摘要
目的:构建随机对照试验(RCT)课题执行质量评估的指标体系。方法:以逻辑框架法(LFA)为指导,构建RCT课题执行质量评估的问题树、目标树、逻辑框架,进而构建综合指标体系。结果:所构建的RCT课题执行质量评估的指标体系,准则层包括课题质量控制和不良事件,要素层包括随机化、病例资料的可靠性、依从性、数据质量和不良事件,指标层包括随机方案的执行、随机方案的隐藏、原始病例资料的完整性、源文件的可溯源性、研究者的依从性、受试者的依从性、病例报告表数据的涂改/修改、不良事件的个数、不良事件的发生率。没有纳入盲法和伦理部分。结论:建立的指标体系,是在第三方严格质量控制下的课题执行质量评估,可应用于临床RCT研究课题的中间执行质量评估、中期执行质量评估、结题执行质量评估。
Objective： To construct a quality evaluation indicator system for randomized control trial （RCT）. Methods： Guided by the logical framework approach （LFA）, the authors construct the problem tree, objective tree and logical frame in the quality evaluation for RCT projects, which further build a comprehensive indicator system. Results： The finished indicator system includes criteria layer, elements layer and indicators layer. The criteria layer consists of project quality control and adverse events. The elements layer consists of randomization, reliability of case data, compliance, data quality and adverse events. The indicators layer includes allocation implementation, allocation concealment, integrity of original case data, traceability of source file, compliance of researchers, compliance of subjects, alteration or correction of case reports data, amount of adverse events and its incidence rate. The blind methods and ethical factors have not been incorporated. Conclusion： The constructed indicator system assesses projects under the strict quality control of a third party. It can be applied to Medium-term quality evaluation and summative quality evaluation.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2009年第4期433-438,共6页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
“十一五”国家科技支撑计划重大项目资助(No.2006BAI04A21)
第42批中国博士后科学基金资助项目(No.20070420505)
第1批中国博士后特别资助科学基金资助项目(No.200801167)
关键词
逻辑框架法
问题树
目标树
逻辑框架法
指标体系
课题执行质量评估
第三方质量控制
RCT
Logical framework approach
Problem tree
Objective tree
LFA
Indicator system
Quality evaluation for project implementation
The third party quality control
Randomized control trial
