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Objective: In 2016, a revised version of the 2010 American College of Rheumatology fibromyalgia (FM) criteria and the 2011 self-report (survey) FM criteria were published. The 2016 criteria preserved the distinction between physician and patient criteria, but made the individual criteria items identical, added a "generalized pain" criterion, and changed ascertainment and scoring methods, among other changes. In this study, we evaluated diagnostic differences relating to 2016 changes., Methods: We used the National Data Bank for Rheumatic Diseases and evaluated 16,987 participants with painful rheumatic disorders using the 2011 and 2016 methodologies., Results: There were 4731 patients (27.9%) who satisfied the 2011 criteria and 4077 (24.0%) the 2016 revision. This resulted in agreement in 96.2% of cases and disagreement in 3.9%. All disagreements occurred in the 4731 2011-positive cases who failed to meet the 2016 criteria. This result came about because 654 (13.8%) of the 2011-positive cases failed to meet the new generalized pain requirement. When using the approximate polysymptomatic distress diagnostic method, diagnostic misclassification ranged between 7% and 13%., Conclusion: The 2016 FM criteria further refined and increased the usefulness of symptom-based diagnosis of FM by excluding patients with regional pain syndromes. However, these changes, useful as they are, underscore the social construction of symptom-based diagnosis and the inherent limitations in reliability and validity associated with FM criteria.

Objective: Widespread pain is no longer required for fibromyalgia (FM) diagnosis according to the American College of Rheumatology (ACR) 2010 preliminary diagnostic criteria and its 2011 modification, but its absence may be of concern. We investigated whether the widespread pain definition was satisfactory and the consequences of having a small number of painful regions or of not satisfying the widespread pain criterion., Methods: We studied 5011 patients who satisfied the 2011 criteria. FM was identified using the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS): WPI ≥ 7 and SSS ≥ 5 or WPI 3-6 and SSS ≥ 9. Widespread pain was 4 quadrants plus axial pain, according to the 1990 ACR FM criteria., Results: There were 4700 patients (93.8%) who satisfied the ACR 1990 widespread pain criterion. Using a new strict definition for 5 pain regions based on the WPI sites, a modified widespread pain criterion requiring 4 of 5 regions identified 98.8% of criteria-positive patients. Patients without widespread pain or those in the low WPI/high SSS group had milder FM and no evidence of increased psychological or physical distress., Conclusion: In usual clinical and epidemiological studies, the 2011 and 2010 criteria work well, but are not as effective in patients with asymmetrical or regional pain who do not satisfy a widespread pain criterion. A ≥ 4-pain region widespread pain definition will eliminate regional pain false-positives and will identify 98.8% of current 2011 cases. Future revisions of the 2010/2011 criteria should consider incorporating the ≥ 4-region requirement to avoid misclassification.

Objective: Fibromyalgia (FM) in rheumatoid arthritis (RA) can cause consternation because symptoms are seen to be out of proportion to physician and laboratory assessments, and composite RA activity scores such as the 28 joint Disease Activity Score, Clinical Disease Activity Index, and Routine Assessment of Patient Index Data 3 (RAPID-3) can yield apparently "wrong" results. We explored the effect of polysymptomatic distress (PSD), a measure of fibromyalgianess and a quantity derived from the American College of Rheumatology 2010 FM diagnostic criteria, to explain the relationship of patient to physician variables., Methods: We obtained PSD scores on 300 RA patients prior to ordinary clinical care, and assessed the associations of PSD with tender and swollen joints, physician global estimate of RA activity, pain, Health Assessment Questionnaire score, and composite RA activity measures during routine clinic assessments., Results: PSD scores greater than the sample mean (8.8) were associated with increased patient symptoms regardless of the presence or absence of FM, while scores below the mean were associated with better patient outcomes. PSD scores predicted all patient outcomes and less strongly predicted physician outcomes. The discrepancy between patient and physician measures was greatest at low levels of physician-estimated disease activity., Conclusion: PSD rather than FM diagnosis more usefully identifies and predicts disproportionate responses. Just as there are patients who lean disproportionately toward greater severity, there are also patients who disproportionately report milder symptoms. Composite measures used to assess RA are flawed, as they confound RA inflammation and patient distress, and more consideration should be given to disaggregated assessments. PSD also appears to be influenced weakly by RA disease activity., (Copyright © 2014 by the American College of Rheumatology.)

