Design considerations, architecture, and use of the Mini-Sentinel distributed data system
Design considerations, architecture, and use of the Mini-Sentinel distributed data system
复制标题
DOI：
10.1002/pds.2336
复制
发表时间：
2012-01-01
影响因子：
2.6
通讯作者：
Brown, Jeffrey S.
中科院分区：
文献类型：
--
作者：
Curtis, Lesley H.;Weiner, Mark G.;Brown, Jeffrey S.
目的我们描述了一个大型的，多组织的分布式数据库的设计，实施和使用，以支持美国食品和药物管理局（FDA）的迷你哨兵试点计划。正如美国FDA所设想的那样，这一实施将为美国医疗产品（药物、生物制品和器械）安全性监测的主动监测系统的开发提供信息和促进。方法设计了一个通用数据模型，以解决微型哨兵试点的优先事项，并利用参与组织和数据合作伙伴的经验和数据。对现有共同数据模型的审查为这一进程提供了信息。每个参与组织都设计了一个过程来提取、转换和加载其源数据，并应用公共数据模型来创建Mini-Sentinel分布式数据库。使用一系列由参与组织集中开发并在本地执行的程序对转换后的数据进行了表征和评估。设计了一个安全的通信门户，以方便查询小型哨兵分布式数据库和传输机密数据，开发了分析工具，以方便对常见问题作出快速反应，并安装了分布式查询软件，以方便快速查询汇总数据。结果截至2011年7月，99 260 976名健康计划成员的信息被纳入微型哨兵分布式数据库。该数据库包括316 009 067人-年的观察时间，成员平均贡献27.0个月的观察时间。所有数据合作伙伴都成功执行了分布式代码，并将结果返回给Mini-Sentinel运营中心。结论这项工作证明了建立一个大型的，多组织的分布式数据系统，其中组织保留他们的数据，用于主动监测系统的可行性。版权所有（C）2012约翰威利父子有限公司
Purpose We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA. Methods A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data. Results As of July 2011, information on 99 260 976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316 009 067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center. Conclusion This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system. Copyright (C) 2012 John Wiley & Sons, Ltd.