***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: Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement 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 The CONSORT statement is intended to improve reporting of r and omised controlled trials and focuses on minimising the risk of bias ( internal validity ) . The applicability of a trial ’s results ( generalisability or external validity ) is also important , particularly for pragmatic trials . A pragmatic trial ( a term first used in 1967 by Schwartz and Lellouch ) can be broadly defined as a r and omised controlled trial whose purpose is to inform decisions about practice . This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability . Methods At two , two-day meetings held in Toronto in 2005 and 2008 , we review ed the CONSORT statement and its extensions , the literature on pragmatic trials and applicability , and our experiences in conducting pragmatic trials . Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials : the background , participants , interventions , outcomes , sample size , blinding , participant flow , and generalisability of the findings . These extensions are presented , along with illustrative examples of reporting , and an explanation of each extension . Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of r and omised controlled trials are to their own conditions . Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions . In the meantime we recommend that those who support , conduct , and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care . Pragmatic trials are design ed to inform decisions about practice , but poor reporting can reduce their usefulness . The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the 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 Several review s of published cluster r and omised trials have reported that about half did not take clustering into account in the analysis , which was thus incorrect and potentially misleading . In this paper I ask whether cluster r and omised trials are increasing in both number and quality of reporting . Methods Computer search for papers on cluster r and omised trials  since 1980 , h and search of trial reports published in selected volumes of the British Medical Journal over 20 years . Results There has been a large increase in the numbers of method ological papers and of trial reports using the term ' cluster r and om ' in recent years , with about equal numbers of each type of paper . The British Medical Journal contained more such reports than any other journal . In this journal there was a corresponding increase over time in the number of trials where subjects were r and omised in clusters . In 2003 all reports showed awareness of the need to allow for clustering in the analysis . In 1993 and before clustering was ignored in most such trials . Conclusion Cluster trials are becoming more frequent and reporting is of higher quality . Perhaps statistician pressure works 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 The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. This paper addresses the logistical challenges of implementing public health interventions in the setting of cluster r and omized trials ( CRTs ) , drawing on the experience of carrying out a CRT  within a community-based health insurance ( CBHI ) scheme in rural India . Our CRT is seeking to improve the equity impact — i.e. , reduce the differential in cl aims su bmi ssion for hospitalization between poor and less poor — of this CBHI in rural areas . Five main challenges are identified and discussed : 1 ) assigning control clusters , 2 ) blinding , 3 ) implementing interventions simultaneously , 4 ) minimizing leakage , and 5 ) piggy-backing on a changing scheme . These challenges are not likely to be unique to low-income setting s , although the fifth challenge is particularly likely when working with relatively small and re source -constrained programs . While compromises to method ological best- practice may reduce internal validity , they make the intervention more ‘ real ’ , and potentially more applicable , to other programs and setting s. Further , careful documentation of compromises allows them to be considered in the final analysis .RésuméCet article traite des difficultés logistiques rencontrées dans la mise en oeuvre d ’ interventions de santé publique dans le cadre d’essais contrôlés r and omisés par grappes . Il tire les enseignements d’une expérience menée au sein d’un système d’assurance-santé communautaire dans une région rurale de l’Inde . Il s’agit d’une intervention r and omisée par grappes qui a pour but d’améliorer l’équité du système , à savoir réduire l’écart entre les dem and es de remboursement des frais d’hospitalisation soumises par les population s pauvres et moins pauvres . Cinq gr and es difficultés sont présentées et discutées dans l’article : 1 ) la mise en place des groupes de contrôle , 2 ) la création des conditions d’un test en aveugle , 3 ) la simultanéité des interventions , 4 ) le risque de contamination entre les groupes et 5 ) l’implantation sur un dispositif connaissant des modifications . Ces problèmes ne sont pas propres au context e des pays en développement , bien que le dernier soit plus courant dans le cas de petits programmes aux res sources limitées . Les concessions faites par rapport aux canons méthodologiques sont susceptibles de réduire la validité interne de l’étude , mais elles rendent l’intervention plus réaliste et potentiellement plus applicable à d’autres context es . En outre , une documentation précise de ces compromis nous permet de les prendre en compte à la fin de l’analyse Background Evaluation of an  implementation process  and its  fidelity can give insight into the ' black box ' of interventions . However , a lack of st and ardized methods for study ing fidelity and implementation process have been reported , which might be one reason for the fact that few prior studies in the field of health service research have systematic ally evaluated interventions ' implementation processes . The aim of this project is to systematic ally evaluate  implementation fidelity  and possible factors influencing fidelity of complex interventions in health and social care . Methods A modified version of The Conceptual Framework for Implementation Fidelity  will be used as a conceptual model for the evaluation . The modification implies two additional moderating factors : context and recruitment . A systematic evaluation process was developed . Multiple case study method is used to investigate implementation of three complex health service interventions . Each case will be investigated in depth and longitudinally , using both quantitative and qualitative methods . Discussion This study is the first attempt to empirically test The Conceptual Framework for  Implementation Fidelity . The study can highlight mechanism and factors of importance when implementing complex interventions . Especially the role of the moderating factors on implementation fidelity can be clarified . Trial Registration Supported Employment , SE , among people with severe mental illness -- a r and omized controlled trial : NCT00960024 BACKGROUND Cluster r and omized trials increasingly are being used in health services research and in primary care , yet the majority of these trials do not account appropriately for the clustering in their analysis . OBJECTIVES We review the main implication s of adopting a cluster r and omized design in primary care and highlight the practical application of appropriate analytical techniques . METHODS The application of different analytical techniques is demonstrated through the use of empirical data from a primary care-based case study . CONCLUSION Inappropriate analysis of cluster trials can lead to the presentation of inaccurate results and hence potentially misleading conclusions . We have demonstrated that adjustment for clustering can be applied to real-life data and we encourage more routine adoption of appropriate analytical techniques In spite of growing interest in socioeconomic differentials in health outcomes and access to health services , little has been written about method ologies for assessing the impact of equity-enhancing policies or programs . This paper describes three method ological challenges involved in design ing a r and omised trial with an equity outcome , and how these were met in a trial of alternative strategies to improving the uptake of benefits of a health insurance scheme among its poorest members . The Vimo SEWA trial is nested within a community-based insurance scheme in rural India . While conducting this trial , three method ological problems were encountered : ( i ) measuring poverty ( or " wealth " , or " socioeconomic status " ) ( ii ) assessing beneficiaries against an appropriate reference st and ard population and ( iii ) settling on an appropriate equity measure as an outcome indicator . These problems are likely to arise in any policy or program assessment that has an equity outcome . In the Vimo SEWA trial , the socioeconomic status of beneficiaries ( cl aim ants ) is assessed relative to that of all scheme members living in same sub-district by applying a rapid assessment question naire -- which reduces to an integrated index of socioeconomic status -- 
    Output:
    
Discussion Fidelity assessment may be a key tool for making studies more reliable , internally valid , and externally generalizable .