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| Evaluation for quality of serious adverse intrauterine device event case reports and analysis of related factors |
| YANG Yuehua1,2 ZHOU Jian1,2 SHI Wenhui1,2 ZHANG Min1,2 XU Haoqin1,2▲ HANG Guifang3▲ |
1.State Contraceptives Adverse Reaction Surveillance Center, Jiangsu Province, Nanjing 210036, China;
2.Jiangsu Institute of Planned Parenthood Research, Jiangsu Province, Nanjing 210036, China;
3.Department of Ultrasound Integrated Traditional Chinese and Western Hospital in Jiangsu, Jiangsu Province, Nanjing 210028, China |
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Abstract Objective To evaluate the quality of the reports of serious adverse intrauterine device event, and seek the influencing factors in order to further improve the quality of reports. Methods According to the quality assessment standards made by Center for Drug Revaluation of CFDA, 263 case reports collected during the period from July 2016 to June 2017 were evaluated, and the scores of each report were input to a database built by Epidata 3.1 and analyzed by SPSS 19.0 software. Results The quality of the reports was generally good. Missing or filling in a mistake of those items such as time limit, impact on the patient, product number or batch number, production date caused subtraction mainly. The monitoring site category, medical data supported, adverse event were all have significant effects on the quality of reports (P ＜ 0.01). Conclusion Governors and rapporteurs should pay more attention to the problems identified in the evaluation and further improve the quality of reports pertinently.
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