Showing papers by "James F. Fries published in 2007"

The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years.

Abstract: Background:The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes

Hydroxychloroquine and Risk of Diabetes in Patients With Rheumatoid Arthritis

Abstract: ContextHydroxychloroquine, a commonly used antirheumatic medication, has hypoglycemic effects and may reduce the risk of diabetes mellitus.ObjectiveTo determine the association between hydroxychloroquine use and the incidence of self-reported diabetes in a cohort of patients with rheumatoid arthritis.Design, Setting, and PatientsA prospective, multicenter observational study of 4905 adults with rheumatoid arthritis (1808 had taken hydroxychloroquine and 3097 had never taken hydroxychloroquine) and no diagnosis or treatment for diabetes in outpatient university-based and community-based rheumatology practices with 21.5 years of follow-up (January 1983 through July 2004).Main Outcome MeasuresDiabetes by self-report of diagnosis or hypoglycemic medication use.ResultsDuring the observation period, incident diabetes was reported by 54 patients who had taken hydroxychloroquine and by 171 patients who had never taken hydroxychloroquine, with incidence rates of 5.2 per 1000 patient-years of observation compared with 8.9 per 1000 patient-years of observation, respectively (P < .001). In time-varying multivariable analysis with adjustments for possible confounding factors, the hazard ratio for incident diabetes among patients who had taken hydroxychloroquine was 0.62 (95% confidence interval, 0.42-0.92) compared with those who had not taken hydroxychloroquine. In Poisson regression, the risk of incident diabetes was significantly reduced with increased duration of hydroxychloroquine use (P < .001 for trend); among those taking hydroxychloroquine for more than 4 years (n = 384), the adjusted relative risk of developing diabetes was 0.23 (95% confidence interval, 0.11-0.50; P < .001), compared with those who had not taken hydroxychloroquine.ConclusionAmong patients with rheumatoid arthritis, use of hydroxychloroquine is associated with a reduced risk of diabetes.

Proteomic analysis of secreted proteins in early rheumatoid arthritis: anti-citrulline autoreactivity is associated with up regulation of proinflammatory cytokines

Abstract: Objectives: To identify peripheral blood autoantibody and cytokine profiles that characterise clinically relevant subgroups of patients with early rheumatoid arthritis using arthritis antigen microarrays and a multiplex cytokine assay. Methods: Serum samples from 56 patients with a diagnosis of rheumatoid arthritis of Results: Distinct antibody profiles were associated with subgroups of patients who exhibited high serum levels of tumour necrosis factor (TNF)α, interleukin (IL)1β, IL6, IL13, IL15 and granulocyte macrophage colony-stimulating factor. Significantly increased autoantibody reactivity against citrullinated epitopes was observed in patients within the cytokine “high” subgroup. Increased levels of TNFα, IL1α, IL12p40 and IL13, and the chemokines eotaxin/CCL11, monocyte chemoattractant protein-1 and interferon-inducible protein 10, were present in early rheumatoid arthritis as compared with controls (p Conclusions: Increased blood levels of proinflammatory cytokines are associated with autoantibody targeting of citrullinated antigens and surrogate markers of disease activity in patients with early rheumatoid arthritis. Proteomic analysis of serum autoantibodies, cytokines and chemokines enables stratification of patients with early rheumatoid arthritis into molecular subgroups.

Health status disparities in ethnic minority patients with rheumatoid arthritis: a cross-sectional study.

Abstract: OBJECTIVE: To examine disparities in disability, pain, and global health between Caucasian (n = 4294) and African American (n = 283) and Caucasian and Hispanic (n = 153) patients with rheumatoid arthritis (RA). METHODS: Patients were from 9 Arthritis, Rheumatism, and Aging Medical Information System databanks. Cross-sectional data were derived from the Health Assessment Questionnaire. Staged multivariate analysis of covariance was used to explore roles of possible contributing factors (age, sex, education, disease duration, number of comorbid conditions, and treatment) to ethnic minority disparities. RESULTS: The cohort was 91% Caucasian and 76% female. Caucasians were significantly older than African Americans and Hispanics (62 vs 56 and 55 yrs; both p

Standardizing Assessment and Reporting of Adverse Effects in Rheumatology Clinical Trials II: the Rheumatology Common Toxicity Criteria v.2.0

