应用两种方法来检测由于时间变化的变量而导致的未测量的混,在自我控制的风险间隔设计中评估COVID-19疫苗安全信号,使用心肌炎作为案例例
Sophie H Bots1, Svetlana Belitser1, Rolf H H Groenwold2
1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, 3508 TB, Utrecht, The Netherlands.
American journal of epidemiology
|July 3, 2024
概括
自控风险间隔 (SCRI) 设计对于COVID-19疫苗安全性研究是强大的,即使有时间变化的混因素. 定量偏差分析和负对照结果证实了它对评估心肌炎风险的可靠性.
科学领域:
- 药学流行病学 药学流行病学
- 疫苗安全研究 疫苗安全研究
- 生物统计学 生物统计学
背景情况:
- 时间变化的混在疫苗安全研究中带来了挑战.
- 自控风险间隔 (SCRI) 设计是解决这些挑战的潜在方法.
- 对研究设计进行强有力的验证对于可靠的安全信号检测至关重要.
研究的目的:
- 评估自控风险区间 (SCRI) 设计的稳定性.
- 在因COVID-19疫苗接种而导致的时间变化混的背景下评估SCRI设计.
- 检查COVID-19疫苗接种后肌心炎风险估计中的潜在偏差.
主要方法:
- 使用了5个欧洲数据库,包括从2020年9月起接种疫苗的病例.
- 使用SCRI设计,60天的控制窗口和剂量特定的28天的风险窗口.
- 纳入负控制结果 (外耳炎) 和定量偏差分析 (QBA) 来评估混.
主要成果:
- 负对照结果 (外耳炎) 与COVID-19疫苗的相关性很小.
- 定量偏差分析表明,即使是像COVID-19感染这样的强烈混因素也不能完全解释观察到的肌心炎风险.
- 该SCRI设计证明了对未测量的混的稳定性,具有有限的上升偏差的潜力.
结论:
- 自主控制风险间隔 (SCRI) 设计对于评估COVID-19疫苗安全性,包括心肌炎风险,似乎很强大.
- 虽然一般可靠,但未测量混偏差结果的可能性值得考虑.
- 建议对不同的安全信号进行进一步复制,以加强对SCRI方法的信心.
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