How Useful Are Digital Health Terms for Outcomes Research? An ISPOR Special Interest Group Report

Burrell, Anita; Zrubka, Zsombor; Champion, Annette; Zah, Vladimir; Vinuesa, Laura; Holtorf, Anke-Peggy; Bidino, Rossella Di; Earla, Jagadeswara Rao; Entwistle, J; Boltyenkov, Artem Tarasovic; Braileanu, George; Kolasa, Katarzyna; Roydhouse, Jessica; Asche, Carl V.; Redekop, William K.; Pfeiffer, Colin; Le, Long Bao; Janodia, Manthan D; Sharkawy, Menna; Şaylan, Mete; Lee, Sang-Soo; Glynn, Sean; Ganguli, Arijit; Badawy, Sherif M.; Carvalho, Luiz S rgio F.; Ernst, Fredric; Seal, Brian; Steen, Cecile van; Patel, Naiya; Lee, Hailey; Doe, Abigail; Strouss, Lisa; Angelillo, Luigi; Patel, Chad; Paul, Sanjoy Kumar

doi:10.1016/j.jval.2022.04.1730

Cited by 18 publications

(8 citation statements)

References 88 publications

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“…Examples include thermometers and continuous glucose monitors. Thus, because of the ambiguity of definitions in digital health, more comprehensive keyword collections in this area are needed, as these were concluded in a recently accepted scoping review of digital biomarkers [ 88 ] and an ISPOR (International Society for Pharmacoeconomics and Outcomes Research) report [ 89 ].…”

Section: Discussionmentioning

confidence: 99%

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%

Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

et al. 2022

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“…The comprehensive PECUNIA Project represents a network of partners that aim to establish standardized costing and outcome assessment measures with a multi-sectorial and multi-national approach [ 58 ]. In the digital health arena, there are efforts underway to define DHIs [ 59 ], classify them according to risks [ 60 ], or build frameworks to assess their value [ 61 ]. As indicated by our scoping review, the question of DHI program costs has been raised from various perspectives but comprehensive guidance is lacking [ 62 ].…”

Section: Discussionmentioning

confidence: 99%

Developing a Program Costs Checklist of Digital Health Interventions: A Scoping Review and Empirical Case Study

Khan,

Kidholm,

Pedersen

et al. 2024

PharmacoEconomics

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Introduction The rate of development and complexity of digital health interventions (DHIs) in recent years has to some extent outpaced the methodological development in economic evaluation and costing. Particularly, the choice of cost components included in intervention or program costs of DHIs have received scant attention. The aim of this study was to build a literature-informed checklist of program cost components of DHIs. The checklist was next tested by applying it to an empirical case, Mamma Mia, a DHI developed to prevent perinatal depression. Method A scoping review with a structured literature search identified peer-reviewed literature from 2010 to 2022 that offers guidance on program costs of DHIs. Relevant guidance was summarized and extracted elements were organized into categories of main cost components and their associated activities following the standard three-step approach, that is, activities, resource use and unit costs. Results Of the 3448 records reviewed, 12 studies met the criteria for data extraction. The main cost categories identified were development, research, maintenance, implementation and health personnel involvement (HPI). Costs are largely considered to be context-specific, may decrease as the DHI matures and vary with number of users. The five categories and their associated activities constitute the checklist. This was applied to estimate program costs per user for Mamma Mia Self-Guided and Blended, the latter including additional guidance from public health nurses during standard maternal check-ups. Excluding research, the program cost per mother was more than double for Blended compared with Self-Guided (€140.5 versus €56.6, 2022 Euros) due to increased implementation and HPI costs. Including research increased the program costs to €190.8 and €106.9, respectively. One-way sensitivity analyses showed sensitivity to changes in number of users, lifespan of the app, salaries and license fee. Conclusion The checklist can help increase transparency of cost calculation and improve future comparison across studies. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-024-01366-y.

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“…There is variation in the nomenclature of “digital health,” with definitions continuing to evolve [ 20 ]. Although there is no universally accepted definition for “digital health,” digital health refers to all digital, electronic, and computer technologies to improve health [ 21 ]; it is used synonymously with “eHealth” in much of the literature [ 21 ]. Indeed, terms such as “digital health,” “eHealth,” “mobile health (mHealth),” and “telemedicine or telehealth” have been used interchangeably [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

“…Although there is no universally accepted definition for “digital health,” digital health refers to all digital, electronic, and computer technologies to improve health [ 21 ]; it is used synonymously with “eHealth” in much of the literature [ 21 ]. Indeed, terms such as “digital health,” “eHealth,” “mobile health (mHealth),” and “telemedicine or telehealth” have been used interchangeably [ 21 ]. The components of digital health are broad and may include mobile apps (mHealth), web applications, wearable technology, artificial intelligence, analytics, and telemedicine [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

Professional-Facing Digital Health Solutions for the Care of Patients With Chronic Pain: Protocol for a Systematic Scoping Review

McCartney,

Main,

Ibrar

et al. 2024

JMIR Res Protoc

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Background Chronic pain is a highly prevalent condition and one of the most common reasons why people seek health care. As a result, chronic pain has a significant personal and economic burden. The COVID-19 pandemic has aggravated the situation for patients with chronic pain through increased risk factors (eg, anxiety or depression) as well as decreased access to health care. Digital health solutions to support people with chronic pain are becoming increasingly popular. Most of the research has focused on patient-facing digital health solutions, although it is clear that the involvement of health and care professionals is crucial in chronic pain care. Certainly, digital health solutions intended for the use of health and care professionals in the care of patients with chronic pain (ie, professional facing) exist, for example, for clinical decision support; however, no review has investigated the studies reporting these interventions. Objective The overall aim of this scoping review is to identify the available professional-facing digital health solutions for the purpose of chronic pain management. The objectives of this review are to investigate the components, target populations, and user settings of the available professional-facing digital solutions; health and care professionals’ perspectives on using digital health solutions (if reported); the methods in which the digital health solutions are developed; and the outcomes of using professional-facing digital health solutions. Methods Databases including MEDLINE, Embase, CINAHL, PsycInfo, and Inspec will be searched for studies reporting professional-facing digital health solutions for chronic pain care, using a comprehensive search strategy developed for each of the specific databases. A total of 2 independent reviewers will screen the titles and abstracts for review inclusion and then conduct full-text screening. Any conflicts in study inclusion will be resolved by a third reviewer at each stage of the screening process. Following data extraction and quality assessment, a qualitative content analysis of the results will be conducted. This review will identify the available professional-facing digital health solutions for chronic pain management. The results of this review are likely to be heterogeneous in terms of content (ie, the digital solutions will serve a variety of purposes, settings, target populations, etc) and methods (ie, experimental and nonexperimental designs). Results The review is expected to finish in March 2024 and published in the summer of 2024. Conclusions This protocol outlines the need for a scoping review to identify professional-facing digital health solutions for the management of chronic pain. Results from this review will contribute to the growing field of research into the utility of digital health for chronic pain management. International Registered Report Identifier (IRRID) DERR1-10.2196/51311

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How Useful Are Digital Health Terms for Outcomes Research? An ISPOR Special Interest Group Report

Cited by 18 publications

References 88 publications

Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

Digital Biomarker–Based Interventions: Systematic Review of Systematic Reviews

Developing a Program Costs Checklist of Digital Health Interventions: A Scoping Review and Empirical Case Study

Professional-Facing Digital Health Solutions for the Care of Patients With Chronic Pain: Protocol for a Systematic Scoping Review

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