JMIR Publications

ABSTRACT

Background:

Transgender women face significant health inequities, including barriers to gender-affirming care and higher rates of depression and suicidal ideation. Facial feminization surgery is a key intervention that aligns craniofacial structures with female anatomical norms and gender identity. Although international studies suggest facial feminization surgery improves psychosocial outcomes, most have emphasized aesthetic results or relied on generic quality-of-life instruments not validated for this population. In Chile, no study has evaluated the multidimensional impact of Facial feminization surgery using patient-centered measures—such as self- and third-party femininity assessments—combined with objective cephalometric and photometric analyses. Moreover, no validated Spanish-language quality-of-life instrument exists for transgender women undergoing this surgery.

Objective:

This study aims to (1) develop and validate a culturally appropriate quality-of-life questionnaire for transgender women undergoing facial feminization surgeryin Chile, and (2) evaluate postoperative changes in quality of life, perception of facial femininity, and cephalometric and photometric parameters.

Methods:

The study will include two methodological phases: a cross-sectional validation study and a longitudinal cohort study. Phase 1 involves questionnaire development and validation, following COSMIN guidelines, with a systematic literature review conducted according to PRISMA, expert panel content validation, pilot testing, and psychometric evaluation in a cohort of ≥200 transgender women. Phase 2 is a longitudinal cohort study conducted at San Juan de Dios Hospital in Santiago, Chile, following STROBE guidelines. Thirty transgender women scheduled for facial feminization surgery will be assessed at baseline and 12 months postoperatively. Outcomes include quality of life (validated questionnaire), self-perceived and third-party-rated femininity (evaluated via standardized photographs), and cephalometric/photometric changes using cone beam computed tomography. Data analyses include exploratory and confirmatory factor analyses, Cronbach’s alpha, paired t-tests or Wilcoxon signed-rank tests, chi-square/Fisher’s tests, and linear regression models.

Results:

Phase 1 was conducted between January 2024 and January 2025 and included 216 participants, exceeding the minimum sample size requirement. Data analysis is ongoing and results will be reported separately. Phase 2 is currently in progress, with presurgical CBCT scans and photographs being collected. The validated pre-surgical questionnaire will be administered in late 2025, with surgeries scheduled throughout 2026, and postoperative assessments at 12 months. Data collection is expected to conclude in 2027.

Conclusions:

This protocol addresses a critical evidence gap in Latin America by integrating psychometric validation and longitudinal evaluation of facial feminization surgery outcomes among transgender women in Chile. The project is expected to devolope the first validated Spanish-language quality-of-life instrument specific to facial feminization surgery, alongside multidimensional evidence of surgical outcomes. Findings will inform clinical decision-making, contribute to inclusive patient-centered care, and support the development of evidence-based policies for transgender health in the region. Clinical Trial: Not applicable.