Home

Traumatic Brain Injury CDE Standards

Data Standards | Acknowledgements | Feedback | References | Update History | Downloading Files

In civilian, military and Veteran populations, there is an increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders, and of the need to better understand the relationships by integrating research on 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 common set of data elements (to include variable definitions and recommended measures for the purpose of this discussion), comparison of findings across studies is challenging. Co-sponsoring Federal agencies involved in this research led a scientific initiative to develop common data elements for TBI. Scientific experts were invited to participate in working groups to develop recommendations for specific topic-driven common data elements. The draft recommendations were presented and discussed in a workshop, “Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements (CDE)” held on March 23–24, 2009, in Silver Spring, Maryland. The overall process leading to the workshop and the subsequent recommendations by the working groups are published in the Archives of Physical Medicine and Rehabilitation.

Data Standards

Data standards encompass the CDEs as well as case report form (CRF) modules and guidelines. The CRF modules logically organize the CDEs for data collection, while the guidelines provide further information about the CDEs. The CDEs, CRF modules, and guidelines presented below are organized into categories of data which are common to clinical research studies. Choose the category of data you are interested in to find the related data standards.

A beta version of CDEs related to demographic and clinical assessment data (15k PDF) is available while development continues. Please note that final editorial comments may change the demographic and clinical assessment CDEs.

Participant/Subject Characteristics

A beta version of CDEs related to participant/subject characteristics (15k PDF) is available while development continues.

Back to top

Participant/Subject History and Family History

A beta version of CDEs related to participant/subject history and family history (15k PDF) is available while development continues.

Back to top

Disease/Injury Related Events

Disease/Injury Related Events TBI CDE Recommendations
CategoryName of StandardCDEsCRF Module or Guideline
History of InjuryDefinition of Traumatic Brain InjuryN/A32KB icon for word file

A beta version of CDEs related to disease/injury related events (15k PDF) is available while development continues.

Back to top

Assessments and Examinations

Assessments and Examinations TBI CDE Recommendations
CategoryName of StandardCDEsCRF Module or Guideline
Laboratory Tests and Biospecimens/ BiomarkersRecommendations for CDEs for Biospecimens and BiomarkersN/A24KB icon for word file
DNA Guidelines for Genomic Analysis (Table 1)N/A38KB icon for word file
Plasma and Serum Guidelines for Proteomic Analysis (Table 2)N/A35KB icon for word file
Cerebral Spinal Fluid Guidelines (Table 3)N/A36KB icon for word file
Cerebral Microdialysis Guidelines (Table 4)N/A35KB icon for word file
Imaging DiagnosticsPathoanatomic Terms for Definitions of TBI Lesions and Associated Findings (Appendix I)yes opens in Report Viewer100KB icon for word file
Imaging Parameters for MRI and Protocols for MRI and CT (Appendix II)N/A159KB icon for word file
Neuropsychological TestingSee Outcomes and End Points to see measures recommended for assessing Neuropsychological Impairment and Psychological StatusN/AN/A

A beta version of CDEs related to assessments and examinations (15k PDF) is available while development continues.

Back to top

Treatment/Intervention Data

A beta version of CDEs related to treatment/ intervention data (15k PDF) is available while development continues.

Back to top

Protocol Experience

A beta version of CDEs related to protocol experience (15k PDF) is available while development continues.

Back to top

Safety Data

A beta version of CDEs related to safety data (15k PDF) is available while development continues.

Back to top

Outcomes and End Points

NOTE: The CDEs from copyright-protected measures are intentionally excluded from this site. Please contact the publisher or person who holds the copyright to obtain a copy of the measure.

Outcomes and End Points TBI CDE Recommendations
CategoryName of StandardCDEsCRF Module or Guideline
NOTE: The CDEs from copyright-protected measures are intentionally excluded from this site. Please contact the publisher or person who holds the copyright to obtain a copy of the measure.
Summary of All Outcome RecommendationsOutcome Domains and DescriptionsN/A37KB icon for word file
CDE Recommendations - Listing of the Core, Supplemental and Emerging Measures for each Outcome DomainN/A41KB icon for word file
Psychometric Properties of the Recommended TBI Outcome CDEs in Core and Supplemental TiersN/A692KB icon for word file
Global OutcomeCDE Recommendations for Global Outcomeyes opens in Report Viewer33KB icon for excel file
Recovery of ConsciousnessCDE Recommendations for Recovery of Consciousnessyes opens in Report Viewer26KB icon for excel file
Neuropsychological ImpairmentCDE Recommendations for Neuropsychological Impairmentyes opens in Report Viewer36KB icon for excel file
Psychological StatusCDE Recommendations for Psychological Statusyes opens in Report Viewer40KB icon for excel file
Post-concussive/TBI SymptomsCDE Recommendations for Post-concussive/TBI Symptomsyes opens in Report Viewer28KB icon for excel file
Behavioral FunctionCDE Recommendations for Behavioral FunctionN/A25KB icon for excel file
Cognitive Activity LimitationsCDE Recommendations for Cognitive Activity LimitationsN/A26KB icon for excel file
Physical FunctionCDE Recommendations for Physical FunctionN/A31KB icon for excel file
Social Role ParticipationCDE Recommendations for Social Role Participationyes opens in Report Viewer27KB icon for excel file
Perceived Generic and Disease-Specific Health-Related Quality of LifeCDE Recommendations for Perceived Generic and Disease-Specific Health-Related Quality of Lifeyes opens in Report Viewer28KB icon for excel file
Health-economic MeasuresCDE Recommendations for Health-economic MeasuresN/A26KB icon for excel file
Patient Reported OutcomesCDE Recommendations for Patient Reported OutcomesN/A29KB icon for excel file

Back to top

Update History

No updates have been made at this time.

Acknowledgements

Co-Sponsoring Federal Agencies

The TBI CDE initiative involved an Interagency Planning Committee, TBI working groups, and PH working groups. The working groups focused on developing specific topic-driven CDEs. After the TBI CDEs were drafted, an Interagency Steering Committee and an Implementation Group were formed to provide oversight and guidance for managing and updating the TBI-specific data elements.

Please note that the institutions for all individuals acknowledged in this section were those they belonged to when the group was initially formed.

Interagency Planning Committee

  • Veronica A. Thurmond, PhD - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, MD
  • Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, Bethesda, MD
  • Theresa Gleason, PhD - Department of Veterans Affairs, Washington, DC
  • A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education, Washington, DC
  • Nicholas Szuflita - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, MD
  • Jean Langlois-Orman, ScD - Department of Veterans Affairs, Washington, DC
  • Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC

Back to top

Demographics and Clinical Assessment Working Group

  • Andrew I.R. Maas, MD - University Hospital Antwerp, Belgium, Chair
  • Cynthia L. Harrison-Felix, PhD - Craig Hospital, Englewood, Colorado
  • David Menon, MD - University of Cambridge, UK
  • P. David Adelson, MD - Phoenix Children's Neuroscience Institute, Phoenix, Arizona
  • Tom Balkin, PhD - Walter Reed Army Institute of Research
  • Ross Bullock, MD - University of Miami Miller School of Medicine
  • Doortje C. Engel, MD, PhD - University Hospital Heidelberg, Germany
  • Wayne Gordon, PhD - Mount Sinai School of Medicine, New York
  • Jean Langlois-Orman, ScD - Dept. of Veterans Affairs, Rehabilitation Research and Development Service, Washington DC
  • Henry L. Lew, MD, PhD - Boston VA Health Care system and Harvard Medical School
  • Claudia Robertson, MD - Baylor College of Medicine, Houston, Texas
  • Nancy Temkin, PhD - University of Washington, Seattle
  • Alex Valadka, MD - Seton Brain and Spine Institute, Austin, Texas
  • Mieke Verfaellie, PhD - Boston VA Health Care System and Boston University School of Medicine
  • Mark Wainwright, MD - Northwestern University, Chicago, Ill
  • David W. Wright, MD - Emory University School of Medicine, Atlanta GA
  • Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Washington DC

