ME/CFS Common Data Elements Working Group

The Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Common Data Elements (or ME/CFS CDE) project is part of the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements project, which involves research into many neurological diseases.

Common Data Elements or CDEs are standardized terms or concepts used in clinical or research studies thus allowing the data to be compared and combined across studies.

CDEs may be classified as:

• Universal - CDEs used in studies regardless of the specific disease or condition of interest such as demographic information;

• Domain-specific - CDEs designed and intended for use in studies of a particular topic, disease or condition, body system;
• Required- CDEs that are required or expected, as a matter of institutional policy, to be collected for all subjects;

• Core - CDEs that are required or expected to be collected in particular classes of studies.

CDE working groups

There are 11 subgroups focusing on identifying and defining the common data elements in ME/CFS:

Baseline/Covariate subgroup

Co-chairs:

• Anthony Komaroff, Harvard University, Boston, MA
• Jose Montoya, Stanford University, Stanford, CA

Members

• 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 Católica de Valencia San Vicente Mártir, 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 subgroup

Chair:

• David Cella, PhD, Northwestern University, Evanston, IL

Members:

• 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 subgroup

Co-chairs:

• Lily Chu, MD, MSHS, Stanford University, Burlingame, CA
• Mary Dimmock, Patient Advocate

Members:

• 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 subgroup

Members:

• 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 subgroup

Members:

• 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, 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 subgroup

Chair (Overall/Cognitive):

• Gudrun Lange, PhD, Mount Sinai School of Medicine, New York, NY

Chair (CNS Imaging):

• Jarred Younger, PhD, The University of Alabama, Birmingham, AL

Co-Chairs (Neurologic):

• Jose Montoya, MD, Stanford University, Stanford, CA

• Kimberly Sullivan, PhD, Boston University, Boston, MA

Members:

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

Autonomic subgroup

Chair:

• Peter Rowe, Johns Hopkins University, Baltimore, MD

Members:

• 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 subgroup

Chair:

• Nathan Holladay, Salt Lake City, UT

Members:

• Mary Dimmock, Patient Advocate
• Christopher Mullins, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIH/NIDDK), Bethesda, MD

Immune subgroup

Co-Chairs:

• Mady Hornig, Columbia University, New York, NY
• Nancy Klimas, Nova Southeastern University, Ft. Lauderdale, FL

Members:

• Simon Carding, PhD, EMERG (Institute of Food Research/University of East Anglia), Norwich, UK
• Mary Dimmock, Patient Advocate
• Mary Ann 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

QOL/Functional Status/CPET/Activity subgroup

Members:

• 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 subgroup

Chair:

• Elisa Oltra

Members:

• 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

Members:

• 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

Members:

• 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

Online presence

• Twitter
• Facebook
• Website
• YouTube

See also

• National Institute of Neurological Disorders and Stroke

myalgic encephalomyelitis (M.E.) - A disease often marked by neurological symptoms, but fatigue is sometimes a symptom as well. Some diagnostic criteria distinguish it from chronic fatigue syndrome, while other diagnostic criteria consider it to be a synonym for chronic fatigue syndrome. A defining characteristic of ME is post-exertional malaise (PEM), or post-exertional neuroimmune exhaustion (PENE), which is a notable exacerbation of symptoms brought on by small exertions. PEM can last for days or weeks. Symptoms can include cognitive impairments, muscle pain (myalgia), trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, among others. An estimated 25% of those suffering from ME are housebound or bedbound. The World Health Organization (WHO) classifies ME as a neurological disease.

Centers for Disease Control and Prevention (CDC) - The Centers for Disease Control and Prevention is a U.S. government agency dedicated to epidemiology and public health. It operates under the auspices of the Department of Health and Human Services.

Centers for Disease Control and Prevention (CDC) - The Centers for Disease Control and Prevention is a U.S. government agency dedicated to epidemiology and public health. It operates under the auspices of the Department of Health and Human Services.

National Institutes of Health (NIH) - A set of biomedical research institutes operated by the U.S. government, under the auspices of the Department of Health and Human Services.

post-exertional malaise (PEM) - A notable exacerbation of symptoms brought on by small physical or cognitive exertions. PEM may be referred to as a "crash" or "collapse" and can last for days or weeks. Symptoms can include cognitive impairments, muscle pain, trouble remaining upright (orthostatic intolerance), sleep abnormalities, and gastro-intestinal impairments, and others.

cognition Thought processes, including attention, reasoning, and memory.

central nervous system (CNS) - One of the two parts of the human nervous system, the other part being the peripheral nervous system. The central nervous system consists of the brain and spinal cord, while the peripheral nervous system consists of nerves that travel from the central nervous system into the various organs and tissues of the body.

two-day cardiopulmonary exercise test (CPET) - A diagnostic test which involves testing an ME/CFS patient exercising on an exercise machine, while monitoring their respiration, especially oxygen consumption. This test is repeated the following day in order to confirm the patient's inability to replicate the first-day performance. This test is thought to be the most objective way to detect post-exertional malaise.