Simulation Trials for Evaluating Clinical Decision Support Systems

The evaluation of clinical decision support systems (CDSS) during randomized clinical trials in very long and complex to set up. Simulation trials consist of evaluating the CDSS on fictitious patients. While they cannot entirely replace clinical trials, they are simpler to perform and offer additional possibilities. In this paper, we present recommendations for the design of simulation trials evaluating CDSS, based on the lessons learned during two recent studies. We also propose a model of protocol that maximizes statistical power and avoids several common biases, and an R code template for statistical analysis using linear mixed models.

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Publication Details

Journal
Studies in health technology and informatics
Published
2025-05-15
DOI
https://doi.org/10.3233/shti250304
Primary Topic
Business Process Modeling and Analysis
Type
article
Field-Weighted Citation Impact
0.00

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article

Simulation Trials for Evaluating Clinical Decision Support Systems

Sophie Dubois, Hector Falcoff, Rosy Tsopra, Jean-Baptiste Lamy et al.
Studies in health technology and informatics
Business Process Modeling and Analysis
article

Simulation Trials for Evaluating Clinical Decision Support Systems

Sophie Dubois, Hector Falcoff, Rosy Tsopra, Jean-Baptiste Lamy, Pierre Meneton, Antoine Saab
article en

Abstract

The evaluation of clinical decision support systems (CDSS) during randomized clinical trials in very long and complex to set up. Simulation trials consist of evaluating the CDSS on fictitious patients. While they cannot entirely replace clinical trials, they are simpler to perform and offer additional possibilities. In this paper, we present recommendations for the design of simulation trials evaluating CDSS, based on the lessons learned during two recent studies. We also propose a model of protocol that maximizes statistical power and avoids several common biases, and an R code template for statistical analysis using linear mixed models.

Studies in health technology and informaticsVol. 327
Inserm (FR), Université Paris Cité (FR), Sorbonne Université (FR), Université Sorbonne Paris Nord (FR), Sorbonne Paris Cité (FR), Assistance Publique – Hôpitaux de Paris (FR), Hôpital Européen Georges-Pompidou (FR), Hôpital Européen (FR), Lebanese Hospital Geitaoui-University Medical Center (LB), Laboratoire d'Informatique Médicale et d'Ingénierie des Connaissances en e-Santé
Agence Nationale de la Recherche, Centre National de la Recherche Scientifique, Conseil National de la Recherche Scientifique
Peace, Justice and strong institutions
Openalex Percentile: Top 70%
Business Process Modeling and Analysis
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