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Sample Size Requirements in Diagnostic Test Performance Studies

진단검사의 특성 추정을 위한 표본크기

  • Pak, Son-Il (College of Veterinary Medicine and Institute of Veterinary Science, Kangwon National University) ;
  • Oh, Tae-Ho (College of Veterinary Medicine, Kyungpook National University)
  • 박선일 (강원대학교 수의과대학 및 동물의학종합연구소) ;
  • 오태호 (경북대학교 수의과대학)
  • Accepted : 2014.12.08
  • Published : 2015.02.28

Abstract

There has been increasing attention on sample size requirements in peer reviewed medical literatures. Accordingly, a statistically-valid sample size determination has been described for a variety of medical situations including diagnostic test accuracy studies. If the sample is too small, the estimate is too inaccurate to be useful. On the other hand, a very large sample size would yield the estimate with more accurate than required but may be costly and inefficient. Choosing the optimal sample size depends on statistical considerations, such as the desired precision, statistical power, confidence level and prevalence of disease, and non-statistical considerations, such as resources, cost and sample availability. In a previous paper (J Vet Clin 2012; 29: 68-77) we briefly described the statistical theory behind sample size calculations and provided practical methods of calculating sample size in different situations for different research purposes. This review describes how to calculate sample sizes when assessing diagnostic test performance such as sensitivity and specificity alone. Also included in this paper are tables and formulae to help researchers for designing diagnostic test studies and calculating sample size in studies evaluating test performance. For complex studies clinicians are encouraged to consult a statistician to help in the design and analysis for an accurate determination of the sample size.

Keywords

References

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