Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage

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)

Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage study start-up

Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage Highlight Summary: Overview of all Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage-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
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
National Institutes of Health (NIH) Toolbox N/A
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guidance CDEs
Assessments and Examinations Working Group Summary Document N/A
Hospital Course and Acute Therapies Working Group Summary Document N/A
Imaging Working Group Summary Document N/A
Long-Term Therapies Working Group Summary Document N/A
Unruptured Intracranial Aneurysms Working Group Summary Document N/A
Outcomes and Endpoints Working Group Summary Document N/A
Subject Characteristics Working Group Summary Document N/A
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Demographics - Unruptured Intracranial Aneurysms 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
Risk Factors CDE Details
Prior Functional Status CDE Details
Disease/Injury Related Events
History of Disease/Injury Event
CRF Module/Guidance CDEs
Pre-Hospital/Emergency Status CDE Details
Aneurysm History CDE Details
Clinical Presentation CDE Details
Discharge Information
CRF Module/Guidance CDEs
Discharge Status CDE Details
Discharge Medications CDE Details
Classification
CRF Module/Guidance CDEs
SAH Grading CDE Details
UIA Consult/Diagnosis CDE Details
Assessments and Examinations
General and Motor
CRF Module/Guidance CDEs
Action Research Arm Test N/A
Arm Motor Abilities Test N/A
Berg Balance Scale (BBS) CDE Details
Chelsea Critical Care Assessment Tool N/A
Fugl-Meyer Assessment N/A
Functional Ambulation Category N/A
Functional Gait Assessment CDE Details
Functional Independence Measure (FIM) N/A
Physical Function ICU Test (PFIT) N/A
Progressive Upright Mobility Protocol (PUMP) Plus N/A
Rivermeade Mobility Index (RMI) N/A
Imaging Diagnostics
CRF Module/Guidance CDEs
Cardiac Magnetic Resonance Imaging (MRI) CDE Details
Echocardiogram CDE Details
Echocardiogram II CDE Details
Imaging CDE Details
Parenchymal Imaging CDE Details
Perfusion Imaging CDE Details
Radiological Findings CDE Details
Vessel Imaging Angiography CDE Details
Hospital/Care Management
CRF Module/Guidance CDEs
de Morton Mobility Index (DEMMI) N/A
London Handicap Scale (LHS) N/A
Los Angeles Motor Scale (LAMS) N/A
Mobilizing ICU Patients: Safety Assessment Guidelines N/A
Overall Measurement Schema for Intensive Care Unit - Acquired Weakness and Related Conditions N/A
Reintegration to Normal Living Index (RNLI) N/A
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Electrocardiogram (ECG) CDE Details
Electroencephalography (EEG) CDE Details
Holter Exam CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Galveston Orientation and Amnesia Test (GOAT) N/A
Neurobehavioral Symptom Inventory (NSI) N/A
NIH Stroke Scale (NIHSS) CDE Details
Baseline Assessment CDE Details
Concomitant Diseases CDE Details
Neurological Complications CDE Details
Neurological Exam CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Appendix 1: Biomarkers Targets in SAH N/A
Appendix 2: Biospecimen Standard Operating Procedure Guidance N/A
Biospecimen Collection and Processing CDE Details
Laboratory Tests CDE Details
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Intracranial Pressure (ICP) Monitoring CDE Details
Vital Signs and Acute Physiological Measurements CDE Details
Vital Signs and Blood Gases CDE Details
Treatment/Intervention Data
Drugs
CRF Module/Guidance CDEs
Concomitant Medications CDE Details
Surgeries and Other Procedures
CRF Module/Guidance CDEs
Surgical/Procedural Interventions CDE Details
Therapies
CRF Module/Guidance CDEs
ICU Therapies CDE Details
Unruptured Intracranial Aneurysm Management CDE Details
Palliative/Comfort Care and End of Life Issues CDE Details
Rescue Therapy CDE Details
Outcomes and End Points
Cognitive Impairment: Attention
CRF Module/Guidance CDEs
