Multiple Sclerosis

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 Multiple Sclerosis was developed in 2011. 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.

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:

CDEs — Classified as Core, Supplemental - Highly Recommended, Supplemental, or Exploratory
CRF Modules — logically organize CDEs for data collection
Guidelines — to provide further information about the CDEs.

An overview of all Multiple Sclerosis (MS) CDE recommendations can be found in the Multiple Sclerosis (MS) CDE Highlight Summarydocument. For your reference, a zip file containing all the current Multiple Sclerosis (MS) 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.

NIH Resources

NIH Resources
CRF Module/Guidance	CDEs
National Institutes of Health (NIH) Toolbox	N/A
Patient-Reported Outcomes Measurement Information System (PROMIS)	N/A
Quality of Life in Neurological Disorders (Neuro-QOL)	N/A

Participant Characteristics

Demographics
CRF Module/Guidance	CDEs
General Core	CDE Details
Demographics	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 - Affected Relatives and Pedigree	CDE Details
Godin Leisure-Time Exercise Questionnaire	CDE Details
History Data Source and Reliability	CDE Details
Medical History	CDE Details
Pediatric Developmental History	CDE Details
Reproductive and Hormonal History	CDE Details

Disease/Injury Related Events

History of Disease/Injury Event
CRF Module/Guidance	CDEs
Fatigue Visual Analog Scale	CDE Details
Multiple Sclerosis Severity Score (MSSS)	N/A
Relapse	CDE Details

Classification
CRF Module/Guidance	CDEs
Diagnosis and Disease Characteristics	CDE Details

Assessments and Examinations

Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance	CDEs
Biospecimens Summary Statement	N/A
Laboratory Test Recommendations	N/A
Genetics	CDE Details

Physical/Neurological Examination
CRF Module/Guidance	CDEs
Grip Strength Fatigue	CDE Details
Physical Exam	CDE Details

Imaging Diagnostics
CRF Module/Guidance	CDEs
Imaging Analysis Results - Follow Up	CDE Details
Imaging Analysis Technique and Results - Baseline	CDE Details
Imaging OCT Analysis - Contrast and Visual Acuity	CDE Details
Imaging OCT Analysis - RNFL Thickness Analysis	CDE Details
Imaging OCT Analysis - Spectralis Report Analysis	CDE Details
Imaging OCT Analysis - Stratus Retinal Thickness Report	CDE Details
Imaging OCT Analysis -Cirrus Macular Thickness	CDE Details
Imaging Optical Coherence Tomography (OCT) Information	CDE Details
Magnetic Resonance Imaging (MRI)	CDE Details

Non-Imaging Diagnostics
CRF Module/Guidance	CDEs
Non-Imaging Diagnostics Recommendations	N/A

Vital Signs and Other Body Measures
CRF Module/Guidance	CDEs
Vital Signs	CDE Details

Outcomes and End Points

Quality of Life/Patient Reported Outcomes
CRF Module/Guidance	CDEs
Multiple Sclerosis Spasticity Scale (MSSS-88)	N/A
Clinical Global Impression Scale	N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D)	CDE Details
EuroQoL-VAS	N/A
ICIQ-Lower Urinary Tract Symptoms Quality of Life	N/A
MOS Modified Social Support Survey (MSSS) Component of the Multiple Sclerosis Quality of Life Inventory (MSQLI)	CDE Details
Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)	N/A
Multiple Sclerosis Quality of Life Inventory (MSQLI)	N/A
Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54)	CDE Details
Patient Reported Impact of Multiple Sclerosis (PRIMuS)	N/A
Sexual Satisfaction Scale (SSS)	CDE Details
Treatment Satisfaction Questionnaire for Medication	N/A

