Pitfalls of and controversies in cluster randomization trials
Pitfalls of and controversies in cluster randomization trials
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DOI：
10.2105/ajph.94.3.416
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发表时间：
2004-03-01
影响因子：
12.7
通讯作者：
Klar, N
中科院分区：
文献类型：
--
作者：
Donner, A;Klar, N
现在众所周知，标准统计程序在应用于以个体为推理单位的整群随机试验时就会失效。由此产生的结果是，进行此类试验的研究人员面临着多种设计选择，包括主要推理单位的选择、基线时的预后因素对聚类进行匹配或分层的程度，以及与聚类二次抽样相关的决策。此外，为单独随机试验制定的伦理原则的应用也可能需要修改。我们讨论与这些问题相关的几个主题，重点是在试验计划阶段必须做出的选择以及需要避免的一些潜在陷阱。
It is now well known that standard statistical procedures become invalidated when applied to cluster randomized trials in which the unit of inference is the individual. A resulting consequence is that researchers conducting such trials are faced with a multitude of design choices, including selection of the primary unit of inference, the degree to which clusters should be matched or stratified by prognostic factors at baseline, and decisions related to cluster subsampling. Moreover, application of ethical principles developed for individually randomized trials may also require modification.We discuss several topics related to these issues, with emphasis on the choices that must be made in the planning stages of a trial and on some potential pitfalls to be avoided.