Computerized Test of Attentional Performance (TAP 2.3) - Alertness subtest N/A
Computerized Test of Attentional Performance (TAP 2.3) - Divided Attention subtest N/A
Computerized Test of Attentional Performance (TAP 2.3) - Go/No Go subtest N/A
Computerized Test of Attentional Performance (TAP 2.3) - Neglect subtest N/A
Case Fatality/Survival
CRF Module/Guidance CDEs
Death CDE Details
Cognitive Impairment: Behavior
CRF Module/Guidance CDEs
Frontal Systems Behavioral Scale (FrSBe) CDE Details
Emotional and Cognitive Status
CRF Module/Guidance CDEs
Generalized Anxiety Disorder (GAD-7) CDE Details
Cognitive Impairment: Eye-Hand Coordination
CRF Module/Guidance CDEs
Grooved Pegboard Test CDE Details
Emotional Impairment
CRF Module/Guidance CDEs
PTSD Checklist - Civilian (PCL-C) CDE Details
Hospital Anxiety and Depression Scale (HADS) N/A
Beck Anxiety Inventory (BAI) CDE Details
Generalized Anxiety Disorder (GAD-7) N/A
Brief Symptom Inventory-18 (BSI-18) CDE Details
Neuropsychiatric Inventory Questionnaire (NPI-Q) N/A
Beck Depression Inventory II (BDI-II) N/A
Patient Health Questionnaire - 9 (PHQ-9) Depression Scale CDE Details
Center for Epidemiologic Studies-Depression Scale (CES-D) CDE Details
Impact of Event Scale (IES) N/A
Clinician-Administered PTSD Scale (CAPS) CDE Details
Cognitive Impairment: Memory
CRF Module/Guidance CDEs
Rey Auditory Verbal Learning Test [RAVLT] CDE Details
Rey-Osterrieth Complex Figure Test (ROCF) N/A
Cognitive Impairment: Visuoperception
CRF Module/Guidance CDEs
Rey-Osterrieth Complex Figure Test (ROCF) N/A
Cognitive Impairment: Premorbid Intelligence
CRF Module/Guidance CDEs
Similarities Subtest of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) N/A
Cognitive Impairment: Cognitive Speed
CRF Module/Guidance CDEs
Trail Making Test (TMT), Delis-Kaplan Executive Function System (D-KEFS) CDE Details
Cognitive Impairment: Visuospatial Short-Term Memory
CRF Module/Guidance CDEs
Visual Span Forward N/A
Cognitive Impairment: Working Memory
CRF Module/Guidance CDEs
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) - Digit Span Subtest N/A
Physical Impairment
CRF Module/Guidance CDEs
Multidimensional Assessment of Fatigue (MAF) N/A
Headache Pain CDE Details
Cranial Nerve Function CDE Details
Health-Related Quality of Life Outcome
CRF Module/Guidance CDEs
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D) CDE Details
Short Form 36-Item Health Survey (SF-36) CDE Details
12-Item Short Form Health Survey (SF-12) CDE Details
Stroke Specific Quality of Life Scale (SS-QOL) CDE Details
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Stroke Impact Scale (SIS) N/A
Treatment Variables
CRF Module/Guidance CDEs
Shunt Dependency CDE Details
Aneurysm Recanalization CDE Details
Aneurysm Retreatment and Re-rupture CDE Details
Cognitive Impairment: Language
CRF Module/Guidance CDEs
Token Test N/A
Boston Naming Test (BNT) - 30-item version N/A
Participation Restriction/Return to Work
CRF Module/Guidance CDEs
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) N/A
Return to Work CDE Details
Home Time CDE Details
Cognitive Impairment: Executive Functions
CRF Module/Guidance CDEs
Color-Word Interference Test Delis-Kaplan Executive Function System (D-KEFS) CDE Details
Five-Point Test (5-PT) N/A
Trail Making Test (TMT), Delis-Kaplan Executive Function System (D-KEFS) CDE Details
Written Verbal Fluency Test CDE Details
Standardized Link's Probe (SLP) N/A
Disability
CRF Module/Guidance CDEs
Modified Rankin Scale (mRS) CDE Details
Glasgow Outcome Scale (GOS) CDE Details
Glasgow Outcome Scale Extended (GOSE) N/A
Disability-Adjusted Life Years (DALY) CDE Details
Barthel Index N/A
Cognitive Impairment: Screening
CRF Module/Guidance CDEs
Montreal Cognitive Assessment (MoCA) N/A
Mini-Mental State Examination (MMSE) N/A
Telephone Interview for Cognitive Status (TICS) 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 Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) Common Data Element (CDE) Working Group, along with the National Institute of Neurological Disorders and Stroke (NINDS) and National Library of Medicine (NLM) CDE Team, released Version 1.0 of the SAH CDEs in 2017.

