppression . Opportunities for HIV testing could be enhanced by offering self-testing in population s that fear stigma and discrimination when accessing conventional HIV Counselling and Testing ( HCT ) in health care facilities . This qualitative research aims to examine the feasibility and acceptability of unsupervised oral self-testing for home use in an informal settlement of South Africa . Eleven in-depth interviews , two couple interviews , and two focus group discussion s were conducted with seven healthcare workers and thirteen community members . Thematic analysis was done concurrently with data collection . Acceptability to offer home self-testing was demonstrated in this research . Home self-testing might help this population overcome barriers to accepting HCT ; this was particularly expressed in the male and youth groups . Nevertheless , pilot interventions must provide evidence of potential harm related to home self-testing , intensify efforts to offer quality counselling , and ensure linkage to HIV/ART-care following a positive self-test result Background : Self-testing may increase HIV testing and decrease the time people with HIV are unaware of their status , but there is concern that absence of counseling may result in increased HIV risk . Setting : Seattle , Washington . Methods : We r and omly assigned 230 high-risk HIV-negative men who have sex with men to have access to oral fluid HIV self-tests at no cost versus testing as usual for 15 months . The primary outcome was self-reported number of HIV tests during follow-up . To evaluate self-testing 's impact on sexual behavior , we compared the following between arms : non – HIV-concordant condomless anal intercourse and number of male condomless anal intercourse partners in the last 3 months ( measured at 9 and 15 months ) and diagnosis with a bacterial sexually transmitted infection ( STI : early syphilis , gonorrhea , and chlamydial infection ) at the final study visit ( 15 months ) . A post hoc analysis compared the number of STI tests reported during follow-up . Results : Men r and omized to self-testing reported significantly more HIV tests during follow-up ( mean = 5.3 , 95 % confidence interval = 4.7 to 6.0 ) than those r and omized to testing as usual ( 3.6 , 3.2 to 4.0 ; P < 0.0001 ) , representing an average increase of 1.7 tests per participant over 15 months . Men r and omized to self-testing reported using an average of 3.9 self-tests . Self-testing was noninferior with respect to all markers of HIV risk . Men in the self-testing arm reported significantly fewer STI tests during follow-up ( mean = 2.3 , 95 % confidence interval = 1.9 to 2.7 ) than men in the control arm ( 3.2 , 2.8 to 3.6 ; P = 0.0038 ) . Conclusions : Access to free HIV self-testing increased testing frequency among high-risk men who have sex with men and did not impact sexual behavior or STI acquisition IMPORTANCE Self-testing for HIV infection may contribute to early diagnosis of HIV , but without necessarily increasing antiretroviral therapy ( ART ) initiation . OBJECTIVE To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase dem and for ART initiation , compared with HIV self-testing accompanied by facility-based services only . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized trial conducted in Blantyre , Malawi , between January 30 and November 5 , 2012 , using restricted 1:1 r and omization of 14 community health worker catchment areas . Participants were all adult ( ≥16 years ) residents ( n = 16,660 ) who received access to home HIV self-testing through resident volunteers . This was a second-stage r and omization of clusters allocated to the HIV self-testing group of a parent trial . INTERVENTIONS Clusters were r and omly allocated to facility-based care or optional home initiation of HIV care ( including 2 weeks of ART if eligible ) for participants reporting positive HIV self-test results . MAIN OUTCOMES AND MEASURES The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability . Secondary outcomes were uptake of HIV self-testing , reporting of positive HIV self-test results , and rates of loss from ART at 6 months . RESULTS A significantly greater proportion of adults in the home group initiated ART ( 181/8194 , 2.2 % ) compared with the facility group ( 63/8466 , 0.7 % ; risk ratio [ RR ] , 2.94 , 95 % CI , 2.10 - 4.12 ; P < .001 ) . Uptake of HIV self-testing was high in both the home ( 5287/8194 , 64.9 % ) and facility groups ( 4433/8466 , 52.7 % ; RR , 1.23 ; 95 % CI , 0.96 - 1.58 ; P = .10 ) . Significantly more adults reported positive HIV self-test results in the home group ( 490/8194 [ 6.0 % ] vs the facility group , 278/8466 [ 3.3 % ] ; RR , 1.86 ; 95 % CI , 1.16 - 2.97 ; P = .006 ) . After 6 months , 52 of 181 ART initiators ( 28.7 % ) and 15 of 63 ART initiators ( 23.8 % ) in the home and facility groups , respectively , were lost from ART ( adjusted incidence rate ratio , 1.18 ; 95 % CI , 0.62 - 2.25 , P = .57 ) . CONCLUSIONS AND RELEVANCE Among Malawian adults offered HIV self-testing , optional home initiation of care compared with st and ard HIV care result ed in a significant increase in the proportion of adults initiating ART . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01414413
Output:
| Across all RCTs , there was no indication of harm attributable to HIVST and potential increases in risk-taking behaviour appeared to be minimal .
HIVST is associated with increased uptake and frequency of testing in RCTs .
Such increases , particularly among those at risk who may not otherwise test , will likely identify more HIV-positive individuals as compared to st and ard testing services alone . |
MS211071 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background A criticism of R and omized Controlled Trials ( RCTs ) in primary care is that they lack external validity , participants being unrepresentative of the wider population . Our aim was to determine whether published primary care-based RCTs report information about how the study sample is assembled , and whether this is associated with RCT characteristics . Methods We review ed RCTs published in four primary care journals in the years 2001–2004 . Main outcomes were : ( 1 ) eligibility fraction ( proportion eligible of those screened ) , ( 2 ) enrolment fraction ( proportion r and omised of those eligible ) , ( 3 ) recruitment fraction ( proportion of potential participants actually r and omised ) , and ( 4 ) number of patients needed to be screened ( NNS ) in order to r and omize one participant . Results A total of 148 RCTs were review ed . One hundred and three trials ( 70 % ) reported the number of individuals assessed by investigators for eligibility , 119 ( 80 % ) reported the number eligible for participation , and all reported the actual number recruited . The median eligibility fraction was 83 % ( IQR 40 % to 100 % ) , and the median enrolment fraction was 74 % ( IQR 49 % to 92 % ) . The median NNS was 2.43 , with some trials reportedly recruiting every patient or practice screened for eligibility , and one trial screening 484 for each patient recruited . We found no association between NNS and journal , trial size , multi- or single-centre , funding source or type of intervention . There may be associations between provision of sufficient recruitment data for the calculation of NNS and funding source and type of intervention . Conclusion RCTs reporting recruitment data in primary care suggest that once screened for eligibility and found to match inclusion criteria patients are likely to be r and omized . This finding needs to be treated with caution as it may represent inadequate identification or reporting of the eligible population . A substantial minority of RCTs did not provide sufficient information about the patient recruitment process The transition to college has been identified as a critical period for increases in overweight status . Overweight college students are at-risk of becoming obese adults , and , thus prevention efforts targeting college age individuals are key to reducing adult obesity rates . The current study evaluated an Internet intervention with first year college students ( N=170 ) r and omly assigned to one of four treatment conditions : 1 ) no treatment , 2 ) 6-week online intervention 3 ) 6-week weight and caloric feedback only ( via email ) , and 4 ) 6-week combined feedback and online intervention . The combined intervention group had lower BMI s at post-testing than the other three groups . This study demonstrated the effectiveness and feasibility of an online intervention to prevent weight gain among college students This study examines the combined effects of caloric restriction on body composition , blood lipid , and satiety in slightly overweight women by varying food density and aerobic exercise . Twenty-three women were r and omly assigned to one of two groups for a four-week weight management program : the high-energy density diet plus exercise ( HDE : n = 12 , 22 ± 2 yrs , 65 ± 7 kg , 164 ± 5 cm , 35 ± 4 % fat ) and low-energy density diet plus exercise ( LDE : n = 11 , 22 ± 1 yrs , 67 ± 7 kg , 161 ± 2 cm , 35 ± 4 % fat ) groups . Subjects maintained a low-calorie diet ( 1,500 kcal/day ) during the program . Isocaloric ( 483 ± 26 for HDE , 487 ± 27 kcal for LDE ) but different weight ( 365 ± 68 for HDE , 814 ± 202 g for LDE ) of lunch was provided . After lunch , they biked at 60 % of maximum capacity for 40 minutes , five times per week . The hunger level was scaled ( 1 : extremely hungry ; 9 : extremely full ) at 17:30 each day . Before and after the program , the subjects ' physical characteristics were measured , and fasting blood sample s were drawn . The daily energy intake was 1,551 ± 259 for HDE and 1,404 ± 150 kcal for LDE ( P > 0.05 ) . After four weeks , the subjects ' weights and % fat decreased for both LDE ( -1.9 kg and -1.5 % , P < 0.05 ) and HDE ( -1.6 kg and -1.4 % , respectively , P < 0.05 ) . The hunger level was significantly higher for HDE ( 2.46 ± 0.28 ) than for LDE ( 3.10 ± 0.26 ) ( P < 0.05 ) . The results suggest that a low-energy density diet is more likely to be tolerated than a high-energy density diet for a weight management program combining a low-calorie diet and exercise , mainly because of a reduced hunger sensation Aim : The aim of the study was to develop and implement an obesity and weight gain prevention program targeted to a high-risk group . Method : Women , 18–28 years old , with at least one severely obese parent , were r and omized to the intervention or control group of the ‘ Health Hunters ’ program . During 1 year of follow-up , the intervention group received an individualized behavioral program focusing on food choice , physical activity and other lifestyle factors . Anthropometric measures , DXA-based body composition and fitness levels were measured at baseline and after 1 year . Self-reported changes in obesity-related behaviors were also assessed . Results : Baseline examinations were conducted in 40 women , of whom 30 completed follow-up examinations 1 year later . Pregnancy was the most common reason for failure to complete the study . Compared to the control group ( which gained weight ) , the intervention group displayed significant improvements in body weight , body mass index , waist circumference , waist-to-hip ratio and self-reported physical activity . Changes in body composition , although not significant , suggested that the intervention tended to be associated with improved body composition . Further analysis of changes in diet and fitness in relation to concurrent weight changes indicated that the strongest ‘ protective ’ associations were for energy percent protein , fiber density and fitness . Conclusion : Pilot data from the Health Hunters obesity prevention program indicates that it is effective in high-risk young women with familial predisposition for obesity OBJECTIVE This paper describes the design and findings of a pilot Mothers In Motion ( P-MIM ) program . DESIGN A r and omized controlled trial that collected data via telephone interviews and finger stick at 3 time points : baseline and 2 and 8 months post-intervention . SETTING Three Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) sites in southern Michigan . PARTICIPANTS One hundred and twenty nine overweight and obese African-American and white mothers , 18 - 34 years old . INTERVENTION The 10-week , theory-based , culturally sensitive intervention messages were delivered via a series of 5 chapters on a DVD and complemented by 5 peer support group teleconferences . MAIN OUTCOME MEASURES Dietary fat , fruit , and vegetable intake ; physical activity ; stress ; feelings ; body weight ; and blood glucose . ANALYSIS General linear mixed model was applied to assess treatment effects across 2 and 8 months post-intervention . RESULTS No significant effect sizes were found in primary and secondary outcome variables at 2 and 8 months post-intervention . However , changes in body weight and blood glucose showed apparent trends consistent with the study 's hypotheses . CONCLUSIONS AND IMPLICATION S The P-MIM showed promise for preventing weight gain in low-income overweight and obese women . However , a larger experimental trial is warranted to determine the effectiveness of this intervention Background The literature on changes in health-related quality of life ( HRQOL ) in weight loss studies is inconsistent , and few studies use more than one type of measure . The purpose of the current study was to compare one-year changes in HRQOL as a function of weight change using three different measures : a weight-related measure ( Impact of Weight on Quality of Life-Lite [ IWQOL-Lite ) ] ) and two generic measures ( SF-36 ; EQ-5D ) . Methods Data were obtained from 926 participants ( mean Body Mass Index ( BMI ) ( kg/m2 ) = 35.4 ; 84 % female ; mean age = 49.5 years ) in a placebo-controlled r and omized trial for weight loss . At baseline and one-year , participants completed all three HRQOL measures . HRQOL was compared across weight change categories ( ≥ 5 % and 0–4.9 % gain , 0–4.9 % , 5.0–9.9 % and ≥ 10 % loss ) , using effect sizes . Results The weight-related measure of HRQOL exhibited greater improvements with one-year weight loss than either of the generic instruments , with effect sizes ranging from 0.24 to 0.62 for 5–9.9 % weight reductions and 0.44 to 0.95 for ≥ 10 % reductions . IWQOL-Lite Self-Esteem also showed a small improvement with weight gain . Changes in the two generic measures of HRQOL were inconsistent with each other , and in the case of the SF-36 , variable across domains . For participants gaining ≥ 5 % of weight , the greatest reductions in HRQOL occurred with respect to SF-36 Mental Health , MCS , and Vitality , with effect sizes of -0.82 , -0.70 , and -0.63 respectively . Conclusion This study found differences between weight-related and generic measures of health-related quality of life in a one-year weight loss trial , reflecting the potential value of using more than one measure in a trial . Although weight loss was generally associated with improved IWQOL-Lite , physical SF-36 subscale and EQ-5D scores , a small amount of weight gain was associated with a slight improvement on weight-specific HRQOL and almost no change on the EQ-5D , suggesting the need for further research to more fully study these relationships . We believe our findings have relevance for weight loss patients and obesity clinicians/ research ers in informing them of likely HRQOL outcomes associated with varying amounts of weight loss or gain PURPOSE To describe the theoretical rationale , intervention design , and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media . METHODS A total of 404 overweight or obese college students from three Southern California universities ( M(age ) = 22 ( ± 4 ) years ; M ( BMI ) = 29 ( ± 2.8 ) ; 70 % female ) were r and omized to participate in the intervention or to receive an informational web-based weight loss program . The intervention is based on behavioral theory and integrates intervention elements across multiple touch points , including Facebook , text messaging , smartphone applications , blogs , and e-mail . Participants are encouraged to seek social support among their friends , self-monitor their weight weekly , post their health behaviors on Facebook , and e-mail their weight loss questions /concerns to a health coach . The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback . Measures of body mass index , waist circumference , diet , physical activity , sedentary behavior , weight management practice s , smoking , alcohol , sleep , body image , self-esteem , and depression occur at 6 , 12 , 18 , and 24 months . Currently , all participants have been recruited , and all are in the final year of the trial . CONCLUSION Theory-driven , evidence -based strategies for physical activity , sedentary behavior , and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults Exercise is recommended by public health agencies for weight management ; however , the role of exercise is generally considered secondary to energy restriction . Few studies exist that have verified completion of exercise , measured the energy expenditure of exercise , and prescribed exercise with equivalent energy expenditure across individuals and genders . Objective The objective of this study was to evaluate aerobic exercise , without energy restriction , on weight loss in sedentary overweight and obese men and women . Design and Methods This investigation was a r and omized , controlled , efficacy trial in 141 overweight and obese participants ( body mass index , 31.0 ± 4.6 kg/m2 ; age 22.6 ± 3.9 years ) . Participants were r and omized ( 2:2:1 ratio ) to exercise at either 400 kcal/session or 600 kcal/session or to a non-exercise control . Exercise was supervised , 5 days/week , for 10 months . All participants were instructed to maintain usual ad libitum diets . Due to the efficacy design , completion of ≥ 90 % of exercise sessions was an a priori definition of per protocol , and these participants were included in the analysis . Results Weight loss from baseline to 10 months for the 400 and 600 kcal/session groups was 3.9 ± 4.9 kg ( 4.3 % ) and 5.2 ± 5.6 kg ( 5.7 % ) , respectively compared to weight gain for controls of 0.5 ± 3.5 kg ( 0.5 % ) ( p<0.05 ) . Differences for weight loss from baseline to 10 months between the exercise groups and differences between men and women within groups were not statistically significant . Conclusions Supervised exercise , with equivalent energy expenditure , results in clinical ly significant weight loss with no significant difference between men and women OBJECTIVE To conduct a prospect i ve , longitudinal study examining weight fluctuation and its predictors before and during the first year of college . DESIGN Men ( n = 266 ) and women ( n = 341 ) enrolled at Dartmouth College
Output:
| Over half of the studies were effective in the short term for significantly reducing body weight and /or BMI ; however , few showed long-term maintenance . |
MS211072 | ***TASK*** the task is to summarize an input biomedical literature in 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: Cognitive therapy and antidepressant medications are effective treatments for depression , but little is known about their relative efficacy in reducing individual depressive symptoms . Using data from a recent clinical trial comparing cognitive therapy , antidepressant medication , and placebo in the treatment of moderate-to-severe depression , we examined whether there was a relative advantage of any treatment in reducing the severity of specific depressive symptom clusters . The sample consisted of 231 depressed out patients r and omly assigned to : cognitive therapy for 16 weeks ( n = 58 ) ; paroxetine treatment for 16 weeks ( n = 116 ) ; or pill placebo for 8 weeks ( n = 57 ) . Differential change in five subsets of depressive symptoms was examined : mood , cognitive/suicide , anxiety , typical-vegetative , and atypical-vegetative symptoms . Medication led to a greater reduction in cognitive/suicide symptoms relative to placebo by 4 weeks , and both active treatments reduced these symptoms more than did placebo by 8 weeks . Cognitive therapy reduced the atypical-vegetative symptoms more than placebo by 8 weeks and more than medications throughout the trial . These findings suggest that medications and cognitive therapy led to different patterns of response to specific symptoms of depression and that the general efficacy of these two well-vali date d treatments may be driven in large part by changes in cognitive or atypical-vegetative symptoms IMPORTANCE In the United States , approximately 1 physician dies by suicide every day . Training physicians are at particularly high risk , with suicidal ideation increasing more than 4-fold during the first 3 months of internship year . Despite this increase , to our knowledge , very few efforts have been made to prevent the escalation of suicidal thoughts among training physicians . OBJECTIVE To assess the effectiveness of a web-based cognitive behavioral therapy ( wCBT ) program delivered prior to the start of internship year in the prevention of suicidal ideation in medical interns . DESIGN , SETTING , AND PARTICIPANTS A r and omized clinical trial conducted at 2 university hospitals with 199 interns from multiple specialties during academic years 2009 - 2010 or 2011 - 2012 . The current study was conducted from May 2009 to June 2010 and May 2011 to June 2012 , and data were analyzed using intent-to-treat principles , including last observation carried forward . INTERVENTIONS Interns were r and omly assigned to 2 study groups ( wCBT and attention-control group [ ACG ] ) , and completed study activities lasting 30 minutes each week for 4 weeks prior to starting internship year . Participants assigned to wCBT completed online CBT modules and those assigned to ACG received emails with general information about depression , suicidal thinking , and local mental health professionals . MAIN OUTCOMES AND MEASURES The Patient Health Question naire-9 was used to assess suicidal ideation ( ie , " thoughts that you would be better off dead or hurting yourself in some way " ) prior to the start of intern year and at 3-month intervals throughout the year . RESULTS A total of 62.2 % of interns ( 199 of 320 ) agreed to take part in the study ; 100 were assigned to the wCBT group and 99 to the ACG . During at least 1 point over the course of internship year , 12 % of interns ( 12 of 100 ) assigned to wCBT endorsed suicidal ideation compared with 21.2 % of interns ( 21 of 99 ) assigned to ACG . After adjusting for covariates identified a priori that have previously shown to increase the risk for suicidal ideation , interns assigned to wCBT were less likely to endorse suicidal ideation during internship year ( relative risk , 0.40 ; 95 % CI , 0.17- 0.91 ; P = .03 ) compared with those assigned to ACG . CONCLUSIONS AND RELEVANCE This study demonstrates that a free , easily accessible , brief wCBT program is associated with reduced likelihood of suicidal ideation among medical interns . Prevention programs with these characteristics could be easily disseminated to medical training programs across the country . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12610000628044 A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials Objectives The effect of web-based interventions for depression on suicide ideation in callers to helplines is not known . The aim of this study was to determine if web-based Cognitive Behaviour Therapy ( CBT ) with and without telephone support is effective in reducing suicide ideation in callers to a helpline compared with treatment as usual ( TAU ) . A secondary aim was to examine the factors that predict change in suicide ideation . Putative predictors included level of baseline depression , suicide behaviour , baseline anxiety and type of intervention . Design R and omised controlled trial . Setting Lifeline , Australia 's 24 h telephone counselling service participants : 155 callers to a national helpline service with moderate-to-high psychological distress . Interventions Participants were recruited and r and omised to receive either 6 weeks of internet CBT plus weekly telephone follow-up ; internet CBT only ; weekly telephone follow-up only or a wait-list TAU control group . Primary and secondary outcome measures Suicidal ideation was measured using four items from the 28-item General Health Question naire . Predictors of change in ideation were tested using logistic regression analysis . Results Regardless of the intervention condition , participants showed significant reductions in suicidal ideation over 12 months ( p<0.001 ) . Higher baseline suicidal behaviour decreased the odds of remission of suicidal ideation at postintervention ( OR 0.409 , p<0.001 ) . However , change in depression over the course of the interventions was associated with improvement in suicide ideation ( OR 1.165 , p<0.001 ) . Conclusions Suicide ideation declines with and without proactive intervention . Improvements in depression are associated with the resolution of suicide ideation . Specific interventions focusing on suicide ideation should be further investigated . Trial registration Controlled-Trials.com IS RCT N93903959 OBJECTIVE The authors evaluated the effectiveness of brief cognitive-behavioral therapy ( CBT ) for the prevention of suicide attempts in military personnel . METHOD In a r and omized controlled trial , active-duty Army soldiers at Fort Carson , Colo. , who either attempted suicide or experienced suicidal ideation with intent , were r and omly assigned to treatment as usual ( N=76 ) or treatment as usual plus brief CBT ( N=76 ) . Assessment of incidence of suicide attempts during the follow-up period was conducted with the Suicide Attempt Self-Injury Interview . Inclusion criteria were the presence of suicidal ideation with intent to die during the past week and /or a suicide attempt within the past month . Soldiers were excluded if they had a medical or psychiatric condition that would prevent informed consent or participation in outpatient treatment , such as active psychosis or mania . To determine treatment efficacy with regard to incidence and time to suicide attempt , survival curve analyses were conducted . Differences in psychiatric symptoms were evaluated using longitudinal r and om-effects models . RESULTS From baseline to the 24-month follow-up assessment , eight participants in brief CBT ( 13.8 % ) and 18 participants in treatment as usual ( 40.2 % ) made at least one suicide attempt ( hazard ratio=0.38 , 95 % CI=0.16 - 0.87 , number needed to treat=3.88 ) , suggesting that soldiers in brief CBT were approximately 60 % less likely to make a suicide attempt during follow-up than soldiers in treatment as usual . There were no between-group differences in severity of psychiatric symptoms . CONCLUSIONS Brief CBT was effective in preventing follow-up suicide attempts among active-duty military service members with current suicidal ideation and /or a recent suicide attempt BACKGROUND Bereavement following suicide is associated with an increased vulnerability for depression , complicated grief , suicidal ideation , and suicide . There is , however , a paucity of studies of the effects of interventions in suicide survivors . AIMS This study therefore examined the effects of a cognitive behavioral therapy (CBT)-based psychoeducational intervention on depression , complicated grief , and suicide risk factors in suicide survivors . METHOD In total , 83 suicide survivors were r and omized to the intervention or the control condition in a cluster r and omized controlled trial . Primary outcome measures included maladaptive grief reactions , depression , suicidal ideation , and hopelessness . Secondary outcome measures included grief-related cognitions and coping styles . RESULTS There was no significant effect of the intervention on the outcome measures . However , the intensity of symptoms of grief , depressive symptoms , and passive coping styles decreased significantly in the intervention group but not in the control group . CONCLUSION The CBT-based psychoeducational intervention has no significant effect on the development of complicated grief reactions , depression , and suicide risk factors among suicide survivors . The intervention may , however , serve as supportive counseling for suicide survivors BACKGROUND Depression and alcohol misuse are among the most prevalent diagnoses in suicide fatalities . The risk posed by these disorders is exacerbated when they co-occur . Limited research has evaluated the effectiveness of common depression and alcohol treatments for the reduction of suicide vulnerability in individuals experiencing comorbidity . METHODS Participants with depressive symptoms and hazardous alcohol use were selected from two r and omised controlled trials . They had received either a brief ( 1 session ) intervention , or depression-focused cognitive behaviour therapy ( CBT ) , alcohol-focused CBT , therapist-delivered integrated CBT , computer-delivered integrated CBT or person-centred therapy ( PCT ) over a 10-week period . Suicidal ideation , hopelessness , depression severity and alcohol consumption were assessed at baseline and 12-month follow-up . RESULTS Three hundred three participants were assessed at baseline and 12 months . Both suicidal ideation and hopelessness were associated with higher severity of depressive symptoms , but not with alcohol consumption . Suicidal ideation did not improve significantly at follow-up , with no differences between treatment conditions . Improvements in hopelessness differed between treatment conditions ; hopelessness improved more in the CBT conditions compared to PCT and in single-focused CBT compared to integrated CBT . LIMITATIONS Low retention rates may have impacted on the reliability of our findings . Combining data from two studies may have result ed in heterogeneity of sample s between conditions . CONCLUSIONS CBT appears to be associated with reductions in hopelessness in people with co-occurring depression and alcohol misuse , even when it is not the focus of treatment . Less consistent results were observed for suicidal ideation . Establishing specific procedures or therapeutic content for clinicians to monitor these outcomes may result in better management of individuals with higher vulnerability for suicide BACKGROUND The World Health Organisation SUicide PREvention-Multisite Intervention Study on Suicide ( WHO/SUPRE-MISS ) investigates suicidal behaviours in a number of nations . The feasibility of the different branches of the study was piloted in Queensl and , Australia . This paper reports on the community survey component . METHOD R and omised telephone interviews ( n=11,572 ) were conducted to determine the lifetime prevalence of suicidal ideation and attempts , and corresponding socio-demographic and cultural characteristics . A subsequent postal survey sent to consenting individuals reporting lifetime suicide ideation/attempt ( n=1311 ) was meant to ascertain the possible development of that behaviour along a continuum , psychiatric and psychological factors , suicidal transmission , help-seeking , and service utilisation . RESULTS Suicide ideation and attempts prevailed in individuals aged 25 - 44 years , and declined with increasing age . In most cases , suicidal experience/s did not develop over time with progressively increasing severity . Knowledge of someone else 's suicidal behaviour significantly increased the risk of similar acts . Almost half of the subjects contended with their suicidal crisis by over-drinking alcohol , and 1/3 through other forms of reckless behaviour . The ratio completed/attempted suicide was 1 to 23 . Less than 30 % of subjects went to the hospital after their suicidal behaviour , and treatment received and staff attitudes were rated less favourably than that of General Practitioners . CONCLUSIONS This survey provides a reliable picture of suicide ideation and behaviour in the general population . Information on the development of suicidal process , recklessness , and help-seeking attitudes may be valuable for future prevention strategies The outcome of a r and omized controlled trial of cognitive behavior therapy in addition to treatment as usual ( CBT plus TAU ) compared with TAU alone ( TAU ) in one hundred and six participants meeting diagnostic criteria for borderline personality disorder is described . We anticipated that CBT plus TAU would decrease the number of participants with in
Output:
| There was a statistically significant , small to medium effect for face-to-face delivered CBT in reducing suicidal ideation and behaviour although there was significant heterogeneity between the included studies . |
MS211073 | ***TASK*** the task is to summarize an input biomedical literature in 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 Screening for colorectal cancer is widely recommended , but the preferred strategy remains unidentified . We aim ed to compare participation and diagnostic yield between screening with colonoscopy and with non-cathartic CT colonography . METHODS Members of the general population , aged 50 - 75 years , and living in the regions of Amsterdam or Rotterdam , identified via the registries of the regional municipal administration , were r and omly allocated ( 2:1 ) to be invited for primary screening for colorectal cancer by colonoscopy or by CT colonography . R and omisation was done per household with a minimisation algorithm based on age , sex , and socioeconomic status . Invitations were sent between June 8 , 2009 , and Aug 16 , 2010 . Participants assigned to CT colonography who were found to have one or more large lesions ( ≥10 mm ) were offered colonoscopy ; those with 6 - 9 mm lesions were offered surveillance CT colonography . The primary outcome was the participation rate , defined as number of invitees undergoing the examination relative to the total number of invitees . Diagnostic yield was calculated as number of participants with advanced neoplasia relative to the total number of invitees . Invitees and screening centre employees were not masked to allocation . This trial is registered in the Dutch trial register , number NTR1829 . FINDINGS 1276 ( 22 % ) of 5924 colonoscopy invitees participated , compared with 982 ( 34 % ) of 2920 CT colonography invitees ( relative risk [ RR ] 1·56 , 95 % CI 1·46 - 1·68 ; p<0·0001 ) . Of the participants in the colonoscopy group , 111 ( 9 % ) had advanced neoplasia of whom seven ( < 1 % ) had a carcinoma . Of CT colonography participants , 84 ( 9 % ) were offered colonoscopy , of whom 60 ( 6 % ) had advanced neoplasia of whom five ( < 1 % ) had a carcinoma ; 82 ( 8 % ) were offered surveillance . The diagnostic yield for all advanced neoplasia was 8·7 per 100 participants for colonoscopy versus 6·1 per 100 for CT colonography ( RR 1·46 , 95 % CI 1·06 - 2·03 ; p=0·02 ) and 1·9 per 100 invitees for colonoscopy and 2·1 per 100 invitees for CT colonography ( RR 0·91 , 0·66 - 2·03 ; p=0·56 ) . The diagnostic yield for advanced neoplasia of 10 mm or more was 1·5 per 100 invitees for colonoscopy and 2·0 per 100 invitees for CT colonography , respectively ( RR 0·74 , 95 % CI 0·53 - 1·03 ; p=0·07 ) . Serious adverse events related to the screening procedure were post-polypectomy bleedings : two in the colonoscopy group and three in the CT colonography group . INTERPRETATION Participation in colorectal cancer screening with CT colonography was significantly better than with colonoscopy , but colonoscopy identified significantly more advanced neoplasia per 100 participants than did CT colonography . The diagnostic yield for advanced neoplasia per 100 invitees was similar for both strategies , indicating that both techniques can be used for population -based screening for colorectal cancer . Other factors such as cost-effectiveness and perceived burden should be taken into account when deciding which technique is preferable . FUNDING Netherl and s Organisation for Health Research and Development , Centre for Translational Molecular Medicine , and the Nuts Ohra Foundation BACKGROUND Adenoma detection rate ( ADR ) has become the most important quality indicator for colonoscopy . OBJECTIVE The aim of this study was to investigate which modifiable factors , directly related to the endoscopic procedure , influenced the ADR in screening colonoscopies . DESIGN Observational , nested study . SETTING Multicenter , r and omized , controlled trials . PATIENTS Asymptomatic people aged 50 to 69 years were eligible for a multicenter , r and omized , controlled trial design ed to compare colonoscopy and fecal immunochemical testing in colorectal cancer screening . A total of 4539 individuals undergoing a direct screening colonoscopy were included in this study . INTERVENTION Colonoscopy . MAIN OUTCOME MEASUREMENTS Bowel cleansing , sedation , withdrawal time in normal colonoscopies , and cecal intubation were analyzed as possible predictors of adenoma detection by using logistic regression analysis , adjusted for age and sex . RESULTS In multivariate analysis , after adjustment for age and sex , factors independently related to the ADR were a mean withdrawal time longer than 8 minutes ( odds ratio [ OR ] 1.51 ; 95 % CI , 1.17 - 1.96 ) in normal colonoscopies and split preparation ( OR 1.26 ; 95 % CI , 1.01 - 1.57 ) . For advanced adenomas , only withdrawal time maintained statistical significance in the multivariate analysis . For proximal adenomas , withdrawal time and cecal intubation maintained independent statistical significance , whereas only withdrawal time longer than 8 minutes and a < 10-hour period between the end of preparation and colonoscopy showed independent associations for distal adenomas . LIMITATIONS Only endoscopic variables have been analyzed . CONCLUSION Withdrawal time was the only modifiable factor related to the ADR in colorectal cancer screening colonoscopies associated with an increased detection rate of overall , advanced , proximal , and distal adenomas BACKGROUND AND STUDY AIM Following acute diverticulitis , colonoscopy is advised to rule out malignancy . Commonly , the colonoscopy is postponed to avoid the potential risk of perforation . In a previous pilot , noncontrolled study , we showed that early colonoscopy is feasible in patients with acute diverticulitis . This r and omized controlled trial compared early and late colonoscopy in hospitalized patients with acute diverticulitis . PATIENTS AND METHODS 154 patients diagnosed with acute diverticulitis were hospitalized between January 2004 and June 2006 . Of these , 35 patients were excluded because of either free perforation or pericolic air on computed tomography ( CT ) , and another 18 because they had undergone colonoscopy in the previous year . The remaining 101 patients were offered the possibility of participating in the study , with r and om allocation to either early in-hospital colonoscopy or late colonoscopy , 6 weeks later . R and omization was refused by 15 patients , and 86 were included in the study . RESULTS 45 patients were r and omly allocated for early colonoscopy and 41 for late colonoscopy . Three and 10 did not present for the examination , in the early and late group respectively . The cecum could not be reached in eight and three patients from the early and late groups , respectively . The colonoscopy revealed polyps in five patients , two in the early group and three in the late group . No malignancy was detected . There were no complications in either group . CONCLUSIONS Early colonoscopy in acute diverticulitis is feasible and safe in the absence of pericolic air on CT , and has greater compliance . However , no added value is apparent compared with the CT scan currently used BACKGROUND Although the risk of bowel perforation is often cited as a major factor in the choice between colonoscopy and sigmoidoscopy for colorectal screening , good estimates of the absolute and relative risks of perforation are lacking . METHODS We used a large population -based cohort that consisted of a r and om sample of 5 % of Medicare beneficiaries living in regions of the United States covered by the Surveillance , Epidemiology , and End Results ( SEER ) Program registries to determine rates of perforation in people aged 65 years and older . We identified individuals who were cancer-free and had undergone colonoscopy or sigmoidoscopy between 1991 and 1998 , calculated both the incidence and risk of perforation within 7 days of the procedure , and explored the impact on incidence and risk of perforation of age , race/ethnicity , sex , comorbidities , and indication for the procedure . We also estimated the risk of death after perforation . Risks were calculated with odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) . All statistical tests were two-sided . RESULTS There were 77 perforations after 39 286 colonoscopies ( incidence = 1.96/1000 procedures ) and 31 perforations after 35 298 sigmoidoscopies ( incidence = 0.88/1000 procedures ) . After adjustment , the OR for perforation from colonoscopy relative to perforation from sigmoidoscopy was 1.8 ( 95 % CI = 1.2 to 2.8 ) . Risk of perforation from either procedure increased in association with increasing age ( P(trend)<.001 for both procedures ) and the presence of two or more comorbidities ( P(trend)<.001 for colonoscopy and P(trend ) = .03 for sigmoidoscopy ) . Compared with those who were endoscopied and did not have a perforation , the risk of death was statistically significantly increased for those who had a perforation after either colonoscopy ( OR = 9.0 , 95 % CI = 3.0 to 27.3 ) or sigmoidoscopy ( OR = 8.8 , 95 % CI = 1.6 to 48.5 ) . The risk of perforation after colonoscopy , especially for screening procedures , declined during the 8-year study period . CONCLUSIONS The risk of perforation after colonoscopy is approximately double that after sigmoidoscopy , but this difference appears to be decreasing . These observations should be useful to clinicians making screening and diagnostic decisions for individual patients and to policy officials setting guidelines for colorectal cancer screening programs Several risk factors for colorectal cancer ( CRC ) have been identified . If individuals with risk factors are more likely to harbor cancer or it precursors screening programs should be targeted toward this population . We evaluated the predictive value of colorectal cancer risk factors for the detection of advanced colorectal adenoma in a population based CRC colonoscopy screening program . Data were collected in a multicenter trial conducted in the Netherl and s , in which 6600 asymptomatic men and women between 50 and 75 years were r and omly selected from a population registry . They were invited to undergo a screening colonoscopy . Based on a review of the literature CRC risk factors were selected . Information on risk factors was obtained from screening attendees through a question naire . For each CRC risk factor , we estimated its odds ratio ( OR ) relative to the presence of advanced neoplasia as detected at colonoscopy . Of the 1426 screening participants who underwent a colonoscopy , 1236 ( 86 % ) completed the risk question naire . 110 participants ( 8.9 % ) had advanced neoplasia . The following risk factors were significantly associated with advanced neoplasia detected by colonoscopy : age ( OR : 1.06 per year ; 95 % CI : 1.03 - 1.10 ) , calcium intake ( OR : 0.99 per mg ; 95 % CI : 0.99 - 1.00 ) , positive CRC family history ( OR : 1.55 per first degree family member ; 95%CI : 1.11 - 2.16 ) and smoking ( OR : 1.75 ; 95%CI : 1.09 - 2.82 ) . Elderly screening participants , participants with lower calcium intake , a CRC family history , and smokers are at increased risk of harboring detectable advanced colorectal neoplasia at screening colonoscopy To define the syndrome of vasovagal reactions that occur during colonoscopy and to identify those risk factors associated with this development , we prospect ively evaluated patients undergoing colonoscopy with monitored sedation . A total of 223 consecutive patients were evaluated during the 60-day study period . A vasovagal reaction was defined as the occurrence of one or more of the following : diaphoresis , sustained bradycardia of less than 60 beats/min or a decrease in heart rate of 10 % , or hypotension ( systolic blood pressure less than 90 mm Hg , diastolic blood pressure less than 60 mm Hg , or a reduction in blood pressure of more than 10 % below a baseline measurement before colonoscopy and after sedation ) . Thirty-seven ( 16.5 % ) of the 223 patients experienced a vasovagal reaction by our criteria . The remaining 186 patients did not ; 100 of these patients were r and omly selected by computer to form a control group . No statistically significant differences were observed between the vasovagal and control groups with regard to demographics , cardiopulmonary disease , cardiac medications , procedure success , the endoscopist , patient procedure tolerance , colon preparation , or procedure difficulty . A significant difference was seen in the mean dose of midazolam used in the vasovagal group as compared with that used in the control group ( 4.6 mg versus 3.9 mg , p < 0.04 ) , and moderate to severe diverticulosis was more commonly seen in the vasovagal group as compared with the control group ( 43 % versus 16 % , p < 0.02 ) . Thirteen ( 35 % ) of the 37 patients who had a vasovagal reaction required medical intervention ( 5.8 % of the 223 patients ) . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Serrated cancers account for 10 % to
Output:
| Because of high sensitivity of 94 % , a specificity of 99 % , and a low interobserver variability , this modality is currently preferred for the diagnosis of diverticulitis , although US also has a good sensitivity .
