Abstract
BACKGROUND
Uterine fibroids are the most common tumour in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort, subfertility and reduced quality of life. For women wishing to retain their uterus and who do not respond to medical treatment, myomectomy and uterine artery embolisation are therapeutic options.
OBJECTIVES
We examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids.
DESIGN
A multicentre, open, randomised trial with a parallel economic evaluation.
SETTING
Twenty-nine UK hospitals.
PARTICIPANTS
Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolisation were recruited. Women were excluded if they had significant adenomyosis, any malignancy or pelvic inflammatory disease or if they had already had a previous open myomectomy or uterine artery embolisation.
INTERVENTIONS
Participants were randomised to myomectomy or embolisation in a 1 : 1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic. Embolisation of the uterine arteries was performed under fluoroscopic guidance.
MAIN OUTCOME MEASURES
The primary outcome was the Uterine Fibroid Symptom Quality of Life questionnaire (with scores ranging from 0 to 100 and a higher score indicating better quality of life) at 2 years, adjusted for baseline score. The economic evaluation estimated quality-adjusted life-years (derived from EuroQol-5 Dimensions, three-level version, and costs from the NHS perspective).
RESULTS
A total of 254 women were randomised - 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolisation (98 underwent embolisation). Information on the primary outcome at 2 years was available for 81% (n = 206) of women. Primary outcome scores at 2 years were 84.6 (standard deviation 21.5) in the myomectomy group and 80.0 (standard deviation 22.0) in the uterine artery embolisation group (intention-to-treat complete-case analysis mean adjusted difference 8.0, 95% confidence interval 1.8 to 14.1, p = 0.01; mean adjusted difference using multiple imputation for missing responses 6.5, 95% confidence interval 1.1 to 11.9). The mean difference in the primary outcome at the 4-year follow-up time point was 5.0 (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. Perioperative and postoperative complications from all initial procedures occurred in similar percentages of women in both groups (29% in the myomectomy group vs. 24% in the UAE group). Twelve women in the uterine embolisation group and six women in the myomectomy group reported pregnancies over 4 years, resulting in seven and five live births, respectively (hazard ratio 0.48, 95% confidence interval 0.18 to 1.28). Over a 2-year time horizon, uterine artery embolisation was associated with higher costs than myomectomy (mean cost £7958, 95% confidence interval £6304 to £9612, vs. mean cost £7314, 95% confidence interval £5854 to £8773), but with fewer quality-adjusted life-years gained (0.74, 95% confidence interval 0.70 to 0.78, vs. 0.83, 95% confidence interval 0.79 to 0.87). The differences in costs (difference £645, 95% confidence interval -£1381 to £2580) and quality-adjusted life-years (difference -0.09, 95% confidence interval -0.11 to -0.04) were small. Similar results were observed over the 4-year time horizon. At a threshold of willingness to pay for a gain of 1 QALY of £20,000, the probability of myomectomy being cost-effective is 98% at 2 years and 96% at 4 years.
LIMITATIONS
There were a substantial number of women who were not recruited because of their preference for a particular treatment option.
CONCLUSIONS
Among women with symptomatic uterine fibroids, myomectomy resulted in greater improvement in quality of life than did uterine artery embolisation. The differences in costs and quality-adjusted life-years are very small. Future research should involve women who are desiring pregnancy.
TRIAL REGISTRATION
This trial is registered as ISRCTN70772394.
FUNDING
This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in Health Technology Assessment; Vol. 26, No. 22. See the NIHR Journals Library website for further project information.
Plain language summary
WHAT IS THE PROBLEM?
Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. Uterine fibroids are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (via myomectomy) or to completely remove the womb. A newer approach, known as uterine artery embolisation, involves blocking the blood supply to the fibroids in the womb.
WHAT DID WE PLAN TO DO?
We compared myomectomy with uterine artery embolisation in women with fibroids who wanted to keep their womb. We wanted to see which treatment improved quality of life, was associated with the fewest complications and was the best value for money for the NHS. We also wanted to see if either treatment had an impact on women’s ability to get pregnant and give birth. We included 254 women in a clinical trial. Women were assigned to have myomectomy or uterine artery embolisation at random to ensure a fair comparison. Women completed questionnaires about their symptoms and quality of life at intervals up to 4 years after treatment.
WHAT DID WE FIND?
We found that myomectomy improved women’s quality of life more than uterine artery embolisation. Complications from the treatments occurred in a similar proportion of women. There appeared to be no difference on reproductive hormone levels between treatments. Too few women in the trial got pregnant for any difference in the numbers of women having children to be seen. The differences in costs and overall disease burden were small.
WHAT DOES THIS MEAN?
Both treatments improve quality of life and cost about the same to the NHS but, on average, myomectomy will provide greater benefit to women. There is no evidence to suggest that either treatment is unsuitable for women wanting to get pregnant, but more research is needed in younger women.
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References
- McPherson K, Manyonda I, Lumsden MA, Belli AM, Moss J, Wu O, et al. A randomised trial of treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy (the FEMME study): study protocol for a randomised controlled trial. Trials 2014;15:468. https://doi.org/10.1186/1745-6215-15-468 doi: 10.1186/1745-6215-15-468. [DOI] [PMC free article] [PubMed]
- Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet 2015;131:117–22. https://doi.org/10.1016/j.ijgo.2015.04.051 doi: 10.1016/j.ijgo.2015.04.051. [DOI] [PubMed]
- Downes E, Sikirica V, Gilabert-Estelles J, Bolge SC, Dodd SL, Maroulis C, et al. The burden of uterine fibroids in five European countries. Eur J Obstet Gynecol Reprod Biol 2010;152:96–102. https://doi.org/10.1016/j.ejogrb.2010.05.012 doi: 10.1016/j.ejogrb.2010.05.012. [DOI] [PubMed]
- Borah BJ, Nicholson WK, Bradley L, Stewart EA. The impact of uterine leiomyomas: a national survey of affected women. Am J Obstet Gynecol 2013;209:319.e1–319.e20. https://doi.org/10.1016/j.ajog.2013.07.017 doi: 10.1016/j.ajog.2013.07.017. [DOI] [PMC free article] [PubMed]
- Somigliana E, Vercellini P, Daguati R, Pasin R, De Giorgi O, Crosignani PG. Fibroids and female reproduction: a critical analysis of the evidence. Hum Reprod Update 2007;13:465–76. https://doi.org/10.1093/humupd/dmm013 doi: 10.1093/humupd/dmm013. [DOI] [PubMed]
- Pritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril 2009;91:1215–23. https://doi.org/10.1016/j.fertnstert.2008.01.051 doi: 10.1016/j.fertnstert.2008.01.051. [DOI] [PubMed]
- Sundermann AC, Velez Edwards DR, Bray MJ, Jones SH, Latham SM, Hartmann KE. Leiomyomas in pregnancy and spontaneous abortion: a systematic review and meta-analysis. Obstet Gynecol 2017;130:1065–72. https://doi.org/10.1097/AOG.0000000000002313 doi: 10.1097/AOG.0000000000002313. [DOI] [PMC free article] [PubMed]
- NHS Digital. Hospital Episode Statistics, Admitted Patient Care, England – 2012–2013: Diagnosis. London: NHS Digital; 2013.
- Munro MG, Critchley HOD, Fraser IS. The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions. Int J Gynaecol Obstet 2018;143:393–408. [Corrigendum published in Int J Gynaecol Obstet 2019;144:237.] https://doi.org/10.1002/ijgo.12666 doi: 10.1002/ijgo.12666. [DOI] [PubMed]
- National Collaborating Centre for Women’s and Children’s Health. Heavy Menstrual Bleeding. Clinical Guideline CG044. London: Royal College of Obstetrics and Gynaecology Press; 2007.
