***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***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 commonly reported problem with the conduct of multicentre r and omised controlled trials ( RCTs ) is that recruitment is often slower or more difficult than expected , with many trials failing to reach their planned sample size within the timescale and funding originally envisaged . The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies : the UK Medical Research Council ( MRC ) and the Health Technology Assessment ( HTA ) Programme . Methods The cohort of trials was identified from the administrative data bases held by the two funding bodies . 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria . The full scientific applications and subsequent trial reports su bmi tted by the trial teams to the funders provided the principal data sources . Associations between trial characteristics and recruitment success were tested using the Chi-squared test , or Fisher 's exact test where appropriate . Results Less than a third ( 31 % ) of the trials achieved their original recruitment target and half ( 53 % ) were awarded an extension . The proportion achieving targets did not appear to improve over time . The overall start to recruitment was delayed in 47 ( 41 % ) trials and early recruitment problems were identified in 77 ( 63 % ) trials . The inter-relationship between trial features and recruitment success was complex . A variety of strategies were employed to try to increase recruitment , but their success could not be assessed . Conclusion Recruitment problems are complex and challenging . Many of the trials in the cohort experienced recruitment difficulties . Trials often required extended recruitment periods ( sometimes supported by additional funds ) . While this is of continuing concern , success in addressing the trial question may be more important than recruitment alone Purpose The purpose of this article is to describe methods used to recruit and retain high-risk , Spanish-speaking adults of Mexican origin in a r and omized clinical trial that adapts Diabetes Prevention Program ( DPP ) content into a community-based , culturally tailored intervention . Methods Multiple passive and active recruitment strategies were analyzed for effectiveness in reaching the recruitment goal . Of 91 potential participants assessed for eligibility , 58 participated in the study , with 38 in the intervention and 20 in the attention control group . The American Diabetes Association Risk Assessment Question naire , body mass index , and casual capillary blood glucose measures were used to determine eligibility . Results The recruitment goal of 50 individuals was met . Healthy living diabetes prevention presentations conducted at churches were the most successful recruiting strategy . The retention goal of 20 individuals was met for the intervention group . Weekly reminder calls were made by the promotora to each intervention participant , and homework assignments were successful in facilitating participant engagement . Conclusions A community advisory board made significant and crucial contributions to the recruitment strategies and refinement of the intervention . Results support the feasibility of adapting the DPP into a community-based intervention for reaching adults of Mexican origin at high risk for developing diabetes BACKGROUND Cancer patients want access to reliable information about currently recruiting clinical trials . PATIENTS AND METHODS Oncologists and their patients were r and omly assigned to access a consumer-friendly cancer clinical trials web site [ Australian Cancer Trials ( ACT ) , www.australiancancertrials.gov.au ] or to usual care in a cluster r and omized controlled trial . The primary outcome , measured from audio recordings of oncologist-patient consultations , was the proportion of patients with whom participation in any clinical trial was discussed . Analysis was by intention-to-treat accounting for clustering and stratification . RESULTS Thirty medical oncologists and 493 patients were recruited . Overall , 46 % of consultations in the intervention group compared with 34 % in the control group contained a discussion about clinical trials ( P=0.08 ) . The mean consultation length in both groups was 29 min ( P=0.69 ) . The proportion consenting to a trial was 10 % in both groups ( P=0.65 ) . Patients ' knowledge about r and omized trials was lower in the intervention than the control group ( mean score 3.0 versus 3.3 , P=0.03 ) but decisional conflict scores were similar ( mean score 42 versus 43 , P=0.83 ) . CONCLUSIONS Good communication between patients and physicians is essential . Within this context , a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation Background R and omised controlled trials are generally regarded as the ‘ gold st and ard ’ experimental design to determine the effectiveness of an intervention . Unfortunately , many trials either fail to recruit sufficient numbers of participants , or recruitment takes longer than anticipated . The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial . Methods A three-arm , embedded r and omised methodology trial was conducted within the National Institute for Health Research -funded REducing Falls with ORthoses and a Multifaceted podiatry intervention ( REFORM ) cohort r and omised controlled trial . Routine National Health Service podiatry patients over the age of 65 were r and omised to receive either the control patient information sheet ( PIS ) for the host trial or one of two optimised versions , a bespoke user-tested PIS or a template-developed PIS . The primary outcome was the proportion of patients in each group who went on to be r and omised to the host trial . Results Six thous and and nine hundred patients were r and omised 1:1:1 into the embedded trial . A total of 193 ( 2.8 % ) went on to be r and omised into the main REFORM trial ( control n = 62 , template-developed n = 68 ; bespoke user-tested n = 63 ) . Information sheet allocation did not improve recruitment to the trial ( odds ratios for the three pairwise comparisons : template vs control 1.10 ( 95 % CI 0.77–1.56 , p = 0.60 ) ; user-tested vs control 1.01 ( 95 % CI 0.71–1.45 , p = 0.94 ) ; and user-tested vs template 0.92 ( 95 % CI 0.65–1.31 , p = 0.65 ) ) . Conclusions This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information material s on recruitment and retention rates in the REFORM study .Trial registration International St and ard R and omised Controlled Trials Number registry , IS RCT N68240461 . Registered on 01 July 2011 The objectives of the Prostate , Lung , Colorectal and Ovarian Cancer Screening Trial are to determine in screenees ages 55 - 74 at entry whether screening with flexible sigmoidoscopy ( 60-cm sigmoidoscope ) can reduce mortality from colorectal cancer , whether screening with chest X-ray can reduce mortality from lung cancer , whether screening men with digital rectal examination ( DRE ) plus serum prostate-specific antigen ( PSA ) can reduce mortality from prostate cancer , and whether screening women with CA125 and transvaginal ultrasound ( TVU ) can reduce mortality from ovarian cancer . Secondary objectives are to assess screening variables other than mortality for each of the interventions including sensitivity , specificity , and positive predictive value ; to assess incidence , stage , and survival of cancer cases ; and to investigate biologic and /or prognostic characterizations of tumor tissue and biochemical products as intermediate endpoints . The design is a multicenter , two-armed , r and omized trial with 37,000 females and 37,000 males in each of the two arms . In the intervention arm , the  PSA and CA125 tests  are performed at entry , then annually for 5 years . The  DRE , TVU , and chest X-ray exams  are performed at entry and then annually for 3 years . Sigmoidoscopy is performed at entry and then at the 5-year point . Participants in the control arm follow their usual medical care practice s. Participants will be followed for at least 13 years from r and omization to ascertain all cancers of the prostate , lung , colorectum , and ovary , as well as deaths from all causes . A pilot phase was undertaken to assess the r and omization , screening , and data collection procedures of the trial and to estimate design parameters such as compliance and contamination levels . This paper describes eligibility , consent , and other design features of the trial , r and omization and screening procedures , and an outline of the follow-up procedures . Sample -size calculations are reported , and a data analysis plan is presented Background Falls are a major cause of morbidity among older people . A multifaceted podiatry intervention may reduce the risk of falling . This study evaluated such an intervention . Design Pragmatic cohort r and omised controlled trial in Engl and and Irel and . 1010 participants were r and omised ( 493 to the Intervention group and 517 to Usual Care ) to either : a podiatry intervention , including foot and ankle exercises , foot orthoses and , if required , new footwear , and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet . The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following r and omisation . Secondary outcomes included : proportion of fallers and those reporting multiple falls , time to first fall , fear of falling , Frenchay Activities Index , Geriatric Depression Scale , foot pain , health related quality of life , and cost-effectiveness . Results In the primary analysis were 484 ( 98.2 % ) intervention and 507 ( 98.1 % ) control participants . There was a small , non statistically significant reduction in the incidence rate of falls in the intervention group ( adjusted incidence rate ratio 0.88 , 95 % CI 0.73 to 1.05 , p = 0.16 ) . The proportion of participants experiencing a fall was lower ( 49.7 vs 54.9 % , adjusted odds ratio 0.78 , 95 % CI 0.60 to 1.00 , p = 0.05 ) as was the proportion experiencing two or more falls ( 27.6 % vs 34.6 % , adjusted odds ratio 0.69 , 95 % CI 0.52 to 0.90 , p = 0.01 ) . There was an increase ( p = 0.02 ) in foot pain for the intervention group . There were no statistically significant differences in other outcomes . The intervention was more costly but marginally more beneficial in terms of health-related quality of life ( mean quality adjusted life year ( QALY ) difference 0.0129 , 95 % CI -0.0050 to 0.0314 ) and had a 65 % probability of being cost-effective at a threshold of £ 30,000 per QALY gained . Conclusion There was a small reduction in falls . The intervention may be cost-effective . Trial Registration IS RCT N IS RCT CONTEXT Gulf War veterans ' illnesses ( GWVI ) , multisymptom illnesses characterized by persistent pain , fatigue , and cognitive symptoms , have been reported by many Gulf War veterans . There are currently no effective therapies available to treat GWVI . OBJECTIVE To compare the effectiveness of cognitive behavioral therapy ( CBT ) , exercise , and the combination of both for improving physical functioning and reducing the symptoms of GWVI . DESIGN , SETTING , AND PATIENTS R and omized controlled 2 x 2 factorial trial conducted from April 1999 to September 2001 among 1092 Gulf War veterans who reported at least 2 of 3 symptom types ( fatigue , pain , and cognitive ) for more than 6 months and at the time of screening . Treatment assignment was unmasked except for a masked assessor of study outcomes at each clinical site ( 18 Department of Veterans Affairs [ VA ] and 2 Department of Defense [ DOD ] medical centers ) . INTERVENTIONS Veterans were r and omly assigned to receive usual care ( n = 271 ) , consisting of any and all care received from inside or outside the VA or DOD health care systems ; CBT plus usual care ( n = 286 ) ; exercise plus usual care ( n = 269 ) ; or CBT plus exercise plus usual care ( n = 266 ) . Exercise sessions were 60 minutes and CBT sessions were 60 to 90 minutes ; both met weekly for 12 weeks . MAIN OUTCOME MEASURES The primary end point was a 7-point or greater increase ( improvement ) on the Physical Component Summary scale of the Veterans Short Form 36-Item Health Survey at 12 months . Secondary outcomes were st and ardized measures of pain , fatigue , cognitive symptoms , distress , and mental health functioning . Participants were evaluated at baseline and at 3 , 6 , and 12 months . RESULTS The percentage of veterans with improvement in physical function at 1 year was 11.5 % for usual care , 11.7 % for exercise alone , 18.4 % for CBT plus exercise , and 18.5 % for CBT alone . The adjusted odds ratios ( OR ) for improvement in exercise , CBT , and exercise plus CBT vs usual care were 1.07 ( 95 % confidence interval [ CI ] , 0.63 - 1.82 ) , 1.72 ( 95 % CI , 0.91 - 3.23 ) , and 1.84 ( 95 % CI , 0.95 - 3.55 ) , respectively . The OR for the overall ( marginal ) effect of receiving CBT ( n = 552 ) vs no CBT ( n = 535 ) was 1.71 ( 95 % CI , 1.15 
    Output:
    
These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants , especially if it includes people with lived experience of the health condition under study .