Traumatic Brain Injury

Data Standards

The National Institute of Neurological Disorders and Stroke (NINDS) and several Co-sponsoring Federal agencies have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. The first set of CDEs were developed in 2010 and were well-suited for hospital-based studies of acute TBI in adults. To broaden the utility of the TBI CDEs, experts were asked to update the recommendations to make them relevant to all ages, injury severity, and phases of recovery. The second version of the TBI CDEs (v.2) were developed in 2012 to be organized around four major study types:

  • Epidemiological research
  • Studies on acute, hospitalized patients
  • Studies of the rehabilitation for moderate/severe TBI
  • Mild TBI/Concussion research

The outline that follows includes all of the CDE data associated with the CRF modules and instrument recommendations, organized by study type, domain, and sub-domain. Choose your type of TBI study (Acute Hospitalized, Concussion/Mild TBI, Moderate/Severe TBI: Rehabilitation, or Epidemiology) or Comprehensive if your study falls outside of the study types or incorporates aspects of more than one type of study and then browse the resulting outline.

The Comprehensive template CRFs include the Core CDEs and CDEs Basic to at least one of the study types. Additional Supplemental CDEs are listed for possible inclusion at the bottom of the template CRFs. Recommended proprietary instruments/scales are included on this page regardless of classification. For the classifications assigned to instruments/scales, please see the Table of Recommended Outcome Measures. The classifications used in the TBI CDEs are described in the TBI CDE Overview.

In 2017, the Biomechanical Devices in Traumatic Brain Injury (TBI) CDE Working Group was developed and recommendations posted February 2018. The Biomechanical Devices in TBI CDE Working Group was divided into the following subgroups: (1) Head Accelerometry; (2) Impact Video; and (3) Blast Exposure. The recommendations are part of the Disease/Injury Related Events Domain/Biomechanical Devices Subdomain.

Organized into domains often used in clinical studies, data standards include:

  • CDEs
  • CRF Modules logically organize CDEs for data collection
  • Guidelines to provide further information about the CDEs.
  • Start-up Resource Listing provides investigators with a set of Core and Supplemental-Highly Recommended (for Biomechanical Devices in TBI) data elements to use when beginning a research study.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. The consistency of the data elements and the CDE format are made to improve the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the TBI CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.

    For your reference, a zip file containing all the current TBI CDE template CRF modules can be downloaded below.

    Overview

    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 differing metrics to assess outcomes may limit important advances in PH and TBI research. Without a common set of data elements (which include variable definitions and recommended measures), comparison of findings across studies is challenging.

    To develop the TBI CDE standards a variety of Co-sponsoring Federal agencies led a scientific initiative to develop common data elements for TBI. Scientific experts were invited to participate in a Working Group to develop recommendations for specific topic-driven common data elements. The resulting TBI CDE Version 1.0 recommendations were published in the Archives of Physical Medicine and Rehabilitation in November 2010. Additional pediatric-specific recommendations were developed and published in The Journal of Neurotrama in March 2012.

    The Working Group reconvened in late 2011 to refine and reorganize the CDEs according to type of TBI study (Concussion/mild TBI studies, Acute Hospitalized studies, Moderate/Severe TBI: Rehabilitation studies, and Epidemiology studies), reduce the list of “Core” CDEs strongly recommended for NINDS-funded studies, and expand the CDEs to be more comprehensive and fill gaps. Version 2.0 of the TBI CDEs was published on this site in late June 2012 and was used to construct the Federal Interagency Traumatic Brain Injury Research informatics system, which was available for use in mid-July 2012.

    The American Association of Neurological Surgeons (AANS) has stated its commitment to the NINDS Traumatic Brain Injury Common Data Element project since the development of version 1.0 and has participate in the development, organization, and distribution of version 2.0 of the Traumatic Brain Injury Common Data Elements and recently circulated a letter of support.

    The American Congress of Rehabilitation Medicine (ACRM) have also recently endorsed Version 2 TBI CDEs through a letter of support.

