Post-licensure rapid immunization safety monitoring program (PRISM) data characterization
Post-licensure rapid immunization safety monitoring program (PRISM) data characterization
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DOI：
10.1016/j.vaccine.2013.04.088
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发表时间：
2013-12-30
期刊：
影响因子：
5.5
通讯作者：
Lieu, Tracy A.
中科院分区：
文献类型：
--
作者：
Baker, Meghan A.;Michael Nguyen;Lieu, Tracy A.
背景：许可后快速免疫安全监测 (PRISM) 计划是 FDA 迷你哨兵项目的免疫安全监测组成部分，该项目是一个利用电子健康信息主动监测医疗产品安全性的计划。 FDA 试图通过表征基础数据来评估这个基于索赔的大型分布式疫苗安全监测数据库的监测能力。方法：我们表征了 PRISM 中疫苗暴露的可用数据，估计通过与选定的州和地方免疫登记处匹配获得了多少额外数据，并将基于 PRISM 数据的疫苗接种覆盖率估计值与其他可用数据源进行了比较。我们生成了代表与疫苗安全监测相关的潜在健康结果的计算机代码率。使用包括 ICD-9 代码、所需代码数量、排除标准和接种地点在内的标准化算法来获得背景率。结果：索赔数据很好地捕获了大多数常规接种给婴儿、儿童、青少年和成人的疫苗，最多七个州的免疫登记数据占所有疫苗类别数据的 5% 至 9%，但乙型肝炎为 10%，轮状病毒和带状疱疹分别为 3% 和 4%。基于 PRISM 计算机化数据的疫苗接种覆盖率估计类似于但低于国家免疫调查和医疗保健有效性数据和信息集的覆盖率估计。对于所研究的 25 种感兴趣的健康结果，基于 ICD-9 代码的潜在结果率通常高于文献中描述的比率，这些结果通常是临床确诊病例。结论：PRISM 计划有关疫苗暴露和健康结果的数据似乎足够完整，足以支持强有力的安全监测。 (C) 2013 Elsevier Ltd. 保留所有权利。
Background: The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data.Methods: We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates.Results: The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases.Conclusion: PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring. (C) 2013 Elsevier Ltd. All rights reserved.