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Langhorst J.,University of Duisburg - Essen | Hofstetter A.,University of Duisburg - Essen | Wolfe F.,National Data Bank for Rheumatic Diseases | Wolfe F.,University of Kansas | And 2 more authors.
Inflammatory Bowel Diseases | Year: 2013

Background: Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. Psychological factors such as depression and stress are under debate to contribute to the risk of relapse. The impact of mucosal healing to reduce the risk of relapse had not been studied prospectively. The aim of this study was to identify whether depression and stress increase and mucosal healing reduces the risk of clinical relapse in patients with UC in clinical remission. Methods: Patients in clinical remission were followed prospectively for 1 year, or less if they relapsed. Endoscopy and histology score and long-term perceived stress (Perceived Stress Questionnaire) were measured at baseline. Mucosal healing was defined by a Mayo Endoscopy score of 01. Depression (Hospital Anxiety and Depression Scale) and acute perceived stress (Cohen Perceived Stress Scale) were measured at baseline and after 1, 3, 6, 9, and 12 months. A time-dependent multivariate Cox regression model determined the predictors of time to relapse. Results: Seventy-five patients were included into final analysis, of which 28 (37.3%) relapsed. Short-term stress at the last visit before relapse (hazard ratio [HR] = 1.05, 95% confidence interval [CI] = 1.011.10) and male gender (HR = 2.38, 95% CI = 1.015.61), but not baseline mucosal healing (HR = 0.86, 95% CI = 0.352.11), baseline long-term stress (HR = 0.20, 95% CI = 0.013.31), and depression at the last visit before relapse (HR = 1.08, 95% CI = 0.951.22) were predictive for a relapse. Conclusions: Short-term stress but not depression nor mucosal healing was predictive for the risk of relapse in patients with UC in clinical remission. Larger multicentre studies are necessary to confirm our findings. © 2013 Crohn's & Colitis Foundation of America, Inc.


Hauser W.,Clinical Center Saarbrucken | Hauser W.,TU Munich | Wolfe F.,National Data Bank for Rheumatic Diseases | Wolfe F.,University of Kansas | And 3 more authors.
CNS Drugs | Year: 2012

Background: The role of antidepressants in the management of fibromyalgia syndrome (FMS) still needs to be determined. Objective: The objective of this study was to provide a quantitative analysis (meta-analysis) of the efficacy and harms of antidepressants in the management of adult FMS patients. Data sources: The data sources used were the databases MEDLINE, SCOPUS and the Cochrane Central Register of Controlled Trials (until December 30, 2010), the reference lists of included articles, and the websites of the US National Institutes of Health (NIH) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Study selection: Studies with a randomized controlled trial (RCT) design comparing any types of antidepressants with pharmacological placebo or head-to-head comparisons of different types of antidepressants in FMS patients were included. RCTs in which antidepressants were combined with any other defined treatment or antidepressants were tested against anything but drug placebo were excluded. Patients diagnosed with FMS according to predefined criteria of any age were included. To be included, studies had to assess at least one key domain of FMS (pain, sleep, fatigue, health-related quality of life [HRQOL]) as outcomes of efficacy and report total treatment discontinuation rates and/or dropout rates due to adverse events as outcomes for harms. Data extraction: Data were extracted according to protocols of previous systematic reviews on antidepressants in FMS. Methodology quality was assessed by the van Tulder score. Data synthesis: Standardized mean differences (SMD) were calculated for continuous outcomes by means and standard deviations and relative risks (RR) for 30% pain reduction and total dropout rate for comparisons of antidepressants with placebo. Examination of the combined results was performed by a random effects model. We used Cohen's categories to evaluate the magnitude of the effect size, calculated by SMD. Heterogeneity was tested by the I 2 statistic. Thirty-five studies were included in the meta-analysis. The SMDs of serotonin noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) on pain, sleep, fatigue, depression and HRQOL were significant. Based on Cohen's categories, the effect size on pain was small and the ones on sleep, fatigue, depression and HRQOL were not substantial. 1481/3528 (42.0%) patients with SNRIs and 737/2304 (32.0%) patients with placebo reported a 30% pain reduction (number needed to treat [NNT] 10.0; 95% CI 8.00, 13.4; I 2=4%). The RR of dropouts due to adverse events was 1.83 (95% CI 1.53, 2.18; I 2=33%). The SMDs of selective serotonin reuptake inhibitors (SSRIs) on pain, sleep, depression and HRQOL were significant. Based on Cohen's categories, the effect sizes on pain, depression and HRQOL were small and the one on sleep not substantial. 72/198 (36.4%) patients with SSRIs and 40/194 (20.6%) patients with placebo reported a 30% pain reduction (NNT 6.3; 95% CI 4.1, 14.1). The RR of dropouts due to adverse events was 1.60 (95% CI 0.84, 3.04; I 2=0%). The SMDs of tricyclic antidepressants (TCAs) on pain, sleep, fatigue and HRQOL were significant. Based on Cohen's categories, the effect sizes on pain and sleep were moderate and the ones on fatigue and HRQOL were small. 140/290 (48.3%) patients with TCAs and 70/252 (27.8%) patients with placebo reported a 30% pain reduction (NNT 4.9; 95% CI 3.5, 8.0). The RR of dropouts due to adverse events was 0.84 (95% CI 0.46, 1.52; I 2=0%). Conclusions: The TCA amitriptyline and the SNRIs duloxetine and milnacipran are first-line options for the treatment of FMS patients. Physicians and patients should be realistic about the potential benefits of antidepressants in FMS. A small number of patients experience a substantial symptom relief with no or minor adverse effects. However, a remarkable number of patients dropout of therapy because of intolerable adverse effects or experience only a small relief of symptoms, which does not outweigh the adverse effects. © 2012 Adis Data Information BV. All rights reserved.