To develop the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage CDEs, the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Subject Characteristics
  • Assessments and Examinations
  • Hospital Course and Acute Therapies
  • Biospecimens and Biomarkers
  • Imaging
  • Long-Term Therapies
  • Unruptured Intracranial Aneurysms
  • Outcomes and Endpoints

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.

Roster

The Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) CDE Working Group (WG) was comprised of eight different subgroups and a Steering Committee. Chairs were appointed to lead the overall Steering Committee and the individual subgroups. Superusers, who had the capability to create and revise CDEs on the NIH Repository website, were also appointed for each WG. The WG members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The SAH CDE WG was supported by the NINDS and National Library of Medicine (NLM) CDE Team. The complete SAH CDE Working Group roster and the rosters by Subgroup are shown below:

Complete Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage CDE Roster

SAH CDE Steering Committee

SAH CDE Steering Committee

  • Jose Ignacio Suarez, MD, FNCS, FANA
    Johns Hopkins University School of Medicine, Baltimore, Maryland
    Co-Chair
  • R. Loch Macdonald, MD, PhD
    University of Toronto, Toronto, Ontario, Canada
    Co-Chair
  • Sepideh Amin-Hanjani, MD
    University of Illinois College of Medicine, Chicago, Illinois
  • Robert D. Brown, Jr., MD, MPH
    Mayo Clinic, Rochester, Minnesota
  • Airton Leonardo de Oliveira Manoel, MD, PhD
    University of Toronto, Toronto, Ontario, Canada
  • Colin Derdeyn, MD, FACR
    University of Iowa, Carver College of Medicine, Iowa City, Iowa
  • Nima Etminan, MD
    University Hospital Mannheim, Mannheim, Germany
  • Emanuela Keller, MD
    University of Zurich, Zurich, Switzerland
  • Peter D. LeRoux, MD, FACS
    MLHC Brain and Spine Center at Lankenau Medical Center, Philadelphia, Pennsylvania
  • Stephan Mayer, MD
    Icahn School of Medicine at Mount Sinai, New York, New York
  • Akio Morita, MD, PhD
    Nippon Medical School, Tokyo, Japan
  • Gabriel Rinkel, MD
    University Medical Center, Utrecht, Netherlands
  • Daniel Rufennacht, MD
    University of Bern, Bern, Switzerland
  • Martin N. Stienen, MD
    Geneva University Hospital, Geneva, Switzerland
  • James Torner, MSc, PhD
    University of Iowa, Iowa City, Iowa
  • Mervyn D.I. Vergouwen, MD, PhD
    University Medical Center, Utrecht, Netherlands
  • George K. C. Wong, MD
    Chinese University of Hong Kong, Shatin, Hong Kong

Subject Characteristics Working Group

Subject Characteristics Working Group

  • Robert D. Brown, Jr., MD, MPH
    Mayo Clinic, Rochester, Minnesota
    Co-Chair
  • Akio Morita, MD, PhD
    Nippon Medical School, Tokyo, Japan
    Co-Chair
  • Philippe Bijlenga, MD, PhD
    Geneva University Hospital, Geneva, Switzerland
    Superuser
  • Nerissa Ko, MD
    Working Group Member
  • Cameron G. McDougall, MD
    Working Group Member
  • J. Mocco, MS, MD
    Working Group Member
  • Yuuichi Murayama, MD
    Working Group Member
  • Marieke J.H. Werner, MD, PhD
    Working Group Member

