疫苗上市后安全性准实时监测的概括性评价

Scoping review of near real-time surveillance of vaccine safety

目的梳理国际现有疫苗安全性准实时主动监测系统的特征、流程与机制,建立准实时监测的实施框架。方法应用概括性评价,定义、检索、筛选与提取疫苗安全性准实时监测系统与研究的相关信息,嵌合框架整合法确定分析框架,编码与标绘有关数据特征、监测流程与运行机制等方面的内容,解构准实时监测的核心要素,建立准实时监测的标准化工作流程。结果纳入相关资料55篇,发现全球共有6个系统或组织常规开展准实时监测,其中“自动链接与分布式计算”模式能够有效提升监测效率,适用于准实时监测对于及时性的较高要求。总结准实时监测的标准化工作流程为:(1)借助计算机程序自动提取数据;(2)利用个体层面通用数据模型(CDM)进行数据标准化处理;(3)利用汇总层面CDM定期提交数据;(4)从信号描述、信号检测到信号验证的逐步分析。结论国际多个主动监测系统已经实现了准实时监测的自动化与常规化,可为未来完善我国主动监测模式、建立长效的准实时监测机制提供参考。

Objective To review the characteristics,processes and mechanisms of current near real-time surveillance systems for vaccine afety worldwide,and to establish a standardized workflow.Methods The scoping review was used to evaluate,define,retrieve and screen information related to the near real-time surveillance systems of vaccine safety.The framework synthesis was applied to determine the analytical framework,coding and mapping information about characteristics of data,surveillance procedures and operational mechanisms before the core elements of near real-time surveillance were summarized and a standardized workflow was established.Results Fifty pieces of literature were included in this study.A total of six systems or organizations worldwide were identified to routinely conduct near real-time surveillance.The“automatic linkage and distributed computing”model could effectively improve monitoring efficiency and meet the higher requirements of timeliness.The standardized workflow for near real-time surveillance was summarized as follows:(1)Automatic data extraction by computer programs;(2)Data standardization using individual-level CDM;(3)Regular data submission using aggregate-level CDM;(4)Step-by-step analyses involving signal description,detection,and validation.Conclusion Near real-time surveillance has become automatic and regular in several active surveillance systems worldwide.It is believed that this review would serve as a framework for future vaccine-safety endeavors in China to establish a valuable,population-based near real-time surveillance system.