A Common Language for Gulf War Illness (GWI) Research Studies: GWI Common Data Elements

Devra E Cohen; Kimberly A Sullivan; Rebecca B McNeil; J Wesson Ashford; Alison Bested; James Bunker; Amanpreet K Cheema; Dane Cook; Jeffrey Cournoyer; Travis Craddock; Julia Golier; Anthony Hardie; Drew A Helmer; Jacob B Lindheimer; Patricia Janulewicz Lloyd; Kathleen Kerr; Maxine Krengel; Shree Nadkarni; Shannon Nugent; Bonnie Paris; Matthew Reinhard; Peter Rumm; Aaron Schneiderman; Kellie J Sims; Lea Steele; Marsha Turner; Lea Steele; Laila Abdullah; Maria M Abreu; Mohamed Abu-Donia; Kristina Aenlle; Jimmy Arocho; Elizabeth G Balbin; James N Baraniuk; Karen Block; Michelle L Block; Bryann DeBeer; Brian Engdahl; Nikolay Filipov; Mary Ann Fletcher; Victor Kalasinsky; Efi G Kokkotou; Kristy Lidie; Deborah M Little; William Loging; Mariana Morris; Lubov Nathanson; Montra Denise Nichols; Giulio Pasinetti; Dikoma C Shungu; Paula Waziry; Jon VanLeeuwen; Jarred Younger

doi:10.1016/j.lfs.2021.119818

A Common Language for Gulf War Illness (GWI) Research Studies: GWI Common Data Elements

Devra E Cohen
, Kimberly A Sullivan
, Rebecca B McNeil
, J Wesson Ashford
, Alison Bested
, James Bunker
, Amanpreet K Cheema
, Dane Cook
, Jeffrey Cournoyer
, Travis Craddock
, Julia Golier
, Anthony Hardie
, Drew A Helmer
, Jacob B Lindheimer
, Patricia Janulewicz Lloyd
, Kathleen Kerr
, Maxine Krengel
, Shree Nadkarni
, Shannon Nugent
, Bonnie Paris

Matthew Reinhard, Peter Rumm, Aaron Schneiderman, Kellie J Sims, Lea Steele, Marsha Turner, Lea Steele, Laila Abdullah, Maria M Abreu, Mohamed Abu-Donia, Kristina Aenlle, Jimmy Arocho, Elizabeth G Balbin, James N Baraniuk, Karen Block, Michelle L Block, Bryann DeBeer, Brian Engdahl, Nikolay Filipov, Mary Ann Fletcher, Victor Kalasinsky, Efi G Kokkotou, Kristy Lidie, Deborah M Little, William Loging, Mariana Morris, Lubov Nathanson, Montra Denise Nichols, Giulio Pasinetti, Dikoma C Shungu, Paula Waziry, Jon VanLeeuwen, Jarred Younger

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	American English
Pages (from-to)	119818
Journal	Life Sciences
Volume	290
DOIs	https://doi.org/10.1016/j.lfs.2021.119818
State	Published - Feb 1 2022

Bibliographical note

Funding

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. 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. 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.

Funders	Funder number
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
U.S. Department of Veteran Affairs Biomedical Laboratory Research and Development
U.S. Department of Defense
Centers for Disease Control and Prevention
National Institute of Neurological Disorders and Stroke
Congressionally Directed Medical Research Programs
Department of Veterans Affairs	IK2CX001679
National Center for Emerging and Zoonotic Infectious Diseases
Office of Research and Development

ASJC Scopus Subject Areas

General Pharmacology, Toxicology and Pharmaceutics
General Biochemistry,Genetics and Molecular Biology

Keywords

National Institute of Neurological Disorders and Stroke (U.S.)
Persian Gulf Syndrome
United States
United States Department of Veterans Affairs
biomedical research
common data elements
humans
information dissemination
veterans health
CDE
GWV
VA
GW
DoD
GWI
CDMRP

Disciplines

Psychology

Access to Document

10.1016/j.lfs.2021.119818

https://doi.org/10.1016/j.lfs.2021.119818

Cite this

Cohen, D. E., Sullivan, K. A., McNeil, R. B., Ashford, J. W., Bested, A., Bunker, J., Cheema, A. K., Cook, D., Cournoyer, J., Craddock, T., Golier, J., Hardie, A., Helmer, D. A., Lindheimer, J. B., Lloyd, P. J., Kerr, K., Krengel, M., Nadkarni, S., Nugent, S., ... Younger, J. (2022). A Common Language for Gulf War Illness (GWI) Research Studies: GWI Common Data Elements. Life Sciences, 290, 119818. https://doi.org/10.1016/j.lfs.2021.119818

