Background/Purpose: The provisional criteria of the ACR 2010 and the 2011 self-report modification for survey and clinical research are valid, reliable and widely used for fibromyalgia diagnosis. In this 2016 fibromyalgia criteria update, we address identify problems and provide further guidelines for use.

Methods: Based on analysis of criteria studies and clinician and researchers comments, we identified problematic areas, including a) misclassification in asymmetric pain disorders, b) inconsistent and unclear instructions in the presence of other medical conditions, c) different clinician (2010) and self-report criteria (2011), d) unclearly defined pain assessment regions.

Results: Based on the above data and clinic usage data, we developed a (2016) revision of the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met:

1) Widespread pain index (WPI) ≥7 and symptom severity scale (SSS) score ≥5 OR WPI 4–6 and SSS score ≥9.

2) Generalized pain, defined as pain in at least 4 of 5 regions, is present.

3) Symptoms have been present at a similar level for at least 3 months.

4) A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.

The revision makes the following changes:

1) Changes criterion 1 to “Widespread pain index (WPI) ≥7 and Symptom Severity Scale (SSS) score ≥5 OR WPI 4–6 and SSS score ≥9.” (WPI minimum must be ≥4 instead of previous ≥3)

2) Adds a generalized pain criterion (Criterion 2) that is defined as pain in at least 4 of 5 regions (Left upper, right upper, left lower, right lower, axial). In this definition, jaw, chest and abdominal pain are not evaluated as part of the generalized pain definition.

3. Standardizes and makes 2010 and 2011 criterion (criterion 3) wording the same: “Symptoms have been generally present for at least 3 months.”

4) Removes the exclusion regarding disorders that could (sufficiently) explain the pain (criterion 4) and adds the following text: “A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.”

5) Adds the Fibromyalgia Symptom (FS) [or polysymptomatic distress (PSD)] scale as a full component of the fibromyalgia criteria.

6) Creates one set of criteria (2016) instead of having separate physician (2010) and patient (2011) criteria by replacing the physician estimate of somatic symptom burden with ascertainment of the presence of headaches, pain or cramps in lower abdomen, and depression during the previous 6 months.

Conclusion: 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 are not valid for clinical diagnosis in individual patients, but are valid for research studies. The changes to the criteria allow them to function as diagnostic criteria, while still being useful for classification.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/2016-revisions-to-the-20102011-fibromyalgia-diagnostic-criteria/