Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome study start-up

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Highlight Summary: Overview of all Myalgic Encephalomyelitis/Chronic Fatigue Syndrome-specific CDE recommendations as they appear on the website

ME/CFS Common Data Elements Project Frequently Asked Questions

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

 

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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
Overview of Working Group Recommendations
Summary Documents
CRF Module/Guidance CDEs
ME/CFS Overall Working Group Summary N/A
Baseline/Covariate Information Subgroup Summary N/A
Fatigue Subgroup Summary N/A
Post-Exertional Malaise Subgroup Summary N/A
Sleep Subgroup Summary N/A
Pain Subgroup Summary N/A
Neurologic/Cognitive/CNS Imaging Subgroup Summary N/A
Autonomic Subgroup Summary N/A
Neuroendocrine Subgroup Summary N/A
Immune Subgroup Summary N/A
Quality of Life/Functional Status/CPET/Activity Subgroup Summary N/A
Biomarkers Subgroup Summary N/A
Participant Characteristics
Social Status
CRF Module/Guidance CDEs
Adult Employment and Education History CDE Details
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Past and Current Illnesses CDE Details
Medical History - Immune Module CDE Details
Reproductive and Hormonal History CDE Details
Exposure History CDE Details
Family Health History CDE Details
Disease/Injury Related Events
History of Disease/Injury Event
CRF Module/Guidance CDEs
DePaul Symptom Questionnaire (DSQ) N/A
ME/CFS Symptom Checklist N/A
DSQ-Pediatric Screening Questionnaire (DSQ-PSQ) N/A
Fatigue Visual Analog Scale CDE Details
Neuroendocrine/Hypothalamic Symptoms CDE Details
Assessments and Examinations
Exercise Physiology
CRF Module/Guidance CDEs
Cardiopulmonary Exercise Testing (CPET) CDE Details
Autonomic
CRF Module/Guidance CDEs
Composite Autonomic Symptom Scale (COMPASS-31) N/A
Modified Orthostatic Symptom Grading Scale CDE Details
Passive Standing Test Protocol CDE Details
Post-Exertional Malaise
CRF Module/Guidance CDEs
Guidance for Core PEM Assessment N/A
Core PEM Assessment Questionnaire CDE Details
Guidance for PEM-Focused Studies N/A
PEM-Focused Studies Questionnaire CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Laboratory Test Results CDE Details
Laboratory Tests - Immune Module CDE Details
Neuroendocrine Labs CDE Details
Biomarkers Guidelines N/A
Biomarkers Reference Table N/A
Biomarker-Related Sample and Collection Questions CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Neurological Exam CDE Details
Physical Examination CDE Details
Physical Exam - Immune Module CDE Details
Polysomnography (PSG) for ME/CFS CDE Details
Pain Assessment CDE Details
Beighton Score CDE Details
Grip Strength Fatigue CDE Details
Imaging Diagnostics
CRF Module/Guidance CDEs
Special Imaging Considerations N/A
Suggested Parameters for Common Magnetic Resonance Imaging (MRI) Scans N/A
Magnetic Resonance Imaging (MRI) CDE Details
Functional Magnetic Resonance Imaging (fMRI) CDE Details
Diffusion Tensor Imaging (DTI) CDE Details
Magnetic Resonance Spectroscopy (MRS) CDE Details
Positron Emission Tomography (PET) CDE Details
Magnetoencephalography (MEG) CDE Details
Non-Quantitative Electroencephalography (EEG) CDE Details
Quantitative Electroencephalography (qEEG) CDE Details
Low Resolution Electromagnetic Tomography (LORETA) CDE Details
ME/CFS Functional Imaging Task Summaries N/A
Treatment/Intervention Data
Drugs
CRF Module/Guidance CDEs
Medication and Other Treatments CDE Details
Outcomes and End Points
Emotional/Behavioral
CRF Module/Guidance CDEs
Beck Anxiety Inventory (BAI) CDE Details
Center for Epidemiologic Studies-Depression Scale (CES-D) CDE Details
State-Trait Anxiety Inventory (STAI) N/A
Beck Depression Inventory II (BDI-II) CDE Details
Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) CDE Details
Pain
