Stroke

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

To develop the Stroke CDEs, the Stroke CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

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

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 Stroke Clinical Trials icon for download word file OR Checklist for Other Stroke 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 a Stroke 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 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 Stroke CDE 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
  • Michael Hill, MD, MSPH
    University of Calgary, Calgary, Canada (2012-2017)
  • Virginia Howard, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
  • Kennedy Lees, MD
    University of Glasgow, Glasgow, United Kingdom (2012-2017)
  • David Levy, MD
    University of California San Diego, San Diego, California (2012-2017)
  • Bo Norrving, MD, PhD
    Lund University Hospital, Lund, Sweden (2012-2017)
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina
  • Lee Schwamm, MD
    Massachusetts General Hospital, Harvard Medical School, Cambridge, Massachusetts
  • Jose Ignacio Suarez, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland
  • Salina Waddy, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland (2012-2016)

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, Rochester, Minnesota
  • 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
    NYU Langone Health, New York, New York
  • 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
  • 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
  • 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 Schoool, 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

Stroke Presentation

  • Lee Schwamm, MD
    Harvard Medical School, Cambridge, Massachusetts
    Chair
  • Mark Chimowitz, MD
    Medical University of South Carolina, Charleston, South Carolina
  • Heather Fullerton, MD
    University of California San Francisco, San Francisco, California
  • Judy Guzy, RN
    University of California Los Angeles, Los Angeles, California
  • David Levy, MD
    University of California San Diego, San Diego, California
  • James Meschia, MD
    Mayo Clinic College of Medicine, Rochester, Minnesota
  • Lisa Michael Nassif, MD
    Texas Children?s Hospital, Houston, Texas

Medical History and Prior Health Status

  • Oscar Benavente, MD
    University of British Columbia, Vancouver, Canada
    Chair
  • Deborah Attix, PhD
    Duke University, Durham, North Carolina
  • Lisa Davis, RN, MSN, CCRC
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Mitchell Elkind, MD
    Columbia University, New York, New York
  • Heather Fullerton, MD
    University of California San Francisco, San Francisco, California
  • 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

  • Joseph Broderick, MD
    University of Cincinnati, Cincinnati, Ohio
    Chair
  • Hakan Ay, MD
    Harvard Medical School, Cambridge, Massachusetts
  • Timothy Bernard, MD
    University of Colorado Denver, Denver, Colorado
  • Robert Brown, MD
    Mayo Clinic, Rochester, Minnesota
  • Louis Caplan, MD
    Beth Israel Deaconess Medical Center, Cambridge, Massachusetts
  • Rebecca Ichord, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • J.P. Mohr, MD
    Columbia University, New York, New York

Laboratory Tests and Vital Signs

  • Kyra Becker, MD
    University of Washington School of Medicine, Seattle, Washington
    Chair
  • Roderick Corriveau, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Judy Guzy, RN
    University of California Los Angeles, Los Angeles, California
  • Steven Pavlakis, MD
    Maimonides Infants and Children?s Hospital, Brooklyn, New York
  • J.J. Strouse, MD
    The Johns Hopkins University School of Medicine, Baltimore, Maryland
  • Mark Wainwright, MD
    Northwestern University, Evanston, Illinois

Hospital Course and Acute Therapies

  • Karen Johnston, MD
    University of Virginia, Charlottesville, Virginia
    Chair
  • Kyra Becker, MD
    University of Washington School of Medicine, Seattle, Washington
  • Joseph Broderick, MD
    University of Cincinnati, Cincinnati, Ohio
  • Colin Derdeyn, MD
    Washington University School of Medicine, St. Louis, Missouri
  • Gabrielle deVeber, MD
    Hospital for Sick Children, Toronto, Canada
  • Mary G. George, MD, MSPH, FACS
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Daniel Hanley, MD
    The Johns Hopkins University, Baltimore, Maryland
  • Kennedy Lees, MD
    University of Glasgow, Glasgow, United Kingdom
  • Stephan Mayer, MD
    Columbia University, New York, New York
  • Lee Schwamm, MD
    Harvard Medical School, Cambridge, Massachusetts
  • Mark Wainwright, MD
    Northwestern University, Evanston, Illinois

