Design of Clinical Trials to Validate Cuffless Blood Pressure Monitors

Currently the market is flooded with cuffless blood pressure monitors. However, these devices are not always as accurate as consumers and physicians might expect. Therefore, the clinical accuracy of these blood pressure monitors should be verified using a suitable standard. As the current standards for blood pressure monitors are designed for cuff-based devices these are not suitable for verifying the accuracy of monitors without cuffs due to essential differences between blood pressure monitors with and without cuffs. For example, almost all cuffless monitors must be calibrated, may be used as wearables during activity and may measure blood pressure at body parts other than upper-arm and wrist. For this reason, there is an urgent need for a new standard to test cuffless monitors that covers these different aspects. This chapter describes characteristics of cuffless monitors, highlights the differences between cuff-based and cuffless monitors, and proposes methods for testing. Additionally, attention is paid to the selection of participants in relation to good clinical practice and to statistical reporting of the figures. Finally, some published clinical studies to the accuracy of cuffless blood pressure monitors are discussed.