中医临床研究中期评估量化指标的构建及权重  

The Construction and Weights of Midterm Evaluation Quantitative Indicators in TCM Clinical Research

作　　者：田元祥[1] 翁维良[2] 谢雁鸣[1] 陆芳[2] 李睿[2] 

机构地区：[1]中国中医科学院中医临床基础医学研究所 [2]中国中医科学院西苑医院

出　　处：《中医杂志》2014年第11期916-919,共4页Journal of Traditional Chinese Medicine

基　　金："十一五"国家科技支撑计划资助项目(2006BAI04A21);国家中医药管理局中医药行业科研专项资助项目(201107006)

摘　　要：依据层次分析法的基本思路和中期评估的目的和要求,形成中医临床研究中期评估量化指标的递阶层次结构。根据专家咨询意见结合联合监查指标,确定中期评估量化指标,运用组合权重乘积法,确定各指标主观权重。量化指标由纳入病例数/总病例数、研究药物的回收记录及受试者接收药物记录、研究病历的不合理涂改、实验室理化检查溯源、受试者真实性的核实、知情同意书签署、电子研究数据上报、在规定的时间窗内填报电子数据、电子病例报告表与研究病历关键指标的一致性核对、二级监查10项组成,各自的归一化权重依次为0.131、0.069、0.085、0.085、0.077、0.300、0.054、0.054、0.054、0.092。The hierarchical structure of midterm evaluation quantitative indicators in TCM clinical research was established according to the basic ideas of analytic hierarchy process （AHP） and the purpose and requirements of midterm evaluation. The midterm evaluation quantitative indicators were determined according to expert advice and joint inspection indicators. The multiplication method of combining weights was used to determine the subjective weights of indicators. The quantitative indicators were composed of 10 items such as included cases/total cases, recycling records of study drugs/drug-receiving records of subjects, unreasonable altered medical records, origin of physical and chemical testing, verifying the authenticity of subjects, signing informed consent, reporting electronic research data, completing the electronic data within a specified time window, checking the consistency of electronic case report forms and key indicators in medical record research and two-stage inspection. The normalized weights of these 10 items mentioned above were 0. 131, 0. 069, 0. 085, 0. 085, 0. 077, 0. 300, 0. 054, 0. 054, 0. 054 and 0. 092 in turn.

关 键 词：中医临床研究 中期评估 定量评估 主观权重 组合权重 归一化 

分 类 号：R24[医药卫生—中医临床基础]