CRF Module/Guidance CDEs
Brief Pain Inventory (Short Form) CDE Details
Revised Fibromyalgia Impact Questionnaire (FIQR) N/A
McGill Pain Questionnaire (MPQ) N/A
Faces Pain Scale - Revised (FPS-R) N/A
Pain Frequency-Severity-Duration Scale (PFSD) N/A
Neuropathic Pain Symptom Inventory (NPSI) N/A
PROMIS Pain Interference Short Form N/A
PROMIS Pain Behavior Short Form N/A
Memory
CRF Module/Guidance CDEs
California Verbal Learning Test - Second Edition (CVLT-II) CDE Details
Wechsler Memory Scale IV (WMS-IV) N/A
Rey-Osterrieth Complex Figure Test (ROCF) N/A
California Verbal Learning Test - Children (CVLT-C) CDE Details
Children's Memory Scale (CMS) N/A
Summary of All Outcome Measure Recommendations
CRF Module/Guidance CDEs
Cognitive Subgroup Instrument Summary by Classification N/A
Cognitive Subgroup Instrument Summary by Subdomain N/A
Executive Functioning
CRF Module/Guidance CDEs
Delis-Kaplan Executive Function System (D-KEFS) N/A
NIH Toolbox Cognitive Battery CDE Details
Cambridge Neuropsychological Test Automated Battery (CANTAB) N/A
Cogstate Tests N/A
Intellectual Functioning
CRF Module/Guidance CDEs
Edinburgh Handedness Inventory N/A
North American Adult Reading Test (NAART) N/A
Test of Premorbid Functioning CDE Details
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) N/A
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) CDE Details
Woodcock-Johnson III Test of Cognitive Abilities CDE Details
Wechsler Intelligence Scale for Children-V (WISC-V) N/A
Fatigue
CRF Module/Guidance CDEs
Fatigue Severity Scale (FSS) CDE Details
Checklist for Individual Strength - Fatigue (CIS) CDE Details
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue N/A
Wood Mental Fatigue Inventory N/A
Pediatric Quality of Life Inventory, Multidimensional Fatigue Scale N/A
PROMIS Fatigue Short Form N/A
Neuro-QOL Adult Bank - Fatigue CDE Details
Modified Fatigue Impact Scale (MFIS) CDE Details
Multidimensional Fatigue Inventory (MFI) N/A
Activities of Daily Living/Performance
CRF Module/Guidance CDEs
Fatigue/Activity Record and Diary CDE Details
Modifiable Activity Questionnaire (MAQ) N/A
Physical Functioning and Activities of Daily Living CDE Details
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Mental Fatigue Scale (MFS) N/A
Short Form 36-Item Health Survey (SF-36) CDE Details
Child Health Questionnaire (CHQ) N/A
Functional Disability Inventory - Child and Adolescent Form (FDI) N/A
Functional Disability Inventory - Parent Form (FDI) N/A
Bell CFIDS Disability Scale CDE Details
EuroQoL-5 Dimension Questionnaire (EQ-5D) CDE Details
Health Related Quality of Life-14 (HRQOL-14) N/A
Karnofsky Performance Scale CDE Details
World Health Organization Disability Assessment Schedule (WHODAS) N/A
Attention/Information Processing
CRF Module/Guidance CDEs
Paced Auditory Serial Addition Test (PASAT) N/A
Automated Neuropsychological Assessment Metrics (ANAM) N/A
Deary-Liewald Reaction Time Task N/A
Stroop Test N/A
Test of Variables of Attention (TOVA) N/A
Children's Paced Auditory Serial Addition Task (ChiPASAT) N/A
Sleep
CRF Module/Guidance CDEs
Sleep Questions For All Studies CDE Details
Sleep Focused Study Questionnaire CDE Details
Sleep Assessment Questionnaire - Moldofsky N/A
Pittsburgh Sleep Quality Index (PSQI) CDE Details
Stanford Sleepiness Scale (SSS) N/A
Sleep Disorders Screening Checklist N/A
Holland Sleep Disorders Questionnaire (HSDQ) N/A
Epworth Sleepiness Scale (ESS) - Children's Version CDE Details
Nonrestorative Sleep Scale (NRSS) N/A
Global Sleep Assessment Questionnaire (GSAQ) N/A
Restorative Sleep Questionnaire (RSQ) N/A
Adolescent Sleep Hygiene Scale Revised (ASHSr) N/A
Motor Function
CRF Module/Guidance CDEs
Speeded Tapping Test N/A
Academic Achievement
CRF Module/Guidance CDEs
Word Reading Subtest of the Wide Range Achievement Test (WRAT-4) CDE Details
Visual-Spatial Processing
CRF Module/Guidance CDEs
Rey-Osterrieth Complex Figure Test (ROCF) N/A

