J Rheumatol
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Randomized Controlled Trial
Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial.
To perform a cost-consequence analysis of the substitution of specialized rheumatology nurses (SRN) for rheumatologists (RMT) in the diagnostic process of fibromyalgia (FM), using both a healthcare and societal perspective and a 9-month period. ⋯ From both a healthcare and societal perspective, the nurse-led diagnostic process can be recommended. Patients in the SRN group were significantly more satisfied, improvements in health status were similar in both groups, and total societal costs were lower for the SRN group compared to the RMT group after 9 months' followup. Registered with Current Controlled Trials, no. ISRCTN77212411.
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Following development of the core domain set for fibromyalgia (FM) in Outcome Measures in Rheumatology Clinical Trials (OMERACT) meetings 7 to 9, the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains, utilizing outcome indices of these domains from archived randomized clinical trials in FM. Possible clinical domains that could be included in a responder index and disease activity score include pain, fatigue, sleep disturbance, cognitive dysfunction, mood disturbance, tenderness, stiffness, and functional impairment. ⋯ The process of developing candidate dichotomous responder definitions and continuous quantitative disease activity measures is described, along with participant discussions from OMERACT 10. Final results of this work will be published in a separate report pending completion of analyses.
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To compare tumor necrosis factor-α (TNF-α) inhibitors to nonbiological disease-modifying antirheumatic drugs (DMARD) for the risk of serious infection in Japanese patients with rheumatoid arthritis (RA). ⋯ Our study has provided the first epidemiological data on Japanese patients with RA for the safety of TNF inhibitors compared to nonbiological DMARD for up to 1 year of treatment. Anti-TNF therapy was associated with a significantly increased risk for serious infections, compared to treatment with nonbiological DMARD.
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Randomized Controlled Trial Multicenter Study
Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study.
This double-blind, 1-year extension study investigated the longterm efficacy and safety of milnacipran 100, 150, and 200 mg/day in the treatment of fibromyalgia (FM) in completers of a 3-month European double-blind lead-in study of milnacipran 200 mg/day versus placebo. ⋯ Over 1 year, milnacipran 100, 150, and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM. Registered as trial no. NCT00757731.
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The interstitial lung diseases (ILD) are a group of heterogeneous diseases that exert significant morbidity and mortality in connective tissue diseases (CTD). There is no consensus on measures of disease activity or therapeutic responsiveness, which hampers effective drug development and regulatory evaluation of candidate therapies. The CTD-ILD Special Interest Group represents an international multidisciplinary effort to identify consensus on criteria to measure disease activity and therapeutic response in CTD-ILD. We summarize the design of the studies we are conducting and progress leading to the OMERACT 10 and 2010 EULAR meetings.