Velentgas Priscilla, Bohn Rhonda L, Brown Jeffrey S, Chan K Arnold, Gladowski Patricia, Holick Crystal N, Kramer Judith M, Nakasato Cynthia, Spettell Claire M, Walker Alexander M, Zhang Fang, Platt Richard
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA 02215, USA.
Pharmacoepidemiol Drug Saf. 2008 Dec;17(12):1226-34. doi: 10.1002/pds.1675.
We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative.
This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls.
The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007.
This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system.
我们描述了一项多中心上市后安全性研究，该研究采用分布式数据方法，以尽量减少受保实体共享受保护健康信息（PHI）的需求。实施过程解决了与创建美国食品药品监督管理局（FDA）哨兵计划所设想的大规模上市后药物安全监测系统相关的几个问题。
这项关于脑膜炎球菌结合疫苗接种后格林-巴利综合征（GBS）的回顾性队列研究纳入了与美国健康保险公司密切相关的五个研究机构的数据和分析专业知识。该研究使用行政索赔数据，外加对全文医疗记录的审查，以判定患有GBS诊断代码（ICD9 357.0）的个体的状况。采用分布式网络方法来创建分析文件并执行分析的大部分方面，几乎所有数据都保留在机构防火墙之后。转移到中心站点的汇总分析文件将为大约0.2%的研究人群中的每人包含一条记录，并且包含的PHI仅限于GBS发病月份和年份（对于病例）或匹配对照的索引日期。
首次计划的数据提取在11至21岁的目标年龄范围内确定了超过900万符合条件的青少年。在27个日历月的时间里，他们平均贡献了14个月的符合研究条件的时间。到2007年第二季度，17 - 18岁人群中的四价脑膜炎球菌结合疫苗（MCV4）接种覆盖率超过20%，11 - 13岁和14 - 16岁年龄组中的接种覆盖率超过16%。
本研究证明了使用分布式数据网络方法进行大规模上市后安全性分析的可行性，并且可扩展以纳入更多组织和数据源。我们相信这些结果可为大型国家监测系统的开发提供参考。
