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.

journal_name

Biometrics

journal_title

Biometrics

authors

Tang ML,Tang NS,Chan IS,Chan BP

doi

10.1111/j.0006-341x.2002.00957.x

subject

Has Abstract

pub_date

2002-12-01 00:00:00

pages

957-63

issue

4

eissn

0006-341X

issn

1541-0420

journal_volume

58

pub_type

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