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Position Statement: Definition of Traumatic Brain Injury
David K. Menon, Karen Schwab, David W. Wright, Andrew I. Maas
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1637-1640 DOI: 10.1016/j.apmr.2010.05.017)
Abstract
A clear, concise definition of traumatic brain injury (TBI) is fundamental for reporting, comparison, and
interpretation of studies on TBI. Changing epidemiologic patterns, an increasing recognition of significance
of mild TBI, and a better understanding of the subtler neurocognitive neuroaffective deficits that may result
from these injuries make this need even more critical. 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 has therefore formed an expert group that proposes the following definition:TBI
is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force.
In this article, we discuss criteria for considering or establishing a diagnosis of TBI, with a particular focus
on the problems 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. Technologic advances in magnetic resonance imaging
and the development of biomarkers offer potential for improving diagnostic accuracy in these situations.
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Common Data Elements for Traumatic Brain Injury: Recommendations From the Interagency Working Group on Demographics and Clinical Assessment
Andrew I. Maas, Cynthia L. Harrison-Felix, David Menon, P. David Adelson, Tom Balkin, Ross Bullock, Doortje C. Engel, Wayne Gordon, Jean Langlois Orman, Henry L. Lew, Claudia Robertson, Nancy Temkin, Alex Valadka, Mieke Verfaellie, Mark Wainwright, David W. Wright, Karen Schwab
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1641-1649 DOI: 10.1016/j.apmr.2010.07.232)
Abstract
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.
The process was consensus driven, with input from experts over a broad range of disciplines. Special consideration
was given to military and pediatric TBI. Categorizing clinical elements as core versus supplemental proved difficult,
given the great variation in types of studies and their interests. The data elements are contained in modules, which
are grouped together in categories. Three levels of detail for coding data elements were developed: basic,
intermediate, and advanced, with the greatest level of detail in the advanced version. In every case, the more
detailed coding can be collapsed into the basic version. 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.
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Common Data Elements in Radiologic Imaging of Traumatic Brain Injury
Ann-Christine Duhaime, Alisa D. Gean, E. Mark Haacke, Ramona Hicks, Max Wintermark, Pratik Mukherjee, David Brody, Lawrence Latour, Gerard Riedy
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1661-1666 DOI: 10.1016/j.apmr.2010.07.238)
Abstract
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. This article is the initial result of a workshop
convened by multiple national health care agencies in March 2009 to begin to make recommendations for potential
data elements dealing with specific radiologic features and definitions needed to characterize injuries, as well
as specific techniques and parameters needed to optimize radiologic data acquisition. The neuroimaging work group
included professionals with expertise in basic imaging research and physics, clinical neuroradiology, neurosurgery,
neurology, physiatry, psychiatry, TBI research, and research database formation. This article outlines the rationale
and overview of their specific recommendations. In addition, we review the contributions of various imaging
modalities to the understanding of TBI and the general principles needed for database flexibility and evolution
over time to accommodate technical advances.
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Common Data Elements for Traumatic Brain Injury: Recommendations From the Biospecimens and Biomarkers Working Group
Geoffrey T. Manley, Ramon Diaz-Arrastia, Mary Brophy, Doortje Engel, Clay Goodman, Katrina Gwinn, Timothy D. Veenstra, Geoffrey Ling, Andrew K. Ottens, Frank Tortella, Ronald L. Hayes
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1667-1672 DOI: 10.1016/j.apmr.2010.05.018)
Abstract
Recent advances in genomics, proteomics, and biotechnology have provided unprecedented opportunities for translational
research and personalized medicine. 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. The aim of the Biospecimens
and Biomarkers Working Group was to provide recommendations for core data elements for TBI research and develop best
practice guidelines to standardize the quality and accessibility of these specimens. Consensus recommendations were
developed through interactions with focus groups and input from stakeholders participating in the interagency workshop
on Standardization of Data Collection in TBI and Psychological Health held in Washington, DC, in March 2009. 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 metabolomic research in TBI.
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Recommendations for the Use of Common Outcome Measures in Traumatic Brain Injury Research
Elisabeth A. Wilde, Gale G. Whiteneck, Jennifer Bogner, Tamara Bushnik, David X. Cifu, Sureyya Dikmen, Louis French, Joseph T. Giacino, Tessa Hart, James F. Malec, Scott R. Millis, Thomas A. Novack, Mark Sherer, David S. Tulsky, Rodney D. Vanderploeg, Nicole von Steinbuechel
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1650-1660.e17 DOI: 10.1016/j.apmr.2010.06.033)
Abstract
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. Consistent with other Common Data Elements Workgroups, the TBI Outcomes Workgroup
adopted the standard 3-tier system in its selection of measures. In the first tier, core measures included valid,
robust, and widely applicable outcome measures with proven utility in TBI from each identified domain, including
global level of function, neuropsychological impairment, psychological status, TBI-related symptoms, executive
functions, cognitive and physical activity limitations, social role participation, and perceived health-related
quality of life. In the second tier, supplemental measures were recommended for consideration in TBI research
focusing on specific topics or populations. In the third tier, emerging measures included important instruments
currently under development, in the process of validation, or nearing the point of published findings that have
significant potential to be superior to some older ("legacy") measures in the core and supplemental lists and
may eventually replace them as evidence for their utility emerges.
