Abstract
BackgroundNew 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.ObjectiveThe 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.MethodsWe 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.ResultsOf 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%.ConclusionsBoth 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.
Highlights
Principal Results We enrolled a total of 127 subjects, and data from 41 participants were discarded because of excessive variation in sequential standard blood pressure (BP) measurements, as specified by the American National Standards Institute (ANSI)/Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 2013 standards for evaluating noninvasive automated sphygmomanometers [3,9,10], and from 1 participant because of repeated failure of BodiMetrics calibration; 85 subjects were included in the final analysis
The BodiMetrics tricorder failed in 6 (7%) participants for a total of 13 (5%) of the maximum 255 BP measurements that could have been obtained in the 85 participants
We found that the accuracy guidelines for heart rate (HR) measurements were met by both investigational devices
Summary
New consumer devices are being developed to monitor multiple physiological parameters at home or on the go—often connecting with mobile devices to provide user-friendly updates of health status (mobile health) The vision behind these devices is that they will transform conventional medicine into digital medicine, facilitating a transition from treating disease to promoting health, from being reactive to being proactive, from being general to being individualized, from offering office-based health care to bringing health care to patients, and from interrupting daily life to being incorporated into it [1]. This vision is appealing, but presently, some of the publicized work in the field of consumer physiological monitoring appears to be characterized by excessive hype [2] Many of these new technologies have yet to be formally studied in a clinical setting, and there are more than a few examples of digital snake oil [2] with substantial societal uptake of devices before their eventual discrediting [3]. This practice appears to be a barrier to truly advancing the field of consumer physiological monitoring
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