Prospective Assessments for Suicidal Ideation and Behavior

 Investigators should review the FDA’s guidance regarding suicidal ideation and behavior.

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

The first set of Common Data Elements (CDEs) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) was developed in partnership with the Centers for Disease Control and Prevention (CDC) in 2018.

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.

Roster

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

Oversight Committee Members

Oversight Committee Members

  • Kimberly Sullivan, PhD
    Boston University School of Public Health, Boston, Massachusetts
    Co-Chair
  • Jarred Younger, PhD
    The University of Alabama, Birmingham, Alabama
    Co-Chair
  • David Cella, PhD
    Northwestern University, Evanston, Illinois
  • Lily Chu, MD, MSHS
    Stanford University, Burlingame, California
  • Dane B. Cook, PhD
    University of Wisconsin, Madison, Wisconsin
  • John DeLuca, PhD
    Kessler Foundation, West Orange, New Jersey
  • Mary Dimmock
    Patient Advocate
  • Nathan Holladay, MD, PhD
    Salt Lake City, Utah
  • Mady Hornig, MA, MD
    Columbia University, New York, New York
  • Nancy Klimas, MD
    Nova Southeastern University, Ft. Lauderdale, Florida
  • Anthony L. Komaroff, MD
    Brigham and Women's Hospital Harvard Medical School, Boston, Massachusetss
  • Gudrun Lange, PhD
    Mount Sinai School of Medicine, New York, New York
  • Elisa Oltra, PhD
    Universidad Catolica de Valencia San Vicente Martir, Valencia, Spain
  • Daniel Peterson, MD
    Sierra Internal Medicine/ Simmaron Research Institute, Incline Village, Nevada
  • Peter Rowe, MD
    Johns Hopkins University, Baltimore, Maryland

Baseline/Covariate

Baseline/Covariate

  • Anthony L. Komaroff, MD
    Brigham and Women's Hospital Harvard Medical School, Boston, Massachusetts
    Chair
  • Alison Bested, MD
    Nova Southeastern University, Davie, Florida
  • Fred Friedberg, PhD
    Stony Brook Health Sciences, Stony Brook, New York
  • Leonard Jason, PhD
    DePaul University, Chicago, Illinois
  • Eliana Mattos Lacerda, MD, PhD
    London School of Hygiene, London, United Kingdom
  • Denise Lopez-Majano
    Patient Advocate
  • Anna-Louise Midsem
    European ME Alliance, Hobro, Denmark
  • Zaher Nahle, PhD, MPA
    Solve ME/CFS Initiative, Los Angeles, California
  • Lubov Nathanson, PhD
    Nova Southeastern University, Ft. Lauderdale, Florida
  • Matina Nicholson
    Patient Advocate
  • Elisa Oltra, PhD
    Universidad Catolica de Valencia San Vicente Martir, Valencia, Spain
  • Nicole Prestley
    The University of British Columbia, Vancouver, British Columbia, Canada
  • Richard Simpson
    European ME Alliance
  • Michael Zeineh, MD, PhD
    Stanford University, Stanford, California