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Common Data Elements for Research on Traumatic Brain Injury and Psychological Health: Current Status and Future Development
John Whyte, Jennifer Vasterling, Geoffrey T. Manley
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1692-1696 DOI: 10.1016/j.apmr.2010.06.031)
Abstract
The National Institute of Neurologic Disorders and Stroke, Defense Centers of Excellence for Psychological Health
and Traumatic Brain Injury, National Institute on Disability and Rehabilitation Research, and Defense and Veterans
Brain Injury Center jointly supported an effort to develop common data elements (CDEs, ie, consensus-based content
domains of importance and recommended ways to measure them) for research on traumatic brain injury and psychological
health. The authors served as participants in this effort as well as editors of the resulting articles. This article
describes the current status of this multiagency endeavor, the obstacles encountered, and possible directions for
future development. Challenges that occurred within the working groups that developed the CDE recommendations and
similarities and differences among the articles that describe those recommendations were reviewed. Across all of
the working groups, there were challenges in striking a balance between specificity in recommendations to
researchers and the need to tailor the selection of variables to specific study aims. The domains addressed by the
different working groups varied in the research available to guide the selection of important content areas to be
measured and the specific tools for measuring them. The working groups also addressed this challenge in somewhat
different ways. The CDE effort must enhance consensus among researchers with similar interests while not stifling
innovation and scientific rigor. This will require regular updating of the recommendations and may benefit from
more standardized criteria for the selection of important content areas and measurement tools across domains.
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Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements
Veronica A. Thurmond, Ramona Hicks, Theresa Gleason, A. Cate Miller, Nicholas Szuflita, Jean Orman, Karen Schwab
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1633-1636 DOI: 10.1016/j.apmr.2010.06.034)
Abstract
In civilian, military, and veteran populations, there is increased recognition of the interrelationship between
traumatic brain injury (TBI) and some psychological health (PH) disorders and the need to better understand the
relationships by integrating research for these topics. The use of different measures to assess similar study
variables and/or assess outcomes may limit important advances in PH and TBI research. Without a set of common data
elements (CDEs; to include variable definitions and recommended measures for the purpose of this discussion),
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. Draft recommendations were presented and discussed in the
workshop “Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data
Elements (CDE)” held on March 23–24, 2009, in Silver Spring, MD. The overall process leading to the workshop
and subsequent recommendations by the working groups are presented in this article. Topic-driven recommendations
for CDEs are presented in individual reports in this edition.
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Consensus Recommendations for Common Data Elements for Operational Stress Research and Surveillance: Report of a Federal Interagency Working Group
William P. Nash, Jennifer Vasterling, Linda Ewing-Cobbs, Sarah Horn, Thomas Gaskin, John Golden, William T. Riley, Stephen V. Bowles, James Favret, Patricia Lester, Robert Koffman, Laura C. Farnsworth, Dewleen G. Baker
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1673-1683 DOI: 10.1016/j.apmr.2010.06.035)
Abstract
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. Recommendations for data elements are divided into 3
tiers: core, supplemental, and emerging, including variable domains and specific measures for assessing operational
stressor exposures, stress outcomes, moderating factors, and mediating processes. Attention is drawn to the emerging
construct of stress injury as a generic term for subclinical operational stress, and to emerging data elements
addressing biological, psychological, and spiritual mediators of risk. Methodologies are needed for identifying
preclinical and subclinical states of distress or dysfunction that are markers of risk for failure of role
performance and future clinical mental disorders, so that targeted prevention interventions can be developed and
evaluated.
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Common Data Elements for Posttraumatic Stress Disorder Research
Danny G. Kaloupek, Kathleen M. Chard, Michael C. Freed, Alan L. Peterson, David S. Riggs, Murray B. Stein, Farris Tuma
Archives of Physical Medicine and Rehabilitation 1 November 2010 (volume 91 issue 11 Pages 1684-1691 DOI: 10.1016/j.apmr.2010.06.032)
Abstract
An expert work group with 7 members was formed under the cosponsorship of 5 U.S. federal agencies to identify
common data elements for research related to posttraumatic stress disorder (PTSD). The work group reviewed both
previous and contemporary measurement standardization efforts for PTSD research and engaged in a series of
electronic and live discussions to address a set of predefined aims. 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. Measures assigned to the core data elements category
have relatively low time-and-effort costs in order to make them potentially applicable across a wide range of
studies for which PTSD is a relevant condition. Measures assigned to the supplemental data elements category have
greater costs but generally demonstrate stronger psychometric performance and provide more extensive information.
Accordingly, measures designated as supplemental are recommended instead of or in addition to corresponding core
measures whenever resources and study design allow. The work group offered 4 caveats that highlight potential
limitations and emphasize the voluntary nature of standardization for PTSD-related measurement.