Faculty Bibliography

OBJECTIVE: To compare 4 categories (high, moderate, and low severity, and near-remission) of RAPID3 (Routine Assessment of Patient Index Data 3), an index without formal joint counts, which is scored in < 10 seconds to 4 categories of the Disease Activity Score (DAS28) and Clinical Disease Activity Index (CDAI) in patients with rheumatoid arthritis (RA). METHODS: All patients complete a Multidimensional Health Assessment Questionnaire (MDHAQ) at each visit. A physician/assessor 28-joint count and erythrocyte sedimentation rate (ESR) were completed in 285 patients with RA in usual care by 3 rheumatologists to score DAS28, CDAI, and RAPID3. RAPID3 includes the 3 MDHAQ patient self-report RA Core Data Set measures for physical function, pain, and patient global estimate. Proposed RAPID3 (range 0-10) severity categories of high (> 4), moderate (2.01-4), low (1.01-2), and near-remission (</= 1) were compared to DAS (0-10) activity categories of high (> 5.1), moderate (3.21-5.1), low (2.61-3.2), and remission (</= 2.6), and CDAI (0-76) categories of > 22, 10.1-22.0, 2.9-10.0, and </= 2.8. Additional RAPID scores, which add to RAPID3 a physician/assessor or patient self-report joint count and/or assessor global estimate, were also analyzed. Statistical significance was analyzed using Spearman correlations, cross-tabulations, and kappa statistics. RESULTS: All RAPID scores were correlated significantly with DAS28 and CDAI (rho > 0.65, p < 0.001). Overall, 78%-84% of patients who met DAS28 or CDAI moderate/high activity criteria met similar RAPID severity criteria, and 68%-77% who met DAS28 or CDAI remission/low activity criteria also met similar RAPID criteria. RAPID3 was as informative as other indices. CONCLUSION: RAPID3 provides a feasible, informative quantitative index for busy clinical settings

OBJECTIVE: To analyze visual analog scales (VAS) for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ) in formats other than a traditional 10 cm horizontal line, designed to facilitate scoring on MDHAQ in usual clinical care. METHODS: The MDHAQ with VAS for pain and global estimate was completed by each patient at each visit. VAS formats other than a traditional (unnumbered) 10 cm horizontal line based on 21 circles at 0.5 intervals were analyzed. Formats included unnumbered, symbol at the 11th circle, numbers and/or squares (instead of circles) at selected intermittent scores, and numbers at each circle. Analyses were performed to study the time to score MDHAQ with different VAS formats, possible 'clustering' of responses in any format, particularly with intermittent numbers and/or symbols, and test-retest reliability of various formats. RESULTS: The median time to score MDHAQ with a 10 cm line VAS was 15.6 seconds, compared to 7.4 seconds for the 21 numbered circle VAS. No other format was scored in fewer seconds. Clustering was seen for scores of VAS formats with intermittent numbers or symbols, which rendered them unsuitable for use. No clustering was seen for the 21 numbered circle VAS format, for which test-retest agreement was significant, and similar to the 10 cm line VAS format. CONCLUSION: A 21 numbered circle VAS may be a desirable alternative to a 10 cm horizontal line, yielding similar results and requiring less than half the time to score

OBJECTIVE: Regular physical activity is associated with decreased morbidity and mortality. Traditionally, patients with rheumatoid arthritis (RA) have been advised to limit physical exercise. We studied the prevalence of physical activity and associations with demographic and disease-related variables in patients with RA from 21 countries. METHODS: The Questionnaires in Standard Monitoring of Patients with Rheumatoid Arthritis (QUEST-RA) is a cross-sectional study that includes a self-report questionnaire and clinical assessment of nonselected consecutive outpatients with RA who are receiving usual clinical care. Frequency of physical exercise (>or=30 minutes with at least some shortness of breath, sweating) is queried with 4 response options: >or=3 times weekly, 1-2 times weekly, 1-2 times monthly, and no exercise. RESULTS: Between January 2005 and April 2007, a total of 5,235 patients from 58 sites in 21 countries were enrolled in QUEST-RA: 79% were women, >90% were white, mean age was 57 years, and mean disease duration was 11.6 years. Only 13.8% of all patients reported physical exercise>or=3 times weekly. The majority of the patients were physically inactive with no regular weekly exercise: >80% in 7 countries, 60-80% in 12 countries, and 45% and 29% in 2 countries, respectively. Physical inactivity was associated with female sex, older age, lower education, obesity, comorbidity, low functional capacity, and higher levels of disease activity, pain, and fatigue. CONCLUSION: In many countries, a low proportion of patients with RA exercise. These data may alert rheumatologists to motivate their patients to increase physical activity levels

