NINDS Common Data Elements Harmonizing information. Streamlining research.

TBI Version 2.0 CDEs - Call for Public Review

The TBI Version 2.0 CDEs are now open for review from May 7, 2012 through June 15, 2012. Please submit your feedback by June 15, 2012.

The TBI Version 2.0 CDE Working Group and the NINDS CDE Team have released a draft version of the TBI Version 2.0 CDEs for public review. After the open comment period, the TBI Version 2.0 CDE Working Group will review comments and make updates in order to publish Version 2.0 of the TBI CDEs by early July 2012.

For your reference, a zip file containing the DRAFT TBI Version 2.0 CDE review package can be downloaded below. Please read the overview document first (“1. TBI CDE Public Review Package Overview.doc”) after unzipping the file.

Download TBI Version 2.0 CDE review package

The TBI Version 1.0 CDEs are included directly below. Version 2.0 will replace Version 1.0 when it is officially published on this site.

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.

Select a domain of interest below to find the related data standards.

Participant/Subject Characteristics

Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.

Participant/Subject Characteristics

CRF Module/Guideline by Sub-Domain	Download	CDEs
Demographics
Demographics - Adult	N/A	HTML
Demographics - Pediatric	N/A	HTML
Social Status
Socioeconomic Status - Adult	N/A	HTML
Socioeconomic Status - Pediatric	N/A	HTML

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Participant/Subject History and Family History

Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.

Participant/Subject History and Family History

CRF Module/Guideline by Sub-Domain	Download	CDEs
General Health History
Significant Medical History - Adult	N/A	HTML
Significant Medical History - Pediatric	N/A	HTML
Behavioral History	N/A	HTML

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Disease/Injury Related Events

Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.

Disease/Injury Related Events

CRF Module/Guideline by Sub-Domain	Download	CDEs
History of Disease/Injury Event
Definition of Traumatic Brain Injury	32KB DOC	N/A
Ohio State University TBI Identification Method Short Form	N/A	HTML
Screening for TBI in Military Personnel	N/A	HTML
Injury Presentation - Early/Late - Adult	N/A	HTML
Injury Presentation - Early/Late - Pediatric	N/A	HTML
Type, Place, Cause and Mechanism of Injury - Adult	N/A	HTML
Type, Place, Cause and Mechanism of Injury - Pediatric	N/A	HTML
Classification
Injuries and Injury Severity - Adult	N/A	HTML
Injuries and Injury Severity - Pediatric	N/A	HTML
Baseline Risk Assessment	N/A	HTML
Second Insults
Second Insults: Pre-hospital and Post-admission - Adult	N/A	HTML
Second Insults: Pre-hospital and Post-admission - Pediatric	N/A	HTML
Discharge Information
Discharge Status	N/A	HTML
ER Destination	N/A	HTML

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Assessments and Examinations

Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.

Assessments and Examinations

CRF Module/Guideline by Sub-Domain	Download	CDEs
Vital Signs and Other Body Measures
ABC and Vital Signs on Admission - Adult	N/A	HTML
ABC and Vital Signs on Admission - Pediatric	N/A	HTML
Intracranial Pressure (ICP) Monitoring - Adult	N/A	HTML
Intracranial Pressure (ICP) Monitoring - Pediatric	N/A	HTML
Vital Signs and Blood Gases Daily/Hourly - Adult	N/A	HTML
Vital Signs and Blood Gases Daily/Hourly - Pediatric	N/A	HTML
Physical/Neurological Examination
Neurological assessment: GCS and Pupils - Adult	N/A	HTML
Neurological assessment: GCS and Pupils - Pediatric	N/A	HTML
Neurological Assessment: Neuroworsening - Adult	N/A	HTML
Neurological assessment: Neuroworsening - Pediatric	N/A	HTML
Neurological Assessment: LOC, PTA, and AOC	N/A	HTML
Laboratory Tests and Biospecimens/Biomarkers
Laboratory Tests - Adult	N/A	HTML
Laboratory Tests - Pediatric	N/A	HTML
Recommendations for CDEs for Biospecimens and Biomarkers	29KB DOC	N/A
Plasma and Serum Guidelines for Proteomic Analysis (Table 2)	94KB DOC	N/A
Cerebral Spinal Fluid Guidelines (Table 3)	45KB DOC	N/A
Cerebral Microdialysis Guidelines (Table 4)	35KB DOC	N/A
DNA Guidelines for Genomic Analysis (Table 1)	38KB DOC	N/A
Imaging Diagnostics
Pathoanatomic Terms for Definitions of TBI Lesions and Associated Findings (Appendix I)	106KB DOC	HTML
Imaging Parameters for MRI and Protocols for MRI and CT (Appendix II)	179KB DOC	N/A

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Treatment/Intervention Data

Note: The data elements included in the modules labeled “Pediatric” were considered to be specific to pediatric TBI. However, the modules labeled “Adult” may also include elements relevant but not specific to pediatric TBI.

