The George Institute for Global Health, University of New South Wales, Sydney, Australia.
MRC Clinical Trials Unit at University College London, London, UK.
J Epidemiol Popul Health. 2024 Feb;72(1):202196. doi: 10.1016/j.jeph.2024.202196. Epub 2024 Feb 10.
In cluster randomized trials, individuals from the same cluster tend to have more similar outcomes than individuals from different clusters. This correlation must be taken into account in the analysis of every cluster trial to avoid incorrect inferences. In this paper, we describe the principles guiding the analysis of cluster trials including how to correctly account for intra-cluster correlations as well as how to analyze more advanced designs such as stepped-wedge and cluster cross-over trials. We then describe how to handle specific issues such as small sample sizes and missing data.
在整群随机临床试验中,同一群组的个体往往比不同群组的个体具有更相似的结局。在分析每项整群试验时,必须考虑这种相关性,以避免错误的推论。本文描述了指导整群试验分析的原则,包括如何正确考虑组内相关性以及如何分析更先进的设计,如阶乘设计和群组交叉设计。然后,我们描述了如何处理小样本量和缺失数据等具体问题。