基于德尔菲法的中药人用经验评估核心指标研究

Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method

目的:科学构建中药人用经验评估指标,为“三结合”注册审评证据体系的形成提供参考。方法:基于德尔菲法,在文献研究和专家调查的基础上,开展2轮专家咨询,从均数、变异指数、协调系数等角度对专家咨询结果进行评价,进一步筛选和优化中药人用经验评估核心指标。结果:选取各领域专家共22名进行问卷调查,2轮咨询的专家积极性系数分别为100%,95.46%,专家权威程度分别为0.852,0.865,根据指标均值和变异系数,结合专家修改建议,最终形成包含4个一级指标、22个二级指标的人用经验评估核心指标。结论:中药人用经验评估核心指标可引导人用经验数据资料的规范收集和总结,促进形成高质量、可评价的人用经验证据,推进中药新药研发。

Objective:To scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine(TCM)and provide reference for the formation of“triple combination”registration review evidence system.Methods:Based on the Delphi method,after literature research and expert investigation,two rounds of expert consultation were carried out,and the expert consultation results were evaluated by the mean,variation index,coordination coefficient,etc.,and the core indicators for human use experience evaluation of TCM were further screened and optimized.Results:22 experts in various fields were selected to conduct a questionnaire survey.The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%,and the authority indicators of involved experts were 0.852 and 0.865.According to the mean value and coefficient of variation of the indicators,combined with the revision suggestions of experts,the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.Conclusion:The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data,promote the formation of high-quality and evaluable human use experience evidence,and support the research and development of new TCM products.