Other Patient-reported Outcomes (other + patient-reported_outcome)

Distribution by Scientific Domains

Selected Abstracts

Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT , a double-blind, placebo-controlled trial

M. D. Vardy
Summary Aim:, The aim of this study was to evaluate the efficacy of solifenacin on symptom bother using the Overactive Bladder Questionnaire (OAB-q). Methods:, In VIBRANT, a double-blind, US-based trial, patients with OAB for , 3 months received flexibly dosed solifenacin or placebo for 12 weeks. At baseline and 4-week intervals, patients completed the OAB-q [symptom bother and health-related quality of life (HRQL) scales] and 3-day bladder diaries; other patient-reported outcome measures were also assessed at baseline and week 12. The primary efficacy end-point was the change from baseline to end of treatment (EOT) on the OAB-q Symptom Bother scale. Adverse events (AEs) were monitored. Results:, At EOT, solifenacin (n = 377) vs. placebo (n = 374) significantly improved mean symptom bother (,29.9 vs. ,20.4, p < 0.0001), HRQL total (25.3 vs. 16.7, p < 0.0001) and all HRQL domain scores (Ps < 0.0001). Solifenacin vs. placebo significantly improved daily episodes of urgency, incontinence and frequency but not nocturia. Significant separation from placebo was evident as early as week 4. Overall, significantly more solifenacin vs. placebo patients reported treatment benefit (84% vs. 63%), satisfaction (80% vs. 59%) and willingness to continue (79% vs. 60%; Ps< 0.0001). Treatment-related AEs in solifenacin vs. placebo patients were dry mouth (13% vs. 2%), constipation (8% vs. 2%) and dry eye (2% vs. 0.3%). Conclusions:, As early as week 4 and through EOT, flexibly dosed solifenacin significantly improved OAB symptom bother and HRQL as well as the symptoms of urgency, frequency and incontinence compared with placebo. Significantly more solifenacin patients reported treatment benefit and satisfaction at week 12 compared with placebo. [source]

Measuring social activities and social function in long-term cancer survivors who received hematopoietic stem cell transplantation

Karen L. Syrjala
Abstract Objective: Cancer survivors report deficits in social functioning even years after completing treatment. Commonly used measures of social functioning provide incomplete understanding of survivors' social behavior. This study describes social activities of survivors and evaluates the psychometric properties of the Social Activity Log (SAL) in a cohort of long-term survivors of hematopoietic stem cell transplantation (HSCT) for cancer. Methods: One hundred and two (5,20 year) survivors completed the SAL, Short-Form-36 Health Survey (SF-36), and other patient-reported outcomes. Principal components analysis determined the factor structure of the SAL along with correlations and regressions to establish validity. Results: Principal component analysis yielded three factors in the SAL: ,non-contact events' (e.g. telephone calls), ,regular events' (e.g. played cards), and ,special events' (e.g. concerts), which explained 59% of the total variance. The SAL possessed good internal consistency (Cronbach's ,=0.82). SF-36 social function and SAL were moderately correlated (r=0.31). In linear regressions, physical function and depression explained 16% of the variance in the SAL (P<0.001), while physical function, depression, and fatigue predicted 55% of the variance in SF-36 social function (P<0.001). Conclusions: Results support the use of the SAL as a measure of social activity in cancer survivors who received HSCT. Although the SAL is designed to measure social behaviors, SF-36 social function assesses subjective experience and is more strongly associated with depression and fatigue. The SAL appears to be a promising tool to understand the behavioral social deficits reported by long-term survivors of cancer. Copyright 2009 John Wiley & Sons, Ltd. [source]

Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasis

D. Revicki
Summary Background, Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) are important in evaluating the impact of psoriasis and its treatment. Objectives, To assess the impact of adalimumab treatment on HRQOL and other PROs in patients with moderate to severe psoriasis. Methods, A 16-week, double-blind, double-dummy, randomized controlled trial evaluated the efficacy and safety of adalimumab in 271 adults with moderate to severe chronic plaque psoriasis. Patients were randomized in a 2 : 2 : 1 ratio to adalimumab, methotrexate (MTX) or placebo. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity, plaque psoriasis and psoriatic arthritis pain visual analogue scale (VAS), Psoriasis-Related Pruritus Assessment and EuroQOL 5D (EQ-5D). Results, Statistically significant differences were observed between the adalimumab- and placebo-treated and the MTX-treated groups on mean DLQI total scores during the 16-week double-blind study (both P < 0001). Significant differences, favouring adalimumab compared with placebo, were also observed on the Patient's Global Assessment of disease severity (P < 0001), VAS for pain (P < 0001), Psoriasis-Related Pruritus Assessment (P < 0001), EQ-5D VAS (P < 0001) and EQ-5D index score (P < 001). Compared with MTX, adalimumab resulted in statistically significantly greater improvements in the Patient's Global Assessment of disease severity (P < 0001), the VAS for pain (P < 001) and the Psoriasis-Related Pruritus Assessment (P < 0001). Conclusions, Adalimumab was efficacious in improving dermatology-specific HRQOL, disease control and symptom outcomes in patients with moderate to severe psoriasis. [source]