Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 15, 2021
Date Accepted: Jul 26, 2022
Scoping review of systematic reviews of digital biomarker-based studies
ABSTRACT
Background:
Sensors and digital devices have revolutionized the process of measuring, collecting, and storing health data. Digital biomarkers are defined as objective, quantifiable, physiological, and behavioral measures contained in digital devices that are portable, wearable, implantable, or digestible. The clinical utility of digital biomarkers is being supported by an increasing body of research.
Objective:
The present study intends to investigate the scope of digital biomarker-based systematic reviews.
Methods:
The current scoping review was organized using PRISMA-ScR. Limiting the search to English full-text systematic reviews of digital biomarkers that included at least one randomized controlled trial involving a human population and reporting changes in participants' health status. PubMed and the Cochrane library were searched. Separately, two reviewers screened and selected records. In addition, the qualified papers' reference lists were examined for additional reviews. The World Health Organization's (WHO) classification systems for diseases (ICD-11), health interventions (ICHI), and bodily functions (ICF) were used to classify populations, interventions, and outcomes.
Results:
66 reviews met the inclusion criteria, mostly were published by authors from the United States of America (18, 27.28%). The most prevalent disease areas were Circulatory System (n=12, 18.18%) and External Causes (n=12, 18.18%). 27 and 23 interventions were connected to health-related behaviors and the circulatory system, respectively. Looking after one's health (physical activity) (n=22) and demographic changes (mortality) (n=19) were the most commonly reported outcomes. A substantial number of digital devices, mostly in the form of wearables (n=39/66, 59.09 %) were employed as interventions (n=43/66, 65.15 %). Position sensors (n=33/66) and heart /pulse rate sensors (n=32/66) were identified as the most prevalent types of sensors utilized to capture digital biomarkers.
Conclusions:
Digital biomarker clinical research encompasses a wide range of technologies, populations, interventions, and clinical outcomes, with cardiovascular and physical activity sensors being the most explored. This necessitates a more thorough examination of the strength and quality of evidence regarding the health consequences of digital biomarker-based therapy.
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