Klar N, Donner A
Department of Epidemiology and Biostatistics, University of Western Ontario London, Canada.
Stat Med. 1997 Aug 15;16(15):1753-64. doi: 10.1002/(sici)1097-0258(19970815)16:15<1753::aid-sim597>3.0.co;2-e.
Concern about potential imbalance on risk factors in community intervention trials often prompts researchers to adopt a pair-matched design in which similar clusters of individuals are paired and one member of each matched pair is then randomly assigned to the intervention group. It is known that if there are few clusters in trial, it becomes increasingly difficult to obtain close matches on all potential risk factors. One may thus offset any gain in precision with loss in degrees of freedom due to matching. We shown in this paper that there are also several analytic limitations with pair-matched designs. These include: the restriction of prediction models to cluster-level baseline risk factors (for example, cluster size), the inability to test for homogeneity of odds ratios, and difficulties in estimating the intracluster correlation coefficient. These limitations lead us to present arguments that favour stratified designs in which there are more than two clusters in each stratum.
对社区干预试验中危险因素潜在不平衡的担忧常常促使研究人员采用配对设计,即把相似的个体群组配对,然后将每对中的一个成员随机分配到干预组。众所周知,如果试验中的群组数量很少,就越来越难以在所有潜在危险因素上实现紧密匹配。这样一来,由于匹配而导致的自由度损失可能会抵消在精度上的任何提升。我们在本文中表明,配对设计在分析上也存在若干局限性。这些局限性包括:预测模型仅限于群组层面的基线危险因素(例如群组规模),无法检验比值比的同质性,以及估计组内相关系数存在困难。这些局限性促使我们提出支持分层设计的观点,即在每个分层中有两个以上的群组。