***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: Solutions are employed to support clinical research trial tasks in community-based practice setting s. Using the IT Implementation Framework ( ITIF ) , an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use , we sought to underst and the barriers and facilitators to clinical research in community-based practice setting s preliminary to implementing new informatics solutions for improving clinical research infrastructure . The studies were conducted in practice s within the Columbia University Clinical Trials Network . A mixed- method approach , including surveys , interviews , time-motion studies , and observations was used . The data collected , which incorporates predisposing , enabling , and reinforcing factors in IT use , were analyzed according to each phase of ITIF . Themes identified in the first phase of ITIF were 1 ) processes and tools to support clinical trial research and 2 ) clinical research peripheral to patient care processes . Not all of the problems under these themes were found to be amenable to IT solutions . Using the multi-level orientation of the ITIF , we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice -based setting s. Developing strategies to target enabling and reinforcing factors , which focus on organizational factors , and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes , is most challenging . The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice setting Background The feasibility of r and omized trials often depends on successful patient recruitment . Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most . Also , most surveys have focused on the patients ' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention . Therefore , our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment . Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease . We developed and pilot-tested a self-administered question naire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 ( full agreement with statement = very substantial recruitment barrier ) to 7 ( no agreement with statement = no recruitment barrier ) . Results 38 of 55 recruiting physicians returned question naires ( 69 % response rate ) , of which 35 could be analyzed ( 64 % useable response rate ) . Recruiting physicians reported that " time constraints " ( median agreement of 3 , interquartile range 2–5 ) had the most negative impact on recruitment followed by " difficulties including identified eligible patients " ( median agreement of 5 , IQR 3–6 ) . Other barriers such as " trial design barriers " , " lack of access to treatment " , " individual barriers of recruiting physicians " or " insufficient training of recruiting physicians " were perceived to have little or no impact on patient recruitment . Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a r and omized trial . To overcome recruitment barriers interventions , that are affordable for both industry- and investigator-driven trials , need to be developed and tested in r and omized trials . Trial registration IS RCT 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 cohort studies of r and omised controlled trials have provided evidence of within- study selective reporting bias ; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes . Bias result ing from selective reporting can impact on meta-analyses , influencing the conclusions of systematic review s , and in turn , evidence based clinical practice guidelines .In 2006 we received funding to investigate if there was evidence of within- study selective reporting in a cohort of RCTs su bmi tted to New Zeal and Regional Ethics Committees in 1998/99 . This research involved accessing ethics applications , their amendments and annual reports , and comparing these with corresponding publications . We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons .In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee . The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application . This initiated a seventeen month process to obtain ethical approval . This publication outlines what we planned to do , the issues we encountered , discusses the legal and ethical issues , and presents some potential solutions . Discussion and conclusion Method ological research such as this has the potential for public benefit and there is little or no harm for the participants ( trialists ) in undertaking it . Further , in New Zeal and , there is freedom of information legislation , which in this circumstance , unambiguously provided rights of access and use of the information in the ethics applications . The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research . Method ological research , such as this , can be used to develop processes to improve quality in research reporting . Recognition of the potential benefit of this research in the broader research community , and those who sit on ethics committees , is perhaps needed . In addition , changes to the ethical review process which involve separation between those who review proposals to undertake method ological research using ethics applications , and those with responsibility for review ing ethics applications for trials , should be considered . Finally , we contend that the research community could benefit from quality improvement approaches used in allied sectors Public health interventions