Designing Clinical Decision Support Systems (CDSS)—A User-Centered Lens of the Design Characteristics, Challenges, and Implications: Systematic Review

Background: Clinical decision support systems (CDSS) have the potential to play a crucial role in enhancing health care quality by providing evidence-based information to clinicians at the point of care. Despite their increasing popularity, there is a lack of comprehensive research exploring their design characterization and trends. This limits our understanding and ability to optimize their functionality, usability, and adoption in health care settings. Objective: This systematic review examined the design characteristics of CDSS from a user-centered perspective, focusing on user-centered design (UCD), user experience (UX), and usability, to identify related design challenges and provide insights into the implications for future design of CDSS. Methods: This review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations and used a grounded theory analytical approach to guide the conduct, data analysis, and synthesis. A search of 4 major electronic databases (PubMed, Web of Science, Scopus, and IEEE Xplore) was conducted for papers published between 2013 and 2023, using predefined design-focused keywords (design, UX, implementation, evaluation, usability, and architecture). Papers were included if they focused on a designed CDSS for a health condition and discussed the design and UX aspects (eg, design approach, architecture, or integration). Papers were excluded if they solely covered technical implementation or architecture (eg, machine learning methods) or were editorials, reviews, books, conference abstracts, or study protocols. Results: Out of 1905 initially identified papers, 40 passed screening and eligibility checks for a full review and analysis. Analysis of the studies revealed that UCD is the most widely adopted approach for designing CDSS, with all design processes incorporating functional or usability evaluation mechanisms. The CDSS reported were mainly clinician-facing and mostly stand-alone systems, with their design lacking consideration for integration with existing clinical information systems and workflows. Through a UCD lens, four key categories of challenges relevant to CDSS design were identified: (1) usability and UX, (2) validity and reliability, (3) data quality and assurance, and (4) design and integration complexities. Notably, a subset of studies incorporating Explainable artificial intelligence highlighted its emerging role in addressing key challenges related to validity and reliability by fostering explainability, transparency, and trust in CDSS recommendations, while also supporting collaborative validation with users. Conclusions: While CDSS show promise in enhancing health care delivery, identified challenges have implications for their future design, efficacy, and utilization. Adopting pragmatic UCD design approaches that actively involve users is essential for enhancing usability and addressing identified UX challenges. Integrating with clinical systems is crucial for interoperability and presents opportunities for AI-enabled CDSS that rely on large patient data. Incorporating emerging technologies such as Explainable Artificial Intelligence can boost trust and acceptance. Enabling functionality for CDSS to support both clinicians and patients can create opportunities for effective use in virtual care.