Long Term Therapies

  • Alexander Dromerick, MD
    Georgetown University School of Medicine, Washington, District of Columbia
    Chair
  • Oscar Benavente, MD
    University of British Columbia, Vancouver, Canada
  • Robert Brown, MD
    Mayo Clinic, Rochester, Minnesota
  • Mark Chimowitz, MD
    Medical University of South Carolina, Charleston, South Carolina
  • Pamela Duncan, PhD
    Duke University, Durham, North Carolina
  • Neil Friedman, MD
    Cleveland Clinic, Cleveland, Ohio
  • J.P. Mohr, MD
    Columbia University, New York, New York
  • Mubeen Rafay, MB, BS
    Winnipeg Children?s Hospital, Winnipeg, Canada
  • Cathy Sila, MD
    Case Western Reserve University, Cleveland, Ohio

Outcomes and Endpoints

  • Pamela Duncan, PhD
    Duke University, Durham, North Carolina
    Chair
  • Deborah Attix, PhD
    Duke University, Durham, North Carolina
  • Lisa Davis, RN, MSN, CCRC
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • William Dunn, Jr., MD
    Food and Drug Administration (FDA), Silver Spring, Maryland
  • George Howard, DrPH
    University of Alabama at Birmingham, Birmingham, Alabama
  • Rebecca Ichord, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Kennedy Lees, MD
    University of Glasgow, Glasgow, United Kingdom
  • Mark MacKay, MD
    Royal Children?s Hospital, Victoria, Australia
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina
  • Cathy Sila, MD
    Case Western Reserve University, Cleveland, Ohio
  • Michael Walker, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

Imaging

  • Chelsea Kidwell, MD
    Georgetown University, Washington, Ohio
    Chair
  • Hakan Ay, MD
    Harvard Medical School, Cambridge, Massachusetts
  • Colin Derdeyn, MD
    Washington University School of Medicine, St. Louis, Missouri
  • Edward Feldmann, MD
    Brown University, Providence, Rhode Island
  • Daniel Hanley, MD
    The Johns Hopkins University, Baltimore, Maryland
  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
  • Stephan Mayer, MD
    Columbia University, New York, New York
  • Michael Rivkin, MD
    Children's Hospital Boston, Boston, Massachusetts
  • Max Wintermark, MD
    University of Virginia, Charlottesville, Virginia

Biospecimens and Biomarkers

  • James Meschia, MD
    Mayo Clinic College of Medicine, Rochester, Minnesota
    Chair
  • Catherine Amlie-Lefond, MD
    Medical College Wisconsin, Milwaukee, Wisconsin
  • Jennifer Armstrong-Wells, MD, MPH
    University of Colorado Denver, Denver, Colorado
  • Roderick Corriveau, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Bruce Coull, MD
    University of Arizona College of Medicine, Tucson, Arizona
  • Mitchell Elkind, MD
    Columbia University, New York, New York
  • Karen Furie, MD
    Brown University, Providence, Rhode Island
  • Edward Jauch, MD
    Medical University of South Carolina, Charleston, South Carolina
  • Alex Rai, PhD
    Columbia University, New York, New York

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
  • Joanne Odenkirchen, MPH
    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 Corporation
  • Damon Collie, MSHS
    The Emmes Corporation
  • Katelyn Gay, BS
    The Emmes Corporation
  • Marybeth Montoro, MPH, CPH
    The Emmes Corporation
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation
  • Pamela West
    The Emmes Corporation
  • Ethan Beaudett
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Stacie Grinnon, MS
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Lisa Hunegs, MSW, MPH
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland

References

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