Currently submitted to: JMIR Research Protocols
Date Submitted: Nov 3, 2025
Open Peer Review Period: Nov 4, 2025 - Dec 30, 2025
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Effectiveness of Guideline-based Clinical Decision Support Systems: Protocol for a Systematic Review
ABSTRACT
Background:
Clinical guidelines (CGs) standardize care through evidence-based recommendations, while Clinical Decision Support Systems (CDSS) can assist in applying these guidelines to individual patients. The scientific basis for the decisions offered by decision-support systems is often not explicitly stated or not clearly specified in the literature on CDSS. To our knowledge, no rigorous, systematic review has been conducted on the effectiveness of guideline-based decision support systems in which the technical integration and algorithmic embedding of clinical guidelines have been described or can be inferred from secondary literature.
Objective:
To systematically collect, describe, and synthesize evidence of randomized controlled studies of interventions using clinical decision support systems with a well-defined integration of evidence-based clinical guidelines on a direct medical outcome.
Methods:
This systematic review adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-SR) and its extension for Scoping Reviews (PRISMA-ScR) checklists. The eligibility criteria for this review are defined using the PICOS framework, including studies involving patients with any medical condition or disease. Study interventions need to include guideline-based clinical decision support systems (CDSS), encompassing all types of interventions used for treatment. Each intervention must provide a sufficiently accessible technical description detailing the types of data and algorithms used for decision-support procedures. The guidelines employed within these CDSS interventions must be derived from a clearly defined, evidence-based guideline development process. Studies must utilize a randomized controlled study design. Only studies on the effectiveness of the interventions on direct medical outcomes are included. Web of Science, including MEDLINE, and Scopus, are searched with search expressions aligned with the eligibility criteria. An update of the review is planned for autumn 2025.
Results:
On 11 August 2022, the initial search was conducted on PubMed, WoS, and Scopus. From a total of 6,282 records, 1,456 were removed prior to screening due to being duplicates, 2,506 records were excluded during the first screening step, and 2,350 were excluded during the second step. Fifty-nine papers were excluded based on their full texts, and 18 papers were finally included in the review following this initial search. This review is expected to demonstrate that CDSS based on CGs can improve clinical outcomes, although their effectiveness may vary depending on various factors. Potential limitations, such as high study heterogeneity, have already been identified.
Conclusions:
To our knowledge, this is the first rigorous systematic review on the effectiveness of guideline-based decision support systems in which the technical integration and algorithmic embedding of clinical guidelines have been described or can be inferred from secondary literature. With this review, we aim to address this gap by providing a detailed analysis of existing research and identifying best practices, challenges, and areas for future investigation. Clinical Trial: This systematic review has been registered with PROSPERO under the identifier CRD42024605679.
Citation
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