Credence of Device Acceptability: A Statistical Method for Comparing Blood Pressure Measurement Device Accuracy Across Studies

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.