Construction of quality evaluation indicator system for randomized control trial based on logic framework approach
Tian Yuan-xiang, Weiliang Weng, Yan‐Ming Xie, Qiu ZeQi, Zhao Jian-xin · Zhonghua zhongyiyao zazhi · 2009
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.