TY - JOUR
T1 - Comparison of (cost-)effectiveness of magnetic resonance image-guided high-intensity-focused ultrasound with standard (minimally) invasive fibroid treatments
T2 - Protocol for a multicenter randomized controlled trial (MYCHOICE)
AU - Anneveldt, Kimberley J.
AU - Nijholt, Ingrid M.
AU - Schutte, Joke M.
AU - Dijkstra, Jeroen R.
AU - Frederix, Geert W. J.
AU - Ista, Erwin
AU - Verpalen, Inez M.
AU - Veersema, Sebastiaan
AU - Huirne, Judith A. F.
AU - Hehenkamp, Wouter J. K.
AU - Boomsma, Martijn F.
N1 - Funding Information: This study is funded by Isala Hospital, Medical Specialist Company Isala (MSB-I), The Focused Ultrasound Foundation, and Profound Medical. The subsiding parties have no decisive role in study design, data collection, and data analysis nor data interpretation. Publisher Copyright: © 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, Martijn F Boomsma. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.11.2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2021/11/1
Y1 - 2021/11/1
N2 - Background: Magnetic 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. Objective: The objective of our study is to determine the long-term (cost-)effectiveness of MR-HIFU compared with 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 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. 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.
AB - Background: Magnetic 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. Objective: The objective of our study is to determine the long-term (cost-)effectiveness of MR-HIFU compared with 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 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. 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.
KW - Clinical trial protocol
KW - Cost-effectiveness analysis
KW - High-intensity-focused ultrasound ablation
KW - Leiomyoma
KW - Magnetic resonance imaging, interventional
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85120427396&partnerID=8YFLogxK
U2 - https://doi.org/10.2196/29467
DO - https://doi.org/10.2196/29467
M3 - Article
C2 - 34821569
SN - 1929-0748
VL - 10
JO - JMIR research protocols
JF - JMIR research protocols
IS - 11
M1 - e29467
ER -