Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
HUMAN USE PROTOCOL
ROUTING SLIP
FROM (Principal Investigator):
Rudolph Rull, PhD
(TYPED NAME)
(PI SIGNATURE)
In accordance with NAVHLTHRSCHCENINST 3900.2G, I am submitting the attached human use protocol
for consideration.
TITLE OF PROTOCOL: Prospective Studies of U.S. Military Forces: The Millennium Cohort Study
ABBREVIATED TITLE: The Millennium Cohort Study
PROPOSED DATES OF RESEARCH: 2000/10/01 to 2067/09/30
FUNDING SOURCE: USAMRMC (MOMRP) / VA (VHA, OPH, ORD)
MOMRP: 67 years (see Appendix A) / VA: 5 years (2018 June)
WORK UNIT TITLE AND NUMBER: Deployment Health Research, 60002
JON FUNDING THE PROTOCOL:
8LH2HA
SUBMISSION (CHECK ONE):
INITIAL SUBMISSION
MODIFICATION OF PREVIOUS SUBMISSION
CONTINUING/ANNUAL REVIEW
PROTOCOL OBJECTIVE (Brief sentence or two): The primary objective is to determine how the health of
U.S. military veterans changes over time and compare the adjusted incidence of chronic disease between
cohorts
DoD PROTOCOL NUMBER (Assigned by IRB Administrator upon submission for initial review. Be sure to
add this number where indicated on the title page): NHRC.2000.0007
Note: You must obtain required
signatures before you submit the
protocol to the IRB.
Date
Received
Initials
Date
Reviewed
Approved
JON
Initials
1
DEPARTMENT HEAD
2
DIRECTOR*
N/A
3
SCIENCE DIRECTOR*
N/A
4
IRB ADMINISTRATOR
N/A
N/A
NOTES
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
I. COVER PAGE(S)
1. Protocol Number: NHRC.2000.0007 (previously 32227)
2. Title: Prospective Studies of U.S. Military Forces: The Millennium Cohort Study
3. Date of Submission: originally August 2000
4. Approved Work Unit Title: Deployment Health Research, 60002
5. Approximate Dates of Research: 10/01/2000 to 09/30/2067
6. Principal Investigators:
Rudolph Rull, PhD
Deployment Health Research Department
Naval Health Research Center, San Diego, CA
7. Co-Investigators:
Valerie Stander, PhD
NHRC, San Diego, CA
8. Key Support
Denise Lovec-Jenkins
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Beverly Sheppard
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Jennifer Walstrom
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Lauren Bauer, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Gia Gumbs, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Evelyn Sun, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Anet Petrosyan
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
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Alexis Takata
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Deanne Millard
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Steven Speigle
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
William Lee
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Daniel Vaughan
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Gordon Lynch
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Jacqueline Pflieger, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Sabrina Richardson, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Chris Phillips, MD, MPH
NHRC, San Diego, CA
Ben Porter, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Teresa Powell, MS
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Cynthia LeardMann, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
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Daniel Trone, PhD
NHRC, San Diego, CA
Deborah Bookwalter, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Richard Armenta, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Anna Rivera, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Isabel Jacobson, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Chiping Nieh, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Rayna Matsuno, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Marleen Welsh, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Zeina Khodr, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Adam Cooper, PhD
CPT, MSC, US Army
NHRC, San Diego, CA
Anna Bukowinski
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Satbir Boparai, MBA
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
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Toni Geronimo, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Claire Kolaja, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Alejandro Esquivel, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Carlos Carballo, MA
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Kelly Woodall, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Kimberly Roenfeldt, MAS
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
Steven Warner, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc
9. Identification Research Monitor/Ombudsman
N/A
10. Primary Performing Institution(s):
Deployment Health Research Department, Naval Health Research Center, San Diego, CA
11. Collaborators / Collaborating Institution(s):
Edward Boyko, MD, MPH
Seattle ERIC, Seattle, WA
Gary Gackstetter, DVM, MPH, PhD
ANSER, Inc., Washington, DC
Tomoko Hooper, MD, MPH
USUHS, Bethesda, MD
•
The Millennium Cohort team provides de-identified datasets to the following two
institutions for specific projects: Walter Reed National Military Medical Center
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Uniformed Services University of the Health Sciences. DUAs are approved or
pending and collaborations were approved.
•
The following are unfunded collaborators. Individuals from these institutions work
on projects with our team, but are not funded to do so.
o USAPHC
o WRAIR
o USARIEM
o WRNMC
o Keller Army Hospital, West Point
o NMCPHC
o NMRC
o NMCSD
o Navy Hospital Camp Pendleton
o VA Medical Centers
o Veterans Affairs
o Columbia University
o Pace University
o San Diego State University
o University of California, San Diego
o University of Connecticut
o University of Minnesota
o Boston University
o University of Washington
o University of Cincinnati
o Loma Linda University
o University of Pennsylvania
o University of Arizona
o University of Washington
o University of South Carolina
o Uniformed Services University of the Health Sciences
o King’s College London
o Duke University
o Yale University
o Pearson Knowledge Technologies
o Children’s Hospital, Boston
o National Intrepid Center of Excellence
o US Army Center for Health Promotion & Preventive Medicine (USACHPPM)
o Armed Forces Medical Examiner System
o Bureau of Medicine and Surgery
o West Point NY
o WRAMC
o Medical University of South Carolina
o Purdue University
o Analytic Services Inc (ANSER)
o National University
o Madigan Army Medical Center
o Fred Hutchinson Cancer Research Center
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12. Funding Source
USAMRMC (MOMRP) / VA (VHA, OPH, ORD) MOMRP: 67 years; VA: 5 years (2018
June)
13. Number of MilCo Subjects: 202,160
a. Number of Female Subjects: TBD, approximately 20%
b. Number of Male Subjects: TBD, approximately 80%
c. Number of Civilian Subjects:
d. Number of Active-Duty Subjects: 100% initially
14. Is an IAIR/IIRR needed? [If yes, submit draft agreement(s) with protocol]
N/A
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II. SIGNATURE PAGE(S)
1. Principal Investigators:
_______________________________
Rudolph Rull, PhD,
NHRC, San Diego, CA
2. Directorate Head/Dept. Head: _______________________________
Natalie Wells, MD, MPH
CDR, MSC, USN
NHRC, San Diego, CA
_______________________________
Susan Farrish, MD, MPH
LtCol, USAF, MC
Department Head, Deployment Health Research Dept.
NHRC, San Diego, CA
3. Principal Director of Research _______________________________
Kenneth Earhart, MD
NHRC, San Diego, CA
4. Ombudsman:
N/A
5. Research Monitor:
N/A
6. Commanding Officer:
_______________________________
M. R. MONTEVILLE
CAPT MSC USN
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III.
RECORD OF CHANGES TO THE PROTOCOL
December 2017 – Continuing Review
1. Under this continuing review report, we respectfully request to modify the study protocol to
add Deanne Millard and Alexis Takata as key personnel. They will be located at the Naval
Health Research Center and will serve as key support staff as a research assistants.
Additionally, Alejandro Esquivel, MPH has been moved to an Analyst position due to his
promotion and Christopher Lo is being removed from the protocol due to his recent
resignation.
September 2017 Staff and Mailing Update
We respectfully request the review of the following:
1. This protocol has undergone a change of staff. CDR Dennis Faix had received transfer orders;
therefore, Dr. Rudolph Rull will assume the role of Principle Investigator. In addition, due to
Danielle Mitchell’s and Kyna Long’s recent resignations, they are being removed from the
protocol.
We also request permission to add Zeina Khodr, PhD, Christopher Lo, BS and Daniel
Vaughn, BS as key personnel. Lastly, due to promotions, Alejandro Esquivel, MPH has been
moved to a Research Assistant position and Toni Geronimo, MPH has been moved to an
Analyst position.
2. We are submitting to the IRB for review and approval the text for the upcoming Veterans
Day Postcard and email contacts that are within the previously approved number of contacts.
April 2017 Staff Update
We respectfully request the review of the following staff update:
1. We request permission to add Sabrina Richardson, PhD and Marleen Welsh, PhD as
key personnel. Their roles are outlined below:
Dr. Sabrina Richardson will serve as key support staff as a Research Psychologist.
Her duties will include assisting in program design and maintenance of survey
instruments alongside the research team; planning epidemiologic studies and
designing the study methodology; performing statistical analyses for diverse research
projects with complex study designs; working with team members to derive an indepth understanding of the data findings; drafting proposals and writing peerreviewed publications.
Dr. Welsh will serve as key support staff as an Epidemiologist. Her duties will
consist of planning epidemiologic studies and designing the study methodology;
performing statistical analyses for diverse research projects with complex study
designs; working with team members to derive an in-depth understanding of the data
findings; drafting proposals and writing peer-reviewed publications.
The training certificates (HIPAA, CITI and Research Integrity and Responsible
Conduct) for Dr. Richardson’s are currently on file with the IRB and Dr. Welsh’s are
included with this submission.
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March 2017 Staff Update and Mailings
We respectfully request the review of the following:
1. We are submitting to the IRB for review and approval the text for next set of email
and postal contacts that are within the previously approved number of contacts.
2. In addition, this protocol has undergone a change of staff and we request permission
to add Kimberly Roenfeldt, MAS and Steven Warner, MPH as key personnel. Their
roles are outlined below:
Kimberly Roenfeldt will be located at the Naval Health Research Center and will
serve as key support staff as an Analyst. Her duties will include providing statistical
and analytical support for diverse research projects; assist in processing and
maintenance of research databases; assist in writing of reports and scientific
manuscripts for peer-reviewed professional journals and presentations.
Mrs. Roenfeldt’s training certificates (HIPAA, CITI and Research Integrity and
Responsible Conduct) are included with this submission.
Steven Warner will be located at the Naval Health Research Center and will serve as
key support staff as an Analyst. His duties will include providing statistical and
analytical support for diverse research projects; assist in processing and maintenance
of research databases; assist in writing of reports and scientific manuscripts for peerreviewed professional journals and presentations.
Mr. Warner’s training certificates (HIPAA, CITI and Research Integrity and
Responsible Conduct) are included with this submission.
Memorial Day 2017 Post Card
Post Card Front: In memory of many, in honor of all.
Back: On this Memorial Day, we remember those Servicemen and women who have
given their lives so that we and our nation may be free. No words can express the debt we
owe to these brave men and women.
The information provided by Cohort members makes it possible to understand long term
health outcomes of military service and will help shape military policy now and in the
future.
Please know that you will make a difference by remaining engaged in the Cohort over
time. You will receive your next survey to complete later this year.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
Primary Institutional Review Board Protocol Naval Health Research Center.2000.0007.
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Memorial Day Email plain text version
Subject line: We Remember
Dear {NAME},
On this Memorial Day, we remember those Servicemen and women who have given their
lives so that we and our nation may be free. No words can express the debt we owe to
these brave men and women.
The information provided by Cohort members makes it possible to understand long term
health outcomes of military service and will help shape military policy now and in the
future.
Please know that you will make a difference by remaining engaged in the Cohort over
time. You will receive your next survey to complete later this year.
You will also receive a Memorial Day postcard in the mail from the Millennium Cohort
Study team. You can view it online at
Thank you for your continued support of this important project!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Memorial Day Email HTML version
Subject line: We Remember
Dear {NAME},
On this Memorial Day, we remember those Servicemen and women who have given their
lives so that we and our nation may be free. No words can express the debt we owe to
these brave men and women.
The information provided by Cohort members makes it possible to understand long term
health outcomes of military service and will help shape military policy now and in the
future.
Please know that you will make a difference by remaining engaged in the Cohort over
time. You will receive your next survey to complete later this year.
Thank you for your continued support of this important project!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Millennium Cohort Desktop Calendar
Dear {Name},
The Millennium Cohort Study Team would like to thank you for your continued
involvement in this important program. Only through your continued participation will
we be able to understand how military service affects service members’ long-term health.
As a token of our appreciation for your continued involvement, we have enclosed a 20172018 desktop calendar. We truly value your time and input. You will receive your next
survey to complete later this year.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
November 2016 Continuing Review (Year 2017)
We respectfully request to modify the study protocol to remove the following individuals
as they no longer have an affiliation with the study:
Col Paul Amorose, Tim Wells, PhD, CAPT Margaret Ryan, Dennis Hernando, CPT
Carrie Donoho, Dr. Hector Lemus, Dr. Amy Millikan, Kathleen Gunn, and Kristin
Motylinski.
We would also like to update Anna’s name to reflect her name change from Nagel to
Rivera as well as update the Scientific Director from Dr. Richard Shaffer to Dr. Kenneth
Earhart.
In addition, we would like to add Chiping Nieh, PhD as key personnel. Her role is
outlined below:
Chiping Nieh, PhD will serve as key support staff as an Analyst. Her duties include
providing statistical and analytical support for diverse research projects; assist in
processing and maintenance of research databases; assist in writing of reports and
scientific manuscripts for peer-reviewed professional journals and presentations.
November 2016 (IRB APPROVAL RECEIVED 09JAN2017)
We respectfully request the following modification to the protocol:
We would like to request permission to obtain selected variables regarding military
assessment and treatment provision, as well as other medical care referral from the
Department of Defense and Service specific Family Advocacy Program (FAP) Central
Registry Databases. The Family Advocacy program provides various treatment and
support services for perpetrators and victims, and makes referrals for additional care
where needed. Within the DON, the Family Advocacy Program services are provided as
part of the Fleet and Family Counseling Support Centers. We would request the specified
variables for all incidents involving Millennium Cohort Study research participants, with
recurring data extracts to be completed annually or triannually.
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Permission to receive these data will be obtained from DoD and the Service specific FAP
offices, as well as from the Defense Manpower Data Center (DMDC) which maintains
the DoD-level repository for cases meeting full criteria as family violence incidents. We
currently have a Memorandum of Understanding (MOU) in place with DMDC and an
existing approved data request for FAP data for Millennium Cohort Family Study
participants. The existing DMDC request has been updated to include all Millennium
Cohort participants (see attached); and once IRB approval has been received, NHRC will
provide a list of the SSNs for Millennium Cohort Study participants to DMDC. DMDC
will then provide NHRC with all matching records in the DoD Central Registry for those
SSNs. Separate data use agreements will be established with the Service specific FAP
offices in order to obtain additional information regarding suspected incidents meeting
partial criteria. Similar procedures will be used for data matching with Service specific
registries, and all data transfers will be made using encrypted files either using the
Army’s AMRDEC Safe Site or a secure data transfer site supported by DMDC.
The requested variables include the following personnel and treatment information for
Service members in the Millennium Cohort Study with substantiated cases of intimate
partner violence victimization or intimate partner/child abuse offending:
Name
Social Security Number
Incident report date
Legal event context code (emotional maltreatment, neglect, physical abuse, sexual abuse)
Person Association reason code (only codes AA = spouse, AD=parent, BH=former
spouse, BE=intimate partner, CC=relationship unknown)
Victim maltreatment severity level (mild, moderate, severe)
Clinical intervention program provided to Family Study participant as a victim (FAP,
Other DoD, Other Non-DoD, None, missing)
Clinical intervention program provided to Family Study participant as an offender (FAP,
Other DoD, Other Non-DoD, None, missing)
September 2016
We respectfully request the following modification to the protocol:
1. We are submitting to the IRB for review and approval the text for the annual Veterans
Day postcard and email.
2. In addition, this protocol has undergone the following staff changes; therefore we
respectfully request permission to:
Remove Soyeon Kong, PhD from the protocol as she has resigned and is no longer
affiliated with NHRC, and
Add Kelly Woodall, MPH as key personnel. Her role is outlined below:
Kelly Woodall will be located at the Naval Health Research Center and will serve as
key support staff as an Analyst. Her duties include providing statistical and analytical
support for diverse research projects; assist in processing and maintenance of research
databases; assist in writing of reports and scientific manuscripts for peer-reviewed
professional journals and presentations.
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Ms. Woodall’s training certificates (HIPAA, CITI and Research Integrity and
Responsible Conduct) are included with this submission.
Veteran’s Day Postcard-2016
On this Veterans Day, the Millennium Cohort Study Team thanks all who have served
to preserve this Nation’s freedom.
Information provided by you and your fellow Cohort members helps make it possible
to understand long-term health outcomes of military service, and will help shape
military policy both now, and in the future.
We will be in contact with you again in 2017 to learn about any changes that may
have occurred in your health and well-being since we last heard from you.
Thank you again for your selfless service and your continued support of this
important project!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of The Millennium Cohort Study Team
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Veteran’s Day Email-2016 Plaintext
Subject line: This Veterans Day We Salute Your Service
Dear ,
On this Veterans Day, the Millennium Cohort Study Team thanks all who have served to
preserve this Nation’s freedom.
Information provided by you and your fellow Cohort members helps make it possible to
understand long-term health outcomes of military service, and will help shape military
policy both now, and in the future.
We will be in contact with you again in 2017 to learn about any changes that may have
occurred in your health and well-being since we last heard from you.
You will receive a Veterans Day postcard in the mail from the Millennium Cohort Study
team. You can also view it online at
Thank you again for your selfless service and your continued support of this important
project!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of The Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Veteran’s Day Email-2016 HTML
Subject line: This Veterans Day We Salute Your Service
Dear ,
On this Veterans Day, the Millennium Cohort Study Team thanks all who have served to
preserve this Nation’s freedom.
Information provided by you and your fellow Cohort members help makes it possible to
understand long-term health outcomes of military service, and will help shape military
policy both now, and in the future.
We will be in contact with you again in 2017 to learn about any changes that may have
occurred in your health and well-being since we last heard from you.
Thank you again for your selfless service and your continued support of this important
project!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of The Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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July 2016
We respectfully request the following modification to the protocol:
The contacting of Millennium Cohort Study (MCS) participants to inform them of the
opportunity to enroll in the Million Veteran Program (MVP) study in support of the
national Precision Medicine Initiative (PMI). The MVP is a national, voluntary research
program conducted by the Department of Veterans Affairs (VA) Office of Research and
Development (ORD). A data use agreement between NHRC/MCS and VA/MVP is
pending to cover the activities listed here, specifically the bi-directional sharing of
contact information to determine appropriate MCS participants to contact. No research
data will be sent to the MVP until these agreements are in effect.
This effort will initially be restricted to Millennium Cohort Study (MCS) participants
who have separated from active duty service, but is planned to also include active duty
MCS participants once appropriate high-level DoD and VA agreements are in place.
Additional restrictions will apply depending on the study panel. For Panel 1 and 2
participants, only those participants who meet the following criteria will be contacted:
1. Have a good postal address.
2. Answered YES to question #114 in the 2014 MCS follow-up survey: “A great deal
has been learned from this study and as a result we may be asked to consider other
research possibilities. If other related research studies become available, may we
contact you to let you know about them?"
3. Have not already enrolled or refused to enroll in MVP.
For Panel 3 and 4 participants, only those participants who meet the following criteria
will be contacted:
1. Have a good postal address.
2. Have not answered NO to question #114 on the 2014 MCS follow-up survey.
3. Have not already enrolled or refused to enroll in MVP.
In order to determine those MCS participants who have already enrolled in MVP or
refused to join MVP, MVP study staff will send to MCS encrypted social security
numbers (SSNs) of those MCS participants. These data will be sent via the U. S. Army
Aviation and Missile Research Development and Engineering Center (AMRDEC) Safe
Access File Exchange (SAFE) site. Upon receipt of these data, MCS staff will remove
these participants with matching SSNs from the list of MCS participants who have met
the other eligibility criteria. These remaining eligible participants will be sent one postal
contact with information about enrolling in MVP along with the option to opt out from
receiving any information. This letter includes information about PMI. Those participants
who do not wish to receive information and enrollment materials from MVP will be
asked to tear off the postcard on the bottom portion of the letter and return it to the
Millennium Cohort Study within 30 days of receipt of the letter. After 60 days of the
expected receipt of the letter, MCS study staff will generate lists of SSNs of eligible
participants who did not return the postcard along with their respective current contact
addresses. This list will be encrypted and sent to MVP staff via the AMRDEC SAFE site.
The MVP will then send these individuals an invitation to enroll in the MVP study.
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MVP Postal Mailing
Dear {Participant],
Your participation in the Millennium Cohort Study is invaluable to our understanding of
the long-term health of military Service members. Thank you!
We are committed to improving the health of former, current, and future Service
Members, and by working closely with other research efforts, we are now better equipped
to reach this goal. As a participant of the Millennium Cohort Study, we would like to let
you know about an exciting research opportunity available to you from the Department of
Veterans Affairs.
The Millennium Cohort Study, along with the Department of Veterans Affairs Million
Veteran Program (MVP), will be working to understand how health and lifestyle factors
affect military Service members and Veterans. MVP is a national research program that is
seeking to enroll 1 million Veterans to study how genes, lifestyle, and military exposures
affect health and illness. The Millennium Cohort Study and MVP are two leading
research initiatives of the Precision Medicine Initiative (PMI) - a national research effort
developed to revolutionize how we improve health and treat disease.
As a valued participant in the Millennium Cohort Study, we invite you to consider
joining MVP. Participation in MVP is entirely voluntary and will not in any way
affect your access to health care or benefits. For additional information about MVP,
please visit http://www.research.va.gov/mvp.
Thank you for your continued participation in the Millennium Cohort Study. We
hope you will consider this opportunity to further our understanding of Service
member and Veteran health outcomes.
Very respectfully,
If you do not wish to receive information about the Million Veteran Program (MVP)
at this time, please tear off the bottom portion of this letter and return it in the next
30 days. Your decision regarding participation in MVP will not affect your status in
the Millennium Cohort Study.
June 2016
We respectfully request the IRB approval to incorporate:
1. The linkage with Global Assessment Tool (GAT) data.
The Millennium Cohort Study (MCS) seeks to understand the impact of military
service on the short-and long- term health of service members and veterans. This
mission would be enhanced by connecting with the Global Assessment Tool (GAT)
implemented by the Comprehensive Soldier and Family Fitness Program (CSF2)
person-event data environment (PDE) built by the Army Analytics Group (AAG).
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The GAT is a confidential self-assessment tool that includes information on Soldiers
well-being, resilience, and their overall health. The MCS collects data on the wellbeing of military members from all services, however, does not have data on
resilience or other factors included in the GAT that may be useful.
GAT data is stored in the PDE, a virtual secure platform designed for integrating data,
linking commands for analysis, and conducting studies/projects. This repository is an
ever-evolving cloud-based, virtual technology that provides strong protections of
human subjects via encoded and de-identified data. It boasts Personally Identifiable
Information (PII) protection and data security and information assurance. To link
MCS data with the GAT data, MCS data must be uploaded into the PDE and linked to
the GAT data. To link the data sources SSNs of MCS participants must be uploaded,
however, all other PII will be stripped from the dataset before it is uploaded.
NHRC will conduct analyses with the linked MCS and GAT data using the PDE
environment, which includes statistical analysis tools. All results from analyses will
be reported in aggregate. Linking to the GAT will allow NHRC researchers to
conduct research to address study aims to better understand factors associated with
the long term health of military service members. Please refer to the “Supplemental
Information: Person-Event Data Environment” attachment for further details
regarding the use and security measures.
2. A staff change to include Satbir Boparai as key personnel. Also, in compliance with
the Army Analytics Group’s (AAG) policies, the AAG’s Person-Event Data
Environment (PDE) Team coding specialists that AAG refers to as ETL will need to
be added to the protocol; therefore in addition to the staff changes previously
mentioned we are adding Dr. Kevin Mason and Mr. Brian Hufford AAG’s PDE team
members as key personnel.
Satbir Boparai will be located at the Naval Health Research Center and will serve as
key support staff as Data Manager. As data manager, Ms. Boparai will be responsible
for processing and managing data and related programs.
Ms. Boparai’s CITI and HIPAA training certificates are included with this
submission.
Dr. Kevin Mason is the AAG certified Database Manager for handling PHI and
ensuring PDE HIPAA compliance. Dr. Mason will assist in de-identification using
the SQL data-scrubbing procedures and will ensure there is no leakage of PHI across
the physical servers (PDE-S to PDE-A). He will create Oracle Tables containing the
various de-identified data assets, conduct validity checks, and provide metadata for
any new data assets obtained for the project.
Mr. Brian Hufford is an SME Database Developer for AAG. He is responsible for
creating fully scrubbed and de-identified Oracle Tables with both PHI and PII data.
He has experience in the SharePoint environment that serves as the interface for
collaboration among PDE-A researchers. He is the lead developer for the PDE
software system with Oracle, .NET, SAS and Web service training. He is by training
a systems engineer with experience in the design and execution of complex computer
systems.
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3. In addition to the data linkage request above, we have removed Serguey
Parkhomovosky from the protocol as he has resigned and is no longer affiliated with
the Deployment Health Research at the Naval Health Research Center, San Diego.
May 2016
We are submitting to the IRB for review and approval the text for the annual Memorial
Day email and postal contact.
April 2016
We respectfully request the review of the following:
1. We are submitting to the IRB for review and approval the text for next set of email
and postal contacts that are within the previously approved number of contacts.
2. In addition this protocol has undergone a change of staff and we request permission to
Carlos Carballo, MA as key personnel. His role is outlined below:
Carlos Carballo will be located at the Naval Health Research Center and will serve as
key support staff as an Analyst. His duties will include providing statistical and
analytical support for diverse research projects; assist in processing and maintenance
of research databases; assist in writing of reports and scientific manuscripts for peerreviewed professional journals and presentations.
Mr. Carballo’s training certificates (HIPAA, CITI and Research Integrity and
Responsible Conduct) are included with this submission.
Also, due to Kari Sausedo’s and Christopher O’Malley’s recent resignations we are
removing them from the protocol
Along with the above-mentioned protocol changes, we request to add Theatre Medical D
Store data as have received permission to access Theatre Medical D Store (TMDS) data;
thereforeThe rationale for this request is that the protocol depends on the healthcare
encounter data, lab data, procedure data, and pharmacy data delivered at any military
treatment facility, including the first echelons of care at deployed locations, which will
now be available via the TMDS datasets. These data will help us fully describe the
burden of disease and health outcomes during wartime.
April Email 1
Dear ,
What lasting effect does military service have on the health of the men and women of our
armed forces? When you joined the Millennium Cohort, you took a step towards helping
answer this important question. Your continued participation is vital to the success of
this project!
The survey cycle is closing soon. Even if you have no current health issues or are no
longer on active military service, we want to hear from you!
Please take a moment to log on to our website and begin your survey by copying and
pasting the following web address into your browser:
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Thank you again for your service to all future military members by participating in the
Millennium Cohort!
This survey is "Official Business". Military members may complete this at their duty
station, using government equipment. If you choose, you can also complete the survey at
home or elsewhere.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of The Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at [email protected]
or [email protected]. Or call toll free 1-888-942-5222 or DSN 553-7465, and
reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note Defense
Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Email (Panel 4 Married Version)
To be sent to the Panel 4 non-responders whose Family Study spouse has completed their
survey and self-reported being married.
Dear _[name]__,
When you joined the Millennium Cohort Study and your spouse, , joined the
Family Study a few years ago, you became part of a special community of couples. The
survey responses you provide inform leadership, guide interventions and shape support
programs designed to target the specific needs of military couples and families.
has already completed the Family Study follow-up survey, but we have
yet to hear from you. The participation of both you and your spouse is what makes the
Millennium Cohort Study and the Family Study such powerful resources for
understanding the impact of military life. We hope you will complete the Millennium
Cohort follow-up survey designed for current and former Service members soon.
In order to complete your survey, please click on the following link:
[link]
Thank you again for working with us to protect the health of current and future members
of our military and their families.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Email (Panel 4 Married Version)
To be sent to the Panel 4 non-responders whose Family Study ex-spouse has completed
their survey.
Dear _[name]__,
When you joined the Millennium Cohort Study and joined the Family
Study a few years ago, you became part of a special community of people. Our records
indicate that your marital status has changed since your last survey, so we are especially
interested in hearing from you. A better understanding of your situation helps inform
leadership, guide interventions and shape support programs designed to target the specific
needs of military couples and families.
has already completed the Family Study follow-up survey. The
participation of both of you is what makes the Millennium Cohort Study and the Family
Study such powerful resources for understanding the impact of military life on couples
and families. We hope you will complete the Millennium Cohort follow-up survey
designed for current and former Service members soon.
In order to complete your survey, please click on the following link:
[link]
Thank you again for working with us to protect the health and well-being of current and
future members of our military and their families.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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April Email 2
Dear ,
We hope you are considering completing the selected questions from the Millennium
Cohort Study survey we mailed to you last week. Your participation will help to evaluate
the impact of military service on your health.
Every survey counts, which is why it is essential to stay involved with the Study even if
you have separated from service, or currently have no health concerns.
If you have already completed your survey, we wish to thank you. If you have not yet
had time to consider our request, we hope you will be able to do so soon. Simply
complete the brief paper version of the survey and return it in the postage pre-paid
envelope.
Alternatively, if you prefer to complete the full online survey, please log on to our
website and begin your survey by copying and pasting the following web address into
your browser:
Thank you again for your time and continued participation.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Final Email
Dear ,
As the Millennium Cohort survey cycle comes to a close I am reaching out one final time
to let you know that your opportunity to participate in this important study will be ending
soon. I would like to encourage you to take a few minutes and complete your online
survey. Even if you have no current health issues or are no longer on active military
service, we want to hear from you!
To complete your survey online, please copy and paste the following web address into
your browser:
Thank you for considering this final opportunity to respond – we truly appreciate your
participation!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id:
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit our
unsubscribe page by copying and pasting the following web address into your browser:
***Millennium Cohort Study - Protecting Service Member Health***
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Short Survey 2 Cover Letter
Dear ,
By joining the Millennium Cohort Study a few years ago, you became part of a select
group of individuals who help inform policy, guide leadership and shape programs
designed to target the specific needs of military service members. Only through the
continued involvement of all Study participants can we begin to understand the
complexities of military life and make an impact in the lives of our Service members and
Veterans.
We realize that your time is valuable, which is why we have created a shortened paper
version of our online survey with carefully selected questions. Please consider taking 5
minutes to complete this very brief survey and return it in the postage pre-paid envelope.
Alternatively, if you would prefer to complete the full survey, please visit our study
website, www.millenniumcohort.org, click “Start Survey” and enter your Subject ID:
XXXXXXX.
Thank you for your continued commitment to current, former and future Service
members.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
2016 Continuing Review
Under the Continuing Review we request permission to update the protocol to include
Armed Forces Health Surveillance Center (AFHSC) as a resource used to obtain data that
will supplement the survey instruments enhancing the ability to track study outcomes.
In addition this protocol has undergone a change of staff and we request permission to
add CPT Adam Cooper as key personnel. His role is outlined below:
CPT Cooper will be located at the Naval Health Research Center and will serve as key
support staff as an Epidemiologist. His duties will consist of planning epidemiologic
studies and designing the study methodology; performing statistical analyses for diverse
research projects with complex study designs; working with team members to derive an
in-depth understanding of the data findings; drafting proposals and writing peer-reviewed
publications.
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10 December 2015
We respectfully request the review of the following:
1. We are submitting to the IRB for review and approval the text for next set of email
and postal contacts that are within the previously approved number of contacts.
2. In addition this protocol has undergone a change of staff and we request permission to
add Rayna Matsuno PhD, and Soyeon "Joyce" Kong PhD, as key personnel. Their
roles are outlined below:
Dr. Rayna Matsuno will be located at the Naval Health Research Center and will
serve as key support staff as an Epidemiologist. Her duties will consist of planning
epidemiologic studies and designing the study methodology; performing statistical
analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals
and writing peer-reviewed publications.
Dr. Joyce Kong will be located at the Naval Health Research Center and will serve as
key support staff as an Epidemiologist. Her duties will consist of planning
epidemiologic studies and designing the study methodology; performing statistical
analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals
and writing peer-reviewed publications.
Desktop Calendar Cover Letter
Dear Name,
The Millennium Cohort Study Team would like to wish you a Happy New Year!
As we enter into this New Year, we would like to encourage you to take some time to fill
out your Millennium Cohort Survey. As a token of our appreciation for your continued
involvement, we have enclosed a 2016 desktop calendar featuring the artwork of some of
our past holiday postcards. We truly value your time and input in order to complete the
survey.
If you have not already done so please complete your survey by going to
www.millenniumcohort.org, click Start Survey, and enter your Subject ID: xxxxxx.
Thank you for your continued participation in this important project.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
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Thank You Coin Mailer
Launched in the summer of 2001, the Millennium Cohort Study has
become the largest health study in military history, and one of the largest
cohort studies in the world! The information provided by members like
you makes it possible to better understand the long-term health of our
Service members and Veterans!
Thank You Coin Mailer Card
Dear Name,
Thank you for you submitting your Millennium Cohort survey in . We would
like to offer this challenge coin as a token of our appreciation for your continued
involvement in this important study. Only through your continued participation will we
be able to understand how military service affects service members’ long-term health.
Remaining engaged in the Cohort over time makes it possible for us to better understand
the long-term health of our Service members and Veterans, which ultimately can help
lead to changes in healthcare and other DoD and VA policies.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
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Incomplete Reminder email
Dear Name,
Thank you for logging on to the Millennium Cohort website to begin your survey!
By participating in this study, you are helping to determine the potential health effects of
military service. The information you provide will significantly help generations of U.S.
service members.
We understand your time is valuable. Please return to the website to complete your
survey now, or as soon as you have a moment. If you need to stop and continue at a later
time, your responses will be saved. All information will be kept confidential.
Please go to:
https://secure.MillenniumCohort.org/users/login/sid:xxxxxx
Your Subject ID is: xxxxxx
If you have any questions or concerns, please email [email protected] or call
our team toll free at 1-888-942-5222. If you have questions on the legitimacy of this
DoD-sponsored survey, please contact DSN: 553-7465, Phone: 619-553-7465 or E-Mail:
[email protected]
Thank you for your time and for your participation in the Millennium Cohort Study!
If you have already completed your survey, please disregard this email and accept my
thanks for your continued voluntary participation in this important work.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
*** This is an automated message, please do not reply***
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id: 103.
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit
(unsubscribe link)
***Millennium Cohort Study - Protecting Service Member Health***
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17 November 2015
We respectfully request the review of the following:
1. We are submitting to the IRB for review and approval the text for next set of email
contacts that are within the previously approved number of contacts.
2. Also, the Millennium Cohort Study had previously planned and implemented a
shorter, condensed contact schedule. However, due to logistical challenges, this
condensed plan was interrupted. As a result, response rates have been lower than
expected. Therefore in order to increase response rates to at least 55%, we are
requesting permission to add 5 additional postal contacts for a total of 18 postal
contacts for the survey cycle. Thus, the survey cycle will continue for an additional 5
months for a total of 20 months as in previous survey cycles. We have included for
IRB review the text for 2 of the 5 additional contacts (scheduled one month between
postal mailings).
3. In addition this protocol has undergone a change of staff and we request permission to
add Alejandro (Alex) Esquivel and Isabel Jacobson, MPH, as key personnel. Their
roles are outlined below:
Alex Esquivel will be located at the Naval Health Research Center and will serve as
key support staff. He will collect and organize survey data, perform data entry,
literature searches, and assist with maintenance of databases for research projects.
Isabel Jacobson will be located at the Naval Health Research Center and will serve as
key support staff as an Epidemiologist. Her duties will consist of planning
epidemiologic studies and designing the study methodology; performing statistical
analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals
and writing peer-reviewed publications.
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December Email
Dear name,
Thank you for your past participation in the Millennium Cohort Study, the largest health
study in US history.
You are one of only 2% of military and veteran men and women who have been chosen
to represent their fellow Service members in this important project. Your experiences,
including those after you leave the military, are vital to understanding how military
service affects your long-term health.
In the next few weeks you should receive a questionnaire asking for your continued help
in learning how military service affects your health.
You may also complete your questionnaire online by going to:
Your Subject ID: (SID)
The Millennium Cohort Study is a DoD authorized project being conducted by the Naval
Health Research Center in San Diego California. The study team is comprised of active
duty, retired and prior service personnel from the Air Force, Navy and Army as well as
civilian researchers. Several of the study’s staff members are also military spouses who
provide insight into daily military life.
Whether you are still actively serving, or if you have separated from the service, your
continued participation is critical to the success of this study.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On behalf of
The Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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January Email
Dear _[name]__,
Last week you should have received a follow-up survey to update your current health
information. Your continuing participation and dedication make it possible to learn about
the long-term impact of military service, even after you have left the service.
Since you enrolled in the Millennium Cohort Study, you have been asked to complete a
health survey every 3 years. Each survey asks some of the same questions over time
about health topics such as physical activity. Habits may change over time, and asking
about these factors every 3 years provides a series of “snapshots” that will help give us a
better picture over time. Even if little has changed or if you have remained healthy,
keeping your information up to date is crucial to being able to draw the right conclusions
from this study.
If you have already completed your survey, please accept our sincere thanks. If you
would like to complete the survey online, you can do so at www.millenniumcohort.org;
just click Start Survey and enter your Subject ID: xxxxxx.
We hope to hear from each one of you, so that the study is as informative as it can be to
you and to future generations of Service members and Veterans.
Very respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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February Email Separated
Dear _[name]__,
You should have received a newsletter last week highlighting why it is important to
continue to fill out the Millennium Cohort Study survey every few years. In a nutshell,
your continued participation is vital!
Using data that you previously provided, we were able to investigate changes in meeting
federal Physical Activity Guidelines following military discharge. Moderate to vigorous
activity declined for former service members that were active duty, had deployed with
combat exposure, had 14-25 years of service, and had separated within the past year. In a
separate studyresearchers also found that vigorous physical activity was associated with
decreased symptoms of PTSD. For the full text of this article, please see the publications
page on our website.
Now that you have left the service, we will be able to get a better sense of the present
issues that our Veterans are facing today by you telling us your current experiences
through our survey. Please go to www.millenniumcohort.org, click Start Survey and
enter your Subject ID: xxxxxx to take your survey.
Thank you for being part of this important study.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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February Email Active Duty
Dear _[name]__,
You should have received a newsletter last week highlighting why it is important to
continue to fill out the Millennium Cohort Study survey every few years. In a nutshell,
your continued participation is vital!
Using data that you previously provided,researchers found that vigorous physical activity
was associated with decreased symptoms of PTSD. For the full text of this article, please
see the publications page on our website.
By letting us know your current experiences, even if you have never deployed, we will be
able to get a better sense of the present issues that our Service members are facing today,
and how those issues may affect their health in the future. Please go to
www.millenniumcohort.org, click Start Survey and enter your Subject ID: xxxxxx to
take your survey.
Thank you for being part of this important study.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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December Q4 Cover Letter
Dear {Name}
Recently, we sent you an invitation to complete a follow-up survey for the Millennium
Cohort Study. By continuing to participate in this study, you are helping to determine
both current and long-term health effects of military service that may be relevant to you
and will help future generations of service members.
Your response is crucial, even if you have never deployed or if you have left military
service!
You can also complete the survey online at:
http://www.MillenniumCohort.org
Enter your unique Subject ID: xxxxxx
If you have any questions, please call DSN 553-7465 or toll-free 1-888-942-5222. You
may also email [email protected] or use the contact form at
http://www.MillenniumCohort.org.
If you have already completed your survey, please accept my thanks and disregard this
packet.
Very respectfully,
(insert signature)
CDR Dennis Faix, MC, USN,
for the Millennium Cohort Study Team
P.S. for families: We would like to hear from all invited participants, even those
deployed or away for other reasons. If possible, please forward this message to the
military family member addressed above.
Be assured that this is an authorized study supported by the highest levels of the Department of
Defense. Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the Assistant
Secretary of Defense (Health Affairs), TRICARE Management Activity Protocol # CDO-06-206,
and Primary Institutional Review Board Protocol #NHRC.2000.0007.
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January Newsletter
Address page
How do I fill out my survey?
If you haven’t already, you can complete your survey
online:
www.millenniumcohort.org
Click on Start Survey and enter your Subject ID located
below the barcode on the address side of this
newsletter.
Feel free to contact us with questions:
Toll-free: 1-888-942-5222
DSN: 553-7465
Email: [email protected]
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Thank you
Special thanks to those who have completed your 2014-2015 survey. It’s
still not too late! We hope to hear from each one of you, so that the study
is as informative as it can be to you and to future generations of Service
members and Veterans.
Another survey? Why?
Since you enrolled in the Millennium Cohort Study, you have been asked
to complete a health survey every 3 years.
The study is designed as a “follow-up study” where the same participants
are followed over time. No one can take your place. This type of study
helps researchers to examine a variety of factors and their influence on a
variety of health conditions that may occur over the course of a lifetime.
This is the largest follow-up study of its kind in military history, and you
are key to its success.
Your continuing participation and dedication make it possible to learn
about the long-term impact of military service, even after you have left the
service.
But the same questions… again?
Each survey cycle, we ask many of the same questions, such as level of
physical activity and amount of cigarette smoking. Habits may change
over time, and asking about these factors every 3 years provides a series of
“snapshots” that will help give us a better picture over time.
Even if not very much has changed, or if you have stayed healthy, we ask
that you respond. Keeping your information up to date is critical to our
ability to draw the correct conclusions from this kind of study.
What about new questions?`
As we learn more as time goes on, we may add new survey questions to
better understand the various health concerns of Service members and
Veterans.
For example, on the current survey, we have added questions about
diagnoses of traumatic brain injury and degenerative joint disease.
Rest assured that when we add new questions, we will work to prioritize
and scale back other questions. We value your time and appreciate your
ongoing help.
08 October 2015
We are submitting to the IRB for review and approval, the Veteran’s Day and November
contact material that is within the permissible number of contacts.
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In addition this protocol has undergone a change of staff; therefore, we request approval
to remove Madeline Cross and Navjot Kaur as their roles within the department have
changed and they are no longer involved with the study. We also request permission to
add Claire Kolaja and Kyna Long as key personnel. Their roles are outlined below:
Claire Kolaja, MPH and Kyna Long, will be located at the Naval Health Research Center
and serve a key support staff as a Data Analyst. There duties will include providing
statistical and analytical support for diverse research projects; assist in processing and
maintenance of research databases; assist in writing of reports and scientific manuscripts
for peer-reviewed professional journals and presentations.
25 August 2015
This protocol has undergone staff changes due to Dr. Luxton’s recent resignation and
Chelsea Schafer no longer being affiliated with NHRC. Therefore with the IRB’s
approval, Dr. Faix, a co-investigator, will now assume the role of Principal Investigator
(PI) and Dr. Luxton along with Chelsea Schafer will be removed from the study protocol.
As a result of the PI change, the recently approved Phase 2 participant contacts have been
updated to remove Dr. Luxton and are included for IRB re-approval.
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Email
Dear {Name},
A week ago we sent you a newsletter highlighting just a few pieces of information that
we have been able to gather from contributions to an important health study called the
Millennium Cohort Study. The new information that we are collecting on the 2014-2015
survey will provide a more complete picture of the health of current and former Service
members.
Why take up some of your time to complete this survey? Everyone has his or her own
reasons...
For some who have already completed this survey, it was simply a matter of duty, of
doing the right thing. For others, it was more personal - having suffered health problems
themselves during or after their service. And for others still, giving some of their time
was driven by a concern for the health of future generations who will serve in the US
military.
Whatever your reason, we ask that you take few minutes to begin your survey today.
We are sending this by email in the hopes that it will make it easier for you to respond.
Just go to www.millenniumcohort.org, click Start Survey and enter your Subject ID:
xxxxxx.
Thank you for working with us to protect the health of our military service members and
for helping to make this the largest and most important DoD health study in US military
history.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the
The Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
xxxix
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Email
Dear _[name]__,
Over (insert number) of your fellow Soldiers, Sailors, Airmen, and Marines have already
completed their 2014-2015 surveys, but every individual response is needed for us to
understand the potential impact of military service on the health and well-being of our
Service members and veterans.
Therefore, we are sending this email to provide an electronic link, which we hope will
make it easier for you to respond. Just go to www.millenniumcohort.org and click
Start Survey and enter your Subject ID: xxxxxx.
Even if you are no longer serving, or do no presently have any health concerns we still
hope that you will complete your survey. Ultimately, the greatest benefits of this study
will not be known for many years. This is why it is essential to stay involved with the
study even after you have left the service or if you are not currently having any health
concerns.
Thank you for working with us to protect the health of our military service members and
for helping to make this the largest and most important DoD health study in US military
history.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the
The Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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Email
Dear name,
We recently sent you a paper copy of the 2014-2015 Millennium Cohort Study. We
understand that your time is very valuable, so we’ve also included a link to our online
version of the survey. When completing the survey online, you can come back to your
survey at any time, and the website will automatically open to the next unanswered
question.
Just go to www.millenniumcohort.org and click Start Survey and enter your Subject
ID: xxxxxx.
Even if you are no longer serving, or do no presently have any health concerns we still
hope that you will complete your survey. Ultimately, the greatest benefits of this study
will not be known for many years. This is why it is essential to stay involved with the
study even after you are out of the service or if you are not currently having any health
concerns.
Thank you for your continued help in making this the largest and most important DoD
study in US military history and working with us to protect the health of members of our
military service.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the
The Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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Dear Name,
As a Millennium Cohort Study participant, you have been selected to represent your
fellow Service members in the largest health study in military history. Even if you have
never deployed or are no longer in the service, your contribution is still very important.
Your past participation, and the participation of others like you, has already helped us
better understand how deployments and other military experiences impact Service
members’ physical and mental health. For example, we found that combat-related trauma
and predeployment insomnia symptoms increased the risk for developing post-traumatic
stress symptoms, depression, and anxiety following deployment.
So far only {30%} of our participants have responded to our requests to submit their
survey. The survey cycle is ending soon, so your response is vital.
We thank you for completing the enclosed survey and returning it in the postage-paid
envelope. Or, if you would prefer to complete the survey online, please go to the
website:
http://www.MillenniumCohort.org
Enter your unique Subject ID: xxxxxx.
We look forward to hearing from you as one of our valued Millennium Cohort members!
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the
The Millennium Cohort Study Team
If you have any questions, please contact the Millennium Cohort team at our toll-free
number, 1-888-942-5222, or DSN 553-7465, or email [email protected].
Be assured that this is an authorized study supported by the highest levels of the Department of
Defense. Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity Protocol #
CDO-06-206, and Primary Institutional Review Board Protocol #NHRC.2000.0007.
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Dear {Name}
Thank you for your past participation in the Millennium Cohort Study. The current
survey cycle is ending soon and we would still like to hear from you. We understand that
your time is valuable and you may not have had the opportunity to fill out our previous
surveys. For this reason we have included a small selection of survey questions on the
included 4 page questionnaire.
The Millennium Cohort Study is unique in that it is designed to survey participants once
every 3 years over the course of their military career and beyond. We are interested in
your health during and long after your military commitment is up.