Cohen, DE, Sullivan, KA, McNeil, RB, Ashford, JW, Bested, A, Bunker, J, Cheema, AK, Cook, D, Cournoyer, J, Craddock, T, Golier, J, Hardie, A, Helmer, DA, Lindheimer, JB, Lloyd, PJ, Kerr, K, Krengel, M, Nadkarni, S, Nugent, S, Paris, B, Reinhard, M, Rumm, P, Schneiderman, A, Sims, KJ, Steele, L, Turner, M, Steele, L, Abdullah, L, Abreu, MM, Abu-Donia, M, Aenlle, K, Arocho, J, Balbin, EG, Baraniuk, JN, Block, K, Block, ML, DeBeer, B, Engdahl, B, Filipov, N, Fletcher, MA, Kalasinsky, V, Kokkotou, EG, Lidie, K, Little, DM, Loging, W, Morris, M, Nathanson, L, Nichols, MD, Pasinetti, G, Shungu, DC, Waziry, P, VanLeeuwen, J & Younger, J 2022, 'A Common Language for Gulf War Illness (GWI) Research Studies: GWI Common Data Elements', Life Sciences, vol. 290, pp. 119818. https://doi.org/10.1016/j.lfs.2021.119818

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abstract = " 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.",

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author = "Cohen, \{Devra E\} and Sullivan, \{Kimberly A\} and McNeil, \{Rebecca B\} and Ashford, \{J Wesson\} and Alison Bested and James Bunker and Cheema, \{Amanpreet K\} and Dane Cook and Jeffrey Cournoyer and Travis Craddock and Julia Golier and Anthony Hardie and Helmer, \{Drew A\} and Lindheimer, \{Jacob B\} and Lloyd, \{Patricia Janulewicz\} and Kathleen Kerr and Maxine Krengel and Shree Nadkarni and Shannon Nugent and Bonnie Paris and Matthew Reinhard and Peter Rumm and Aaron Schneiderman and Sims, \{Kellie J\} and Lea Steele and Marsha Turner and Lea Steele and Laila Abdullah and Abreu, \{Maria M\} and Mohamed Abu-Donia and Kristina Aenlle and Jimmy Arocho and Balbin, \{Elizabeth G\} and Baraniuk, \{James N\} and Karen Block and Block, \{Michelle L\} and Bryann DeBeer and Brian Engdahl and Nikolay Filipov and Fletcher, \{Mary Ann\} and Victor Kalasinsky and Kokkotou, \{Efi G\} and Kristy Lidie and Little, \{Deborah M\} and William Loging and Mariana Morris and Lubov Nathanson and Nichols, \{Montra Denise\} and Giulio Pasinetti and Shungu, \{Dikoma C\} and Paula Waziry and Jon VanLeeuwen and Jarred Younger",

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doi = "10.1016/j.lfs.2021.119818",

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AU - Cohen, Devra E

AU - Sullivan, Kimberly A

AU - McNeil, Rebecca B

AU - Ashford, J Wesson

AU - Bested, Alison

AU - Bunker, James

AU - Cheema, Amanpreet K

AU - Cook, Dane

AU - Cournoyer, Jeffrey

AU - Craddock, Travis

AU - Golier, Julia

AU - Hardie, Anthony

AU - Helmer, Drew A

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 - Steele, Lea

AU - Abdullah, Laila

AU - Abreu, Maria M

AU - Abu-Donia, Mohamed

AU - Aenlle, Kristina

AU - Arocho, Jimmy

AU - Balbin, Elizabeth G

AU - Baraniuk, James N

AU - Block, Karen

AU - Block, Michelle L

AU - DeBeer, Bryann

AU - Engdahl, Brian

AU - Filipov, Nikolay

AU - Fletcher, Mary Ann

AU - Kalasinsky, Victor

AU - Kokkotou, Efi G

AU - Lidie, Kristy

AU - Little, Deborah M

AU - Loging, William

AU - Morris, Mariana

AU - Nathanson, Lubov

AU - Nichols, Montra Denise

AU - Pasinetti, Giulio

AU - Shungu, Dikoma C

AU - Waziry, Paula

AU - VanLeeuwen, Jon

AU - Younger, Jarred

PY - 2022/2/1

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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 - National Institute of Neurological Disorders and Stroke (U.S.)

KW - Persian Gulf Syndrome

KW - United States

KW - United States Department of Veterans Affairs

KW - biomedical research

KW - common data elements

KW - humans

KW - information dissemination

KW - veterans health

KW - CDE

KW - GWV

KW - VA

KW - GW

KW - DoD

KW - GWI

KW - CDMRP

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DO - 10.1016/j.lfs.2021.119818

M3 - Article

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SN - 0024-3205

VL - 290

SP - 119818

JO - Life Sciences

JF - Life Sciences

ER -

A Common Language for Gulf War Illness (GWI) Research Studies: GWI Common Data Elements

Abstract

Bibliographical note

Funding

ASJC Scopus Subject Areas

Keywords

Disciplines

Access to Document

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