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.

NIH Resources
NIH Resources
CRF Module/Guidance CDEs
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guidance CDEs
Biomarkers Working Group Summary Document N/A
Demographics Working Group Summary Document N/A
Diagnostics and Characteristic Working Group Summary Document N/A
Imaging and Neurophysiology Working Group Summary Document N/A
Therapies and Interventions Working Group Summary Document N/A
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
General Health History
CRF Module/Guidance CDEs
Behavioral History CDE Details
Medical and Family History CDE Details
Pregnancy Information CDE Details
Pregnancy Outcome CDE Details
Disease/Injury Related Events
Classification
CRF Module/Guidance CDEs
ID Migraine Screener N/A
International Classification of Headache Disorders-3 Beta (ICHD3-Beta) N/A
Migraine Diagnosis Questionnaire CDE Details
Structured Diagnostic Interview for Headache (SDIH) N/A
History of Disease/Injury Event
CRF Module/Guidance CDEs
Medical and Family History of Headache/Migraine CDE Details
Assessments and Examinations
Imaging Diagnostics
CRF Module/Guidance CDEs
Anatomical Imaging CDE Details
Cortical Evoked Potentials CDE Details
Functional Magnetic Resonance Imaging (fMRI) CDE Details
Magnetic Resonance Angiography (MRA) CDE Details
Magnetic Resonance Spectroscopy (MRS) CDE Details
Magnetoencephalography (MEG) CDE Details
Nociceptive Blink Reflex and Pain-Related Evoked Potentials CDE Details
Positron Emission Tomography Localization (PET) CDE Details
Quantitative Sensory Testing (QST) CDE Details
Transcranial Magnetic Stimulation (TMS) CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Biospecimens Collection and Processing CDE Details
DNA Elements CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Physical Exam CDE Details
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Drugs
CRF Module/Guidance CDEs
Concomitant Medications CDE Details
Rescue Treatments CDE Details
Outcomes and End Points
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
24-Hour Migraine Quality of Life Questionnaire (24-Hr-MQoLQ) N/A
Clinical Global Impression Scale N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D) CDE Details
Headache Impact Questionnaire (HImQ) CDE Details
Headache Impact Test-6 (HIT-6) N/A
Health Related Quality of Life-14 (HRQOL-14) N/A
Migraine Specific Quality of Life Questionnaire (MsQoL v2.1) N/A
Pediatric Quality of Life Inventory (PEDSQL) CDE Details
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Short Form 12- Item Health Survey (SF-12) N/A
Short Form 36-Item Health Survey (SF-36) CDE Details
Emotional Status
CRF Module/Guidance CDEs
Beck Anxiety Inventory (BAI) CDE Details
Beck Depression Inventory II (BDI-II) CDE Details
Behavior Rating Inventory of Executive Function - Self Report Version (BRIEF-SR) N/A
Children's Depression Inventory - 2 (CDI-2) CDE Details
Columbia - Suicide Severity Rating Scale (C-SSRS) N/A
Generalized Anxiety Disorder (GAD-7) CDE Details
Hospital Anxiety and Depression Scale (HADS) N/A
Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) CDE Details
Patient Health Questionnaire - 4 (PHQ-4) N/A
Patient Health Questionnaire - 9 (PHQ-9) Depression Scale CDE Details
State-Trait Anxiety Inventory (STAI) N/A
Activities of Daily Living/Performance
CRF Module/Guidance CDEs
Functional Disability Inventory - Child and Adolescent Form (FDI) CDE Details
Functional Disability Inventory - Parent Form (FDI) CDE Details
Functional Impairment Scale N/A
Headache Needs Assessment Survey (HANA) N/A
Migraine Disability Assessment Test (MIDAS) CDE Details
Migraine Functional Impact Questionnaire (MFIQ) N/A
Migraine Interictal Burden Scale (MIBS-4) N/A
National Institutes of Health (NIH) Toolbox N/A
Migraine Physical Function Impact Diary (MPFID) N/A
Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) CDE Details
Patient Reported Outcomes
CRF Module/Guidance CDEs
Headache Calendar CDE Details
Headache Diary - Acute Therapies CDE Details
Headache Diary - Preventive Therapies CDE Details
Patient Global Impression of Change Scale N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Cognitive Status
CRF Module/Guidance CDEs
Mig S-Cog N/A
Assessing Comorbidities
CRF Module/Guidance CDEs
Mini International Neuropsychiatric Interview (M.I.N.I.) N/A
Mood Disorder Questionnaire (MDQ) N/A
Structured Clinical Interview for DSM-5 Axis I Disorders Research Version (SCID-5-RV) N/A

Prospective Assessments for Suicidal Ideation and Behavior

Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at http://www.cssrs.columbia.edu).

Accessibility Statement

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guideline’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.

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