中医临床研究二级质控——监查的实施现状评估

Evaluation of the Current Situation and Secondary Monitoring of Chinese Medicine Clinical Studies

目的:本研究调查评估中医临床研究二级质控实施现状。方法:对科技部"十一五"国家科技支撑计划"重大疑难疾病中医防治研究"项目42个课题"二级质控"与课题总体执行质量进行检查、量化评估;对量化评分进行等级划分、图形展示;并对"二级质控"实施情况与量化评估方法进行评价。结果:全部42个课题质控评估总得分的平均分177.05,执行情况"优秀"、"良好"的比重较大(76.19%),执行"中等"、"较差"的比重较少(23.81%)。二级质控指标的平均分14.72,执行情况"优秀"和"较差"的比重较大(85.72%),"良好"或"中等"比重则较少(14.28%)。现有量化评估标准下,二级质控量化得分与课题总体执行质量评分相关性不显著(r=0.083,P>0.05)。结论:42个课题二级质控与课题总体执行质量良好;但检查频次、规范性、有效性及检查问题的及时修正仍需进一步改善。同时,二级质控的量化评估方法有待进一步优化与完善。

This study aimd to explore the current situation and secondary monitoring of Chinese medicine clinical studies. All the 42 projects in the ＂Prevention and Treatment of Difficult and Complicated Disease of TCM＂ plan, sponsored by the 11 th Five-Year National Key Technology R ＆ D Program, were given a concludingquantitative evaluation. The secondary monitoring scores and the total quality control were hierarchical and described with a radar map. At last, the performance of secondary monitoring and the quantitative evaluation method were reevaluated. It was found that the average score of total quality control was 177.05. The proprtion of outstanding- and good-level studies accounted for 76.19%, while the proprtion of medium- to low-grade studies accounted for 23.81%. The average score of secondary monitoring was 14.72 with the studies in outstanding and low levels accounting for 85.72%, and with those in good and medium levels accounting for 14.28%.There was no significant correlation between the secondary monitoring score and the total quality control score, using the current quantitative evaluation method（r=0.083, P 〉0.05）. In conclusion, the secondary monitoring and the total quality control of all the 42 studies generally performed well. However, priorities of the secondary monitoring, such as frequency standardization, comprehensive monitoring content, diversity of the monitoring form and timely correction, remained to be pushed ahead. In addition, the quantitative evaluation criteria need to be modified.ava