基于德尔菲法和层次分析法构建《药品临床综合评价主题遴选指南》研究问题及主题遴选评估指标体系  

Construction of the research questions and topic selection evaluation index system of Guideline for Topic Selection for Comprehensive Clinical Evaluation of Drugs based on Delphi method and analytic hierarchy process

作　　者：段蓉[1] 李正翔[1] DUAN Rong;LI Zhengxiang(Dept.of Pharmacy,Tianjin Medical University General Hospital,300052,China)

机构地区：[1]天津医科大学总医院药剂科,天津300052

出　　处：《中国药房》2025年第7期789-793,共5页China Pharmacy

基　　金：“白求恩·求索-药学科研能力建设”项目(No.B-19-H-20200622)。

摘　　要：目的构建《药品临床综合评价主题遴选指南》研究问题及主题遴选评估指标体系,为该指南的制定提供依据。方法通过文献研究,初步构建《药品临床综合评价主题遴选指南》研究问题及主题遴选评估指标体系专家问卷。根据指南制定和德尔菲法相关要求遴选专家,通过电子问卷函询并筛选指南研究问题及评估指标,采用层次分析法对主题遴选评估指标体系进行权重赋值。结果构建了5个《药品临床综合评价主题遴选指南》研究问题,包括主题遴选的组织管理、评审流程、评估方法、评估指标体系和指标权重赋值,并构建包括5个一级指标、9个二级指标、17个三级指标在内的主题遴选评估指标体系。研究问题及各级指标的肯德尔协调系数均大于0.4,χ^(2)检验P值均小于0.05,评价结果具有较好的一致性。利用层次分析法对主题遴选评估指标体系的各级指标进行权重赋值,一致性比率为0.0076(<0.1),模型矩阵通过一致性检验。结论本研究构建的《药品临床综合评价主题遴选指南》的研究问题及主题遴选评估指标体系具有较高的权威性、科学性和可靠性,可为该指南的标准化制定奠定基础。OBJECTIVE To construct the research questions and topic selection evaluation index system of the Guideline for Topic Selection for Comprehensive Clinical Evaluation of Drugs(hereinafter referred to as the Guideline),so as to provide the basis for the formulation of the Guideline.METHODS Through literature research,an expert questionnaire on the research questions and evaluation index system of the Guideline was initially constructed.Experts were selected according to relevant requirements of the guideline formulation and Delphi method;the research questions and evaluation indicators of the Guideline were screened by electronic questionnaire communication,and the weights of evaluation index system of topic selection were assigned by the analytic hierarchy process.RESULTS Five research questions of the Guideline were constructed,including the organization and management of theme selection,evaluation process,evaluation methods,evaluation index system,and index weight assignment.And a theme selection and evaluation index system,including 5 primary indexes,9 secondary indexes and 17 tertiary indexes,was constructed.Kendall coefficients of the research questions and all indexes were>0.4,and the P values ofχ^(2) test were<0.05,which meant the evaluation results were consistent.The weights of all levels of the evaluation index system were assigned by analytic hierarchy process with consistency ratio of 0.0076(<0.1),and the model matrix passed the consistency test.CONCLUSIONS The research questions and topic selection evaluation index system of the Guideline established in this study are highly authoritative,scientific and reliable,which lay a foundation for the standardization of the Guideline.

关 键 词：药品临床综合评价 主题遴选 研究问题 指标体系 德尔菲法 层次分析法 指南 

分 类 号：R95[医药卫生—药学]