The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata

OBJECTIVE: To create and validate a questionnaire for assessing symptom severity and symptom impact on health-related quality of life for women with leiomyomata. METHODS: The questionnaire was derived from focus groups of women with leiomyomata. Content validity was established through cognitive debriefings of women with leiomyomata and review by expert clinicians. Patients for the validation study were recruited from five gynecologists' offices, an interventional radiology department, and a University campus. Instruments used for validation were the Short Form-36, Menorrhagia Questionnaire, the Revicki-Wu Sexual Function Scale, and a physician and a patient assessment of severity. Item and exploratory factor analysis were performed to assess the subscale structure of the questionnaire. Psychometric evaluation was conducted to assess reliability and validity. Test-retest was performed on a random subset of the sample within 2 weeks of the initial visit. RESULTS: A total of 110 patients with confirmed leiomyomata and 29 normal subjects participated in the validation. The final questionnaire consists of eight symptom questions and 29 health-related quality of life questions with six subscales. Subscale Cronbach's α ranged from 0.83 to 0.95, with the overall health-related quality of life score α = 0.97. The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire subscales discriminated not only from normal controls but also among leiomyomata patients with varying degrees of symptom severity. Test-retest reliability was good with intraclass correlation coefficients of 0.76–0.93. CONCLUSION: The UFS-QOL appears to be a useful new tool for detecting differences in symptom severity and health-related quality of life among patients with uterine leiomyomata. Additional study is underway to determine the responsiveness of the UFS-QOL to therapies for leiomyomata.