- Donnez J, Tomaszewski J, Vázquez F, Bouchard P, Lemieszczuk B, Baró F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012;366:421–32. https://doi.org/10.1056/NEJMoa1103180 doi: 10.1056/NEJMoa1103180. [DOI] [PubMed]
- Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, et al. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril 2016;105:165–73.e4. https://doi.org/10.1016/j.fertnstert.2015.09.032 doi: 10.1016/j.fertnstert.2015.09.032. [DOI] [PubMed]
- DTB Team. Ulipristal acetate (Esmya): restrictions on use. Drug Ther Bull 2018;56:11. doi: 10.1136/dtb.2018.11.000033. [DOI] [PubMed]
- Diamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, et al. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open 2019;2019:hoz027. https://doi.org/10.1093/hropen/hoz027 doi: 10.1093/hropen/hoz027. [DOI] [PMC free article] [PubMed]
- Ciebiera M, Vitale SG, Ferrero S, Vilos GA, Barra F, Caruso S, et al. Vilaprisan, a new selective progesterone receptor modulator in uterine fibroid pharmacotherapy-will it really be a breakthrough? Curr Pharm Des 2020;26:300–9. https://doi.org/10.2174/1381612826666200127092208 doi: 10.2174/1381612826666200127092208. [DOI] [PubMed]
- LaCroix AZ, Freeman EW, Larson J, Carpenter JS, Joffe H, Reed SD, et al. Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: a randomized controlled trial. Maturitas 2012;73:361–8. https://doi.org/10.1016/j.maturitas.2012.09.006 doi: 10.1016/j.maturitas.2012.09.006. [DOI] [PMC free article] [PubMed]
- Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med 2020;382:328–40. https://doi.org/10.1056/NEJMoa1904351 doi: 10.1056/NEJMoa1904351. [DOI] [PubMed]
- Osuga Y, Enya K, Kudou K, Hoshiai H. Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women. Fertil Steril 2019;112:922–9.e2. https://doi.org/10.1016/j.fertnstert.2019.07.013 doi: 10.1016/j.fertnstert.2019.07.013. [DOI] [PubMed]
- Pohl O, Marchand L, Bell D, Gotteland JP. Effects of combined GnRH receptor antagonist linzagolix and hormonal add-back therapy on vaginal bleeding-delayed add-back onset does not improve bleeding pattern. Reprod Sci 2020;27:988–95. https://doi.org/10.1007/s43032-020-00172-z doi: 10.1007/s43032-020-00172-z. [DOI] [PubMed]
- Hehenkamp WJ, Volkers NA, Broekmans FJ, de Jong FH, Themmen AP, Birnie E, et al. Loss of ovarian reserve after uterine artery embolization: a randomized comparison with hysterectomy. Hum Reprod 2007;22:1996–2005. https://doi.org/10.1093/humrep/dem105 doi: 10.1093/humrep/dem105. [DOI] [PubMed]
- Rashid S, Khaund A, Murray LS, Moss JG, Cooper K, Lyons D, et al. The effects of uterine artery embolisation and surgical treatment on ovarian function in women with uterine fibroids. BJOG 2010;117:985–9. https://doi.org/10.1111/j.1471-0528.2010.02579.x doi: 10.1111/j.1471-0528.2010.02579.x. [DOI] [PubMed]
- Kaump GR, Spies JB. The impact of uterine artery embolization on ovarian function. J Vasc Interv Radiol 2013;24:459–67. https://doi.org/10.1016/j.jvir.2012.12.002 doi: 10.1016/j.jvir.2012.12.002. [DOI] [PubMed]
- National Institute for Health and Care Excellence (NICE). Magnetic Resonance Image-Guided Transcutaneous Focused Ultrasound for Uterine Fibroids. Interventional Procedures Guidance [IPG413]. London: NICE; 2011.
- Laughlin-Tommaso S, Barnard EP, AbdElmagied AM, Vaughan LE, Weaver AL, Hesley GK, et al. FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery. Am J Obstet Gynecol 2019;220:174.e1–174.e13. https://doi.org/10.1016/j.ajog.2018.10.032 doi: 10.1016/j.ajog.2018.10.032. [DOI] [PMC free article] [PubMed]
- Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-year results of the SONATA pivotal trial. J Gynecol Surg 2019;35:345–9. https://doi.org/10.1089/gyn.2019.0012 doi: 10.1089/gyn.2019.0012. [DOI] [PMC free article] [PubMed]
- Ierardi AM, Savasi V, Angileri SA, Petrillo M, Sbaraini S, Pinto A, et al. Percutaneous high frequency microwave ablation of uterine fibroids: systematic review. Biomed Res Int 2018;2018. https://doi.org/10.1155/2018/2360107 doi: 10.1155/2018/2360107. [DOI] [PMC free article] [PubMed]
- Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol 2006;126:226–33. https://doi.org/10.1016/j.ejogrb.2005.10.008 doi: 10.1016/j.ejogrb.2005.10.008. [DOI] [PubMed]
- Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol 2008;31:73–85. https://doi.org/10.1007/s00270-007-9195-2 doi: 10.1007/s00270-007-9195-2. [DOI] [PMC free article] [PubMed]
- Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life – results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) trial. Cardiovasc Intervent Radiol 2012;35:530–6. https://doi.org/10.1007/s00270-011-0228-5 doi: 10.1007/s00270-011-0228-5. [DOI] [PubMed]
- Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, et al. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG 2011;118:936–44. https://doi.org/10.1111/j.1471-0528.2011.02952.x doi: 10.1111/j.1471-0528.2011.02952.x. [DOI] [PubMed]
- Jun F, Yamin L, Xinli X, Zhe L, Min Z, Bo Z, Wenli G. Uterine artery embolization versus surgery for symptomatic uterine fibroids: a randomized controlled trial and a meta-analysis of the literature. Arch Gynecol Obstet 2012;285:1407–13. https://doi.org/10.1007/s00404-011-2065-9 doi: 10.1007/s00404-011-2065-9. [DOI] [PubMed]
- Ruuskanen A, Hippeläinen M, Sipola P, Manninen H. Uterine artery embolisation versus hysterectomy for leiomyomas: primary and 2-year follow-up results of a randomised prospective clinical trial. Eur Radiol 2010;20:2524–32. https://doi.org/10.1007/s00330-010-1829-0 doi: 10.1007/s00330-010-1829-0. [DOI] [PubMed]
- Hehenkamp WJ, Volkers NA, Donderwinkel PF, de Blok S, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trial. Am J Obstet Gynecol 2005;193:1618–29. https://doi.org/10.1016/j.ajog.2005.05.017 doi: 10.1016/j.ajog.2005.05.017. [DOI] [PubMed]
- Pinto I, Chimeno P, Romo A, Paúl L, Haya J, de la Cal MA, Bajo J. Uterine fibroids: uterine artery embolization versus abdominal hysterectomy for treatment – a prospective, randomized, and controlled clinical trial. Radiology 2003;226:425–31. https://doi.org/10.1148/radiol.2262011716 doi: 10.1148/radiol.2262011716. [DOI] [PubMed]
- Fonseca MCM, Castro R, Machado M, Conte T, Girao MJBC. Uterine artery embolization and surgical methods for the treatment of symptomatic uterine leiomyomas: a systemic review and meta-analysis followed by indirect treatment comparison. Clin Ther 2017;39:1438–55.e2. https://doi.org/10.1016/j.clinthera.2017.05.346 doi: 10.1016/j.clinthera.2017.05.346. [DOI] [PubMed]
- Torre A, Fauconnier A, Kahn V, Limot O, Bussierres L, Pelage JP. Fertility after uterine artery embolization for symptomatic multiple fibroids with no other infertility factors. Eur Radiol 2017;27:2850–9. https://doi.org/10.1007/s00330-016-4681-z doi: 10.1007/s00330-016-4681-z. [DOI] [PubMed]
- El Shamy T, Amer SAK, Mohamed AA, James C, Jayaprakasan K. The impact of uterine artery embolization on ovarian reserve: a systematic review and meta-analysis. Acta Obstet Gynecol Scand 2020;99:16–23. https://doi.org/10.1111/aogs.13698 doi: 10.1111/aogs.13698. [DOI] [PubMed]
- You JH, Sahota DS, Yuen PM. Uterine artery embolization, hysterectomy, or myomectomy for symptomatic uterine fibroids: a cost–utility analysis. Fertil Steril 2009;91:580–8. https://doi.org/10.1016/j.fertnstert.2007.11.078 doi: 10.1016/j.fertnstert.2007.11.078. [DOI] [PubMed]
- Zowall H, Cairns JA, Brewer C, Lamping DL, Gedroyc WM, Regan L. Cost-effectiveness of magnetic resonance-guided focused ultrasound surgery for treatment of uterine fibroids. BJOG 2008;115:653–62. https://doi.org/10.1111/j.1471-0528.2007.01657.x doi: 10.1111/j.1471-0528.2007.01657.x. [DOI] [PMC free article] [PubMed]
- Wu O, Briggs A, Dutton S, Hirst A, Maresh M, Nicholson A, McPherson K. Uterine artery embolisation or hysterectomy for the treatment of symptomatic uterine fibroids: a cost-utility analysis of the HOPEFUL study. BJOG 2007;114:1352–62. https://doi.org/10.1111/j.1471-0528.2007.01525.x doi: 10.1111/j.1471-0528.2007.01525.x. [DOI] [PubMed]
