Abstract
BACKGROUND: Digital biomarkers are defined as objective, quantifiable, physiological, and behavioral data that are collected and measured using digital devices such as portables, wearables, implantables, or digestibles. For their widespread adoption in publicly financed health care systems, it is important to understand how their benefits translate into improved patient outcomes, which is essential for demonstrating their value. OBJECTIVE: The paper presents the protocol for a systematic review that aims to assess the quality and strength of the evidence reported in systematic reviews regarding the impact of digital biomarkers on clinical outcomes compared to interventions without digital biomarkers. METHODS: A comprehensive search for reviews from 2019 to 2020 will be conducted in PubMed and the Cochrane Library using keywords related to digital biomarkers and a filter for systematic reviews. Original full-text English publications of systematic reviews comparing clinical outcomes of interventions with and without digital biomarkers via meta-analysis will be included. The AMSTAR-2 tool will be used to assess the methodological quality of these reviews. To assess the quality of evidence, we will evaluate the systematic reviews using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. To detect the possible presence of reporting bias, we will determine whether a protocol was published prior to the start of the studies. A qualitative summary of the results by digital biomarker technology and outcomes will be provided. RESULTS: This protocol was submitted before data collection. Search, screening, and data extraction will commence in December 2021 in accordance with the published protocol. CONCLUSIONS: Our study will provide a comprehensive summary of the highest level of evidence available on digital biomarker interventions, providing practical guidance for health care providers. Our results will help identify clinical areas in which the use of digital biomarkers has led to favorable clinical outcomes. In addition, our findings will highlight areas of evidence gaps where the clinical benefits of digital biomarkers have not yet been demonstrated. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28204.