Wolfe F.,National Data Bank for Rheumatic Diseases | Walitt B.T.,Washington Hospital Center | Katz R.S.,Rush University Medical Center | Hauser W.,TU Munich
Arthritis Care and Research | Year: 2014

Objective. To determine prevalence and incidence of US Social Security Disability and Supplemental Security Income (SSD) in patients with fibromyalgia and to investigate prediction of SSD. Methods. Over a mean of 4 years (range 1-13 years), we studied 2,321 patients with physician-diagnosed fibromyalgia (prevalent cases) and applied modified American College of Rheumatology (ACR) 2010 research criteria to identify criteria-positive patients. Results. During the study, 34.8% (95% confidence interval [95% CI] 32.9-36.8%) of fibromyalgia patients received SSD. The annual incidence of SSD among patients not receiving SSD at study enrollment was 3.4% (95% CI 3.0-3.9%), and 25% were estimated to be work disabled at 9.0 years of followup. By comparison, the prevalence of SSD in rheumatoid arthritis (RA) patients with concomitant fibromyalgia was 55.6% (95% CI 54.3-57.0%) and was 42.4% in osteoarthritis (OA). By study conclusion, 31.4% of SSD awardees were no longer receiving SSD. In univariate models, incident SSD in patients with fibromyalgia was predicted by sociodemographic measures and by symptom burden; but the strongest predictor was functional status (Health Assessment Questionnaire disability index [HAQ DI]). In multivariable models, the HAQ DI and the Short Form 36-item health survey physical and mental component summary scores, but no other variables, predicted SSD. Fibromyalgia criteria-positive patients had more SSD, but the continuous scale, polysymptomatic distress index derived from the ACR criteria was a substantially better predictor of SSD than a criteria-positive diagnosis. Conclusion. The prevalence of SSD is high in fibromyalgia, but not higher than in RA and OA patients who satisfy fibromyalgia criteria. The best predictors of work disability are functional status variables. Copyright © 2014 by the American College of Rheumatology.


Wolfe F.,National Data Bank for Rheumatic Diseases | Michaud K.,National Data Bank for Rheumatic Diseases
Arthritis Research and Therapy | Year: 2010

Introduction: The long-term course of rheumatoid arthritis (RA) in terms of health status is not well understood, nor is the degree of effectiveness of biologic therapy in the community. We modeled the progression of loss of health status, and measured incremental costs and effectiveness of biologic therapy in the community.Methods: We studied change in function and health status in 18,485 RA patients (135,731 observations) at six-month intervals for up to 11 years, including a group of 4,911 patients (59,630 observations) who switched to biologic therapy from non-biologic therapy. We measured the SF-36 Physical Component (PCS) and Mental Component (MCS) Summary scales, the EQ-5D health utility scale, and the Health Assessment Questionnaire (HAQ) disability scale; and we calculated treatment and direct medical costs.Results: RA onset caused an immediate and substantial reduction in physical but not mental health status. Thereafter, the progression of dysfunction in RA was very slow (HAQ 0.016 units and PCS -0.125 units annually), only slightly worse than the age and sex-adjusted US population. We estimated biologic treatment to improve HAQ by 0.29 units, PCS by 5.3 units, and EQ-5D by 0.05 units over a 10-year period. The estimated incremental 10-year total direct medical cost for this benefit was $159,140.Conclusions: Biologic therapy retards RA progression, but its effect is far less than is seen in clinical trials. In the community, cost-effectiveness is substantially less than that estimated from clinical trial data. The study results represent the incremental benefit of adding biologic therapy to optimum non-biologic therapy. © 2010 Wolfe et al.; licensee BioMed Central Ltd.


