Measuring outcomes of importance to women with stress urinary incontinence

Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
BJOG An International Journal of Obstetrics & Gynaecology (Impact Factor: 3.86). 05/2009; 116(5). DOI: 10.1111/j.1471-0528.2008.02106.x
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ABSTRACT Peer reviewed Postprint

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    ABSTRACT: Background: Analysis of EQ-5D data often focuses on changes in utility, ignoring valuable information from other parts of the instrument. Our objective was to explore how the utility index, EQ-5D profile, and EQ-VAS captured change in clinical trials of mirabegron, a new treatment for overactive bladder (OAB). Data: Data were pooled from three phase III clinical trials that investigated the efficacy and safety of mirabegron versus placebo. Tolterodine ER 4mg was included as an active control in one study: (1) placebo, mirabegron 50mg and 100mg, and tolterodine 4mg ER; (2) placebo, mirabegron 50mg and 100mg); (3) placebo, and mirabegron 25mg and 50mg. Data were collected at baseline, week 4, 8 and 12. Methods: Analyses were performed on full analysis and modified intention to treat (ITT) data sets using UK utilities. Analysis controlled for relevant patient characteristics. Analysis of Covariance identified changes from baseline at each time point in utilities and EQ-VAS. Areas Under the Curve were estimated to summarise intertemporal differences in effect. EQ-5D profile data were analysed using the Paretian Classification of Health Change. Results: In modified ITT analyses, mirabegron 50mg was superior to tolterodine 4mg in changes from baseline utilities after 12 weeks (p<0.05); similarly, AUC results showed mirabegron 50mg to be superior to tolterodine (p<0.05) and placebo (p<0.05) with the benefit already apparent at 4 weeks (p<0.05). EQ-VAS more consistently indicated superior outcomes: all three mirabegron doses showed statistically significant greater effectiveness compared to tolterodine at 12 weeks. Individual EQ-5D dimensions and the overall profile showed no significant differences between study arms. Conclusion: Mirabegron showed quicker and superior improvement in HR-QoL compared to tolterodine 4mg ER. A limitation of the study is that EQ-5D was a secondary outcome in the pivotal trials, which were not powered to measure differences on EQ-5D.
    Journal of Medical Economics 05/2013; 15(4). DOI:10.3111/13696998.2013.802240
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    ABSTRACT: Urinary incontinence can cause embarrassment and can impact on daily activities and quality of life. Generic health related quality of life instruments, such as the EQ-5D, are designed to be applicable across a variety of disease areas. However, it is sometimes claimed that they are not applicable to a certain disease area because they are missing a domain which directly captures the impact of that particular disease. For example, none of the domains of the EQ-5D relate directly to incontinence, although the impact of incontinence on quality of life may be expected to be picked up indirectly through changes in domains such as usual activities or anxiety/depression. The objective of this review was to examine the appropriateness of the EQ-5D in people with urinary incontinence by reviewing published evidence relating to the psychometric performance of the EQ-5D. A systematic search was conducted to identify studies reporting data that permitted assessment of the construct validity, responsiveness or reliability of the EQ-5D in people with urinary incontinence. Included papers were those that reported EQ-5D alongside other measures of health related quality of life or clinical measures in patients with urinary incontinence or in a broader population where results were reported for a subgroup of patients with urinary incontinence. Data were extracted and a narrative synthesis was undertaken. Seventeen papers were included in the review. In most of the tests performed, EQ-5D was consistent with clinical or disease specific outcome measures. The EQ-5D demonstrated validity in the majority of 'known group' comparisons, although statistical significance was not always reported. Correlations between the EQ-5D and disease specific outcomes were statistically significant and in the expected direction for most but not all of the disease specific instruments and clinical measures. For responsiveness, there was general agreement between changes in EQ-5D and changes in clinical or disease specific measures. Evidence on reliability was limited to one study. The EQ-5D was generally found to perform well on tests of construct validity, responsiveness and reliability, in people with urinary incontinence although no definitive conclusion can be made on its appropriateness based on these measures alone.
    Health and Quality of Life Outcomes 02/2013; 11(1):20. DOI:10.1186/1477-7525-11-20 · 2.10 Impact Factor
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    ABSTRACT: The patient-generated index (PGI) is a more novel approach to evaluating health-related quality of life (HRQOL) that allows patients to formulate their own responses in an open-ended format in order to measure HRQOL based on each patient’s own stated goals and expectations. To date the use of PGI in the setting of patients diagnosed with cancer remains relatively less common compared to other health conditions. This systematic review primarily aims to identify current literature in which PGI has been used as a tool to assess quality of life in cancer patients. A systematic review using the MEDLINE database from January 1990 to July 2013 was performed with the following search terms to identify the implementation of PGI in oncology settings: (PGI OR patient generated index OR patient-generated OR patient-reported OR patient generated OR patient reported) AND (cancer OR oncology OR tumor OR neoplasm OR malignancy). Of the 2167 papers initially identified, 10 papers evaluated quality of life in oncology patients by collecting free-form responses from the patient, 4 of which actually used PGI. An overarching theme observed in these studies highlighted the concerns mentioned by patients that were not targeted or detected by standardized quality of life measures. While implementing the PGI may require slightly more investment of resources in the beginning, the potential implications of allowing patients to characterize their quality of life on their own terms are tremendous.
    Oncology Reviews 06/2014; 8(1). DOI:10.4081/oncol.2014.245

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