Neuropsychological Testing
CRF Module/Guidance	CDEs
Neuropsychology/Cognition Recommendations - Adult and Pediatric	N/A
Automated Neuropsychological Assessment Metrics (ANAM)	CDE Details
Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)	CDE Details
Brief Visuospatial Memory Test Revised (BVMT-R)	CDE Details
California Verbal Learning Test - Children (CVLT-C)	CDE Details
California Verbal Learning Test - Second Edition (CVLT-II)	CDE Details
Center for Epidemiologic Studies-Depression Scale (CES-D)	CDE Details
Clinical Evaluation of Language Fundamentals - Fifth Edition (CELF-5)	N/A
Conner's Continuous Performance Test III	N/A
Contingency Naming Test (CNT)	N/A
Controlled Oral Word Association Test (COWAT) subtest of the Multilingual Aphasia Examination (MAE)	CDE Details
Delis-Kaplan Executive Function System (D-KEFS)	N/A
Expanded Disability Status Scale (EDSS)	CDE Details
Expressive One-Word Picture Vocabulary Test	N/A
Nonverbal Selective Reminding Test (NVSRT)	N/A
Rey Auditory Verbal Learning Test (RAVLT)	CDE Details
Stroop Test	CDE Details
Symbol Digit Modalities Test	CDE Details
Test of Memory and Learning Revised (TOMAL-2)	CDE Details
Wechsler Abbreviated Scale of Intelligence (WASI)	N/A
Wechsler Intelligence Scale for Children-V (WISC-V)	N/A
Wide Range Assessment of Memory and Learning, Second Edition (WRAML-2)	CDE Details
Wisconsin Card Sorting Test (WCST)	N/A
Woodcock-Johnson III Test of Cognitive Abilities	CDE Details

Performance Measures
CRF Module/Guidance	CDEs
10 Meter Timed Walk	N/A
6 Minute Walk Test	N/A
Grooved Pegboard Test	CDE Details
Hauser Ambulation Index (AI)	CDE Details
Modified Ashworth Scale for Grading Spasticity	CDE Details
Multiple Sclerosis Walking Scale (MSWS)	N/A
National Eye Institute 25 Item Visual Functioning Questionnaire (NEI-VFQ-25)	CDE Details
Nine Hole Peg Test	N/A
Pelli Robson Test	N/A
Scale for the Assessment and Rating of Ataxia	N/A
Sloan Low Contrast Letter Acuity	N/A
Timed 25-Foot Walk (T25-FW)	CDE Details
Timed Up and Go (TUG)	N/A

Activities of Daily Living/Performance
CRF Module/Guidance	CDEs
Activities Specific Balance Confidence Scale (ABC-Scale)	CDE Details
Barthel Index	N/A
Berg Balance Scale (BBS)	CDE Details
Bladder Control Scale (BLCS)	CDE Details
Bowel Control Scale (BWCS)	CDE Details
Brief Pain Inventory (Short Form)	CDE Details
Disease Steps (DS)	CDE Details
Fatigue Scale for Motor and Cognitive Functions	N/A
Fatigue Severity Scale (FSS)	CDE Details
Fatigue/Activity Record and Diary	CDE Details
Functional Assessment of Multiple Sclerosis (FAMS)	N/A
Functional Independence Measure	N/A
Impact of Visual Impairment Scale	N/A
McGill Pain Questionnaire (MPQ)	N/A
Modified Fatigue Impact Scale (MFIS)	CDE Details
MOS Pain Effects Scale (PES) Component of Multiple Sclerosis Quality of Life Inventory (MSQLI)	N/A
Multiple Sclerosis Functional Composite Timed 25 Foot Walk 9-Hole Peg Test Paced Auditory Serial Addition Test	N/A
Multiple Sclerosis Impact Scale (MSIS-29)	N/A
Patient Determined Disease Steps	N/A
PROMIS Fatigue Short Form	N/A
PROMIS Pain Interference Short Form	N/A
Short Form 12- Item Health Survey (SF-12)	N/A
Short Form 36-Item Health Survey (SF-36)	CDE Details

Summary of All Outcome Recommendations
CRF Module/Guidance	CDEs
Clinical Outcomes Summary Statement	N/A
MS CDE Instrument Recommendations by Outcome Domain and Classification	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 http://www.cssrs.columbia.edu).

Accessibility Statement

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/Guideline’ 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

To develop the Multiple Sclerosis (MS) CDEs, the MS CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

Biospecimens
Demographics and Clinical Assessments
Imaging
Neuropsychology/Cognition
Operations/Special Advisors

Roster

The National Institute of Neurological Disorders and Stroke (NINDS) has formed an Oversight Committee to direct the updating and further development of Multiple Sclerosis CDEs. The Multiple Sclerosis CDE Committee is supported by the NINDS CDE Team.

