Original Title: Uso de la radiofrecuencia en la ablación de miomas uterinos

Authors' objectives: The main objective of this evaluation report is to determine the comparative effectiveness and clinical safety of RFA via the transvaginal/transcervical route in the treatment of symptomatic uterine fibroids in women at least 18 years of age who wish to preserve the uterus vs. usual treatment.

Authors' results and conclusions: Conclusions: The lack of comparison studies does not allow conclusions to be drawn on the benefit-risk of radiofrequency ablation with transvaginal or transcervical approach in the treatment of symptomatic uterine fibroids compared to alternative uterine-sparing procedures. Studies without a comparator indicate that radiofrequency ablation with a transvaginal or transcervical approach for symptomatic uterine fibroids has an acceptable safety profile. In terms of efficacy, the studies without a comparator indicate that technique shows a significant reduction in myoma volume, symptom severity and vaginal bleeding, as well as an improvement in quality of life. It is recommended that clinical practice guidelines on the management of symptomatic uterine fibroids be developed that list the available treatment alternatives and their specific indications.

Authors' methods: The research question, in PICOD (Patient, Intervention, Comparator, Outcome and Study Design) format, was developed by means of a systematic review of the current literature on RFA via the transvaginal/transcervical route. The methodology used was that described in the “Guide for the preparation and adaptation of rapid health technology assessment reports” published within the Spanish Network of Health Technology Assessment Agencies (RedETS) and NHS Benefits. This document was the main source for selecting the relevant evaluation elements to be dealt with in the report, among which were: the health problem, the current situation of the technology, health variables (safety and effectiveness) and the economic and organizational aspects derived from the implementation of the evaluated technology in clinical practice. The bibliographic search was performed in different biomedical databases such as: Cochrane library, International HTA database, INAHTA, Tripdatabase, GIN, Medline and Embase, using different descriptors (MesH, Thesaurus, etc) and free terms to make up for possible deficiencies in the indexing of some articles. The search was carried out in July 2020 and receiving weekly alerts until March 2021 with the closing of the paper. A manual search of the articles’ bibliographies and a search of ongoing studies in the Clinicaltrials and EU Clinical Trials Register databases were also performed. Two authors (MCMR and PCM) carried out the study selection, data extraction and quality assessment, according to predefined selection and extraction criteria, summarizing the most relevant aspects in evidence tables. The quality of the studies and the level of bias were assessed using the specific scales recommended for each type of study according to the “Guide for the preparation and adaptation of rapid health technology assessment reports”, mentioned above. Specifically, in this work we used the AMSTAR-2 scale for systematic reviews and assessment reports and the IHE (Institute of Health Economics) scale for the assessment of evidence from case series. The evaluation of the quality of the evidence for safety and effectiveness was performed following the GRADE (Grade of Recommendations, Assessment, Development and Evaluation) methodology. In the results, the statistics tools of the Excel program version 2016 were used to calculate the means, standard deviations and medians of the data obtained.

Project Status: Completed

URL for project: https://acis.sergas.gal/cartafol/Documents/1645/avalia-t02011RadiofrecuenciaUterineFibroids-sum.pdf

Year Published: 2022

URL for published report: http://hdl.handle.net/20.500.11940/16102

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: The Health Knowledge Agency, ACIS. Scientific advice unit, Avalia-t