The journal of pain : official journal of the American Pain Society
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Multicenter Study Clinical Trial
Initial Psychometric Properties of the Pain Care Quality Survey (PainCQ).
This study examined the psychometric properties of the Pain Care Quality (PainCQ) survey, a new instrument to measure the quality of nursing and interdisciplinary care related to pain management. Hospitalized medical/surgical oncology patients with pain from 3 states completed the 44-item version of the PainCQ survey following completion of a nursing shift. Interdisciplinary items were evaluated over the entire hospital stay; nursing care was evaluated during the previous shift. The sample included 109 patients ranging in age from 20 to 84 (mean = 53.09). The sample was 58.7% female, 88% non-Hispanic white. Principal Axis Factoring with an oblimin rotation was used as factors were correlated. Two scales resulted. The PainCQ-Interdisciplinary scale included 11 items representing 2 constructs and explaining 47.1% of shared item variance: partnership with the health care team (k = 6 items; α = .85) and comprehensive interdisciplinary pain care (k = 5 items; α = .76). The PainCQ-Nursing scale measured three constructs and explained 60.8 % of shared item variance: being treated right (k = 15 items; α = .95), comprehensive nursing pain care (k = 3 items; α = .77), and efficacy of pain management (k =4 items; α = .87). Results supported the internal consistency reliability and structural validity of the PainCQ survey with 33 items. ⋯ This article presents the psychometric properties of a new tool to measure interdisciplinary and nursing care quality related to pain management from the patient's perspective. This tool can be used for research and as a clinical performance measure to monitor and improve quality of care and patient outcomes.
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Randomized Controlled Trial Multicenter Study
Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial.
This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of ≥ 4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either ≥ 30% or ≥ 50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life-5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P ≤ .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients. ⋯ This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP.