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

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.

Keywords:

• Health-related quality of life
• HRQL
• HRQoL
• psychometric validation
• recall period
• UFS-QoL
• uterine fibroids

Transparency

Declaration of funding

This study was funded by AbbVie Inc. which also develops the oral GnRH antagonist elagolix (in collaboration with Neurocrine Biosciences) for the management of endometriosis and uterine fibroids. The design and financial support for the study was provided by AbbVie. AbbVie participated in data analysis, interpretation of data, review, and approval of the manuscript.

Author contributions All authors participated in data analysis and interpretation, and contributed to the development of the manuscript. The authors maintained control over the final contents of the manuscript and the decision to publish.

Declaration of financial/other relationships

K.S.C. and C.L.T. have disclosed that they are employees of Evidera and were paid scientific consultants for AbbVie in connection with The Psychometric Validation of the 4-Week Recall Version of the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL) study. M.K.M. has disclosed that she is currently employed by the Patient-Centered Outcomes Research Institute (PCORI) in Washington, DC, USA but was employed by Evidera at the time the study was conducted and the manuscript completed. A.M.S. and K.C. have disclosed that they are AbbVie employees and may own AbbVie stock or stock options.

CMRO Peer Reviewer 1 has disclosed that he has been a consultant to Avita, Medical Ltd, Bayer plc, Daiichi-Sankyo Europe, EUSA Pharma, GlaxoSmithKline, Ipsen Pharma, Janssen EMEA, Janssen UK, Menarini Pharma UK and Norgine Lttd. Peer Reviewers 2 and 3 have no relevant financial relationships to disclose.

Acknowledgements

Medical writing services were provided by Erica Zaiser PhD of Evidera; this support was funded by AbbVie.