Abstract Criteria for fibromyalgia developed from the conceptualization and hypotheses of Smythe and Moldofsky in 1977 and gradually evolved to a set of classification criteria endorsed by the American College of Rheumatology that emphasized tender points and widespread pain, measures of decreased pain threshold. In 2010, American College of Rheumatology fibromyalgia diagnostic criteria were published that abandoned the tender point count and placed increased emphasis of patient symptoms. The 2010 criteria also contained severity scales and offered physicians the opportunity to assess polysymptomatic distress on a continuous scale. This enabled physicians who were opposed to the idea of fibromyalgia to also assess and diagnose patients using an alternative nomenclature.

Objective: To describe the diagnosis status and outcome of patients diagnosed with fibromyalgia (FM) by US rheumatologists., Methods: We assessed 1555 patients with FM with detailed outcome questionnaires during 11,006 semiannual observations for up to 11 years. At entry, all patients satisfied American College of Rheumatology preliminary 2010 FM criteria modified for survey research. We determined diagnosis status, rates of improvement, responder subgroups, and standardized mean differences (effect sizes) between start and study completion scores of global well-being, pain, sleep problems, and health related quality of life. (QOL) RESULTS: The 5-year improvement rates were pain 0.4 (95% CI 0.2, 0.5), fatigue 0.4 (95% CI 0.2, 0.05), and global 0.0 (95% CI -0.1, 0.1). The standardized mean differences were patient global 0.03 (95% CI -0.02, 0.08), pain 0.22 (95% CI 0.16, 0.28), sleep problems 0.20 (95% CI 0.14, 0.25), physical component summary of the Short-form 36 (SF-36) 0.11 (95% CI -0.14, -0.07), and SF-36 mental component summary 0.03 (95% CI -0.07, 0.02). Patients switched between criteria-positive and criteria-negative states, with 716 patients (44.0%) failing to meet criteria at least once during 4228.5 patient-years (7448 observations). About 10% of patients had substantial improvement and about 15% had moderate improvement of pain. Overall, FM severity worsened in 35.9% and pain in 38.6%., Conclusion: Although we found no average clinically meaningful improvement in symptom severity overall, 25% had at least moderate improvement of pain over time. The result that emerged from this longitudinal study was one of generally continuing high levels of self-reported symptoms and distress for most patients, but a slight trend toward improvement.

Objective: An OMERACT consensus process recommended domains for investigation in fibromyalgia (FM) clinical trials. We used patient data to investigate variable importance in the determination of patient global and health-related quality of life (HRQOL) in FM and non-FM patients to determine whether variables were valued differently in FM compared with non-FM states., Methods: We used ACR 2010 diagnostic FM criteria modified for epidemiological and clinical research to identify patients with rheumatoid arthritis (RA; N = 5884) with and without FM, and also characterized previously diagnosed patients with FM (N = 808) as to current criteria status. We measured variable importance by multivariable regression, decomposing regression variance by averaging over model orderings. We examined the distributions of key variables in the various disorders, and the distributions as a function of a FM severity index (fibromyalgianess)., Results: Out of 9 measures, pain, Health Assessment Questionnaire disability index, and fatigue explained more than 50% of explainable variance (50.49%-56.59%). Explained variance was similar across all disorders and diagnostic groups. In addition, the SF-36 physical component summary score varied across disorders as a function of fibromyalgianess., Conclusion: The main determinants of global severity and HRQOL in FM are pain, function, and fatigue. But these variables are also the main determinants in RA and other rheumatic diseases. The content and impact of FM, whether measured by discrete variables or a fibromyalgianess scale, seems to be independent of diagnosis. These data argue for a common set of variables rather than disease-specific variables. Clinical use is supported and enhanced by simple measures.

