The DoD Center for Deployment Health Research Presentation to Public Health Advisory Body, Armed Forces Epidemiological Board 18 February 2003 CDR Margaret Ryan, MC, USN CDR Kevin Russell, MC, USNR

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The DoD Center for Deployment Health Research
Presentation to Public Health Advisory Body,
Armed Forces Epidemiological Board18 February
2003CDR Margaret Ryan, MC, USNCDR Kevin
Russell, MC, USNR
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• Epidemiological studies of the
• health of military members and
• their families
• Emerging infectious disease
• studies of importance to the
• military
• 75 research professionals
• 30 active protocols in FY03

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• The Legacy of the Gulf War of 1991

• Multiple expert review panels
• VA and DoD Registries
• Over 150M in medical research
• Extensive risk management program (OSAGWI)
• Overall, US spent estimated 1 billion on
  deployment-associated morbidity.

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Gulf War Epidemiological Studies at NHRC

• Hospitalization study (N Eng J Med, 1996)
• Birth defects study (N Eng J Med, 1997)
• Goldenhar syndrome (Teratology, 1997)
• Registry study (Amer J Epidemiol, 1998)
• Testicular cancer (Epidemiol, 1998)
• M. fermentans study (Am J Trop Med, 1999)
• Seabee study (Am J Trop Med, 1999)
• Khamisiyah study (Am J Epidemiol, 1999)
• Mental health hosp (Clin Epidemiol, 1999)
• Nonfederal hospitalization study (Am J Epidemiol,
  2000)
• Factor analysis study (Am J Epidemiol, 2000)
• PB and Gulf War veterans (Mil Med, 2000)
• SLE, ALS, and fibromyalgia (Amer J Epidemiol,
  2000)
• GWV and birth defects, Hawaii (Teratology, 2000)
• Birth Defect Registry (Teratology 2001)
• Combined GW Registries (J Occ Environ Med 2002)
• Symptoms in GW Seabees (Am J Epidemiol 2002)
• Oil well smoke exposure (Am J Epidemiol 2002)

GW Bibliography, 2001
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DoD Centers for Deployment Health
Established Sep 1999
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Research Collaborators
US Army Center for Health Promotion and
Preventive Medicine US Army Research Inst of
Environmental Medicine Walter Reed Army Institute
of Research Deployment Health Clinical Center,
WRAMC Navy Environmental Health Center Naval
Medical Center San Diego Naval Medical Center
Portsmouth National Naval Medical Center Wilford
Hall Medical Center Madigan Army Medical
Center Defense Manpower Data Center All Basic
Training Commands Lackland Air Force Base, Fort
Sill, Fort Jackson, Fort Knox, Fort Leonard
Wood, RTC Great Lakes, MCRD Parris Island, MCRD
San Diego, CGTC Cape May
Department of Veterans Affairs VA Medical Center,
Boise VA Medical Center, Seattle Centers for
Disease Control and Prevention Mayo Clinic and
Foundation University of Iowa University of
California San Diego San Diego State
University Uniformed Services University
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Select FY03 Projects

• Southwest Asia vs. Bosnia vs. Gulf War
  hospitalizations
• In-theatre Gulf War hospitalizations
• DoD and VA Health Registry analyses
• Squalene antibodies in GW era Seabees
• Anthrax vaccines and hospitalizations
• Anthrax vaccines and birth defects
• Survey of alternative medicine use in Navy/
  Marine Corps
• Ciprofloxicin use after bioterrorism in US mail
• Clinical Trials Center studies
• Emerging infectious disease studies (many)
• The DoD Birth and Infant Health Registry
• The Recruit Assessment Program
• The Millennium Cohort Study

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Emerging Respiratory Infection Studies

• Navy hub for DoD Global Emerging Infection
  Surveillance (GEIS)
• DoD-unique capabilities for diagnosis of
  militarily important respiratory pathogens
• Influenza A B
• Adenovirus
• Mycoplasma pneumoniae
• Chlamydia pneumoniae
• Streptococcus pyogenes
• Streptococcus pneumoniae
• Bordetella pertussis

