Eligible publications will consider priority communities, which may be defined by location (eg, rurality), socioeconomic status, race, ethnicity, disability, older population, gender, children, culture, or other demographic factors.

All papers that include approaches or tools for improving digital health equity, defined as equitable inclusion in the development of DHTs [6], will be eligible.

This scoping review will consider DHT used by priority communities to manage health or access health care services. As articulated by the National Institute for Health and Care Excellence (UK), DHTs include “standalone software and apps that are used to improve health outcomes or to improve how the health and care system runs.” [37] These can include (1) regulated medical devices classed as software as a medical device; (2) software and apps designed to help people to manage their own health and well-being; (3) software that is designed to help the health and care system to run more efficiently or to help staff manage their time, staffing, or resources; and (4) apps or software designed to work alongside a medical device.

To improve the feasibility of the review, traditional imaging that has been transformed into digital imaging and data-driven technologies (blockchain and AI-based algorithms) will be excluded as these are not routinely used in health care services.

The review will consider project contextual inquiry, value specification, design, operationalization, and summative evaluation. Given digital health inequities affect priority communities across high-income and low- and middle-income countries, studies from all countries will be eligible for inclusion in the review.

The review will include quantitative studies of experimental and quasi-experimental designs, including peer-reviewed journal articles, relevant to the research question, which meet the inclusion and quality criteria as eligible for inclusion. Study types such as randomized controlled trials, nonrandomized controlled trials, before and after studies, and interrupted time-series studies will be eligible. In addition, analytical observational studies including prospective and retrospective cohort studies, case-control studies, and analytical cross-sectional studies will be considered for inclusion. Descriptive observational study designs including case series, individual case reports, and descriptive cross-sectional studies will also be eligible for inclusion.

Qualitative studies including, but not limited to, designs such as phenomenology, grounded theory, ethnography, qualitative description, action research, and feminist research will also be considered.

Literature reviews will not be included; however, their bibliographies will be hand searched to identify relevant studies. Commentary papers that do not generate empirical evidence will not be eligible. Preprints and theses will also be excluded.

This work is a literature review of previously published analyses. The University of Melbourne’s Office of Research and Integrity advised that it did not meet the criteria for requiring human ethics review (personal communication, May 17, 2024).

This review will be based on the Arksey and O’Malley [38] framework for scoping reviews [39] and will be informed by contemporary guidance from the Joanna Briggs Institute [40]. The 6-stage framework includes identifying research questions; identifying relevant studies; study selection; charting the data; summarizing and reporting the results; and a consultation exercise with groups who are targeted by digital health equity initiatives.

Inclusion and exclusion criteria will be iteratively refined to answer the research question as the scoping review progresses. A 2-stage (title or abstract and full article) screening process will be conducted to choose eligible studies for final inclusion. A standardized data extraction tool will be used to extract and chart the data. Included studies will be analyzed using a qualitative analysis approach summarizing the findings.

The search strategy will aim to locate published studies. An initial limited search of MEDLINE and ACM Digital Library was undertaken to identify articles on the topic, from both the health and IT literature. The text words contained in the titles and abstracts of relevant articles and the index terms used to describe the articles were used to develop a full search strategy for the targeted databases (listed in Multimedia Appendix 1). The search strategy, including all identified keywords and index terms, was adapted for each included database or information source. The reference lists of all included sources of evidence will be screened for additional studies. A search is also being conducted for forward citations of key publications identified in this process.

Eligible sources for this scoping review will be peer-reviewed papers that report on a tool or approach that has been implemented to promote equitable inclusion during technology innovation. We will include studies published in the English language after 2010. Items in other languages will be included if they include an English abstract that clearly reports the required data. The authors of relevant studies will also be contacted where necessary for study details. Items for which full text is not available will be excluded.

Following the search, all identified citations will be collated and uploaded into Covidence (Veritas Health Innovation) for the removal of duplicates and management of the subsequent stages of the review screening and data extraction processes [41]. After the pilot screening test of 10% of the citations, 1 reviewer will screen the items in the title or abstract stage, against the inclusion criteria for the review. Potentially relevant sources will be retrieved in full. The full text of selected citations will be assessed in detail against the inclusion criteria by 2 or more independent reviewers. The reasons for the exclusion of sources of evidence at the full-text stage that do not meet the inclusion criteria will be recorded and reported in the scoping review. Any disagreements that arise between the reviewers at each stage of the selection process will be resolved through discussion or with an additional reviewer. The results of the search and the study inclusion process will be reported in full in the final scoping review and presented in a PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) flow diagram [42].

Data will be extracted from papers by 2 independent reviewers using a data extraction tool developed for the project and piloted by authors across multiple fields of research (Textbox 1). The data extracted will include specific details about the participants, concept, context, study methods, and key findings relevant to the review questions and mapped to the digital innovation pathway through the CeHRes roadmap for the development of eHealth technologies [26].

Data will be deductively mapped to the CeHRes roadmap for the development of eHealth technologies [26]. The roadmap includes 5 stages; however, some technologies may be distributed across multiple stages, and emergent stages may also be discovered:

A narrative summary will accompany the data map to describe how the results relate to the review objectives and research question.

Noting the apparent absence of an overarching review of evidence-based tools and methods to translate digital health equity in all stages of digital health innovation, our scoping review will identify these tools and methods and map them to stages in the CeHRes roadmap (contextual inquiry, value specification, design, operationalization, and summative evaluation). Our work is aimed at synthesizing how priority communities initiate or are brought into the development and evaluation of DHTs and how they describe the tool’s acceptability. We will also note how researchers measure the acceptability of the tools or approaches used.

We may encounter limitations in the published literature that prevent us from building a factual account of the range of methods or tools that have been trialed with priority groups. In particular, there might be an absence of reports of negative initiatives or tools that failed to achieve equity outcomes, since positive study results are more likely to be published [43]. We acknowledge that excluding non-English language studies may bias the outcomes we are able to include. Additional research using material in data repositories and non-English studies could remedy these issues.

The scoping review will identify tools and approaches that have been validated for use by health care technology developers to enable equitable digital innovations. Where gaps are detected in either the available evidence or in their span across the 5 stages of the CeHRes roadmap, these will be highlighted, and their possible implications will be proposed. The work described in this protocol supports the methodological development of the Digital Health Validitron, a collaborative and interdisciplinary research group that assists digital health innovators from health care, academia, and industry to accelerate the creation of evidence that proves the real-world value of their ideas and products.