Sample size requirements for establishing clinical test-retest standards

Ear Hear. Mar-Apr 2014;35(2):283-6. doi: 10.1097/01.aud.0000438377.15003.6b.


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.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Antineoplastic Agents / adverse effects
  • Audiometry, Pure-Tone
  • Cisplatin / adverse effects
  • False Negative Reactions
  • Hearing Loss / chemically induced
  • Hearing Loss / diagnosis*
  • Hearing Loss / physiopathology
  • Humans
  • Normal Distribution
  • Otoacoustic Emissions, Spontaneous / physiology
  • Sample Size


  • Antineoplastic Agents
  • Cisplatin