Elizabeth Haney, MD; M.E. Beth Smith, DO; Marian McDonagh, PharmD; Miranda Pappas, MA; Monica Daeges, BA; Ngoc Wasson, MPH; Heidi D. Nelson, MD, MPH
Disclaimer: The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of the Agency for Healthcare Research and Quality (AHRQ). No statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.
Acknowledgment: The authors thank the following individuals for their contributions to this project: Richard Bryant, MD, for providing expert consultation throughout the report; Andrew Hamilton, MLS, MS, for conducting literature searches; and Spencer Dandy, BS, for assistance with preparing this report (all are located at the Oregon Health & Science University). They also thank Suchitra Iyer, PhD, Task Order Officer at the Agency for Healthcare Research and Quality; Carmen Green, MD, National Institutes of Health (NIH) Working Group Chair; the NIH; the Technical Expert Panel; and reviewers of the draft report.
Financial Support: By the Agency for Healthcare Research and Quality (contract 290-2012-00014-i, task order 4), Rockville, Maryland.
Disclosures: Dr. Haney reports grants from the Agency for Healthcare Research and Quality during the conduct of the study. Ms. Daeges reports grants from the Agency for Healthcare Research and Quality during the conduct of this study. Authors not named here have disclosed no conflicts of interest. Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0443.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Requests for Single Reprints: Elizabeth Haney, MD, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Haney, Smith, McDonagh, and Nelson; Ms. Pappas; Ms. Daeges; and Ms. Wasson: 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239.
Author Contributions: Conception and design: E. Haney, M.E.B. Smith, M. McDonagh, H.D. Nelson.
Analysis and interpretation of the data: E. Haney, M.E.B. Smith, M. McDonagh, M. Pappas, N. Wasson, H.D. Nelson.
Drafting of the article: E. Haney, M.E.B. Smith, M. McDonagh, M. Pappas, H.D. Nelson.
Critical revision of the article for important intellectual content: E. Haney, M.E.B. Smith, M. McDonagh, H.D. Nelson.
Final approval of the article: E. Haney, M.E.B. Smith, M. McDonagh, M. Pappas, N. Wasson, H.D. Nelson.
Obtaining of funding: M.E.B. Smith, M. McDonagh, H.D. Nelson.
Administrative, technical, or logistic support: M. Pappas, N. Wasson.
Collection and assembly of data: E. Haney, M.E.B. Smith, M. Pappas, N. Wasson, H.D. Nelson.
The diagnosis of myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is based on clinical criteria, yet there has been no consensus regarding which set of criteria best identifies patients with the condition. The Institute of Medicine has recently proposed a new case definition and diagnostic algorithm.
To review methods to diagnose ME/CFS in adults and identify research gaps and needs for future research.
MEDLINE, PsycINFO, and Cochrane databases (January 1988 to September 2014); clinical trial registries; and reference lists.
English-language studies describing methods of diagnosis of ME/CFS and their accuracy.
Data on participants, study design, analysis, follow-up, and results were extracted and confirmed. Study quality was dual-rated by using prespecified criteria, and discrepancies were resolved through consensus.
Forty-four studies met inclusion criteria. Eight case definitions have been used to define ME/CFS; a ninth, recently proposed by the Institute of Medicine, includes principal elements of previous definitions. Patients meeting criteria for ME represent a more symptomatic subset of the broader ME/CFS population. Scales rating self-reported symptoms differentiate patients with ME/CFS from healthy controls under study conditions but have not been evaluated in clinically undiagnosed patients to determine validity and generalizability.
Studies were heterogeneous and were limited by size, number, applicability, and methodological quality. Most methods were tested in highly selected patient populations.
Nine sets of clinical criteria are available to define ME/CFS, yet none of the current diagnostic methods have been adequately tested to identify patients with ME/CFS when diagnostic uncertainty exists. More definitive studies in broader populations are needed to address these research gaps.
Agency for Healthcare Research and Quality. (PROSPERO: CRD42014009779)
Haney E, Smith MB, McDonagh M, et al. Diagnostic Methods for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162:834–840. doi: 10.7326/M15-0443
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Published: Ann Intern Med. 2015;162(12):834-840.
Chronic Fatigue Syndrome/Fibromyalgia, Rheumatology.
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