Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: May 13, 2019
Open Peer Review Period: May 16, 2019 - Jun 16, 2019
Date Accepted: Jun 28, 2019
(closed for review but you can still tweet)
Validation and acceptability of a cuffless wrist-worn wearable blood pressure monitoring device among users and healthcare professionals: A mixed-method study
ABSTRACT
Background:
Blood pressure (BP) is an important modifiable cardiovascular risk factor yet its long-term monitoring remains problematic. Wearable cuffless devices enable the capture of multiple BP measures during everyday activities and could improve BP monitoring, but little is known about their validity or acceptability.
Objective:
This study aimed to validate a wrist-worn cuffless wearable BP device, and assess its acceptability among users and healthcare professionals.
Methods:
A mixed-methods study was conducted to examine validity and comparability of a wearable cuffless BP device against ambulatory and home devices. BP was measured simultaneously over 24-hours using wearable and ambulatory devices, and over 7-days using wearable and home devices. Pearson’s correlation coefficients compared the degree of association between the measures, and limits of agreement (LOA; Bland-Altman plots) were generated to assess measurement bias. Semi-structured interviews were conducted with users and 10 healthcare professionals to assess acceptability, facilitators and barriers to using the wearable device. Interviews were audio recorded, transcribed and analysed.
Results:
9090 BP measurements were collected from 20 healthy volunteers (20.3±5.4 years, N=10 females). Mean±SD systolic (SBP)/diastolic (DBP) pressures measured using the ambulatory (24-hours), home (7 days) and wearable (7 days) devices were 126±10/75±6 mmHg, 112±10/71±9 mmHg and 125±4/77±3 mmHg, respectively. Mean (LOA) biases and precision between the wearable and ambulatory devices over 24-hours were 0.5 (-10.1 to 11.1) mmHg for SBP and 2.24 (-17.6 to 13.1) mmHg for DBP. The mean biases (LOA) and precision between the wearable and home device over 7 days were -12.7 (-28.7 to 3.4) mmHg for SBP and -5.6 (-20.5 to 9.2) mmHg for DBP. The wearable BP device was well accepted by participants who found the device easy to wear and use. Both participants and health care providers agreed of the utility and potential role of wearable cuffless devices to improve BP monitoring.
Conclusions:
Wearable BP measures compared well against a gold-standard ambulatory device, indicating potential for this user-friendly method to augment BP management—particularly by enabling long-term monitoring that could improve treatment titration and increase understanding of users’ BP response during daily activity and stressors. Clinical Trial: Not applicable
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.