The success of this study depends on you and others like you. We thank you for
completing the enclosed survey and returning it in the postage-paid envelope. Or, if you
would prefer to complete the full survey, please go to our website:
http://www.MillenniumCohort.org
Enter your unique Subject ID: xxxxxx.
Very Respectfully,
Dennis Faix, CDR, MC, USN
On Behalf of the
The Millennium Cohort Study Team
If you have any questions, please contact the Millennium Cohort team at our toll-free
number, 1-888-942-5222, or DSN 553-7465, or email [email protected].
Be assured that this is an authorized study supported by the highest levels of the Department of
Defense. Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity Protocol #
CDO-06-206, and Primary Institutional Review Board Protocol #NHRC.2000.0007.
August 2015
A request to link Millennium Cohort Study datasets to existing DoD datasets currently at
NHRC containing modeled environmental exposures occurring during the Gulf War.
Specifically, we will link to datasets containing potential exposure to neurological agents
from demolitions at Khamisiyah and exposure to oil well smoke. These data were
compiled and sent to NHRC by US Army Center for Health Promotion and Preventive
Medicine (now US Army Public Health Command). The Naval Health Research Center
currently maintains these datasets detailing potential exposure to oil well smoke and
chemical weapons occurring in 1991 during the Gulf War. SSN’s will be used to link
data, but will not be transmitted externally, and will be confidentially maintained on-site.
In addition this protocol has undergone a change of staff; therefore, a request approval to
remove Laura Tobin, MPH as she is no longer affiliated with the studyand to add Chelsea
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Schafer, Jacqueline Pflieger, PhD, and Deborah Bookwalter, PhD, as key personnel.
Their roles are outlined below:
Chelsea Schafer will be located at the Naval Health Research Center and will serve as
key support staff as a Research Intern. As a Research Intern she will collect and organize
survey data and forms for research projects. In addition, her duties will include scanning
and verifying survey data, performing data entry and literature searches, and assisting
with the maintenance of databases for research projects.
Jacqueline Pflieger, PhD will be located at the Naval Health Research Center and will
serve as key support staff as Research Psychologist. Her duties will include assisting in
program design and maintenance of survey instruments alongside research team;
planning epidemiologic studies and designing the study methodology; performing
statistical analyses for diverse research projects with complex study designs; working
with team members to derive an in-depth understanding of the data findings; drafting
proposals and writing peer-reviewed publications.
Deborah Bookwalter, PhD will be located at the Naval Health Research Center and will
serve as key support staff as an Epidemiologist. Her duties will consist of planning
epidemiologic studies and designing the study methodology; performing statistical
analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals and
writing peer-reviewed publications.
Along with the above updates, we are also submitting to the IRB for review and approval,
the remainder of the participant contact material that is within the permissible number of
contacts.
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Email
Dear {Name},
A week ago we sent you a newsletter highlighting just a few pieces of information that we have
been able to gather from contributions to an important health study called the Millennium Cohort
Study. The new information that we are collecting on the 2014-2015 survey will provide a more
complete picture of the health of current and former Service members.
Why take up some of your time to complete this survey? Everyone has his or her own reasons...
For some who have already completed this survey, it was simply a matter of duty, of doing the
right thing. For others, it was more personal - having suffered health problems themselves during
or after their service. And for others still, giving some of their time was driven by a concern for
the health of future generations who will serve in the US military.
Whatever your reason, we ask that you take few minutes to begin your survey today.
We are sending this by email in the hopes that it will make it easier for you to respond. Just go
to www.millenniumcohort.org, click Start Survey and enter your Subject ID: xxxxxx.
Thank you for working with us to protect the health of our military service members and for
helping to make this the largest and most important DoD health study in US military history.
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
For any questions, please contact the Millennium Cohort Team at [email protected]
or [email protected]. Or call toll free 1-888-942-5222 or DSN 553-7465, and
reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note Defense
Manpower Data Center Reference # 00-0019, Report Control Symbol # DD-HA(AR)2106,
Office of Management and Budget Approval # 0720-0029, Office of the Assistant Secretary of
Defense (Health Affairs), TRICARE Management Activity Protocol # CDO-06-206, and
Primary Institutional Review Board Protocol # NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
xlvi
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Email
Dear _[name]__,
Over (insert number) of your fellow Soldiers, Sailors, Airmen, and Marines have already
completed their 2014-2015 surveys, but every individual response is needed for us to understand
the potential impact of military service on the health and well-being of our Service members and
veterans.
Therefore, we are sending this email to provide an electronic link, which we hope will make it
easier for you to respond. Just go to www.millenniumcohort.org and click Start Survey and
enter your Subject ID: xxxxxx.
Even if you are no longer serving, or do no presently have any health concerns we still hope that
you will complete your survey. Ultimately, the greatest benefits of this study will not be known
for many years. This is why it is essential to stay involved with the study even after you have left
the service or if you are not currently having any health concerns.
Thank you for working with us to protect the health of our military service members and for
helping to make this the largest and most important DoD health study in US military history.
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
For any questions, please contact the Millennium Cohort Team at [email protected]
or [email protected]. Or call toll free 1-888-942-5222 or DSN 553-7465, and
reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note Defense
Manpower Data Center Reference # 00-0019, Report Control Symbol # DD-HA(AR)2106,
Office of Management and Budget Approval # 0720-0029, Office of the Assistant Secretary of
Defense (Health Affairs), TRICARE Management Activity Protocol # CDO-06-206, and
Primary Institutional Review Board Protocol # NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
xlvii
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Email
Dear name,
We recently sent you a paper copy of the 2014-2015 Millennium Cohort Study. We understand
that your time is very valuable, so we’ve also included a link to our online version of the survey.
When completing the survey online, you can come back to your survey at any time, and the
website will automatically open to the next unanswered question.
Just go to www.millenniumcohort.org and click Start Survey and enter your Subject ID:
xxxxxx.
Even if you are no longer serving, or do no presently have any health concerns we still hope that
you will complete your survey. Ultimately, the greatest benefits of this study will not be known
for many years. This is why it is essential to stay involved with the study even after you are out
of the service or if you are not currently having any health concerns.
Thank you for your continued help in making this the largest and most important DoD study in
US military history and working with us to protect the health of members of our military service.
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
For any questions, please contact the Millennium Cohort Team at [email protected]
or [email protected]. Or call toll free 1-888-942-5222 or DSN 553-7465, and
reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note Defense
Manpower Data Center Reference # 00-0019, Report Control Symbol # DD-HA(AR)2106,
Office of Management and Budget Approval # 0720-0029, Office of the Assistant Secretary of
Defense (Health Affairs), TRICARE Management Activity Protocol # CDO-06-206, and
Primary Institutional Review Board Protocol # NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit link
[UNSUBSCRIBE LINK]
***Millennium Cohort Study - Protecting Service Member Health***
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Dear Name,
As a Millennium Cohort Study participant, you have been selected to represent your fellow
Service members in the largest health study in military history. Even if you have never deployed
or are no longer in the service, your contribution is still very important.
Your past participation, and the participation of others like you, has already helped us better
understand how deployments and other military experiences impact Service members’ physical
and mental health. For example, we found that combat-related trauma and predeployment
insomnia symptoms increased the risk for developing post-traumatic stress symptoms,
depression, and anxiety following deployment.
So far only {30%} of our participants have responded to our requests to submit their survey.
The survey cycle is ending soon, so your response is vital.
We thank you for completing the enclosed survey and returning it in the postage-paid envelope.
Or, if you would prefer to complete the survey online, please go to the website:
http://www.MillenniumCohort.org
Enter your unique Subject ID: xxxxxx.
We look forward to hearing from you as one of our valued Millennium
Cohort members!
[Insert Signature]
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
If you have any questions, please contact the Millennium Cohort team at our toll-free number, 1888-942-5222, or DSN 553-7465, or email [email protected].
Be assured that this is an authorized study supported by the highest levels of the Department of Defense.
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DD-HA(AR)2106,
Office of Management and Budget Approval # 0720-0029, Office of the Assistant Secretary of Defense
(Health Affairs), TRICARE Management Activity Protocol # CDO-06-206, and Primary Institutional
Review Board Protocol #NHRC.2000.0007.
xlix
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Dear {Name}
Thank you for your past participation in the Millennium Cohort Study. The current survey cycle
is ending soon and we would still like to hear from you. We understand that your time is
valuable and you may not have had the opportunity to fill out our previous surveys. For this
reason we have included a small selection of survey questions on the included 4 page
questionnaire.
The Millennium Cohort Study is unique in that it is designed to survey participants once every 3
years over the course of their military career and beyond. We are interested in your health
during and long after your military commitment is up.
The success of this study depends on you and others like you. We thank you for completing the
enclosed survey and returning it in the postage-paid envelope. Or, if you would prefer to
complete the full survey, please go to our website:
http://www.MillenniumCohort.org
Enter your unique Subject ID: xxxxxx.
Very Respectfully,
[Insert Signature]
Dr. David D. Luxton
Principal Investigator and Military Veteran
If you have any questions, please contact the Millennium Cohort team at our toll-free number, 1888-942-5222, or DSN 553-7465, or email [email protected].
Be assured that this is an authorized study supported by the highest levels of the Department of Defense.
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DD-HA(AR)2106,
Office of Management and Budget Approval # 0720-0029, Office of the Assistant Secretary of Defense
(Health Affairs), TRICARE Management Activity Protocol # CDO-06-206, and Primary Institutional
Review Board Protocol #NHRC.2000.0007.
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JULY 2015: WITHDREW MODIFICATION REQUEST
In order to increase response rates, the Millennium Cohort Study requests permission to
use a third party calling service, Infinity (based in Cedar Rapids, Iowa), to call
approximately 16,000 follow-up participants who have not received any postal mailings
since the beginning of the 2014-2015 survey cycle due to a bad address. Updated contact
information for participant bad addresses is usually obtained by utilizing IRS address
updates; however, we are experiencing some logistical challenges with the renewal of the
NIOSH agreement (still pending).
Therefore, we request approval to use Infinity to only call those participants who
provided a phone number on their baseline or previous follow-up survey as a means to
remain in contact. Calls will be made by Infinity, contracted for the sole purpose of this
phone call outreach task. Infinity will sign confidentiality and a non-disclosure
agreement prior to initiating the task, and will return all logs upon completion of the
calls. All callers will be required to follow the approved script (A copy of the script is
included for IRB review).
Infinity staff will attempt to contact participants via telephone Monday through Friday
between the hours of 8am and 8pm within the respective time zones of study participants.
Infinity will adhere to all state specific calling laws and will not call a participant if state
law dictates an earlier end time. A maximum of three phone call attempts will be made
per participant and a log of each attempt will be maintained. An Infinity employee will
leave a live message on the participant’s voicemail if a participant cannot be reached by
the third phone call attempt. Infinity calling service will not collect any information from
participants, and if a participant has any questions or concerns, they will be immediately
directed to call the study staff at NHRC.
In addition this protocol has undergone a change of staff; therefore, we request approval
to add Jacqueline Pflieger, PhD, as key personnel. Her role is outlined below:
Jacqueline Pflieger, PhD will be located at the Naval Health Research Center and will
serve as key support staff as Research Psychologist. Her duties will include assisting in
program design and maintenance of survey instruments alongside research team;
planning epidemiologic studies and designing the study methodology; performing
statistical analyses for diverse research projects with complex study designs; working
with team members to derive an in-depth understanding of the data findings; drafting
proposals and writing peer-reviewed publications
2015 Bad Address Non-responder Millennium Cohort Study Phone Call Script
Phase II 2015: Contact by Phone
Subjects will be contacted via telephone Monday through Friday between the hours of
8am and 8pm within their respective time zones. Infinity will adhere to all state specific
calling laws and will not call a participant if state law dictates an earlier end time. A
maximum of three phone call attempts will be made per participant and a log of each
attempt will be maintained. An Infinity employee will leave a live message on the
participant’s voicemail if a participant cannot be reached by the third phone call attempt.
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Script
Hello, my name is (insert name) and I’m calling on behalf of the Department of Defense
Millennium Cohort Study. Am I speaking with (participant name)?
[When participant is clearly not the one answering]
May I please speak with (insert participant name)?
[If not available] Is there a better time for me to call to speak to (insert name)?
[When number is incorrect]
I apologize for the inconvenience. Have a nice day. [Mark the number as a wrong phone
number in the call log]
[When speaking to the correct participant]
A few years ago you participated in a very important Department of Defense study
designed to understand the impact of deployment on the health and well being of Service
members. We have been trying to reach you over the last several months to ask for your
continued participation in the Millennium Cohort Study, and to provide you with a small
token of our appreciation.
Unfortunately it seems that we do not have current contact information on file for you.
We want to make sure that our gifts of appreciation are making it to your door. Would
you like to update your contact information, so we can make sure that you receive your
invitation to take the survey?
[If Yes] Great! Thank you for providing the study team with updated contact
information. You can securely and simply update it via the study website. Go to
www.millenniumcohort.org and select “Update Contact Information.” Your
continued participation makes it possible to provide evidence-based policy
recommendations to military and civilian leaders and to guide interventions that have
the potential to make life better for Service members. Thank you for your
participation in the Millennium Cohort Study. Have a nice day!
[If No] Your email and home address information make it possible for us to send you
study updates and gifts of appreciation. The survey is only once every three years and
is the Department of Defense’s largest study of the military over time, and includes
all branches of the military, including Reserve and National Guard. Even if you have
separated from the military, your participation is still vital!
• Would you like to speak to a member of the Millennium Cohort Study research
team to find out more about the study?
♦ [If Yes] Please let me know the best time to call and I will have a member of
the research team call you at this number. (Record suggested time and a phone
number to call if different.)
Thank you. A team member will call you in a few days. We appreciate
your interest in the Millennium Cohort Study and your participation. Have
a nice day.
♦ [If No] Would you like the website address so you can update your contact
information simply and securely?
[If Yes] Just go to www.millenniumcohort.org and select “Update Contact
Information.” We hope you choose to complete the follow-up survey.
From the website you can easily select the “Start Survey” button to
complete your survey.
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[If No] We hope you choose to complete your follow-up survey. Thank
you for your time, have a nice day.
[When leaving a message]
Hello, my name is (insert name) and I’m calling (insert name) on behalf of the
Department of Defense Millennium Cohort Study. A few years ago you participated in a
very important project designed to follow Service members over time called the
Millennium Cohort Study. You are one of a select group chosen to represent the military
from all branches of service, including the Reserve and National Guard. Your feedback
allows us to provide military and civilian leaders with evidence-based policy
recommendations and helps guide the development of interventions that have the
potential to improve the lives of Service members. We hope you choose to complete this
year’s survey by visiting our study website www.millenniumcohort.org. Thank you for
your past participation and for your service.
[If at any time a participant has any questions or concerns]
I apologize, but I am unable to help you with your request. I can provide you with
the direct number of the study staff, and they would be happy to help you to (insert
issue).
June 2015 No and/or Bad Address/Participant Calls—(IRB APPROVAL
RECINDED—NEW MODIFICATION SUBMITTED JULY 2015—SEE ABOVE)
In order to increase response rates, the Millennium Cohort Study requests permission to
call approximately 16,000 follow-up participants who have not received any postal
mailings since the beginning of the 2014-2015 survey cycle due to a bad address.
Updated contact information for participant bad addresses is usually obtained by utilizing
IRS address updates; however, we are experiencing some logistical challenges with the
renewal of the NIOSH agreement.
Therefore, approval to only call those participants who provided a phone number on their
baseline or previous follow-up survey as a means to remain in contact from IRB is being
sought. Attempts to contact participants via telephone Monday through Friday will be
between the hours of 8am and 7pm within their respective time zones. A maximum of
three phone call attempts will be made per participant and a log of each attempt will be
maintained. A message will be left on the participant’s voicemail if a person cannot be
reached by the third phone call attempt. A copy of the script is included for IRB review
and approval.
2015 Bad Address Non-responder Millennium Cohort Study Phone Call Script
Phase II 2015: Contact by Phone
Subjects will be contacted via telephone Monday through Friday between the hours of
8am and 7pm within their respective time zones. A maximum of three phone call
attempts will be made per participant and a log of each attempt will be maintained. A
message will be left on the participant’s voicemail if a person cannot be reached by the
third phone call attempt.
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Script
Hello, my name is (insert name) and I’m calling on behalf of the Department of Defense
Millennium Cohort Study. Am I speaking with (participant name)?
[When participant is clearly not the one answering]
May I please speak with (insert participant name)?
[If not available] Is there a better time for me to call to speak to (insert name)?
[When number is incorrect]
I apologize for the inconvenience. Have a nice day. [Mark the number as a wrong phone
number in the call log]
[When speaking to the correct participant]
A few years ago you participated in a very important Department of Defense study
designed to understand the impact of deployment on the health and well being of Service
members. We have been trying to reach you over the last several months to ask for your
continued participation in the Millennium Cohort Study, and to provide you with a small
token of our appreciation.
In the last several months have you received emails from the Millennium Cohort Study
team?
[If Yes or No]
We have also attempted to send Postal mailings that have included postcards, a survey,
and a small gift but unfortunately it seems that we do not have a current mailing address
on file for you. We want to make sure that our gifts of appreciation are making it to your
door. Would you like to update your contact information, so we can make sure that you
receive your invitation to take the survey and study gifts?
[If Yes] Great! Thank you for providing the study team with updated contact
information. If your contact information changes in the future, you can securely
and simply update it via the study website. Go to www.millenniumcohort.org and
select “Update Contact Information.” Your continued participation makes it
possible to provide evidence-based policy recommendations to military and
civilian leaders and to guide interventions that have the potential to make life
better for Service members. Thank you for your participation in the Millennium
Cohort Study. Have a nice day!
[If No] Your email and home address information make it possible for us to send
you study updates and gifts of appreciation. The survey is only once every three
years and is the Department of Defense’s largest study of the military over time,
and includes all branches of the military, including Reserve and National Guard.
Even if you have separated from the military, your participation is still vital!
• Would you like to speak to a member of the Millennium Cohort Study
research team to find out more about the study?
♦ [If Yes] Please let me know the best time to call and I will have a
member of the research team call you at this number. (Record
suggested time and a phone number to call if different.)
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Thank you. A team member will call you in a few days. We
appreciate your interest in the Millennium Cohort Study and
your participation. Have a nice day.
♦ [If No] Would you like the website address so you can update
your contact information simply and securely?
[If Yes] Just go to www.millenniumcohort.org and select
“Update Contact Information.” We hope you choose to
complete the follow-up survey. From the website you can
easily select the “Start Survey” button to complete your survey.
[If No] Would you like to be removed from this wave of the
study, and touch base again during the next follow-up?
[If Yes] We respect your decision. You will be removed
from future contacts for this follow-up period. Have a nice
day.
[If No] We hope you choose to complete your follow-up
survey. Thank you for your time, have a nice day.
[When leaving a message]
Hello, my name is (insert name) and I’m calling (insert name) on behalf of the
Department of Defense Millennium Cohort Study. A few years ago you participated in a
very important project designed to follow Service members over time called the
Millennium Cohort Study. You are one of a select group chosen to represent the military
from all branches of service, including the Reserve and National Guard. Your feedback
allows us to provide military and civilian leaders with evidence-based policy
recommendations and helps guide the development of interventions that have the
potential to improve the lives of Service members. We hope you choose to complete this
year’s survey by visiting our study website www.millenniumcohort.org. Thank you for
your past participation and for your service.
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May 2015: Millennium Fourth of July Mailings
In accordance with the guidance received on April 9, 2015 regarding an additional
contact, the Millennium Cohort Study Independence Day Postcard (2 versions
responder and non-responder) and Millennium Cohort Study Independence Day email (2 versions responder and non-responder) were submitted for IRB review and
approval. This will modify the total approved contacts for this cycle to 13 mail items.
Independence Day 2015 Postcard
Responder
Subject Line: Independence Day-Celebrating Our Freedom
As we celebrate our nation’s freedom on this Independence Day, we also honor the
courageous men and women dedicated to preserving it.
We would like to thank you for completing your 2014-2015 questionnaire. Never in
history has such a large group of active duty Service members, Reservists,
National Guardsmen and Veterans from all military branches been included
in a health study of this magnitude. By understanding how military factors
contribute to long term health, military and VA leaders will be provided with
valuable information to improve Service members' quality of life.
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
Primary Institutional Review Board Protocol # NHRC.2000.0007
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Independence Day 2015 Postcard
Non-Responder
Subject Line: Independence Day-Celebrating Our Freedom
As we celebrate our nation’s freedom on this Independence Day, we also honor the
courageous men and women dedicated to preserving it.
The Millennium Cohort Study is currently mid-cycle for the 2014-2015 survey effort.
If you have already completed and submitted the survey, please accept our
sincere thanks.
If you have not already done so, please use your Subject ID located below the barcode
to complete your survey online at www.millenniumcohort.org.
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
Primary Institutional Review Board Protocol # NHRC.2000.0007
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Independence Day 2015 e-mail
Responder
Subject Line: Independence Day-Celebrating Our Freedom
As we celebrate our nation’s freedom on this Independence Day, we also honor the
courageous men and women dedicated to preserving it.
You should receive an Independence Day postcard in the mail from the Millennium Cohort
Study team. You can also view it online at
[link]
We would like to thank you for completing your 2014-2015 questionnaire. Never in
history has such a large group of active duty Service members, Reservists,
National Guardsmen and Veterans from all military branches been included
in a health study of this magnitude. By understanding how military factors
contribute to long term health, military and VA leaders will be provided with
valuable information to improve Service members' quality of life.
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1888-942-5222 or DSN 553-7465, and reference your Subject ID: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of
the Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit [link]
***Millennium Cohort Study - Protecting Service Member Health***
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Independence Day 2015 e-mail
Non-Responder
Subject Line: Independence Day-Celebrating Our Freedom
As we celebrate our nation’s freedom on this Independence Day, we also honor the
courageous men and women dedicated to preserving it.
You should receive an Independence Day postcard in the mail from the Millennium Cohort
Study team. You can also view it online at
[link]
The Millennium Cohort Study is currently mid-cycle for the 2014-2015 survey effort. If you
have already completed and submitted the survey, please accept our sincere thanks.
If you have not already done so, please take a moment to complete your questionnaire by
following the link below:
[link]
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1888-942-5222 or DSN 553-7465, and reference your Subject ID: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of
the Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our email list, please visit [link]
***Millennium Cohort Study - Protecting Service Member Health***
April 2015: Millennium Cohort Staff Updates/Mailings
This protocol has undergone a change of staff; therefore, we request approval to remove
Lauren Kearney, MPH, Jill MacDougall, MPH, and Andrew Lin as they are no longer
affiliated with the study. We also request approval to add Kristin Motylinski, Toni
Geronimo, and Richard Armenta, MPH, as key personnel. Their roles are outlined below.
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Kristin Motylinski and Toni Geronimo, will be located at the Naval Health Research
Center and will serve as key support staff as Research Interns. As Research Interns they
will collect and organize survey data and forms for research projects. In addition, their
duties as an intern are to scan and verify survey data, perform data entry, literature
searches, and assist with maintenance of databases for research projects.
Richard Armenta, MPH, will be located at the Naval Health Research Center and will
serve as key support staff as a Biostatistician. His duties will include assisting in program
design and maintenance of survey instruments alongside research team; planning
epidemiologic studies and designing the study methodology; performing statistical
analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals and
writing peer-reviewed publications
March 2015: Millennium Cohort and Family Separation/Staff Updates/Mailings
Due to logistical reasons, we respectfully request approval from the IRB to separate the
Family component of the Millennium Cohort study. Dr. Valerie Stander will assume the
role of Principal Investigator for the Family component and will formally submit to the
IRB the initial sub-study for review and approval by the IRB. For all regulatory
approvals/requirements related to the Millennium Cohort Family study up to and through
the 2014-2015 survey cycle remain under the Millennium Cohort regulatory approvals
(OMB Control Number 0720 – 0029 RCS: DD-HA(AR) 2016 and SORN N06500-1).
Any future regulatory approvals needed for the Millennium Cohort Family study will be
submitted under the standalone sub-study.
Also, this protocol has undergone a change of staff; therefore, we request approval to
remove Donald Slymen, MS, PhD, as he is no longer affiliated with the study. We also
request approval to update Dr. Valerie Stander’s, role from Key Personnel to CoInvestigator and to add Evelyn Sun, MPH as key personnel. Their roles are outlined
below.
Valerie Stander, PhD, will be located at the Naval Health Research Center and serve
as co-investigator. She has considerable experience conducting epidemiological
studies among military populations. She will plan epidemiologic studies and
designing the study methodology; performing statistical analyses for diverse research
projects with complex study designs; working with team members to derive an indepth understanding of the data findings; drafting proposals and writing peerreviewed publications.
Evelyn Sun, Assistant Study Coordinator for the Millennium Cohort Family study will
serve as key support staff and will work with the Millennium Cohort study team with
coordinating the study and sub-study data as well as web site and survey testing.
The protocol has also been updated to clarify the mortality data request are submitted to
the Armed Forces Medical Examiner System (AFMES) at the Joint Pathology Center
(JPC) formerly known as the Armed Forces Institute of Pathology AFIP.
Along with the above-mention updates, we are also submitting to the IRB for review and
approval the remaining of the Phase 1 participant contact material which is within the
permissible number of contacts.
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Endorsement Letter Email
Subject: Endorsement of DoD Health Study
Dear [name]
Last week we sent you a postal letter to share with you [endorsement name] support for
our DoD study of the health concerns and needs of military members.
This request was sent to you because you had previously completed a survey and we are
especially interested in hearing about any changes to your health that have occurred since
your last survey, whether or not you are still serving in the military. Your participation
will help provide greater insight into the issues facing today’s military Service members
and Veterans.
If you have already completed the online questionnaire, we wish to thank you. If you
have not yet had time to consider our request, we hope you will be able to do so soon.
Please follow the link below to complete your survey:
[link]
Thanks so much for being a part of this important study.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our mailing list, click here.
***Millennium Cohort Study - Protecting Service Member Health***
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Q2 Cover Letter
Dear [name]__,
We have contacted you a few times this year to ask for your help with a DoD survey of
the current health status of current and former members of the military. We are writing
to you again to remind you about this important survey. The sooner we receive your
survey, the sooner we are able to begin answering important questions about the health
and well-being of Service members and Veterans.
We are very pleased with the large number of Service members – both former and
current- who have already sent back their surveys. We hope that you too will help us to
improve the lives of future military members.
We have sent this paper survey to you because your response is important in making sure
this study provides accurate results. However, if you prefer to complete your survey
online, please visit www.milleniumcohort.org, click on Start Survey and enter your
Subject ID: xxxxxx.
Thank you for considering our request, and we hope to hear from you soon!
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007
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Memorial Day 2015 Postcard
Responder
On this Memorial Day, we recognize the valiant efforts of the hundreds of thousands of
men and women who put country before self and gave their lives for our nation. They
felt a sense of duty, and they dedicated their lives to fulfill that duty.
We would like to thank you for completing your 2014-2015 questionnaire. We
appreciate the time that you took in providing information about your current heath on
our recent survey. By understanding how military factors contribute to long term health,
military and VA leaders will be provided with valuable information to improve Service
members’ quality of life.
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
Primary Institutional Review Board Protocol # NHRC.2000.0007
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Memorial Day 2015 Postcard
Non-Responder
On this Memorial Day, we recognize the valiant efforts of the hundreds of thousands of
men and women who put country before self and gave their lives for our nation. They
felt a sense of duty, and they dedicated their lives to fulfill that duty.
The Millennium Cohort Study is currently mid-cycle for the 2014-2015 survey effort. If
you have not already done so, please use your Subject ID located below the barcode to
complete your survey online at www.millenniumcohort.org.
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
Primary Institutional Review Board Protocol # NHRC.2000.0007
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Memorial Day 2015 Email
Responder
On this Memorial Day, we recognize the valiant efforts of the hundreds of thousands of
men and women who put country before self and gave their lives for our nation. They
felt a sense of duty, and they dedicated their lives to fulfill that duty.
We would like to thank you for completing your 2014-2015 questionnaire. We
appreciate the time that you took in providing information about your current heath on
our recent survey. By understanding how military factors contribute to long term health,
military and VA leaders will be provided with valuable information to improve Service
members’ quality of life.
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our mailing list, click here.
***Millennium Cohort Study - Protecting Service Member Health***
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Memorial Day 2015 Email
Non-Responder
On this Memorial Day, we recognize the valiant efforts of the hundreds of thousands of
men and women who put country before self and gave their lives for our nation. They
felt a sense of duty, and they dedicated their lives to fulfill that duty.
The Millennium Cohort Study is currently mid-cycle for the 2014-2015 survey effort. If
you have already completed the online questionnaire, we wish to thank you. If you have
not yet had time to consider our request, we hope you will be able to do so soon.
Please follow the link below to complete your survey:
[link]
Thank you for your continued support of this important project!
Respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research, San Diego, CA
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our mailing list, click here.
***Millennium Cohort Study - Protecting Service Member Health***
2015 Continuing Review
Changes made under the 2015 continuing review submission were related to the
Millennium Cohort Family study. Please refer to Appendix J for modification request and
Appendix L for copies of mailings.
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FOR HISTORICAL PROTOCOL MODIFICATIONS
PLEASE REFER TO APPENDIX E –J
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TABLE OF CONTENTS
I. COVER PAGE(S) ................................................................................................................ i
II. SIGNATURE PAGE(S) ................................................................................................. vii
III. RECORD OF CHANGES TO THE PROTOCOL ........................................................viii
IV. TABLE OF CONTENTS ............................................................................................... lxxi
V. SCIENTIFIC BACKGROUND AND OBJECTIVES ..................................................... 1
1....Background ......................................................................................................................... 1
2....Objectives ........................................................................................................................... 7
a. Primary Objective: ....................................................................................................... 7
b. Secondary Objectives: .................................................................................................. 7
VI. EXPERIMENTAL METHODS ........................................................................................ 7
1....Experimental Procedures and Rationale ............................................................................ 7
a. Subjects ......................................................................................................................... 7
b. Methods ........................................................................................................................ 9
2....Sample Size Determination .............................................................................................. 23
3. Justification for Exclusion of Specific Groups.......................................................... 27
4. Required Equipment and Supplies............................................................................. 27
VII. ORGANIZATION OF RESEARCH EFFORT ............................................................. 27
1....Duties and Responsibilities .............................................................................................. 27
2....Chain of Command .......................................................................................................... 30
VIII. RISKS AND DISCOMFORTS TO RESEARCH VOLUNTEERS ............................ 30
1....Risk to the Volunteer and Means of Mitigation .............................................................. 30
2....Special Risks to Pregnant Women ................................................................................... 31
3....Safety Precautions and Emergency Procedures .............................................................. 31
4....Assessment of Sufficiency of Plans to Deal With Untoward Events or Injuries ........... 31
5....Qualification of Medical Monitor and Medical Support Personnel................................ 31
IX. DESCRIPTION OF THE SYSTEM FOR MAINTENANCE OF RECORDS ............. 31
1....Experimental Data ............................................................................................................ 31
2....Research Protocol, Consent Forms, and Related Documents for Protection of Human
Research Volunteers ............................................................................................................... 31
3....Individual Medical Records ............................................................................................. 32
X. APPENDICES .................................................................................................................. 33
APPENDIX A: Consent Documents ..................................................................................A-1
APPENDIX B.INVESTIGATOR ASSURANCE AGREEMENT(s)................................ B-1
APPENDIX C.REFERENCES ............................................................................................ C-1
APPENDIX D.NONTECHNICAL SYNOPSIS .................................................................D-1
APPENDIX E. RECORD OF CHANGES TO THE PROTOCOL CONTINUED ........... E-1
APPENDIX F. MILLENNIUM COHORT PARTICIPANT CONTACT MATERIALS . F-1
APPENDIX F. MILLENNIUM COHORT FAMILY HISTORICAL PROTOCOL.........G-1
APPENDIX G.MILLENNIUM COHORT FAMILY PARTICIPANT CONTACT
MATERIALS ........................................................................................................................ G1
Appendix H.COLLABORATION PROTOCOLS ............................................................... H1
Appendix I.SERVICE AGREEMENTS .................................................................................I1
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IV. SCIENTIFIC BACKGROUND AND OBJECTIVES
1. Background
In response to Iraq’s invasion of Kuwait (August 2, 1990) the United States began deploying
troops to the Arabian Gulf region five days later in Operation Desert Shield (Operation Desert
Storm, 1997). A total of 40 coalition countries deployed troops to the region, including the
United Kingdom, Canada, and France. On January 17, 1991, the air war against Iraq began
(Operation Desert Storm), which was followed by a 4-day ground war starting on February 24,
1991.
By the end of active hostilities on February 28, 1991, the United States had deployed
approximately 697,000 troops to the theater of operations, the British had deployed 53,000
troops, and the Canadians had deployed 4,500 military personnel. In contrast to previous
conflicts, a larger proportion of U.S. troops were from the reserves/National Guard (17%) and
were female (7%). Mortality and morbidity rates during the fighting were markedly lower than
expected. By May 1991, most U.S. military personnel had left the theater of operations.
Beginning soon after the Desert Storm fighting ended in 1991, numerous Gulf War veterans
complained of morbidity that they attributed to their deployment exposures. With the aid of a
number of expert external review panels,1-5 the U.S. government created intensive health registry
examinations,6,7 sponsored medical research,8 and created large investigative organizations with
a focus of risk management.9 As of 1999, the U.S. government has invested approximately one
billion dollars (Riddle, LTC James R., OASD/HA, personal communication) in examining the
health of Gulf War veterans.
Expert External Review Panels
The federal government has commissioned numerous external review panels to examine the
health of Gulf War veterans or to monitor actions of the federal government in conducting such
examinations. The external review panels have included:
• Defense Science Board1,10
• Presidential Advisory Committee on Gulf War Veterans’ Illnesses2,5,11
• Institute of Medicine(IOM) Committee on Measuring Health of Gulf War Veterans3,4,12-16
• General Accounting Office17-29
• Presidential Special Oversight Board for Department of Defense Investigations of Gulf
War Chemical and Biological Incidents30,31
While it is beyond the scope of this introduction to review the findings of the external review
panels, it should be recognized that review panel findings have greatly influenced the directions
of clinical care, research, public relations, and veteran compensation.
Health Registry Evaluations
The Department of Veterans Affairs (DVA) established comprehensive clinical evaluations of
Gulf War veterans in 1992. The Department of Defense (DoD) followed this example in
establishing similar structured evaluations in 1994. The United Kingdom established similar
evaluations soon thereafter. In the United States more than 150,000 Gulf War veterans and
family members have registered in these programs.6,32 In the United Kingdom more than 1,000
Gulf War veterans have been evaluated.33
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Since registry participants are self-referred, registry health findings are really a series of cases.
While these case series are not generally valuable in determining exposure risk, they have been
valuable in demonstrating that few Gulf War veterans have unexplained symptoms without a
recognized medical condition or diagnoses.7,32 They have also been helpful in identifying the
most frequent self-reported symptoms among Gulf War veterans and in demonstrating that
among symptomatic Gulf War veterans, many would meet diagnostic criteria for multi-symptom
conditions, such as chronic fatigue syndrome and posttraumatic stress disorder (PTSD).34
Previous Gulf War Veteran Research
The investment in medical research concerning Gulf War veterans has resulted in numerous
important findings. Research reports and manuscripts are best chronicled in the DVA Annual
8
Report to Congress and in a 4,462-citation Topical Bibliography of Published Works Regarding
the Health of Veterans of the Persian Gulf War.35
Much of Gulf War veteran research has involved epidemiological studies. Empirically, we
categorized these studies into four areas:
• Studies of mortality-Several studies have examined deaths among Gulf War veterans,36-38
and with the exception of increased deaths due to accidents,38 found little evidence of
unexplained deaths associated with service in the Gulf War.
• Studies of hospitalizations–Numerous comparisons of post-1991 hospitalizations of Gulf
War veterans and those of other veterans of the same era have been published.39-43 Data
from DoD, VA, and California hospitals do not support arguments that Gulf War veterans
are being hospitalized at a higher rate for Gulf War-related conditions.
• Studies of symptoms-Controlled studies of Gulf War veterans unanimously document
that Gulf War veterans report more conditions and have evidence of more psychological
morbidity.44-48 However, investigators have not been able to implicate specific Gulf War
exposures as causing these symptoms. While one team of scientists used factor analysis
to suggest unique aggregations of symptoms among Gulf War veterans,49 other
investigators have found the same factor-analysis symptom aggregations among nondeployed veterans.50-52
• Studies of reproductive outcomes–While a number of news reports have suggested that
Gulf War veterans are experiencing unusual reproductive outcomes, published research
studies have not validated these reports. Thus far, researchers have not found increases in
the number of birth defects among the offspring of Gulf War veteran families.53-56
• Etiologic exposures–A number of investigators have championed hypotheses concerning
the cause of increased symptom reporting among Gulf War veterans. While often not in
the mainstream of etiologic thinking, these hypotheses have influenced some
investigative research.4,15,57,58 These hypotheses have implicated:
o Mycoplasma fermentans59-61
o
Pyridostigmine bromide62,63
o Multiple chemical sensitivity64
o Depleted uranium65
o Sand exposure66
o Deployment vaccinations67
o Chemical agent resistant coating (CARC)
o Oil well fires17
o Nerve agents42
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In general, no one specific exposure or group of exposures has been implicated as the cause of
illnesses among Gulf War veterans.
Data Limitations
The lack of predeployment health data and deployment exposure data have been chief limitations
in examining Gulf War veteran morbidity questions. Numerous improvements have or are being
made to gain such data for future U.S. military deployments. These efforts include capturing
better service-entry health data, before and after deployment health data, environmental and
morbidity data during deployments; improving communications regarding deployment risks; and
focusing clinical and epidemiological research programs on deployed populations.13,68-71
Risk Management
Following the Gulf War, veterans from the 123rd Army Reserve Unit in Indiana began to
complain of health problems they associated with their service in the Gulf. An investigation by
the Army Medical Corps was unrevealing. Soon afterward, stories of individual illnesses and
clusters of illnesses came to public attention. The media soon labeled these illnesses Gulf War
syndrome. The DVA (1992) and DoD (1994) responded to veterans’ concerns with initiation of
two comprehensive self-referral clinical evaluation programs. Early reports finding neither
common illnesses nor a specific cause for Gulf War syndrome, were attacked as incomplete by
veterans’ groups and the media. More vocal commentators pointed to a “conspiracy of silence”
and a large-scale coverup. In late 1996, the story acquired new urgency, with several reports
documenting the “probable” exposure of U.S. personnel to enemy chemical weapons destroyed
in the Khamisiyah area in March 1991 and highlighting the lapses of Pentagon authorities in
publicizing that information. In 1996, the Special Assistant to the Deputy Secretary of Defense
for Gulf War Illnesses (OSAGWI) was appointed to investigate the possible chemical and
biological events and environmental exposures during Operations Desert Shield and Desert
Storm that might have caused veterans’ illnesses. Over the ensuing months, news reports
appeared almost daily focusing on “hidden” exposures, new and often not biologically plausible
hypotheses about disease causation, and strident criticisms of government efforts to address the
problems of Gulf War illnesses.72 Since then, OSAGWI, comprising over 100 risk management
and medical staff, has done much to investigate and inform veterans of exposures and health
risks concerning their Gulf War service. OSAGWI has published a number of case narratives
and environmental exposure reports, which have been disseminated via the Internet:(see
http://www.gulflink.osd.mil/)
Recommendations for the Longitudinal Study of Deployed Forces
The 1999 IOM Measuring Health Report12 surmised that numerous investigations and research
efforts have been undertaken because of concern about the impact of the Gulf War on the health
of U.S. troops who served in that conflict. Some of these efforts addressed the federal
government’s preparedness to meet its obligations and responsibilities to protect U.S. military
service members, veterans, and their families. Others attempted to determine what health effects
might be attributed to service in the Gulf War. Still others have identified possible causes for the
myriad reports of health problems among Gulf War veterans.
IOM also recognized that the continuing focus on the health problems of Gulf War veterans is
attributable in no small part to the efforts of individual veterans and the organizations that
represent them. They have tirelessly pressured policy officials and the Congress that more needs
to be done to help those Gulf War veterans who are experiencing health problems. In its report
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on measuring health, the IOM committee recommended implementation of a research portfolio
centered on a prospective cohort study of deployed forces. The IOM committee maintained that
establishing a prospective cohort study of deployed forces would lead to a greater understanding
of the longer-term health effects of military service, including service in deployments such as the
Gulf War.
IOM also noted that a schism has developed, with ill veterans and their representatives on one
side and the federal agencies charged with addressing veterans’ health problems on the other.
IOM recommended that coordinated and concerted efforts must be made to bridge this gap. The
IOM committee believes that if DoD and DVA initiate the recommendations in this report, the
actions will greatly facilitate that unification process.
One of the current difficulties inherent in researching deployment health concerns is the lack of a
system for monitoring the longitudinal health of active, reserve, and National Guard forces, as well
as the health of veterans and their families. The VA and DoD have developed health registries for
active-duty service members and for veterans involved in specific events and deployments. While
these registries serve useful purposes, they reflect the health of a self-selected sample of veterans,
and thus they are not representative of the active-duty and veteran population in general. Of
fundamental importance is the development of a longitudinal monitoring system that is
representative of active-duty, National Guard, reserve troops, and veterans; that measures health at
specific time points; and that measures changes in health over time.
The 1999 IOM report presents a research portfolio and prospective cohort study that could, with
appropriate extension, provide a model for a long-term tracking system of the health of veterans
of military deployments. The portfolio encompasses three principal categories of research:
population studies, health-services research, and clinical and biomedical investigations. An
essential feature of the research portfolio is facilitating linkages across individual studies through
the collection of a core set of key data elements (describing health, individual, and cultural
characteristics) in order to provide for comparisons across all research.
Additionally, future efforts to measure the health of those individuals deployed to military
conflicts and peacekeeping missions should include, to the extent possible, information obtained
before, during, and after deployment. The National Academy of Sciences is currently conducting
an evaluation of strategies to protect the health of deployed U.S. forces, and a component of this
study examines improvements in keeping medical records and documenting exposures,
treatment, tracking of individuals through the medical evacuation system, and
health/administrative outcomes. Data obtained before, during, and after deployment through the
kinds of systems reviewed in this forthcoming Academy report will be important components of
future deployment-related health research.
Section 743 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999
authorized the Secretary of Defense to establish a center devoted to “…longitudinal study to
evaluate data on the health conditions of members of the Armed Forces upon their return from
deployment…” On September 30, 1999, Dr. Sue Bailey, Assistant Secretary of Defense, Health
Affairs, under delegated authority from the Secretary of Defense directed the Services to
establish a Research and Clinical Center for Deployment Health. The research component of the
Center has been designated as a responsibility of the Naval Health Research Center (NHRC),
San Diego, California.
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Planning, funding, and implementing the deployed forces study recommended in the IOM report
is the next logical course. No other national studies provide follow-up of active military forces
that explicitly address exposures specific to operational deployments.
Future Efforts
Federal Gulf War veteran research is coordinated by the Research Working Group of the
Military and Veterans Health Coordinating Board. This body also guides new research
activity.8,73
In 1998, considering all the completed and existing research regarding Gulf War veterans, the
Research Working Group established four priorities for future research:
• Research on treatments for Gulf War veterans’ illnesses
• Longitudinal follow-up of Gulf War veterans’ illnesses
• Research on improved disease prevention, especially in the area of stress-related
symptoms
• Research to improve environmental and occupational hazard identification and risk
assessment
Various new studies have been commissioned in accordance with these priority areas.
In response to health questions following the Gulf War and the increasing demands of a series of
hazardous deployments, the military health system has undergone a fundamental reorientation. A
new strategy has been developed and is being implemented to protect U.S. forces against all
foreseeable physical and psychological threats. This "Force Health Protection" strategy balances
our key responsibilities to (1) promote and sustain health and wellness throughout each person's
military service; (2) prevent acute and chronic casualties; (3) rapidly stabilize, treat, and evacuate
casualties; and (4) perform medical surveillance, longitudinal health studies, and ensure adequate
medical records documentation and clinical follow-up for deployed forces. The Force Health
Protection strategy has played a key role in further reductions in illness and injury rates since the
Gulf War.
In the report to the Committee on National Security, House of Representatives and the Armed
Services Committee, U.S. Senate on Effectiveness of Medical Research Initiatives Regarding
Gulf War Illnesses, the DoD identified the need for a coordinated capability to apply
epidemiological research to determine whether deployment-related exposures are associated with
postdeployment health outcomes. The proposed Millennium Cohort Study, a prospective study
of U.S. military forces, responds to this need and to recent recommendations from IOM to
systematically collect population-based demographic and health data on service personnel
throughout their military careers and after leaving military service. IOM, in making the
recommendations that initiated this study, recognized that the study will be challenging and that
it will require a sustained commitment of resources by Congress, DVA, and DoD, and of time
and cooperation by study participants. Nevertheless, IOM felt that these commitments are
important and worthwhile if the nation is to adequately understand and respond to the health
needs of not only Gulf War veterans, but veterans of future conflicts in which U.S. military
forces are committed.
IOM recognized that if a prospective study had been ongoing at the time of the Gulf War, many
of the problems researchers have faced in attempting to resolve Gulf War veterans’ health issues
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several years removed from the end of that conflict, could have been eliminated. The IOM,
DoD, and DVA agreed that such efforts would contribute greatly to our understanding of the
impact of military conflict on the health of the men and women who served in those conflicts.
This study design will permit estimation of the distribution within the population of a broad
variety of health-related measurements, including psychological measurements. The study
design will also capitalize on existing and planned DoD and VA infrastructure and resources to
track and measure the health of military forces and veterans.
The proposed Millennium Cohort Study is an essential component of DoD’s Force Health
Protection strategy. The lack of ongoing prospective longitudinal health studies was recognized
as a critical shortfall in our ability to answer questions concerning illness among Gulf War
veterans. The planning, funding, and development of the infrastructure to accomplish
population-based prospective studies to examine the impact of military service, including
deployments, on the physical and mental health of veterans has been ongoing for seveal years.
Million Veteran Program (MVP)
The MVP is a national, voluntary research program conducted by the Department of Veterans
Affairs (VA) Office of Research and Development (ORD). A data use agreement between
NHRC/MCS and VA/MVP is pending to cover the activities listed here, specifically the bidirectional sharing of contact information to determine appropriate MCS participants to contact.
No research data will be sent to the MVP until these agreements are in effect.
