The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety
The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety
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DOI：
10.1542/peds.2010-1722h
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发表时间：
2011-05-01
期刊：
影响因子：
8
通讯作者：
Weintraub, Eric
中科院分区：
文献类型：
--
作者：
Baggs, James;Gee, Julianne;Weintraub, Eric
疫苗安全数据链（VSD）项目是美国疾病控制和预防中心与8个管理式护理组织（MCO）之间的合作项目。该项目成立于1990年，目的是对疫苗安全性进行上市后评估，它建立了一个基础设施，可以进行高质量的研究和监测。8个参与的MCO每年有880万成员（占美国人口的3%），这使研究人员能够进行评估免疫接种后不良事件的研究。每个MCO通过使用标准化数据词典准备计算机化数据文件，其中包含其成员的人口统计学和医疗信息，如年龄和性别、健康计划登记、疫苗接种、住院、门诊访视、急诊科访视、紧急护理访视和死亡率数据，以及其他出生信息（如出生体重）（如可用）。其他信息来源，如病历审查，成员调查，药房，实验室和放射学数据，通常用于VSD研究，以验证结果和疫苗接种数据。自2000年以来，VSD发生了重大变化，包括参与的MCO和入组人群数量增加，数据收集程序变更，近实时数据文件的创建，以及对新许可疫苗或疫苗建议变更的近实时上市后监测的发展。VSD被认为是疫苗安全的重要资源，它正在努力通过数据共享和外部输入来提高透明度。随着其最近的增强，VSD提供科学专业知识，继续开发疫苗安全性研究的创新方法，并可作为其他患者安全合作研究项目的典范。儿科2011;127：S45-S53
The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8 managed care organizations (MCOs) in the United States. Established in 1990 to conduct postmarketing evaluations of vaccine safety, the project has created an infrastructure that allows for high-quality research and surveillance. The 8 participating MCOs comprise a large population of 8.8 million members annually (3% of the US population), which enables researchers to conduct studies that assess adverse events after immunization. Each MCO prepares computerized data files by using a standardized data dictionary containing demographic and medical information on its members, such as age and gender, health plan enrollment, vaccinations, hospitalizations, outpatient clinic visits, emergency department visits, urgent care visits, and mortality data, as well as additional birth information (eg, birth weight) when available. Other information sources, such as medical chart review, member surveys, and pharmacy, laboratory, and radiology data, are often used in VSD studies to validate outcomes and vaccination data. Since 2000, the VSD has undergone significant changes including an increase in the number of participating MCOs and enrolled population, changes in data-collection procedures, the creation of near real-time data files, and the development of near real-time postmarketing surveillance for newly licensed vaccines or changes in vaccine recommendations. Recognized as an important resource in vaccine safety, the VSD is working toward increasing transparency through data-sharing and external input. With its recent enhancements, the VSD provides scientific expertise, continues to develop innovative approaches for vaccine-safety research, and may serve as a model for other patient safety collaborative research projects. Pediatrics 2011;127:S45-S53