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.
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| http://dx.doi.org/10.1097/01.aud.0000438377.15003.6b | DOI Listing |
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