Clinical research capability enhanced for medical undergraduates: an innovative simulation-based clinical research curriculum development

Abstract

Background Clinical research has frequently not been taught in a practical way, often resulting in a very didactic approach rendering it not very accessible for medical undergraduates. Simulation can provide an immersive, interactive, and reflective experience and may be applied to the clinical research curriculum. Methods A 7-step model, modified from Kern’s six-step approach and Khamis’s stepwise model, was used to develop the curriculum. A questionnaire survey on undergraduates’ attitude towards, knowledge and practice of clinical research and simulation education was conducted to generate a targeted needs assessment. The simulation framework was integrated into the development of educational strategies. Experts were consulted to assess the curriculum prior to implementation. Results Talent construction in China needs an innovative capability-enhanced clinical research curriculum. Sixty-six clinical undergraduates in our school completed the survey. 89.39% (59/66) of them hadn’t participated in clinical research, while 93.94% (62/66) would like to conduct clinical trials if possible. 75.76% of respondents didn’t have knowledge of or practical abilities in clinical trials. The mean score for practical ability (2.02 ± 0.92) was lower than that of knowledge (2.20 ± 0.93) (P < 0.01). The dimension of case report form got the lowest score among the five dimensions. Participating in clinical research (P = 0.04) and learning for themselves (P < 0.01) by a few students may have increased the total score. The curriculum was designed to simulate the whole process from protocol writing, registration, ethical approval, implementation, and data analysis to reporting based on one case study, and was divided into two parts to simulate different types of research: randomized controlled trials and observational studies. It was conducted in semesters 5 and 7 respectively, both including 16 sessions. After expert consultation, one session having a 29.01% coefficient of variation was adjusted and replaced. The final simulation class design scenario scripts are provided for reference. Conclusions The targeted needs assessment exposed medical undergraduates’ poor knowledge of and abilities in clinical research. This is the first report of a simulation-based clinical research curriculum developed in China, and adds curriculum development and design details to the limited related published studies.

Effectiveness of simulation-based clinical research curriculum for undergraduate medical students - a pre-post intervention study with external control

“…Objective development and assessment is crucial to any curricular innovation prior to widespread implementation. The development process of our innovative simulation-based clinical research curriculum has been published, with a detailed teaching plan attached [ 17 ]. The Prescribed-Intended-Enacted-Sustainable (PIES) framework was proposed for evaluative research on implementation of curricular innovations [ 25 ].…”

“…The curriculum content was further reviewed and approved by the course administrators. Development process and teaching scripts have been comprehensively detailed [ 17 ].…”

“…Both clinical research 1 and 2 included 11 classes. Comprehensive details, including the learning objectives, equipment, task-based simulation processes and time schedule, and required deliverables, were provided in the Supplementary files 4 and 5 of our previous work [ 17 ].…”

“…To address the existing gap, we have systematically developed a novel simulation-based clinical research curriculum framework [ 17 ]. In this study, we apply a pre-post intervention study on undergraduate medical students with external controls to quantitatively the effectiveness of SBME for clinical research training.…”

Perception, practice, and barriers toward research among pediatric undergraduates: a cross-sectional questionnaire-based survey

“…According to the data, the Pediatric College could conduct more scientific research training directed at clinical research, such as the design, conduct and administration of clinical trials. The simulation-based clinical research curriculum is considered to be a better approach training of clinician-scientists compared with traditional clinical research teaching [ 24 ]. On the other hand, we might need to do more to improve the interest in basic research for pediatric undergraduates.…”