Back to top

Neuroimaging Working Group

  • Ann-Christine Duhaime MD - Pediatric Neurosurgery, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
  • Alisa D. Gean MD - Department of Radiology, Brain and Spinal Cord Injury Center, San Francisco General Hospital, San Francisco, California
  • E. Mark Haacke PhD - Department of Biomedical Engineering, Wayne State University, Detroit, Michigan
  • Ramona Hicks PhD - Repair and Plasticity Program, National Institutes of Health
  • Max Wintermark MD - Department of Radiology, University of California, San Francisco, San Francisco, California
  • Pratik Mukherjee MD PhD - Department of Radiology, Bioengineering, University of California, San Francisco, San Francisco, California
  • David Brody MD - Department of Neurology, Washington University, St. Louis, Missouri
  • Lawrence Latour PhD - Stroke Diagnostic and Therapeutic Section, Stroke Branch, NINDS, Bethesda, Maryland
  • Gerard Riedy MD - Department of Radiology, Walter Reed Army Medical Center, Washington, DC, Chair
  • Thomas DeGraba MD - National Naval Medical Center, Bethesda, Maryland
  • Timothy Duncan MD - Department of Radiology, Naval Medical Center San Diego, San Diego, California
  • Elie Elovic MD - Department of Physical Medicine and Rehabilitation, New Jersey Medical School, West Orange, New Jersey
  • Robin Hurley MD - Hefner VA Medical Center, Salisbury, North Carolina
  • James Smirniotopoulos MD - Department of Radiology and Radiological Sciences, Uniformed Services University, Bethesda, Maryland
  • Doug Smith MD - Department of Neurosurgery, Center for Brain Injury and Repair, University of Pennsylvania, Philadelphia, Pennsylvania

Back to top

Biospecimens/ Biomarkers Working Group

  • Geoffrey T. Manley, MD, PhD - University of California San Francisco, Chair
  • Ramon Diaz-Arraistia, MD - University of Texas Southwestern Medical Center, Dallas
  • Mary Brophy, MD - Department of Veteran Affairs, Boston
  • Doortje Engel, MD, PhD - University Hospital Heidelberg, Germany
  • Clay Goodman, MD - Baylor College of Medicine, Houston, Texas
  • Katrina Gwinn-Hardy, PhD - Baylor College of Medicine, Houston, Texas
  • Ronald Hayes, PhD - Banyan Biomarkers, Florida
  • Geoffrey Ling, MD, PhD - Walter Reed Army Institute of Research, Maryland
  • Andrew Ottens, PhD - Virginia Commonwealth University, Virginia
  • Frank Tortella, PhD - Walter Reed Army Institute of Research, Maryland
  • Timothy Veenstra, PhD - National Cancer Institute, Maryland

Back to top

Outcome Measures Working Group

  • Elisabeth A. Wilde, PhD - Departments of Physical Medicine and Rehabilitation, Neurology and Radiology, Baylor College of Medicine, Houston, Texas
  • Gale G. Whiteneck, PhD - Craig Hospital, Englewood, Colorado, Chair
  • Jennifer Bogner, PhD - Department of Physical Medicine and Rehabilitation, Ohio State University, Columbus, Ohio
  • Tamara Bushnik, PhD - Department of Rehabilitation Medicine, Rusk Institute for Rehabilitation, New York, New York
  • David X. Cifu, MD - Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, PM&R Service, Hunter Holmes McGuire Veterans Administration Medical Center, Richmond, Virginia
  • Sureyya Dikmen, PhD - Department of Rehabilitation Medicine, University of Washington, Seattle, Washington
  • Louis French, PsyD - Department of Orthopaedics and Rehabilitation, Walter Reed Army Medical Center, Washington DC
  • Joseph T. Giacino, PhD - JFK Johnson Rehabilitation Institute, Edison, New Jersey
  • Tessa Hart PhD - Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania
  • James F. Malec, PhD - Department of Physical Medicine and Rehabilitation, Indiana University School of Medicine, and Rehabilitation Hospital of Indiana, Indianapolis, Indiana
  • Scott R. Millis, PhD - Departments of Physical Medicine and Rehabilitation and Emergency Medicine, Wayne State University School of Medicine, Detroit, Michigan
  • Thomas A. Novack, PhD - Department of Physical Medicine and Rehabilitation, University of Alabama at Birmingham
  • Mark Sherer, PhD - TIRR Memorial Hermann, Houston, Texas and Department of Physical Medicine and Rehabilitation, Baylor College of Medicine and University of Texas Medical School at Houston, Houston, Texas
  • David S. Tulsky, PhD - Kessler Foundation, West Orange, New Jersey
  • Rodney D. Vanderploeg, PhD - Psychology Service, James A. Haley Veterans’ Hospital, Tampa, Florida and University of South Florida Departments of Psychology and Psychiatry, Tampa, Florida
  • Nicole von Steinbuechel, PhD - Department of Medical Psychology and Medical Sociology, University Medical Center Göttingen Georg-August-University, Göttingen, Germany