    Version 2.0 includes 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 available are organized into domains which are intuitive and common in clinical research studies. Investigators can choose from this catalog of CDEs when assembling their clinical study materials. Please note that the classifications are named differently from the other disease recommendations (e.g., classification of “Supplemental” for TBI would be “Exploratory” in all other diseases). The Version 2.0 CDEs are classified according to the following definitions:

    • Core — small set of data elements that are relevant to all TBI clinical studies
    • Basic (Supplemental for all other diseases) — small set of data elements, beyond the Core, that are recommended for inclusion in studies of Concussion/mild TBI, Acute Hospitalized, Moderate/Severe TBI: Rehabilitation, or Epidemiology
    • Supplemental (Exploratory for all other diseases) — additional recommended data elements where inclusion depends upon the particulars of the study

    Researchers working on acute hospitalized, concussion or mild TBI, rehabilitation of moderate or severe TBI, and epidemiology studies can use these classifications as guidelines to find customized sets of elements that they can incorporate into their studies.

    Please note the Version 1.0 TBI CDE recommendations of the Demographics and Clinical Assessment Working Group are available on the IMPACT Web site. These CDE recommendations are presented using an alternate classification scheme of three levels of detail: Basic, Intermediate and Advanced, with the greatest level of detail in the Advanced version.

    In 2017, the Biomechanical Devices in Traumatic Brain Injury (TBI) CDE Working Group was developed and recommendations are posted on the TBI Data Standards page under the subdomain of Biomechanical Devices.

    History and Acknowledgements

    Co-Sponsoring Federal Agencies

    The National Institute of Neurological Disorders and Stroke (NINDS) has formed the International Traumatic Brain Injury (TBI) Steering Committee to direct the updating and further development of Traumatic Brain Injury CDEs.

    The Federal Liaisons and Consultants for the TBI CDE Project formed four new working groups to build upon the success of the first set of recommendations (i.e., TBI CDEs Version 1.0). The goal was to expand the list of definitions to fill gaps, to update some of the recommendations based on the “beta-testing”, and to organize the CDEs in modules to make them easier to use. The committees who worked on TBI CDEs Version 2.0 are shown below. Also included below is an archived version of the original working group members who were responsible for creating Version 1.0 of the TBI CDEs. TBI CDE Steering Committee was developed in 2013.

    In 2017, Biomechanical Devices in TBI Working Group developed their first set of recommendations that were posted in early 2018.

    Complete Traumatic Brain Injury CDE Roster

    International Traumatic Brain Injury (TBI) CDE Steering Committee

    • Joseph T. Giacino, PhD
      Spaulding Rehabilitation Hospital, Charlestown, Massachusetts
      Co-Chair
    • Cindy Harrison-Felix, PhD
      Craig Hospital, Englewood, Colorado
      Co-Chair
    • Kristy Arbogast, PhD
      The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
    • Steven P. Broglio, PhD, ATC
      University of Michigan, Ann Arbor, Michigan
    • Isabelle Gagnon, PT, PhD
      Montr?al Children's Hospital, Montr?al, Qu?bec, Canada
    • Jamie Hutchison, MD
      The Hospital for Sick Children, Toronto, Ontario, Canada
    • Geoffrey T. Manley, MD, PhD
      University of California San Francisco, San Francisco, California
    • Andrew I. R. Maas, MD, PhD
      University Hospital Antwerp, Edegem, Belgium
    • Gerard Riedy, MD
      National Intrepid Center of Excellence (NICoE), Bethesda, Maryland
    • Elisabeth A. Wilde, PhD
      Baylor College of Medicine, Houston, Texas
    • Alex Valadka, MD, FAANS, FACS
      Seton Brain and Spine Institute, Austin, Texas

