Evidence map›Paper›PMID 34821569›Full record

ArticleJMIR research protocols2021

Comparison of (Cost-)Effectiveness of Magnetic Resonance Image-Guided High-Intensity-Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: Protocol for a Multicenter Randomized Controlled Trial (MYCHOICE).

Kimberley J Anneveldt, Ingrid M Nijholt, Joke M Schutte, Jeroen R Dijkstra, Geert W J Frederix, Erwin Ista, Inez M Verpalen, Sebastiaan Veersema, Judith A F Huirne, Wouter J K Hehenkamp and 1 more

Open access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

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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

11 authors at 4 institutions in 1 country.

Kimberley J Anneveldt *Department of Radiology, Isala Hospital, Zwolle, Netherlands.ORCID https://orcid.org/0000-0002-4546-1148
Ingrid M Nijholt *Department of Radiology, Isala Hospital, Zwolle, Netherlands.ORCID https://orcid.org/0000-0003-4820-7505
Joke M SchutteDepartment of Gynecology, Isala Hospital, Zwolle, Netherlands.ORCID https://orcid.org/0000-0003-2362-8602
Jeroen R DijkstraDepartment of Gynecology, Isala Hospital, Zwolle, Netherlands.ORCID https://orcid.org/0000-0002-9593-8311
Geert W J FrederixJulius Center for Health Science and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.ORCID https://orcid.org/0000-0002-0355-3466
Erwin IstaDepartment of Internal Medicine, Section of Nursing Science, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands.ORCID https://orcid.org/0000-0003-1257-3108
Inez M VerpalenDepartment of Radiology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0002-3267-0637
Sebastiaan VeersemaDepartment of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, Netherlands.ORCID https://orcid.org/0000-0002-9264-4908
Judith A F HuirneDepartment of Gynecology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0002-8248-2677
Wouter J K HehenkampDepartment of Gynecology, Amsterdam University Medical Center, Academic Medical Center, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0003-3678-7899
Martijn F BoomsmaDepartment of Radiology, Isala Hospital, Zwolle, Netherlands.ORCID https://orcid.org/0000-0002-7878-0970
Isala · NLAmsterdam UMC Location University of Amsterdam · NLUniversity Medical Center Utrecht · NLErasmus MC · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMagnetic resonance image-guided high-intensity-focused ultrasound (MR-HIFU) is a rather new, noninvasive option for the treatment of uterine fibroids. It is safe, effective, and has a very short recovery time. However, a lack of prospectively collected data on long-term (cost-)effectiveness of the MR-HIFU treatment compared with standard uterine fibroid care prevents the MR-HIFU treatment from being reimbursed for this indication. Therefore, at this point, when conservative treatment for uterine fibroid symptoms has failed or is not accepted by patients, standard care includes the more invasive treatments hysterectomy, myomectomy, and uterine artery embolization (UAE). Primary outcomes of currently available data on MR-HIFU treatment often consist of technical outcomes, instead of patient-centered outcomes such as quality of life (QoL), and do not include the use of the latest equipment or most up-to-date treatment strategies. Moreover, data on cost-effectiveness are rare and seldom include data on a societal level such as productivity loss or use of painkillers. Because of the lack of reimbursement, broad clinical implementation has not taken place, nor is the proper role of MR-HIFU in uterine fibroid care sufficiently clear.

objectiveThe objective of our study is to determine the long-term (cost-)effectiveness of MR-HIFU compared with standard (minimally) invasive fibroid treatments.

methodsThe MYCHOICE study is a national, multicenter, open randomized controlled trial with randomization in a 2:1 ratio to MR-HIFU or standard care including hysterectomy, myomectomy, and UAE. The sample size is 240 patients in total. Women are included when they are 18 years or older, in premenopausal stage, diagnosed with symptomatic uterine fibroids, conservative treatment has failed or is not accepted, and eligible for MR-HIFU. Primary outcomes of the study are QoL 24 months after treatment and costs of treatment including direct health care costs, loss of productivity, and patient costs.

resultsInclusion for the MYCHOICE study started in November 2020 and enrollment will continue until 2024. Data collection is expected to be completed in 2026.

conclusionsBy collecting data on the long-term (cost-)effectiveness of the MR-HIFU treatment in comparison to current standard fibroid care, we provide currently unavailable evidence about the proper place of MR-HIFU in the fibroid treatment spectrum. This will also facilitate reimbursement and inclusion of MR-HIFU in (inter)national uterine fibroid care guidelines.

trial registrationNetherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29467.

Indexed as

clinical trial protocolcost-effectiveness analysishigh-intensity–focused ultrasound ablationleiomyomamagnetic resonance imaging, interventionalrandomized controlled trial

Identifiers

PMID34821569
PMCPMC8663707
OpenAlexW3198524409

What OpenQuestion holds

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Registered trials

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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.