• Nian-Sheng Tang, Bo Zhang, and Hu-Qiong Li.
• a Department of Statistics , Yunnan University , Kunming , China.
• J Biopharm Stat. 2013 Jan 1; 23 (6): 1261-80.

AbstractStratified matched-pair studies are often designed for adjusting stratification factors in modern medical researches. This article investigates a homogeneity test of differences between two correlated proportions in stratified matched-pair studies. We propose three test procedures, including an asymptotic test, bootstrap test, and multiple comparison procedures, and determine sample size requirements for such tests in a stratified matched-pair study. Simulation studies are conducted to evaluate the performance of the three test procedures and the accuracy of our derived sample size formulas. Empirical results show that (1) the likelihood ratio statistic is robust, while the score statistic and the modified score statistic are conservative in some cases of our considered settings; (2) the likelihood ratio statistic and the score statistic with the bootstrap method and the MaxT procedure behave satisfactorily in the sense that their type I error rates are close to the pre-given significance level; and (3) the derived sample size formulas are rather accurate. A real example from a clinical laboratory study is used to illustrate the proposed methodologies.

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