Outcome Measures Reported Following Feminising Genital Reconstructive Surgery for Gender Affirmation in Transgender Women and Gender Diverse Individuals: A Systematic Review

The comparison of differing methods of feminising genital reconstructive vaginoplasty (fGRS) in transgender women and gender diverse individuals can be confounded by variable outcome reporting and the use of inconsistent outcomes and definitions. This impairs clinical decision making and patient care. The study's objectives were to identify: the number of individual outcomes reported in published clinical research studies of all forms of gender affirming fGRS; when these outcomes were measured post-operatively; the proportion of these outcomes that were clearly defined; and the proportion of studies that declared a primary outcome. This PRISMA-compliant systematic review examined all outcomes and outcome definitions reported in published studies after gender affirming fGRS in transgender women. Candidate studies were sourced via an electronic, multi-database literature search. Search terms were broad to maximise capture of fGRS procedures. All primary, clinical research studies were included with no date limits. Paired collaborators screened each study for inclusion and performed data extraction. Analysis was performed using statistical software R. After screening 1225 studies, 93 studies proceeded to data extraction, representing 7681 patients. 2621 separate individual outcomes were reported, 857 (32.7%) were defined, and the time of outcome assessment was given for 1856 outcomes (70.8%) but relied on wide, non-specific ranges of follow-up dates. 24 discreet outcomes were reported 10 or more times and comprised 20.7% of all outcomes reported. Profound heterogeneity existed in the definitions used for these and for all outcomes reported in general. Only 6 studies declared a primary outcome. Outcomes and outcome definitions reported following fGRS in transgender women and gender diverse individuals were varied and heterogenous. Improved outcome definitions and the adoption of a consistent Core Outcome Set (COS) will aid the fair comparison of future studies evaluating the outcomes of fGRS. This review is the first step in the process of developing a COS. None of the authors has a financial interest in any product, device, or drug mentioned in this manuscript.