Suissa S, Shuster J J
Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada.
Biometrics. 1991 Jun;47(2):361-72.
An exact unconditional method for the design and analysis of the 2 x 2 matched-pairs trial is presented. Unlike the exact conditional method, which is based on only the number of discordant pairs, the exact unconditional method uses the total number N of sampled pairs. This unconditional test, based on a simple Z statistic, yields sample sizes that are generally smaller than those produced by the exact conditional test for the cases tabulated herein, namely one-sided alpha = .01, .025, and .05 along with 80% and 90% power. Moreover, it is found to be uniformly more powerful than the latter for all the combinations of parameters considered in this paper, namely alpha = .01, .025, and .05, and N = 10(1)200. The method is illustrated by assessing various design options of an in vitro study of the effectiveness of antimicrobial agents. Some numerical examples of matching efficiency are also given.
本文提出了一种用于2×2配对试验设计与分析的精确无条件方法。与仅基于不一致配对数的精确条件方法不同，精确无条件方法使用抽样配对的总数N。这种基于简单Z统计量的无条件检验，对于本文所列表格中的情况，即单侧α = 0.01、0.025和0.05以及80%和90%的检验效能，所得到的样本量通常比精确条件检验产生的样本量小。此外，对于本文所考虑的所有参数组合，即α = 0.01、0.025和0.05以及N = 10(1)200，发现该方法始终比精确条件方法更具检验效能。通过评估抗菌剂有效性体外研究的各种设计选项来说明该方法。还给出了一些匹配效率的数值示例。