Previously, the Multiple Sclerosis CDE Committee was currently comprised of five 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 subgroups began meeting by teleconference in February 2011 and continued to hold calls every four to six weeks through the fall of 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for MS research. The Multiple Sclerosis CDE Oversight Committee was created in 2013.

Complete Multiple Sclerosis CDE Roster

Oversight Committee Members

Fred Lublin, MD

Mount Sinai Medical Center, New York, New York

Chair
Douglas Arnold, MD

McGill University, Montreal, Canada
Ralph Benedict, PhD

University at Buffalo, Buffalo, New York
Peter S. Chin, MD, MSHS

Genentech-Roche, San Francisco, California
Gary Cutter, PhD

The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama
Robert J. Fox, MD, FAAN

Neurological Institute, Cleveland Clinic, Cleveland, Ohio
Gordon Francis, MD

Novartis Pharmaceuticals, San Francisco, California
Mark Freedman, MD, CSPQ, FAAN, FRCP(C)

Ottawa Hospital Research Institute, Ottawa, Canada
Deborah Hertz, MPH

National Multiple Sclerosis Society, New York, New York (until 2018)
Mary Hughes, MD

Augusta MS Center, Augusta, Georgia
Nicholas LaRocca, PhD

National Multiple Sclerosis Society, New York, New York
Ruth Ann Marrie, MD, PhD, FRCP(C)

University of Manitoba, Winnipeg, Canada
Penny Pennington, MAS

Advancing Research in MS, Buffalo, New York
Richard Rudick, MD

Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio (until 2018)

Working Group Co-Chairs

Fred Lublin, MD

Mount Sinai Medical Center, New York, New York
Chris Polman, MD, PhD

VU University Medical Center Amterdam, Amsterdam, The Netherlands

Biospecimens

Gordon Francis, MD

Novartis Pharmaceuticals, San Francisco, California
Philip de Jager, MD, PhD

Brigham and Women's Hospital, Boston, Massachusetts
Suhayl Dhib-Jalbut, MD

Robert Wood Johnson Medical School, New Brunswick, New Jersey
Steven Jacobson, PhD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Jens Kuhle, MD

University Hospital of Basel, Basel, Switzerland
Jorge Oksenberg, PhD

University of California San Francisco, San Francisco, California
Michael Racke, MD

The Ohio State University Medical Center, Columbus, Ohio

Demographics and Clinical Assessments

Howard Weiner, MD

Brigham and Women's Hospital, Boston, Massachusetts

Chair

Demographics and Clinical Assessments (Demographics and Medical History)

Richard Rudick, MD

Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio

Vice Chair
Brenda Banwell, MD

The Hospital for Sick Children, University of Toronto, Toronto, Canada
Tanuja Chitnis, MD

Brigham and Women's Hospital, Boston, Massachusetts
Christian Confavreux, MD

H?pital Neurologique Pierre Wertheimer, Bron, France
Yossi Gilgun-Sherki, PhD

Teva Pharmaceuticals Industries Ltd, Petah Tikva, Israel
Deborah Hertz, MPH

National Multiple Sclerosis Society, New York, New York
Annette Langer-Gould, MD

Kaiser Permanente Department of Research & Evaluation, Pasadena, California
Ruth Ann Marrie, MD, PhD, FRCP(C)

University of Manitoba, Winnipeg, Canada
Luanne Metz, MD, FRCP

University of Calgary, Calgary, Canada
Daniel Mikol, MD, PhD

Amgen, Thousand Oaks, California
William Pryse-Phillips, MD

Memorial University of Newfoundland, St. John's, Canada
Dessa Sadovnick, PhD

University of British Columbia, Vancouver, Canada
Leslie Weiner, MD

Keck School of Medicine of University of Southern California, Los Angeles, California

Demographics and Clinical Assessments (Laboratory Tests and Non-Imaging Diagnostics)

Bibiana Bielekova, MD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

Vice Chair
Jack Antel, MD

McGill University, Montreal, Canada
Patricia Coyle, MD

State University of New York at Stony Brook, Stony Brook, New York
Anne Cross, MD

Washington University School of Medicine, St. Louis, Missouri
Mark Freedman, MD, CSPQ, FAAN, FRCP(C)

Ottawa Hospital Research Institute, Ottawa, Canada
Robert Lisak, MD, FAAN, FRCP

Wayne State University School of Medicine, Detroit, Michigan
John Richert, MD

Business Partner-MD, Henderson, Nevada

Demographics and Clinical Assessments (Outcomes and Neurological/Physical Exam)

