Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study

Abstract

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 (SpO2) 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 SpO2. 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 SpO2 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.

Smartwatch, oxygen saturation, and COVID-19: Trustworthy?

“…In an Everlast TR10 ® analytical survey, despite not measuring SpO 2 , the study results showed that this smartwatch was not accurate enough to be used as a vital sign measurement device 3 . Administration (FDA) of the United States of America.…”

“…The availability and accessibility of smartwatches allow the measurement of SpO 2 at home. However, many of these vital sign measurement devices have not been formally studied in a clinical setting 3 .…”

Smartwatch, oxygen saturation, and COVID-19: Trustworthy?

“…In an Everlast TR10 ® analytical survey, despite not measuring SpO 2 , the study results showed that this smartwatch was not accurate enough to be used as a vital sign measurement device 3 .…”

Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network

“…30 Consequently, in many studies included in our review, participants with known systolic or diastolic blood pressure abnormalities were excluded 31 32 or at least reported. [33][34][35][36][37][38] Other considerations concern the use of medication and dietary supplements that may affect HR recordings and should be considered when designing validation protocols. Interestingly,…”