Abstract:
AIMS:Studies of antimuscarinics for overactive bladder (OAB) typically use objective and subjective measures to assess efficacy, as each provides unique information about patient outcome. We evaluated the relationships between changes in diary-documented OAB symptoms and other patient-reported outcome (PRO) measures. METHODS:In VIBRANT, OAB patients received solifenacin (5/10 mg) or placebo for 12 weeks. During the study, patients completed 3-day bladder diaries and other generic and disease-specific PRO measures. Data from both treatment groups were combined (n=738). Categorical changes in diary variables were compared with changes in PRO measures. Partial correlations controlling for treatment and Spearman correlations were also calculated. RESULTS:Categorical improvements in diary variables were significantly associated with greater improvements in PRO measures. Pair-wise comparisons showed that patients with major symptomatic improvements had significantly greater improvements on PROs vs. those with some or no improvement. Odds ratios ranged from 1.52 to 4.09 (p≤0.002). Linear relationships between changes in PRO measures and diary variables were low to moderate but statistically significant (p<0.001). Partial correlations were highest for diary variables and OAB-Questionnaire Symptom Bother. Spearman correlations ranged from 0.170 to 0.450 (p<0.001). CONCLUSIONS:In patients with OAB, changes in objectively measured symptoms of urgency, incontinence and frequency showed low-to-moderate correlations to changes in PRO measures. While providing evidence for similar change patterns in symptoms and patient perceptions, correlations were not high, lending support to the concept that in OAB clinical trials, both bladder diaries and PRO measures are important independent measures of efficacy.
journal_name
Int J Clin Practjournal_title
International journal of clinical practiceauthors
Crosby RD,Mathias SD,Marshall TSdoi
10.1111/j.1742-1241.2010.02532.xsubject
Has Abstractpub_date
2011-02-01 00:00:00pages
211-8issue
2eissn
1368-5031issn
1742-1241journal_volume
65pub_type
杂志文章,随机对照试验abstract::This randomised, double-blind, placebo-controlled, parallel-group study compared the efficacy and tolerability of lumiracoxib (a novel COX-2 selective inhibitor) with rofecoxib, celecoxib and placebo in patients with moderate-to-severe post-operative dental pain. Following third molar extraction, patients received sin...
journal_title:International journal of clinical practice
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:International journal of clinical practice
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journal_title:International journal of clinical practice
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abstract::Thyroid cancer is uncommon with an estimated lifetime risk of 0.8% for women and 0.3% for men. The incidence appears to be increasing by 4% per year and is currently the eighth commonest cancer in women. Managing thyroid cancer is challenging, as no prospective randomised trials exist. Most of the information is deriv...
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pub_type: 共识发展会议,杂志文章,评审
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