Assessments and Examinations Working Group

Assessments and Examinations Working Group

  • Stephan Mayer, MD
    Icahn School of Medicine at Mount Sinai, New York, New York
    Co-Chair
  • Jose Ignacio Suarez, MD, FNCS, FANA
    Johns Hopkins University School of Medicine, Baltimore, Maryland
    Co-Chair
  • Rahul Damani, MD, MPH
    Baylor College of Medicine, Houston, Texas
    Superuser
  • Joseph Broderick, MD
    Working Group Member
  • Raj Dhar, MD, FRCPC
    Working Group Member
  • Edward C. Jauch, MD, MS, FACEP, FAHA
    Working Group Member
  • Peter J. Kirkpatrick, MD
    Working Group Member
  • Renee Martin, PhD
    Working Group Member
  • J. Mocco, MD
    Working Group Member
  • Susanne Muehlschlegel, MD, MPH
    Working Group Member
  • Tatsushi Mutoh, MD, DVM, PhD
    Working Group Member
  • Paul Nyquist, MD, MPH
    Working Group Member
  • Daiwai Olson, RN, PhD
    Working Group Member
  • Jorge H. Mejia-Mantilla, MD, MSc
    Ad hoc member

Hospital Course and Acute Therapies Working Group

Hospital Course and Acute Therapies Working Group

  • Sepideh Amin-Hanjani, MD
    University of Illinois College of Medicine, Chicago, Illinois
    Co-Chair
  • Peter D. LeRoux, MD, FACS
    MLHC Brain and Spine Center at Lankenau Medical Center, Philadelphia, Pennsylvania
    Co-Chair
  • Airton Leonardo de Oliveira Manoel, MD, PhD
    University of Toronto, Toronto, Ontario, Canada
    Superuser
  • Mathieu van der Jagt, MD, PhD
    Erasmus MC Rotterdam, The Netherlands
    Superuser
  • Nicholas Bambakidis, MD
    Working Group Member
  • Gretchen Brophy, PharmD, BCPS, FCCP, FCCM, FNCS
    Working Group Member
  • Ketan Bulsara, MD
    Working Group Member
  • Jan Claassen, MD, PhD
    Working Group Member
  • E. Sander Connolly, MD, FACS
    Working Group Member
  • S. Alan Hoffer, MD
    Working Group Member
  • Brian L. Hoh, MD, FACS
    Working Group Member
  • Robert G. Holloway, MD, MPH
    Working Group Member
  • Adam Kelly, MD
    Working Group Member
  • Stephan Mayer, MD
    Working Group Member
  • Peter Nakaji, MD
    Working Group Member
  • Alejandro Rabinstein, MD
    Working Group Member
  • Jose Ignacio Suarez, MD, FNCS, FANA
    Working Group Member
  • Peter Vajkoczy, MD
    Working Group Member
  • Mervyn D.I. Vergouwen, MD, PhD
    Working Group Member
  • Paul M. Vespa, MD, FCCM, FAAN, FANA, FNCS
    Working Group Member
  • Henry Woo, MD
    Working Group Member
  • Gregory Zipfel, MD
    Working Group Member

Biospecimens and Biomarkers Working Group

Biospecimens and Biomarkers Working Group

  • Emanuela Keller, MD
    University of Zurich, Zurich, Switzerland
    Co-Chair, Superuser
  • R. Loch Macdonald, MD, PhD
    University of Toronto, Toronto, Ontario, Canada
    Co-Chair
  • Sherry Chou, MD, MMSc
    Working Group Member
  • Sylvain Dore, PhD, FAHA
    Working Group Member
  • Aaron S. Dumont, MD
    Working Group Member
  • Murat Gunel, MD, FACS, FAHA
    Working Group Member
  • Hidetoshi Kasuya, MD
    Working Group Member
  • Alexander Roederer, PhD
    Working Group Member
  • Ynte Ruigrok, MD
    Working Group Member
  • Paul M. Vespa, MD, FCCM, FAAN, FANA, FNCS
    Working Group Member
  • Asita Simone Sarraf Zadeh-Khorrasani, PhD
    Working Group Member