Previous qualitative studies have revealed discrepancies between patients' and physicians' perceptions of rheumatoid arthritis (RA) and its treatment. Questionnaires were administered to 2795 patients with RA (756 from Europe; 2039 from the USA) to measure patients' perceptions regarding pain management in RA. Although the majority of patients reported their RA as somewhat-to-completely controlled, 75% of European and 82% of US patients reported their pain as moderate-to-severe in the previous 2 months. The majority of European (60%) and US (65%) patients reported dissatisfaction with their arthritis pain. Patients' pain levels corresponded with their disease severity. A higher percentage of patients who reported severe pain were being treated for depression than those who had moderate or mild pain. Patients in the USA rated pain relief as the top required benefit from their RA medication. A comprehensive examination of patients' perspectives regarding pain could lead to better patient care and pain management strategies.

Objective: To develop simple, practical criteria for clinical diagnosis of fibromyalgia that are suitable for use in primary and specialty care and that do not require a tender point examination, and to provide a severity scale for characteristic fibromyalgia symptoms., Methods: We performed a multicenter study of 829 previously diagnosed fibromyalgia patients and controls using physician physical and interview examinations, including a widespread pain index (WPI), a measure of the number of painful body regions. Random forest and recursive partitioning analyses were used to guide the development of a case definition of fibromyalgia, to develop criteria, and to construct a symptom severity (SS) scale., Results: Approximately 25% of fibromyalgia patients did not satisfy the American College of Rheumatology (ACR) 1990 classification criteria at the time of the study. The most important diagnostic variables were WPI and categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and number of somatic symptoms. The categorical scales were summed to create an SS scale. We combined the SS scale and the WPI to recommend a new case definition of fibromyalgia: (WPI > or =7 AND SS > or =5) OR (WPI 3-6 AND SS > or =9)., Conclusion: This simple clinical case definition of fibromyalgia correctly classifies 88.1% of cases classified by the ACR classification criteria, and does not require a physical or tender point examination. The SS scale enables assessment of fibromyalgia symptom severity in persons with current or previous fibromyalgia, and in those to whom the criteria have not been applied. It will be especially useful in the longitudinal evaluation of patients with marked symptom variability.

Objective: To determine the incidence of self-reported depression (SRD) in rheumatoid arthritis and to identify and rank clinically useful predictors of depression., Methods: We assessed 22,131 patients for SRD between 1999 and 2008. We collected demographic, clinical and treatment data, household income, employment and work disability status, comorbidity, scales for function, pain, global, and fatigue, the Regional Pain Scale (RPS), the Symptom Intensity (SI) scale (a linear combination of the RPS and the fatigue scales) and linear combinations of the Health Assessment Questionnaire, pain and global severity. We used logistic regression analyses with multivariable fractional polynomial predictors, and Random Forest analysis to determine the importance of the predictors., Results: The cross-sectional prevalence of self-reported depression was 15.2% (95% confidence interval [95% CI] 14.7-15.7%) and the incidence rate was 5.5 (95% CI 5.3-5.7) per 100 patient years of observation. The cumulative risk of SRD after 9 years was 38.3% (95% CI 36.6-40.1%). Almost all variables were significant predictors in logistic models. In Random Forest analyses, the SI scale, followed by comorbidity, best predicted self-reported depression, and no other variable or combination of variables improved prediction compared with the SI scale., Conclusion: Pain extent and fatigue (SI scale) are the dominant predictors of SRD. These variables, also of central importance in the symptomatology of fibromyalgia, are powerful markers of distress. A strong case can be made for the inclusion of these assessments in routine rheumatology practice. In addition, actual knowledge of comorbidity provides important insights into the patient's global health and associated perceptions.

