积极疫苗安全监测的最低数据集和元数据:系统性审查
Mengdi Zhang1,2, Junting Yang1,2, Yan Li3
1Department of Epidemiology and Biostatistics, School of Public Health, Peking University, 38 Xueyuan Road, Haidian District, Beijing, 100191, China, 86 10-82805162, 86 10-82805162.
JMIR public health and surveillance
|June 17, 2025
概括
本研究定义了疫苗安全研究的最小数据范围,对于全球活跃疫苗安全监测 (AVSS) 系统至关重要. 建立标准化数据和元数据可以加强全球疫苗安全监测.
科学领域:
- 药物监测和公共卫生
- 流行病学 流行病学
- 监管科学 监管科学
背景情况:
- 主动疫苗安全监测 (AVSS) 是世界卫生组织 (WHO) 的优先事项,表明监管机构的成熟度.
- 有效的AVSS对于确保全球疫苗安全至关重要,特别是在资源有限的环境中.
研究的目的:
- 定义疫苗安全相关性研究的最小数据范围.
- 为全球实施AVSS系统建立一个参考框架.
- 支持低收入和中等收入国家制定强有力的疫苗安全监测.
主要方法:
- 对AVSS (2018-2022) 的队列和病例控制研究的系统文献综述.
- 为最小数据集 (MDS) 开发一个4D框架:疫苗,结果,人口数据,共变量.
- 包括频率>=5%的变量,以世卫组织和CIOMS指南为指导.
主要成果:
- 包括123项研究;82.9%是队列研究,79.7%来自高收入国家.
- 确定了COVID-19疫苗MDS的54个变量和母体人口MDS的96个变量.
- 世卫组织的指导方针显示出比CIOMS更好的实际调整;元数据描述不足.
结论:
- 拟议的MDS为AVSS数据范围提供了明确的要求.
- 全球标准化的MDS和全面的元数据对于改善全球疫苗安全生态系统至关重要.
- 根据MDS的发现,需要进一步优化指南和元数据.
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