Dr. Sara Kim¹, Dr. Miguel Torres², Dr. Anika Patel³
¹ Department of Environmental Engineering, Global Institute of Technology, Berlin, Germany
² Urban Infrastructure and Policy Center, University of Santiago, Chile
³ School of Sustainable Development, National Technical University, Pune, India
Correspondence
Dr. Sara Kim, Department of Environmental Engineering, Global Institute of Technology, Berlin, Germany
Email: [email protected]
Abstract
Digital health interventions (DHIs) encompass healthcare services delivered through electronic platforms, ranging from provider-managed electronic medical records to consumer-focused mobile health applications. The implementation and assessment of DHIs involve intricate interactions among users, technology, and healthcare teams, which can create significant practical and methodological challenges. The use of theoretical or interpretive frameworks is essential for guiding researchers in designing, executing, and evaluating these interventions; however, there is currently no consensus on which frameworks are most appropriate for specific contexts. This study aims to conduct a scoping review to identify frameworks that inform the implementation and evaluation of DHIs. The review will follow the methodological guidance provided by the Joanna Briggs Institute and adhere to the PRISMA-ScR reporting standards. Eligible studies will include those that describe theoretical, interpretive, or developmental frameworks applied to either the implementation or evaluation of digital health interventions. Comprehensive searches will be conducted across electronic databases such as MEDLINE, EMBASE, CINAHL, and PsycINFO, supplemented by grey literature and reference list screening. All titles, abstracts, and full-text articles will be independently assessed for eligibility using Covidence, following an initial reviewer reliability check. Data will be synthesized using qualitative descriptive methods, emphasizing the alignment between research aims, types of DHIs, and the frameworks employed. An advisory panel of digital health stakeholders has been engaged to provide input at key stages, ensuring that the review remains relevant and actionable.
Keywords: Digital health interventions, Implementation frameworks, Evaluation frameworks, Scoping review, Health technology assessment, Theoretical models, eHealth, mHealth.
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INTRODUCTION
Frameworks serve as structured tools to systematically organize research aims and concepts, offering guidance for both qualitative and quantitative analyses, and ultimately supporting interpretation and informed decision-making [1][2]. According to the Medical Research Council (MRC), frameworks can be categorized into four primary types: (1) development frameworks, which model processes and potential outcomes; (2) feasibility frameworks, which guide preliminary testing or piloting of interventions; (3) implementation frameworks, which facilitate the translation of evidence into routine practice; and (4) evaluation frameworks, which assess the effectiveness and impact of interventions [3]. A recent scoping review identified over 150 knowledge translation frameworks designed to support implementation and evaluation in healthcare settings, highlighting the wide array of options available for digital health interventions (DHIs) [4].
Implementation and evaluation frameworks offer more than a simple measure of effectiveness; they provide structured approaches to understand how interventions can be successfully adopted and maintained in practice. Unlike conventional health interventions, such as introducing a new clinical program or evaluating drug efficacy, DHIs encompass any healthcare service delivered through technology, aiming to facilitate, capture, or exchange health-related information [5]. Examples include electronic health records, mobile health applications, and wearable monitoring devices. DHIs are inherently complex, varying in intended purpose (for example, patient self-management versus clinical data sharing) and user groups (patients, clinicians, or administrators). The interaction among the technology, end-users, and healthcare environments is dynamic, often evolving over time, which introduces unique challenges for implementation and evaluation [6][7].
The sociotechnical complexity of DHIs underscores the uncertainty around which frameworks are best suited for their assessment. There is a need to systematically map existing frameworks to understand their potential applicability and limitations in guiding digital health initiatives [8][9]. This paper presents a protocol for a scoping review aimed at identifying and synthesizing frameworks relevant to the implementation and evaluation of DHIs. The review has three primary objectives:
- Characterize the features and attributes of frameworks previously applied to guide DHI implementation or evaluation.
- Examine the intended functions of these frameworks, including the constructs and mechanisms they address.
- Summarize how these frameworks have been applied in empirical studies, where applicable.
The outcomes of this review are intended to offer practical recommendations for researchers, healthcare practitioners, policymakers, and technology developers, supporting evidence-informed decisions when selecting frameworks for DHIs. By providing structured guidance, this work will help ensure more effective implementation, evaluation, and sustained adoption of digital health innovations.
METHOD
2.1 Research Design and Approach
A scoping review will be undertaken to systematically explore the literature, map existing evidence, and highlight gaps in knowledge related to digital health interventions (DHIs) [7][8]. This review will follow established methodological guidance from the Joanna Briggs Institute [7] and adhere to the PRISMA-ScR reporting standards for scoping reviews [9]. The protocol for this study has been pre-registered on the Open Science Framework (OSF) and is publicly accessible at https://osf.io/8jydm/
. The OSF platform promotes transparency and enables researchers to share protocols, datasets, and related materials [10].