    Federal Liaisons and Consultants

    • Patrick S. F. Bellgowan, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Matthew J. Breiding, PhD
      Centers for Disease Control and Prevention, Atlanta, Georgia
    • A. Tamara Crowder, PhD
      US Army Medical Research and Materi?l Command, Fort Detrick, Frederick, Maryland
    • Thomas J. DeGraba, MD, FAHA
      National Intrepid Center of Excellence (NICoE), Bethesda, Maryland
    • Alison Garcia, BSE
      Sapient Corporation, Consultant to Center for Information Technology, National Institutes of Health, Bethesda, Maryland
    • Juliet Haarbauer-Krupa, PhD
      Centers for Disease Control and Prevention, Atlanta, Georgia
    • Stuart W. Hoffman, PhD
      U.S. Department of Veterans Affairs, Washington, District of Columbia
    • Saafan Z. Malik, MD
      Defense and Veterans Brain Injury Center, Silver Spring, Maryland
    • Matthew McAuliffe, PhD
      National Institutes of Health (NIH), Bethesda, Maryland
    • Mary Ellen Michel, PhD
      National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland
    • A. Cate Miller, PhD
      National Institute on Disability and Rehabilitation Research (NIDRR), U.S. Department of Education, Washington, District of Columbia
    • Joanne Odenkirchen, MPH
      NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland (until 2016)
    • Col. Wanda Salzer, USAF, MC
      US Army Medical Research and Materi?l Command, Fort Detrick, Frederick, Maryland
    • Carol Taylor-Burds, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

    Biomechanical Devices in TBI, Head Accelerometry Subgroup

    • Adam Bartsch, PhD, PE
      Prevent Biometrics, Minneapolis, Minnesota
      Co-Chair
    • David Camarillo, PhD
      Stanford University, Stanford, California
      Co-Chair
    • Philip Bayly, PhD
      Washington University in St. Louis, St. Louis, Missouri
    • Kate Burdekin, MPH
      Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, Maryland
    • Stefan Duma, PhD
      Virginia Tech, Blacksburg, Virginia
    • Richard Greenwald, PhD
      Simbex, Lebanon, New Hampshire
    • Songbai Ji, PhD
      Worcester Polytechnic Institute, Worcester, Massachusetts
    • Susan Margulies, PhD
      Georgia Institute of Technology and Emory University School of Medicine, Atlanta, Georgia
    • Michael McCrea, PhD, ABPP
      Medical College of Wisconsin, Milwaukee, Wisconsin
    • David Meaney, PhD
      University of Pennsylvania, Philadelphia, Pennsylvania
    • Bryson Reynolds, PhD
      Vanderbilt University, Nashville, Tennessee
    • Tyler Rooks, MS
      U.S. Army Aeromedical Research Laboratory
    • Joel Stitzel, PhD
      Virginia Tech - Wake Forest University, Winston-Salem, North Carolina
    • Thomas Talavage, PhD
      Purdue University, West Lafayette, Indiana
    • Olga Vovk, PhD
      Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, Maryland
    • Lyndia Wu, PhD
      Stanford University, Stanford, California

    Biomechanical Devices in TBI, Impact Video Subgroup

    • Tyler Rooks, MS
      U.S. Army Aeromedical Research Laboratory
      Co-Chair
    • Lyndia Wu, PhD
      Stanford University, Stanford, California
      Co-Chair
    • Kristy Arbogast, PhD
      The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
    • Adam Bartsch, PhD, PE
      Prevent Biometrics, Minneapolis, Minnesota
    • Kate Burdekin, MPH
      Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, Maryland
    • David Camarillo, PhD
      Stanford University, Stanford, California
    • Steven Rowson, PhD
      Virginia Tech, Blacksburg, Virginia
    • Jillian Urban, PhD
      Virginia Tech - Wake Forest University, Winston-Salem, North Carolina
    • Olga Vovk, PhD
      Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, Maryland