This effort will initially be restricted to Millennium Cohort Study (MCS) participants who have
separated from active duty service, but is planned to also include active duty MCS participants
once appropriate high-level DoD and VA agreements are in place. Additional restrictions will
apply depending on the study panel. For Panel 1 and 2 participants, only those participants who
meet the following criteria will be contacted:
1. Have a good postal address.
2. Answered YES to question #114 in the 2014 MCS follow-up survey: “A great deal has
been learned from this study and as a result we may be asked to consider other research
possibilities. If other related research studies become available, may we contact you to let
you know about them?"
3. Have not already enrolled or refused to enroll in MVP.
For Panel 3 and 4 participants, only those participants who meet the following criteria will be
contacted:
1. Have a good postal address.
2. Have not answered NO to question #114 on the 2014 MCS follow-up survey.
3. Have not already enrolled or refused to enroll in MVP.
In order to determine those MCS participants who have already enrolled in MVP or refused to
join MVP, MVP study staff will send to MCS encrypted social security numbers (SSNs) of those
MCS participants. These data will be sent via the U. S. Army Aviation and Missile Research
Development and Engineering Center (AMRDEC) Safe Access File Exchange (SAFE) site.
Upon receipt of these data, MCS staff will remove these participants with matching SSNs from
the list of MCS participants who have met the other eligibility criteria. These remaining eligible
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participants will be sent one postal contact with information about enrolling in MVP along with
the option to opt out from receiving any information. This letter includes information about PMI.
Those participants who do not wish to receive information and enrollment materials from MVP
will be asked to tear off the postcard on the bottom portion of the letter and return it to the
Millennium Cohort Study within 30 days of receipt of the letter. After 60 days of the expected
receipt of the letter, MCS study staff will generate lists of SSNs of eligible participants who did
not return the postcard along with their respective current contact addresses. This list will be
encrypted and sent to MVP staff via the AMRDEC SAFE site. The MVP will then send these
individuals an invitation to enroll in the MVP study.
Military Significance
This study is supported by the highest officials in the DoD healthcare system. It will serve as a
foundation for many future health policy decisions and as the framework for numerous follow-on
studies. The information is not known to be collected in this format across DoD at this time.
Background: Family Study Component
Due to logistical reasons, the Family component of the Millennium Cohort study was separated
as a standalone sub-study. Dr. Valerie Stander assumed the role of Principal Investigator for the
Family component and formally submitted to the IRB the initial sub-study for review and
approval by the IRB in March 2015. All regulatory approvals/requirements related to the
Millennium Cohort Family study up to and through the 2014-2015 survey cycle remain under the
Millennium Cohort regulatory approvals (OMB Control Number 0720 – 0029 RCS: DDHA(AR) 2016 and SORN N06500-1). Any future regulatory approvals needed for the
Millennium Cohort Family study will be submitted under the standalone sub-study.
2. Objectives
• To determine how the health of U.S. military veterans changes over time.
a. Primary Objective:
• To compare the adjusted incidence of chronic disease between cohorts.
b. Secondary Objectives:
• To compare the adjusted change in health between cohorts by Short Form-36
Questions/Veterans (SF-36V) scores.74
• To compare the change in health between cohorts by Patient Health Questionnaire
(PHQ) score diagnostics.75
• To serve as the foundation for a portfolio of future studies of the impact of military
service, including anthrax vaccination, on the health of members of the armed forces.
VI. EXPERIMENTAL METHODS
1. Experimental Procedures and Rationale
a. Subjects
This prospective cohort study will follow regular active duty, National Guard, and
reserve military personnel.
The cohorts will be followed via serial postal surveys with on-line completion options
and telephone interviews. The sample will be drawn randomly from the electronic rosters
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of active-duty and reserve personnel at Defense Manpower Data Center (DMDC),
California. The cohort will be selected as a probability sample, stratified for deployment
vs. nondeployment, active duty vs. reserve, and male vs. female. Subjects will be
contacted in four phases.
1. First Phase: 2001 Cohort (Millennium Cohort). Panel 1 members included regular
active duty, National Guard, and Reserve U.S. military personnel. A probabilitybased sample of 256,400 active duty and reserve military personnel was randomly
drawn from the electronic service member rosters at the Defense Manpower Data
Center (DMDC), Seaside, California, as of October 1, 2000. Veterans who served in
Southwest Asia, Bosnia, and Kosovo (after 1997) made up 18% of the military
population at this time but were over-sampled such that 30% of the population was
invited to participate. Females comprised 15% of the military population at this time
but were over-sampled such that 24% of females were invited. The expected cohort
response of 100,000 will represent approximately a 3.7% sample of the 2.7 million
persons in uniform at that time.
2. Second Phase: 2004 Cohort. Panel 2 members included regular active duty, National
Guard, and Reserve U.S. military personnel with 1 - 2 years of service. A
probability-based sample of 150,000 service members was randomly drawn from the
electronic rosters of active duty and reserve personnel as of October 1, 2003 at
Defense Manpower Data Center (DMDC), Seaside, California. To achieve a higher
proportion of Marines, the population was comprised of 20% Marines and 80% other
service branches (Army, Navy, Air Force, and Coast Guard). Females were also
over-sampled; the 80% non-Marine group was comprised of 70% males and 30%
females with random distributions of all other variables.
3. Third Phase: 2007 Cohort. Panel 3 members included regular active duty, National
Guard, and Reserve U.S. military personnel with 1-3 years of service. A probabilitybased sample of 250,000 service members was randomly drawn from the electronic
rosters of active duty and reserve personnel as of October 1, 2007. To achieve a
higher proportion of Marines, the population was comprised of 20% Marines and
80% other service branches (Army, Navy, Air Force, and Coast Guard). Females
were also over-sampled; the 80% non-Marine group was comprised of 70% males
and 30% females with random distributions of all other variables.
4. Fourth Phase: 2011 Cohort. Panel 4 members included regular active duty, National
Guard, and Reserve U.S. military personnel with 2-5 (24-60 months) years of service.
A probability-based sample of 250,000 service members was randomly drawn from
the electronic rosters of active duty and reserve personnel as of October 1, 2010 at
Defense Manpower Data Center (DMDC), Seaside, California. To achieve a higher
proportion of married participants, the population was comprised of 80% male and
20% female service members. For each gender, the sample was comprised of 50%
married and 50% not married with random distributions of all other variables.
These cohorts will be followed with repeat surveys at 3-year intervals through the year
2068 (8 samplings for 2001 cohort).
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b. Methods
General Approach
The specific goal of the Millennium Cohort Study is to identify and prospectively follow
health outcomes in future U.S. military cohorts beginning in the year 2001. The
prospective methodology will permit the accurate description of the incidence and natural
history of medical conditions in this population. Most importantly, the impact of future
deployments will be captured and addressed by determining whether conditions brought
to medical attention postdeployment represent new occurrences or predeployment health
states. In this study, we intend to adapt and possibly guide the dynamic medical
information systems that are currently being developed such that future investigators will
not need special investigative studies to aggregate disparate data sets in determining the
effects of military deployments. The data from the survey will not be weighted, and
findings from all subgroups will be reported.
Outcomes
We plan to evaluate the following:
• Self-reported medical conditions (primary objective)
• SF-36V score76–provides physical and mental health component score
• PHQ score75–self-administered screening for mental health diagnoses
• Medical conditions classified by International Classification of Diseases, 9th Revision
(ICD-9) code from inpatient and outpatient encounters
• A limited array of self-reported symptoms
• PTSD Checklist-17 (PCL-17) score – screening for PTSD
• Mortality
• CAGE questions – alcohol use
• Tobacco use
These outcomes were chosen because of their representative value as diverse core
measures of health. As per IOM Committee on Measuring Health of Gulf War Veterans13
recommendations, these outcomes will include measures of:
• Death and duration of life
• Impairment
• Functional status
• Health perceptions
• Opportunity (the capacity for health, the ability to withstand stress, and physiological
reserve)
The selection of outcomes for this study was made after numerous considerations. Of
primary importance, we wanted to satisfy the IOM recommendations.13 However,
adopting all IOM recommendations would cause the postal survey instrument to be too
long and likely detract from participation. With time economy in mind, we chose an
empirical target postal survey completion time of 30 min and believe, after some piloting
among research staff, that we have achieved this goal. Additionally, standardized
instruments (SF-36V, Patient Health Questionnaire, and PCL-17) were chosen because of
their use in previous veterans studies and published data of their reliability and validity.
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Assessment of Medical Conditions and Symptoms
Survey data collection will include participant’s self-reported medical conditions. A
survey instrument composed specifically for this study and modeled after the DVA
National Health Survey of Persian Gulf War Era Veterans will provide the framework to
ask participants about current and historical medical conditions, health complaints and
symptoms, and approaches to self-medication and self-care. A random subsample of
subjects will be chosen for validation using DoD or non-DoD medical records. The
questionnaire assessment of symptoms will include a short list of items based on those
reported most frequently in recent studies that have focused on the health effects of
deployment, including the Seabees Study and the DVA National Health Survey of
Persian Gulf War Era Veterans.
As previous federal research has shown, veterans often request disease-specific risk
factor comparisons. For this reason we have made self-reported medical conditions our
primary outcome from which to derive sample size needs. When it is not possible to
determine in advance which medical conditions will be of most concern to veterans
regarding future deployments, it seems prudent to plan for relatively infrequent
conditions. Gulf War veterans have requested studies of Goldenhar syndrome,56 lupus,
amylotrophic lateral sclerosis,77 Mycoplasma fermentans infections, 61 and leishmaniasis
infections78 (all are infrequent conditions). Similarly, expert panel reviews of the Air
Force Ranch Hand Study (Agent Orange exposed) have criticized the inability of the
small cohort size to determine risk.79 Investigators for the Women’s Health Initiative
have similarly targeted infrequent medical conditions.80 Hence, we have guided sample
size estimations based on relatively infrequent medical conditions.
Evaluating General Health and Functional Status
The SF-36 has been widely used in clinical and epidemiological studies to assess
functional status and general health across eight dimensions. A veteran-specific
instrument has been developed that differs only slightly from the original instrument in
providing for a spectrum of responses to two items dealing with work or leisure-time
limitations due to physical or emotional problems.81,82 This instrument has been used to
assess functional status in over 1.5 million veterans who receive care at a VA medical
facility. Therefore, a rich database exists to serve as a point of reference and comparison
for the data to be collected using this instrument in the Millennium Cohort Study.
The SF-36 (and SF-36V) measures health status over eight dimensions: physical
functioning (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT),
social function (SF), role emotional (RE) and mental health (MH). Two summary scales
are generated based on the scoring in these eight dimensions: Physical Component
Summary (PCS) Score, whose main elements include physical functioning, role physical,
and body pain; and Mental Component Summary (MCS) Score, whose main elements
include mental health, role emotional and social functioning. These dimensions are
shown in the figure below, graph A. The solid line indicates the mean for the U.S.
population. Scores for each dimension are standardized to a 0 to 100 point scale. For the
MCS and PCS, scores are standardized to a “50-10” scale, with 50 being the mean score
for the general U.S. population, and the standard deviation being a 10 unit difference
(figure, graph B). Similar scoring schemes have been used for presentation and
interpretation of the scores on the eight dimensions as well (figure, graph C).
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Figures (www.sf-36.com)
A
B
The advantages of the SF-36V includes its measurement of health status across several
dimensions, its brevity and ease of administration in both interviewer- and selfadministered settings, and its ability to measure health status in ranges where changes and
effects are most likely to be detected. Limitations include lack of condition specificity.
It has been shown that disease-specific instruments outperform the SF-36 when the
primary research focus in on a particular pathologic process (e.g., inflammatory bowel
disease, coronary artery disease).83,84 Since no one disease entity is targeted in the
Millennium Cohort Study, this limitation is not pertinent to the proposed research design.
Furthermore, there is no basis in selecting one disease focus, given that no one entity
seemed to occur with higher incidence as a result of military deployment in the Gulf War.
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These statements apply to medical disease only. The issue of measurement of psychiatric
diseases as outcomes will be covered in the following text.
The Short Form-12 Question and Short Form-12 Questions/Veterans have also been
developed as even briefer measures of functional status. Although the SF-12 scores
explain 85% of the various of SF-36 scores when measured in identical populations, the
SF-12 output only includes the MCS and PCS, and does not provide information on the
eight dimensions covered by the SF-36. Given this deficiency, and given the fact that a
much greater track record exists for the SF-36V than the SF-12V in veterans, we have
decided to use the SF-36V in the Millennium Cohort Study.
Other instruments exist to assess general health and quality of life. The Sickness Impact
Profile contains 136 items and can be self- or interviewer-administered.85 The
characteristics that make it unsuitable for the Millennium Cohort Study are the time
needed for completion, and its utility for health status measurement exists mainly in
sicker individuals. The Duke Health Profile is primarily suited for health status
measurement over a brief (1-week) time interval, and may therefore be less stable than
the SF-36V in capturing one’s usual state of health. Other instruments available through
the Medical Outcomes Trust (www.outcomes-trust.org/instruments) for generic health
status measurement that we considered include the London Handicap scale, which was
developed mainly for persons with chronic diseases, and the Quality of Well-Being Scale,
which must be interviewer-administered. For these reasons, neither seems suitable for
the proposed research.
Assessment of Psychiatric Conditions
The assessment of psychiatric outcomes in a brief, self-administered format presents a
particular challenge in this study. We propose that the general assessment of psychiatric
comorbidity be performed using the PHQ derived from the Primary Care Evaluation of
Mental Disorders (PRIME-MD) interviewer-administered instrument.75,86 The PHQ
consists of 15-16 questions (one additional question is included for women to capture
premenstrual stress and reproductive information). The following psychiatric disorders
are captured by this instrument: depression, somatization, panic disorder, anxiety, alcohol
abuse/dependence, binge eating disorder, and bulimia nervosa. The diagnostic properties
of the PHQ compare favorably to clinician psychiatric diagnoses using the Diagnostic
and Statistical Manual of Mental Disorders, 4th edition, with specificities >90% and
sensitivities of 62% to 89%.86 The PHQ requires a clinician interview for final
interpretation of results. For example, to properly attribute somatization disorder to a
patient on the basis of PHQ responses, the developers of this instrument recommend
clinician assessment to rule out underlying organic diseases responsible for the reported
symptoms. This will not be possible in the proposed study due to the large size of the
cohort and the expected infrequency of chronic disorders responsible for such symptoms.
The medical disease checklist that will be used in this survey will help in some degree to
capture this information. A computerized coding algorithm will be used to perform batch
analyses of completed PHQ instruments.
Due to the high incidence of PTSD following traumatic events of the type experienced
during military service and deployment, we will use an instrument to specifically assess
the presence or absence of this outcome. We have chosen the PCL-17, since it can be
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self-administered in a brief period of time.87 It consists of 17 items, and has been
validated extensively in male Vietnam veterans and small samples of trauma-exposed
women.88
Assessment of Physical Conditions
Those military personnel who deploy and sustain an injury and are in both the
Millennium Cohort Study and Joint Theater Trauma Registry (JTTR) will be looked at
over the long term in order to better understand the effects of combats injuries on
psychological and functional health outcomes. The JTTR provides data in detail about
wounds received and the medical care provided from combat support hospitals, aboard
ships and aircraft, and throughout the course of their treatment.
Morbidity Tracking
Self-reported morbidity data may be validated by a variety of methods. While receiving
care in DoD medical treatment facilities, veteran healthcare data, including diagnoses,
may be obtained from the Standard Ambulatory Data Record (SADR) and Standard
Inpatient Data Record (SIDR) inpatient and outpatient billing data. Similarly, various
DVA databases will be examined for DVA healthcare utilization. These electronic
records archive diagnoses in the ICD-9 format.
Questionnaire Development
Teleform scanned mark-sense questionnaires will be used. This method has been shown
to greatly reduce data entry error. To maximize data quality, study instruments will be
evaluated by multiple focus groups and via a pilot survey of 1,000 respondents (2,564
surveyed). We plan to run the pilot test as if it were the actual study.
Address Finding
One of the most difficult challenges in studying military populations is gaining accurate
addresses. Numerous Gulf War veteran surveys have shown that once found, veterans
willingly participate in mail and telephone surveys.13,44, 48,91 Fortunately, for cohorts who
remain affiliated with the military, address finding is much simpler than attempts at
finding the addresses of separated veterans. Investigators have access to Defense
Enrollment Eligibility Reporting (DEERS) which has recently been found to be 93%
accurate in address recording. Hence, we hope to experience better address finding than
the 65% we found in the Seabee Health Study among non-Gulf War veteran Seabees
(60% participated). With a goal of studying 1,000 subjects in the pilot study and 100,000
subjects in the actual Millennium Cohort Study, and conservatively estimating 65% good
addresses and 60% responses among those we find, we derived the following number of
necessary initial postcard mailings:
Desired respondents: X(0.65)(0.60)
Pilot study (1,000 respondents desired): X=2564
The Millennium Cohort Study (100,000 respondents desired): X=256,400 (Appendix L)
Deployed service personnel will be oversampled to comprise 30% of the study
population. This will result in an oversampling of deployed reservists, women, and
deployed women reservists. Nondeployed service personnel will comprise 70% of the
study population. Women will be oversampled in this strata to consist of 30% of the
nondeployed, and reservists will be oversampled to consist of 50% of the nondeployed.
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Maximizing Participation
Another difficult aspect of this type of study is gaining and maintaining sufficient
participation. We plan to follow standard techniques92,93 of gaining high participation
percentages: presurvey introductory postcard mailing, cover letter with survey, postcard
reminders, and three repeat survey mailings (Appendix H). We will mail the subjects a
preliminary postcard to alert them to the forthcoming survey. This will also allow us to
gather address information inexpensively for subjects who have changed addresses after
our data extraction. The questionnaire will next be sent by first-class U.S. mail, with a
cover letter describing the study, and a consent form. The investigators will employ a
commercial address tracking company to locate subjects with inaccurate addresses. One
month after the initial mailing, a postcard reminder will be sent. Two months after the
first survey mailing, a second survey with a cover letter will be mailed, and this will
again be followed with another reminder postcard 1 month later. Four months after the
second questionnaire mailing, a final questionnaire with cover a letter will be mailed, and
this mailing will again be followed with a third postcard reminder. After three survey
mailings, a tracking service and additional data updates will be used to find correct
addresses for undelivered mail. Previous research at NHRC has shown that the use of
minor incentives (such as photographs, military pencils, and phone cards) may be helpful
in increasing participation rates. We plan to use such incentives. DSN and regular-line
phone numbers will be given to permit veterans to gain answers to questions regarding
the study. A web site has been established at http://www.MillenniumCohort.org to keep
study participants informed and to facilitate address changes. The paper form of the
survey will be mailed to the subject’s home to be filled out there at his or her
convenience.
All items mailed to the subject will be identified by bar codes, which will contain
embedded Subject Identification Numbers (SID), mailing numbers, and item codes. The
SID is randomly generated and unique to each participant. It is assigned and attached to
each record that is obtained from DoD health and administrative files upon receipt at
NHRC. From all the files that come to NHRC, two databases will be created for study
use. The first database will contain participant data such as name, current address,
address history, last 4-digits of the social security number, and SID. This database will
be the source of names and addresses when the questionnaire is mailed out and will be
used for tracking purposes. The questionnaire will have the SID bar coded onto it when
it is mailed to the participant and scanned for identification purposes once returned. The
second database will contain participant questionnaire responses along with
corresponding information linked by SID from administrative and medical files. This
procedure will separate individual identifiers from participant data, while making it
possible to pair names and addresses with SIDs for update and tracking purposes. Once
all the files (survey response, medical, and administrative) have been matched by SID,
the SID will be stripped from this database at the end of all data collection. A list pairing
the SID with the last 4-digits of the social security number will be created and stored by
the Principal Investigator in a locked file cabinet.
Outgoing envelopes will be hand-scanned when returned by the United States Postal
Service as undeliverable due to bad address and this will identify subjects having invalid
addresses. Business reply envelopes (BRE) will also be identified with a bar code.
When scanned, the BRE bar code will identify the subject as a tentative respondent. A
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final bar code will appear on the questionnaire itself. This bar code, when hand-scanned
during data review, will identify the subject as a true respondent if the questionnaire has
been filled out substantially complete, and will delete him/her from the next mailing list.
The questionnaire bar code will also be read into the data file created by the questionnaire
scanner so as to eliminate the need for hand entry of subject ID numbers into data
records.
As noted above, a subject is presumed to have received a questionnaire if the postal
service does not return it as undeliverable. Some subjects presumed to have received the
survey instrument will return the questionnaire uncompleted. Under these circumstances,
we will continue to send surveys to them until one of the following occurs: (a) we receive
a completed survey from them; (b) they explicitly decline to participate; or (c) they do
not respond after three questionnaires have reached them successfully.
Further, plans have been established to make the questionnaire available on the Internet at
the above mentioned web site. The electronic form of the questionnaire will be accessible
from any PC with an Internet connection. Subjects who so choose will be able to
complete the questionnaire electronically and send an encrypted copy of their completed
survey to NHRC over Secure Sockets Layer (SSL) data transmission lines. Participants
will take the survey in much the same manner as the hard copy. On-line participants will
go to the web site where they will be able to read background information and preview
the survey. Electronic versions of the introduction and endorsement letters will be
available for review. The participant will select from the menu to complete the
questionnaire on-line. Then the participants will be prompted to enter their unique,
encrypted SID (as described above) from the postal correspondence and the last four
digits of their social security number. Only valid entries will be allowed to participate in
the study. Valid entries will then proceed to the informed consent document
automatically. The informed consent document will be exactly the same in content as the
hard-copy version. The only difference will lie in the acknowledgment of consent. The
electronic version of informed consent will have a “YES, I AGREE” box and “NO, I DO
NOT AGREE” box that the participant may check to show whether or not they
understand the purpose and risks of their participation and still wish to participate in the
study. Participants who check “NO” will be thanked and then returned to the study home
page. Participants who check “YES” will be asked to again enter their study ID number
and last four digits of their social security number that is then encrypted and will serve as
their “digital signature.” Each encrypted digital signature is solitary and unique to every
study participant and confirms that the consent came from only that individual. This
signature would be confirmed by the system as valid before acceptance of the agreement.
The use of digital signatures has been established as accepted procedure in lieu of
physical signatures for Internet commerce for the past few years.100,101
There are no firmly established procedures for on-line informed consent as of yet for the
field of human subjects research.102 A report sponsored by the American Association for
the Advancement of Science was released in November, 1999, focused on human subject
research on the Internet.103 The report, titled, “Ethical and Legal Aspects of Human
Subjects Research on the Internet,” states that the three principles of protecting human
subjects, autonomy, beneficence, and justice, must still be met in on-line informed
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consent documents. The informed consent document to be used for the Millennium
Cohort Study will meet those principles, outlining risks for both on-line and hardcopy
completion. Further, in terms of the physical signature issue, a main concern for on-line
consent deals with the validity of the consent in terms of the researcher not knowing the
“age, competency, or comprehension”103 of the participant. The Millennium Cohort
Study does not have those concerns since the study population will be drawn from a
known source, rather than soliciting unknown respondents. Additionally, the validity
check at the very beginning of the survey process and at the end of the informed consent
document will confirm that the participant is part of the known sample population.
Plans to create an organization page on the Facebook platform as well as a Millennium
Cohort Study Facebook application is underway. Participants will be sent an email with
a link to be able to "Like" the Millennium Cohort Organization page. The link to our
Facebook page may also be included on our webpage and in some of the study materials
sent as part of the routine mailings (these will be submitted prior to mailing). Millennium
Cohort Study administrators will post links on the Facebook page about recent study
findings and provide updates on survey cycles. We will restrict posting on the Facebook
page to only authorized users, in this case it would be the Millennium Cohort Study team.
The linkage will only be used to send information about the survey and its findings to
individuals who “Like” the Millennium Cohort Organization page; no collection of
information about the individuals “liking” Millennium Cohort will be accessed, collected,
or maintained.
•
Individuals “liking” the Millennium Cohort Organization page will be reminded that
they can “Edit Privacy” on each site they like to limit those who can see their “likes.”
The communications described above will also include a link for those interested in the
Facebook application. To use the application, the participant must provide consent after
reading a disclosure statement (a standard feature for getting an app on Facebook).
Authorized users (i.e., Millennium Cohort investigators) can control the information
shown in the application, and therefore we can ensure privacy in the application itself by
never exposing personal information/details of individual members. Similar to ‘liking’
the Millennium Cohort Facebook Page, visibility of a specific user as having added the
Millennium Cohort application is based on their privacy settings. This information is
generally not available to the public unless the user allows for it.
The Facebook application will be hosted at the same secure co-location center as the
Millennium Cohort web surveys. The application will be used to send participants study
information. We will not collect any data from their profile. The Facebook page and
application are voluntary features and a person can cancel their consent or involvement
with the Facebook site at any time. When a user removes the app from their profile, we
are sent a de-authentication notice and at that time we can remove their data from our
server (the user ID and information is no longer given to the application). Both the
application and organization page are still under development, but a few screen shots are
enclosed for review. Screen shots of both items in their entirety will be sent for IRB
review once constructed.
The Millennium Cohort Study, received approval to call those participants who
completed the paper survey, but failed to sign the informed consent form in the survey
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document. These phone calls will be the last contact attempt during the cycle in attempt
to have the subject provide consent, and hence for the study team to utilize their survey
data. Approximately 460 participants will be called. Those who did not sign the consent
and who did not complete at least 75% of the survey will not be contacted rather they will
simply be excluded from the study.
Subjects will be contacted via telephone Monday through Friday between the hours of 8
am to 8 pm within their time zone, and/or Saturday between 10 am to 6 pm in their time
zone. No calls will be made on Sundays. A maximum of 5 phone call attempts will be
made per subject and a log of every attempt will be kept. Staff making phone calls will
not leave a voice message on the first four attempts and only then would leave a message
on the fifth attempt. A verbal “yes” or “no” reply will be accepted as the subject’s
consent and documented by caller who will be a member of the study team. If the subject
responds with a “no”, they will no longer be contacted and their survey data will not be
utilized. Calls will end once the 5 call limit occurs or we are able to reach the participant
in person, whichever occurs first. All participants who agree to consent to the study will
be offered a copy of the consent form which will be mailed to them.
A log of all of the phone calls will also be kept. A copy of the log is also submitted for
review.
The script for the phone calls is as follows:
Hi (interviewee name):
My name is (caller name), and I am calling from the Naval Health Research Center.
We appreciate the time you spent completing our survey on (Date) for the Millennium
Cohort Study which is being conducted by the Department of Defense.
When we reviewed your survey, we noticed that you did not sign the consent form on
the 2nd page of the survey. In order to use your data for our study, we would need to
have your consent to participate in the study. Will you give your consent for
participation?
If the subject responds yes:
Thank you. We will document your response. We know your time is valuable and we
thank you for helping with this important project. We would be happy to send you a
copy of the study’s consent to your home address? Would you like a copy? If yes,
(confirm address).
If the subject responds no:
Thank you. We will document your response. Unfortunately, we will not be able to use
the information you gave us in the survey you completed. Thank you for your time.
Sampling Non-respondents
Computer-assisted telephone interview (CATI) techniques will be used to reach a 3%
sample of nonrespondents. CATI survey work will be performed via contract with
survey consultants. A similar procedure will be employed to obtain reliability estimates
from respondents.
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Reliability Evaluation
We plan to resample 5% of the respondents in the first wave with a briefer study
instrument to evaluate questionnaire reliability. This will likely occur in the third
mailing.
Bias and External Validity
The evaluation of response bias is a key component to assessing the validity of a
prospective study. For example, those who consent to participate in a long-term
prospective study may be more motivated to do so if they have more health concerns than
those who do not. Alternatively, those with serious health problems may not participate
because they are too ill to do so. In either case, this may result in the participant
population not well representing the target population.
Service members decline to participate in one of two ways: they either ignore all
invitations, or they submit a response that clearly shows they decline the invitation for
enrollment. All such cases are considered non-participants, and none of these receive
further invitations or contact.
Analysis of response bias, however, requires accessing existing information on healthcare
utilization among both participants and non-participants. Existing data sources include,
but are not limited to, demographic files from the Defense Manpower Data Center, and
healthcare utilization data from the Tricare, Executive Information and Decision Support
Program, Management Analysis and Reporting Tool (M2).
In assessing existing DoD data on non-participants, as well as participants, extreme care
is taken to protect personal identifying information. Such data are used for linking
purposes only. After linking, only de-identified demographic, administrative, and
medical data for non-responders and decliners will be maintained to explore potential
differences between survey participants and non-participants.
Supplemental Medical and Administrative Data
• NHRC manages or has access to numerous established military data sets.
Information from these data sources can be used to supplement the survey
instruments and enhance the ability to track study outcomes. Data linkage for the
Millennium and Family Cohort will be linked to Department of Defense personnel
and medical records obtained from the following sources: DMDC (Data Manpower
Data Center) and Defense Health Administration. For mortality data, we submit
requests to Armed Forces Medical Examiner System (AFMES), Armed Forces Health
Surveillance Center (AFHSC), JPC (Joint Pathology Center), NDI (National Death
Index), Defense Suicide Prevention Office (DSPO), DMDC and VA (US Department
of Veterans Affairs). In addition, if the spouse is an active duty member and retires
or separates from military service and utilizes Department of Veterans Affairs for
medical services, we will link to VA medical and personnel data as well as the DoD
Joint Theater Trauma Registry and the Navy/Marine Corps Trauma Registry. These
data will complement subjective measures with objective measures of exposures and
health outcomes. These databases are accessed electronically through secure
computers located at the Naval Health Research Center. Unique identifiers are used
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to link each participant with their electronic data; however, in some cases name and
SSN will be provided. All data upon receipt will be confidentially maintained on-site
in our secure computer database. No data regarding a child and his/her health will be
linked from any source for the purposes of this study. Appropriate
agreements/approvals will be in place prior to any data sharing for any linkages.
Additionally the following sources are available:
Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)CHAMPUS contains one record for each claim voucher for care by a civilian
provider. Care is rendered to dependents of the military, and retirees and their
dependents who are not Medicare eligible. These files contain historical data from
December 1979.
Defense Enrollment Eligibility Reporting (DEERS)-DEERS is the central source for
personnel information from the DoD personnel community. This database is used to
determine medical benefits eligibility, insurance, immunizations, and patient
information. This data set is thought to be 93% accurate for the addresses of military
personnel, and the accuracy continues to improve.
Defense Outplacement Referral System (DORS)-DORS is a national resume and
referral network established to help separating DoD personnel transition into civilian
life. DORS provides private and public sector employers with immediate access to
resumes from transitioning service members and federal civilian employees.
DoD Birth Defects Registry-Beginning in January 1999, a DoD Birth Defect Registry
was established at NHRC. The registry uses a hybrid system of intensive active
surveillance among the largest military population in the United States (Naval
Medical Center San Diego) and passive surveillance via electronic hospitalization
databases for the rest of the DoD dependents.
Health Enrollment Assessment Review (HEAR)-HEAR was created to assist
providers and managers in identifying individuals and groups of individuals in their
panel who require proactive interventions. Soon to be routinely administered to all
active-duty personnel, HEAR identifies patients whose clinical preventive services
are not current or have never been performed. Additionally, HEAR describes a
patient’s risk factors, his or her chronic medical conditions, and whether the enrollee
falls into the high resource utilization category.
Master Crosswalk File-This file provides "crosswalks" between military
occupational codes of the four military services and the Coast Guard and their civilian
counterparts as defined by the standard occupational classification codes,
occupational employment statistics codes, census codes, Office of Personnel
Management codes, and classification of instructional programs codes.
Military Operation Rosters-As DoD deploys large groups of military personnel for
sustained time periods, participants are recorded by the various services and compiled
in databases at DMDC. Such military operation databases are now available for the
Gulf War, Bosnia, and Kosovo. The latter two operations continue to document new
participants.
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Recruit Assessment Program (RAP)-This electronic database is in pilot testing. RAP
will represent a collection of baseline demographic, medical, psychological,
occupational, and risk factor data from all U.S. military personnel at the time of their
entry into military service.
Pre and Post-Deployment Health Assessments (DD2795 and DD2796) - Health
assessments prior to and following deployments are forwarded to the Army Medical
Surveillance Activity (AMSA) where they are scanned and entered into the Defense
Medical Surveillance System (DMSS). Information regarding health status, health
perceptions, mental health screening and potential environmental exposures are
captured by these health assessments as well as relevant medical referrals and
dispositions before and after deployment.
Department of Defense Trauma Registry (DoDTR) U.S. Army Institute of Surgical
Research - The DoDTR captures details about wounds received and the medical care
provided from combat support hospitals, aboard ships and aircraft, and throughout the
course of their treatment, as well as the results.
Theatre Medical Data Store (TMDS).TMDS provides healthcare encounter data, lab
data, procedure data, and pharmacy data delivered at any military treatment facility,
including the first echelons of care at deployed locations,
Army Center for Substance Abuse Programs' (ACSAP) Drug and Alcohol
Management Information System (DAMIS). The ACSAP and DAMIS will allow us
to capture individual data on drug test positivity among participants who screened
positive during their service time.
Global Assessment Tool (GAT). The GAT is a confidential self-assessment tool that
includes information on Soldiers well-being, resilience, and their overall health. GAT
data is stored in the PDE, a virtual secure platform designed for integrating data,
linking commands for analysis, and conducting studies/projects. This repository is an
ever-evolving cloud-based, virtual technology that provides strong protections of
human subjects via encoded and de-identified data.
Family Advocacy Program (FAP). We would like to request permission to obtain
selected variables regarding military assessment and treatment provision, as well as
other medical care referral from the Department of Defense and Service specific
Family Advocacy Program (FAP) Central Registry Databases. The Family Advocacy
program provides various treatment and support services for perpetrators and victims,
and makes referrals for additional care where needed. Within the DON, the Family
Advocacy Program services are provided as part of the Fleet and Family Counseling
Support Centers. We would request the specified variables for all incidents involving
Millennium Cohort Study research participants, with recurring data extracts to be
completed annually or triannually.
Permission to receive these data will be obtained from DoD and the Service specific
FAP offices, as well as from the Defense Manpower Data Center (DMDC) which
maintains the DoD-level repository for cases meeting full criteria as family violence
incidents. We currently have a Memorandum of Understanding (MOU) in place with
DMDC and an existing approved data request for FAP data for Millennium Cohort
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Family Study participants. The existing DMDC request has been updated to include
all Millennium Cohort participants (see attached); and once IRB approval has been
received, NHRC will provide a list of the SSNs for Millennium Cohort Study
participants to DMDC. DMDC will then provide NHRC with all matching records in
the DoD Central Registry for those SSNs. Separate data use agreements will be
established with the Service specific FAP offices in order to obtain additional
information regarding suspected incidents meeting partial criteria. Similar procedures
will be used for data matching with Service specific registries, and all data transfers
will be made using encrypted files either using the Army’s AMRDEC Safe Site or a
secure data transfer site supported by DMDC.
The requested variables include the following personnel and treatment information
for Service members in the Millennium Cohort Study with substantiated cases of
intimate partner violence victimization or intimate partner/child abuse offending:
Name
Social Security Number
Incident report date
Legal event context code (emotional maltreatment, neglect, physical abuse, sexual
abuse)
Person Association reason code (only codes AA = spouse, AD=parent, BH=former
spouse, BE=intimate partner, CC=relationship unknown)
Victim maltreatment severity level (mild, moderate, severe)
Clinical intervention program provided to Family Study participant as a victim (FAP,
Other DoD, Other Non-DoD, None, missing)
Clinical intervention program provided to Family Study participant as an offender
(FAP, Other DoD, Other Non-DoD, None, missing)
In addition, the DVA has agreed to collaborate regarding mortality studies using its
previous mortality study approach.89,90 The following databases are available for use
through the DVA:
Beneficiary Identification and Records Locator System (BIRLS)–BIRLS provides
the social security number and the state in which death occurred for all veterans
whose survivors apply for a death benefit. This database is updated quarterly and
contains 8.32 million records that are in SAS file format.
National Patient Care Database (NPCD)–NPCD combines several DVA databases,
including Patient Treatment File (PTF) and Outpatient Clinic File (OPC). NPCD is
currently under development.
National VA Enrollment File–This database consists of veterans eligible for care and
is currently under development.
Outpatient Clinic File–OPC provides information regarding principal diagnosis and
location of all VA-provided episodes of outpatient care. The database contains over
20 million records per year with weekly updates.
Patient Treatment File– PTF contains up to 10 discharge diagnoses and 5 procedure
codes for all VA-provided hospital care. PTF is updated weekly.
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Veterans Information Systems Technology Architecture (VISTA)–This is a
comprehensive clinical and administrative database that contains laboratory,
radiology, and pharmacy data. Access to VISTA is usually made through individual
DVA medical centers.
Statistical Analysis
Comparing the adjusted probabilities of new onset chronic disease between cohorts will
be conducted by examining self-reported data, and by validating these data with
electronic data systems (SIDR and SADR) when possible. One difficulty in study design
is determining which chronic disease outcomes to select for sample size estimation. For
purposes of this example, we have selected outcomes that we would generally expect a
survey respondent to accurately report, most of which are drawn from the DVA’s
National Health Survey of Persian Gulf War Era Veterans: all-cause hospitalization,
hypertension, diabetes, stroke, myocardial infarction, renal failure, and asthma. These
outcomes should be relatively rare for the generally young and healthy military
population that we will target in the future study years.
Covariate adjustment will include age, gender, occupation, marital status, race, ethnicity,
deployment status, branch of service, income, and length of service. Multivariable Cox
proportional hazard modeling will be used for each outcome. SAS statistical analysis
program software (SAS Institute, Inc., Cary, NC) will be used.
Interpretation of Results
Study work will be guided by a Scientific Steering and Advisory Committee. This
Committee will be composed of 5 distinguished external researchers and 3
representatives from veterans service organizations. This group first met June 22-23,
2000, in San Diego to finalize study design. The group will continue to review study
design, progress, and data analyses and serve to frequently advise investigators. We
expect to conduct Committee meetings approximately twice a year.
All research work will be reviewed and approved by the NHRC’s Committee for the
Protection of Human Subjects (CPHS). Investigators will report study results to various
policy groups including:
Research Working Group-In conjunction with other deployment health research,
the Research Working Group will receive annual progress updates and review study
progress in light of other federally sponsored veteran research. The Research
Working Group update will be included in the annual report to Congress.
U.S. Army Medical Research Acquisition Activity Annual Peer Review-This
annual review is generally conducted by the American Institute of Biological
Sciences (AIBS). Several AIBS scientists are invited to review deployment health
research programs.
Missing Data/Attrition
We have identified subject matter experts from the Institute for Measurement,
Methodology, Analysis and Policy (IMMAP) at Texas Tech University to assist us in
meeting the OMB requirement to provide an approach to handle missing data and
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adjustments for selective attrition. Faculty and scientific staff of IMMAP will be
provided with raw numbers which have no identifiers. There will be no need for the
researchers to have access to the key that identifies the data. A subcontract between
NHRC/Henry Jackson Foundation and Texas Tech will be in place before any data
analysis is performed. The Naval Health Research Center’s IRB will serve as the primary
IRB.
Methodology of Family Component:
2. Sample Size Determination
We estimated the necessary study sample sizes by knowing the estimated incidence for our
healthy young population and using the following equation94:
Formula 1:
N
={Zα√P(1-P)
(1/q1+1/q2) + Zβ√P1 (1-P1) (1/q1) +P2 (1-P2) (1/q2)}2
(P1-P2)2
Where
P1
P2
N=
Zα
Zβ
q1
q2
P
= rate of outcome of interest in exposed group
= rate of these outcomes in nonexposed group
estimated minimum sample size required
= standardized normal deviate for a two-tailed probability of an α-error
= standardized normal deviate for a two-tailed probability of a β-error
= proportion of sample population in group 1
= proportion of sample population in group 2
= q1P1+ q2P2
The level of acceptable alpha error was set at <0.05, and beta error at 0.20 (statistical power at
>0.80). The statistical power of this study depends on the incidence of the conditions of interest
in the comparison groups. Estimates of incidence of hospitalization in the active-duty military
population for the chronic diseases were calculated by scanning for the specific disease in fiscal
year 1995 hospitalization data. These data were output and match-merged by social security
number to any hospitalization with that specific disease for fiscal years 1989 to 1994. If a match
occurred, that record was dropped, resulting in only new diagnoses of the specific disease. The
minimum sample sizes required to detect a significant difference for the overall hospitalization
incidence and incidence of specific chronic diseases over a 3-year and over a 6-year period are
calculated in Tables 1 and 2 respectively. Included are various relative risks for power equal to
0.80 and 0.90.
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Table 1.
Sample Size Necessary at Different Levels of Statistical Power to Detect a
Difference of Given Magnitude in Incidence (as Reflected by Relative Risk) Over Three Years.
Population Numbers
Reflect Total of Two Equal Cohort Sizes.
Outcome (ICD-9 Codes)
Incidence Rate
Any cause hospitalization
0.222
Hypertension (401-404)
0.0035
Diabetes (250)
0.0016
Stroke (436)
0.0001
Myocardial infarction (410)
0.0005
Renal failure (584)
0.0001
Asthma (743)
0.0004
Relative
Risk
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
80%
Power
2,934
508
139
245,449
44,602
13,367
538,049
97,802
29,327
8,623,049
1,567,802
470,327
1,723,849
313,402
94,007
8,623,049
1,567,802
470,327
2,155,049
391,802
117,527
90%
Power
3,927
679
185
328,650
59,720
17,897
720,436
130,953
39,267
11,546,086
2,099,253
629,757
2,308,198
419,637
125,873
11,546,086
2,099,253
629,757
2,885,566
524,613
157,365
In addition to hospitalization data from DoD facilities, we searched the medical literature to
obtain reasonable incidence rates of these medical conditions to confirm or refute our
hospitalization-based estimates. We found, as expected, for most conditions that data from
population-based studies yielded higher incidence rates for conditions that do not usually require
hospitalization for diagnosis and treatment. This means that the sample size calculations that we
have presented are likely to represent conservative estimates, and that smaller effect sizes (i.e.,
relative risks) will be detectable with 80% power than are shown in Tables 1 and 2.
Hypertension incidence in middle-aged men in the Atherosclerosis Risk in Communities Study
was estimated at 0.172 over a 6-year follow-up period, for an annual incidence of 0.032.95 A
similar estimate of hypertension incidence comes from an additional study of middle-aged
normotensive subjects (mean age 44 years) followed over a 7-year period (cumulative incidence
0.255, annual incidence 0.042).96,97 These estimates are considerably smaller than the cumulative
incidence estimate of 0.0035 over 3 years (or approximately 0.0012 annually) used in the sample
size calculations. The same is true for asthma, with an annual incidence reported in the literature
of 0.001, compared with the 3-year cumulative incidence of 0.0004 (or 0.00013 annually) based
on DoD hospitalization data, and diabetes mellitus (0.0016 per 3 years based on hospitalization
data or 0.0005 annually, compared to an annual incidence of 0.0018 in the U.S. in the 25-44 year
age category based on data from the 1990-92 National Health and Nutrition Examination Survey
(http://diabetes-in-america.s-3.com/contents.htm - Chapter 4).
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Yearly incidence of stroke based on U.S. national data was 0.00017 for persons ages 24-34 year
old and 0.00045 for 35-44 years. Both of these estimates exceed that of 0.0001 per 3 years based
on hospitalization data used in the power calculations. Sparse data exist on myocardial
infarction incidence in younger subjects. In one British study, this outcome occurred in 0.00029
men aged 49 years or younger, and 0.00004 women annually in this same age range.98 These
estimates exceed the 0.0005 per 3-year incidence obtained from hospitalization data (0.00017
annually) for men but do not exceed the incidence for younger women reported in the literature.
Yearly incidence for end stage renal disease incidence estimates that come from the U.S. Renal
Data System for subjects ages 25-44 years, where new cases occurred in 1999 at an incidence of
0.0001 (http://www.usrds.org/1999_adr.htm - Chapter 2). This rate also exceeds the hospitalbased rate of 0.0001 over 3 years.
Table 2.
Sample Size Necessary at Different Levels of Statistical Power to Detect a Difference
of Given Magnitude in Incidence (as Reflected by Relative Risk) Over 6 Years.
Population Numbers Reflect Total of Two Equal Cohort Sizes.
Outcome (ICD-9 Codes)
Incidence
Rate
Any cause
0.444
Hypertension (401-404)
0.0070
Diabetes (250)
0.0032
Stroke (436)
0.0002
Myocardial infarction (410)
0.0011
Renal failure (584)
0.0002
Asthma (743)
0.0009
Relative
Risk
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
1.2
1.5
2.0
80%
Power
991
155
33
122,249
22,202
6,647
268,549
48,802
14,627
4,311,049
783,802
235,127
783,049
142,347
42,691
4,311,049
783,802
235,127
957,271
174,024
52,194
90%
Power
1,326
206
43
163,688
29,727
8,899
359,581
65,343
19,584
5,772,406
1,049,493
314,829
1,048,486
190,599
57,161
5,772,406
1,049,493
314,829
1,281,766
233,013
69,885
Another objective is to compare the age- and gender-adjusted change in health between cohorts
by SF-36V scores. The SF-36V has a Physical Component Summary Scale (PCS) and a Mental
Component Summary (MCS) Scale. SF-36V data from healthy military populations are not
available. However, Ware et al.99 have reported that among adults with chronic disease,
approximately 20% will have more than a 5.43-point increase in the PCS scores one year from
baseline. Changes in scores among a healthy population should be much smaller. If we assume,
as have previous DVA Gulf War study planners, that a 7-point change in PCS score is a
significant change and further assume that on average between 5% and 10% of subjects will
report such a 7-point increase (health decline) after 3 years, we can then use this 5-10% as the
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estimated incidence of a new condition. Table 3 demonstrates the necessary total sample size
(using equal groups) to detect a small effect size difference of between 5-20%.
In a similar fashion, if we compare the difference in incidence of psychiatric diagnoses between
cohorts by the Patient Health Questionnaire and further estimate that the incidence of the 18
different mental health conditions detected by the Patient Health Questionnaire ranges from 0.01
to 0.10 every 3 years, we can infer from Tables 1-3 that we should be able to detect small risk
differences between cohorts.
Table 3.
Sample Size Necessary to Detect Differences Between Cohorts at Different Levels of
Statistical Power With an Expected 5% or 10% Incidence Over 3 Years (2-Tailed)
Power
Expected
Incidence
Effect size to detect
.80
5%
243,877
.85
.90
.95
279,944
326,505
404,180
10%
62,350
71,566
83,464
103,311
15%
28,322
32,507
37,909
46,919
20%
16,274
18,677
21,779
26,954
5%
115,301
132,344
154,345
191,046
10%
29,422
33,766
39,374
48,728
15%
13,339
15,307
17,846
22,082
20%
7,650
8,777
10,232
12,658
.05
.10
From our previous studies, we can estimate that among the 2.7 million U.S. servicepersons
serving on January 1, 2001, less than 20,000 (<0.7%) will have served in the Gulf War, 185,703
(6.9%) will have served in Southwest Asia (since August 1991), 86,263 (3.2%) will have served
in the Bosnia conflict (since December 1995), and 18% will have served in more than one
conflict. Approximately 15% of the force will be women. These data will be used in planning
the stratified, probability-based sampling.
