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| Quality evaluation of two auditing methods for adverse event reports of intrauterine device |
| Jiangsu Health Development Research Center, State Contraceptives Adverse Reaction Surveillance Center, Nanjing, Jiangsu Province, 210036 |
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Abstract 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.
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