usually operate at the level of groups rather than individuals , and cluster r and omized controlled trials ( RCTs ) are one means of evaluating their effectiveness . Using examples from six such trials in Bangladesh , India , Malawi and Nepal , we discuss our experience of the ethical issues that arise in their conduct . We set cluster RCTs in the broader context of public health research , highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income setting s in general . After a brief introduction to cluster RCTs , we discuss particular challenges we have faced . These include the nature of - and responsibility for - group consent , and the need for consent by individuals within groups to intervention and data collection . We discuss the timing of consent in relation to the implementation of public health strategies , and the problem of securing ethical review and approval in a complex domain . Finally , we consider the debate about benefits to control groups and the st and ard of care that they should receive , and the issue of post-trial adoption of the intervention under test Background Excessive protocol violations ( PV ) , which can be defined as preventable mistakes in study conduct , may result in patient harm and introduce errors into a clinical trial 's results leading to flawed trial conclusions .The purpose of this project was to gain a better underst and ing of reported PVs , to describe current practice with regards to the use of methods for the reduction of PVs and to investigate relationships between clinical trial characteristics and PVs . Methods We review ed 80 clinical trials conducted across a broad range of medical specialties published in four major general medical journals ( The Lancet , NEJM , JAMA , BMJ ) . Eligible papers were identified using a PubMed search . For each included trial , two authors independently abstract ed information on trial characteristics , PV reporting and PV rates and interventions used to reduce PVs . PVs were categorised into one of five distinct types : enrolment , r and omisation , study intervention , patient compliance and data collection errors . Associations between PVs and study characteristics were investigated using logistic regression . Results Eighty clinical trials ( 20 from each journal ) were identified from 101 consecutive PubMed abstract s. The median number of participants was 701 ( range : 20 to 162 , 367 ) and the median number of participating sites was 15 ( range : 1 to 701 ) . Nineteen percent ( 15/80 ) of included trials were single centre trials . The median study duration was 24 months ( range : 5.81 - 127 months ) and 74 % ( 59/80 ) of included trials were primarily academic funded . Thirty two percent ( 26/80 ) of included trials failed to provide explicit reporting of any type of PV and none ( 0/80 ) of the trials provided explicit reporting of all five types of PVs . Larger clinical trials ( more patients , more sites , longer duration , more complex management structure ) were more likely to have more complete reporting of PV's . Only 9 % ( 7/80 ) of trials reported the use of a specific study method to prevent PVs . Use of a run-in phase was the only method reported . Conclusions PVs are under-reported . Although the CONSORT statement provides guidance on the reporting of PVs , reporting requirements are not explicit for all types of PVs . As a first step towards improved reporting by authors , we recommend the CONSORT statement highlight the importance of PVs by making reporting requirements more explicit Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction OBJECTIVE Latinas are underrepresented in clinical trials despite the rise in Hispanic population . This study examines the factors associated with Latinas ' willingness to participate in preventive breast cancer r and omized clinical trials ( RCTs ) . METHODS Women self-identifying as Latina , over age 40 , with no prior history of breast cancer were eligible . Using the Behavior Model for Vulnerable Population s , we administered a  survey ( n=168 ) to assess predisposing ( e.g. , knowledge ) , enabling ( e.g. , trust ) and need factors ( e.g. , risk perception ) . Intention to participate was defined using a lenient ( maybe , probably or definitely ) and a stringent criterion ( probably and definitely ) . Chi-square tests and logistic regression models examined the associations of predisposing , enabling , and need factors with women 's intentions to participate in RCTs . RESULTS Most participants ( 74.9 % ) were monolingual Spanish-speaking immigrants . Most ( 83.9 % ) reported willing to participate in clinical trials using the lenient definition ( vs. 43.1 % under the stringent definition ) . Using the lenient definition , the odds of willing to participate in RCTs  were significantly lower for unmarried women ( OR=.25 , 95 % CI=.08-.79 ) and those with lower cancer risk perceptions ( OR=.20 , 95 % CI=.06-.63 ) , while being significantly higher for women with lower language acculturation ( OR=6.2 , 95 % CI=1. 
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The challenge related to design was poor planning .
Conclusion : Based on the results of this systematic review , the most important challenges were barriers related to h and ling ethical and regulatory systems , patient recruitment , and lack of budget and skilled staff for conducting clinical trials .