Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL)

Karin S Coyne, Amanda Harrington, Brooke M Currie, Jun Chen, Patrick Gillard, James B Spies, Karin S Coyne, Amanda Harrington, Brooke M Currie, Jun Chen, Patrick Gillard, James B Spies

Abstract

Background: To evaluate the psychometric characteristics of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), including the Revised Activities subscale.

Methods: VENUS I and II were phase III, randomized, double-blind, placebo-controlled trials of ulipristal acetate in women with uterine fibroids (UF) and abnormal uterine bleeding. Women completed the 1-month recall UFS-QOL at baseline and after 12 weeks' treatment. Uterine bleeding was assessed via a daily diary (both studies); the Patient Global Impression of Improvement scale (PGI-I) was completed in VENUS II. Psychometric analyses examined internal consistency reliability and construct validity of the UFS-QOL; confirmatory factor analysis (CFA) compared model fit of the original and Revised Activities subscales. Analyses were conducted separately for VENUS I and II.

Results: One hundred and fifty-seven patients in VENUS I and 429 in VENUS II were included. Changes in mean Symptom Severity and health-related quality of life (HRQoL) scale scores indicated symptom burden reductions and HRQoL improvements. Cronbach's alpha coefficients were high at baseline and after 12 weeks' treatment (all ≥0.76, meeting the >0.70 threshold), demonstrating strong internal consistency reliability. Correlations between UFS-QOL scores and bleeding diary responses (range: -0.35 to -0.63), and UFS-QOL scores and PGI-I responses (range: -0.48 to -0.70), ranged from moderate to strong after 12 weeks' treatment (all p < 0.0001). Patients with absence of bleeding or controlled bleeding after 12 weeks' treatment scored significantly better (p < 0.001) on each UFS-QOL scale than patients not achieving those end points, supporting construct validity. CFA confirmed model fit for the Revised Activities subscale.

Conclusions: The 1-month recall UFS-QOL, including the Revised Activities subscale, is a valid, reliable measure to assess UF symptoms and their impact on HRQoL.

Trial registration: ClinicalTrials.gov, NCT02147197 . Registered May 26, 2014; retrospectively registered. ClinicalTrials.gov, NCT02147158 . Registered May 26, 2014; retrospectively registered.

Keywords: Health-related quality of life; Patient-reported outcomes; Symptoms; Uterine fibroids.

Conflict of interest statement

Karin S. Coyne, Brooke M. Currie, and Jun Chen are employees of Evidera, and received funding from Allergan to conduct this study. Amanda Harrington and Patrick Gillard are employees of Allergan. James B. Spies has nothing to disclose.

Figures

Fig. 1
Fig. 1
Patient populations and dispositions in (a) VENUS I and (b) VENUS II. PRO patient-reported outcome; UFS-QOL Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire; UPA ulipristal acetate
Fig. 2
Fig. 2
Known groups validity: UFS-QOL scale scores by achievement of absence of bleeding and controlled bleeding after 12 weeks of treatment in (a) VENUS I and (b) VENUS II: per protocol population (patient-reported outcome approach). p < 0.001 for comparisons of absence of bleeding versus no absence of bleeding, and controlled bleeding versus no controlled bleeding, for all scales; error bars represent standard deviation. HRQoL health-related quality of life; UFS-QOL Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire

