Epilepsy

The NINDS CDE Team will be attending the American Epilepsy Society meeting from December 7 - 9, 2019. Please visit us at booth #734.

Data Standards

The National Institute of Neurological Disorders and Stroke (NINDS) and 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 Epilepsy was developed in 2010. The Core data elements 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-analysis across studies. Consistency of the data elements and the CDE formats is 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:

An overview of all Epilepsy CDE recommendations can be found in the Epilepsy CDE Highlight Summary document. For your reference, a zip file containing all the current Epilepsy 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.

Participant Characteristics
Demographics
CRF/Module Guideline CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF/Module Guideline CDEs
Social Status CDE Details
Disease/Injury Related Events
Outcomes and End Points
Assessing Comorbidities
CRF/Module Guideline CDEs
Overview of Instruments for Assessing Comorbidities N/A
Recommended Cognitive Instruments N/A
Recommended Migraine Instruments N/A
Recommended Psychiatric Instruments N/A
ADHD Comprehensive Teachers Rating Scale (ACTeRS) N/A
Adolescent Symptom Inventory (ASI) N/A
Adult ADHD Self-Report Scale (ASRS) CDE Details
American National Adult Reading Test (AmNART) CDE Details
Beck Anxiety Inventory (BAI) CDE Details
Beck Depression Inventory II (BDI-II) CDE Details
Boston Naming Test (BNT) - 30-item version N/A
Brief Psychiatric Rating Scale (BPRS) CDE Details
Checklist for Autism in Toddlers (CHAT) CDE Details
Child Behavior Checklist (CBCL) N/A
Child Depression Inventory (CDI) N/A
Child Health Questionnaire (CHQ) N/A
Child Symptom Inventory (CSI) N/A
Childhood Autism Rating Scale (CARS) N/A
Conner's Continuous Performance Test III N/A
Conners (Teacher and Parent) Rating Scale (CRS-R) N/A
Controlled Oral Word Association Test (COWAT) subtest of the Multilingual Aphasia Examination (MAE) CDE Details
Davidson Trauma Scale (DTS) N/A
Generalized Anxiety Disorder (GAD-7) CDE Details
Headache Diagnosis Questionnaire N/A
Hopkins Verbal Learning Test - Revised (HVLT-R) CDE Details
Longitudinal Interval Follow-Up Evaluation DSM-IV VERSION (LIFE DSM-IV) CDE Details
Migraine Headaches Questionnaire 21-Item CDE Details
Mini International Neuropsychiatric Interview (M.I.N.I.) N/A
Modified Checklist for Autism in Toddlers (M-CHAT) N/A
Montreal Cognitive Assessment (MoCA) N/A
National Institute of Mental Health Diagnostic Interview for Children (NIMH-DISC) N/A
Neurological Disorders Depression Inventory in Epilepsy (NDDI-E) N/A
Patient Health Questionnaire - 9 (PHQ-9) Depression Scale CDE Details
Post-Traumatic Epilepsy Screening Form CDE Details
Psychiatric Diagnostic Screening Questionnaire (PDSQ) N/A
Social Communication Questionnaire (SCQ) N/A
World Health Organization (WHO) Composite International Diagnostic Interview (WMH-CIDI) N/A
Neuropsychological Testing
CRF/Module Guideline CDEs
Overview of Recommended Neuropsychology Instruments N/A
Recommended Neuropsychology Instruments - Adult N/A
Recommended Neuropsychology Instruments - Pediatric N/A
Neuropsychological Testing Background Information CDE Details
Adaptive Behavior Assessment Scale (ABAS-II) CDE Details
Bayley Scales of Infant Development (Bayley III, BSID) N/A
Behavior Rating Inventory of Executive Function (BRIEF) ? Second Edition (BRIEF-2) CDE Details
Brief Visuospatial Memory Test Revised (BVMT-R) CDE Details
California Verbal Learning Test - Children (CVLT-C) CDE Details
California Verbal Learning Test - Second Edition (CVLT-II) CDE Details
Clinical Evaluation of Language Fundamentals - Fifth Edition (CELF-5) N/A
Conners Kiddie Continuous Performance Test 2 (K-CPT 2) N/A
Delis-Kaplan Executive Function System (D-KEFS) N/A
Grooved Pegboard Test CDE Details
Mullen Scales of Early Learning (MSEL) N/A
Peabody Picture Vocabulary Test 4th Edition (PPVT?-4) N/A
Processing Speed Index of the Wechsler Intelligence Scale for Children-IV/ Wechsler Preschool and Primary Scale of Intelligence (WISC-IV/WPPSI-III) N/A
Processing Speed Index Subtest of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) CDE Details
Purdue Pegboard N/A
Rey Auditory Verbal Learning Test (RAVLT) CDE Details
Rey-Osterrieth Complex Figure Test (ROCF) N/A
Scales of Independent Behavior-Revised (SIB-R) N/A
Test of Variables of Attention (TOVA) N/A
Vineland Adaptive Behavior Scales, second edition (Vineland-II) N/A
Wechsler Abbreviated Scale of Intelligence (WASI) N/A
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) N/A
Wisconsin Card Sorting Test (WCST) N/A

Overview

The Epilepsy Common Data Elements (CDEs) follow the recommendations of the Epilepsy CDE Working Group (WG), a committee of experts in the field (see History and Acknowledgements).

