Adjusted homogeneity tests of odds ratios when data are clustered

Three modified tests for homogeneity of the odds ratio for a series of 2 × 2 tables are studied when the data are clustered. In the case of clustered data, the standard tests for homogeneity of odds ratios ignore the variance inflation caused by positive correlation among responses of subjects within the same cluster, and therefore have inflated Type I error. The modified tests adjust for the variance inflation in the three existing standard tests: Breslow–Day, Tarone and the conditional score test. The degree of clustering effect is measured by the intracluster correlation coefficient, ρ . A variance correction factor derived from ρ is then applied to the variance estimator in the standard tests of homogeneity of the odds ratio. The proposed tests are an application of the variance adjustment method commonly used in correlated data analysis and are shown to maintain the nominal significance level in a simulation study. Copyright © 2004 John Wiley & Sons, Ltd.