title: 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria.
abstract: The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria.
  
  
  
  We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement.
  
  
  
  Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification.
authors.affiliation: National Data Bank for Rheumatic Diseases, 1035 N Emporia, Ste 288, Wichita, KS 67214; University of Kansas School of Medicine, Wichita, KS. Electronic address: fwolfe@arthritis-research.org.
authors.forename: Frederick
authors.initials: F
authors.lastname: Wolfe
authors.affiliation: Chronic Pain and Fatigue Research Center, University of Michigan Medical School, Ann Arbor, MI.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Clauw
authors.affiliation: Division of Rheumatology, McGill University Health Center, Montreal, Quebec, Canada.
authors.forename: Mary-Ann
authors.initials: MA
authors.lastname: Fitzcharles
authors.affiliation: Oregon Health Science University, Portland, OR; Tufts University School of Medicine, Boston, MA.
authors.forename: Don L
authors.initials: DL
authors.lastname: Goldenberg
authors.affiliation: Department Internal Medicine 1, Saarbrücken, Germany; Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, München, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Häuser
authors.affiliation: Rheumatology, Rush Medical College, Chicago, IL.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Katz
authors.affiliation: Swedish Medical Center, Seattle, WA; University of Washington, Seattle, WA.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Mease
authors.affiliation: Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Russell
authors.affiliation: Fibromyalgia Research and Consulting, San Antonio, TX.
authors.forename: Irwin Jon
authors.initials: IJ
authors.lastname: Russell
authors.affiliation: National Institute of Nursing Research, National Institutes of Health, Bethesda, MD.
authors.forename: Brian
authors.initials: B
authors.lastname: Walitt
mesh_terms: D005356:Fibromyalgia / Q000175:diagnosis*; D006801:Humans; D015203:Reproducibility of Results; D012219:Rheumatology; D057566:Self Report; D012680:Sensitivity and Specificity; D012955:Societies, Medical; D014481:United States
keywords: Classification; Criteria; Diagnosis; Fibromyalgia