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
Editorial
. 2022 Oct;36(5):1241-1243.
doi: 10.1007/s10877-022-00853-x. Epub 2022 Apr 19.

Sample size determination in method comparison and observer variability studies

Oke Gerke  1   2 , Andreas Kristian Pedersen  3   4 , Birgit Debrabant  5 , Ulrich Halekoh  6 , Sören Möller  7   8
Affiliations
Editorial

Sample size determination in method comparison and observer variability studies

Oke Gerke et al. J Clin Monit Comput. 2022 Oct.

Abstract

The comparison of two quantitative measuring devices is often performed with the Limits of Agreement proposed by Bland and Altman in their seminal Lancet paper back in 1986. Sample size considerations were rare for such agreement analyses in the past, but recently several proposals have been made depending on how agreement is to be assessed and the number of replicates to be used. We have summarized recent developments and recommendations in various situations including a distinction between method comparison and observer variability studies. These include current state-of-the-art analysis of and reporting guidelines for agreement studies. General recommendations close the paper.

Keywords: Agreement; Bland-Altman analysis; Limits of Agreement; Repeatability; Reproducibility; Sample size.

PubMed Disclaimer

References

    1. Kottner J, Audigé L, Brorson S, Donner A, Gajewski BJ, Hróbjartsson A, Roberts C, Shoukri M, Streiner DL. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. J Clin Epidemiol. 2011;64:96–106. https://doi.org/10.1016/j.jclinepi.2010.03.002 . - DOI - PubMed
    1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307–10. https://doi.org/10.1016/S0140-6736(86)90837-8 . - DOI - PubMed
    1. Jan SL, Shieh G. The Bland-Altman range of agreement: Exact interval procedure and sample size determination. Comput Biol Med. 2018;100:247–52. https://doi.org/10.1016/j.compbiomed.2018.06.020 . - DOI - PubMed
    1. Shieh G. Assessing agreement between two methods of quantitative measurements: Exact test procedure and sample size calculation. Stat Biopharm Res. 2020;12:352–9. https://doi.org/10.1080/19466315.2019.1677495 . - DOI
    1. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999;8:135–60. https://doi.org/10.1177/096228029900800204 . - DOI - PubMed

Publication types

LinkOut - more resources