Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Sep 30;22(4):177-185.
doi: 10.4103/2452-2473.357348. eCollection 2022 Oct-Dec.

User's guide to sample size estimation in diagnostic accuracy studies

Haldun Akoglu  1
Affiliations
Review

User's guide to sample size estimation in diagnostic accuracy studies

Haldun Akoglu. Turk J Emerg Med. .

Abstract

Sample size estimation is an overlooked concept and rarely reported in diagnostic accuracy studies, primarily because of the lack of information of clinical researchers on when and how they should estimate sample size. In this review, readers will find sample size estimation procedures for diagnostic tests with dichotomized outcomes, explained by clinically relevant examples in detail. We hope, with the help of practical tables and a free online calculator (https://turkjemergmed.com/calculator), researchers can estimate accurate sample sizes without a need to calculate from equations, and use this review as a practical guide to estimating sample size in diagnostic accuracy studies.

Keywords: Calculator; diagnostic accuracy; online; sample size; sensitivity; specificity.

PubMed Disclaimer

Conflict of interest statement

None declared.

Figures

Figure 1
Figure 1
Major study designs that are used to compare the diagnostic accuracy of tests
See this image and copyright information in PMC

References

    1. Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014;48:193–204. - PubMed
    1. Bachmann LM, Puhan MA, ter Riet G, Bossuyt PM. Sample sizes of studies on diagnostic accuracy: Literature survey. BMJ. 2006;332:1127–9. - PMC - PubMed
    1. Bochmann F, Johnson Z, Azuara-Blanco A. Sample size in studies on diagnostic accuracy in ophthalmology: A literature survey. Br J Ophthalmol. 2007;91:898–900. - PMC - PubMed
    1. Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003;20:453–8. - PMC - PubMed
    1. Holtman GA, Berger MY, Burger H, Deeks JJ, Donner-Banzhoff N, Fanshawe TR, et al. Development of practical recommendations for diagnostic accuracy studies in low-prevalence situations. J Clin Epidemiol. 2019;114:38–48. - PubMed