Key result
This protocol describes an international, multicenter observational study to assess the feasibility of using patient-held wearable sensors for vital signs during acute medical emergencies.
Why the study?
Comparing distress vital signs to an individual's personal baseline from consumer sensors may be more appropriate than standard reference ranges, but patient usage rates are unknown.
Observational
Yes
This study protocol describes a multicenter European observational study to assess the feasibility of using patient-owned wearable devices to provide baseline vital signs during acute medical emergencies.
Personalized vital sign baselines via wearables remain untested at scale; leaves open whether adoption improves emergency assessment over population norms.
BACKGROUND Abnormalities of vital signs are quantified by comparison with normal ranges, which are those observed in resting healthy populations. It might be more appropriate to compare the vital sign values of an individual in distress with their own usual values recorded when they were stable and well. Sensors from smartwatches or smartphones might make this possible at scale, but the proportion of patients using them is not known. OBJECTIVE This study aimed to assess the feasibility of using heart rate and mobility data from patients’ own wearable sensors as part of clinical assessments at the time of presentation to hospitals with medical emergencies, and to quantify the difference between heart rate and the change in daily steps taken by the patient on admission to acute care compared with the previously recorded values at home. METHODS This is an international, multicenter observational study using the flashmob research design. The study will recruit patients aged 18 years and older who present to emergency departments, acute medical departments, or ambulatory emergency care with an acute medical complaint. Main end points of the study include the proportion of patients assessed for an acute complaint who use wearable devices to record vital signs. The study will describe the population that uses devices that collect vital signs in terms of sex, age group, digital literacy, and the severity of illness on presentation (as measured by a standard set of vital signs and frailty). Trends in heart rate and step counts measured in the month before presentation to acute care services will be reported according to discharge or admission status. Data will be collected during a pilot phase and during a single week in centers across Europe. RESULTS The study has been registered and passed the required approvals in the Netherlands Medical Ethics Committee (MEC-2022-0795) and the United Kingdom Integrated Research Application System (IRAS 321129). Based on the results of a pilot study performed at a single site in the United Kingdom, a flashmob study has been concluded in hospitals throughout Europe in May 2024 and reported in 2025. CONCLUSIONS With the increasing availability of consumer held devices able to record medically relevant information this study will provide information about the availability of these data for clinical use in a number of European settings. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/55975
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Barrington et al. (2024) conducted an observational in Medical emergencies. Patient-held wearable sensors (heart rate and mobility data) was evaluated on Proportion of patients assessed for an acute complaint who use wearable devices to record vital signs. This protocol describes an international, multicenter observational study to assess the feasibility of using patient-held wearable sensors for vital signs during acute medical emergencies.
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