Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) was developed in 2017. The Core and Supplemental-Highly Recommended data elements to be used by an investigator when beginning a research study in ME/CFS 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:

ME/CFS Common Data Elements Project Frequently Asked Questions

Please view additional tabs for more information about the development of these CDEs. An overview of all Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) CDE recommendations can be found in the ME/CFS CDE Highlight Summary document.

 

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
Adult Employment and Education History CDE Details
Demographics
CRF Module/Guideline CDEs
General Core CDE Details
Demographics CDE Details
Assessments and Examinations
Exercise Physiology
CRF Module/Guideline CDEs
Cardiopulmonary Exercise Testing (CPET) CDE Details
Treatment/Intervention Data
Drugs
CRF Module/Guideline CDEs
Medication and Other Treatments CDE Details
Outcomes and End Points
Summary of All Outcome Measure Recommendations
CRF Module/Guideline CDEs
Cognitive Subgroup Instrument Summary by Classification N/A
Cognitive Subgroup Instrument Summary by Subdomain N/A
Motor Function
CRF Module/Guideline CDEs
Speeded Tapping Test N/A
Academic Achievement
CRF Module/Guideline CDEs
Word Reading Subtest of the Wide Range Achievement Test (WRAT-4) CDE Details
Visual-Spatial Processing
CRF Module/Guideline CDEs
Rey-Osterrieth Complex Figure Test (ROCF) N/A

Overview

To develop the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) CDEs, the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome CDE Working Groups are divided into 11 subgroups to focus on identifying and defining data elements in the domains of:

  • Baseline/Covariate
  • Fatigue
  • Post-Exertional Malaise
  • Sleep
  • Pain
  • Neurologic/Cognitive/CNS Imaging
  • Autonomic
  • Neuroendocrine
  • Immune
  • QOL/Functional Status/CPET/Activity
  • Biomarkers

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 Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) CDE Working Group is comprised of eleven different subgroups. The Working Group members have developed the CDEs for their specific subgroups. The ME/CFS CDE Working Group is supported by the NINDS/CDC CDE Team. The subgroups began meeting by teleconference in March 2017 and held calls every four to six weeks to define the CDEs for their domains and to recommend standardized, validated instruments for ME/CFS research.

Complete Myalgic Encephalomyelitis/Chronic Fatigue Syndrome CDE Roster

Baseline/Covariate

  • Anthony Komaroff, MD
    Harvard University , Boston, MA
    Co-Chair
  • Jose Montoya, MD
    Stanford University, Stanford, CA
    Co-Chair
  • Alison Bested, MD
    Nova Southeastern University, Davie, FL
  • Fred Friedberg, PhD
    Stony Brook Health Sciences, Stony Brook, NY
  • Leonard Jason, PhD
    DePaul University, Chicago, IL
  • Eliana Mattos Lacerda, MD, PhD
    London School of Hygiene, London, UK
  • Denise Lopez-Majano
    Patient Advocate
  • Anna-Louise Midsem
    European ME Alliance
  • Zaher Nahle, PhD, MPA
    Solve ME/CFS Initiative, Los Angeles, CA
  • Lubov Nathanson, PhD
    Nova Southeastern University, Ft. Lauderdale, FL
  • Matina Nicholson
    Patient Advocate
  • Elisa Oltra, PhD
    Catholic University of Valencia, Valencia, Spain
  • Nicole Prestley
    The University of British Columbia, Vancouver, BC, Canada
  • Richard Simpson
    European ME Alliance
  • Michael Zeineh, MD, PhD
    Stanford University, Stanford, CA

Fatigue

  • David Cella, PhD
    Northwestern University, Evanston, IL
    Chair
  • Mary Dimmock
    Patient Advocate
  • Fred Friedberg, PhD
    Stony Brook Health Sciences, Stony Brook, NY
  • Jin-Mann Sally Lin, PhD
    Centers for Disease Control and Prevention (CDC), Atlanta, GA
  • Luis Nacul, MD, PhD
    London School of Hygiene, London, UK
  • Leorey Saligan, RN, PhD
    National Institute of Nursing Research (NINR/NIH), Bethesda, MD

Post-Exertional Malaise

  • Lily Chu, MD, MSHS
    Stanford University, Burlingame, CA
    Co-Chair
  • Mary Dimmock
    Patient Advocate
    Co-Chair
  • David Cella, PhD
    Northwestern University, Evanston, IL
  • Dane Cook, PhD
    University of Wisconsin, Madison, WI
  • Betsy Keller, PhD
    Ithaca College, Ithaca, NY
  • Anna-Louise Midsem
    European ME Alliance
  • David Patrick, MD
    The University of British Columbia, Vancouver, BC, Canada
  • Richard Simpson
    European ME Alliance

Sleep

  • Lily Chu, MD, MSHS
    Stanford University, Burlingame, CA
  • Susan Levine, MD
    New York, NY
  • Katherine Rowe, MBBS, MD
    Royal Childrens Hospital, Melbourne, Australia
  • Kimberly Sullivan, PhD
    Boston University, Boston, MA

Pain

  • Lucinda Bateman, MD
    Bateman Horne Center, Salt Lake City, UT
  • Emmeline Edwards, PhD
    Division of Extramural Research, National Center for Complementary and Integrative Health (NCCIH), Bethesda, MD
  • Rachael Korinek
    Patient Advocate
  • Leorey Saligan, RN, PhD
    National Institute of Nursing Research (NINR/NIH), Bethesda, MD
  • Yolanda Vallejo, PhD
    Integrative Biology and Infectious Diseases Branch,<br />National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD
  • Marcie Zinn, PhD
    DePaul University, Chicago, IL

