在急性中风试验中实用设计的方法审查
Ayooluwanimi Peniel Okikiolu1, Sucharita Ray1,2, Kamalesh Chakravarty2
1Department of Clinical Neurosciences & Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
概括
实用设计在III期急性中风试验中越来越多地使用,现在超过一半的人采用了这种方法. 这一转变反映了改善的中风护理和对现实世界的适用性的关注.
科学领域:
- 临床试验方法论 临床试验方法论
- 神经学 神经学
- 公共卫生 公共卫生
背景情况:
- 传统的随机对照试验 (RCT) 通常使用"解释性"方法.
- 这与结合现实世界,务实考虑的设计形成鲜明对比.
研究的目的:
- 评估在III期急性中风RCT中采用实用设计的情况.
- 评估中风研究中对现实世界的适用性趋势.
主要方法:
- 在主要数据库 (MEDLINE,Embase,Cochrane) 进行全面的文献搜索,截至2024年7月.
- 使用实用解释连续性指标摘要 (PRECIS-2) 工具对136个III期急性中风RCT进行了评分.
- 使用Cochrane偏差风险工具评估偏差风险.
主要成果:
- 52% (共136项中的71项) 的试验使用PRECIS-2被归类为实用性试验.
- 大多数实用试验 (63.2%) 显示偏差风险较低.
- 实用试验规模较大,多中心,跨国,并具有更广泛的纳入标准.
结论:
- 在过去的十年中,急性中风干预的实用试验设计显著增加.
- 这一趋势表明急性中风护理的进步,以及对现实世界的相关性日益强调.
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