Apart from diagnosing CRC , the detection of AA is of great importance because it bears the potential to progress to carcinoma .
Colonoscopy is accompanied by such disadvantages as invasiveness and discomfort , potential adverse events such as perforation , and additional costs . |
MS211074 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The inflammatory cytokines , tumor necrosis factor-alpha ( TNF-alpha ) and interleukin-1-beta ( IL-1 beta ) , have been associated with accelerated metabolism and protein turnover following exogenous administration in normal humans . We hypothesized that these inflammatory cytokines might contribute to the weight-losing process in patients with chronic obstructive pulmonary disease ( COPD ) . COPD patients were identified prospect ively as " weight losers " ( WL ; n = 10 ) if they reported > 5 % weight loss during the preceding year or as " weight stable " ( WS ; n = 10 ) if their body weight fluctuated < or = 5 % . Age-matched healthy volunteers were selected as the control group ( C ; n = 13 ) . Monocytes were isolated from a peripheral blood sample , cultured , and exposed to lipopolysaccharide ( LPS ) . The concentration of TNF-alpha and IL-1 beta in the monocyte supernatant was measured using a four layer enhanced ELISA . No significant difference in LPS-stimulated IL-1 beta production was found in the three study population s. However , LPS-stimulated TNF-alpha production ( mean [ range ] ng/ml ) by monocytes was significantly higher in the WL COPD patients ( 20.2 [ 6.3 to 44.8 ] ) , compared with WS patients ( 6.9 [ 1.5 to 16.6 ] ) , and C subjects ( 5.7 [ 0 to 61.8 ] ) . This difference was not maintained at 6 mo follow-up in the absence of ongoing weight loss . Definition of a causal relationship between TNF-alpha production and weight loss will require further underst and ing of the relationship between energy metabolism and TNF-alpha production in these patients The relation between vitamin A status and the degree of lung airway obstruction was examined in a cross-sectional study of 36 male subjects aged 43 - 74 y who were assigned to five groups as follows : healthy nonsmokers ( n = 7 ) , healthy smokers ( n = 7 ) , mild chronic obstructive pulmonary disease ( COPD -mild ) patients ( n = 9 ) , COPD -moderate-severe patients ( n = 7 ) , and COPD -moderate-severe patients with exacerbation ( + ex ; n = 6 ) . Smoking habits , pulmonary function tests , energy-protein status were assessed ; serum concentrations of retinyl esters , retinol , retinol binding protein , and transthyretin and relative dose responses were measured . In addition , 12 male smokers aged 45 - 61 y with mild COPD were r and omly assigned to two groups for a longitudinal study : six subjects consumed vitamin A ( 1000 RE/d ; COPD -vitamin A ) and six subjects received placebo for 30 d. Lowered serum retinol concentrations were found in the COPD -moderate-severe and COPD -moderate-severe+ex groups . Measurements of vitamin A status in healthy smokers and in COPD -mild patients were not different from those in healthy nonsmokers . The improvement of pulmonary function test results after vitamin A supplementation [ mean increase for 1-s forced expiratory volume ( FEV1 ) = 22.9 % in the COPD -vitamin A group ] may support the assumption of a local ( respiratory ) vitamin A deficiency in patients with this disease STUDY OBJECTIVE Weight loss is a common complication of COPD , associated with negative outcomes . Weight restoration has been associated with improved outcomes . The effects of ox and rolone , an adjunct to help restore weight , were evaluated in patients with COPD . DESIGN Prospect i ve , open-label , 4-month clinical trial . SETTING Twenty-five community-based pulmonary practice s throughout the United States . PATIENTS A primary pulmonary diagnosis of moderate-to-severe COPD as defined by FEV1 < 50 % of predicted and FEV1/FVC ratio < 0.7 , along with significant involuntary weight loss ( weight < or = 90 % ideal body weight ) . INTERVENTIONS Oral ox and rolone , 10 mg bid . MEASUREMENTS AND RESULTS Body weight , body composition ( bioelectric impedance analysis ) , spirometry , and 6-min walking distance were measured . Data for 82 patients at 2 months and 55 patients at 4 months are presented . At month 2 , 88 % of patients had gained a mean + /- SD of 6.0 + /- 4.36 lb ( p < 0.05 ) and 12 % had lost a mean of 1.7 + /- 2.15 lb ( not statistically significant [ NS ] ) . At month 4 , 84 % had gained a mean of 6.0 + /- 5.83 lb ( p < 0.05 ) and 16 % had lost a mean of 1.8 + /- 1.74 lb ( NS ) . Month 4 bioelectric impedance analysis showed the weight to be primarily lean tissue , with a mean increase in body cell mass of 3 + /- 2.6 lb ( p < 0.05 ) , and a mean increase in fat of 1.2 + /- 4.6 lb ( NS ) . CONCLUSIONS Ox and rolone is an effective adjunct to facilitate weight restoration in patients with COPD -associated weight loss . Weight gain is primarily lean body mass . Ox and rolone was relatively well tolerated and , therefore , should be a consideration in the comprehensive management of patients with COPD and weight loss The effects of adding L-carnitine to a whole-body and respiratory training program were determined in moderate-to-severe chronic obstructive pulmonary disease ( COPD ) patients . Sixteen COPD patients ( 66 + /- 7 years ) were r and omly assigned to L-carnitine ( CG ) or placebo group ( PG ) that received either L-carnitine or saline solution ( 2 g/day , orally ) for 6 weeks ( forced expiratory volume on first second was 38 + /- 16 and 36 + /- 12 % , respectively ) . Both groups participated in three weekly 30-min treadmill and threshold inspiratory muscle training sessions , with 3 sets of 10 loaded inspirations ( 40 % ) at maximal inspiratory pressure . Nutritional status , exercise tolerance on a treadmill and six-minute walking test , blood lactate , heart rate , blood pressure , and respiratory muscle strength were determined as baseline and on day 42 . Maximal capacity in the incremental exercise test was significantly improved in both groups ( P < 0.05 ) . Blood lactate , blood pressure , oxygen saturation , and heart rate at identical exercise levels were lower in CG after training ( P < 0.05 ) . Inspiratory muscle strength and walking test tolerance were significantly improved in both groups , but the gains of CG were significantly higher than those of PG ( 40 + /- 14 vs 14 + /- 5 cmH2O , and 87 + /- 30 vs 34 + /- 29 m , respectively ; P < 0.05 ) . Blood lactate concentration was significantly lower in CG than in PG ( 1.6 + /- 0.7 vs 2.3 + /- 0.7 mM , P < 0.05 ) . The present data suggest that carnitine can improve exercise tolerance and inspiratory muscle strength in COPD patients , as well as reduce lactate production The impact of oral nutritional supplementation during an acute exacerbation of COPD on functional status was assessed through measuring change in lung function , strength testing , and general well-being . Subjects hospitalized for an acute exacerbation of COPD ( n = 33 ) were r and omized to extra nutritional support or the regular hospital care . They consumed an additional 10 kcal/kg/d . Outcome measures were measured at 2 wk as change scores . Forced vital capacity ( % predicted ) improved in the treatment group as compared with the control group ( + 8.7 % versus -3.5 % , p = 0.015 ) , and change in FEV1 was in the same direction but not significantly different ( p = 0.099 ) . There were no changes in h and grip strength or respiratory muscle strength , but there was a trend towards more improvement in the general well-being score ( + 11.96 versus -10.25 , p = 0.066 ) . Almost all subjects were in negative nitrogen balance , indicating muscle wasting . The degree of muscle wasting was strongly correlated with the dose of corticosteroids ( r = 0.73 , p < 0.005 ) . In conclusion , it is difficult to prevent important muscle wasting in patients with COPD treated with corticosteroids , but some small gains were observed with increased dietary intake Nutritional depletion commonly occurs in patients with COPD , causing muscle wasting and impaired physiologic function . Two hundred seventeen patients with COPD participated in a placebo-controlled , r and omized trial investigating the physiologic effects of nutritional intervention alone ( N ) for 8 wk or combined with the anabolic steroid n and rolone decanoate ( N + A ) . N and rolone decanoate or placebo ( P ) was injected intramuscularly ( women , 25 mg ; men , 50 mg ) in a double-blind fashion on Days 1 , 15 , 29 , and 43 . Nutritional intervention consisted of a daily high caloric supplement ( 420 kcal ; 200 ml ) . Also , all patients participated in an exercise program . In the depleted patients , both treatment regimens induced a similar significant body weight gain ( 2.6 kg ) but different body compositional changes . Particularly in the last 4 wk of treatment , weight gain in the N group was predominantly due to an expansion of fat mass ( p < 0.03 versus P and N + A ) , whereas the relative changes in fat-free mass ( FFM ) and other measures of muscle mass were more favorable in the N + A group ( p < 0.03 versus P ) . Maximal inspiratory mouth pressure improved within both treatment groups in the first 4 wk of treatment , but after 8 wk only N + A was significantly different from P ( p < 0.03 ) . Nutritional supplementation in combination with a short course of anabolic steroids may enhance the gain in FFM and respiratory muscle function in depleted patients with COPD without causing adverse side effects Background : Pulmonary rehabilitation is effective in improving exercise performance and health status in chronic obstructive pulmonary disease ( COPD ) . However , the role of nutritional support in the enhancement of the benefits of exercise training has not been explored . A double blind , r and omised , controlled trial of carbohydrate supplementation was undertaken in patients attending outpatient pulmonary rehabilitation . Methods : 85 patients with COPD were r and omised to receive a 570 kcal carbohydrate rich supplement or a non-nutritive placebo daily for the duration of a 7 week outpatient pulmonary rehabilitation programme . Primary outcome measures were peak and submaximal exercise performance using the shuttle walk tests . Changes in health status , body composition , muscle strength , and dietary macronutrient intake were also measured . Results : Patients in both the supplement and placebo groups increased shuttle walking performance and health status significantly . There was no statistically significant difference between treatment groups in these outcomes . Patients receiving placebo lost weight whereas supplemented patients gained weight . In well nourished patients ( BMI > 19 kg/m2 ) improvement in incremental shuttle performance was significantly greater in the supplemented group ( mean difference between groups : 27 ( 95 % CI 1 to 53 ) m , p<0.05 ) . Increases in incremental shuttle performance correlated with increases in total carbohydrate intake . Conclusions : When universally prescribed , carbohydrate supplementation does not enhance the rehabilitation of patients with COPD . This study suggests that exercise training results in negative energy balance that can be overcome by supplementation and that , in selected patients , this may improve the outcome of training . The finding of benefit in well nourished patients may suggest a role for nutritional supplementation beyond the treatment of weight loss in COPD Unexplained weight loss is common in chronic obstructive pulmonary disease ( COPD ) . Blood levels of tumor necrosis factor-alpha ( TNF-alpha ) , a cytokine causing cachexia in laboratory animals , are elevated in various human diseases associated with weight loss . We therefore prospect ively measured TNF-alpha serum levels ( immunoradiometric assay ) in patients with clinical ly stable COPD ( n = 30 ; all male ; mean age , 65 yr ) whose weight was less ( Group I ; n = 16 ) or more ( Group II ; n = 14 ) than the lower limit of normal taken from Metropolitan Life Insurance Company tables . The patients had no cause known to elevate TNF-alpha serum levels ; notably , they were not infected . Group I patients had unintentionally lost weight during the previous year , whereas the weight of Group II patients had not changed during the same period . The two groups had similar chronic airflow obstruction and arterial blood gas impairment ; hyperinflation and reduction in diffusing capacity were more pronounced in Group I , but differences were not significant . TNF-alpha serum levels ( pg/ml ; mean [ SD ] ) were significantly higher in Group I than in Group II ( 70.2 [ 100.0 ] versus 6.7 [ 6.4 ] ; p < 0.001 ) . Group II TNF-alpha serum levels did not differ significantly from those of healthy subjects ( 7.8 [ 3.9 ] ) , whereas those of Group I were significantly higher ( p < 0.001 ) . Because renal function was in the normal range , we
Output:
| Nutritional support had no significant effect on anthropometric measures , lung function or exercise capacity in patients with stable COPD |
MS211075 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches Background : There is still debate over the benefit of self-management programmes for adults with asthma . A brief self-management programme given during a hospital admission for acute asthma was tested to determine whether it would reduce readmission . Method : A r and omised controlled trial was performed in 280 adult patients with acute asthma admitted over 29 months . Patients on the self-management programme ( SMP ) received 40–60 minutes of education supporting a written self-management plan . Control patients received st and ard care ( SC ) . Results : One month after discharge SMP patients were more likely than SC patients to report no daytime wheeze ( OR 2.6 , 95 % CI 1.5 to 5.3 ) , no night disturbance ( OR 2.0 , 95 % CI 1.2 to 3.5 ) , and no activity limitation ( OR 1.5 , 95 % CI 0.9 to 2.7 ) . Over 12 months 17 % of SMP patients were re-admitted compared with 27 % of SC patients ( OR 0.5 , 95 % CI 0.3 to 1.0 ) . Among first admission patients , OR readmission ( SMP v SC ) was 0.2 ( 95 % CI 0.1 to 0.7 ) , p<0.01 . For patients with a previous admission , OR readmission was 0.8 ( 95 % CI 0.4 to 1.6 ) , p=0.6 . SMP patients were more likely than SC patients to be prescribed inhaled steroids at discharge ( 99 % v 92 % , p=0.03 ) , oral steroids ( 98 % v 90 % , p=0.06 ) , and to have hospital follow up ( 98 % v 84 % , p<0.01 ) but adjustment for these differences did not diminish the effect of the self-management programme . Conclusions : A brief self-management programme during hospital admission reduced post discharge morbidity and readmission for adult asthma patients . The benefit of the programme may have been greater for patients admitted for the first time . The programme also had a small but significant effect on medical management at discharge OBJECTIVES to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients . DESIGN r and omized controlled trial . SUBJECTS AND SETTING S we r and omized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care . INTERVENTIONS the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient . A copy was given to the patient and to all relevant professionals and carers . This was followed by a domiciliary assessment by a community pharmacist . In the control group , patients were discharged from hospital following st and ard procedures that included a discharge letter to the general practitioner listing current medications . OUTCOMES the primary outcome was re-admission to hospital within 6 months . Secondary outcomes included the number of deaths , attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period , together with patients ' general well-being , satisfaction with the service and knowledge of and adherence to prescribed medication . RESULTS we recruited 362 patients , of whom 181 were r and omized to each group . We collected hospital and general practice data on at least 91 and 72 % of patients respectively at each follow-up point and interviewed between 43 and 90 % of the study subjects . There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months . There were no significant differences in any of the secondary outcomes . CONCLUSIONS we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes Background Pre-discharge home visits aim to maximise independence in the community . These visits involve assessment of a person in their own home prior to discharge from hospital , typically by an occupational therapist . The therapist may provide equipment , adapt the home environment and /or provide education . The aims of this study were to investigate the feasibility of a r and omised controlled trial in a clinical setting and the effect of pre-discharge home visits on functional performance in older people undergoing rehabilitation . Methods Ten patients participating in an inpatient rehabilitation program were r and omly assigned to receive either a pre-discharge home visit ( intervention ) , or st and ard practice in-hospital assessment and education ( control ) , both conducted by an occupational therapist . The pre-discharge home visit involved assessment of the older person 's function and environment , and education , and took an average of 1.5 hours . The hospital-based interview took an average of 40 minutes . Outcome data were collected by a blinded assessor at 0 , 2 , 4 , 8 and 12 weeks . Outcomes included performance of activities of daily living , reintegration to community living , quality of life , readmission and fall rates . Results Recruitment of 10 participants was slow and took three months . Observed performance of functional abilities did not differ between groups due to the small sample size . Difference in activities of daily living participation , as recorded by the Nottingham Extended Activities of Daily Living scale , was statistically significant but wide confidence intervals and low statistical power limit interpretation of results . Conclusion Evaluation of pre-discharge home visits by occupational therapists in a rehabilitation setting is feasible , but a more effective recruitment strategy for a main study is favored by application of a multi-centre setting AIMS To test the effect of education and support by a nurse on self-care and re source utilization in patients with heart failure . METHODS A total of 179 patients ( mean age 73 , 58 % male , NYHA III-IV ) hospitalized with heart failure were evaluated prospect ively . Patients were r and omized to the study intervention or to ' care as usual ' . The supportive educative intervention consisted of intensive , systematic and planned education by a study nurse about the consequences of heart failure in daily life , using a st and ard nursing care plan developed by the research ers for older patients with heart failure . Education and support took place during the hospital stay and at a home visit within a week of discharge . Data were collected on self-care abilities , self-care behaviour , readmissions , visits to the emergency heart centre and use of other health care re sources . RESULTS Education and support from a nurse in a hospital setting and at home significantly increases self-care behaviour in patients with heart failure . Patients from both the intervention and the control group increased their self-care behaviour within 1 month of discharge , but the increase in the intervention group was significantly more after 1 month . Although self-care behaviour in both groups decreased during the following 8 months , the increase from baseline remained statistically significant in the intervention group , but not in the control group . No significant effects on re source utilization were found . CONCLUSIONS Intensive , systematic , tailored and planned education and support by a nurse results in an increase in patients ' self-care behaviour . No significant effects were found on use of health care re sources . Additional organisational changes , such as longer follow-up and the availability of a heart failure specialist would probably enhance the effects of education and support To select patients for early discharge planning , a r and omized clinical trial evaluated a protocol that used risk factors identified upon hospital admission . The goal of the study was to determine if intervention with high-risk patients could reduce the need for hospital admission or skilled care . Of 13,255 patients screened , 835 study participants were identified as " at risk " for frequent health care re source use . Half of the high-risk patients were r and omly assigned to the experimental group ( n=417 ) and received discharge planning from day 3 of their hospital stay , while the control group ( n=418 ) received discharge planning only if there was a written physician request . Those patients receiving early , systematic discharge planning experienced an increased likelihood of successful return to home after hospital admission and a decreased chance of unscheduled readmission for the 9-month study period . Length of the index hospital stay was not affected by early planning , however . The major clinical implication is the potential for discharge planners to decrease the need for , and use of , health care re sources after hospital admission Background Readmission rates for patients with heart failure are a major concern for hospitals worldwide . The importance of patient education and a structured care plan to ease the transition from hospital to home has been the focus of many intervention strategies to reduce readmission rates . The use of transitioning of care plans is believed to improve medication reconciliation , communication , patient education , and follow‐up . To date , the evidence has not been systematic ally evaluated to support the effectiveness of a nurse coordinated transitioning of care for patients with heart failure in reducing readmission rates . Objective The objective of the systematic review was to identify the best available evidence on the effectiveness of nurse coordinated transitioning of care between hospital and home on hospital readmission rates for all causes in adult patients hospitalised with heart failure . Search strategy The search strategy aim ed to find both published and unpublished studies in the English language from January 1975 through July 2010 . A search of MEDLINE , CINAHL , PsycINFO , Health source Nursing/academic edition , EMBASE , the Cochrane Library , and the Joanna Briggs Institute Library of Systematic Review s was conducted followed by a reference search of relevant studies . The initial key words search ed were : heart failure , readmission , and transitional care . Inclusion criteria R and omised controlled trials that evaluated the effect of nurse coordinated transitioning of care from hospital to home in adult patients with heart failure on readmission rates were selected . The outcome was defined as hospital readmissions for all causes following an initial admission for heart failure . Data collection and analysis Studies selected for retrieval were critically evaluated by two independent review ers for method ological validity using st and ardised critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument ( JBI‐MAStARI ) . Data were extracted and analysed using the JBI‐MAStARI program . Results A total of 16 r and omised controlled studies were included . Ten of the 16 studies included in the review show that a nurse led transitioning of care intervention can reduce the rate of readmission for patients with heart failure . Interventions utilising home visits , or home visits coupled with telephone follow‐up , show a more favourable reduction in readmission rates . Conclusions Reduced readmissions occur when transitioning of care interventions are carried out by a heart failure trained nurse who conducts at least one home visit and follows the patient at least weekly for a minimum of 30 days post discharge with either additional home visits or telephone contact . Implication s for practice This review supports the development of a nurse coordinated transitioning of care plan which will require improvements in communication , in addition to changes in health policy and payment systems that align incentives and performance measures in caring for patients with heart failure . Implication s for research Future research should evaluate the effect of the intensity and duration of the transitioning of care intervention on readmission rates in a large r and omised control trial on an adult population with heart failure to determine the ideal frequency and duration of the post discharge interventions Background Hospital readmission soon after discharge is common and costly . To date , published studies of effectiveness of structured discharge process addressing reduction of hospital readmission have focused on patients with chronic conditions and complex needs , but not in adult patients with community acquired pneumonia . Objectives To examine and synthesis e the best available evidence related to effectiveness of structured discharge process in reducing hospital readmission of adult patients with community acquired pneumonia . Inclusion criteria Types of participants This review considered studies that included hospitalised adult patients diagnosed with community acquired pneumonia regardless of gender , ethnicity , severity , and co‐morbidities . Types of interventions Structured discharge process related to early patient engagement , patient‐caregiver dyad intervention , transitional care , coordinated care , and multidisciplinary team approach . Types of outcome measures The outcome measures included in this review were hospital readmission , emergency room visits , and unscheduled visits to healthcare provider . Types of Studies R and omised controlled trials ( RCTs ) and quasi‐experimental studies were considered for inclusion . Search strategy The search strategy aim ed to find both published and unpublished studies in English language without date limits . A search of PubMed / MEDLINE , CINAHL , CINAHL Plus , EMBASE , Cochrane Central Register of Controlled Trials ( CENTRAL ) , PsycINFO , Academic Search Premier , Health Source Nursing/Academic Edition and seven other data bases was conducted . Method o
Output:
| Interventions design ed to improve the care transition from hospital to home are effective in reducing hospital readmission .
These interventions preferably start in the hospital and continue after discharge rather than starting after discharge .
Enhancing patient empowerment is a key factor in reducing hospital readmissions .
Interventions that support patient empowerment are more effective in reducing hospital readmissions ( grade B recommendation ) . |
MS211076 | ***TASK*** the task is to summarize an input biomedical literature in 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 To examine the objective physical function of the lower extremities , to measure the properties of quadriceps femoris muscle ( QFM ) , and to assess subjective disabilities in men with knee osteoarthritis ( OA ) and to compare the results with those obtained from age- and sex-matched control subjects . DESIGN Cross-sectional study . SETTING Rehabilitation clinic in a university hospital . PARTICIPANTS Male volunteers ( n=54 ) ( age range , 50 - 69y ) with knee OA and r and omly selected healthy , age- and sex-matched control subjects ( n=53 ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Physical function evaluated with a test battery including the QFM composition measurement , the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , and the R AND 36-Item Short-Form Health Survey , version 1.0 . RESULTS Knee OA patients had 13 % to 26 % poorer ( P range , .050-.001 ) physical function and muscle strength compared with the controls . There were also significant differences in QFM composition . WOMAC ( P range , .050-.001 ) and muscle strength ( P<.001 ) associated with physical function tests , but subjective pain correlated with neither physical function nor muscle strength in knee OA patients . The radiographic knee OA grade did not have any significant effect on physical function , but passive knee motion , knee extension strength , and WOMAC were related to the severity of the disease ( P<.05 ) . CONCLUSIONS The patients with knee OA exhibited impaired physical function and muscle strength and QFM composition compared with healthy controls . The severity of radiographic knee OA clearly had adverse effects on functional ability at the later stages of the disease . The results highlight the effect of QFM strength on physical function as well as the importance of patient 's subjective and objective physical function when deciding on knee OA treatment policy OBJECTIVE Although knee malalignment is assumed to correlate with knee osteoarthritis ( OA ) , it is still unknown whether malalignment precedes the development of OA or whether it is a result of OA . The aim of this study was to assess the relationship between malalignment and the development of knee OA as well as progression of knee OA . METHODS A total of 1,501 participants in the Rotterdam study were r and omly selected . Knee OA at baseline and at followup ( mean followup 6.6 years ) was scored according to the Kellgren/Lawrence ( K/L ) grading system . Alignment was measured by the femorotibial angle on radiographs at baseline . Multivariable logistic regression for repeated measurements was used to analyze the association of malalignment with the development and progression of OA . RESULTS Of 2,664 knees , 1,012 ( 38 % ) were considered to have normal alignment , 693 ( 26 % ) had varus alignment , and 959 ( 36 % ) had valgus alignment . A comparison of valgus alignment and normal alignment showed that valgus alignment was associated with a borderline significant increase in development of knee OA ( odds ratio [ OR ] 1.54 , 95 % confidence interval [ 95 % CI ] 0.97 - 2.44 ) , and varus alignment was associated with a 2-fold increased risk ( OR 2.06 , 95 % CI 1.28 - 3.32 ) . Stratification for body mass index showed that this increased risk was especially seen in overweight and obese individuals but not in non-overweight persons . The risk of OA progression was also significantly increased in the group with varus alignment compared with the group with normal alignment ( OR 2.90 , 95 % CI 1.07 - 7.88 ) . CONCLUSION An increasing degree of varus alignment is associated not only with progression of knee OA but also with development of knee OA . However , this association seems particularly applicable to overweight and obese persons OBJECTIVES Foot orthoses are commonly used in the management of knee OA , although the relationship between foot function and knee OA is still unclear . The purpose of the study was to examine foot function during walking in people with and without medial compartment knee OA . METHODS Motion of the tibia , rearfoot and forefoot in 32 patients with medial compartment knee OA and 28 age-matched control subjects was investigated . Multivariate analysis was used to compare the groups . RESULTS The knee OA group contacted the ground with a more everted rearfoot , demonstrated greater peak rearfoot eversion and exhibited reduced rearfoot frontal plane range of motion and reduced rearfoot peak inversion . The tibia was more internally rotated and laterally tilted throughout the gait cycle , with reduced peak external rotation . CONCLUSION People with medial compartment knee OA exhibit altered foot kinematics during gait that are indicative of a less mobile , more everted foot type . The presence and degree of tibial malalignment and the available rearfoot range of motion during walking may affect individual responses to load-altering interventions , such as foot orthoses and footwear modifications . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry , www.anzctr.org.au/ , ACTRN12608000116325 OBJECTIVE To compare age-related patterns of gait with patterns associated with knee osteoarthritis ( OA ) , the following hypotheses were tested : ( H1 ) The sagittal-plane knee function during walking is different between younger and older asymptomatic subjects ; ( H2 ) The age-related differences in H1 are increased in patients with knee OA . DESIGN Walking trials were collected for 110 participants ( 1.70 ± 0.09 m , 80 ± 14 kg ) . There were 29 younger asymptomatic subjects ( 29 ± 4 years ) and 81 older participants ( 59 ± 9 years ) , that included 27 asymptomatic subjects and 28 and 26 patients with moderate and severe medial knee OA . Discrete variables characterizing sagittal-plane knee function were compared among the four groups using ANOVAs . RESULTS During the heel-strike portion of the gait cycle at preferred walking speed , the knee was less extended and the shank less inclined in the three older groups compared to the younger asymptomatic group . There were similar differences between the severe OA group and the older asymptomatic and moderate OA groups . Both OA groups also had the femur less posterior relative to the tibia and smaller extension moment than the younger group . During terminal stance , the severe OA group had the knee less extended and smaller knee extension moment than the younger asymptomatic and older moderate OA groups . CONCLUSIONS The differences in knee function , particularly those during heel-strike which were associated with both age and disease severity , could form a basis for looking at mechanical risk factors for initiation and progression of knee OA on a prospect i ve basis OBJECTIVE To describe the association between chondral defects , bone marrow lesions , knee and hip radiographic osteoarthritis ( OA ) , and knee pain . METHODS Knee pain was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index . T1- and T2-weighted fat saturation magnetic resonance imaging was performed on the right knee to assess chondral defects and subchondral bone marrow lesions . Radiography was performed on the right knee and hip and scored for radiographic OA . Body mass index ( BMI ) and knee extension strength were measured . RESULTS A total of 500 r and omly selected men and women participated . The prevalence of knee pain was 48 % . In multivariable analysis , prevalent knee pain was significantly associated with medial tibial chondral defects ( odds ratio [ OR ] 2.32 , 95 % confidence interval [ 95 % CI ] 1.02 - 5.28 for grade 3 versus grade 2 or less ; OR 4.93 , 95 % CI 1.07 - 22.7 for grade 4 versus grade 2 or less ) , bone marrow lesions ( OR 1.44 , 95 % CI 1.04 - 2.00 per compartment ) , and hip joint space narrowing ( OR 1.36 , 95 % CI 1.07 - 1.73 per unit ) , as well as greater BMI and lower knee extension strength . It was not significantly associated with radiographic knee OA . These variables were also associated with more severe knee pain . In addition , there was a dose response association between knee pain and number of sites having grade 3 or 4 chondral defects ( OR 1.39 , 95 % CI 1.12 - 1.73 per site ) , with all subjects having knee pain if all compartments of the knee had these defects . CONCLUSION Knee pain in older adults is independently associated with both full and non-full-thickness medial tibial chondral defects , bone marrow lesions , greater BMI , and lower knee extension strength , but is not associated with radiographic knee OA . The association between radiographic hip OA and knee pain indicates that referred pain from the hip needs to be considered in unexplained knee pain BACKGROUND Given the complexity of the gait of patients with knee osteoarthritis , a multiple correspondence analysis may be helpful to optimise the extraction of relevant gait and clinical information . Therefore , the aims of this study are to identify the main associations with clinical and gait biomechanical parameters and to evaluate whether there are more specific knee osteoarthritis groups with different gait profiles . METHODS Ninety patients with severe knee osteoarthritis and twenty-six healthy individuals participated in this study . Pain and function were assessed with the WOMAC Index ; knee joint deformity was assessed by the hip-knee-ankle angle on full-limb radiography ; and full body gait analysis was performed with a motion analysis system and force plates . FINDINGS Using multiple correspondence analysis , two categories of gait parameters that best explain the gait variance of patients with knee osteoarthritis were highlighted . The forward displacement category is composed of the parameters speed , stride length , hip flexion and knee flexion . The frontal category is composed of the parameters thorax obliquity and knee adductor moments . Moreover , based on these parameters , four distinct gait profiles were identified : two gait profiles were associated with knee varus deformities , increased thorax obliquity and different forward displacements , while two gait profiles were associated with valgus deformities and different forward displacements . INTERPRETATION These gait parameters can be used to simplify the characterisation of the gait of the knee osteoarthritis population . Patients in varus profiles increase thorax obliquity on the stance limb and may reduce forward displacement . Patients in valgus profiles , however , only reduce forward displacement OBJECTIVE To examine the relationship of knee malalignment to the occurrence of knee osteoarthritis ( OA ) among subjects without radiographic OA at baseline to determine whether malalignment is a risk factor for incident disease or simply a marker of increasing disease severity . METHODS We selected 110 incident tibiofemoral ( TF ) OA case knees ( 76 subjects ) and 356 r and om control knees ( 178 subjects ) from among participants in the Framingham Osteoarthritis Study . Case knees did not have OA at baseline ( 1992 - 1994 examination ) but had developed OA ( Kellgren/Lawrence grade > or=2 ) at followup ( 2002 - 2005 examination ) ( mean of 8.75 years between examinations ) . Control knees did not have OA at baseline . St and ardized digital radiographs of the fully extended knee with weight-bearing were read using a st and ard protocol and eFilm viewing software . We measured the anatomic axis , the condylar angle , the tibial plateau angle , and the condylar tibial plateau angle . The interobserver intraclass correlation coefficient ( ICC ) ranged from 0.93 to 0.96 and the intraobserver ICC from 0.94 to 0.97 . In a knee-specific analysis , we examined the relationship of each alignment measurement to the risk of TF OA using generalized estimating equations , adjusting for age , sex , and body mass index ( BMI ) . We used the same approach to assess the association between each alignment measurement and the risk of medial TF OA . RESULTS Subjects in the case population were older and had a higher BMI than the controls . The alignment values were normally distributed and were not different between the cases and the controls . After adjustment for age , sex and BMI , there was no significant increase in incident OA in the highest quartile compared with the lowest quartile category for any of the alignment measures ( P for trend for anatomic axis and condylar tibial plateau angle was 0.83 and 0.80 , respectively ) . Similar results were also observed for medial compartment OA . CONCLUSION We found that baseline knee alignment is not associated with either incident radiographic TF OA or medial TF OA . These results suggest that malalignment is not a risk factor for OA , but rather is a marker of disease severity and /or its progression OBJECTIVE To compare the gait of adults with unilateral and bilateral symptomatic and radiographic knee osteoarthritis ( OA ) to determine whether these subgroups can be treated similarly in the clinic and when recruiting for r and omized clinical trials , and to use these data to generate future hypotheses regarding gait in these subsets of knee OA patients . METHODS Cross-sectional investigation of patients with unilateral and bilateral knee OA on gait mechanics using 136 older adults ( age ≥55 yrs ; 27 kg m(-2 ) ≥ BMI ≤ 41 kg m(-2 ) ; 82 % female ) with radiographic knee OA . Comparisons were made between the most affected side of the
Output:
| Compared with healthy controls , patients with knee osteoarthritis have higher odds of having lower muscle strength , proprioception deficits , more medial varus-valgus laxity and less lateral varus-valgus laxity .
