2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria

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Abstract

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:

  • (1)

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

  • (2)

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

  • (3)

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

  • (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.

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.

Introduction

In 1990, the American College of Rheumatology (ACR) first approved criteria for fibromyalgia, “The American College of Rheumatology 1990 criteria for the classification of fibromyalgia” [1]. In 2010, the ACR endorsed the “The American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and Measurement of Symptom Severity” as “an alternative method of diagnosis” [2], but indicated that “This criteria set has been approved by the American College of Rheumatology (ACR) Board of Directors as Provisional. This signifies that the criteria set has been quantitatively validated using patient data, but it has not undergone validation based on an external data set. All ACR-approved criteria sets are expected to undergo intermittent updates.” However, in 2015 the ACR altered its view of diagnostic criteria, writing that “the ACR will provide approval only for classification criteria and will no longer consider funding or endorsement of diagnostic criteria” [3]. Since the publication of the 2010/2011 criteria, multiple studies have been performed with respect to validation. In addition, extensive research and clinical use of the criteria have identified areas for update. In this article we review validation and clinical data, combine the 2010/2011 criteria into a single set, provide clarifying modifications to the criteria, and describe how the new (2016) combined criteria should be used. In these respects we follow the original 2010 recommendations of the ACR for intermittent updates.

A detailed description of the history of fibromyalgia criteria is available [4]. Modern criteria for fibromyalgia arose in 1977 from the observations and criteria of Smythe and Moldofsky [5]. These authors first proposed a tender point count and a requirement of “widespread aching.” In 1981, Yunus et al. [6] formally proposed criteria that included tender points and the “presence of generalized aches and pains involving 3 or more anatomic sites ….” In an effort to standardize fibromyalgia criteria, a multi-center study was organized that resulted in the ACR 1990 classification criteria for fibromyalgia [1]. The criteria fixed the number of tender points at 11 out of a possible 18 and added the requirement for widespread pain—defined as 4-quadrant plus axial pain. The widespread pain criterion was not an essential part of the criteria, as the criteria worked just as well in terms of accuracy without the widespread pain requirement [1]. Defined widespread pain was an ad hoc measure added only to aid in epidemiologic screening. However, with the passage of time, the widespread pain definition became an essential element and central part of the fibromyalgia definition, even though it was not part of pre-1990 criteria definitions.

There is no gold standard for fibromyalgia diagnosis. The 1990 criteria were based on the consensus of unblinded rheumatology physician investigators in the 1990 study regarding the degree of symptom severity and how many tender points were needed to diagnose fibromyalgia. The 1990 criteria were widely accepted by the research community, but generally ignored by most physicians for reasons that included the difficulty non-rheumatologists had in performing the tender point examination. Although there are few data on this point, it is likely that most diagnoses in the community were made by physicians who used symptoms rather than the tender point examination and the absolute widespread pain requirement. Using 2012 US National Health Interview Survey (NHIS) data [7], Walitt et al. [8] have recently reported that more 70% of persons reporting a diagnosis of fibromyalgia do not satisfy NHIS (surrogate) fibromyalgia criteria.

Partly in response to the tender point difficulty, the 2010 criteria dropped the tender point and widespread pain requirements, replacing them with a count of 19 painful regions and a series of fibromyalgia symptom assessments. These changes altered the case definition of fibromyalgia somewhat. Practically, the 2010 criteria study found that there was ≥85% agreement in diagnosis when using the 1990 and 2010 criteria set definitions, and that 93–94% of 2010 positive individuals satisfied the 1990 widespread pain criterion—a level the 2010 authors considered satisfactory [2].

The 1990 classification and 2010 diagnostic criteria were developed among rheumatology patients and were physician based, meaning that the physician evaluated the patient by interview and used usual medical examinations to consider other diagnostic possibilities. The 1990 criteria assessment also required the physician to perform a tender point examination. The 2010 criteria required no specific physical examination. Instead, it depended on the number of reported painful body regions, as assessed by the widespread pain index (WPI), and the severity of symptoms, as measured by the symptom severity scale (SSS). In 2011, the authors of the 2010 criteria published a modification of the 2010 criteria that allowed diagnosis to be accomplished entirely by self-report. In recognition of the problems with self-report diagnosis, the 2011 authors cautioned that the modified criteria should be used only for research and not for clinical diagnosis. The 2011 criteria also introduced a fibromyalgia severity (FS) score—the sum of the WPI and SSS—which permitted a quantitative measurement of the severity of fibromyalgia symptoms.1 This scale can also be used with the 2010 criteria as the WPI and SSS are part of both criteria sets. In the text that follows we often refer to the “2010/2011” criteria when we want to address the 2010 as well as the 2011 criteria, as both sets are extremely similar.

