DOI QR코드

DOI QR Code

진단검사의 특성 추정을 위한 표본크기

Sample Size Requirements in Diagnostic Test Performance Studies

  • 박선일 (강원대학교 수의과대학 및 동물의학종합연구소) ;
  • 오태호 (경북대학교 수의과대학)
  • 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)
  • 심사 : 2014.12.08
  • 발행 : 2015.02.28

초록

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.

키워드

참고문헌

  1. Alonzo TA, Pepe MS, Moskowitz CS. Sample size calculations for comparative studies of medical tests for detecting presence of disease. Stat Med 2002; 21: 835-852. https://doi.org/10.1002/sim.1058
  2. Altman DG. Practical statistics for medical research. London, England: Chapman and Hall, 1993.
  3. Cameron AR, Baldock FC. A new probability formula for surveys to substantiate freedom from disease. Prev Vet Med 1998; 34: 1-17. https://doi.org/10.1016/S0167-5877(97)00081-0
  4. Cannon RM. Sense and sensitivity: designing surveys based on an imperfect test. Prev Vet Med 2001; 49: 141-163. https://doi.org/10.1016/S0167-5877(01)00184-2
  5. Carley S, Dosman S, Jones SR, Harrison M. Simple nomograms to calculate sample size in diagnostic studies, Emerg Med J 2005; 22: 180-181. https://doi.org/10.1136/emj.2003.011148
  6. Carpenter TE. Use of sample size for estimating efficacy of a vaccine against an infectious disease. Am J Vet Res 2001; 62: 1582-1584. https://doi.org/10.2460/ajvr.2001.62.1582
  7. Christensen J, Gardner IA. Herd-level interpretation of test results for epidemiologic studies of animal diseases. Prev Vet Med 2000; 45: 83-106. https://doi.org/10.1016/S0167-5877(00)00118-5
  8. Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol 2005; 58: 859-862. https://doi.org/10.1016/j.jclinepi.2004.12.009
  9. Georgiadis MP, Johnson WO, Gardner IA. Sample size determination for estimation of the accuracy of two conditionally independent tests in the absence of a gold standard. Prev Vet Med 2005; 71: 1-10. https://doi.org/10.1016/j.prevetmed.2005.04.004
  10. Hardon DC, Rufenacht J, Hauser R, Stark KDC. Risk-based design of repeated surveys for the documentation of freedom from non-highly contagious diseases. Prev Vet Med 2002; 56: 179-192. https://doi.org/10.1016/S0167-5877(02)00193-9
  11. Karl E. Peace, The alternative hypothesis: one-sided or twosided? J Clin Epidemiol 1989; 42: 473-476. https://doi.org/10.1016/0895-4356(89)90137-6
  12. Knottnerus JA, Bouter LM. The ethics of sample size: twosided testing and one-sided thinking. J Clin Epidemiol 2001; 54: 109-110. https://doi.org/10.1016/S0895-4356(00)00276-6
  13. Knottnerus JA, Muris JW. Assessment of the accuracy of diagnostic tests: the cross-sectional study. J Clin Epidemiol 2003; 56: 1118-1128. https://doi.org/10.1016/S0895-4356(03)00206-3
  14. Li J, Fine J. On sample size for sensitivity and specificity in prospective diagnostic accuracy studies. Stat Med 2004; 23: 2537-2550. https://doi.org/10.1002/sim.1836
  15. Obuchowski NA. Sample size calculations in studies of test accuracy. Stat Methods Med Res 1998; 7: 371-392. https://doi.org/10.1191/096228098678080061
  16. Obuchowski NA, Graham RJ, Baker ME, Powell KA. Ten criteria for effective screening: their application to multislice CT screening for pulmonary and colorectal cancers. Am J Roentgenol 2001; 176: 1357-1362. https://doi.org/10.2214/ajr.176.6.1761357
  17. Pak SI, Oh TH. Sample Size Calculation in Medical Research. J Vet Clin 2012; 29: 68-77.
  18. Wagner B, Salman MD. Strategies for two-stage sampling designs for estimating herd-level prevalence. Prev Vet Med 2004; 66: 1-17. https://doi.org/10.1016/j.prevetmed.2004.07.008
  19. Young MJ, Bresnitz EA, Strom BL. Sample size nomograms for interpreting negative clinical studies. Ann Intern Med 1983; 99: 248-251. https://doi.org/10.7326/0003-4819-99-2-248