The MYCHOICE study was designed and set up by the MR-HIFU team of Isala Zwolle. This team consists of radiologist and principal investigator dr. M.F. Boomsma, gynecologist dr. J.M. Schutte, gynecologist drs. J.R. Dijkstra, senior scientist dr. I.M. Nijholt and physician-researcher drs. K.J. Anneveldt. Outside Isala, there will be support from local investigators. Gynecologist Prof. Dr. A. Franx, HTA expert Dr. G.W.J. Frederix, implementation expert Dr. E. Ista, the patient organizations Ikone and Bekkenbodem4all and the professional societies NVOG and NVvR support the team.
Since 2016, MR-HIFU treatments for fibroids have been performed in Isala Zwolle. This took place within the framework of a study to develop screening tools for the MR-HIFU treatment of fibroids. This study was completed in 2019. During this study, the research team became convinced of the effectiveness of the MR-HIFU treatment for at least some patients. However, after the completion of the study there was no longer any possibility to offer this treatment because the Dutch health insurance companies do not reimburse it. The team therefore decided to set up a new study to investigate the effectiveness, but also the cost-effectiveness, of the MR-HIFU treatment and compare it with the existing treatment options for fibroids. The MYCHOICE study started at October 1, 2020.
To make the MYCHOICE study a success, but also to create support for the final design of the study, collaborations were set up. In the first instance, this was done with the University Medical Center Utrecht, who are experienced with MR-HIFU treatment, and the Elizabeth Tweestedenziekenhuis, where many embolizations are performed. There is close cooperation with the relevant professional associations: the NVOG and the NVvR. To support technical aspects of the MR-HIFU treatment, cooperation takes place with the Focused Ultrasound (FUS) foundation and the developer of the MR-HIFU device: Profound. To support the study design, HTA expert Dr. G.W.J. Frederix of the Julius Center for Health Sciences, Prof. Dr. A. Franx gynecologist and Dr. E. Ista, implementation expert of the EMC have been supporting the team. Finally, the Board of Directors of Isala and the Medical Specialist Board (MSB) of Isala are important partners.
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