多维度多准则儿童中成药临床综合评价指标框架的构建

Construction of multi-dimensional and multi-criteria clinical comprehensive evaluation index framework for children’s Chinese patent medicine

目的构建多维度多准则儿童中成药临床综合评价指标框架。方法采用文献综述法与头脑风暴法建立指标池、初步拟定指标框架;通过德尔菲法对相关领域专家进行2轮问卷调查,遴选评价指标;结合专家函询结果与小组讨论结果,构建儿童中成药临床综合评价指标框架。结果建立了包含安全性、有效性、经济性、适宜性、可及性、创新性6个维度的3级指标框架,包括6个一级指标(即维度)、20个二级指标、52个三级指标。结论该指标框架从卫生体系角度出发,具有中医药和儿童特点,为儿童中成药临床综合评价的实施提供方法学建议,为其他领域中成药临床综合评价体系的建立提供参考,丰富了我国药品临床综合评价技术体系。

Objective To establish a clinical comprehensive evaluation index framework for children’s Chinese patent medicine.Methods Using the literature review method and brainstorming method to establish an indicator pool,and preliminarily formulate an indicator framework.By Delphi method,two rounds of questionnaire survey were conducted among experts in related fields to select evaluation indicators.Combined with the results of expert letter consultation and group discussion,the clinical comprehensive evaluation index framework of children’s Chinese patent medicine was established.Results A 3-level index framework was established with six dimensions of safety,effectiveness,economy,suitability,accessibility and innovation,including six first-level indicators(i.e.,dimensions),20 second-level indicators and 52 third-level indicators.Conclusion This index framework,from the perspective of health system,has the characteristics of traditional Chinese medicine and children,provides methodological suggestions for the implementation of clinical comprehensive evaluation of children’s Chinese patent medicine,provides reference for the establishment of clinical comprehensive evaluation system of Chinese patent medicine in other fields,and enriches the technical system of clinical comprehensive evaluation of drugs in China.