中医防治慢病临床研究项目研究者依从性分析.docVIP

中医防治慢病临床研究项目研究者依从性分析 　　摘要：目的 通过对中医防治慢病临床研究项目研究者依从性的评估和分析，探索提高研究者依从性的途径和方法。方法 选取2010、2011年中医药行业科研专项“中医防治慢病临床研究”项目截至2015年底已结题的28个研究课题，采用中医慢病临床研究项目质控核心小组自拟《中医慢病临床研究项目研究者依从性评估表》，分别从“研究设计方法的执行”“按照方案纳入排除标准入组病例”“研究病例记录的完整准确规范性”3个指标评估研究者依从性。结果 研究者依从性得分优秀的研究课题有19个（67.9%），其中得分为满分的研究课题有3个（10.7%），得分良好的研究课题8个（28.6%），得分合格的研究课题1个（3.6%）。11个研究课题实施过程中存在研究记录中有不合理的涂改，12个研究课题实施过程中存在研究记录漏填的情况。结论 中医防治慢病临床研究项目28个研究课题实施过程中整体上研究者依从程度高，存在的问题主要表现在研究记录的完整规范性方面。 　　关键词：中医临床研究；慢病；质量控制；研究者依从性 　　DOI：10.3969/j.issn.1005-5304.2017.05.003 　　中图分类号：R2-05 文献标识码：A 文章编号：1005-5304（2017）05-0008-04 　　Investigator Compliance Quality Analysis on Clinical Research of TCM Prevention and Treatment for Chronic Diseases SUN Ai-jun， LU Fang， WENG Wei-liang （Xiyuan Hospital， China Academy of Chinese Medical Sciences， Beijing 100091， China） 　　Abstract： Objective To explore ways and means to improve the investigator compliance through the evaluation and analysis of the investigator compliance of TCM clinical research projects of chronic diseases. Methods Totally 28 studies from the project “Chinese medicine clinical study on prevention and treatment of chronic disease” started in 2010 or 2011 and ended in 2015 were collected. The investigator compliance was analyzed by the evaluation form， which were drafted by quality control core team of TCM projects of chronic diseases， as “research method performance”， “compliance of subjects inclusion and exclusion”， “integrity， accuracy and normalization of case report form” in final quality evaluation for TCM clinical research on chronic diseases. Results There were 19 excellent studies according to investigator compliance， accounting for 67.9%， including 3 studies with ten score， accounting for 10.7%. There were 8 good studies according to investigator compliance， accounting for 28.6%. There was 1 study up to standard， accounting for 3.6%. 11 studies included unreasonable changes in the record during the process of implementation. 12 studies included missing in the filling