Organized into domains often used in clinical studies, data standards
include:
- CDEs
- CRF Modules logically organize CDEs for data collection
- Guidelines to provide further information about the CDEs.
- Recommended Instruments spreadsheets with details (descriptions,
scoring, references, etc.) for all recommended proprietary instruments/ scales/
tests. If proprietary instruments/scales/tests are made available for use, they
are populated in the table below.
For your reference, a zip file containing all of the Stroke CDE CRF modules can
be downloaded below.
Download Stroke CDE Recommendations
The outline that follows includes all the CDEs associated with the CRF modules,
organized by domain and sub-domain.
Participant/Subject Characteristics
Participant/Subject Characteristics
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Demographics |
| Demographics
|
89KB DOC |
HTML |
|
| Social Status |
| Social Status
|
67KB DOC |
HTML |
|
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Participant/Subject History and Family History
Participant/Subject History and Family History
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| General Health History |
| Medical History
|
207KB DOC |
HTML |
|
| Family History
|
64KB DOC |
HTML |
|
| Behavioral History
|
113KB DOC |
HTML |
|
| Pregnancy and Perinatal History
|
71KB DOC |
HTML |
|
| History Data Source and Reliability
|
64KB DOC |
HTML |
|
| Prior Health Status |
| Prior Functional Status
|
59KB DOC |
HTML |
|
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Disease/Injury Related Events
Disease/Injury Related Events
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| History of Disease/Injury Event |
| Pre-Hospital/Emergency Medical Service (EMS) Course
|
53KB DOC |
HTML |
|
| Hospital Arrival/Admission
|
62KB DOC |
HTML |
|
| Stroke Symptoms/Comorbid Events
|
204KB DOC |
HTML |
|
| Glasgow Coma Scale (GCS)
|
77KB PDF |
HTML |
|
| Classification |
| Stroke Types and Subtypes
|
181KB DOC |
HTML |
|
| Discharge Information |
| Hospital Discharge
|
53KB DOC |
HTML |
|
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Assessments and Examinations
Assessments and Examinations
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Physical/Neurological Examination |
| Physical/Neurological Exam Note: Also refer to Outcomes and End Points for additional measures recommended for assessing neurological impairment and functional status.
|
87KB DOC |
HTML |
|
| Vital Signs and Other Body Measures |
| Vital Signs
|
73KB DOC |
HTML |
|
| Laboratory Tests and Biospecimens/Biomarkers |
| Coriell's Cerebrovascular Data Elements
|
Coriell  |
N/A |
|
| Laboratory Tests
|
331KB DOC |
HTML |
|
| Laboratory Tests Permissible Values for Stroke
|
107KB XLS |
N/A |
|
| Biospecimen Collection and Processing
|
104KB DOC |
HTML |
|
| Biomarker Guidelines
|
68KB DOC |
N/A |
|
| Imaging Diagnostics |
| Parenchymal Imaging
|
628KB DOC |
HTML |
|
| Perfusion and Penumbral Imaging
|
98KB DOC |
HTML |
|
| Vessel Carotid Ultrasound
|
144KB DOC |
HTML |
|
| Vessel Imaging Angiography
|
635KB DOC |
HTML |
|
| Vessel Imaging Transcranial Color-Coded Real-time Sonography (TCCS)
|
194KB DOC |
HTML |
|
| Vessel Imaging Transcranial Doppler (TCD)
|
176KB DOC |
HTML |
|
| Non-Imaging Diagnostics |
| Electrocardiogram (ECG)
|
71KB DOC |
HTML |
|
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Treatment/Intervention Data
Treatment/Intervention Data
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
DrugsNote: The General CDE Standards contain additional useful CRF Modules and CDEs for this sub-domain. |
| Prior and Concomitant Medications
|
121KB DOC |
HTML |
|
| Antithrombotics and Risk Factor Controlling Medications
|
56KB DOC |
HTML |
|
| Thrombolytic/Reperfusion Therapies
|
70KB DOC |
HTML |
|
| Surgeries and Other Procedures |
| Surgical and Procedural Interventions
|
85KB DOC |
HTML |
|
| Therapies |
| Lifestyle Modification Therapies
|
73KB DOC |
HTML |
|
| Rehabilitation Therapies
|
103KB DOC |
HTML |
|
| Palliative/Comfort Care and End of Life Issues
|
53KB DOC |
HTML |
|
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Protocol Experience
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Safety Data
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Outcomes and End Points
The CDEs from copyright-protected measures are intentionally excluded from this site unless permission was received from the copyright holder. If the measure is not included, please contact the publisher or person who holds the copyright to obtain a copy of the measure.