Neurologic/Cognitive/CNS Imaging

  • Gudrun Lange, PhD
    Mount Sinai Beth Israel Medical Center, New York, NY
    Chair (Overall/Cognitive)
  • Jarred Younger, PhD
    The University of Alabama, Birmingham, AL
    Chair (CNS Imaging)
  • Jose Montoya, MD
    Stanford University, Stanford, CA
    Co-Chair (Neurologic)
  • Kimberly Sullivan, PhD
    Boston University, Boston, MA
    Co-Chair (Neurologic)
  • James Baraniuk, MD
    Georgetown University, Washington, DC
  • Jonas Bergquist, MD, PhD
    EMERG (Uppsala University), Uppsala, Sweden
  • Emmeline Edwards, PhD
    Division of Extramural Research, National Center for Complementary and Integrative Health (NCCIH), Bethesda, MD
  • Neil Harrison, MB, BS, PhD, MRCP, MRCPsych
    EMERG (Sussex University), East Sussex, UK
  • Eliana Mattos Lacerda, MD, PhD
    London School of Hygiene, London, UK
  • Jin-Mann Sally Lin, PhD
    Centers for Disease Control and Prevention (CDC), Atlanta, GA
  • Denise Lopez-Majano
    Patient Advocate
  • Anna-Louise Midsem
    European ME Alliance
  • Zaher Nahle, PhD, MPA
    Solve ME/CFS Initiative, Los Angeles, CA
  • Benjamin Natelson, MD
    Pain and Fatigue Study Center, New York, NY (Ad Hoc)
  • Lubov Nathanson, PhD
    Nova Southeastern University, Ft. Lauderdale, FL
  • Matina Nicholson
    Patient Advocate
  • Nicole Prestley
    The University of British Columbia, Vancouver, BC, Canada
  • Richard Simpson
    European ME Alliance
  • Terri Wilder
    Patient Advocate
  • Michael Zeineh, MD, PhD
    Stanford University, Stanford, CA
  • Marcie Zinn, PhD
    DePaul University, Chicago, IL

Autonomic

  • Peter Rowe, MD
    Johns Hopkins University, Baltimore, MD
    Chair
  • Italo Biaggioni, MD
    Vanderbilt University, Nashville, TN
  • Mady Hornig, MD
    Columbia University, New York, NY
  • Ben Katz, MD
    Lurie Children's Hospital, Chicago, IL
  • Denise Lopez-Majano
    Patient Advocate
  • Katherine Rowe, MBBS, MD
    Royal Childrens Hospital, Melbourne, Australia

Neuroendocrine

  • Nathan Holladay, MD, PhD
    Salt Lake City, UT
    Chair
  • Mary Dimmock
    Patient Advocate
  • Christopher Mullins, PhD
    National Institute of Diabetes and Digestive and Kidney Diseases (NIH/NIDDK), Bethesda, MD

Immune

  • Mady Hornig, MD
    Columbia University, New York, NY
    Co-Chair
  • Nancy Klimas, MD
    Nova Southeastern University, Ft. Lauderdale, FL
    Co-Chair
  • Simon Carding, PhD
    EMERG (Institute of Food Research/University of East Anglia), Norwich, UK
  • Mary Dimmock
    Patient Advocate
  • Mary Anne Fletcher, PhD
    Nova Southeastern University, Ft. Lauderdale, FL
  • Nathan Holladay, MD, PhD
    Salt Lake City, UT
  • Andreas Kogelnik, MD, PhD
    Open Medicine Institute, Mountain View, CA

Quality of Life/Functional Status (CPET)/Activity

  • Drew Helmer, MD, MS
    War Related Illness and Injury Study Center VA- New Jersey Health Care System, East Orange, NJ
  • Nathan Holladay, MD, PhD
    Salt Lake City, UT
  • Betsy Keller, PhD
    Ithaca College, Ithaca, NY
  • Rachael Korinek
    Patient Advocate
  • Christopher Snell, PhD
    Workwell Foundation, Stockton, CA
  • Staci Stevens, MA
    Workwell Foundation, Stockton, CA
  • Mark VanNess, PhD
    University of the Pacific, Stockton, CA

Biomarkers

  • Elisa Oltra, PhD
    Catholic University of Valencia, Valencia, Spain
    Chair
  • Jonas Bergquist, MD, PhD
    EMERG (Uppsala University), Uppsala, Sweden
  • Simon Carding, PhD
    EMERG (Institute of Food Research/University of East Anglia), Norwich, UK
  • Lily Chu, MD, MSHS
    Stanford University, Burlingame, CA
  • Ronald Davis, PhD
    Stanford University, Stanford, CA
  • Maureen Hanson, PhD
    Cornell University, Ithaca, NY
  • Lubov Nathanson, PhD
    Nova Southeastern University, Ft. Lauderdale, FL
  • David Patrick, MD
    The University of British Columbia, Vancouver, BC, Canada

NIH/NINDS/CDC

  • Elizabeth Unger, MD, PhD
    The Centers for Disease Control and Prevention (CDC), Atlanta, GA
  • Vicky Whittemore, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • 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), National Institutes of Health (NIH), Bethesda, Maryland
  • Andrew Breeden, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland

NINDS CDE Team

  • Katelyn Gay, BS
    The Emmes Corporation
  • Sherita Ala'i, MS
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation
  • Kristen Joseph, MA
    The Emmes Corporation
  • Muniza Sheikh, MS, MBA
    The Emmes Corporation
  • Sarah Tanveer, BS
    The Emmes Corporation

References

A publication related to the ME/CFS 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.

ME/CFS CDEs Revision History