St. Louis, MO, November 11, 2010 The November 2010 issue of the Archives of Physical Medicine and Rehabilitation, Official Journal of the American Congress of Rehabilitation Medicine, has published a set of 9 articles on traumatic brain injury (TBI) that will accelerate future research in the field by establishing common language for the degree of injury, how it is measured and classified, treatment and potential outcomes. It provides the first set of recommendations intended to promote greater consistency and collaboration among researchers on TBI and psychological health regardless of funding source.
According to the Archive's Deputy Editor Dr. Leighton Chan, "This was a monumental undertaking, bringing together the NIH, DOD, VA, CDC, and other international partners. This set of papers will set the stage for all future clinical research on TBI and post-traumatic stress disorder (PTSD), diverse, yet interrelated, fields."
Commentary: Common Data Elements for Research on Traumatic Brain Injury and Psychological Health: Current Status and Future Development
John Whyte, MD, PhD, Jennifer Vasterling, PhD, Geoffrey T. Manley, MD, PhD
The commentary describes the current status of this multiagency endeavor, the obstacles encountered, and possible directions for future development. The authors point out that links between TBI and psychological health (PH) have long been recognized. However, the recent wars in Iraq and Afghanistan have highlighted how intertwined TBI and stress-related PH conditions may be, their sequelae often sharing common risk factors (eg, intensive combat), symptoms (eg, irritability, concentration problems), associated features (eg, sleep disturbance), and functional impairment (eg, occupational dysfunction).
Advancing Integrated Research in Psychological Health and Traumatic Brain injury: Common Data Elements
Veronica A. Thurmond, PhD, Ramona Hicks, PhD, Theresa Gleason, PhD, A. Cate Miller, PhD, Nicholas Szuflita, BA, Jean Orman, ScD, Karen Schwab, PhD
The use of different measures to assess similar study variables and/or assess outcomes limits important advances in psychological health (PH) and TBI research. Without a set of common data elements (CDE) comparison of findings across studies is challenging. The federal agencies involved in PH and TBI research, the National Institute of Neurological Disorders and Stroke, Department of Veterans Affairs, National Institute on Disability and Rehabilitation Research, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, and Defense and Veterans Brain Injury Center, therefore cosponsored a scientific initiative to develop CDEs for PH and TBI research. Scientific experts were invited to participate in 1 of 8 working groups to develop recommendations for specific topic driven CDEs.
Position Statement: Definition of Traumatic Brain Injury
David K. Menon, MD, PhD, Karen Schwab, PhD, David W. Wright, MD, Andrew I. Maas, MD, PhD, on behalf of The Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health
A clear, concise definition of traumatic brain injury (TBI) is fundamental for reporting, comparison, and interpretation of studies on TBI. TBI is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force. This article discusses new criteria for considering or establishing a diagnosis of TBI, with a particular focus on the problems of how a diagnosis of TBI can be made when patients present late after injury and how mild TBI may be differentiated from non-TBI causes with similar symptoms.
Common Data Elements for Traumatic Brain Injury: Recommendations from the Interagency Working Group on Demographics and Clinical Assessment
Andrew I. Maas, MD, Cynthia L. Harrison-Felix, PhD, David Menon, MD, P. David Adelson, MD, Tom Balkin, PhD, Ross Bullock, MD, Doortje C. Engel, MD, PhD, Wayne Gordon, PhD, Jean Langlois Orman, ScD, Henry L. Lew, MD, PhD, Claudia Robertson, MD, Nancy Temkin, PhD, Alex Valadka, MD, Mieke Verfaellie, PhD, Mark Wainwright, MD, David W. Wright, MD, Karen Schwab, PhD
Comparing results across studies in traumatic brain injury (TBI) has been difficult because of the variability in data coding, definitions, and collection procedures. The global aim of the Working Group on Demographics and Clinical Assessment was to develop recommendations on the coding of clinical and demographic variables for TBI studies applicable across the broad spectrum of TBI, and to classify these as core, supplemental, or emerging. Templates were produced to summarize coding formats, motivation of choices, and recommendations for procedures. Work is ongoing to include more international participation and to provide an electronic data entry format with pull-down menus and automated data checks. This proposed standardization will facilitate comparison of research findings across studies and encourage high-quality meta-analysis of individual patient data.
