National Data Bank for Rheumatic Diseases

Wichita, KS, United States

National Data Bank for Rheumatic Diseases

Wichita, KS, United States
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Michaud K.,National Data Bank for Rheumatic Diseases | Michaud K.,University of Nebraska Medical Center
Clinical and Experimental Rheumatology | Year: 2016

The National Data Bank for Rheumatic Diseases (NDB) is a longitudinal observational patient-driven database, founded as a non-profit research organisation in 1998 by Dr Frederick Wolfe. Patients are sent a primary questionnaire twice a year. More than 50,000 patients with more than 100 various rheumatic diseases under the care of more than 1,500 rheumatologists have completed at least one 6-month questionnaire. Many important publications concerning rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus, fibromyalgia, and pharmacoepidemiology have resulted from NDB research. © Clinical and Experimental Rheumatology 2016.


Katz P.,University of California at San Francisco | Pedro S.,National Data Bank for Rheumatic Diseases | Michaud K.,University of Nebraska Medical Center
Arthritis Care and Research | Year: 2017

Objective: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to improve measurement of patient-reported outcomes. We examined performance of the 29-item PROMIS Profile (PROMIS-29) in persons with rheumatoid arthritis (RA), osteoarthritis (OA), fibromyalgia (FM), and systemic lupus erythematosus (SLE). Methods: Participants in the National Data Bank for Rheumatic Diseases completed the PROMIS-29, which includes 4-item forms for 7 PROMIS domains. Scales were scored and converted to T scores. Distributions of scale scores were examined, convergent and known-groups validity was tested, and differences in scores from online versus paper questionnaires were examined. Results: Sample sizes were 4,346 for RA, 727 for OA, 241 for FM, and 240 for SLE. Participants were predominantly female, with a mean disease duration ≥20 years, and were ages ∼60 years. Large ceiling effects occurred for some PROMIS-29 scales. Correlations of PROMIS-29 scores with scales measuring similar constructs ranged from high to moderate for RA, OA, and SLE; correlations for FM were markedly lower for some scales. Consistent patterns of worsening PROMIS-29 scores with increasing disease severity or declining health status were observed. Differences in scores obtained by online versus paper questionnaires ranged from 0.3 to 2.2 points. Conclusion: Results provide guarded support for using the PROMIS-29 in these conditions. The PROMIS-29 4-item static forms appear to identify differences among levels of health and to measure constructs similar to those measured by legacy questionnaires. However, large ceiling effects suggest that measurement may be more precise at the “bad” ends of the scales, which may limit responsiveness, and differences by mode of administration appear to exist. © 2016, American College of Rheumatology


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.


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 | 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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