Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 17, 2025
Open Peer Review Period: Mar 17, 2025 - May 12, 2025
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Time for clarity: Exploring the Evidence and Key Concepts of Human-Centered Design in Digital Healthcare - A Comprehensive Scoping Review
ABSTRACT
Background:
Methods such as Human Centered Design (HCD), Design Thinking (DT), User Centered Design (UCD) co-creation, and participatory design (PD) have been adopted to facilitate user and stakeholder involvement in the development of eHealth applications. However, there is frequent confusion around these methodologies leading to a fragmentation of the discourse and limiting integration opportunities. The absence of an empirically grounded framework for HCD limits research and theoretical consensus particularly in the highly regulated context of development of eHealth solutions.
Objective:
This scoping review aims to explore and analyse the scope, definitions, key concepts, and motivations reported in peer-reviewed studies that have applied stakeholder engagement methods like HCD, PD or DT in developing eHealth applications.
Methods:
The conduct of this scoping review follows the JBI methodology for scoping reviews and the guidelines for conducting systematic mapping studies in software engineering. The reporting of the results will be guided by the PRISMA-ScR extension. A single reviewer will conduct the initial screening and charting, with random quality checks by a second reviewer. Inclusion Criteria: This review will include only primary studies reporting on the experience, challenges and applicability of HCD for the design and development of eHealth applications, identified through PubMed, IEEE Xplore, and Web of Science, and limited to articles from the past 10 years.
Results:
This review is expected to summarize the current understanding, terms, definitions and methods of HCD in the development of eHealth tools. We identify research gaps, and trends that will inform the current and future development of mHealth technologies to enhance mHealth adoption and sustainability with special focus on vulnerable populations. A preliminary search applying the search strategy resulted in 3181 records. The search was initiated in July 2024 and the results are expected in 2025.
Conclusions:
This review will provide knowledge about what, how and why are HCD methods being applied in the development of eHealth tools. This knowledge will translate in consistency reducing confusion, facilitating collaboration and implementation of HCD methodologies. To our knowledge, this is the first scoping literature review aiming to shed light in how the HCD processes are specifically applied in complex and highly regulated environments such as digital healthcare. Furthermore, we aim to understand why the application of the HCD methodology within the eHealth sector is surprisingly limited, especially concerning solutions for vulnerable patient groups.
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