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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >The Vaccine Safety Datalink: a model for monitoring immunization safety.
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The Vaccine Safety Datalink: a model for monitoring immunization safety.

机译:疫苗安全性数据链接:用于监视免疫安全性的模型。

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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.
机译:疫苗安全数据链(VSD)项目是美国疾病控制与预防中心与8个管理医疗组织(MCO)之间的合作项目。该项目成立于1990年,旨在对疫苗安全性进行上市后评估,并创建了可进行高质量研究和监控的基础设施。参加活动的8个MCO每年有880万成员(美国人口的3%),这使研究人员能够进行评估免疫后不良事件的研究。每个MCO都使用标准化的数据字典来准备计算机化数据文件,该字典包含有关其成员的人口统计和医学信息,例如年龄和性别,健康计划登记,疫苗接种,住院,门诊就诊,急诊就诊,急诊就诊以及死亡率数据,以及其他可用的出生信息(例如出生体重)。其他信息来源,例如病历检查,会员调查以及药房,实验室和放射学数据,经常用于VSD研究中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MCO的数量和登记人口的增加,数据收集程序的变化,近实时数据文件的创建以及对开发人员的近实时售后监控的发展。新许可的疫苗或疫苗建议的变更。作为疫苗安全的重要资源,VSD正在通过数据共享和外部输入来提高透明度。通过最近的增强,VSD提供了科学的专业知识,继续开发用于疫苗安全性研究的创新方法,并且可以作为其他患者安全性协作研究项目的模型。

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