Headache | NINDS Common Data Elements

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:

CDEs - Classified a Core, Supplemental - Highly Recommended, Supplemental, or Exploratory
CRF Modules - logically organize CDEs for data collection
Guidelines - to provide further information about the CDEs.

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/Guideline	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/Guideline	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/Guideline	CDEs
General Core	CDE Details
Demographics	CDE Details

Social Status
CRF Module/Guideline	CDEs
Social Status	CDE Details

Participant History and Family History

General Health History
CRF Module/Guideline	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/Guideline	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/Guideline	CDEs
Medical and Family History of Headache/Migraine	CDE Details

Assessments and Examinations

Imaging Diagnostics
CRF Module/Guideline	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/Guideline	CDEs
Biospecimens Collection and Processing	CDE Details
DNA Elements	CDE Details

Physical/Neurological Examination
CRF Module/Guideline	CDEs
Physical Exam	CDE Details

Vital Signs and Other Body Measures
CRF Module/Guideline	CDEs
Vital Signs	CDE Details

Treatment/Intervention Data

Drugs
CRF Module/Guideline	CDEs
Concomitant Medications	CDE Details
Rescue Treatments	CDE Details

Outcomes and End Points

Quality of Life/Patient Reported Outcomes
CRF Module/Guideline	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/Guideline	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/Guideline	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/Guideline	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/Guideline	CDEs
Mig S-Cog	N/A

Assessing Comorbidities
CRF Module/Guideline	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 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 Office of Clinical Research at carolina.mendoza-puccini@nih.gov.

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