Outcomes and End Points
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Summary of All Outcome Recommendations |
| Stroke CDE Instrument Recommendations by Outcome Domain and Classification
|
41KB DOC |
N/A |
|
| Neurological Impairment |
| Summary of Recommended Measures for Neurological Impairment
|
31KB DOC |
N/A |
|
| NIH Stroke Scale (NIHSS)
|
107KB DOC |
HTML |
|
| Activities of Daily Living/Performance |
| Summary of Recommended Measures for Activities of Daily Living/Functional Status
|
89KB DOC |
N/A |
|
| Modified Rankin Scale (mRS)
|
53KB DOC |
HTML |
 |
| Glasgow Outcome Scale (GOS) and Glasgow Outcome Scale - Extended (GOSE)
|
51KB DOC |
HTML |
|
| Emotional and Cognitive Status |
| Summary of Recommended Measures for Emotional and Cognitive Status
|
98KB DOC |
N/A |
|
| Center for Epidemiologic Studies-Depression Scale (CES-D)
|
11KB PDF |
HTML |
|
| Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
|
62KB PDF |
HTML |
|
| Quality of Life |
| Summary of Recommended Measures for Participation/ Quality of Life
|
61KB DOC |
N/A |
|
| Stroke Specific Quality of Life Scale (SS-QOL)
|
113KB PDF |
HTML |
|
| 36-Item Short Form Health Survey (SF-36)
|
132KB DOC |
HTML |
|
| Performance Measures |
| Summary of Recommended Measures for Performance
|
135KB DOC |
N/A |
|
| Walking Speed
|
135KB DOC |
HTML |
|
| Pediatric |
| Summary of Recommended Measures for Pediatrics
|
48KB DOC |
N/A |
|
| King's Outcome Scale for Childhood Head Injury (KOSCHI)
|
48KB DOC |
HTML |
|
| Pediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE) - Child Version (Children Aged 2 Years and Older)
|
589KB PDF |
HTML |
|
| Pediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE) - Infant Version (Infants Term Birth to Two Years)
|
452KB DOC |
HTML |
|
| Clinical Event End Points |
| Summary of Recommended Measures for Clinical Event End Points
|
37KB DOC |
N/A |
|
| Stroke Adjudication Worksheet
|
104KB DOC |
HTML |
|
| Atherosclerosis Risk in Communities Study (ARIC) TIA/Stroke Form
|
2817KB PDF |
HTML |
|
| Questionnaire for Verifying Stroke-Free Status (QVSFS)
|
41KB DOC |
HTML |
|
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Prospective Assessments for Suicidality
Investigators should use the Columbia Suicide Severity Rating Scale (C-SSRS) (available
at
http://www.cssrs.columbia.edu, see additional C-SSRS information for
background materials provided to the NINDS CDE project by Dr. Posner) or another
instrument that maps to the Columbia Classification Algorithm for Suicide Assessment
(C-CASA) (Posner et al. 2007).
Posner, K, MA Oquendo, M Gould, B Stanley, and M Davies, 2007, Columbia Classification
Algorithm of Suicide Assessment
(C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk
Analysis of Antidepressants, Am J Psychiatry, 164:1035-1043.
Accessibility Statement
The NINDS CDE Team has requested, and in many cases received, permission to post
proprietary instruments/scales recommended by the CDE Working Groups to this site.
When permission is granted, the documents are posted in the exact format they were
received in order to maintain the validity of the instrument. If approval is not
granted for the instrument to be reproduced on this site, with the author/copyright
holder’s permission, a link is posted to an external Web site where users can get
more information about the instrument. If you have difficulty accessing either the
proprietary instruments/scales or the external links, please contact the
NINDS CDE Project Officer, Joanne Odenkirchen.
Download readers:
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
OR Checklist for Other Stroke 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 a Stroke clinical trial/ other type of
clinical study.
The Stroke CDE Working Group is currently 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 Stoke CDE Working Group is supported by the
NINDS CDE Team. The complete Stroke CDE Working Group roster and the rosters
by Subgroup are shown below.
Complete Stroke CDE Working
Group Roster 
The Working Group members serve 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.
