Browsing by Subject "Common data elements"

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    A common language for Gulf War Illness (GWI) research studies: GWI common data elements
    (Elsevier, 2022) Cohen, Devra E.; Sullivan, Kimberly A.; McNeil, Rebecca B.; Gulf War Illness Common Data Elements Working Group; Symptoms Assessment Working Group; McNeil, Rebecca B.; Ashford, Wes; Bested, Alison; Bunker, James; Cheema, Amanpreet; Cohen, Devra E.; Cook, Dane; Cournoyer, Jeffrey; Craddock, Travis; Golier, Julia; Hardie, Anthony; Helmer, Drew; Lindheimer, Jacob B.; Janulewicz Lloyd, Patricia; Kerr, Kathleen; Krengel, Maxine; Nadkarni, Shree; Nugent, Shannon; Paris, Bonnie; Reinhard, Matthew; Rumm, Peter; Schneiderman, Aaron; Sims, Kellie J.; Steele, Lea; Turner, Marsha; Systems Assessment Working Group; Sullivan, Kimberly A.; Abdullah, Laila; Abreu, Maria; Abu-Donia, Mohamed; Aenlle, Kristina; Arocho, Jimmy; Balbin, Elizabeth; Baraniuk, James; Block, Karen; Block, Michelle; DeBeer, Bryann; Engdahl, Brian; Filipov, Nikolay; Fletcher, Mary Ann; Kalasinsky, Victor; Kokkotou, Efi; Lidie, Kristy; Little, Deborah; Loging, William; Morris, Marianna; Nathanson, Lubov; Nichols, Montra Denise; Pasinetti, Giulio; Shungu, Dikoma; Waziry, Paula; VanLeeuwen, Jon; Younger, Jarred; Pharmacology and Toxicology, School of Medicine
    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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    Comparing the Quality of Life after Brain Injury-Overall Scale and Satisfaction with Life Scale as Outcome Measures for Traumatic Brain Injury Research
    (Mary Ann Liebert, 2021) Kreitzer, Natalie; Jain, Sonia; Young, Jacob S.; Sun, Xiaoying; Stein, Murray B.; McCrea, Michael A.; Levin, Harvey S.; Giacino, Joseph T.; Markowitz, Amy J.; Manley, Geoffrey T.; Nelson, Lindsay D.; Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Investigators; Psychiatry, School of Medicine
    It is important to measure quality of life (QoL) after traumatic brain injury (TBI), yet limited studies have compared QoL inventories. In 2579 TBI patients, orthopedic trauma controls, and healthy friend control participants, we compared the Quality of Life After Brain Injury-Overall Scale (QOLIBRI-OS), developed for TBI patients, to the Satisfaction with Life Scale (SWLS), an index of generic life satisfaction. We tested the hypothesis that group differences (TBI and orthopedic trauma vs. healthy friend controls) would be larger for the QOLIBRI-OS than the SWLS and that the QOLIBRI-OS would manifest more substantial changes over time in the injured groups, demonstrating more relevance of the QOLIBRI-OS to traumatic injury recovery. (1) We compared the group differences (TBI vs. orthopedic trauma control vs. friend control) in QoL as indexed by the SWLS versus the QOLIBRI-OS and (2) characterized changes across time in these two inventories across 1 year in these three groups. Our secondary objective was to characterize the relationship between TBI severity and QoL. As compared with healthy friend controls, the QOLIBRI reflected greater reductions in QoL than the SWLS for both the TBI group (all time points) and the orthopedic trauma control group (2 weeks and 3 months). The QOLIBRI-OS better captured expected improvements in QoL during the injury recovery course in injured groups than the SWLS, which demonstrated smaller changes over time. TBI severity was not consistently or robustly associated with self-reported QoL. The findings imply that, as compared with the SWLS, the QOLIBRI-OS appears to identify QoL issues more specifically relevant to traumatically injured patients and may be a more appropriate primary QoL outcome measure for research focused on the sequelae of traumatic injuries.