Stroke

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)

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.

 

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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
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guidance CDEs
Stroke Presentation and Vital Signs Subgroup Summary N/A
Medical History and Prior Health Status Subgroup Summary N/A
Stroke Types and Subtypes Subgroup Summary N/A
Hospital Course and Acute Therapies Subgroup Summary N/A
Long Term Therapies Subgroup Summary N/A
Outcomes and Endpoints Subgroup Summary N/A
Imaging Subgroup Summary N/A
Biospecimens, Biomarkers, and Laboratory Tests Subgroup Summary 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
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Behavioral History CDE Details
Family History CDE Details
History Data Source and Reliability CDE Details
Medical History CDE Details
Pregnancy and Perinatal History CDE Details
Prior Functional Status CDE Details
Disease/Injury Related Events
History of Disease/Injury Event
CRF Module/Guidance CDEs
Assessment of Transient Neurologic Deficits Resolved Prior to Presentation CDE Details
Hospital Arrival/Admission CDE Details
Pre-Hospital/Emergency Medical Service (EMS) Course CDE Details
Discharge Information
CRF Module/Guidance CDEs
Hospital Discharge CDE Details
Classification
CRF Module/Guidance CDEs
Stroke Types and Subtypes CDE Details
Assessments and Examinations
Imaging Diagnostics
CRF Module/Guidance CDEs
Aneurysm Location and Dimensions CDE Details
Cardiac Magnetic Resonance Imaging (MRI) CDE Details
Echocardiogram CDE Details
Echocardiogram II CDE Details
Imaging Acquisition CDE Details
Parenchymal Imaging CDE Details
Perfusion and Penumbral Imaging CDE Details
Vessel Carotid Ultrasound CDE Details
Vessel Imaging Angiography CDE Details
Vessel Imaging Transcranial CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Appendix 1: Biomarker Targets in Stroke N/A
Appendix 2: Biospecimen Standard Operating Procedure Guidance N/A
Biospecimen Collection and Processing CDE Details
Laboratory Tests CDE Details
Laboratory Tests Permissible Values for Stroke N/A
NINDS Repository Cerebrovascular Data Elements N/A
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Electrocardiogram (ECG) CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Glasgow Coma Scale (GCS) CDE Details
Neurobehavioral Symptom Inventory (NSI) N/A
NIH Stroke Scale (NIHSS) N/A
Physical/Neurological Exam CDE Details
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Surgeries and Other Procedures
CRF Module/Guidance CDEs
SAH Surgical/Procedural Interventions CDE Details
Stroke Surgical and Procedural Interventions CDE Details
Drugs
CRF Module/Guidance CDEs
Antithrombotics and Risk Factor Controlling Medications CDE Details
Prior and Concomitant Medications CDE Details
Thrombolytic/Reperfusion Therapies CDE Details
Therapies
CRF Module/Guidance CDEs
Lifestyle Modification Therapies CDE Details
Palliative/Comfort Care and End of Life Issues CDE Details
Rehabilitation Therapies CDE Details
Unruptured Intracranial Aneurysm Management CDE Details
Outcomes and End Points
Activities of Daily Living/Performance
CRF Module/Guidance CDEs
Assessment of Motor and Process Skills (AMPS) N/A
Barthel Index N/A
Functional Independence Measure (FIM) N/A
Glasgow Outcome Scale (GOS) CDE Details
Glasgow Outcome Scale Extended (GOSE) N/A
Modified Rankin Scale (mRS) CDE Details
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function Assessments N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Performance Measures
CRF Module/Guidance CDEs
6 Minute Walk Test N/A
Action Research Arm Test N/A
Animal Naming N/A
Berg Balance Scale (BBS) CDE Details
Brief Visuospatial Memory Test Revised (BVMT-R) N/A
Controlled Oral Word Association Test (COWAT) subtest of the Multilingual Aphasia Examination (MAE) N/A
Fugl-Meyer Assessment N/A
Grooved Pegboard Test N/A
Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES) N/A
Token Test N/A
Walking Speed CDE Details
Pediatric
CRF Module/Guidance CDEs
Bayley Scales of Infant Development (Bayley III, BSID) N/A
King's Outcome Scale for Childhood Head Injury (KOSCHI) CDE Details
Pediatric Modified Rankin Scale (mRS) N/A
Pediatric Quality of Life Inventory (PEDSQL) N/A
Pediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE) - Child Version (Children Aged 2 Year and Older) N/A
Pediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE) - Infant Version (Infants Term Birth to Two Years) N/A
Pediatric Stroke Recurrence and Recovery Questionnaire (RRQ) N/A
Perceived Efficacy and Goal Setting System (PEGS) N/A
Emotional Status
CRF Module/Guidance CDEs
Beck Anxiety Inventory (BAI) N/A
Beck Depression Inventory II (BDI-II) N/A
Center for Epidemiologic Studies-Depression Scale (CES-D) CDE Details
Generalized Anxiety Disorder (GAD-7) CDE Details
Neuropsychiatric Inventory Questionnaire (NPI-Q) N/A
Patient Health Questionnaire - 9 (PHQ-9) Depression Scale CDE Details
PTSD Checklist - Civilian (PCL-C) CDE Details
Cognitive Status
CRF Module/Guidance CDEs
Boston Naming Test (BNT) - 30-item version N/A
Color-Word Interference Test Delis-Kaplan Executive Function System (D-KEFS) CDE Details
Delis-Kaplan Executive Function System (D-KEFS) N/A
Hopkins Verbal Learning Test - Revised (HVLT-R) N/A
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) N/A
Montreal Cognitive Assessment (MoCA) N/A
Repeatable Battery for Assessment of Neuropsychological Status (RBANS) CDE Details
Rey Auditory Verbal Learning Test (RAVLT) N/A
Rey-Osterrieth Complex Figure Test (ROCF) N/A
Similarities Subtest of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) N/A
Six-Item Screener N/A
Stroop Test CDE Details
Telephone Interview for Cognitive Status (TICS) N/A
Trail Making Test (TMT), Delis-Kaplan Executive Function System (D-KEFS) CDE Details
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) N/A
Western Aphasia Battery Revised N/A
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Canadian Occupational Performance Measure (COPM) N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D) CDE Details
Home Time CDE Details
PROMIS Item Bank v1.2 - Global Health CDE Details
PROMIS-29 Profile N/A
Return to Work CDE Details
Short Form 36-Item Health Survey (SF-36) N/A
Stroke and Aphasia Quality of Life-39 (SAQOL-39) N/A
Stroke Impact Scale (SIS) N/A
Stroke Specific Quality of Life Scale (SS-QOL) N/A
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) N/A
Clinical Event End Points
CRF Module/Guidance CDEs
Death CDE Details
Questionnaire for Verifying Stroke-Free Status (QVSFS) N/A
Stroke Adjudication Form CDE Details
Caregiver Reported Outcomes
CRF Module/Guidance CDEs
Zarit Burden Interview (ZBI) 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 National Institute of Neurological Disorders and Stroke (NINDS) formed the Stroke v1.0 CDE Working Group (WG) in July 2009. Chairs were appointed to lead the overall WG and the nine individual subgroups. The subgroups met regularly by teleconference in 2009 and 2010 to define the Common Data Elements (CDEs) for their domains and to recommend standardized, validated instruments for stroke research. The first set of CDEs for Stroke was completed in 2010.

