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关于随机对照试验外部有效性的定义和评估的共识:德尔菲研究
Andres Jung1,2, Tobias Braun3,4, Susan Armijo-Olivo5,6
1Department of Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), Institute of Health Sciences, Universität zu Lübeck, Lübeck, Germany.
Research synthesis methods
|December 25, 2023
概括
研究人员建立了一个共识定义和14个标准来评估随机对照试验 (RCT) 的外部有效性. 这为开发测量健康研究结果通用性的工具提供了基础.
科学领域:
- 卫生研究方法论 卫生研究方法论
- 临床试验评估的临床试验评估
- 证据综合 证据综合
背景情况:
- 外部有效性对于健康研究决策至关重要,但缺乏随机对照试验 (RCT) 的标准化评估工具.
- 显著的异质性和缺乏共识阻碍了RCT外部有效性的测量工具的开发.
研究的目的:
- 达成对RCT外部有效性定义的共识.
- 在系统性审查中建立评估RCT外部有效性的标准.
主要方法:
- 一项为期三轮的Delphi在线研究,涉及来自不同学科和国家的84名小组成员.
- 在各轮调查中追踪了小组成员的参与和共识 (>=67%的同意).
- 德尔菲调查的开发是通过先前的系统文献审查得到的信息.
主要成果:
- 在对外部有效性的定义上达成共识:试验结果在多大程度上支持对其他情况 (人群,环境,干预措施,结果,背景) 的概括.
- 专家小组成员同意了在系统审查中评估RCT外部有效性的14个标准.
结论:
- 德尔菲研究提供了一个基于共识的标准,用于开发未来的外部有效性测量工具.
- 建议进行进一步的研究,以适应,试点测试,并将这些标准验证为实际的评估工具.
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