基于EVIDEM框架的中成药临床综合评价指标体系构建及解读  

Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework

作　　者：戴泽琦 景城阳 吴雪 张乐 廖星[1] DAI Zeqi;JING Chengyang;WU Xue;ZHANG Le;LIAO Xing(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国实验方剂学杂志》2024年第6期134-143,共10页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(82174239);中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2);中国中医科学院科技创新工程项目(CI2021A00701-3,CI2021A05503,CI2021A05501);中国中医科学院第十四批自主选题(Z0718)。

摘　　要：目的:构建基于证据与价值对决策的影响(EVIDEM)框架的中成药临床综合评价指标体系,推动中成药临床综合评价的科学、系统、规范实施。方法:通过文献调研、半结构化访谈、德尔菲法确定中成药临床综合评价指标体系,采用层次分析法明确各指标权重。结果:两轮专家咨询回收率均为100.0%,专家权威程度分别为0.90、0.905;第一轮咨询二、三级指标的肯德尔协调系数(W)分别为0.320、0.283(P<0.001);第二轮咨询二、三级指标的W分别为0.411、0.351(P<0.001)。最终构建的中成药临床综合评价指标体系包括6个一级指标、13个二级指标、28个三级指标。一级指标中,有效性、安全性、经济性、创新性、适宜性、可及性的权重分别为37.34%、32.68%、11.85%、5.87%、5.79%、6.47%。结论:该研究构建了一套普适性的中成药临床综合评价指标体系,并对指标进行了详细的介绍和解读,可为开展中成药临床综合评价提供借鉴和参考,但有待结合专科疾病中成药临床应用特点进行细化和改良。Objective:To establish the clinical comprehensive evaluation index system for Chinese patent medicine(CPM)based on Evidence and Value:Impact on DEcisionMaking(EVIDEM)framework,so as to promote the scientific,systematic and standardized implementation of clinical comprehensive evaluation of CPM.Method:The clinical comprehensive evaluation index system was determined through literature review,semi-structured interview and Delphi method,and the weights of each index were clarified by analytic hierarchy process(AHP).Result:The recovery rates of both rounds of expert consultation were 100%,and the authority coefficient of experts was 0.90 and 0.905,respectively.Kendall's coordination coefficients(W)of the secondand third-level indicators in the first-round consultation were 0.320 and 0.283(P<0.001),and in the second round were 0.411 and 0.351,respectively(P<0.001).The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators,13 second-level indicators and 28 third-level indicators.Among the first-level indicators,the weights of effectiveness,safety,economy,innovation,suitability and accessibility were 37.34%,32.68%,11.85%,5.87%,5.79% and 6.47%,respectively.Conclusion:This study has constructed a universal clinical comprehensive evaluation index system for CPM,and the domain and criteria are introduced and interpreted in detail,which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM,but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

关 键 词：证据与价值对决策的影响(EVIDEM) 临床综合评价 卫生技术评估(HTA)报告 指标体系 中成药 多准则决策分析(MCDA)模型 层次分析法(AHP) 

分 类 号：R22[医药卫生—中医基础理论] R24[医药卫生—中医学] R273[生物学—细胞生物学] Q279