Performance of wearable watch-type home blood pressure measurement devices in a real-world clinical sample.
Blood pressure
Hypertension
Monitoring
Wearable blood pressure watches
Journal
Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123
Informations de publication
Date de publication:
19 Dec 2023
19 Dec 2023
Historique:
received:
18
09
2023
accepted:
29
11
2023
medline:
19
12
2023
pubmed:
19
12
2023
entrez:
19
12
2023
Statut:
aheadofprint
Résumé
Independent testing of home blood pressure (BP) measurement (HBPM) devices is often lacking, particularly among older and multi-morbid patients. We studied the Bpro G2 (using tonometry), Omron HeartGuide (using occlusive oscillometric technology), and Heartisans (using photoplethysmography) wrist watch HBPM devices against a gold standard brachial sphygmomanometer. To test device performance, we used the ISO81060-2 protocol (though this protocol cannot formally validate cuffless devices). We also used linear mixed models to compare adjusted longitudinal BP measurements between devices. Finally, as a surrogate for usability, we recorded instances of device failure where no BP measurement was returned. We enrolled 128 participants (median [Q1-Q3] age 53 [40-65] years, 51% male, 46% on antihypertensive drugs), of whom 100 were suitable for the primary analysis. All three devices had mean BP values within 5 mmHg of sphygmomanometry. However, due to insufficient reliability (e.g., wider than accepted standard deviations of mean BP), none of the three devices passed all criteria required by the ISO81060-2 protocol. In adjusted longitudinal analyses, the Omron device also systematically underestimated systolic and diastolic BP (- 8.46 mmHg; 95% CI 6.07, 10.86; p < 0.001; and - 2.53 mmHg; 95% CI - 4.03, - 1.03; p = 0.001; respectively). Nevertheless, compared to the Omron device, BPro and Heartisans devices had increased odds of failure (BPro: odds ratio [OR] 5.24; p < 0.0001; Heartisans: OR 5.61; p < 0.001). While we could not formally validate the cuffless devices, our results show that wearable technologies will require improvements to offer reliable BP assessment. This study also highlights the need for validation protocols specifically designed for cuffless BP measurement technologies.
Sections du résumé
BACKGROUND
BACKGROUND
Independent testing of home blood pressure (BP) measurement (HBPM) devices is often lacking, particularly among older and multi-morbid patients.
METHODS
METHODS
We studied the Bpro G2 (using tonometry), Omron HeartGuide (using occlusive oscillometric technology), and Heartisans (using photoplethysmography) wrist watch HBPM devices against a gold standard brachial sphygmomanometer. To test device performance, we used the ISO81060-2 protocol (though this protocol cannot formally validate cuffless devices). We also used linear mixed models to compare adjusted longitudinal BP measurements between devices. Finally, as a surrogate for usability, we recorded instances of device failure where no BP measurement was returned.
RESULTS
RESULTS
We enrolled 128 participants (median [Q1-Q3] age 53 [40-65] years, 51% male, 46% on antihypertensive drugs), of whom 100 were suitable for the primary analysis. All three devices had mean BP values within 5 mmHg of sphygmomanometry. However, due to insufficient reliability (e.g., wider than accepted standard deviations of mean BP), none of the three devices passed all criteria required by the ISO81060-2 protocol. In adjusted longitudinal analyses, the Omron device also systematically underestimated systolic and diastolic BP (- 8.46 mmHg; 95% CI 6.07, 10.86; p < 0.001; and - 2.53 mmHg; 95% CI - 4.03, - 1.03; p = 0.001; respectively). Nevertheless, compared to the Omron device, BPro and Heartisans devices had increased odds of failure (BPro: odds ratio [OR] 5.24; p < 0.0001; Heartisans: OR 5.61; p < 0.001).
CONCLUSIONS
CONCLUSIONS
While we could not formally validate the cuffless devices, our results show that wearable technologies will require improvements to offer reliable BP assessment. This study also highlights the need for validation protocols specifically designed for cuffless BP measurement technologies.
Identifiants
pubmed: 38112747
doi: 10.1007/s00392-023-02353-7
pii: 10.1007/s00392-023-02353-7
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Science Foundation Ireland Research
ID : 15/RP/2765
Organisme : Science Foundation Ireland Research
ID : 19/FFP/7002
Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
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