- Babashov V, Palimaka S, Blackhouse G, O’Reilly D. Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) for treatment of symptomatic uterine fibroids: an economic analysis. Ont Health Technol Assess Ser 2015;15:1–61. [PMC free article] [PubMed]
- Cain-Nielsen AH, Moriarty JP, Stewart EA, Borah BJ. Cost-effectiveness of uterine-preserving procedures for the treatment of uterine fibroid symptoms in the USA. J Comp Eff Res 2014;3:503–14. https://doi.org/10.2217/cer.14.32 doi: 10.2217/cer.14.32. [DOI] [PMC free article] [PubMed]
- O’Sullivan AK, Thompson D, Chu P, Lee DW, Stewart EA, Weinstein MC. Cost-effectiveness of magnetic resonance guided focused ultrasound for the treatment of uterine fibroids. Int J Technol Assess Health Care 2009;25:14–25. https://doi.org/10.1017/S0266462309090035 doi: 10.1017/S0266462309090035. [DOI] [PMC free article] [PubMed]
- Kong CY, Meng L, Omer ZB, Swan JS, Srouji S, Gazelle GS, Fennessy FM. MRI-guided focused ultrasound surgery for uterine fibroid treatment: a cost-effectiveness analysis. Am J Roentgenol 2014;203:361–71. https://doi.org/10.2214/AJR.13.11446 doi: 10.2214/AJR.13.11446. [DOI] [PMC free article] [PubMed]
- Beinfeld MT, Bosch JL, Isaacson KB, Gazelle GS. Cost-effectiveness of uterine artery embolization and hysterectomy for uterine fibroids. Radiology 2004;230:207–13. https://doi.org/10.1148/radiol.2301021482 doi: 10.1148/radiol.2301021482. [DOI] [PubMed]
- Canadian Agency for Drugs and Technologies in Health. Uterine-Preserving Interventions for the Management of Symptomatic Uterine Fibroids: A Systematic Review of Clinical and Cost-Effectiveness. 2016. URL: www.cadth.ca/interventions-for-the-management-of-symptomatic-uterine-fibroids (accessed 2 June 2020). [PubMed]
- Royal College of Obstetricians and Gynaecologists, Royal College of Radiologists. Clinical Recommendations on the Use of Uterine Artery Embolisation in the Management of Fibroids. 2nd edn. London: Royal College of Obstetricians and Gynaecologists, Royal College of Radiologists; 2009.
- American Association of Gynecologic Laparoscopists. AAGL practice report: practice guidelines for the diagnosis and management of submucous leiomyomas. J Minim Invasive Gynecol 2012;19:152–71. https://doi.org/10.1016/j.jmig.2011.09.005. doi: 10.1016/j.jmig.2011.09.005. [DOI] [PubMed]
- Knuttinen MG, Stark G, Hohenwalter EJ, Bradley LD, Braun AR, Gipson MG, et al. ACR Appropriateness Criteria® radiologic management of uterine leiomyomas. J Am Coll Radiol 2018;15:S160–70. https://doi.org/10.1016/j.jacr.2018.03.010 doi: 10.1016/j.jacr.2018.03.010. [DOI] [PubMed]
- Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Uterine Artery Embolisation for the Treatment of Uterine Fibroids. 2020. URL: https://ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical%20-%20Gynaecology/Uterine-Artery-Embolisation-(C-Gyn-23)_2.pdf?ext=.pdf (accessed 2 June 2020).
- Sandberg EM, Tummers FHMP, Cohen SL, van den Haak L, Dekkers OM, Jansen FW. Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis. Fertil Steril 2018;109:698–707.e1. https://doi.org/10.1016/j.fertnstert.2017.11.033 doi: 10.1016/j.fertnstert.2017.11.033. [DOI] [PubMed]
- Khaw SC, Anderson RA, Lui MW. Systematic review of pregnancy outcomes after fertility-preserving treatment of uterine fibroids. Reprod Biomed Online 2020;40:429–44. https://doi.org/10.1016/j.rbmo.2020.01.003 doi: 10.1016/j.rbmo.2020.01.003. [DOI] [PubMed]
- Homer H, Saridogan E. Uterine artery embolization for fibroids is associated with an increased risk of miscarriage. Fertil Steril 2010;94:324–30. https://doi.org/10.1016/j.fertnstert.2009.02.069 doi: 10.1016/j.fertnstert.2009.02.069. [DOI] [PubMed]
- DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005;365:711–22. https://doi.org/10.1016/S0140-6736(05)17965-3 doi: 10.1016/S0140-6736(05)17965-3. [DOI] [PubMed]
- Great Britain. Mental Capacity Act 2005. London: The Stationery Office; 2005.
