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Statistical Methodology: I. Incorporating the Prevalence of Disease into the Sample Size Calculation for Sensitivity and Specificity
Abstract
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.
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Cited by
Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis
Bujang, M. A. (2016) · JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH · doi:10.7860/jcdr/2016/18129.8744 · Cited by 624
Geocadin, R. G., Callaway, C. W., Fink, E. L., Golan, E., Greer, D. M., Ko, N. U., Lang, E., Licht, D. J., Marino, B. S., McNair, N. D., et al. (2019) · Circulation · doi:10.1161/cir.0000000000000702 · Cited by 428
D'Agostino, M. A., Conaghan, P., Le Bars, M., Baron, G., Grassi, W., Martin-Mola, E., Wakefield, R., Brasseur, J.-L., So, A., Backhaus, M., et al. (2005) · Annals of the Rheumatic Diseases · doi:10.1136/ard.2005.037994 · Cited by 288
Le Guellec, B., Lefèvre, A., Geay, C., Shorten, L., Bruge, C., Hacein-Bey, L., Amouyel, P., Pruvo, J.-P., Kuchcinski, G., & Hamroun, A. (2024) · Radiology: Artificial Intelligence · doi:10.1148/ryai.230364 · Cited by 115
Udedi, M., Muula, A. S., Stewart, R. C., & Pence, B. W. (2019) · BMC Psychiatry · doi:10.1186/s12888-019-2062-2 · Cited by 113
Metadata
- Authors
- Buderer, N. M. F.
- Venue
- Academic Emergency Medicine
- Publisher
- Wiley
- Published
- 1996-09
- Volume
- 3
- Issue
- 9
- Pages
- 895-900
- ISSN
- 1069-6563 (ISSN-L)
- 1553-2712
- OpenAlex
- W2022961959
- Cited by
- 921
- References
- 0
- FWCI
- 1.19
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Statistical Methodology: I. Incorporating the Prevalence of Disease into the Sample Size Calculation for Sensitivity and Specificity. https://app.cochat.ai/papers/10.1111/j.1553-2712.1996.tb03538.x
- The paper
- 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. https://doi.org/10.1111/j.1553-2712.1996.tb03538.x
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