In selecting the deployed and nondeployed groups for the Millennium Cohort Study, we will
avoid selecting servicepersons who have been deployed to the Gulf War, or who have been
deployed to Southwest Asia, Bosnia, or Kosovo prior to September 1997.
The study group sizes are:
Southwest Asia, Bosnia, Kosovo Veterans-30,000
Millennium Cohort-70,000
From our previous experience, we found good addresses for about 65% of Gulf War veterans
potential subjects and among those we reached approximately 65% agreed to participate in our
postal surveys.
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With this percentage in mind, we will send the initial preliminary postcard mailing to 256,400
subjects with the goal of gaining the 100,000 respondents.
In summary, the large sample size and follow-up for up to 20 years should assure excellent
power to detect small effects on health outcomes occurring with a frequency similar to that of
many important chronic diseases. Using the cohort sizes of 50,000 will give us considerable
power to detect small differences in risk for chronic diseases, such as hypertension, diabetes,
myocardial infarction, and asthma during the first 9 years of observation. Less common disease
risks will take longer.
A large sample size is fundamental to the successful detection of disease-exposure relationships
in a timely fashion such that preventive measures may be taken to reduce risk for future
deployments. It is difficult to predict which diseases will merit study for possible associations
with future deployments. Some may be too rare to study, but it seems prudent to have a
significant sample size to evaluate most common chronic diseases.
3. Justification for Exclusion of Specific Groups
Other than the selection exclusion criteria mentioned previously, no specific groups will be
excluded.
4. Required Equipment and Supplies
Supplies needed for this protocol will include postage for the introductory postcard, three
first-class mailings, address correction, and business reply returns. A mail contractor will
coordinate the mailings. Office supplies will include NHRC letterhead, envelopes, and
business reply envelopes. Questionnaire printing and optical scanning as well as a
professional address tracking service will be used. One new microcomputer will be used.
An additional license copy for the SAS statistical analysis program software will be
obtained. Finally, several four-drawer lockable, lateral filing cabinets will be obtained to
organize proper filing of project documents in a secure environment.
VII. ORGANIZATION OF RESEARCH EFFORT
1. Duties and Responsibilities
Rudolph Rull, PhD, will serve as a Principal Investigator for this study. He will be responsible
to NHRC’s IRB, and to the various external review bodies for the financial accounting and
scientific merit of the study. He will also be responsible for ensuring that all NHRC personnel
involved with this protocol are properly trained and qualified.
Edward Boyko, MD, MPH, will serve as the senior VA investigator in this project. He has
extensive experience conducting epidemiological studies of chronic disease among veteran
populations and will lend much knowledge to investigators in selecting and interpreting survey
instruments. It is likely that he will pursue follow-on clinical studies based on foundation data
collected from survey instruments. He will coordinate other VA collaborative studies using
study data and share in data analysis and interpretation.
Gary Gackstetter, DVM, MPH, PhD, will serve as a study investigator, an expert
epidemiological consultant, and the senior Uniformed Services University of the Health Sciences
(USUHS) liaison. Dr. Gackstetter is the Director of Graduate Programs at USUHS and teaches
epidemiological methodology and infectious disease epidemiology to masters and doctoral level
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graduate students, as well as medical students. He has extensive experience as a senior health
policy analyst and research scientist investigating health outcomes in military and veteran
populations.
Tomoko Hooper, MD, MPH, of the USUHS, will serve as an investigator for this study. She
will assist in study design, coordination of USUHS Institutional Review Board review and
facilitate Millennium Cohort Study promotion as a potential source of USUHS graduate student
projects.
Valerie Stander, PhD, will be located at the Naval Health Research Center and serve as coinvestigator. She has considerable experience conducting epidemiological studies among military
populations. She will plan epidemiologic studies and designing the study methodology;
performing statistical analyses for diverse research projects with complex study designs; working
with team members to derive an in-depth understanding of the data findings; drafting proposals
and writing peer-reviewed publications.
Denise Lovec-Jenkins will serve will serve as key support staff as the Regulatory Affairs
Manager. She will prepare IRB submission and other research activities to ensure compliance
with relevant federal and local regulations and policies of research for this protocol.
Beverly Sheppard will serve as key support staff as Study Coordinator. Her duties will include
assisting in program design and maintenance of survey instruments alongside research team, as
well as assisting with writing peer-reviewed publications; assisting in the development of
strategies to maintain study participant retention, including the utilization of newsletters, mailers,
and other incentives.
Jennifer Walstrom will serve as key support staff as Assistant Study Coordinators and will
assist with coordinating the study, and web site and survey testing. She will manage and organize
the on-site work, including responding to any emails from participants.
Lauren Bauer, MPH, Study Coordinator for the Millennium Cohort Study and Evelyn Sun,
MPH study will serve as key support staff and will work with the Millennium Cohort study team
with coordinating the Millennium Cohort Family study and sub-study data as well as web site
and survey testing.
Gia Gumbs, MPH, Study Coordinator for the Birth and Infant Health Research Study will serve
as key support staff and will work with the Millennium Cohort study team with coordinating the
Birth and Infant Health Research study data.
Anet Petrosyan, Alexis Takata and Deanne Millard will be located at the Naval Health
Research Center and will serve as key support staff as Research Assistants. As Research
Assistants they will assist in the preparation of technical research reports, summaries, literature
reviews, and scholarly presentations and/or publications as well as maintain clear and accurate
research records, inventories, logbooks, and standard operating procedures. She will also assist
with data collection, data entry, and data clean-up for research project.
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Steven Speigle and William Lee have extensive knowledge in computer and internet technology,
website maintenance and development. They will work to ensure data security and integrity, as well as
designing, creating, modifying, and updating web pages. They will also be responsible for building and
maintaining the web-based component of the survey in addition to cleaning and maintaining email
addresses, as well as implementing a system to track incorrect email addresses.
Daniel Vaughan, BS will be located at the Naval Health Research Center and will serve as key support
staff as a Programmer Analyst. His duties will include ensuring data security and integrity and assist in
processing and maintenance of research databases. He will also be responsible for cleaning and
maintaining email addresses, and maintaining the current system to track incorrect email and postal
addresses.
Gordon Lynch will be located at the Naval Health Research Center and will serve as key support staff as
Web Developers. Their duties will include ensuring data security and integrity, as well as designing,
creating, modifying, and updating web pages. They will also be responsible for building and maintaining
the web-based component of the survey.
Jacqueline Pflieger, PhD and Sabrina Richardson, PhD will be located at the Naval Health
Research Center and will serve as key support staff as Research Psychologists. Their duties will
include assisting in program design and maintenance of survey instruments alongside the
research team; planning epidemiologic studies and designing the study methodology; performing
statistical analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals and writing
peer-reviewed publications.
Christopher Phillips, MD, MPH, / Ben Porter, PhD, / Teresa Powell, MS and Richard
Armenta, PhD will be located at the Naval Health Research Center and will serve as key
support personnel as a Biostatistician. Duties will include assisting in program design and
maintenance of survey instruments alongside research team; planning epidemiologic studies and
designing the study methodology; performing statistical analyses for diverse research projects
with complex study designs; working with team members to derive an in-depth understanding of
the data findings; drafting proposals and writing peer-reviewed publications.
Cynthia LeardMann, MPH, / Daniel Trone, PhD, / Deborah Bookwalter, PhD, / Anna
Rivera, MPH, / Isabel Jacobson, / MPH, / Rayna Matsuno, PhD, / Zeina Khodr, PhD, , and
Adam Cooper, PhD will be located at the Naval Health Research Center along with Chiping
Nieh, PhD and Marleen Welsh who will serve as key support staff as Epidemiologists. Their
duties will consist of planning epidemiologic studies and designing the study methodology;
performing statistical analyses for diverse research projects with complex study designs; working
with team members to derive an in-depth understanding of the data findings; drafting proposals
and writing peer-reviewed publications.
Anna Bukowinski and Satbir Boparai, MBA will be located at the Naval Health Research
Center and will serve as key support staff as Data Managers. As data mangers, Ms. Bukowinski
and Ms. Boparai will be responsible for processing and managing data and related programs.
Toni Geronimo, MPH / Clair Kolaja, MPH / Carlos Carballo, MA, / Kelly Woodall, MPH, /
Kimberly Roenfeldt, MAS, / Steven Warner, MPH, and Alejandro Esquivel will be located
at the Naval Health Research Center and serve a key support staff as Data Analysts. Their duties
will include providing statistical and analytical support for diverse research projects; assist in
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processing and maintenance of research databases; assist in writing of reports and scientific
manuscripts for peer-reviewed professional journals and presentations.
Key support staff at NHRC will carry out the day-to-day duties of study implementation and
analysis. They will report directly to the PI, Dr. Rudolph Rull.
2. Chain of Command
Dr. Rudolph Rull serves as the principal investigator on this study. All investigators and
collaborators will coordinate study activities with him. Dr. Rudolph Rull will report to the
Commanding Officer.
VIII. RISKS AND DISCOMFORTS TO RESEARCH VOLUNTEERS
1. Risk to the Volunteer and Means of Mitigation
This research study will collect self-reported mail and telephone survey responses. Study
staff will store data in secure locations and maintain limited password access to digital data.
All results will be reported as aggregate data without identifying individuals. Thus, this
study poses no physical risk to the participant. When the participants receive the
introductory letter and questionnaire, the letter will explain that their participation is
voluntary and the Privacy Act Statement will be the first item on the cover of the
questionnaire.
The data of interest are of a highly confidential nature, and strict procedures will be followed
to minimize any risk of mental or emotional distress to the participant.
The following procedures will be followed to ensure that confidential information will not be
used or abused in ways that might directly or indirectly harm the individuals involved:
Administrative
• All study staff will receive training in confidentiality protection procedures.
• Supervisors will monitor staff to ensure that they follow proper confidentiality
procedures.
• An annual review of confidentiality procedures will be conducted.
• If study staff resign or otherwise leave the program, they will remain under obligation to
protect the confidentiality of all data collected as part of the study.
Procedural
• The respective service survey approval managers will review the introductory letter and
mail questionnaire. Their approval will be required before initiating the mailing.
• The participants will be informed of the process that will be used to link their answers
with pre-existing data. It is required that NHRC’s CPHS permit the investigators to forgo
use of the formal informed consent documentation.
• Study staff will store study paper records in locked metal cabinets at NHRC. Paper
records that are no longer needed will be shredded.
Computer Security
• To gain entry into the study database, staff will be required to enter their personal ID
numbers and password.
• Study staff will download study data from the Corporate Executive Information System
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(CEIS) and DEERS through secure data transmission links meeting standard DoD
requirements. The database will be stored on existing NHRC information systems
network. This system meets current DoD data security requirements.
• Supervisors will grant access to the confidential database only to those staff who require
it.
• The NHRC network fire wall is in place to deter unauthorized access to these files.
• All data will be carefully guarded and used only to meet the stated study objectives.
• Personal identifying information will be removed from the analytic database once the
survey, medical facility use, and demographic information are linked and stored
separately. Only the statistician, who is familiar with the database, will link personal
identifiers with the data for the initial match or any subsequent matches, and the
identifiers will again be stripped following the match.
• The study database will reside within the NHRC network environment. There are no
subcontractors who would have access to or possession of this database at any time. A
public-release database will be created with the social security number and any other
identifying data removed. DMDC will also receive a full copy of this database once it
has been created.
• Information transmitted over the Internet will be done so using SSL-encrypted
transmission lines. Further, users will have to enter their unique study ID number and
last four digits of their social security number to send completed questionnaires.
• NHRC will periodically review the computer security procedures, including challenges to
the security fire wall erected to assure its integrity.2.Special Risks to Pregnant Women
None
3. Safety Precautions and Emergency Procedures
None.
4. Assessment of Sufficiency of Plans to Deal With Untoward Events or Injuries
Previous studies at NHRC involving similar procedures have not led to significant injury of a
subject. The use of standard Navy medical procedures has been deemed sufficient to deal
with any untoward events and/or injuries.
5. Qualification of Medical Monitor and Medical Support Personnel
N/A
IX. DESCRIPTION OF THE SYSTEM FOR MAINTENANCE OF RECORDS
1. Experimental Data
All study data, including paper questionnaires, will be managed by the principal investigator
and stored in locked rooms at NHRC. Computerized Privacy Act data will be similarly
handled in a confidential, controlled access fashion in compliance with
NAVHLTHRESCENINST 3900.2F and NAVHLTHRESCENINST 6500.1A.
2. Research Protocol, Consent Forms, and Related Documents for Protection of Human
Research Volunteers
The principal investigator will keep the research protocols and consent forms in a locked file
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at NHRC. Computer data files will be stored in compliance with NAVHLTHRESCENINST
3900.2F and NAVHLTHRESCENINST 6500.1A.
3. Individual Medical Records
Individual computerized medical records will be used to abstract demographics, lifestyle, and
medical data into the study database. Personal identifiers will be stored in a separate data file
that can be linked only be the study statistician.
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X. APPENDICES
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APPENDIX A: Consent Documents
NHRC 2000
0007-CR13-EP9-A_Co
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
APPENDIX B.
INVESTIGATOR ASSURANCE AGREEMENT(s)
INVESTIGATOR ASSURANCE AGREEMENT
I, the Department Head, Principal Investigator or Co-Investigator, cited as responsible for
performing and monitoring the research under the protocol titled, "Prospective Studies of U.S.
Military Forces: The Millennium Cohort Study" have read and understand the provisions of Title
32 Code of Federal Regulations Part 219 (Protection of Human Subjects), Department of
Defense (DoD) Directive 3216.2 (Protection of Human Subjects in DoD-Supported Research),
Secretary of the Navy Instruction (SECNAVINST) 3900.39B (Protection of Human Subjects),
Naval Medical Command Instruction (NAVMEDCOMINST) 6710.4 "Use of Investigational
Agents in Human Beings" - if applicable), and Naval Medical Research and Development
Command Instruction (NMRDCINST) 3900.2 (Protection of Human Research Volunteers from
Research Risks), SECNAVINST 5370.2H (Standards of Conduct) (and local instructions, as
applicable). I will abide by all applicable laws and regulations, and I agree that in all cases, the
most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during
the conduct of this Navy-sponsored project, I have ready access to each of these regulations, as
either my personal copy or available on file from the Chair, Committee for the Protection of
Human Subjects. I understand that my immediate resource for clarification of any issues related
to the protection of research volunteers is the Chair, Committee for the Protection of Human
Subjects.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
COL Paul Amoroso, MD, MPH
Co-Investigator
___/___/___
_________________________________________________
Edward Boyko, MD, MPH
Co-Investigator
___/___/___
_________________________________________________
Gary Gackstetter, DVM, MPH, PhD
Co-Investigator
___/___/___
_________________________________________________
Tomoko Hooper, MD, MPH
Co-Investigator
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B- 1
___/___/___
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
INVESTIGATOR ASSURANCE AGREEMENT
I, the Department Head, Principal Investigator or Co-Investigator, cited as responsible for
performing and monitoring the research under the protocol titled, "Prospective Studies of U.S.
Military Forces: The Millennium Cohort Study" have read and understand the provisions of Title
32 Code of Federal Regulations Part 219 (Protection of Human Subjects), Department of
Defense (DoD) Directive 3216.2 (Protection of Human Subjects in DoD-Supported Research),
Secretary of the Navy Instruction (SECNAVINST) 3900.39B (Protection of Human Subjects),
Naval Medical Command Instruction (NAVMEDCOMINST) 6710.4 "Use of Investigational
Agents in Human Beings" - if applicable), and Naval Medical Research and Development
Command Instruction (NMRDCINST) 3900.2 (Protection of Human Research Volunteers from
Research Risks), SECNAVINST 5370.2H (Standards of Conduct) (and local instructions, as
applicable). I will abide by all applicable laws and regulations, and I agree that in all cases, the
most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during
the conduct of this Navy-sponsored project, I have ready access to each of these regulations, as
either my personal copy or available on file from the Chair, Committee for the Protection of
Human Subjects. I understand that my immediate resource for clarification of any issues related
to the protection of research volunteers is the Chair, Committee for the Protection of Human
Subjects.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Tyler Smith, MS, PhD
Principal Investigator
___/___/___
_________________________________________________
Col Tim Wells, BSC, USAF
Co-Investigator
___/___/___
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INVESTIGATOR COMPLIANCE ATTESTATION
I, the Department Head, Principal Investigator and/or Co-Investigator(s), cited as responsible for
performing and monitoring the research under the protocol titled, "Prospective Studies of U.S.
Military Forces: The Millennium Cohort Study," have read and understand the provisions of
Title 32 Code of Federal Regulations Part 219 (Protection of Human Subjects), Department of
Defense (DoD) Directive 3216.2 (Protection of Human Subjects in DoD-Supported Research),
DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D (Human Research
Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys), NAVHLTHRSCHCEN
Instruction 3900.2E (Protection of Human Subjects), NAVHLTHRSCHCEN Notice 6500
(Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts 50,
56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions.
I have disclosed all potential and actual conflict of interest(s) related to the design, conduct,
analysis, or reporting of this research. I will abide by all applicable laws and regulations, and I
agree that in all cases, the most restrictive regulation related to a given aspect of research
involving protection of research volunteers will be followed. In the event that I have a question
regarding my obligations during the conduct of this Navy-sponsored project, I have ready access
to each of these regulations, as either my personal copy or available on file from the Chairperson
of the Institutional Review Board. I understand that my immediate resource for clarification of
any issues related to the protection of research volunteers is the Chairperson of the Institutional
Review Board.
Signatures and dates:
(DD/MM/YY)
__________________________________________
Nancy F. Crum-Cianflone, MD, MPH
Department Head, Deployment Health Research Department
Principal Investigator, Millennium Cohort Study
______/______/______
__________________________________________
CAPT Margaret Ryan, MD, MPH
Co-Investigator
______/______/______
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APPENDIX B.
INVESTIGATOR ASSURANCE AGREEMENT(s)
Key support personnel have all signed this agreement in separate documentation.
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APPENDIX C.
REFERENCES
1.
Defense Science Board. Final Report: Defense Science Board Task Force on Persian Gulf
War Health Effects. Washington, DC: Office of the Under Secretary of Defense for
Acquisition and Technology, 1994.
2.
Presidential Advisory Committee on Gulf War Veterans' Illnesses. Final Report, December
1996. Washington, DC: US Government Printing Office, 1996.
3.
Institute of Medicine. Adequacy of the Comprehensive Clinical Evaluation Program: A
Focused Assessment. Washington, DC: National Academy Press, 1997.
4.
Institute of Medicine (U.S.). Committee to Review the Health Consequences of Service
During the Persian Gulf War. Health consequences of service during the Persian Gulf War :
recommendations for research and information systems. Washington, D.C.: National
Academy Press, 1996:xii, 193.
5.
Presidential Advisory Committee on Gulf War Veterans' Illnesses. Special Report,
November 1997. Washington, DC: US Government Printing Office, 1997.
6.
Kang HK, Dalager NA, Lee KY. Health Surveillance of Persian Gulf War Veterans: a
Review of the Department of Veterans Affairs Persian Gulf Registry and in-Patient
Treatment Files. Washington, DC: Environmental Epidemiology Service, Department of
Veterans Affairs, 1995.
7.
Gray GC, Hawksworth AW, Smith TC, Kang HK, Knoke JD, Gackstetter GD. Gulf War
veterans' health registries. Who is most likely to seek evaluation? Amer J Epidemiol 1998;
148:343-349.
8.
Department of Veterans Affairs. Annual Report to Congress: Federally Sponsored
Research on Persian Gulf Veterans' Illnesses for 1998. Washington, DC: Department of
Veterans Affairs, The Research Working Group of the Persian Gulf Veterans Coordinating
Board, 1999.
9.
Office of the Special Assistant to the Deputy Secretary of Defense for Gulf War Illnessees.
Annual Report, November 1996 - November 1997. Washington, DC: Department of
Defense, 1997.
10. Report of the Defense Science Board Task Force on Persian Gulf War Health Effects.
Washington, DC: Office of the Under Secretary of Defense for Acquisition and
Technology, 1994.
11. Presidential Advisory Committee on Gulf War Veterans' Illnesses. Interim Report,
February 1996. Washington, DC: US Government Printing Office, 1996.
12. Committee on a National Center on War-Related Illnesses and Postdeployment Health
Issues IoM. National Center for Military Deployment Health Research. In: Hernandez L,
Liverman C, Greenlick M, eds. Washington, DC: National Academy Press, 1999.
13. Committee on Measuring the Health of Gulf War Veterans IoM. Gulf War Veterans:
Measuring Health. In: Hernandez L, Durch J, Blazer II D, Hoverman I, eds. Washington,
DC: National Academy Press, 1999.
14. Institute of Medicine. Veterans at Risk: The Health Effects of Mustard Gas and Lewisite.
In: Pechura C, Rall D, eds. Washington, DC: National Academy Press, 1993.
15. Institute of Medicine. Health Consequences of Service During the Persian Gulf War: Initial
Findings and Recommendations for Immediate Action. Washington, DC: National
Academy Press, 1995.
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Evaluation Program: Nerve Agents. Washington, DC: National Academy Press, 1997.
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Effects of the Kuwait Oil Well Fires. Washington, DC: United States General Accounting
Office, 1992.
United States General Accounting Office. Operation Desert Storm: DoD Met Need for
Chemical Suits and Masks, But Longer Term Actions Are Needed. Washington, DC:
United States General Accounting Office, 1992.
United States General Accounting Office. Operation Desert Storm: Improvements
Required in the Navy's Wartime Medical Care Program. Washington, DC: United States
General Accounting Office, 1993.
United States General Accounting Office. Operation Desert Storm: Potential for
Reproductive Dysfuction Is Not Being Adequately Monitored. Washington, DC: United
States General Accounting Office, 1994.
United States General Accounting Office. Operation Desert Storm: Questions on Possible
Exposure to Reproductive Toxicants. : GAO; 1994. Washington, DC: US General
Accounting Office, 1994.
United States General Accounting Office. Operation Desert Storm: Health Concerns of
Selected Indiana Persian Gulf War Veterans. Washington, DC: United States General
Accounting Office, 1995.
United States General Accounting Office. Foreign Assistance: Contributions to Child
Survival Are Significant, But Challenges Remain. Washington, DC: US General
Accounting Office, 1996.
United States General Accounting Office. Defense Health Care: Medical Surveillance
Improved Since Gulf War, But Mixed Results in Bosnia. Washington, DC: United States
General Accounting Office, 1997.
United States General Accounting Office. Gulf War Illnesses: Improved Monitoring of
Clinical Progress and Reexamination of Research Emphasis Are Needed. Washington, DC:
United States General Accounting Office, 1997.
United States General Accounting Office. Operation Desert Storm: Evaluation of the Air
Campaign. Washington, DC: United States General Accounting Office, 1997.
United States General Accounting Office. Gulf War Illness: Public and Private Efforts
Relating to Exposures of U.S. Personnel to Chemical Agents. Washington, DC: United
States General Accounting Office, 1997.
United States General Accounting Office. Gulf War Veterans: Incidence of Tumors Cannot
Be Reliably Determined from Available Data. Washington, DC: United States General
Accounting Office, 1998.
United States. Congress. House. Committee on Government Reform and Oversight.
Subcommittee on Human Resources. The status of efforts to identify Persian Gulf War
syndrome : recent GAO findings : hearing before the Subcommittee on Human Resources
of the Committee on Government Reform and Oversight, House of Representatives, One
Hundred Fifth Congress, first session, June 24, 1997. Washington: U.S. G.P.O. : For sale
by the U.S. G.P.O. Supt. of Docs. Congressional Sales Office, 1997:iii, 97.
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Washington, DC: Presidential Special Oversight Board for Department of Defense
Investigations of Gulf War Chemical and Biological Incidents, 1999.
Richter P. Clinton to form oversight panel on Gulf War illnesses. Los Angeles Times. Los
Angeles, CA, 1997.
Joseph S, The Comprehensive Clinical Evaluation Program Evaluation Team. A
comprehensive clinical evaluation of 20,000 Persian Gulf War veterans. Mil Med 1997;
162:149-155.
Coker WJ, Bhatt BM, Blatchley NF, Graham JT. Clinical findings for the first 1000 Gulf
war veterans in the Ministry of Defence's medical assessment programme. Bmj 1999;
318:290-4.
Pollet C, Natelson BH, Lange G, et al. Medical evaluation of Persian Gulf veterans with
fatigue and/or chemical sensitivity. J Med 1998; 29:101-13.
Henry L, Gray G. Topical Bibliography of Published Works Regarding the Health of
Veterans of the Persian Gulf War. San Diego: Naval Health Research Center, 1999.
Helmkamp JC. Epidemiological characteristics of US fatalities during Desert Storm. Mil
Med 1992; 157:A7.
Writer JV, DeFraites RF, Brundage JF. Comparative mortality among US military
personnel in the Persian Gulf region and worldwide during Operations Desert Shield and
Desert Storm. JAMA 1996; 275:118-121.
Kang HK, Bullman T. Mortality among US veterans of the Persian Gulf War. N Engl J
Med 1996; 335:1498-1504.
Gray G, Coate B, Anderson C, et al. The postwar hospitalization experience of US veterans
of the Persian Gulf War. The New England Journal of Medicine 1996; 335:1505-1513.
Knoke JD, Gray GC. Hospitalizations for unexplained illnesses among US Persian Gulf
War veterans. Emerging Infectious Diseases 1998; 4:211-219.
Knoke JD, Gray GC, Garland FC. Testicular cancer and Persian Gulf War service.
Epidemiology 1998; 9:648-653.
Gray G, Smith T, Knoke J, Heller J. The postwar hospitalization experience of Gulf War
veterans possibly exposed to chemical munitions destruction at Khamisiyah, Iraq. Amer J
Epidemiol 1999; 150:532-540.
Gray GC, Smith TC, Kang HK, Knoke JD. Are Gulf War veterans suffering war-related
illnesses? Federal and civilian hospitalizations examined, June 1991 to December 1994.
Am J Epidemiol 2000; 151:63-71.
The Iowa Persian Gulf Study Group. Self-reported illness and health status among Persian
Gulf War veterans: a population-based study. JAMA 1997; 277:238-245.
Gray GC, Kaiser KS, Hawksworth AW, Hall FW, Barrett-Connor E. Increased postwar
symptoms and psychological morbidity among U.S. Navy Gulf War veterans. Am J Trop
Med Hyg 1999; 60:758-66.
Fukuda K, Nisenbaum R, Stewart G, et al. Chronic multisymptom illness affecting Air
Force veterans of the Gulf War. JAMA 1998; 280:981-988.
Unwin C, Blatchley N, Coker W, et al. The health of United Kingdom servicemen who
served in the Persian Gulf War. Lancet 1999; 353:169-78.
Goss Gilroy Inc. Health study of Canadian forces personnel involved in the 1991 conflict in
the Persian Gulf Vol I. Ottawa, Ontario: Gos Gilroy Inc., 1998.
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Haley RW, Kurt TL, Hom J. Is there a Gulf War syndrome? Searching for syndromes by
factor analysis of symptoms. JAMA 1997; 277:215-222.
Ismail K, Everitt B, Blatchley N, et al. Is there a Gulf War syndrome? Lancet 1999;
353:179-82.
Nisenbaum R, Reyes M, Mawle AC, Reeves WC. Factor analysis of unexplained severe
fatigue and interrelated symptoms: overlap with criteria for chronic fatigue syndrome. Am
J Epidemiol 1998; 148:72-7.
Knoke J, Smith T, Gray G, Kaiser K, Hawksworth A. Factor analysis of self-reported
symptoms: Does it identify a Gulf War syndrome? Amer J Epidemiol, in press. 2000.
Penman AD, Tarver RS, Currier MM. No evidence of increase in birth defects and health
problems among children born to Persian Gulf War veterans in Mississippi. Mil Med 1996;
161:1-6.
Cowan DN, DeFraites RF, Gray GC, Goldenbaum MB, Wishik SM. The risk of birth
defects among children of Persian Gulf War veterans. N Engl J Med 1997; 336:1650-1656.
Araneta M, Kamens D, Gastanaga V, et al. Reproductive and Perinatal Outcomes Among
Conceptions and Pregnancies during the Persian Gulf War., Conference on Federally
Sponsored Gulf War Veterans' Illnesses Research, June 17-19, Arlington, Virginia., 1998.
Araneta MR, Moore CA, Olney RS, et al. Goldenhar syndrome among infants born in
military hospitals to Gulf War veterans. Teratology 1997; 56:244-251.
Hyams KC, Wignall FS. Identification of Gulf War syndrome: methodological issues and
medical illnesses. JAMA 1997; 278:384.
Hyams KC, Roswell RH. Resolving the Gulf War syndrome question. Am J Epidemiol
1998; 148:339-42.
Nicolson GL, Nicolson NL. Mycoplasmal infections--diagnosis and treatment of Gulf War
illness/CFIDS. Int J Occup Med Immunol Tox 1996; 9:66-69.
Nicolson GL, Rosenberg-Nicolson NL. Doxycycline treatment and Desert Storm. JAMA
1995; 273:618-619.
Nicolson GL, Nicolson NL. The eight myths of Operation "Desert Storm" and Gulf War
syndrome. Med Confl Surviv 1997; 13:140-146.
Golomb B. A review of the scientific literature as it pertains to Gulf War illnesses. Vol 2
Pyridostigmine bromide. Washington, DC: National Defense Research Institute, Rand,
1999.
Kaiser K, Hawksworth A, Gray G. Pyridostigmine bromide intake during the Persian Gulf
War not associated with postwar handgrip strength,. Mil Med, in press 2000.
Bell IR, Warg-Damiani L, Baldwin CM, Walsh ME, Schwartz GEW. Self-reported
chemical sensitivity and wartime chemical exposures in Gulf War veterans with and
without decreased global health ratings. Mil Med 1998; 163:725-732.
Study cites danger from Gulf War depleted uranium. Associated Press, 1998.
Hafemeister R. Sand linked to Gulf War syndrome. Tampa (FL) Tribune. Tampa, 1999.
Foster S. Vaccine Role Cited in Gulf War Illness. Vol. 1999: World Net Daily, 1999.
Executive Order of the President. A National Obligation: Planning for Health preparedness
for and Readjustment of the Military, Veterans, and their Families After Future
Deployments. Presidential Review Directive 5. Washington, DC: Executive Order of the
President,, 1998.
Brundage JF. Military preventive medicine and medical surveillance in the post-cold war
era. Mil Med 1998; 163:272-7.
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Medical Surveillance for Deployments.: Department of Defense, 1997.
Rostker B. DoD not ignoring issue. USA Today. Arlington, VA, 1996:14A.
Department of Veterans Affairs. Annual Report to Congress: Federally Sponsored
Research on Persian Gulf Veterans' Illnesses for 1997. Washington, DC: Department of
Veterans Affairs, The Research Working Group of the Persian Gulf Veterans Coordinating
Board, 1998.
McHorney CA, Ware JE, Jr., Raczek AE. The MOS 36-Item Short-Form Health Survey
(SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental
health constructs. Med Care 1993; 31:247-63.
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mental disorders in primary care. The PRIME-MD 1000 study (see comments). Jama 1994;
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conceptual framework and item selection. Med Care 1992; 30:473-483.
Smith T, Gray G, Knoke J. Is systemic lupus erythematosus, amyotrophic lateral sclerosis,
or fibromyalgia associated with Persian Gulf War service? An examination of Department
of Defense hospitalization data. Amer J Epidemiol, in press. 2000.
Ballou RW, Ohl CA. Viscerotropic Leishmaniasis in Returnees From Operation Desert
Shield/Storm. Chester, MD: Armed Forces Epidemiological Board, Parson's Island, 1992.
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Communications of Air Force Ranch Hand Study Data and Results. Washington, DC:
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APPENDIX D.
NONTECHNICAL SYNOPSIS
The Millennium Cohort Study is a probability-based, cross-sectional sample of 100,000 military
personnel (as of October 2000) who will be followed prospectively by postal surveys with
options of on-line completion every 3 years over a 21-year period. The 100,000 persons will be
composed of 30,000 veterans who have been deployed to Southwest Asia, Bosnia, or Kosovo
since August 1997, and 70,000 veterans who have not been deployed to these conflicts. In
October 2004 and October 2007, 20,000 new military personnel will be added to the cohort. The
total of 140,000 veterans will be followed until the year 2022.
The primary objective of this study is to compare change in health status between deployed and
nondeployed personnel and the adjusted incidence rates of chronic disease between cohorts.
Secondary objectives include comparing the adjusted change in health between the cohorts as
reflected by Short Form-36 Questions/Veterans Health Survey scores and the Patient Health
Questionnaire diagnostic assessment.
This study will serve as a foundation upon which other routinely captured medical and
deployment data may be added to answer future military questions regarding the health risks of
military deployments, military occupations, and general military service.
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APPENDIX E.
RECORD OF CHANGES TO THE PROTOCOL CONTINUED
Continuing Review 2015:
We respectfully request review of the proposed subject communications; these are within
the number of contacts previously approved by the IRB.
1. Millennium Cohort Family Study targeted letters; 7 versions for specific sub-groups
Millennium Cohort Family Study Non-responder letter
Millennium Cohort Family Study Non-responder with Panel 4 Responder letter
Millennium Cohort Family Study Male Non-responder letter
Millennium Cohort Family Study Dual-military Non-responder letter
Millennium Cohort Family Study Reserve/Guard Non-responder letter
Millennium Cohort Family Study Non-responder with children letter
Millennium Cohort Family Study Widowed Non-responder letter
2. Millennium Cohort Family Study targeted emails; 7 versions for specific sub-groups
Millennium Cohort Family Study Non-responder email
Millennium Cohort Family Study Non-responder with Panel 4 Responder email
Millennium Cohort Family Study Male Non-responder email
Millennium Cohort Family Study Dual-military Non-responder email
Millennium Cohort Family Study Reserve/Guard Non-responder email
Millennium Cohort Family Study Non-responder with children email
Millennium Cohort Family Study Widowed Non-responder email
3. Millennium Cohort Family Study Month of the Military Child postcard; 2 versions
Millennium Cohort Family Study Month of the Military Child Non-responder
postcard
Millennium Cohort Family Study Month of the Military Child Responder postcard
4. Millennium Cohort Family Study Month of the Military Child Non-responder email
5. Millennium Cohort Family Study Non-responder phone call pilot test procedure and
script
January 26, 2015
This protocol has undergone a change of staff; therefore, we respectfully request approval
to remove Martin White, Toni Rush and Lawrence Wang from the study as they are no
longer affiliated with NHRC as well as add Danielle Mitchell and Kathleen Gunn as key
personnel. Their roles are outlined below.
Danielle Mitchell will be located at the Naval Health Research Center and will serve as
key support staff as a Research Assistant. As a Research Assistant she will assist in the
preparation of technical research reports, summaries, literature reviews, and scholarly
presentations and/or publications as well as maintain clear and accurate research records,
inventories, logbooks, and standard operating procedures. She will also assist with data
collection, data entry, and data clean-up for research project.
Kathleen Gunn will be located at the Naval Health Research Center and will serve as key
support staff as a Research Intern. As a research Intern she will collect and organize
survey data and forms for research projects. In addition, her duties as an intern are to
scan and verify survey data, perform data entry, literature searches, and assist with
maintenance of databases for research projects.
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In addition we provided clarification within the study protocol that database linkages
which are accessed electronically through secure computers located at the Naval Health
Research Center using unique identifiers such SIDs or via the participant’s name and
SSN are performed under both the Millennium and Family Cohort and is only done when
appropriate agreements/approvals are in place prior to any data sharing.
Along with the above-mentioned modifications, we have identified subject matter experts
from the Institute for Measurement, Methodology, Analysis and Policy (IMMAP) at
Texas Tech University to assist us in meeting the OMB requirement to provide an
approach to handle missing data and adjustments for selective attrition. Faculty and
scientific staff of IMMAP will be provided with de-identified data under federal
regulations before being transferred. A subcontract between NHRC/Henry Jackson
Foundation and Texas Tech will be in place before any data analysis is performed. The
Naval Health Research Center’s IRB will serve as the primary IRB.
Also, included for IRB review and approval are the next set of emails/mailings to be sent
to the study population. These mailing are within the permissible number of contacts (See
Appendix K and L).
•
•
•
•
Incomplete reminder – sent to those MilCo and Family participants that have logged
into the web survey, but have not completed
Graphic Postcard – 3 versions: Active Duty Non-responder, Separated Nonresponder, and Incomplete (MilCo participants that have logged into the web survey,
but have not completed)
Reminder email – 2 versions: Panel 4 non-responders whose Family Study spouse has
completed their survey, and one to all other non-responders
Endorsement letter – 2 versions: One including VADM Nathan’s endorsement, and
one including LTG Horoho’s endorsement.
We would also like to take this opportunity to notify the IRB that a new protocol will be
submitted shortly that encompasses the family cohort effort that has been part of this
protocol.
November 2014 Millennium Family Holiday Mailings and Staff Update) This
protocol has undergone a change of staff; therefore, we respectfully request approval to
remove Julia Schwartz from the study as she is no longer affiliated with NHRC. In
addition, we are submitting the following Millennium Cohort Family study mailings for
review:
1.
December reminder e-mail, thank you letter, holiday postcard and
postcard e-mail. The thank you letter mailing will include a five dollar gift
card to Starbucks, and will be sent to our early responders as a token of
appreciation for prompt response. The envelope will not have any
notation that a gift card is included nor will the contents of the mailing be
visible. These mailings and the two e-mails are within the permissible
number of contacts (See Appendix L).
October 2014 (Millennium Family Cohort Month of the Military Family and Staff
Update) This protocol has undergone a change of staff; therefore, we respectfully request
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approval to remove Alka Malhotra, PhD from the study as she is no longer affiliated with
NHRC. In addition, we are submitting the following Millennium Cohort Family study
mailings for review:
1. Month of the Military Family cover letter, the Month of the Military Family
envelopes, the Month of the Military Family e-mail, and the November reminder email. The Month of the Military Family mailing will include a five dollar gift card to
Starbucks as a pre-incentive. In order to understand the impact of using Priority Mail,
half of the participants will receive this mailing in a Priority Mail envelope, while the
other half will receive the mailing in a graphic envelope. Neither of the envelopes
will have any notation that an incentive is included nor will the contents of the
mailing be visible. This mailing and the two e-mails are within the permissible
number of contacts (see Appendix L).
October 2014 (Millennium Cohort Veterans Day Postcard/Follow-up
correspondence)
Millennium Cohort Study Veterans Day Postcard (2 versions responder and nonresponder), follow-up email, cover letter for the questionnaire, and endorsement letter
mailing (2 versions Army and Navy). These emails and mailings will be within the
permissible number of contacts.
October 2014 (Milco Study Extension/Family Mailing and Survey Skip Patterns
Update)
Submitted for IRB review was the extension of the Millennium Cohort study to 67 years:
2000/10/01 to 2067/09/30 (MOMRP memo attached).Millennium Cohort Family Study
follow-up email, sample survey cover letter, sample survey, and sample survey email.
These emails and mailings will be within the permissible number of contacts.
We have made one revision to the skip pattern included in the previously approved 2014
follow-up Family survey. The questions were not altered in any way. The only changes
made were to the title of the section and the skip pattern. The skip pattern outlined in the
previously approved survey originally only directed spouses of active duty Service
members to answer one section of the survey. This skip pattern has now been changed to
direct all participants, except those who select ‘Widowed’ as their marital status, to now
answer these questions.
September 2014 (Survey/Staff Update)
The Dual Military Families email which was cued for last submission did not get
included; therefore, a request to review the email under this submission made. The IRB
was reassured that this email contact is within the permissible number of contacts.
In addition, a change in staff occurred. Teresa Powell, MS has rejoined the Millennium
Cohort study team. She will be located at the Naval Health Research Center and will
serve as key support staff as a Biostatistician. Her duties will include assisting in
program design and maintenance of survey instruments alongside research team;
planning epidemiologic studies and designing the study methodology; performing
statistical analyses for diverse research projects with complex study designs; working
with team members to derive an in-depth understanding of the data findings; drafting
proposals and writing peer-reviewed publications.
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Along with the changes mentioned above, the surveys for both the Millennium and
Family Cohort Studies have been updated in preparation for the upcoming survey cycle.
For the Millennium Cohort Study, a combined document including all questions from the
paper and web survey versions was submitted for IRB review and approval. A clean copy
and another highlighted where changes have been made, in addition to a document
outlining the items that were deleted from the 2011 survey was included for the IRB’s
convenience. Please note that the variables are visible on the copy of the web based
survey provided but will not be visible to the participant once we receive IRB approval
and officially launch the survey.
For the Millennium Cohort Family Study, the web address and a created login for the
2014 web based Follow-up survey has been included. Included in this submission is a
document highlighting the questions that have been added to the 2014 survey, and a copy
of the 2011 Baseline survey with highlighted questions that have been removed from the
2014 Follow- Up survey. Please note that the Family study will only be utilizing the web
based survey this cycle, there will be no paper version of the 2014 Follow-Up survey.
Also, to get a sense of how the survey will be displayed to the participants and how the
participant will navigate the web based surveys, we have provided the links to both the
Millennium Cohort and Family Cohort surveys as well as established the following
pseudo Subject IDs for the IRB’s use. In order to allow maximum visibility of the
questions, the Family Subject ID was created as if the subject's Millennium Cohort Panel
4 spouse provided secondary consent at baseline. Therefore, this should allow the IRB to
see the section entitled 'Your Spouse's Behavior'. This section will only be viewed by
participants whose Panel 4 spouse provided secondary consent at baseline. Please note
the sites are not live and will not be made available to our participants until IRB approval
has been received.
https://devmilco2014.millenniumcohort.org/
Subject ID : 10001
Last 4: 9999
http://devfamily2014.millenniumcohort.org/
Subject ID: 10000
Last 4: 9999
We have also enclosed under this submission the OMB approval for the IRB’s records.
July 2014 (Staff/Mailings/Website)
This protocol has undergone a change of staff; therefore, we respectfully request approval
to remove Melissa Frasco, PhD and Evelyn Davila, PhD, MPH as their employment as
contractors for NHRC has ended and would like to add Alka Malhotra, PhD, Rudolph
Rull, PhD, Andrew Lin, Anna Bukowinski and Serguey Parkhomovsky. Their roles are
outlined below.
Duties and Responsibilities of new staff
Alka Malhotra, PhD, will be located at the Naval Health Research Center and will serve
as key support staff as an Epidemiologist. Duties will include planning epidemiologic
studies and designing the study methodology; performing statistical analyses for diverse
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research projects with complex study designs; working with team members to derive an
in-depth understanding of the data findings; drafting proposals and writing peer-reviewed
publications.
Rudolph Rull, PhD, will be located at the Naval Health Research Center and serve as key
support staff as a Data Analyst. Duties will include providing statistical and analytical
support for diverse research projects; assist in processing and maintenance of research
databases; assist in writing of reports and scientific manuscripts for peer-reviewed
professional journals and presentations.
Anna Bukowinski and Andrew Lin, will be located at the Naval Health Research Center
and will serve as key support staff as Data Managers. As data managers, Ms. Bukowinski
and Mr. Lin will be responsible for processing and managing data and related programs.
Serguey Parkhomovsky will be located at the Naval Health Research Center and will
serve as key support staff as a database programmer. As the database programmer, Mr.
Parkhomovsky will be responsible for creating and maintaining the study database.
Millennium Cohort Study
Also, because we were alerted that some of our official study emails are being delivered
to junk or spam folders, along with the staff update we respectfully request a review and
approval of the attached spam email. This email was developed with the intent to alert
our participants of this possibility so they can make the necessary adjustments allowing
our emails to reach their inbox.
Millennium Family Cohort Study
Along with the above-mentioned documents, we have made revision to the previously
approved Millennium Family Cohort participant mailings and have attached a copy for
IRB review and approval as well as images of the lunch bag pre-incentive and card insert
and provided its text and the follow-up email text.
Millennium Cohort and Family Cohort
In addition we have included in this submission is a PDF version of the updated study
websites for both the Millennium Cohort and Family Cohort studies. The websites
contents differ tremendously from the already/live websites. The updates include recent
briefings, press, publications, mailings, study findings and information regarding the
upcoming survey cycle. Both websites were modified to enhance usability and improve
site navigation.
The following are links that will allow you to peruse the website (please note the sites are
not live and will not be made available to our participants until IRB approval has been
received).
http://devnewmilco.millenniumcohort.org/
http://devnewfamily.familycohort.org/
July 2014 (Staff/Family Mailings)
This protocol has undergone a change of staff; therefore, we respectfully request the
review and approval to add Christopher O’Malley, Julia Schwartz, Anet Petroysan,
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Madeline Cross and Navjot Kaur. Their roles are outlined below and their training
certificates (CITI and HIPAA) are being submitted at this time.
Duties and Responsibilities of new staff
Dr. Dennis Faix the current Principal Investigator (PI), will relinquish his role as PI to Dr.
David Luxton who recently accepted the Millennium Cohort Study Principal Investigator
position. Dr. Luxton will be responsible to NHRC’s IRB, and to the various external
review bodies for the financial accounting and scientific merit of the study. He will also
be responsible for ensuring that all NHRC personnel involved with this protocol are
properly trained and qualified. Dr. Dennis Faix, will remain on the protocol as a coinvestigator. His experience with epidemiological studies and the previous Millennium
Cohort PI will lend much to the investigation team in form of background knowledge.
Christopher O’Malley, MPH, will be located at the Naval Health Research Center and
serve a key support staff as a Data Analyst. Duties will include providing statistical and
analytical support for diverse research projects; assist in processing and maintenance of
research databases; assist in writing of reports and scientific manuscripts for peerreviewed professional journals and presentations.
Julia Schwartz, will be located at the Naval Health Research Center and will serve as key
support staff as a Research Assistant. As a Research Assistant she will assist in the
preparation of technical research reports, summaries, literature reviews, and scholarly
presentations and/or publications as well as maintain clear and accurate research records,
inventories, logbooks, and standard operating procedures. She will also assist with data
collection, data entry, and data clean-up for research project.
