title: Sample size determination for equivalence test using rate ratio of sensitivity and specificity in paired sample data.
abstract: Before implementing a new diagnostic test, we may wish to study whether this test is noninferior to a reference test with respect to the sensitivity and/or the specificity. This paper discusses sample size determination for one-sided equivalence (or noninferiority) testing of the rate ratio using paired-sample data. Using large sample theory, this paper derives asymptotic sample size formulae for the required number of subjects giving a desired power 100(1 - beta)% at a specified alpha-level. To evaluate the accuracy of these formulae, this paper considers several test statistics and uses Monte Carlo simulation to estimate the corresponding type I error and power with the given resulting sample sizes in a variety of situations. Finally, this paper notes those situations for which the asymptotic sample size formulae developed here are of limited use and suggests a simple empirical adjustment to alleviate this limitation.
authors.affiliation: Department of Mathematical and Computer Sciences, San Diego State University, San Diego, CA 92182, USA. kjl@rohan.sdsu.edu
authors.forename: K J
authors.initials: KJ
authors.lastname: Lui
authors.forename: W G
authors.initials: WG
authors.lastname: Cumberland
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D016555:Matched-Pair Analysis; D015233:Models, Statistical; D009010:Monte Carlo Method; D011336:Probability; D018401:Sample Size; D015983:Selection Bias; D012680:Sensitivity and Specificity; D013810:Therapeutic Equivalency