宫内节育器不良事件报告两种审核方式的质量评估

Quality evaluation of two auditing methods for adverse event reports of intrauterine device

目的:对宫内节育器(IUD)不良事件报告的人工和计算机自动审核方式进行质量评估比较,探讨计算机自动审核报告的应用效果和局限性。方法:收集本中心审核合格的49688份IUD不良事件报告,主要表现为妊娠、月经问题、疼痛、IUD位置和形状改变等4类事件,从中分层随机抽取人工审核和计算机自动审核的报告共800例进行质量评估,比较两种审核方式的报告得分情况。结果:计算机自动审核报告占总报告数的43.8%。两种方式审核报告总体质量均为优。在主要表现为妊娠、疼痛、IUD位置和形状改变3类不良事件中计算机自动审核得分(92.9±2.7分、92.0±2.8分、93.7±3.5分)均高于人工审核(91.6±4.0分、89.8±2.7分、91.1±5.0分)(P<0.05);在主要表现为妊娠、IUD位置和形状改变的不良事件中,计算机自动审核的抽样报告得分为优者占比(55.4%、56.1%)均高于人工审核(44.6%、44.0%)(P<0.05)。在计算机自动审核的4类抽样报告中,失分最多的均为产品编号或批号、生产日期2个项目。结论:IUD不良事件报告计算机自动审核效率高、范围广、审核质量高且不低于人工审核,可作为人工审核的辅助,但其应用效果评估取决于上报人员是否规范使用了填报模板,以及各类不良事件报告本身的数量和质量,尚不能完全取代人工审核。

Objective:To evaluate and compare the quality of adverse event reports of intrauterine device(IUD)by manual reports and automatic computer audit reports,and to explore the application effect and limitation of automatic computer audit reports.Methods:49688 IUD adverse event reports that audited by Jiangsu health development research center were collected,which included four types of events,such as pregnancy,menstrual problems,pain,position and shape changes.Among them,800 reports were randomly selected for quality evaluation of manually audited and automatically audited by computer.And the report scores of the two auditing methods were compared.Results:Automatic audit reports accounted for 43.8%of the total reports.The overall quality of audit reports by both methods was excellent.Among the three kinds of events that included pregnancy,pain,and position and shape changes of IUD,the average scores of which(92.9±2.7 points,92.0±2.8 points,and 93.7±3.5 points,respectively)by computer automatically audited were significantly higher than those(91.6±4.0 points,89.8±2.7 points,and 91.1±5.0 points,respectively)by manually audited(P<0.05).Among the two kinds of events about pregnancy and the position and shape changes of IUD,the proportions of those scored excellent(55.4%and 56.1%)of sampling reports automatically audited by computer were significantly higher than those(44.6%and 44.0%)by manually audited(P<0.05).Among the four kinds of sampling reports automatically audited by computer,the items with the most scores lost were product number or batch number and production date.Conclusion:In IUD adverse event reports,the automatically audited by computer has a high audit efficiency and a wide range,and its audit quality is not lower than those by manual audit.So it can be used as a powerful assistant for manual audit.But its application effect depends on whether the reporting personnel have standardized the reporting templates,and the quantity and quality of various adverse event reports.So manual audit cannot be completely replaced.