Anet Petroysan will be located at the Naval Health Research Center and will serve as key
support staff as a Research Assistant. As a Research Assistant she will assist in the
preparation of technical research reports, summaries, literature reviews, and scholarly
presentations and/or publications as well as maintain clear and accurate research records,
inventories, logbooks, and standard operating procedures. She will also assist with data
collection, data entry, and data clean-up for research project.
Madeline Cross and Navjot Kaur will be located at the Naval Health Research Center and
will serve as key support staff as a Research Interns. As a research Interns they will
collect and organize survey data and forms for research projects. In addition, their duties
as an intern are to scan and verify survey data, perform data entry, literature searches, and
assist with maintenance of databases for research projects.
Millennium Family Cohort Study
Along with the above-mentioned modification the attached Millennium Family Cohort
Study mailings are being submitted for review and approval. These mailings are within
the IRB’s protocol's approved allowable contacts.
May 2014 (Staff/Family Collaboration/Mailings/Incentives)
This protocol has undergone a change of staff; therefore, we respectfully request the
review and approval of the following modification to the protocol:
•
To remove Isabel Jacobson, MPH and Raechel Del Rosario, MPH as they have
resigned and their employment with NHRC has ceased. In addition, to the above staff
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modification, we respectfully request permission to modify the Millennium Cohort
Family study to include the following six primary aims that include objectives and
specific study questions:
•
•
•
•
•
•
Explore the association between service member deployment (e.g. combat, duration,
dwell time, and frequency) and the health and well-being of spouses and children.
Explore the association between service member readjustment issues (e.g., PTSD,
anxiety, depression, alcohol misuse/abuse) and the health and well-being of spouses
and children.
Examine factors related to resiliency and vulnerability that moderate the association
between deployment experiences and service member readjustment issues, and the
health and well-being of spouses and children.
Examine factors related to marital quality and family function.
Evaluate methodological approaches to ensure adequate representation of spouses
from all service branches, Reserve and National Guard; and assess validity of
assessment measures and instruments.
Contribute data to the service member cohort study on spouse and child factors that
are associated with service member health and well-being, as well as length of
service.
We will collaborate with Abt Associates and their subcontractors Duke University
(Duke) and New York University (NYU) to accomplish these objectives. NHRC will not
transfer any data involving names, dates (including dates of birth), social security
numbers, or any contact information to Abt Associates. Proposals will be written for
each proposed analysis using the Family Study data containing a list of required data
elements and investigators which will be provided to the IRB at the study’s annual review
or at the time of development should any data requirements and/or aims fall outside those
presented under this modification. Data transfers will only occur through secure means
using password-protected encrypted files. The data provided by NHRC to the Abt
Associates team is restricted to the minimum necessary to complete the approved Family
sub-studies and access to these data will be limited to a minimum number of individuals
necessary at each institution to achieve the purpose. Data will be stored in a manner
consistent with Federal and DoD regulations and data security best practices.
Millennium Cohort Study
Along with the above-mentioned modifications the following Millennium Cohort Study
mailings are being submitted for review and approval. These mailings are within the
IRB’s protocol's approved allowable contacts.
The postal mailer text and email text for the upcoming survey cycle have been included
review under Appendix K. The timeframe listed for each item is approximate, and may
be adjusted due to survey operation logistical reasons.
As part of the Millennium Cohort’s mailing, in order to understand the impact of
including cash as a pre-incentive on the study population, we request permission to send
a letter to all participants in panels 1-4 (3a and 3b mailings) which will include one of
five versions of a randomly assigned pre-incentive:
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•
•
•
•
•
Group one will receive a cash pre-incentive in the form of either two, one dollar bills,
or a two dollar bill
Group two will receive an equivalent material gift (magnet)
Group three will receive only the invitation card - no cash or gift card included
Group four will receive a five dollar gift card
Group five will be put into a drawing. For every 500 survey responses received from
participants included in this group, 1 participant will be randomly selected to receive
an iPad or its equivalent. The drawing will be completed using computerized random
selection from the database of eligible participants who return their completed survey
within the specified timeframe.
Please note: The envelopes will not have any notation that an incentive is included
nor will any of these mailings be sent using an envelope where the contents are
visible. The Millennium Cohort mailings for Phase 1are scheduled to launch
June/July 2014: The following provides the IRB with an outline of the timelines
proposed.
1. Pre-notice letter with key study findings graphic insert (week 1)
a. Active Duty
b. Separated/Retired
2. Pre-notice email: (week 3)
3. Card (week 8)
a. NOT LINKED to Family participant
b. LINKED to Family participant
4. Email (week 9)
a. Active Duty NOT LINKED to Family participant
b. Separated/Retired NOT LINKED to Family participant
c. Active Duty LINKED to Family participant
d. Separated/Retired LINKED to Family participant
In addition, we have included the Millennium Cohort Family mailing scheduled to be
mailed within the first couple weeks of June for IRB review.
April 2014
• For the Millennium Cohort Study, the Memorial Day Postcard and email text was
submitted for IRB review and approval. The postcards/emails will be sent to
Millennium Cohort participants and fall within the protocol's approved number of
contacts allowed during a survey cycle.
February 2014
• Mr. Martin White will no longer serve as interim Principal Investigator on this
protocol, due to the arrival of the Department Head, CDR Dennis Faix. CDR Faix
will now serve as the Principal Investigator for this protocol. Updated HIPAA and
CITI documents will be provided to Ms. Kathy Snell.
•
In order to obtain some data from non-responders towards the end of the survey
cycle, we are seeking to use a 4-page short survey as the last postal item for the
Millennium Cohort Study. There will be two versions of the short survey, one for
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Active Duty participants and one for retired/separated participants, which will only
contain a few core questions. The two versions of the MilCo short surveys are
submitted for review.
•
Samples of postal mailer text and email text for the upcoming survey cycle are
included for review. The timeframe listed for each item is approximate, and may be
adjusted due to survey operation logistical reasons. Artwork for additional items will
be submitted for review as it is created.
•
The Report Control Symbol (RCS: DoD RCS#DD-HA(AR)2106 ) expires 31 March
2014. Approval is still pending and will be submitted to NHRC IRB once obtained.
•
Office of Management and Budget (OMB #0720-0029) expires 31 March 2014. The
2014 survey instruments for both MilCo and Family were submitted for OMB review
in November 2012. Approval is still pending and will be submitted to NHRC IRB
once obtained.
•
Because OMB and DoD approvals for surveys are still pending, finalized surveys will
be submitted for IRB review after those approvals are obtained. Please note that
during the next survey cycle no recruitment will be done—only follow-up will be
done at this point. Also, under this continuing review submission because this study
has undergone further staff changes we are seeking IRB approval to modifying the
protocol removing LTCOL Nisara Granado, LCDR Kendall Egan, Ms. Andrea
Ippolito and Emma Schaller as well as Mr. James Whitmer from the protocol as they
no longer work for the DoD Center for Deployment Health Research. Along with the
removal of the above mentioned key personnel, we would like approval to add Drs.
Hector Lemus, Amy Bell and Ben Porter as well as Lawrence Wang and Lauren
Kearney. Their roles are outlined below and their training certificates (CITI and
HIPAA) are being submitted at this time.
Duties and Responsibilities of new staff
Hector Lemus, DrPh will be located at the Naval Health Research Center and will
serve as key support personnel and co-investigator as a Biostatistician. Duties will
include assisting in program design and maintenance of survey instruments alongside
research team; planning epidemiologic studies and designing the study methodology;
performing statistical analyses for diverse research projects with complex study
designs; working with team members to derive an in-depth understanding of the data
findings; drafting proposals and writing peer-reviewed publications.
Amy Millikan Bell, MD, MPH, manager of the Behavioral and Social Health
Outcomes Program (BSHOP) for the Army Institute of Public Health, U.S. Army
Public Health Command., has been added to the study team/protocol as a consultant
in which she will participate in the interpretation of the data analyses, and the drafting
and publishing of manuscripts. In her role, Dr. Bell will not have access to
identifiable data.
Ben Porter, PhD, will be located at the Naval Health Research Center and will serve
as key support personnel and co-investigator as a Biostatistician. Duties will include
assisting in program design and maintenance of survey instruments alongside
research team; planning epidemiologic studies and designing the study methodology;
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performing statistical analyses for diverse research projects with complex study
designs; working with team members to derive an in-depth understanding of the data
findings; drafting proposals and writing peer reviewed publications.
Lauren Kearney, MPH, will be located at the Naval Health Research Center and
serve a key support staff as a Data Analyst. Duties will include providing statistical
and analytical support for diverse research projects; assist in processing and
maintenance of research databases; assist in writing of reports and scientific
manuscripts for peer-reviewed professional journals and presentations.
Lawrence Wang, MPH, will be located at the Naval Health Research Center and
serve as key support staff as a Data Analyst. Duties will include providing statistical
and analytical support for diverse research projects; assist in processing and
maintenance of research databases; assist in writing of reports and scientific
manuscripts for peer-reviewed professional journals and presentations.
October 2013
This protocol has undergone staff changes. LTCOL Nisara Granado, MPH, PhD has
been added as new key support personnel.
October 2013
Prior to the submission of this study protocol modification, the Millennium Cohort Study
team sought and received permission from the Institutional Review Board Chairman, Mr.
Jay Heaney to implement the following “Document retention/Shredding” Policy.
Document Retention/Shredding Policy:
All Millennium Cohort paper surveys will be digitized and a permanent electronic copy
will be maintained. After a minimum 3 years of storage, the survey portion will be
securely destroyed by a shredding company performing on-site service. Paper consent
pages will NOT be destroyed. The paper consent will be removed from the survey, stored
separately, and retained permanently in a secured location.
In addition, this protocol has undergone staff changes. Mr. John Wesner no longer works
for the DoD Center for Deployment Health Research and Valerie Stander, PhD has been
added as new key support personnel.
Duties and Responsibilities of new staff
Valerie Stander, PhD, will be located at the Naval Health Research Center and serve as
key support staff as an Epidemiologist. Duties will include planning epidemiologic
studies and designing the study methodology; performing statistical analyses for diverse
research projects with complex study designs; working with team members to derive an
in-depth understanding of the data findings; drafting proposals and writing peer-reviewed
publications.
Along with the above-mentioned modifications, the Millennium Cohort Veteran’s Day
postcard as well as the National Military Family Month” postcard for the Family study
are being submitted for review and approval (Appendix K and L). The postcards will be
sent within the protocol's approved contacts via an email.
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September 2013
This protocol has undergone a change of staff. Dr. Crum-Cianflone has resigned,
therefore, Martin White, MPH will assume the role of Principle Investigator. In addition
Ms. Michelle Linfesty, Jaime Horton, Teresa Powell, and Amber Seelig no longer work
for the DoD Center for Deployment Health Research. Laura Tobin has been added as
new key support personnel. The training certificates (CITI and HIPAA) for Martin White
and Laura Tobin are being submitted at this time.
Please note that the informed consent(s) for this study provides the participant with an
email and phone number that is sent to the PI of the study if the participant has
questions or wishes to end their participation; therefore no change to the informed
consent is required.
Duties and Responsibilities of new staff
Martin White, MPH, will serve as a Principal Investigator for this study. He will be
responsible to NHRC’s IRB, and to the various external review bodies for the financial
accounting and scientific merit of the study. He will also be responsible for ensuring that
all NHRC personnel involved with this protocol are properly trained and qualified
Laura Tobin will be located at the Naval Health Research Center and will serve as key
support staff as a Research Intern. As a research Intern she will collect and organize
survey data and forms for research projects. In addition, her duties as an intern are to
scan and verify survey data, perform data entry, literature searches, and assist with
maintenance of databases for research projects.
•
We request permission to create an organization page on the Facebook platform as
well as a Millennium Cohort Study Facebook application. Participants will be sent an
email with a link to be able to "Like" the Millennium Cohort Organization page. The
link to our Facebook page may also be included on our webpage and in some of the
study materials sent as part of the routine mailings (these will be submitted prior to
mailing). Millennium Cohort Study administrators will post links on the Facebook
page about recent study findings and provide updates on survey cycles. We will
restrict posting on the Facebook page to only authorized users, in this case it would be
the Millennium Cohort Study team. The linkage will only be used to send information
about the survey and its findings to individuals who “Like” the Millennium Cohort
Organization page; no collection of information about the individuals “liking”
Millennium Cohort will be accessed, collected, or maintained Individuals “liking” the
Millennium Cohort Organization page will be reminded that they can “Edit Privacy”
on each site they like to limit those who can see their “likes.”
The communications described above will also include a link for those interested in the
Facebook application. To use the application, the participant must provide consent after
reading a disclosure statement (a standard feature for getting an app on Facebook).
Authorized users (i.e., Millennium Cohort investigators) can control the information
shown in the application, and therefore we can ensure privacy in the application itself by
never exposing personal information/details of individual members. Similar to ‘liking’
the Millennium Cohort Facebook Page, visibility of a specific user as having added the
Millennium Cohort application is based on their privacy settings. This information is
generally not available to the public unless the user allows for it.
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The Facebook application will be hosted at the same secure co-location center as the
Millennium Cohort web surveys. The application will be used to send participants study
information. We will not collect any data from their profile. The Facebook page and
application are voluntary features and a person can cancel their consent or involvement
with the Facebook site at any time. When a user removes the app from their profile, we
are sent a de-authentication notice and at that time we can remove their data from our
server ( the user ID and information is no longer given to the application). Both the
application and organization page are still under development, but a few screen shots are
enclosed for review. Screen shots of both items in their entirety will be sent for IRB
review once constructed.
Also for the Millennium Cohort Study, similar to that for the Family Study, we are
seeking permission to call those participants who completed the paper survey, but failed
to sign the informed consent form in the survey document. These phone calls will be the
last contact attempt during the cycle in attempt to have the subject provide consent, and
hence for the study team to utilize their survey data. Approximately 460 participants will
be called. Those who did not sign the consent and who did not complete at least 75% of
the survey will not be contacted, rather they will simply be excluded from the study.
Subjects will be contacted via telephone Monday through Friday between the hours of 8
am to 8 pm within their time zone, and/or Saturday between 10 am to 6 pm in their time
zone. No calls will be made on Sundays. A maximum of 5 phone call attempts will be
made per subject and a log of every attempt will be kept. Staff making phone calls will
not leave a voice message on the first four attempts and only then would leave a message
on the fifth attempt. A verbal “yes” or “no” reply will be accepted as the subject’s
consent and documented by caller who will be a member of the study team. If the subject
responds with a “no”, they will no longer be contacted and their survey data will not be
utilized. Calls will end once the 5 call limit occurs or we are able to reach the participant
in person, whichever occurs first. All participants who agree to consent to the study will
be offered a copy of the consent form which will be mailed to them.
A log of all of the phone calls will also be kept. A copy of the log is also submitted for
review.
The script for the phone calls is as follows:
Hi (interviewee name):
My name is (caller name), and I am calling from the Naval Health Research Center. We
appreciate the time you spent completing our survey on (Date) for the Millennium Cohort
Study which is being conducted by the Department of Defense.
When we reviewed your survey, we noticed that you did not sign the consent form on the
2nd page of the survey. In order to use your data for our study, we would need to have
your consent to participate in the study. Will you give your consent for participation?
If the subject responds yes:
Thank you. We will document your response. We know your time is valuable and we
thank you for helping with this important project. We would be happy to send you a
copy of the study’s consent to your home address? Would you like a copy? If yes,
(confirm address).
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If the subject responds no:
Thank you. We will document your response. Unfortunately, we will not be able to use
the information you gave us in the survey you completed. Thank you for your time.
1.
Millennium Cohort Organization page:
2. Main page of Facebook App:
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July 2013
• With respect to our June 12, 2013 modification request; we appreciate the IRB’s review
and consideration however, based on the comments, we would like to withdraw our June
12, 2013 submission and resubmit for review once we have adequately researched the
IRB’s concerns and obtain science signoff. In addition to our withdraw request, we
respectfully request review of the following drug data use and family modification:
Recently, we obtained IRB approval to investigate the prevalence and types of illicit drug
use as detected by DoD mandatory drug screens among Army active duty members
within the Millennium Cohort Study. The Army has a direct interest in better
understanding the risk factors for illicit drug use within their service branch and the
recent IOM report has highlighted the need for further research in this area.
After IRB approval, we received the following data from the office that maintains drug
screen results for the Army. Of a total of 89,303 Army participants, 77,861 had at least
one drug test performed in the databank, and 2,844 had a positive drug screen. This is
3.7% of participants screened positive during their service time. The most common
drugs were THC, cocaine, and amphetamines/methamphetamines.
Given the adequacy of the sample size, we wish to now request obtaining individual data
on drug test positivity among this group. A DUA will be signed between NHRC and the
Army Center for Substance Abuse Programs' (ACSAP) Drug and Alcohol Management
Information System (DAMIS). Similar to the last request, we propose to create an
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encrypted password protected disk, and send it to the DAMIS program manager, Mr.
Michael Biggerstaff (ACSAP), Building 1467, Fort Knox, KY 40121. In return, we will
be provided with the date and the result of the test for our Army Cohort members via an
encrypted CDROM that will also be sent to our site via FedEx. Upon arrival, the data
would securely be stored on our in-house computers and the SSN would be replaced with
the subject identification number for ensuring confidentiality. The original data file
provided to DAMIS will be destroyed in accordance with INFOSEC guidelines.
We will utilize this data to perform statistical analyses to examine if specific military
experiences increase the likelihood of a positive drug screen. Hypotheses will include
that deployments and combat experiences (traumatic events) increase the likelihood of
drug use and that injury relating from military service (e.g., leg amputation) increase the
likelihood of drug use.
Once all final projects are performed, the drug use data may be destroyed as advised by
the IRB.
•
For the Millennium Cohort Family Study, we are seeking permission to call those
participants who completed the paper survey, but failed to sign the informed consent
form in the survey document. These phone calls will be the last contact attempt during
the cycle in attempt to have the subject provide consent, and hence for the study team to
utilize their survey data. Approximately 100 participants will be called. Those who did
not sign the consent and who did not complete the majority of the survey will not be
contacted, rather they will simply be excluded from the study.
Subjects will be contacted via telephone during Monday through Friday between the
hours of 8 am to 8 pm within their time zone, and/or Saturday between 10 am to 6 pm in
their time zone. No calls will be made on Sundays. A maximum of 10 phone call
attempts will be made per subject and a log of every attempt will be kept. Staff making
phone calls will not leave a voice message. A verbal “yes” or “no” reply will be accepted
as the subject’s consent and documented by caller who will be a member of the study
team. If the subject responds with a “no”, they will no longer be contacted and their
survey data will not be utilized. Calls will end once the 10 call limit occurs or we are
able to reach the participant in person, whichever occurs first. All participants who agree
to consent to the study will be offered a copy of the consent form which will be mailed to
them.
The script for the phone calls is as follows:
Hi (interviewee name):
My name is (caller name), and I am calling from the Naval Health Research Center. We
appreciate the time you spent completing our survey on (Date) for the Family Study
which is being conducted by the Department of Defense.
When we reviewed your survey, we noticed that you did not sign the consent form on the
2nd page of the survey. In order to use your data for our study, we would need to have
your consent to participate in the study. Will you give your consent for participation?
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If the subject responds yes:
Thank you. We will document your response. We know your time is valuable and we
thank you for helping with this important project. We would be happy to send you a
copy of the study’s consent to your home address? Would you like a copy? If yes,
(confirm address).
If the subject responds no:
Thank you. We will document your response. Unfortunately, we will not be able to use
the information you gave us in the survey you completed. Thank you for your time. ]
June 2013
MODIFICATION WITHDRAWN—WILL RESUBMIT ONCE PRIVACY ISSUES CAN
BE INVESTIGATED AND PROPERLY ADDRESSED—SEE JULY MODIFICATION
BELOW FOR WITHDRAWAL NOTIFICATION
•
This protocol has undergone a change of staff. Ms. Jaime Horton no longer works for the
DoD Center for Deployment Health Research.
•
With the longitudinal design of the Millennium Cohort Study, we would like to utilize
new technologies to keep in contact with our participants and to provide those interested
with study updates (e.g., when the next survey cycle is starting). Therefore, we request
permission to create an organization page on the Facebook platform and a Millennium
Cohort Study Facebook application. Participants will be sent an email with a link to be
able to "Like" the Millennium Cohort Organization page which allows for posts on their
home feed. The link to our Facebook page may also be included in some of the study
materials sent as part of the routine mailings and these will be submitted prior to mailing.
Millennium Cohort Study administrators will post links on the Facebook page about
recent study findings and provide updates on survey cycles.
The communications described above will also include a link for those interested in the
Facebook application. Some of the benefits of accessing the Facebook application
include (1) a user experience more tailored for Millennium Cohort Participants, (2) the
ability to receive Facebook notifications of study updates, (3) access to Millennium
Cohort media and select survey statistics, and (4) streamlined survey tools that make
actions such as updating address and contact information easier. To use the application,
the participant must provide consent (a standard feature for getting an app on Facebook).
As part of this process, the Millennium Cohort Study team can also visualize their
Facebook public profile, friend list, email address, relationships, birthday, work history,
and education history that they’ve chosen to make public. The information may be used
to inform the study team of areas of health concern, help determine survey questions, and
target study finding emails.
The Facebook application will be hosted at the same secure colocation center as the
Millennium Cohort web surveys. The application will only collect information that it has
been given permission to access via the Facebook API platform. The Facebook page and
application are voluntary features and a person can cancel their consent or involvement
with the Facebook site at any time. When a person turns off the application, the user ID
and information is no longer given to the application.
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Both the application and organization page are still under development, but a few screen
shots are enclosed for review. Screen shots of both items in their entirety will be sent for
IRB review once constructed.
May 2013
• This protocol has undergone a change of staff. Ms. Kelly (Jones) Woodall and LtCOL
Nisara Granado no longer works for the DoD Center for Deployment Health Research.
Ms. Evelyn Davila, PhD, MPH, Ms. Denise Lovec-Jenkins, Ms. Sara Echols, and CPT
Carrie Donoho, PhD have been added as new key support personnel.
April 2013
• The following people have been added as new key support personnel to the protocol:
Kartavya Vyas and Anna Nagel.
•
The last decade of sustained and straining military operations has been witnessed an
increase in not only alcohol use but also the use of illicit substances and misuse of
prescription medications, including controlled substances (Blume et al., 2010; Bray et al.,
2010; Horgan et al., 2001; Marshall et al., 2012; Rosenbaum et al., 2012; SAMHSA,
2011; U.S. Air Force Special Operations Command, 2011). A recently published paper
reported the prevalence of any illicit drug use, to include prescription drug misuse,
significantly increased from 5% in 2005 to 12% in 2008 (IOM, 2012). In response to
such findings, the Army has expressed concern about the increasing availability and use
of prescription resulting in higher rates of abuse (U.S. Army, 2012). While illicit drug
use, not including prescription drug misuse, has remained relatively stable according to
official urinalysis testing figures, those testing positive represent an at-risk population,
which warrants further scientific study as to better understand the underlying causes of
use and to inform prevention and intervention programs. Also, this percentage might not
fully represent the prevalence of the problems as self-reports in the HRB Survey reported
the rate of illicit drug use at 2.3% (Bray et al., 2009).
Despite efforts to prevent and mitigate such issues, substance misuse and abuse continue
to present concerns for the DoD leadership (IOM, 2012). Additionally, current DoD
policies do not fully address evolving patterns of drug and alcohol use in an empirically
driven manner (IOM, 2012). Given this shortcoming, there exists a need to study the
relationship between illicit drug and prescription medication, the indication for which the
medication was prescribed (e.g., pain, sleep disorder, anxiety disorder, obesity), and the
environmental and individual factors contributing to drug/medication abuse. We are
therefore interested in determining the feasibility of incorporating data from the Army
Center for Substance Abuse Program (ACSAP) into our Millennium Cohort study to
address this need. ACSAP routinely tests Soldiers for Codeine, Morphine,
Amphetamines, Methamphetamines, Oxycodone, OxyMorphone, Hydrocodone,
Hydromorphone, and five types of benzodiazepines. In addition to monitoring illicit drug
use, all of these drugs can test positive due to a valid prescription or by illegal misuse
(i.e., using a controlled substance without a prescription, taking a controlled substance
after the prescription has expired).
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We request approval to match Millennium Cohort Study participants who have served in
the Army to the Army Center for Substance Abuse Program (ACSAP) database to
ascertain the aggregate number of Soldiers from our Cohort who have been tested and
screened positive for a monitored substance. To accomplish this, under Millennium
Cohort SORN N06150-5 and Army Substance Abuse Program SORN A0600-85, we
propose sending SSN information via a password protected, encrypted CDROM sent via
FedEx with a tracking number, to the Department of the Army Management Information
System (DAMIS) program manager, Mr. Michael Biggerstaff (ACSAP), Building 1467,
Fort Knox, KY 40121. In return, we will be provided with the overall number and types
of results and tests with positive results for our Army Cohort members via an encrypted
CDROM that will also be sent to our site via FedEx. No individual data will be provided
to us. After one week, the original data file provided to DAMIS will be destroyed IAW
with INFOSEC guidelines.
We previously requested approval to obtain individual identifiable results, however, the
IRB at that time (8/29/2012) expressed concerns about the number of results available
(i.e., study feasibility), availability of data from other service branches, as well as the
sensitive nature of individual data. Given these concerns, we have modified our request
to simply explore the number and types of results and positive tests to determine the
feasibility of future analyses of substance use in the Millennium Cohort Study. If
deemed feasible based on the number of tests and positive screens, we would
subsequently propose to link to the ACSAP dataset by submitting a modification request
to the IRB to request individual results from the Army as well as the other branches.
Beginning with the Army is an important first step as it is the most represented branch in
the Millennium Cohort Study (n=63,006, 42% of the cohort) and it has been heavily
burdened by recent combat operations. It should also be noted that other DoD-sponsored
research studies (e.g., the $60 million Army Study to Assess Risk and Resilience in
Service members) routinely pulls identifiable data from ACSAP.
•
For the Family Study, we are seeking permission to send a postal letter to those
participants who signed the consent on the web, but failed to complete the survey. There
are to be a total of three remaining contacts which include two emails and a $5 preincentive mailing. At present, one email has already been sent this month of April. If the
subject does not complete the survey after the $5 pre-incentive mailing is sent, a final
email will be sent and this will be the last contact during the cycle. The postal letter is
enclosed for review.
February 2013
• This protocol has undergone a change of staff. Ms. Melissa Bagnell, Ms. Charlene
Wong, and Ms. Hope McMaster no longer work for the DoD Center for Deployment
Health Research.
Updates have been made to both the Millennium Cohort Study and Family Study
Informed Consent Document for the 2014 survey cycle. Documents are enclosed for
review.
•
A previous protocol modification was approved in November 2012 with email text to
Panel 4 participants who submitted a paper survey, but had not submitted a signed
consent form. We have revised the email text, which is submitted for review. We sent
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the original email version to 216 Panel 4 participants, but only received 42 responses
back. For the Family Study, 125 emails were sent, but only 50 responses were received.
Because these individuals put in the time and effort to fill out the survey and mail it back
to us, we would like to make another attempt to obtain their consent by sending the
revised email.
•
•
Report Control Symbol review and renewal of survey instruments was completed in
2013; documentation attached. DoD RCS#DD-HA(AR)2106 (expires 03/31/14).
Office of Management and Budget (OMB) review and approval of survey instruments
was completed in 2011; documentation attached. OMB #0720-0029 (expires 03/31/14).
January 2013
• The following people have been added as new key support personnel to the protocol: Dr.
Melissa Frasco and Dr. Daniel Trone.
•
The Millennium Cohort Study 2014 survey versions were previously IRB approved in
June 2012. One section of both the Follow-Up and New Enrollee approved surveys
included a10-item question on Adverse Childhood Experiences (ACE).
Recommendations were made from a subject matter expert to condense the 10-item
question into comparable a 4-item question. Therefore we request approval of the
following 4-item question for inclusion into the 2014 Millennium Cohort Surveys. The
old version of the 10-item question is attached for reference.
“ It would be helpful for this study to know about the background experiences that
may have happened to some people:
a. Before the age of 18, how often did a parent or other adult in your home ever hit,
beat, kick, or physically hurt you in any way?
Answer choices: Never, Once, More than once, Prefer not to answer
b. Before the age of 18, how often did a parent or other adult in your home ever
touch your private parts when they shouldn’t have or make you touch their private
parts? Or did a parent or other adult that took care of you force you to have sex?
Answer choices: Never, Once, More than once, Prefer not to answer
c. Before the age of 18, how often did you get scared or feel really bad because a
parent or other adult in your home called you names, said mean things to you, or
said that they didn’t want you?
Answer choices: Never, Once, More than once, Prefer not to answer
d. When someone is neglected, it means that the grown-ups in their life don’t take
care of them the way that they should. They might not get enough food, take
them to the doctor when they are sick, or make sure they have a safe place to stay.
At any time before the age of 18, were you neglected?
Answer choices: Never, Once, More than once, Prefer not to answer”
•
Despite utilizing DMDC information, we still have a significant amount of outdated
contact information for participants, resulting in a large amount of returned mail. We
request the ability to use the MDR for both the Millennium Cohort Study and the Family
Study as a means to obtain updated contact info.
December 2012
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•
In order to increase the number of spouses referred to the Family Study from our New
Enrollee service members, we request permission to change the referral web page so that
it no longer asks for secondary consent from service members. We’ve removed all items
requiring secondary consent. This page will only ask the New Enrollee for their spouse’s
contact information. A PDF of the web page is attached for review.
•
The following questions were added to the 2014 Family Study Follow-Up Survey
(approved June 8, 2011) :
• To best understand the dynamics of health care utilization and the needs of service
members and their families, are you willing to allow us to link your survey data to
DoD medical records of any children you may have that are under the age of five
years old?
• A great deal has been learned from this study, and as a consequence we’ve been
asked to consider other research possibilities. If other related research studies become
available, is it ok to contact you to let you know about these opportunities?
• The 2014 Family Follow-Up Survey is attached.
• A Welcome to the Family Study holiday card will be sent to those subjects who have
completed the Family Study. A PDF of the card is attached for review.
October 2012
• The following people have been added as new key support personnel to the protocol:
LCDR Kendall Egan, and Jill MacDougall.
•
We wish to obtain data from two DoD data sources to use in analyses. The first is to reestablish a link to the Department of Defense Trauma Registry (DoDTR) (previously
JTTR). Name and SSN will be provided to the DoDTR via established encrypted
methods (POC Susan West Susan A. West, BSN, Institute of Surgical Research, 3698
Chambers Pass Bldg 3611, Fort Sam Houston, TX 78234-6315) for a query against the
DoDTR for injury data. Data on occurrence and types of injuries will be obtained and
utilized in our analyses looking at long-term health outcomes among deployed personnel.
The second linkage request is with the United States Army Physical Disability Agency
(USAPDA). Information on physical disabilities among service members and those
separating will be obtained. Specifically we will explore the deployment history of the
participant and causes for disability with the specific interest in respiratory causes of
disability as an extension of the prior respiratory work in the Cohort. SSN information
on participants would be provided to USAPDA (POC: Mr. Harold Alexander, 2900
Crystal Drive, Suite 386, Arlington, VA 22202) and then data on physical disabilities
would be provided using a password protected CD Rom disk mailed via FedEx. All data
upon receipt will be confidentially maintained on-site in our secure computer database.
DUAs will be written and approved in advance of any data sharing for both linkages.
•
In May 2012, a cover letter was approved to send to Panel 4 participants who submitted a
paper survey but had not signed or submitted a consent form. We are seeking permission
to send an email first to these participants, to request an electronic consent. We would
like to offer this option first, as this method is easier and is less burdensome on the
participant. We also recognize that a paper responder may have a preference to
responding via paper again. Therefore if the participant does not respond to the email
consent request, then we seek permission to send the originally approved cover letter and
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paper consent along with a $5 Starbucks gift card via postal mail. The email text is
enclosed for review.
•
Subject matter experts have been identified and we request their collaboration on several
Millennium Cohort sub-study projects. Several of these investigators have been on prior
projects and previously provided to the IRB. They will not have access to any personally
identifiable information or access to the database. Those affiliated with USUHS and
WRAIR have limited access to the data via prior IRB approvals and a LDUA/DUA. A
file with the information on the sub-study topic and the collaborators are attached.
•
Data Recognition Corporation (DRC), a survey scanning organization, will provide bulk
receiving, scanning services and bulk return-shipping of paper surveys for the
Millennium Cohort Family Study. DRC will be given limited access to the data. Surveys
will be sent from NHRC to DRC without direct identifiers such as names, social security
numbers, and addresses. Data from surveys will include information such as:
demographics, occupation, mental health symptoms, physical conditions, functional
health, habits (smoking, drinking, exercise, and diet), and other non-identifiable data.
Consent pages will also be removed before sending surveys to DRC. At the end of the
project, DRC will bulk ship scanned paper surveys back to NHRC and will send NHRC
data files via a secure file transfer site. DRC will provide services within a DoD Defense
Information Assurance Certification and Accreditation Process (DIACAP) environment
and so all information transmitted is stored and processed in accordance with DoD
security requirements. All research data will be returned to NHRC at the conclusion of
the work. The LDUA is attached.
August 2012
• The protocol has undergone a change of staff. Lawrence Wang no longer works for the
Deployment Health Research Department. Emma Schaller, Toni Rush, and Raechel Del
Rosario have been added as new key support personnel.
•
The study previously received approval to directly contact spouses of Panel 4 married
Millennium Cohort Study responders who "skip" the Family Study secondary
consent/referral page. A 10-week mailing schedule has been designed, which will
involve directly contacting spouses with a Family Study invitation. In order to test the
effectiveness of two mailing approaches, we will randomly assign these spouses to one of
two groups (Group A or Group B).
GROUP A:
A1: Magnet Frame and Card (week 1)
A2: Postcard (week 2)
A3: Sample Survey with $5 Starbucks (week 5)
A4: Letter along with Deanie Dempsey endorsement letter (week 6)
A5: Survey sent FedEx (week 9)
A6: Postcard (week 10)
GROUP B:
B1: Survey with Magnet Frame (week 1)
B2: Postcard (week 2)
B3: Survey with $5 Starbucks (week 5)
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B4: Letter along with Deanie Dempsey endorsement letter (week 6)
B5: Survey sent FedEx (week 9)
B6: Postcard (week 10)
We currently have 9,909 spouses who we will approach with this process.
Group A began on August 2, 2012 with mailing A1 (Magnet Frame and card) to 2,478
spouses.
Group B will begin mid-September 2012 with B1 (Survey with Magnet Frame) to 2,477
spouses.
Once we have response data on Groups A and B, we will determine the approach that
will be utilized for the remaining 4,954 spouses. The mailing cycle for both groups will
be complete after approximately 10 weeks, and for the spouses that do not complete their
survey we have no planned further contact for this group.
Non-referred spouses that continue to “roll in” with Panel 4 service member responders
will be assigned to Group A, on an ongoing basis. Similarly, all referred spouses will
also be assigned to Group A, and will receive emails as previously approved in the study
protocol. All contact are planned to stop for referred and non-referred spouses after
approximately 10 weeks once they completed a cycle in Group A. Artwork for all items
will be submitted for review as it is created.
July 2012
• We request to add CPT Dale Russell as a collaborator onto the study. CPT Russell is an
active duty Army member identified by the sponsor of the Millennium Cohort Study,
MOMRP, as a potential collaborator to the Millennium Cohort Study Team. In the near
future, there is a plan for him to PCS to NHRC as a staff member. In the interim, it is
requested that CPT Russell assist with the study in a specified capacity without remote
access to any secure databases. Specifically, he will assist with writing emails,
administrative duties including helping with strategies for study non-response, and
assisting in the conduct of sub-studies. In addition, he may be listed as the signatory on
outgoing emails to participants. CPT Russell’s HIPAA and CITI certificates are
enclosed.
•
Previous Millennium Cohort outgoing emails were blocked by AKO and marked as
SPAM. This may be one of the reasons why the Army participant response rates have
been low. In an effort to remedy this impediment and increase the Army representation
in our study population, we request to send an email specifically for Army participants.
The text for this email is enclosed for review and lists CPT Dale Russell as the signatory.
•
We request additional response options to be added onto the preapproved 2014 New
Enrollee and Follow Up Millennium Cohort Study survey versions. The following are
the added responses:
• Preapproved question: “Since 2001, have you taken any educational course?”
o Response added: “Yes, trade or technical school”
•
Preapproved question: “If you did NOT seek care, what were some of the reasons
why you did NOT seek care”
o Response added: “Cannot afford treatment/no health insurance”
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June 2012
• The Millennium Cohort Study and Family Study have revised survey instruments for the
2014 cycle. There are four survey versions for Millennium Cohort, which include: (1)
New Enrollee-web version, (2) New Enrollee- paper version, (3) Follow-Up – web
version, and (4) Follow-Up – paper version. There are 3 survey versions for the Family
Study, which include: (1) Baseline, (2) Follow-up, (3) Follow-Up for divorced, separated,
and widowed participants. All versions are submitted for review.
•
In March 2012, we obtained IRB approval to mail a $5 gift card as a pre-incentive to
obtain more referrals to the Family Study. The pre-incentive will go to Panel 4 married
participants who have completed their survey and did not explicitly refuse to refer their
spouse to the Family Study. This mailer will be known as the New Enrollee pre-referral.
We would like to pair this mailer with an email, and therefore are requesting permission
to send a follow-up email to these recipients. The email text is submitted for review.
May 2012
• We would like to add a text box to the web version of both the Follow Up and New
Enrollee surveys above the contact information section. The intent of the text box is to
provide an explanation as to why we are asking for participant’s mailing and email
address. The text will read:
“Thank you so much for responding to this health issues survey. We would like to
verify your contact information. Although we obtain address information from DoD
sources, we would like to ensure that we have the best information to reach you. We
will also use this data to send you a token of appreciation after completion of the survey.
If you have any questions or concerns, you can contact the Millennium Cohort Study
Team at toll-free (888) 942-5222 or DSN 553-7465. You can also email us at
[email protected].”
•
We are limited to the email and mailing addresses provided in DMDC, which are not
always accurate. We would like to update participant email and mailing addresses with
the one provided on the New Enrollee and Follow Up web surveys for individuals who
had consented to and started the web survey, but did not fully complete the survey. The
provided email addresses can then be used in sending incomplete reminder emails
(previous approval). This will assist in limiting the number of follow-up emails since
more accurate information will be utilized. We would also like to use the mailing
address the participant provided to send a $5 incentive to complete the survey (Artwork
to be submitted).
•
We also request permission to contact participants who have completed and returned a
paper survey but did not sign or send back their consent form. Participants will be sent a
$5 incentive to return a signed consent document. This cover letter is attached for
review.
•
We request to remove the “Survey Complete – Submit” button on the bottom of the web
survey pages. This button may be causing confusion for our participants, who may be
hitting this button instead of the “Next” button and inadvertently not completing the
whole survey. On the last page of the survey questions, we will update the text box to
state “This is the last page of the survey, please click ‘Continue to Incentive’. Thank
you for participation in this important study!” The “Survey Complete-Submit” button
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•
will be changed to state “Continue to Incentive”.
We request to update the Online Survey Instructions to read:
“Here are three suggestions that you might find helpful for completing this survey.
• To move backwards or forward in the survey use the dark blue PREVIOUS and
CONTINUE arrows, which save your completed answers. Please do not use the
browser’s back button.
•
•
If you lose connectivity all of your completed answers will be saved, so you can sign
on later to finish without having to start over at the beginning.
The SAVE & CONTINUE LATER button is on each page in case you need to
temporarily stop and finish answering later.”
•
We request to add the following text to the top of the Consent Form web page:
“In order for you to participate in this study, we need for you to check below that you
“consent to participate”. We are required to obtain your consent to ensure that all
participants are informed of what is expected of them, the potential risks of participation
(if any), and how their questionnaire answers are protected. If you wish to print and keep
a copy of the consent form you can do that by clicking here.
•
The Millennium Cohort Study team requests approval for collaborating with Dr. Andrew
Golub, National Development and Research Institutes (NDRI) on a project entitled
“Veteran Reintegration, Mental Health and Substance Abuse in the Inner-City” (National
Institute on Alcohol Abuse and Alcoholism, NIAAA, Project #R01 AA020178). The
study involves examining Millennium Cohort Study participants who reside in specific
locations in New York to investigate the sociodemographics as well as the mental and
physical outcomes of this subset of the Millennium Cohort Study. The specific aims and
usage of the Millennium Cohort data are described in pages 23-26 of the grant (attached).
All data analyses will occur at NHRC, and no access to identifiable data or subjects will
be provided. Aggregate information on the prevalence of conditions and demographics
of this subset will be shared with collaborators, and we will work together to co-author
presentations and/or publications from these data. No financial support for this substudy
work will be obtained.
March 2012
• To increase Family Study response rates, we request permission to directly contact
spouses of Panel 4 married Millennium Cohort Study responders who “skip” the Family
Study secondary consent/referral page, as well as Panel 4 married responders that
complete a paper survey.
• Panel 4 responders that said “No” to the Family Study referral page will not be
further contacted.
• In addition, the current enrollment process will remain for Panel 4 married responders
that gave their secondary consent and referred their spouse to the Family Study.
•
This new enrollment process will require the following changes to the current spouse
enrollment protocol:
• The spouse consent form will need to be updated to remove text referring to the Panel
4 service member referral. The third sentence of the first section will be edited to
“You were selected to be a part of this study because your spouse is a participant of
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•
•
•
•
the Millennium Cohort Study.”
Invitation Email text, as well as the Reminder Email text, will be slightly modified to
remove text referring to the Panel 4 service member referral.
The Survey Log-in page and “Having Trouble Logging In? Click Here.” webpage
will be updated to remove text referring to the Panel 4 service member referral.
The Study Update, What’s New and About the Study www.familycohort.org
webpages will be updated to reflect the new enrollment process.
Since secondary consent from the Panel 4 service member will not be attained, the
following questions in the section, “Your Spouse’s Behavior” will be removed from the
Family Study web survey:
•
How often have you observed these behaviors IN YOUR SPOUSE within the PAST
MONTH (or the most recent month your spouse w as home)?
a) Sudden bad memories/flashbacks
b) Spaces out
c) Lack of interest in sex/intimacy
d) Difficulty sharing thoughts and feelings
e) Avoids former interests/activities
f) Hyper-alert/startles easily
g) Anxious/nervous
h) Fearful
i) Withdrawn/detached
j) Irritable
k) Quick temper
l) Secretive
m) Difficulty falling or staying asleep
n) Nightmares or bad dreams
o) Taking more risks with his/her safety
p) Lack of interest in parenting/children (skip to the next question if you don't
have children)
Response Options:
• Never
• Seldom
• Sometimes
• Often
• Very often
•
Within the PAST MONTH (or the most recent month your spouse was home)
how DIFFICULT has it been for YOUR SPOUSE to do the following:
a) Do his/her work
b) Take care of things at home
c) Get along with other people
d) Fulfill supporting role as spouse/parent
Response Options:
• Not at all
• Somewhat
• Very
• Extremely
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•
•
In your opinion, does YOUR SPOUSE consume too much alcohol in a typical week
when he/she is at home?
• No
• Yes
Millennium Cohort investigators request evaluating response rates to determine potential
biases among the study population by comparing non-responders and responders to the
study invitation. These data are essential to determine the representativeness of the
current study population. In order to complete these comparisons, we request comparing
the demographic information among panel 2 and 3 responders and nonresponders which
have already been collected from DMDC during the enrollment process, and in addition
compare deployment experiences and prior health care utilization prior to the enrollment
cycle among these two groups. These data are critical in determining any differences
between responders/nonresponders and the utility of the current study data and its
interpretation.
February 2012
• The protocol has undergone a change of staff. Ms. Michelle Linfesty and Charles Nesbitt
have been added as new key support personnel.
•
We request permission to disseminate a Millennium Cohort Study Newsletter. It will be
mailed to the study population and will list recent publications, presentations, and key
findings. The newsletter may help build participant interest and can be of great
assistance in obtaining more completed surveys. The art and text is submitted for
approval.
•
We request permission to mail a $5 gift card as a pre-incentive to obtain more referrals to
the Family Study. The pre-incentive will go to Panel 4 married participants who have
completed their survey and did not explicitly refuse to refer their spouse to the Family
Study. The art and text for the gift card mailer is to be completed and submitted for
approval.
•
Previously the IRB approved an email reminder to be sent to all individuals who began
the online survey but failed to complete or submit the survey (July 2005). We request
permission to send this email twice a month as a reminder to these individuals. The text
for these incomplete reminder emails for both Follow-Up and New Enrollee individuals
are submitted for approval.
•
In order to validate Air Force self-reported height and weight data reported on
Millennium Cohort Study questionnaires, we would like to link Millennium Cohort data
to height and weight data from annual fitness test scores from June 2001 to December
2008 at Health Care Informatics Division (HCID), Lackland Air Force Base. NHRC will
send an encrypted password protected text file through a secure website, ARMDEC Safe
Access File Exchange. This file will contain a list of social security numbers of all
Airmen that are participants in the Millennium Cohort Study from June 2001 to
December 2008. HCID will send an encrypted password protected text file through the
ARMDEC secure website back to NHRC with SSN linked height, weight, and dates.
HCID will destroy the social security numbers after completing the linkage, and will have
no interactions with any record holders.
•
An error in the New Enrollee web survey was previously discovered and reported in
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September 2011. Questions designed only for women on the New Enrollee web survey
were omitted from 7 June 2011 to 22 August 2011. The participants who were affected
were given the opportunity to complete those questions through a mailed paper version or
on the web. We are requesting to send these women who have not yet responded to the
questions, an email reminder to complete them. The email text is enclosed for approval.
•
Report Control Symbol review and approval of survey instruments was completed in
2010; documentation attached. DoD RCS#DD-HA(AR)2106 (expires 01/31/13).
•
Office of Management and Budget (OMB) review and approval of survey instruments
was completed in 2011; documentation attached. OMB #0720-0029 (expires 03/31/14).
•
As a note of clarification, the following people are listed as study collaborators, and not
co-investigators
• Dr. Tomoko Hooper at Uniformed Services University of the Uniformed Health
Sciences
• Dr. Edward Boyko at the VA Puget Sound/University of Washington
• Dr. Paul Amoroso at MultiCare Health System Research Institute
• Dr. Margaret Ryan at Naval Hospital Camp Pendleton
• Dr. Gary Gackstetter at Analytic Services Inc. (ANSER)
• Dr. Tyler Smith at National University Technology and Health Sciences Center
• Dr. Timothy Wells at Advanced Analytics Optum Insight
January 2012
• This protocol has undergone a change of staff. Dr. Besa Smith no longer works for the
DoD Center for Deployment Health Research. She will continue to be a collaborator on
this study, and will not have access to the data files, but rather will serve in an advisory
role to the study and its publications. In addition, the following people have been added
as new key support personnel: Sheila Medina-Torne, Andrea Ippolito, and John Wesner.
