Abstract
BACKGROUND: Wearable devices could be used to continuously monitor vital signs in patients who are hospitalized, but they require validation. OBJECTIVE: This study aimed to evaluate the clinical validity of the prototype of a semiautomated wearable wrist device (ChroniSense Polso) to measure vital signs and provide National Early Warning Scores (NEWSs). METHODS: Vital signs and NEWSs measured using the wearable device were compared with standard, nurse-lead manual measurements. We enrolled adult patients (aged ≥18 years) who required vital sign measurements at least every 6 hours in a UK teaching district general hospital. Wearable device measurements were not used for clinical decision-making. The primary outcome was the agreement on the individual National Early Warning parameter scores and vital sign measurements: respiratory rate, oxygen saturation, body temperature, systolic blood pressure, and heart rate. Secondary outcomes were the agreement on the total NEWS, incidence of adverse events, and user acceptance. To compare the wearable device measurements with the standard measurements, we analyzed vital sign measurements by limits of agreement (Bland-Altman analysis) and conducted κ agreement analyses for NEWSs. A user experience survey was conducted with questions about comfort of the wrist device, safety, preference, and use. RESULTS: We included 132 participants in the study, with a mean age of 62 (SD 15.81) years; most of them were men (102/132, 77.3%). The highest weighted κ values were found for heart rate (0.69, 95% CI 0.57-0.81 for all 385 measurements) and systolic blood pressure (0.39, 95% CI 0.30-0.47 for all 339 measurements). Weighted κ values were low for respiration rate (0.03, 95% CI -0.001 to 0.05 for all 445 measurements), temperature (0, 95% CI 0-0 for all 231 measurements), and oxygen saturation (-0.11, 95% CI -0.20 to -0.02 for all 187 measurements). Weighted κ using Cicchetti-Allison weights showed κ of 0.20 (95% CI 0.03-0.38) when using all 56 total NEWSs. The user acceptance survey found that approximately half (45/91, 49%) of the participants found it comfortable to wear the device and liked its appearance. Most (85/92, 92%) of them said that they would wear the device during their next hospital visit, and many (74/92, 80%) said that they would recommend it to others. CONCLUSIONS: This study shows the promising use of a prototype wearable device to measure vital signs in a hospital setting. Agreement between the standard measurements and wearable device measurements was acceptable for systolic blood pressure and heart rate, but needed to be improved for respiration rate, temperature, and oxygen saturation. Future studies need to improve the clinical validity of this wearable device. Large studies are required to assess clinical outcomes and cost-effectiveness of wearable devices for vital sign measurement. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-028219.