title: Further validation of the uterine fibroid symptom and quality-of-life questionnaire.
abstract: 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 test-retest 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: United BioSource Corporation, Bethesda, MD 20814, USA. karin.coyne@unitedbiosource.com
authors.forename: Karin S
authors.initials: KS
authors.lastname: Coyne
authors.forename: Mary Kay
authors.initials: MK
authors.lastname: Margolis
authors.forename: Linda D
authors.initials: LD
authors.lastname: Bradley
authors.forename: Richard
authors.initials: R
authors.lastname: Guido
authors.forename: G Larry
authors.initials: GL
authors.lastname: Maxwell
authors.forename: James B
authors.initials: JB
authors.lastname: Spies
mesh_terms: D000328:Adult; D015897:Comorbidity; D005260:Female; D006304:Health Status; D006801:Humans; D007889:Leiomyoma / Q000503:physiopathology / Q000523:psychology*; D008603:Mental Health; D008875:Middle Aged; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires