使用"群体内的试验" (TwiCs) 设计的随机试验的特征,同意模式和挑战 - - 范围审查
Alain Amstutz1, Christof M Schönenberger2, Benjamin Speich2
1CLEAR Methods Center, Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Oslo Center for Biostatistics and Epidemiology, Oslo University Hospital, University of Oslo, Oslo, Norway; Bristol Medical School, University of Bristol, Bristol, UK.
群体内试验 (TwiCs) 与传统试验相比具有务实优势,但其使用仍然有限. 需要进行进一步的研究,以解决这种创新的试验设计的同意和干预不吸收方面的挑战.
科学领域:
- 临床试验方法论 临床试验方法论
- 实用研究设计实用研究设计
背景情况:
- 传统的随机试验面临的挑战包括缓慢的招聘和有限的外部有效性.
- 群体内试验 (TwiCs) 是解决这些局限性的务实替代方案.
研究的目的:
- 识别和总结使用TwiCs设计的随机对照试验.
- 分析TwiC的设计特征,同意程序,结果和挑战.
主要方法:
- 系统地搜索主要数据库和试验注册表的文献,直到2022年12月.
- 定义TwiCs作为嵌入式随机试验与后随机化同意干预.
- 数据提取和对已识别的TwiCs进行描述/定性分析.
主要成果:
- 在全球范围内,在各种医学领域 (瘤学,传染病,心理健康) 发现了46个TwiCs.
- 大多数TwiC都是由调查人员发起的,由公共资金资助的,并招募了门诊患者.
- 观察到知情同意程序的显著变化和25%的中位数干预不吸收.
结论:
- 虽然TwiC在各个领域都有应用,但仍然很少见.
- 不一致的同意程序和实质性干预不采用需要进一步调查.
- 额外的研究对于优化TwiCs的规划,实施和分析至关重要.
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