    Biomechanical Devices in TBI, Blast Exposure Subgroup

    • Walter Carr, PhD, MAJ, MS, USA
      Walter Reed Army Institute of Research
      Co-Chair
    • Thuvan Piehler, PhD
      U.S. Army Research Laboratory Weapons and Materials Research Directorate and U.S. Army Medical Research and Materiel Command
      Co-Chair
    • Rohan Banton, PhD
      U.S. Army Research Laboratory Weapons and Materials Research Directorate
    • David Camarillo, PhD
      Stanford University, Stanford, California
    • Josh Duckworth, MD, CDR, MC, USN
      Uniformed Services University of the Health Sciences
    • Raj Gupta, PhD, BCE
      U.S. Army Medical Research and Materiel Command
    • Sidney R. Hinds, MD, COL, MC, USA
      U.S. Army Medical Research and Materiel Command
    • Stephen Recchia, PhD
      U.S. Army Armament Research, Development and Engineering Center
    • Tyler Rooks, MS
      U.S. Army Aeromedical Research Laboratory
    • Eric B. Schneider, PhD
      The Johns Hopkins University School of Medicine, Baltimore, Maryland
    • Richard Shoge, PhD
      Military Operational Medicine Research Program
    • Olga Vovk, PhD
      Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, Maryland

    Core CDEs and Epidemiology Subgroup

    • Cindy Harrison-Felix, PhD
      Craig Hospital, Englewood, Colorado
      Chair
    • Davida M. Carr, MPH
      Walter Reed National Military Medical Center, Bethesda, Maryland
    • Wayne A. Gordon, PhD, ABPP/Cn
      Mount Sinai School of Medicine, New York, New York
    • Harvey Levin, PhD
      Baylor College of Medicine, Houston, Texas
    • David K. Menon, MD, PhD
      University of Cambridge, Cambridge, United Kingdom
    • Jennie Ponsford, MA, PhD
      Monash University, Clayton, Australia
    • Karen Schwab, PhD
      Walter Reed National Military Medical Center, Bethesda, Maryland
    • Grahame Simpson, PhD
      Ingham Institute of Applied Medical Research, Liverpool, Australia
    • Hilaire J. Thompson, PhD, RN, CNRN, FAAN
      University of Washington, Seattle, Washington
    • Pieter E. Vos, MD, PhD
      Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
    • Jerry Wright, MS, CBIST
      Santa Clara Valley Medical Center, San Jose, California

    Concussion/Mild TBI Subgroup

    • Elisabeth A. Wilde, PhD
      Baylor College of Medicine, Houston, Texas
      Chair
    • Vicki Anderson, PhD
      University of Melbourne, Melbourne, Australia
    • Victor G. Coronado, MD
      National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
    • Gavin Davis, MBBS
      Cabrini Medical Centre, New York, New York
    • Thomas J. DeGraba, MD, FAHA
      National Intrepid Center of Excellence (NICoE), Bethesda, Maryland
    • Sureyya Dikmen, PhD
      University of Washington, Seattle, Washington
    • Gerard A. Gioia, PhD
      Children's National Medical Center, Washington, District of Columbia
    • Robin A. Hurley, MD
      Hefner VA Medical Center, Salisbury, North Carolina
    • Grant L. Iverson, PhD
      University of British Columbia, Vancouver, Canada
    • Andy Jagoda, MD, FACEP
      Mount Sinai School of Medicine, New York, New York
    • Michael W. Kirkwood, PhD, ABPP/CN
      University of Colorado Denver School of Medicine, Aurora, Colorado
    • Russell R. Lonser, MD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Geoffrey T. Manley, MD, PhD
      University of California San Francisco, San Francisco, California
    • Jeffrey Max, MD
      University of California San Diego, La Jolla, California
    • Thomas W. McAllister, MD
      Dartmouth-Hitchcock Psychiatric Associates, Lebanon, New Hampshire
    • Michael McCrea, PhD, ABPP
      Medical College of Wisconsin, Milwaukee, Wisconsin
    • Paul McCrory, MBBS, PhD
      Melbourne School of Health Sciences, Victoria, Australia
    • Pratik Mukherjee, MD, PhD
      University of California San Francisco, San Francisco, California
    • Douglas C. Oberly, MS
      BrainScope Company, Bethesda, Maryland
    • Ross H. Pastel, PhD
      Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, Silver Spring, Maryland
    • Leslie S. Prichep, PhD
      New York University School of Medicine, New York, New York
    • Michael E. Singer, PhD
      BrainScope Company, Bethesda, Maryland
    • Keith O. Yeates, PhD
      University of Calgary, Alberta, Canada