- Great Britain. Adults with Incapacity (Scotland) Act 2000. London: The Stationery Office; 2000.
- 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. https://doi.org/10.1097/00006250-200202000-00021 doi: 10.1097/00006250-200202000-00021. [DOI] [PubMed]
- 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 Qual Life Outcomes 2008;6:99. https://doi.org/10.1186/1477-7525-6-99 doi: 10.1186/1477-7525-6-99. [DOI] [PMC free article] [PubMed]
- Coyne KS, Margolis MK, Bradley LD, Guido R, Maxwell GL, Spies JB. Further validation of the uterine fibroid symptom and quality-of-life questionnaire. Value Health 2012;15:135–42. https://doi.org/10.1016/j.jval.2011.07.007 doi: 10.1016/j.jval.2011.07.007. [DOI] [PubMed]
- The EuroQol Group. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. https://doi.org/10.1016/0168-8510(90)90421-9 doi: 10.1016/0168-8510(90)90421-9. [DOI] [PubMed]
- Higham JM, O’Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990;97:734–9. https://doi.org/10.1111/j.1471-0528.1990.tb16249.x doi: 10.1111/j.1471-0528.1990.tb16249.x. [DOI] [PubMed]
- Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. New York, NY: Springer; 2000. https://doi.org/10.1007/978-1-4419-0300-6 doi: 10.1007/978-1-4419-0300-6. [DOI]
- Little RJ, Rubin DB. Statistical Analysis with Missing Data. 2nd edn. New York, NY: John Wiley & Sons, Inc.; 2002. https://doi.org/10.1002/9781119013563 doi: 10.1002/9781119013563. [DOI]
- Manyonda I, Belli A, Lumsden MA, Moss J, McKinnon W, Middleton L et al. Uterine artery embolisation or myomectomy for uterine fibroids. New Engl J Med 2020;383:440–51. https://doi.org/10.1056/NEJMoa1914735 doi: 10.1056/NEJMoa1914735. [DOI]
- Daniels J, Middleton LJ, Cheed V, McKinnon W, Sirkeci F, Manyonda I, et al. Uterine artery embolization or myomectomy for women with uterine fibroids: four-year follow-up of a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol 2021;13:100139. doi: 10.1016/j.eurox.2021.100139. [DOI] [PMC free article] [PubMed]
- Rana D, Wu O, Cheed V, Middleton LJ, Moss J, Lumsden M-A, et al. Uterine artery embolisation or myomectomy for women with uterine fibroids wishing to avoid hysterectomy: a cost–utility analysis of the FEMME trial. BJOG 2021;128:1793–802. https://doi.org/10.1111/1471-0528.16781 doi: 10.1111/1471-0528.16781. [DOI] [PubMed]
- National Institute for Health and Care Excellence (NICE). Guide to the Methods of Technology Appraisal. London: NICE; 2013. [PubMed]
- Department of Health and Social Care. Reference Costs 2017–2018. 2018. URL: www.england.nhs.uk/national-cost-collection/ (accessed 2 June 2020).
- Curtis L, Burns A. Unit Costs of Health and Social Care 2018. 2018. URL: www.pssru.ac.uk/project-pages/unit-costs/unit-costs-2018 (accessed 2 June 2020).
- The Royal Pharmaceutical Society. British National Formulary. 2020. URL: www.medicinescomplete.com (accessed 2 June 2020).
- NHS Cost Inflation Index 2018/19. 2019. URL: www.google.com/url?sa=t%26rct=j%26q=%26esrc=s%26source=web%26cd=%26ved=2ahUKEwjZve78juP0AhVbilwKHRsZB-8QFnoECBAQAQ%26url=https%3A%2F%2Fwww.pssru.ac.uk%2Fpub%2Fuc%2Fuc2019%2FNHS-Inflation-Index-version-1.9A.xlsx%26usg=AOvVaw1N3WPzF18cF5tFAsG3djog (accessed 14 December 2021).