The NINDS recognizes that the Epilepsy CDEs are dynamic tools that will continue to evolve over time. Consequently, the Epilepsy CDEs will be periodically reviewed and updated based on feedback from the epilepsy community and changes in the clinical research landscape.

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.

Download a “checklist” – Checklist for Epilepsy Clinical Trials icon for download word file OR Checklist for Other Epilepsy Clinical Studies icon for download word file – to help locate the CRF Modules in the Data Standards. Each checklist provides an outline of the CRF Modules that may be needed for an Epilepsy clinical trial/ other type of clinical study.

History and Acknowledgements

The National Institute of Neurological Disorders and Stroke (NINDS) has currently formed an Oversight Committee to direct the updating and further development of Epilepsy CDEs. The Epilepsy CDE Committee is supported by the NINDS CDE Team.

Previously, the Epilepsy CDE Committee was comprised of nine different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively develop the CDEs for their specific subgroups and also have an opportunity to review and comment on the recommendations of the other subgroups.

The Epilepsy CDE Committee first convened in December 2009 and divided into subgroups to focus on identifying and defining data elements across epilepsy domains. Members served on either one or two subgroups. Subgroup conference calls began in April 2009 and continued every four to six weeks through the spring of 2010. The subgroups of the Epilepsy CDE WG took a couple different approaches. Some groups opted to define the CDEs by creating template data collection form(s) and others decided it was more appropriate to recommend standardized, validated instruments for specific domains of epilepsy research. The Epilepsy CDE Oversight Committee was created in 2011.

Complete Epilepsy CDE Roster

Oversight Committee Members

  • Nicholas Barbaro, MD
    Indiana University, Indianapolis, IN
    Co-Chair
  • Daniel Lowenstein, MD
    University of California San Francisco, San Francisco, California
    Co-Chair
  • Joan Austin, PhD, RN, FAAN
    Indiana University, Indianapolis, Indiana
  • Dennis Dlugos, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Jackie French, MD
    New York University, New York, New York
  • William Gaillard, MD
    Children's National Medical Center, Washington, District of Columbia
  • Dale Hesdorffer, PhD
    Columbia University, New York, New York
  • David Loring, PhD
    Emory University, Atlanta, Georgia
  • John Messenheimer, MD
    GlaxoSmithKline, Raleigh, North Carolina
  • Emilo Perucca, MD, PhD
    University of Pavia, Pavia, Italy

Working Group Co-Chairs

  • Nicholas Barbaro, MD
    Indiana University, Indianapolis, IN
  • Daniel Lowenstein, MD
    University of California San Francisco, San Francisco, California

Anti Epileptic Drugs (AEDs) and Other Anti Epileptic Treatments (AETs) Subgroup

  • Jackie French, MD
    New York University, New York, New York
    Chair
  • Peggy Clark, RN, MSN
    Cincinnati Children?s Hospital Medical Center, Cincinnati, Ohio
  • James Cloyd, PharmD
    University of Minnesota, Minneapolis, Minnesota
  • Tracy Glauser, MD
    Cincinnati Children?s Hospital Medical Center, Cincinnati, Ohio
  • Nina Graves, PharmD
    Medtronic, Minneapolis, Minnesota
  • Daniel Lowenstein, MD
    University of California San Francisco, San Francisco, California
  • Gerry Nesbitt, MBA
    University of California San Francisco, San Francisco, California

Comorbidities Subgroup

  • Bruce Hermann, PhD
    University of Wisconsin, Madison, Wisconsin
    Chair
  • Joan Austin, PhD, RN, FAAN
    Indiana University, Indianapolis, Indiana
  • Anne Berg, PhD
    Northwestern University, Evanston, Illinois
  • Kristen Fowler, MA
    Beth Israel Deaconess Medical Center, Cambridge, Massachusetts
  • Tracy Glauser, MD
    Cincinnati Children?s Hospital Medical Center, Cincinnati, Ohio
  • Allen Hauser, MD
    Columbia University, New York, New York
  • Dale Hesdorffer, PhD
    Columbia University, New York, New York
  • Curt LaFrance, MD
    Rhode Island Hospital, Providence, Rhode Island
  • Ruth Ottman, PhD
    Columbia University, New York, New York
  • Shlomo Shinnar, MD, PhD
    Montefiore Medical Center, New York, New York
  • Anne Van Cott, MD
    University of Pittsburgh, Pittsburgh, Pennsylvania

Electrophysiology Subgroup

  • Anne Van Cott, MD
    University of Pittsburgh, Pittsburgh, Pennsylvania
    Chair
  • Dennis Dlugos, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • William Gaillard, MD
    Children's National Medical Center, Washington, District of Columbia
  • Gerry Nesbitt, MBA
    University of California San Francisco, San Francisco, California
  • Susan Spencer, MD
    Yale School of Medicine, New Haven, Connecticut