Conclusions Patients with knee osteoarthritis are more likely to display a number of biomechanical characteristics . |
MS211077 | ***TASK*** the task is to summarize an input biomedical literature in 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 article investigates various reasons for sickness presenteeism ( SP ) , that is , going to work despite illness . The research questions asked is : What are the main reported reasons for SP in Norway and Sweden ? Design Cross-sectional survey in Norway and Sweden . Use of binomial logistic regression analysis . Participants A r and om sample of people aged between 20 and 60 years was obtained from complete and up date d data bases of the Norwegian and Swedish population s. A postal question naire was sent to the selected individuals , with response rate 33 % ( n=2843 ) . 2533 workers responded to questions about SP during the last 12 months . Primary and secondary outcome measures The article informs about the distribution of reasons for SP in Norway and Sweden , selected by the respondents from a closed list . The article also examines which factors influence the most often reported reasons for SP . Results 56 % of the Norwegian and Swedish respondents experienced SP in the previous year . The most frequently reported reasons for SP include not burden colleagues ( 43 % ) , enjoy work ( 37 % ) and feeling indispensable ( 35 % ) . A lower proportion of Norwegians state that they can not afford taking sick leave adjusted OR ( aOR 0.16 ( 95 % CI 0.10 to 0.22 ) ) , while a higher proportion of Norwegians refer to that they enjoy their work ( aOR=1.64 ( 95 % CI 1.28 to 2.09 ) ) . Women and young workers more often report that they do not want to burden their colleagues . Managers ( aOR=2.19 ( 95 % CI 1.67 to 2.86 ) ) , highly educated persons and the self-employed more often report that they are indispensable . Conclusions Positive and negative reasons for SP are reported , and there are significant differences between respondents from the two countries . The response rate is low and results must be interpreted with caution . Study design Cross-sectional study Background Burnout in healthcare is a worldwide problem . However , most studies focus narrowly on work-related factors and outcomes in one health profession or speciality . Aims To investigate the prevalence of burnout and its association with job dem and s , job re sources , individual well-being , work-related attitudes and behaviour in physicians and nurses across different specialties . Methods Multi-centre cross-sectional study of physicians and nurses working in Belgian hospitals . An electronic question naire was used to assess job dem and s ( e.g. workload ) , job re sources ( e.g. autonomy ) and indicators of well-being , work-related attitudes and behaviours . Structural equation modelling was used to examine interrelationships between explanatory variables and outcomes . Results 1169 physicians and 4531 nurses participated ; response rate 26 % . High scores ( > 75th percentile in reference group of Dutch health care workers ) were seen in 6 % of the sample on three burnout dimensions ( i.e. emotional exhaustion , depersonalization and personal competence ) and in 13 % for at least two dimensions . In contrast to the other dimensions , emotional exhaustion strongly related to almost all variables examined in the model . Positive associations were seen with workload , role conflicts , emotional burden and work-home interference and negative associations with learning and development opportunities and co-worker support . Emotional exhaustion correlated negatively with well-being , turnover intention , being prepared and able to work until retirement age , medication use , absenteeism and presenteeism . Conclusions Work-related factors were critical correlates of emotional exhaustion , which strongly related to poor health and turnover intention . R and omized controlled trials are suggested to underpin the effectiveness of interventions tackling job stressors and promoting job re sources OBJECTIVES Nurses are at elevated risk of burnout , anxiety and depressive disorders , and may then become less productive . This begs the question if a preventive intervention in the work setting might be cost-saving from a business perspective . MATERIAL AND METHODS A cost-benefit analysis was conducted to evaluate the balance between the costs of a preventive intervention among nurses at elevated risk of mental health complaints and the cost offsets stemming from improved productivity . This evaluation was conducted alongside a cluster-r and omized trial in a Dutch academic hospital . The control condition consisted of screening without feedback and unrestricted access to usual care ( N = 206 ) . In the experimental condition screen-positive nurses received personalized feedback and referral to the occupational physician ( N = 207 ) . RESULTS Subtracting intervention costs from the cost offsets due to reduced absenteeism and presenteeism result ed in net-savings of 244 euros per nurse when only absenteeism is regarded , and 651 euros when presenteeism is also taken into account . This corresponds to a return-on-investment of 5 euros up to 11 euros for every euro invested . CONCLUSIONS Within half a year , the cost of offering the preventive intervention was more than recouped . Offering the preventive intervention represents a favorable business case as seen from the employer 's perspective The aim of this study is to assess the impact of a broad range of possible factors relating to work , personal circumstances and attitudes towards sickness absence on a person 's decision to go to work despite feeling ill , a phenomenon that has been termed sickness presence ( SP ) , or ' presenteeism ' , in the literature . Using data from a r and om sample of 12,935 members from the core Danish work force the hypotheses were tested in a cross-sectional design utilising ordered logistic regression models . The results indicate that more than 70 % of the core work force goes ill to work at least once during a 12-month period . This means that SP is just as prevalent a phenomenon as sickness absence . Many of the results from earlier studies of SP were replicated and new factors were discovered : for example time pressure ( having a supervisory role and /or working more than 45 h per week ) and relationship with colleagues ( measured by working in a small company , having non-st and ard hours and degree of cooperation ) both increase the likelihood of SP . However , personal circumstances and attitudes , e.g. treating work as home ( cf . Hochschild 's thesis ) and being over-committed to work , were also found to lead to higher levels of SP . Finally , we found that those with a conservative attitude to absence were most likely to turn up ill at work . Overall , work-related factors seem to be slightly more important than personal circumstances or attitudes in determining people 's ' decision ' to go ill at work . However , the relatively low explanatory power of these combined factors suggests that there are still many unknowns in this field of research Objective Although research has been conducted on how nurse staffing levels affect outcomes , there has been little investigation into how the health-related productivity of nurses is related to quality of care . Two major causes of worker presenteeism ( reduced on-the-job productivity as a result of health problems ) are musculoskeletal pain and mental health issues , particularly depression . This study sought to investigate the extent to which musculoskeletal pain or depression ( or both ) in RNs affects their work productivity and self-reported quality of care and considered the associated costs . Methods Using a cross-sectional survey design , a r and om sample of 2,500 hospital-employed RNs licensed in North Carolina were surveyed using a survey instrument sent by postal mail . Specific measures included questions on individual and workplace characteristics , self-reported quality of care , and patient safety ; a numeric pain rating scale , a depression tool ( the Patient Health Question naire ) , and a presenteeism tool ( the Work Productivity and Activity Impairment Question naire : General Health ) were also incorporated . A total of 1,171 completed surveys were returned and used for analysis . Results Among respondents , the prevalence of musculoskeletal pain was 71 % ; that of depression was 18 % . The majority of respondents ( 62 % ) reported a presenteeism score of at least 1 on a 0-to-10 scale , indicating that health problems had affected work productivity at least “ a little . ” Pain and depression were significantly associated with presenteeism . Presenteeism was significantly associated with a higher number of patient falls , a higher number of medication errors , and lower quality -of-care scores . Baseline cost estimates indicate that the increased falls and medication errors caused by presenteeism are expected to cost $ 1,346 per North Carolina RN and just under $ 2 billion for the United States annually . Upper-boundary estimates exceed $ 9,000 per North Carolina RN and $ 13 billion for the nation annually . Conclusion More attention must be paid to the health of the nursing workforce to positively influence the quality of patient care and patient safety and to control costs We examined the effect of interview characteristics ( ie , recall interval , interview version ) on estimates of health-related lost productive work time ( LPT ) . Three versions of a telephone interview were administered using 7-day and 4-week recall periods . In a population -based survey , 7674 workers r and omly were assigned to one of six interviews at contact ; 615 participants received a follow-up interview . We found strong evidence of under-reporting using a 4-week recall period and a not significant trend in over-reporting LPT using a 7-day recall period . Of the three interviews , version 3 could be administered most quickly , on average , and yielded the most discriminating estimates of LPT by health condition ( ie , headache , allergic rhinitis , and cold/flu ) . Our data suggest that variation in relatively short recall periods influences estimates of health-related LPT . A 2-week recall period may be optimal for minimizing overall reporting error but requires additional research to verify OBJECTIVE Although major depression is thought to have substantial negative effects on work performance , the possibility of recall bias limits self-report studies of these effects . The authors used the experience sampling method to address this problem by collecting comparative data on moment-in-time work performance among service workers who were depressed and those who were not depressed . METHOD The group studied included 105 airline reservation agents and 181 telephone customer service representatives selected from a larger baseline sample ; depressed workers were deliberately over sample d. Respondents were given pagers and experience sampling method diaries for each day of the study . A computerized autodialer paged respondents at r and om time points . When paged , respondents reported on their work performance in the diary . Moment-in-time work performance was assessed at five r and om times each day over a 7-day data collection period ( 35 data points for each respondent ) . RESULTS Seven conditions ( allergies , arthritis , back pain , headaches , high blood pressure , asthma , and major depression ) occurred often enough in this group of respondents to be studied . Major depression was the only condition significantly related to decrements in both of the dimensions of work performance assessed in the diaries : task focus and productivity . These effects were equivalent to approximately 2.3 days absent because of sickness per depressed worker per month of being depressed . CONCLUSIONS Previous studies based on days missed from work significantly underestimate the adverse economic effects associated with depression . Productivity losses related to depression appear to exceed the costs of effective treatment BACKGROUND The specific job dem and s of working in a hospital may place nurses at elevated risk for developing distress , anxiety and depression . Screening followed by referral to early interventions may reduce the incidence of these health problems and promote work functioning . OBJECTIVE To evaluate the comparative cost-effectiveness of two strategies to promote work functioning among nurses by reducing symptoms of mental health complaints . Three conditions were compared : the control condition consisted of online screening for mental health problems without feedback about the screening results . The occupational physician condition consisted of screening , feedback and referral to the occupational physician for screen-positive nurses . The third condition included screening , feedback , and referral to e-mental health . DESIGN The study was design ed as an economic evaluation alongside a pragmatic cluster r and omised controlled trial with r and omisation at hospital-ward level . SETTING AND PARTICIPANTS The study included 617 nurses in one academic medical centre in the Netherl and s. METHODS Treatment response was defined as an improvement on the Nurses Work Functioning Question naire of at least 40 % between baseline and follow-up . Total per-participant costs encompassed intervention costs , direct medical and non-medical costs , and indirect costs stemming from lost productivity due to absenteeism and presenteeism . All costs were indexed for the year 2011 . RESULTS At 6 months follow-up , significant improvement in work functioning occurred in 20 % , 24 % and 16 % of the participating nurses in the control condition , the occupational physician condition and the e-mental health condition , respectively . In these conditions the total average annualised costs were € 1752 , € 1266 and € 1375 per nurse . The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was dominant , suggesting cost savings of € 5049 per treatment responder . The incremental cost-effectiveness ratio for the e-mental health condition versus the control condition was estimated at € 4054 ( added costs ) per treatment responder . Sensitivity analyses attested to the robustness of these findings . CONCLUSIONS The occupational physician condition result ed in greater treatment responses for less costs relative to the control condition and can therefore be recommended . The e-mental health condition produced less treatment response than the control condition and can not be recommended as an intervention to improve work functioning among nurses AIM This paper is a report of a cohort study of healthcare workers ' work attendance , and its long-term consequences ' on health , burnout , work ability and performance . BACKGROUND Concepts and measures of work attendance have varied in the scientific literature . Attending work in spite of being sick can have serious consequences on health . There is little knowledge on which individual and work-related conditions that increase work attendance and the long-term impact on health and performance . METHOD Prospect i ve analyses of three measures of work attendance i.e. sickness attendance , uninterrupted long-term attendance and balanced attendance ( ≤7 days of sick leave per year and no sickness attendance ) were done using question naire data from a 2-year cohort
Output:
| Conclusion The heterogeneity of published research and limited quality of measurement tools yielded no conclusive evidence on the association of presenteeism with hypothesized exposures , economic costs , or interventions amongst hospital healthcare workers . |
MS211078 | ***TASK*** the task is to summarize an input biomedical literature in 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 Multiple groups have reported on the use of repetitive transcranial magnetic stimulation ( rTMS ) in treatment-resistant major depression . The purpose of this study is to assess the efficacy of rTMS in unmedicated , treatment-resistant patients who meet criteria for major depression . METHODS Depressed subjects , who had failed to respond to a median of four treatment trials , were assigned in a r and omized double-blind manner to receive either active ( n = 10 ; 20 2-sec trains of 20 Hz stimulation with 58-sec intervals ; delivered at 80 % motor threshold with the figure-of-eight coil positioned over the left dorsolateral prefrontal cortex ) or sham ( n = 10 ; similar conditions with the coil elevated and angled 45 degrees tangentially to the scalp ) rTMS . These sequences were applied during 10 consecutive weekdays . Continuous electroencephalogram sampling and daily motor threshold determinations were also obtained . RESULTS The group mean 25-item Hamilton Depression Rating Scale ( HDRS ) score was 37.2 ( + /- 2.0 SEM ) points . Adjusted mean decreases in HDRS scores were 14.0 ( + /- 3.7 ) and 0.2 ( + /- 4.1 ) points for the active and control groups , respectively ( p < .05 ) . One of 10 subjects receiving active treatment demonstrated a robust response ( i.e. , HDRS decreased from 47 to 7 points ) ; three other patients demonstrated 40 - 45 % decreases in HDRS scores . No patients receiving sham treatment demonstrated partial or full responses . CONCLUSIONS A 2-week course of active rTMS result ed in statistically significant but clinical ly modest reductions of depressive symptoms , as compared to sham rTMS in a population characterized by treatment resistance Major depressive disorder ( MDD ) is a prevalent and disabling condition , and many patients do not respond to available treatments . Deep transcranial magnetic stimulation ( dTMS ) is a new technology allowing non-surgical stimulation of relatively deep brain areas . This is the first double-blind r and omized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD . We recruited 212 MDD out patients , aged 22 - 68 years , who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode . They were r and omly assigned to monotherapy with active or sham dTMS . Twenty sessions of dTMS ( 18 Hz over the prefrontal cortex ) were applied during 4 weeks acutely , and then biweekly for 12 weeks . Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale ( HDRS-21 ) score and response/remission rates at week 5 , respectively . dTMS induced a 6.39 point improvement in HDRS-21 scores , while a 3.28 point improvement was observed in the sham group ( p=0.008 ) , result ing in a 0.76 effect size . Response and remission rates were higher in the dTMS than in the sham group ( response : 38.4 vs. 21.4 % , p=0.013 ; remission : 32.6 vs. 14.6 % , p=0.005 ) . These differences between active and sham treatment were stable during the 12-week maintenance phase . dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred . These results suggest that dTMS constitutes a novel intervention in MDD , which is efficacious and safe in patients not responding to antidepressant medications , and whose effect remains stable over 3 months of maintenance treatment Repetitive transcranial magnetic stimulation ( rTMS ) of the dorsolateral prefrontal cortex is a relatively non-invasive technique with putative therapeutic effects in major depression . However , the exact neurophysiological basis of these effects needs further clarification . Therefore , we studied the impact of ten daily sessions of left , dorsolateral prefrontal rTMS on motor cortical excitability , as revealed by transcranial magnetic stimulation-elicited motor-evoked potentials in 30 patients . As compared to the non-responders , responders ( 33 % ) showed changes in parameters pointing towards a reduced cortical excitability . These results suggest that repetitive transcranial magnetic stimulation of the dorsolateral , prefrontal cortex may have inhibitory effects on motor cortical neuronal excitability in patients with major depressive disorder . Furthermore , measurement of motor cortical excitability may be a useful tool for investigating and monitoring inhibitory brain effects of antidepressant stimulation techniques like rTMS 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 Abstract Objectives . Intensified repetitive transcranial magnetic stimulation ( rTMS ) applied to the left dorsolateral prefrontal cortex ( DLPFC ) may result in fast clinical responses in treatment resistant depression ( TRD ) . In these kinds of patients , subgenual anterior cingulate cortex ( sgACC ) functional connectivity ( FC ) seems to be consistently disturbed . So far , no de novo data on the relationship between sgACC FC changes and clinical efficacy of accelerated rTMS were available . Methods . Twenty unipolar TRD patients , all at least stage III treatment resistant , were recruited in a r and omized sham-controlled crossover high-frequency (HF)-rTMS treatment study . Resting-state ( rs ) functional MRI scans were collected at baseline and at the end of treatment . Results . HF-rTMS responders showed significantly stronger resting-state functional connectivity ( rsFC ) anti-correlation between the sgACC and parts of the left superior medial prefrontal cortex . After successful treatment an inverted relative strength of the anti-correlations was observed in the perigenual prefrontal cortex ( pgPFC ) . No effects on sgACC rsFC were observed in non-responders . Conclusions . Strong rsFC anti-correlation between the sgACC and parts of the left prefrontal cortex could be indicative of a beneficial outcome . Accelerated HF-rTMS treatment design s have the potential to acutely adjust deregulated sgACC neuronal networks in TRD patients BACKGROUND Electroconvulsive therapy ( ECT ) is an effective alternative for pharmacotherapy in treatment-resistant depressive patients , but the side effects limit its use . Transcranial magnetic stimulation ( TMS ) has been proposed as a refined alternative , but most studies do not indicate that TMS is as effective as ECT for severe depression . OBJECTIVE We propose that the limited effectiveness of st and ard TMS resides in its superficial effect on the cortex , although much of the pathophysiology of depression is associated with deeper and larger brain regions implicated in the reward system . Herein , we tested the effectiveness and safety of a novel TMS coil , the " H-coil , " which enables direct stimulation of deeper brain regions , at the expense of focality . METHODS We have studied the antidepressant and cognitive effects induced by 4 weeks of high-frequency ( 20 Hz ) repeated deep TMS ( DTMS ) over the prefrontal cortex ( PFC ) of 65 medication-free depressive patients , who have failed to benefit from prior medications . Patients were r and omly assigned to various treatment configurations , differing in stimulation intensity and laterality . Effects were assessed by the 24-item Hamilton depression rating scale ( HDRS-24 ) and several secondary outcome measures . RESULTS A significant improvement in HDRS scores was found when high , but not low , stimulation intensity was used . Several cognitive improvements were evident , and no treatment-related serious adverse events were observed . CONCLUSIONS DTMS over the PFC was found safe and effective in alleviating depression . The results accentuate the significance of deep , high-intensity stimulation over low , and serve as the first study to indicate the potential of DTMS in psychiatric and neurologic disorders BACKGROUND We tested whether transcranial magnetic stimulation ( TMS ) over the left dorsolateral prefrontal cortex ( DLPFC ) is effective and safe in the acute treatment of major depression . METHODS In a double-blind , multisite study , 301 medication-free patients with major depression who had not benefited from prior treatment were r and omized to active ( n = 155 ) or sham TMS ( n = 146 ) conditions . Sessions were conducted five times per week with TMS at 10 pulses/sec , 120 % of motor threshold , 3000 pulses/session , for 4 - 6 weeks . Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale ( MADRS ) . Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale ( HAMD ) and response and remission rates with the MADRS and HAMD . RESULTS Active TMS was significantly superior to sham TMS on the MADRS at week 4 ( with a post hoc correction for ine quality in symptom severity between groups at baseline ) , as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6 . Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6 . Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales ( but not the HAMD17 scale ) . Active TMS was well tolerated with a low dropout rate for adverse events ( 4.5 % ) that were generally mild and limited to transient scalp discomfort or pain . CONCLUSIONS Transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported . It offers clinicians a novel alternative for the treatment of this disorder OBJECTIVE Preliminary studies have indicated that daily left prefrontal repetitive transcranial magnetic stimulation might have antidepressant activity . The authors sought to confirm this finding by using a double-blind crossover design . METHOD Twelve depressed adults received in r and om order 2 weeks of active treatment ( repetitive transcranial magnetic stimulation , 20 Hz at 80 % motor threshold ) and 2 weeks of sham treatment . RESULTS Changes from the relevant phase baseline in scores on the 21-item Hamilton depression scale showed that repetitive transcranial magnetic stimulation significantly improved mood over sham treatment . During the active-treatment phase , Hamilton depression scale scores decreased 5 points , while during sham treatment the scores increased or worsened by 3 points . No adverse effects were noted . CONCLUSIONS These placebo-controlled results suggest that daily left prefrontal repetitive transcranial magnetic stimulation has antidepressant activity when administered at these parameters . Further controlled studies are indicated to explore optimal stimulation characteristics and location , potential clinical applications , and possible mechanisms of action It has been 30 years since the discovery that repeated electrical stimulation of neural pathways can lead to long-term potentiation in hippocampal slices . With its relevance to processes such as learning and memory , the technique has produced a vast literature on mechanisms of synaptic plasticity in animal models . To date , the most promising method for transferring these methods to humans is repetitive transcranial magnetic stimulation ( rTMS ) , a noninvasive method of stimulating neural pathways in the brain of conscious subjects through the intact scalp . However , effects on synaptic plasticity reported are often weak , highly variable between individuals , and rarely last longer than 30 min . Here we describe a very rapid method of conditioning the human motor cortex using rTMS that produces a controllable , consistent , long-lasting , and powerful effect on motor cortex physiology and behavior after an application period of only 20 - 190 Background The aim of the current study was to investigate the cognitive correlates of repetitive transcranial magnetic stimulation ( rTMS ) in 10 treatment-resistant depression patients . Methods Patients received forty 20-min sessions of fast-frequency ( 10 Hz ) rTMS of the left dorsolateral prefrontal cortex ( DLPFC ) over 20 days . Concept-shift ability ( accuracy and duration of performance ) was assessed daily with a Modified Concept-Shifting Task ( mCST ) in patients and in eight healthy volunteers . General cognitive functioning test ( Repeatable Battery for the Assessment of Neuropsychological Status ; RBANS ) , Beck Depression Inventory ( BDI ) and Hamilton Depression Rating Scale ( HAM-D ) were applied before the first and after the last rTMS . Results Compared to before rTMS on the first 10 days , the patients performed the mCST significantly more accurately after rTMS on the last 10 days ( p < .001 , partial eta squared=.78 ) while the same comparison in healthy volunteers was not statistically significant ( p = .256 , partial eta squared=.18 ) . A significant improvement in immediate memory on RBANS and reduction in BDI and HAM-D scores were also observed after the last compared to before the first rTMS . Conclusion The rTMS is associated with an improvement in selective cognitive functions that is not explained by practice effects on tasks administered repeatedly . Trial registration Name : " Repetitive Transcranial Magnetic Stimulation ( rTMS ) in the treatment of depression , assessed with HAM-D over a four week period."URL : www.actr.org.au Registration number : R and omized controlled trials support the antidepressant efficacy of transcranial magnetic stimulation ( TMS ) ; however , there is individual variability in the magnitude of response . Examination of response predictors has been hampered by method ological limitations such as small sample sizes and single-site study design s. Data from a multisite sham-controlled trial of the antidepressant efficacy
Output:
| Reduction in depression severity was greater in studies with younger patients using either coil .
The comparison between coils showed a larger reduction in depression severity in H1-coil vs. F8-coil studies ( independent of the study design or the concurrent pharmacotherapy ) and a trend towards higher remission rates in F8-coil vs. H1-coils studies .
Conclusion When matched on frequency , the higher-intensity and less focal stimulation with the H1-coil reduces depression more than the lower-intensity and more focal stimulation with the F8-coil . |
MS211079 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To investigate whether early catheter removal following transurethral prostatectomy ( TURP ) is safe and whether it has any effect on the length of hospital stay . PATIENTS AND METHODS Following transurethral prostatectomy 59 patients were r and omized into one of two groups : those whose catheter was removed on day 1 after surgery and those whose catheter was removed on day 2 . The incidence of complications and the duration of post-operative hospital stay were assessed . RESULTS Catheter removal on day 1 led to a significantly shorter post-operative hospital stay ( 2.3 days versus 3.3 days ) and did not incur a higher incidence of complications . CONCLUSIONS Removal of the catheter on the first day following TURP is safe in selected patients and leads to a shorter post-operative hospital stay In the fields of both nursing and medicine there is a dearth of published literature on the optimum time to remove indwelling urinary catheters ( IDCs ) following urological surgery . Tradition seems to be in favour of removing IDCs at 0600 hours despite a lack of evidence to support this practice . This study was undertaken to determine whether midnight removal of IDCs result ed in patients ' resuming normal voiding patterns . A prospect i ve clinical trial was conducted to determine the impact midnight removal of urinary catheters would have on the patients ' voiding pattern , and subsequent discharge from hospital . One hundred and sixty patients were entered into the study . The patients were allocated at r and om to have their urinary catheter removed either at midnight or at 0600 hours . Patients who had their catheters removed at midnight passed a greater volume of urine with both their first ( 268 ml compared with 177 ml ; P<0.0001 ) and second voids ( 322 ml compared with 195 ml ; P<0.0001 ) than their counterparts in the 0600 group . This permitted earlier discharge from hospital . The results reported in this study support the findings of earlier research that midnight removal of IDC leads to an earlier resumption of normal voiding patterns , permits earlier discharge from hospital and appears to reduce patients ' anxiety . The recommendation from this study is that there should be a change in hospital policy so that the majority of IDCs are removed at midnight Patients who had undergone bladder neck surgery were r and omized to having their urethral catheters removed either early in the morning or late at night . There was no difference in the incidence of urinary retention between these two groups of patients . However , patients who presented with acute urinary retention had a higher incidence of postoperative urinary retention . This study suggests that a urethral catheter may be safely removed in the evening without increasing the risk of urinary retention . There also seems to be no greater chance of the patient having to be recatheterized at an unsocial hour OBJECTIVES Postoperative urethral catheter drainage after radical prostatectomy is bothersome to patients . A pilot study was initiated to determine if urethral catheter removal prior to hospital discharge is feasible . METHODS Thirty-three consecutive men undergoing radical retropubic prostatectomy were prospect ively studied and followed for a minimum of 6 months ( mean , 8.5 ) . Postoperative cystography was utilized to direct early catheter removal . RESULTS Of 33 patients , 27 ( 82 % ) underwent successful catheter removal at a mean of 4.2 postoperative days . No patient experienced urinary retention , urinoma development , pelvic abscess , or anastomotic stricture . Urinary continence is excellent ( no pads required ) in 70 % and good ( stress incontinence requiring 1 to 2 pads/24 hours ) in 18 % of patients at last follow-up . CONCLUSIONS Following radical prostatectomy , early catheter removal prior to hospital discharge is feasible . Early results suggest no deleterious consequences . Prospect i ve monitoring of more patients is needed to determine if this practice is widely applicable The interval before removal of the catheter used in prostatic transurethral surgery depends to a great extent on the surgeon , with a frequently empirical orientation . We conducted a prospect i ve , r and omized and controlled study of 213 patients who underwent transurethral surgery for benign prostatic hyperplasia . The catheter was removed systematic ally 24 hours after transurethral incision and 48 hours after transurethral resection of the prostate ( group 1 - 52 and 54 patients , respectively ) or the catheterization interval was determined by each surgeon in accordance with the usual criteria ( group 2 - 52 and 55 patients , respectively ) . No statistically significant differences were noted between these 2 groups in regard to complications . We conclude that systematic removal of the catheter at the aforementioned periods is cost-effective , safe and comfortable for the patient This study shows that removal of urinary catheters at midnight has several advantages over removal at 6 AM . The midnight group had a significantly greater initial voided volume and a longer time to first void than the equivalent 6 AM group . Advantages to midnight catheter removal also exist for nursing staff . Midnight tends to be less busy on the nursing unit compared with 6 AM , thus making it a preferable time for performance of routine tasks . Catheter removal at midnight also allows for convenient observation of patient voiding and assessment earlier in the day . This means that any necessary intervention can take place during working hours when more staff are on duty . There is also the potential for earlier discharge , with economic benefits related to shorter bed stay and more efficient discharge planning . We believe midnight catheter removal offers considerable benefits over the traditional 6 AM time on both general and urology units BACKGROUND Voiding dysfunction is frequently observed after rectal resection and justifies urinary drainage . However , there is no agreement about the optimal duration of this postoperative drainage . The aim of this controlled trial was to compare 1 versus 5 days of transurethral catheterization after rectal resection , with special reference to urinary tract infection and bladder retention . METHODS One hundred twenty-six patients undergoing rectal resection were included in a prospect i ve r and omized study design ed to compare the results for patients undergoing 1 day of transurethral catheterization after rectal resection ( 1-day group ) with those for patients undergoing 5 days ' catheterization ( 5-day group ) . RESULTS Patients were r and omly assigned to the 1-day and 5-day groups ( n = 64 and 62 , respectively ) . Clinical findings and surgical procedures were comparable in both groups . Acute urinary retention occurred in 16 patients ( 25 % ) in the 1-day group versus 6 ( 10 % ) in the 5-day group ( P < .05 ) . Urinary tract infection was observed in 13 of 64 patients ( 20 % ) in the 1-day group versus 26 of 62 ( 42 % ) in the 5-day group ( P < .01 ) . Multivariate analysis revealed that after 1 day of catheterization carcinoma of the low rectum and lymph node metastasis were significant risk factors for acute urinary retention ( P < .05 for both factors ) . After selection of patients without low rectum carcinoma , the acute urinary retention rate was comparable in both groups ( 14 % in the 1-day group versus 7 % in the 5-day group ) , but the urinary tract infection rate was significantly lower in the 1-day group versus the 5-day group ( 14 % vs 40 , P < .01 ) . CONCLUSIONS Our controlled study showed that after rectal resection 1 day of urinary drainage can be recommended for most patients . Five-day drainage should be reserved for patients with low rectal carcinoma OBJECTIVES Shortening hospital stay yet not compromising quality of care can result in significant cost savings for children undergoing surgical correction of vesicoureteral reflux . METHODS We review ed the medical records of pediatric patients who underwent ureteroneocystostomy between July 1995 and July 1997 . A total of 43 patients , aged 0.2 to 18 years ( mean 5.2 ) who all received identical postoperative care , except for their pain management and the time of bladder catheter removal , were included in the study . Twenty-three were treated with intravenous ketorolac tromethamine ( Toradol ) ; the remaining 20 received narcotics in the immediate postoperative period . The bladder catheter was removed in less than 24 hours in 22 children , and greater than 24 hours in 21 . RESULTS Patients who received ketorolac tromethamine for postoperative analgesia had on average shorter hospital length of stays than those treated with narcotics ( 1.4 versus 2.5 days , respectively ; P < 0.001 ) . The average stay for children whose bladder catheter was removed within 24 hours postoperatively was significantly shorter than those whose catheter was removed after a 24-hour period ( 1.4 versus 2.4 days , respectively ; P < 0.001 ) . There were no reimplantation failures . One child presented 2 days postoperatively with anemia , which did not require transfusion . CONCLUSIONS Our review demonstrates that ketorolac tromethamine can be used safely and effectively in children for immediate postoperative analgesia , and that its proper use combined with early catheter removal can reduce the length of hospital stay for pediatric patients undergoing ureteroneocystostomy PURPOSE We prospect ively tested the safety of routine removal of the catheter as early as 2 to 4 days after laparoscopic radical prostatectomy . MATERIAL S AND METHODS Between March 1998 and March 2001 , 228 patients underwent laparoscopic radical prostatectomy for clinical ly organ confined prostate cancer . The last 113 consecutive patients were included in a prospect i ve study according to gravitational cystography performed 2 to 4 days postoperatively . If no leak was seen the catheter was removed . If a leak was apparent the catheter was left indwelling for another 6 days and cystography was repeated . RESULTS Cystography 2 to 4 days postoperatively showed an anastomosis without a leak in 96 ( 84.9 % ) patients who subsequently had the catheters removed . There were 28 patients who had the catheter removed on postoperative day 2 , 28 day 3 and 40 day 4 . In 17 ( 15.1 % ) patients an anastomotic leak was observed , and the catheter was not removed at that time . Of the 96 patients in whom the catheter was removed early 10 ( 10.4 % ) had urinary retention that necessitated re-catheterization . This procedure was performed without the need for cystoscopy . After the catheter was removed all patients were able to void 24 hours later . Median followup was 7 months ( range 1 to 15 ) and showed continence rates greater than 93 % . No anastomotic stricture , pelvic abscess or urinoma developed in any patient . CONCLUSIONS Patients who undergo laparoscopic radical prostatectomy can have the catheter safely removed 2 to 4 days postoperatively without a higher risk of incontinence , stricture or leak related problems OBJECTIVE To compare three methods for a trial of micturition ( TOM ) ( the midnight removal of the catheter , dawn removal , and a new infusion method ) in a r and omized prospect i ve study . PATIENTS AND METHODS A total of 118 consecutive patients who had undergone transurethral resection of the prostate ( TURP ) or bladder neck incision ( BNI ) underwent TOM by one of the three methods . In the infusion method , the bladder was filled at a fast-drip rate via the catheter from a bag of normal saline connected by an intravenous supply set . The catheter was then removed , the patient voided and the volume was measured . From the volume of saline remaining , it was possible to calculate the residual volume in the patient . RESULTS The infusion TOM took a mean 13 h less than the other two methods , which were statistically indistinguishable . CONCLUSION The infusion TOM is safe and simple , is quick to carry out and can be performed at any time . It establishes the completeness of bladder emptying , which helps in the assessment of voiding PURPOSE We tested the hypothesis that early catheter removal may be accomplished safely after radical prostatectomy . MATERIAL S AND METHODS Cystography on postoperative day 4 or 5 in 42 of 67 consecutive patients who underwent radical retropubic prostatectomy revealed no extravasation in 30 and the urethral catheter was removed ( group 1 ) . The control group included 25 patients who did not undergo cystography , and the catheter was removed 14 days postoperatively ( group 2 ) . RESULTS Immediate and late continence was achieved in 14 ( 46.7 % ) and 25 ( 83.3 % ) cases in group 1 , and in 8 ( 32 % ) and 22 ( 88 % ) cases in group 2 , respectively ( p>0.05 ) . Catheterization was performed easily without any endoscopic or surgical procedure in 2 patients ( 6.7 % ) in group 1 who presented in urinary retention after catheter removal . Wound infection and pelvic abscess developed in 1 case ( 3.3 % ) . There were no late complications . In group 2 urinary retention developed in 1 patient ( 4 % ) , wound infection in 1 ( 4 % ) and hematuria in 1 ( 4 % ) . Two patients ( 8 % ) had late vesical neck contracture at 4 and 10 months , respectively , which required urethrotomy in 1 . In 1 patient ( 4 %
Output:
| There was no significant difference in need for recatheterisation , although recatheterisation after removal at night was more likely to be during working hours .
There is suggestive but inconclusive evidence of a benefit from midnight removal of the indwelling urethral catheter .
The evidence also suggests shorter hospital stay after early rather than delayed catheter removal but the effects on other outcomes are unclear .
