2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria
Two pages on PainSci cite Wolfe 2016: 1. A Rational Guide to Fibromyalgia 2. Is fibromyalgia a “wastebasket” diagnosis?
PainSci notes on Wolfe 2016:
This revision to earlier diagnostic criteria for fibromyalgia ditches “tender points,” factors in symptom severity, and eliminates exclusion criteria.
original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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:
- Generalized pain, defined as pain in at least 4 of 5 regions, is present.
- Symptoms have been present at a similar level for at least 3 months.
- Widespread pain index (WPI) ≥ 7 and symptom severity scale (SSS) score ≥ 5 OR WPI of 4–6 and SSS score ≥ 9.
- A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
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.
related content
- “The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity,” Wolfe et al, Arthritis Care Res (Hoboken), 2010.
- “Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia,” Wolfe et al, Journal of Rheumatology, 2011.
This page is part of the PainScience BIBLIOGRAPHY, which contains plain language summaries of thousands of scientific papers & others sources. It’s like a highly specialized blog. A few highlights:
- The Problematic Nature of Fibromyalgia Diagnosis in the Community. Srinivasan 2019 ACR Open Rheumatol.
- Fibromyalgia diagnosis and biased assessment: Sex, prevalence and bias. Wolfe 2018 PLoS One.
- Restoring trust in menopause management: menopause hormone therapy is not a panacea, and physical activity remains a critical intervention. Tulloh 2025 Br J Sports Med.
- Common interventional procedures for chronic non-cancer spine pain: a systematic review and network meta-analysis of randomised trials. Wang 2025 BMJ.
- Gabapentinoids and Risk of Hip Fracture. Leung 2024 JAMA Netw Open.