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NHRC Respiratory Disease Surveillance Sites
Madigan Army MC
Great Lakes
Cape May
Bethesda
Ft Leonard Wood
WRAIR
Ft Knox
Portsmouth
Ft Sill
Ft Bragg
NMC San Diego
Ft Jackson
MCRD San Diego
MCRD Parris Island
BUDS
Ft Benning
Wilford Hall
Viral pathogens
S. pyogenes
S. pneumoniae
Pneumo vaccine
Pertussis
Ensenada, Mexico
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Surveillance results shared via GEISto guide
prevention effortshttp//www.nhrc.navy.mil/geis
Febrile Respiratory Illness Rates
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Expansion of FRI Surveillance to Floating
Platforms and Current Deployment

• Ship Surveillance
• USS Nimitz
• USS Boxer
• USS Higgins
• USS Rushmore
• USS Peleliu
• Forward Deployable Preventive Medicine Unit
  (MMART) support
• Enhance Diagnostic Capability
• Light Cycler on-site dx of
• ADENOVIRUS
• INFLUENZA A
• INFLUENZA B

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New Emerging Infectious Disease Projects

• Expansion of molecular diagnostics
• Break-through adenovirus infections from
  vaccinated recruits
• Multiplex PCR for adenovirus
• Development of MLST for S. pneumoniae, Group A
  strep, MRSA
• New pathogens in FRI cases (rhinovirus, hMPV,
  coronavirus)
• Partnering with others developing novel
  diagnostic techniques
• (e.g., genetic mass spectrometry and genetic
  microarrays)

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Pneumococcal Vaccine Trial

• Double-blind, placebo-controlled trial
• of 23-valent pneumococcal vaccine in
• military recruits.
• Vaccine, FDA-approved, commonly
  
  
• given to elderly. Similar vaccine
• given to infants since 2000. Vaccine
• value in healthy young adults unclear.
• This is one of the largest vaccine trials in
  military history
• (gt130,000 people already enrolled). Underway
  at 4 sites.
• AFEB endorsement was critical to
  implementation.
• Collaborators include Mayo Clinic and CDC.
• Results of interest to military and civilian
  public health professionals.

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Notable Products of Infectious Disease Research

• Azithromycin trial (Clin Infect Dis, 1998)
• DoD respiratory threats (Emerg Infect Dis, 1999)
• Ft Jackson outbreak (Emerg Infect Dis, 1999)
• Ft Benning outbreak (MSMR, 1999)
• Navy Respiratory Disease Laboratory (Mil Med,
  2000)
• Adenovirus orphaned vaccine (Clin Infect Dis
  2001)
• USS Arkansas flu outbreak (Emerg Infect Dis 2001)
• Pertussis PCR (Mol Cell Probes 2001)
• Adenovirus DNA testing (J Med Micro 2001)
• USNA study (Mil Med 2001)
• BUDS study (Clin Infect Dis 2001)
• Pneumococcal vaccine study (Mil Med 2001)
• Pneumococcal surveillance (JID 2001)
• Handwashing and resp infections (Am J Prev Med,
  2001)
• Adenovirus serotyping (J Clin Micro 2001)
• Adenovirus deaths (MMWR 2001)
• Adenovirus 73 outbreak (Clin Infect Dis 2002)
• TB screening (Int J Infect Dis 2002)
• Pneumococcal outbreak in Rangers (Mil Med 2002)

• CAP Certification (since 1999)
• WHO Collaborating Center - pnd

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The DoD Birth and Infant Health Registry

• US Senate Committee on Veterans Affairs
  recommended establishing a birth defects
  registry Report of the special investigation on
  Gulf War illnesses, 1998. Washington, DC.

• Additional support for the Registry
• Committee to Review the Health Consequences of
  Services during the Persian Gulf War (1996)
• The Presidential Advisory Committee on Gulf War
  Veterans Illnesses, Special Report (1997)
• OPNAVINST 5100.23D

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Justification for Birth Defects Registries

• Birth defects are common
• may be present in gt15 of all conceptions.
• major defects are found in 3-4 of live births.
• Birth defects are costly
• account for 25-30 of all pediatric
  hospitalizations.
• leading cause of infant mortality in the US.
• Birth defects are concerning
• 35 states have birth defect surveillance.
• occupational and environmental exposures
• concern both parents and policymakers.

