The responsiveness of the uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL)

Gale Harding, Karin S Coyne, Christine L Thompson, James B Spies, Gale Harding, Karin S Coyne, Christine L Thompson, James B Spies

Abstract

Background: A number of noninvasive alternatives to hysterectomy have become available as treatments for uterine fibroids. These alternative therapies, however, may not relieve all symptoms. Consequently, the need for patient-reported outcomes to assess symptom reduction of uterine fibroids has become increasingly important to evaluate the clinical success of patients who choose these alternative therapies. The purpose of the study was to examine the responsiveness of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) with treatment of uterine fibroids.

Methods: The responsiveness of the UFS-QOL was assessed as a post-hoc analysis of patients treated with MRI-guided focused ultrasound thermal ablation (MRgFUS) for uterine fibroids. The UFS-QOL and SF-36 were completed at baseline and months 1, 3, and 6. Patient perceived overall treatment effect (OTE) was assessed at month 3, while satisfaction with treatment was collected at month 6. The responsiveness of the UFS-QOL was examined using effect sizes and change scores by patient-reported overall treatment effect and satisfaction.

Results: A total of 102 women with complete UFS-QOL data were included in the analysis; the mean age was 45 years and 79% were Caucasian. From baseline to 6 months, significant improvements were observed in UFS-QOL Symptom Severity and all Health-Related Quality of Life (HRQL) subscale scores (p < 0.0001). When examining change in general health status over the 6-month follow-up period, significant improvements were noted in all 8 SF-36 subscales. The UFS-QOL was highly responsive with subscale effect sizes ranging from 0.74 for Sexual Function to -1.9 for Symptom Severity. Improvements in UFS-QOL subscales were associated with patient perceptions of perceived benefit and treatment satisfaction.

Conclusion: The UFS-QOL is responsive to treatment for uterine fibroids and is a useful outcome measure for uterine-sparing uterine fibroid treatments.

