招聘偏差在阶梯集群随机对照试验中的作用:系统性审查
Antonina Yakimova1, Fraser Wiggins2, Mona Kanaan2
1Department of Health Sciences, University of York, York, UK tonya.yakimova@york.ac.uk.
BMJ open
|November 28, 2025
概括
阶梯集群随机试验 (SW-CRT) 显示出招聘偏差的高风险,类似于传统的集群RCT. 当随机化前招募不可能时,需要缓解策略.
科学领域:
- 临床试验方法论 临床试验方法论
- 流行病学 流行病学
- 生物统计学 生物统计学
背景情况:
- 步集群随机试验 (SW-CRTs) 是越来越受欢迎的设计.
- 了解和减轻偏见,特别是招聘偏见,对于SW-CRT至关重要.
- 众所周知,传统集群RCT的招聘偏差风险比单独随机试验更高.
研究的目的:
- 估计SW-CRT中招聘偏差的风险.
- 评估报告的质量和SW-CRT中偏差风险.
- 将SW-CRT中的招聘偏差风险与传统集群RCT进行比较.
主要方法:
- 使用四个数据库 (MEDLINE,Embase,CINAHL,Cochrane图书馆) 进行了系统审查.
- 偏差风险使用Cochrane风险偏差工具2.0 (集群RCT的扩展) 的子域1a和1b进行了评估.
- 包括2023年发布的64个SW-CRT,其中有两个独立审查员选和提取数据.
主要成果:
- 在包含的64个SW-CRT中,55% (n=35) 具有偏差的高风险.
- 23% (n=15) 的研究存在随机化过程的问题,33% (n=21) 的研究存在采样策略问题 (在没有面具的人员随机化后的招聘).
- 发现SW-CRT中招聘偏差的风险与集群RCT中的风险相当.
结论:
- SW-CRT容易受到招聘偏见的影响,风险与集群RCT相似.
- 建议在随机化之前不能进行招聘时实施缓解策略.
- 需要一个专门的工具来评估SW-CRT中的偏差风险,以考虑设计复杂性.
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