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DoD Birth and Infant Health Registry Methodology

• Includes all DoD beneficiaries.
• Birth defects defined by standard ICD9 codes in
  first year of life.
• Diagnoses validated through select medical
  record review.

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DoD Birth Registry Results

• gt95,000 infants born to military families each
  year.
• 19 of infants are born to active duty mothers,
  others
• are born to dependent wives or other
  beneficiaries.
• Military births take place in all 50 states and
  gt20 foreign
• countries.
• By simple linking to Defense Manpower Data
• Center data, the Registry can analyze
• parents past duty stations or deployment,
• parents occupational codes,
• other exposures (e.g., anthrax vaccination)

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DoD Birth Registry Results

• Overall prevalence of major defects among
  infants born to
• military families is 3.2
• Factors associated with defects include
• Advanced maternal age
• Multiple births (twins, etc)
• Male gender of infant
• Overall prevalence, types of defects, and
  factors associated
• with defects are consistent with civilian
  data.

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• Limitations
• Surveillance limited to live births.
• Cannot capture defects diagnosed after one year
  of age.
• Strengths
• System completely captures its intended data.
• Record reviews demonstrate diagnoses in
  electronic data are accurate.
• Ability to link data to parental environmental
  and occupational data is a unique attribute.
• Military system complements civilian public
  health efforts.

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DoD Birth and Infant Health Registry Products

• Teratology publication, 2001
• Annual DoD Reports since 1998.
• National Birth Defect Prevention Network
  surveillance reports.
• Newer evaluation of Neoplasms of Infancy
  complements both birth defect and pediatric
  cancer surveillance.
• Evaluation of maternal anthrax vaccine and birth
  defects has been provocative contributed to
  MMWR and IOM Reports prompted validation
  efforts, valuable in interpreting DoD electronic
  vaccine data.

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The Recruit Assessment Program

• Collection of baseline health data on all
  military members is essential for

• understanding health risks prior to entrance,
• understanding how service-related
• exposures (especially deployments) affect
• health,
• developing early intervention and prevention
• programs to protect health and readiness.

• RAP was called for by a Presidential Review
  Directive (PRD-5, 11Nov98)
• RAP was endorsed by the Armed Forces Epidemiology
  Board in 2002.

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The Recruit Assessment Program

• RAP questionnaire includes
• demographic data
• clinical and medical history
• family history
• psychosocial history
• occupational history
• substance abuse and risk factor screens
• Sources of Questions
• AUDIT Alcohol Use Disorders Identification Test
• HEAR Health Enrollment Assessment Review 2.0
  (DoD)
• HOI-R History, Opinion, Inventory - Revised
  (DoD)
• NCS National Comorbidity Study
• PRIME-MD Patient Questionnaire
• SF-12/36 Medical Outcomes Short Form
• SF-93 Standard Form 93 (DoD, revised 6/96)

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The Recruit Assessment Program
Pilot study at Marine Corps Recruit Depot (MCRD),
San Diego Original survey 17 pages, 60 minutes
to complete. Current revision is 12 pages, 25
minutes to complete. Revised questions improved

readability and comprehension.
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The Recruit Assessment Program

• Current Status at MCRD San Diego

• Incorporated into general recruit in-processing
  June 2001.
• All recruits (gt30,000 to date) entered.
• Automated CHCS registration made RAP well
  received.
• Multiple test-retest results (kappa statistics)
  are very strong.
• Pilot testing continues to hone survey
• all questions now gt90 complete within 25
  minutes.

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The Recruit Assessment Program
Examples of RAP Data
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The Recruit Assessment Program
Question specific completion rates
RAP Survey Analyses
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The Recruit Assessment Program

• Summary and Future Direction
• RAP will provide baseline data essential to
  future
  military readiness.
• Successfully implemented at MCRD San Diego.
• Army piloting RAP at Ft Jackson.
• Other US recruit commands moving forward.
  
