J Rheumatol
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Randomized Controlled Trial Clinical Trial
Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis.
To determine the minimal perceptible clinical improvement (MPCI) in patients with osteoarthritis (OA) with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, and patient and investigator global assessment of disease status in randomized clinical trials for treatment of OA. ⋯ In this analysis, mean changes of roughly 9 to 12 mm (100 mm normalized VAS) on WOMAC scales were perceptible changes to patients with hip and knee OA. A mean decrease of 0.4 in global disease status (0 to 4 Likert scale) as assessed by the investigator corresponded to the patients' MPCI. Understanding the minimal perceptible differences may permit a better assessment of the clinical relevance of therapeutic interventions in OA.
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Randomized Controlled Trial Clinical Trial
Responsiveness of fibromyalgia clinical trial outcome measures.
To assess the responsiveness of the Fibromyalgia Impact Questionnaire (FIQ), patient ratings of pain intensity, number of tender points, and total tender point pain intensity score to perceived changes in clinical status in patients with fibromyalgia (FM). ⋯ The FIQ was the most responsive measure to perceived clinical improvement and we recommend its inclusion as a primary endpoint in FM clinical trials.