Treatment/Intervention Data

CRF Module/Guideline by Sub-Domain	Download	CDEs
Drugs
Concomitant Medications - Adult	N/A	HTML
Concomitant Medications - Pediatric	N/A	HTML
Surgeries and Other Procedures
ER/Admission Therapeutic Procedures - Adult	N/A	HTML
ER/Admission Therapeutic Procedures - Pediatric	N/A	HTML
Surgical Therapy	N/A	HTML
Therapies
Post Discharge/Outpatient Treatment - Adult	N/A	HTML
Post Discharge/Outpatient Treatment - Pediatric	N/A	HTML

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Protocol Experience

The General CDE Standards contain useful CRF Modules and CDEs for this domain.

Safety Data

The General CDE Standards contain useful CRF Modules and CDEs for this domain.

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

CRF Module/Guideline by Sub-Domain	Download	CDEs
Summary of All Outcome Recommendations
Outcome Domains and Descriptions	43KB DOC	N/A
CDE Recommendations - Listing of the Core, Supplemental and Emerging Measures for each Outcome Domain	63KB DOC	N/A
Psychometric Properties of the Recommended TBI Outcome CDEs in Core and Supplemental Tiers	692KB DOC	N/A
Global Outcome
CDE Recommendations for Global Outcome	44KB XLS	HTML
Disability Rating Scale (DRS)	60KB DOC	HTML
Mayo-Portland Adaptability Inventory-4 (MPAI-4)	44KB PDF	HTML
Academics
CDE Recommendations for Academics	38KB XLS	N/A
Adaptive and Daily Living Skills
CDE Recommendations for Adaptive and Daily Living Skills	48KB XLS	N/A
Behavioral Function
CDE Recommendations for Behavioral Function	25KB XLS	N/A
Clinical Event End Points
Death	N/A	HTML
Cognitive Activity Limitations
CDE Recommendations for Cognitive Activity Limitations	26KB XLS	N/A
Family and Environment
CDE Recommendations for Family and Environment	38KB XLS	N/A
Infant and Toddler Measures
CDE Recommendations for Infant and Toddler Measures	36KB XLS	N/A
Language and Communication
CDE Recommendations for Language and Communication	46KB XLS	N/A
Neuropsychological Impairment
CDE Recommendations for Neuropsychological Impairment	85KB XLS	HTML
Physical Function
CDE Recommendations for Physical Function	51KB XLS	N/A
Post-concussive/TBI Symptoms
CDE Recommendations for Post-concussive/TBI Symptoms	32KB XLS	HTML
Psychological Status
CDE Recommendations for Psychological Status	39KB XLS	HTML
Substance Abuse Questions from the TBI Model System Dataset	59KB DOC	HTML
Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST)	82KB PDF	HTML
The Alcohol Use Disorders Identification Test: Self-Report Version (AUDIT)	62KB DOC	HTML
PTSD Checklist - Civilian (PCL-C)	74KB DOC	HTML
PTSD Checklist - Military (PCL-M)	74KB DOC	HTML
PTSD Checklist - Stressor Specific (PCL-S)	75KB DOC	HTML
Psychiatric and Psychological Functions
CDE Recommendations for Psychiatric and Psychological Functions	46KB XLS	N/A
Quality of Life
CDE Recommendations for Perceived Generic and Disease-Specific Health-Related Quality of Life	35KB XLS	HTML
CDE Recommendations for Health-economic Measures	27KB XLS	N/A
CDE Recommendations for Patient Reported Outcomes	30KB XLS	N/A
Recovery of Consciousness
CDE Recommendations for Recovery of Consciousness	29KB XLS	HTML
Social Cognition
CDE Recommendations for Social Cognition	31KB XLS	N/A
Social Role Participation
CDE Recommendations for Social Role Participation	48KB XLS	N/A
Participation Assessment with Recombined Tools-Objective (PART)	103KB DOC	HTML
Craig Handicap and Assessment Reporting Technique (CHART-SF)	67KB DOC	HTML

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Prospective Assessments for Suicidality

Investigators should use the Columbia Suicide Severity Rating Scale (C-SSRS) (available at http://www.cssrs.columbia.edu, see additional C-SSRS information for background materials provided to the NINDS CDE project by Dr. Posner) or another instrument that maps to the Columbia Classification Algorithm for Suicide Assessment (C-CASA) (Posner et al. 2007).