    Acute Hospitalized Subgroup

    • Alex Valadka, MD, FAANS, FACS
      Seton Brain and Spine Institute, Austin, Texas
      Chair
    • Rachel P. Berger, MD, MPH
      Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
    • Ann-Christine Duhaime, MD
      Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
    • Ronald L. Hayes, PhD
      Banyan Biomarkers, Alachua, Florida
    • Ramona Hicks, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Jamie Hutchison, MD
      The Hospital for Sick Children, Toronto, Canada
    • Andrew I. R. Maas, MD, PhD
      University Hospital Antwerp, Edegem, Belgium
    • David K. Menon, MD, PhD
      University of Cambridge, Cambridge, United Kingdom
    • JosÉ A. Piñeda, MD, MSc
      Washington University School of Medicine, St. Louis, Missouri
    • Robert D. Stevens, MD
      The Johns Hopkins University School of Medicine, Baltimore, Maryland
    • Willie Stewart, MBChB, PhD
      Southern General Hospital, Glasgow, United Kingdom
    • Nino Stocchetti, MD
      University of Milan, Milan, Italy
    • Monica S. Vavilala, MD
      Harborview Injury Prevention and Research Center, Seattle, Washington
    • David W. Wright, MD, FACEP
      Emory University School of Medicine, Atlanta, Georgia
    • Esther L. Yuh, MD, PhD
      University of California San Francisco, San Francisco, California

    Moderate/Severe TBI: Rehabilitation Subgroup

    • Joseph T. Giacino, PhD
      JFK Johnson Rehabilitation Institute, Edison, New Jersey
      Chair
    • Beth M. Ansel, PhD, CCC-SLP
      National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland
    • Kathleen R. Bell, MD
      University of Washington, Seattle, Washington
    • Tamara Bushnik, PhD, FACRM
      Rusk Institute for Rehabilitation, New York, New York
    • David X. Cifu, MD
      Virginia Commonwealth University, Richmond, Virginia
    • Linda Ewing-Cobbs, PhD
      University of Texas at Houston, Houston, Texas
    • Tessa Hart, PhD
      Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania
    • Stuart W. Hoffman, PhD
      U.S. Department of Veterans Affairs, Washington, District of Columbia
    • Stephanie A. Kolakowsky-Hayner, PhD, CBIST
      Santa Clara Valley Medical Center, San Jose, California
    • Steven Laureys, MD, PhD
      University Hospital of Li?ge, Li?ge, Belgium
    • A. Cate Miller, PhD
      National Institute on Disability and Rehabilitation Research (NIDRR), U.S. Department of Education, Washington, District of Columbia
    • Jennie Ponsford, MA, PhD
      Monash University, Clayton, Australia
    • Louis Puybasset, MD, PhD
      The Piti?-Salp?tri?re Hospital, Paris, France
    • M. Elizabeth Sandel, MD
      Kaiser Foundation Rehabilitation Center, Vallejo, California
    • David S. Tulsky, PhD
      University of Delaware, Newark, Delaware
    • Shari L. Wade, PhD
      Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

    TBI CDE Project Team

    • Patrick S. F. Bellgowan, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Ramona Hicks, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland (through 2014)
    • M. Carolina Mendoza-Puccini, MD
      Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Claudia Moy, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Joanne Odenkirchen, MPH
      NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland (until 2016)
    • Carol Taylor-Burds, PhD
      National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
    • Alison Garcia, BSE
      Sapient Corporation, Consultant to Center for Information Technology, National Institutes of Health, Bethesda, Maryland
    • Sherita Ala'i, MS
      The Emmes Corporation
    • Robin Feldman, BS, MBA
      The Emmes Corporation
    • Stacie Grinnon, MS
      KAI Research, Inc. (An Altarum Company), Rockville, Maryland (2007?2012)
    • Amy Price, MS
      KAI Research, Inc. (An Altarum Company), Rockville, Maryland

    References

    Publications

    Publications in the Journal of Neurotrauma 2012

    Archives of Physical Medicine and Rehabilitation (2010 Nov;91(11)): Special Communications and Commentary, NINDS TBI CDEs Version 1.0

    Publications

    Sample Protocols

    Updates

    Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

    Traumatic Brain Injury CDEs Revision History