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A core outcome SET (COS) for masculinizing gender-affirming surgery: the gendercos project

P. Roijer, M. S. Vallinga, M. Angelini, T. Pidgeon, T. C. van de Grift, M. G. Mullender

Journal of Sexual Medicine, 2025

Abstract

Masculinizing genital gender-affirming surgery (mgGAS) refers to the array of various surgical techniques that can be offered to transgender and gender-diverse (TGD) individuals. However, due to the significant variation in outcome reporting, comparisons of these techniques in terms of safety and effectiveness remain challenging. Currently, it is not clear which outcomes TGD individuals consider most valuable and no consensus exists on which parameters should be measured. The lack of standardized outcome definitions and measurement instruments complicates efforts to synthesize data across studies. The GenderCOS project addresses these issues by identifying key outcomes for mgGAS that should be measured and reported consistently across all clinical trials, improving evidence-based practice and shared decision-making.

The development of the mgGAS COS followed a multi-stage protocol (https://doi.org/10.1080/26895269.2023.2288881) and involved a multidisciplinary steering group of professionals and TGD individuals at all stages. The key phases included: i) a systematic literature review to identify reported outcomes, ii) collection of additional outcomes through focus groups and interviews with TGD individuals, iii) synthesis of clinician-reported and patient-reported outcomes into a preliminary outcome list, iv) a multi-stakeholder Delphi survey where outcomes were rated based on importance by professionals and TGD individuals, and v) a final consensus meeting to determine the…

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