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Biostatistics Advance Access published online on October 27, 2006
Biostatistics, doi:10.1093/biostatistics/kxl034
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© The Author 2006. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org
Received June 21, 2005
Revised September 17, 2006
Accepted October 20, 2006

Article

Sample size determination for matched-pair equivalence trials using rate ratio

Nian-Sheng Tang 1, Man-Lai Tang 2 *, and Shun-Fang Wang 1

1 Department of Statistics, Yunnan University, Kunming 650091, China
2 Department of Mathematics, Hong Kong Baptist University, Kowloon, Hong Kong

* To whom correspondence should be addressed.
Man-Lai Tang, E-mail: mltang{at}math.hkbu.edu.hk


  Abstract

In this article, we compare Wald-type, logarithmic-transformation and Fieller-type statistics for the classical two-sided equivalence testing of the rate ratio under matched-pair designs with a binary endpoint. These statistics can be implemented through sample-based, constrained least-squares estimation and constrained maximum likelihood estimation methods. Sample size formulae based on the constrained maximum likelihood estimation method are developed. We consider formulae that control a pre-specified power or confidence width. Our simulation studies show that statistics based on the constrained maximum likelihood estimation method generally out-perform other statistics and methods with respect to actual type I error rate and average width of confidence intervals. Also, the corresponding sample size formulae are valid asymptotically in the sense that the exact power and actual coverage probability for the estimated sample size are generally close to their pre-specified values. The methods are illustrated with a real example from a clinical laboratory study.

Keywords: constrained maximum likelihood estimation method; equivalence study; sample size formula; score test statistic.
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