Digital Biomarker–Based Studies: Scoping Review of Systematic Reviews

• Published in: JMIR mHealth and uHealth 2022-10, Vol.10 (10), p.e35722-e35722
• Main Authors: Motahari-Nezhad, Hossein, Fgaier, Meriem, Mahdi Abid, Mohamed, Péntek, Márta, Gulácsi, László, Zrubka, Zsombor
• Format: Article
• Language: English
• Subjects: Biomarkers; Coronaviruses; COVID-19; Digital Object Identifier; Disease; Intervention; Medical equipment; Pandemics; Physiology; Population; Review; Sensors
• ISSN: 2291-5222; 2291-5222
• DOI: 10.2196/35722

Background: Sensors and digital devices have revolutionized the measurement, collection, and storage of behavioral and physiological data, leading to the new term digital biomarkers. Objective: This study aimed to investigate the scope of clinical evidence covered by systematic reviews (SRs) of randomized controlled trials involving digital biomarkers. Methods: This scoping review was organized using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. With the search limited to English publications, full-text SRs of digital biomarkers included randomized controlled trials that involved a human population and reported changes in participants’ health status. PubMed and the Cochrane Library were searched with time frames limited to 2019 and 2020. The World Health Organization’s classification systems for diseases (International Classification of Diseases, Eleventh Revision), health interventions (International Classification of Health Interventions), and bodily functions (International Classification of Functioning, Disability, and Health [ICF]) were used to classify populations, interventions, and outcomes, respectively. Results: A total of 31 SRs met the inclusion criteria. The majority of SRs studied patients with circulatory system diseases (19/31, 61%) and respiratory system diseases (9/31, 29%). Most of the prevalent interventions focused on physical activity behavior (16/31, 52%) and conversion of cardiac rhythm (4/31, 13%). Looking after one’s health (physical activity; 15/31, 48%), walking (12/31, 39%), heart rhythm functions (8/31, 26%), and mortality (7/31, 23%) were the most commonly reported outcomes. In total, 16 physiological and behavioral data groups were identified using the ICF tool, such as looking after one’s health (physical activity; 14/31, 45%), walking (11/31, 36%), heart rhythm (7/31, 23%), and weight maintenance functions (7/31, 23%). Various digital devices were also studied to collect these data in the included reviews, such as smart glasses, smartwatches, smart bracelets, smart shoes, and smart socks for measuring heart functions, gait pattern functions, and temperature. A substantial number (24/31, 77%) of digital biomarkers were used as interventions. Moreover, wearables (22/31, 71%) were the most common types of digital devices. Position sensors (21/31, 68%) and heart rate sensors and pulse rate sensors (12/31, 39%) were the most prevalent types of senso