Caplan L.,University of Colorado at Denver | Wolfe F.,University of Kansas | Michaud K.,National Data Bank for Rheumatic Diseases | Michaud K.,University of Nebraska Medical Center | And 2 more authors.
Arthritis Care and Research | Year: 2014

Objective Studies linking health literacy to outcomes in rheumatoid arthritis (RA) have been underpowered and have not adequately accounted for confounders. We examined the association of health literacy with functional status in 6,052 subjects participating in a prospective observational study, controlling for numerous important covariates. Methods Using linear regression, we analyzed the cross-sectional association of health literacy, as measured by 2 validated single-item literacy screening questions (SILS1 and SILS2), and functional status, assessed by the Health Assessment Questionnaire (HAQ) disability index. Subjects reported demographics, comorbidities, social support, educational attainment, visual problems, and memory problems, as well as use of prednisone, disease-modifying antirheumatic drugs, and biologic agents. Each SILS measure was forced into the final model. Results Low health literacy was present in 7.0% and 4.3% of subjects (per SILS1 and SILS2, respectively). When controlling for all covariates, low health literacy was associated with a 0.376-point greater HAQ score, compared to subjects with adequate health literacy (95% confidence interval 0.306, 0.447; P < 0.001). This relationship persisted, even after modeling educational attainment. Results were similar for the 2 SILS instruments. Low health literacy was also associated with poorer self-reported adherence to RA medications. Visual and memory problems were associated with worse functional status. Conclusion Health literacy was more strongly associated with functional status than prednisone use, smoking history, and biologic agent use, and independent of educational attainment. Health literacy may play an important role in understanding functional status in RA patients. Single-item questions amenable to use in the clinical setting may identify subjects with low health literacy, who are at risk for poor RA outcomes. © Published 2014. This article is a U.S. Government work and is in the public domain in the USA.


Wolfe F.,National Data Bank for Rheumatic Diseases | Clauw D.J.,University of Michigan | Fitzcharles M.-A.,McGill University | Goldenberg D.L.,Tufts University | And 6 more authors.
Journal of Rheumatology | Year: 2011

Objective. To develop a fibromyalgia (FM) survey questionnaire for epidemiologic and clinical studies using a modification of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010). We also created a new FM symptom scale to further characterize FM severity. Methods. The ACR 2010 consists of 2 scales, the Widespread Pain Index (WPI) and the Symptom Severity (SS) scale. We modified these ACR 2010 criteria by eliminating the physician's estimate of the extent of somatic symptoms and substituting the sum of 3 specific self-reported symptoms. We also created a 0-31 FM Symptom scale (FS) by adding the WPI to the modified SS scale. We administered the questionnaire to 729 patients previously diagnosed with FM, 845 with osteoarthritis (OA) or with other noninflammatory rheumatic conditions, 439 with systemic lupus erythematosus (SLE), and 5210 with rheumatoid arthritis (RA). Results. The modified ACR 2010 criteria were satisfied by 60% with a prior diagnosis of FM, 21.1% with RA, 16.8% with OA, and 36.7% with SLE. The criteria properly identified diagnostic groups based on FM severity variables. An FS score ≥ 13 best separated criteria+ and criteria- patients, classifying 93.0% correctly, with a sensitivity of 96.6% and a specificity of 91.8% in the study population. Conclusion. A modification to the ACR 2010 criteria will allow their use in epidemiologic and clinical studies without the requirement for an examiner. The criteria are simple to use and administer, but they are not to be used for self-diagnosis. The FS may have wide utility beyond the bounds of FM, including substitution for widespread pain in epidemiological studies. The Journal of Rheumatology Copyright © 2011. All rights reserved.


Wolfe F.,National Data Bank for Rheumatic Diseases | Wolfe F.,University of Kansas | Hauser W.,TU Munich
Annals of Medicine | Year: 2011

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. © 2011 Informa UK, Ltd.


