Stroke

Data Standards

Public Review Period for Stroke v2.0 CDEs: February 26, 2020 – April 8, 2020

The Stroke v2.0 Working Group and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team have released a draft version of the Stroke v2.0 CDEs for public review.

After the public review period, the Stroke v2.0 CDE Working Group will review and revise the draft recommendations as needed. Final Stroke v2.0 CDE recommendations will be posted by June 2020.

Click the zip file below to download the Stroke v2.0 CDE Public Review documents.

[zip file]

Stroke v2.0 CDE Public Review Package Overview

The Stroke v2.0 Public Review zip file consists of the following documents:

  • Instructions
  • Stroke v2.0 Working Group roster
  • Subgroup Public Review Packets:
    1. Stroke Presentation and Vital Signs
    2. Medical History and Prior Health Status
    3. Stroke Types and Subtypes
    4. Hospital Course and Acute Therapies
    5. Long Term Therapies
    6. Outcomes and Endpoints
    7. Imaging
    8. Biospecimens, Biomarkers, and Laboratory Tests
  • Comments spreadsheet

    Changes from Stroke v1.0 are shown in red line/strike out where practical. Documents may also contain outstanding comments requiring input.

    Each Subgroup Public Review Packet contains:

    • Template case report form (CRF) Modules using CDEs* identified and defined by the Stroke v2.0 Working Group.
    • Guidance Documents
    • Notice of Copyright documents with instrument* recommendations.

      *Each CDE or instrument should be classified according to the NINDS classification definitions

 

Please send all comments to NINDSCDE@emmes.com or the NINDS CDE Project Officer at Carolina.mendoza-puccini@nih.gov by April 8, 2020.


 

Organized by domains and sub-domains 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 — to provide further information about the CDEs.
  • Instrument Notice of Copyright (NOC) documents: include pertinent information on recommended instruments
     

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

Stroke Highlight Summary: Overview of all Stroke-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.

 

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
Summary of All Outcome Recommendations
CRF Module/Guideline CDEs
Stroke CDE Instrument Recommendations by Outcome Domain and Classification N/A
Performance Measures
CRF Module/Guideline CDEs
Summary of NINDS Recommended Measures for Performance N/A
Walking Speed CDE Details

Overview

The first set of Common Data Elements (CDEs) for Stroke was developed in 2010.

The Stroke CDE Oversight Committee (OC) was created in 2012 to periodically review the Stroke CDEs and provide recommendations on needed updates. Based on the Stroke OC’s input, a Stroke v2.0 Working Group was convened in 2018 to perform a comprehensive review of the Stroke CDEs. The WG was also asked to review the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) CDEs for inclusion and harmonization. The Stroke v2.0 WG was divided into eight domain-specific subgroups:

  • Stroke Presentation and Vital Signs
  • Medical History and Prior Health Status
  • Stroke Types and Subtypes
  • Hospital Course and Acute Therapies
  • Long Term Therapies
  • Outcomes and Endpoints
  • Imaging
  • Biospecimens, Biomarkers, and Laboratory Tests

Download a “checklist” to help locate the CRF modules that are part of the Data Standards. Each checklist provides an outline of the CRF modules that may be needed for a stroke clinical trial/other type of clinical study.

Checklist for Stroke Clinical Trials
Checklist for Other Stroke Clinical Studies

Roster

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

Previously, the Stroke 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 developed the CDEs for their specific subgroups and had an opportunity to review and comment on the recommendations of the other subgroups.

The Working Group members served on either one or two subgroups. The subgroups began meeting by teleconference in July 2009 and continued to hold calls every four to six weeks through the spring of 2010 to define the CDEs for their domains and to recommend standardized, validated instruments for stroke research. The Stroke CDE Oversight Committee was created in 2012.

Complete Version 1.0 Stroke CDE Working Group Roster

Oversight Committee Members

  • Jeffrey Saver, MD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Steven Warach, MD, PhD
    The University of Texas at Austin, Austin, Texas
    Co-Chair
  • Catherine Amlie-Lefond, MD
    Seattle Children's Hospital, Seattle Washington
  • Joseph Broderick, MD
    University of Cincinnati, Cincinnati, Ohio
  • Colin Derdeyn, MD
    Carver College of Medicine, University of Iowa, Iowa City, Iowa
  • William Dunn, Jr., MD
    Food and Drug Administration (FDA), Silver Spring, Maryland
  • Mitchell Elkind, MD
    Columbia University, New York, New York
  • Lawrence Fine, MD
    National Heart Lung and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, Maryland
  • Mary G. George, MD, MSPH, FACS
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Virginia Howard, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
  • Lee Schwamm, MD
    Massachusetts General Hospital, Harvard Medical School, Cambridge, Massachusetts
  • Jose Ignacio Suarez, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland

Working Group Chairs

  • Jeffrey Saver, MD
    University of California Los Angeles, Los Angeles, California
    Co-Chair
  • Steven Warach, MD, PhD
    The University of Texas at Austin, Austin, Texas
    Co-Chair

