Phase I Study Protocol To Develop A Short-Form Patient-Reported Outcomes Measure For Gender-Affirming Surgery
Benjamin C. Park, B.S.1, Alan T. Makhoul, BA1, Kent Higdon, MD2, Shalyn Vanderbloemen, MBA, PA2, Julian Winocour, MD2, Salam A. Kassis, MD2, Galen Perdikis, MD2, Brian C. Drolet, MD2.
1Vanderbilt University School of Medicine, Nashville, TN, USA, 2Vanderbilt University Medical Center, Nashville, TN, USA.
PURPOSE:
A critical barrier to measuring outcomes in gender-affirming surgery (GAS) is the lack of a short-form patient-reported outcomes measure (PROM). This protocol characterizes the development of a novel GAS PROM, the Vanderbilt Mini Pro for Gender Affirming Surgery (VMP-G).
METHODS:
Studies discussing GAS PROMs were searched using the National Library of Medicine's PubMed database through September 1, 2021. Item generation began with focus groups of transgender health experts, plastic surgeons, and community members. Cognitive interviews were conducted with 32 GAS patients and feedback was used to refine the phase I field test questionnaire (Figure 1).
RESULTS:
The characteristics of the 33 phase I participants were: pre-operative (37.5%), post-operative (62.5%), transfeminine (46.9%), transmasculine (50.0%), non-binary (3.1%), chest/breast surgery (43.8%), genital surgery (12.5%), and other surgery patients (9.4%). The conceptual framework included six domains: quality of life, daily experiences, self-concept, satisfaction, mental health, and gender dysphoria. A 20-item GAS-specific short-form PROM was developed (Table 1).
CONCLUSION:
By measuring transgender-specific aspects of health outcomes, the VMP-G will be used to assess the clinical benefit of GAS and support future transgender research. 
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