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INSPECT-SR:用于评估随机对照试验可靠性的工具

Jack Wilkinson¹, Calvin Heal¹, Ella Flemyng²

¹Centre for Biostatistics, Manchester Academic Health Science Centre, Faculty of Biology, Medicine, and Health, University of Manchester, Manchester, UK.

medRxiv : the preprint server for health sciences

|September 15, 2025

概括

有问题的随机对照试验 (RCT) 威胁到证据综合. INSPECT-SR工具有助于识别和排除不可靠的RCT,提高系统性审查和临床指南的可靠性.

科学领域:

临床研究方法论临床研究方法论
证据综合证据综合
研究诚信研究诚信

背景情况:

有问题的随机对照试验 (RCT) 对证据综合的完整性构成重大威胁.
关于数据可靠性的担忧,包括研究不当行为或关键错误,可能会危及RCT的发现.
未被检测到的问题RCT可能会被纳入系统审查和指导方针中,导致结果扭曲.

研究的目的:

开发一个工具来评估RCT的可信度.
为了使有问题的RCT从系统审查中识别和排除.
介绍INSPECT-SR工具及其附带的指导文件.

主要方法:

开发INSPECT-SR (在系统审查中调查有问题的临床试验) 工具.
创建一个相关的指导文件,以支持该工具的应用.
专注于评估RCT数据和研究结果的可靠性.

主要成果:

已经开发了INSPECT-SR工具.
为配合该工具,已创建了一份指导文件.
该工具有助于识别有问题的RCT.

结论:

INSPECT-SR工具解决了在证据综合中存在问题的RCT的关键问题.
通过识别不值得信赖的RCT,该工具提高了系统性审查的可靠性.
该工具和指南旨在提高指南中使用的临床证据的整体质量.

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