Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage

Data Standards

The Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) Common Data Elements (CDE) Working Groups, along with the National Institute of Neurological Disorders and Stroke (NINDS) and National Library of Medicine (NLM) CDE Team, have released Version 1.0 of the SAH CDEs. The NINDS, 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 CDEs for SAH was developed in 2015–2017. The Core and Supplemental-Highly Recommended CDEs 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-analyses across studies. Consistency of the data elements and the CDE formats are 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 working groups (Subject Characteristics, Assessments and Examinations, Hospital Course and Acute Therapies, Biospecimens and Biomarkers, Imaging, Long-Term Therapies, Unruptured Intracranial Aneurysms and Outcomes and Endpoints) often used in clinical studies, data standards include:

An overview of all SAH CDE recommendations can be found in the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage CDE Highlight Summary document. For your reference, a zip file containing all the current SAH 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
Social Status
CRF Module/Guideline CDEs
Social Status CDE Details
Disease/Injury Related Events
Discharge Information
CRF Module/Guideline CDEs
Discharge Status CDE Details
Discharge Medications CDE Details
Classification
CRF Module/Guideline CDEs
SAH Grading CDE Details
UIA Consult/Diagnosis CDE Details
Assessments and Examinations
Treatment/Intervention Data
Outcomes and End Points
Case Fatality/Survival
CRF Module/Guideline CDEs
Death CDE Details
Cognitive Impairment: Behavior
CRF Module/Guideline CDEs
Frontal Systems Behavioral Scale (FrSBe) CDE Details
Cognitive Impairment: Eye-Hand Coordination
CRF Module/Guideline CDEs
Grooved Pegboard Test CDE Details
Cognitive Impairment: Memory
CRF Module/Guideline CDEs
Rey Auditory Verbal Learning Test [RAVLT] CDE Details
Rey-Osterrieth Complex Figure Test (ROCF) N/A
Cognitive Impairment: Visuoperception
CRF Module/Guideline CDEs
Rey-Osterrieth Complex Figure Test (ROCF) N/A
Cognitive Impairment: Premorbid Intelligence
CRF Module/Guideline CDEs
Similarities Subtest of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) N/A
Cognitive Impairment: Cognitive Speed
CRF Module/Guideline CDEs
Trail Making Test (TMT), Delis-Kaplan Executive Function System (D-KEFS) CDE Details
Cognitive Impairment: Visuospatial Short-Term Memory
CRF Module/Guideline CDEs
Visual Span Forward N/A
Cognitive Impairment: Working Memory
CRF Module/Guideline CDEs
Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) - Digit Span Subtest N/A
Cognitive Impairment: Language
CRF Module/Guideline CDEs
Token Test N/A
Boston Naming Test (BNT) - 30-item version N/A
Participation Restriction/Return to Work
CRF Module/Guideline CDEs
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) N/A
Return to Work CDE Details
Home Time CDE Details

Overview

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.

History and Acknowledgements

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

  • 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

  • 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

  • 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

  • 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

  • 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 DorÉ, 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

  • 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

  • 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

  • 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 FrÖsen, 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

  • 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

  • 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

  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, 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

References

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