title: Sample size determination for establishing equivalence/noninferiority via ratio of two proportions in matched-pair design.
abstract: In this article, we propose approximate sample size formulas for establishing equivalence or noninferiority of two treatments in match-pairs design. Using the ratio of two proportions as the equivalence measure, we derive sample size formulas based on a score statistic for two types of analyses: hypothesis testing and confidence interval estimation. Depending on the purpose of a study, these formulas can be used to provide a sample size estimate that guarantees a prespecified power of a hypothesis test at a certain significance level or controls the width of a confidence interval with a certain confidence level. Our empirical results confirm that these score methods are reliable in terms of true size, coverage probability, and skewness. A liver scan detection study is used to illustrate the proposed methods.
authors.affiliation: Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA. stmlt@channing.harvard.edu
authors.forename: Man-Lai
authors.initials: ML
authors.lastname: Tang
authors.forename: Nian-Sheng
authors.initials: NS
authors.lastname: Tang
authors.forename: Ivan Siu-Fung
authors.initials: IS
authors.lastname: Chan
authors.forename: Ben Ping-Shing
authors.initials: BP
authors.lastname: Chan
mesh_terms: D001706:Biopsy; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006801:Humans; D008107:Liver Diseases / Q000175:diagnosis / Q000473:pathology; D016555:Matched-Pair Analysis; D018401:Sample Size