Both the 1990 and the 2010/2011 criteria separate cases and non-cases based on severity. The 2010/2011 criteria discriminate based on the levels of WPI and SSS, but can easily and appropriately be modeled by the 0–31 FS score. By criteria definition, it is impossible to satisfy the 2010/2011 criteria with an FS score < 12. The overall accuracy of an FS classification using an FS cut point of 12–13 depends on the distribution of FS scores, but has been shown to be about 92–96% (see discussion below and Ref. [9]). The 1990 criteria require the presence of widespread pain (4-quadrant pain), but once that is present, all persons with ≥11 tender points satisfy the fibromyalgia criteria. Approximately 10–12% of the general population report widespread pain [10]. The tender point count depends not only on the intrinsic decrease in pain threshold but also on the self-report of the patient and the performance and interpretation of the physician examiner. The tender point count is highly correlated with patient symptoms, but the dolorimetry measure of pain threshold, which may be considered a semi-objective measure of pain threshold, is not. Gracely et al. [11] called the tender point count “some unspecified combination of tenderness and distress”; it has also been called “a sedimentation rate for distress” [12].

The absence of a gold standard to identify fibromyalgia confounds evaluation of fibromyalgia criteria. This problem begins with the arbitrary nature of 1990 caseness and extends to measurement issues in the 1990 and 2010/2011 criteria. For the 1990 criteria, measurement error, difficulty in the performance of the tender point examination, and subjective contribution of physicians and patients leads to reduced reliability and validity. However, except for concern about circularity expressed after the publication of the 1990 criteria [13], there has been almost no criticism of the validity or reliability of the 1990 criteria. The few data available show reliability coefficients ≤0.71 [14], [15], [16], [17]. The tender point count appears to work best when there is unspoken interaction between doctors and patients who take clues from each other and adjust their examinations and response, as fibromyalgia symptoms are always on the minds of the physician and patient. One could argue that during the clinical interview for 1990 criteria diagnosis, elements of the 2010/2011 criteria are almost always included. However, no study has examined that possibility.

In the evaluation of 2010/2011 criteria, the 1990 criteria have been used as a reference standard, with the result that inherent measurement error in the 1990 criteria will be carried over to the 2010/2011 criteria. The idea that valid sensitivity and specificity can be derived from comparisons with the 1990 criteria is only partially true, as the 1990 criteria examination will often be unreliable. A second major factor in any disagreement between the 1990 and 2010/2011 criteria is that the 2010 criteria deliberately altered the definition of fibromyalgia slightly by explicitly giving more emphasis to symptoms by the use of the SSS. Thus, in evaluating external data that includes the 1990 criteria, a level of 85% agreement, as observed in the 2010 study [2], can be interpreted as very close agreement.

In accordance with ACR criteria committee’s recommendation in 2010 regarding external validation and intermittent updates, the purpose of this report is to evaluate published data relating to external validation of the 2010/2011 criteria, examine published and unpublished problems with the criteria, and to update the criteria to address problems that have been noted. In addition, we further propose to combine the 2010 and 2011 criteria sets and clarify definitions that would enable the combined 2016 revision to function as diagnostic and classification criteria.

Section snippets

Studies

We evaluated studies of adults primarily with respect to sensitivity/specificity, fibromyalgia severity (FS), and study methodology, and we sought reports regarding problems with the 2010/2011 criteria in Figure 1. All published reports that evaluated either 2010 criteria or 2011 criteria are included in Table 1 if they were comparison studies and provided sufficient information for evaluation. We also included information from databanks or epidemiology studies if the studies provided FS

Characterizations in Table 1

We categorized each study by type: whether they evaluated 2010, 2011, or were databank or epidemiology studies. Based on the comparison of the 2010 or 2011 study with 1990 or clinical criteria, we reported sensitivity, specificity, FS, WPI, SSS, and tender point counts, when available. Clinical criteria were defined as those criteria based on the investigator or clinician’s experience or intuition. We categorized studies according to whether the FM 2010/2011 criteria study used FM 1990 “ACR

Discussion

At the time of diagnosis, fibromyalgia in adults may be seen as a syndrome of moderate-to-severe symptoms and findings that usually include widespread pain and point tenderness, together with fatigue, sleep disturbance, cognitive complaints, and a general increase in somatic complaints. In populations, the symptoms exist as a continuum, cornucopia-like—from few to many and from mild to severe, and may be recognized by plotting the FS scale against specific symptoms [23].

Fibromyalgia may be

Summary

With more than 5 years of experience, the 2010/2011 criteria have been shown to be useful and valid in multiple settings. We have now combined the ACR 2010 criteria set and the 2011 modified criteria into a single set of dual purpose criteria (2016 modified criteria—Table 4). These criteria can continue to serve as diagnostic criteria when used in the clinic, but also as classification criteria when used for research. The combined criteria introduce several changes based on experience in

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