Objective: To compare a visual analog pain scale (VAS) with the Medical Outcomes Study Short Form-36 Health Survey (SF-36) bodily pain; to define the minimal clinically important change (MCIC) for pain in observational studies; to define clinically useful cutpoints for pain; to quantify the predictors of pain; and to estimate the effect of anti-tumor necrosis factor (TNF) therapy on pain., Methods: Over 6 years we studied 12,090 patients with rheumatoid arthritis (RA). Pain was assessed by VAS and SF-36 pain scales., Results: Compared with the SF-36 scale, the 0-10 VAS pain scale was better correlated with all clinical variables. The mean VAS score was 3.4 (standard deviation 2.8), and the best cutpoint for an "acceptable" level of pain was

Background: Glucosamine and chondroitin sulfate are used to treat osteoarthritis. The multicenter, double-blind, placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis., Methods: We randomly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily, 1200 mg of chondroitin sulfate daily, both glucosamine and chondroitin sulfate, 200 mg of celecoxib daily, or placebo for 24 weeks. Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia. Assignment was stratified according to the severity of knee pain (mild [N=1229] vs. moderate to severe [N=354]). The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24., Results: The mean age of the patients was 59 years, and 64 percent were women. Overall, glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent. As compared with the rate of response to placebo (60.1 percent), the rate of response to glucosamine was 3.9 percentage points higher (P=0.30), the rate of response to chondroitin sulfate was 5.3 percentage points higher (P=0.17), and the rate of response to combined treatment was 6.5 percentage points higher (P=0.09). The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group (P=0.008). For patients with moderate-to-severe pain at baseline, the rate of response was significantly higher with combined therapy than with placebo (79.2 percent vs. 54.3 percent, P=0.002). Adverse events were mild, infrequent, and evenly distributed among the groups., Conclusions: Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain. (ClinicalTrials.gov number, NCT00032890.)., (Copyright 2006 Massachusetts Medical Society.)

Unlabelled: OBJECTIVE. Jaw pain may occur in rheumatoid arthritis (RA), osteoarthritis (OA), and fibromyalgia (FM). We investigated the prevalence and correlates of jaw pain, and whether jaw pain is increased in RA, where intrinsic articular disease can be noted radiographically, or is a manifestation of a generalized pain problem., Methods: We analyzed data from 22,720 patients participating in a longitudinal outcome study of rheumatic diseases, including 17,683 with RA, 4,011 with OA, and 1,026 with FM. Jaw pain was considered to be present if a patient indicated it in either the left or right jaw. In addition to standard rheumatic disease measures, we also obtained self-report assessments that included a count of painful nonarticular regions (the regional pain score, RPS), a joint count, and a count of symptoms., Results: The age and sex adjusted rate of jaw pain was 18.7% in RA, 18.6% in OA, and 35.4% in FM. Jaw pain was best predicted by joint count, RPS, and a count of somatic symptoms in univariate analyses. In multivariate analyses jaw pain was predicted by joint count, RPS, symptom count, and fatigue. The ROC area under the curve for this model was 0.79, and 82.8% of patients were correctly classified. There was little difference in predictor variables for RA and OA patients. Covariate adjusted analyses controlling for age, sex, symptom count, fatigue, RPS, and joint count predicted jaw pain in 14.7% (95% CI 14.1 to 15.3) of RA and 11.6% (95% CI 10.6 to 12.7) of OA patients. This difference, 3.1%, may represent the increment in jaw pain attributable to RA., Conclusion: Jaw pain is present in about 19% of patients with RA and OA, and is primarily a marker for a general pain increase and symptom sensitivity problem. Patients who have jaw pain have worse outcomes manifested by decreased functional ability, lower household income, and decreased quality of life. Variables not usually formally measured in clinical practice best identify this problem: self-reported joint count, symptom count, count of painful regions (RPS), and a visual analog scale for fatigue.

