To propose a checklist that can be used to assess trustworthiness of randomized controlled trials (RCTs). 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. 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. The TRACT checklist is the first checklist developed specifically 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.

中文翻译：

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评估随机对照试验可信度的清单（TRACT 清单）：概念提案和试点

提出可用于评估随机对照试验 (RCT) 可信度的清单。使用 Moher 等人提出的四阶段方法开发了筛选工具。这包括确定范围、审查证据基础、提出试点项目清单以及召开共识会议。最初的清单是由一个核心小组制定的，该小组多年来一直参与有问题的随机对照试验的评估。我们在由多个利益相关者组成的共识小组中进行了试点，其中包括卫生专业人员、审稿人、期刊编辑、政策制定者、研究人员和证据综合专家。要求每个成员使用清单对三篇文章进行评分，然后在共识会议上讨论结果。随机临床试验可信度 (TRACT) 清单包括 19 个项目，分为七个领域，适用于每个 RCT：1) 治理，2) 作者组，3) 干预使用的合理性，4) 时间范围，5) 退出率，6) 基线特征，以及 7) 结果。每个项目都可以回答为“不关心”、“有些关心/无信息”或“主要关心”。如果一项研究经过评估并发现大多数项目被评为主要关注级别，那么编辑、审稿人或证据合成者应考虑进行更彻底的调查，包括评估原始个体参与者数据。TRACT 检查表是第一个专门为检测 RCT 中的可信度问题而开发的检查表。它可能会帮助编辑，