Headache

Data Standards

The National Institute of Neurological Disorders and Stroke (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 Common Data Elements (CDEs) for Headache were developed in 2011. In June 2017, the Headache CDE Working Group finished their work on version 2.0 of the Headache CDEs. The Core and Supplemental-Highly Recommended CDEs to be used by an investigator when beginning a research study in Headache are listed in the Start-up Resource Listing 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 domains and sub-domains, often used in clinical studies, data standards include:

 

Please view additional tabs for more information about the development of these CDEs. An overview of all Headache CDE Version 2.0 recommendations can be found in the Headache CDE Highlight Summary document

For your reference, a zip file containing all the Headache Version 2.0 CDE template CRF modules can be downloaded below.

Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Participant History and Family History
Treatment/Intervention Data
Outcomes and End Points
Cognitive Status
CRF Module/Guidance CDEs
Mig S-Cog N/A

Overview

To develop the Headache v2.0 CDEs, the Headache Version 2.0 CDE Working Group divided into five (5) subgroups to focus on identifying and defining data elements in the domains of:

  • Biomarkers
  • Demographics
  • Diagnostics and Characteristics
  • Imaging and Neurophysiology
  • Therapies and Interventions

Roster

The Headache Version 2.0 CDE Working Group was comprised of five (5) 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 Headache CDE Working Group was supported by the NINDS CDE Team. The complete Headache CDE Version 2.0 Working Group roster by subgroup are shown below.

Complete Version 1.0 Headache CDE Working Group Roster

Biomarkers Version 2.0

  • Michael Harrington, MB, ChB, FRCP
    Huntington Medical Research Institutes, Pasadena, California
    Co-Chair
  • B. Lee Peterlin, DO
    Johns Hopkins University, Baltimore, Maryland
    Co-Chair
  • Angel L. Guerrero, MD, PhD
    University Clinical Hospital of Valladolid, Valladolid, Spain
  • Andrew Hershey, MD, PhD, FAHS
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Timothy Houle, PhD
    Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • Gisela Terwindt, MD, PhD
    Leiden Headache Research Group, Leiden, Netherlands
  • Gretchen Tietjen, MD
    University of Toledo, Toledo, Ohio
  • Arn M.J.M. van den Maagdenberg, PhD
    Leiden University Medical Center, Leiden, Netherlands
  • Gerrit L.J. Onderwater, MD
    (AdHoc Member) Leiden Headache Research Group, Leiden, Netherlands
  • Robin van Dongen, MD
    (AdHoc Member) Leiden Headache Research Group, Leiden, Netherlands
  • Irene de Boer, MD
    (AdHoc Member) Leiden Headache Research Group, Leiden, Netherlands

Demographics Version 2.0

  • Ann Scher, PhD
    Uniformed Services University of the Health<br />Sciences (USUHS), Bethesda, Maryland
    Chair
  • Lenore Launer, PhD
    National Institute of Health (NIH), Bethesda, Maryland
  • Kathleen Merikangas, PhD
    National Institute of Mental Health (NIMH), Bethesda, Maryland
  • Elizabeth Seng, PhD
    Yeshiva University, Bronx, New York
  • Todd Smitherman, MS, PhD
    University of Mississippi, University, Mississippi

Diagnostics and Characteristics Version 2.0

  • David Dodick, MD
    Mayo Clinic, Phoenix, Arizona
    Co-Chair
  • Stephen Silberstein, MD, FACP
    Thomas Jefferson University, Philadelphia, Pennsylvania
    Co-Chair
  • Andrew Ahn, MD, PhD
    Eli Lilly and Company, Indianapolis, Indiana
  • Sheena Aurora, MD
    Eli Lilly and Company, Indianapolis, Indiana
  • Michel Lanteri-Minet, MD
    C.H.U. Hopital Pasteur, Nice, France
  • Sagar Munjal, MD, MS
    Dr. Reddy's Laboratories Inc, Princeton, New Jersey
  • Eric M. Pearlman, MD, PhD
    Eli Lilly and Company, Indianapolis, Indiana
  • Donald Penzien, PhD
    University of Mississippi Medical Center, Jackson, Mississippi
  • Caryn Seebach, PsyD
    Jefferson Headache Center, Philadelphia, Pennsylvania
  • Nicole M. Spare, DO
    Jefferson Headache Center, Philadelphia, Pennsylvania
  • Christina Szperka, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, PA
  • Hsiangkuo Scott Yuan, MD, PhD
    Jefferson Headache Center, Philadelphia, Pennsylvania

Imaging and Neurophysiology Version 2.0

  • Todd Schwedt, MD, MSCI
    Mayo Clinic, Phoenix, Arizona
    Chair
  • Hans-Christoph Diener, MD, PhD, FAHA, FAAN
    University Duisburg-Essen, Duisburg and Essen, North Rhine-Westphalia, Germany
  • Manjit Matharu, MRCP, PhD
    National Hospital for Neurology and Neurosurgery, London, United Kingdom
  • Scott Powers, PhD, ABPP
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Jean Schoenen, MD, PhD
    University of Liege, Liege, Wallonia, Belgium
  • Jing Xiang, MD, PhD
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

Therapies and Interventions Version 2.0

  • David Dodick, MD
    Mayo Clinic, Phoenix, Arizona
    Co-Chair
  • Stephen Silberstein, MD, FACP
    Thomas Jefferson University, Philadelphia, Pennsylvania
    Co-Chair
  • Aftab Alam, MD, MBA
    Dr. Reddy's Laboratories Inc, Princeton, New Jersey
  • Ernesto Aycardi, MD
    Teva Pharmaceuticals, Cambridge, Massachusetts
  • David Borsook, MD
    Children's Hospital, Belmont, Massachusetts
  • Mitchell Brin, MD, FAAN
    Allergan, Irvine, California
  • Roger Cady, MD, FAHS
    Alder BioPharmaceuticals Inc, Bothell, Washington
  • Benjamin Friedman, MD, MS, FAAEM
    Montefiore Medical Center, Bronx, New York
  • Peter Goadsby, MD, PhD
    University of California, San Francisco, San Francisco, California
  • Scott Powers, PhD, ABPP
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Michael Rapoff, PhD
    University of Kansas Medical Center, Kansas City, Kansas
  • Uwe Reuter, MD
    The Headache Clinic of the Charite, Berlin, Germany
  • William Young, MD, FAHS, FAAN
    Thomas Jefferson University, Philadelphia, Pennsylvania

NINDS CDE Team

  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Michael L. Oshinsky, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS
    The Emmes Company, LLC
  • Joy Esterlitz, MS
    The Emmes Company, LLC
  • Katelyn Gay, BS
    The Emmes Company, LLC
  • Aria Lans, MPH
    The Emmes Company, LLC
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC
  • Amanda Suller, BS
    The Emmes Company, LLC
  • Sarah Tanveer, BS
    The Emmes Company, LLC

Publications

A publication related to the Headache CDE initiative is in development. The citation for this publication will be included on this site as soon as it is available.

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.

Headache CDEs Revision History