Cargando…

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)

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-)effectiven...

Descripción completa

Detalles Bibliográficos
Autores principales: Anneveldt, Kimberley J, Nijholt, Ingrid M, Schutte, Joke M, Dijkstra, Jeroen R, Frederix, Geert W J, Ista, Erwin, Verpalen, Inez M, Veersema, Sebastiaan, Huirne, Judith A F, Hehenkamp, Wouter J K, Boomsma, Martijn F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8663707/
https://www.ncbi.nlm.nih.gov/pubmed/34821569
http://dx.doi.org/10.2196/29467
_version_ 1784613701386502144
author Anneveldt, Kimberley J
Nijholt, Ingrid M
Schutte, Joke M
Dijkstra, Jeroen R
Frederix, Geert W J
Ista, Erwin
Verpalen, Inez M
Veersema, Sebastiaan
Huirne, Judith A F
Hehenkamp, Wouter J K
Boomsma, Martijn F
author_facet Anneveldt, Kimberley J
Nijholt, Ingrid M
Schutte, Joke M
Dijkstra, Jeroen R
Frederix, Geert W J
Ista, Erwin
Verpalen, Inez M
Veersema, Sebastiaan
Huirne, Judith A F
Hehenkamp, Wouter J K
Boomsma, Martijn F
author_sort Anneveldt, Kimberley J
collection PubMed
description 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. TRIAL REGISTRATION: Netherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29467
format Online
Article
Text
id pubmed-8663707
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher JMIR Publications
record_format MEDLINE/PubMed
spelling pubmed-86637072021-12-30 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) Anneveldt, Kimberley J Nijholt, Ingrid M Schutte, Joke M Dijkstra, Jeroen R Frederix, Geert W J Ista, Erwin Verpalen, Inez M Veersema, Sebastiaan Huirne, Judith A F Hehenkamp, Wouter J K Boomsma, Martijn F JMIR Res Protoc Protocol 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. TRIAL REGISTRATION: Netherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29467 JMIR Publications 2021-11-24 /pmc/articles/PMC8663707/ /pubmed/34821569 http://dx.doi.org/10.2196/29467 Text en ©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. https://creativecommons.org/licenses/by/4.0/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.
spellingShingle Protocol
Anneveldt, Kimberley J
Nijholt, Ingrid M
Schutte, Joke M
Dijkstra, Jeroen R
Frederix, Geert W J
Ista, Erwin
Verpalen, Inez M
Veersema, Sebastiaan
Huirne, Judith A F
Hehenkamp, Wouter J K
Boomsma, Martijn F
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8663707/
https://www.ncbi.nlm.nih.gov/pubmed/34821569
http://dx.doi.org/10.2196/29467
work_keys_str_mv AT anneveldtkimberleyj comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT nijholtingridm comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT schuttejokem comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT dijkstrajeroenr comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT frederixgeertwj comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT istaerwin comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT verpaleninezm comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT veersemasebastiaan comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT huirnejudithaf comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT hehenkampwouterjk comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice
AT boomsmamartijnf comparisonofcosteffectivenessofmagneticresonanceimageguidedhighintensityfocusedultrasoundwithstandardminimallyinvasivefibroidtreatmentsprotocolforamulticenterrandomizedcontrolledtrialmychoice