Chiari I Malformation

Data Standards

The purpose of the Chiari I Malformation Common Data Elements (CDEs) is to facilitate research by providing a standard definition for common, previously used research variables so that they may be used in a more uniform fashion across the available literature. The listing of Common Data Element and Instrument definitions and tools is not intended to limit the consideration of any other variables in the investigation of Chiari I Malformation, but merely to standardize the use of frequently observed variables, where possible. It is recognized, for example, that other metrics, especially those involving the characterization of soft tissue and CSF volume and shape, or those involving dynamic physiological measures, are likely important to future Chiari investigation and perhaps, ultimately, its evaluation and treatment. These metrics have not yet been included in this iteration of the Chiari I Malformation CDEs because there are no current standardization methods available. It is our hope that these elements may be part of future versions of the CDEs to further advance the literature. Finally, we should be mindful that it is not the purpose of these CDEs to define Chiari I Malformation itself or to guide surgical treatment; these CDEs are a tool for research purposes.

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 Chiari I Malformation was developed in 2016. The Core and Supplemental-Highly Recommended 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 Chiari I Malformation (CM1) CDE recommendations can be found in the Chiari I Malformation (CM1) CDE Highlight Summary document. For your reference, a zip file containing all the current Chiari I Malformation (CM1) 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
Demographics
CRF Module/Guideline CDEs
General Core CDE Details
Demographics CDE Details
Disease/Injury Related Events
Treatment/Intervention Data
Drugs
CRF Module/Guideline CDEs
Medications (Prior and Current) CDE Details
Surgeries and Other Procedures
CRF Module/Guideline CDEs
Surgical Site Assessment CDE Details
Outcomes and End Points
Assessing Comorbidities
CRF Module/Guideline CDEs
Co-Morbidities CDE Details
Emotional and Cognitive Status
CRF Module/Guideline CDEs
Zung Depression Score N/A
Other Non-Motor
CRF Module/Guideline CDEs
Assessment of Shunt Function CDE Details

Overview

The Chiari I Malformation CDE Working Group was comprised of six 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 also had an opportunity to review and comment on the recommendations of the other subgroups. The Chiari I Malformation CDE Working Group was supported by the NINDS CDE Team.

History and Acknowledgements

The Chiari I Malformation CDE Working Group was comprised of six 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 also had an opportunity to review and comment on the recommendations of the other subgroups. The Chiari I Malformation CDE Working Group was supported by the NINDS CDE Team. The complete Chiari I Malformation CDE Working Group roster and the rosters by Subgroup are shown below:

Complete Chiari I Malformation CDE Roster

Oversight Committee Members

  • Allison Ashley-Koch, PhD
    Duke University, Durham, North Carolina
  • Ulrich Batzdorf, MD
    University of California, Los Angeles, Los Angeles, California
    Chair
  • Ari Blitz, MD
    Johns Hopkins Hospital, Baltimore, Maryland
  • Paolo Bolognese, MD
    Chiari Neurosurgical Center at NSPC, Lake Success, New York
  • John Heiss, MD
    Surgical Neurology Branch, NINDS, NIH, Bethesda, Maryland
  • Petra Klinge, MD, PhD
    Warren Alpert Medical School of Brown University, Providence, Rhode Island
  • Roger Kula, MD
    The Chiari Institute, Great Neck, New York
  • David Limbrick, MD, PhD
    Washington University School of Medicine in St. Louis, St. Louis, Missouri
  • Brandon Rocque, MD
    Children?s of Alabama ? Neurosurgery, Birmingham, Alabama

Core Demographic Database, Epidemiology

  • Cormac Maher, MD
    University of Michigan, Ann Arbor, Michigan
    Co-Chair
  • Brandon Rocque, MD
    Children?s of Alabama, Birmingham, Alabama
    Co-Chair
  • Tim George, MD
    Pediatric Neurosurgery Center of Central Texas, Austin, Texas

Presentation, Natural History, Signs Symptoms

  • Ulrich Batzdorf, MD
    University of California, Los Angeles, Los Angeles, California
    Co-Chair
  • Roger Kula, MD
    The Chiari Institute, Great Neck, New York
    Co-Chair
  • Gavin Britz, MD
    Houston Methodist Hospital, Houston, Texas
  • Graham Flint, MD
    Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom
  • Petra Klinge, MD, PhD
    Rhode Island Hospital, Hasbro Children?s Hospital, Providence, Rhode Island
  • Yong Liu, MD
    Tsinghua University YuQuan Hospital, Beijing, China
  • Jeffrey Wisoff, MD
    NYU Pediatric Neurosurgery Associates, New York, New York

