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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 assess the quality of project execution by objectively analyzing the interim assessment indicators of units and sub-centers of TCM clinical research units and sub-centers so as to improve the quality of the overall accomplishments of the project leader and sub-center units. Methods According to the indicators of TCM chronic disease research project of all sub-topics for medium-term leader unit and sub-center quantitative score by radar chart describing the actual score of each subject, Pearson correlation analysis of the subject unit of the sub-center units The impact of completing the situation. Results The performance of the leader unit was generally higher than that of the sub-center unit. The two indicators showed 78% of the mid-term evaluation indicators as positive correlation coefficient, of which X4 (study case completeness), X10 (electronic data report), X12 And the consistency of the key indicators of medical records check) and other indicators of the head unit and sub-centers have a significant correlation between. Conclusion Strengthening the training and supervision over the sub-centers by the project leader units can effectively improve the quality of completion of the sub-center projects and ensure the overall implementation quality of the projects.