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Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study
BACKGROUND: New consumer health devices are being developed to easily monitor multiple physiological parameters on a regular basis. Many of these vital sign measurement devices have yet to be formally studied in a clinical setting but have already spread widely throughout the consumer market. OBJECT...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055753/ https://www.ncbi.nlm.nih.gov/pubmed/32049066 http://dx.doi.org/10.2196/16811 |
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author | Hahnen, Christina Freeman, Cecilia G Haldar, Nilanjan Hamati, Jacquelyn N Bard, Dylan M Murali, Vignesh Merli, Geno J Joseph, Jeffrey I van Helmond, Noud |
author_facet | Hahnen, Christina Freeman, Cecilia G Haldar, Nilanjan Hamati, Jacquelyn N Bard, Dylan M Murali, Vignesh Merli, Geno J Joseph, Jeffrey I van Helmond, Noud |
author_sort | Hahnen, Christina |
collection | PubMed |
description | BACKGROUND: New consumer health devices are being developed to easily monitor multiple physiological parameters on a regular basis. Many of these vital sign measurement devices have yet to be formally studied in a clinical setting but have already spread widely throughout the consumer market. OBJECTIVE: The aim of this study was to investigate the accuracy and precision of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO(2)) measurements of 2 novel all-in-one monitoring devices, the BodiMetrics Performance Monitor and the Everlast smartwatch. METHODS: We enrolled 127 patients (>18 years) from the Thomas Jefferson University Hospital Preadmission Testing Center. SBP and HR were measured by both investigational devices. In addition, the Everlast watch was utilized to measure DBP, and the BodiMetrics Performance Monitor was utilized to measure SpO(2). After 5 min of quiet sitting, four hospital-grade standard and three investigational vital sign measurements were taken, with 60 seconds in between each measurement. The reference vital sign measurements were calculated by determining the average of the two standard measurements that bounded each investigational measurement. Using this method, we determined three comparison pairs for each investigational device in each subject. After excluding data from 42 individuals because of excessive variation in sequential standard measurements per prespecified dropping rules, data from 85 subjects were used for final analysis. RESULTS: Of 85 participants, 36 (42%) were women, and the mean age was 53 (SD 21) years. The accuracy guidelines were only met for the HR measurements in both devices. SBP measurements deviated 16.9 (SD 13.5) mm Hg and 5.3 (SD 4.7) mm Hg from the reference values for the Everlast and BodiMetrics devices, respectively. The mean absolute difference in DBP measurements for the Everlast smartwatch was 8.3 (SD 6.1) mm Hg. The mean absolute difference between BodiMetrics and reference SpO(2) measurements was 3.02%. CONCLUSIONS: Both devices we investigated met accuracy guidelines for HR measurements, but they failed to meet the predefined accuracy guidelines for other vital sign measurements. Continued sale of consumer physiological monitors without prior validation and approval procedures is a public health concern. |
format | Online Article Text |
id | pubmed-7055753 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-70557532020-03-16 Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study Hahnen, Christina Freeman, Cecilia G Haldar, Nilanjan Hamati, Jacquelyn N Bard, Dylan M Murali, Vignesh Merli, Geno J Joseph, Jeffrey I van Helmond, Noud JMIR Mhealth Uhealth Original Paper BACKGROUND: New consumer health devices are being developed to easily monitor multiple physiological parameters on a regular basis. Many of these vital sign measurement devices have yet to be formally studied in a clinical setting but have already spread widely throughout the consumer market. OBJECTIVE: The aim of this study was to investigate the accuracy and precision of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO(2)) measurements of 2 novel all-in-one monitoring devices, the BodiMetrics Performance Monitor and the Everlast smartwatch. METHODS: We enrolled 127 patients (>18 years) from the Thomas Jefferson University Hospital Preadmission Testing Center. SBP and HR were measured by both investigational devices. In addition, the Everlast watch was utilized to measure DBP, and the BodiMetrics Performance Monitor was utilized to measure SpO(2). After 5 min of quiet sitting, four hospital-grade standard and three investigational vital sign measurements were taken, with 60 seconds in between each measurement. The reference vital sign measurements were calculated by determining the average of the two standard measurements that bounded each investigational measurement. Using this method, we determined three comparison pairs for each investigational device in each subject. After excluding data from 42 individuals because of excessive variation in sequential standard measurements per prespecified dropping rules, data from 85 subjects were used for final analysis. RESULTS: Of 85 participants, 36 (42%) were women, and the mean age was 53 (SD 21) years. The accuracy guidelines were only met for the HR measurements in both devices. SBP measurements deviated 16.9 (SD 13.5) mm Hg and 5.3 (SD 4.7) mm Hg from the reference values for the Everlast and BodiMetrics devices, respectively. The mean absolute difference in DBP measurements for the Everlast smartwatch was 8.3 (SD 6.1) mm Hg. The mean absolute difference between BodiMetrics and reference SpO(2) measurements was 3.02%. CONCLUSIONS: Both devices we investigated met accuracy guidelines for HR measurements, but they failed to meet the predefined accuracy guidelines for other vital sign measurements. Continued sale of consumer physiological monitors without prior validation and approval procedures is a public health concern. JMIR Publications 2020-02-12 /pmc/articles/PMC7055753/ /pubmed/32049066 http://dx.doi.org/10.2196/16811 Text en ©Christina Hahnen, Cecilia G Freeman, Nilanjan Haldar, Jacquelyn N Hamati, Dylan M Bard, Vignesh Murali, Geno J Merli, Jeffrey I Joseph, Noud van Helmond. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 12.02.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Hahnen, Christina Freeman, Cecilia G Haldar, Nilanjan Hamati, Jacquelyn N Bard, Dylan M Murali, Vignesh Merli, Geno J Joseph, Jeffrey I van Helmond, Noud Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study |
title | Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study |
title_full | Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study |
title_fullStr | Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study |
title_full_unstemmed | Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study |
title_short | Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study |
title_sort | accuracy of vital signs measurements by a smartwatch and a portable health device: validation study |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055753/ https://www.ncbi.nlm.nih.gov/pubmed/32049066 http://dx.doi.org/10.2196/16811 |
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