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Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016;46(3):319-329. PMID 27916278

One-paragraph summary

The criteria committee reviewed 14 validation studies (2010–2016) comparing the ACR 2010 physician criteria and 2011 self-report modification against 1990 classification and clinical criteria, plus epidemiologic, clinical, and databank analyses of criteria-level variables. Against 1990/clinical standards, median sensitivity of 2010/2011 was 86% and specificity 90%. The key defect found: the 2010/2011 rules could classify regional pain syndromes as FM. The fix: a "generalized pain" criterion requiring pain in ≥4 of 5 body regions (jaw, chest, and abdominal pain excluded from the region count), which in companion databank work eliminated regional-pain misclassification while retaining 98.8% of 2011-positive cases (Wolfe 2016, PMID 27370877). The 2016 criteria merge physician and questionnaire versions into one set — WPI ≥7 & SSS ≥5, or WPI 4–6 & SSS ≥9, plus generalized pain and ≥3 months of symptoms (scoring detail per Galvez-Sánchez 2020, PMID 32340369) — and delete the exclusion clause: FM is diagnosable irrespective of other diagnoses. Physician-based criteria are declared valid for individual diagnosis; the self-report version for research only.

Key findings

  • Median sensitivity 86%, specificity 90% for 2010/2011 criteria across 14 validation studies (interpreted by the authors as excellent given definitional differences from 1990).
  • Regional-pain misclassification eliminated by the ≥4-of-5-region generalized-pain criterion; companion analysis: 93.8% of 2011-positive patients had 1990-style widespread pain, and the new criterion retained 98.8% of cases (PMID 27370877).
  • Exclusion requirement removed — FM valid alongside other illnesses — ending a decades-long ambiguity about "secondary" FM (continuous with the 1990 paper's abandonment of the primary/secondary distinction, PMID 2306288).
  • Criteria now double as diagnostic criteria and classification criteria; severity measured continuously via the 0–31 polysymptomatic distress scale.

Limitations

  • Not an ACR-endorsed product: only the 1990 and 2010 versions carry official ACR status (Galvez-Sánchez 2020, PMID 32340369) — "2016 criteria" are a committee revision published independently.
  • Validation is against prior criteria and clinical judgment, not against any external biological standard or outcomes; the circularity of 1990 propagates forward.
  • Self-report version invalid for individual diagnosis yet widely usable, inviting misuse; clinician–criteria agreement in practice remains poor (κ 0.30–0.41; Wolfe 2019, PMID 30724039; Srinivasan 2019, PMID 31777779).
  • Thresholds (WPI/SSS cut-points) inherited from fit to clinic samples; their optimality for prognosis or treatment response is untested.

Why it matters

This is the operative research case definition of fibromyalgia: subsequent epidemiology (e.g., sex-ratio work, PMID 30212526), the recommendation to report WPI/SSS/PSD in all studies, and comparisons with AAPT criteria (PMID 32206792) all run through it. It completes the 26-year arc from tender points (peripheral tenderness, examiner-dependent, extreme female skew) to a symptom-distribution instrument (self-reportable, ~60% female in unbiased samples), and it hard-codes the committee's continuum view: a categorical diagnosis stapled onto a continuous polysymptomatic-distress scale.

Cited by wiki pages

  • diagnostic-criteria
  • history-and-nosology
  • epidemiology (criteria-dependence of prevalence and sex ratio)