Spinal Cord Injury

Data Standards

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 Spinal Cord Injury was developed in 2014. Pediatric SCI CDE recommendations were developed in 2015, supplementing the existing adult recommendations. The Core 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. An overview of all Spinal Cord Injury (SCI) CDE recommendations can be found in the SCI CDE Highlight Summary document.

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 working group (Demographic, Care, Electrodiagnostics, Functional, Imaging, Neurological, Pain, Participation/Quality of Life, and Psychological) recommendations, the data standards include:

Please view additional tabs for more information about the development of these CDEs. For your reference, a zip file containing all the current SCI CDE template CRF modules can be downloaded below

Select a domain of interest below to find the related data standards.

Overview of Working Group Recommendations
Summary Documents
CRF Module/Guideline CDEs
Summary of Recommendations for Pediatric SCI N/A
Participant Characteristics
Demographics
CRF Module/Guideline CDEs
General Core CDE Details
Demographics CDE Details
Disease/Injury Related Events
History of Disease/Injury Event
CRF Module/Guideline CDEs
Birth Injuries CDE Details
History of Injury CDE Details
Pre-Hospital Assessment Form CDE Details
Outcomes and End Points
Functional Outcomes
CRF Module/Guideline CDEs
Functional Instrument Recommendations N/A
10 Meter Timed Walk N/A
2 Minute Walk Test N/A
6 Minute Walk Test N/A
Bayley Scales of Infant Development (Bayley III, BSID) N/A
Berg Balance Scale (BBS) CDE Details
Borg Rating of Perceived Exertion (RPE) Scale N/A
Bruininks Oseretsky Test of Motor Proficency-2 (BOT-2) N/A
Canadian Occupational Performance Measure (COPM) N/A
Capabilities Upper Extremity Questionnaire (CUE-Q) N/A
Capabilities Upper Extremity Test (CUE-T) N/A
Five Times to Sit and Stand Test N/A
Functional Independence Measure for Children (WeeFIM) N/A
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) N/A
Grasp and Release Test N/A
Gross Motor Function Measure (GMFM-88, GMFM-66) N/A
International SCI Upper Extremity Basic Data Set CDE Details
Jebsen-Taylor Hand Function Test N/A
Neuromuscular Recovery Scale N/A
Nine Hole Peg Test N/A
Patient Reported Outcomes Measurement Information System (PROMIS) ? Pediatric N/A
Peabody Developmental Motor Scale Second Edition (PDMS-2) N/A
Pediatric Evaluation of Disability Inventory (PEDI) N/A
Pediatric Neuromuscular Recovery Scale N/A
Pediatric Spinal Cord Injury Activity Measure (PEDI-SCI AM) N/A
Quadriplegia Index of Function N/A
Quality of Life in Neurological Disorders (Neuro-QOL) - Pediatric Functional Health N/A
Segmental Assessment of Trunk Control (SATCo) N/A
Sollerman Hand Function Test N/A
Spinal Cord Independence Measure N/A
Spinal Cord Independence Measure (SCIM) ? III Self Report for Youth N/A
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) N/A
Spinal Cord Injury Functional Index (SCI-FI) N/A
Stair Climb N/A
Stride Analysis and Gait Variability N/A
Tetraplegia Hand Activity Questionnaire (THAQ) N/A
The Activities Based Balance Level Evaluation (ABLE) Scale N/A
Timed Up and Go (TUG) N/A
Toronto Rehabilitation Institute Hand Function Test N/A
Walking Index for Spinal Cord Injury (WISCI II) N/A
Wheelchair Circuit N/A
Wheelchair Skills Test N/A
The International SCI Data Sets
The International SCI Data Sets
CRF Module/Guideline CDEs
International SCI Pain Basic Data Subset CDE Details
International SCI Pain Extended Data Set CDE Details
International SCI Spinal Column Injury Basic Data Set CDE Details
International Standards for Neurological Classification of SCI Worksheet CDE Details
International Non-Traumatic Spinal Cord Injury Basic and Extended Data Sets CDE Details
International SCI Activities and Participation Basic Data Set CDE Details
International SCI Bowel Function Basic Data Set CDE Details
International SCI Bowel Function Basic Data Set Version 2.0 CDE Details
International SCI Bowel Function Extended Data Set CDE Details
International SCI Cardiovascular Function Basic Data Set CDE Details
International SCI Core Data Set CDE Details
International SCI Core Data Set v2.0 CDE Details
International SCI Endocrine and Metabolic Function Basic Data Set CDE Details
International SCI Endocrine and Metabolic Function Extended Data Set CDE Details
International SCI Female and Male Sexual Function Basic Data Sets CDE Details
International SCI Female and Male Sexual Function Basic Data Sets v2.0 CDE Details
International SCI Fracture History Extended Data Set N/A
International SCI Lower Urinary Tract Function Basic Data Set CDE Details
International SCI Musculoskeletal Basic Data Set CDE Details
International SCI Pain Basic Data Set Version 2.0 CDE Details
International SCI Pulmonary Basic Data Set CDE Details
International SCI Quality of Life Basic Data Set CDE Details
International SCI Skin and Thermoregulation Function Basic Data Set CDE Details
International SCI Spinal Intervention and Spinal Procedures Basic Data Set CDE Details
International SCI Upper Extremity Basic Data Set CDE Details
International SCI Urinary Tract Imaging Basic Data Set CDE Details
International SCI Urinary Tract Infection Basic Data Set CDE Details
International SCI Urodynamic Basic Data Set CDE Details

