A core outcome SET (COS) for feminizing gender-affirming surgery: the gendercos project
Abstract
Feminizing genital gender-affirming surgery (fgGAS) for transgender and gender-diverse (TGD) people includes a variety of procedures and techniques. However, the lack of consistency in reported outcomes of fgGAS across studies poses a significant challenge to evidence-based decision-making in this clinical population. Current research shows considerable variability in the rationale, definition, and measurement of outcomes. Furthermore, the relevance of these outcomes to TGD individuals is unclear. The lack of standardization hinders data comparison and meta-analyses, and ultimately the development of clinical guidelines. The GenderCOS project aims to develop and validate a Core Outcome Set (COS) for fgGAS to enable standardization of the measurement and reporting of key outcomes in clinical trials.
A multidisciplinary steering group, including professionals and TGD people, guided the development and validation of the COS throughout all phases of the study. The project was conducted according to the published protocol (https://doi.org/10.1080/26895269.2023.2288881) and involved 4 key phases: (i) an extensive literature review and focus group discussions with TGD individuals to identify relevant outcomes, (ii) selection and prioritization of outcomes, (iii) a three-round Delphi study with international stakeholders, and (iv) a consensus meeting to finalize the COS. Appropriate measurement instruments for each outcome will be defined in the next phase.
Initial data collection…
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