PMID- 29695375 OWN - NLM STAT- MEDLINE DCOM- 20190610 LR - 20230502 IS - 1438-8871 (Electronic) IS - 1439-4456 (Print) IS - 1438-8871 (Linking) VI - 20 IP - 4 DP - 2018 Apr 25 TI - A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices. PG - e111 LID - 10.2196/jmir.8009 [doi] LID - e111 AB - BACKGROUND: Clinical guidelines recommend monitoring of blood pressure at home using an automatic blood pressure device for the management of hypertension. Devices are not often calibrated against direct blood pressure measures, leaving health care providers and patients with less reliable information than is possible with current technology. Rigorous assessments of medical devices are necessary for establishing clinical utility. OBJECTIVE: The purpose of our study was 2-fold: (1) to assess the validity and perform iterative calibration of indirect blood pressure measurements by a noninvasive wrist cuff blood pressure device in direct comparison with simultaneously recorded peripheral and central intra-arterial blood pressure measurements and (2) to assess the validity of the measurements thereafter of the noninvasive wrist cuff blood pressure device in comparison with measurements by a noninvasive upper arm blood pressure device to the Canadian hypertension guidelines. METHODS: The cloud-based blood pressure algorithms for an oscillometric wrist cuff device were iteratively calibrated to direct pressure measures in 20 consented patient participants. We then assessed measurement validity of the device, using Bland-Altman analysis during routine cardiovascular catheterization. RESULTS: The precalibrated absolute mean difference between direct intra-arterial to wrist cuff pressure measurements were 10.8 (SD 9.7) for systolic and 16.1 (SD 6.3) for diastolic. The postcalibrated absolute mean difference was 7.2 (SD 5.1) for systolic and 4.3 (SD 3.3) for diastolic pressures. This is an improvement in accuracy of 33% systolic and 73% diastolic with a 48% reduction in the variability for both measures. Furthermore, the wrist cuff device demonstrated similar sensitivity in measuring high blood pressure compared with the direct intra-arterial method. The device, when calibrated to direct aortic pressures, demonstrated the potential to reduce a treatment gap in high blood pressure measurements. CONCLUSIONS: The systolic pressure measurements of the wrist cuff have been iteratively calibrated using gold standard central (ascending aortic) pressure. This improves the accuracy of the indirect measures and potentially reduces the treatment gap. Devices that undergo auscultatory (indirect) calibration for licensing can be greatly improved by additional iterative calibration via intra-arterial (direct) measures of blood pressure. Further clinical trials with repeated use of the device over time are needed to assess the reliability of the device in accordance with current and evolving guidelines for informed decision making in the management of hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03015363; https://clinicaltrials.gov/ct2/show/NCT03015363 (Archived by WebCite at http://www.webcitation.org/6xPZgseYS). CI - (c)Sarah Melville, Robert Teskey, Shona Philip, Jeremy A Simpson, Sohrab Lutchmedial, Keith R Brunt. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 25.04.2018. FAU - Melville, Sarah AU - Melville S AUID- ORCID: 0000-0003-4867-3979 AD - Department of Pharmacology, Dalhousie Medicine New Brunswick, Saint John, NB, Canada. AD - Cardiovascular Research New Brunswick, New Brunswick Heart Centre, Saint John, NB, Canada. FAU - Teskey, Robert AU - Teskey R AUID- ORCID: 0000-0003-0204-9732 AD - Cardiovascular Research New Brunswick, New Brunswick Heart Centre, Saint John, NB, Canada. AD - Department of Cardiology, Saint John Regional Hospital, Horizon Health Network, Saint John, NB, Canada. FAU - Philip, Shona AU - Philip S AUID- ORCID: 0000-0002-4209-5779 AD - Department of Pharmacology, Dalhousie Medicine New Brunswick, Saint John, NB, Canada. AD - Cardiovascular Research New Brunswick, New Brunswick Heart Centre, Saint John, NB, Canada. FAU - Simpson, Jeremy A AU - Simpson JA AUID- ORCID: 0000-0003-4482-547X AD - Department of Human Health Nutritional Sciences, University of Guelph, Guelph, ON, Canada. FAU - Lutchmedial, Sohrab AU - Lutchmedial S AUID- ORCID: 0000-0003-3253-080X AD - Cardiovascular Research New Brunswick, New Brunswick Heart Centre, Saint John, NB, Canada. AD - Department of Cardiology, Saint John Regional Hospital, Horizon Health Network, Saint John, NB, Canada. FAU - Brunt, Keith R AU - Brunt KR AUID- ORCID: 0000-0002-5728-8135 AD - Department of Pharmacology, Dalhousie Medicine New Brunswick, Saint John, NB, Canada. AD - Cardiovascular Research New Brunswick, New Brunswick Heart Centre, Saint John, NB, Canada. AD - Department of Cardiology, Saint John Regional Hospital, Horizon Health Network, Saint John, NB, Canada. LA - eng SI - ClinicalTrials.gov/NCT03015363 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180425 PL - Canada TA - J Med Internet Res JT - Journal of medical Internet research JID - 100959882 SB - IM MH - Adult MH - Aged MH - Blood Pressure/*physiology MH - Blood Pressure Determination/*instrumentation MH - Blood Pressure Monitors/*standards MH - Calibration MH - Female MH - Humans MH - Hypertension/*diagnosis MH - Male MH - Middle Aged MH - Reproducibility of Results MH - Wrist/*blood supply PMC - PMC5943631 OTO - NOTNLM OT - diastolic hypertension OT - patient self-management OT - smartphone applications OT - telemonitoring OT - vital signs COIS- Conflicts of Interest: None declared. EDAT- 2018/04/27 06:00 MHDA- 2019/06/14 06:00 PMCR- 2018/04/25 CRDT- 2018/04/27 06:00 PHST- 2017/05/10 00:00 [received] PHST- 2017/11/16 00:00 [accepted] PHST- 2017/11/10 00:00 [revised] PHST- 2018/04/27 06:00 [entrez] PHST- 2018/04/27 06:00 [pubmed] PHST- 2019/06/14 06:00 [medline] PHST- 2018/04/25 00:00 [pmc-release] AID - v20i4e111 [pii] AID - 10.2196/jmir.8009 [doi] PST - epublish SO - J Med Internet Res. 2018 Apr 25;20(4):e111. doi: 10.2196/jmir.8009.