Overview

The use of different measures to assess similar study variables and/or differing metrics to assess outcomes may limit important advances in Spinal Cord Injury (SCI) research. Adoption of common data elements, or CDEs, (which include variable definitions and recommended measures), can facilitate comparison of findings across studies. 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.

To develop the SCI CDEs, scientific experts were invited to participate in subject-specific Working Groups to develop recommendations for specific topic-driven common data elements. The resulting SCI CDE Version 1.0 recommendations were published in Spinal Cord in 2015. The CDEs and case report forms (CRFs) can be viewed on the Data Standards tab. Additional pediatric-specific recommendations were developed in 2015.

The purpose of the International SCI data sets is to standardize the collection and reporting of minimal information necessary to describe a study population that would allow meaningful comparison of study data. The American Spinal Injury Association (ASIA)International Spinal Cord Society (ISCoS) and the NINDS CDE Team collaborated to incorporate the International SCI data sets into the NINDS Spinal Cord Injury CDEs.  

The SCI CDE recommendations provide consistent variable names for the data elements and proposed structures for relational data tables. The SCI CDE recommendations will facilitate the adoption of these standardized variables by clinicians and researchers who are developing projects or databases. These recommended variables are intended for free use by researchers and clinicians, so clinical/research data can be easily shared and/or combined.

The References section includes publications that further describe and outline the development of the data sets listed below.

History and Acknowledgements

The Spinal Cord Injury CDE Working Group is comprised of eight different subgroups. The Working Group members have developed the CDEs for their specific subgroups. The SCI CDE Working Group is supported by the NINDS CDE Team. The subgroups began meeting by teleconference in July 2013 and held calls every four to six weeks to define the CDEs for their domains and to recommend standardized, validated instruments for SCI research.

Staff members from the NINDS CDE Team (composed of NINDS Program Directors along with their contractor) approached the Executive Committee of the International SCI Standards and Data Sets committees (ECSCI) after they became aware of the work performed by the various SCI data set working groups. The International Spinal Cord Society (ISCoS) and the American Spinal Injury Association (ASIA) have since collaborated to incorporate the International SCI data sets into the NINDS CDEs. The NINDS CDE Team has worked with members of the Executive Committee of the International SCI Standards and Data Sets committees (ECSCI) to develop the SCI CDEs. The Spinal Cord Injury CDE Oversight Committee was created in 2015.

The complete SCI CDE Working Group roster and the rosters by Subgroup are shown below.

Complete Spinal Cord Injury Roster

Oversight Committee Members

  • Vanessa Noonan, PhD, PT
    Rick Hansen Institute, Vancouver, Canada
    Chair
  • Fin Biering-SØrensen, MD, DMSc
    University of Copenhagen, Copenhagen, Denmark
  • Andrew R. Blight, PhD
    Acorda Therapeutics, Ardsley, New York
  • Susan Charlifue, PhD, FACRM
    Craig Hospital, Englewood, Colorado
  • Yuying Chen, MD, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
  • Dalton Dietrich, III, PhD
    Miami Project to Cure Paralysis, Miami, Florida
  • Jennifer French, MBA
    Neurotech Network, St. Petersburg, Florida
  • Allen W. Heinemann, PhD, ABPP (RP), FACRM
    Northwestern University, Chicago, Illinois
  • Linda Jones, PT, MS
    Craig H. Nielsen Foundation, Boulder, Colorado
  • Naomi Kleitman, PhD
    Craig H. Neilsen Foundation, Encino, California (2015-2017)
  • John Kramer, PhD
    University of British Columbia, Vancouver, BC, Canada
  • Brian Kwon, MD, PhD, FRCSC
    University of British Columbia and Vancouver Coastal Health, Vancouver, Canada (2015-2017)
  • Vance Lemmon, PhD
    University of Miami, Miami, Florida
  • MJ Mulcahey, PhD, OTR\L
    Thomas Jefferson University, Philadelphia, Pennsylvania
  • Jan Schwab, MD, PhD
    The Ohio State University, Columbus, Ohio
  • John Steeves, PhD
    University of British Columbia and Vancouver Coastal Health, Vancouver, Canada (2015-2017)
  • Michele Towle, BS
    DP Clinical, Inc., Rockville, Maryland
  • Eva WiderstrÖm-Noga, DDS, PhD
    University of Miami Miller School of Medicine, Miami, Florida