There is little evidence on which to judge other aspects of management , such as catheter clamping |
MS211080 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Sixty newly admitted acute schizophrenic patients were r and omly assigned to a double-blind trial of metiapine with a maximum dose of 450 mg per day versus a maximum dose of 450 mg per day versus a maximum daily dose of 900 mg chlorpromazine per day . At the conclusion of the study , 21 patients in each group showed marked to moderate improvement . There were significantly more marked improvers in the metiapine group then the chlorpromazine group on the Physician 's Posttreatment Global Impression . Evaluation by analysis of covariance of the Brief Psychiatric Rating Scale showed a significant difference between treatment groups favoring chlorpromazine on the item of blunted affect . The spectrum of side effects was similar in the two groups , except for six patients treated with metiapine who displayed tachycardia on the EKG . This pulse elevation was reflected in the group data and is probably dose related . In conclusion , both drugs appeared to be equally efficacious in the treatment of newly admitted acute schizophrenic patients OBJECTIVES Clotiapine is a classic neuroleptic with a chemical structure similar to clozapine . It was said that patients unresponsive to other neuroleptics respond to clotiapine although it causes extrapyramidal syndromes ( EPS ) like other typical neuroleptics . We conducted a study of clotiapine vs. chlorpromazine in severe chronic active psychotic hospitalized schizophrenia patients . METHODS The design was double-blind crossover of clotiapine vs chlorpromazine . No washout was necessary from previous neuroleptic treatment , and flexible overlap with the study medication was individualized for each patient . Patients were treated after reaching neuroleptic monotherapy for 3 months with clotiapine and 3 months with chlorpromazine , in r and om order . Medication was supplied in identical capsules of 100 mg chlorpromazine or 40 mg of clotiapine . Positive and Negative Syndrome Scale ( PANSS ) and Clinical Global Impression ( CGI ) were rated every 2 weeks and Nurse 's Observation Scale for Inpatient Evaluation ( NOSIE ) every month . RESULTS Fifty-eight patients were r and omized . Forty-three patients completed at least one phase of the study , and thirty-three completed both phases . Because of the small number of hostel patients and the very high dropout rate in the hostel patients , data analysis was done separately for in patients and hostel patients . Clotiapine was significantly superior to chlorpromazine in 26 in patients completing the crossover , on the PANSS , NOSIE and CGI . Clotiapine was also superior to chlorpromazine in an analysis of the parallel inpatient groups in the first three months before the crossover . CONCLUSION Some classic neuroleptic compounds may have superiority to chlorpromazine in a " clozapine-like " manner , despite a typical profile for EPS BACKGROUND A recent review suggested an association between using unpublished scales in clinical trials and finding significant results . AIMS To determine whether such an association existed in schizophrenia trials . METHOD Three hundred trials were r and omly selected from the Cochrane Schizophrenia Group 's Register . All comparisons between treatment groups and control groups using rating scales were identified . The publication status of each scale was determined and cl aims of a significant treatment effect were recorded . RESULTS Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison ( relative risk 1.37 ( 95 % CI 1.12 - 1.68 ) ) . This effect increased when a ' gold-st and ard ' definition of treatment superiority was applied ( RR 1.94 ( 95 % CI 1.35 - 2.79 ) ) . In non-pharmacological trials , one-third of ' gold-st and ard ' cl aims of treatment superiority would not have been made if published scales had been used . CONCLUSIONS Unpublished scales are a source of bias in schizophrenia trials In a non-blind assessment of 3 neuroleptic drugs , chlorpromazine ( Largactil ) , thioridazine ( Melleril ) and clotiapine ( Etomine ) , we found Etomine to be the drug of choice when the diagnosis is in doubt between a toxic psychosis or schizophrenia . This drug also offered the highest discharge rate , 77'7 % at 12 weeks compared with 73'5 % in the thioridazine group , and 55'5 % in the chlorpromazine group . No clouding of consciousness was seen in the clotiapine group , whereas it was troublesome in the chlorpromazine group in patients having received high parenteral doses 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 ( enrollment , 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
Output:
| Clinical ly important improvement in global state was measured using the Clinical Global Impression ( CGI ) . |
MS211081 | ***TASK*** the task is to summarize an input biomedical literature in 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: Effective use of ultrasound requires an underst and ing of the physics , combined with the ability to interpret the sonographic images . The aim of our study was to evaluate the impact of a basic ultrasound curriculum using a phantom to train medical students . Twenty-eight first- to fourth-year medical students were r and omized to two groups : a control group that received no formal training and a trained group that received basic ultrasound training . Both groups took an initial multiple-choice written test and an ultrasound h and s-on test using an agarose-based tissue mimic containing various objects . The curriculum for the trained group consisted of reading the principles of ultrasound and a h and s-on session over the phantom . After training , both groups underwent a second multiple-choice exam and ultrasound practical test . The initial and the post-training test results were analyzed using a two-tailed Student 's t-test . Baseline written and practical test scores were similar for both groups . After training , written test scores improved ( 82 % trained vs. 66 % control , P < 0.001 ) . H and s-on ultrasound task performance also improved with training ( 96 % trained vs. 60 % control , P < 0.001 ) . The trained group took a shorter time to obtain a clear image and found on average one more object per scan . Parameters such as time to obtain a useful image and number of objects recognized also improved with training . Basic sonographic physics , imaging , and interpretation can be effectively taught to medical students during a short training session Endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) is very operator dependent and has a long learning curve . Simulation-based training might shorten the learning curve , and an assessment tool with solid validity evidence could ensure basic competency before unsupervised performance . A total of 16 respiratory physicians , without EBUS experience , were r and omised to either virtual-reality simulator training or traditional apprenticeship training on patients , and then each physician performed EBUS-TBNA procedures on three patients . Three blinded , independent assessor assessed the video recordings of the procedures using a newly developed EBUS assessment tool ( EBUSAT ) . The internal consistency was high ( Cronbach 's α=0.95 ) ; the generalisability coefficient was good ( 0.86 ) , and the tool had discriminatory ability ( p<0.001 ) . Procedures performed by simulator-trained novices were rated higher than procedures performed by apprenticeship-trained novices : mean±sd are 24.2±7.9 points and 20.2±9.4 points , respectively ; p=0.006 . A pass/fail st and ard of 28.9 points was established using the contrasting groups method , result ing in 16 ( 67 % ) and 20 ( 83 % ) procedures performed by simulator-trained novices and apprenticeship-trained novices failing the test , respectively ; p<0.001 . The endobronchial ultrasound assessment tool could be used to provide reliable and valid assessment of competence in EBUS-TBNA , and act as an aid in certification . Virtual-reality simulator training was shown to be more effective than traditional apprenticeship training . Virtual-reality simulation-based training shortens the learning curve for endobronchial ultrasound ( EBUS ) 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 need for surgeons to become proficient in performing and interpreting ultrasound examinations has been well recognized in recent years , but providing st and ardized training remains a significant challenge . The UltraSim ( MedSim , Ft . Lauderdale , Fla ) ultrasound simulator is a modified ultrasound machine that stores patient data in three-dimensional images . By scanning on the UltraSim mannequin , the student can reconstruct these images in real-time , eliminating the need for finding normal and abnormal models , while providing an objective method of both teaching and testing . The objective of this study was to compare the posttest results between residents trained on a real-time ultrasound simulator versus those trained in a traditional h and s-on patient format . We hypothesized that both methods of teaching would yield similar results as judged by performance on the interpretive portion of a st and ardized posttest . It is design ed as a prospect i ve , cohort study from two university trauma centers involving residents at the beginning of their first or second postgraduate year of training . The main outcome measure was performance on a st and ardized posttest , which included interpretation of ultrasound cases recorded on videotape . METHODS Students first took a written pretest to evaluate their baseline knowledge of ultrasound physics as well as their ability to interpret basic ultrasound images . The didactic portion of the course used the same teaching material s for all residents and included lectures on ultrasound physics , ultrasound use in trauma/critical care , and a series of instructional videos . This didactic session was followed by 1 hour for each student of h and s-on training on medical models/medical patients ( group I ) or by training on the ultrasound simulator ( group II ) . The pretest was repeated at the completion of the course ( posttest ) . Data were stratified by postgraduate year , i.e. , PG1 or PG2 . RESULTS A total of 74 residents were trained and tested in this study ( PG1 = 48 , PG2 = 26 ) . All residents showed significant improvement in their pretest and posttest scores ( p = 0.00 ) in both their knowledge of ultrasound physics and in their interpretation of ultrasound images . Importantly , we could not demonstrate any significant difference between groups trained on models/ patients ( group I ) versus those trained on the simulator ( group II ) when comparing their posttest interpretation of ultrasound images presented on videotapes ( PG1 , group I mean score 6.9 + /- 1.4 vs. PG1 , group II mean score 6.5 + /- 1.6 , p = 0.32 ; PG2 , group I mean score 7.7 + /- 1.4 vs. PG2 , group II mean score 7.9 + /- 1.2 , p = 0.70 ) . CONCLUSION The use of a simulator is a convenient and objective method of introducing ultrasound to surgery residents and compares favorably with the experience gained with traditional h and s-on patient models As medical education research advances , it is important that education research ers employ rigorous methods for conducting and reporting their investigations . In this article we discuss several important yet oft neglected issues in design ing experimental research in education . First , r and omization controls for only a subset of possible confounders . Second , the posttest-only design is inherently stronger than the pretest – posttest design , provided the study is r and omized and the sample is sufficiently large . Third , demonstrating the superiority of an educational intervention in comparison to no intervention does little to advance the art and science of education . Fourth , comparisons involving multifactorial interventions are hopelessly confounded , have limited application to new setting s , and do little to advance our underst and ing of education . Fifth , single-group pretest – posttest studies are susceptible to numerous validity threats . Finally , educational interventions ( including the comparison group ) must be described in detail sufficient to allow replication Purpose To compare pelvic ultrasound simulators ( PSs ) with live models ( LMs ) for training in transvaginal sonography ( TVS ) . Method The authors conducted a prospect i ve , r and omized controlled trial of 145 eligible medical students trained in TVS in 2011–2012 with either a PS or an LM . A patient educator was used for LM training . Simulated intrauterine and ectopic pregnancy models were used for PS training . Students were tested using a st and ardized patient who evaluated their professionalism . A proctor , blinded to training type , scored their scanning technique . Digital images were saved for blinded review . Students rated their training using a Likert scale ( 0 = not very well ; 10 = very well ) . The primary outcome measure was students ’ overall performance on a 40-point assessment tool for professionalism , scanning technique , and image acquisition . Poisson regression and Student t test were used for comparisons . Results A total of 134 students participated ( 62 trained using a PS ; 72 using an LM ) . Mean overall test scores were 56 % for the PS group and 69 % for the LM group ( P = .001 ) . A significant difference was identified in scanning technique ( PS , 60 % versus LM , 73 % ; P = .001 ) and image acquisition ( PS , 37 % versus LM , 59 % ; P = .001 ) . None was observed for professionalism . The PS group rated their training experience at 4.4 , whereas the LM group rated theirs at 6.2 ( P < .001 ) . Conclusions Simulators do not perform as well as LMs for training novices in TVS , but they may be useful as an adjunct to LM training OBJECTIVES Ultrasonography is of growing importance within internal medicine ( IM ) , but the optimal method of training doctors to use it is uncertain . In this study , the authors provide the first objective comparison of two approaches to training IM residents in ultrasonography . METHODS In this r and omised trial , a simulation-based ultrasound training curriculum was implemented during IM intern orientation at a tertiary care teaching hospital . All 72 incoming interns attended a lecture and were given access to online modules . Interns were then r and omly assigned to a 4-hour faculty-guided ( FG ) or self-guided ( SG ) ultrasound training session in a simulation laboratory with both human and manikin models . Interns were asked to self-assess their competence in ultrasonography and underwent an objective structured clinical examination ( OSCE ) to assess their competence in basic and procedurally oriented ultrasound tasks . The primary outcome was the score on the OSCE . RESULTS Faculty-guided training was superior to self-guided training based on the OSCE scores . Subjects in the FG training group achieved significantly higher OSCE scores on the two subsets of task completion ( 0.9-point difference , 95 % confidence interval [ CI ] 0.27 - 1.54 ; p = 0.008 ) and ultrasound image quality ( 2.43-point difference , 95 % CI 1.5 - 3.36 ; p < 0.001 ) . Both training groups demonstrated an increase in self-assessed competence after their respective training sessions and there was little difference between the groups . Subjects rated the FG training group much more favourably than the SG training group . CONCLUSIONS Both FG and SG ultrasound training curricula can improve the self-reported competence of IM interns in ultrasonography . However , FG training was superior to SG training in both skills acquisition and intern preference . Incorporating m and atory ultrasound training into IM residencies can address the perceived need for ultrasound training , improve confidence and procedural skills , and may enhance patient safety . However , the optimal training method may require significant faculty input The traditional apprenticeship model is being challenged in medical education . The “ see-one , do-one , teach-one ” approach does not live up to the dem and s regarding efficient training and patient safety . Ultrasound imaging is traditionally considered safe but the quality of the exam is very operator-dependent due to its dynamic nature 1 . Highly skilled operators are essential as false negative findings could lead to inadequate investigation and treatment , and false positive findings might result in unnecessary interventions 2 . This is true in particular because sonographic competence is a basic requirement for US as a dialog-based examination 3 . Most trainees participate in defined ultrasound courses but specialized ultrasound examination expertise is mainly acquired in daily clinical practice 4 5 . Fundamental problems are r and om occurrence of specific cases and also insufficient formalized supervision and feedback may occur due to scarce personnel re sources 6 . Ultrasound diagnostics quality assurance is a main concern for the European Federation of Societies for Ultrasound in Medicine and Biology ( EFSUMB ) 7 8 . However , the current training conditions are likely to impair the quality 9 . Virtual-reality ( VR ) simulation training has been m and atory in aviation for decades and is rapidly gaining importance in medical education . VR simulators have been developed for a multitude of different medical procedures , each consisting of a procedure-specific interface and a computer that generates images according to the movements of the user . A simulator has potential to deliver a safe , controlled and stress-free learning environment providing different performance scores as automatic feedback . Furthermore , st and ardized “ patient”-cases allow for a systematic assessment of competence and simulation-based mastery learning 10 . A systematic review and meta- analysis of more than 600 papers found large effects of VR simulation for outcomes of knowledge , skills , and behaviors , but very few of these papers related to ultrasound simulators 11 . Several VR ultrasound simulators have become commercially available over the last years 12 13 14 15 16 17 . A single system uses a haptic device to control the probe and the others use physical patient phantoms combined with electromagnetic tracking to track the position of the probe . The haptic device allows measuring the force that is applied but has a limited working range making probe movements less realistic . Electromagnetic tracking allow a greater range of motion on the patient phantom but the absence of haptics makes it possible to generate simulated images without actually touching the phantom . Furthermore , image deformation as a result of pressure applied to the “ patient ” is not simulated . The simulators use two different methods to generate images : interpolative or generative model-based . Interpolative simulation creates 2-dimensional ultrasound images from previously recorded 3-dimensional volumes acquired from real patients . It is relatively easy to acquire many different cases with very realistic images , but it is difficult to simulate view-dependent artifacts correctly . Generative model-based simulation uses manually generated computer models to create images , which makes detailed 4-dimensional simulation possible , e. g. echocardiography . However , the images are less realistic ( “ cartoon-like ” ) and building multiple cases is
Output:
| In all studies simulation training was equally or more beneficial than other instructions or no instructions . |
MS211082 | ***TASK*** the task is to summarize an input biomedical literature in 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 Heart failure patients are regularly admitted to hospital and frequently use multiple medication . Besides intentional changes in pharmacotherapy , unintentional changes may occur during hospitalisation . The aim of this study was to investigate the effect of a clinical pharmacist discharge service on medication discrepancies and prescription errors in patients with heart failure . Setting A general teaching hospital in Tilburg , the Netherl and s. Method An open r and omized intervention study was performed comparing an intervention group , with a control group receiving regular care by doctors and nurses . The clinical pharmacist discharge service consisted of review of discharge medication , communicating prescribing errors with the cardiologist , giving patients information , preparation of a written overview of the discharge medication and communication to both the community pharmacist and the general practitioner about this medication . Within 6 weeks after discharge all patients were routinely scheduled to visit the outpatient clinic and medication discrepancies were measured . Main outcome measure The primary endpoint was the frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined . Results Forty-four patients were included in the control group and 41 in the intervention group . Sixty-eight percent of patients in the control group had at least one discrepancy or prescription error against 39 % in the intervention group ( RR 0.57 ( 95 % CI 0.37–0.88 ) ) . The percentage of medications with a discrepancy or prescription error in the control group was 14.6 % and in the intervention group it was 6.1 % ( RR 0.42 ( 95 % CI 0.27–0.66 ) ) . Conclusion This clinical pharmacist discharge service significantly reduces the risk of discrepancies and prescription errors in medication of patients with heart failure in the 1st month after discharge Abstract Background : Increased life expectancy is associated with an increased prevalence of chronic diseases and drug consumption . Changes often occur in the medication regimen after hospitalization . The extent and nature of these changes and the adherence of elderly patients have not yet been fully investigated . Objective : To investigate the extent and reasons for modifications to the medication regimens of elderly patients and their adherence to treatment during the first month following hospital discharge . Methods : This was a prospect i ve cohort study of 198 patients aged ≥65 years in the Acute Geriatric Ward , Beilinson Hospital , Rabin Medical Center , Israel . Clinical , demographic and medication regimen data were recorded for all patients at an interview conducted prior to discharge . After 1 month , the patient , caregiver or general practitioner ( GP ) were interviewed regarding the extent and reasons for modifications to the medication regimen and adherence to treatment . Results : At 1-month post-discharge , on average , 36.7 % of patient medications had been modified compared with the discharge prescription . No modification was found in 16 % of patients . During the observation month , 62 % of prescribed long-term medications were taken without modification as recommended at discharge and during follow-up , 50 % of all changes were characterized by the addition of a drug or an increase in dosage , and 26 % , 16 % and 8 % consisted of cancelling , omission or switching within the same medication type , respectively . Seventy percent of medication regimen changes were based on specialists ’ recommendations or secondary to a change in the patients ’ medical state , and 13 % , 8 % , 3 % and 6 % were as a result of poor adherence , adverse effects , administrative restrictions and other reasons , respectively . There was no correlation between medication regimen change and age , gender , physical function , cognitive function and length of hospital stay . Patients discharged home experienced less regimen modification than those discharged elsewhere ( p = 0.02 ) . Patients who visited their GP only once experienced less regimen modification ( p = 0.03 ) . Regression analysis showed that the only factors affecting medication regimen changes were GP visits and chronic diseases ( p < 0.01 , R2 = 0.09 ) . The overall mean adherence among 145 home-dwelling patients was 96.7 % . Twenty-seven percent and 6 % were under- and over-adherent , respectively , to at least one drug ; under-adherence was more widespread than over-adherence . No correlation was found between the overall mean adherence and other clinical parameters or regimen change . However , non-adherence to at least one drug was associated with more medication regimen changes ( p = 0.001 ) , was more common in patients discharged with prescriptions for seven or more drug types per day ( p = 0.01 ) and was associated with failing to visit the patient ’s GP 1 month after discharge ( p = 0.02 ) . Conclusion : The majority of elderly patients experienced modifications in their medication regimen during the first month following hospital discharge . Thirty percent of patients were non-adherent to at least one drug . To improve adherence to a hospital medication regimen , patients should be encouraged to visit their GP and the number of long-term drugs should be reduced OBJECTIVE To examine the reliability and validity of the Medication Adherence Individual Review -Screening Tool ( MedAdhIR-ST ) for assessing medication adherence in a community-dwelling elderly population . DESIGN A prospect i ve , observational pilot study comparing the reliability and validity of the MedAdhIR-ST and the Medication Adherence Question naire ( MAQ ) . SETTING Independent senior-housing apartments and senior centers in Wake County , North Carolina . PARTICIPANTS Eligible subjects included individuals 60 years of age or older who were living in the community and managing their own medication regimens . INTERVENTIONS Each subject was asked to participate in two assessment visits , two weeks ( + /- 3 days ) apart , in which the questions of the MedAdhIR-ST and MAQ were administered . MAIN OUTCOME MEASURE Medication adherence . RESULTS Both tools showed moderate-to-high test/retest reliability in the study population ( correlation coefficient of 0.632 for MAQ , and 0.699 for MedAdhIR-ST ) , and moderate internal consistency ( Cronbach 's a of 0.551 and 0.584 , respectively ) . Moderate concordance in the ability to assess adherence was observed between MedAdhIR-ST and MAQ ( positive correlation coefficient of 0.450 ) . When compared with refill records , MedAdhIR-ST was slightly more sensitive ( 67 % vs. 43 % ) and specific ( 60 % vs. 50 % ) for detecting adherence and nonadherence , respectively , compared with MAQ . Exploratory factor analysis indicated that MedAdhIR-ST is multidimensional . CONCLUSION MedAdhIR-ST appears to be a reliable and valid tool for screening nonadherence in a community-dwelling elderly population BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients ) ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P < .0001 ) , and the daily dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P < .0001 ) . In Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes Abstract Objectives . Many hospital admissions are due to inappropriate medical treatment , and discharge of fragile elderly patients involves a high risk of readmission . The present study aim ed to assess whether a follow-up programme undertaken by GPs and district nurses could improve the quality of the medical treatment and reduce the risk of readmission of elderly newly discharged patients . Design and setting . The patients were r and omized to either an intervention group receiving a structured home visit by the GP and the district nurse one week after discharge followed by two contacts after three and eight weeks , or to a control group receiving the usual care . Patients . A total of 331 patients aged 78 + years discharged from Glostrup Hospital , Denmark , were included . Main outcome measures . Readmission rate within 26 weeks after discharge among all r and omized patients . Control of medication , evaluated 12 weeks after discharge on 293 ( 89 % ) of the patients by an interview at home and by a question naire to the GP . Results . Control-group patients were more likely to be readmitted than intervention-group patients ( 52 % v 40 % ; p = 0.03 ) . In the intervention group , the proportions of patients who used prescribed medication of which the GP was unaware ( 48 % vs. 34 % ; p = 0.02 ) and who did not take the medication prescribed by the GP ( 39 % vs. 28 % ; p = 0.05 ) were smaller than in the control group . Conclusion . The intervention shows a possible framework securing the follow-up on elderly patients after discharge by reducing the readmission risk and improving medication control Lowering blood pressure ( BP ) in stroke survivors reduces the risk of recurrent stroke . We tested the hypothesis that a nurse-led nonpharmacologic intervention would lower the BP of participants in an intervention group compared with a control group . A total of 349 patients who had sustained acute stroke or transient ischemic attack were r and omly assigned to either usual care or to 4 home visits by a nurse . During the visits , the nurse measured and recorded BP and provided individually tailored counseling on a healthy lifestyle . A total of 303 patients completed the 1-year follow up . No change in systolic BP was noted in either the intervention group or the control group . Because of an increase in diastolic BP in the control group ( P = .03 ) , a difference in mean diastolic BP between the 2 groups was found at follow-up ( P = .007 ) . Mean BP at follow-up was 139/82 mm Hg in the intervention group and 142/86 mm Hg in the control group . Linear regression analysis demonstrated that BP at the point of discharge was the strongest predictor of BP 1 year later ( P < .0001 ) . The proportion of patients on antihypertensive medication increased in the intervention group ( P = .002 ) . Patients were compliant with antihypertensive therapy , and 92 % of the hypertensive patients in the intervention group followed the advice to see a general practitioner ( GP ) for BP checkups . At follow-up , 187 patients ( 62 % ) were hypertensive , with no difference in the rate of hypertension seen between the groups . Our data indicate that home visits by nurses did not result in a lowering of BP . Patients complied with antihypertensive therapy and GP visits in the case of hypertension . Nonetheless , the majority of patients were hypertensive at the 1-year follow up UNLABELLED An integrated care intervention including education , coordination among levels of care , and improved accessibility , reduced hospital readmissions in chronic obstructive pulmonary disease ( COPD ) after 1 year . This study analyses the effectiveness of this intervention in terms of clinical and functional status , quality of life , lifestyle , and self-management , under the hypothesis that changes in these factors could explain the observed reduction in readmissions . A total of 113 exacerbated COPD patients ( 14 % female , mean ( SD ) age 73(8 ) years , FEV(1 ) 1.2(0.5 ) l ) were recruited after hospital discharge in Barcelona , Spain , and r and omly assigned ( 1:2 ) to integrated care ( IC ) ( n=44 ) or usual care ( UC ) ( n=69 ) . The intervention consisted of an individually tailored care plan at discharge shared with the primary care team and access to a specialized case manager nurse through a web-based call centre . After 1 year of intervention , subjects in the intervention group improved body mass index by 1.34 kg/m(2 ) . Additionally , they scored better in self-management items : COPD knowledge 81 % vs. 44 % , exacerbation identification 85 % vs. 22 % , exacerbation early treatment 90 % vs. 66 % , inhaler adherence 71 vs. 37 % , and inhaler correctness 86 vs. 24 % . There were no differences in the evolution of dyspnea , lung function , quality of life scores , lifestyle factors , or medical treatment . CONCLUSIONS This IC trial improved disease knowledge , and treatment adherence , after 1 year of intervention , suggesting that these factors may play a role in the prevention of severe COPD exacerbations triggering hospital admissions OBJECTIVE : To compare medication adherence calculated from four different data sources including a pill count and self-report obtained during a home medication history , as well as calculations based on refill frequency derived from a provincial prescription cl aims data
Output:
| Conclusion nurse-led and nurse-collaborative interventions moderately improved adherence among discharged older adults . |
MS211083 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Abstract Purpose : To determine the tear osmolarity in patients with tearing secondary to dry eye and other pathologies , and to determine the prevalence of dry eye disease among patients with tearing in an oculoplastics setting . Methods : 108 eyes of 54 patients with a chief complaint of tearing were prospect ively recruited . Subjects were excluded if they used eye drops or contact lenses within 2 hours of assessment , had a history of refractive surgery , an active ocular allergy , or evidence of a systemic disease which affects tear production . A full medical and ocular history was taken with a complete eye exam pertinent to dry eye . Tear osmolarity was measured using the TearLab device . A clinical diagnosis of dry eye was made based on findings , without reference to tear osmolarity . Results : Among 86 eyes symptomatic for tearing , 32 eyes had dry eye disease ( 37 % ) . Patients with dry eye had a significantly higher median tear osmolarity compared to that in patients with other diagnoses ( 308 mOsm/L vs. 294 mOsm/L , p < 0.0001 ) . At a cut-off of 308 mOsm/L , tear osmolarity result ed in a sensitivity of 50 % and a specificity of 88 % for the diagnosis of dry eye . Conclusions : A significant proportion of patients with tearing in an oculoplastics practice had dry eye disease . The high specificity of tear osmolarity may render it a useful tool to rule in dry eye disease and may assist the oculoplastic surgeon in more accurately determining the cause of tearing PURPOSE To evaluate the use of tear osmolarity in the diagnosis of dry eye disease . DESIGN A prospect i ve , observational case series to determine the clinical usefulness of tear osmolarity and commonly used objective tests to diagnose dry eye disease . METHODS A multicenter , 10-site study consisting of 314 consecutive subjects between 18 and 82 years of age . Bilateral tear osmolarity , tear film break-up time ( TBUT ) , corneal staining , conjunctival staining , Schirmer test , and meibomian gl and grading were performed . Diagnostic performance was measured against a composite index of objective measurements that classified subjects as having normal , mild or moderate , or severe dry eye . The main outcome measures were sensitivity , specificity , area under the receiver operating characteristic curve , and intereye variability . RESULTS Of the 6 tests , tear osmolarity was found to have superior diagnostic performance . The most sensitive threshold between normal and mild or moderate subjects was found to be 308 mOsms/L , whereas the most specific was found at 315 mOsms/L. At a cutoff of 312 mOsms/L , tear hyperosmolarity exhibited 73 % sensitivity and 92 % specificity . By contrast , the other common tests exhibited either poor sensitivity ( corneal staining , 54 % ; conjunctival staining , 60 % ; meibomian gl and grading , 61 % ) or poor specificity ( tear film break-up time , 45 % ; Schirmer test , 51 % ) . Tear osmolarity also had the highest area under the receiver operating characteristic curve ( 0.89 ) . Intereye differences in osmolarity were found to correlate with increasing disease severity ( r(2 ) = 0.32 ) . CONCLUSIONS Tear osmolarity is the best single metric both to diagnose and classify dry eye disease . Intereye variability is a characteristic of dry eye not seen in normal subjects PURPOSE A prospect i ve , multisite clinical study ( 10 sites in the European Union and the United States ) evaluated the clinical utility of commonly used tests and tear osmolarity for assessing dry eye disease severity . METHODS Three hundred fourteen consecutive subjects between the ages of 18 and 82 years were recruited from the general patient population , 299 of which qualified with complete data sets . Osmolarity testing , Schirmer test without anesthesia , tear film breakup time ( TBUT ) , corneal staining , meibomian dysfunction assessment , and conjunctival staining were performed bilaterally . A symptom question naire , the Ocular Surface Disease Index ( OSDI ) , was also administered to each patient . Distributions of clinical signs and symptoms against a continuous composite severity index were evaluated . RESULTS Osmolarity was found to have the highest correlation coefficient to disease severity ( r(2 ) = 0.55 ) , followed by conjunctival staining ( r(2 ) = 0.47 ) , corneal staining ( r(2 ) = 0.43 ) , OSDI ( r(2 ) = 0.41 ) , meibomian score ( r(2 ) = 0.37 ) , TBUT ( r(2 ) = 0.30 ) , and Schirmer result ( r(2 ) = 0.17 ) . A comparison of st and ard threshold-based classification with the composite severity index revealed significant overlap between the disease severities of prospect ively defined normal and dry eye groups . Fully 63 % of the subjects were found to be poorly classified by combinations of clinical thresholds . CONCLUSIONS Tear film osmolarity was found to be the single best marker of disease severity across normal , mild/moderate , and severe categories . Other tests were found to be informative in the more severe forms of disease ; thus , clinical judgment remains an important element in the clinical assessment of dry eye severity . The results also indicate that the initiation and progression of dry eye is multifactorial and supports the rationale for redefining severity on the basis of a continuum of clinical signs . ( Clinical Trials.gov number , NCT00848198 . ) Purpose : To evaluate the tear osmolarity and ocular surface changes in patients with polycystic ovary syndrome ( PCOS ) . Material s and Methods : Forty-eight patients with recently diagnosed PCOS and thirty-three control volunteers were enrolled in this prospect i ve , observational study . Ocular surface disease index ( OSDI ) score was calculated . Tear osmolarity was measured using the TearLab Osmolarity System ( Tearlab , San Diego , CA , USA ) . All subjects also underwent the following ophthalmologic evaluation : Schirmer I test , tear-film breakup time ( TBUT ) , ocular surface flourescein staining , and conjunctival impression cytology . Results : Mean OSDI score was significantly higher in patients with PCOS than control subjects ( P = 0.001 ) . Tear osmolarity was similar in both groups ( P = 0.404 ) . There were no significant differences between groups in Schirmer I test results , TBUT , and ocular surface flourescein staining scores ( P > 0.05 ) . Compared to control group , a statistically significant squamous metaplasia was observed in temporal bulbar conjunctival impression cytology specimens in PCOS group ( P = 0.032 ) . Conclusions : In patients with recently diagnosed PCOS , tear volume and osmolarity are not affected but , conjunctival morphology may be affected , though on a limited scale UNLABELLED It has been suggested that tear fluid is isotonic with plasma , and plasma osmolality ( P(osm ) ) is an accepted , albeit invasive , hydration marker . Our aim was to determine whether tear fluid osmolarity ( T(osm ) ) assessed using a new , portable , noninvasive , rapid collection and measurement device tracks hydration . PURPOSE This study aim ed to compare changes in T(osm ) and another widely used noninvasive marker , urine specific gravity ( USG ) , with changes in P(osm ) during hypertonic-hypovolemia . METHODS In a r and omized order , 14 healthy volunteers exercised in the heat on one occasion with fluid restriction ( FR ) until 1 % , 2 % , and 3 % body mass loss ( BML ) and with overnight fluid restriction until 08:00 h the following day , and on another occasion with fluid intake ( FI ) . Volunteers were rehydrated between 08:00 and 11:00 h. T(osm ) was assessed using the TearLab osmolarity system . RESULTS P(osm ) and USG increased with progressive dehydration on FR ( P < 0.001 ) . T(osm ) increased significantly on FR from 293 ± 9 to 305 ± 13 mOsm·L(-1 ) at 3 % BML and remained elevated overnight ( 304 ± 14 mOsm·L(-1 ) ; P < 0.001 ) . P(osm ) and T(osm ) decreased during exercise on FI and returned to preexercise values the following morning . Rehydration restored P(osm ) , USG , and T(osm ) to within preexercise values . The mean correlation between T(osm ) and P(osm ) was r = 0.93 and that between USG and P(osm ) was r = 0.72 . CONCLUSIONS T(osm ) increased with dehydration and tracked alterations in P(osm ) with comparable utility to USG . Measuring T(osm ) using the TearLab osmolarity system may offer sports medicine practitioners , clinicians , and research investigators a practical and rapid hydration assessment technique Abstract Aim : To generate data on the variability of tear osmolarity in a control ( normal , non-dry eye ) and symptomatic dry eye population ( Ocular Surface Disease Index : OSDI ≥20 ) . A secondary outcome is the determination of the effect that tear collection technique has on the osmolarity of the sample . Material s and methods : This was a two-phase study that recruited 20 subjects ( n = 10 normal , n = 10 dry eye ) to evaluate the influence of time between measurements ( Phase I ) and 30 subjects ( n = 15 normal , n = 15 dry eye ) to evaluate the influence of collection technique ( Phase II ) . As part of Phase I , serial tear osmolarity measurements were performed on each eye ; four separated by 15 min followed by four separated by 1 min , at each of three visits . Phase II compared the consecutive measurement of four in vivo tear sample s to four in vitro measurements on tears collected and dispensed from a glass capillary tube . Results : During Phase I , the dry eye group had a significantly higher maximum osmolarity ( 334.2 ± 25.6 mOsm/L ) compared to the normal group ( 304.0 ± 8.4 mOsm/L , p = 0.002 ) . No significant differences were observed whether collection s were performed at 15 or 1 min intervals . During Phase II , the in vivo osmolarity was equivalent to in vitro measurements from glass capillary tube sample s for both the dry eye group ( 323.0 ± 16.7 mOsm/L versus 317.7 ± 24.8 , p = 0.496 ) , and for the normal subjects ( 301.2 ± 7.2 mOsm/L versus 301.9 ± 16.0 mOsm/L , p = 0.884 ) . Conclusion : Symptomatic dry eye subjects exhibited a significantly higher tear osmolarity and variation over time than observed in normal subjects , reflecting the inherent tear film instability of dry eye disease . There was no change in the distribution of tear osmolarity measurements whether tears were collected in rapid succession or given time to equilibrate , and collection method had no impact on tear osmolarity PURPOSE To independently assess the measurement variability of TearLab System in a clinical setting of one visit and to estimate the minimum number of measurements required for reliable readings of tear osmolarity . METHODS Ten consecutive osmolarity measurements were taken from both eyes by the same examiner at one visit for fourteen subjects . The ocular surface disease index symptoms question naire and tear film break up time were also performed . Group average cumulative mean and cumulative coefficient of variation were calculated to assess the TearLab measurement variation . Repeated application of Thompson 's tau method was performed to identify the outliers in tear osmolarity readings for each eye . Results from both eyes were analysed separately . RESULTS Up to two r and omly occurring outlying values in 10 consecutive measurements were found in 19 out of 28 measured eyes . No statistically significant differences between the left and right eye were found for the group mean and group st and ard deviation ( paired t-test , p=0.099 and p=0.068 , respectively ) , however the cumulative coefficient of variation indicated higher measurement group variability on one eye . Estimated cumulative coefficient of variation indicated the minimum of three consecutive acquisitions required for the measurement to be reliable . CONCLUSIONS TearLab Osmolarity System required at least three consecutive measurements to be taken in order to provide clinical ly reliable tear osmolarity readings . Also , taking the maximum osmolarity value for detecting dry eye disease should be viewed with caution since outlying readings of tear osmolarity frequently occur Purpose : Tear film hyperosmolarity is recognized as an important pathogenetic factor in dry eye syndrome , but difficulties in its measurement have limited its utility in the recent past . This prospect i ve , nonr and omized , clinical single-center study investigates the osmolarity in tear sample s of patients with keratoconjunctivitis sicca compared with healthy controls . Methods : One hundred thirty-three patients [ aged 58 years ( 51–64 years ) , 86 women and 47 men ] with moderate to severe keratoconjunctivitis sicca and 95 controls [ aged 52 years ( 48–61 years ) , 55 women and 40 men ] were enrolled in the trial . Tear sample s were collected directly from the inferior lateral tear meniscus . Inclusion criteria were a tear breakup time of less than 5 seconds , a Schirmer test with anest
Output:
| Conclusions : There is a high variability of osmolarity measurements with the TearLab system .
A substantial number of healthy subjects fulfill the DEWS 's definition of DED . |
MS211084 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Computed tomography ( CT ) lung densitometry has been demonstrated to be the most sensitive and specific outcome measure for the assessment of emphysema-modifying therapy , but the optimum densitometric index has yet to be determined and targeted sampling may be more sensitive than whole lung assessment . The EXAcerbations and CT scan as Lung Endpoints ( EXACTLE ) trial aim ed to clarify the optimum approach to the use of CT densitometry data for the assessment of alpha 1-antitrypsin ( AAT ) augmentation therapy on the progression of emphysema in AAT deficiency ( AATD ) . Methods Patients with AATD ( n = 77 ) were r and omised to weekly infusions of 60 mg/kg human AAT ( Prolastin ® ) or placebo over 2 to 2.5 years . Lung volume was included as a covariate in an endpoint analysis and a comparison was made of different CT densitometric indices ( 15th percentile lung density [ PD15 ] , mean lung density [ MLD ] and voxel index at a threshold of -910 [ VI-910 ] and -950 [ VI-950 ] Hounsfield Units ) obtained from whole lung scans at baseline and at 24 to 30 months . Targeted regional sampling was compared with whole lung assessment . Results Whole lung analysis of the total change ( baseline to last CT scan ) compared with placebo indicated a concordant trend that was suggestive of a treatment effect for all densitometric indices ( MLD [ 1.402 g/L , p = 0.204 ] ; VI-910 [ -0.611 , p = 0.389 ] ; VI-950 [ -0.432 , p = 0.452 ] ) and that was significant using PD15 ( 1.472 g/L , p = 0.049 ) . Assessment of the progression of emphysema in the apical , middle and basal regions of the lung by measurement with PD15 showed that this treatment effect was more evident when the basal third was sample d ( 1.722 g/L , p = 0.040 ) . A comparison between different densitometric indices indicated that the influence of inspiratory variability between scans was greatest for PD15 , but when adjustment for lung volume was made this index was the most sensitive measure of emphysema progression . Conclusion PD15 is the most sensitive index of emphysema progression and of treatment modification . Targeted sampling may be more sensitive than whole lung analysis .Trial registration Registered in Clinical Trials.gov as ' Antitrypsin ( AAT ) to Treat Emphysema in AAT-Deficient Patients ' ; Clinical Trials.gov Identifier : NCT00263887 Abstract The Dutch-Belgian R and omized Lung Cancer Screening Trial ( Dutch acronym : NELSON study ) was design ed to investigate whether screening for lung cancer by low-dose multidetector computed tomography ( CT ) in high-risk subjects will lead to a decrease in 10-year lung cancer mortality of at least 25 % compared with a control group without screening . Since the start of the NELSON study in 2003 , 7557 participants underwent CT screening , with scan rounds in years 1 , 2 , 4 and 6 . In the current review , the design of the NELSON study including participant selection and the lung nodule management protocol , as well as results on validation of CT screening and first results on lung cancer screening are described PURPOSE To prospect ively evaluate airway wall thickness and lung attenuation at spirometrically gated thin-section computed tomography ( CT ) in patients with chronic obstructive pulmonary disease ( COPD ) and to correlate gated CT findings with pulmonary function test ( PFT ) results . MATERIAL S AND METHODS The ethical committee approved the study , and all patients gave informed consent . Forty-two consecutive patients with COPD ( 20 with and 22 without chronic bronchitis [ CB ] ) underwent gated thin-section CT and PFTs on the same day . The percentage wall area ( PWA ) and the thickness-to-diameter ratio ( TDR ) for all depicted bronchi that were round and larger than 2 mm in diameter , the mean lung attenuation ( MLA ) , and the pixel index ( PI ) at -950 HU were determined . The reproducibility of the airway measurements was preliminarily tested by performing a five-trial examination in a patient with COPD and in a control patient . Differences in airway and lung attenuation measurements between the patients with and those without CB were evaluated at Mann-Whitney U testing . Simple and multiple regression analyses were used to assess the correlation between thin-section CT and PFT measurements . RESULTS The mean intraoperator coefficient of variation for airway measurements was 7.8 % ( range , 3.8%-13.4 % ) . An average of nine bronchi per patient were assessed . Patients with CB had significantly higher PWAs , TDRs , and MLAs and significantly lower PIs than patients without CB ( P < .05 for all values ) . The combination of PWA , TDR , and PWA normalized to body weight correlated significantly ( P < .05 ) with the forced expiratory volume in 1 second-to-slow vital capacity ratio and the diffusing capacity of the lung for carbon monoxide in patients with but not in patients without CB . PFT results correlated better with MLA and PI in patients without CB . CONCLUSION Bronchial wall measurements differ between patients who have COPD with CB and those who have COPD without CB . The correlation between airway dimensions and indexes of airway obstruction in patients with COPD and CB indicates that the bronchial tree is the site of anatomic-functional alterations in this patient group Background The Korean Obstructive Lung Disease ( KOLD ) Cohort Study is a prospect i ve longitudinal study of patients with chronic obstructive pulmonary disease ( COPD ) , asthma , or other unclassified obstructive lung diseases . It was design ed to develop new classification models and biomarkers that predict clinical ly relevant outcomes for patients with obstructive lung diseases . Methods Patients over 18 years old who have chronic respiratory symptoms and airflow limitations or bronchial hyper-responsiveness were enrolled at 17 centers in South Korea . After a baseline visit , the subjects were followed up every 3 months for various assessment s. Results From June 2005 to October 2013 , a total of 477 subjects ( 433 [ 91 % ] males ; 381 [ 80 % ] diagnosed with COPD ) were enrolled . Analyses of the KOLD Cohort Study identified distinct phenotypes in patients with COPD , and predictors of therapeutic responses and exacerbations as well as the factors related to pulmonary hypertension in COPD . In addition , several genotypes were associated with radiological phenotypes and therapeutic responses among Korean COPD patients . Conclusion The KOLD Cohort Study is one of the leading long-term prospect i ve longitudinal studies investigating heterogeneity of the COPD and is expected to provide new insights for pathogenesis and the long-term progression of COPD Background Emphysema on CT is common in older smokers . We hypothesised that emphysema on CT predicts acute episodes of care for chronic lower respiratory disease among older smokers . Material s and Methods Participants in a lung cancer screening study age ≥60 years were recruited into a prospect i ve cohort study in 2001–02 . Two radiologists independently visually assessed the severity of emphysema as absent , mild , moderate or severe . Percent emphysema was defined as the proportion of voxels ≤ −910 Hounsfield Units . Participants completed a median of 5 visits over a median of 6 years of follow-up . The primary outcome was hospitalization , emergency room or urgent office visit for chronic lower respiratory disease . Spirometry was performed following ATS/ERS guidelines . Airflow obstruction was defined as FEV1/FVC ratio < 0.70 and FEV1<80 % predicted . Results Of 521 participants , 4 % had moderate or severe emphysema , which was associated with acute episodes of care ( rate ratio 1.89 ; 95 % CI : 1.01–3.52 ) adjusting for age , sex and race/ethnicity , as was percent emphysema , with similar associations for hospitalisation . Emphysema on visual assessment also predicted incident airflow obstruction ( HR 5.14 ; 95 % CI 2.19–21.1 ) . Conclusion Visually assessed emphysema and percent emphysema on CT predicted acute episodes of care for chronic lower respiratory disease , with the former predicting incident airflow obstruction among older smokers Background Diary cards are useful for analyzing exacerbations in chronic obstructive pulmonary disease ( COPD ) , although factors influencing the length and frequency of each episode are poorly understood . This study investigated factors that influence the features of exacerbations in patients with alpha-1 antitrypsin ( AAT ) deficiency ( PiZ phenotype ) and COPD . Methods Daily diary cards were collected over 2 years . Patients had emphysema visualized and quantified by computed tomography scan , and had at least one documented exacerbation in the previous year . Results The patients ( n = 23 ) had a mean age of 52.5 years , forced expiratory volume in one second ( FEV1 ) of 1.2 L ( 38.4 % predicted ) , corrected gas transfer ( KCO ) of 0.90 mmol/min/kPa/L ( 59.7 % predicted ) , and 15th percentile lung density of 44.55 g/L. Two hundred and sixty-three exacerbations ( 164 treated ) were identified . The frequency of treated exacerbations correlated negatively with KCO% predicted ( r = −0.432 ; P = 0.022 ) . Exacerbation length ( determined for 17 of the patients for whom diary card data through the episode were available ) correlated negatively with baseline 15th percentile lung density ( r = −0.361 ; P = 0.003 ) , and increased the longer treatment was delayed ( r = 0.503 ; P < 0.001 ) . Treatment delay was shorter with higher day 1 symptom score , lower baseline FEV1 , FEV1/forced vital capacity , and lower 15th percentile lung density ( r = −0.368 , 0.272 , 0.461 , and 0.786 ; P = 0.004 , 0.036 , < 0.001 , and < 0.001 , respectively ) . Time to resolution of exacerbation after treatment initiation was not affected by treatment delay , but correlated negatively with KCO% predicted ( r = −0.647 ; P = 0.007 ) . Conclusion In alpha-1 antitrypsin deficiency , the frequency and length of resolution of exacerbation were related to baseline gas transfer . Treatment delay adversely affected exacerbation length , and lung density was the best independent predictor of delay in starting treatment Chronic obstructive pulmonary disease ( COPD ) is a heterogeneous disease and responses to therapies are highly variable . The aim of this study was to identify the predictors of pulmonary function response to 3 months of treatment with salmeterol/fluticasone in patients with COPD . A total of 127 patients with stable COPD from the Korean Obstructive Lung Disease ( KOLD ) Cohort , which were prospect ively recruited from June 2005 to September 2009 , were analyzed retrospectively . The prediction models for the FEV1 , FVC and IC/TLC changes after 3 months of treatment with salmeterol/fluticasone were constructed by using multiple , stepwise , linear regression analysis . The prediction model for the FEV1 change after 3 months of treatment included wheezing history , pre-bronchodilator FEV1 , post-bronchodilator FEV1 change and emphysema extent on CT ( R = 0.578 ) . The prediction models for the FVC change after 3 months of treatment included pre-bronchodilator FVC , post-bronchodilator FVC change ( R = 0.533 ) , and those of IC/ TLC change after 3 months of treatment did pre-bronchodilator IC/TLC and post-bronchodilator FEV1 change ( R = 0.401 ) . Wheezing history , pre-bronchodilator pulmonary function , bronchodilator responsiveness , and emphysema extent may be used for predicting the pulmonary function response to 3 months of treatment with salmeterol/fluticasone in patients with COPD BACKGROUND Retinoids promote alveolar septation in the developing lung and stimulate alveolar repair in some animal models of emphysema . METHODS One hundred forty-eight subjects with moderate-to-severe COPD and a primary component of emphysema , defined by diffusing capacity of the lung for carbon monoxide ( Dlco ) [ 37.1 + /- 12.0 % of predicted ] and CT density mask ( 38.5 + /- 12.8 % of voxels < - 910 Hounsfield units ) [ mean + /- SD ] were enrolled into a r and omized , double-blind , feasibility study at five university hospitals . Participants received all-trans retinoic acid ( ATRA ) at either a low dose ( LD ) [ 1 mg/kg/d ] or high dose ( HD ) [ 2 mg/kg/d ] , 13-cis retinoic acid ( 13-cRA ) [ 1 mg/kg/d ] , or placebo for 6 months followed by a 3-month crossover period . RESULTS No treatment was associated with an overall improvement in pulmonary function , CT density mask score , or health-related quality of life ( QOL ) at the end of 6 months . However , time-dependent changes in
Output:
| There was marked heterogeneity between studies secondary to large variety of disease severity within commonly included cohorts and differences in CT acquisition parameters .
