TY - JOUR
T1 - A common language for Gulf War Illness (GWI) research studies
T2 - GWI common data elements
AU - the Gulf War Illness Common Data Elements Working Group:
AU - Symptoms Assessment Working Group:
AU - Systems Assessment Working Group:
AU - Cohen, Devra E.
AU - Sullivan, Kimberly A.
AU - McNeil, Rebecca B.
AU - Ashford, Wes
AU - Bested, Alison
AU - Bunker, James
AU - Cheema, Amanpreet
AU - Cook, Dane
AU - Cournoyer, Jeffrey
AU - Craddock, Travis
AU - Golier, Julia
AU - Hardie, Anthony
AU - Helmer, Drew
AU - Lindheimer, Jacob B.
AU - Lloyd, Patricia Janulewicz
AU - Kerr, Kathleen
AU - Krengel, Maxine
AU - Nadkarni, Shree
AU - Nugent, Shannon
AU - Paris, Bonnie
AU - Reinhard, Matthew
AU - Rumm, Peter
AU - Schneiderman, Aaron
AU - Sims, Kellie J.
AU - Steele, Lea
AU - Turner, Marsha
AU - Abdullah, Laila
AU - Abreu, Maria
AU - Abu-Donia, Mohamed
AU - Aenlle, Kristina
AU - Arocho, Jimmy
AU - Balbin, Elizabeth
AU - Baraniuk, James
AU - Block, Karen
AU - Block, Michelle
AU - DeBeer, Bryann
AU - Engdahl, Brian
AU - Filipov, Nikolay
AU - Fletcher, Mary Ann
AU - Kalasinsky, Victor
AU - Kokkotou, Efi
AU - Lidie, Kristy
AU - Little, Deborah
AU - Loging, William
AU - Morris, Marianna
AU - Nathanson, Lubov
AU - Nichols, Montra Denise
AU - Pasinetti, Giulio
AU - Shungu, Dikoma
AU - Waziry, Paula
N1 - Funding Information:
The GWI Common Data Element (CDE) initiative was sponsored by the United States Department of Veteran Affairs (VA) and the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) and aimed to establish consensus on data collection measures across important illness domains to improve the interpretation and applicability of GWI study results. The CDE GWI initiative developed recommendations across survey instruments, case report forms, and laboratory measures to improve data quality, and to increase the efficiency and effectiveness of clinical and laboratory studies.The opinions and assertions contained herein are the private views of the authors and do not reflect the views of the United States Department of Veteran Affairs (VA) or the United States Department of Defense Congressionally Directed Medical Research Programs (CDMRP). The support for this project was provided, in part, through a field-based grant from the U.S. Department of Veteran Affairs Biomedical Laboratory Research and Development (Klimas –PI). The authors acknowledge the significant investment of time and effort of the GWI Common Data Elements Working Group members. The authors are grateful for the support and encouragement of Dr. Karen Block, Gulf War Senior Scientific Program Manager, Office of Research and Development, U.S. Department of Veterans Affairs, and Dr. Kristie Lidie, GWI Program Manager, Congressionally Directed Medical Research Programs, Department of Defense, for their help in operationalizing these recommendations. We also thank Dr. Vicky Whittemore, Program Director, NINDS, and Dr. Elizabeth Unger, Chief of the Chronic Viral Diseases Branch, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control, for their advice and assistance in the GWI CDE process and their leadership in the development of the ME/CFS CDEs.
Funding Information:
The foundation of this undertaking was supported by the National Institute of Neurologic Disorders and Stroke (NINDS) for a comparator illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). [4] ME/CFS is phenotypically similar to GWI and presents with an inability to identify markers of disease activity. [5,6] Both illnesses are currently diagnosed and managed based on presenting symptomatology, necessitating objective measures and valid, reliable tools.
Funding Information:
The opinions and assertions contained herein are the private views of the authors and do not reflect the views of the United States Department of Veteran Affairs (VA) or the United States Department of Defense Congressionally Directed Medical Research Programs (CDMRP). The support for this project was provided, in part, through a field-based grant from the U.S. Department of Veteran Affairs Biomedical Laboratory Research and Development (Klimas –PI). The authors acknowledge the significant investment of time and effort of the GWI Common Data Elements Working Group members.
Publisher Copyright:
© 2018
PY - 2022/2/1
Y1 - 2022/2/1
N2 - Aims: The Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community. Main methods: A collective working group of GWI advocates, Veterans, clinicians, and researchers convened to provide consensus on instruments, case report forms, and guidelines for GWI research. A similar initiative, supported by the National Institute of Neurologic Disorders and Stroke (NINDS) was completed for a comparative illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and provided the foundation for this undertaking. The GWI working group divided into two sub-groups (symptoms and systems assessment). Both groups reviewed the applicability of instruments and forms recommended by the NINDS ME/CFS CDE to GWI research within specific domains and selected assessments of deployment exposures. The GWI CDE recommendations were finalized in March 2018 after soliciting public comments. Key findings: GWI CDE recommendations are organized in 12 domains that include instruments, case report forms, and guidelines. Recommendations were categorized as core (essential), supplemental-highly recommended (essential for specified conditions, study types, or designs), supplemental (commonly collected, but not required), and exploratory (reasonable to use, but require further validation). Recommendations will continually be updated as GWI research progresses. Significance: The GWI CDEs reflect the consensus recommendations of GWI research community stakeholders and will allow studies to standardize data collection, enhance data quality, and facilitate data sharing.
AB - Aims: The Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community. Main methods: A collective working group of GWI advocates, Veterans, clinicians, and researchers convened to provide consensus on instruments, case report forms, and guidelines for GWI research. A similar initiative, supported by the National Institute of Neurologic Disorders and Stroke (NINDS) was completed for a comparative illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and provided the foundation for this undertaking. The GWI working group divided into two sub-groups (symptoms and systems assessment). Both groups reviewed the applicability of instruments and forms recommended by the NINDS ME/CFS CDE to GWI research within specific domains and selected assessments of deployment exposures. The GWI CDE recommendations were finalized in March 2018 after soliciting public comments. Key findings: GWI CDE recommendations are organized in 12 domains that include instruments, case report forms, and guidelines. Recommendations were categorized as core (essential), supplemental-highly recommended (essential for specified conditions, study types, or designs), supplemental (commonly collected, but not required), and exploratory (reasonable to use, but require further validation). Recommendations will continually be updated as GWI research progresses. Significance: The GWI CDEs reflect the consensus recommendations of GWI research community stakeholders and will allow studies to standardize data collection, enhance data quality, and facilitate data sharing.
KW - CDE
KW - CDMRP
KW - DoD
KW - GW
KW - GWI
KW - GWV
KW - VA
UR - http://www.scopus.com/inward/record.url?scp=85123891806&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85123891806&partnerID=8YFLogxK
U2 - 10.1016/j.lfs.2021.119818
DO - 10.1016/j.lfs.2021.119818
M3 - Article
C2 - 34352259
AN - SCOPUS:85123891806
SN - 0024-3205
VL - 290
JO - Life Sciences
JF - Life Sciences
M1 - 119818
ER -