Campbell Marion K, Thomson Sean, Ramsay Craig R, MacLennan Graeme S, Grimshaw Jeremy M
Health Services Research Unit, University of Aberdeen, Polwarth Building Foresterhill, Aberdeen, Scotland AB25 2ZD UK.
Comput Biol Med. 2004 Mar;34(2):113-25. doi: 10.1016/S0010-4825(03)00039-8.
Cluster randomized trials, where individuals are randomized in groups are increasingly being used in healthcare evaluation. The adoption of a clustered design has implications for design, conduct and analysis of studies. In particular, standard sample sizes have to be inflated for cluster designs, as outcomes for individuals within clusters may be correlated; inflation can be achieved either by increasing the cluster size or by increasing the number of clusters in the study. A sample size calculator is presented for calculating appropriate sample sizes for cluster trials, whilst allowing the implications of both methods of inflation to be considered.
整群随机试验,即将个体分组进行随机化,在医疗保健评估中越来越多地被采用。采用整群设计对研究的设计、实施和分析都有影响。特别是,由于整群内个体的结果可能存在相关性,整群设计的标准样本量必须增加;可以通过增加整群大小或增加研究中的整群数量来实现样本量增加。本文提供了一个样本量计算器,用于计算整群试验的合适样本量,同时考虑两种样本量增加方法的影响。