Posner, K, MA Oquendo, M Gould, B Stanley, and M Davies, 2007, Columbia Classification Algorithm of Suicide Assessment
(C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants, Am J Psychiatry, 164:1035-1043.

Accessibility Statement

The NINDS CDE Team has requested, and in many cases received, permission to post proprietary instruments/scales recommended by the CDE Working Groups to this site. When permission is granted, the documents are posted in the exact format they were received in order to maintain the validity of the instrument. If approval is not granted for the instrument to be reproduced on this site, with the author/copyright holder’s permission, a link is posted to an external Web site where users can get more information about the instrument. If you have difficulty accessing either the proprietary instruments/scales or the external links, please contact the NINDS CDE Project Officer, Joanne Odenkirchen.

Download readers:

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 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 include 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.

The original TBI CDE recommendations were formulated using three general descriptive levels - core, supplemental and
emerging – which were intended to provide further description to the recommendations and use of data elements. Data elements described as core are intended to encompass the minimal set of measures to characterize a broad spectrum of subjects on the domain. A supplemental element is one intended for greater depth/breadth of exploration and/or intended for more specialized subpopulations. Data elements described as emerging are those that may require further validation but may fill gaps in currently validated measures and/or substitute for recommended measures once validation is complete. Please note that in order to be consistent with the classification of other NINDS CDEs on this site, the term “emerging” has been replaced with the synonymous term “exploratory”.

The TBI CDEs only include an abridged version of the recommendations of the Demographics and Clinical Assessment Working Group. That Working Group presented its CDE recommendations using three levels of detail: Basic, Intermediate and Advanced, with the greatest level of detail in the Advanced version. This Web site currently only includes the Basic level of detail. For a complete listing of all Demographic and Clinical Assessment CDEs and modular CRFs, please see the IMPACT Web site. Additional CDEs and CRF Modules will be added to this site once beta testing of the TBI CDEs is complete.

Co-Sponsoring Federal Agencies

The Federal Liaisons and Consultants for the TBI CDE Project have 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 is 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 working on TBI CDEs Version 2.0 are shown directly 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.

Complete Version 2.0 Traumatic Brain Injury CDE Working Group Roster

Federal Liaisons and Consultants

• Beth M. Ansel, PhD, CCC-SLP - National Center for Medical Rehabilitation Research, The Eunice Kennedy Shriver National Institute of Child Health and Human Development
• Victor G. Coronado, MD - National Center for Injury Prevention and Control, Centers for Disease Control and Prevention
• Thomas J. DeGraba, MD, FAHA - National Intrepid Center of Excellence
• Alison Garcia - Sapient
• Douglas B. Gibson, PhD - U.S. Army Medical Research and Materiel Command, Combat Casualty Care Research Program
• Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, National Institutes of Health
• Stuart W. Hoffman, PhD - Office of Research and Development, U.S. Department of Veterans Affairs
• Geoffrey T. Manley, MD, PhD - University of California, San Francisco, San Francisco General Hospital, Brain and Spinal Injury Center
• Matthew McAuliffe, PhD - Center for Information Technology, National Institutes of Health
• A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education
• Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke, National Institutes of Health
• Ross H. Pastel, PhD - National Intrepid Center of Excellence, National Naval Medical Center
• Lt. Wanda Salzer - Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
• Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center

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Core CDEs and Epidemiology Subgroup

• Cindy Harrison-Felix, PhD - Craig Hospital, Chair
• Davida M. Carr, MPH - HJF Contractor for Defense and Veterans Brain Injury Center/Defense Centers of Excellence
• Wayne A. Gordon, PhD, ABPP/Cn - Department of Rehabilitation Medicine, Mount Sinai School of Medicine
• Harvey Levin, PhD - Baylor College of Medicine
• David K. Menon, MD, PhD - Division of Anaesthesia, University of Cambridge
• Jennie Ponsford, MA, PhD - School of Psychology and Psychiatry, Monash University
• Karen Schwab, PhD - Defense and Veterans Brain Injury Center, Walter Reed Army Medical Center
• Grahame Simpson, PhD - Brain Injury Rehabilitation Unit
• Hilaire J. Thompson, PhD, RN, CNRN, FAAN - Biobehavioral Nursing and Health Systems, School of Nursing, University of Washington
• Pieter E. Vos, MD, PhD - Department of Neurology, Radboud University Nijmegen Medical Centre
• Jerry Wright, MS, CBIST - Rehabilitation Research Center, Santa Clara Valley Medical Center

