背景:临床研究经常没有以实用的方式进行教学,通常会导致一种非常说教的方法,使医学本科生不太容易接受。模拟可以提供身临其境的,互动式,和反思经验,并可应用于临床研究课程。
方法:7步模型,从克恩的六步方法和哈米斯的逐步模型修改而成,被用来开发课程。大学生对,进行了临床研究和模拟教育的知识和实践,以产生有针对性的需求评估。模拟框架已集成到教育策略的开发中。在实施之前咨询了专家以评估课程。
结果:中国的人才建设需要提高创新能力的临床研究课程。我们学校的66名临床本科生完成了调查。89.39%(59/66)未参与临床研究,而93.94%(62/66)希望在可能的情况下进行临床试验。75.76%的受访者没有临床试验知识或实践能力。实践能力的平均得分(2.02±0.92)低于知识的平均得分(2.20±0.93)(P<0.01)。病例报告表的维度在五个维度中得分最低。少数学生参加临床研究(P=0.04)和自学(P<0.01)可能会增加总分。课程设计是为了模拟协议编写的整个过程,注册,伦理批准,实施,以及基于一个案例研究的数据分析报告,分为两部分来模拟不同类型的研究:随机对照试验和观察性研究。它分别在第5和第7学期进行,包括16次会议。经过专家咨询,一个变异系数为29.01%的会话被调整和替换。最后提供了仿真类设计场景脚本,以供参考。
结论:有针对性的需求评估暴露了医学本科生对临床研究的知识和能力不足。这是国内首份以模拟为基础的临床研究课程的报告,并在有限的相关已发表研究中增加课程开发和设计细节。
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.