VA Cooperative Studies Program 585: Information for Researchers

Overview

The goal of the project was to create a longitudinal research database and linked biorepository to integrate epidemiologic, survey, clinical, and environmental exposure data from a cohort of 1990-1991 Gulf War Era Veterans. The longitudinal cohort database and biorepository can be used to enhance ongoing research, facilitate new research on conditions affecting Gulf War Era Veterans, and study chronic diseases that currently or may later affect Veterans of the Gulf War Era. This will support a wide range of future genomic and genetic studies, biologic and immunologic research, and epidemiologic, clinical, and health services research.

Aims of the project

The goal of the project was to establish a cohort of Gulf War Era Veterans in support of future research studies. Participants completed a mailed survey, provided access to medical and research records, and provided a blood specimen.

The first phase of the pilot project began in August 2014 and ended in May 2016. There were two specific aims:

• Assess feasibility of recruitment, consenting, and blood drawing and shipping processes;
• Develop, test, and implement databases needed for enrollment tracking, blood sample tracking, and data storage

Inclusion criteria

• Members of Uniformed Services who served during the 1990-1991 Gulf War Era (August 1990-July 31, 1991)
• Eligibility was not dependent on deployment or combat status
• Included users and non-users of Veterans Health Administration (VHA) care

Sampling frame

Participants were recruited from a stratified random sample of 90,000 Gulf War Era Veterans (original source: Defense Manpower Data Center). The sampling frame oversampled women and non-white race in an effort to assure that subgroups of interest to researchers would have adequate representation in the cohort. Participants could also be enrolled through self-nomination.

Recruitment and Enrollment

During the first phase of the pilot, 10,000 Veterans were contacted, with the goal of enrolling 3,000. As of May 2, 2016, there are 1275 Veterans enrolled. An Enrollment Coordinating Center (ECC) was used to recruit and enroll Veterans. The ECC mailed an invitation packet containing consent documents (informed consent and HIPAA), a request for medical records release, a survey, and an opt-out card. The ECC called Veterans who did not return the opt-out card, and administered informed consent by phone. Veterans mailed in completed forms and survey, and then completed a blood draw.

Data Collection

Collection Process

The project gathered data from a survey, medical records, and blood specimens. The participant completed the mailed survey on paper, and the ECC scanned the survey to a database. Medical records may be accessed using electronic, administrative and other sources.

Potential Data Sources

• VA electronic medical records
• Non-VA health records
• Death records
• Research records from other studies

Biorepository (Blood Samples)

Blood Sample Quantity

The project collected 10ml of blood.

Blood Collection Process

The phlebotomist arranged to meet with participants for blood collection at their home or other convenient location. After the blood sample was obtained, the phlebotomist mailed the samples overnight on frozen gel packs to the Boston VA (MAVERIC) biorepository for processing and storage.

Blood Processing and Storage

Upon receipt at the MAVERIC biorepository, the blood specimens were checked for problems such as clotting, hemolysis, or insufficient volume. Two vials of buffy coat (with DNA) and two aliquots of plasma were stored for all samples. Additional processing may have occurred as needed to meet the requirements of research studies using the samples. The samples are stored in a fully-automated freezer at -80°F.

Survey

Survey Development

Early in survey development, the project team conducted a review of survey measures and research tools used by 12 epidemiologic studies and 2 government registries. The review found that many studies used similar instruments, but this varied by the type of questions being asked. Therefore, issues of comparability with past data were considered in developing the GWECB survey. For more details, see the publication by McNeil et al. here.

A Survey Development Committee was formed to create the survey. The goals of the survey were to:

1. Include the entire Million Veteran Program (MVP) short baseline survey, while adding additional questions specific to Gulf War Era Veterans
2. Provide researchers with enough information to use the biorepository and determine subsets of the Gulf War Era cohort
3. Avoid overburdening Veterans and keep the survey short (less than 1 hour)

Survey Questions

Topics included:

• Military service and geographic location
• Lifestyle behaviors
• Physical and mental health
• Family and family health

All questions came from previously developed instruments. If available, validated instruments from prior Gulf War research studies were chosen to support data comparability between studies. Sources for the survey questions included the National Survey of Veterans, VR-12, PHQ-8, PCL-C, AUDIT-C, UK Biobank (Version 4.6), and others.

Survey Pilot Tested

Pilot testing included in-person usability testing interviews with a small number of Gulf War Era Veterans, in order to ensure comprehension and reduce respondent burden. We used the results of pilot testing to revise the survey prior to its use in the pilot project.

Contact Information

We invite interested researchers to contact the project team with any questions.