A checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist)

Abstract

<title>Abstract</title> <bold>Objectives:</bold> To develop a checklist to screen, for trustworthiness, papers reporting the results of randomised controlled trials (RCTs). <bold>Design:</bold> A screening tool was developed using the four-stage approach proposed by Moher <italic>et al.</italic> This included defining the scope, reviewing the evidence base, suggesting a list of items from piloting, and holding a consensus meeting as part of a Delphi method. The initial checklist was set-up by a core group who had been involved in the assessment of dubious RCTs for several years. We piloted this in a Delphi panel of several stakeholders, including health professionals, reviewers, journal editors, policymakers, researchers and evidence-synthesis specialists. Each member was asked to score three articles with the checklist and the the results were then discussed in two Delphi sessions. <bold>Results:</bold> The Trustworthiness in RAndomised Clinical Trials (TRACT) checklist includes seven domains that are applicable to every RCT: governance, author group, plausibility of intervention usage, timeframe, drop-out rates, baseline characteristics and outcomes. Each domain contains two or three signalling questions that can be answered as either no concerns, some concerns/no information, or major concerns. If a study is assessed and found to have significant concerns, then editors or reviewers should consider a more thorough investigation, including assessment of original individual participant data. <bold>Conclusions:</bold> The TRACT checklist is the first checklist developed in a formal process to detect trustworthiness issues in RCTs. It might help editors, publishers and researchers to screen for such issues in submitted or published RCTs in a transparent and replicable manner.

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