Recommendations for the Use of Common Outcome Measures in Traumatic Brain Injury Research
Elisabeth A. Wilde, PhD, Gale G. Whiteneck, PhD, Jennifer Bogner, PhD, Tamara Bushnik, PhD, David X. Cifu, MD, Sureyya Dikmen, PhD, Louis French, PsyD, Joseph T. Giacino, PhD, Tessa Hart, PhD, James F. Malec, PhD, Scott R. Millis, PhD, Thomas A. Novack, PhD, Mark Sherer, PhD, David S. Tulsky, PhD, Rodney D. Vanderploeg, PhD, Nicole von Steinbuechel, PhD
This article summarizes the selection of outcome measures by the interagency Traumatic Brain Injury (TBI) Outcomes Workgroup to address primary clinical research objectives, including documentation of the natural course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies.
Common Data Elements in Radiologic Imaging of Traumatic Brain Injury
Ann-Christine Duhaime, MD, Alisa D. Gean, MD, E. Mark Haacke, PhD, Ramona Hicks, PhD, Max Wintermark, MD, Pratik Mukherjee, MD, PhD, David Brody, MD, Lawrence Latour, PhD, Gerard Riedy, MD, Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members
Radiologic brain imaging is the most useful means of visualizing and categorizing the location, nature, and degree of damage to the central nervous system sustained by patients with traumatic brain injury (TBI). In addition to determining acute patient management and prognosis, imaging is crucial for the characterization and classification of injuries for natural history studies and clinical trials.
Common Data Elements for Traumatic Brain Injury: Recommendations from the Biospecimens and Biomarkers Working Group
Geoffrey T. Manley, PhD, Ramon Diaz-Arrastia, MD, PhD, Mary Brophy, MD, MPH, Doortje Engel, MD, PhD, Clay Goodman, MD, Katrina Gwinn, MD, Timothy D. Veenstra, PhD, Geoffrey Ling, MD, PhD, Andrew K. Ottens, PhD, Frank Tortella, PhD, Ronald L. Hayes, PhD
Human biospecimens and biofluids represent an important resource from which molecular data can be generated to detect and classify injury and to identify molecular mechanisms and therapeutic targets. To date, there has been considerable variability in biospecimen and biofluid collection, storage, and processing in traumatic brain injury (TBI) studies. To realize the full potential of this important resource, standardization and adoption of best practice guidelines are required to insure the quality and consistency of these specimens. With the adoption of these standards and best practices, future investigators will be able to obtain data across multiple studies with reduced costs and effort and accelerate the progress of genomic, proteomic, and metabolic research in TBI.
Consensus Recommendations for Common Data Elements for Operational Stress Research and Surveillance: Report of a Federal Interagency Working Group
William P. Nash, MD, Jennifer Vasterling, PhD, Linda Ewing-Cobbs, PhD, Sarah Horn, BBA, Thomas Gaskin, PhD, John Golden, PhD, William T. Riley, PhD, Stephen V. Bowles, PhD, James Favret, PhD, Patricia Lester, MD, Robert Koffman, MD, Laura C. Farnsworth, BS, Dewleen G. Baker, MD
Empirical studies and surveillance projects increasingly assess and address potentially adverse psychological health outcomes from the stress of military operations, but no standards yet exist for common concept definitions, variable categories, and measures. This article reports the consensus recommendations of the federal interagency Operational Stress Working Group for common data elements to be used in future operational stress research and surveillance with the goal of improving comparability across studies. Operational stress encompasses more than just combat; it occurs everywhere service members and their families live and work. Posttraumatic stress is not the only adverse mental or behavioral health outcome of importance. The Operational Stress Working Group contends that a primary goal of operational stress research and surveillance is to promote prevention of adverse mental and behavioral outcomes, especially by recognizing the preclinical and subclinical states of distress and dysfunction that portend a risk for failure of role performance or future mental disorders.
Common Data Elements for Posttraumatic Stress Disorder Research
Danny G. Kaloupek, PhD, Kathleen M. Chard, PhD, Michael C. Freed, PhD, Alan L. Peterson, PhD, David S. Riggs, PhD, Murray B. Stein, MD, MPH, Farris Tuma, ScD, MHS
An expert work group with 7 members was formed under the co-sponsorship of 5 U.S. federal agencies to identify common data elements for research related to posttraumatic stress disorder (PTSD). Eight construct domains relevant to PTSD were identified: (1) traditional demographics, (2) exposure to stressors and trauma, (3) potential stress moderators, (4) trauma assessment, (5) PTSD screening, (6) PTSD symptoms and diagnosis, (7) PTSD related functioning and disability, and (8) mental health history.
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