• Other military systems (Canada, Australia) have
  expressed strong interest in RAP as well.

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The Millennium Cohort Study

• Section 743 of the FY1999 Strom Thurmond Act
  authorized the Secretary of Defense to establish
  a longitudinal study to evaluate data on the
  health conditions of members of the Armed
  Forces...

• Institute of Medicine Reports
• Recommended a prospective cohort study of service
  members.
• Encouraged capitalization on new DoD surveillance
  and health data, not available at the time of the
  Gulf War.
• In the model of Framingham and other cohorts,
  measure deployment impact prospectively.

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The Millennium Cohort Study

• Primary objective
• Assess adjusted risk for development of common
  chronic diseases of concern (e.g., asthma,
  diabetes, hypertension, heart disease) and
  multi-symptom illnesses within the cohort.
• Secondary objectives
• Assess functional health status, over time,
  within the cohort.

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The Millennium Cohort Study

• Methods
• Enroll a large, stratified random sample of the
  2.7M US military personnel on duty as of October
  2000.
• Re-survey at 3-year intervals through 2022.
• In 2004 and 2007, add new accession cohorts.
• Link to other data to assess long-term effects of
  military exposures.

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The Millennium Cohort Study
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The Millennium Cohort Study

• Some data sets to be linked to core survey data
• Demographic and deployment data (DMDC)
• Immunizations
• Outpatient care
• Hospitalizations
• Birth Registry data
• VA disability data
• Mortality data

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The Millennium Cohort Study

• Enrollment Methodology
• Using standard instruments, focus groups and
  pilot testing honed survey.
• Simple, mark-sense form created using advanced
  software (Teleform, Cardiff, Inc.)
• Modified Dillman methods, augmented with email
  invitations, used to enroll.
• Complex algorithms developed for
  response tracking.
• Addresses sought from multiple
  sources (DEERS, IRS, other).
• Marketing consultation very valuable.

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www.millenniumcohort.org
Website provides information and option for
online enrollment.

• Advanced security and backup
• features.
• Automatic confirmation emails sent.
• Update address and other pages
• facilitate communication.
• T-shirts and phone cards offered as
• cost-effective incentives for use of
• website.

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The Millennium Cohort Study

• Current status
• Enrollment initiated in Aug 2001
• Enrollment year marked by challenges, including
  Sep 11th terrorist attacks, anthrax in US mail
  system in Oct 2001, and deployment to Operation
  Enduring Freedom.
• gt77,000 enrolled to date.
• Complement to 120,000 expected with enrollment in
  2004 expect total of 140,000 by
  2007.
• Internet enrollment gt50.

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The Millennium Cohort Study
Intensive Analyses of Data Quality
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The Millennium Cohort Study

• Oversight
• Co-investigators from all services and the VA
• (Drs Amoroso, Boyko, Gackstetter, Gray, Hooper,
  Riddle, Ryan)
• Protocols designed with external consultation
• Multiple IRBs review
• AIBS external review
• AFEB annual review
• Scientific Steering and
  
  Advisory Committee
  
  

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The Millennium Cohort Study Importance to DoD
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• Future Projects of the DoD Center for
  Deployment Health Research
• Evaluation of long-term health effects
  associated with
• smallpox vaccine
• Evaluation of reproductive health effects
  associated with
• smallpox vaccine (including Pregnancy
  Registry
• collaboration with CDC)
• Evaluation of post-Gulf War II deployment data
  in
• relationship to RAP (as indicated)
• Collaborative work on the Millennium Cohort
  Study

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• AFEB as Advisory Body to the
• DoD Center for Deployment
• Health Research
• Recommendations of AFEB may drive DoD
• research and resources.
• Comments on current projects and future
• directions are of tremendous value.
• Perspectives on new resources and
  collaborations
• are also of great value.

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DoD Center for Deployment Health Research
http//www.nhrc.navy.mil/rsch/code25/program5.htm
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DoD Center for Deployment Health Research at the
Naval Health Research Center