Design considerations, architecture, and use of the Mini-Sentinel distributed data system

被引:169
作者
Curtis, Lesley H. [3 ,4 ]
Weiner, Mark G. [5 ]
Boudreau, Denise M. [6 ]
Cooper, William O. [7 ,8 ]
Daniel, Gregory W. [9 ]
Nair, Vinit P. [10 ]
Raebel, Marsha A. [11 ]
Beaulieu, Nicolas U. [1 ,2 ]
Rosofsky, Robert
Woodworth, Tiffany S. [1 ,2 ]
Brown, Jeffrey S. [1 ,2 ]
机构
[1] Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Boston, MA 02215 USA
[2] Harvard Univ, Sch Med, Boston, MA USA
[3] Duke Univ, Duke Clin Res Inst, Sch Med, Durham, NC USA
[4] Duke Univ, Sch Med, Dept Med, Durham, NC 27706 USA
[5] Univ Penn, Sch Med, Dept Med, Philadelphia, PA 19104 USA
[6] Grp Hlth Inst, Seattle, WA USA
[7] Vanderbilt Univ, Med Ctr, Dept Pediat, Nashville, TN 37232 USA
[8] Vanderbilt Univ, Med Ctr, Dept Prevent Med, Nashville, TN USA
[9] HealthCore Inc, Wilmington, DE USA
[10] Humana, Louisville, KY USA
[11] Kaiser Permanente Colorado Inst Hlth Res, Denver, CO USA
关键词
distributed network; postmarketing evaluation; safety surveillance; HEALTH DATA; SAFETY; SURVEILLANCE; VACCINE; NETWORK; RISK;
D O I
10.1002/pds.2336
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
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.
引用
收藏
页码:23 / 31
页数:9
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