Checklist to assess Trustworthiness in RAndomised Controlled Trials (TRACT checklist): concept proposal and pilot

作者：Ben W. Mol, Shimona Lai, Ayesha Rahim, Esmée M Bordewijk, Rui Wang, Rik van Eekelen, Lyle C. Gurrin, Jim Thornton, Madelon van Wely, Wentao Li · 发表于：Research Integrity and Peer Review · 年份：2023 · DOI：10.1186/s41073-023-00130-8 · 被引用次数：140 · 研究领域：Meta-analysis and systematic reviews、Ethics in Clinical Research、Health Policy Implementation Science

OBJECTIVES: To propose a checklist that can be used to assess trustworthiness of randomized controlled trials (RCTs). DESIGN: A screening tool was developed using the four-stage approach proposed by Moher et al. This included defining the scope, reviewing the evidence base, suggesting a list of items from piloting, and holding a consensus meeting. The initial checklist was set-up by a core group who had been involved in the assessment of problematic RCTs for several years. We piloted this in a consensus 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 results were then discussed in consensus meetings. OUTCOME: The Trustworthiness in RAndomised Clinical Trials (TRACT) checklist includes 19 items organised into seven domains that are applicable to every RCT: 1) Governance, 2) Author Group, 3) Plausibility of Intervention Usage, 4) Timeframe, 5) Drop-out Rates, 6) Baseline Characteristics, and 7) Outcomes. Each item can be answered as either no concerns, some concerns/no information, or major concerns. If a study is assessed and found to have a majority of items rated at a major concern level, then editors, reviewers or evidence synthesizers should consider a more thorough investigation, including assessment of original individual participant data. CONCLUSIONS: The TRACT checklist is the first checklist ...