Blood Pressure Measurement Device Accuracy Evaluation: Statistical Considerations with an Implementation in R
Date
Authors
Chandel, Tanvi
Miranda, Victor
Lowe, Andrew
Lee, Tet Chuan
Supervisor
Item type
Journal Article
Degree name
Journal Title
Journal ISSN
Volume Title
Publisher
MDPI AG
Abstract
Inaccuracies from devices for non-invasive blood pressure measurements have been well reported with clinical consequences. International standards, such as ISO 81060-2 and the seminal AAMI/ANSI SP10, define protocols and acceptance criteria for these devices. Prior to applying these standards, a sample size of N >= 85 is mandatory, that is, the number of distinct subcjects used to calculate device inaccuracies. Often, it is not possible to gather such a large sample. Many studies apply these standards with a smaller sample. The objective of the paper is to introduce a methodology that broadens the method first developed by the AAMI Sphygmomanometer Committee for accepting a blood pressure measurement device. We study changes in the acceptance region for various sample sizes using the sampling distribution for proportions and introduce a methodology for estimating the exact probability of the acceptance of a device. This enables the comparison of the accuracies of existing device development techniques even if they were studied with a smaller sample size. The study is useful in assisting BP measurement device manufacturers. To assist clinicians, we present a newly developed “bpAcc” package in R to evaluate acceptance statistics for various sample sizes.Description
Keywords
40 Engineering, 4008 Electrical Engineering, Bioengineering, 4 Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, 4008 Electrical engineering
Source
Technologies, ISSN: 2227-7080 (Print); 2227-7080 (Online), MDPI AG, 12(4), 44-44. doi: 10.3390/technologies12040044
Publisher's version
Rights statement
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).