Outcomes of Digital Biomarker–Based Interventions: Protocol for a Systematic Review of Systematic Reviews

Motahari-Nezhad, Hossein; Péntek, Márta; Gulàcsi, László; Zrubka, Zsombor

doi:10.2196/28204

Cited by 21 publications

(15 citation statements)

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“…One of the study’s possible weaknesses is the short search duration (2019 and 2020). Only systematic reviews published in 2019 and 2020 were considered in this study according to the published protocol [ 23 ]. Because of the scope of the topic, we limited our assessment to a shorter period.…”

Section: Discussionmentioning

confidence: 99%

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Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

et al. 2022

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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

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Section: Discussionmentioning

confidence: 99%

“…This study follows the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for reporting systematic reviews ( Multimedia Appendix 1 ) [ 22 ]. The protocol of the current systematic review was published in JMIR Research Protocols [ 23 ].…”

Section: Methodsmentioning

confidence: 99%

Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

et al. 2022

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“…We used the following digital biomarker–related search terms: “digital biomarker” OR “digital biomarkers” OR “implantable” OR “implantables” OR “wearable” OR “wearables” OR “portable” OR “portables” OR “digestible” OR “digestibles” [ 28 ] (refer to Multimedia Appendix 1 for details of the search strategy).…”

Section: Methodsmentioning

confidence: 99%

“…The purpose of this scoping review was to categorize the building blocks of the research questions, not to synthesize or evaluate the quality of clinical evidence on digital biomarkers; this will be addressed in a separate SR of SRs of digital biomarker–based interventions, which will assess the methodological quality and quality of evidence for digital biomarkers in meta-analyses using A Measurement Tool to Assess Systematic Reviews-2 and Grading of Recommendations Assessment, Development, and Evaluation, respectively [ 28 ].…”

Section: Introductionmentioning

confidence: 99%

Digital Biomarker–Based Studies: Scoping Review of Systematic Reviews

Motahari-Nezhad¹,

Fgaier²,

Abid³

et al. 2022

JMIR Mhealth Uhealth

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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.

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“…Others gave broader definitions including further defining features, for example defining digital biomarkers as "objective, quantifiable, quantitative, physiological, and behavioural data that are collected and measured by means of digital devices such as portables, wearables, implantables, or digestibles. The data collected are used to explain, influence, and/or predict health-related outcomes" 2,6,11 .…”

Section: Introductionmentioning

confidence: 99%

Definitions of digital biomarkers: a systematic mapping of the biomedical literature

Alonso,

Hirt,

Woelfle

et al. 2023

Preprint

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Background Technological devices such as smartphones, wearables, sensors, or virtual assistants allow to collect data on health and disease processes and are thus increasingly considered a useful digital alternative to conventional biomarkers. We aimed to provide a systematic overview of the emerging literature on "digital biomarkers" with their definitions, features, and citations in biomedical research. Methods We analyzed all articles in PubMed that used the term "digital biomarker(s)" in title or abstract, considering any study involving humans and any review, editorial, perspective, or other opinion-based article up to 8 March 2023. We systematically extracted characteristics of publications and research studies, and any definitions and features of "digital biomarkers" mentioned. We described the most influential literature on digital biomarkers and their definitions using thematic categorizations of definitions considering the FDA BEST framework (i.e., data type, data collection method, purpose of biomarker), analysing the structural similarity of definitions by performing text analyses (hierarchical clustering on the distance-matrix) and citation analyses (based on citation metrics obtained from OpenAlex via Local Citation Network; last search 26 June 2023). Results We identified 415 articles prominently using the term "digital biomarker". They were published between 2014 and 2023 (median 2021), mostly describing primary research (283 articles; 68%). Most articles did not provide a definition of a digital biomarker (n=287; 69%). The 128 articles providing a definition of a digital biomarker reported 127 different definitions. Of these 127 definitions, 78 considered data collection, 56 data type, 50 the purpose, and 23 were based on all three key components. The 128 articles with a definition were cited a median of 6 times (interquartile range 2-20) with up to 517 citations. Of the ten most frequently cited articles using a definition, all used a different one. Conclusions The most frequently used definitions for digital biomarkers are highly different and there is no consensus about what this emerging term means. Our overview highlights key defining characteristics of digital biomarkers which can inform the development of a harmonized and more widely accepted definition.

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Outcomes of Digital Biomarker–Based Interventions: Protocol for a Systematic Review of Systematic Reviews

Cited by 21 publications

References 50 publications

Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

Digital Biomarker–Based Studies: Scoping Review of Systematic Reviews

Definitions of digital biomarkers: a systematic mapping of the biomedical literature

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