Further validation of the uterine fibroid symptom and quality-of-life questionnaire

摘要

Objective: To further examine the reliability, validity and responsiveness of the uterine fibroid symptom and quality-of-life (UFS-QOL) questionnaire among women with and without uterine fibroids. Methods: A multicenter, non-randomized, prospective study was conducted with women undergoing treatment for uterine fibroids (fibroid treatment group FTG) and normal controls (normal control group NCG). Women in the FTG were recruited when they were scheduled for treatment; women in the NCG were recruited during their annual exam. Participants completed the UFS-QOL and a short form 36 health survey (SF-36) at enrollment and at 6 and 12 months. Descriptive statistics, Cronbach's alpha, Spearman's correlations, t tests, and general linear models were used to analyze the internal consistency and testretest reliability, concurrent and discriminant validity, and responsiveness of the UFS-QOL. Results: There were 89 NCG and 234 FTG women who completed the study. Mean age was 43.1 years for FTG and 40.8 for NCG (P < 0.001). The FTG reported significantly greater symptom severity and worse health-related quality of life (HRQL) than the NCG (all UFS-QOL subscales P < 0.001). The UFS-QOL subscales were significantly correlated in the expected direction and magnitude with each SF-36 subscale in the FTG, indicating acceptable concurrent validity. Cronbach's alphas were 0.73 to 0.97, reflecting adequate internal consistency. Each UFS-QOL subscale was responsive to changes after treatment in the FTG with effect sizes ranging between 1.1 and -2.35. The UFS-QOL remained stable in the NCG during the 1 year follow-up. Conclusion: The UFS-QOL is a valid and reliable measure to assess symptoms and HRQL in women with uterine fibroids and is highly responsive to treatment-related changes.