Co-morbidities, Risk Factors, Genetics

  • Clair Francomano, MD
    Greater Baltimore Medical Center, Towson, Maryland
    Co-Chair
  • Allison Ashley-Koch, PhD
    Duke University Medical Center, Durham, North Carolina
    Co-Chair
  • Deven Atnoor, PhD
    Data Analytics, Lexington, Massachusetts
  • Andrew Brodbelt, PhD
    The Walton Centre, Fazakerley Liverpool, United Kingdom
  • Miroslav Gjurasin, MD, PhD
    Children's Hospital Zagreb, Zagreb, Croatia
  • Rodney Grahame, MD
    Hospital of St John and St Elizabeth, London, United Kingdom
  • Alfons Macaya, MD
    Vall d'Hebron University Hospital, Barcelona, Spain
  • Juan Sahuquillo, MD
    Vall d'Hebron University Hospital, Barcelona, Spain
  • Eric Trumble, MD
    Florida Hospital Medical Group, Orlando, Florida
  • Roy Weller, MD, PhD
    University of Southampton School of Medicine, Southampton, United Kingdom

Spinal Anomaly, Stability/ Imaging

  • Ed Benzel, MD
    Cleveland Clinic Center for Spine Health, Cleveland, Ohio
    Co-Chair
  • Douglas Brockmeyer, MD, FAAP
    Primary Children's Hospital, Salt Lake City, Utah
    Co-Chair
  • Harold Rekate, MD
    The Chiari Institute, Great Neck, New York
    Co-Chair
  • Brandon Rocque, MD
    Children?s of Alabama, Birmingham, Alabama
    Co-Chair
  • Noam Alperin, PhD
    University of Miami Miller School of Medicine, Miami, Florida
  • Olivier Baledent, PhD
    The Amiens-Picardie University Hospital, Amiens, France
  • Barth Green, MD
    University of Miami, Miami, Florida
  • Jeffrey Greenfield, MD, PhD
    Weill Cornell Brain and Spine Center, New York, New York
  • Victor Haughton, MD
    University of Wisconsin School of Medicine, Madison, Wisconsin
  • John Heiss, MD
    National Institute of Health Neurosurgery, Bethesda, Maryland
  • Fraser Henderson, Sr, MD
    Metropolitan Neurosurgery Group, Chevy Chase, Maryland
  • Jamie Jacobs, BS, MAT
    Intrinsic Medical Imaging, Boston, Massachusetts
  • Bryn Martin, PhD
    University of Idaho, Moscow, Idaho
  • Arnold Menezes, MD
    University of Iowa Hospital & Clinic, Iowa City, Iowa
  • Misao Nishikawa, MD, PhD
    Moriguchi-Ikuno Memorial Hospital, Osaka, Japan
  • John Oshinski, PhD
    Emory University School of Medicine, Atlanta, Georgia
  • Marcus Stoodley, MD
    Macquarie University Hospital, Sydney, Australia

Treatment

  • Paolo Bolognese, MD
    Chiari Neurosurgical Center at NSPC, Lake Success, New York
    Co-Chair
  • David Limbrick, MD, PhD
    St. Louis Children?s Hospital, St. Louis, Missouri
    Co-Chair
  • Palma Ciaramitaro, MD
    Centro Regionale Esperto Siringomielia-S. Chiari<br />S.C. di Neurochirurgia, Torino, Italy
  • Jorg Klekamp, MD
    Christliches Krankenhaus Quakenbr?ck, Quakenbr?ck, Germany
  • W. Jerry Oakes, MD
    Children?s of Alabama, Birmingham, Alabama
  • Gerald Rodts, MD
    Emory Healthcare, Atlanta, Georgia
  • Marshall Wisoff, BS
    ConMed Orthopedics, Largo, Florida

Outcomes

  • John Heiss, MD
    National Institute of Health Neurosurgery, Bethesda, Maryland
    Co-Chair
  • Mark Luciano, MD, PhD
    The Johns Hopkins Hospital, Baltimore, Maryland
    Co-Chair
  • Simon Archibald, PhD
    Integra LifeSciences, New York, New York
  • Richard Ellenbogen, MD
    Seattle Children?s Hospital, Seattle, Washington
  • Bermans Iskandar, MD
    University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin
  • Richard Kuntz, MD
    Medtronic Inc., Minneapolis, Minnesota
  • Fabrice Parker, MD
    Le Centre de R?f?rence ? Syringomy?lie, Le Kremlin Bic?tre C?dex, France

CSF Staff Representatives

  • Kaitlyn Esposito
    Chiari & Syringomyelia Foundation, Staten Island, New York
  • Paul Farrell
    Chiari & Syringomyelia Foundation, New York, New York
  • Andrea Grosz
    Chiari & Syringomyelia Foundation, Forest Hills, New York
  • Dorothy Poppe
    Chiari & Syringomyelia Foundation, Staten Island, New York
  • Cathy Poznik
    Chiari & Syringomyelia Foundation, Twinsburg, Ohio

NINDS/NIH

  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Robert Riddle, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

NINDS CDE Team

  • Sherita Ala'I, MS
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation
  • Robin S. Feldman, BS, MBA
    The Emmes Corporation
  • Kristen Joseph, MA
    The Emmes Corporation

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.

Chiari I Malformation CDE Revision History