Conclusion CT density shows a good relationship to clinical ly relevant parameters ; however , study heterogeneity and lack of longitudinal data mean that it is difficult to compare studies or derive a minimal clinical ly important difference . |
MS211085 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: We investigated the effects of emotion perception training on depressive symptoms and mood in young adults reporting high levels of depressive symptoms ( trial registration : IS RCT N02532638 ) . Participants were r and omised to an intervention procedure design ed to increase the perception of happiness over sadness in ambiguous facial expressions or a control procedure , and completed self-report measures of depressive symptoms and mood . Those in the intervention condition had lower depressive symptoms and negative mood at 2-week follow-up , but there was no statistical evidence for a difference . There was some evidence for increased positive mood . Modification of emotional perception may lead to an increase in positive affect Previous studies of gender differences in the phenomenology of depression have focused mostly on symptoms as measured by self-report question naires or clinician-rated scales . In this study , we examined gender differences in the interpersonal behavior of depressed patients by using ethological techniques which involve direct observation of behavior . The nonverbal behavior of 72 nondepressed volunteers and 68 patients with a DSM-III-R diagnosis of nonpsychotic unipolar depression was videorecorded during clinical interviews and scored according to an ethological scoring system including 37 behavior patterns , mostly facial expressions and h and movements . Both male and female depressed patients showed a global restriction of nonverbal expressiveness reflecting a tendency towards social withdrawal . Nonverbal expression of hostility was the only behavioral category on which depressed patients scored higher than nondepressed volunteers . Even though clinical status exerted marked effects on the ethological profile , depression did not obscure some important differences in the nonverbal behavior of males and females . As a group , depressed women showed more socially interactive behaviors than depressed men . Their modality of interacting included higher levels both of nonverbal hostility and of su bmi ssive and affiliative behaviors . These results are discussed in view of clinical data indicating a relationship between gender , style of social interaction and response to antidepressant drugs The goal of this investigation was to identify microlevel processes in the support provider that may foster or inhibit the provision of spousal support . Specifically , the authors focused on ( a ) how emotional similarity between the support provider and support seeker and ( b ) how empathic accuracy of the support provider relate to support provision in marriage . In a laboratory experiment , 30 couples were r and omly assigned to 1 of 2 conditions ( support provider : man vs. woman ) of a factorial design . The couples provided question naire data and participated in a social support interaction design ed to assess behaviors when offering and soliciting social support . A video- review task was used to assess emotional similarity and empathic accuracy during the support interaction . As expected , greater similarity between the support provider 's and support seeker 's emotional responses , as well as more accurate insights into the support-seeking spouse 's thoughts and feelings were found to be predictive of more skilful support ( i.e. , higher levels of emotional and instrumental support and lower levels of negative types of support ) OBJECTIVE Schizophrenia patients often exhibit impairments in facial affect recognition which contribute to their poor social functioning . These impairments are stable in the course of the disorder and seem not to be affected by conventional treatment . The present study investigates the efficacy and specificity of a new training program for the remediation of such impairments . METHOD A newly developed training program tackling affect recognition ( TAR ) was compared with a cognitive remediation training program ( CRT ) and treatment as usual ( TAU ) within a r and omized three group pre-post design in n=77 post-acute schizophrenia patients . The TAR is a computer-aided 12-session program focussing on facial affect recognition , whereas the CRT aims to improve attention , memory and executive functioning . Facial affect recognition , face recognition , and neurocognitive performance were assessed before ( T0 ) and after ( T1 ) the six week training phase . During the training period all patients received antipsychotic medication . RESULTS Patients under TAR significantly improved in facial affect recognition , with recognition performance after training approaching the level of healthy controls from former studies . Patients under CRT and those without special training ( TAU ) did not improve in affect recognition , though patients under CRT improved in verbal memory functions . CONCLUSION According to these results , remediation of disturbed facial affect recognition in schizophrenia patients is possible , but not achievable with a traditional cognitive rehabilitation program such as the CRT . Instead , functional specialized remediation programs such as the newly developed TAR are a more suitable option
Output:
| The results indicated that depression was related to one type of affective empathy .
Specifically , depression was related to high levels of empathic stress but not to abnormal empathic concern .
Further , depression was related to limited cognitive empathy , as indicated by poor perspective taking , theory of mind , and empathic accuracy .
Poor performance on the more objective laboratory tasks might partially be explained by the broader cognitive deficits commonly observed in depression .
Empathic abilities may be impaired in depression .
The relation between empathy , depression , and gender is unclear .
Insight into impaired empathy in depression may not only help explain poor social functioning in MDD but also benefit clinician-patient interactions |
MS211086 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND To investigate the incidence , risk factors and clinical implication s of venous thromboembolism ( VTE ) in advanced cancer patients treated in phase I studies . PATIENTS AND METHODS Patients enrolled and treated in phase I studies conducted by SENDO ( Southern Europe New Drugs Organization ) Foundation between 2000 and 2010 in 15 experimental centers were considered for the study . Clinical data , including adverse events , were prospect ively collected during the studies and retrospectively pooled for VTE analysis . RESULTS Data of 1415 patients were considered for analysis . Five hundred and twenty-six ( 37.2 % ) patients were males , and median age was 57.3 years ( range : 13 - 85 ) . Eighty-five percent of patients had metastatic disease , while the remaining had locally advanced irresectable disease . For 706 ( 49.9 % ) of the patients , the study treatment was with cytotoxic agent(s ) only , for 314 with target therapy(ies ) only , while the remaining patients received a target therapy in combination with a cytotoxic drug . Fifty-six ( 3.96 % ) patients who developed a VTE , almost all ( 89.3 % ) during the course of treatment , the remaining during the follow-up . At univariate analysis , the Khorana score , the combination of an antiangiogenic agent with a cytotoxic drug , and the time from first cancer diagnosis to study entry ( as continuous variable ) were associated with a statistically significant increase of VTE occurrence . The multivariate analysis confirmed only a statistically significant association for the Khorana score . The hazard ratio of VTE occurrence was 7.88 [ 95 % confidence interval ( CI ) 2.86 - 21.70 ) and 2.74 ( 95 % CI 1.27 - 5.92 ) times higher for the highest ( ≥3 ) and intermediate ( 1 - 2 ) scores as compared with score = 0 . CONCLUSIONS VTE is a relatively common complication among patients treated in the context of phase I studies . The Khorana score predicts VTE development and can be used to identify patients at high of VTE BACKGROUND Several studies have reported that patients who present with idiopathic deep vein thrombosis ( DVT ) have an increased risk of subsequently developing cancer . A clinical trial had previously been conducted examining the optimal duration of oral anticoagulant therapy following initial heparin treatment in patients with proximal DVT . METHODS A historical cohort study was performed on patients enrolled in the duration of anticoagulant trial . Patients known to have cancer at the time of entry into the trial were excluded . The qualifying DVTs were classified as idiopathic ( no known associated risk factors ) or secondary without knowledge of subsequent recurrent venous thrombosis or cancer . The patients were then followed for the development of cancer . RESULTS Thirteen ( 8.6 % ) of the 152 patients in the idiopathic cohort subsequently developed cancer compared to eight ( 7.1 % ) of 112 patients in the secondary cohort , P = 0.86 . Two ( 5.4 % ) of 37 patients with recurrent venous thromboembolism and 19 ( 8.4 % ) of 227 patients without recurrent thromboembolism developed cancer , P = 0.7 . CONCLUSION Our study did not detect an increased risk of subsequent cancer in patients presenting with idiopathic DVT compared to secondary DVT ; nor did we detect an increased incidence of cancer in patients with recurrent venous thromboembolism . Further studies are required prior to pursuing a policy of aggressive screening for cancer in patients with idiopathic venous thromboembolism Summary Background Data : The epidemiology of venous thromboembolism ( VTE ) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis ( DVT ) . However , the clinical relevance of asymptomatic venography-detected DVT is unclear , and the population of these clinical trials is not necessarily representative of the overall cancer surgery population . Objective : The aim of this study was to evaluate the incidence of clinical ly overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE . Methods : @RISTOS was a prospect i ve observational study in patients undergoing general , urologic , or gynecologic surgery . Patients were assessed for clinical ly overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days . All outcome events were evaluated by an independent Adjudication Committee . Results : A total of 2373 patients were included in the study : 1238 ( 52 % ) undergoing general , 685 ( 29 % ) urologic , and 450 ( 19 % ) gynecologic surgery . In-hospital prophylaxis was given in 81.6 % and postdischarge prophylaxis in 30.7 % of the patients . Fifty patients ( 2.1 % ) were adjudicated as affected by clinical ly overt VTE ( DVT , 0.42 % ; nonfatal pulmonary embolism , 0.88 % ; death 0.80 % ) . The incidence of VTE was 2.83 % in general surgery , 2.0 % in gynecologic surgery , and 0.87 % in urologic surgery . Forty percent of the events occurred later than 21 days from surgery . The overall death rate was 1.72 % ; in 46.3 % of the cases , death was caused by VTE . In a multivariable analysis , 5 risk factors were identified : age above 60 years ( 2.63 , 95 % confidence interval , 1.21–5.71 ) , previous VTE ( 5.98 , 2.13–16.80 ) , advanced cancer ( 2.68 , 1.37–5.24 ) , anesthesia lasting more than 2 hours ( 4.50 , 1.06–19.04 ) , and bed rest longer than 3 days ( 4.37 , 2.45–7.78 ) . Conclusions : VTE remains a common complication of cancer surgery , with a remarkable proportion of events occurring late after surgery . In patients undergoing cancer surgery , VTE is the most common cause of death at 30 days after surgery 9572 Background : To assess the thrombogenic role of adjuvant chemotherapy , following radical surgical resection , in ambulatory cancer patients , is of particular interest , because of the little or no tumor burden . The relation between adjuvant chemotherapy and thrombosis has been investigated in breast cancer . Limited information is available in GI cancers . Aim of this study was to investigate the acquired and inherited risk factors for VTE and the incidence of symptomatic VTE in patients on adjuvant chemotherapy for breast or GI cancer . METHODS In a prospect i ve observational study ( January 2003 and February 2006 ) , 199 GI ( 82F/117 M ; age range , 26 - 84 years ) and 182 breast ( 180F/2 M ; age range , 29 - 85 years ) cancer patients were enrolled and followed-up for symptomatic VTE during adjuvant chemotherapy . We prospect ively evaluated the effect of acquired ( i.e. age , chemotherapy , tumor hystotype , history of thrombosis , body mass index and smoke ) and inherited risk factors ( i.e. antithrombin , protein C , protein S , homocysteine , activated protein C [ APC ] resistance , factor V Leiden [ FVL ] and Prothrombin [ PT ] mutations ) . RESULTS Overall 30 VTE events ( 7.87 % ) were recorded : 28 ( 7.35 % ) during treatment and 2 ( 0.52 % ) during the subsequent follow-up . Among all the 381 cancer patients , FVL was detected in 14 cases ( 3.67 % ) and PT mutation in 10 cases ( 2.62 % ) . At multivariate analysis thrombocytosis ( HR 2.8 ; 95 % CI , 1.13 - 7.30 , P < 0.026 ) and a previous episode of thrombosis ( HR 12.4 ; 95 % CI , 2.48 - 62.6 , P < 0.0026 ) were significantly associated to the development of VTE . There was no association between the FVL or PT mutations and the risk of VTE . CONCLUSIONS Our data demonstrate that , in the adjuvant setting , most VTE occur during therapy . Thrombocytosis prechemotherapy and an history of VTE strongly predict the developing of VTE in the adjuvant setting . No significant financial relationships to disclose INTRODUCTION Systemic chemotherapy and surgery for patients with recurrent ovarian cancer ( ROC ) constitute a therapeutic challenge . Venous thromboembolism ( VTE ) seems to have a negative prognostic impact in patients with solid tumors including primary ovarian cancer in many series . Only limited contemporary data exist regarding the impact of VTE on ROC . PATIENTS AND METHODS Two large multicenter prospect i ve controlled phase I/II-III studies on 2nd-line topotecan-based chemotherapy with platinum-sensitive or resistant ROC ( N=525 ) were conducted on both operated and non-operative patients by the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group ( NOGGO ) . Analysis was performed to identify incidence , predictors and prognosis of VTE . Survival analysis , univariate and Cox-regression analysis were performed to identify independent predictors of VTE , overall and progression free survival . RESULTS Thirty-seven ( 7 % ) VTE-episodes during chemotherapy were identified ; 70 % of them occurred within the first 2 months after initiation of chemotherapy . Ascites , as a sign of peritoneal carcinomatosis and advanced tumor disease , was identified as independent predictor of VTE . Advanced age and high BMI did not appear to affect significantly the VTE-incidence . High performance status , platinum-sensitivity , serous-papillary histology , lack of ascites and surgery appeared to positively affect survival by multivariate analysis . Overall survival and progression free survival were similar between the VTE and no-VTE patients . CONCLUSION ROC- patients appear to have the highest risk for developing VTE when ascites exists and during the first 2 months following chemotherapy initiation . In contrast to primary ovarian cancer , VTE could not be identified to affect overall survival in relapsed malignant ovarian disease Cancer and its treatment are recognized risk factors for VTE . Compliance rate with published VTE prophylaxis guidelines is low . Decision on when to offer prophylaxis for hospitalized cancer patients is difficult to make . This paper describes current clinical practice in offering VTE prophylaxis to hospitalized cancer patients . Prophylaxis rate and rate of VTE will be correlated with the risk level . We prospect ively followed all consecutive adult cancer patients admitted to medical units over a 5-month period . Caprini risk assessment model , with some modifications , was utilized to determine risk of VTE . Six hundred and six patients ( 51 % males , median age 52 years , range 18–91 ) were included . Reasons for admission included infections ( 25 % ) , chemotherapy ( 22 % ) and palliative care ( 10 % ) . In addition to cancer , the most frequently encountered risk factors for VTE were : Immobilization ( 35 % ) , age > 60 years ( 31 % ) and body mass index > 30 in ( 20 % ) . Patients were grouped according to their total risk score : low ( 9 % ) , moderate ( 44 % ) and high risk ( 47 % ) . VTE prophylaxis rate was 55.1 % for the whole study group . Following discharge , patients were followed for 60 days . The incidence of VTE was 3.4 % in the moderate and 4.2 % in the high risk groups , while none in the low risk group developed VTE . Many additional risk factors for VTE are usually encountered in hospitalized cancer patients . Cancer alone may not be an enough reason for VTE prophylaxis . Risk assessment model able to stratify patients into different risk categories will simplify decision making and enhance VTE prophylaxis rate Introduction : The risk of symptomatic deep vein thrombosis ( DVT ) among patients with non-small cell lung cancer ( NSCLC ) has not been well studied . We conducted a retrospective cohort study of patients with NSCLC to determine the incidence of DVT and to characterize predictors of DVT in patients with NSCLC . Methods : The pulmonary oncology data base of the Sir Mortimer B. Davis – Jewish General Hospital contains prospect ively collected clinical data on lung cancer patients since January 1 , 1997 . We identified all consecutive patients with histologically confirmed new diagnoses of NSCLC between January 1 , 1997 and December 31 , 2004 , and we determined the occurrence of an objective ly defined DVT . Data on clinical and tumor characteristics were collected and compared among patients with DVT and patients without DVT . Results : Of the 493 NSCLC patients included in the cohort for a total of 634 person-years , 67 ( 13.6 % ) patients developed objective ly confirmed DVTs , with an incidence of 110 cases ( 95 % confidence interval [ CI ] 80 , 130 ) per 1000 person-years . An adjusted multivariable regression analysis showed that advanced stage ( rate ratio [ RR ] 2.63 , 95 % CI 1.38 , 5.00 ) and male sex ( RR 1.75 , 95 % CI 1.03–2
Output:
| On the basis of the literature , cancer patients experience between two-fold and 20-fold higher risk of developing VTE than noncancer patients .
They are more likely to experience a VTE event during the first 3 - 6 months after cancer diagnosis .
In addition , an increased risk of VTE in patients with distant metastases and certain types of cancer ( i.e. pancreatic or lung ) was revealed .
VTE was found to be a leading cause of mortality in cancer patients .
The annual average total cost for cancer patients with VTE was found to be almost 50 % higher than that of cancer patients without VTE . |
MS211087 | ***TASK*** the task is to summarize an input biomedical literature in 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 identify the effects of substance abuse status ( active , former , and never ) on utilization of highly active antiretroviral therapy ( HAART ) , medication adherence , and virologic and immunologic responses to therapy . Design : Prospect i ve cohort study of 764 HIV‐1‐infected patients who attended an urban HIV clinic and participated in a st and ardized interview . Main Outcome Measures : Past utilization of HAART , self‐reported nonadherence with antiretroviral therapy , and changes in HIV‐1 RNA level and CD4 + lymphocyte count relative to prior peak and nadir , respectively . Results : Forty‐four percent of active drug users failed to utilize HAART compared with 22 % of former drug users and 18 % of non‐drug users ( p < .001 for both comparisons ) . Among participants who were taking antiretroviral therapy when interviewed , active drug users were more likely to report medication nonadherence ( 34 % vs. 24 % of nonusers and 17 % of former users ) , had a smaller median reduction in HIV‐1 RNA from baseline ( 0.8 log10 copies/ml vs. 1.7 in nonusers and 1.6 in former users ) , and had smaller median increases in CD4 + lymphocyte count from baseline ( 65 cells/mm3 vs. 116 in nonusers and 122 in former users ) ( p < .05 for all comparisons with active users ) . Conclusions : Active drug use was strongly associated with underutilization of HAART , nonadherence , and inferior virologic and immunologic responses to therapy , whereas former drug users and non‐drug users were similar in all outcomes . Effective strategies are needed that integrate HIV‐1 and substance abuse treatments 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 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 Directly administered antiretroviral therapy ( DAART ) is one approach to improving adherence to among human immunodeficiency virus (HIV)-infected drug users . We evaluated the essential features of a community-based DAART intervention in a r and omized , controlled trial of DAART versus self-administered therapy . Of the initial 72 subjects , 78 % were racial minorities , and 32 % were women . Social and medical comorbidities among subjects included homelessness ( 35 % of subjects ) , lack of interpersonal support ( 86 % ) , major depression ( 57 % ) , and alcoholism ( 36 % ) . At baseline , the median CD4 + cell count was 403 cells/mL and the median HIV-1 RNA load was 146,333 copies/mL ( log10 5.31 copies/mL ) . During the prior 6 months , 33 % of subjects had missed a medical appointment , and 47 % had visited an emergency department . Although most subjects ( 67 % ) preferred to take their own medications , 76 % would accept DAART if it were made compulsory . A methadone clinic was the DAART venue acceptable to the fewest subjects ( 36 % ) , and a mobile syringe-exchange program was acceptable to the most subjects ( 83 % ) . Adherence was higher for supervised than for unsupervised medication administration ( P<.0001 ) , a finding that supports use of daily supervision of once-daily regimens . Moreover , DAART should incorporate enhanced elements such as convenience , flexibility , confidentiality , cues and reminders , responsive pharmacy and medical services , and specialized training for staff To evaluate the impact of injection drug users ( IDUs ) adherence on effectiveness of highly active antiretroviral therapy ( HAART ) , repeated measures of plasma viral load and CD4 + counts before HAART initiation and at last visit in the cohort were studied . Data were collected by means of patient 's face-to-face and self-administered question naires about adherence to HAART during the week prior to the last visit . Of a total of 119 patients treated with HAART , undetectable viral load was obtained for 55 patients ( 46.2 % ) ( G3 ) ; 34 patients ( 28.6 % ) ( G2 ) had a viral load decline > 0.5 log copies/ml but still detectable viral load at last visit in the cohort , while 30 patients ( 25.2 % ) ( G1 ) had no decline or decline ≤ 0.5 log copies/ml . Proportion of 100 % adherent patients was significantly higher in G3 ( 83.6 % ) than in G2 ( 64.7 % ) and G1 ( 56.7 % ) . In spite of differences in virological success and adherence , mean increase in CD4 + counts was similar in G3 ( 123 ± 160 counts/mm3 ) and G2 ( 143 ± 147 ) while no immunological improvement was observed in G1 . For the sub-groups of patients whose limited adherence has implied virological failure but did not impede short-term immunological reconstitution following HAART initiation , decision to switch HAART regimens could be delayed until interventions for improving future adherence have been carried out Objective To assess the temporal association of changes in substance abuse with antiretroviral therapy use and adherence , HIV-1 RNA suppression , and CD4 cell count changes in patients attending an urban clinic . Design Prospect i ve cohort study . Methods Six-hundred and ninety-five HIV-1-infected individuals , who completed two or more semi-annual st and ardized surveys and in whom antiretroviral therapy was indicated , were included in the analysis . Surveys addressed antiretroviral therapy use and adherence , and use of illicit drugs and alcohol . Substance abuse was defined as active heroin , cocaine , or heavy alcohol use in the 6 months preceding survey . The units of analysis were consecutive pairs of surveys ( couplets ) in individual participants . Couplets in which participants denied substance abuse in both surveys were compared to couplets in which participants switched from non-use to substance abuse , and couplets in which participants reported substance abuse in both surveys were compared to couplets where participants switched from substance abuse to non-use . Results Switching from non-use to substance abuse was strongly associated with worsening antiretroviral therapy use and adherence , less frequent HIV-1 RNA suppression , and blunted CD4 cell increases , compared to remaining free of substance abuse . Alternatively , switching from substance abuse to non-use was strongly associated with improvements in antiretroviral therapy use and adherence , and HIV-1 treatment outcomes , compared to persisting with substance abuse . Conclusions This longitudinal study highlights the dynamic nature of substance abuse and its temporal association with the effectiveness of HIV-1 treatment in patients attending an inner-city clinic Objective : To assess the efficacy of a peer-delivered intervention to promote short-term ( 6-month ) and long-term ( 12-month ) adherence to HAART in a Mozambican clinic population . Design : A 2-arm r and omized controlled trial was conducted between October 2004 and June 2006 . Participants : Of 350 men and women ( ≥18 years ) initiating HAART , 53.7 % were female , and 97 % were on 1 fixed-dose combination pill twice a day . Intervention : Participants were r and omly assigned to receive 6 weeks ( Monday through Friday ; 30 daily visits ) of peer-delivered , modified directly observed therapy ( mDOT ) or st and ard care . Peers provided education about treatment and adherence and sought to identify and mitigate adherence barriers . Outcome : Participants ' self-reported medication adherence was assessed 6 months and 12 months after starting HAART . Adherence was defined as the proportion of prescribed doses taken over the previous 7 days . Statistical analyses were performed using intention-to-treat ( missing = failure ) . Results : Intervention participants , compared to those in st and ard care , showed significantly higher mean medication adherence at 6 months ( 92.7 % vs. 84.9 % , difference 7.8 , 95 % confidence interval [ CI ] : 0.0.02 , 13.0 ) and 12 months ( 94.4 % vs. 87.7 % , difference 6.8 , 95 % CI : 0.9 , 12.9 ) . There were no between-arm differences in chart- abstract ed CD4 counts . Conclusions : A peer-delivered mDOT program may be an effective strategy to promote long-term adherence among persons initiating HAART in re source -poor setting This study 's hypothesis is that human immunodeficiency virus-infected patients in the inner city ( predominantly injection drug users and ethnic minorities ) do not take highly active antiretroviral therapy ( HAART ) as prescribed and that nonadherence leads to virologic failure . A prospect i ve , observational , 3-month study of adherence to HAART was undertaken at an inner-city clinic . There were 40 subjects [ 110 subject-months ] ; 30 were male , 10 were female , 75 % were Hispanic , 23 % were African American , 68 % were injection drug users , and 68 % were receiving triple therapy . At 3 months , adherence , which was determined by use of the Medication Event Monitoring System ( Aprex ) was significantly associated with virologic success : lower virus loads were associated with a rate of adherence of > 80 % ( P<.05 ) . Although nonadherence predicted virologic failure , virologic success was not always predicted by adherence : 11 ( 27.5 % ) of 40 subjects with suboptimal adherence rates ( < 90 % ) had complete virologic suppression Background : Directly administered antiretroviral therapy ( DAART ) is a promising intervention for improving HIV outcomes among active drug users , but the elements associated with successful DAART programs remain largely unknown . This study aim ed to assess the impact of colocated medical , case management , and referral to substance abuse services ( DAART-Plus ) among the subjects receiving DAART as part of a larger r and omized controlled trial comparing DAART with self-administered therapy . Methods : The health services utilization of 72 subjects receiving DAART was analyzed for its impact on changes in HIV-1 RNA levels at 6 months . The primary outcome was virologic success , defined as achieving an HIV-1 RNA level ≤400 copies/mL or a ≥1.0 log10 reduction in HIV-1 RNA level . A second analysis consisted of linear regression assessing the effect of covariates on log10 HIV-1 RNA reduction from baseline to 6 months . Results : In multivariate analyses , achieving virologic success at 6 months was associated with high medical services utilization [ adjusted odds ratio [ AOR ] = 10.0 ( 1.4 , 73.9 ) ; P = 0.02 ] and with the use of case management services [ AOR = 5.8 ( 1.1 , 30.5 ) ; P = 0.04 ] . Both services result ed in a larger reduction in log10 HIV-1 RNA from baseline ( difference in slopes : −0.9 and −1.0 , respectively ; P = 0.02 for both ) . Referral to off-site substance abuse services treatment did not significantly predict either virologic outcome . Conclusions : Among individuals who receive DAART , the utilization of on-site medical and case management services was independently associated with improved virologic outcomes . These results suggest the potential utility of integrating these services into DAART interventions ( DAART-Plus ) targeting HIV-infected drug users with problematic adherence Objectives To assess adherence to highly active antiretroviral therapies ( H
Output:
| The systematic review identified better HAART outcomes among former DU , those with less severe psychiatric conditions , those receiving opioid substitution therapy and /or psychosocial support .
Patients initiating HAART with lower viral load and higher CD4 counts , and those without co-infections also had better treatment outcomes .
