不同类型的集群成员在平行集群集群随机试验中,集群是机构:用于帮助识别的分类系统,有六个拟议的设计
L E Marsden1, C A Surr2, A W Griffiths3
1Leeds Institute of Clinical Trials Research, University of Leeds, Worsley Building, Clarendon Way, Leeds, LS2 9JT, UK.
Trials
|September 30, 2025
概括
本研究引入了一种新的分类系统,用于对平行组集群随机试验 (PG-CRT) 的集群成员资格. 它确定了六种类型,以改善试验设计和报告.
科学领域:
- 临床试验方法论 临床试验方法论
- 医疗保健服务研究 医疗服务研究
背景情况:
- 集群随机试验 (CRT) 已经建立了类型 (平行组,因数组,阶梯,交叉组).
- 现有的指南缺乏关于将CRT设计特征与个体级暴露和集群内的测量联系的细节.
- 护理家庭试验的经验强调了需要在平行组CRT中对集群成员的精细分类系统.
研究的目的:
- 在平行组集群随机试验 (PG-CRT) 中,为不同类型的集群成员制开发一个全面的分类系统.
- 在现有的类型学基础上构建,并解决指导指南中的差距,以描述集群中的个人如何暴露和测量.
主要方法:
- 采用了七个阶段的开发过程.
- 包括对开放队列PG-CRT的范围审查,逐步型CRT类型的调整,以及与已发表的试验进行测试.
- 通过研讨会收录了15名经验丰富的试验者的反,通过在线调查收录了39名试验者的反.
主要成果:
- 开发了一个分类系统,识别了PG-CRT中的六种类型的集群成员资格.
- 这些包括已建立的封闭队列和横截面设计,以及新的类别:新入学持续招聘,开放队列与离散招聘,开放队列与持续招聘,以及非标准的封闭队列设计.
- 该系统包括六个核心设计特征和五个额外的考虑因素,用图表说明.
结论:
- 需要进一步研究这些集群成员区别的统计影响.
- CONSORT报告准则需要更新,以包括关于集群成员类型的具体指导.
- 方法研究应该调查以前未被标记的集群成员类型的统计和实际影响.
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