Stephen Hauser, MD

University of California San Francisco, San Francisco, California

Vice Chair
Peter S. Chin, MD, MSHS

Genentech-Roche, San Francisco, California
Michel Clanet, MD

Hospital Center University Toulouse, Toulouse, France
Jeffrey Cohen, MD

Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio
Jenny Freeman, PhD

University of Plymouth, Plymouth, United Kingdom
Ludwig Kappos, MD

University Hospital of Basel, Basel, Switzerland
Aaron Miller, MD

Mount Sinai School of Medicine, New York, New York
Xavier Montalban, MD

Hospital Universitari Vall D'Hebron, Barcelona, Spain
Paul O'Connor, MD

University of Toronto, Toronto, Canada
Stephen Reingold, PhD

Scientific and Clinical Review Associates LLC, Salisbury, Connecticut
Per Soelberg Sorensen, MD, DMsc, FAAN

Copenhagen University Hospital, Kobenhavn, Denmark
Emmanuelle Waubant, MD, PhD

University of California San Francisco, San Francisco, California

Imaging

Jerry Wolinsky, MD

University of Texas Health Science Center at Houston, Houston, Texas

Chair
Douglas Arnold, MD

McGill University, Montreal, Canada
Laura Balcer, MD, MSCE

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
Frederik Barkhof, MD

VU Medical Center Amsterdam, Amsterdam, The Netherlands
Massimo Filippi, MD

University Ospedale San Raffaele, Milano, Italy
Elizabeth Fisher, PhD

Cleveland Clinic Lerner Research Institute, Cleveland, Ohio
Volker Knappertz, MD

Teva Pharmaceuticals Industries Ltd, Philadelphia, Pennsylvania
David Miller, MD

UCL Institute of Neurology, London, United Kingdom
Jack Simon, MD

Oregon Health and Sciences University, Portland, Oregon

Neuropsychology/Cognition

Ralph Benedict, PhD

University at Buffalo, Buffalo, New York

Chair
Maria Pia Amato, MD

University of Florence, Florence, Italy
Gordon Francis, MD

Novartis Pharmaceuticals, San Francisco, California
Laura Julian, PhD

University of California San Francisco, San Francisco, California
Lauren Krupp, MD

Stony Brook University Hospital, Stony Brook, New York
Dawn Langdon, PhD

Royal Holloway, University of London, Egham, United Kingdom
Nicholas LaRocca, PhD

National Multiple Sclerosis Society, New York, New York
Stephen Rao, PhD

Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio
Christine Till, PhD, Cpsych

York University, Toronto, Canada

Operations/Special Advisors

Timothy Coetzee, PhD

National Multiple Sclerosis Society, New York, New York
Gary Cutter, PhD

The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama
George Ebers, MD

University of Oxford, Oxford, United Kingdom
Maria Pia Sormani, PhD

University of Genoa, Genova, Italy

NINDS CDE Team

Robin Conwit, MD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Codrin Lungu, MD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
M. Carolina Mendoza-Puccini, MD

NINDS CDE Program Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Claudia S. Moy, PhD

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Joanne Odenkirchen, MPH

NINDS CDE Project Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Ursula Utz, PhD, MBA

National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
Sherita Ala'i Hansen, MS (Until 2018)

The Emmes Company, LLC, Rockville, Maryland
Ilar Edun, BA (Until 2020)

The Emmes Company, LLC, Rockville, Maryland
Joy Esterlitz, MS (Until 2020)

The Emmes Company, LLC, Rockville, Maryland
Robin Feldman, BS, MBA

The Emmes Company, LLC, Rockville, Maryland
Katelyn Gay, BS

The Emmes Company, LLC, Rockville, Maryland
Stacie Grinnon, MS

KAI Research, Inc. (An Altarum Company), Rockville, Maryland
Megan Schmidt

KAI Research, Inc. (An Altarum Company), Rockville, Maryland
Alexandra Stout

KAI Research, Inc. (An Altarum Company), Rockville, Maryland

Publications

A publication related to the MS CDE initiative will be written at a later date. The citation for this publication will be included on this site as soon as it is available.

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.

Multiple Sclerosis CDEs Revision History