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在随机对照试验中评估可靠性的检查清单 (TRACT检查清单):概念建议和试点建议

Ben W Mol^1,2, Shimona Lai¹, Ayesha Rahim¹

¹Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.

Research integrity and peer review

|June 19, 2023

概括

一个新的检查清单,随机临床试验可靠性 (TRACT) 检查清单,有助于评估随机对照试验 (RCT) 的可靠性. 该工具帮助编辑和研究人员识别已发表或提交的RCT中的潜在问题.

科学领域:

临床试验临床试验
基于证据的医学基于证据的医学.
研究诚信研究诚信

背景情况:

随机对照试验 (RCT) 对医学研究至关重要.
评估RCT的可信度对于可靠的证据综合至关重要.
现有的工具可能无法全面解决RCT可信度的所有方面.

研究的目的:

开发和提出一个新的检查清单来评估随机对照试验 (RCT) 的可靠性.
提供一种标准化工具,用于识别RCT中的潜在问题.

主要方法:

采用了四个阶段的开发方法,包括定义范围和证据审查.
一个核心小组创建了一个初始的检查清单,该核心小组具有评估有问题的RCT的专业知识.
一个由多方利益相关者组成的共识小组试行了检查清单,随后进行了讨论和改进.

主要成果:

随机临床试验可信度 (TRACT) 检查清单包括七个领域的19个项目:治理,作者组,干预可信度,时间框架,退学率,基线特征和结果.
每个项目都在没有担忧,一些担忧/没有信息或重大担忧等级上进行评级.
许多"重大问题"表明需要进行更深入的调查,可能包括个人参与者数据.

结论:

"TRACT检查清单"是第一个专门用于检测RCT可信度问题的工具.
它为编辑,出版商和研究人员提供了一种透明和可复制的方法来选RCT.
这份清单可以提高已发表的研究成果的整体质量和可靠性.

关键词:

检查清单检查清单检查清单随机对照试验是随机对照试验.研究完整性研究完整性可信度值得信赖值得信赖

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