JMIR Publications

ABSTRACT

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.