Our findings suggest that HIV+ DU tend to be inappropriately assumed to be less adherent and unlikely to achieve desirable treatment outcomes , when compared to their non-DU cohort |
MS211088 | ***TASK*** the task is to summarize an input biomedical literature in 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 Qualitative interpretation of myocardial contrast echocardiography ( MCE ) improves the accuracy of wall-motion analysis for assessment of coronary artery disease ( CAD ) . We examined the feasibility and accuracy of quantitative MCE for diagnosis of CAD . METHODS Dipyridamole/exercise stress MCE ( destruction-replenishment protocol with real-time imaging ) was performed in 90 patients undergoing quantitative coronary angiography , 48 of whom had significant ( > 50 % ) stenoses . MCE was repeated with exercise alone in 18 patients . Myocardial blood flow ( A*beta ) was obtained from blood volume ( A ) and time to refill ( beta ) . RESULTS Quantification of flow reserve was feasible in 88 % . The mean A*beta reserve in the anterior wall was significantly impaired for patients with left anterior descending coronary artery disease ( n = 28 ) compared with those with no disease ( 1.6 + /- 1.2 vs 4.0 + /- 2.5 , P < or = .001 ) . This reflected impaired beta reserve , with no difference in the A reserve . Applying a receiver operating characteristic curve derived cutoff of 2.0 for A*beta reserve , quantitative MCE was 76 % sensitive and 71 % specific for the diagnosis of significant left anterior descending coronary artery stenosis . Posterior circulation results were similar , with 78 % sensitivity and 59 % specificity for detection of posterior CAD . Overall , quantitative MCE was similarly sensitive to qualitative approach for diagnosis of CAD ( 88 % vs 93 % ) , but with lower specificity ( 52 % vs 65 % , P = .07 ) . In 18 patients restudied with pure exercise stress , the mean myocardial blood flow reserve was less than after combined stress ( 2.1 + /- 1.6 vs 3.7 + /- 1.9 , P = .01 ) . CONCLUSION Quantitative MCE is feasible for the diagnosis of CAD with dipyridamole/exercise stress . Dipyridamole prolongs postexercise hyperemia , augmenting the degree of hyperemia at the time of imaging Myocardial contrast echocardiography ( MCE ) is a new technique for assessing myocardial perfusion that uses intracoronary injections of microbubbles of air . Because these microbubbles have a mean diameter of 4.3 + /- 0.3 microns and an intravascular rheology similar to that of red blood cells ( RBCs ) , we hypothesized that their mean myocardial transit rates recorded on echocardiography would provide an estimation of regional myocardial blood flow in the in vivo beating heart . Accordingly , blood flow to the left anterior descending coronary artery ( LAD ) of 12 open-chest anesthetized dogs ( group I ) was adjusted to 4 to 6 flows ( total of 60 flows ) , and microbubbles and radiolabeled RBCs were injected into the LAD in a r and om order at each stage . The mean myocardial RBC transit rates were measured by fitting a gamma-variate function to time-activity plots generated by placing a miniature CsI2 probe over the anterior surface of the heart , and the mean myocardial microbubble transit rates were measured from time-intensity plots derived from off-line analysis of MCE images obtained during the injection of microbubbles . An excellent correlation was noted between flow ( measured with an extracorporeal electromagnetic flow probe ) and mean myocardial RBC transit rate ( y = 2.83 x 10(-3)x + 0.01 , r = .96 , SEE = 0.02 , P < .001 ) . A close correlation was also noted between mean RBC and microbubble myocardial transit rates ( y = 1.01x + 0.01 , r = .89 , SEE = 0.02 , P < .001 ) . Despite its theoretical advantages , a lagged normal density function did not provide a better fit to the MCE data than the gamma-variate function . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVES The purpose of this study was to compare the assessment of myocardial perfusion by myocardial parametric quantification ( MPQ ) with technetium-99 m sestamibi single-photon emission computed tomographic ( SPECT ) imaging in humans . BACKGROUND Accurate visual interpretation of myocardial contrast echocardiographic ( MCE ) images is qualitative and requires considerable experience . Current computer-assisted quantitative perfusion protocol s are tedious and lack spatial resolution . Myocardial parametric quantification is a novel method that quantifies , color encodes , and displays perfusion data as a set of myocardial parametric images according to the relative degree of perfusion . METHODS Forty-six consecutive patients underwent prospect i ve stress/rest technetium-99 m sestamibi gated-SPECT imaging and MCE using intravenous Optison or Definity . Apical two- and four-chamber cine loops at rest and after dipyridamole ( 0.56 mg/kg ) stress were acquired . For each patient , the following assessment s of myocardial perfusion were performed : 1 ) . visual cine-loop assessment ( VIS ) ; 2 ) . MPQ assessment ; and 3 ) . combined VIS + MPQ assessment . RESULTS The segmental rates of agreement for myocardial perfusion with SPECT were 83 % , 89 % , and 92 % ( kappa = 0.46 , 0.58 , and 0.68 ) for VIS , MPQ , and VIS + MPQ , respectively . Similar trends were seen for the classification of the presence or absence of a moderate to severe perfusion defect , with the agreement for VIS , MPQ , and VIS + MPQ being 92 % , 97 % , and 97 % , respectively . CONCLUSIONS Myocardial parametric quantification demonstrates good agreement with SPECT and incremental agreement with VIS . Analysis strategies that incorporate MPQ demonstrate better agreement with SPECT than visual analysis alone AIMS Parametric imaging of myocardial perfusion provides useful visual information for the diagnosis of coronary artery disease ( CAD ) . We developed a technique for automated detection of perfusion defects based on quantitative analysis of parametric perfusion images and vali date d it against coronary angiography . METHODS AND RESULTS Contrast-enhanced , apical 2- , 3- and 4-chamber images were obtained at rest and with dipyridamole in 34 patients with suspected CAD . Images were analyzed to generate parametric perfusion images of the st and ard contrast-replenishment model parameters A , beta and A.beta . Each parametric image was divided into six segments , and mean parameter value ( MPV ) was calculated for each segment . Segmental MPV ratio between stress and rest was defined as a flow reserve index ( FRI ) . Receiver operating characteristics ( ROC ) analysis was used in a Study group ( N=17 ) to optimize FRI threshold and the minimal number of abnormal segments per vascular territory ( LAD and non-LAD ) , required for automated detection of stress-induced perfusion defects . The optimized detection algorithm was then tested prospect ively in the remaining 17 patients ( Test group ) . LAD and non-LAD stenosis > 70 % was found in 19 and 17 patients , respectively . In the Study group , FRI threshold was : LAD=0.95 and non-LAD=0.68 , minimal number of abnormal segments was four and two , correspondingly . Sensitivity , specificity and accuracy in the Test group were : 75 % , 67 % and 71 % in the LAD , and 75 % , 75 % and 75 % in the non-LAD territories . CONCLUSION Automated quantitative analysis of contrast echocardiographic parametric perfusion images is feasible and may aid in the objective detection of CAD
Output:
| Evidence supports the use of quantitative MCE as a non-invasive test for detection of CAD . |
MS211089 | ***TASK*** the task is to summarize an input biomedical literature in 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 investigated whether children 's spatial recall performance shows three separable characteristics : ( 1 ) biases away from symmetry axes ( geometric effects ) ; ( 2 ) systematic drift over delays ; and ( 3 ) biases toward the exemplar distribution experienced in the task ( experience-dependent effects ) . In Experiment 1 , the location of one target within each geometric category was varied . Children 's responses showed biases away from a midline axis that increased over delays . In Experiment 2 , multiple targets were placed within each category at the same locations used in Experiment 1 . After removing geometric effects , 6-year-olds'--but not 11-year-olds'--responses were biased toward the average remembered location over learning . In Experiment 3 , children responded to one target more frequently than the others . Both 6- and 11-year-olds showed biases toward the most frequent target over learning . These results provide a bridge between the performance of younger children and adults , demonstrating continuity in the processes that underlie spatial memory abilities across development The Corsi Block-Tapping task has been utilized as a measure of spatial memory in both clinical and research context s for several decades . Despite its wide application , the task has been employed with extraordinary variability in administration and scoring and in the composition of stimulus item sets . We have generated a set of test items containing quasi-r and omly derived block-tapping sequences . In another study , we investigated item difficulty as a function of path configuration and showed a decline in performance with increasing span capacity load . In the current cross-sectional study , we evaluated developmental differences in span capacity by measuring performances of school children from grade 1 ( M age = 7 years ) to grade 8 ( M age = 14 ) and a young adult sample ( M age = 21 years ) . Mean span capacity increased incrementally and linearly with age , and no gender difference was observed . The increase in performance with advancing age supports the notion that spatial immediate memory capacity increases with maturation throughout childhood . Comparisons indicated that the span capacity of eighth grade rs ( M = 6.9 ) was not statistically different from that of the young adults ( M = 7.1 ) , suggesting an upper developmental plateau for spatial span in early adolescence . This study provides a normative data base for this widely utilized measure of spatial memory . Some of the data contained in this paper were presented at the meeting of the International Neuropsychological Society , Honolulu , February 2003 Thelen and colleagues recently proposed a dynamic field theory ( DFT ) to capture the general processes that give rise to infants ' performance in the Piagetian A-not-B task . According to this theory , the same general processes should operate in noncanonical A-not-B-type tasks with children older than 12 months . Three predictions of the DFT were tested by examining 3-year-olds ' location memory errors in a task with a homogeneous task space . Children pointed to remembered locations after delays of 0 s to 10 s. The spatial layout of the possible targets and the frequency with which children moved to each target was varied . As predicted by the DFT , children 's responses showed a continuous spatial drift during delays toward a longer term memory of previously moved-to locations . Furthermore , these delay-dependent effects were reduced when children moved to an " A " location on successive trials , and were magnified on the first trial to a nearby " B " location . Thus , the DFT generalized to capture the performance of 3-year-old children in a new task . In contrast to predictions of the DFT , however , 3-year-olds ' responses were also biased toward the midline of the task space-an effect predicted by the category adjustment ( CA ) model . These data suggest that young children 's spatial memory responses are affected by delay- and experience-dependent processes as well as the geometric structure of the task space . Consequently , two current models of spatial memory-the DFT and the CA model-provide incomplete accounts of children 's location memory abilities Two experiments examined how information about what objects are influences memory for where objects are located . Seven- , 9- , and 11-year-old children and adults learned the locations of 20 objects marked by dots on the floor of a box . The objects belonged to 4 categories . In one condition , objects belonging to the same category were located in the same quadrant of the box . In another condition , objects and locations were r and omly paired . After learning , participants attempted to replace the objects without the aid of the dots . Children and adults placed the objects in the same quadrant closer together when they were related than when they were unrelated , indicating that object information led to systematic biases in location memory 25 infants were tested every 2 weeks on the AB Object Permanence Task devised by Piaget , from the age when they first reached for a hidden object until they were 12 months . The delay between hiding and retrieval necessary to produce the AB error increased continuously throughout this period at an average rate of 2 sec/month , from under 2 sec at 7 1/2 months to over 10 sec by 12 months . All children displayed the AB error repeatedly over the months of testing . Large between-children differences in delay needed for the AB error were found at each age . Girls tolerated longer delays than boys . The characteristic pattern to the AB error did not vary over age or sex . Range of delay producing the AB error in any child was small . Errors disappeared when delays were reduced by 2 - 3 sec , and reaching became r and om or severely perseverative when delays were increased 2 - 3 sec above the level producing AB error . AB provides an index of the ability to carry out an intention based on stored information despite a conflicting habitual tendency Recently , Smith , Thelen , and colleagues proposed a dynamic systems account of the Piagetian " A-not-B " error in which infants ' errors result from general processes that make goal -directed actions to remembered locations . Based on this account , the A-not-B error should be a general phenomenon , observable in different tasks and at different points in development . Smith , Thelen , et al. 's proposal was tested using an A-not-B version of a s and box task . During three training trials and three " A " trials , 2-year-olds watched as a toy was buried in a s and box at Location A. Following a 10-s delay , children search ed for the object . Across five experiments , children 's ( total N = 92 ) performance on the A trials was accurate . After the A trials , children watched as a toy was hidden at Location B , 8 to 10 inches from Location A. In all experiments , children 's search es after a 10-s delay were significantly biased in the direction of Location A. Furthermore , this bias toward Location A decreased with repeated trials to Location B , as well as when children completed fewer trials to Location A. Together , these data suggest that A-not-B-type errors are pervasive across tasks and development People use geometric cues to form spatial categories . This study investigated whether people also use the spatial distribution of exemplars . Adults pointed to remembered locations on a tabletop . In Experiment 1 , a target was placed in each geometric category , and the location of targets was varied . Adults ' responses were biased away from a midline category boundary toward geometric prototypes located at the centers of left and right categories . Experiment 2 showed that prototype effects were not influenced by cross-category interactions . In Experiment 3 , subsets of targets were positioned at different locations within each category . When prototype effects were removed , there was a bias toward the center of the exemplar distribution , suggesting that common categorization processes operate across spatial and object domains
Output:
| A systematic review of the literature around these examples reveals that computational modeling is having an impact on empirical research in cognitive development ; however , this impact does not extend to neural and clinical research . |
MS211090 | ***TASK*** the task is to summarize an input biomedical literature in 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 Emergency calls to ambulance services are frequent for older people who have fallen , but ambulance crews often leave patients at the scene without ongoing care . Evidence shows that when left at home with no further support older people often experience subsequent falls which result in injury and emergency-department attendances . SAFER 2 is an evaluation of a new clinical protocol which allows paramedics to assess and refer older people who have fallen , and do not need hospital care , to community-based falls services . In this protocol paper , we report methods and progress during trial implementation . SAFER 2 is recruiting patients through three ambulance services . A successful trial will provide robust evidence about the value of this new model of care , and enable ambulance services to use re sources efficiently . Design Pragmatic cluster r and omised trial . Methods and analysis We r and omly allocated 25 participating ambulance stations ( clusters ) in three services to intervention or control group . Intervention paramedics received training and clinical protocol s for assessing and referring older people who have fallen to community-based falls services when appropriate , while control paramedics deliver care as usual . Patients are eligible for the trial if they are aged 65 or over ; resident in a participating falls service catchment area ; and attended by a trial paramedic following an emergency call coded as a fall without priority symptoms . The principal outcome is the rate of further emergency contacts ( or death ) , for any cause and for falls . Secondary outcomes include further falls , health-related quality of life , ‘ fear of falling ’ , patient satisfaction reported by participants through postal question naires at 1 and 6 months , and quality and pathways of care at the index incident . We shall compare National Health Service ( NHS ) and patient/carer costs between intervention and control groups and estimate quality -adjusted life years ( QALYs ) gained from the intervention and thus incremental cost per QALY . We shall estimate wider system effects on key-performance indicators . We shall interview 60 intervention patients , and conduct focus groups with contributing NHS staff to explore their experiences of the assessment and referral service . We shall analyse quantitative trial data by ‘ treatment allocated ’ ; and qualitative data using content analysis . Ethics and dissemination The Research Ethics Committee for Wales gave ethical approval and each participating centre gave NHS Research and Development approval . We shall disseminate study findings through peer- review ed publications and conference presentations . Trial Registration : IS RCT N AIMS To investigate the feasibility of delivering titrated oxygen therapy to adults with return of spontaneous circulation ( ROSC ) following out-of-hospital cardiac arrest ( OHCA ) caused by ventricular fibrillation ( VF ) or ventricular tachycardia ( VT ) . METHODS We used a multicentre , r and omised , single blind , parallel groups design to compare titrated and st and ard oxygen therapy in adults resuscitated from VF/VT OHCA . The intervention commenced in the community following ROSC and was maintained in the emergency department and the Intensive Care Unit . The primary end point was the median oxygen saturation by pulse oximetry ( SpO2 ) in the pre-hospital period . RESULTS 159 OHCA patients were screened and 18 were r and omised . 17 participants were analysed : nine in the st and ard care group and eight in the titrated oxygen group . In the pre-hospital period , SpO2 measurements were lower in the titrated oxygen therapy group than the st and ard care group ( difference in medians 11.3 % ; 95 % CI 1.0 - 20.5 % ) . Low measured oxygen saturation ( SpO2<88 % ) occurred in 7/8 of patients in the titrated oxygen group and 3/9 of patients in the st and ard care group ( P=0.05 ) . Following hospital admission , good separation of oxygen exposure between the groups was achieved without a significant increase in hypoxia events . The trial was terminated because accumulated data led the Data Safety Monitoring Board and Management Committee to conclude that safe delivery of titrated oxygen therapy in the pre-hospital period was not feasible . CONCLUSIONS Titration of oxygen in the pre-hospital period following OHCA was not feasible ; it may be feasible to titrate oxygen safely after arrival in hospital AIM To determine whether in patients with an ambulance response time of > 5min who were in VF cardiac arrest , 3min of CPR before the first defibrillation was more effective than immediate defibrillation in improving survival to hospital discharge . METHODS This r and omised control trial was run by the South Australian Ambulance Service between 1 July , 2005 , and 31 July , 2007 . Patients in VF arrest were eligible for r and omisation . Exclusion criteria were : ( i ) < 18 years of age , ( ii ) traumatic arrest , ( iii ) paramedic witnessed arrest , ( iv ) advanced life support performed before arrival of paramedics and ( v ) not for resuscitation order or similar directive . The primary outcome was survival to hospital discharge with secondary outcomes being neurological status at discharge , the rate of return of spontaneous circulation ( ROSC ) and the time from first defibrillation to ROSC . RESULTS For all response times , no differences were observed between the immediate defibrillation group and the CPR first group in survival to hospital discharge ( 17.1 % [ 18/105 ] vs. 10.3 % [ 10/97 ] ; P=0.16 ) , the rate of ROSC ( 53.3 % [ 56/105 ] vs. 50.5 % [ 49/97 ] ; P=0.69 ) or the time from the first defibrillation to ROSC ( 12:37 vs. 11:19 ; P=0.49 ) . There were also no differences between the immediate defibrillation group and the CPR first group , for response times of < or = or > 5min : survival to hospital discharge ( 50.0 % [ 7/14 ] vs. 25.0 % [ 4/16 ] ; P=0.16 or 12.1 % [ 11/91 ] vs.7.4 % [ 6/81 ] ; P=0.31 , respectively ) and the rate of ROSC ( 71.4 % [ 10/14 ] vs. 75.0 % [ 12/16 ] ; P=0.83 or 50.5 % [ 46/91 ] vs. 45.7 % [ 37/81 ] ; P=0.54 , respectively ) . No differences were observed in the neurological status of those surviving to hospital discharge . CONCLUSION For patient in out-of-hospital VF cardiac arrest we found no evidence to support the use of 3min of CPR before the first defibrillation over the accepted practice of immediate defibrillation Background The utility of advanced prehospital interventions for severe blunt traumatic brain injury ( BTI ) remains controversial . Of all trauma patient subgroups it has been anticipated that this patient group would most benefit from advanced prehospital interventions as hypoxia and hypotension have been demonstrated to be associated with poor outcomes and these factors may be amenable to prehospital intervention . Supporting evidence is largely lacking however . In particular the efficacy of early anaesthesia/muscle relaxant assisted intubation has proved difficult to substantiate . Methods This article describes the design and protocol of the Head Injury Retrieval Trial ( HIRT ) which is a r and omised controlled single centre trial of physician prehospital care ( delivering advanced interventions such as rapid sequence intubation and blood transfusion ) in addition to paramedic care for severe blunt TBI compared with paramedic care alone . Results Primary endpoint is Glasgow Outcome Scale score at six months post injury . Issues with trial integrity result ing from drop ins from st and ard care to the treatment arm as the result of policy changes by the local ambulance system are discussed . Conclusion This r and omised controlled trial will contribute to the evaluation of the efficacy of advance prehospital interventions in severe blunt TBI.Trial Registration Clinical Trials.gov : Background Advanced prehospital interventions for severe brain injury remains controversial . No previous r and omised trial has been conducted to evaluate additional physician intervention compared with paramedic only care . Methods Participants in this prospect i ve , r and omised controlled trial were adult patients with blunt trauma with either a scene GCS score < 9 ( original definition ) , or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 ( modified definition ) . Patients were r and omised to either st and ard ground paramedic treatment or st and ard treatment plus a physician arriving by helicopter . Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale ( GOS ) scores . Due to high non-compliance rates , both intention-to-treat and as-treated analyses were preplanned . Results 375 patients met the original definition , of which 197 was allocated to physician care . Differences in the 6-month GOS scores were not significant on intention-to-treat analysis ( OR 1.11 , 95 % CI 0.74 to 1.66 , p=0.62 ) nor was the 30-day mortality ( OR 0.91 , 95 % CI 0.60 to 1.38 , p=0.66 ) . As-treated analysis showed a 16 % reduction in 30-day mortality in those receiving additional physician care ; 60/195 ( 29 % ) versus 81/180 ( 45 % ) , p<0.01 , Number needed to treat = 6 . 338 patients met the modified definition , of which 182 were allocated to physician care . The 6-month GOS scores were not significantly different on intention-to-treat analysis ( OR 1.14 , 95 % CI 0.73 to 1.75 , p=0.56 ) nor was the 30-day mortality ( OR 1.05 , 95 % CI 0.66 to 1.66 , p=0.84 ) . As-treated analyses were also not significantly different . Conclusions This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care ( original definition only ) . Confirmatory studies which also address non-compliance issues are needed . Trial registration number NCT00112398 IMPORTANCE A strategy using mechanical chest compressions might improve the poor outcome in out-of-hospital cardiac arrest , but such a strategy has not been tested in large clinical trials . OBJECTIVE To determine whether administering mechanical chest compressions with defibrillation during ongoing compressions ( mechanical CPR ) , compared with manual cardiopulmonary resuscitation ( manual CPR ) , according to guidelines , would improve 4-hour survival . DESIGN , SETTING , AND PARTICIPANTS Multicenter r and omized clinical trial of 2589 patients with out-of-hospital cardiac arrest conducted between January 2008 and February 2013 in 4 Swedish , 1 British , and 1 Dutch ambulance services and their referring hospitals . Duration of follow-up was 6 months . INTERVENTIONS Patients were r and omized to receive either mechanical chest compressions ( LUCAS Chest Compression System , Physio-Control/Jolife AB ) combined with defibrillation during ongoing compressions ( n = 1300 ) or to manual CPR according to guidelines ( n = 1289 ) . MAIN OUTCOMES AND MEASURES Four-hour survival , with secondary end points of survival up to 6 months with good neurological outcome using the Cerebral Performance Category ( CPC ) score . A CPC score of 1 or 2 was classified as a good outcome . RESULTS Four-hour survival was achieved in 307 patients ( 23.6 % ) with mechanical CPR and 305 ( 23.7 % ) with manual CPR ( risk difference , -0.05 % ; 95 % CI , -3.3 % to 3.2 % ; P > .99 ) . Survival with a CPC score of 1 or 2 occurred in 98 ( 7.5 % ) vs 82 ( 6.4 % ) ( risk difference , 1.18 % ; 95 % CI , -0.78 % to 3.1 % ) at intensive care unit discharge , in 108 ( 8.3 % ) vs 100 ( 7.8 % ) ( risk difference , 0.55 % ; 95 % CI , -1.5 % to 2.6 % ) at hospital discharge , in 105 ( 8.1 % ) vs 94 ( 7.3 % ) ( risk difference , 0.78 % ; 95 % CI , -1.3 % to 2.8 % ) at 1 month , and in 110 ( 8.5 % ) vs 98 ( 7.6 % ) ( risk difference , 0.86 % ; 95 % CI , -1.2 % to 3.0 % ) at 6 months with mechanical CPR and manual CPR , respectively . Among patients surviving at 6 months , 99 % in the mechanical CPR group and 94 % in the manual CPR group had CPC scores of 1 or 2 . CONCLUSIONS AND RELEVANCE Among adults with out-of-hospital cardiac arrest , there was no significant difference in 4-hour survival between patients treated with the mechanical CPR algorithm or those treated with guideline -adherent manual CPR . The vast majority of survivors in both groups had good neurological outcomes by 6 months . In clinical practice , mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00609778 Background There is little in-depth research into how patients feel about emergency medical trials , and what influences these feelings . Objectives To investigate patients ’ feelings on taking part in emergency medical research , particularly tri
Output:
| Issues relating to consent were the most significant theme identified .
Type of consent differed depending on the condition or intervention being studied .
The country in which the research took place did not appear to influence the type of consent , apart from the USA where exception from consent appeared to be most commonly used .
A wide range of terms were used to describe consent .
Conclusions Consent was the main ethical consideration in published ambulance based research .
A range of consent models were used ranging from informed consent to exception from consent ( waiver of consent ) . |
MS211091 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM The aim of this paper is to present the results of a study design ed to determine the effect of scenario-based simulation training on nursing students ' clinical skills and competence . BACKGROUND Using full-scale , realistic , medical simulation for training healthcare professionals is becoming more and more common . Access to this technology is easier than ever before with the opening of several simulation centres throughout the world and the availability on the market of more sophisticated and affordable patient simulators . However , there is little scientific evidence proving that such technology is better than more traditional techniques in the education of , for example , undergraduate nursing students . METHODS A pretest/post-test design was employed with volunteer undergraduate students ( n = 99 ) from second year Diploma of Higher Education in Nursing programme in United Kingdom using a 15-station Objective Structured Clinical Examination . Students were r and omly allocated to either a control or an experimental group . The experimental group , as well as following their normal curriculum , were exposed to simulation training . Subsequently , all students were re-tested and completed a question naire . The data were collected between 2001 and 2003 . RESULTS The control and experimental groups improved their performance on the second Objective Structured Clinical Examination . Mean test scores , respectively , increased by 7.18 and 14.18 percentage points . The difference between the means was statistically significant ( P < 0.001 ) . However , students ' perceptions of stress and confidence , measured on a 5-point Likert scale , was very similar between groups at 2.9 ( 1 , not stressful ; 5 , very stressful ) and 3.5 ( 1 , very confident ; 5 , not confident ) for the control group , and 3.0 and 3.4 for the experimental group . CONCLUSIONS Intermediate-fidelity simulation is a useful training technique . It enables small groups of students to practise in a safe and controlled environment how to react adequately in a critical patient care situation . This type of training is very valuable to equip students with a minimum of technical and non-technical skills before they use them in practice setting Nowadays simulation is taking an important place in training and education of healthcare professionals . The University of Hertfordshire is carrying out a study which aims to determine the effect of realistic scenario-based simulation on nursing students ' competence and confidence . This project is sponsored by the British Heart Foundation and takes place in the Hertfordshire Intensive Care and Emergency Simulation Centre ( HICESC ) , a simulated three adult beds Intensive Care Unit . The simulation platform used is a Laerdal SimMan Universal Patient Simulator . A unique and robust study design , and results of the study are presented in this article . Consecutive cohorts of students are being assessed and reassessed after six months using an Objective Structured Clinical Examination ( OSCE ) . Students are r and omly divided into a control and experimental group for the period intervening between the two examinations . The experimental group is exposed to simulation training while the other students follow their usual nursing courses . Comparison is made between the OSCE results of the two groups of students . The experimental group had a greater improvement in performance than the control group ( 13.43 % compared with 6.76 % ( p<0.05 ) ) . The results and feedback received from students and lecturers suggest that simulation training in nursing education is beneficial The project purpose was to determine whether measures of critical thinking show differences between three groups ( simulator , non-simulator , control ) of baccalaureate nursing students . The second purpose was to determine the moderating effect of students ' preferred learning style . All groups experienced a moderate to large effect size in critical thinking scores . The corrected model for the total scale gain score was statistically significant but not significant for learning style or group Background Despite the recent wave of interest being shown in high‐fidelity simulators , they do not represent a new concept in healthcare education . Simulators have been a part of clinical education since the 1950s . The growth of patient simulation as a core educational tool has been driven by a number of factors . Declining inpatient population s , concerns for patient safety and advances in learning theory are forcing healthcare educators to look for alternatives to the traditional clinical encounter for skill acquisition for students . Objective The aim of this review was to identify the best available evidence on the effectiveness of using simulated learning experiences in pre‐licensure health profession education . Inclusion criteria Types of studies : This review considered any experimental or quasi‐experimental studies that addressed the effectiveness of using simulated learning experiences in pre‐licensure health profession practice . In the absence of r and omised controlled trials , other research design s were considered for inclusion , such as , but not limited to : non‐r and omised controlled trials and before‐ and ‐after studies . Types of participants : This review included participants who were pre‐licensure practitioners in nursing , medicine , and rehabilitation therapy . Types of intervention(s)/phenomena of interest : Studies that evaluated the use of human physical anatomical models with or without computer support , including whole‐body or part‐body simulators were included . Types of outcome measures Student outcomes included knowledge acquisition , skill performance , learner satisfaction , critical thinking , self‐confidence and role identity . Search strategy Using a defined search and retrieval method , the following data bases were accessed for the period 1995‐2006 : Medline , CINAHL , Embase , PsycINFO , HealthSTAR , Cochrane Data base of Systematic Review s and ERIC . Method ological quality Each paper was assessed by two independent review ers for method ological quality prior to inclusion in the review using the st and ardised critical appraisal instruments for evidence of effectiveness , developed by the Joanna Briggs Institute . Disagreements were dealt with by consultations with a third review er . Data collection Information was extracted from each paper independently by two review ers using the st and ardised data extraction tool from the Joanna Briggs Institute . Disagreements were dealt with by consultation with a third review er . Data synthesis Due to the type of design s and quality of available studies , it was not possible to pool quantitative research study results in statistical meta‐ analysis . As statistical pooling was not possible , the findings are presented in descriptive narrative form . Results Twenty‐three studies were selected for inclusion in this review including partial task trainers and high‐fidelity human patient simulators . The results indicate that there is high learner satisfaction with using simulators to learn clinical skills . The studies demonstrated that human patient simulators which are used for teaching higher level skills , such as airway management , and physiological concepts are useful . While there are short‐term gains in knowledge and skill performance , it is evident that performance of skills over time after initial training decline . Conclusion At best , simulation can be used as an adjunct for clinical practice , not a replacement for everyday practice . Students enjoyed t he sessions and using the models purportedly makes learning easier . However , it remains unclear whether the skills learned through a simulation experience transfer into real‐world setting s. More research is needed to evaluate whether the skills acquired with this teaching methodology transfer to the practice setting such as the impact of simulation training on team function & NA ; The purpose of this study was to compare the effectiveness of an interactive , multimedia CD‐ROM with traditional methods of teaching the skill of performing a 12‐lead ECG . A r and omized pre/posttest experimental design was used . Seventy‐seven baccalaureate nursing students in a required , senior‐level critical‐care course at a large midwestern university were recruited for the study . Two teaching methods were compared . The traditional method included a self‐ study module , a brief lecture and demonstration by an instructor , and h and s‐on experience using a plastic manikin and a real 12‐lead ECG machine in the learning laboratory . The second method covered the same content using an interactive , multimedia CD‐ROM embedded with virtual reality and supplemented with a self‐ study module . There were no significant ( p < .05 ) baseline differences in pretest scores between the two groups and no significant differences by group in cognitive gains , student satisfaction with their learning method , or perception of self‐efficacy in performing the skill . Overall results indicated that both groups were satisfied with their instructional method and were similar in their ability to demonstrate the skill correctly on a live , simulated patient . This evaluation study is a beginning step to assess new and potentially more cost‐effective teaching methods and their effects on student learning outcomes and behaviors , including the transfer of skill acquisition via a computer simulation to a real patient As computer-assisted instruction ( CAI ) use has increased during the past few years , nurse educators have expressed concern regarding its effectiveness . The purpose of this quasiexperimental study was to determine if completion of a computerized simulation about a surgical patient increased baccalaureate nursing students ' self-efficacy about caring for surgical patients in the clinical environment . Such an association is desirable because increased levels of self-efficacy have been associated with increased motivation , goal - setting , and achievement . A nonprobability , convenience sample ( N = 23 ) of second-year baccalaureate nursing students was assigned r and omly to experimental and control groups . The self-efficacy of the experimental group was measured three times : on an initial pretest ; following the intervention of a computer simulation ; and after an 8-week clinical rotation . The self-efficacy of the control group was measured on an initial pretest and after the 8-week rotation . Higher pre clinical self-efficacy scores ( p<.01 ) of the experimental group support the use of CAI as an important aspect of clinical education . Implication s for nursing education , practice , and research are addressed . Computer-assisted instruction ( CAI ) has been available for several decades ; however , its use in nursing education has escalated during the past few years . This intensified interest is the result of a decrease in the cost of computer hardware and an increase in the availability of relevant educational software ( Wright , 1995 ) . Cutbacks to educational funding , along with the rising costs of clinical teaching , have motivated studies of this method of nursing education . The purpose of this pilot study was to determine if completion of a supplemental computerized simulation about a surgical patient increased baccalaureate nursing students ' self-efficacy about caring for surgical patients in the clinical area . The exploration of a link between CAI and self-efficacy focused on the processes of learning , thereby extending the literature The actual effect of the use of simulations on clinical decision making is inconclusive . This pilot study used a posttest design to determine the effect of a simulation strategy on the clinical decision-making process of midwifery students . Thirty-six graduate diploma students volunteered and were r and omly assigned to two groups , with the experimental group receiving two simulation sessions ( normal labor and physiological jaundice ) , and the control group receiving the two usual lectures . The main findings were that students who received the simulation strategy collected more clinical information , revisited collected clinical information less , made fewer formative inferences , reported higher confidence levels , and for the posttest normal labor simulation , reached a final decision more quickly . Such effects are reasonable for this type of intervention with the existent variability in each group . Further research with a larger sample size and more rigorous data collection strategies is required R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task
Output:
| The results indicate that the use of human patient simulation manikins improved knowledge acquisition and critical thinking ; and enhanced students ' satisfaction with learning .
There is lack of unequivocal evidence on the effectiveness of using high-fidelity human patient simulation manikins in the teaching of clinical reasoning skills to undergraduate nursing students .
CONCLUSION Further research is required to ascertain the effectiveness of the use of human patient simulation manikins as an educational strategy to improve clinical reasoning skills of undergraduate nursing students .
The importance of this research is underscored by the potential for patient outcomes to be improved by enhancing the clinical reasoning skills of undergraduate graduate nursing students and graduates .
IMPLICATION S FOR EDUCATION This review presents evidence to suggest that using HPSMs significantly improve learning outcomes related to clinical reasoning namely : critical thinking ; clinical skill performance and knowledge acquisition .
In addition , results indicate high student satisfaction with HPSMs simulation experience . |
MS211092 | ***TASK*** the task is to summarize an input biomedical literature in 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 prevalence of sexual dysfunction in schizophrenia patients was investigated as part of this large ( n = 7655 ) , prospect i ve , international ( 27 countries ) study . Based on patient reports , sexual dysfunction affected approx . 50 % of patients and the prevalence of complaints varied significantly between regions ( p < 0.0001 ) . The prevalence of sexual dysfunction , as perceived by psychiatrists , also varied significantly across regions ( p < 0.0001 ) . Psychiatrists significantly underestimated the presence of impotence/sexual dysfunction ( p < 0.0001 ) and loss of libido ( p < 0.0001 ) , compared to reports from patients . The frequency of sexual dysfunction was significantly higher in patients who had been using prolactin-elevating antipsychotics prior to study entry , compared to those who had been treated with prolactin-sparing antipsychotics ( patient reports , p = 0.002 ; psychiatrist perception , p = 0.0004 ) . This study has shown that the prevalence of sexual dysfunction is high in both male and female patients with schizophrenia and frequently underestimated by psychiatrists . Regional variation is evident in both psychiatrist perceptions and patient reports of sexual dysfunction . Given the importance of sexual function to quality of life and treatment compliance , proactive assessment of sexual function is required to optimize schizophrenia management This study compares two methods for elicitation of treatment-emergent side effects . One is the open-ended general inquiry and the other is a specific inquiry that asks about a wide range of events thought to be treatment-related . The study goal was to determine the extent to which the specific inquiry method elicits clinical ly useful information over and above that elicited by the general inquiry method . The assessment instrument we used is SAFTEE , a structured interview schedule developed by the National Institute of Mental Health . We looked for differences between general and specific inquiry formats in terms of number of events elicited , type of event , severity , functional impairment , and clinician action taken . We found that both methods contributed to elicitation of events that , in the clinician 's opinion , required some change in management . However , events reported on the General Inquiry form were significantly more distressing , more often interfered with daily functioning , and elicited more extensive changes in clinical management . No medically serious events were elicited on the specific inquiry form alone . Based on these findings , and in view of the amount of time and effort required to administer and score it , we do not recommend the specific inquiry form of SAFTEE as a st and ard assessment tool for routine use in all clinical trials . We do consider it to be a useful method for comprehensive elicitation about treatment-emergent effects in targeted and specific research context s. We see the schedule as a comprehensive document or library of queries to be tailored to the needs of individual protocol CONTEXT R and omized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting ; however , generalizable data on drug safety reporting are sparse . OBJECTIVE To scrutinize the completeness of safety reporting in r and omized trials . DESIGN , SETTING , AND PATIENTS Survey of safety reporting in 192 r and omized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm ( N = 130074 patients ) . Trial reports were identified from comprehensive meta-analyses in 7 medical areas . MAIN OUTCOME MEASURES Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects ; article space allocated to safety reporting and predictors of such reporting . RESULTS Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39 % and 29 % of trial reports , respectively . Only 46 % of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity . For these 3 parameters , there was significant heterogeneity in rates of adequate reporting across topics ( P = .003 , P<.001 , and P = .02 , respectively ) . Overall , the median space allocated to safety results was 0.3 page . A similar amount of space was devoted to contributor names and affiliations ( P = .16 ) . On average , the percentage of space devoted to safety in the results section was 9.3 % larger in trials involving dose comparisons than in those that did not ( P<.001 ) and 3.8 % smaller in trials reporting statistically significant results for efficacy outcomes ( P = .047 ) . CONCLUSIONS The quality and quantity of safety reporting vary across medical areas , study design s , and setting s but they are largely inadequate . Current st and ards for safety reporting in r and omized trials should be revised to address this inadequacy Background We would expect information on adverse drug reactions in r and omised clinical trials to be easily retrievable from specific search es of electronic data bases . However , complete retrieval of such information may not be straightforward , for two reasons . First , not all clinical drug trials provide data on the frequency of adverse effects . Secondly , not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data . We have determined how often automated search methods , using indexing terms and /or textwords in the title or abstract , would fail to retrieve trials with adverse effects data . Methods We used a sample set of 107 trials known to report frequencies of adverse drug effects , and measured the proportion that ( i ) were not assigned the appropriate adverse effects indexing terms in the electronic data bases , and ( ii ) did not contain identifiable adverse effects textwords in the title or abstract . Results Of the 81 trials with records on both MEDLINE and EMBASE , 25 were not indexed for adverse effects in either data base . Twenty-six trials were indexed in one data base but not the other . Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper . Simultaneous use of textword and indexing terms retrieved only 82/107 ( 77 % ) papers . Conclusions Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects We sought to identify differences in the description of adverse drug experiences in reports of r and omized clinical trials ( RCTs ) from the United States and Japan , using diclofenac and simvastatin as test drugs . Reports were identified in Medline ( Index Medicus 1966 - 1990 ) , EMBASE ( Excerpta Medica 1974 - 1990 ) , JAPICDOC ( 1979 - 1990 ) , and JOIS-III ( JMEDICINE 1980 - 1990 ) . In each search keywords describing study design were paired with the drugs ' generic names , chemical names , and development numbers . Twenty-seven U.S. reports ( 18 for diclofenac and 9 for simvastatin ) and 22 Japanese reports ( 17 for diclofenac and 5 for simvastatin ) identified in these four data bases were selected for review . For each paper we identified the relation of the article to the data ( preliminary , primary , and secondary reports , review s ) , the means of identifying adverse reactions , the principal outcomes of the trials , and a variety of descriptive measures relating to study design , authors hip , and elements of presentation . With few exceptions , Japanese reports were not indexed in English- language data bases , and studies from the United States were not carried out in the Japanese data bases . The Japanese literature consisted exclusively of primary reports of clinical trials , whereas the U.S. literature was dominated by review articles and secondary reports of data from trials not fully published elsewhere . Japanese reports contained more detail on adverse experiences but reported principally those attributed to the drugs by attending clinicians . U.S. reports by contrast offered little detail but tended to include all adverse experiences , whether or not clinical ly attributed to drugs . A preponderance of U.S. articles reported significant differences between drugs in safety or treatment efficacy , whereas only one third of the Japanese articles did so for the same agents . Reports from both countries offered few details of the methods used to gather information on adverse drug experiences , and as a result the reported absolute frequencies of such events are difficult to compare between trials or to generalize to other setting s. In conclusion , the reporting of adverse reactions in clinical trials is inadequate in both the United States and Japanese literature . The shortcomings are complementary in that reports of U.S. trials contain insufficient detail and Japanese reports do not interpret or synthesize experience . Clinical research into drug safety in both countries could be improved through the adoption of simple st and ards of clarity and consistency in the monitoring and reporting of drug adverse effects BACKGROUND Reports of clinical trials usually emphasize efficacy results , especially when results are statistically significant . Poor safety reporting can lead to misinterpretation and inadequate conclusions about the interventions assessed . Our aim was to describe the reporting of harm-related results from r and omized controlled trials ( RCTs ) . METHODS We search ed the MEDLINE data base for reports of RCTs published from January 1 , 2006 , through January 1 , 2007 , in 6 general medical journals with a high impact factor . Data were extracted by use of a st and ardized form to appraise the presentation of safety results in text and tables . RESULTS Adverse events were mentioned in 88.7 % of the 133 reports . No information on severe adverse events and withdrawal of patients owing to an adverse event was given in 27.1 % and 47.4 % of articles , respectively . Restrictions in the reporting of harm-related data were noted in 43 articles ( 32.3 % ) with a description of the most common adverse events only ( n = 17 ) , severe adverse events only ( n = 16 ) , statistically significant events only ( n = 5 ) , and a combination of restrictions ( n = 5 ) . The population considered for safety analysis was clearly reported in 65.6 % of articles . CONCLUSION Our review reveals important heterogeneity and variability in the reporting of harm-related results in publications of RCTs Objective : This r and omized double‐blind multicenter trial evaluated the effects of olanzapine vs. clozapine on subjective well‐being , quality of life ( QOL ) and clinical outcome Background : Despite much being written on the topic , there are few surveys investigating the prevalence of anticholinergic adverse effects of antipsychotic drugs . One study , however , used trial-derived data to calculate estimates . Objectives : To investigate the prevalence/incidence rates of anticholinergic effects as viewed from within relevant r and omized trials . Methods : Data were extracted from each relevant study included in Cochrane review s. Data were checked , extracted , and simple frequencies , and 95 % confidence intervals ( CIs ) were calculated . Results : Many trials in relevant review s reported no data on anticholinergic effects ( estimate 40,000 participants ) . However , data were extracted from 177 studies within 54 review s ( N = 27,328 participants ) . Most data are short-term ( < 12 weeks ) . For blurred vision , the newer generations of drugs have rates of between 10 % and 20 % ( eg , risperidone , n = 1460 , 6 r and omized controlled trials [ RCTs ] , 11.9 % prevalence ; CI , 10 - 14 ; olanzapine , n = 1584 ; 4 RCTs , 12.2 % prevalence ; CI , 11 - 14 ) . These estimates are similar to those of sulpiride ( n = 186 ; 2 RCTs , 12.4 % ; CI , 8 - 18 ) and chlorpromazine ( n = 294 ; 10 RCTs , 11.2 % ; CI , 8 - 15 ) , less than trifluoperazine ( n = 167 ; 8 RCTs , 31.1 % ; CI , 25 - 39 ) , but considerably more than perphenazine ( n = 410 ; 8 RCTs , 3.7 % ; CI , 2 - 6 ) . Data are presented on a range of anticholinergic effects across different periods . Conclusions : Anticholinergic symptoms are common adverse effects associated with the use of all antipsychotic drugs , and newer-generation drugs are not clearly distinguishable from many older compounds . Adverse effect data should be more accessible Recent research indicates that subjective well-being is a major determinant of medication compliance in schizophrenia . However , it is yet unresolved whether atypical neuroleptics differ regarding subjective side-effects . A self-report instrument has been constructed to evaluate ' subjective well-being under neuroleptics ' ( SWN ) . The primary aims of the present study were to develop a short form of the SWN and to investigate the extent to which the atypical antipsychotic improves the patient 's subjective well-being . The short form of the SWN was constructed following an item analysis based on data from 212 schizophrenic patients medicated with either typical or atypical antipsychotics . The short form of the SWN showed sufficient internal consistency and good construct validity . The SWN was only moderately correlated with positive and negative syndrome scale ( PANSS ) scores or changes in psychopathology ( r=-0.20 to -0.37 ) . SWN-ratings in patients receiving olanzapine were superior compared to those of patients medicated with either clozapine or risperidone on three of five domains of well-being . Clozapine reduced global psychiatric symptoms significantly more than risperidone . It is concluded that the assessment of subjective well-being under antipsychotic treatment provides an independent outcome measure which is relevant to compliance This study examined the relationship of the therapeutic alliance to the treatment course and outcome of 143 patients with nonchronic schizophrenia . Results showed that patients who formed good alliances with their therapists within the first 6 months of treatment were significantly more likely
Output:
| RESULTS Neurological , metabolic , and sedation-related cognitive effects were reported more systematic ally than affective , anticholinergic , autonomic , cutaneous , hormonal , miscellaneous , and nonsedative cognitive effects .