References

    1. Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence. American Journal of Obstetrics and Gynecology. 2003;188(1):100–107. doi: 10.1067/mob.2003.99.
    1. Stewart EA, Laughlin-Tommaso SK, Catherino WH, Lalitkumar S, Gupta D, Vollenhoven B. Uterine fibroids. Nature Reviews. Disease Primers. 2016;2:16043. doi: 10.1038/nrdp.2016.43.
    1. Stewart EA. Uterine fibroids. Lancet. 2001;357(9252):293–298. doi: 10.1016/S0140-6736(00)03622-9.
    1. Ghant MS, Sengoba KS, Recht H, Cameron KA, Lawson AK, Marsh EE. Beyond the physical: A qualitative assessment of the burden of symptomatic uterine fibroids on women’s emotional and psychosocial health. Journal of Psychosomatic Research. 2015;78(5):499–503. doi: 10.1016/j.jpsychores.2014.12.016.
    1. Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. American Journal of Obstetrics and Gynecology. 2013;209(4):319.e1–319.e20. doi: 10.1016/j.ajog.2013.07.017.
    1. Coyne, K. S., Margolis, M. K., Bradley, L. D., Guido, R., Maxwell, G. L., & Spies, J. B. (2012). Further validation of the uterine fibroid symptom and quality-of-life questionnaire. Value in Health, 15(1), 135–142.
    1. Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstetrics & Gynecology. 2002;99(2):290–300.
    1. Norquist JM, Girman C, Fehnel S, DeMuro-Mercon C, Santanello N. Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration. Quality of Life Research. 2012;21(6):1013–1020. doi: 10.1007/s11136-011-0003-8.
    1. Horak P, Mara M, Dundr P, et al. Effect of a selective progesterone receptor modulator on induction of apoptosis in uterine fibroids in vivo. International Journal of Endocrinology. 2012;2012:436174. doi: 10.1155/2012/436174.
    1. Biglia N, Carinelli S, Maiorana A, D’Alonzo M, Lo Monte G, Marci R. Ulipristal acetate: a novel pharmacological approach for the treatment of uterine fibroids. Drug Design, Development and Therapy. 2014;8:285–292.
    1. Donnez J, Tomaszewski J, Vázquez F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. New England Journal of Medicine. 2012;366(5):421–432. doi: 10.1056/NEJMoa1103180.
    1. Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. New England Journal of Medicine. 2012;366(5):409–420. doi: 10.1056/NEJMoa1103182.
    1. Donnez J, Vázquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate. Fertility and Sterility. 2014;101(6):1565–1573. doi: 10.1016/j.fertnstert.2014.02.008.
    1. Donnez J, Hudecek R, Donnez O, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertility and sterility. 2015;103(2):519–527.e3. doi: 10.1016/j.fertnstert.2014.10.038.
    1. Donnez J, Donnez O, Matule D, et al. Long-term medical management of uterine fibroids with ulipristal acetate. Fertility and sterility. 2016;105(1):165–173.e4. doi: 10.1016/j.fertnstert.2015.09.032.
    1. Liu JH, Soper D, Lukes A, et al. Ulipristal acetate for treatment of uterine leiomyomas. A randomized controlled trial. Obstetrics & Gynecology. 2018;132(5):1241–1251. doi: 10.1097/AOG.0000000000002942.
    1. Simon JA, Catherino W, Segars JH, et al. Ulipristal acetate for treatment of symptomatic uterine leiomyomas. A randomized controlled trial. Obstetrics & Gynecology. 2018;131(3):431–439. doi: 10.1097/AOG.0000000000002462.
    1. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials. The CONSORT PRO extension. JAMA. 2013;309(8):814–822. doi: 10.1001/jama.2013.879.
    1. Harding G, Coyne KS, Thompson CL, Spies JB. The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL) Health and Quality of Life Outcomes. 2008;6:99. doi: 10.1186/1477-7525-6-99.
    1. Coyne KS, Soliman AM, Margolis MK, Thompson CL, Chwalisz K. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QOL) questionnaire. Current Medical Research and Opinion. 2017;33(2):193–200. doi: 10.1080/03007995.2016.1248382.
    1. Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD, the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value in Health. 2007;10(Suppl 2):S94–S105. doi: 10.1111/j.1524-4733.2007.00272.x.
    1. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297–334. doi: 10.1007/BF02310555.
    1. Hu L-T, Bentler PM. Evaleuating model fit. In: Hoyle RH, editor. Structural equation modeling. Concepts, issues, and applications. Thousand Oaks: Sage Publications; 1995. pp. 76–99.
    1. Browne MW, Cudeck R. Alternative ways of assessing model fit. In: Bollen KA, Long JS, editors. Testing structural equation models. Newbury Park: Sage Publications; 1993. pp. 136–162.
    1. Hu L-T, Bentler PM. Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural equation modeling: a multidisciplinary journal. 1999;6(1):1–55. doi: 10.1080/10705519909540118.
    1. Muthén LK, Muthén BO. Mplus. Statistical Analysis With Latent Variables. User’s Guide. 7 2015.
    1. SAS . SAS® 9.4. 2013.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2. Hillsdale: Lawrence Erlbaum Associates; 1988.
    1. Kenny DA, Kaniskan B, McCoach DB. The performance of RMSEA in models with small degrees of freedom. Sociological Methods & Research. 2015;44(3):486–507. doi: 10.1177/0049124114543236.
    1. Stull, D. E., Leidy, N. K., Parasuraman, B., & Chassany, O. (2009). Optimal recall periods for patient-reported outcomes: Challenges and potential solutions. Current Medical Research and Opinion, 25(4), 929–942.

Source: PubMed

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