Rational and Design of the SIMULATOR Study: A Multicentre Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Residents

Abstract

Introduction: Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies. To assess the impact of simulation-based vs. traditional teaching on TEE knowledge and performance for medical residents in cardiology.Materials and Methods: Nationwide prospective randomized multicenter study involving 43 centers throughout France allowing for the inclusion of >70% of all French cardiology residents. All cardiology residents naive from TEE will be included. Randomization with stratification by center will allocate residents to either a control group receiving theoretical knowledge by e-learning only, or to an intervention group receiving two simulation-based training sessions on a TEE simulator in addition.Results: All residents will undergo both a theoretical test (0–100 points) and a practical test on a TEE simulator (0–100 points) before and 3 months after the training. Satisfaction will be assessed by a 5-points Likert scale. The primary outcomes will be to compare the scores in the final theoretical and practical tests between the two groups, 3 months after the completion of the training.Conclusion: Data regarding simulation-based learning in TEE are limited to non-randomized or single-center studies. The randomized multicenter SIMULATOR study will assess the impact of simulation-based vs. traditional teaching on TEE knowledge and performance for medical residents in cardiology, and whether such an educational program should be proposed in first line for TEE teaching.

Effectiveness of Simulation-Based Training on Transesophageal Echocardiography Learning

“…Details regarding the determination of sample size have been reported previously. 19 Based on recent available literature 7,9,16 and considering the normalized 0-to 100-point score ranges for the 2 co-primary outcomes, a minimally important difference of 5 points (SD, 7 points) was considered for the differences in changes in the pretraining and posttraining scores on the theoretical and practical tests between the 2 randomized groups. Under these assumptions, a sample size of 50 participants per group (for an overall population of 100 participants) provides 90% power to detect a statistically significant difference between the 2 groups at a significance level of α = 2.5%, applying a Bonferroni correction to account for multiple testing of the 2 coprimary outcomes.…”

“…Beyond access to traditional e-learning, the simulation group attended 2 teaching sessions using a TEE simulator. The simulation session involved standardized initial teaching of normal cardiac findings, including anatomy of the mitral valve (with some mitral regurgitation cases), aortic valve, tricuspid valve, interatrial septum, and left atrial appendage, followed by demonstration of image acquisition by the teacher (time duration, 30 minutes) . Eighteen simulators were used for this study.…”

“…Details regarding design of the SIMULATOR study have been published previously. 19 In brief, SIMULATOR was a multicenter, parallel-group, unblinded, randomized study in which all consecutive cardiology fellows of all training levels (year 1 to year 4) from 42 French centers were randomized (1:1) into either a TEE simulation group or to a traditional group. Fellows who had already performed a TEE, with or without supervision, were excluded.…”

“…The required views are presented in eFigure 1 in Supplement 1. 19 The teacher timed the duration between TEE probe introduction and obtention by the trainee of all 10 required views. The practical test was stopped after a maximum of 10 minutes.…”

“…All trainers asked for the 10 basic views in a preestablished order. 19 These examinations were evaluated by the local teacher who was a nationally certified echocardiography teacher. At each center, the same…”