ME/CFS Studies - searchMECFS

CFI

Chronic Fatigue Initiative Study

The Chronic Fatigue Initiative (CFI) was an organization created and funded by the Hutchins Family Foundation to drive wide-scale research into the causes of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Its goal was to disseminate its research findings to better equip the broader research community to work on mechanisms of ME/CFS and associated diagnostics, treatment, and prevention.

The Chronic Fatigue Initiative (CFI) was an organization created and funded by the Hutchins Family Foundation to drive wide-scale research into the underlying infectious, immunological, and toxicological causes of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). CFI's goal was to disseminate its research findings to better equip the broader research community to work on mechanisms of ME/CFS and associated diagnostics, treatment, and prevention.

From 2011 to 2013, CFI conducted a large U.S. multicenter case-control study to compare adults with ME/CFS (cases) from five geographically distinct clinical research sites (Miami, Salt Lake City, Boston, New York City, and Nevada) with healthy controls matched by sex and geographic location (within 100 miles of the clinical location). To be eligible for study inclusion, ME/CFS participants had to have a diagnosis of ME/CFS from an expert clinician that met one or both internationally recognized case definitions: the 1994 Fukuda criteria (Fukuda et al., 1994) or the 2003 Canadian criteria (Carruthers et al., 2003) with expansion by Jason et al. (2010). A total of 401 study participants (201 ME/CFS cases, 200 controls) are included in the database, having contributed questionnaire, medical record, physical exam, and laboratory data, in addition to a wide range of biological specimens (RNA, DNA, plasma, serum, peripheral blood mononuclear cells, saliva, tears, and urine). The following table displays the number of ME/CFS participants and control participants by sex. For more information on CFI study participant recruitment, data collection, and findings, see Klimas et al. (2015).

Cross tabulation of Case Status by Sex for the CFI dataset.

Case Status	Sex		Total
Case Status	M	F	Total
Control Participant	57	143	200
ME/CFS Participant	58	143	201
Total	115	286	401

References

Carruthers BM, Jain AK, De Meirleir KL, Peterson DL, Klimas N, Lerner AM, Bested AC, Flor-Henry P, Joshi P, Powles ACP, Sherkey JA, van de Sande MI. Myalgic encephalomyelitis/chronic fatigue syndrome: Clinical working definition, diagnostic and treatment protocols (PDF). Journal of Chronic Fatigue Syndrome. 2003; 11(1):7-36.
Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A: International Chronic Fatigue Study Group. The chronic fatigue syndrome: A comprehensive approach to its definition and study. Annals of Internal Medicine. 1994; 121(12):953-959.
Jason LA, Evans M, Porter N, Brown M, Brown A, Hunnell J, Anderson V, Lerch A, De Meirleir K, Friedberg F. The development of a revised Canadian myalgic encephalomyelitis chronic fatigue syndrome case definition. American Journal of Biochemistry and Biotechnology. 2010; 6(2):120-135.
Klimas NG, Ironson G, Carter A, Balbin E, Bateman L, Felsenstein S, Peterson LD, Chiu K, Allen A, Cunningham K, Gottschalk CG, Fletcher M, Hornig M, Canning C, Komaroff AL. Findings from a clinical and laboratory database developed for discovery of pathogenic mechanisms in myalgic encephalomyelitis/chronic fatigue syndrome. Fatigue: Biomedicine, Health & Behavior. 2015; 3(2):75-96.

Chronic Fatigue Initiative Study Data documentation CFI Demographics Form CFI Participant Questionnaire Form CFI Medical History Questionnaire Form Demographics Data Dictionary Participant questionnaire Data Dictionary Medical History questionnaire Data Dictionary Demographics Codebook Participant questionnaire Codebook Medical History questionnaire Codebook

MCAM

Multi-Site Clinical Assessment of ME/CFS Study

The Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM) is a multisite clinical study of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), initiated and funded by the Centers for Disease Control and Prevention (CDC).

The Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (MCAM) Study was conducted in multiple stages between 2012 and 2020. Stage 1 only enrolled ME/CFS participants and was completed in September 2013, with 471 ME/CFS participants completing at least 80% of each instrument and form. In stage 2, we collected follow-up information from those enrolled in stage 1 and started recruiting control groups: a group of healthy controls and an ill comparison group comprising patients with other chronic illnesses. Biologic samples were collected at the first visit for all participants enrolled in stage 2 and subsequent stages. The study collected the first set (baseline) of biologic samples on 802 participants: 459 ME/CFS and 343 healthy controls. The study conducted enrollment through seven clinics specializing in ME/CFS across the United States (Mount Sinai Beth Israel, New York, New York; Institute for Neuro Immune Medicine, Miami and Fort Lauderdale, Florida; Bateman Horne Center, Salt Lake City, Utah; Hunter-Hopkins Center, Charlotte, North Carolina; Open Medicine Clinic, Mountain View, California; Richard Podell N. Medical, Summit, New Jersey; and Sierra Internal Medicine, Incline Village, Nevada). ME/CFS patients were those between 18 and 70 years of age who had been diagnosed with CFS, ME, or postinfectious fatigue or who were managed as were other ME/CFS patients in the clinical practice. Healthy controls were matched to ME/CFS cases based on sex and age.

For more information on MCAM study participant recruitment, data collection, and findings, see [Unger et al. (2017)].

Cross tabulation of Case Status by Sex for the MCAM dataset.

Case Status	Sex		Total
Case Status	M	F	Total
Control Participant	117	226	343
ME/CFS Participant	126	333	459
Total	243	559	802

References

Unger ER, Lin J-MS, Tian H, et al. (2017). Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM): Design and Implementation of a Prospective/Retrospective Rolling Cohort Study. Am J Epidemiol 185:617-626.
Unger ER, Lin J-MS, Chen Y, Cornelius ME, Helton B, Issa AN, Bertolli J, Klimas NG, Balbin EG, Bateman L, et al. (2024). Heterogeneity in Measures of Illness among Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Is Not Explained by Clinical Practice: A Study in Seven U.S. Specialty Clinics. J Clin Med 13(5):1369. doi: 10.3390/jcm13051369.

MCAM Data Dictionary MCAM Methods Paper CDC - Symptom Inventory Scoring Algorithm