Objective: To develop and validate a pain scale that measures the extent of body pain., Methods: A total of 12,799 patients with rheumatoid arthritis (RA), osteoarthritis (OA), and fibromyalgia (FM) completed a mailed survey regarding the location and intensity of their pain in 38 articular and nonarticular regions. The data were analyzed using item response theory (IRT) by nonparametric Mokken analysis followed by Rasch analysis. The resultant scale was examined for its association with clinical severity variables and its ability to distinguish patients diagnosed with and without FM., Results: The resultant 19 item regional pain scale (RPS) was composed primarily of nonarticular regions. The scale had strong scalability as measured by the Mokken H statistic (H = 0.52), and satisfied the Mokken monotonicity and double monotonicity criteria. The RPS also fit the Rasch model and had satisfactory reliability and separation statistics. Of all clinical variables assessed by survey, the RPS best identified patients diagnosed with FM. In addition, the scale correlated with measures of clinical severity, regardless of diagnosis, and predicted measures of utilization., Conclusion: The RPS is a valid scale of pain extent. It can be useful to identify patients with FM or can be used to develop a new definition of FM, even among patients with concomitant illnesses such as RA and OA. In addition, it is a measure of pain extent that is disease independent, and works as well in RA and OA as in FM to identify patients with increased severity and resource utilization.

The clinical and neurochemical association between depression and season noted in seasonal affective disorder (SAD) has suggested that clinical pain might also be linked to season, perhaps through similar neurochemistry or the known association of depression with pain. We investigated the pain-light season/dark season hypothesis in 2523 rheumatic disease outpatients by examining VAS Pain and VAS Global Severity scores, as well as levels of depression and functional disability. No clinically significant difference in pain severity between season (or individual month) was noted for the consecutive outpatients at their first clinic visit, nor in sub-analyses using paired light and dark season visits. A slight trend toward increased pain severity in lighter months by about 3% compared to darker months was identified. No effect of season was seen on depression scores. In a subset of patients with high depression scores, rheumatoid arthritis and osteoarthritis patients, respectively, reported 16% and 7% greater pain scores in light compared to dark months, but fibromyalgia patients had stable scores. Season does not appear to play an important role in pain and/or depression in rheumatic disorders.

Four experts on myofascial pain syndrome (MFP) performed trigger point examinations and 4 experts on fibromyalgia performed tender point examinations on 3 groups of subjects (7 patients with fibromyalgia, 8 with MFP, and 8 healthy persons) while blinded as to diagnosis. Local tenderness was common in both disease groups (65-82%), but was elicited in a greater proportion of MFP experts' examinations (82%). Active trigger points were found in about 18% of examinations of patients with fibromyalgia and MFP, but latent trigger points were rare in all groups. A more liberal definition of trigger point, however, resulted in a 38 and 23% positive rate among patients with fibromyalgia and MFP, respectively. Taut muscle bands and muscle twitches were common (50 and 30%, respectively) and noted equally in all 3 diagnostic groups. Problems with reliability were identified for taut bands, muscle twitch, and active trigger points. Our data are exploratory and tentative, but suggest that attention to definition and reliability are required to advance our knowledge of these common syndromes.

We studied the pain, Stanford Health Assessment Questionnaire functional disability, pain/disability ratio, and psychological scores in 1,522 patients with rheumatic disease with 7 distinct disorders. Individual differences between patients were more striking than differences among diagnostic groups. Patients with rheumatoid arthritis (RA) had the greatest disability, least pain, lowest pain/disability ratio, and least abnormal psychological scores. Highest pain and psychological distress was noted in low back pain, neck pain, and fibromyalgia (axial disorders). Disability in activities of daily living was as high in fibromyalgia as in RA, but low in axial skeletal disorders. There appears to be a continuum for disability that begins with axial but not articular disease (neck and back pain) and ends with multiple articular and periarticular involvement (RA and fibromyalgia).

Tender point examinations were performed on 1520 consecutive patients with various rheumatic diseases. The mean tender point count was 2.1 (3.6 SD). Four or more tender points were found in 22.9%, 7 or more in 13.6%, 12 or more 4.3%, but 60.1% had no tender points. The tender point count increased gradually with age, reaching a maximum at age 70. Women had more tender points than men, Caucasians more than blacks or Hispanics. Isolated regional clusters of tender points occurred at the shoulder girdle in 7.8%, and the knees in 7.4%. Correlation between tender points and associated peripheral joint tenderness was poor.