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目的对国家人口计生委计划生育药具不良反应监测中心收集到的江苏地区宫内节育器(intrauterine devices,IUD)不良事件报告表进行质量评价。方法根据二阶段抽样原则,随机抽取2012-2014年间收集的IUD不良事件报告表769份,利用自行设计的质评表进行质量评价。结果 769份报告平均得分为(91.76±5.38),各年分值差异有统计学意义(X~2=293.87,P<0.001),报告表中不良事件和IUD情况两部分填写不规范和缺项是失分的主要原因。结论应继续加强针对本地区不同水平的业务培训,采用量化评价指标有利于监测试点报告质量的进一步提高。
Objective To assess the quality of adverse events reported by intrauterine devices (IUD) in Jiangsu Province collected by the National Family Planning Commission Family Planning Commission Adverse Drug Reaction Monitoring Center. Methods According to the principle of two-stage sampling, 769 IUD adverse event reports collected during 2012-2014 were randomly selected and evaluated by using self-designed quality assessment tables. Results The average score of 769 reports was (91.76 ± 5.38). There was significant difference between the scores in each year (X ~ 2 = 293.87, P <0.001). The non-standard and missing items Is the main reason for losing points. Conclusion The business training for different levels in the region should be continuously strengthened. The adoption of quantitative evaluation indicators is conducive to the further improvement of the quality of monitoring pilot reports.