• To increase response rates, we request permission to use different versions of email
messages to the study population. These emails will be sent out within previously
approved timelines (See attached “NE_E8_Single.doc”, “NE_E8_Married.doc”,
“NE_E9_Single.doc”, “NE_E9_Married.doc”, “NE_E10_Single.doc”,
“NE_E10_Married.doc”, “NE_E11_Single.doc”, “NE_E11_Married.doc”, “FollowUp_E9”)
• The IRB previously approved permission to mail a $5 gift card as a pre-incentive to
Family Study participants that have been invited to participate, but did not respond to the
initial invitation email. The gift card will be inserted in a Family Study note card. The
art for this note card is submitted for approval. (See attached,
“pre_incentive_inside_panel_v2.pdf”, “pre_incentive_outside_panel_v3.pdf”). The
inside panel text was slightly modified from the pdf version and is submitted for review
(See attached, “pre-incentive-inside modified txt.doc”)
• The Publications section of the Millennium Cohort Study webpage will be updated with
graphics consisting of publication journal logos (See example attached, “publication
webpage.pdf”).
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November 2011
• This protocol has undergone a change of staff. Dr. Donald Slymen has been added as
new key support personnel to the Millennium Cohort Study data analyst team.
• This protocol involves consultation with researchers, Dr. Karen S. Mitchell, a Clinical
Research Psychologist at the Women's Health Sciences Division, National Center for
PTSD and an Assistant Professor at Boston University for the Department of Psychiatry
VA Boston Healthcare System and Dr. Alison E. Field, at the Children’s Hospital
Boston, Division of Adolescent/Young Adult Medicine. No data will be provided to Dr.
Mitchell and Dr. Field and Dr. Mitchell and Dr. Field will have no interactions with any
record holders.
• In order to offer New Enrollees that complete their survey by paper an opportunity to
refer their spouses to the Family Study, we request permission to send them an email one
time (see attached previously approved “Automated Email Panel 4 Spouse Referral
Reminder.doc”). To refer their spouse, participants will use an email link to be taken to a
new landing page (see attached previously approved “Spouse Referral Landing
Page.png”). Once logged in, New Enrollees will be taken to the secondary consent form
(see attached previously approved “FamilyInvitePage2.png”) and then see a thank you
page (see attached previously approved “FamilyInvitePage3.png”).
• We request permission to include an insert (art and text to be completed and submitted
for approval) describing the Family Study in incentive mailers (gift cards, coins and
hats). The insert will direct New Enrollees to the new landing page (see attached
previously approved “Spouse Referral Landing Page.png”), and they will be taken
through the same process as described above. Please note that New Enrollees that select
“NO, you do not have permission to contact my spouse” on the secondary consent form
will NOT receive this insert.
• We request permission to mail a $5 gift card as a pre-incentive to Family Study
participants that have been invited to participate, but did not respond to the initial
invitation email. On a monthly basis, $5 gift cards will be mailed to all referred spouses
that are obtained during the month, but that do not respond to the initial invitation email.
The gift card will be inserted in a Family Study note card (art and text to be completed
and submitted for approval).
September 2011
• This protocol has undergone a change of staff. Mr. Lawrence Wang has been added as
new key support personnel. Lawrence will be assisting with mail processing of returned
Millennium Cohort Study surveys, postcards and incentives, as well as verifying
completed paper surveys.
• Based on suggestions from Dr. Don Dillman, a highly respected survey methodologist
known for the “Dillman Method” of survey implementation, we have revised many of our
marketing materials, including the attached emails, cover letters, Blast automated call
scripts, and Veterans Day postcard (see attached).
• We discovered an error in the New Enrollee web survey. The questions designed for only
women to answer didn’t appear from 7 June 2011 until the problem was discovered on 22
August 2011. This affected approximately 5,200 participants. We would like to mail
these participants paper versions of the questions, see attached “Women only questions to
be mailed.pdf,” along with a $5 Starbucks gift card. A cover letter (see attached “Women
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Only Questions Cover Letter.doc”) will be sent with the mailing to inform participants
that they can also go online to complete the questions. To log-in to complete the
questions, participants will be taken to a new landing page (see attached “Women Only
Landing Page.png”). Once logged-in, participants will see the following page
“ConfirmQuestions_AlreadySubmitted.png” where they can complete the questions.
•
Female participants that began but didn’t submit their survey during these dates will
see the questions at the end of the survey, when they log back in to complete their
survey - see attached “ConfirmQuestions.png”.
•
In order to increase the number of New Enrollees referring their spouses to the Family
Study, we request permission to use a web page (see attached “FamilyInvitePage1.png”)
prior to secondary consent form (referral form) to succinctly describe the Family Study.
This page will allow the participant to choose to a) read more about the study by
continuing to the secondary consent form on the next page or b) skip to the “select gift”
page. The consent form will not be changed except for design/graphic elements (see
attached “FamilyInvitePage1.png”, “OriginalFamilyConsent_2.PNG”). The secondary
consent form will include a “print” function that allows the participants to print a full
copy of the consent with the contact information they provide (see
FamilyConsent_Printable.PNG”).
•
In order to offer New Enrollees that skip the page describing the Family Study an
opportunity to refer their spouses to the Family Study in a different context, we request
permission to send them an email one time (see attached “Automated Email Panel 4
Spouse Referral Reminder.doc”). To refer their spouse, participants will use an email link
to be taken to a new landing page (see attached “Spouse Referral Landing Page.png”).
Once logged in, New Enrollees will be taken to the secondary consent form (see attached
“FamilyInvitePage2.png”) and then see a thank you page (see attached
“FamilyInvitePage3.png”). Please note that New Enrollees that select “NO, you do not
have permission to contact my spouse” on the secondary consent form will NOT be
contacted with the proposed automated email.
August 2011
• This protocol has undergone a change of staff. Dr. Tim Wells no longer works for the
DoD Center for Deployment Health Research, but will remain listed as a “CoInvestigator” on the protocol; Dr. Wells will not have access to the data files, but rather
will serve in an advisory role to the study and its publications. We also wish to clarify
the role of Dr. Tyler Smith who also recently resigned. He will continue to be a
collaborator on this study with the same role (no access to the data files, but rather will
serve in an advisory role to the study and its publications).
•
To increase response rates, we request permission to send married New Enrollees that
haven’t completed the survey a large format postcard that describes both the Millennium
Cohort Study and the Family Study, in addition to the regularly scheduled postcards
previously approved. We further request permission to randomly assign married New
Enrollees to receive one of the three versions of the postcard, in order to determine the
most effective postcard format (see attached).
• ~24,000 Letter Size Postcards (6.125 X 11.5) without survey images
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•
•
•
~24,000 Jumbo Postcards (9 x 12) with survey images on front
~24,000 Jumbo Postcards (9x12) without survey images on front
~24,000 No Special Mailing (standard reminder postcard)
We request permission to send non-married New Enrollees an additional standard
reminder postcard (previously approved) in order to maintain a consistent number of
postal contacts for married and non-married participants.
July 2011
• This protocol has undergone a change of staff. Dr. Marleen Welsh, Mr. Travis LeLeu,
Ms. Jamie McGrew, and Ms. Stacie Nguyen no longer work for the DoD Center for
Deployment Health Research. Mrs. Jennifer Walstrom and Mr. William Lee have been
added as new key support personnel.
•
Based on pilot testing that resulted in an increased response rate, we request permission
to call the study population using an automated tailored voice message one time during
the survey cycle. The message will encourage participation, but state that this is a
voluntary study. The provider uses a web-based auto dialer. The message will be left
whether or not the call reaches a live person or an answering machine. Overseas phone
numbers will not be included. See attached for a script of the messages (married, single,
and follow-up versions).
• The system will dial each number up to 3 times to attempt to connect. Upon
completion of each call, the result will be logged into the software's database (i.e.
human pick up, voice machine, busy, not in service). If a number is answered by a
person or the answering machine picks up, the report will indicate a successful
delivery, and the number will not be dialed again. If a number is not in service, does
not answer, is invalid or hangs up after connection, the result is listed as a failed
connection in the database, and the number will not be called again. If however, a
number experiences a technical error, or is busy, the system will attempt 2 additional
times (5 minutes apart) and then list the final status on the database report. Once the
list has been executed a comma delimited text file will be exported and uploaded into
our database. The data results file will be used to remove bad telephone numbers and
identify successful call attempts.
•
The provider has a technical support team in-house 24 hours a day to monitor the
software and ensure there aren’t any technical malfunctions, and to answer calls.
•
To ensure that auto dialing will only take place during reasonable hours telephone
numbers will be categorized by time zone and the software will be set-up to call
during mid-day in all time zones. If the list is not completed within the time limit that
we specify for that day, the calls will be stopped and resumed the next day during the
specified time frame.
•
To increase response rates, we request permission to increase email contact with the
study population from one time per month to two times per month during the survey
cycle.
•
To increase response rates, we request permission to send weekly emails (4 emails)
during one month of the survey cycle to New Enrollees and Family Study participants.
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•
In order to understand the impact of increasing email contact on the study population, we
request permission to follow-up any request to unsubscribe from emails with one
question regarding the reason for unsubscribing. The follow-up question is not a required
field to unsubscribe from the email list.
Please let us know your main reason for unsubscribing:
o I am not the intended recipient for this survey
o I do not want to participate in this survey
o I do not have time to participate in the survey
o I am concerned that this is Spam or Phishing
o I have privacy concerns
o I received too many e-mails from this study team
o I receive too many e-mails in general
o I do not want to provide a reason for unsubscribing
o Other (open text field)
•
In order to better understand barriers to responding, we request permission to ask a single
question when a participant leaves the survey before submitting.
Please let us know why you are not submitting your survey.
o I don’t have time now, but will complete the survey later
o I only wanted to see the questions and I don’t plan to complete the survey
o The questions are too personal, so I don’t plan to complete the survey
o The survey is too long, so I don’t plan to complete the survey
o Other (open text field)
May 2011
• In order to complete a study on hearing loss that will include analyses of all services, we
would like to link Millennium Cohort Study data to the Defense Occupational and
Environmental Health Readiness System, Data Repository (DOEHRS-DR), which is
located at the US Army Public Health Command (Provisional), Aberdeen Proving
Ground, MD. LT Jason M. Jones, an audiologist at Camp Pendleton, will sponsor Amber
Seelig, a Millennium Cohort Study team member, in obtaining a DOEHRS-DR account.
LT Jones will serve as an expert in the field of hearing loss. No Millennium Cohort Study
data will be provided to LT Jones, and LT Jones will have no interactions with any record
holders. Amber Seelig will use secure web-based interfaces to pull SSN-matched
audiometric data for Millennium Cohort Study participants. All data will be stored on
secure NHRC servers.
April 2011
• This protocol has undergone a change of staff. Dr. Tyler Smith will no longer serve as
Principal Investigator on this protocol, due to his resignation from his position with the
Deployment Health Research Department at the Naval Health Research Center. Dr.
Nancy Crum-Cianflone will continue to serve as the Principal Investigator for this
protocol. The informed consent document for this study has been reviewed and remains
accurate, indicating consistent general information for contact of the Principal
Investigator. In addition, Dr. Chris Phillips has been added as new key support
personnel.
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March 2011
• This protocol has undergone a change of staff. Dr. Don Sandweiss no longer works for
the Deployment Health Research Department. Carter Sevick and Dr. Marleen Welsh have
been added as new key support personnel. Dr. Nancy Crum-Cianflone has replaced Dr.
Tyler Smith as Department Head, Deployment Health Research Department. CAPT
Margaret Ryan has been added to the protocol as a co-investigator. CAPT Ryan was
previously designated as a medical monitor, however, it has been determined that a
medical monitor is not necessary for this protocol.
•
Dr. Nancy Crum-Cianflone will be added to the protocol as a Principal Investigator. Dr.
Smith and Dr. Crum-Cianflone will share Principal Investigator duties. The informed
consent document for this study has been reviewed and remains accurate, indicating
consistent general information for contact of the Principal Investigator.
•
In order to complete a study on physical activity and fitness in the Air Force, we would
like to link Millennium Cohort data to annual fitness test scores from May 2007 to
December 2008 at Health Care Informatics Division (HCID) at Brooks Air Force Base.
NHRC will FedEx an encrypted password protected text file burned to a CD to HCID
with the list of social security numbers of active duty Airmen that are participants in the
Millennium Cohort study. HCID will FedEx an encrypted password protected text file
burned to a CD back to NHRC with SSN linked fitness test scores and dates. HCID will
destroy the social security numbers after completing the linkage, and will have no
interactions with any record holders.
•
The following changes have been made to the Millennium Cohort Study Follow-up and
New Enrollee questionnaires:
• The paragraph following Question 19 on Follow-up and Question 20 on New
Enrollee has been removed. The paragraph states, “If you have been bothered by any
of the items listed above on this page, you may want to seek help from a health
professional in your area” has been removed. This paragraph is no longer required to
follow this question because question 19i and question 20i “Thoughts that you would
be better off dead or of hurting yourself in some way” has been removed.
•
The following change has been made to the Millennium Cohort Study New Enrollee
questionnaire:
•
•
Due to the delay in receiving OMB approval, we decided to pull a new sample based
on an October 2010 snapshot of military rosters. The language in the first section of
the consent form has been changed to reflect this - October 2009 was changed to
October 2010.
The risk statement has been updated to “The main risks to you are those associated
with the inappropriate disclosure of data that we collect from or about you. While
inappropriate disclosure has the potential to impact your reputation, insurability, or
employability, it is important for you to understand that this research group has
collected similar information from numerous studies over many years without any
cases of inappropriate disclosure.”
o The Consent Button at the top of the Consent Form has been removed and a link
to download the consent has been added (online questionnaire).
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•
When developing the Millennium Cohort Family Study e-survey, the following changes
from the print version were made in order to improve comprehension and usability:
Descriptive headings, introductory paragraphs, and informational icons were added and
question order was modified.
•
•
Headings: Background Information, Physical Health, Well-Being, Coping Skills, Life
Experiences, Your Alcohol And Tobacco Use, Your Alcohol Use, Your Tobacco
Use, Your Sleep Quality, Your Military Service, Relationship With Your Spouse,
Your Spouse’s Deployment, Deployment Return And Reunion, Your Spouse’s
Behavior, Military Life, Your Family, Demographics, Contact Information, Open
Response
Introductory Paragraphs:
o To get started, we would like to ask you some background questions. These
questions are used to determine which sections of the survey apply to you and
your family, so the questions may seem unrelated to each other.
o We’d like to remind you that all your answers are strictly confidential.
o Now, we would like to ask you some questions about your physical health, how
you feel, and how well you are able to do your usual activities. These items allow
us to assess changes in your general health over time and if these changes may be
related to other information you provide.
o We would like to end this section by asking about your (or your spouse’s)
pregnancy and fertility history.
o Now, we would like to ask you about your mental well-being. These questions are
about how you feel and how things have been going over the last month. Some of
these questions will seem slightly repetitive, but we assure you that they are
actually different and each has a specific purpose. Remember, there are no right
or wrong answers.
o Below is a list of problems and complaints that people sometimes have in
response to stressful life experiences. Some of these may not apply to you,
however, please read each one carefully and mark the answer that best reflects
how much you have been bothered by each problem in the last month.
o The next several questions focus on your eating behavior.
o Now, we would like to ask you how you’ve been feeling in the last 2 weeks.
o Because we will re-survey you every three years, the last question of this section
asks you to think back three years and compare yourself to now.
o Now we’ll ask you about the coping skills you use in daily life. In order to
determine some that you might use, we have included a list below.
o One example of an action-based coping mechanism is seeking care for a mental
health, emotional, or stress related reason. Even if you haven’t sought such care,
we’d like to know what reasons might prevent you from seeking care.
o The following section concerns life experiences that have the potential to act as
protective or risk factors. We are aware that many of these questions are quite
personal, but we would appreciate your candid response.
We’d like to remind you that all your answers are strictly confidential.
o Now we would like to ask you some questions about your drinking and smoking
behavior.
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o Now we would like to ask you some questions about how you are sleeping. Even
if you are pregnant or have a newborn that is disturbing your sleep, please answer
the questions by reflecting on your current sleep pattern.
o In order to better understand how military life affects families, this next section
includes questions about your relationship with your spouse.
Once again, we’d like to remind you that all your answers are strictly
confidential.
o Now, we would like to ask you some questions regarding the deployment
experience.
o The deployment return and reunion process can often be challenging, so the next
several questions are about that experience.
o Your perception of your spouse’s behavior is very important to the study.
Please be assured that your answers will NEVER be shared with your spouse or
your spouse’s supervisors.
o Now, we’d like to ask you some questions about the stress of military life and the
military’s efforts to help you and your family deal with those stressors.
o We would now like to ask you some questions about your family. By family we
mean you, your spouse, and your children (if applicable).
o Now, we would like to ask you about your children. We realize that these
questions are sensitive, but it is important to answer them as accurately as you
can. Your answers will provide insight into how families and children are coping
with military life and deployment.
We want to remind you that this is a population-based study and data collected
will not be used to make decisions about treatment. If you feel your child needs
medical care or counseling, you should make contact with the appropriate
medical personnel.
•
Because we’re interested in how military life and deployment affect families over
time, it is important for us to have contact information that you will have for at least
the next three years. We realize that many of you will be moving locations before
then, but you may have cell phones and email addresses that you will maintain for
long periods of time.
•
To help us contact you in the future, please provide the name and contact information
for two people who are likely to know where you can be reached. Please do not
include individuals that live in your household. We will NOT share your
questionnaire responses with these individuals and they will ONLY be contacted if
we have difficulty contacting you.
Please make sure these individuals are willing to provide your contact information if
they are contacted by the Family Study team.
•
The following questions were removed:
o M26: Sea Bee: Chronic Multi-symptom Illness measure
o M91: WRAIR Land Combat Study – except for item h
•
The following response methods were changed from a “Yes/No” to an affirmative
response text box:
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•
•
•
o M89: Core Data Set and M92: CDC Children's Health
o In order to assess the validity of responses for M89 and M92, the "page load
to page submittal" time will be collected for pages 29 and 30 of the e-survey.
The following text box was removed:
o If you have been bothered by any of the items listed above, you may want to seek
help from a health professional in your area.
Spouses that don’t have SSNs in DEERS will be asked for their full SSN after they
submit their survey using the following text:
o We were not able to retrieve your full Social Security Number (SSN) from your
sponsor's record. In order to assist us in maintaining contact with you and to be
included in all analyses, please provide your full SSN. Your full SSN will not be
stored with your survey responses and will never be shared with anyone outside
the study. Thank You!
Additional Information Icons were added:
o M58. Military members meet deployment criteria anytime they leave the physical
locale of the parent command and enter an environment for operational
deployment or are stationed in hostile territory.
o M25. Hospitalized means that you were admitted to the hospital for treatment.
Please do not check if you went to the ER, but were not admitted to the hospital.
o M24. Serious means that you experience depression, anxiety, irritability, anger, or
mood swings.
o M69. This question refers to your spouse's current military job.
o M76. Never experienced in the last 12 months.
o M17. Please include your sponsor even if currently deployed, on temporary duty,
or in training, if he/she lives and sleeps in your household the majority of the
time. Please DO NOT include anyone that does not live and sleep in your
household the majority of the time (e.g. visiting relatives).
o M6. This information is used to verify your identity against our records. It will
also be used as your login for follow-up surveys.
o M87. Please include any biological, adopted, or foster children that are 21 years
old or younger, if they live and sleep in your household the majority of the time.
o M16. A mutually agreed upon commitment to one another involving exclusivity,
honesty, or some other agreed upon behavior.
o M61e. Refers to the act of communicating and emotionally connecting with your
spouse.
o M61f. Refers to your ability to make contact via email, phone, or web cam.
The risk statement has been updated to “The main risks to you are those associated
with the inappropriate disclosure of data that we collect from or about you. While
inappropriate disclosure has the potential to impact your reputation, insurability, or
employability, it is important for you to understand that this research group has
collected similar information from numerous studies over many years without any
cases of inappropriate disclosure.”
•
Report Control Symbol approval has been obtained. DoD RCS#DD-HA(AR)2106
(expires 01/31/13). See attached renewal document, “Millennium Cohort Studies - RCS
renewal DD-HA(AR)2106.pdf”.
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•
Office of Management and Budget (OMB) approval has been obtained. OMB #07200029 (expires 03/31/14). See attached renewal document “Prospective Studies of US
Military Forces The Millennium Cohort Study_OMB #0720-0029_March 2011.pdf”.
August 2010
• This protocol has undergone a change of staff. Dr. Hope McMaster, Ms. Stacie Nguyen,
and Ms. Lauren Kipp have been added as new key support personnel.
•
Attached are all marketing materials for the 2010-11 Millennium Cohort Study and
Millennium Cohort Family Study survey cycle. Items include emails, postcards, cover
letters, envelopes, and the Family Cohort refrigerator magnet.
•
This protocol involves consultation with a researcher, Dr. Tomoko Hooper, at Uniformed
Services University of the Uniformed Health Sciences (USUHS). Data to be provided to
Dr. Hooper will not contain any direct or indirect identifiers and Dr. Hooper will have no
interactions with any record holders.
A pilot study has been added to the protocol that involves 200 Panel 4 Millennium
Cohort Study participants taking the web version of the survey. Once subjects have
consented to participate in the Millennium Cohort Study, and have indicated their marital
status as “now married” in the first section of the survey, they will be randomly assigned
to one of two groups. Group 1 will see the Family Cohort Permission Form immediately
after indicating marital status, and Group 2 will see the Family Cohort Permission Form
after they submit their completed survey. All 200 participants will be given the
opportunity to view the Family Cohort survey when they see the Family Cohort
Permission Form.
The rationale for this pilot is to investigate the effect of effort justification (cognitive
dissonance) on recruitment into the Millennium Cohort Family Study. Discovering
methods of increasing enrollment in the Millennium Cohort Family Study is of
considerable value.
•
•
March 2010
• This protocol has undergone a change of staff. Mrs. Lacy Farnell and Mrs. Molly Kelton
no longer work for the DoD Center for Deployment Health Research. Mrs. Beverly
Sheppard, Mrs. Teresa Powell, Ms. Amanda Pietrucha, Ms. Melissa Bagnell and Mr.
Dennis Hernando have been added as new key support personnel.
• Based on external consultant review and sponsor driven additions, the following changes
have been made to the Panels 1, 2 and 3 “follow-up” questionnaires, the Panel 4 “new
enrollee” questionnaire, and the Millennium Cohort Family Study questionnaire:
• Follow-up:
o Q13 (b) - Changed answer choice titles to sentence caps.
o Q18 (m-n) - Added “Ringing in the ears” and “Difficulty with balance.”
o Informational blue box underneath Q19, added words “above on this page” for
clarity.
o Q27-29 – Added questions to measure infertility in both men and women.
o Q57 – Added question to measure support.
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o Q62 – Posttraumatic Growth Inventory (PTGI): the Millennium Cohort Study
team and the Psych Health Program Area Team developed (Bliese, P., Hoge, C.,
Smith, T., Smith, B., & Adler, A). Moved from the deployment section of the
survey to a general area so all participants complete the question.
The items are now written in the present tense and without reference to
changes since the traumatic event in order to remove retrospective bias (a
criticism of the original version of the scale). Because the Millennium Cohort
study surveys people over time, some individuals will be surveyed before and
after exposure to deployment/traumatic events. So any changes following
deployment can be directly examined by comparing attitudes pre and post
deployment. PTGI research has not historically been able to assess people preexposure so they've had to rely on retrospective recall.
The directions and response options were changed in order to match the
item edits. Previously, the response options had reflected how much change had
occurred since the traumatic event, now the items can be matched in terms of how
much an individual feels the statements are true for them.
One item was added so it is now an 11 item scale (since the item about
how you "learned a great deal about how wonderful people are" is awkward and
previous publications suggest that an alternative item has equally good
psychometric properties, the item about compassion was added).
o Q82-83 – Revision of injury variable to better assess injury and cause of injury
with ability to crosswalk back to previously collected data.
o Q89 – Added a 3 item measure to determine resiliency.
o Q100 - Added a question on use of a separate location decompression program.
•
New Enrollee:
o Q14 (b) - Changed answer choice titles to sentence caps.
o Q19 (m-n) - Added “Ringing in the ears” and “Difficulty with balance.”
o Informational blue box underneath Q20, added words “above on this page” for
clarity.
o Q28-30 – Added questions to measure infertility in both men and women.
o Q58 – Added question to measure support.
o Q63 – Posttraumatic Growth Inventory (PTGI): the Millennium Cohort Study
team and the Psych Health Program Area Team developed (Bliese, P., Hoge, C.,
Smith, T., Smith, B., & Adler, A). Moved from the deployment section of the
survey to a general area so all participants complete the question.
The items are now written in the present tense and without reference to
changes since the traumatic event in order to remove retrospective bias (a
criticism of the original version of the scale). Because the Millennium Cohort
study surveys people over time, some individuals will be surveyed before and
after exposure to deployment/traumatic events. So any changes following
deployment can be directly examined by comparing attitudes pre and post
deployment. PTGI research has not historically been able to assess people preexposure so they've had to rely on retrospective recall.
The directions and response options were changed in order to match the
item edits. Previously, the response options had reflected how much change had
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o
o
o
o
•
•
•
occurred since the traumatic event, now the items can be matched in terms of how
much an individual feels the statements are true for them.
One item was added so it is now an 11 item scale (since the item about
how you "learned a great deal about how wonderful people are" is awkward and
previous publications suggest that an alternative item has equally good
psychometric properties, the item about compassion was added).
Q84-85 – Revision of injury variable to better assess injury and cause of injury
with ability to crosswalk back to previously collected data.
Q91 – Added a 3 item measure to determine resiliency.
Q98 - Added a question on use of a separate location decompression program.
Due to survey movement the Privacy Act Statement and Q99 were able to be
moved back onto the 24-page survey instrument rather than be an additional page
as previously submitted.
Family: Many of the below question additions were added to remain consistent with
the Millennium
o Cohort Study questionnaires. Various minor formatting revisions have also been
made since initial IRB approval.
o Consent Form – Replaced language of gift card incentive to generalize the various
options we’ll offer.
o Q21-23 - Added questions to measure infertility in both men and women.
o Q24 – Moved “Are you currently pregnant?” to e instead of a. Removed h and
i to avoid repetition with new infertility questions.
o Q29 (m-n) - Added “Ringing in the ears” and “Difficulty with balance.”
o Informational blue box underneath Q30, added words “above on this page” for
clarity.
o Q41 – Added oral health question.
o Q49 – Added question to measure support.
o Q50 - Added a 3 item measure to determine resiliency.
o Q56(o-q) – Added response options to include mental health care stereotypes.
o Q78-81 - Added the Adverse Childhood Events (ACE) scale that was taken
directly from the RAP survey instrument (Section 10 General History Q1219).
o Q117 – Added sleep question.
o Q118(d) – Added ‘snoring’ to response options.
o Q124 – Added question to determine if spouse has ‘ever’ served in the
military.
Report Control Symbol approval has been obtained. DoD RCS#DD-HA(AR)2106
(expires 01/31/13). See attached renewal document, “Millennium Cohort Studies RCS renewal DD-HA(AR)2106.pdf”
Office of Management and Budget (OMB) review and approval will be pursued once
IRB approval is attained.
October 2009
• The following procedures are in place to ensure that confidential information will not be
used or abused in ways that might directly or indirectly harm the individuals involved:
• Administrative
o All study staff will receive training in confidentiality protection procedures.
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•
•
o Supervisors will monitor staff to ensure that they follow proper confidentiality
procedures.
o An annual review of confidentiality procedures will be conducted.
o If study staff resign or otherwise leave the program, they will remain under
obligation to protect the confidentiality of all data collected as part of the study.
Procedural
o The respective service survey approval managers will review the introductory
letter and mail questionnaire. Their approval will be required before initiating the
mailing.
o Study staff will store study paper records in locked metal cabinets at NHRC.
Paper records that are no longer needed will be shredded.
o All data files will be destroyed when all research questions have been answered.
Computer Security
o To gain entry into the study database, staff will be required to enter their personal
ID numbers and password.
o Study staff will download study data through secure data transmission links
meeting standard DoD requirements. The database will be stored on existing
NHRC information systems network. This system meets current DoD data
security requirements.
o All identifiable data will be maintained at NHRC only and not further disclosed.
o Supervisors will grant access to the confidential database only to those staff who
require it.
o The NHRC network fire wall is in place to deter unauthorized access to these
files.
o All data will be carefully guarded and used only to meet the stated study
objectives.
o Personal identifying information will be removed from the analytic database once
the survey, medical facility use, and demographic information are linked and
stored separately. Only the statistician, who is familiar with the database, will
link personal identifiers with the data for the initial match or any subsequent
matches, and the identifiers will again be stripped following the match.
o The study database will reside within the NHRC network environment. Only
IRB-approved NHRC researchers will have access to identifiable data.
o Information transmitted over the Internet will be done so using SSL-encrypted
transmission lines. Further, users will have to enter their unique study ID number
and last four digits of their social security number to send completed
questionnaires.
o NHRC will periodically review the computer security procedures, including
challenges to the security fire wall erected to assure its integrity.
October 2009
• Based on external consultant review and sponsor driven additions, the following changes
have been made to the Panels 1, 2 and 3 “follow-up” questionnaires and the Panel 4 “new
enrollee” questionnaire:
• Women-only question set has been slightly modified to include a pregnancy and a
gestational diabetes question. See Q12e&g (Follow-up) and Q13e&g (New
Enrollee).
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•
4 health conditions have been added to the general health condition list based on the
most frequent diseases that were written in the “Other” open text field in past surveys,
including ‘High cholesterol requiring medication,’ ‘Kidney stones,’ ‘Acid
reflux/gastroesophageal reflux disease requiring medication,’ ‘Tinnitus/ringing of the
ears,’ and ‘Infertility.’ Q13b,p,bb,ee,ss (Follow-up) and Q14b,p,bb,ee,ss (New
Enrollee).
o Dominant hand question has been added to evaluate the possible relationship
between handedness and PTSD, Q26 (Follow-up) and Q27 (New Enrollee).
o Infertility questions have been added for both men and women to answer, Q27-28
(Follow-up) and Q28-29 (New Enrollee).
o Five questions have been added regarding sleep distribution from the Insomnia
Severity Index standardized instrument, and one question was added regarding
over the counter medicine use. Q33-38 (Follow-up) and Q34-39 (New Enrollee).
o Added the NHANES’ standardized oral health measure. Q41 (Follow-up) and
Q42 (New Enrollee).
o Added a social support measure, which seems to be an important resilience factor
for many of the mental health factors. Q56 (Follow-up) and Q57 (New Enrollee).
o 4 complementary and alternative medicine treatments that the National Center for
Complementary and Alternative Medicine found to have had significant increases
from 2002-2007 have been added to the CAM question, including ‘Yoga,’
‘Meditation,’ ‘Movement therapy,’ ‘Breathing techniques.’ Q57g,h,o,p (Followup) and Q58g,h,o,p (New Enrollee).
o Expanded serious injury question set to include amount of time lost from work
and specific associations for motor vehicle accidents/crashes. Q82, 84-85
(Follow-up) and Q84, 86-87 (New Enrollee).
o Added an employment status question. Q89 (Follow-up) and Q91 (New Enrollee).
In lieu of this addition, the question “Do you have a civilian job at this time?
Answer choices: ‘Yes,’ ‘No civilian employment at this time,’ ‘Homemaker’”
was removed.
o Added a household income question. Q90 (Follow-up) and Q92 (New Enrollee).
o With approximately 25% of Millennium Cohort participants now separated from
the service, a couple of VA medical care use questions have been added, Q94-96
(Follow-up only). Also added a question to determine if a participant is employed
by a US Federal agency or the US Federal government. Q97 (Follow-up only).
o Added ‘exposure to smoke from burning trash and/or feces’ to the deployment
exposure question. Q99n (Follow-up) and Q96 (New Enrollee).
o Added the Posttraumatic Growth Inventory Short Form 10-item questions which
measures resiliency after a traumatic event. Q102 (Follow-up) and Q97 (New
Enrollee).
o Please note, the PHQ (i) “Thoughts that you would be better off dead or hurting
yourself in some way” has been removed from the PHQ standardized instrument.
•
Office of Management and Budget (OMB) review and approval will be pursued once
IRB approval is attained.
•
Based on the success of the Starbucks gift card pilot study encouraging voluntary
participation, we request permission to include a “Hallmark Reward Choice” $5.00
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rewards gift card as a cost-saving initiative for all online survey completers. As with past
survey cycles, the Millennium Cohort Study hat and coin are the two other cost-saving
initiatives that will be offered during the 2010-11 survey cycle for participating online.
• The “Hallmark Rewards Choice” certificate program offers a centralized mechanism
for the Millennium Cohort Study to offer participants a selection of gift cards from 51
national merchants (i.e. Applebee’s, Target, Home Depot, etc.). From Hallmark, the
Study would receive codes and/or URLs to their website to distribute to participants
after completion of the online Millennium Cohort Study survey. This code will be
emailed from the Millennium Cohort servers to the participant. In it will be a link
that will direct them to the Hallmark Insights website, where they can select which
retailer their gift card will be issued from. Hallmark only collects the minimum
information necessary to deliver the card (name, address, and phone number), and
does not require the participant to register for any sort of account before redemption.
The information they do collect is only used for delivery purposes, although they may
telephone the participant in case of an incorrect / undeliverable address. This
information is not shared with any third party entities.
• The Hallmark Insights program is SAS70 Type II compliant (application pending at
this date, expected to be completed by the end of 2009), and follows security
measures compliant with the Payment Card Industries (PCI) best practices. This
includes robust technical and physical security safeguards as well as regular auditing
to prevent fraud. Additionally, regular security scans are performed by trusted 3rd
party vendors to assess the technical security levels of the different components of
their program. At no point during these scans are client data (i.e. any Millennium
Cohort participant information) exposed to any outside entities.
• Expiration: The Hallmark Insights gift card does not expire nor does it decrease in
value, and can't be exchanged for cash.
August 2009
• Collaborating Institution(s): Abt Associates, Inc., Cambridge, MS; New York
University Langone Medical Center, New York, NY; Duke University Medical Center,
Durham, NC
• Millennium Cohort Family Collaborator(s):
William Schlenger, PhD, Abt Associates, Inc, Cambridge, MS
Charles Marmar, MD, New York University Langone Medical Center, New York, NY,
John Fairbank, PhD, Duke University Medical Center, Durham, NC
• The collaborators listed above will provide expertise on family behavioral and mental
health epidemiologic issues. They will assist in the study and survey instrument
design, and collaborate and/or serve as their intuition’s liaison on research projects
for the Millennium Cohort Family Study. All data exchanged which will include selfreported survey data as well as supportive military medical/personnel records, will be
deidentified and will follow JRRA/BAA/MOU guidance as directed by NHRC IRB.
o Each collaborator is operating under a valid assurance to protect human subjects
involved in research.
o CVs for each collaborator are attached.
o The Naval Health Research Center’s IRB will provide primary review over the
Millennium Family Cohort Study necessary approvals.
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•
Background
• In recent decades, mental health and related outcomes for US military service
members following deployment have been documented for multiple conflicts. Much
less attention has been paid, however, to deployment-related outcomes for spouses
and other family members of those deployed. Family member functioning can be
degraded by separation and associated worries, and service member functioning can
be degraded when concern over events at home reduces their ability to concentrate or
to be attentive and vigilant. Additionally, war zone stress exposure has been shown to
have substantial impact on service members after they return home, which can
produce additional stressors for both the service member and their families when they
are re-united.
• Family relationships play an important role in the functioning and well-being of US
military service members. It has been suggested that family relationships can be an
important source of support that bolsters force readiness, or alternatively, a stressor
that depletes service members’ resources and reduces readiness. Few epidemiologic
studies have examined the impact of war zone deployment on family members and
family functioning. The Millennium Cohort Study is strategically positioned to
complete this research. This research will also facilitate identification of specific
areas of intervention, such as deployment-related stress, family member resilience,
family support dynamics, service member and family well-being, and force readiness.
•
Objectives
• The primary Millennium Cohort Family Study objective is to compare the adjusted
probabilities of new onset diseases and conditions among military spouses and
children.
•
•
Hypothesis
• Stressors associated with deployment (e.g. geographical separation, increased risk of
being wounded or killed) are associated with adverse mental health and related
outcomes for spouses and children of deployed service members.
•
•
The secondary Millennium Cohort Family Study objective is to assess the importance
of family support and other factors on positive and negative health outcomes.
Strong family support is associated with positive mental health and related outcomes
for spouses and children of deployed service members.
Procedures
• Based on recommendations from sponsors and advisory committees, and the success
of the Millennium Cohort, a fourth enrollment panel will be added to the next survey
cycle beginning in 2010. The Millennium Cohort was originally designed to follow
three panels of participants that enrolled in 2001, 2004, and 2007 through 2022. The
team plans to invite approximately 250,000 individuals of active-duty, Reserve, or
National Guard status, with 2-5 years military service experience, oversampling for
women, Reserve/National Guard, and those with a deployment-related injury. Out of
the 250,000, an estimated 62,500 new participants will enroll. This group will be
consented to complete 7 follow-up surveys over 21 years, with one survey to
complete every 3 years. The invited group will be a stratified random sample from
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the Defense Manpower Data Center. The current total number enrolled is 151,597, so
this new enrollment will bring the total number enrolled to approximately 214,000
individuals.
•
In addition to Panel 4, a Family Cohort component will be added to the next survey
cycle beginning in 2010. In order to assess the interrelated health effects of military
service and deployment on service members, spouses, and co-resident children, the
Millennium Cohort Study team and collaborators will survey the spouses of newly
enrolled Panel 4 participants that consent to this assessment. The team estimates that
about 10,000 spouses will enroll in the study, about half of whose service member
will have been deployed to the conflicts in Iraq and Afghanistan at least once.
•
Surrogate data on children health will be obtained from the spouse. The data collected
on these children will be generalized. No child will be individually identified for the
purposes of this study. Because families and family relationships change over time
and to maintain methodological consistency with the Millennium Cohort Study,
spouses will be asked to complete 7 follow-up surveys over 21 years, with one survey
to complete every 3 years. Participants of the Family Cohort Study will only have the
option of completing a web survey.
o In October of 2009, 250,000 service members will be randomly selected from
military rosters. These individuals will be invited to participate in the Millennium
Cohort’s fourth enrollment cycle once OMB and RCS approvals are in place.
These participants will be referred to as Panel 4 participants/members. Out of
these Panel 4 members, the married service members will view the following: the
Millennium Cohort Family Study survey instrument, and the Panel 4 Millennium
Cohort Family Study informed consent document and permission form. From this
group of consenters, the first 100 spouses to consent to the study and complete
their surveys will be included in a pilot sample. This group of 100 individuals will
be treated the same as the large group of Millennium Cohort Family Study
participants, however, the internal team of analysts will review their survey to
ensure participants are understanding the survey questions. Based on survey
research, missing data along with data completion rates will indicate how the
survey is interpreted. Also, an open-ended question will be added to the end of the
first 100 surveys, "Is there anything you didn't understand or would change in this
survey?" This will provide us with information on how the questions were
interpreted and understood. We will not be requesting further feedback from these
participants.
o Millennium Cohort Study contact methods will be employed, including the
modified Dillman survey methodology. Complex algorithms will be developed
for email, mail and response tracking.
o A separate website will be built for this sub-study, but will link directly to the
Millennium Cohort Study website, www.millenniumcohort.org. The URL will be
www.familycohort.org
o Like the Millennium Cohort Study, nominal incentives will be offered to
participants that complete the survey online, participants will be offered the
choice of a $10 gift card to the following; military exchange (AAFES/NEX gift
card), Starbucks, or Amazon.com. AAFES/NEX and Starbucks gift cards will be
mailed to participants within 6 weeks of survey completion, and Amazon.com
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electronic gift cards will be emailed within one week of survey completion. None
of the gift cards are exchangeable for cash.
•
Data Analysis
• The adjusted probabilities of new-onset diseases and conditions among military
spouses will be conducted by examining self-reported data, and by validating these
data with objective electronic medical data when possible. Spouse-reported data on
children will be analyzed but not linked with objective data. Multivariable logistic
regression modeling will be used for each outcome, and multivariable Cox
proportional hazard modeling when possible. Similar to previous analyses conducted
within the Millennium Cohort Study, covariate adjustment will include age, gender,
occupation, marital status, race ethnicity, deployment status, branch of service,
income, and length of service. SAS statistical analysis program software (SAS
Institute, Inc., Cary, NC) will be used for the Millennium Cohort Family Study
analyses.
•
Risks
• The data collection procedures are not expected to involve any risk or discomfort for
spouses or children. The only risks are those associated with the inappropriate
disclosure of data provided. However, this research group has collected similar
information from several studies over many years without any cases of inappropriate
disclosure.
•
Data
• We will link to Department of Defense personnel and medical records obtained from
the following sources: DMDC (Data Manpower Data Center) and TMA (Tricare
Management Activity). For mortality data only, we will link to AFIP (Armed Forces
Institute of Pathology), NDI (National Death Index), and VA (US Dept of Veterans
Affairs). In addition, if the spouse is an active duty member and retires or separates
from military service and utilizes Department of Veterans Affairs for medical
services, we will link to VA medical and personnel data as well as the DoD Joint
Theater Trauma Registry and the Navy/Marine Corps Trauma Registry. These data
will complement subjective measures with objective measures of exposures and
health outcomes. These databases are accessed electronically through secure
computers located at the Naval Health Research Center. Unique identifiers are used
to link each participant with their electronic data. No data regarding a child and
his/her health will be linked from any source for the purposes of this study.
•
The term “Family” will be defined as: An individual(s) living in household for
majority of the time who has an impact on the household environment. Co-residency
is not a requirement for the spouse.
•
The term “Sponsor” will be defined as the military service member who is a member
of the Millennium Cohort Study and has named the invited participant as his/her
spouse. The term "your sponsor" will be referred to as "your spouse" throughout the
survey. Continued participation of a spouse regardless of relationship status is
important since the aim of the study is to look at the long-term health effects.
Therefore, co-residency of the spouse is not necessary since some spouses are non-
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co-residents (i.e. military to military married who are in different services, and
spouses that live with parents or other family members while military member is
deployed or stationed overseas); however, co-residency of children will be a
requirement. Following participants in the study long after they are divorced,
separated, or no longer co-residing is still relevant, since such data will be used to
assess the long-term health of family members. The relevancy of collected data on
the sponsor may be diminished if contact with the ex-spouse becomes limited.
o Attached is the Panel 4 Millennium Family Cohort consent form. This web-based
consent form is to be digitally signed by the Panel 4 Millennium Cohort member
prior to his/her spouse being invited to participate in the Millennium Family
Cohort Study. Prior to providing permission for the spouse to participate, there
will be a link to the Millennium Family Cohort Study survey for review, and the
Panel 4 participant will be able to print the consent form for his/her records. Once
electronic consent has been obtained, the spouse of the Panel 4 member will be
contacted and invited to participate in the Millennium Family Cohort Study.
o Confirmation of electronic consent will be recorded by each participant (both
the Panel 4 member and spouse) typing out their full name and checking the
“voluntary consent” box. All information collected through the Internet
survey is done by Microsoft Sequel Server and is backed up daily by NHRC
database systems.
o Note, we request a waiver of signed informed consent for both spousal
informed consent and Panel 4 participant consent to be a secondary subject, as
consenting will occur online.
o The Millennium Family Cohort Survey instrument and consent form are attached.
The survey instrument uses a number of validated scales to assesses the following
(sources listed on pg. 33 of Family Survey):
o Demographic information
o Relationship status
o Child information
o General health (including sleep)
o Spouse, family, child, and service member stress
o Impact of deployment
o Impact of military service
o Family cohesion, expressiveness and conflict
o Child behavioral, developmental and health problems
o Services received
o Alcohol and tobacco use
o Military specific questions for spouses serving in the military
o CAPT Margaret Ryan’s (Naval Hospital Camp Pendleton) status has changed
from co-investigator to solely acting as the Millennium Cohort Study’s medical
monitor.
April 2009
• This protocol has undergone a change of staff. Ms. Skye Endara and Ms. Lauren
Zimmerman no longer work for the DoD Center for Deployment Health Research. Ms.
Amber Seelig, Dr. Donald Sandweiss, , Ms. Kelly Jones, and Mr. Gordon Lynch have
been added as new key support personnel.
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February 2009
• To determine new techniques to better encourage participants in the future to continue to
participate and to maintain interest in the study, we request approval to conduct a mock
administration of the Millennium Cohort survey in order to get input from nonparticipants.
o The purpose of the focus group testing session is to go over items in the approved
survey (mock administration) and gain insights from non-participants about the
instrument. Participants will be asked to address any aspect of the survey including
clarity of approved subject materials, visual appeal of the approved materials, and
thoughts about what might be done to increase respondent participation.
o Focus groups will consist of 9 or less active duty service members, including
Reserve/Guard status, with 1-3 years of service, per location.
o Focus groups will last no longer than 60 minutes per session.
o Each session will be audio recorded and have a note-taker separate from the
moderator. Audio recordings will be destroyed once they are transcribed.
o Participants will be asked to provide oral consent after reading “Information to
Participants” form.
o Millennium Cohort co-investigators will serve as the moderators and recruit
individuals based on the composition goals. Each moderator will post a flyer for
solicitation (see attached document).
o Study will include 5 focus groups at the following locations: Camp Pendleton - CAPT
Margaret Ryan, Wright-Patterson AFB - Col Tim Wells, Madigan Army Medical
Center - COL Paul Amoroso, Veterans Affairs Puget Sound - Edward Boyko, MD,
MPH, Uniformed Services University of the Health Sciences - Tomoko Hooper, MD,
MPH, FACPM
o Guidelines will be distributed to each moderator. Also, a packet of group materials
(notepad, pen, cost-saving initiatives, and copies of a survey packet, postcard, and
email) will be sent to each moderator to distribute to each individual. Moderators
will provide a background of the Millennium Cohort Study and then begin an open
discussion about current Millennium Cohort marketing techniques.
o Moderators will provide a summary of the testing session that will be added to the
Millennium Cohort Study Manual of Operations and will include: date and location of
test session, number of participants, relevant demographic information on each, and
response to screener questions, a summary of the discussion for each section of the
moderator guidelines, and a summary conclusion of the findings and
recommendations based on consensus reached at the focus group testing session.
Identities of participants will not be recorded.
o Small gifts of appreciation, such as a Millennium Cohort hat and coin, will be
distributed to each focus group participant.
