Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial.

OBJECTIVE: This study, lasting up to 90 days, was undertaken in patients with osteoarthritis with persistent moderate to severe pain uncontrolled by standard therapy (nonsteroidal anti-inflammatory drugs, acetaminophen, and/or short-acting opioids) to evaluate functional outcomes, as well as efficacy and safety, of controlled-release oxycodone versus placebo. METHODS: One hundred seven patients received either controlled-release oxycodone or placebo every 12 hours in this double blind, randomized, placebo-controlled, parallel-group study. Stable previous regimens of acetaminophen or nonsteroidal anti-inflammatory agents were allowed to continue. Primary efficacy variables included Brief Pain Inventory average pain intensity scores at completion of initial titration, Western Ontario and McMaster Universities Osteoarthritis Index scores at days 30 and 60, and the percentage of patients discontinuing due to inadequate pain control. RESULTS: Controlled-release oxycodone was significantly superior to placebo in decreasing average pain intensity and in reducing pain-induced interference with general activity, walking ability (except at day 30), and normal work, as well as mood, sleep, relations with people (at days 60 and 90), and enjoyment in life. Daily functioning, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index, was also significantly improved in the controlled-release oxycodone group. In the placebo group, a significantly greater percentage of patients discontinued due to inadequate pain control. Adverse events were consistent with opioid adverse events, and no safety concerns were noted. DISCUSSION: Treatment with controlled-release oxycodone of patients with osteoarthritis with persistent moderate to severe pain uncontrolled by standard therapy resulted in significant pain control and improvements in physical functioning.

Reading and interpreting economic evaluations in rheumatoid arthritis: an assessment of selected instruments for critical appraisal.

OBJECTIVE: To describe and compare the relative attributes (reliability, ease of use, applicability, and relevance) of different assessment tools for economic analyses as they pertain to rheumatoid arthritis (RA) literature. METHODS: An expert panel, comprising rheumatology researchers and clinicians, operationalized 2 economic appraisal instruments and applied them to 11 articles used for analysis. Each expert reviewed 3 articles, with each article independently reviewed by a pair of experts. A summary score for each article per appraisal instrument was calculated by dividing the number of items that received a "positive" response by the total number of items in the appraisal instrument. RESULTS: Scores for each article were similar across reviewers and appraisal instruments. CONCLUSION: There is a need for a more comprehensive approach for evaluating this rapidly growing body of economic literature that is not only valid and reliable, but also easy to apply and understand. Although consistency between reviewers was good on both guidelines, inter-guideline discrepancies were noted and reviewers reported some difficulty in using the operationalized format.

The use of rheumatoid arthritis health-related quality of life patient questionnaires in clinical practice: lessons learned.

OBJECTIVE: The utilization of health-related quality of life (HRQOL) patient questionnaires by clinical rheumatologists is limited. Yet, considerable literature exists defining the value of such data. In an effort to understand this apparent paradox, we performed a literature review and conducted a survey to describe what has been learned over the past 2 decades concerning the use of these measures in clinical care and explore the reasons for their underutilization. METHODS: A panel of rheumatologists with extensive clinical experience was convened to review the relevant literature pertaining to the use of HRQOL patient instruments in clinical practice. Additionally, a survey of all American College of Rheumatology practicing clinicians was conducted to assess the use of and beliefs about these measures. RESULTS: The literature provided evidence to support the use of HRQOL patient measures in clinical practice. Forty-seven percent of the responding rheumatologists stated that none of their patients complete HRQOL patient questionnaires. The majority of respondents (63%) reported that such information is "somewhat valuable." The most frequently reported reason for the underutilization was that such instruments "require too much staff time." CONCLUSIONS: The literature supports the potential value of HRQOL patient questionnaires in clinical practice. Few rheumatologists routinely gather such information as part of patient care. Reasons for this discrepancy between utility and use are given along with recommendations intended to help increase their utilization in clinical care.

Effects of disease management programs on functional status of patients with rheumatoid arthritis.

OBJECTIVE: To perform a systematic review of the published literature on disease management of rheumatoid arthritis (RA) and to use meta-analysis to estimate the magnitude of benefit these programs have on functional status in patients with RA. METHODS: Computerized databases for English articles from 1966 to September 2001 were searched. Two reviewers evaluated 1,029 published titles, identified 11 studies meeting explicit inclusion criteria, and extracted data about study characteristics, interventions used, and outcomes measured. Pooled effect sizes for functional status were calculated using a random-effects model. RESULTS: Four out of 8 disease management programs showed significant improvements in functional status; however, the pooled effect size (ES) was small and statistically non-significant (ES 0.27; 95% confidence interval [95% CI] -0.01, 0.54). Studies with longer intervention durations (>5 weeks) had significantly improved patient functional status (ES 0.49; 95% CI 0.12, 0.86), compared with studies with shorter intervention durations (