Abstract: OBJECTIVE: The OMERACT Drug Safety Working Group focuses on standardization of assessment and reporting of adverse events in clinical trials and longitudinal and observational studies in rheumatology. This group developed the Rheumatology Common Toxicity Criteria (RCTC) in 1999, building on the Oncology Common Toxicity Criteria. At OMERACT 8, a workshop group reviewed the use of the RCTC and other instruments in rheumatology clinical trials to date, to revise and to stimulate its implementation. METHODS: The Working Group drafted a revision of the RCTC after an iterative examination of its contents, terms, and definitions. The RCTC were compared with the Oncology Common Toxicity Criteria (CTC v.2.0), and the Common Terminology Criteria for Adverse Events (CTCAE v.3.0). In addition a pharmaceutical company focus group met to clarify the challenges of application of RCTC terms and definitions, relative to the standard in pharmaceutical clinical trials, i.e., verbatim recording of adverse events followed by mapping to Medical Dictionary of Drug Regulatory Activities (MedDRA) terms. The workshop focused on the proposed revision of RCTC to version 2.0 and on the research agenda, including a validation of the RCTC in future trials. RESULTS: At OMERACT 8, breakout groups amended the contents of the 4 current and 2 new categories of adverse event terms within the draft RCTC v.2.0. Participants recognized the need to standardize the definitions for disease flares, infection, malignancy, and certain syndromes such as drug hypersensitivity and infusion reactions. Moderate consensus (62%) was reached in the final plenary session that the amended RCTC v.2.0 should be promulgated and tested in available trials of anti-tumor necrosis factor agents. CONCLUSION: The RCTC has face validity and construct validity. However, documentation of discrimination and feasibility (the other elements of the OMERACT filter) is needed. Collaboration with drug safety working groups in rheumatology professional organizations is necessary to enable this project.

Improving patient reported outcomes using item response theory and computerized adaptive testing.

Abstract: OBJECTIVE: Patient reported outcomes (PRO) are considered central outcome measures for both clinical trials and observational studies in rheumatology. More sophisticated statistical models, including item response theory (IRT) and computerized adaptive testing (CAT), will enable critical evaluation and reconstruction of currently utilized PRO instruments to improve measurement precision while reducing item burden on the individual patient. METHODS: We developed a domain hierarchy encompassing the latent trait of physical function/disability from the more general to most specific. Items collected from 165 English-language instruments were evaluated by a structured process including trained raters, modified Delphi expert consensus, and then patient evaluation. Each item in the refined data bank will undergo extensive analysis using IRT to evaluate response functions and measurement precision. CAT will allow for real-time questionnaires of potentially smaller numbers of questions tailored directly to each individual9s level of physical function. RESULTS: Physical function/disability domain comprises 4 subdomains: upper extremity, trunk, lower extremity, and complex activities. Expert and patient review led to consensus favoring use of present-tense "capability" questions using a 4- or 5-item Likert response construct over past-tense "performance"items. Floor and ceiling effects, attribution of disability, and standardization of response categories were also addressed. CONCLUSION: By applying statistical techniques of IRT through use of CAT, existing PRO instruments may be improved to reduce questionnaire burden on the individual patients while increasing measurement precision that may ultimately lead to reduced sample size requirements for costly clinical trials.

Primary knee and hip arthroplasty among nonagenarians and centenarians in the United States.

Abstract: Objective The number of individuals ages ≥100 years in the US is expected to increase considerably in the future along with the need for arthroplasties. This report focuses on the poorly studied epidemiology and mortality outcomes of arthroplasty among these individuals. Methods We describe the epidemiology of knee and hip arthroplasties among centenarians using data from a large hospital discharge database in the US (the Nationwide Inpatient Sample) during the period 1993 through 2002. We used nonagenarians as the comparison group with adjustment for differences in the prevalence of congestive heart failure, neurologic diseases such as dementia and stroke, renal and hepatic diseases, obesity, anemia, malignancy, coagulopathy, and depression and other psychiatric illnesses. Cox regression models were used to study the mortality outcomes following arthroplasty. Results Overall, there were 679 hip arthroplasties and 7 knee arthroplasties among centenarians in this database. The corresponding figures for nonagenarians were 33,975 and 2,050, respectively. A vast majority (83%) of hip arthroplasty recipients were women. Risk-adjusted mortality estimates following arthroplasty for centenarians were higher than for nonagenarians (hazard ratio 1.46, 95% confidence interval 1.10–1.95). However, this was similar to differences in overall in-hospital mortality (hazard ratio 1.36, 95% confidence interval 1.32–1.40) between these 2 age categories. Conclusion In the US population, hip and knee arthroplasty are very rarely performed among centenarians. Our in-hospital mortality data suggest that arthroplasties should not be denied to centenarians solely because of short-term postoperative life expectancy estimates.