个人参与者数据完整性工具用于评估随机试验的完整性
Kylie E Hunter1, Mason Aberoumand1, Sol Libesman1
1NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Research synthesis methods
|August 13, 2024
概括
研究人员开发了个人参与者数据 (IPD) 完整性工具,以评估随机对照试验 (RCT). 该工具对IPD的可信度进行选,确保可靠的政策和实践证据综合.
科学领域:
- 生物医学研究方法的方法.
- 临床试验的完整性临床试验的完整性
背景情况:
- 越来越多的人对研究可信度的担忧,需要对个人参与者数据 (IPD) 进行严格审查.
- 缺乏标准化指导来评估IPD完整性一直是研究方法的重大差距.
研究的目的:
- 开发和验证一个全面的工具,用于选随机对照试验 (RCT) 的数据完整性问题.
- 提供一个结构化的方法来评估IPD在临床研究中的可靠性.
主要方法:
- 该IPD诚信工具是通过文献审查,专家咨询和对元分析的试点开发的.
- 该工具包括31个项目 (13个研究层面,18个IPD特定),涵盖数据模式,基线特征和一致性检查.
- 初步验证涉及评估13个数据集,包括5个已知的完整性问题,并根据评估完善工具.
主要成果:
- IPD完整性工具有效地使用自动化和用户评级项目的组合在八个领域中检查RCT的完整性问题.
- 初步验证证明了该工具在识别已知的数据完整性问题研究中的准确性.
- 该工具将试验分类为"没有问题"",一些问题"或"重大问题",以指导决策.
结论:
- IPD完整性工具提供了一种系统方法来评估使用IPD的RCT的完整性.
- 该工具使证据综合师,编辑和研究人员能够确定RCT的可靠性,以便将其纳入证据库.
- 通过IPD审查提高研究证据的可靠性,可以支持明智的政策和临床实践.
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