在SARS-CoV-2疫苗有效性的观察研究中,混和负控制方法:一项全国性,基于人口的丹麦卫生登记册研究
Niels Obel1,2, Matthew P Fox3, Malte M Tetens2
1Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Copenhagen, 2300, Denmark.
Clinical epidemiology
|July 31, 2024
概括
关于SARS-CoV-2疫苗有效性的观察性研究可能会显示出混. 负对照方法显示,在接种疫苗的人群中,某些结果的风险较高,突出了随机试验的必要性.
科学领域:
- 流行病学 流行病学
- 疫苗学 疫苗学 疫苗学
- 生物统计学 生物统计学
背景情况:
- 评估SARS-CoV-2疫苗有效性的观察性研究容易引起混.
- 负控制方法可以有效地说明和量化这种混偏差.
研究的目的:
- 使用负对照结果调查SARS-CoV-2疫苗有效性的观察性研究中的混.
- 评估SARS-CoV-2疫苗接种与各种健康结果 (包括感染和其他疾病) 之间的关联.
主要方法:
- 全国范围的,以人口为基础的丹麦居民年龄在60-90岁之间的队列研究.
- 建立了接种疫苗和未接种疫苗的匹配队列,并为特定疾病 (例如癌症,中风) 建立了负控制队列.
- 使用考克斯回归分析计算调整后的发病率和死亡率比率.
主要成果:
- 接种疫苗的个体显示SARS-CoV-2感染的风险较高,以及几个负面对照结果,如恶性黑色素瘤 (aIRR: 3.05) 和眼睛检查 (aIRR: 1.15).
- 相反,接种疫苗的人在所有研究的队列中死亡风险较低,包括SARS-CoV-2感染 (aMRR:0.23) 和中风 (aMRR:0.50).
结论:
- 这些发现表明,SARS-CoV-2疫苗有效性的观察性研究存在显著的混.
- 随机试验对于确定疫苗的有效性至关重要,特别是在新变种和强剂推出时.
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