Fatigue

Fatigue

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

Post-Exertional Malaise

Post-Exertional Malaise

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

Sleep

Sleep

  • Lily Chu, MD, MSHS
    Stanford University, Burlingame, California
  • Susan Levine, MD
    New York, New York
  • Katherine Rowe, MBBS, MD
    Royal Children's Hospital, Melbourne, Australia
  • Kimberly Sullivan, PhD
    Boston University, Boston, Massachusetts

Pain

Pain

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

Neurologic/Cognitive/CNS Imaging

Neurologic/Cognitive/CNS Imaging

  • Gudrun Lange, PhD
    Mount Sinai School of Medicine, New York, New York
    Chair (Overall/Cognitive)
  • Jarred Younger, PhD
    The University of Alabama, Birmingham, Alabama
    Chair (CNS Imaging)
  • Kimberly Sullivan, PhD
    Boston University School of Public Health, Boston, Massachusetts
    Chair (Neurologic)
  • James Baraniuk, MD
    Georgetown University, Washington, District of Columbia
  • 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, Maryland
  • Neil Harrison, MB, BS, PhD, MRCP, MRCPsych
    EMERG (Sussex University), East Sussex, United Kingdom
  • Eliana Mattos Lacerda, MD, PhD
    London School of Hygiene, London, United Kingdom
  • Jin-Mann Sally Lin, PhD
    Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Denise Lopez-Majano
    Patient Advocate
  • Anna-Louise Midsem
    European ME Alliance
  • Zaher Nahle, PhD, MPA
    Solve ME/CFS Initiative, Los Angeles, California
  • Benjamin Natelson, MD
    Pain and Fatigue Study Center, New York, New York (Ad Hoc)
  • Lubov Nathanson, PhD
    Nova Southeastern University, Ft. Lauderdale, Florida
  • Matina Nicholson
    Patient Advocate
  • Nicole Prestley
    The University of British Columbia, Vancouver, British Columbia, Canada
  • Richard Simpson
    European ME Alliance
  • Michael Zeineh, MD, PhD
    Stanford University, Stanford, California
  • Marcie Zinn, PhD
    The Neuro-Cognitive Research Institute (NCRI), Chicago, Illinois

Autonomic

Autonomic

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

Neuroendocrine

Neuroendocrine

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

Immune

Immune

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

Quality of Life/Functional Status (CPET)/Activity

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, New Jersey
  • Nathan Holladay, MD, PhD
    Salt Lake City, Utah
  • Betsy Keller, PhD
    Ithaca College, Ithaca, New York
  • Rachael Korinek
    Patient Advocate
  • Christopher Snell, PhD
    Workwell Foundation, Stockton, California
  • Staci Stevens, MA
    Workwell Foundation, Stockton, California
  • Mark VanNess, PhD
    University of the Pacific, Stockton, California

Biomarkers

Biomarkers

  • Elisa Oltra, PhD
    Universidad Catolica de Valencia San Vicente Martir, 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, United Kingdom
  • Lily Chu, MD, MSHS
    Stanford University, Burlingame, California
  • Ronald Davis, PhD
    Stanford University, Stanford, California
  • Maureen Hanson, PhD
    Cornell University, Ithaca, New York
  • Lubov Nathanson, PhD
    Nova Southeastern University, Ft. Lauderdale, Florida
  • David Patrick, MD
    The University of British Columbia, Vancouver, British Columbia, Canada

NIH/NINDS/CDC

NIH/NINDS/CDC

  • Elizabeth Unger, MD, PhD
    The Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
  • Vicky Whittemore, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, 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

NINDS CDE Team

  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Kristen Joseph, MA (Until 2019)
    The Emmes Company, LLC, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Ian Spector, BS, MPS
    The Emmes Company, LLC, Rockville, Maryland
  • Sarah Tanveer, BS
    The Emmes Company, LLC, Rockville, Maryland

Publications

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