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:

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.

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.

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	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	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)	CDE Details
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)	CDE Details
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)	CDE Details
Functional Disability Inventory - Parent Form (FDI)	CDE Details
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)	CDE Details
Deary-Liewald Reaction Time Task	N/A
Stroop Test	CDE Details
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)	CDE Details
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

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

Kimberly Sullivan, PhD

Boston University School of Public Health, Boston, MA

Co-Chair
Jarred Younger, PhD

The University of Alabama, Birmingham, AL

Co-Chair
David Cella, PhD

Northwestern University, Evanston, IL
Lily Chu, MD, MSHS

Stanford University, Burlingame, CA
Dane B. Cook, PhD

University of Wisconsin, Madison, WI
John DeLuca, PhD

Kessler Foundation, West Orange, NJ
Mary Dimmock

Patient Advocate
Nathan Holladay, MD, PhD

Salt Lake City, UT
Mady Hornig, MA, MD

Columbia University, New York, NY
Nancy Klimas, MD

Nova Southeastern University, Ft. Lauderdale, FL
Anthony L. Komaroff, MD

Brigham and Women's Hospital Harvard Medical School, Boston, MA
Gudrun Lange, PhD

Mount Sinai School of Medicine, New York, NY
Elisa Oltra, PhD

Universidad Catolica de Valencia San Vicente Martir, Valencia, Spain
Daniel Peterson, MD

Sierra Internal Medicine/ Simmaron Research Institute, Incline Village, NV
Peter Rowe, MD

Johns Hopkins University, Baltimore, MD

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, Hobro, Denmark
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

Universidad Catolica de Valencia San Vicente Martir, 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 B. 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 Children's 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

The Neuro-Cognitive Research Institute (NCRI), Chicago, IL

Neurologic/Cognitive/CNS Imaging

Gudrun Lange, PhD

Mount Sinai School of Medicine, 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
Michael Zeineh, MD, PhD

Stanford University, Stanford, CA
Marcie Zinn, PhD

The Neuro-Cognitive Research Institute (NCRI), 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 Children's 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

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, 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

NINDS CDE Program Officer, 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 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, 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