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Concussion/Mild TBI Subgroup

• Elisabeth Wilde, PhD - Departments of Physical Medicine and Rehabilitation, Neurology and Radiology, Baylor College of Medicine, Chair
• Vicki Anderson, PhD - Integrated Mental Health Program, Royal Children's Hospital
• Victor G. Coronado, MD - National Center for Injury Prevention and Control, Centers for Disease Control and Prevention
• Gavin Davis, MBBS - Cabrini Medical Centre
• Thomas J. DeGraba, MD, FAHA - National Intrepid Center of Excellence
• Sureyya Dikmen, PhD - Department of Rehabilitation Medicine, University of Washington
• Gerard A. Gioia, PhD - Children's National Medical Center, George Washington University School of Medicine
• Robin A. Hurley, MD - W. G. (Bill) Hefner VA Medical Center
• Grant L. Iverson, PhD - Department of Psychiatry, University of British Columbia
• Andy Jagoda, MD, FACEP - Department of Emergency Department, Mount Sinai School of Medicine
• Michael W. Kirkwood, PhD, ABPP/CN - University of Colorado Denver School of Medicine, Department of Physical Medicine & Rehabilitation
• Russell R. Lonser, MD - National Institute of Neurological Disorders and Stroke, National Institutes of Health
• Geoffrey T. Manley, MD, PhD - University of California, San Francisco, San Francisco General Hospital, Brain and Spinal Injury Center
• Jeffrey Max, MD - Department of Psychiatry, University of California, San Diego & Director
• Thomas W. McAllister, MD - Dartmouth-Hitchcock Psychiatric Associates
• Michael McCrea, PhD, ABPP - Departments of Neurosurgery and Neurology, Medical College of Wisconsin
• Paul McCrory, MBBS, PhD - Melbourne School of Health Sciences
• Pratik Mukherjee, MD, PhD - Department of Radiology, University of California, San Francisco
• Douglas C. Oberly, MS - BrainScope Company, Inc.
• Ross H. Pastel, PhD - National Intrepid Center of Excellence, National Naval Medical Center
• Leslie S. Prichep, PhD - Brain Research Laboratories, Department of Psychiatry, New York University School of Medicine
• Michael E. Singer, PhD - BrainScope Company, Inc.
• Keith O. Yeates, PhD - The Research Institute at Nationwide Children's Hospital

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Acute Hospitalized Subgroup

• Alex Valadka, MD, FAANS, FACS - Seton Brain and Spine Institute, Chair
• Rachel P. Berger, MD, MPH - Child Advocacy Center, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
• Ann-Christine Duhaime, MD - Massachusetts General Hospital
• Ronald L. Hayes, PhD - Center of Innovative Research, Banyan Biomarkers, Inc.
• Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke, National Institutes of Health
• Jamie Hutchison, MD - The Hospital for Sick Children
• Andrew I.R. Maas, MD, PhD - Department of Neurosurgery, University Hospital of Antwerp
• David K. Menon, MD, PhD - Division of Anaesthesia, University of Cambridge
• Jose A. Pineda, MD, MSc - Department of Pediatrics and Neurology, Washington University School of Medicine
• Robert D. Stevens, MD - Departments of Anesthesiology/Critical Care Medicine, Neurology, Neurosurgery, and Radiology, The Johns Hopkins University School of Medicine, Division of Neurosciences Critical Care
• Willie Stewart, MBChB, PhD - Department of Neuropathology, Institute of Neurological Sciences, Southern General Hospital
• Nino Stocchetti, MD - University of Milan
• Monica S. Vavilala, MD - Harborview Injury Prevention and Research Center
• David W. Wright, MD, FACEP - Department of Emergency Medicine, Emory University School of Medicine
• Esther L. Yuh, MD, PhD - University of California, San Francisco

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Moderate/Severe TBI: Rehabilitation Subgroup

