Developing the core content and training formats for clinical research training courses based on the Delphi method of expert consultation
Objective This study utilized the Delphi method to screen the core content and training formats of specialized training courses for clinical research,enhancing the specificity 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,coefficient 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 first round,the authoritative coefficients 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 coefficients 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 classification in clinical research(EV=3.13),data collection and process management in clinical research(EV=4.63),scientific 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 identified,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.
Delphi methoddevelopment of clinical research training programtraining formatassessment methodtraining duration