The global impact of AEs on patient well-being was poorly assessed . |
MS211093 | ***TASK*** the task is to summarize an input biomedical literature in 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 Single-incision surgery has gained in popularity , and the recent development of specialized robotic and laparoscopic instruments may remove some of the ergonomic and technical difficulties associated with this approach . However , questions of cost and efficiency remain . METHODS We prospect ively collected perioperative outcome and efficiency ( operative time , case volume ) data for our single-site robotic cholecystectomy cases and retrospectively review ed data for our single-incision laparoscopic cholecystectomy cases . RESULTS There were no differences in patient characteristics or perioperative outcomes between the robotic ( n = 20 ) and laparoscopic ( n = 10 ) groups ; operative times were equivalent ( 84.6 vs 85.5 min ; p = 0.8737 ) and blood loss and complications were minimal . There was a higher robotic case volume , with an average of two robotic cases ( range 1 - 4)/day vs one/day for laparoscopic cases ( range 1 - 1 ; p = 0.0306 ) . Streamlined instrument costs were essentially equivalent . CONCLUSIONS Robotic single-site cholecystectomy is a safe , cost-effective alternative to single-incision laparoscopic cholecystectomy in a robot-existing model Background and aims Laparoscopic surgery has become the treatment of choice for cholecystectomy . Many studies showed that while this approach benefits the patient , the surgeon faces such distinct disadvantages as a poor ergonomic situation and limited degrees of freedom with limited motion as a consequence . Robots have the potential to overcome these problems . To evaluate the efficiency and feasibility of robotically assisted surgery ( RAC ) , we design ed a prospect i ve study to compare it with st and ard laparoscopic cholecystectomy ( SLC ) . Material s and methods Between 2001 and 2003 , 26 patients underwent SLC and 20 patients underwent RAC using the ZEUS system . The feasibility , safety , and possible advantages were evaluated . To assess the efficacy , the total time in the operating room was divided into preoperative , operative , and postoperative time frames . Results For RAC in comparison with SLC , the preoperative phase including equipment setup was significantly longer . In the intraoperative phase , the cut-closure time and camera and trocar insertion times were significantly longer . It is interesting to note that the net dissection time for the cystic artery , duct , and the gall bladder was not different from SLC . Conclusions The study demonstrates the feasibility of robotically assisted cholecystectomy without system-specific morbidity . There is time loss in several phases of robotic surgery due to equipment setup and deinstallation and therefore , presents no benefit in using the robot in laparoscopic cholecystectomy Abstract Background Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique . Prior trials have demonstrated improved cosmesis with the single-incision technique . Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach . This is the first prospect i ve , r and omized , controlled study comparing robotic single-site cholecystectomy ( RSSC ) and multiport laparoscopic cholecystectomy ( MPLC ) in terms of cosmesis and patient satisfaction . Methods Patients with symptomatic benign gallbladder disease were r and omized to RSSC or MPLC . Data included perioperative variables such as operative time , conversion and complications and cosmesis satisfaction , body image perception , quality of life using vali date d question naires , at postoperative visits of 2 , 6 weeks and 3 months . Results One hundred thirty-six patients were r and omized to RSSC ( N = 83 ) and MPLC ( N = 53 ) at 8 institutions . Both cohorts were dominated by higher enrollment of females ( RSSC = 78 % , MPLC = 92 % ) . The RSSC and MPLC cohorts were otherwise statistically matched . Operative time was longer for RSSC ( 61 min vs. 44 min , P < 0.0001 ) . There were no differences in complication rates . RSSC demonstrated a significant superiority in cosmesis satisfaction and body image perception ( P value < 0.05 at every follow-up ) . There was no statistically significant difference in patient-reported quality of life . Multivariate analysis of female patients demonstrated significantly higher preference for RSSC over MPLC in cosmesis satisfaction and body image perception with no difference seen in overall quality of life . Conclusions Results from this trial show that RSSC is associated with improved cosmesis satisfaction and body image perception without a difference in observed complication rate . The uncompromised safety and the improved cosmesis satisfaction and body image perception provided by RSSC for female patients support consideration of the robotic single-site approach . Clinical Trials.gov identifier NCT01932216 Background The aim of this study was to examine the advantages and risks of the Automated Endoscopic System for Optical Positioning ( AESOP ) 3000 robot system during uncomplicated laparoscopic cholecystectomies or laparoscopic hernioplasty . Methods In a r and omized study , we examined two groups of 120 patients each with the diagnosis cholecystolithiasis respectively the unilateral inguinal hernia . We worked with the AESOP 3000 , a robotic arm system that is voice-controlled by the surgeon . The subjective and objective comfort of the surgeon as well as the course and length of the operation were measured . Results The robot-assisted operations required significantly longer preparation and operation times . With regard to the necessary comm and s and manual camera corrections , the assistant group was favored . The same was true for the subjective evaluation of the surgical course by the surgeon . Conclusions Our study showed that the use of AESOP during laparoscopic cholecystectomy and hernioplasty is possible in 94 % of all cases . The surgeon must accept a definite loss of comfort as well as a certain loss of time against the advantage of saving on personnel Abstract Background R and omized studies could not demonstrate significant outcome benefit after single-incision laparoscopic cholecystectomy compared to classic four-port laparoscopic cholecystectomy ( CLC ) . The new robotic single-site platform might offer potential benefits on local inflammation and postoperative pain due to its technological advantages . This prospect i ve r and omized double-blind trial compared the short-term outcomes between single-incision robotic cholecystectomy ( SIRC ) and CLC . Methods Two groups of 30 eligible patients were r and omized for SIRC or CLC . During the first postoperative week , patients and study monitors were blinded to the type of procedure performed by four dressing tapes applied on the abdomen . Pain was assessed at 6 h and on day 1 , 7 and 30 after surgery , along with a 1–10 cosmetic score . Results No significant difference in postoperative pain occurred in the two groups at any time point nor for any of the abdominal sites . Nineteen ( 63 % ) SIRC patients reported early postoperative pain in extra-umbilical sites . Intraoperative complications which might influence postoperative pain , such as minor bleeding and bile spillage , were similar in both groups and no conversions occurred . The cosmetic score 1 month postoperatively was higher for SIRC ( p < 0.001 ) . Two SIRC patients had wound infection , one of which developed an incisional hernia . Conclusions SIRC does not offer any significant reduction of postoperative pain compared to CLC . SIRC patients unaware of their type of operation still report pain in extra-umbilical sites like after CLC . The cosmetic advantage of SIRC should be balanced against an increased risk of incisional hernias and higher costs . Trial registration numberACTRN12614000119695 ( http://www.anzctr.org.au ) 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 : Laparoscopic surgery might be beneficial for the patient , but it imposes increased physical and mental strain on the surgeon . Robot-assisted laparoscopic surgery addresses some of the laparoscopic drawbacks and may potentially reduce mental strain . This could reduce the risk of surgeon 's fatigue , mishaps and strain-induced illnesses , which may eventually improve the safety of laparoscopic surgical procedures . Methods : To test this hypothesis , a r and omized study was performed , comparing both heart rate and heart rate variability ( HRV ) of the surgeon as a measure of total and mental strain , respectively , during conventional and robot-assisted laparoscopic cholecystectomy . Results : Both heart rate and HRV ( the low-frequency b and /high-frequency b and ratio ) were significantly decreased when using robotic assistance . Conclusions : These data suggest the use of the daVinci ® Surgical System leads to less physical and mental strain of the surgeon during surgery . However , assessing mental strain by means of HRV is cumbersome since there is no clear cutoff point or scale for maximum tolerated strain levels and its related effects on surgeon 's health Background Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site ™ platform for cholecystectomy is safe , feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy . Moreover , the robot-assisted technology has been shown to reduce the surgeon ’s stress load compared to st and ard single-incision laparoscopy in an experimental setup , suggesting an important advantage of the da Vinci platform . However , the above-mentioned observations are based solely on case series , case reports and experimental data , as high- quality clinical trials to demonstrate the benefits of the da Vinci Single-Site ™ cholecystectomy have not been performed to date . Methods This study addresses the question whether robot-assisted Single-Site ™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon ’s stress load , while matching the st and ards of the conventional single-incision approach with regard to peri- and postoperative outcomes . It is design ed as a single centre , single-blinded r and omized controlled trial , which compares both surgical approaches with the primary endpoint surgeon ’s physical and mental stress load at the time of surgery . In addition , the study aims to assess secondary endpoints such as operating time , conversion rates , additional trocar placement , intra-operative blood loss , length of hospital stay , costs of procedure , health-related quality of life , cosmesis and complications . Patients as well as ward staff are blinded until the 1st postoperative year . Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon ’s comfort of 0.8 ( power of 0.8 , alpha-error level of 0.05 , error margin of 10–15 % ) result ed in a number of 30 r and omized patients per arm . Discussion The study is the first r and omized controlled trial that compares the da Vinci Single Site ™ platform to conventional laparoscopic approaches in cholecystectomy , one of the most frequently performed operations in general surgery . Trial registration This trial is registered at clinical trials.gov ( trial number : NCT02485392 ) . Registered February 19 , 2015 Objective : To compare safety and costs of robotic-assisted and laparoscopic cholecystectomy in patients with symptomatic cholecystolithiasis . Background : Technical benefits of robotic-assisted surgery are well documented . However , pressure is currently applied to decrease costs , leading to restriction of development , and implementation of new technologies . So far , no convincing data are available comparing outcome or costs between computer assisted and conventional laparoscopic cholecystectomy . Methods : A prospect i ve case-matched study was conducted on 50 consecutive patients , who underwent robotic-assisted cholecystectomy ( Da Vinci Robot , Intuitive Surgical ) between December 2004 and February 2006 . These patients were matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy , according to age , gender , American Society of Anesthesiologists score , histology , and surgical experience . Endpoints were complications after surgery ( mean follow-up of 12.3 months [ SD 1.2 ] ) , conversion rates , operative time , and hospital costs ( Clinical Trial.gov ID : NCT00562900 ) . Results : No minor , but 1 major complication occurred in each group ( 2 % ) . No conversion to open surgery was needed in either group . Operation time ( skin-to-skin , 55 minutes vs. 50 minutes , P < 0.85 ) and hospital stay ( 2.6 days vs. 2.8 days ) were similar . Overall hospital costs were significantly higher for robotic-assisted cholecystectomy $ 7985.4 ( SD 1760.9 ) versus $ 6255.3 ( SD 1956.4 ) , P < 0.001 , with a raw difference of $ 1730.1(95 % CI 991.4–2468.7 ) and a difference adjusted for confounders of $ 1606.4 ( 95 % CI 1076.7–2136.2 ) . This difference was mainly related to the amortization and consumables of the robotic system . Conclusions : Robotic-assisted cholecystectomy is safe and , therefore , a valuable approach . Costs of robots , however , are high and do not justify the use of this technology considering the lack of benefits for patients . A reduction of acquisition and maintenance costs for the robotic system is a prerequisite for large-scale adoption and implementation Abstract Background Surgeons continually strive to improve technology and
Output:
| Conclusions The RAC was not found to be more effective or safer than LC for benign gallbladder diseases , which indicated that RAC is a developing procedure instead of replacing LC at once .
Given the higher costs , the current evidence is in favor of LC in cholecystectomy |
MS211094 | ***TASK*** the task is to summarize an input biomedical literature in 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 — Intracranial hemorrhage is the most devastating complication of anticoagulation . Outcomes associated with different sites of intracranial bleeding occurring with warfarin versus dabigatran have not been defined . Methods — Analysis of 18 113 participants with atrial fibrillation in the R and omized Evaluation of Long-term anticoagulant therapY ( RE-LY ) trial assigned to adjusted-dose warfarin ( target international normalized ratio , 2–3 ) or dabigatran ( 150 mg or 110 mg , both twice daily ) . Results — During a mean of 2.0 years of follow-up , 154 intracranial hemorrhages occurred in 153 participants : 46 % intracerebral ( 49 % mortality ) , 45 % subdural ( 24 % mortality ) , and 8 % subarachnoid ( 31 % mortality ) . The rates of intracranial hemorrhage were 0.76 % , 0.31 % , and 0.23 % per year among those assigned to warfarin , dabigatran 150 mg , and dabigatran 110 mg , respectively ( P<0.001 for either dabigatran dose versus warfarin ) . Fewer fatal intracranial hemorrhages occurred among those assigned dabigatran 150 mg and 110 mg ( n=13 and n=11 , respectively ) versus warfarin ( n=32 ; P<0.01 for both ) . Fewer traumatic intracranial hemorrhages occurred among those assigned to dabigatran ( 11 patients with each dose ) compared with warfarin ( 24 patients ; P<0.05 for both dabigatran doses versus warfarin ) . Independent predictors of intracranial hemorrhage were assignment to warfarin ( relative risk , 2.9 ; P<0.001 ) , aspirin use ( relative risk , 1.6 ; P=0.01 ) , age ( relative risk , 1.1 per year ; P<0.001 ) , and previous stroke/transient ischemic attack ( relative risk , 1.8 ; P=0.001 ) . Conclusions — The clinical spectrum of intracranial hemorrhage was similar for patients given warfarin and dabigatran . Absolute rates at all sites and both fatal and traumatic intracranial hemorrhages were lower with dabigatran than with warfarin . Concomitant aspirin use was the most important modifiable independent risk factor for intracranial hemorrhage Background and Purpose — Patients with atrial fibrillation and previous ischemic stroke (IS)/transient ischemic attack ( TIA ) are at high risk of recurrent cerebrovascular events despite anticoagulation . In this prespecified subgroup analysis , we compared warfarin with edoxaban in patients with versus without previous IS/TIA . Methods — ENGAGE AF-TIMI 48 ( Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infa rct ion 48 ) was a double-blind trial of 21 105 patients with atrial fibrillation r and omized to warfarin ( international normalized ratio , 2.0–3.0 ; median time-in-therapeutic range , 68.4 % ) versus once-daily edoxaban ( higher-dose edoxaban regimen [ HDER ] , 60/30 mg ; lower-dose edoxaban regimen , 30/15 mg ) with 2.8-year median follow-up . Primary end points included all stroke/systemic embolic events ( efficacy ) and major bleeding ( safety ) . Because only HDER is approved , we focused on the comparison of HDER versus warfarin . Results — Of 5973 ( 28.3 % ) patients with previous IS/TIA , 67 % had CHADS2 ( congestive heart failure , hypertension , age , diabetes , prior stroke/transient ischemic attack ) > 3 and 36 % were ≥75 years . Compared with 15 132 without previous IS/TIA , patients with previous IS/TIA were at higher risk of both thromboembolism and bleeding ( stroke/systemic embolic events 2.83 % versus 1.42 % per year ; P<0.001 ; major bleeding 3.03 % versus 2.64 % per year ; P<0.001 ; intracranial hemorrhage , 0.70 % versus 0.40 % per year ; P<0.001 ) . Among patients with previous IS/TIA , annualized intracranial hemorrhage rates were lower with HDER than with warfarin ( 0.62 % versus 1.09 % ; absolute risk difference , 47 [ 8–85 ] per 10 000 patient-years ; hazard ratio , 0.57 ; 95 % confidence interval , 0.36–0.92 ; P=0.02 ) . No treatment subgroup interactions were found for primary efficacy ( P=0.86 ) or for intracranial hemorrhage ( P=0.28 ) . Conclusions — Patients with atrial fibrillation with previous IS/TIA are at high risk of recurrent thromboembolism and bleeding . HDER is at least as effective and is safer than warfarin , regardless of the presence or the absence of previous IS or TIA . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00781391 BACKGROUND Specific reversal agents for non-vitamin K antagonist oral anticoagulants are lacking . Idarucizumab , an antibody fragment , was developed to reverse the anticoagulant effects of dabigatran . METHODS We undertook this prospect i ve cohort study to determine the safety of 5 g of intravenous idarucizumab and its capacity to reverse the anticoagulant effects of dabigatran in patients who had serious bleeding ( group A ) or required an urgent procedure ( group B ) . The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab , on the basis of the determination at a central laboratory of the dilute thrombin time or ecarin clotting time . A key secondary end point was the restoration of hemostasis . RESULTS This interim analysis included 90 patients who received idarucizumab ( 51 patients in group A and 39 in group B ) . Among 68 patients with an elevated dilute thrombin time and 81 with an elevated ecarin clotting time at baseline , the median maximum percentage reversal was 100 % ( 95 % confidence interval , 100 to 100 ) . Idarucizumab normalized the test results in 88 to 98 % of the patients , an effect that was evident within minutes . Concentrations of unbound dabigatran remained below 20 ng per milliliter at 24 hours in 79 % of the patients . Among 35 patients in group A who could be assessed , hemostasis , as determined by local investigators , was restored at a median of 11.4 hours . Among 36 patients in group B who underwent a procedure , normal intraoperative hemostasis was reported in 33 , and mildly or moderately abnormal hemostasis was reported in 2 patients and 1 patient , respectively . One thrombotic event occurred within 72 hours after idarucizumab administration in a patient in whom anticoagulants had not been reinitiated . CONCLUSIONS Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes . ( Funded by Boehringer Ingelheim ; RE-VERSE AD Clinical Trials.gov number , NCT02104947 . ) Background Idarucizumab , a monoclonal antibody fragment , was developed to reverse the anticoagulant effect of dabigatran . Methods We performed a multicenter , prospect i ve , open‐label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding ( group A ) or were about to undergo an urgent procedure ( group B ) . The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab , on the basis of the diluted thrombin time or ecarin clotting time . Secondary end points included the restoration of hemostasis and safety measures . Results A total of 503 patients were enrolled : 301 in group A , and 202 in group B. The median maximum percentage reversal of dabigatran was 100 % ( 95 % confidence interval , 100 to 100 ) , on the basis of either the diluted thrombin time or the ecarin clotting time . In group A , 137 patients ( 45.5 % ) presented with gastrointestinal bleeding and 98 ( 32.6 % ) presented with intracranial hemorrhage ; among the patients who could be assessed , the median time to the cessation of bleeding was 2.5 hours . In group B , the median time to the initiation of the intended procedure was 1.6 hours ; periprocedural hemostasis was assessed as normal in 93.4 % of the patients , mildly abnormal in 5.1 % , and moderately abnormal in 1.5 % . At 90 days , thrombotic events had occurred in 6.3 % of the patients in group A and in 7.4 % in group B , and the mortality rate was 18.8 % and 18.9 % , respectively . There were no serious adverse safety signals . Conclusions In emergency situations , idarucizumab rapidly , durably , and safely reversed the anticoagulant effect of dabigatran . ( Funded by Boehringer Ingelheim ; RE‐VERSE AD Clinical Trials.gov number , NCT02104947 .
Output:
| CONCLUSIONS Non-vitamin K oral anticoagulants halve the risk of fatal ICH in patients with non-valvular atrial fibrillation compared with VKAs , whereas indirect comparisons indicate that NOAC-specific reversal agents may be associated with a lower case fatality rate in NOAC-related ICH |
MS211095 | ***TASK*** the task is to summarize an input biomedical literature in 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: Cumulative exposure to socioeconomic disadvantage across the life course may be inversely associated with coronary heart disease ( CHD ) ; the mechanisms are not fully clear . An objective of this study was to determine whether cumulative life-course socioeconomic position ( SEP ) is associated with CHD incidence in a well-characterized US cohort that had directly assessed childhood and adulthood measures of SEP and prospect ively measured CHD incidence . Furthermore , analyses aim ed to evaluate whether adjustment for CHD risk factors reduces the association between cumulative life-course SEP and CHD . The authors examined 1,835 subjects who participated in the Framingham Heart Study Offspring Cohort from 1971 through 2003 ( mean age , 35.0 years ; 52.4 % women ) . Childhood SEP was measured as father 's education ; adulthood SEP was assessed as own education and occupation . CHD incidence included myocardial infa rct ion , coronary insufficiency , and coronary death . Cox proportional hazards analyses indicated that cumulative SEP was associated with incident CHD after adjustment for age and sex ( hazard ratio = 1.82 , 95 % confidence interval : 1.17 , 2.85 for low vs. high cumulative SEP score ) . Adjustment for CHD risk factors reduced that magnitude of association ( hazard ratio = 1.29 , 95 % confidence interval : 0.78 , 2.13 ) . These findings underscore the potential importance of CHD prevention and treatment efforts for those whose background s include low SEP throughout life Background : The optimal length of bed rest after femoral coronary angiography is still unknown . Short immobilisation could cause puncture site complications due to the modern antiplatelet therapy used , while long immobilisation time increases the risk of back pain for the patient . Purpose : To assess the safety , as well as perceived comfort , of early mobilisation after coronary angiography with femoral approach . Methods : A r and omised , single centre pilot trial with 104 coronary angiography patients ( including 58 patients with non ST-elevation acute coronary syndrome ) assigned to a post-procedural bed rest time for either 1.5 or 5 h. The primary endpoint was any incidence of vascular complication . Patients ' discomfort was measured as self-perceived grade of pain in the back . Results : The presence of haematomas ≥ 5 cm was 5.8 % in the short immobilisation group vs. 3.8 % in the control group ( ns ) . There was a significantly lower rate of perceived back pain in the short immobilisation group , compared to the controls , at the time of mobilisation , which remained significant also after 2 h of mobilisation . Conclusion : Early ambulation after coronary angiography is safe , without affecting the incidence of vascular complications , and decreases the patients ' pain , both during and after the bed rest Background : Vascular access complications may be a cause of discomfort , prolonged hospital stay , and impaired outcomes in patients undergoing cardiac catheterisation . Aims : To assess vascular access complication in our patients with/without the use of closure devices as a first local benchmark for subsequent quality improvement . Methods : A nurse-led single-centre prospect i ve survey of all vascular access complications in consecutive patients su bmi tted to cardiac catheterisation during 4 months . Results : The radial and femoral access were used in 78 ( 14 % ) and 470 ( 83 % ) , respectively , of 564 procedures , and a closure device was used in 136 of the latter . A haemathoma ( any size ) was isolated and uneventful in 9.6 % of cases . More severe complications ( haemoglobin loss > 2 g , need for blood transfusion or vascular repair ) occurred in 1.2 % of cases , namely : in none of the procedures with radial access , and in 0.4 % and 2.4 % of femoral diagnostic and interventional coronary procedures , respectively . During complicated ( n = 40 ) vs uncomplicated ( n = 172 ) transfemoral interventions , the activated coagulation time was 309 ± 83 vs 271 ± 71 s ( p = 0.004 ) , but the use of closure devices was similar . Conclusion : Severe vascular access complications in our patients were fewer than in most reports , and virtually absent in radial procedures . Vigorous anticoagulation was associated with increased complications in our patients , but closure devices were not . A new policy including both the use of the radial access whenever possible , and a less aggressive anticoagulation regimen during transfemoral interventions will be tested 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 examine the effects of ambulation at 3 versus 6 hours on delayed bleeding , pain , and anxiety in patients after cardiac angiogram . DESIGN Experimental , pretest posttest , r and om assignment . SETTING Western Canadian University-affiliated tertiary care hospital . PATIENTS Thirty-nine patients who underwent cardiac angiograms . OUTCOME MEASURES Delayed bleeding , pain , and anxiety . INTERVENTION The experimental group ambulated at 3 hours after cardiac angiogram ; the control group ambulated at 6 hours . Delayed bleeding was evaluated by sanguinous drainage through a st and ard gauze pressure dressing and /or the presence of a palpable hematoma greater than 5 cm in width . Melzack 's Present Pain Intensity Scale and Spielberger 's State Anxiety Inventory were used to evaluate patient comfort at 2 , 4 , and 7 hours after angiogram and the next day . RESULTS None of the patients experienced any delayed bleeding . Student 's t test was used to compare pain levels and anxiety scores . In addition , repeated measures analysis of variance was applied to pain scores taken at 4 hours , 7 hours , and the next day . The 2-hour observation data were used as a covariate and a basis for comparison of pain at the next three observations . Patients ambulating early had significantly less pain overall ( p < 0.005 ) and less back pain at 4 and 7 hours after angiogram ( p < 0.05 ) . There was no significant difference in the mean anxiety scores . CONCLUSION The significant decrease in back pain of patients who ambulated earlier demonstrates the need to consider patient comfort as well as the potential risks and sequelae of delayed bleeding INTRODUCTION After coronary angiography to prevent potential complications , patients are restricted to 4 - 24 hours bed rest in the supine position due to the complications . This study was design ed to assess the effect of changing position and early ambulation on low back pain , urinary retention , bleeding and hematoma after cardiac catheterization . METHODS In this clinical trial , 140 patients by using a convenience sampling r and omly divided into four 35-individual groups . The patients in the control group were in the supine position for 6 hours without a movement . Change position was applied to the second group ( based on a specific protocol ) , early ambulation was applied to the third group and both early ambulation and change position were applied to the fourth group . Then , severity of bleeding , hematoma , back pain and urinary retention were measured at zero , 1 , 2 , 4 , 6 , and 24 hours after angiography . The data was collected through an individual data question naire , Numerical Rating Scale ( NRS ) of pain and Kristin Swain 's check list was applied to evaluate the severity of bleeding and hematoma . RESULTS None of patients developed vascular complications . Incidence of urinary retention was higher in the control group , although this difference was not significant . The mean of pain intensity in the fourth and sixth hours showed a significant difference . CONCLUSION Based on the findings of this study , changing patients ' position can be safe and they can be ambulated early after angiography The general recommended strategy after arterial invasive procedures is a 4- to 6-hour bed rest that is associated with patient discomfort and increased medical costs . We hypothesized that mobilization of selected patients at the second hour would not increase vascular complications . Coronary angiography was performed through the femoral route via 6-Fr catheters . Homeostasis was achieved by manual compression and maintained with a compressive b and age . A total of 1446 patients were ambulated at the second hour and 1226 of them were discharged without complication . A total of 220 patients required further follow-up due to blood oozing ; 154 patients were conventionally ambulated due to difficult arterial access , longer ( > 15 minutes ) compression time , hematoma formation within 2 hours , or hypertensive state ( blood pressure > 180/100 mm Hg ) . Twenty-five ( 16 % ) of those patients developed minor bleeding after ambulation . No major bleeding or large hematoma was observed during in-hospital observation . Ecchymosis ( 10 % [ 2-hour group ] vs 21 % [ 4—5 hour group ] ) and small hematomas ( 22 % vs 9 % ) were the most frequent complications after discharge . Early mobilization of selected patients undergoing diagnostic heart catheterization through the femoral artery via 6-Fr catheters is safe and associated with acceptable bleeding complication rates AIM This paper is a report of a study to investigate the effect of three positioning protocol s on back pain , heart rate , blood pressure and vascular complications after cardiac catheterization . BACKGROUND After cardiac catheterization , bed rest is prescribed in order to minimize vascular complications , but this often leads to back pain and other complications , such as hemodynamic instability . METHODS A three-group quasi-experimental design was used in this study , which was conducted in 2006 . A convenience sample of 105 patients was r and omly assigned to either the control or the two experimental groups ( A and B ) . The control group received routine care . Group B was treated only with modified positioning and group A with modified positioning and a pillow under their body . Back pain , heart rate , arterial blood pressure , haematoma formation and bleeding were measured at regular time intervals . FINDINGS The control group experienced higher levels of pain after 3 , 6 , 8 hours and the morning after catheterization . The level of pain in group B was also higher than in group A at 3 hours after the procedure . Mean heart rate and blood pressure were lower in the experimental groups compared with the control group at 6 and 8 hours after catheterization . No statistically significant difference between the three groups regarding the amounts of overall bleeding and overall haematoma formation was observed . CONCLUSION Changing position in bed and using a supportive pillow during the early hours after cardiac catheterization can effectively minimize pain and hemodynamic instability without increasing vascular complications BACKGROUND Small trials have suggested that radial access for percutaneous coronary intervention ( PCI ) reduces vascular complications and bleeding compared with femoral access . We aim ed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes ( ACS ) who were undergoing coronary angiography with possible intervention . METHODS The RadIal Vs femorAL access for coronary intervention ( RIVAL ) trial was a r and omised , parallel group , multicentre trial . Patients with ACS were r and omly assigned ( 1:1 ) by a 24 h computerised central automated voice response system to radial or femoral artery access . The primary outcome was a composite of death , myocardial infa rct ion , stroke , or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days . Key secondary outcomes were death , myocardial infa rct ion , or stroke ; and non-CABG-related major bleeding at 30 days . A masked central committee adjudicated the primary outcome , components of the primary outcome , and stent thrombosis . All other outcomes were as reported by the investigators . Patients and investigators were not masked to treatment allocation . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov
Output:
| The findings of these studies suggest that early ambulation and modified positioning were effective to reduce back pain in patients undergoing coronary angiography .
The use of early ambulation 2 - 4 hours after angiography and changing the patients ' position along with modified positioning cause a reduction in the back pain of the patients |
MS211096 | ***TASK*** the task is to summarize an input biomedical literature in 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 This study aim ed to compare the effect of single-visit full-mouth mechanical debridement ( FMD ) and quadrant-wise mechanical debridement ( QMD ) on the levels of serum interleukin (IL)-6 , C-reactive protein ( CRP ) and soluble thrombomodulin . MATERIAL AND METHODS Thirty-six subjects with chronic periodontitis were r and omly allocated to three groups : undergoing QMD , single-visit FMD with povidone iodine or with water . Serum IL-6 and soluble thrombomodulin were measured by enzyme-linked immunosorbent assay , and serum CRP was measured by the latex-enhanced nephelometric method . RESULTS Serum IL-6 level increased significantly immediately after debridement in all the three groups , with this increase being greatest in the full-mouth groups . However , the increase in the full-mouth groups was not significantly higher than that of quadrant-wise group . In the quadrant-wise group , serum IL-6 level decreased significantly 1 month after debridement compared with baseline . Serum-soluble thrombomodulin decreased significantly in the full-mouth groups but not in the quadrant-wise group . Changes in CRP level were not significant at baseline or after debridement in all the three groups . CONCLUSIONS FMD increased serum IL-6 and reduced serum-soluble thrombomodulin to a greater extent than QMD , suggesting that the former technique has stronger transient effects on systemic vascular endothelial functions than the latter A classical treatment for chronic adult periodontitis consists of four to six consecutive sessions of scaling and root planing at a 1- to 2-week interval . Such a so-called " quadrant or sextant therapy " might result in a reinfection of a previously disinfected area by bacteria from an untreated region . The purpose of this study was to investigate , over an 8-month period , the clinical benefits of full-mouth disinfection within a 24-hour period in the control of chronic periodontitis . Ten adult patients with advanced chronic periodontitis were r and omly assigned to a test and a control group . The control group received the st and ard scheme of initial periodontal therapy , consisting of scaling and root planing of the four quadrants was performed within 24 hours and immediately followed by a thorough supra- and subgingival chlorhexidine application to limit any transfer of bacteria . The latter involved tongue brushing with a 1 % chlorhexidine gel for 60 seconds , mouthrinsing with a 0.2 % chlorhexidine solution twice for 60 seconds , repeated subgingival irrigation of all pockets with a 1 % chlorhexidine gel ( 3 times within 10 minutes ) , and mouthrinsing twice daily with a 0.2 % chlorhexidine solution during 2 weeks . In addition , both groups received thorough oral hygiene instructions . The plaque index , gingival index , probing depth , gingival recession , and bleeding on probing were recorded prior to professional cleaning and at 1 , 2 , 4 , and 8 months afterwards . Although the test group scored higher plaque indices than the control group , especially at months 2 and 4 , the gingival index and bleeding tendency showed similar improvements with time . However , when the gingival/plaque ratio was considered , the latter was lower in the test group at all follow-up visits . For pockets > or = 7 mm , full-mouth disinfection showed a significantly ( P = 0.01 ) higher reduction in probing depth at each follow-up visit with , at month 8 , a reduction of 4 mm ( from 8 mm to 4 mm ) , in comparison to 3 mm ( from 8 mm to 5 mm ) for the classical therapy . The increase in gingival recession in the full-mouth disinfection group remained below 0.7 mm , while in the control group it reached 1.9 mm after 8 months . This result ed in a gain of clinical attachment level of 3.7 mm for the test group versus 1.9 mm for the control group . A radiographical examination also indicated a superior improvement for the test group when compared to the control group . This pilot study suggests that a full-mouth disinfection in one day results in an improved clinical outcome in chronic periodontitis as compared to scalings per quadrant at 2-week intervals over several weeks A treatment for periodontal infections often consists of consecutive rootplanings ( per quadrant , at a 1- to 2-week interval ) , without a proper disinfection of the remaining intra-oral niches ( untreated pockets , tongue , saliva , mucosa and tonsils ) . Such an approach , could theoretically lead to a reinfection of previously-treated pockets . The present study aims to examine the effect of a full-mouth disinfection on the microbiota in the above-mentioned niches . Moreover , the clinical benefit of such an approach was investigated . 16 patients with severe periodontitis were r and omly allocated to a test and a control group . The patients from the control group were scaled and rootplaned , per quadrant , at 2-week intervals and obtained oral hygiene instructions . The patients from the test group received a full-mouth disinfection consisting of : scaling and rootplaning of all pockets in 2 visits within 24 h , in combination with tongue brushing with 1 % chlorhexidine gel for 1 min , mouth rinsing with a 0.2 % chlorhexidine solution for 2 min and subgingival irrigation of all pockets ( 3x in 10 min ) with 1 % chlorhexidine gel . Besides oral hygiene , the test group rinsed 2x daily with 0.2 % chlorhexidine and sprayed the tonsils with a 0.2 % chlorhexidine for 2 months . Plaque sample s ( pockets , tongue , mucosa and saliva ) were taken at baseline and after 2 and 4 months , and changes in probing depth , attachment level and bleeding on probing were reported . The full-mouth disinfection result ed in a statistically significant additional reduction/elimination of periodontopathogens , especially in the subgingival pockets , but also in the other niches . These microbiological improvements were reflected in a statistically-significant higher probing depth reduction and attachment gain in the test patients . These findings suggest that a disinfection of all intra-oral niches within a short time span leads to significant clinical and microbiological improvements for up to 4 months AIM To test recolonization of periodontal lesions after full-mouth scaling and root planing ( FM-SRP ) or multiple session-SRP ( MS-SRP ) in a r and omized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes . MATERIAL S AND METHODS Thirty-nine subjects were r and omly assigned to FM-SRP or MS-SRP groups . At baseline and after 3 months , probing pocket depth ( PPD ) , plaque index ( PlI ) and bleeding on probing ( BoP ) were recorded . At baseline , immediately after treatment , after 1 , 2 , 7 , 14 and 90 days , paper point sample s from a single site from the maxillary right quadrant were collected for microbiological analysis of five putative pathogens by polymerase chain reaction . RESULTS FM-SRP and MS-SRP result ed in significant reductions in PPD , BoP and PlI and the overall detection frequencies of the five species after 3 months without significant differences between treatments . Compared with MS-SRP , FM-SRP result ed in less recolonization of the five species , significantly for Treponema denticola , in the tested sites . CONCLUSION FM-SRP and MS-SRP result in overall clinical ly and microbiologically comparable outcomes where recolonization of periodontal lesions may be better prevented by FM-SRP OBJECTIVES The beneficial effects of the one-stage , full-mouth disinfection remain controversial in the scientific literature . This might be due to the fact that an entire mouth disinfection with the use of antiseptics has been confused with a full-mouth scaling and root planing . This parallel , single blind RCT study aim ed to compare several full-mouth treatment strategies with each other . MATERIAL AND METHODS Seventy-one patients with moderate periodontitis were r and omly allocated to one of the following treatment strategies : scaling and root planing , quadrant by quadrant , at two-week intervals ( negative control , NC ) , full-mouth scaling and root planing within 2 consecutive days ( FRP ) , or three one-stage , full-mouth disinfection ( FM ) protocol s within 2 consecutive days applying antiseptics to all intra-oral niches for periopathogens using as antiseptics : chlorhexidine ( FMCHX ) for 2 months , amine fluoride/stannous fluoride for 2 months ( FMF ) , or chlorhexidine for 2 months followed by amine fluoride/stannous fluoride for another 6 months ( FMCHX+F ) . At baseline and after 2 , 4 , and 8 a series of periodontal parameters were recorded . RESULTS All treatment strategies result ed in significant ( p<0.05 ) improvements of all clinical parameters over the entire duration of the study . Inter-treatment differences were often encountered . The NC group nearly always showed significant smaller improvements than the two CHX groups . The differences between the FRP or FM groups , and the two CHX groups only sporadically reached a statistical significance . CONCLUSION These observations indicate that the benefits of the " OSFMD " protocol are partially due to the use of the antiseptics and partially to the completion of the therapy in a short time BACKGROUND / AIMS Recent studies reported significant additional clinical and microbiological improvements when severe adult periodontitis was treated by means of a " one-stage full-mouth " disinfection instead of a st and ard treatment strategy with consecutive root planings quadrant per quadrant . The one stage full-mouth disinfection procedure involves scaling and root planing of all pockets within 24 h in combination with an extensive application of chlorhexidine to all intra-oral niches such as periodontal pockets , tongue dorsum , tonsils ( chairside , and at home for 2 months ) . This study aims to examine the relative importance of the use of chlorhexidine in the one stage full-mouth disinfection protocol . METHODS Therefore , 3 groups of 12 patients each with advanced periodontitis were followed , both from a clinical and microbiological point of view , over a period of 8 months . The patients from the control group were scaled and root planed , quadrant per quadrant . at two-week intervals . The 2 other groups underwent a one stage full-mouth scaling and root planing ( all pockets within 24 h ) with ( Fdis ) or without ( FRp = full-mouth root planing ) the adjunctive use of chlorhexidine . At baseline and after 1 , 2 , 4 and 8 months , the following clinical parameters were recorded : plaque and gingivitis indices , probing depth , bleeding on probing and clinical attachment level . Microbiological sample s were taken from different intra-oral niches ( tongue , mucosa , saliva and pooled sample s from single- and multi-rooted teeth ) . The sample s were cultured on selective and non-selective media in order to evaluate the number of CFU/ml for the key-periodontopathogens . At baseline , an anonymous question naire was given to the patients to record the perception of each treatment ( post operative pain , fever , swelling etc . ) . RESULTS All 3 treatment strategies result ed in significant improvements for all clinical parameters , but the Fdis and FRp patients reacted always significantly more favourably than the control group , with an additional probing depth reduction of + /- 1.5 mm and an additional gain in attachment of + /- 2 mm ( for pockets > or = 7 mm ) . Also from a microbiological point of view both the FRp and Fdis patients showed additional improvements when compared to the control group , as well in the reduction of spirochetes and motile organisms as in the number of CFU/ml of the key-pathogens , especially when the subgingival plaque sample s were considered . The differences between FRp and Fdis patients were negligible . CONCLUSIONS These findings suggest that the benefits of a " one-stage full-mouth disinfection " in the treatment of patients suffering from severe adult periodontitis probably results from the full-mouth scaling and root planing within 24 h rather than the beneficial effect of chlorhexidine . The raise in body temperature the second day after the full-mouth scaling and root planing seems to indicate a Shwartzman reaction PURPOSE To explore the clinical effect of full-mouth scaling and root planning ( FM-SRP ) on chronic periodontitis with the comparison of quadrant scaling and root planning ( Q-SRP ) . METHODS 60 patients with chronic periodontitis were r and omly divided into 2 groups . The FM-SRP group received full-mouth scaling and root planning completed within the same day , while the Q-SRP group received quadrant scaling and root planning once a week for 4 weeks . Clinical parameters of plaque index ( PI ) , gingival index ( GI ) , bleeding on probing ( BOP ) , probing depth ( PD ) and attachment loss ( AL ) were collected at baseline , 3 and 6 months after treatment , as well as the postoperative reaction . The data were analyzed by rank sum test ( PI , GI ) , t test ( PD , AL ) and Chi square test ( BOP ) , respectively . RESULTS When compared with the baseline , both therapies result ed in significant improvements in all clinical parameters at the end of 3 and 6 months ( P<0.01 ) . However , there were no significant difference between the two groups at any time point ( P>0.05 ) . 24 hours after the first treatment , the percentage of patients with postoperative reactions were significantly higher in FM-SRP group than that in Q-SRP group ( P<0.05 ) , but the patients could tolerate these reactions . CONCLUSION Both FM-SRP and Q-SRP are efficacious in treating chronic periodontitis , and the clinician can select the proper treatment modality according to the dem and of clinical practice AIM To clinical ly , microbiologically and immunologically characterize periodontal debridement as a therapeutic approach for severe chronic periodontitis . MATERIAL AND
Output:
| The most important harm identified was an increased body temperature after FMS or FMD treatments .