• Joseph T. Giacino, PhD - Spaulding Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation, Harvard Medical School, Chair
• Beth M. Ansel, PhD, CCC-SLP - National Center for Medical Rehabilitation Research, The Eunice Kennedy Shriver National Institute of Child Health and Human Development
• Kathleen R. Bell, MD - Department of Rehabilitation Medicine, University of Washington
• Tamara Bushnik, PhD, FACRM - Department of Rehabilitation Medicine, Rusk Institute for Rehabilitation
• David X. Cifu, MD - Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Physical Medicine and Rehabilitation Program Office, U.S. Department of Veterans Affairs
• Linda Ewing-Cobbs, PhD - Dan L Duncan Children's Neurodevelopmental Clinic, Children's Learning Institute
• Tessa Hart, PhD - Moss Rehabilitation Research Institute
• Stuart W. Hoffman, PhD - Office of Research and Development, U.S. Department of Veterans Affairs
• Stephanie A. Kolakowsky-Hayner, PhD, CBIST - Rehabilitation Research Center, Santa Clara Valley Medical Center
• Steven Laureys, MD, PhD - University Hospital of Liège
• A. Cate Miller, PhD - National Institute on Disability and Rehabilitation Research, U.S. Department of Education
• Jennie Ponsford, MA, PhD - School of Psychology and Psychiatry, Monash University
• Louis Puybasset, MD, PhD - The Pitié-Salpêtrière Hospital
• M. Elizabeth Sandel, MD - Kaiser Foundation Rehabilitation Center
• David S. Tulsky, PhD - University of Michigan, North Campus Research Complex
• Shari Wade, PhD - UC Department of Pediatrics, Cincinnati Children's Hospital Medical Center

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NINDS CDE Team

• Stacie Grinnon, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA
• Ramona Hicks, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
• Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
• Amy Price, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA

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The TBI CDE version 1.0 Working Group initiative involved an Interagency Planning Committee, TBI working groups, and PH working groups. The working groups focused on developing specific topic-driven CDEs. Each working group actively developed the CDEs for their specific topic and also had an opportunity to review and comment on the recommendations of the other working groups. 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. The complete version 1.0 TBI CDE Working Group roster can be viewed below.

Complete Version 1.0 Traumatic Brain Injury CDE Working Group Roster

Note: Institutions for all individuals acknowledged in this section were those they belonged to when they joined the Working Group. All Working Group members were asked to voluntarily disclose all potential sources of bias in their involvement with the NINDS CDE Project. The summary disclosure information is available upon request by contacting NINDSCommonData@kai-research.com.

The NINDS Common Data Element Project is committed to creating useful tools for the neurological research community. To send questions, comments, or concerns regarding the Project, please fill out the form below. Thank you in advance for your feedback! Required fields are marked with Feedback Form Topic What your comments/questions primarily pertain to: Content of CDEs Overall NINDS CDE Project Web Site Other Subject Field is limited to 50 characters. Comments/Questions Field is limited to 5000 characters. Contact Information First Name Last Name Suffix Title Email

Publications in the Archives of Physical Medicine and Rehabilitation

• Thurmond VA, Hicks R, Gleason T, Miller AC, Szuflita N, Orman J, Schwab K. Advancing integrated research in psychological health and traumatic brain injury: common data elements. Arch Phys Med Rehabil. 2010 Nov;91(11):1633-6. [DOI: 10.1016/j.apmr.2010.06.034]
• Menon DK, Schwab K, Wright DW, Maas AI; 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. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. [DOI: 10.1016/j.apmr.2010.05.017]
• Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Orman JL, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Common data elements for traumatic brain injury: recommendations from the interagency working group on demographics and clinical assessment. Arch Phys Med Rehabil. 2010 Nov;91(11):1641-9. [DOI: 10.1016/j.apmr.2010.07.232]
• Wilde EA, Whiteneck GG, Bogner J, Bushnik T, Cifu DX, Dikmen S, French L, Giacino JT, Hart T, Malec JF, Millis SR, Novack TA, Sherer M, Tulsky DS, Vanderploeg RD, von Steinbuechel N. Recommendations for the use of common outcome measures in traumatic brain injury research. Arch Phys Med Rehabil. 2010 Nov;91(11):1650-1660.e17. [DOI: 10.1016/j.apmr.2010.06.033]
• Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1661-6. [DOI: 10.1016/j.apmr.2010.07.238]
• Manley GT, Diaz-Arrastia R, Brophy M, Engel D, Goodman C, Gwinn K, Veenstra TD, Ling G, Ottens AK, Tortella F, Hayes RL. Common data elements for traumatic brain injury: recommendations from the biospecimens and biomarkers working group. Arch Phys Med Rehabil. 2010 Nov;91(11):1667-72. [DOI: 10.1016/j.apmr.2010.05.018]
• Nash WP, Vasterling J, Ewing-Cobbs L, Horn S, Gaskin T, Golden J, Riley WT, Bowles SV, Favret J, Lester P, Koffman R, Farnsworth LC, Baker DG. Consensus recommendations for common data elements for operational stress research and surveillance: report of a federal interagency working group. Arch Phys Med Rehabil. 2010 Nov;91(11):1673-83. [DOI: 10.1016/j.apmr.2010.06.035]
• Kaloupek DG, Chard KM, Freed MC, Peterson AL, Riggs DS, Stein MB, Tuma F. Common data elements for posttraumatic stress disorder research. Arch Phys Med Rehabil. 2010 Nov;91(11):1684-91. [DOI: 10.1016/j.apmr.2010.06.032]
• Whyte J, Vasterling J, Manley GT. Common data elements for research on traumatic brain injury and psychological health: current status and future development. Arch Phys Med Rehabil. 2010 Nov;91(11):1692-6. [DOI: 10.1016/j.apmr.2010.06.031]

