Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 24, 2021
Open Peer Review Period: Feb 24, 2021 - Apr 21, 2021
Date Accepted: Apr 13, 2021
Date Submitted to PubMed: Nov 25, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Outcomes of digital biomarker-based interventions: protocol for a systematic review of systematic reviews
ABSTRACT
Background:
Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables or digestibles. For their widespread adoption in publicly financed healthcare systems, it is important to understand how their benefits translate into improved patient outcomes, which is essential for demonstrating their value.
Objective:
To assess the quality and strength of evidence of the impact of digital biomarkers on clinical outcomes compared to interventions without digital biomarkers, reported in systematic reviews.
Methods:
A comprehensive search for 2019-2020 will be conducted in the 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 reviews. To assess the quality of evidence, we will evaluate systematic reviews using the GRADE tool. To detect the possible presence of reporting bias, we will record whether the protocol of the systematic reviews was published before the start of the study. A qualitative summary of results by digital biomarker technology and outcome will be provided.
Results:
This protocol was submitted before data collection. The next steps in this review will be initiated after the protocol is accepted for publication.
Conclusions:
Our study will provide a comprehensive summary of the highest level of evidence available on digital biomarker interventions. Our results will help identify clinical areas where the use of digital biomarkers leads 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.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.