***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***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 Objectives : To determine the effects of risk and payment on  subjects ’ willingness to participate  , and to examine how payment influences subjects ’ potential behaviours and risk evaluations . Methods : A 3 ( level of risk ) × 3 ( level of monetary payment ) , between subjects , completely r and omised factorial design was used . Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study , and completed a question naire . Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects . Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide . Five dependent variables were assessed in the question naire : willingness to participate , willingness to participate with no payment , propensity to neglect to tell about restricted activities , propensity to neglect to tell about negative effects , and risk rating . Results : Monetary payment had positive effects on respondents ’ willingness to participate in research , regardless of the level of risk . However , higher monetary payments did not appear to blind respondents to the risks of a study . Payment had some influence on respondents ’ potential behaviours regarding concealing information about restricted activities . However , payment did not appear to have a significant effect on respondents ’ propensity to neglect to tell research ers about negative effects . Conclusions : Monetary payments appear to do what they are intended to do : make subjects more willing to participate in research . Concerns about payments blinding subjects to risks could not be substantiated in the present study . However , the findings do raise other concerns — notably the potential for payments to diminish the integrity of a study ’s findings . Future research is critical to make sound decisions about the payment of research subjects Background It is notoriously difficult to recruit patients to r and omised controlled trials in primary care . This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window . Bell 's palsy , an acute unilateral paralysis of the facial nerve is just such a relatively rare condition . In this case study we describe the organisational issues presented in setting up a large r and omised controlled trial of the management of Bell 's palsy across primary and secondary care in Scotl and and how we managed to successfully recruit and retain patients presenting in the community . Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention . We consider that the key issues in the success of this study were ; the fact that the research was seen as clinical ly important by the clinicians who had initial responsibility for recruitment ; employing an experienced trial co-ordinator and dedicated research ers willing to recruit participants seven days per week and to visit them at home at a time convenient to them , hence reducing missed patients and ensuring they were retained in the study ; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community ; encouraging recruitment by payment to practice s and reducing the workload of the referring doctors by providing immediate access to specialist care ; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations , enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale . Conclusion While difficult , recruitment to and retention within multi-centre trials from primary care can be successfully achieved through the application of the best available evidence , establishing good relationships with practice s , minimising the workload of those involved in recruitment and offering enhanced care to all participants . Primary care trialists should describe their experiences of the methods used to persuade patients to participate in their trials when publishing their results OBJECTIVES To evaluate the impact of an information booklet on HIV clinical trials , Clinical Trials in HIV and AIDS : Information For People Who Are Thinking About Joining a Trial , in addition to the st and ard trial information ( SI ) on patients ' knowledge ; underst and ing and attitudes about clinical trials ; and to investigate patients ' motivations and reasons for enrolling or not enrolling in a clinical trial . METHODS Fifty HIV-1 positive patients who attended the HIV clinic at a west London hospital were r and omized to receive either SI alone ( n = 27 ) or SI and a 16 page information booklet explaining the principles and procedures of HIV clinical trials ( n = 23 ) . A self-administered question naire was used at baseline to assess past experience and attitudes to clinical trials ( 10 questions ) , knowledge and underst and ing of HIV treatments ( 8 questions ) and clinical trials ( 11 questions ) . At 2 - 6 months after r and omization , a second interviewer-administered question naire addressed the patient 's assessment of the usefulness and comprehensiveness of the information provided by the SI and information booklet , whether or not the patient had enrolled in a clinical trial and reasons for enrolling/not enrolling , knowledge of specific aspects of the trial protocol the patient was eligible to join ( 13 questions ) and general knowledge of clinical trial procedures ( repeat of 11 baseline questions ) . Changes in the attitudes and scores on knowledge and underst and ing of clinical trials were compared for the two groups . RESULTS In both groups , patient knowledge of clinical trial procedures improved significantly over the study period . The median score increased from 30 at baseline to 35/44 at follow-up ( SI only ) vs. 24 - 31/44 ( SI plus booklet ) , but this did not differ significantly between the two groups . However , knowledge of the specific trial protocol was poor [ median score 13/25 , interquartile range ( IQR ) 8 - 14 ] , and there was no difference in the scores for the two groups . The prime motivations for joining a clinical trial were to benefit personal health and to gain access to new treatments . Potential side-effects were the main concern of prospect i ve trial participants . CONCLUSIONS This small trial shows that , while the patients ' general knowledge and underst and ing of clinical trials improved over time , this was not improved by the information booklet and re collection of the details of the relevant trial protocol remained poor Background Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment . We report three controlled trials of interventions to increase recruitment to the Txt2stop trial . Purpose To evaluate : Trial 1 . The impact on registration s of a text message regarding an online registration facility ; Trial 2 . The impact on r and omizations of sending £ 5 with a covering letter to those eligible to join the trial ; Trial 3 . The impact on r and omizations of text messages containing quotes from existing participants . Methods Single blind controlled trials with allocation concealment . Interventions : Trial 1 : A text message regarding our new online registration facility ; Trial 2 : A letter with £ 5 enclosed ; Trial 3 : A series of four text messages containing quotes from participants . The control group in each trial received st and ard Txt2stop procedures . Results Trial 1 : 3.6 % ( 17/470 ) of the intervention group and 1.1 % ( 5/467 ) of the control group registered for the trial , risk difference 2.5 % ( 95 % CI 0.6—4.5 ) . 