Health-related quality of life in venous leg ulcer patients successfully treated with Apligraf: a pilot study.

Apligraf (Graftskin) is a bilayered, living human skin construct that is indicated for use with standard therapeutic compression for the treatment of noninfected partial- and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration that have not adequately responded to conventional ulcer therapy. A pilot study was conducted to assess the health-related quality of life impact of patients with venous leg ulcers treated with Apligraf. A 2-part questionnaire was administered over the telephone to patients treated with Apligraf whose ulcers had healed within the past 12 weeks. The patients were asked to respond to questions when thinking about the past week and when thinking about the time immediately prior to treatment. A total of 14 participants completed the questionnaire. All patients reported improvement in health-related quality of life after successful treatment of Apligraf. Compared with the time before treatment, 79% of respondents said their health was "much better" now. The greatest improvement was reported in pain and in other physical health dimensions. Despite the small sample size and cross-sectional design of the study, statistically significant differences were observed on a number of scales.

A health related quality of life measure for use in patients with urge urinary incontinence: a validation study.

OBJECTIVE: Urge incontinence has substantial impact on health related quality of life (HRQOL). The purpose of this research was to test the psychometric properties of the Urge-Incontinence Impact Questionnaire (U-IIQ) and Urge-Urinary Distress Inventory (U-UDI). METHODS: The U-IIQ and the U-UDI were incorporated in a single arm study of an investigational once-a-day formulation of oxybutynin (Ditropan XL) for urge incontinence. The U-IIQ contains 7 scales scored separately: Travel, Activities, Physical activities, Feelings, Relationships, Sexual function and Nighttime bladder control. We also calculated a single index score. The U-UDI contains 9 items summarized in a single score that measures the extent to which incontinence symptoms bother patients and an urge symptoms summary score. Patients completed the questions at: start of baseline week, end of baseline week, week 4 and week 12 (final dose). RESULTS: The questions were completed by the 257 patients enrolled in the study (91% female, mean age = 60 years). All item responses showed good variability. Internal-consistency reliability was very good (Cronbach's alpha = 0.82-0.96). Test-retest reliability was good for all scales ([ICC] = 0.68-0.83). Discriminant validity was noted for all scales for patients with and without frequent incontinence (p < or = 0.006 all scales). All scales demonstrated responsiveness to change over time (Guyatt's statistic = magnitude of -1.04 - magnitude of -1.71). CONCLUSIONS: Psychometric testing indicated that the scales measured distinct and relevant domains of HRQOL for patients with urge incontinence, and that these two instruments are reliable, valid, and responsive to change in this condition.