J Rheumatol
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Multicenter Study
Measuring pain in systemic sclerosis: comparison of the short-form McGill Pain Questionnaire versus a single-item measure of pain.
Studies of pain in systemic sclerosis (SSc) have used a variety of measures, including single-item measures and the 15-item short-form McGill Pain Questionnaire (MPQ-SF). The objective of our study was to compare the performance of the MPQ-SF to a single-item pain numerical rating scale (NRS) and determine whether the MPQ-SF effectively differentiates between sensory and affective components of pain in SSc. ⋯ The substantial overlap between sensory and affective subscales of the MPQ-SF and the similarity of the MPQ-SF and NRS pain measures compared to other patient-reported outcomes suggest that the 15-item MPQ-SF does not provide tangible advantages compared to the single-item pain NRS. These findings support recommendations to use a single-item NRS pain measure in SSc as it is less burdensome to patients than the MPQ-SF.
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Multicenter Study
Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma (PHAROS): baseline characteristics and description of study population.
Pulmonary arterial hypertension (PAH) increases mortality in systemic sclerosis (SSc). The multicenter PHAROS registry (Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma) prospectively follows subjects with SSc at high risk for or with incident pulmonary hypertension (PH). We describe the registry design and baseline characteristics of subjects enrolled during the first 18 months since the start of the study. ⋯ PHAROS is the largest US and Canadian cohort of subjects with SSc at high risk for or with incident PAH. PAH-specific therapies are approved for 49/71 subjects with RHC-confirmed PAH. Analyses of PHAROS registry data will permit identification of risk factors for development of PAH among SSc patients at high risk for PAH and enhance understanding of the course of SSc-PAH.
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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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Randomized Controlled Trial Multicenter Study Clinical Trial
A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia.
This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population. ⋯ Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM. Registered as trial no. NCT00436033.
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We studied a large clinical practice and multicenter database to estimate the minimally important difference (MID) in systemic sclerosis (SSc) using global rating of change anchors for the Health Assessment Questionnaire-Disability Index (HAQ-DI) and visual analog scale (VAS) in pain, fatigue, sleep, global status, and the Medical Outcomes Study Short-Form 36 (SF-36) in clinical practice. ⋯ This study provides MID estimates in SSc from 2 large databases for commonly used patient-reported outcomes in a clinical practice setting, which could differ from MID in trials.