Validation of the UFS-QOL-hysterectomy questionnaire: modifying an existing measure for comparative effectiveness research.

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.