Statistical Methodology: I. Incorporating the Prevalence of Disease into the Sample Size Calculation for Sensitivity and Specificity
Article first published online: 29 SEP 2008
© 1996 Society for Academic Emergency Medicine
Academic Emergency Medicine
Volume 3, Issue 9, pages 895–900, September 1996
How to Cite
Buderer, N. M. F. (1996), Statistical Methodology: I. Incorporating the Prevalence of Disease into the Sample Size Calculation for Sensitivity and Specificity. Academic Emergency Medicine, 3: 895–900. doi: 10.1111/j.1553-2712.1996.tb03538.x
- Issue published online: 29 SEP 2008
- Article first published online: 29 SEP 2008
- Received: September 15, 1995; revision received: January 11, 1996; accepted: February 8, 1996; updated: February 22, 1996.
- sample size;
- test performance;
- disease prevalence;
Careful consideration of statistical issues related to the choice of a sample size is critical for achieving meaningful results in research studies designed to evaluate diagnostic tests. When assessing the ability of a diagnostic test to screen for disease, the parameters sensitivity, specificity, and predictive values are of interest. Study sample size requirements can be calculated based on a clinically acceptable degree of precision, the hypothesized values of sensitivity and specificity, and the estimated prevalence of disease in the target population. The simple methods and tables in this paper guide the researcher when deciding how many subjects to sample in a study designed to estimate both the sensitivity and the specificity of a diagnostic test, given a specified precision and estimated disease prevalence.