A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program
A Vaccine Study Design Selection Framework for the Postlicensure Rapid Immunization Safety Monitoring Program
复制标题
DOI：
10.1093/aje/kwu322
复制
发表时间：
2015-04-15
影响因子：
5
通讯作者：
Nguyen, Michael D.
中科院分区：
文献类型：
--
作者：
Baker, Meghan A.;Lieu, Tracy A.;Nguyen, Michael D.
美国食品药品监督管理局（FDA）的Mini-Sentinel项目的疫苗接种安全性监测组成部分Postlicensure Rapid Immunization Safety Monitoring Program是目前美国普通人群中最大的疫苗安全性监测队列。我们开发了一个研究设计选择框架，以提供路线图和方法描述，这些方法可用于评估许可后快速免疫安全性监测项目和其他使用管理数据的系统中疫苗与关注健康结局之间的潜在关联。以表格形式描述和总结了疫苗安全性监测设计的优缺点，包括队列设计、病例中心设计、风险区间设计、病例对照设计、自身对照风险区间设计、自身对照病例系列方法和病例交叉设计。提供结构化决策表以帮助规划未来的疫苗安全性监测活动，并描述构成结构化决策表的数据组成部分。研究设计选择框架为使用基于声明的数据源规划疫苗安全性评价提供了起点。
The Postlicensure Rapid Immunization Safety Monitoring Program, the vaccination safety monitoring component of the US Food and Drug Administration's Mini-Sentinel project, is currently the largest cohort in the US general population for vaccine safety surveillance. We developed a study design selection framework to provide a roadmap and description of methods that may be utilized to evaluate potential associations between vaccines and health outcomes of interest in the Postlicensure Rapid Immunization Safety Monitoring Program and other systems using administrative data. The strengths and weaknesses of designs for vaccine safety monitoring, including the cohort design, the case-centered design, the risk interval design, the case-control design, the self-controlled risk interval design, the self-controlled case series method, and the case-crossover design, are described and summarized in tabular form. A structured decision table is provided to aid in planning of future vaccine safety monitoring activities, and the data components comprising the structured decision table are delineated. The study design selection framework provides a starting point for planning vaccine safety evaluations using claims-based data sources.