Demographics WG

  • Yuying Chen, MD, PhD
    University of Alabama at Birmingham, Birmingham, Alabama
    Chair
  • Fin Biering-SØrensen, MD, DMSc
    University of Copenhagen, Copenhagen, Denmark
  • Susan Charlifue, PhD, FACRM
    Craig Hospital, Englewood, Colorado
  • Peter New, MBBS, FAFRM
    Caulfield Hospital, Alfred Health, Caulfield, Australia
  • Vanessa Noonan, PhD, PT
    Rick Hansen Institute, Vancouver, Canada
  • Marcel Post, PhD
    University Medical Center Utrecht and De Hoogstraat, Utrecht, The Netherlands

Care

  • Vanessa Noonan, PhD, PT
    Rick Hansen Institute, Vancouver, Canada
    Chair
  • David Berlowitz, PhD
    Victorian Respiratory Support Service Department of Respiratory and Sleep Medicine, Melbourne, Australia
  • Fin Biering-SØrensen, MD, DMSc
    University of Copenhagen, Copenhagen, Denmark
  • Michael Fehlings, MD, FACS, FRCSC, PhD
    Toronto Western Hospital, Toronto, Canada
  • James S. Harrop, MD
    Jefferson Medical College, Philadelphia, Pennsylvania
  • David W. Wright, MD, FACEP
    Emory University School of Medicine, Atlanta, Georgia

Neurological WG

  • John Steeves, PhD
    University of British Columbia and Vancouver Coastal Health, Vancouver, Canada
    Chair
  • Andrew R. Blight, PhD
    Acorda Therapeutics, Ardsley, New York
  • Armin Curt, MD FRCPC
    University of Zurich, University Hospital Balgrist, Zurich, Switzerland
  • Linda Jones, PT, MS
    Craig H. Neilsen Foundation, Encino, California
  • Daniel P. Lammertse, MD
    Craig Hospital, Englewood, Colorado
  • Keith Tansey, MD, PhD
    Emory University, Atlanta, Georgia

Functional WG

  • Kim Anderson-Erisman, PhD
    The Miami Project to Cure Paralysis, Miami, Florida
    Chair
  • Andrea L. Behrman, PT, PhD, FAPTA
    University of Louisville, Louisville, Kentucky
  • Edelle Field-Fote, PhD, PT, FAPTA
    University of Miami Miller School of Medicine, Miami, Florida
  • MJ Mulcahey, PhD, OTR\L
    Thomas Jefferson University, Philadelphia, Pennsylvania
  • Milos R. Popovic, PhD
    University of Toronto, Toronto, Canada

Participation/QOL WG

  • Susan Charlifue, PhD, FACRM
    Craig Hospital, Englewood, Colorado
    Chair
  • Allen W. Heinemann, PhD, ABPP (RP), FACRM
    Northwestern University, Chicago, Illinois
  • Alan M Jette, PT, PhD
    Boston University, Boston, Massachusetts
  • Marcel Post, PhD
    University Medical Center Utrecht and De Hoogstraat, Utrecht, The Netherlands
  • Denise G Tate PhD, ABPP, FACRM
    University of Michigan Medical School, Ann Arbor, Michigan
  • David S. Tulsky, PhD
    University of Delaware, Newark, Delaware
  • Gale G. Whiteneck, PhD, FACRM
    Craig Hospital, Englewood, Colorado

Electrodiagnostics WG

  • Keith Tansey, MD, PhD
    Emory University, Atlanta, Georgia
    Chair
  • Peter Ellaway, PhD
    Imperial College of London, London, United Kingdom
  • Keith C. Hayes, PhD
    The University of Western Ontario, Londo, Canada
  • John Kramer, PhD
    Shepherd Center, Atlanta, Georgia
  • Barry McKay, BS
    Shepherd Center, Atlanta, Georgia
  • Martin Schubert, MD
    Balgrist University Hospital, Zurich, Switzerland
  • Arthur M. Sherwood, PE, PhD
    Baylor College of Medicine, Houston, Texas

