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A standardized validity assessment protocol for physiological signals from wearable technology: Methodological underpinnings and an application to the E4 biosensor.

ABSTRACT: Wearable physiological measurement devices for ambulatory research with novel sensing technology are introduced with ever increasing frequency, requiring fast, standardized, and rigorous validation of the physiological signals measured by these devices and their derived parameters. At present, there is a lack of consensus on a standardized protocol or framework with which to test the validity of this new technology, leading to the use of various (often unfit) methods. This study introduces a comprehensive validity assessment protocol for physiological signals (electrodermal activity and cardiovascular activity) and investigates the validity of the E4 wearable (an example of such a new device) on the three levels proposed by the protocol: (1) the signal level, with a cross-correlation; (2) the parameter level, with Bland-Altman plots; and (3) the event level, with the detection of physiological changes due to external stressor levels via event difference plots. The results of the protocol show that the E4 wearable is valid for heart rate, RMSSD, and SD at the parameter and event levels, and for the total amplitude of skin conductance responses at the event level when studying strong sustained stressors. These findings are in line with the prior literature and demonstrate the applicability of the protocol. The validity assessment protocol proposed in this study provides a comprehensive, standardized, and feasible method for assessment of the quality of physiological data coming from new wearable (sensor) technology aimed at ambulatory research.

SUBMITTER: van Lier HG

PROVIDER: S-EPMC7148282 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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A standardized validity assessment protocol for physiological signals from wearable technology: Methodological underpinnings and an application to the E4 biosensor.

van Lier Hendrika G HG Pieterse Marcel E ME Garde Ainara A Postel Marloes G MG de Haan Hein A HA Vollenbroek-Hutten Miriam M R MMR Schraagen Jan Maarten JM Noordzij Matthijs L ML

Behavior research methods 20200401 2

Wearable physiological measurement devices for ambulatory research with novel sensing technology are introduced with ever increasing frequency, requiring fast, standardized, and rigorous validation of the physiological signals measured by these devices and their derived parameters. At present, there is a lack of consensus on a standardized protocol or framework with which to test the validity of this new technology, leading to the use of various (often unfit) methods. This study introduces a com ...[more]

PMID: 31290128

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Project description:BackgroundMonitoring glucose and other parameters in persons with type 1 diabetes (T1D) can enhance acute glycemic management and the diagnosis of long-term complications of the disease. For most persons living with T1D, the determination of insulin delivery is based on a single measured parameter-glucose. To date, wearable sensors exist that enable the seamless, noninvasive, and low-cost monitoring of multiple physiological parameters.ObjectiveThe objective of this literature survey is to explore whether some of the physiological parameters that can be monitored with noninvasive, wearable sensors may be used to enhance T1D management.MethodsA list of physiological parameters, which can be monitored by using wearable sensors available in 2020, was compiled by a thorough review of the devices available in the market. A literature survey was performed using search terms related to T1D combined with the identified physiological parameters. The selected publications were restricted to human studies, which had at least their abstracts available. The PubMed and Scopus databases were interrogated. In total, 77 articles were retained and analyzed based on the following two axes: the reported relations between these parameters and T1D, which were found by comparing persons with T1D and healthy control participants, and the potential areas for T1D enhancement via the further analysis of the found relationships in studies working within T1D cohorts.ResultsOn the basis of our search methodology, 626 articles were returned, and after applying our exclusion criteria, 77 (12.3%) articles were retained. Physiological parameters with potential for monitoring by using noninvasive wearable devices in persons with T1D included those related to cardiac autonomic function, cardiorespiratory control balance and fitness, sudomotor function, and skin temperature. Cardiac autonomic function measures, particularly the indices of heart rate and heart rate variability, have been shown to be valuable in diagnosing and monitoring cardiac autonomic neuropathy and, potentially, predicting and detecting hypoglycemia. All identified physiological parameters were shown to be associated with some aspects of diabetes complications, such as retinopathy, neuropathy, and nephropathy, as well as macrovascular disease, with capacity for early risk prediction. However, although they can be monitored by available wearable sensors, most studies have yet to adopt them, as opposed to using more conventional devices.ConclusionsWearable sensors have the potential to augment T1D sensing with additional, informative biomarkers, which can be monitored noninvasively, seamlessly, and continuously. However, significant challenges associated with measurement accuracy, removal of noise and motion artifacts, and smart decision-making exist. Consequently, research should focus on harvesting the information hidden in the complex data generated by wearable sensors and on developing models and smart decision strategies to optimize the incorporation of these novel inputs into T1D interventions.

Project description:BackgroundThe term posthospital syndrome has been used to describe the condition in which older patients are transiently frail after hospitalization and have a high chance of readmission. Since low activity and poor sleep during hospital stay may contribute to posthospital syndrome, the continuous monitoring of such parameters by using affordable wearables may help to reduce the prevalence of this syndrome. Although there have been systematic reviews of wearables for physical activity monitoring in hospital settings, there are limited data on the use of wearables for measuring other health variables in hospitalized patients.ObjectiveThis systematic review aimed to evaluate the validity and utility of wearable devices for monitoring hospitalized patients.MethodsThis review involved a comprehensive search of 7 databases and included articles that met the following criteria: inpatients must be aged >18 years, the wearable devices studied in the articles must be used to continuously monitor patients, and wearables should monitor biomarkers other than solely physical activity (ie, heart rate, respiratory rate, blood pressure, etc). Only English-language studies were included. From each study, we extracted basic demographic information along with the characteristics of the intervention. We assessed the risk of bias for studies that validated their wearable readings by using a modification of the Consensus-Based Standards for the Selection of Health Status Measurement Instruments.ResultsOf the 2012 articles that were screened, 14 studies met the selection criteria. All included articles were observational in design. In total, 9 different commercial wearables for various body locations were examined in this review. The devices collectively measured 7 different health parameters across all studies (heart rate, sleep duration, respiratory rate, oxygen saturation, skin temperature, blood pressure, and fall risk). Only 6 studies validated their results against a reference device or standard. There was a considerable risk of bias in these studies due to the low number of patients in most of the studies (4/6, 67%). Many studies that validated their results found that certain variables were inaccurate and had wide limits of agreement. Heart rate and sleep were the parameters with the most evidence for being valid for in-hospital monitoring. Overall, the mean patient completion rate across all 14 studies was >90%.ConclusionsThe included studies suggested that wearable devices show promise for monitoring the heart rate and sleep of patients in hospitals. Many devices were not validated in inpatient settings, and the readings from most of the devices that were validated in such settings had wide limits of agreement when compared to gold standards. Even some medical-grade devices were found to perform poorly in inpatient settings. Further research is needed to determine the accuracy of hospitalized patients' digital biomarker readings and eventually determine whether these wearable devices improve health outcomes.

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Dataset Information

A standardized validity assessment protocol for physiological signals from wearable technology: Methodological underpinnings and an application to the E4 biosensor.

Publications

A standardized validity assessment protocol for physiological signals from wearable technology: Methodological underpinnings and an application to the E4 biosensor.

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