Hernandez Alava M.,University of Sheffield | Wailoo A.,University of Sheffield | Wolfe F.,National Data Bank for Rheumatic Diseases | Michaud K.,National Data Bank for Rheumatic Diseases | Michaud K.,University of Nebraska Medical Center
Medical Decision Making | Year: 2014

Background: Analysts frequently estimate health state utility values from other outcomes. Utility values like EQ-5D have characteristics that make standard statistical methods inappropriate. We have developed a bespoke, mixture model approach to directly estimate EQ-5D. An indirect method, "response mapping," first estimates the level on each of the 5 dimensions of the EQ-5D and then calculates the expected tariff score. These methods have never previously been compared.Results: The linear model fits poorly, particularly at the extremes of the distribution. The bespoke mixture model and the indirect approaches improve fit over the entire range of EQ-5D. Mean average error is 10% and 5% lower compared with the linear model, respectively. Root mean squared error is 3% and 2% lower. The mixture model demonstrates superior performance to the indirect method across almost the entire range of pain and HAQ. These lead to differences in cost-effectiveness of up to 20%.Methods: We use a large observational database from patients with rheumatoid arthritis (N = 100,398). Direct estimation of UK EQ-5D scores as a function of the Health Assessment Questionnaire (HAQ), pain, and age was performed with a limited dependent variable mixture model. Indirect modeling was undertaken with a set of generalized ordered probit models with expected tariff scores calculated mathematically. Linear regression was reported for comparison purposes. Impact on cost-effectiveness was demonstrated with an existing model.Conclusions: There are limited data from patients in the most severe HAQ health states. Modeling of EQ-5D from clinical measures is best performed directly using the bespoke mixture model. This substantially outperforms the indirect method in this example. Linear models are inappropriate, suffer from systematic bias, and generate values outside the feasible range. © The Author(s) 2013.


Vincent A.,Mayo Medical School | Lahr B.D.,Mayo Medical School | Wolfe F.,National Data Bank for Rheumatic Diseases | Clauw D.J.,University of Michigan | And 4 more authors.
Arthritis Care and Research | Year: 2013

Objective To estimate and compare the prevalence of fibromyalgia by 2 different methods in Olmsted County, Minnesota. Methods The first method was a retrospective review of medical records of potential cases of fibromyalgia in Olmsted County using the Rochester Epidemiology Project (from January 1, 2005, to December 31, 2009) to estimate the prevalence of diagnosed fibromyalgia in clinical practice. The second method was a random survey of adults in Olmsted County using the fibromyalgia research survey criteria to estimate the percentage of responders who met the fibromyalgia research survey criteria. Results Of the 3,410 potential patients identified by the first method, 1,115 had a fibromyalgia diagnosis documented in the medical record by a health care provider. The age- and sex-adjusted prevalence of diagnosed fibromyalgia by this method was 1.1%. By the second method, of the 2,994 people who received the survey by mail, 830 (27.6%) responded and 44 (5.3%) met the fibromyalgia research survey criteria. The age- and sex-adjusted prevalence of fibromyalgia in the general population of Olmsted County by this method was estimated at 6.4%. Conclusion To the best of our knowledge, this is the first report of the rate at which fibromyalgia is being diagnosed in a community. This is also the first report of prevalence as assessed by the fibromyalgia research survey criteria. Our results suggest that patients, particularly men, who meet the fibromyalgia research survey criteria are unlikely to have been given a diagnosis of fibromyalgia. Copyright © 2013 by the American College of Rheumatology.


Wolfe F.,National Data Bank for Rheumatic Diseases | Walitt B.,Georgetown University
Nature Reviews Rheumatology | Year: 2013

Fibromyalgia is a common but contested illness. Its definition and content have changed repeatedly in the 110 years of its existence. The most important change was the requirement for multiple tender points and extensive pain that arose in the 1980s, features that were not required previously. By 2010, a second shift occurred that excluded tender points, allowed less extensive pain, and placed reliance on patient-reported somatic symptoms and cognitive difficulties ('fibro fog') that had never been part of past definitions or content. Fibromyalgia is closely allied with and often indistinguishable from neurasthenia, a disorder of the late 19th and early 20th centuries that lost favour when it was perceived as being a psychological illness. Fibromyalgia's status as a 'real disease', rather than a psychocultural illness, is buttressed by social forces that include support from official criteria, patient and professional organizations, pharmaceutical companies, disability access, and the legal and academic communities. © 2013 Macmillan Publishers Limited. All rights reserved.

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