department of health and human services an overview of the defense medical surveillance system the...
DESCRIPTION
DEPARTMENT OF HEALTH AND HUMAN SERVICES Purpose To perform hypothesis testing and hypothesis generation with the DMSS Examine the possibility that long term adverse effects are associated with AVATRANSCRIPT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
An Overview of theDefense Medical Surveillance System
The DMSS Project
Laura H. Franzke, PhD, MPH
National Immunization Program
NVAC, June 4th, 2003
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Purpose
To perform hypothesis testing and hypothesis generation with the DMSS
Examine the possibility that long term adverse effects are associated with AVA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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”
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DMSS Structure and Functional Relationships
(Adapted from: AJPH, Dec 2002, Vol 92, No. 12)
Personnel
Data
DMSS
Medical Data In-patient Ambulatory Reportable Events Immunizations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DMSS Structure and Functional Relationships
(Adapted from: AJPH, Dec 2002, Vol 92, No. 12)
DMSS
Serologic Data Serum Specimens
PersonnelData
Medical Data
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DMSS Structure and Functional Relationships
(Adapted from: AJPH, Dec 2002, Vol 92, No. 12)
DMSS
PersonnelData
Medical Data
Serologic Data
Deployment Data Deployment Rosters Pre/Post Health Assessment Disease & non-battle injury (aggregate)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DMSS Structure and Functional Relationships
(Adapted from: AJPH, Dec 2002, Vol 92, No. 12)
MSMR
Ad hoc Requests
Studies/Analyses
Reports
Defense Medical Epidemiology
Database (DMED)
DMSS
PersonnelData
Medical Data
Serologic Data
Deployment Data
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Medical Surveillance Monthly Report (MSMR)
DMED: Defense Medical Epidemiological Databasehttp://amsa.army.mil
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DMSS Project Organizational Structure
Internal Steering Committee
AMSAFOH Hiring &
Administrative Support Vaccine Analytic Unit
(VAU) CDC/DoD/FDA
DMSS
IRBsDATA
Outside
External Consultative Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Acknowledgements
DODMark Rubertone
John GrabensteinJohn Brundage
Jeff LangeDMSS Staff
CDCBen SchwartzMike McNeil
Bruce TierneyPhil Rhodes
Stacey MartinPaul Stehr-Green
Betsy CadwellRoseanne English-
BullardKelly Bell
FDA Bob Ball
Dale BurwenJane Woo
FOHWayne GrantRichard HornAVEC