References

    1. Ryan GL, Syrop CH, Van Voorhis BJ. Role, epidemiology, and natural history of benign uterine mass lesions. Clin Obstet Gynecol. 2005;48:312–324. doi: 10.1097/01.grf.0000159538.27221.8c.
    1. Agency for Healthcare Research and Quality (AHRQ) Management of Uterine Fibroids. Summary, Evidence Report/Technology Assessment: Number 34. AHRQ Publication No. 01-E051. Rockville, MD: Agency for Healthcare Research and Quality; 2001.
    1. Iverson RE, Jr, Chelmow D, Strohbehn K, Waldman L, Evantash EG. Relative morbidity of abdominal hysterectomy and myomectomy for management of uterine leiomyomas. Obstet Gynecol. 1996;88:415–419. doi: 10.1016/0029-7844(96)00218-9.
    1. Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally MJ, Peterson HB, DeStefano F, Rubin GL, Ory HW. Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. The Collaborative Review of Sterilization. Am J Obstet Gynecol. 1982;144:841–848.
    1. Batra N, Khunda A, O'Donovan PJ. Hysteroscopic myomectomy. Obstet Gynecol Clin North Am. 2004;31:669–685. doi: 10.1016/j.ogc.2004.06.003. xi.
    1. Dohi M, Harada J, Mogami T, Fukuda K, Kobayashi S, Yasuda M. MR-guided transvaginal cryotherapy of uterine fibroids with a horizontal open MRI system: initial experience. Radiat Med. 2004;22:391–397.
    1. Glasser MH. Minilaparotomy myomectomy: a minimally invasive alternative for the large fibroid uterus. J Minim Invasive Gynecol. 2005;12:275–283. doi: 10.1016/j.jmig.2005.03.009.
    1. Soysal ME, Soysal SK, Vicdan K. Thermal balloon ablation in myoma-induced menorrhagia under local anesthesia. Gynecol Obstet Invest. 2001;51:128–133. doi: 10.1159/000052908.
    1. Mettler L. Long-term results in the treatment of menorrhagia and hypermenorrhea with a thermal balloon endometrial ablation technique. JSLS. 2002;6:305–309.
    1. Scheurig C, Gauruder-Burmester A, Kluner C, Kurzeja R, Lembcke A, Zimmermann E, Hamm B, Kroencke T. Uterine artery embolization for symptomatic fibroids: short-term versus mid-term changes in disease-specific symptoms, quality of life and magnetic resonance imaging results. Hum Reprod. 2006;21:3270–3277. doi: 10.1093/humrep/del275.
    1. Siskin GP, Shlansky-Goldberg RD, Goodwin SC, Sterling K, Lipman JC, Nosher JL, Worthington-Kirsch RL, Chambers TP. A prospective multicenter comparative study between myomectomy and uterine artery embolization with polyvinyl alcohol microspheres: long-term clinical outcomes in patients with symptomatic uterine fibroids. J Vasc Interv Radiol. 2006;17:1287–1295.
    1. Smith WJ, Upton E, Shuster EJ, Klein AJ, Schwartz ML. Patient satisfaction and disease specific quality of life after uterine artery embolization. Am J Obstet Gynecol. 2004;190:1697–1703. doi: 10.1016/j.ajog.2004.02.043.
    1. Spies JB, Allison S, Flick P, McCullough M, Sterbis K, Cramp M, Bruno J, Jha R. Polyvinyl alcohol particles and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a randomized comparative study. J Vasc Interv Radiol. 2004;15:793–800.
    1. Spies JB, Allison S, Flick P, Cramp M, Bruno J, Jha RC, Ascher SA. Spherical polyvinyl alcohol versus tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a limited randomized comparative study. J Vasc Interv Radiol. 2005;16:1431–1437.
    1. Spies JB, Myers ER, Worthington-Kirsch R, Mulgund J, Goodwin S, Mauro M. The FIBROID Registry: symptom and quality-of-life status 1 year after therapy. Obstet Gynecol. 2005;106:1309–1318.
    1. Bergamini V, Ghezzi F, Cromi A, Bellini G, Zanconato G, Scarperi S, Franchi M. Laparoscopic radiofrequency thermal ablation: a new approach to symptomatic uterine myomas. Am J Obstet Gynecol. 2005;192:768–773. doi: 10.1016/j.ajog.2004.10.591.
    1. Ghezzi F, Cromi A, Bergamini V, Scarperi S, Bolis P, Franchi M. Midterm outcome of radiofrequency thermal ablation for symptomatic uterine myomas. Surg Endosc. 2007;21:2081–2085. doi: 10.1007/s00464-007-9307-8.
    1. Kim HS, Tsai J, Jacobs MA, Kamel IR. Percutaneous image-guided radiofrequency thermal ablation for large symptomatic uterine leiomyomata after uterine artery embolization: a feasibility and safety study. J Vasc Interv Radiol. 2007;18:41–48. doi: 10.1016/j.jvir.2006.10.010.
    1. Smart OC, Hindley JT, Regan L, Gedroyc WG. Gonadotrophin-releasing hormone and magnetic-resonance-guided ultrasound surgery for uterine leiomyomata. Obstet Gynecol. 2006;108:49–54.
    1. So MJ, Fennessy FM, Zou KH, McDannold N, Hynynen K, Jolesz FA, Stewart EA, Rybicki FJ, Tempany CM. Does the phase of menstrual cycle affect MR-guided focused ultrasound surgery of uterine leiomyomas? Eur J Radiol. 2006;59:203–207. doi: 10.1016/j.ejrad.2006.05.004.
    1. Stewart EA, Rabinovici J, Tempany CM, Inbar Y, Regan L, Gostout B, Hesley G, Kim HS, Hengst S, Gedroyc WM. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril. 2006;85:22–29. doi: 10.1016/j.fertnstert.2005.04.072.
    1. Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006;108:1381–1387.
    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. Obstet Gynecol. 2002;99:290–300. doi: 10.1016/S0029-7844(01)01702-1.
    1. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994;47:81–87. doi: 10.1016/0895-4356(94)90036-1.
    1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415. doi: 10.1016/0197-2456(89)90005-6.
    1. Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003;189:48–54. doi: 10.1067/mob.2003.345.
    1. Ware JE, Snow KK, Kosinski MK, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center; 1993.
    1. Crosignani PG, Vercellini P, Apolone G, De Giorgi O, Cortesi I, Meschia M. Endometrial resection versus vaginal hysterectomy for menorrhagia: long-term clinical and quality-of-life outcomes. Am J Obstet Gynecol. 1997;177:95–101. doi: 10.1016/S0002-9378(97)70445-9.
    1. Schulpher MJ, Dwyer N, Byford S, Stirrat GM. Randomized trial comparing hysterectomy and transcervical endometrial resection: effect on health related quality of life and costs two years after surgery. Br J Obstet Gynaecol. 1996;103:142–149.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться