摘要
目的通过对中医临床研究课题组长单位与分中心中期评估指标进行相关性分析,客观评估课题执行质量,有助于提高组长单位及分中心单位课题的整体完成质量。方法依据指标对中医防治慢病研究项目的全部子课题进行中期组长单位及分中心的量化评分,通过雷达图描述各课题的实际得分,利用Pearson相关性分析课题组长单位对分中心单位课题完成情况的影响。结果组长单位的执行情况普遍高于分中心单位,二者比较,78%中期评估指标为正相关系数,其中在X4(研究病例的完整性)、X10(电子数据上报)、X12(电子CRF与研究病历关键指标的一致性核对)等指标组长单位与分中心之间具有显著相关性。结论加强课题组长单位对各分中心的培训与监管,可有效提高分中心课题的完成质量,使各课题总体执行质量得到保证。
Objective To improve the research quality of the leading research institutes and participating research institutes by comparing mid-term Chinese medicine research quality assessment indicators. Methods In accordance with the quality control indexes, a mid-term evaluation was carried out in all research groups of the projects of＂Prevention and Treatment of Chronic Disease with Traditional Chinese Medicine＂,and the scores of each research group were described with radar map method. The influence of leading research institutes on the research quality of the participating research institutes was analyzed with Pearson correlation methods. Results The implementation capacity of leading research institutes was better than that of the participating research institutes. Positive correlation was shown in78 % of mid-term research quality assessment indicators,and significant correlation was shown in indicator X4（case report integrity）,X10（electronic data reporting）and X12（correction of electronic CRF to key indicators of original case report） between the leading research institutes and participating research institutes. Conclusion To guarantee the overall quality of the projects, the leading research institutes should reinforce the training and supervision on the participating research institutes.
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2017年第2期249-252,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家中医药管理局项目:中医防治慢病临床科研体系及其成果转化应用模式研究(201107006)
关键词
中医临床研究
质量控制
中期评估
Chinese medicine clinical research
quality control
mid-term evaluation