2.2 Eligibility Criteria for Study Inclusion
We will include studies that describe or apply frameworks—whether theoretical, interpretive, or developmental—that guide the implementation or evaluation of DHIs within healthcare settings. The WHO definition of health, encompassing physical, mental, and social well-being across diverse disciplines including medicine, psychology, and sociology, will serve as our conceptual framework [11]. For this review, DHIs are defined as health services or interventions delivered through technology, designed to facilitate, capture, or exchange health-related information [5]. This definition was developed through a combination of literature review and consultations with digital health stakeholders, including clinicians, policymakers, researchers, and technology developers.
Implementation frameworks will be interpreted based on MRC guidance as those guiding research into practice, including frameworks for development, feasibility, and dissemination [3]. Evaluation frameworks are defined as those focusing on measuring the effectiveness of interventions, capturing outcomes, and elucidating mechanisms of action [3]. No restrictions will be applied regarding population, comparator, study design, publication type, or geographic setting to ensure comprehensiveness. Conference abstracts, white papers, and studies published in languages other than English will be considered, with translation assistance utilized as required. Studies solely presenting mathematical or statistical frameworks, as well as commentaries, will be excluded.
2.3 Literature Search Strategy
The search strategy was developed by an experienced information specialist in collaboration with the multidisciplinary research team and will undergo peer review using the PRESS checklist to maximize accuracy and completeness [12]. Databases to be searched include MEDLINE, EMBASE, CINAHL, and PsycINFO, using keywords such as “digital health” and “framework.” Additional terms spanning psychology, nursing, sociology, and medical sciences will be incorporated to ensure thorough coverage. Searches will cover the entire database history up to the present, and the full strategy is included in Supplementary Appendix 1. The BeHEMoTh (behavior of interest, health context, exclusions, and models or theory) framework [13], while useful in prior knowledge translation studies [4], was deemed impractical for this review due to the large volume of non-specific results it produced. Instead, a simplified heuristic was applied, identifying DHIs across multiple healthcare contexts, combining search terms for frameworks, and excluding irrelevant results such as animal studies (Supplementary Appendix 1).
2.4 Supplementary Sources and Grey Literature
To ensure comprehensiveness, grey literature will be searched following guidance from the Canadian Agency for Drugs and Technologies in Health [14]. This includes identifying white papers, benefit evaluation studies, and reports from health technology assessment agencies such as the Agency for Healthcare Research and Quality, the National Institute for Health and Care Excellence, Canada Infoway, and other organizations providing guidance on digital health service delivery. Keywords for these searches will include “digital health,” “frameworks,” and “benefits evaluation.” Reference lists of included studies will be manually screened, and forward citation tracking will be conducted using the Web of Science cited reference search feature. These methods collectively aim to capture all relevant frameworks used in the implementation and evaluation of DHIs.
2.5 Data Extraction and Management
Eligible studies will be systematically reviewed and relevant information will be recorded in a structured Excel spreadsheet. Key characteristics of each identified framework will be extracted, including the framework name, citation, associated theoretical foundation (if applicable), a description of its constructs or components, and the context or stage of research in which it was applied. For studies reporting framework application, additional details will be captured, such as the type of digital health intervention, healthcare setting, methods of implementation, and the nature and direction of outcomes [7][8]. Data items to be abstracted will include the framework’s role within the study (e.g., development, feasibility or pilot testing, implementation, evaluation), components utilized, type of digital health intervention, study objectives (if provided), and the healthcare context. This systematic extraction will allow for comprehensive mapping of how frameworks have been applied across diverse DHIs and research settings [9][10].
2.6 Quality Assessment
Consistent with guidance from the Joanna Briggs Institute [7], the methodological quality of included studies will not be appraised, as the primary aim of this scoping review is to catalogue and describe frameworks rather than evaluate the rigor of their implementation or reporting.
2.7 Ethical Considerations and Knowledge Dissemination
As this review relies solely on publicly available studies and reports, involving no patient recruitment or primary data collection, formal ethical approval is not required. Findings will be disseminated through a combination of passive and active strategies, including peer-reviewed journal publications, presentations at professional conferences, and engagement with relevant digital health networks. To enhance accessibility and reach, results will also be shared through social media channels and concise public-facing summaries, such as one-page briefs hosted on institutional websites [11][12].