NINDS formed an Oversight Committee (OC) to periodically review, direct the updating, and advance the development of Stroke CDEs in 2012.

In 2015, the Stroke OC reviewed the Core Stroke CDEs and determined needed classification updates based on disease stage and study type.

Based on the Stroke OC’s input, a Stroke v2.0 CDE 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 CDE 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

The Stroke v2.0 CDEs were posted in summer 2020.

The Stroke CDE Working Group and Oversight Committee are supported by the NINDS CDE Team.

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

Complete Version 1.0 Stroke CDE Working Group Roster – Lists members of the Stroke v1.0 CDE Working Group by subgroup, previous members of the Oversight Committee, and the NINDS CDE Team.

Members of the Stroke v2.0 CDE Working Group by subgroup, current members of the Oversight Committee, and the NINDS CDE Team are listed below.

Please see the Overview tab for additional project background and timeline information.

Oversight Committee Members

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
    University of Virginia, Charlottesville, Virginia
  • Mitchell Elkind, MD
    Columbia University, New York, New York
  • Virginia Howard, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Omoye Imoisili, MD, MPH
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Pooja Khatri, MD
    University of Cincinnati, Cincinnati, Ohio
  • Ronald M. Lazar, PhD, FAHA, FAAN
    University of Alabama at Birmingham, Birmingham, Alabama
  • Lee Schwamm, MD
    Yale School of Medicine, New Haven, Connecticut
  • Jose Ignacio Suarez, MD
    Johns Hopkins University School of Medicine, Baltimore, Maryland

Previous Stroke Oversight Committee Members

Previous Stroke Oversight Committee Members

  • Lawrence Fine, MD
    National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
  • Mary George, MD, MSPH, FACS
    Centers for Disease Control and Prevention, Atlanta, Georgia
  • Cindy Tong, MPH
    Centers for Disease Control and Prevention, Atlanta, Georgia

Working Group Chairs

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

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

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

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

Hospital Course and Acute Therapies Version 2.0

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

Long Term Therapies Version 2.0

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, MPH
    Mayo Clinic, Rochester, Minnesota
  • Wuwei (Wayne) Feng, MD, MS
    Duke University School of Medicine, Durham, North Carolina
  • Mubeen F. Rafay, MB.BS, MSc.
    Winnipeg Children's Hospital, University of Manitoba, Manitoba, 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

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, Shirley Ryan AbilityLab, Chicago, Illinois
  • Rebecca Ichord, MD
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Stephanie Kemp, CRC
    Stanford University, Stanford, California
  • Brett Kissela, MD, MS
    University of Cincinnati, Cincinnati, Ohio
  • Ronald Lazar, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Trudy Mallinson, PhD
    The George Washington University, Washington, District of Columbia
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina

Imaging Version 2.0

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

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
    Cizik School of Nursing at UTHealth, 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

NINDS CDE Team

  • Carlos Faraco, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • 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 Program Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Damon Collie, MSHS
    The Emmes Company, LLC
  • Robin Feldman, BS, MBA
    The Emmes Company, LLC
  • Katelyn Gay, BS
    The Emmes Company, LLC
  • Muniza Sheikh, MS, MBA
    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