Back to top

Interagency Steering Committee

  • Ann-Christine Duhaime, MD - Dartmouth College, Hanover, NH
  • Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, Bethesda, MD, Ad hoc member
  • Andrew I.R. Maas, MD - University Hospital Antwerp, Belgium
  • Geoffrey T. Manley, MD, PhD - University of California San Francisco, CA
  • A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education, Washington, DC
  • Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke, Bethesda, MD, Chair
  • Jean Orman, ScD - Department of Veterans Affairs, Washington, DC
  • Ross Pastel, PhD - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, MD
  • Gerard Riedy, MD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC
  • Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC
  • Gale G. Whiteneck, PhD - Craig Hospital, Englewood, Colorado

Back to top

Implementation Group

  • Victoria Anderson-Barnes - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC
  • Jim Christensen, MS - Medred, LLC, Washington, DC
  • Thomas DeGraba, MD - National Naval Medical Center, Bethesda, MD
  • Howard Eisenberg, MD - University of Maryland Medical Center, Baltimore, MD
  • Yang Fann, PhD - National Institute of Neurological Disorders and Stroke, Bethesda, MD
  • David Fullerton - Medred, LLC, Washington, DC
  • Stacie Grinnon, MS - KAI Research, Inc., Rockville, MD
  • Margaret Hale, PhD - Altarum Institute, Washington, DC
  • Cindy Harrison-Felix, PhD - Craig Hospital, Englewood, Colorado
  • Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, Bethesda, MD
  • Mike Jarrett - Quesgen Systems, Inc., Burlingame, CA
  • Walter Koroshetz, MD - National Institute of Neurological Disorders and Stroke, Bethesda, MD
  • Lawrence Latour, PhD - National Institute of Neurological Disorders and Stroke, Bethesda, MD
  • Chris Leonard, PhD - Uniformed Services University of the Health Sciences, Bethesda, MD
  • Andrew I.R. Maas, MD - University Hospital Antwerp, Belgium
  • Geoff Manley, MD, PhD - University of California San Francisco, CA
  • Jay Mansfield, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC
  • Matthew McAuliffe, PhD - Center for Information Technology, NIH, Bethesda, MD
  • A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education, Washington, DC
  • Diane Moribido, RN - University of California San Francisco, CA
  • Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke, Bethesda, MD
  • Jean Orman, ScD - Department of Veterans Affairs, Washington, DC
  • Ross Pastel, PhD - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, MD
  • Alvin Ramsey, PhD - Vecna Technologies, Inc., Falls Church, VA
  • Gerard Riedy, MD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC
  • Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC
  • Vadim Smirnoof, MOT - National Naval Medical Center, Bethesda, MD
  • William K. Smith, MD - Medred, LLC, Washington, DC
  • Nick Szuflita - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, MD
  • Rene Wilson - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center, Washington, DC

Back to top

Feedback

The TBI CDE Working Groups welcome feedback about these data standards. We are in the process of designing a feedback form to allow users to submit feedback about the TBI CDEs on this Web site. While this form is being developed, please submit any comments/questions you may have about the TBI CDEs to NINDSCommonData@kai-research.com and the NINDS CDE Team will forward your feedback to the appropriate parties. In your email correspondence, please indicate in the subject line that your message relates to the TBI CDEs.

References

  • Traumatic brain injury: time to end the silence. The Lancet Neurology, Vol. 9, No. 4. (April 2010), pp. 331-331.
  • Miller G. New guidelines aim to improve studies of traumatic brain injury. Science 328:297 (2010).

Several additional publications related to the inter-agency TBI CDE initiative are in press in the Archives of Physical Medicine and Rehabilitation. The citations for those publications will be included on this site as soon as they are available.

Downloading Files


Page last updated on Thursday, April 29, 2010