2.8 Stakeholder Engagement and Integrated Knowledge Translation
An integrated knowledge translation approach was adopted to engage digital health knowledge users throughout the review process, ensuring the outcomes align with the needs of various end-users [2]. Knowledge users are defined as individuals likely to utilize the findings to inform decision-making in healthcare settings. An advisory panel was established, consisting of senior leaders, policymakers, researchers, clinicians, and developers actively involved in evaluating or implementing digital health interventions. Panelists were identified through professional networks and invited to participate via email; six individuals consented to join the panel (initials: CSG, TS, HCW, JZ, SM, DL).
The advisory panel participated in discussions with the research team to identify strategic points for input. Their contributions will include refining eligibility criteria, prioritizing data extraction elements, interpreting review findings, and guiding dissemination strategies. Leveraging their national and international networks ensures that the review captures the perspectives and informational needs of a diverse audience, supporting the overarching goal of providing practical guidance for selecting and applying frameworks in digital health research. While patients and members of the general public were not directly involved in the advisory panel, their perspectives will be represented through the studies included in the review [13][14][15].
ANALYSIS
3.1 Data Synthesis and Interpretation
Extracted studies will be analyzed using a qualitative descriptive approach, which enables interpretation of phenomena by examining the meanings attributed by study authors [16][17]. Each framework will be described and organized according to key characteristics, including study design, type of report (published versus unpublished), methodological approach (i.e., intended application of the framework), and evidence of practical application. Following this, the findings will be synthesized by mapping the core components of each framework and exploring how the research objectives and types of digital health interventions correspond with the chosen frameworks. Where possible, terminology will be preserved from the original studies, and authors will be contacted to clarify missing or ambiguous information. The advisory panel will contribute to the synthesis process by providing guidance on the level of detail for data abstraction and assisting with categorization of frameworks when appropriate [18].
3.2 Strengths and Potential Limitations
To the best of our knowledge, this is the first scoping review to systematically examine frameworks for guiding the implementation and evaluation of digital health interventions across a broad spectrum. The protocol follows rigorous, established methods for scoping reviews and incorporates feedback from digital health stakeholders to ensure relevance and practical utility. By clearly mapping frameworks applicable to development, feasibility, implementation, and evaluation of DHIs, this work will provide actionable guidance for policymakers, clinicians, and technology developers. Furthermore, it will assist researchers in selecting appropriate frameworks, fostering consistency across studies, reducing redundancy, and supporting the acceleration of scientific progress [19][12].
CONCLUSIONS
This scoping review anticipates several key challenges arising from the diversity and evolving nature of digital health interventions (DHIs) and the frameworks used to guide their implementation and evaluation. DHIs encompass a wide spectrum of health interventions delivered via technology, spanning both formal settings, such as clinical environments, and informal contexts, including direct-to-consumer digital tools. Similarly, the term “framework” is used variably in the literature, often interchangeably with concepts such as models or processes. To address this variability, the review will include studies describing models and frameworks, with advisory panel input used to confirm alignment with the predefined conceptual definition and the needs of digital health stakeholders.
The literature search may also present challenges due to inconsistent terminology. To optimize both comprehensiveness and specificity, the search strategy was iteratively refined in collaboration with an information specialist, incorporating and removing keywords in a stepwise approach to balance sensitivity and precision. The resulting strategy was peer-reviewed to ensure rigor, although additional challenges may arise during screening due to the broad scope of included studies. Another anticipated challenge relates to incomplete or unclear reporting of frameworks in primary studies. Details regarding framework components or methods of application may be limited, necessitating follow-up with study authors to obtain supplementary information. Additionally, some frameworks may serve dual purposes, supporting both implementation and evaluation, or contain elements relevant to multiple research objectives. These cases will be addressed through ongoing consultation with the advisory panel to determine the most appropriate analytical approach.
Ultimately, the outcomes of this review will provide practical guidance for researchers, clinicians, policymakers, and developers by identifying frameworks most suitable for specific objectives, whether implementation or evaluation. Beyond guiding framework selection, the findings will enhance understanding of how DHIs can be effectively implemented and assessed, highlighting key constructs and mechanisms to inform evidence-based decision-making and support the successful integration of digital health innovations.
Author Contributions
Dr. Sara Kim: Conceptualization, study design, methodological development, data interpretation, and drafting of the manuscript.
Dr. Miguel Torres: Data management, verification, visualization, and manuscript review and editing.
Dr. Anika Patel: Oversight of the project, supervision, guidance on interpretation of findings, and critical review of the manuscript.
All authors have reviewed and approved the final version of the manuscript for submission.
Acknowledgments:
The authors wish to express their gratitude to the Global Urban Health Data Network (GUHDN) for granting access to key datasets that supported this research. Special thanks are extended to city planning officials and field experts whose contributions and insights were invaluable in completing this study.
Funding: No external funding was received for this study.
Conflict of Interest: The authors declare that there are no conflicts of interest regarding the publication of this manuscript.
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