Sample Size Calculation for Agreement between Two Raters with Binary Endpoints using Exact Tests

Document Type

Article

Publication Date

11-16-2016

Publication Title

Statistical Methods in Medical Research

Volume

27

Issue

7

First page number:

2132

Last page number:

2141

Abstract

In an agreement test between two raters with binary endpoints, existing methods for sample size calculation are always based on asymptotic approaches that use limiting distributions of a test statistic under null and alternative hypotheses. These calculated sample sizes may be not reliable due to the unsatisfactory type I error control of asymptotic approaches. We propose a new sample size calculation based on exact approaches which control for the type I error rate. The two exact approaches are considered: one approach based on maximization and the other based on estimation and maximization. We found that the latter approach is generally more powerful than the one based on maximization. Therefore, we present the sample size calculation based on estimation and maximization. A real example from a clinical trial to diagnose low back pain of patients is used to illustrate the two exact testing procedures and sample size determination.

Keywords

Agreement test; Exact test; Kappa coefficient; Sample size; Unconditional test

Disciplines

Applied Statistics | Community Health

Language

English

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