| 基于逻辑框架法的随机对照试验课题执行质量评估指标体系的构建 |
| |
| 引用本文： | 田元祥,翁维良,谢雁鸣,邱泽奇,赵建新. 基于逻辑框架法的随机对照试验课题执行质量评估指标体系的构建[J]. 中华中医药杂志, 2009, 0(4) |
| |
| 作者姓名： | 田元祥 翁维良 谢雁鸣 邱泽奇 赵建新 |
| |
| 作者单位： | 中国中医科学院中医临床基础医学研究所;北京大学中国社会科学调查中心;河北医科大学中医学院; |
| |
| 基金项目： | “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) |
| |
| 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。
|
| 关 键 词： | 逻辑框架法 问题树 目标树 指标体系 课题执行质量评估 第三方质量控制 RCT |
Construction of quality evaluation indicator system for randomized control trial based on logic framework approach |
| |
| TIAN Yuan-xiang,WENG Wei-liang,XIE Yan-ming,QIU Ze-qi,ZHAO Jian-xin. Construction of quality evaluation indicator system for randomized control trial based on logic framework approach[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2009, 0(4) |
| |
| Authors: | TIAN Yuan-xiang WENG Wei-liang XIE Yan-ming QIU Ze-qi ZHAO Jian-xin |
| |
| Affiliation: | TIAN Yuan-xiang1,WENG Wei-liang1,XIE Yan-ming1,QIU Ze-qi2,ZHAO Jian-xin3 (1Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China,2Chinese Social Science Research Center of Peking University,Beijing 100871,3TCM College of Hebei Medical University,shijiazhuang 050091,China) |
| |
| Abstract: | 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 elemen... |
| |
| Keywords: | Logical framework approach Problem tree Objective tree LFA Indicator system Quality evaluation for project implementation The third party quality control Randomized control trial |
| 本文献已被 CNKI 等数据库收录！ |
|