Stroke Presentation and Vital Signs Version 2.0

  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
    Chair
  • Yu-Feng Yvonne Chan, MD, PhD
    Icahn School of Medicine at Mount Sinai, New York, New York
  • Heather Fullerton, MD
    University of California San Francisco, San Francisco, California
  • James Meschia, MD
    Mayo Clinic College of Medicine, Jacksonville, Florida
  • Steven Pavlakis, MD
    SUNY Downstate School of Medicine, Brooklyn, New York
  • Lee Schwamm, MD
    Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
  • Olajide Williams, MD
    Columbia University Medical Center, New York, New York

Medical History and Prior Health Status Version 2.0

  • Mitchell Elkind, MD
    Columbia University, New York, New York
    Chair
  • Mary G. George, MD, MSPH, FACS
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • George Howard, DrPH
    University of Alabama at Birmingham, Birmingham, Alabama
  • Irene Katzan, MD
    Cleveland Clinic, Cleveland, Ohio
  • Warren Lo, MD
    Nationwide Children?s Hospital, Columbus, Ohio

Stroke Types and Subtypes Version 2.0

  • Joseph Broderick, MD
    University of Cincinnati, Cincinnati, Ohio
    Chair
  • Hakan Ay, MD
    Harvard Medical School, Boston, Massachusetts
  • Timothy Bernard, MD
    University of Colorado Denver, Denver, Colorado
  • Christine Fox, MD
    University of California, San Francisco, San Francisco, California

Hospital Course and Acute Therapies Version 2.0

  • Magdy Selim, MD, PhD
    Harvard Medical School, Boston, Massachusetts
    Chair
  • Opeolu Adeoye, MD
    University of Cincinnati, Cincinnati, Ohio
  • Gabrielle deVeber, MD
    Hospital for Sick Children, Toronto, Canada

Long Term Therapies Version 2.0

  • Alexander Dromerick, MD
    Georgetown University School of Medicine, Washington, District of Columbia
    Chair
  • Robynne Braun, MD, PhD
    University of Maryland School of Medicine, Baltimore, Maryland
  • Robert Brown, MD
    Mayo Clinic, Rochester, Minnesota
  • Wuwei (Wayne) Feng, MD
    Duke University School of Medicine, Durham, North Carolina
  • Mubeen Rafay, MB, BS
    Winnipeg Children?s Hospital, Winnipeg, Canada
  • Preeti Raghavan, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland
  • Jose Ignacio Suarez, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland

Outcomes and Endpoints Version 2.0

  • Pamela Duncan, PhD
    Wake Forest School of Medicine, Winston-Salem, North Carolina
    Chair
  • Julius Fridriksson, PhD
    University of South Carolina, Columbia, South Carolina
  • Allen W. Heinemann, PhD, ABPP (RP), FACRM
    Northwestern University, Chicago, Illinois
  • Rebecca Ichord, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Stephanie Kemp, CRC
    Stanford University, Stanford, California
  • Brett Kissela, MD
    University of Cincinnati, Cincinnati, Ohio
  • Ronald Lazar, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Trudy Mallinson, PhD
    George Washington University, Washington, District of Columbia
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina

Imaging Version 2.0

  • David Liebeskind, MD
    University of California Los Angeles, Los Angeles, California
    Chair
  • Colin Derdeyn, MD
    University of Iowa, Iowa City, Iowa
  • Edward Feldmann, MD
    University of Massachusetts Medical School, Worcester, Massachusetts
  • Maarten Lansberg, MD
    Stanford University, Stanford, California
  • Stephan Mayer, MD
    Henry Ford Health System, Detroit, Michigan
  • Michael Rivkin, MD
    Boston Children's Hospital, Boston, Massachusetts
  • Max Wintermark, MD
    Stanford University, Stanford, California

Biospecimens, Biomarkers, and Laboratory Tests Version 2.0

  • Sean Savitz, MD
    The University of Texas McGovern Medical School, Houston, Texas
    Chair
  • Catherine Amlie-Lefond, MD
    Seattle Children's Hospital, Seattle Washington
  • Jennifer Beauchamp, PhD, RN
    The University of Texas McGovern Medical School, Houston, Texas
  • Huimahn Alex Choi, MD, MS
    The University of Texas McGovern Medical School, Houston, Texas
  • Bruce Coull, MD
    University of Arizona College of Medicine, Tucson, Arizona
  • Anthony Kim, MD
    University of California, San Francisco, San Francisco, California
  • John J. Strouse, MD
    Duke University, Durham, North Carolina
  • Mark Wainwright, MD
    University of Washington, Seattle, Washington
  • Dileep R. Yavagal, MD, FAHA, FAAN, FSVIN
    University of Miami Miller School of Medicine, Miami, Florida

NINDS CDE Team

  • Scott Janis, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Clinton Wright, MD, MSc
    Director, Office of Clinical Research, Associate Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS
    The Emmes Company, LLC
  • Damon Collie, MSHS
    The Emmes Company, LLC
  • Joy Esterlitz, MS
    The Emmes Company, LLC
  • Katelyn Gay, BS
    The Emmes Company, LLC
  • Marybeth Montoro, MPH, CPH
    The Emmes Company, LLC
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC
  • Pamela West
    The Emmes Company, LLC

Publications

Publications

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.

Stroke CDEs Revision History