基于德尔菲专家会商法制定临床研究培训课程核心内容和培训形式研究

Developing the core content and training formats for clinical research training courses based on the Delphi method of expert consultation

目的 本研究应用德尔菲专家会商法,筛选出临床研究专题培训课程核心内容及培训形式,以期提升临床研究培训的针对性,保障临床研究高质量开展。方法 采用德尔菲法,邀请16名相关领域专家进行两轮次评分,基于评分加权平均值、评分等级和、变异系数及满分比等指标,综合确定临床研究规范课程的架构,明确培训内容、课程时长安排、培训形式和考核方式等内容。结果 两轮专家积极系数均为1.00,课程内容、时长安排、培训形式及考核方式在第1轮的权威系数分别为0.80、0.89、0.88和0.81;第2轮权威系数分别为0.85、0.90、0.91和0.94;第2轮协调系数分别为0.60、0.87、0.65和0.67,专家意见趋势一致。依据期望值(expected value,EV)综合评价,排在前10位的培训内容包括:临床研究数据分类和统计分析基础(EV=1.00)、临床研究设计要点和规范(EV=2.13)、临床研究选题和研究分类(EV=3.13)、临床研究的数据采集和过程管理(EV=4.63)、临床研究科学性立项和伦理审查(EV=5.75)、病例报告表设计和编制(EV=6.38)、临床研究数据质量核查和质控要点(EV=6.50)、临床研究相关管理要求(EV=7.63)、科研论文撰写要点和规范(EV=8.63)以及临床研究数据集和数据统计分析(EV=9.50);最佳培训时长安排为45分钟、最佳培训形式为现场授课,最佳考核方式为课堂参与度+培训后笔试。结论 本研究筛选出临床研究培训最需要的前10位培训内容,并确定最佳培训时长和考核形式。建议今后在设置临床研究培训课程时,可参考并积极采用上述培训模式,改善培训效果,提高医务人员的临床研究能力,为临床用药提供新思路和新方向。

Objective This study utilized the Delphi method to screen the core content and training formats of specialized training courses for clinical research,enhancing the speciffcity of clinical research training and ensuring the high-quality conduct of clinical studies.Method Utilizing the Delphi method,16 relevant domain experts were invited to conduct two rounds of scoring.Based on the weighted average score,total score,coefffcient of variation and full score ratio,the framework of standardized clinical research course was comprehensively established,and the content of training,course duration,training formats and assessment methods were clearly defined.Results The positive coefficients for both rounds of experts were 1.00. In the ffrst round, the authoritative coefffcients for course content, duration, training formats and assessment methods were 0.80, 0.89, 0.88, and 0.81, respectively. In the second round, these coefficients were 0.85, 0.90, 0.91 and 0.94, respectively. The coordination coefffcients for the second round were 0.60, 0.87, 0.65 and 0.67, respectively, indicating a consistent trend of expert opinions. According to the expected value(EV) comprehensive assessment, the top ten training contents include: classification and basic statistical analysis of clinical research data(EV=1.00), key points and standards in clinical research design(EV=2.13), topic selection and research classiffcation in clinical research(EV=3.13), data collection and process management in clinical research(EV=4.63), scientiffc initiation and ethical review in clinical research (EV=5.75), case report form design and preparation(EV=6.38), clinical research data quality check and control points(EV=6.50), clinical research relevant management requirements(EV=7.63), academic paper writing key points and standards(EV=8.63), clinical research data sets and statistical analysis(EV=9.50). The optimal training duration is 45 minutes, with on-site lectures as the preferred training format and assessment based on classroom participation and post-training written tests. Conclusion The ten most essential training contents were identiffed, the optimal training duration, format and assessment method were determined. It is recommended that in the future development of clinical research training courses, reference to and active adoption of the aforementioned training model could improve training effectiveness, enhance the clinical research capabilities of medical personnel, provide new ideas and directions for clinical medication.