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Advances in Oncology and Radiotherapy · Journal article
Jmir Research Protocols · July 27, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol paper describing an ongoing quasi-experimental study designed to evaluate the impact of high-fidelity simulation training on peripheral angioplasty performance across three interventional specialties. No outcome results are presented; the study remains under enrollment (35% complete as of December 2025) with full results anticipated after June 2026.
Quasi-experimental observational cross-sectional study. Novice fellows from Interventional Cardiology (target n=20), Interventional Radiology (target n=20), and Vascular Surgery (target n=20) at the Simulation Center of the Faculty of Medicine of Sfax, Tunisia.. Intervention: High-fidelity Mentice simulator training comprising five standardized clinical scenarios addressing peripheral angioplasty of complex iliac and femoral lesions (TASC B-D); 4-hour hands-on session.. n = 60. Simulation Center of the Faculty of Medicine of Sfax, Tunisia.
21 of 60 target fellows enrolled as of December 2025, representing 35% of planned sample (15 Cardiology, 3 Radiology, 3 Vascular Surgery) All 21 enrolled participants completed the full simulation training protocol with pre- and post-test assessments using 25-item Global Score Primary outcome threshold for clinical significance set at ≥25% improvement in performance scores from baseline to posttraining
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Pending full results; if completed as designed with adequate enrollment, this study may inform the development of specialty-tailored simulation training pathways for peripheral angioplasty. However, clinicians should note the current enrollment imbalance and incomplete data collection.
Protocol paper for an ongoing quasi-experimental study with only 35% enrollment and no outcome results yet; provides methodological framework but no efficacy or comparative data to evaluate.
As stated by the source record.
Quoted from the source exactly as published.
Pending full results; if completed as designed with adequate enrollment, this study may inform the development of specialty-tailored simulation training pathways for peripheral angioplasty. However, clinicians should note the current enrollment imbalance and incomplete data collection.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background: Simulation-based training has demonstrated effectiveness in enhancing proficiency in interventional procedures. The endovascular treatment of peripheral arterial lesions has become a prominent minimally invasive therapeutic option. However, operators from various specialties, including Interventional Cardiology, Interventional Radiology, and Vascular Surgery, often follow diverging guideline recommendations and training pathways. Despite growing use of simulation in this field, the influence of an operator's specialty on learning outcomes remains poorly understood. Objective: This study aimed to evaluate the impact of simulation training on peripheral angioplasty performance scores across different interventional specialties and assess how specialty-specific factors influence skill acquisition. Methods: This quasi-experimental observational study will be conducted at the Simulation Center of the Faculty of Medicine of Sfax, Tunisia (trial registration: PACTR Trial ID 30697). Participants consist of 60 novice fellows from three specialties: Cardiology (n=20), Interventional Radiology (n=20), and Vascular Surgery (n=20). All participants will undergo identical simulation training using a high-fidelity Mentice simulator, comprising five standardized clinical scenarios addressing peripheral angioplasty of complex iliac and femoral lesions (TASC B-D). Each participant will receive a 4-hour hands-on training session with pre- and posttest assessments using a 25-item Global Score (10 knowledge items, 15 competence items). Primary outcomes consist of percentage change in performance scores from baseline to posttraining (threshold for clinical significance:≥25% improvement) and comparison across specialty groups using nonparametric statistics. Secondary outcomes consist of radiation protection parameters, including fluoroscopy duration, cumulative radiation dose, air kerma, and dose area product (KAP), measured by a simulator with real-time ALARA (As Low As Reasonably Achievable) feedback. Results: Study enrollment started on September 15, 2024. As of December 2025, 42 fellows were screened, and 21 have been enrolled (15 Cardiology, 3 Radiology, 3 Vascular Surgery), representing 35% of the target sample (21/60). All 21 enrolled participants completed the full simulation training protocol, with radiation protection parameters recorded for all sessions. Enrollment and data collection are expected to be completed by June 2026, with full results anticipated for publication thereafter. Conclusions: This protocol describes the first comparative study evaluating the impact of high-fidelity simulation on peripheral angioplasty performance across three distinct specialties. Findings are anticipated to provide novel evidence regarding specialty-specific learning trajectories and may inform the development of standardized, specialty-tailored training pathways for complex peripheral interventions.
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