Credence of Device Acceptability: A Statistical Method for Comparing Blood Pressure Measurement Device Accuracy Across Studies
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Journal Article
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Springer Science and Business Media LLC
Abstract
Accurate blood pressure measurement (BPM) is critical for managing hypertension, a leading global health concern. While international standards like ISO 81060-2 are applied to ensure commercial BPM device safety and effectiveness, gauging compliance earlier in research and development can be challenging. This study proposes an enhanced statistical evaluation framework that calculates a credence of device acceptability, aligned with international standards, which can be used to assess and compare results of device evaluation experiments having various sample sizes, blood pressure ranges, mean, standard deviation and correlations in error. Applied to ten studies featuring diverse BPM methods, the framework demonstrates its capability to provide insights beyond the face-value application of the performance criteria of international standards. This framework advances BPM technology by providing more appropriate tools to assess device accuracy.Description
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Journal of Human Hypertension, ISSN: 1476-5527 (Print); 1476-5527 (Online), Springer Science and Business Media LLC, 1-8. doi: 10.1038/s41371-025-01040-6
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Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.