Sample size for case-control studies using Cochran's statistic

Abstract

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.