Vasculitic syndromes are among the most complicated diseases for primary care physicians and rheumatologists to diagnose and treat. There are a myriad of symptoms that can be mimicked by other conditions, and choice of medications can be complex. Some agents are toxic and determining which to prescribe and for how long can be a multifaceted, complex decision process. Developing new treatments and new ways of using already available therapies, while minimizing potential side effects, are of paramount importance. This review will focus on recently published data that could have an impact on the way we treat systemic vasculitis patients

OBJECTIVE: Current tools for assessing Behcet's syndrome (BS) do not include patient-reported outcomes such as functional disability, pain or fatigue. We examined various outcome measures using the multi-dimensional Health Assessment Questionnaire (MDHAQ) and compared them between BS patients with and without arthritis. We also compared the results to those for patients with rheumatoid arthritis (RA), the disease in relation to which the MDHAQ has been most thoroughly studied. METHODS: We conducted a comparative review of BS and early RA patients being followed at the New York University Hospital for Joint Diseases (NYU HJD) and the Behcet's Syndrome Center. All patients completed an MDHAQ at each visit, which included functional disability, pain, morning stiffness, fatigue, and patient and physician global assessments of disease activity. A chart review for BS manifestations and treatments was also carried out. All patient evaluations reported here represent the baseline values at first visit. RESULTS: 129 patients with BS and 116 with early RA were surveyed. BS patients had similar pain levels and physician global assessment of disease activity to the RA patients and higher functional disability, fatigue and patient assessments of global disease activity. Among BS patients, those with arthritis had significantly higher scores for all the outcome measures examined except the physician global assessment of disease activity. CONCLUSION: Using the MDHAQ could reveal previously under-recognized problems in BS, as was observed in this survey of BS patients with arthritis. Such information might be helpful in the management of patients with BS

BACKGROUND: Treatment of rheumatoid arthritis (RA) has shifted toward earlier and more aggressive therapy with tra- ditional disease-modifying antirheumatic drugs (DMARDs) and biologics. However, the extent to which these agents are used in current clinical practice in the United States (U.S.) has not been systematically evaluated. MATERIALS AND METHODS: This analysis of a large claims database assessed patterns of use of biologics within clinical practice in a broad U.S. population with RA. We identifed two cohorts of adults with RA using Thomson Healthcare MarketScan Research databases. Patients newly diagnosed with RA between 1999 and 2004 with 12 months or more of continuous enrollment prior to diagnosis and with 24 months or more post-diagnosis were included in one cohort. The second cohort included RA patients who appeared to be newly treated with biologic therapy and had continu- ous enrollment for 12 months or more prior to frst use of a biologic agent and 18 months or more following initial treatment. A total of 16,752 patients, newly diagnosed with RA, and 8218, new to biologics therapy, were included. RESULTS: Utilization of biologics increased from 3% of patients in 1999 to 26% in 2006. Patients initiated biolog- ics both as monotherapy (30%) and in combination with methotrexate (36%). Regimen modifcations were frequent, with a large percentage of patients requiring addition or subtraction of methotrexate. CONCLUSIONS: The use of biologics to treat RA is increas- ing, either as monotherapy or in combination with another DMARD. Modifcations to drug regimens are frequent and episodes are often of comparatively short duration

Reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking and with limited application in the real world, as RCTs are of short duration, include small numbers of patients, and are selective for subjects lacking in comorbid conditions. It is not surprising that new and unexpected safety concerns emerge with any new drug after it has been launched and used by many more patients. Part of the problem is inherent to the way safety data are reported in RCTs. This article focuses on some of the shortcomings of AE reporting in RCTs, especially those involving tumor necrosis factor (TNF) inhibitors. Discussion focuses on reporting of 'time-to-event' issues, use of standardized incidence ratios for comparison to normal population or disease controls, use of 'patient-years' when reporting AEs, and the problem of adequate sample size and power calculations that are lacking in safety outcome data trials