Epilepsy

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

Epilepsy Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Epilepsy study start-up

Epilepsy Highlight Summary: Overview of all Epilepsy-specific CDE recommendations as they appear on the website

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

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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
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Disease/Injury Related Events
Classification
CRF Module/Guidance CDEs
Diagnostic Interview for Seizure Classification Outside of Video EEG Recording (DISCOVER) N/A
Diagnostic Interview for Seizure Identification (DISI) N/A
Classification of Etiology CDE Details
Classification of Seizures CDE Details
Syndromes by Age of Onset CDE Details
Assessments and Examinations
Imaging Diagnostics
CRF Module/Guidance CDEs
Magnetic Resonance Imaging (MRI) CDE Details
Functional Magnetic Resonance Imaging (fMRI) CDE Details
Ictal Single-photon Emission Computed Tomography (SPECT) Localization CDE Details
Magnetoencephalography (MEG) Acquisition CDE Details
MRI for Registration of MEG N/A
Positron Emission Tomography (PET) Localization CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Neurological Exam CDE Details
Physical Exam CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
NINDS Repository Epilepsy Data Elements N/A
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Scalp Electroencephalography (EEG) CDE Details
Short Scalp Electroencephalography (EEG) CDE Details
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Drugs
CRF Module/Guidance CDEs
AED Plasma Concentration CDE Details
AED Resistance Log CDE Details
Anti Epileptic Drug (AED) Log CDE Details
Non Anti Epileptic Medication Log CDE Details
Devices
CRF Module/Guidance CDEs
Device Revision/Replacement Log CDE Details
Devices Log CDE Details
Implanted Devices Log CDE Details
Surgeries and Other Procedures
CRF Module/Guidance CDEs
Surgery and Pathology CDE Details
Safety Data
Adverse Events
CRF Module/Guidance CDEs
Overview of Recommended Adverse Event Reporting Instruments N/A
Recommended Adverse Event Reporting Instruments N/A
Adverse Event Tracking Log CDE Details
Hague Side Effects Scale N/A
VA Toxicity Scale N/A
Outcomes and End Points
Assessing Comorbidities
CRF Module/Guidance 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) N/A
American National Adult Reading Test (AmNART) N/A
Beck Anxiety Inventory (BAI) N/A
Beck Depression Inventory II (BDI-II) N/A
Boston Naming Test (BNT) - 30-item version N/A
Brief Psychiatric Rating Scale (BPRS) CDE Details
Checklist for Autism in Toddlers (CHAT) N/A
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) N/A
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) N/A
Longitudinal Interval Follow-Up Evaluation DSM-IV VERSION (LIFE DSM-IV) N/A
Migraine Headaches Questionnaire 21-Item N/A
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 N/A
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/Guidance 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) N/A
Bayley Scales of Infant Development (Bayley III, BSID) N/A
Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2) N/A
Brief Visuospatial Memory Test Revised (BVMT-R) N/A
California Verbal Learning Test - Children (CVLT-C) N/A
California Verbal Learning Test - Second Edition (CVLT-II) N/A
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 N/A
Mullen Scales of Early Learning (MSEL) N/A
Peabody Picture Vocabulary Test 4th Edition (PPVT-4) N/A
Processing Speed Index of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) CDE Details
Processing Speed Index of the Wechsler Intelligence Scale for Children-IV/ Wechsler Preschool and Primary Scale of Intelligence (WISC-IV/WPPSI-III) N/A
Purdue Pegboard N/A
Rey Auditory Verbal Learning Test (RAVLT) N/A
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
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Epilepsy Quality of Life Instrument Recommendations N/A
Quality of Life in Epilepsy Inventory-31 (QOLIE-31) N/A
Quality of Life in Childhood Epilepsy (QOLCE-55) N/A
Childhood Quality of Life in Epilepsy (CHEQOL) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) - Measurement System N/A
Patient Reported Outcomes
CRF Module/Guidance CDEs
Seizure Diary CDE Details
Epilepsy Seizure Severity Instrument Recommendations N/A
Liverpool Seizure Severity Scale 2.0 (LSSS 2.0) N/A
Seizure Severity Questionnaire (SSQ) V2.2 (Baseline and Follow-Up Versions) 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 https://cssrs.columbia.edu/).

