Evidence map›Paper›PMID 35435818›Full record

Trial reportHealth technology assessment (Winchester, England)2022

Uterine artery embolisation versus myomectomy for premenopausal women with uterine fibroids wishing to avoid hysterectomy: the FEMME RCT.

Jane Daniels, Lee J Middleton, Versha Cheed, William McKinnon, Dikshyanta Rana, Fusun Sirkeci, Isaac Manyonda, Anna-Maria Belli, Mary Ann Lumsden, Jonathan Moss and 2 more

Open access · diamondAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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  20. Complications of transvaginal radiofrequency ablation of fibroids: A 5-year experience.European journal of obstetrics & gynecology and reproductive biology: X · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Jane DanielsNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.ORCID 0000-0003-3324-6771
Lee J MiddletonBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.ORCID 0000-0003-4621-1922
Versha CheedBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.ORCID 0000-0002-6713-0913
William McKinnonBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.ORCID 0000-0001-8734-2932
Dikshyanta RanaInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.ORCID 0000-0001-9133-3094
Fusun SirkeciDepartment of Obstetrics and Gynaecology, Whipps Cross Hospital, London, UK.ORCID 0000-0002-8221-5763
Isaac ManyondaDepartment of Gynaecology, St George's Hospital and Medical School, London, UK.ORCID 0000-0003-3080-2357
Anna-Maria BelliDepartment of Radiology, St George's Hospital and Medical School, London, UK.ORCID 0000-0002-3703-9596
Mary Ann LumsdenSchool of Medicine, University of Glasgow, Glasgow, UK.ORCID 0000-0003-2998-9185
Jonathan MossSchool of Medicine, University of Glasgow, Glasgow, UK.ORCID 0000-0002-4589-9174
Olivia WuInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.ORCID 0000-0002-0570-6016
Klim McPhersonDepartment of Primary Care, University of Oxford, Oxford, UK.ORCID 0000-0002-5461-2569
University of Glasgow · GBCancer Research UK Clinical Trials Unit · GBSt George's Hospital · GBUniversity of Nottingham · GBUniversity of Oxford · GBWhipps Cross University Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUterine 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.

objectivesWe examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids.

designA multicentre, open, randomised trial with a parallel economic evaluation.

settingTwenty-nine UK hospitals.

participantsPremenopausal 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.

interventionsParticipants 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 measuresThe 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).

resultsA 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% ( LIMITATIONS: There were a substantial number of women who were not recruited because of their preference for a particular treatment option.

conclusionsAmong 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 registrationThis trial is registered as ISRCTN70772394.

fundingThis study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in

Indexed as

LeiomyomaUterine Artery EmbolizationUterine MyomectomyFemaleHumansHysterectomyPregnancyQuality of LifeADULTCOST-BENEFIT ANALYSISFEMALEHUMANMYOMECTOMYOVARIAN RESERVEPREGNANCY RATEQUALITY-ADJUSTED LIFE YEARSQUALITY OF LIFERANDOMISED CONTROLLED TRIALUNITED KINGDOMUTERINE ARTERY EMBOLISATIONUTERINE FIBROID

Identifiers

PMID35435818
PMCPMC9082260
OpenAlexW4223943049

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.