- Geue C, Lewsey J, Lorgelly P, Govan L, Hart C, Briggs A. Spoilt for choice: implications of using alternative methods of costing hospital episode statistics. Health Econ 2012;21:1201–16. https://doi.org/10.1002/hec.1785 doi: 10.1002/hec.1785. [DOI] [PubMed]
- Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095–108. https://doi.org/10.1097/00005650-199711000-00002 doi: 10.1097/00005650-199711000-00002. [DOI] [PubMed]
- Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ 2005;14:487–96. https://doi.org/10.1002/hec.944 doi: 10.1002/hec.944. [DOI] [PubMed]
- Faria R, Gomes M, Epstein D, White IR. A guide to handling missing data in cost-effectiveness analysis conducted within randomised controlled trials. PharmacoEconomics 2014;32:1157–70. https://doi.org/10.1007/s40273-014-0193-3 doi: 10.1007/s40273-014-0193-3. [DOI] [PMC free article] [PubMed]
- Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health 2005;8:521–33. https://doi.org/10.1111/j.1524-4733.2005.00045.x doi: 10.1111/j.1524-4733.2005.00045.x. [DOI] [PubMed]
- Glick H, Doshhi J, Sonnad S, Polsky D. Economic Evaluation in Clinical Trials. Oxford: Oxford University Press; 2007.
- Briggs A, Claxton K, Sculpher M. Decision Modelling for Health Economic Evaluation. Oxford: Oxford University Press; 2011.
- Cohen J. Statistical Power Analysis for Behavioral Sciences: Revised. New York, NY: Academic Press; 1977.
- Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005;14:1523–32. https://doi.org/10.1007/s11136-004-7713-0 doi: 10.1007/s11136-004-7713-0. [DOI] [PubMed]
- Gupta JK, Sinha AS, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev 2006;1:CD005073. https://doi.org/10.1002/14651858.CD005073.pub2 doi: 10.1002/14651858.CD005073.pub2. [DOI] [PubMed]
- Narayan A, Lee AS, Kuo GP, Powe N, Kim HS. Uterine artery embolization versus abdominal myomectomy: a long-term clinical outcome comparison. J Vasc Interv Radiol 2010;21:1011–17. https://doi.org/10.1016/j.jvir.2010.03.012 doi: 10.1016/j.jvir.2010.03.012. [DOI] [PMC free article] [PubMed]
- Goodwin SC, Bradley LD, Lipman JC, Stewart EA, Nosher JL, Sterling KM, et al. Uterine artery embolization versus myomectomy: a multicenter comparative study. Fertil Steril 2006;85:14–21. https://doi.org/10.1016/j.fertnstert.2005.05.074 doi: 10.1016/j.fertnstert.2005.05.074. [DOI] [PubMed]
- Janssen MF, Bonsel GJ, Luo N. Is EQ-5D-5L better than EQ-5D-3L? A head-to-head comparison of descriptive systems and value sets from seven countries. PharmacoEconomics 2018;36:675–97. https://doi.org/10.1007/s40273-018-0623-8 doi: 10.1007/s40273-018-0623-8. [DOI] [PMC free article] [PubMed]
- Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev 2014;8:CD005355. https://doi.org/10.1002/14651858.CD005355.pub5 doi: 10.1002/14651858.CD005355.pub5. [DOI] [PMC free article] [PubMed]
- Zullo F, Venturella R, Raffone A, Saccone G. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy. Cochrane Database Syst Rev 2020;5:CD013352. https://doi.org/10.1002/14651858.CD013352.pub2 doi: 10.1002/14651858.CD013352.pub2. [DOI] [PMC free article] [PubMed]
- Yadavali R, Ananthakrishnan G, Sim M, Monaghan K, McNaught G, Hamoodi I, et al. Randomised trial of two embolic agents for uterine artery embolisation for fibroids: gelfoam versus embospheres (RAGE trial). CVIR Endovasc 2019;2:4. https://doi.org/10.1186/s42155-018-0044-y doi: 10.1186/s42155-018-0044-y. [DOI] [PMC free article] [PubMed]
- Das R, Champaneria R, Daniels JP, Belli AM. Comparison of embolic agents used in uterine artery embolisation: a systematic review and meta-analysis. Cardiovasc Intervent Radiol 2014;37:1179–90. https://doi.org/10.1007/s00270-013-0790-0 doi: 10.1007/s00270-013-0790-0. [DOI] [PubMed]
- COMET Initiative. CoreUF: Developing a Core Outcome Set for Symptomatic Uterine Fibroids. 2020. URL: www.comet-initiative.org/studies/details/1361 (accessed 2 June 2020).