•
The third Millennium Cohort Study enrollment cycle concluded 31 December 2008.
Responses for the new Panel 3 enrollment group totaled 43,440. 198,275 individuals that
were randomly selected through the Defense Manpower Data Center were contacted to
participate in the Panel 3 enrollment group. The original IRB protocol estimated that
140,000 participants would be enrolled in the Cohort (Panels 1, 2, and 3). However, after
the completion of the third enrollment cycle there are now 151,597 participants enrolled.
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Due to the methodology of the research (mailed invitation to complete a selfadministered survey), once invited, all surveys of participants contacted to complete the
2007-08 survey were accepted. This resulted in more participants enrolled than was
anticipated when the original study protocol was created.
November 2008
• This amendment seeks to allow a bi-yearly data extract from the Joint Trauma Theater
Registry (JTTR) so as to allow linkage of records that occur in both the JTTR and the
Millennium Cohort data base. This linkage will allow researchers to classify the types
and severity of injuries sustained during combat and to analyze the data together for long
term psychological and functional health outcomes. Data transfer will be encrypted via
password protected e-mail and all data will only reside on secured servers in password
protected files after it arrives at NHRC.
The following variables will be requested from the JTTR: Admitting Service, Age, AIS,
AIS Coder, Arrival-Ref Fac, ASCOT, Burn Type, Burn P, Cause-Level IV&V, Cause of
Injury Specify, Causes-Level III, City-Injury Location, Classification of Injury, Conflict
Related, Country-Injury Location, Date of Birth, Days in Sick Quarters, Days on Light
Duty, Departure-Ref Fac, Discharge Condition, Discharged To, Disease Related, E-Code,
Ethnicity, Extent of Body Surface Involved 948, Gender, GCS-Discharge Vitals, GCSED, GCS-Pre-Facility, GCS-Ref-Fac, GCS-Ref Fac(transport 1), GCS-Ref Fac(transport
2), Height/Units, ICD-9,Inhalation Injury, Injury Date and Time, ISS, ISS Body Region,
Job Description, Mechanism-Level IV&V, Medication Given, Military Coding, Military
Rank, NISS, Non-Trauma Diagnoses, Patient Military Service, Pre-Existing Conditions,
Race, Revised Trauma Score, SSN, Time in ED, Total Days Hospitalized, Total Days
ICU, Weight/Units-Discharge Vitals, Wounded By.
May 2008
• (Modification accepted) Dr. Tyler Smith’s role changed from Co-Investigator to Principal
Investigator. Dr. Tyler Smith replaced CAPT Margaret Ryan as Principal Investigator
due to her permanent change of station to Naval Hospital, Camp Pendleton. CAPT Ryan
will remain on the study as an external co-investigator. As an external co-investigator,
CAPT Ryan will have no access to primary study data. Her role will be to assist in
developing analysis plans, reviewing/interpreting results, and developing scientific
manuscripts. The informed consent document for this study has been reviewed and
remains accurate, indicating consistent general information for contact of the Principal
Investigator.
•
(Modification accepted) To increase response rate, we request permission to conduct a
pilot study in which a designated group of participants are called with an automated
tailored voice message. The pilot group will consist of Panel 1 and Panel 2 consented
participants that have not completed the 2007 questionnaire and that have a phone
number on record. The message will encourage participation, but state that this is a
voluntary study. The provider uses a web-based auto dialer. The message will be left
whether or not the call reaches a live person or an answering machine. Overseas phone
numbers will not be included in this pilot study. See attached for a script of the message.
o The system will dial each number up to 3 times to attempt to connect. Upon
completion of each call the result will be logged into the software's database (i.e.
human pick up, voice machine, busy, not in service). If a number is answered by a
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person or the answering machine picks up, the report will indicate a successful
delivery, and the number will not be dialed again. If a number is not in service, does
not answer, is invalid or hangs up after connection, the result is listed as a failed
connection in the database, and the number will not be called again. If however, a
number experiences a technical error, or is busy, the system will attempt 2 additional
times (5 minutes apart) and then list the final status on the database report. Once the
list has been executed a comma delimited text file will be exported and uploaded into
our database. The data results file will be used to remove bad telephone numbers and
identify successful call attempts.
o The provider has a technical support team in-house 24 hours a day to monitor the
software and ensure there aren’t any technical malfunctions, and to answer calls.
o To ensure that auto dialing will only take place during reasonable hours telephone
numbers will be categorized by time zone and the software will be set-up to call
during mid-day in all time zones. If the list is not completed within the time limit that
we specify for that day, the calls will be stopped and resumed the next day during the
specified time frame.
•
(Modification accepted) The 2005 Millennium Cohort Study: Telephone Study of 3,000
Non-Responders conducted by RTI for the Millennium Cohort suggested that some type
of a cash incentive up front would increase and encourage participation. The 2007-08
Millennium Cohort questionnaire cycle launched on May 17, 2007 and will conclude in
July 2008. To reach response rate goals, we request permission to conduct a pilot study
in which a gift card incentive will be added to a designated group of Panel 1 and Panel 2
consented participants that have not completed the 2007-08 questionnaire.
o The pilot group will consist of two groups of approximately 18,500 Panel 1 and Panel
2 consented participants that may be of active duty or separated status. One group
will be the control and will not receive a gift card in their Certified mail packet, and
the other group will receive a $5 Starbucks coffee gift card. The current text on the
outside questionnaire packet envelope that promotes a free gift after completing the
questionnaire online will be revised to indicate the inclusion of a gift inside the
envelope.
•
This protocol has undergone a change of staff. Mr. Robb Reed no longer works for the
DoD Center for Deployment Health Research. Ms. Jamie McGrew, Ms. Molly Kelton,
Mr. Martin White, Ms. Skye Endara, and Maj Nisara Granado have been added as new
key support personnel.
CAPT Margaret Ryan will replace CDR Kevin Russell as the Medical Monitor of the
Millennium Cohort Study.
Co-investigators Dr. Gregory Gray and Col (Ret) James Riddle have transitioned to
consultants.
•
•
May 2007:
• This protocol has undergone a change of staff. Mr. Rob Shipps, Mr. Adam Richardson,
Mr. Tony Russo, Ms. Christina Spooner, Ms. Katie Chapman, Ms. Laura Chu, and CDR
Sylvia Young no longer work for the DoD Center for Deployment Health Research. Ms.
Charlene Wong has been added as new key support personnel.
• Col Tim Wells and Dr. Tyler Smith changed roles from research support to CoInvestigators. They have been added to section VII.1 of the protocol, ‘Organization Of
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Research Effort/Duties and Responsibilities’ on page 29 and Appendix B: ‘Investigator
Assurance Agreement.’ Signed Investigator Assurance Agreements are attached. Col
Wells will help with interpretation of results and report writing only. Col Wells will not
have access to any identifiable data in this capacity. Please note that “Co-investigators”
with no access to identifiable study data (these include Col Wells, COL Amoroso, Dr.
Gray, Dr. Boyko, Dr. Gackstetter, and Dr. Riddle) may be considered to work in an
academic “Consultant” capacity.
•
A Joint Research/Review Agreement has been established between the Naval Health
Research Center and Uniformed Services University of the Health Sciences so coinvestigator Dr. Tomoko Hooper can request de-identified data transfers of Millennium
Cohort data. The Joint Research/Review Agreement is attached.
•
USARIEM is no longer a collaborating institution due to co-investigator COL Paul
Amoroso relocation to Madigan Army Medical Center. Memorandum for the Record
attached. As above, COL Amoroso will help with interpretation of results and report
writing only. COL Amoroso will not have access to any identifiable data in this capacity.
•
There have been slight formatting changes made to the 2007 enrollment consent form
since it was approved by the IRB in June 2006. The finalized informed consent form is
attached.
•
A Public Burden Statement has been added to the Privacy Act Statement. The updated
Privacy Act Statement is attached.
•
Letter of support from the Chairman of the Joint Chiefs of Staff, GEN Peter Pace, will be
included in 2007 questionnaire packets to encourage participation. Copy is attached.
•
Based on external consultant review, the following changes have been made to the Panels
1 and 2 follow-up questionnaires and Panel 3 new enrollee questionnaire:
o Q4 on birth year has been added as an extra identifier for quality assurance reasons.
o Women-only question set has been slightly modified to better assess menstrual
periods. See Q12a-b (Panels 1&2) and Q13a-b (Panel 3).
o Fibromyalgia has been added to the list of health conditions, Q13s (Panels 1&2) and
Q14s (Panel 3).
o The Atkins diet specific question has been removed from the questionnaire.
o Complementary and Alternative Medicine (CAM) section of the survey has been
expanded to include use of body building, energy and weight loss supplements, Q47ac (Panels 1&2) and Q48a-c (Panel 3).
o Questions on alcohol use have been slightly modified to better address binge
drinking. See Q50-60 (Panels 1&2) and Q51-62 (Panel 3).
o Additional life stressors have been added to Q67 (Panels 1&2) and Q69 (Panel 3).
o Injuries are assessed through Q70-71 (Panels 1&2) and Q72-73 (Panel 3).
o Occupational code 5H, Social Worker, has been added to the Officer or Warrant
Officer Military Occupational Categories list.
o Separation questions have been added to the survey. See Q76-78 (Panels 1&2) and
Q78-79 (Panel 3).
o The following country and sea locations have been added to the imminent danger pay,
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hardship duty pay, or combat zone tax exclusion list: Bosnia or Herzegovina, and the
Adriatic Sea. Kuwait and Iraq have been separated into separate country codes.
o Additional deployment-specific exposures are assessed in Q82 (Panels 1&2) and Q83
(Panel 3). Several questions, including (m), “…being responsible for the death of a
non-combatant,” are recognized as potentially sensitive. Please note that these
questions are a subset of the WRAIR-developed Mental Health Assessment Tool
(MHAT), recommended by MHAT leaders (COL Charles Hoge and COL Carl
Castro), and selected to specifically exclude incriminating queries (such as
unnecessary use of force against non-combatants).
•
Office of Management and Budget (OMB) review and approval of survey instruments
was completed in 2006; documentation attached.
June 2006:
• This protocol has undergone a change of staff. Mr. Nick Martin, Ms. Angelee Ferber,
and Ms. Sheila Jackson no longer work for the Department of Defense Center for
Deployment Health Research. Ms. Kari Welch, Ms. Laura Chu, Ms. Lacy Farnell, Ms.
Carolyn Reed, and Ms. Kathy Snell have been added as new key support personnel.
•
The consent form for the 2007 enrollment has been modified to include HIPAA language
and minor technical changes. See Appendix A.
July 2005:
• This protocol has undergone a change of staff. Ms. Janette Astiazaran, Mr. Tom Corbeil,
Ms. Doris Diehn, and Ms. Wendy Goldfinger no longer work for the Department of
Defense Center for Deployment Health Research. Ms. Katharine Chapman, Ms. Angelee
Ferber, Ms. Isabel Gomez, Ms. Cynthia Leard, and Ms. Christina Spooner have been
added as new key support personnel. As of 13 June 2005, subjects who begin the survey
online will no longer be asked, “Would you like to receive an email reminder?” Due to
coding/script challenges, investigators have been unable to determine who specifically
requested a reminder and who closed their browser without responding to the prompt.
Per discussion with the IRB Chair and email approval dated 01 June 2005, email
reminders will now be sent to all individuals who began the survey online but fail to
complete/submit.August 2004:
• This protocol has undergone a change of staff. Ms. Suzanne Clark, Ms. Rebecca Gunnill,
and Dr. Paul Sato no longer work for the Department of Defense Center for Deployment
Health Research. Ms. Janette Astiazaran, Ms. Wendy Goldfinger, Mr. Travis Leleu, Mr.
Nick Martin, Mr. Rob Shipps, Mr. Steven Speigle, LtCol Timothy Wells, and CDR
Sylvia Young have been added as new key support personnel. CDR Kevin Russell has
replaced Dr. Paul Sato as the Medical monitor for this study.
•
The consent form has been modified for Panel 2 participants. Panel 2 participants were
drawn from personnel serving as of October 2003 and they will be followed for 18 years.
This change appears in yellow highlight on the consent form. The consent form also has
been modified to clarify that survey data, if provided, will be linked to other military and
medical databases. Consent form also modified to reflect that participation may be
discontinued by investigators in the unlikely event that study ceases earlier than planned.
•
Based on recommendations by the Millennium Cohort Scientific Steering and Advisory
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Committee (SSAC), changes have been made to the Panel 1 follow-up survey and the
Panel 2 enrollment survey. The changes are as follows:
o The previous survey instrument lacked self-reported information on hospitalization
and illness that prevented work. To address this, Q10 and Q11 were added to the
Panel 1 follow-up survey and the response options for Q8 were expanded to gather
hospitalization information for specific conditions.
o Q19-22 and Q32-34 were added to the Panel 1 follow-up survey to better capture
changes in weight over time, general dietary intake information, and physical activity
levels.
o The Complementary and Alternative Medicine (CAM) section of the survey was
expanded to include therapies that now constitute the accepted definition of CAM
therapies. This change is evidenced in Q46 of the Panel 1 follow-up survey and Q38
of the Panel 2 enrollment survey.
o In response to the increased use of smallpox vaccine, participants are now asked if
they have received the smallpox vaccine within the last 3 years. These are Q48 in the
Panel 1 follow-up survey and Q40 in the Panel 2 new enrollee survey.
o To address challenges in deployment data, questions were added to both survey
instruments. These are Q65-67 in the Panel 1 follow-up survey and Q60-62 in the
Panel 2 follow-up survey.
We request permission to access existing data sources on prior healthcare utilization among nonresponders. Data on these individuals are essential for exploring response bias and external
validity of the findings of this study. Only de-identified demographic, administrative, and
medical data for non-responders and decliners will be maintained to explore potential differences
between survey participants and non-participants. Please see description and justification in
protocol text, page 18.
June 2004:
• We have added an additional data source to the Supplemental Medical and
Administrative Data section of the protocol. We will now also link to the Pre and PostDeployment Health Assessments (DD2795 and DD2796) survey data. The addition is
evidenced in yellow highlight on the page numbered 20 of the protocol.
9 Oct 03:
• In the recruitment letters, the clause “If you are willing to participate” has been added
before “please review and sign the Consent Form…” as requested by the IRB.
• The phrasing on the consent form concerning potential benefits of the study has been
changed as per IRB recommendation.
• As requested by the IRB, the email address for the IRB Chair has been added to the
contacts section of the consent form.
• The bullet “Will you be provided medical care based on your responses?” and the
corresponding response as outlined by the IRB has been added to the consent form
document.
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10 Sept 03:
• This protocol has undergone a change of staff. Some key support personnel, Ms.
Jacqueline Valdes and Ms. Dinice Jimenez, no longer work for the Department of
Defense Center for Deployment Health Research.
8 Nov 02:
• Consented participants will be contacted semi-annually to verify their current contact
information. Semi-annual contact, in the form of a postcard or an email, will be a
relatively simple means to maintain current mail and email addresses for study
participants. This change is evidenced in Appendix
•
Email invitations to complete the Millennium Cohort survey online were extended to
invited participants for whom we had email addresses. Since that time, an additional
incentive (phone card) has been added enabling participants to select one of two
incentives (T-shirt or phone card). The participants we previously extended email
invitations to did not have the opportunity to receive the new incentive. A final email
invitation will be extended to these individuals so that they will have an opportunity to
receive either incentive.
•
This protocol has undergone a change of staff. Some key support personnel (Lacey
Evans, James Ramage, and Karen Schlangen, MA) no longer work for the Department of
Defense Center for Deployment Health Research. Ms. Jacqueline Valdes, Ms. Dinice
Jimenez, and Mr. Thomas Corbeil have been added as new key support personnel.
4 Jun 02:
• Email addresses were obtained for study participants. Many email respondents have
indicated that postal invitations were never received. Brief emails introducing the
Millennium Cohort Study and inviting individuals to join the study have been sent to
invited participants.
25 Mar 02:
• The consent form has been modified to reflect the transition from the Committee for the
Protection of Human Subject to the Institutional Review Board and the appointment of
Christopher G. Blood, JD, MA, as the Chair. This change is evidenced in Appendix A.
23 Jan 02:
• New duty addresses obtained from DMDC. Letter of endorsement form the Secretary of
Defense will be sent to subjects in lieu of the third reminder postcard. An additional
questionnaire packet will be sent to subjects following the endorsement letter.
Official/duty e-mail addresses will be obtained and used for sending reminders to
participants.
•
There has been a change in staff. Gia Gumbs has replaced Karen Chesbrough as the
study coordinator.
15 Oct 01:
• Added additional signatures for new personnel for Protocol Signature Pages and
Appendix B. Investigator Assurance Agreements.
•
Revised Cover Letter #2 to recognize 11 September 2001 terrorists’ attacks.
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01 Aug 01:
• Quality assurance revisions made to consent form, questionnaire, and cover letters to
reflect program updates.
31 May 01:
• LCDR Ryan’s role changed from Co-Investigator to Principal Investigator. LCDR Ryan
replaced CAPT Gray as Principal Investigator due to his retirement. CAPT Gray will still
remain on the study as a Co-Investigator.
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APPENDIX F.
MILLENNIUM COHORT PARTICIPANT CONTACT MATERIALS
Incomplete reminder
Subject: –DoD Health survey
Dear [Name],
Thank you for taking the time to start filling out your Millennium Cohort survey. We
understand that your time is very valuable, but your participation in this landmark study
is very important.
Please follow the link below to finish the remaining questions:
[link]
Your continued involvement in this important project makes it possible to inform policy
makers regarding your experiences and to guide prevention measures that positively
impact former, current, and future Service members.
Thank you in advance for completing this important DoD survey.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888-9425222 or DSN 553-7465, and reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
If you would like this email address to be removed from our mailing list, click
here.
***Millennium Cohort Study - Protecting Service Member Health***
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Graphic postcard Current Service Member Non-Responder
We greatly appreciate your past participation in the Millennium Cohort Study. Unlike
other surveys you may receive, the Millennium Cohort Study is designed to follow you
and other Service members over time as you experience the unique challenges of military
life. This is why we are again asking for your help. Many of your fellow Service
members have already completed their follow-up survey. But in order for us to fully
understand how military service affects long-term health we need to hear from you.
You may complete the survey online at www.millenniumcohort.org. Just click Start
Survey and enter your Subject ID located below the barcode.
The time that you take to respond to the survey will greatly help improve the
understanding of how military service may affect the health and well-being of our
Service members.
Thank you for considering our request and for your service.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
Primary Institutional Review Board Protocol # NHRC.2000.0007.
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Graphic postcard Veteran Non-Responder
We greatly appreciate your past participation in the Millennium Cohort Study. Unlike
other surveys you may receive, the Millennium Cohort Study is designed to follow you
and other Veterans over the years to understand how your time in service is impacting
your health now. This is why we are again asking for your help. Many of your fellow
Veterans have already completed their follow-up survey. But in order for us to fully
understand how military service affects long-term health we need to hear from you.
You may complete the survey online at www.millenniumcohort.org. Just click Start
Survey and enter your Subject ID located below the barcode.
The time that you take to respond to the survey will greatly help improve the
understanding of how military service may affect the health and well-being of our
Service members.
Thank you for considering our request and for your service.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
Primary Institutional Review Board Protocol # NHRC.2000.0007
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Graphic postcard Partial-Completer
We want to thank you for the time that you have already invested to begin the
Millennium Cohort survey. Your participation goes a long way to helping current,
former, and future Service members and Veterans, so we hope you will consider
completing your survey.
Please visit, www.millenniumcohort.org to complete your survey. Just click Start
Survey and enter your Subject ID located below the barcode.
The survey will continue at the point where you previously stopped, so you will be able
to simply finish the incomplete sections.
The time that you take to respond to the survey will greatly help improve the
understanding of how military service may affect the health and well-being of our
Service members.
Thank you for considering our request and for your service.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
Primary Institutional Review Board Protocol # NHRC.2000.0007
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Email
Dear _[name]__,
We have been writing to you these last few weeks because it is so important that we hear
from you and want you to continue to be part of this important study. Some people have
written and asked us, “How will my participation in this study make a difference?”
Simply stated, without your shared experiences, we will not be able to determine the
potential impact of military service on the health and well-being of our Service members
and Veterans. It is essential that we receive your information because you have been
carefully selected to represent your fellow Soldiers, Sailors, Airmen, and Marines. There
are a limited number of Service members and Veterans taking this survey, so every
individual response is needed for this to be a successful study. Ultimately, the greatest
benefits of this study will not be known for many years. This is why it is essential to stay
involved with the study even after you are out of the service or if you are not currently
having any health concerns.
We have not, to the best of our knowledge, received your completed survey. Therefore,
we are sending this email to provide an electronic link, which we hope will make it easier
for you to respond.
Please follow the link below to complete your survey:
[link]
Thank you again for working with us to make the Millennium Cohort Study a success in
protecting the health of past, current, and future members of our military.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007
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Email (Panel 4 Married Version)
To be sent to the 2,396 Panel 4 non-responders whose Family Study spouse has
completed their survey.
Subject Line: Please help military families
Dear _[name]__,
Your spouse, , has already completed the 2014-2015 Millennium Cohort Family
Study survey and we hope that you will choose to complete the new Millennium Cohort
Service member survey as well!
Your continued participation in the Millennium Cohort Study is especially important
because you are one of nearly 10,000 Service members whose spouse is enrolled in the
Family Study. The Millennium Cohort survey of Service members is designed to work in
partnership with the Family Study to provide a more complete picture of military life.
Simply stated, without your shared experiences and that of other Service members, we
will not be able to determine the potential impact of military service, both recent and in
the past, on the health and well-being of our Service members, Veterans, and their
families.
In order to complete your survey, please click on the following link:
[link]
Thank you again for working with us to make the Millennium Cohort Study and the
Millennium Cohort Family Study successful in the DoD’s effort to protect the health of
current and future Service members and their families.
Very respectfully,
David D. Luxton, PhD
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol
NHRC.2000.0007
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Endorsement Letter
Dear _[name]__,
We truly appreciate the support of [endorsement name] (please see enclosed letter) for
our DoD study of the health and well-being of Service members and Veterans. We also
appreciate your help with this important study.
The Millennium Cohort Study is the largest study in US history on the short- and longterm military effects on the health of Service members and Veterans. The valuable
information that you and other Service members have previously provided has been
utilized by DoD leaders and policymakers to implement strategies to protect the health
and well-being of our Service members and Veterans. We hope you will continue to
share your experiences by completing the newest version of the survey.
We’ve created an easy way for you to complete the survey. Just go to
www.millenniumcohort.org and click Start Survey and enter your Subject ID:
xxxxxx.
We really appreciate your effort to complete the survey online – completing it on the web
saves DoD money and allows us to produce results more quickly.
Thanks so much for your time and sacrifices for our country.
Very respectfully,
David D. Luxton
Principal Investigator and Military Veteran
DoD Center for Deployment Health Research
San Diego, CA
www.millenniumcohort.org
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol #
NHRC.2000.0007
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Millennium Cohort Veterans Day Postcard/Follow-up correspondence
Veterans Day Reminder PC /Email – Non-responder
Contents: 5x7 Postcard
Dear _[name]__,
On this Veterans Day, the Millennium Cohort Study Team thanks you for your service.
We would not enjoy the daily freedoms we do without your selfless sacrifice.
Our team’s primary goal is to improve the health of all Service members. In order to do
so, we need your continued participation, even if you never deployed, or have left
military service. Recording your experiences over time helps reveal important health
issues and unique military exposures that affect Service members.
Please visit our website www.millenniumcohort.org to complete your survey.
Thank you again for your selfless service and dedication to our nation.
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
[Included in email]
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: 100003
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit
https://www.millenniumcohort.org/emailUnsubscribe.php?email=(Beverly.Sheppard@m
ed.navy.mil)
***Millennium Cohort Study - Protecting Service Member Health***
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Contents:
5x7 Postcard
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Veteran’s Day PC/Email - Responder
Dear _[name]__,
On this Veterans Day, the Millennium Cohort Study Team thanks you for your service.
We would not enjoy the daily freedoms we do without your selfless sacrifice.
Our team’s primary goal is to improve the health of all Service members. We would like
to thank you for taking the time to complete your 2014 survey. Recording your
experiences over time helps reveal important health issues and unique military exposures
that affect Service members.
Thank you for your selfless service and dedication to this study and our nation.
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
[Included in email]
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: 100003
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit
https://www.millenniumcohort.org/emailUnsubscribe.php?email=(Beverly.Sheppard@m
ed.navy.mil)
***Millennium Cohort Study - Protecting Service Member Health***
F-12
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Contents:
5x7 Postcard
F-13
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Email
Dear _[name]__,
We recently sent you a postcard to thank you for your service, and for your continued
support of the Millennium Cohort Study.
This request was sent to you because you previously completed a survey. We are
especially interested in your experiences and any changes in your health that may have
occurred since we last heard from you. Even if you have never deployed or are no longer
in the military, your response can provide greater insight into issues facing today’s
military Service members and Veterans. In order to gain a complete picture of military
service and its effects on the health and well-being of Service members over time, we
need to hear from you along with the other military Service members and Veterans
selected to be in this study.
If you have already been able to go online and complete the questionnaire, thank you! If
you have not yet had time to consider our request, we hope you will be able to do so
soon.
To complete the survey, please go to the website, www.milleniumcohort.org, click
Start Survey, and use the following Subject ID: xxxxxx.
Thanks so much for your consideration for completing this important study.
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
For any questions, please contact the Millennium Cohort Team at
[email protected] or [email protected]. Or call toll free 1-888942-5222 or DSN 553-7465, and reference your Subject Id: 100003
The Millennium Cohort Study is an authorized Department of Defense project. Note
Defense Manpower Data Center Reference # 00-0019, Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, Office of the
Assistant Secretary of Defense (Health Affairs), TRICARE Management Activity
Protocol # CDO-06-206, and Primary Institutional Review Board Protocol # Naval
Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit
https://www.millenniumcohort.org/emailUnsubscribe.php?email=(Beverly.Sheppard@m
ed.navy.mil)
***Millennium Cohort Study - Protecting Service Member Health***
F-14
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Questionnaire 1 mailing
Dear _[name]__,
During the last few weeks, we have requested your continued help with this long-term
study of the health and well-being of Service members. It is the only prospective study
that is able to evaluate the effects of military service on long-term health.
We have not, to the best of our knowledge, heard from you. We have enclosed a paper
survey, hoping that this will make it easier for you to fill out and return.
As a member of this study, you are adding to the picture of the overall health of military
Service members throughout their lives. Your past participation, and the participation of
others like you, has already helped us to provide valuable information the health impacts
of deployments and other military experiences. For example, we found that combatrelated trauma and predeployment insomnia symptoms increased the risk for developing
post-traumatic stress symptoms, depression, and anxiety following deployment. Findings
from this study are intended to influence training, health care, and policies of Department
of Defense as well as Department of Veterans Affairs related to serving in the U.S.
military.
We thank you for completing the enclosed survey and returning it in the postage-paid
envelope. Or, to complete the survey online, please go to the website:
http://www.MillenniumCohort.org
Enter your unique Subject ID: xxxxxx.
Be assured that this is an authorized study supported by the highest levels of the
Department of Defense. Note DMDC Reference #00-0019; DoD RCS #DDHA(AR)2106; OMB approval #0720-0029.
We look forward to hearing from you as one of our valued Millennium Cohort members!
[Insert Signature]
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
If you have any questions, please contact the Millennium Cohort team at our toll-free
number, 1-888-942-5222, or DSN 553-7465, or email [email protected].
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Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Contents:
Cover letter
Questionnaire
10x13 Envelope
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
10x13 Business Reply Envelope
F-17
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Endorsement letter – 2 versions Army and Navy
Dear _[name]__,
We truly appreciate the support of [LTG Patricia Horoho, or VADM Matthew Nathan]
(please see enclosed letter) for our DoD study of the health and well-being of Service
members. We also appreciate your help with this important study.
The valuable information that you and other Service members have previously provided
have been utilized by DoD leaders and policymakers to implement strategies to protect
the health and well-being of our Service members. We hope you will continue to share
your experiences by going online and completing the newest version of the survey. Even
if you have never deployed, have retired, or are no longer in the military, your
participation is essential!
We have created an easy way for you to complete the survey. Just go to
www.millenniumcohort.org, click Start Survey and enter your Subject ID: xxxxxx.
Be assured that this is an authorized study supported by the highest levels of the
Department of Defense. Note DMDC Reference #00-0019; DoD RCS #DDHA(AR)2106; OMB approval #0720-0029.
If you have already completed your survey, please accept my thanks and disregard this
request.
We look forward to hearing from you as one of our valued Millennium Cohort members!
Very Respectfully,
Dr. David D. Luxton
Principal Investigator and Military Veteran
If you have any questions, please contact the Millennium Cohort team at our toll-free
number, 1-888-942-5222, or DSN 553-7465, or email [email protected].
F-18
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Contents:
Cover letter
#10 envelope
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Endorsement letter
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
F-21
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
PHASE 1: 2014
1a: Pre-notice letter – ACTIVE DUTY
Week 1 [Proposed start: June/July 2014]
Contents: cover letter, study results pamphlet, #10 business size envelope
Study results insert
Dear _[name]__,
You are one of over 200,000 current and former Service members who completed an important
DoD survey (the Millennium Cohort Study) aimed at understanding the possible effects of
military service
on long-term health. The last questionnaire you completed for the study
was in (survey month/year).
We appreciate enormously your help with this Department of Defense study, and thought you
might appreciate knowing about some of the results from this effort. The enclosed summary
provides just a few of the results and how they are being used. Because of occasional follow-up
questionnaires, we are able to understand how health circumstances change. Even in the short
period since the beginning of this research, we have been able to observe changes in healthrelated situations and the reasons for these changes.
Those of you who have helped with this study come from all branches and components of the
military. Some of you are no longer in the active military service, while others of you continue to
serve. The breadth of this study, the largest of its kind ever conducted, is especially valuable
because it allows for understanding if different kinds of military service and deployments result
in no specific health symptoms or in the development of a health symptom or concern.
Regardless of your specific situation, your information is critically important to this effort.
We hope you’ll find these results of interest. More research findings will be posted to our
website, www.millenniumcohort.org, as analyses are released and used.
In a few weeks, we will be contacting you to learn about any changes that may have occurred in
your health since we last heard from you. We are eager to learn more about how participants’
lives may have been affected by military service, or whether there has been no specific effects
from your military time – both are very important for understanding the ongoing health of
Service members.
Thanks so much for your effort to help the U.S. military provide the best medical care to current
and future members of the military.
Very sincerely,
The Millennium Cohort Study Team
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Version Date: 30 December 2017
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Contents:
#10 business size envelope:
Letterhead for cover letter:
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Active Duty Study Findings insert: (front)
F-24
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Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Study Findings insert: (back)
F-25
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
1b: Pre-notice letter – SEPARATED/RETIRED
Week 1
Contents: cover letter, study results insert, #10 business size envelope
Dear _[name]__,
You are one of 200,000 current and former service members who completed an important DoD
survey (the Millennium Cohort Study) aimed at understanding the possible effects of military
service on
long-term health. The last questionnaire you completed for the study was in (survey month/year).
We appreciate enormously your help with this Department of Defense study, and thought you
might appreciate knowing about some of the results from this effort. The enclosed summary
provides just a few of the results and how they are being used. Because of occasional follow-up
questionnaires, we are able to understand how health circumstances change. Even in the short
period since the beginning of this research, we have been able to observe changes in healthrelated situations and reasons.
We understand that you are no longer in the active military service, but we still need your
continued participation. Because former Service members and Veterans face unique challenges,
sharing your experiences will help the DoD understand the impact of health and life situations of
people even after they leave military service. This knowledge may eventually lead to better
treatments and preventive measures for Veterans.
The breadth of this study, the largest of its kind ever conducted, is especially valuable because it
allows for understanding if different kinds of military service and deployments have resulted in
no specific health symptoms or in the development of a health symptom or concern. Regardless
of your specific situation, your information is critically important to this effort.
We hope you’ll find these results of interest. More research findings will be posted to our
website, www.millenniumcohort.org, as analyses are released and used.
In a few weeks, we will be contacting you to learn about any changes that may have occurred in
your health or life situation since we last heard from you.
Thanks so much for your effort to help provide the best medical care to former and current
members of the military.
Very sincerely,
The Millennium Cohort Study Team
Contents:
#10 business size envelope: same as 1a
Letterhead for cover letter:: same as 1a
F-26
Version Date: 30 December 2017
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Separated/ Retired Study Findings insert: (front)
F-27
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Separated/ Retired Study Findings insert: (back)
F-28
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
2: Pre-notice Email
Week 3
Subject Line: Preliminary results from your participation in research study
Dear _[name]__,
We hope you recently received our letter in the mail which highlights the study progress of the
Service member study since it began in 2001.
You are one of 200,000 current and former Service members who completed an important DoD
survey aimed at understanding the possible effects of military service on long-term health. The
last survey you completed for the study was in [survey month/year]. We greatly appreciate you
sharing your experiences, including those after you leave the military, to evaluate the potential
long-term health effects of military service.
The study produces important results that inform DoD and VA leaders regarding the associations
of military experiences on future health outcomes. Our recent postal letter to you highlighted
some of this study’s findings since 2001. If you did not receive our recent postal letter, we
would appreciate you providing us a current postal address so that we can continue to keep you
informed about results from this important national study.
In a few weeks, we will send you the new survey version, which has some important updates
from the previous version. The 2014 survey also includes some questions that are similar to
those which you have completed in the past so that we can track changes in experiences and
health events since the previous survey.
To view our study progress and to also update your postal address, please visit our study website:
website address
Meantime, as additional analyses are completed, we will post results on our website, and want to
let you know that you may go there to see them.
Thanks so much for your effort to help the U.S. military provide the best medical care to current,
former, and future members of the military, through your participation in this critical study.
Very sincerely,
The Millennium Cohort Study Team
Some people have multiple email addresses. If we’ve reached you at an inappropriate email
address, please visit this web site: [add link]
F-29
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
3a: Card NOT LINKED to Family Study participant.
Week 8
Contents: Card, 5x7 business size envelope:
Dear _[name]__,
A few years ago, you were very helpful in completing a survey for the Millennium Cohort Study
which assesses the health and well-being of Service members over time. We are writing to ask
for your continued help with the largest effort ever undertaken to understand if military service
affects the health of military members during, as well as after, their military service is completed.
We appreciate greatly your previous help with this effort that involves all branches and
components of the military. You may notice that this year’s questionnaire has changed,
removing some questions and adding others that seem to be helpful in understanding what
happens over time with regard to health issues.
Please complete the survey by going to: www.millenniumcohort.org, where you should click
on Start Survey, and enter your Subject ID: xxxxxx.
[text for card with incentive] In appreciation for your contribution to the Millennium Cohort
Study, we are enclosing a [ $2 bill, gift card, magnet] as a small way of expressing our
appreciation for your previous and continued efforts to make a difference in the lives of current
and future military members.
[text for card without incentive] Thank you for your continued help in making this the largest
and most important DoD study in US military history and working with us to protect the health
of members of our military service.
[text for card with opportunity drawing] Upon receipt of your completed survey, your name
will be entered into a drawing to win an i-Pad*
Thank you for your continued help in making this the largest and most important DoD study in
US military history and working with us to protect the health of members of our military service.
Very sincerely,
The Millennium Cohort Study Team
*For every 500 survey respondents one name will be drawn. All surveys must be received by
[date] in order to enter. The winners will be randomly selected and notified via email.
F-30
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Contents:
5x7 envelope:
5x7 Card: (front)
F-31
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
5x7 Card: (back)
Randomly assigned inserts:
•
cash pre-incentive in the form a two dollar bill
•
Magnet
•
•
•
No pre-incentive
$5 Gift card
Opportunity to win I-Pad
3b: Card LINKED to Family Study participant.
F-32
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Week 8
Contents: Card, 5x7 business size envelope:
Dear _[name]__,
A few years ago, you were very helpful in completing a survey for the Millennium Cohort Study
which assesses the health and well-being of Service members over time. We are writing to ask
for your continued help with the largest effort ever undertaken to understand if military service
affects the health of military members during, as well as after, their military service is completed.
We appreciate greatly your previous help with this effort that involves all branches and
components of the military. You may notice that this year’s questionnaire has been changed,
removing some questions and adding others that seem to be helpful in understanding what
happens over time with regard to health issues.
Please complete the survey by going to: www.millenniumcohort.org, click on Start Survey,
and enter your Subject ID: xxxxxx.
[text for card with incentive] In appreciation for your contribution to the Millennium Cohort
Study, we are enclosing a [ $2 bill, gift card, magnet] as a small way of expressing our
appreciation for your previous and continued efforts to make a difference in the lives of current
and future military members.
[text for card without incentive] Thank you for your continued help in making this the largest
and most important DoD study in US military history and working with us to protect the health
of members of our military service.
[text for card with opportunity drawing] Upon receipt of your completed survey, your name
will be entered into a drawing to win an i-Pad*
In addition, your spouse will also receive an invitation in the fall to complete his/her follow-up
survey as part of the Family Study, which works in partnership with this Service member survey.
These two studies are the only ones in history that follow the Service member and their family
over time as they experience both the unique challenges and achievements associated with
military life.
Thank you for your continued help in making this the largest and most important DoD study in
US military history and working with us to protect the health of members of our military service.
Very sincerely,
The Millennium Cohort Study Team
*For every 500 survey respondents one name will be drawn. All surveys must be received by
[date] in order to enter. The winners will be randomly selected and notified via email.
Contents:
5x7 envelope: same as 3a
5x7 Card: same as 3a
Incentives same as 3a
F-33
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
4a: Email ACTIVE DUTY NOT LINKED to Family participant
Week 9
Subject Line: Appreciation for your past participation
Dear _[name]__,
Last week you should have received a letter requesting your continuing participation in the
largest effort ever undertaken to understand how military service may affect the health situation
of military members during, as well as after, their military service is completed.
We are following up with this email to provide an electronic link, which we hope makes it easier
for you to access and complete this follow-up survey. Please go to:
[link to survey]
Unlike many other surveys, this study is designed to follow you over time to understand any
changes to your health and any concerns you may have. Even if you are no longer on active
duty, or are not experiencing any health symptoms, your responses are still very valuable in
understanding how specific military experiences do or do not affect the health of current and
former Service members.
Thank you for working with thousands of other Service members and Veterans to protect the
health of current and future members of our military service.
This survey is “Official Business”. Military members may complete this at their duty station,
using government equipment. If you choose, you can also complete the survey at home or
elsewhere.
If you did not receive our postal mailing, then we may not have your most updated information.
You are a valued participant and we want to assure that we send it to the correct postal address.
Please update your contact info at: [update contact info -website]_.
Very sincerely,
The Millennium Cohort Study Team
Some people have multiple email addresses. If we’ve reached you at an inappropriate address,
please visit this web site to provide a preferred address for contacting you: [unsubscribe email
link]
F-34
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
4b: Email SEPARATED/RETIRED NOT LINKED to Family participant
Week 9
Subject Line: Appreciation for your past participation
Dear _[name]__,
Last week you should have received a letter requesting your continuing participation in the
largest effort ever undertaken to understand how military service may affect the health situation
of military members during, as well as after, their military service is completed.
We are following up with this email to provide an electronic link, which we hope makes it easier
for you to access and complete this follow-up survey. Please go to:
[link to survey]
Some believe their continued participation in this study is no longer valuable because they have
separated or retired from military service. However, the Millennium Cohort Study was designed
to evaluate long-term health effects, so the continued participation of former Service members is
essential to the project’s success.
Thank you for working with thousands of other Service members and Veterans to protect the
health of current and future members of our military service.
If you did not receive our postal mailing, then we may not have your most updated information.
You are a valued participant and we want to assure that we send it to the correct postal address.
Please update your contact info at: [update contact info -website]_.
Very sincerely,
The Millennium Cohort Study Team
Some people have multiple email addresses. If we’ve reached you at an inappropriate address,
please visit this web site to provide a preferred address for contacting you: [unsubscribe email
link]
F-35
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
4c: Email ACTIVE DUTY LINKED to Family Study participant.
Week 9
Purpose: reference recent postal contact. Continue to push for web completion.
Subject Line: Appreciation for your past participation
Dear _[name]__,
Last week you should have received a letter requesting your continuing participation in the
largest effort ever undertaken to understand how military service may affect the health situation
of military members during, as well as after, their military service is completed.
We are following up with this email to provide an electronic link, which we hope makes it easier
for you to access and complete this follow-up survey. Please go to:
[link to survey]
Unlike many other surveys, this study is designed to follow you over time to understand any
changes to your health and any concerns you may have. Even if you are no longer on active
duty, or are not experiencing any health symptoms, your responses are still very valuable in
understanding how specific military experiences do or do not affect the health of current and
former Service members.
In addition, your spouse will also receive an invitation in the fall to complete his/her follow-up
survey as part of the Family Study, which works in partnership with this Service member survey.
These two studies are the only ones in history that follow the Service member and their family
over time as they experience both the unique challenges and achievements associated with
military life.
Thank you for working with thousands of other Service members and Veterans to protect the
health of current and future members of our military service.
This survey is “Official Business”. Military members may complete this at their duty station,
using government equipment. If you choose, you can also complete the survey at home or
elsewhere.
If you did not receive our postal mailing, then we may not have your most updated information.
You are a valued participant and we want to assure that we send it to the correct postal address.
Please update your contact info at: [update contact info -website]_.
Very sincerely,
The Millennium Cohort Study Team
Some people have multiple email addresses. If we’ve reached you at an inappropriate address,
please visit this web site to provide a preferred address for contacting you: [unsubscribe email
link]
F-36
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
4d: Email SEPARATED/RETIRED LINKED to Family participant
Week 9
Purpose: reference recent postal contact. Continue to push for web completion.
Subject Line: Appreciation for your past participation
Dear _[name]__,
Last week you should have received a letter requesting your continuing participation in the
largest effort ever undertaken to understand how military service may affect the health situation
of military members during, as well as after, their military service is completed.
We are following up with this email to provide an electronic link, which we hope makes it easier
for you to access and complete this follow-up survey. Please go to:
[link to survey]
In addition, your spouse will also receive an invitation in the fall to complete his/her follow-up
survey as part of the Family Study, which works in partnership with this Service member survey.
These two studies are the only ones in history that follow the Service member and their family
over time as they experience both the unique challenges and achievements associated with
military life.
Some believe their continued participation in this study is no longer valuable because they have
separated or retired from military service. However, the Millennium Cohort Study was designed
to evaluate long-term health effects, so the continued participation of former Service members is
essential to the project’s success.
Thank you for working with thousands of other Service members and Veterans to protect the
health of current and future members of our military service.
If you did not receive our postal mailing, then we may not have your most updated information.
You are a valued participant and we want to assure that we send it to the correct postal address.
Please update your contact info at: [update contact info -website].
Very sincerely,
The Millennium Cohort Study Team
Some people have multiple email addresses. If we’ve reached you at an inappropriate address,
please visit this web site to provide a preferred address for contacting you: [unsubscribe email
link]
F-37
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
2014 Memorial Day Postcard
May 2014
Contents: 5x7 color postcard
Mail Date: 5/19/14
Message:
On this day, we remember those who gave their lives for our nation, and reflect on the sacrifices
made by current and former service members. Your service, and that of each military member
who lost their life defending our nation, is remembered and honored on this Memorial Day.
The next survey cycle will be starting soon, and your continued participation, even if you have
left military service, is critically important to this study. Your continued involvement makes it
possible to inform policy makers regarding your experiences and to guide prevention measures
that positively impact former, current and future military members.
Very Sincerely,
The Millennium Cohort Study Team
Contents:
5x7 postcard image:
F-38
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
2014 Memorial Day Email
May 2014
Contents: 5x7 color postcard
Email Date: 5/19/14
Dear ________,
On this day, we remember those who gave their lives for our nation, and reflect on the sacrifices
made by current and former service members. Your service, and that of each military member
who lost their life defending our nation, is remembered and honored on this Memorial Day.
You will receive a Memorial Day postcard in the mail from the Millennium Cohort Study team.
You can also view it online at [website].
The next survey cycle will be starting soon, and your continued participation, even if you have
left military service, is critically important to this study. Your continued involvement makes it
possible to inform policy makers regarding your experiences and to guide prevention measures
that positively impact former, current and future military members.
Very Sincerely,
The Millennium Cohort Study Team
For any questions, please contact the Millennium Cohort Team at [email protected]
or [email protected]. Or call toll free 1-888-942-5222 or DSN 553-7465, and
reference your Subject Id: [SID]
The Millennium Cohort Study is an authorized Department of Defense project. Note Defense
Manpower Data Center Reference # 00-0019, Report Control Symbol # DD-HA(AR)2106,
Office of Management and Budget Approval # 0720-0029, Office of the Assistant Secretary of
Defense (Health Affairs), TRICARE Management Activity Protocol # CDO-06-206, and
Primary Institutional Review Board Protocol # Naval Health Research Center.2000.0007.
If you would like this email address to be removed from our email list, please visit:
[Unsubscribe link]
***Millennium Cohort Study – Protecting Service Member Health***
F-39
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
Veteran’s Day 2013
The Millennium Cohort email will read as follows:
Veteran’s Day 2013 Email
Dear {Name},
On this Veterans Day, the Millennium Cohort Study Team joins all Americans in
honoring those who have served our nation as members of the Armed Forces. We thank
all Service members, past and present, for their unyielding sacrifice and dedication to our
great nation.
The Department of Defense launched the Millennium Cohort Study in 2001 to improve
the health of Service members and Veterans. There are now over 200,000 participants
enrolled in this landmark study, which is the largest of its kind working towards
protecting the health of members of our military. We will touch base with you again in
2014 to learn about any changes that may have occurred with your health and well-being
since we last heard from you.
Thank you again for your selfless service and your continued support of this important
project!
Very Sincerely,
The Millennium Cohort Study Team
[image of postcard included on HTML email formats]
F-40
Version Date: 30 December 2017
Rull, The Millennium Cohort Study, Protocol NHRC.2000.0007
APPENDIX G.
MILLENNIUM COHORT FAMILY HISTORICAL PROTOCOL
SCIENTIFIC BACKGROUND
In recent decades, mental health and related outcomes for US military service members
following war zone deployment have been documented empirically for multiple conflicts,
beginning with Vietnam and continuing through the conflicts in Iraq and Afghanistan.
Much less attention has been paid, however, to deployment-related outcomes for spouses
and other family members (e.g., children, parents) of those deployed.
