{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T22:49:27Z","timestamp":1779230967748,"version":"3.51.4"},"reference-count":21,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2008,10,27]],"date-time":"2008-10-27T00:00:00Z","timestamp":1225065600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2008,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>We describe a multi\u2010center post\u2010marketing 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\u2010marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This retrospective cohort study of Guillain\u2010Barr\u00e9 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11\u201321 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\u201318\u2010year olds and 16% among 11\u201313 and 14\u201316\u2010year\u2010old age groups by the second quarter of 2007.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This study demonstrates the feasibility of using a distributed data network approach to perform large scale post\u2010marketing 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. Copyright \u00a9 2008 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.1675","type":"journal-article","created":{"date-parts":[[2008,10,27]],"date-time":"2008-10-27T08:50:34Z","timestamp":1225097434000},"page":"1226-1234","source":"Crossref","is-referenced-by-count":34,"title":["A distributed research network model for post\u2010marketing safety studies: the Meningococcal Vaccine Study"],"prefix":"10.1002","volume":"17","author":[{"given":"Priscilla","family":"Velentgas","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rhonda L.","family":"Bohn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey S.","family":"Brown","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. Arnold","family":"Chan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Gladowski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Crystal N.","family":"Holick","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judith M.","family":"Kramer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cynthia","family":"Nakasato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire M.","family":"Spettell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander M.","family":"Walker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fang","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Platt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2008,10,27]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.298.18.2185"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.607"},{"key":"e_1_2_1_4_2","unstructured":"BaggsJ LewisE AmundsenJH et al. Distributed Data Model for the Vaccine Safety Datalink (VSD) Project. Poster presented at: 10th Annual HMO Research Network Conference; 3\u20135 May 2004; Dearborn Michigan United States.http:\/\/hmoresearchnetwork.org\/archives\/2004\/2004abst\/04_pa_27. pdf[Accessed 14 July2008]."},{"key":"e_1_2_1_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3180616c0a"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2458-6-235"},{"key":"e_1_2_1_7_2","unstructured":"Agency for Healthcare Research and Quality website.Developing a distributed research network to conduct population\u2010based studies and safety surveillance.http:\/\/effectivehealthcare.ahrq.gov\/healthInfo.cfm?infotype=nr&ProcessID=54Published 10 January2008. [Accessed 13 May 2008]."},{"key":"e_1_2_1_8_2","unstructured":"Robert Wood Johnson Foundation website. National effort to measure and report on quality and cost\u2010effectiveness of health care unveiled.www.rwjf.org\/pr\/product.jsp?id=22371&typeid =160Published 3 October2007. [Accessed 13 May 2008]."},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1197\/jamia.M2371"},{"key":"e_1_2_1_10_2","unstructured":"United States Food and Drug Administration. Office of Critical Path Programs. The Sentinel Initiative: National Strategy for Monitoring Medical Product Safety.www.fda.gov\/oc\/initiatives\/criticalpathPublished 22 May2008. 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