title: Validation of the UFS-QOL-hysterectomy questionnaire: modifying an existing measure for comparative effectiveness research.
abstract: OBJECTIVE
  The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, a validated patient-reported outcome measure of fibroid symptoms and health-related quality of life, was modified for use posthysterectomy. This study was conducted to psychometrically validate the UFS-QOL-Hysterectomy questionnaire for potential use in comparative effectiveness research to evaluate uterine fibroid treatments.
  
  
  METHODS
  This multicenter prospective study enrolled premenopausal women aged 30 to 50 years with uterine fibroids who were scheduled for hysterectomy, myomectomy, or uterine fibroid embolization. All participants completed the UFS-QOL questionnaire and short form 36 health survey at baseline prior to treatment and 6 and 12 months postprocedure. Women with hysterectomy completed the UFS-QOL-Hysterectomy questionnaire during follow-up visits. Internal consistency reliability, discriminant and concurrent validity, and responsiveness were assessed.
  
  
  RESULTS
  A total of 274 women were enrolled (107 uterine fibroid embolization, 61 myomectomy, and 106 hysterectomy) and 89 (83%), 55 (90%), and 91 (86%), respectively, completed the 12-month follow-up. The mean age was 43.2 (uterine fibroid embolization), 40.6 (myomectomy), and 44.5 (hysterectomy) years; 53%, 43%, and 37%, respectively, were black. Cronbach's alphas for the UFS-QOL-Hysterectomy questionnaire at 6 months ranged from 0.70 to 0.96 and from 0.66 to 0.95 at 12 months. Effect sizes ranged from 1.23 to 2.55, indicating that the UFS-QOL-Hysterectomy questionnaire was highly responsive.
  
  
  CONCLUSIONS
  The UFS-QOL-Hysterectomy questionnaire is a valid and reliable patient-reported outcome measure of uterine fibroid treatment with hysterectomy and can be used in conjunction with the UFS-QOL questionnaire to compare patient-reported outcomes across treatments.
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: Jeanne
authors.initials: J
authors.lastname: Murphy
authors.forename: James
authors.initials: J
authors.lastname: Spies
mesh_terms: D000328:Adult; D057186:Comparative Effectiveness Research / Q000379:methods*; D004621:Embolization, Therapeutic / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006306:Health Surveys; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D007889:Leiomyoma / Q000473:pathology / Q000601:surgery*; D008875:Middle Aged; D017697:Premenopause; D011446:Prospective Studies; D011594:Psychometrics / Q000295:instrumentation; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000473:pathology / Q000601:surgery*