Sport Related Concussion

Data Standards

The Sport-Related Concussion (SRC) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team have released Version 1.0 of the SRC CDEs. The NINDS, other Federal agencies, and international organizations 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 for SRC was developed in 2016–2017. The Core and Supplemental-Highly Recommended CDEs to be used by an investigator when beginning a research study in this disease/disorder are listed in the Start-up Resource Listing.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analyses across studies. Consistency of the data elements and the CDE formats are kept in order to ensure 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 NINDS 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.

Organized by working groups (Acute, Persistent/Chronic, and Subacute), often used in clinical studies, data standards include:

An overview of all SRC CDE recommendations can be found in the Sport-Related Concussion CDE Highlight Summary document. For your reference, a zip file containing all the current SRC CDE template CRF modules can be downloaded below.

The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and sub-domain. Choose your time-frame for your SRC study (Acute (time of injury until 72 hours), Subacute (after 72 hours to 3 months), and Persistent/Chronic (3 months and greater post concussion) or Comprehensive if your study falls across the study time-frames.

Overview

To develop the Sport-Related Concussion CDEs, the Sport-Related Concussion Working Group divided into subgroups to focus on identifying and defining data elements in the timeframes of:

  • Acute Subgroup (time of injury until 72 hours)
  • Subacute Subgroup (after 72 hours to 3 months)
  • Persistent/Chronic Subgroup (3 months and greater post concussion)

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 presented are organized into domains which are intuitive and common in clinical research studies.

History and Acknowledgements

The Sport-Related Concussion (SRC) CDE Working Group was comprised of three different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The SRC CDE Working Group was supported by the NINDS CDE Team. The complete SRC CDE Working Group roster and the rosters by subgroup are shown below:

Complete Sport-Related Concussion CDE Roster

Acute Subgroup

  • Steven Broglio, PhD
    University of Michigan School of Kinesiology, Ann Arbor, Michigan
    Chair
  • Ruth Brenner, MD, MPH
    National Institute of Child Health and Human Development, Bethesda, Maryland
  • Gordon Fuller, PhD
    The University of Sheffield, Sheffield, United Kingdom
  • Isabelle Gagnon, PhD
    McGill University, Montreal, Quebec, Canada
  • Michael McCrea, PhD, ABPP
    Medical College of Wisconsin, Milwaukee, Wisconsin
  • Lara McKenzie, PhD
    The Research Institute at Nationwide Children's Hospital, Columbus, Ohio
  • Margot Putukian, MD
    Princeton University, Princeton, New Jersey
  • Stefano Signoretti, MD, PhD
    San Camillo Hospital, Roma, Italy
  • Robert Tamburro, MD, MSc
    National Institute of Child Health and Human Development, Bethesda, Maryland
  • Roberto Vagnozzi, MD, PhD
    University of Rome, Roma, Italy
  • Roger Zemek, MD
    CHEO Research Institute, Ottawa, Ontario, Canada

Subacute Subgroup

  • Anthony Kontos, PhD
    University of Pittsburgh, Pittsburgh, Pennsylvania
    Chair
  • Alison Cernich, PhD
    National Institute of Child Health and Human Development,<br />Bethesda, Maryland
  • Nina Feddermann-Demont, MD
    University Hospital Zurich (Universit?tsspital Z?rich), <br />Zurich, Switzerland
  • Gerard Gioia, PhD
    Children's National Medical Center, Washington, District of Columbia
  • John Leddy, MD
    University of Buffalo, Buffalo, New York
  • Harvey Levin, PhD
    Baylor College of Medicine, Houston, Texas
  • Andrew Mayer, PhD
    University of New Mexico, Albuquerque, New Mexico
  • Thomas McAllister, MD
    University of Indiana, Indianapolis, Indiana
  • Stacy Suskauer, MD
    Kennedy Krieger Institute, Baltimore, Maryland
  • Keith Yeates, PhD
    University of Calgary, Calgary, Alberta, Canada

Persistent / Chronic Subgroup

  • Kathryn Schneider, PhD
    University of Calgary, Calgary, Alberta, Canada
    Co-Chair
  • Elisabeth Wilde, PhD
    Baylor College of Medicine, Houston, Texas
    Co-Chair
  • Robert Cantu, MD
    Emerson Hospital, Concord, Massachusetts
  • Sureyya Dikmen, PhD
    University of Washington, Seattle, Washington
  • Christopher Giza, MD
    UCLA Brain Injury Research Center, Neurosurgery, Los Angeles, California
  • LaVon Greer
    Federal Interagency Traumatic Brain Injury Research (FITBIR), Bethesda, Maryland, (AdHoc Member)
  • Grace Griesbach, PhD
    Centre for Neuro Skills, Los Angeles, California
  • Barry Jordan, MD, MPH
    Burke Rehabilitation Hospital, White Plains, New York
  • Michael Lipton, MD, PhD
    Albert Einstein College of Medicine, Bronx, New York
  • Mary Ellen Michel, PhD
    National Center for Medical Rehabilitation (NCMRR), Bethesda, Maryland, (Retired)
  • Michael Turner, MD
    The International Concussion and Head Injury, Research Foundation (ICHIRF), London, United Kingdom

NINDS/NIH

  • Patrick Bellgowan, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)<br />Bethesda, Maryland
  • Claudia Moy, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)<br />Bethesda, Maryland

NINDS CDE Team

  • Kristen Joseph, MA
    The Emmes Corporation, Rockville, Maryland
  • Joy Esterlitz, MS
    The Emmes Corporation, Rockville, Maryland
  • Sherita Ala'i, MS
    The Emmes Corporation, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Corporation, Rockville, Maryland

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.

Sport-Related Concussion CDE Revision History