在印度22家三级医院建立一个多中心的免疫接种后积极不良事件哨兵监测网络:前性观察研究的协议
Apoorva Sharan1, Manoja Kumar Das2, Akhil Pm2
1University of Basel, Basel Switzerland, Swiss Tropical and Public Health Institute (Swiss TPH), Allschwil, Switzerland, Inclen Trust International, New Delhi, India.
这项研究在印度建立了一个大规模的积极监测网络,以监测儿童的疫苗安全性,为低收入国家的公共卫生提供了关键数据.
科学领域:
- 公共卫生 公共卫生
- 流行病学 流行病学
- 免疫接种计划 免疫接种计划
背景情况:
- 在低收入和中等收入国家 (LMICs) 发展免疫计划需要加强许可后的疫苗安全监测.
- 在资源有限的环境中,疫苗安全监测能力建设至关重要.
研究的目的:
- 描述建立印度免疫监测系统 (MAASS) 网络后多中心活性不良事件的协议.
- 为12个特定的不良儿科结果进行前性观察性监测.
主要方法:
- 实施了三级医院的多阶段选址流程.
- 采用去中心化,协作式的方法进行协议开发和数据标准化.
- 对12种不良结果进行了住院儿童 (1-24个月) 的查,收集了人口统计,社会经济和疫苗暴露数据.
主要成果:
- 在印度各地建立了22家三级护理医院的地理代表性网络.
- 选了90,147例入院病例,并确认了8,362例研究结果.
- 创建了一个全面的数据库,用于调查疫苗事件的关联.
结论:
- 马斯网络代表了在LMICs中前所未有的积极监控规模.
- 经验教训为在资源有限的环境中开发监测系统和疫苗效益风险评估提供了宝贵的见解.
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