title: Sample size requirements for establishing clinical test-retest standards.
abstract: OBJECTIVE
  To define sample size requirements for establishing clinical serial monitoring protocols.
  
  
  METHODS
  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.
authors.affiliation: 1VA RR&D National Center for Rehabilitative Auditory Research (NCRAR), Portland VA, Medical Center, Portland, Oregon, USA; 2Oregon Health and Science University, Department of Public Health and Preventive Medicine, Portland, Oregon, USA; and 3Department of Statistics, University of South Carolina, 216 LeConte College Columbia, South Carolina, USA.
authors.forename: Garnett P
authors.initials: GP
authors.lastname: McMillan
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Hanson
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects; D001301:Audiometry, Pure-Tone; D002945:Cisplatin / Q000009:adverse effects; D005188:False Negative Reactions; D034381:Hearing Loss / Q000139:chemically induced / Q000175:diagnosis* / Q000503:physiopathology; D006801:Humans; D016011:Normal Distribution; D017084:Otoacoustic Emissions, Spontaneous / Q000502:physiology; D018401:Sample Size
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin