严重结合流行病学设计并不能改善疫苗安全监测中的总体信号检测
Faaizah Arshad1,2, Martijn J Schuemie1,2,3, Fan Bu1,2
1Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
Drug safety
|June 16, 2023
概括
疫苗安全监测中的连续测试,结合敏感和特定的方法,可能会降低敏感性并增加虚假阴性. 建议对单个流行病学设计进行评估,以确保可靠的信号检测.
科学领域:
- 流行病学 流行病学
- 公共卫生 公共卫生
- 药物监督 药物监督 药物监督
背景情况:
- 疫苗安全监测通常采用连续测试,使用敏感的信号生成方法和特定的验证方法.
- 连续测试对疫苗安全监测的敏感性和特异性的实际影响仍然不清楚.
研究的目的:
- 在疫苗安全监测中评估连续测试策略的整体性能.
- 为了比较不同流行病学设计的有效性,包括历史比较器和自我控制病例系列 (SCCS),在检测疫苗安全信号.
主要方法:
- 评估了三个行政索赔和一个电子健康记录数据库的连续测试性能.
- 对历史比较器,SCCS和串行组合的实证校准前后比较I型和II型错误.
- 使用了六个疫苗暴露组,有93个负面结果和279个归算的阳性对照结果.
主要成果:
- 历史比较器设计通常显示的II型错误比SCCS少,而SCCS的I型错误较少.
- 在实证校准之前,连续测试增加了特异性,但降低了灵敏度,II型错误往往超过50%.
- 在校准后,I型错误正常化,但当连续组合方法时,灵敏度最低.
结论:
- 连续测试可以减少假阳性信号,但与单一方法相比,可能会增加假阴性信号.
- 结合历史比较器和SCCS设计,降低了安全信号评估的灵敏度.
- 单一的流行病学设计可能为监测中检测疫苗安全信号提供有价值的替代方案.
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