Imaging WG

  • Adam E. Flanders, MD
    Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
    Chair
  • David Dungan, MD
    Radiology Imaging Associates, P.C. Englewood, Colorado
  • Michael Fehlings, MD, FACS, FRCSC, PhD
    Toronto Western Hospital, Toronto, Canada
  • Ralph F. Frankowski, BSc, MS, MPH, PhD
    University of Texas Health Science Center at Houston, School of Public Health,Houston, Texas
  • Linda Jones, PT, MS
    Craig H. Neilsen Foundation, Encino, California
  • Daniel P. Lammertse, MD
    Craig Hospital, Englewood, Colorado
  • Edward D. Wirth III, MD, PhD
    Asterias Biotherapeutics Menlo Park, California

Pain WG

  • Eva WiderstrÖm-Noga, DDS, PhD
    University of Miami Miller School of Medicine, Miami, Florida
    Chair
  • Thomas N. Bryce, MD
    Mount Sinai Medical Center, New York, New York
  • Nanna Finnerup, MD, DMSc
    Aarhus University Hospital, Aarhus, Denmark
  • Mark Jensen, PhD
    University of Washington, Seattle, Washington
  • John Kramer, PhD
    Shepherd Center, Atlanta, Georgia
  • Philip Siddall, MD, PhD
    The University of Sydney, Sydney, Australia

Psychological WG

  • Charles Bombardier, PhD
    University of Washington School of Medicine, Seattle, Washington
  • Paul Kennedy, PhD
    The Oxford Institute of Clinical Psychology Training, Oxford, United Kingdom

Pediatrics WG

  • MJ Mulcahey, PhD, OTR\L
    Thomas Jefferson University, Philadelphia, Pennsylvania
    Co-Chair
  • Lawrence C. Vogel, MD
    Rush University Medical Center, Chicago, Illinois
    Co-Chair
  • Juan Carlos Arango-Lasprilla, PhD
    University of Deusto, Bilbao, Spain
  • Marika Augutis, RPT, PhD
    Karolinska Institutet, Stockholm, Sweden
  • Randal R. Betz, MD
    Institute for Spine and Scoliosis, Lawrenceville, New Jersey
  • Christina Calhoun, MSPT
    Shriners Hospitals for Children, Philadelphia, Pennsylvania
  • Loren Davidson, MD
    University of California Davis Health System, Sacramento, California
  • Erin Garner, BHSc(OT)
    The Victorian Spinal Cord Service, Austin Health, Victoria, Australia
  • Ellen Merete Hagen, MD, PhD
    Regional Hospital of Viborg, Viborg, Denmark
  • Erin Hayes Kelly, PhD
    Shriners Hospitals for Children, Chicago, Illinois
  • Rebecca Martin, OTR/L, OTD
    International Center for Spinal Cord Injury at Kennedy Krieger Institute, Baltimore, Maryland
  • Nigel Price, MD
    Children's Mercy Hospital, Kansas City, Missouri
  • Anke Scheel, MD
    Swiss Paraplegic Centre, Nottwil, Switzerland
  • Jennifer Schottler, MPT
    Shriners Hospitals for Children, Chicago, Illinois
  • Heather Taylor, PhD
    TIRR Memorial Hermann, Houston, Texas
  • Kathy Zebracki, PhD
    Shriners Hospitals for Children, Chicago, Illinois

SCI CDE Committee

  • Fin Biering-SØrensen, MD, DMSc
    University of Copenhagen, Copenhagen, Denmark
  • Susan Charlifue, PhD, FACRM
    Craig Hospital, Englewood, Colorado
  • Michael DeVivo, DrPH
    University of Alabama at Birmingham, Birmingham, Alabama
  • Lyn Jakeman, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Linda Jones, PT, MS
    Craig H. Neilsen Foundation, Encino, California
  • Naomi Kleitman, PhD
    Craig H. Neilsen Foundation, Encino, California
  • Joanne Odenkirchen, MPH
    NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), 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
  • Sherita Ala'i Hansen, MS
    The Emmes Corporation
  • Elias R. Feldman
    The Emmes Corporation
  • Andy Franklin
    The Emmes Corporation
  • Aria Lans, MPH
    The Emmes Corporation
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation
  • Ayanna Garland
    The Emmes Corporation
  • Courtney Ashton, MBA
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Stacie Grinnon, MS
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Yun Lu, PhD
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Christina You, MSPH
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland

References

Publications related to the development of the International Spinal Cord Injury Data Sets

Publications related to the SCI CDE effort

Publications related to the development of the International Spinal Cord Injury Data Sets

Publications related to the development of International Spinal Cord Injury

Additional 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.

Spinal Cord Injury CDE Revision History