Stressors associated with service member deployment can have important consequences
for their family members, particularly when tours are long and multiple deployments are
required. Family member functioning can be degraded by separation and associated
worries, and service member functioning is degraded when concern over events at home
reduces their ability to concentrate or to be attentive and vigilant. Additionally, war zone
stress exposure has been shown to have substantial impact on service members after they
return home, which can produce additional stressors for both the service members and
their families when they are re-united. Post-deployment stress also erodes readiness for
future deployment.
In essence, the geographic separation and life threat that are inherent in war zone
deployment open the door to anxiety and mood changes and alcohol abuse among service
members and their families that can degrade the functioning of both in multiple ways,
prior to (e.g., via anticipatory anxiety) and during deployment. Compounding the
problem, family relationships and dynamics can be negatively affected when the service
member returns home if s/he is among the estimated 20-30% of returning troops who
suffer the negative mental health and related outcomes (e.g., PTSD, depression, substance
use) associated with high levels of war zone stress exposure and/or has sustained
significant physical injuries.
Prior research documents that military families are significantly affected by a service
member’s war-related mental health problems, as well as the chronic stress of multiple
and extended wartime deployments characterized by diminished “dwell” time. Findings
from the National Vietnam Veterans Readjustment Study indicated that children of
veterans with PTSD had higher levels of behavioral and emotional problems than
children of veterans without PTSD. Families of veterans with PTSD are also more likely
to suffer domestic violence or intimate partner violence than families of veterans without
PTSD. In the U.S. Army, younger couples, and those with a previous incident of
domestic violence, are at greatest risk for an episode of domestic violence postdeployment.
Adverse childhood experiences (ACE), such as having a parent with a severe mental
illness and exposure to domestic violence and child maltreatment have been found to
contribute to negative adolescent trajectories, including early school drop-out, substance
abuse, severe obesity and promiscuity. In addition, adverse childhood experiences
contribute significantly to adverse adult outcomes, such as depression, PTSD, substance
abuse, poorer medical health, and low occupational attainment. The Department of
Defense Plan to Achieve the Vision of the DoD Task Force on Mental Health
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(September, 2007) addressed these concerns directly by recommending the following
actions to better understand the role that deployment stress and war-related PTSD has on
military families:
• DoD should conduct research on the processes of post-deployment adjustment for
family members
• DoD should conduct research on children who have been separated from their parents
by deployment, including their access to support for psychological health issues
Although much of the existing research suggests that war-time stress and deployments
are associated with a host of negative sequelae for both the service member and their
family, the relationships are not linear, in that some service members and their families
demonstrate resiliency in the face of adversity. Moreover, studies have demonstrated that
other potential factors (e.g., social support, previous exposure to violence) may either
moderate (i.e., reduce or exacerbate the impact of the stressor) or mediate this
relationship suggesting alternate pathways and trajectories. To this end, the family
component seeks to address both the risk and protective factors associated with the
process of post-deployment adjustment for family members. This line of inquiry has
significant implications for both early intervention efforts and future research, given the
potential information gained on patterns of risk and resiliency, and targets for
intervention, particularly for the families of deployed service members.
Systematic documentation of both negative and positive outcomes associated with
deployment to Iraq and Afghanistan, along with detailed analysis of risk and resilience
factors, will provide a scientifically sound foundation for understanding the relationships
among multiple factors related to family member functioning and family dynamics. This
information will facilitate identification of specific interventions aimed at: reducing
deployment-related stress, increasing family member resilience, and increasing the
capability of family members to support service members with negative outcomes
resulting from war zone stressor exposures.
Objectives
• To assess the impact of military service and deployment on the physical and mental
health and related outcomes of spouses and co-resident children of service members
• To assess the impact of military service and deployment on the quality of the
relationships between service members, spouses and their children
• To examine the association between family member outcomes and service member
outcomes
• To identify vulnerability and resilience factors for deployment stress-related
outcomes for spouses and children of deployed service members
Through the Collaboration Protocol (Appendix J) already in place with Abt Associates
the following objectives can be met. Therefore a Data Use Agreement (Appendix K)
between NHRC and Abt Associates and their subcontractors Duke University (Duke) and
New York University (NYU) has been established. The Principal Investigators and CoInvestigators from the NHRC and Abt Associates teams will meet to discuss and
determine the priority of analyses to be conducted based on their scientific merit and
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potential to impact force health protection (to prepare, protect, and treat the families of
Service members):
• Explore the association between service member deployment (e.g. combat, duration,
dwell time, and frequency) and the health and well-being of spouses and children.
• Explore the association between service member readjustment issues (e.g., PTSD,
anxiety, depression, alcohol misuse/abuse) and the health and well-being of spouses
and children.
• Examine factors related to resiliency and vulnerability that moderate the association
between deployment experiences and service member readjustment issues, and the
health and well-being of spouses and children.
• Examine factors related to marital quality and family function.
• Evaluate methodological approaches to ensure adequate representation of spouses
from all service branches, Reserve and National Guard; and assess validity of
assessment measures and instruments.
• Contribute data to the service member cohort study on spouse and child factors that
are associated with service member health and well-being, as well as length of
service.
Data, collected from spouses of service members, may include demographics, health
conditions and symptoms, functional health, habits (e.g., smoking, alcohol use, exercise,
and diet), family relationships and children-related data, and select information from the
main study (the Millennium Cohort Study) including military-related data, such as
deployment information. Additionally, dates of events may be shared with Abt
Associates for specific analyses of the Family Study; these dates will be coded as time
(days) since an agreed upon baseline date and no actual dates will be in the shared
dataset. Survey data may be linked by NHRC to electronic health and administrative data
from other sources as outlined in this protocol, and shared with Abt Associates for
analyses requiring this information. NHRC will not transfer any data involving names,
dates (including dates of birth), social security numbers, or any contact information to
Abt Associates. Proposals will be written for each proposed analysis using the Family
Study data containing a list of required data elements and investigators which will be
provided to the IRB at the study’s annual review or at the time of development should
any data requirements and/or aims fall outside those presented under this modification.
Data transfers will only occur through secure means using password-protected encrypted
files. The data provided by NHRC to the Abt Associates team is restricted to the
minimum necessary to complete the approved Family sub-studies and access to these data
will be limited to a minimum number of individuals necessary at each institution to
achieve the purpose. Data will be stored in a manner consistent with Federal and DoD
regulations and data security best practices as described under section IX “Description Of
The System For Maintenance Of Records”.
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VI.
EXPERIMENTAL METHODS
Methods
Based on recommendations from sponsors and advisory committees, and the success of
the Millennium Cohort, a fourth enrollment panel will be added to the next survey cycle
beginning in 2011. The Millennium Cohort was originally designed to follow three
panels of participants that enrolled in 2001, 2004, and 2007 through 2022. The team
plans to invite approximately 250,000 individuals of active-duty, Reserve, or National
Guard status, with 2-5 years military service experience, oversampling for women and
married personnel. Out of the 250,000, an estimated 62,500 new participants will enroll.
This group will be consented to complete 7 follow-up surveys over 21 years, with one
survey to complete every 3 years. The invited group will be a stratified random sample
from the Defense Manpower Data Center. The current total number enrolled is 151,597,
so this new enrollment will bring the total number enrolled to approximately 214,000
individuals.
In addition to Panel 4, a Family Cohort component will be added to the next survey cycle
beginning in 2011. In order to assess the interrelated health effects of military service and
deployment on service members, spouses, and co-resident children, the Millennium
Cohort Study team and collaborators will survey the spouses of newly enrolled Panel 4
participants that consent to this assessment. The team estimates that about 10,000
spouses will enroll in the study, about half of whose service member will have been
deployed to the conflicts in Iraq and Afghanistan at least once.
•
Surrogate data on children health will be obtained from the spouse. The data collected
on these children will be generalized. No child will be individually identified for the
purposes of this study. Because families and family relationships change over time
and to maintain methodological consistency with the Millennium Cohort Study,
spouses will be asked to complete 7 follow-up surveys over 21 years, with one survey
to complete every 3 years. Participants of the Family Cohort Study will only have the
option of completing a web survey.
• In October of 2010, 250,000 service members were randomly selected from
military rosters. These individuals will be invited to participate in the Millennium
Cohort’s fourth enrollment cycle once OMB and RCS approvals are in place.
These participants will be referred to as Panel 4 participants/members. Out of
these Panel 4 members, the married service members will view the following: the
Millennium Cohort Family Study survey instrument, and the Panel 4 Millennium
Cohort Family Study informed consent document and permission form. From this
group of consenters, the first 100 spouses to consent to the study and complete
their surveys will be included in a pilot sample. This group of 100 individuals will
be treated the same as the large group of Millennium Cohort Family Study
participants, however, the internal team of analysts will review their survey to
ensure participants are understanding the survey questions. Based on survey
research, missing data along with data completion rates will indicate how the
survey is interpreted. Also, an open-ended question will be added to the end of the
first 100 surveys, "Is there anything you didn't understand or would change in this
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survey?" This will provide us with information on how the questions were
interpreted and understood. We will not be requesting further feedback from these
participants.
•
Millennium Cohort Study contact methods will be employed, including the
modified Dillman survey methodology. Complex algorithms will be developed
for email, mail and response tracking.
•
For the Millennium Cohort Family Study, we are seeking permission to call
those participants who completed the paper survey, but failed to sign the
informed consent form in the survey document. These phone calls will be the
last contact attempt during the cycle in attempt to have the subject provide
consent, and hence for the study team to utilize their survey data.
Approximately 100 participants will be called. Those who did not sign the
consent and who did not complete the majority of the survey will not be
contacted, rather they will simply be excluded from the study.
Subjects will be contacted via telephone during Monday through Friday
between the hours of 8 am to 8 pm within their time zone, and/or Saturday
between 10 am to 6 pm in their time zone. No calls will be made on Sundays.
A maximum of 10 phone call attempts will be made per subject and a log of
every attempt will be kept. Staff making phone calls will not leave a voice
message. A verbal “yes” or “no” reply will be accepted as the subject’s
consent and documented by caller who will be a member of the study team. If
the subject responds with a “no”, they will no longer be contacted and their
survey data will not be utilized. Calls will end once the 10 call limit occurs or
we are able to reach the participant in person, whichever occurs first. All
participants who agree to consent to the study will be offered a copy of the
consent form which will be mailed to them.
The script for the phone calls is as follows:
Hi (interviewee name):
My name is (caller name), and I am calling from the Naval Health Research
Center. We appreciate the time you spent completing our survey on (Date) for
the Family Study which is being conducted by the Department of Defense.
When we reviewed your survey, we noticed that you did not sign the consent
form on the 2nd page of the survey. In order to use your data for our study, we
would need to have your consent to participate in the study. Will you give
your consent for participation?
If the subject responds yes:
Thank you. We will document your response. We know your time is valuable
and we thank you for helping with this important project. We would be happy
to send you a copy of the study’s consent to your home address? Would you
like a copy? If yes, (confirm address).
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If the subject responds no:
Thank you. We will document your response. Unfortunately, we will not be able
to use the information you gave us in the survey you completed. Thank you
for your time.
•
A separate website will be built for this sub-study, but will link directly to the
Millennium Cohort Study website, www.millenniumcohort.org. The URL will be
www.familycohort.org
•
Like the Millennium Cohort Study, nominal incentives will be offered to
participants that complete the survey online, participants will be offered the
choice of a $10 gift card to the following; military exchange (AAFES/NEX gift
card), Starbucks, or Amazon.com. AAFES/NEX and Starbucks gift cards will be
mailed to participants within 6 weeks of survey completion, and Amazon.com
electronic gift cards will be emailed within one week of survey completion. None
of the gift cards are exchangeable for cash.
Family Component Domains and Measures
Based on our conceptual model and the existing literature, we intend to focus the
assessment on four broad domains: (1) spouse physical health; (2) spouse mental
health and adjustment; (3) spouse’s reports of their children’s mental/physical health
and functioning; and (4) family functioning and protective and vulnerability factors.
Family Component Domains and Measures
Construct
Inventory
Physical Health History
Self-reported Medical
Conditions
General Health and Functional Status
SF-36
Mental Disorder Screening (depression,
somatization, panic disorder, anxiety, alcohol
PHQ
abuse/dependence, binge eating disorder, and bulimia
nervosa)
PTSD Symptoms
PCL-C
Adverse Childhood Events
ACE
Alcohol Use
CAGE
Sleep Quality
ISS
Child Health
CDC: National Survey of
Children’s Health
Child Functioning
Adapted Strengths and
Difficulties Questionnaire
Family Satisfaction
FACES-IV
Family Communication
FACES-IV
Marital Satisfaction
Adapted Quality of
Marriage Index
Spouse’s Work and Family Conflict
Adapted Work-Family
Conflict Scale
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# Items
46
36
15-16
17
8
4
9
23
15
10
10
4
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SF-36 = Short-Form 36 Health Survey; PHQ = Patient Health Questionnaire; PCL = PTSD
check list; ACE = Adverse Childhood Events; ISS = Insomnia Severity Index; FACES-IV =
Family Adaptability and Cohesion Evaluation Scale, fourth version
Family Study: Sample Size Determination
The sample size for the Family Assessment Component is based on the prevalence of mental
health outcomes among spouses of US service members. As the US military and the Millennium
Cohort are predominantly male populations, it is presumed that the sample of spouse responders
will be predominantly female. Approximately 15% of the 2.2 million US military population in
2000 were female and close to 25% of the current Millennium Cohort Study members are
female. 20 Therefore, prevalence estimates from the general US women population were used to
represent the spouses of service members.
Using standardized self-reported instruments to identify individuals with certain mental health
conditions, previous findings have found the weighted prevalence to be 18.3% for any mental
disorder, 2.4% for PTSD, 3.2% for major depressive disorder, 1.0% for panic syndrome, 2.0%
for other anxiety syndrome, and 12.6% for alcohol abuse among US military service members.21
Higher prevalence of mental disorders was found among 1991 Gulf War veterans and those
deployed to the current wars in Iraq and Afghanistan with combat exposures.21, 22
Among the general US women population, the prevalence of frequent mental distress, which
included stress, depression, and problems with emotions, was 10.6% from 1993-2000.23 Results
from the National Comorbidity Survey showed lifetime prevalence of many mental health
disorders to be approximately twice as high for women compared to men, with 5.0% for panic
disorders and 6.6% for general anxiety disorder.24 Additionally, the Epidemiological Catchment
Area survey found that the 1-month prevalence of all anxiety disorders was twice as high in
women (9.7%) than in men (4.7%).25 Among women in the general US population, the
prevalence of alcohol abuse was 11.5% with alcohol dependence at 8.0%.26
Based on the percent of service members who have already been enrolled in the Millennium
Cohort Study who have deployed in support of the wars in Iraq and Afghanistan, it is estimated
that 30% to 50% of the service members who will be enrolled in the 2010 cohort will have
already been deployed in support of the current conflicts. The statistical power of this study
depends on the prevalence of the various mental health disorders and the percent of spouses
married to service members with and without exposure to deployment. The following formula
estimates the necessary sample size:
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(Z
N=
α
P(1 − P)(1 / q1 + 1 / q 2 ) + Z β P1 (1 − P1 )(1 / q1 ) + P2 (1 − P2 )(1 / q 2 )
)
2
∆2
Where:
N = sample size required
P1 = proportion of outcome among group 1 (spouses of non-deployed)
P2 = proportion of outcome among group 2 (spouses of deployed)
Zα = standardized normal deviate for a two-tailed probability of an α-error, set at α = 0.05
Zβ = standardized normal deviate for a two-tailed probability of an β-error, set at β = 0.80 or 0.90
q1 = proportion of sample population in group 1
q2 = proportion of sample population in group 2
P = q1 P1 + q2 P2
Δ = P1 - P2
For the sample size calculation, it is estimated that the overall prevalence of mental health
outcomes will be from 5 to 10% for spouses of non-deployed military service members. The
necessary study sample size for spouses of military service members to detect specified odds
ratios with 80% and 90% power and the alpha error level set at <0.05 are shown in Table 1. With
a study sample of 10,000 spouses, odds ratios of 1.3 and higher with 80% power will be
detectible regardless of the percent of service members deployed.
Table 4.
Sample Size Necessary at Different Levels of Statistical Power to Detect a Given Magnitude
of Prevalence (as reflected by the Odds Ratio) for Spouses of Service Members
% Prevalence of
Exposure
(Deployment)
30%
30%
30%
30%
Detectable
Odds
Ratio
1.2
1.3
1.5
2.0
Low-End Estimate (5%)
N Required for
N Required for
80% Power
90% Power
21,555
29,034
9,999
13,504
3,903
5,295
1,167
1,596
High-End Estimate (10%)
N Required for
N Required for
80% Power
90% Power
11,502
15,480
5,363
7,234
2,113
2,861
645
879
40%
40%
40%
40%
1.2
1.3
1.5
2.0
18,988
8,836
3,468
1,049
25,497
11,880
4,673
1,418
10,124
4,733
1,874
578
13,589
6,360
2,522
779
50%
50%
50%
50%
1.2
1.3
1.5
2.0
18,348
8,563
3,378
1,031
24,562
11,462
4,521
1,379
9,775
4,581
1,822
566
13,085
6,132
2,438
756
The estimated sample size of spouses of military service members with adequate power to detect
differences in mental health outcomes was determined to be approximately 10,000. To achieve
this spouse sample size, we will begin with a probability sample of personnel 250,000 service
members who will be invited to participate in the 2010 cohort. Based on Millennium Cohort
Study experience to date, we expect a response rate of 25% (62,500 enrolled service members).
Of those, we estimate that 35% (21,875) will be married, and that75% (16,407) of married
service members will consent to our contacting their spouses for enrollment. We further estimate
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a spouse response rate of 60%, thus giving an estimated sample size of approximately 10,000
spouses of military service members for this study. Based on the above table, a sample size of
10,000 will provide adequate power to detect the targeted mental health outcomes among this
population.
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APPENDIX H. MILLENNIUM COHORT FAMILY PARTICIPANT CONTACT
MATERIALS
Millennium Cohort Family Study Non-responder letter
Dear _[name]__,
When you and your spouse joined the Family Study and the Millennium Cohort Study a
few years ago, you became part of a special community of couples that inform leadership,
guide interventions and shape support programs designed to target the specific needs of
military couples and families. As a member of the Millennium Cohort Family Study, you
have the opportunity to represent all military spouses. We are re-contacting you because
your continued participation makes it possible to form a more complete picture of how
military life influences family dynamics, structure and relationships. Whatever your
circumstances and feelings, whether you have children or not, we would like to
encourage you to provide your input by completing your Family Study follow-up survey.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from you since your unique input will help make the Millennium Cohort Family Study a
powerful resource for understanding the unique strengths and challenges experienced by
current and former military couples.
In an effort to be as inclusive and comprehensive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military spouses over time. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed. Even if your spouse is no longer in the
military or if your marital status has changed, your participation is critical to defining
how military life affects families.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject ID: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
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If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Non-responder with Panel 4 Responder letter
Dear _[name]__,
When you and your spouse joined the Family Study and the Millennium Cohort Study a
few years ago, you became part of a special community of couples that inform leadership,
guide interventions and shape support programs designed to target the specific needs of
military families. Your spouse has already completed their Millennium Cohort follow-up
survey, but we have yet to hear from you. We are re-contacting you because your
participation is critically important, even if you are no longer married. The participation
of both you and your spouse makes it possible to form a more complete picture of the
impact of military life, which is why we would like to encourage you to provide your
input by completing your Family Study follow-up survey.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from both you and your spouse since your combined participation is what makes the
Millennium Cohort Family Study such a powerful resource for understanding the
complexities of military life.
In an effort to be as inclusive and comprehensive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military spouses over time. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed. Even if your spouse is no longer in the
military or if your marital status has changed, your participation is critical to defining how
military life affects families.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study M ale Non-responder letter
Dear _[name]__,
The well-being of military spouses and families has become a national priority; however,
there is limited awareness of the unique needs and challenges experienced by male
spouses. In 2011, there were approximately 100,000 male spouses of Service members,
accounting for nearly 9% of all US military spouses. As a member of the Millennium
Cohort Family Study, you have the unique opportunity to help represent all military
husbands, even if you are part of a dual-military couple or have formerly served. We are
re-contacting you because your participation is critically important. Your continued
participation makes it possible to develop a more complete picture of the impact of
military life, which is why we would like to encourage you to provide your input by
completing your Family Study follow-up survey.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from you since your unique input will help make the Millennium Cohort Family Study a
powerful resource for understanding the unique strengths and challenges experienced by
male spouses.
In an effort to be as inclusive and comprehensive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military spouses over time. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed. Even if your spouse is no longer in the
military or if your marital status has changed, your participation is critical to defining how
military life affects families.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Dual-military Non-responder letter
Dear _[name]__,
When you and your spouse joined the Family Study and the Millennium Cohort Study a
few years ago, you became part of a special community of couples that inform leadership,
guide interventions and shape support programs designed to target the specific needs of
military families. As someone who is currently serving or has previously served in the
military, you have a unique perspective of what it means to be part of a dual-military
couple and family. We are re-contacting you because it is especially important that we
hear from you, so that we can gain a better understanding of current and former dualmilitary couples. Your continued participation makes it possible to form a more complete
picture of the impact of military life, which is why we would like to encourage you to
provide your input by completing your Family Study follow-up survey.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from you since your unique input will help make the Millennium Cohort Family Study a
powerful resource for understanding the unique strengths and challenges experienced by
current and former dual-military couples.
In an effort to be as inclusive and comprehensive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military spouses over time. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed. Even if your spouse is no longer in the
military or if your marital status has changed, your participation is critical to defining how
military life affects families.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Reserve/Guard Non-responder letter
Dear _[name]__,
When you and your spouse joined the Family Study and the Millennium Cohort Study a
few years ago, you became part of a special community of couples that inform leadership,
guide interventions and shape support programs designed to target the specific needs of
military couples and families. As the spouse of a Reserve or National Guard Service
member, you have a unique perspective that is especially important. We are re-contacting
you because it is critical that we hear from you, so that we can gain a better understanding
of the experiences of Reserve and National Guard couples and families. Your continued
participation makes it possible to form a more complete picture of the impact of military
life, which is why we would like to encourage you to provide your input by completing
your Family Study follow-up survey.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from you since your unique input will help make the Millennium Cohort Family Study a
powerful resource for understanding the unique strengths and challenges experienced by
Reserve and National Guard families.
In an effort to be as inclusive and comprehensive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military spouses over time. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed. Even if your spouse is no longer in the
military or if your marital status has changed, your participation is critical to defining how
military life affects families.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Non-responder with Children letter
Dear _[name]__,
When you and your spouse joined the Family Study and the Millennium Cohort Study a
few years ago, you became part of a special community of couples that inform leadership,
guide interventions and shape support programs designed to target the specific needs of
military families. As a parent raising children in a military family, you have the
opportunity to provide critical information that will help inform health care providers,
military leaders and policy makers about the challenges, concerns and needs of military
families. We are re-contacting you because your continued participation makes it
possible to form a more complete picture of the impact of military life on families with
children. By sharing your personal perspective and experiences, your contribution will
make a difference in the lives of current and future military spouses and children.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from you; your unique input as a parent will help make the Millennium Cohort Family
Study a powerful resource for understanding the unique strengths and challenges
experienced by current and former military families.
In an effort to be as inclusive and comprehensive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military families over time. As such, the survey includes sections intended for
participants with current or prior military service, as well as those who are separated,
divorced, or widowed. Even if your spouse is no longer in the military or if your marital
status has changed, your participation is critical to defining how military life affects
families.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Widowed Non-responder letter
Dear _[name]__,
As a member of the Family Study, you have the opportunity to provide critical
information that will help inform health care providers, military leaders and policy
makers about the challenges, concerns and needs of military families. We are recontacting you because your continued participation makes it possible to form a more
complete picture of the impact of military life. By sharing your personal perspective and
experiences, your contribution will make a difference in the lives of current and future
military spouses and children.
We realize that relationships and families change over time, so we contacted you last year
and asked you to share your experiences since the last survey. We have heard from a
large number of the military spouses who participated in the initial 2011-2013 survey.
However, the results of this important study will have the greatest impact if we can hear
from you since your unique input will help make the Millennium Cohort Family Study a
powerful resource for understanding the strengths and challenges experienced by current
and former military couples.
We honor the important role that you play in serving our country and supporting our
troops. In an effort to be as comprehensive and inclusive as possible, our survey has been
updated to ensure an understanding of the evolving situations and circumstances of
military spouses over time. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, widowed or divorced.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
If you have any questions, would prefer to not be contacted, or would like to be removed
from this study, please contact the Millennium Cohort Family Study team at our toll-free
number, 1-800-571-9248, or DSN 553-7465, or email [email protected].
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Non-responder Email
Subject: Help make an impact in the lives of military families!
Dear _[name]__,
As an important member of the Millennium Cohort Family Study, you are one of a select
group of individuals helping to inform military leaders and policy makers about the
strengths and challenges associated with military life. In order to fully understand the
impact of military service on spouses and families, it is important that we hear your
unique perspective, which is why we are re-contacting you to complete your Family
Study follow-up survey.
We value your continued participation even if your marital status has changed or your
spouse is no longer in the military. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Non-responder with Panel 4 Responder Email
Subject: Help make an impact in the lives of military families!
Dear _[name]__,
As important members of the Family Study and the Millennium Cohort Study, both you
and your spouse are part of a select group of couples with the unique opportunity to help
represent the experiences and needs of military families. Your spouse has already
completed their follow-up survey, so we would greatly appreciate hearing from you too.
In order to fully understand the impact of military service on couples and families, it is
important that we hear from both you and your spouse, which is why we are re-contacting
you to complete your Family Study follow-up survey.
We value your continued participation even if your marital status has changed or your
spouse is no longer in the military. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study M ale Non-responder Email
Subject: Help make an impact in the lives of male spouses!
Dear _[name]__,
As an important member of the Millennium Cohort Family Study, you are one of a select
group of individuals that has the unique opportunity to help represent all military
husbands. In order to fully understand the impact of military service on male spouses, it is
important that we hear from you, which is why we are re-contacting you to complete your
Family Study follow-up survey.
We value your continued participation even if your marital status has changed or your
spouse is no longer in the military. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Dual-military Non-responder Email
Subject: Help make an impact in the lives of dual-military families!
Dear _[name]__,
As an important member of the Millennium Cohort Family Study, you are part of a select
group of individuals that has the opportunity to represent dual-military spouses. In order
to fully understand the impact of military service on current and former dual-military
couples and families, it is important that we hear from you, which is why we are recontacting you to complete your Family Study follow-up survey.
We value your continued participation even if your marital status has changed or your
spouse is no longer in the military. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Reserve/Guard Non-responder Email
Subject: Help make an impact in the lives of Reserve and National Guard families!
Dear _[name]__,
As an important member of the Millennium Cohort Family Study, you are one of a select
group of individuals that has the unique opportunity to help represent Reserve and
National Guard families. In order to fully understand the impact of military service on
current and former Reserve and National Guard couples and families, it is important that
we hear from you, which is why we are re-contacting you to complete your Family Study
follow-up survey.
We value your continued participation even if your marital status has changed or your
spouse is no longer in the military. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, divorced, or widowed.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Non-responder with children Email
Subject: Help make an impact in the lives of military families!
Dear _[name]__,
As an important member of the Family Study, you are part of a select group of individuals
with the unique opportunity to help represent the experiences and needs of military
parents. In order to fully understand the impact of military service on parents and
families, it is important that we hear your unique perspective, which is why we are recontacting you to complete your Family Study follow-up survey.
We value your continued participation even if your marital status has changed or your
spouse is no longer in the military. As such, the survey includes sections intended for
participants with current or prior military service, as well as those who are separated,
divorced, or widowed.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M illennium Cohort Family Study Widowed Non-responder Email
Subject: Help make an impact in the lives of military families!
Dear _[name]__,
As an important member of the Millennium Cohort Family Study you are one of a select
group of individuals helping to inform military leaders and policy makers about the
strengths and challenges associated with military life. In order to fully understand the
impact of military service on spouses and families, it is important that we hear your
unique perspective, which is why we are re-contacting you to complete your Family
Study follow-up survey.
Our survey has been updated to ensure an understanding of the ever-changing
circumstances of military spouses. As such, the survey includes sections intended for
participants with current or prior military service, with and without children, as well as
those who are separated, widowed or divorced.
To complete your survey, please visit the study website www.familycohort.org, click
Start Survey and enter your Subject I D: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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M onth of the M ilitary Child Non-responder Postcard
Military children bloom everywhere the wind carries them. They are resilient and strong,
cultivated deeply in the culture of the military, planted swiftly and surely. - anonymous
The Millennium Cohort Family Study Team joins the nation in celebrating April as the
Month of the Military Child. We recognize the strength and service of all military
families.
To complete your follow-up survey, please visit www.familycohort.org, click Start
Survey and enter your Subject I D XXXXXXX. Your continued participation is what
makes the Millennium Cohort Family Study such a powerful resource for understanding
the short and long-term impact of military life. Please know that your contribution will
make a difference and will benefit current and future generations of Service members and
their families.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
Primary Institutional Review Board Protocol # NHRC.2000.0007
M onth of the M ilitary Child Responder Postcard
Military children bloom everywhere the wind carries them. They are resilient and strong,
cultivated deeply in the culture of the military, planted swiftly and surely. - anonymous
The Millennium Cohort Family Study Team joins the nation in celebrating April as the
Month of the Military Child. We recognize the strength and service of all military
families.
Thank you for completing your follow-up survey. Your continued participation is what
makes the Millennium Cohort Family Study such a powerful resource for understanding
the short and long-term impact of military life. Please know that your contribution makes
a difference and will benefit current and future generations of Service members and their
families.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
Primary Institutional Review Board Protocol # NHRC.2000.0007
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M onth of the M ilitary Child Non-responder Email
Subject: Celebrating Month of the Military Child
Dear
name ,
During the month of April, the Millennium Cohort Family Study Team joins the nation in
celebrating the Month of the Military Child. We recognize and appreciate the sacrifices
made by military spouses and families on a daily basis.
The Millennium Cohort Family Study was launched in 2011 to help ensure the health and
well-being of military families. As a member of this important study, you are helping to
inform leadership and guide resources designed to support the specific needs of current
and future military couples and families.
To complete your follow-up survey, please visit www.familycohort.org, click Start
Survey and enter your Subject I D: XXXXXXX. Your continued participation is what
makes the Millennium Cohort Family Study such a powerful tool for understanding the
unique strengths and challenges of military life.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
On behalf of the Millennium Cohort Family Study Team
If you have any questions, please contact the Millennium Cohort Family Study team at
our toll-free number, 1-800-571-9248, or DSN 553-7465, or email
[email protected].
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007
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Pilot Test Phone Call Procedures & Script
For IRB Submission
The Family Study is seeking permission to call a small number of participants who have
not completed a follow-up survey as a pilot test to determine the efficacy of phone
contact in participant retention and retrieval of updated contact information. We would
only call those participants who provided a phone number on their baseline survey as a
means to remain in contact. Approximately 37 participants will be called; all of whom
have received limited contact from the Family Study during the current survey cycle due
to the lack of a correct mailing address, email address or both.
Subjects will be contacted via telephone Monday through Friday between the hours of 8
am to 7 pm within their time zone. A maximum of 3 phone call attempts will be made per
subject and a log of every attempt will be kept. For the purposes of this pilot, if we are
not able to reach a specific participant within 3 attempts, we will replace their phone
number in the pilot study call pool so that we can actually speak with up to 37
participants. Staff making phone calls will not leave a voice message for any participant.
A log of all of the phone calls will be kept and submitted for review.
The script for the phone calls is as follows:
Hello, my name is (caller name), and I am calling on behalf of the Department of Defense
Millennium Cohort Family Study team. Am I speaking with (participant name)?
[If speaking to correct person]
I am calling because we have tried to contact you several times over the past few months
to complete a Family Study follow-up survey, but some of our contacts have been
returned to us as undeliverable. We would like to be able to send you a token of
appreciation and keep you informed about the study, but we do not have your current
contact information. Would you like to update your mailing address and email so that we
can send you your gift and future study updates?
[If participant does not want to provide update information]
I understand. Do you wish to continue to participate in this study?
[If no]: We respect your decision. I will remove you from all future contacts.
Thank you for your participation thus far. Have a nice day.
[If yes]: We appreciate your continued participation in this important study. In
order to complete your follow-up survey please visit www.familycohort.org, click on
Start Survey and enter your Subject ID. If you change your mind, and decide you would
like to update your contact information, you can do so on our website.
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[If participant provides updated information]
Thank you for providing your correct address and or email/address. We will send your
gift and information about how to complete your follow-up survey within the next few
days. We appreciate your continued participation in this important study. Have a nice
day.
FAMILY CORRESPONDENCE
January Reminder email
Purpose: Reminder to log back in and complete the survey
Subject: Please help military families
Dear name ,
Happy New Year! We hope that you had a wonderful holiday season.
We want to thank you for the time that you have already invested to begin your
Millennium Cohort Family Study survey. Your participation and survey responses go a
long way toward helping military families, so we hope you will consider completing your
survey.
Please visit, www.familycohort.org click Start Survey and enter the following Subject
ID: xxxxxxx.
Thank you for your past participation in this important Department of Defense survey,
and for your continued participation. Together, we can make a difference in improving
the lives of military families!
Very Respectfully,
The Millennium Cohort Family Study Team
The Millennium Cohort Family Study is an authorized Department of Defense project.
Note Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget
Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
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February Reminder email #1
Purpose: Reminder to log back in and complete the survey
Subject: Please take some time to help military families
Dear name ,
Thank you for logging into the Millennium Cohort Family Study website and starting
your survey. In order to make sure your participation has the greatest impact, we ask that
you log back in and complete the remaining questions.
To complete the remainder of your survey, please visit, www.familycohort.org click
Start Survey and enter the following Subject ID: xxxxxxx.
The survey will continue at the point where you previously stopped, so you will be able
to simply finish the incomplete sections.
By participating in this study, you are helping to determine the potential effects of
military service on US military families.
Thank you for your continued participation in this important study!
Very Respectfully,
The Millennium Cohort Family Study Team
The Millennium Cohort Family Study is an authorized Department of Defense project.
Note Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget
Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
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February Reminder email #2
Purpose: Reminder to log back in and complete the survey
Subject: Please complete your Military Family survey
Dear name ,
We want to thank you for your past participation, and for the time you have already
invested in the 2014-2015 follow-up survey.
Unlike other surveys you may be receiving, the Millennium Cohort Family Study is
designed to follow your family over time as you experience the unique challenges
associated with military life. This is why we are, again, asking for your help.
We understand the demands of military life and greatly appreciate the time that you have
already invested to begin your Family Study survey. We hope you will consider
spending part of your day completing this important military family survey.
To complete the remaining questions on your survey, please visit,
www.familycohort.org click Start Survey and enter the following Subject ID:
xxxxxxx.
We truly appreciate your past and current participation in a study designed to help
improve the lives of military families.
Very Respectfully,
The Millennium Cohort Family Study Team
The Millennium Cohort Family Study is an authorized Department of Defense project.
Note Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget
Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
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MILLENNIUM COHORT FAMILY HOLIDAY MAILING NOVEMBER 2014
Subject: Your response matters!
Dear name ,
Next week you will be receiving a holiday postcard, so keep an eye on your mailbox!
We realize that this time of year is very busy and that your time is limited, but we want to
remind you that your perspective and experiences help to create the full picture of how
military life impacts families.
We appreciate the time that you have already invested to begin your survey, and we hope
that you take the time to complete the remaining questions. This way, all of your
responses can be included in future analyses. To complete the remainder of your survey,
please visit, www.familycohort.org click Start Survey and enter the following Subject ID:
xxxxxxx.
We want to sincerely thank you for taking the time out of your busy schedule to complete
the survey. Hearing from you is very important because families serve too!
Very Respectfully,
The Millennium Cohort Family Study Team
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol #
DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007.
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Thank you for completing the
Millennium Cohort Family Study survey.
Please accept this gift as a token of our
appreciation of your continued support.
For study updates or to change your contact information,
please visit our website at www.FamilyCohort.org
or contact us at 1-800-571-9248.
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol #
DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
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Dear _[name]__,
The Millennium Cohort Family Study Team would like to wish you and your family a
joyful holiday season.
As a member of the Family Study, the information provided by you and other participants
will help provide critical information to health care providers and military leaders about
the specific health and well-being concerns of military families.
We hope that you have been able to complete the survey online. If not, we want to
encourage you to complete the survey soon because this will be one of your last
opportunities to share your thoughts and experiences. To complete the survey, go to
www.familycohort.org click ‘Start Survey’ and enter your Subject ID: xxxxxxx.
We hope to hear from you as the opportunity to be a part of this important study will be
ending at the end of this month.
Happy Holidays,
The Millennium Cohort Family Study Team
Primary Institutional Review Board Protocol # NHRC.2000.0007.
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Subject: Last Chance to Take Part in an Important Military Family Health and
Wellness Study
Dear _[name]__,
We have contacted you many times over the past several months about the Family Study,
and we are writing again because the opportunity to be part of this important study will
be ending in a few short weeks.
This study was specifically designed to understand the impact of military experiences on
the short and long-term health and well-being of military families. As such, it is essential
that we continue to receive responses from all spouses who initially joined the study in
order to determine how families, relationships and health change over time.
Even if your spouse is no longer in the service, or if your relationship status has changed,
your participation is critical to form a complete picture of the impact of military life.
Whatever your circumstances and feelings, we would like to encourage you to take a few
minutes and provide your unique thoughts and experiences for this valuable study.
We appreciate your help and want to make it as easy to respond as possible. Simply go
www.familycohort.org click Start Survey and enter your Subject ID: xxxxxxx.
For any questions, please contact the Family Study Team at our toll-free number (800)
571-9248 or email us at [email protected].
Thank you so much for considering this final opportunity to respond.
Very Respectfully,
The Millennium Cohort Family Study Team
We hope we’ve reached an appropriate email address. However, if you don’t want us to
use this address, please visit: [unsubscribe email link]
The Millennium Cohort Family Study is an authorized Department of Defense project.
Note Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget
Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2000.0007.
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MILLENNIUM COHORT FAMILY MONTH OF THE MILITARY FAMILY
MAILING OCTOBER 2014
Month of the Military Family Cover Letter
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Month of the Military Family Graphic Envelope
Month of the Military Family Priority Mail Envelope
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Month of the Military Family E-mail
Subject: Celebrating National Military Family Month
Dear name ,
You should have received a letter last week with an invitation to complete a Millennium
Cohort Family Study follow-up survey and a small token of gratitude for your continued
participation.
During National Military Family Month, we want to thank you for the sacrifices you have
made in your unwavering support of our nation. We honor the important role you play in
supporting our Service members and in serving our country. As a member of this
important study, you are helping the U.S. military provide the best services possible to
current and future military families. We want to hear your unique perspective on the
health and well-being of military families, even if your spouse is no longer in the service
or if you have separated or divorced.
If you have already been able to complete the Family Study follow-up questionnaire, we
want to say thank you. If you have not yet had time to consider our request, we hope you
will be able to do so soon. To complete your survey, visit www.familycohort.org click
Start Survey and enter the following Subject ID: xxxxxxx.
Thank you for your time and sacrifices for our country.
Very Respectfully,
The Millennium Cohort Family Study Team
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol #
DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007.
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November Reminder E-mail
Subject: Don’t Forget to Complete your Survey
Dear name ,
You should have received a letter last week reminding you to complete the Millennium
Cohort Family Study follow-up survey you previously started, along with a small token
of gratitude for your continued participation.
During National Military Family Month, we want to thank you for the sacrifices you have
made in your unwavering support of our nation. We honor the important role you play in
supporting our Service members, and serving our country.
Unlike other studies, the Family Study is designed to follow your family over time as you
experience the unique challenges associated with military life (e.g., relocation, separation
and deployment). Even if your spouse is no longer in the service, or if you have separated
or divorced, we would still like to hear from you. Your perspective and experiences help
to create the full picture of how military life impacts families.
We appreciate the time you have already invested to begin your survey and we hope you
take the time to complete the remaining questions to assure that your responses can be
included in future analyses. To complete the remainder of your survey, visit
www.familycohort.org click Start Survey and enter the following Subject ID: xxxxxxx.
Thank you for your time and sacrifices for our country.
Very Respectfully,
The Millennium Cohort Family Study Team
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol #
DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2000.0007.
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MILLENNIUM COHORT FAMILY MAILING JULY 2014
Sample Survey Cover Letter
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Sample Survey
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Sample Survey Email
F5: Email ALL NON-RESPONDERS
Purpose: Mention sample survey mailed previous week
Subject Line: Have you Completed Your Family Study Survey Yet?
Dear NAME,
About a week ago we sent you a sample of questions to help you better understand the variety of
topics included in the Millennium Cohort Family Study survey. We hope that it was helpful to
see that the survey covers various experiences of military families, such as changes in
relationships, the birth of children, new health concerns, relocations, and military separation.
The request to complete a follow-up survey was sent to you because you had previously
completed a survey for the study in [survey month/year]. We are especially interested in hearing
about your most recent experiences because they will provide greater insight into the health and
well-being of today’s military families.
If you have already completed the online survey, we wish to thank you. If you have not yet had
time to consider our request, we hope you will be able to do so soon. To complete it, simply visit
the study website, www.familycohort.org, click Start Survey and enter your Subject ID:
XXXXXXX.
Thank you again for making the Family Study a success in improving the lives of military
Service members and their families.
Very Respectfully,
The Millennium Cohort Family Study Team
For more information about the Millennium Cohort Family Study, please visit
www.familycohort.org.
We hope we have reached an appropriate email address. However, if you would prefer we use a
different email address or if you do not want to be contacted at this address, please visit:
[unsubscribe link]
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F2a: Study Findings Email: different versions for those with good or bad mailing addresses
(If F1 mailing returns as bad address, send this version of email)
Week 3
Purpose: 1st email connection. Mention unable to send F1 mailing because of bad address.
Mention more results on website. Have a ‘What’s New’ page on website.
Subject Line: Re-establishing Contact with You
Dear _[name]__,
Two weeks ago we sent you a postal letter that was returned to us.
You are one of an important group of military spouses who completed a DoD survey as a
participant in the Millennium Cohort Family Study in (survey month/year). We are enormously
grateful for your help with this unique study, which seeks to better understand health and
wellness issues facing military families in all branches of the U.S. Armed Forces.
The reason we are contacting you is because we would like to share the progress of the
Millennium Cohort Family Study. We would appreciate you providing us a current postal
address so that we can continue to keep you informed about results from this important study, as
well as to stay in touch so that you can participate in the future. To update your address, just
click on this link (ADD LINK).
We are enormously grateful for your effort to help inform the U.S. military about how to provide
the best health care and support programs possible to current and future military families through
your participation in this critical Department of Defense study. We hope that you will participate
again in the future.
Very sincerely,
The Family Study Team
Some people have multiple email addresses. If we've reached you at an inappropriate address,
please visit this website to provide a preferred address for contacting you .
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F2b: Study Findings Email (If F1 mailing is a good address, send this version of email)
Week 3
Purpose: reconnect by email. Mention more results on website . Have a ‘What’s New’ page on
website.
Subject Line: Preliminary Results from Your Participation
Dear _[name]__,
We hope you recently received our letter in the mail which highlights the preliminary study
findings of the DoD Millennium Cohort Family Study.
You are one of an important group of military spouses who completed this significant DoD
survey aimed at understanding the impact of military service on families. You completed your
first study questionnaire in (survey month/year). We greatly appreciate you sharing your
thoughts and experiences because these will provide greater insight into issues facing today’s
military families.
In a few weeks, we will send you information regarding the follow-up survey, which has some
important new updates from the previous version. We know that families change over time and
would greatly appreciate hearing how you are doing since the last survey. Even if you are no
longer with your Service member spouse, or if your Service member is no longer in the military,
we greatly value your continued participation and input.
Additionally, we would like to share with you some of our study updates:[Web link to “What’s
New” webpage]
Thank you again for your help in completing the current survey and your commitment for
protecting the health and wellness of current and future military families.
Very sincerely,
The Family Study Team
Some people have multiple email addresses. If we've reached you at an inappropriate address,
please visit this website to provide a preferred address for contacting you .
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MILLENNIUM COHORT FAMILY MAILING JUNE 2014
2014 Pre-notice letter with Key Study Findings insert
June 2014
Contents: Cover letter, 6x9 Study Findings bi-fold insert, 6x9 envelope
Mail Date: June 2, 2014
Cover letter Message:
Dear _[name]__,
You are one of 10,000 military spouses who completed a survey as part of an important DoD
survey (the Family Study) initiated to understand the impact of military service on families. You
completed your first study questionnaire in (survey month/year).
We greatly appreciate that you shared your experiences with us and thought you might
appreciate knowing about some of the preliminary findings from this effort. The enclosed
summary provides just a few of the initial results and how they will be used.
Those of you who helped with this study represent families from all branches and components of
the military – active duty, Reserve, and National Guard. Some of your spouses are no longer
serving in the military, while others continue to serve. Regardless of your specific situation, it is
very important that we continue to hear from you. This study is designed to follow military
families over time, including both during and after military service time.
We hope you’ll take a few moments to review the findings that we’ve included in this mailing.
More study information can be found on our website, www.familycohort.org.
In the fall, we will be contacting you to learn about any changes that may have occurred in your
health and well-being since we last heard from you. We are eager to learn more about how
participants’ lives may have changed over time. By completing occasional follow-up
questionnaires, we will be able to understand the unique challenges associated with military life
(such as moves, separation from the military, and deployments).
Thanks so much for your effort to help the U.S. military provide the best services possible to
current and future military families.
Very Sincerely on behalf of the Family Cohort Study Team,
Hope M. McMaster, PhD
Research Psychologist and Military Spouse
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Study Findings content:
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Front Cover:
Inside Panel (left):
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Inside Panel (right):
Back Panel:
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National Military Family Month 2013
The following provides the Family Cohort Study email contents:
National Military Family Month 2013 Postcard Text
During National Military Family Month, we want to thank you for your daily sacrifices
and steadfast support of our nation. We honor your strength, resilience, and the important
role you play in protecting our nation. Military families often make many sacrifices as
they support our men and women in uniform – sacrifices that are worthy of recognition.
As part of America’s commitment to protect the well-being of the family members our
military service men and women hold dear, the Department of Defense launched a longterm study in order to understand the impact of military service on families.
Thank you for completing your Family Study survey and contributing to this important
study. Your participation makes it possible to inform policy makers regarding your
experiences and to guide prevention measures that positively impact military families.
Very sincerely,
The Millennium Cohort Family Study Team
Department Head
DoD Center for Deployment Health Research
San Diego, CA
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Appendix I.
COLLABORATION PROTOCOLS
Signed_FamilyCollab
orationProtocol_2014
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Appendix J.
SERVICE AGREEMENTS
DUA ABT.pdf
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