Current Evidence for Continuous Vital Signs Monitoring by Wearable Wireless Devices in Hospitalized Adults: Systematic Review.

Jobbe P L Leenen,Gijsbert A Patijn,Joris D Van Dijk,Crista Leerentveld,Lisette Schoonhoven,Henderik L Van Westreenen

doi:10.2196/18636

Abstract

BackgroundContinuous monitoring of vital signs by using wearable wireless devices may allow for timely detection of clinical deterioration in patients in general wards in comparison to detection by standard intermittent vital signs measurements. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date.ObjectiveThe aim of this study was to provide a systematic review for health care professionals regarding the current evidence about the validation, feasibility, clinical outcomes, and costs of wearable wireless devices for continuous monitoring of vital signs.MethodsA systematic and comprehensive search was performed using PubMed/MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials from January 2009 to September 2019 for studies that evaluated wearable wireless devices for continuous monitoring of vital signs in adults. Outcomes were structured by validation, feasibility, clinical outcomes, and costs. Risk of bias was determined by using the Mixed Methods Appraisal Tool, quality assessment of diagnostic accuracy studies 2nd edition, or quality of health economic studies tool.ResultsIn this review, 27 studies evaluating 13 different wearable wireless devices were included. These studies predominantly evaluated the validation or the feasibility outcomes of these devices. Only a few studies reported the clinical outcomes with these devices and they did not report a significantly better clinical outcome than the standard tools used for measuring vital signs. Cost outcomes were not reported in any study. The quality of the included studies was predominantly rated as low or moderate.ConclusionsWearable wireless continuous monitoring devices are mostly still in the clinical validation and feasibility testing phases. To date, there are no high quality large well-controlled studies of wearable wireless devices available that show a significant clinical benefit or cost-effectiveness. Such studies are needed to help health care professionals and administrators in their decision making regarding implementation of these devices on a large scale in clinical practice or in-home monitoring.

Highlights

Continuous monitoring of vital signs of inpatients is a common practice in intensive care, medium care, operation theatre, and recovery ward settings [1]
Studies were considered eligible for inclusion when they met the following criteria: consisted of participants older than 18 years; evaluated a continuous monitoring device that measured vital signs such as heart rate (HR), respiratory rate (RR), blood pressure (BP), temperature, and blood oxygen saturation (SpO2) [16]; used a device that measured ≥2 vital signs; used a device that was wireless and wearable; and published after 2009
Studies were excluded when the device was not wearable by the patient and the device had no formal approval as a medical device through the Conformité Européenne (CE) mark or Food and Drug Administration (FDA) clearance or both

Summary

Introduction

Continuous monitoring of vital signs of inpatients is a common practice in intensive care, medium care, operation theatre, and recovery ward settings [1]. Serious unexpected adverse events do occur regularly in general wards, especially in high-risk postsurgical or elderly frail patients [7,8,9,10,11,12,13] This incidence of adverse events is expected to increase owing to the aging population, increasing complexity of in-hospital care, increasing pressure to limit health care costs, and increasing shortage of nursing staff. These adverse events may be prevented or mitigated if continuous monitoring of vital signs would be available to facilitate early detection of the deteriorating trends in vital signs, thereby allowing timely interventions [14,15,16]. A large number of studies on many different wearable devices have been reported in recent years, but a systematic review is not yet available to date

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