Publications in the Journal of Neurotrauma

• Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Langlois-Orman J, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Standardizing data collection in traumatic brain injury. J Neurotrauma. 2011 Feb;28(2):177-87. Epub 2011 Feb 5.
• Gerring JP, Wade S. The Essential Role of Psychosocial Risk and Protective Factors in Pediatric TBI Research. J Neurotrauma. 2012 March; 29: 621-628. PubMed PMID: 22091875.
• Duhaime AC, Holshouser B, Hunter JV, Tong K. Common Data Elements for Neuroimaging of Traumatic Brain Injury: Pediatric Considerations. J Neurotrauma. 2012 March; 29: 629-633. PubMed PMID: 21671798.
• Miller AC, Odenkirchen J, Duhaime AC, Hicks R. Common Data Elements for Research on Traumatic Brain Injury - Pediatric Considerations. J Neurotrauma. 2012 March; 29: 634-638. PubMed PMID: 22091862.
• Adelson PD, Pineda J, Bell MJ, Abend NS, Berger RP, Giza CC, Hotz G, Wainwright M. Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Working Group on Demographics and Clinical Assessment. J Neurotrauma. 2012 March; 29: 639-653. PubMed PMID: 21939389.
• Hunter JV, Wilde EA, Tong KA, Holshouser BA. Emerging Imaging Tools for Use with Traumatic Brain Injury Research. J Neurotrauma. 2012 March; 29: 654-671. PubMed PMID: 21787167.
• Berger RP, Beers SR, Papa L, Bell M. Common Data Elements for Pediatric Traumatic Brain Injury: Recommendations from the Biospecimens and Biomarkers Workgroup. J Neurotrauma. 2012 March; 29: 672-677. PubMed PMID: 22106839.
• McCauley SR, Wilde EA, Anderson VA, Bedell G, Beers SR, Campbell TF, Chapman SB, Ewing-Cobbs L, Gerring JP, Gioia GA, Levin HS, Michaud LJ, Prasad MR, Swaine BR, Turkstra LS, Wade SL, Yeates KO. Recommendations for the Use of Common Outcome Measures in Pediatric Traumatic Brain Injury Research. J Neurotrauma. 2012 March; 29: 678-705. PubMed PMID: 21644810.

Additional Publications

• Traumatic brain injury: time to end the silence. The Lancet Neurology, Vol. 9, No. 4. (April 2010), pp. 331. [DOI:10.1016/S1474-4422(10)70069-7]
• Haacke EM, Duhaime AC, Gean AD, Riedy G, Wintermark M, Mukherjee P, Brody DL, DeGraba T, Duncan TD, Elovic E, Hurley R, Latour L, Smirniotopoulos JG, Smith DH. Common data elements in radiologic imaging of traumatic brain injury. J Magn Reson Imaging. 2010 Sep;32(3):516-43. [DOI: 10.1002/jmri.22259]
• Miller G. New guidelines aim to improve studies of traumatic brain injury. Science 328:297 (2010). [DOI: 10.1126/science.328.5976.297]

Sample Protocols

• 1a. TBI Biospecimen Collection Sample Protocol 
• 1b. TBI Site Specimen Log 

No updates have been made at this time.