设计和分析COVID-19助推剂有效性的观察性研究中的异质性:一项审查和案例研究
Sabir Meah1, Xu Shi1, Lars G Fritsche1,2,3,4
1Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI 48109, USA.
medRxiv : the preprint server for health sciences
|July 10, 2023
概括
针对2019年新冠病毒病 (COVID-19) 助推剂的真实世界疫苗有效性 (VE) 研究显示,随着时间的推移,保护力逐渐减弱. 双对应助推器提供强大的保护,防止严重的COVID-19,分析严重的结果是更强大的研究设计选择.
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:
- 对2019年新冠病毒病 (COVID-19) 疫苗有效性 (VE) 的观察性研究是临床试验的重要补充.
- 研究设计和估计VE的统计方法存在显著的异质性,影响了清晰度.
- 这种异质性对 VE 估计的确切影响尚不清楚.
研究的目的:
- 对2019年新冠肺炎疾病 (COVID-19) 的单价和双价增强剂的真实世界疫苗有效性 (VE) 进行审查.
- 评估不同研究设计和统计方法对使用单一数据集对 VE 估计的影响.
- 为了比较单价增压剂和双价增压剂的有效性.
主要方法:
- 进行了对助推器VE的两步文献审查,包括对单价 (第一/第二) 和双价助推器的搜索.
- 从已识别的研究中提取和总结了研究设计,方法和 VE 估计 (感染,住院,死亡).
- 将已识别的统计方法应用于密歇根医学的单个数据集进行比较分析.
主要成果:
- 确定了第一个增剂的53项研究和第二个增剂的16项研究,涉及近1.3亿人.
- 针对所有结果的 VE 最初很高,但随着时间的推移减弱并变得更加异质.
- 双价增强剂研究 (11项研究,>2000万人) 显示,与单价增强剂相比,效果更高,特别是在住院和死亡方面.
结论:
- 第一个单价增压器和双价增压器提供强有力的保护,防止严重的冠状病毒疾病2019 (COVID-19).
- 针对严重结局 (住院,ICU入院,死亡) 的 VE 分析比感染终点更具设计和分析选择的稳定性.
- 当正确实施时,测试负的设计为严重疾病的结果提供了统计效率.
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