0 % ( 0/ 470 ) of the intervention group and 0.2 % ( 1/467 ) of the control group registered successfully online , risk difference —0.2 ( 95 % CI —0.6—0.2 ) ; Trial 2 : 4.5 % ( 11/246 ) of the intervention group and 0.4 % ( 1/245 ) of the control group were r and omized into the Txt2stop trial , risk difference 4.0 % ( 95 % CI 1.4—6.7 ) ; Trial 3 : 3.5 % ( 14/405 ) of the intervention group and 0 % ( 0/406 ) of the control group were r and omized into the Txt2stop trial , risk difference 3.5 ( 95 % CI 1.7—5.2 ) . Limitations There were no baseline data available for trial 1 . Allocation of participant IDs in trials 2 and 3 were systematic . Conclusion Sending a text message about an online registration facility increased registration s to Txt2stop , but did not increase online registration s. Sending a £ 5 reimbursement for participants ’ time and sending text messages containing quotes from existing participants increased r and omizations into the Txt2stop trial . Clinical Trials 2010 ; 7 : 265—273 . BACKGROUND physical activity studies in older people often have poor recruitment . Including a question naire with the invitation would provide information about non- participants and selection bias , but could reduce recruitment . Telephone contact might encourage participation . OBJECTIVE to test the effects of different strategies for recruitment into a study of physical activity in older people . DESIGN factorial r and omised controlled trial . R and omisation by household into four groups : telephone contact plus question naire , telephone contact only , question naire only , neither . SETTING primary care , Oxfordshire , United Kingdom . PARTICIPANTS 560 patients > or = 65 years r and omly selected after exclusions . INTERVENTIONS question naire to assess health , functional ability and physical activity .  Telephone contact by the research nurse a week after sending study information . MAIN OUTCOME MEASURE recruitment into physical activity study . RESULTS telephone contact increased recruitment : contact 47.9 % ( 134/280 ) , no contact 37.9 % ( 106/280 ) , difference ( adjusted for the clustering effect of household ) 10.0 % ( 95 % CI 0.2 - 19.8 ) . Question naire inclusion did not significantly reduce recruitment : no question naire 44.3 % ( 124/280 ) question naire 41.4 % ( 116/280 ) difference -2.9 % ( 95 % CI -12.7 - 7.0 ) . CONCLUSIONS telephone contact significantly increased recruitment and should be considered in studies where recruitment may be low . While inclusion of a question naire provided valuable information on non- participants and did not significantly reduce recruitment , an adverse recruitment effect could not be excluded BACKGROUND Latinas have low rates of participation in breast cancer prevention trials . We evaluated the feasibility and effectiveness of a r and omized trial of brief counseling and print material s compared to print material s alone to increase intent to participate in a breast cancer prevention trial . METHODS We enrolled 450 women Spanish-speaking women from three urban community primary care clinics . The outcome was intent , defined as might , probably , or definitely would enroll in the trial . We also examined results using a more stringent definition restricted to probably and definitely intend to participate . RESULTS The trial was feasible within these busy clinics , and 96 % of women agreed to participate . The level of breast cancer knowledge was fairly high ( 66 % correct answers ) , but underst and ing about clinical trials was lower ( 40.5 % correct answers ) . Using the less stringent criteria for intent , 72 % of women stated that they intended to enroll in the STAR trial if eligible , but rates of intent decreased to 52 % with framing that included medication side effects and 45 % if uterine cancer was mentioned ( P < 0.01 for trend ) . Using the more stringent definition , slightly fewer than half of the women indicated an interest in participating , with the same trend towards decreasing intent with increasing presentation of side effects . The intervention was only effective using the less stringent definition and if no side effects were mentioned ( 77 % intent vs. 67 % in the intervention and control groups , respectively , P = 0.03 ) . Intention was independently associated with greater worry about breast cancer and younger age , but not acculturation or knowledge . CONCLUSIONS Latina women are interested in participating in clinical trials to prevent breast cancer , although interest declines with increasing discussion of side effects . Unfortunately , brief education only increased rates of intention using the least stringent definition and when no side effects were presented in framing the question . Future work should focus on qualitative research to underst and the theoretical foundations of preventive health behaviors in this population PURPOSE Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population . This study hypothesized that use of an easy-to-read consent statement , when compared with a st and ard consent statement , will result in higher patient comprehension of the clinical treatment protocol , lower patient anx 
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However , the effect of many other strategies is less clear , including the use of video to provide trial information and interventions aim ed at recruiters .
Questions remain as to the applicability of results originating from hypothetical trials , including those relating to the use of monetary incentives , and there is a clear knowledge gap with regard to effective strategies aim ed at recruiters