Re: Assessment of levator hiatal area using 3D/4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: randomized controlled trial

Abstract

We read with great interest the recent randomized controlled trial (RCT) by Del Forno et al. evaluating the value of pelvic floor physiotherapy for the treatment of superficial dyspareunia in patients with deep infiltrating endometriosis1. We recognize the importance of this research to inform our clinical practice and we extend our gratitude to the researchers, the patients who participated in the study and the research funder. Ultrasound in Obstetrics & Gynecology (UOG) has been at the forefront of reducing research waste by implementing several important measures, including the requirement to prospectively register RCTs and adhere to the Consolidated Standards of Reporting Trials (CONSORT) statement, and encouraging the development and reporting of core outcome sets2. Reflecting upon the study of Del Forno et al.1 presents an opportunity to consider the impact of implementing such initiatives on selective outcome reporting and unexplained deviations from prospective registries. The authors registered prospectively their trial on ClinicalTrials.gov (NCT03572075) listing as primary outcomes the impact of pelvic floor physiotherapy on intestinal function, sexual function, urinary function and pelvic floor muscle contractions. However, the primary outcomes of intestinal, sexual and urinary function are not reported in the final publication1. The registered secondary outcome of evaluation of three/four-dimensional transperineal ultrasound as a biofeedback tool is also not reported in the final publication. The CONSORT statement commits researchers to report on all prespecified trial arms and primary and secondary outcomes. When registered outcomes are not reported, this should be made clear in the final publication and a comprehensive explanation provided. It would be useful if the authors clarified the discrepancies between the prospective registry record and the published trial report. Core outcome sets aim to address the challenges of poorly selected, collected and reported outcomes, including tackling outcome reporting bias3,4. The core outcome set for endometriosis research was published recently and was developed using formal consensus methods involving 116 healthcare professionals, 32 researchers and 206 patients with endometriosis from 29 countries5. The core outcomes for trials on endometriosis include: overall pain, improvement in the most troublesome symptom, quality of life, adverse events and patient satisfaction with treatment. It would be useful if the authors could clarify if these core outcomes were collected as part of the trial and report available data. Over 80 journals in the specialty of women’s and newborn health, including UOG, have committed to supporting the development, dissemination and implementation of the core outcome set for endometriosis. The collaboration who developed the endometriosis core outcome set are now assisting with its implementation by systematically examining published endometriosis trials. When inconsistencies between the trial registry record and the outcomes reported in the published trial report are identified, or when the core outcome set has not been fully reported, we write to the authors seeking clarification. Our progress can be followed at https:// twitter.com/EndoOutcomes where we will be posting the prospective registry record, final publication and response to this Correspondence.