Working Group Chair
- Jeffrey Saver, MD - University of California, Los Angeles, Chair
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Stroke Presentation
- Lee Schwamm, MD - Harvard Medical School, Chair
- Mark Chimowitz, MD - Medical University of South Carolina
- Heather Fullerton, MD - University of California, San Francisco
- Judy Guzy, RN - University of California, Los Angeles
- David Levy, MD - Cornell Medical College
- James Meschia, MD - Mayo Clinic College of Medicine
- Lisa Michael Nassif, MD - Texas Children’s Hospital
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Medical History and Prior Health Status
- Oscar Benavente, MD - University of British Columbia, Chair
- Deborah Attix, PhD - Duke University
- Lisa Davis, RN, MSN, CCRC - National Institute of Neurological Disorders and Stroke
- Mitchell Elkind, MD - Columbia University
- Heather Fullerton, MD - University of California, San Francisco
- Mary G. George, MD, MSPH, FACS - Centers for Disease Control and Prevention
- George Howard, DrPH - University of Alabama at Birmingham
- Irene Katzan, MD - Cleveland Clinic
- Warren Lo, MD - Nationwide Children’s Hospital
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Stroke Types and Subtypes
- Joseph Broderick, MD - University of Cincinnati, Chair
- Hakan Ay, MD - Harvard Medical School
- Timothy Bernard, MD - University of Colorado Denver
- Robert Brown, MD - Mayo Clinic
- Louis Caplan, MD - Beth Israel Deaconess Medical Center
- Rebecca Ichord, MD - Children’s Hospital of Philadelphia
- J.P. Mohr, MD - Columbia University Health Sciences
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Laboratory Tests and Vital Signs
- Kyra Becker, MD - University of Washington School of Medicine, Chair
- Roderick Corriveau, PhD - Coriell Institute for Medical Research
- Judy Guzy, RN - University of California, Los Angeles
- Steven Pavlakis, MD - Maimonides Infants and Children’s Hospital
- J.J. Strouse, MD - Johns Hopkins University School of Medicine
- Mark Wainwright, MD - Northwestern University
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Hospital Course and Acute Therapies
- Karen Johnston, MD - University of Virginia, Chair
- Kyra Becker, MD - University of Washington School of Medicine
- Joseph Broderick, MD - University of Cincinnati
- Colin Derdeyn, MD - Washington University School of Medicine
- Gabrielle deVeber, MD - Hospital for Sick Children
- Mary G. George, MD, MSPH, FACS - Centers for Disease Control and Prevention
- Daniel Hanley, MD - Johns Hopkins University
- Kennedy Lees, MD - University of Glasgow
- Stephan Mayer, MD - Columbia University
- Lee Schwamm, MD - Harvard Medical School
- Mark Wainwright, MD - Northwestern University
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Long Term Therapies
- Alexander Dromerick, MD - Georgetown University School of Medicine, Chair
- Oscar Benavente, MD - University of British Columbia
- Robert Brown, MD - Mayo Clinic
- Mark Chimowitz, MD - Medical University of South Carolina
- Pamela Duncan, MD - Duke University
- Neil Friedman, MD - Cleveland Clinic
- J.P. Mohr, MD - Columbia University
- Mubeen Rafay, MB. BS - Winnipeg Children’s Hospital
- Cathy Sila, MD - Case Western Reserve University
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Outcomes and Endpoints
- Pamela Duncan, MD - Duke University, Chair
- Deborah Attix, PhD - Duke University
- Lisa Davis, RN, MSN, CCRC - National Institute of Neurological Disorders and Stroke
- William Dunn, Jr., MD - Food and Drug Administration
- Allen Heinemann, PhD - Northwestern University
- George Howard, DrPH - University of Alabama at Birmingham
- Rebecca Ichord, MD - Children’s Hospital of Philadelphia
- Kennedy Lees, MD - University of Glasgow
- Mark MacKay, MD - Royal Children’s Hospital
- Yuko Palesch, PhD - Medical University of South Carolina
- Cathy Sila, MD - Case Western Reserve University
- Michael Walker, MD - National Institute of Neurological Disorders and Stroke
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Imaging
- Chelsea Kidwell, MD - Georgetown University, Chair
- Hakan Ay, MD - Harvard Medical School
- Colin Derdeyn, MD - Washington University School of Medicine
- Edward Feldmann, MD - Brown University
- Daniel Hanley, MD - Johns Hopkins University
- Pooja Khatri, MD - University of Cincinnati
- Stephan Mayer, MD - Columbia University
- Michael Rivkin, MD - Children’s Hospital Boston
- Max Wintermark, MD - University of Virginia
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Biospecimens and Biomarkers
- James Meschia, MD - Mayo Clinic College of Medicine, Chair
- Jennifer Armstrong-Wells, MD, MPH - University of Colorado Denver
- Roderick Corriveau, PhD - Coriell Institute for Medical Research
- Bruce Coull, MD - University of Arizona College of Medicine
- Mitchell Elkind, MD - Columbia University
- Karen Furie, MD - Massachusetts General Hospital
- Edward Jauch, MD - Medical University of South Carolina
- Catherine Amlie-Lefond, MD - Medical College Wisconsin
- Alex Rai, PhD - Columbia University
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NINDS CDE Team
- Sarah Duwel, RN, MA - The EMMES Corporation, Rockville, Maryland, USA
- Scott Janis, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Petra Kaufmann, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Steven Warach, MD, PhD - University of Texas Southwestern Institute for Healthcare Delivery and Clinical Investigation, Austin, Texas, USA
- Pamela West - The EMMES Corporation, Rockville, Maryland, USA
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Note: Institutions for all individuals acknowledged in this section
were those they belonged to when they joined the Working Group. All Working Group
members were asked to voluntarily disclose all potential sources of bias in their
involvement with the NINDS CDE Project. The summary disclosure information is available
upon request by contacting NINDSCDE@emmes.com.