Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 9, 2021
Date Accepted: Sep 3, 2021
Date Submitted to PubMed: Nov 25, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
MYoma treatment Comparison study: High intensity image guided fOcused ultrasound versus standard (minimally) Invasive fibroid care - a (Cost) Effectiveness analysis (MYCHOICE): Study protocol for a multicenter randomized controlled trial
ABSTRACT
Background:
Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU) is a rather new, non-invasive treatment 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 to standard uterine fibroid care, keeps 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 like quality of life and do not include the use of the latest equipment or most up-to-date treatment strategies. Moreover, data on cost-effectiveness is rare and seldom includes data on a societal level such as productivity loss or use of painkillers. As a results of the lack of reimbursement, broad clinical implementation has not taken place, nor is the proper place of MR-HIFU in uterine fibroid care sufficiently clear.
Objective:
The objective of our study is to determine the long-term (cost)effectiveness of MR-HIFU compared to standard (minimally) invasive fibroid treatments.
Methods:
The 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 18 years or older, premenopausal, diagnosed with symptomatic uterine fibroids in whom conservative treatment failed or is not accepted and eligible for MR-HIFU. Primary outcomes of the study are quality of life 24 months after treatment and costs of treatment including direct health care costs, loss of productivity and patient costs.
Results:
Inclusion for the MYCHOICE study started in November 2020 and enrollment will continue until 2024. Data collection is expected to be completed in 2026.
Conclusions:
By 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. Clinical Trial: trialregister.nl: NL8863
Citation
