Woolson R F, Bean J A, Rojas P B
Biometrics. 1986 Dec;42(4):927-32.
Sample size determination for case-control studies of chronic disease are often based on the simple 2 X 2 tabular cross-classification of exposure and disease, thereby ignoring stratification which may be considered in the analysis. One consequence of this approach is that the sample size may be inadequate to attain a specified power and size when performing a statistical analysis on J 2 X 2 tables using Cochran's (1954, Biometrics 10, 417-451) statistic or the Mantel-Haenszel (1959, Journal of the National Cancer Institute 22, 719-748) statistic. A sample size formula is derived from Cochran's statistic and it is compared with the corresponding one derived when the data are treated as unstratified, and also with two other formulas proposed for stratified data analysis. The formula developed yields values slightly higher than one recently proposed by Muñoz and Rosner (1984, Biometrics 40, 995-1004), which assumes that both margins of each 2 X 2 table are fixed, while the present study considers only the case-control margin to be fixed.
慢性病病例对照研究的样本量确定通常基于暴露与疾病的简单2×2表格交叉分类，从而忽略了在分析中可能会考虑的分层因素。这种方法的一个后果是，当使用 Cochr an（1954年，《生物统计学》10，417 - 451）统计量或Mantel - Haenszel（1959年，《国家癌症研究所杂志》22，719 - 748）统计量对J个2×2表格进行统计分析时，样本量可能不足以达到指定的检验效能和规模。从 Cochr an统计量推导出一个样本量公式，并将其与将数据视为未分层时推导的相应公式进行比较，同时也与为分层数据分析提出的其他两个公式进行比较。所推导的公式得出的值略高于Muñoz和Rosner（1984年，《生物统计学》40，995 - 1004）最近提出的一个公式，后者假设每个2×2表格的两个边缘都是固定的，而本研究仅考虑病例对照边缘是固定的。
