Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire. (1st February 2017)

• Record Type: Journal Article
• Authors: Coyne, Karin S.; Soliman, Ahmed M.; Margolis, Mary Kay; Thompson, Christine L.; Chwalisz, Kristof
• Is Part Of: Current medical research and opinion. Volume 33:Number 2(2017)
• Page Start: 193
• Page End: 200
• Publication Date: 2017-02-01
• Subjects: Health-related quality of life -- HRQL -- HRQoL -- psychometric validation -- recall period -- UFS-QoL -- uterine fibroids; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2016.1248382
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: Objective: To assess the psychometric performance of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire (UFS-QoL), a patient measure of the severity of uterine fibroid (UF) symptoms and their impact on health-related quality of life (HRQL). Methods: This was a retrospective analysis of phase 2a data from pre-menopausal women with heavy menstrual bleeding associated with UF. Participants completed the UFS-QoL at Baseline, Treatment Month 3, and Follow-up Month 3 and a daily diary with a Menstrual Bleeding Scale and the UF Daily Symptom Scale throughout the study duration. Descriptive statistics were performed on patient demographic characteristics; analyses were conducted to assess the internal consistency reliability, validity, and responsiveness of the UFS-QoL 4 week recall version. Results: A total of 271 women were enrolled with a mean age of 41.8 years; 74% were black. The UFS-QoL demonstrated excellent internal consistency reliability, with Cronbach's alpha coefficient values >0.70 for each subscale at each study visit. Results indicated good concurrent validity with the UF Daily Symptom Scale items. The women with amenorrhea at Treatment Month 3 had significantly better scores on all UFS-QoL subscales and HRQL Total than women with menstrual bleeding, indicating acceptable discriminant validity. Mean subscale change scores from Baseline to Treatment Month 3 were 19.2 to 39.8. Effect sizes were moderate to large (0.53 to 1.86), demonstrating responsiveness to change. Limitations: As this study is a post hoc validation of the 4 week recall UFS-QOL, it is limited to the clinical trial data available and does not include a direct comparison to the 3 month recall version of UFS-QOL. Conclusions: The 4 week recall version of the UFS-QoL demonstrated good internal consistency reliability, concurrent validity, and responsiveness and is psychometrically comparable to the original 3 month recall UFS-QoL. Clinical trial registration: Data from a phase 2a, cohort design proof of concept study (trial M12-663); ClinicalTrials.gov identifier NCT01441635. Date of Registration: 6 September 2011.