From the twelve included trials there is no clear evidence that FMS or FMD provide additional benefit compared to conventional scaling and root planing . |
MS211097 | ***TASK*** the task is to summarize an input biomedical literature in 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: High fluid intake is the only preventive dietary measure that can be recommended to all patients with stones . However , the efficacy of dietary advice given to patients is unknown . We compared the impact of dietary advice to increase hydration ( group 1 , 57 patients ) and of no dietary advice ( group 2 , 83 patients ) on 24-hour urine volume . No significant difference was noted between groups 1 ( 1,624 ml . ) and 2 ( 1,732 ml . ) . We then determined if urine specific gravity dipsticks could help patients increase the 24-hour urine volume . A correlation between 24-hour urine volume and mean urine specific gravity was performed on 263 r and omly chosen patients . There was an inverse relationship between urine specific gravity and 24-hour urine volume with a correlation coefficient of 0.522 ( y = 1.0207 - 0.00374x ) . Most patients ( 81.6 % ) with 24-hour urine volumes of less than 2.1 had a urine specific gravity of more than 1.010 . The use of specific gravity dipsticks was evaluated as a tool to help 24 patients increase the 24-hour urine volume . The 24-hour urine volume increased significantly ( p less than 0.05 , paired Student 's t test ) in patients after feedback from specific gravity dipsticks when they were instructed to keep the urine specific gravity at or less than 1.010 ( average 24-hour urine volume increased 192 % ) . We conclude that dietary advice may be insufficient to modify fluid intake habits in stone patients . However , modifications of fluid intake habits may be improved by feedback from specific gravity dipsticks Background and objectives Increased water intake may benefit kidney function . Prior to initiating a larger r and omised controlled trial ( RCT ) , we examined the safety and feasibility of asking adults with chronic kidney disease ( CKD ) to increase their water intake . Design , setting , participants and measurements Beginning in October 2012 , we r and omly assigned 29 adults with stage 3 CKD ( estimated glomerular filtration rate ( eGFR ) 30–60 mL/min/1.73 m2 and albuminuria ) to one of the two groups of water intake : hydration ( n=18 ) or st and ard ( n=11 ) . We asked the hydration group to increase their water intake by 1.0–1.5 L/day ( in addition to usual intake , depending on sex and weight ) for 6 weeks , while the control group carried on with their usual intake . Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after r and omisation . Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks . Results (63%)of participants were men , 81 % were Caucasians and the average age was 61 years ( SD 14 years ) . The average baseline eGFR was 40 mL/min/1.73 m2 ( SD 11 mL/min/1.73 m2 ) ; the median albumin to creatinine ratio was 19 mg/mmol ( IQR 6–74 mg/mmol ) . Between baseline and 6-week follow-up , the hydration group 's average 24 h urine volume increased by 0.7 L/day ( from 2.3 to 3.0 L/day ) and the control group 's 24 h urine decreased by 0.3 L/day ( from 2.0 to 1.7 L/day ; between-group difference in change : 0.9 L/day ( 95 % CI 0.4 to 1.5 ; p=0.002 ) ) . We found no significant changes in urine , serum osmolality or electrolyte concentrations , or eGFR . No serious adverse events or changes in quality of life were reported . Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake . Trial registration Registered with Clinical Trials — government identifier NCT01753466 OBJECTIVES Several animal studies have shown that bladder performance improves as a result of diuresis . Whether increased urine output also has beneficial effects on elderly male bladder function and lower urinary tract symptoms is unknown . METHODS We performed a r and omized placebo-controlled trial of 141 men , 55 to 75 years of age , with moderate lower urinary tract symptoms . The experimental group drank 1.5 L of extra water daily . The control group consumed one tablespoon of placebo syrup daily . After 6 months , we evaluated bladder contractility , voided volumes , and the severity of lower urinary tract symptoms . The actual increase in water consumption was measured using the deuterium urine dilution method . RESULTS Water consumption in the intervention group increased by 359 mL ( 95 % confidence interval [ CI ] 171 to 548 ) per 24 hours compared with the control group . At 6 months , no statistically significant effect was found in the maximal flow rate ( 0.9 mL/s , 95 % CI -0.4 to 2.2 ) compared with placebo . A statistically significant effect was found for bladder pressure ( 20 cm H2O , 95 % CI 6 to 34 ) and bladder wall stress ( 1.9 N/cm2 , 95 % CI 0.3 to 3.5 ) . In addition , it showed that the experimental group had greater maximal ( 44 mL , 95 % CI -1 to 90 ) and average ( 26 mL , 95 % CI 1 to 51 ) voided volumes per urination . The subjective effect parameters improved in both groups , but no statistically significant differences were found between the two groups . CONCLUSIONS It seems possible to improve some aspects of male bladder function by drinking more water . However , the effects are too small to be clinical ly relevant Background : Nephrolithiasis is a recurrent disease , and one of the most effective methods for prevention of stone recurrence is increasing the urine output ( > 2 L/day ) , but it is difficult to achieve it . The aim of this study was to evaluate the effect of behavioral intervention by measurement of urine specific gravity using dipstick on 24-h urine volume in first renal stone patients . Material s and Methods : In this prospect i ve r and omize clinical study , 80 adult patients with history of first renal stone were included . Patients were divided into two groups with 40 patients in each group . We explained the importance of high fluid intake and high urine volume in the prevention of renal stones for all patients . Group A patients were trained to measure 24-h urine volume every 15 days , and group B patients were trained to keep urine specific gravity below 1.010 by using dipstick . We measured 24-h urine volume in each group before intervention , and at 3 months and 6 months after intervention and compared them . Results : There were no significant differences between the two groups in 24-h urine volume before intervention ( P = 0.41 ) , but it was significant 3 months ( P = 0.01 ) and 6 months ( P = 0.01 ) after intervention . Patients ′ compliance was 20 % in group A and 90 % in group B ( P < 0.05 ) . Conclusion : The use of behavioral modification with dipstick is an effective method for control and maintenance of optimal urine volume , and it has result ed in more patient compliance for drinking water and is more effective for prevention of renal stone Dehydration is commonly believed to result in headache , but the effectiveness of increasing the water intake in patients who frequently suffer from headaches has not been studied thus far . In a pilot study , we examined the possible effects and feasibility of increased water intake in headache patients . Eighteen headache patients ( all had migraine , two also had tension-type headache ) were r and omly allocated to placebo medication , or the advice to additionally drink 1.5 l of water per day , for a period of 12 weeks . Effect measurements consisted of a 2 weeks headache diary and the Migraine Specific Quality of Life ( MSQOL ) question naire . The advice to increase the daily fluid intake by 1.5 l increased the fluid intake in the intervention group by approximately 1 l. This reduced the total hours of headache in 2 weeks by 21 h ( 95 % CI : -48 to 5 ) . Mean headache intensity decreased by 13 mm ( 95 % CI : -32 to 5 ) on a visual analogue scale ( VAS ) . The effects on MSQOL , number of headache episodes , and medication seemed to be small . The data of the present study suggest a reduction in the total number of hours and intensity of headache episodes after increased water intake . Our results seem to justify larger scaled research on the effectiveness of increased water intake in headache patients PURPOSE We define the role of urine volume as a stone risk factor in idiopathic calcium stone disease and test the actual preventive effectiveness of a high water intake . MATERIAL S AND METHODS We studied 101 controls and 199 patients from the first idiopathic calcium stone episode . After a baseline study period the stone formers were divided by r and omization into 2 groups ( 1 and 2 ) and they were followed prospect ively for 5 years . Followup in group 1 only involved a high intake of water without any dietetic change , while followup in group 2 did not involve any treatment . Each year clinical , laboratory and radiological evaluation was obtained to determine urinary stone risk profile ( including relative supersaturations of calcium oxalate , brushite and uric acid by Equil 2 ) , recurrence rate and mean time to relapse . RESULTS The original urine volume was lower in male and female stone formers compared to controls ( men with calcium oxalate stones 1,057 + /- 238 ml./24 hours versus normal men 1,401 + /- 562 ml./24 hours , p < 0.0001 and women calcium oxalate stones 990 + /- 230 ml./24 hours versus normal women 1,239 + /- 440 ml./24 hours , p < 0.001 ) . During followup recurrences were noted within 5 years in 12 of 99 group 1 patients and in 27 of 100 group 2 patients ( p = 0.008 ) . The average interval for recurrences was 38.7 + /- 13.2 months in group 1 and 25.1 + /- 16.4 months in group 2 ( p = 0.016 ) . The relative supersaturations for calcium oxalate , brushite and uric acid were much greater in baseline urine of the stone patients in both groups compared to controls . During followup , baseline values decreased sharply only in group 1 . Finally the baseline urine in patients with recurrences was characterized by a higher calcium excretion compared to urine of the patients without recurrences in both groups . CONCLUSIONS We conclude that urine volume is a real stone risk factor in nephrolithiasis and that a large intake of water is the initial therapy for prevention of stone recurrences . In cases of hypercalciuria it is suitable to prescribe adjuvant specific diets or drug therapy BACKGROUND Previously published investigations suggest a positive effect of increased water intake on headache , but a r and omised controlled trial has not been done . OBJECTIVE To investigate the effects of increased water intake on headache . METHODS R and omised controlled trial in primary care with two groups and a follow-up period of 3 months . Patients were included if they had at least two episodes of moderately intense headache or at least five mildly intense episodes per month and a total fluid intake of less than 2.5 l/day . Both groups received written instructions about stress reduction and sleep improvement strategies . The intervention group additionally received the instruction to increase the daily water intake by 1.5 l. The main outcome measures were Migraine-Specific Quality of Life ( MSQOL ) and days with at least moderate headache per month . RESULTS We r and omised 50 patients to the control group and 52 patients to the intervention group . Drinking more water result ed in a statistically significant improvement of 4.5 ( confidence interval : 1.3 - 7.8 ) points on MSQOL . In addition , 47 % in the water group reported much improvement ( 6 or higher on a 10-point scale ) on perceived intervention effect against 25 % in the control group . However , drinking more water did not result in relevant changes in days with at least moderate headache . CONCLUSIONS Considering the observed positive subjective effects , it seems reasonable to recommend headache patients to try this non-invasive intervention for a short period of time to see whether they experience improvement Maintenance of weight loss remains a challenge for most individuals . Thus , practical and effective weight-loss maintenance ( WTLM ) strategies are needed . A two-group 12-month WTLM intervention trial was conducted from June 2007 to February 2010 to determine the feasibility and effectiveness of a WTLM intervention for older adults using daily self-monitoring of body weight , step count , fruit/vegetable ( F/V ) intake , and water consumption . Forty weight-reduced individuals ( mean weight lost=6.7±0.6 kg ; body mass index [ calculated as kg/m² ] 29.2±1.1 ) , age 63±1 years , who had previously participated in a 12-week r and omized controlled weight-loss intervention trial , were instructed to record daily body weight , step count , and F/V intake ( WEV [ defined as weight , exercise , and F/V ] ) . Experimental group ( WEV+ ) participants were also instructed to consume 16 fl oz of water before each main meal ( ie , three times daily ) , and to record daily water intake . Outcome measures included weight change , diet/physical activity behaviors , theoretical
Output:
| Most interventions successfully increased water intake with 13 studies reporting an increase of at least 500 mL. The most effective strategies were instruction and self-monitoring using urine dipstick or 24 h urine volume .
CONCLUSION All interventions carried out in the studies succeeded in increasing water intake , with none leading to decreases in intake , and these could be implemented in potential clinical trials in CKD . |
MS211098 | ***TASK*** the task is to summarize an input biomedical literature in 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 issue of whether regular use of an inhaled beta2-adrenergic agonist worsens airflow and clinical outcomes in asthma is controversial . Retrospective studies have suggested that adverse effects occur in patients with a genetic polymorphism that results in homozygosity for arginine ( Arg/Arg ) , rather than glycine ( Gly/Gly ) , at aminoacid residue 16 of the beta2-adrenergic receptor . However , the existence of any genotype-dependent difference has not been tested in a prospect i ve clinical trial . METHODS Patients with mild asthma , not using a controller medication , were enrolled in pairs matched for forced expiratory volume in 1 s ( FEV1 ) according to whether they had the Arg/Arg ( n=37 ; four of 41 matches withdrew before r and omisation ) or Gly/Gly ( n=41 ) genotype . Regularly scheduled treatment with albuterol or placebo was given in a masked , cross-over design , for 16-week periods . During the study , as-needed albuterol use was discontinued and ipratropium bromide was used as needed . Morning peak expiratory flow rate ( PEFR ) was the primary outcome variable . The primary comparisons were between treatment period for each genotype ; the secondary outcome was a treatment by genotype effect . Analyses were by intention to treat . FINDINGS During the run-in period , when albuterol use was kept to a minimum , patients with the Arg/Arg genotype had an increase in morning PEFR of 23 L/min ( p=0.0162 ) ; the change in patients with the Gly/Gly genotype was not significant ( 2 L/min ; p=0.8399 ) . During r and omised treatment , patients with the Gly/Gly genotype had an increase in morning PEFR during treatment with regularly scheduled albuterol compared with placebo ( 14 L/min [ 95 % CI 3 to 25 ] ; p=0.0175 ) . By contrast , patients with the Arg/Arg genotype had lower morning PEFR during treatment with albuterol than during the placebo period , when albuterol use was limited ( -10 L/min [ -19 to -2 ] ; p=0.0209 ) . The genotype-attributable treatment difference was therefore -24 L/min ( -37 to -12 ; p=0.0003 ) . There were similar genotype-specific effects in FEV1 , symptoms , and use of supplementary reliever medication . INTERPRETATION Genotype at the 16th aminoacid residue of the beta2-adrenergic receptor affects the long-term response to albuterol use . Bronchodilator treatments avoiding albuterol may be appropriate for patients with the Arg/Arg genotype 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 BACKGROUND The study of determinants of asthma is a subject of much interest currently , especially the pharmacogenetic aspects of asthma management . Genetic polymorphisms affecting amino-acids at positions 16 and 27 within beta(2)-adrenoceptor ( beta(2)AR ) gene have been implicated in the asthma phenotypes and influence on the variability observed in response to use of bronchodilator agents used in the treatment of asthma . Whether these polymorphisms alter the bronchoprotection response to beta(2)-agonist treatment in Spanish asthmatic population is unknown . The aim of this study was to investigate whether genetic polymorphisms within beta(2)AR gene modulate the clinical outcomes of the individual response to beta(2)-agonist therapy and the development of desensitization in Spanish asthmatic patients . METHODS In a prospect i ve , case-control study were included 80 asthmatic patients . Based on the st and ard criteria , patients were classified into two groups : patients with tachyphylaxis and good responders to beta(2)-agonist therapy . DNA sample s were genotyped for the Arg(16)Gly and Glu(27)Gln alleles within the beta(2)AR gene as well as in 64 control sample s from blood donors . RESULTS Arg(16 ) allele was slightly more frequent within the group with tachyphylaxis ( P=0.039 ) , whereas Gly(16 ) allele carriers were overrepresented within the group of good responders ( 59.7 % , P=0.028 ) . On the other h and , the allele frequency of Gln(27 ) and the proportion of Gln(27 ) carriers was higher within the group with tachyphylaxis ( P=0.010 and 0.049 , respectively ) and Glu(27 ) allele carriers were overrepresented within the group of good responders ( P=0.026 ) . The Arg(16 ) and Gln(27 ) alleles were in strong linkage disequilibrium across this locus , result ing in the occurrence of disease haplotype . CONCLUSIONS The predisposition to develop tachyphylaxis in our population seems to be linked to the Arg(16 ) and Gln(27 ) alleles and to the Arg(16)/Gln(27 ) risk haplotype ( positive association between the presence of the Arg(16 ) and Gln(27 ) alleles and tachyphylaxis ) . The Arg(16 ) allele is perhaps overrepresented due to the strong linkage disequilibrium between both polymorphisms . The presence of the Glu(27 ) allele seems to be a protective factor against tachyphylaxis in this cohort study Inhaled beta-adrenergic agonists are the most commonly used medications for the treatment of asthma although there is evidence that regular use may produce adverse effects in some patients . Polymorphisms of the beta(2)-adrenergic receptor ( beta(2)-AR ) can affect regulation of the receptor . Smaller studies examining the effects of such polymorphisms on the response to beta-agonist therapy have produced inconsistent results . We examined whether polymorphisms at codon 16 ( beta(2)-AR-16 ) and codon 27 ( beta(2)-AR-27 ) of the beta(2)-AR might affect the response to regular versus as-needed use of albuterol by genotyping the 190 asthmatics who had participated in a trial examining the effects of regular versus as needed albuterol use . During the 16-wk treatment period there was a small decline in morning peak expiratory flow in patients homozygous for arginine at B(2)-AR-16 ( Arg/Arg ) who used albuterol regularly . This effect was magnified during a 4-wk run out period , during which all patients returned to using as-needed albuterol , so that by the end of the study Arg Arg patients who had regularly used albuterol had a morning peak expiratory flow 30 . 5 + /- 12.1 L/min lower ( p = 0.012 ) than Arg/Arg patients who had used albuterol on an as needed basis . There was no decline in peak flow with regular use of albuterol in patients who were homozygous for glycine at beta(2)-AR-16 . Evening peak expiratory flow also declined in the Arg/Arg patients who used albuterol regularly but not in those who used albuterol on an as-needed basis . No significant differences in outcomes between regular and as-needed treatment were associated with polymorphisms at position 27 of the beta(2)-AR . No other differences in asthma outcomes that we investigated occurred in relation to these beta(2)-AR polymorphisms . Polymorphisms of the beta(2)-AR may influence airway responses to regular inhaled beta-agonist treatment The prevalence of asthma in children has doubled over the past 25 years.1 Two common polymorphisms exist in the β adrenoceptor at amino acids 16 ( glycine for arginine ) and 27 ( glutamic acid for glutamine ) . Both are functionally relevant in cultured cells , with the glycine 16 form of the receptor showing enhanced downregulation and the glutamic acid 27 form showing attenuated downregulation after exposure to β agonists.2 The glutamine 27 polymorphism is associated with raised IgE concentrations in families with a history of asthma , and with increased reactivity of the airways in people with asthma . 3 4 We measured the prevalence of these polymorphisms in a r and om population of children to identify their importance in the expression of reported asthma . We approached children between the ages of 5 and 15 years ( mean 10.5 years ) and an accompanying parent who were attending the accident and To examine the roles of genetic polymorphism of the β2-adrenergic receptor ( β2AR ) in the relationship between eosinophil ( EOS ) counts and eosinophil cationic protein ( ECP ) counts and lung function , we recruited a r and om sample from the 1996 nationwide survey of asthma prevalence in middle school children . A total of 149 subjects—42 asthmatic children , 38 asthmatics in remission ( no reported attack for more than 12 months ) , and 69 nonasthmatics — completed a physical evaluation , pulmonary function test , and determination of EOS , ECP , and β2AR genotypes at amino acids 16 and 27 . Asthmatic children had higher EOS and ECP than did nonasthmatics . No association was found between asthma and β2AR genotypes . Lung function was significantly and inversely correlated with EOS but not with ECP in asthmatic children . By genotype , an inverse correlation between lung function and EOS was found in asthmatic children with Arg16Arg or Gln27Glu . A nonsignificant but similar inverse correlation was found in asthmatic children with Arg16Gly or Gln27Gln . However , a nonsignificant but positive correlation was found in asthmatic children with Gly16Gly . In conclusion , we suggest that EOS is a better clinical indicator of airway inflammation than ECP when children are not having an asthma attack . The association between an increase of EOS and lower lung function can be differentiated by β2AR genotypes at amino acid 16 To determine the association between the β2‐adrenoceptor polymorphisms at amino acids 16 and 27 and markers of allergic disease and asthma per se in a r and om adult population , and to determine the degree of linkage disequilibrium existing between polymorphisms at amino acid positions 16 , 27 , 164 and nucleic acid residue 523 Abstract Introduction : Genetic mutations in the β2 receptor could alter its functioning and the response to β2 agonists . The study was done to find out the effect of two commonly occurring polymorphisms-Arg16Gly and Gln27Glu , on cause of asthma and on response to nebulized salbutamol in South Indian subjects of asthma . Methods : After baseline measurements of Forced Expiratory Volume in 1st second ( FEV1 ) , Forced Vital Capacity ( FVC ) and Peak Expiratory Flow Rate ( PEFR ) , five mg of nebulized salbutamol was administered and spirometry was repeated . The increase in these parameters was calculated and patients were included for genotyping if the percentage increase in FEV1 was ≥12 % . The frequencies of these polymorphisms in patients were compared with those of healthy volunteers . Results : 112 patients and 127 healthy volunteers were genotyped . The frequencies of the polymorphisms were found to be similar to previously published Dravidian population frequencies . The frequencies of genotypes in asthmatics were similar to healthy volunteers . The increase in FEV1 , FVC and PEFR was similar across various genotypes and haplotypes in both the polymorphisms . The GG-CG haplotype was associated with 3.1 times increased occurrence of asthma ( p value = 0.02 ) . The G allele of the Arg16Gly polymorphism was associated with lower baseline FEV1 , FVC and PEFR values , but these were not statistically significant . Conclusion : The Arg16Gly and Gln27Glu polymorphisms do not determine the occurrence of asthma individually , but the GG-CG haplotype is associated with an increased risk of asthma . There is no effect of the genotypes on the response to nebulized salbutamol
Output:
| Conclusion The meta- analysis suggests that the ADRB2 rs1042714 polymorphism has a protective association with asthma in the overall population and the pediatric subgroup |
MS211099 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Many patients have symptoms suggestive of coronary artery disease ( CAD ) and are often evaluated with the use of diagnostic testing , although there are limited data from r and omized trials to guide care . METHODS We r and omly assigned 10,003 symptomatic patients to a strategy of initial anatomical testing with the use of coronary computed tomographic angiography ( CTA ) or to functional testing ( exercise electrocardiography , nuclear stress testing , or stress echocardiography ) . The composite primary end point was death , myocardial infa rct ion , hospitalization for unstable angina , or major procedural complication . Secondary end points included invasive cardiac catheterization that did not show obstructive CAD and radiation exposure . RESULTS The mean age of the patients was 60.8±8.3 years , 52.7 % were women , and 87.7 % had chest pain or dyspnea on exertion . The mean pretest likelihood of obstructive CAD was 53.3±21.4 % . Over a median follow-up period of 25 months , a primary end-point event occurred in 164 of 4996 patients in the CTA group ( 3.3 % ) and in 151 of 5007 ( 3.0 % ) in the functional-testing group ( adjusted hazard ratio , 1.04 ; 95 % confidence interval , 0.83 to 1.29 ; P=0.75 ) . CTA was associated with fewer catheterizations showing no obstructive CAD than was functional testing ( 3.4 % vs. 4.3 % , P=0.02 ) , although more patients in the CTA group underwent catheterization within 90 days after r and omization ( 12.2 % vs. 8.1 % ) . The median cumulative radiation exposure per patient was lower in the CTA group than in the functional-testing group ( 10.0 mSv vs. 11.3 mSv ) , but 32.6 % of the patients in the functional-testing group had no exposure , so the overall exposure was higher in the CTA group ( mean , 12.0 mSv vs. 10.1 mSv ; P<0.001 ) . CONCLUSIONS In symptomatic patients with suspected CAD who required noninvasive testing , a strategy of initial CTA , as compared with functional testing , did not improve clinical outcomes over a median follow-up of 2 years . ( Funded by the National Heart , Lung , and Blood Institute ; PROMISE Clinical Trials.gov number , NCT01174550 . ) OBJECTIVES The purpose of this study was to compare the efficiency , cost , and safety of a diagnostic strategy employing early coronary computed tomographic angiography ( CCTA ) to a strategy employing rest-stress myocardial perfusion imaging ( MPI ) in the evaluation of acute low-risk chest pain . BACKGROUND In the United States , > 8 million patients require emergency department evaluation for acute chest pain annually at an estimated diagnostic cost of > $ 10 billion . METHODS This multicenter , r and omized clinical trial in 16 emergency departments ran between June 2007 and November 2008 . Patients were r and omly allocated to CCTA ( n = 361 ) or MPI ( n = 338 ) as the index noninvasive test . The primary outcome was time to diagnosis ; the secondary outcomes were emergency department costs of care and safety , defined as freedom from major adverse cardiac events in patients with normal index tests , including 6-month follow-up . RESULTS The CCTA result ed in a 54 % reduction in time to diagnosis compared with MPI ( median 2.9 h [ 25th to 75th percentile : 2.1 to 4.0 h ] vs. 6.3 h [ 25th to 75th percentile : 4.2 to 19.0 h ] , p < 0.0001 ) . Costs of care were 38 % lower compared with st and ard ( median $ 2,137 [ 25th to 75th percentile : $ 1,660 to $ 3,077 ] vs. $ 3,458 [ 25th to 75th percentile : $ 2,900 to $ 4,297 ] , p < 0.0001 ) . The diagnostic strategies had no difference in major adverse cardiac events after normal index testing ( 0.8 % in the CCTA arm vs. 0.4 % in the MPI arm , p = 0.29 ) . CONCLUSIONS In emergency department acute , low-risk chest pain patients , the use of CCTA results in more rapid and cost-efficient safe diagnosis than rest-stress MPI . Further studies comparing CCTA to other diagnostic strategies are needed to optimize evaluation of specific patient subsets . ( Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment [ CT-STAT ] ; NCT00468325 ) STUDY OBJECTIVE Three large , multicenter , r and omized , clinical trials have shown that coronary computed tomography ( CT ) angiography allows efficient evaluation and safe discharge of patients with low- to intermediate-risk chest pain who present to the emergency department ( ED ) . We report 1-year event rates and re source use from the American College of Radiology Imaging Network-Pennsylvania 4005 multicenter trial . METHODS Patients with low- to intermediate-risk chest pain and presenting to the ED were r and omized in a 2:1 ratio to a coronary CT angiography care pathway or traditional care . Subjects were contacted by telephone at least 1 year after ED presentation . Medical record review was performed for all cardiac hospitalizations , procedures and diagnostic tests , and adverse cardiac events . Our main outcome was the composite of cardiac death and myocardial infa rct ion within 1 year . The secondary outcome was re source use . RESULTS One thous and three hundred sixty-eight patients enrolled and 1,285 ( 94 % ) had direct participant or proxy contact at 1 year . All others had record review or death index search . From index presentation through 1 year , there was no difference between patients in the coronary CT angiography arm versus traditional care with respect to major adverse cardiac event ( 1.4 % versus 1.1 % ; difference 0.3 % ; 95 % CI -5.5 % to 6.0 % ) . From hospital discharge through 1 year , there was also no difference in ED revisits ( 36 % versus 38 % ; difference -2.1 % ; 95 % CI -7.9 % to 3.7 % ) , hospital admissions ( 16 % versus 17 % ; difference -0.9 % ; 95 % CI -6.7 % to 4.9 % ) , or subsequent cardiac testing ( 13 % versus 13 % ; difference -0.4 % ; 95 % CI -6.2 % to 5.5 % ) . One of 640 subjects with a negative coronary CT angiography result had a major adverse cardiac event within 1 year of presentation ( 0.16 % ; 95 % CI 0.004 % to 0.87 % ) . CONCLUSION A coronary CT angiography-based strategy for evaluation of patients with low- to intermediate-risk chest pain who present to the ED does not result in increased re source use during 1 year . A negative coronary CT angiography result is associated with a less than 1 % major adverse cardiac event rate during the first year after testing OBJECTIVES This study sought to compare the safety , diagnostic efficacy , and efficiency of multi-slice computed tomography ( MSCT ) with st and ard diagnostic evaluation of low-risk acute chest pain patients . BACKGROUND Over 1 million patients have emergency center evaluations for acute chest pain annually , at an estimated diagnostic cost of over $ 10 billion . Multi-slice computed tomography has a high negative predictive value for exclusion of coronary artery stenoses . METHODS We r and omized patients to MSCT ( n = 99 ) versus SOC ( n = 98 ) protocol s. The MSCT patients with minimal disease were discharged ; those with stenosis > 70 % underwent catheterization , whereas cases with intermediate lesions or non-diagnostic scans underwent stress testing . Outcomes included : safety ( freedom from major adverse events over 6 months ) , diagnostic efficacy ( clinical ly correct and definitive diagnosis ) , as well as time and cost of care . RESULTS Both approaches were completely ( 100 % ) safe . The MSCT alone immediately excluded or identified coronary disease as the source of chest pain in 75 % of patients , including 67 with normal coronary arteries and 8 with severe disease referred for invasive evaluation . The remaining 25 % of patients required stress testing , owing to intermediate severity lesions or non-diagnostic scans . During the index visit , MSCT evaluation reduced diagnostic time compared with SOC ( 3.4 h vs. 15.0 h , p < 0.001 ) and lowered costs ( 1,586 dollars vs. 1,872 dollars , p < 0.001 ) . Importantly , MSCT patients required fewer repeat evaluations for recurrent chest pain ( MSCT , 2 of 99 ( 2.0 % ) patients vs. SOC , 7 of 99 ( 7 % ) patients ; p = 0.10 ) . CONCLUSIONS Multi-slice computed tomographic coronary angiography can definitively establish or exclude coronary disease as the cause of chest pain . However , inability to determine the physiological significance of intermediate severity coronary lesions and cases with inadequate image quality are present limitations . ( Study of Coronary Artery Computed Tomography to Diagnose Emergency Chest Pain CR ; http:// clinical trials.gov/ct/show/NCT00273832?order=1 ; NCT00273832 ) BACKGROUND It is unclear whether an evaluation incorporating coronary computed tomographic angiography ( CCTA ) is more effective than st and ard evaluation in the emergency department in patients with symptoms suggestive of acute coronary syndromes . METHODS In this multicenter trial , we r and omly assigned patients 40 to 74 years of age with symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to st and ard evaluation in the emergency department on weekdays during daylight hours between April 2010 and January 2012 . The primary end point was length of stay in the hospital . Secondary end points included rates of discharge from the emergency department , major adverse cardiovascular events at 28 days , and cumulative costs . Safety end points were undetected acute coronary syndromes . RESULTS The rate of acute coronary syndromes among 1000 patients with a mean ( ±SD ) age of 54±8 years ( 47 % women ) was 8 % . After early CCTA , as compared with st and ard evaluation , the mean length of stay in the hospital was reduced by 7.6 hours ( P<0.001 ) and more patients were discharged directly from the emergency department ( 47 % vs. 12 % , P<0.001 ) . There were no undetected acute coronary syndromes and no significant differences in major adverse cardiovascular events at 28 days . After CCTA , there was more downstream testing and higher radiation exposure . The cumulative mean cost of care was similar in the CCTA group and the st and ard-evaluation group ( $ 4,289 and $ 4,060 , respectively ; P=0.65 ) . CONCLUSIONS In patients in the emergency department with symptoms suggestive of acute coronary syndromes , incorporating CCTA into a triage strategy improved the efficiency of clinical decision making , as compared with a st and ard evaluation in the emergency department , but it result ed in an increase in downstream testing and radiation exposure with no decrease in the overall costs of care . ( Funded by the National Heart , Lung , and Blood Institute ; ROMICAT-II Clinical Trials.gov number , NCT01084239 . ) OBJECTIVES In patients admitted on suspicion of acute coronary syndrome , with normal electrocardiogram and troponines , we evaluated the clinical impact of a Coronary CT angiography (CCTA)- strategy on referral rate for invasive coronary angiography ( ICA ) , detection of significant coronary stenoses ( positive predictive value [ PPV ] ) and subsequent revascularisations , as compared to a function-based strategy ( st and ard care ) . Secondarily we assessed intermediate term clinical events . METHODS AND RESULTS We r and omised 600 patients to a CCTA-guided strategy ( 299 patients ) or st and ard care ( 301 patients ) . In the CCTA-guided group referral for ICA required a coronary stenosis > 70 % or > 50 % in the left main , and for intermediate stenoses ( 50 - 70 % ) , a stress test was used . A significant stenosis on ICA was defined as a stenosis ≥70 % or reduced FFR ≤0.75 in intermediate stenoses ( 50 - 70 % ) . Referral rate for ICA was 17 % with CCTA vs. 12 % with st and ard care ( p=0.1 ) . ICA confirmed significant coronary artery stenoses in 12 % vs. 4 % ( p=0.001 ) , and 10 % vs. 4 % were subsequently revascularised ( p=0.005 ) . PPV for the detection of significant stenoses was 71 % with CCTA vs 36 % with st and ard care ( p=0.001 ) . Clinical events ( cardiac death , myocardial infa rct ion , unstable
Output:
| Consequently , compared with conventional strategy , CCTA seemed not to improve clinical outcomes for patients with low-to-intermediate risk chest pain |
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