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An Overview of the Defense Medical Surveillance System The DMSS Project

An Overview of the Defense Medical Surveillance System The DMSS Project. Laura H. Franzke, PhD, MPH National Immunization Program NVAC, June 4 th , 2003. Background.

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An Overview of the Defense Medical Surveillance System The DMSS Project

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  1. An Overview of theDefense Medical Surveillance System The DMSS Project Laura H. Franzke, PhD, MPH National Immunization Program NVAC, June 4th, 2003

  2. Background • CDC was charged by Congress to undertake collaborative studies regarding the safety and efficacy of the anthrax vaccine adsorbed (AVA) • NIP is working collaboratively with the DoD and FDA to investigate potential adverse events associated with AVA using the DoD’s Defense Medical Surveillance System (DMSS) database

  3. Purpose • To perform hypothesis testing and hypothesis generation with the DMSS • Examine the possibility that long term adverse effects are associated with AVA

  4. Institute of Medicine (An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, IOM of the National Academies, 2003) • “HIGH PRIORITY: Linkages of the Defense Medical Surveillance Systems and other databases for longer-term follow-up of military personnel who received AVA”

  5. DMSS Structure and Functional Relationships(Adapted from: AJPH, Dec 2002, Vol 92, No. 12) • Personnel Data • Active Duty • Reserve Component • Active Duty Casualty • Military Entrance • Processing Stations DMSS

  6. DMSS Structure and Functional Relationships(Adapted from: AJPH, Dec 2002, Vol 92, No. 12) Personnel Data • Medical Data • In-patient • Ambulatory • Reportable Events • Immunizations DMSS

  7. DMSS Structure and Functional Relationships(Adapted from: AJPH, Dec 2002, Vol 92, No. 12) PersonnelData Medical Data • Serologic Data • Serum Specimens DMSS

  8. DMSS Structure and Functional Relationships(Adapted from: AJPH, Dec 2002, Vol 92, No. 12) • Deployment Data • DeploymentRosters • Pre/Post Health • Assessment • Disease & non-battle • injury (aggregate) PersonnelData Medical Data Serologic Data DMSS

  9. DMSS Structure and Functional Relationships(Adapted from: AJPH, Dec 2002, Vol 92, No. 12) PersonnelData Medical Data Serologic Data Deployment Data DMSS MSMR Ad hoc Requests Studies/Analyses Reports Defense Medical Epidemiology Database (DMED)

  10. Medical Surveillance Monthly Report (MSMR) DMED: Defense Medical Epidemiological Database http://amsa.army.mil

  11. AMSA: Army Medical Surveillance Activity • FOH: Federal Occupational Health • VAU: Vaccine Analytic Unit • Internal Steering Committee: CDC, DoD, FDA • External Consultative Committee: • National Vaccine Advisory Committee

  12. DMSS Project Organizational Structure External Consultative Committee Internal Steering Committee FOH Hiring & Administrative Support AMSA IRBs Vaccine Analytic Unit (VAU) CDC/DoD/FDA DATA Outside DMSS

  13. Mission for theExternal Consultative Committee • The External Consultative Committee will act as an “Advisory” scientific committee providing expert advice regarding the development and growth for the DMSS Project.

  14. Roles and Responsibilities for theExternal Consultative Committee • Make recommendations about priority hypotheses to study • Provide advice and comment on study protocols • Periodically updated about study procedures • and progress • Review results from analyses of DMSS data • Provide advice on study results manuscripts and dissemination

  15. External Consultative Committee • Time Commitment: 3-5 years • Meetings: Twice a year in-person (during NVAC meetings) and occasionally by teleconference • Members: Requesting approximately 5 members from NVAC • Expertise: Epidemiology, internal medicine, immunology, vaccine safety, military medicine

  16. Acknowledgements DOD Mark Rubertone John Grabenstein John Brundage Jeff Lange DMSS Staff CDC Ben Schwartz Mike McNeil Bruce Tierney Phil Rhodes Stacey Martin Paul Stehr-Green Betsy Cadwell Roseanne English-Bullard Kelly Bell FDA Bob Ball Dale Burwen Jane Woo FOH Wayne Grant Richard Horn AVEC

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