Vallinga Marleen, Roijer Pip, Pidgeon Dr. Tom, Ceulemans Dr. Aline, Bakker Alex, Carrière Brenda, Rashid Dr. Tina, Bellringer Dr. James, Belinky Dr. Javier, Buncamper Prof. Marlon, Morrison Shane, Bouman Prof. Walter, Bouman Prof. Mark-Bram, Mullender Prof. Margriet

(22) A PROTOCOL FOR THE DEVELOPMENT OF TWO INTERNATIONAL CORE OUTCOME SETS FOR GENITAL GENDER AFFIRMING SURGERY

  • Urology
  • Reproductive Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Psychiatry and Mental health
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Abstract Objectives Various procedures and techniques for genital surgery are available to transgender and gender diverse individuals. Prior research on feminizing (i.e., vaginoplasty, vulvoplasty, labiaplasty, and clitoroplasty) and masculinizing (i.e. phalloplasty, metoidioplasty, scrotoplasty and coronaplasty) genital gender affirming surgery measures and reports a heterogeneous and non-standardised range of outcomes. It is not known whether these outcomes used by researchers are important or relevant to the population. Yet, no attempt has been made to reach consensus on a standardized set of outcomes and uniform definitions. This inconsistency precludes the comparison and combination of data between studies on similar procedures. In order to advance the practice of genital surgery towards a robust evidence-based one, it is necessary to standardize outcome measurements in retrospective and prospective intervention studies. The aim of this project is to develop a Core Outcome Set (COS) for feminizing- and one for masculinizing genital gender surgery. A COS; i.e., the minimum set of outcomes recommended to be reported in clinical trials, pertaining to this subject will ensure that the most relevant outcomes are measured and reported in a standardized way. Methods The stages of development are; i) A systematic review to identify all outcomes measured and reported in previous research; ii) Identifying outcomes important for transgender and gender diverse individuals during focus groups; iii) Combining these outcomes into preliminary lists iv) Distribute e-Delphi surveys among experts- by experience and profession, in which all potential outcomes will be rated v) An online consensus meeting to decide on the final COS. See figure 1. Results This project will produce two minimum sets of outcomes for genital surgery, based on an international consensus from expert stakeholders, including the population. Conclusions The development and implementation of these COS for genital surgery will ensure that relevant outcomes will be reported. This will facilitate guideline-development and evidence-based informed decision-making. Conflicts of Interest None.

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