Imaging Working Group

Imaging Working Group

  • Colin Derdeyn, MD, FACR
    University of Iowa, Carver College of Medicine, Iowa City, Iowa
    Co-Chair
  • Nima Etminan, MD
    University Hospital Mannheim, Mannheim, Germany
    Co-Chair
  • Katharina Hackenberg, MD
    University Hospital Mannheim, Mannheim, Germany
    Superuser
  • John Huston, III, MD
    Working Group Member
  • Timo Krings, MD, PhD, FRCPC
    Working Group Member
  • Giuseppe Lanzino, MD
    Working Group Member
  • Philip M. Meyers, MD, FACR, FSIR, FAHA
    Working Group Member
  • Gabriel Rinkel, MD
    Working Group Member
  • Daniel Rufennacht, MD
    Working Group Member
  • Max Wintermark, MD
    Working Group Member

Long-Term Therapies Working Group

Long-Term Therapies Working Group

  • James Torner, MSc, PhD
    University of Iowa, Iowa City, Iowa
    Co-Chair, Superuser
  • George K. C. Wong, MD
    Chinese University of Hong Kong, Shatin, Hong Kong
    Co-Chair, Superuser
  • Joseph Broderick, MD
    Working Group Member
  • Janis J. Daly, MSc, PhD
    Working Group Member
  • Christopher Ogilvy, MD
    Working Group Member
  • Emma Patchik, PhD
    Working Group Member
  • Denise H. Rhoney, PharmD, FCCP, FCCM, FNCS
    Working Group Member
  • YB Roos, PhD
    Working Group Member
  • Adnan Siddiqui, MD, PhD, FAHA
    Working Group Member

Unruptured Intracranial Aneurysms Working Group

Unruptured Intracranial Aneurysms Working Group

  • Nima Etminan, MD
    University Hospital Mannheim, Mannheim, Germany
    Co-Chair
  • Gabriel Rinkel, MD
    University Medical Center, Utrecht, Netherlands
    Co-Chair
  • Katharina Hackenberg, MD
    University Hospital Mannheim, Mannheim, Germany
    Superuser
  • David Hasan, MD
    Working Group Member
  • Philip M. Meyers, MD, FACR, FSIR, FAHA
    Working Group Member
  • Ale Algra, MD, FAHA
    Working Group Member
  • Juhanna Frosen, MD
    Working Group Member
  • Seppo Juvela, MD, PhD
    Working Group Member
  • David J. Langer, MD
    Working Group Member
  • Akio Morita, MD, PhD
    Working Group Member
  • Rustam Al-Shahi Salman, MA, PhD, FRCP
    Working Group Member

Outcomes and Endpoints Working Group

Outcomes and Endpoints Working Group

  • Martin N. Stienen, MD
    Geneva University Hospital, Geneva, Switzerland
    Co-Chair, Superuser
  • Mervyn D.I. Vergouwen, MD, PhD
    University Medical Center, Utrecht, Netherlands
    Co-Chair
  • Daniel Hanggi, MD
    Working Group Member
  • R. Loch Macdonald, MD, PhD
    Working Group Member
  • Tom Schweizer, PhD
    Working Group Member
  • Anne Visser-Meily, MD, PhD
    Working Group Member

National Library of Medicine CDE Team

National Library of Medicine CDE Team

  • Liz Amos, MLIS
    National Information Center on Health Services Research and Health Care Technology, National Library of Medicine
  • Christophe Ludet, MS
    National Library of Medicine, Bethesda, Maryland

NINDS CDE Team

NINDS CDE Team

  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Claudia Moy, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland<br />Bethesda, MD, USA
  • Sherita Ala'i, MS
    The Emmes Corporation, Rockville, Maryland
  • Joy Esterlitz, MS
    The Emmes Corporation, Rockville, Maryland
  • Kristen Joseph, MA
    The Emmes Corporation, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation, Rockville, Maryland

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.

Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage CDEs Revision History