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Ear & Hearing:
doi: 10.1097/01.aud.0000438377.15003.6b
Brief Report

Sample Size Requirements for Establishing Clinical Test–Retest Standards

McMillan, Garnett P.1,2; Hanson, Timothy E.3

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Abstract

Objective: To define sample size requirements for establishing clinical serial monitoring protocols.

Design: The 95% confidence bound of a critical difference score is defined and used to identify false-negative regions suitable for sample size calculation.

Results: Reference subject sample sizes vary from about 40 to 480 subjects, depending on the minimum acceptable error rates of the clinical protocol.

Conclusions: Sample size requirements for establishing test–retest standards are generally defined and suitable for any serial monitoring protocol.

© 2014 by Lippincott Williams & Wilkins

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