Instrument Notice of Copyright Information

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/Guidance’ 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

The first set of Common Data Elements (CDEs) for Epilepsy was developed in 2010. The Epilepsy Common Data Elements (CDEs) follow the recommendations of the Epilepsy CDE Working Group (WG), a committee of experts in the field (see Roster).

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  OR Checklist for Other Epilepsy Clinical Studies  – 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.

Roster

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 Version 1.0 Epilepsy CDE Working Group Roster

Oversight Committee Members

Oversight Committee Members

  • Dennis Dlugos, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
    Chair
  • Daniel Drane, PhD
    Emory University School of Medicine, Atlanta, Georgia
  • Jackie French, MD
    New York University, New York, New York
  • William Gaillard, MD
    Children's National Medical Center, Washington, District of Columbia
  • Robert McGovern, MD
    University of Minnesota Medical School, Minneapolis, Minnesota
  • Avani Modi, PhD
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Robert Moss
    Seizure Tracker LLC, Springfield, Virginia
  • Adam Numis, MD
    University of California, San Francisco, School of Medicine, San Francisco, California
  • Brenda Porter, MD, PhD
    Stanford University, Palo Alto, California
  • Gregory Worrell, MD, PhD
    Mayo Clinic, Rochester, Minnesota

Previous Epilepsy Oversight Committee Members

Previous Epilepsy Oversight Committee Members

  • Joan Austin, PhD, RN, FAAN
    Indiana University, Indianapolis, Indiana
  • Nicholas Barbaro, MD
    Indiana University, Indianapolis, Indiana
  • Dale Hesdorffer, PhD
    Columbia University, New York, New York
  • David Loring, PhD
    Emory University, Atlanta, Georgia
  • Daniel Lowenstein, MD
    University of California San Francisco, San Francisco, California
  • John Messenheimer, MD
    GlaxoSmithKline, Raleigh, North Carolina
  • Emilio Perucca, MD, PhD
    University of Pavia, Pavia, Italy

Imaging Updates Working Group

Imaging Updates Working Group

  • Gregory Barkley, MD
    Henry Ford Hospital Clinics, Detroit, Michigan
  • William Gaillard, MD
    Children's National Medical Center, Washington, District of Columbia
  • Robert Knowlton, MD, MSPH
    University of California, San Francisco School of Medicine, San Francisco, California
  • Ruben Kuzniecky, MD
    Hofstra Northwell Health School of Medicine, Hempstead, New York
  • Victoria Morgan, PhD
    Vanderbilt University Institute of Imaging Science, Nashville, Tennessee
  • Heath Pardoe, PhD
    New York University School of Medicine, New York, New York

Quality of Life Updates Working Group

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

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

Surgery and Pathology Updates Working Group

Surgery and Pathology Updates Working Group

  • Nicholas Barbaro, MD
    Indiana University, Indianapolis, Indiana
    Chair
  • Scott Perry, MD
    Cook Children's Medical Center, Fort Worth, Texas
  • Steven Roper, MD
    University of Florida, Gainesville, Florida
  • Samuel Wiebe, MD
    Foothills Medical Center, Calgary, Canada

NINDS CDE Team

NINDS CDE Team

  • Andrew Breeden, PhD (Until 2019)
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Adam Hartman, MD, FAAP, FANA, FAES
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, 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
  • Nicholas Wymbs, PhD (Until 2020)
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Damon Collie, MSHS
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Andy Franklin, BA
    The Emmes Company, LLC, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Sarah Tanveer, BS (Until 2017)
    The Emmes Company, LLC, 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