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. 2023 Jan;32(1):195-206.
doi: 10.1177/09622802221137743. Epub 2022 Nov 9.

Use of clinical tolerance limits for assessing agreement

Patrick Taffé  1
Affiliations

Use of clinical tolerance limits for assessing agreement

Patrick Taffé. Stat Methods Med Res. 2023 Jan.

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] Stat Methods Med Res. 2023 Dec;32(12):2472. doi: 10.1177/09622802231203438. Epub 2023 Oct 4. Stat Methods Med Res. 2023. PMID: 37791706 Free PMC article. No abstract available.

Abstract

In this study, we have further extended the methodology proposed, first, by Lin et al. (2002) and, later, extended by Stevens et al. (2017, 2018), on the coverage probability/probability of agreement, by relaxing the strong parametric assumptions regarding the distribution of the latent trait and developing inference methods allowing to compute both pointwise and simultaneous confidence bands. The methodology requires repeated measurements by at least one of the two measurement methods and accommodates heteroscedastic measurement errors. It performs often very well even when one has only one measurement by one of the two measurement methods and at least five repeated measurements from the other. It circumvents some of the deficiencies of the Bland & Altman limits of agreement method and provides a more direct assessment of the agreement level.

Keywords: Agreement; differential bias; limits of agreement; method comparison; proportional bias; tolerance limits.

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Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Scatter plot of the simulated data.
Figure 2.
Figure 2.
(Left) Scatter plot of the differences y1–y2 versus the true latent trait with tolerance limits, (right) scatter plot of the true conditional probability of agreement.
Figure 3.
Figure 3.
(Left) Scatter plot of the differences y1–y2 versus the BLUP of x with tolerance limits, (right) conditional probability of agreement plot.
Figure 4.
Figure 4.
(Left) Bland & Altman's LoA plot, (right) agreement plot.
Figure 5.
Figure 5.
(Left) Scatter plot of the differences y1–y2 versus the BLUP of x with non-constant tolerance limits, (right) conditional probability of agreement plot.
See this image and copyright information in PMC

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References

    1. Altman DG, Bland JM. Measurement in medicine: the analysis of method comparison studies. Statistician 1983; 32: 307–317.
    1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1: 307–310. - PubMed
    1. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Meth Med Res 1999; 8: 135–160. - PubMed
    1. Taffé P. Effective plots to assess bias and precision in method comparison studies. Stat Meth Med Res 2018; 27: 1650–1660. - PubMed
    1. Taffé P. Assessing bias, precision, and agreement in method comparison studies. Stat Meth Med Res 2020; 29: 778–796. - PubMed