Background The introduction of new medical technologies such as sensors has accelerated the process of collecting patient data for relevant clinical decisions, which has led to the introduction of a new technology known as digital biomarkers. Objective This study aims to assess the methodological quality and quality of evidence from meta-analyses of digital biomarker–based interventions. Methods This study follows the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline for reporting systematic reviews, including original English publications of systematic reviews reporting meta-analyses of clinical outcomes (efficacy and safety endpoints) of digital biomarker–based interventions compared with alternative interventions without digital biomarkers. Imaging or other technologies that do not measure objective physiological or behavioral data were excluded from this study. A literature search of PubMed and the Cochrane Library was conducted, limited to 2019-2020. The quality of the methodology and evidence synthesis of the meta-analyses were assessed using AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) and GRADE (Grading of Recommendations, Assessment, Development, and Evaluations), respectively. This study was funded by the National Research, Development and Innovation Fund of Hungary. Results A total of 25 studies with 91 reported outcomes were included in the final analysis; 1 (4%), 1 (4%), and 23 (92%) studies had high, low, and critically low methodologic quality, respectively. As many as 6 clinical outcomes (7%) had high-quality evidence and 80 outcomes (88%) had moderate-quality evidence; 5 outcomes (5%) were rated with a low level of certainty, mainly due to risk of bias (85/91, 93%), inconsistency (27/91, 30%), and imprecision (27/91, 30%). There is high-quality evidence of improvements in mortality, transplant risk, cardiac arrhythmia detection, and stroke incidence with cardiac devices, albeit with low reporting quality. High-quality reviews of pedometers reported moderate-quality evidence, including effects on physical activity and BMI. No reports with high-quality evidence and high methodological quality were found. Conclusions Researchers in this field should consider the AMSTAR-2 criteria and GRADE to produce high-quality studies in the future. In addition, patients, clinicians, and policymakers are advised to consider the results of this study before making clinical decisions regarding digital biomarkers to be informed of the degree of certainty of the various interventions investigated in this study. The results of this study should be considered with its limitations, such as the narrow time frame. International Registered Report Identifier (IRRID) RR2-10.2196/28204

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 sensors used to acquire behavioral and physiological data in the SRs. Conclusions In recent years, the clinical evidence concerning digital biomarkers has been systematically reviewed in a wide range of study populations, interventions, digital devices, and sensor technologies, with the dominance of physical activity and cardiac monitors. We used the World Health Organization’s ICF tool for classifying behavioral and physiological data, which seemed to be an applicable tool to categorize the broad scope of digital biomarkers identified in this review. To understand the clinical value of digital biomarkers, the strength and quality of the evidence on their health consequences need to be systematically evaluated.

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.

BACKGROUND The introduction of new medical technologies such as sensors has accelerated the process of collecting patient data for relevant clinical decisions, which has led to the introduction of a new technology known as digital biomarkers. OBJECTIVE This study aims to assess the methodological quality and quality of evidence from meta-analyses of digital biomarker-based interventions. METHODS This study follows the PRISMA guideline for reporting systematic reviews, including original English publications of systematic reviews reporting meta-analyses of clinical outcomes (efficacy and safety endpoints) of digital biomarker-based interventions compared with alternative interventions without digital biomarkers. A literature search of PubMed and the Cochrane Library was conducted, limited to 2019-2020. The quality of the methodology and evidence synthesis of the meta-analyses was assessed using AMSTAR-2 and GRADE, respectively. RESULTS 26 studies with 95 reported outcomes were included in the final analysis. Twenty-four (92%), one (4%), and one (4%) studies had critically low, low, and high methodologic quality, respectively. Although only six clinical outcomes (6.3%) had high-quality evidence, 84 outcomes (88.4%) had moderate-quality evidence. In addition, five outcomes (5.3%) were rated with a low level of certainty, mainly due to risk of bias (n=89/95, 93.7%), inconsistency (n= 27/95, 28.4%), and imprecision (n= 27/95, 28.4%). CONCLUSIONS Researchers in this field should consider the AMSTAR-2 criteria and GRADE to produce high-quality studies in the future. In addition, patients, clinicians, and policymakers are advised to consider the results of the current study before making clinical decisions regarding digital biomarkers to be informed of the degree of certainty of the various interventions investigated in this study. INTERNATIONAL REGISTERED REPORT RR2-10.2196/28204