Imaging Subgroup

  • William Gaillard, MD
    Children's National Medical Center, Washington, District of Columbia
    Chair
  • Nicholas Barbaro, MD
    University of California San Francisco, San Francisco, California
  • Gregory Barkley, MD
    Henry Ford Hospital Clinics, Detroit, Michigan
  • Robert Knowlton, MD, MSPH
    University of Alabama at Birmingham, Birmingham, Alabama
  • Ruben Kuzniecky, MD
    New York University, New York, New York
  • Susan Spencer, MD
    Yale School of Medicine, New Haven, Connecticut

Neurological Exam Subgroup

  • Dennis Dlugos, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
    Chair
  • Peggy Clark, RN, MSN
    Cincinnati Children?s Hospital Medical Center, Cincinnati, Ohio
  • Daniel Lowenstein, MD
    University of California San Francisco, San Francisco, California
  • Christine O'Dell, RN, MSN
    Montefiore Medical Center, New York, New York
  • David Thurman, MD, MPH
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Mariann Ward, MS, NP
    University of California San Francisco, San Francisco, California

Neuropsychology Subgroup

  • David Loring, PhD
    Emory University, Atlanta, Georgia
    Chair
  • Avital Cnaan, PhD
    Children's National Medical Center, Washington, District of Columbia
  • Marla Hamberger, PhD
    Columbia University, New York, New York
  • Bruce Hermann, PhD
    University of Wisconsin, Madison, Wisconsin
  • John Langfitt, PhD
    University of Rochester, Rochester, New York
  • Elisabeth Sherman, PhD
    Alberta Children?s Hospital, Calgary, Canada
  • Mary Lou Smith, PhD
    University of Toronto Mississauga and Hospital for Sick Children, Toronto, Canada
  • Michael Westerveld, PhD
    Yale University, New Haven, Connecticut

Quality of Life Subgroup

  • Joan Austin, PhD, RN, FAAN
    Indiana University, Indianapolis, Indiana
    Chair
  • David Cella, PhD
    Northwestern University, Evanston, Illinois
  • Avital Cnaan, PhD
    Children's National Medical Center, Washington, District of Columbia
  • Kristen Fowler, MA
    Beth Israel Deaconess Medical Center, Cambridge, Massachusetts
  • Marla Hamberger, PhD
    Columbia University, New York, New York
  • John Langfitt, PhD
    University of Rochester, Rochester, New York
  • Christine O'Dell, RN, MSN
    Montefiore Medical Center, New York, New York

Seizures and Syndromes Subgroup

  • Dale Hesdorffer, PhD
    Columbia University, New York, New York
    Chair
  • Anne Berg, PhD
    Northwestern University, Evanston, Illinois
  • Jackie French, MD
    New York University, New York, New York
  • Allen Hauser, MD
    Columbia University, New York, New York
  • Shlomo Shinnar, MD, PhD
    Montefiore Medical Center, New York, New York
  • David Thurman, MD, MPH
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia

Surgery and Pathology Subgroup

  • Steven Roper, MD
    University of Florida, Gainesville, Florida
    Chair
  • Nicholas Barbaro, MD
    University of California San Francisco, San Francisco, California
  • Robert Fisher, MD, PhD
    Stanford University, Stanford, California
  • Susan Spencer, MD
    Yale School of Medicine, New Haven, Connecticut
  • Samuel Wiebe, MD
    Foothills Medical Center, Calgary, Canada

Quality of Life Updates Working Group

  • Joan Austin, PhD, RN, FAAN
    Indiana University, Indianapolis, Indiana
  • Nicholas Barbaro, MD
    Indiana University, Indianapolis, Indiana
  • David Cella, PhD
    Northwestern University, Evanston, Illinois
  • Daniel Lowenstein, MD
    University of California, San Francisco, California
  • Cindy Nowinski, PhD
    Northwestern University, Chicago, Illinois
  • Ruth Shinnar, RN, MSN
    Montefiore Medical Center, Bronx, New York

Seizures and Syndromes Updates Working Group

  • Nicholas Barbaro, MD
    Indiana University, Indianapolis, Indiana
  • Dennis Dlugos, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Jackie French, MD
    New York University, New York, New York
  • Dale Hesdorffer, PhD
    Columbia University, New York, New York
  • Daniel Lowenstein, MD
    University of California, San Francisco, California
  • John Messenheimer, MD
    GlaxoSmithKline, Raleigh, North Carolina
  • Shlomo Shinnar, MD, PhD
    Albert Einstein College of Medicine, Bronx, New York

NINDS CDE Team

  • Brandy Fureman, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Vicky Whittemore, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS
    The Emmes Corporation
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation
  • Sarah Tanveer, BS
    The Emmes Corporation
  • Margaret Jacobs
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Stacie Grinnon, MS
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Alexandra Stout
    KAI Research, Inc. (An Altarum Company), 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.

Epilepsy CDEs Revision History