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Development Of A Short-form Patient-Reported Outcomes Measure For Gender-Affirming Surgery
Benjamin C. Park, B.S.1, Alan T. Makhoul, B.A.1, Kent Higdon, M.D.2, Shalyn Vanderbloemen, MBA, PA2, Julian Winocour, M.D.2, Salam A. Kassis, M.D.2, Galen Perdikis, M.D.2, Brian C. Drolet, M.D.2.
1Vanderbilt University School of Medicine, Nashville, TN, USA, 2Vanderbilt University Medical Center, Department of Plastic Surgery, 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). Although a robust PROM may be necessary for settings that require the highest level of measurement precision, a more focused PROM may be appropriate for routine clinical use to minimize item fatigue and response burden. This protocol characterizes the development of a novel GAS PROM, the Vanderbilt Mini Pro for Gender Affirming Surgery (VMP-G). The purpose of this study is to describe the preliminary phase 2 outcomes of VMP-G. Methods:This study describes the three-phase mixed-methods protocol for the development of VMP-G. Phase 1 includes literature review, item generation, conceptual framework formation, and preliminary instrument formation. Item generation began with focus groups of transgender health experts, plastic surgeons, and community members. Cognitive interviews were conducted with 32 transgender patients and feedback was used to refine the phase I field test questionnaire (Table 1). Phase 2 includes field testing and psychometric evaluation (acceptability, reliability, and validity) of the field test questionnaire. Phase 3 includes clinical piloting of the final questionnaire to measure clinical change from GAS. Each question is scored on a 5-point Likert scale with total possible scores ranging from 20 (worst) to 100 (best). Categorical variables were analyzed with Fisher’s exact tests and continuous variables by independent sample t-tests.Results:In phase 1, a conceptual framework was developed and included four domains: quality of life, self-concept, satisfaction, and gender dysphoria. Independent scales were constructed for each domain. In phase 2, a 20-item GAS-specific short-form PROM was developed (Table 1) and field-tested with 31 patients. The patient characteristics and demographics of the 31 phase II participants are shown in Table 2 with no significant differences between patients who did and did not receive GAS. GAS patients scored significantly higher on the self-concept scale (7.36±1.93 vs. 4.17±1.33, p=0.001) and overall (76.36±11.43 vs. 64.33±11.08, p=0.027) compared to patients who did not receive GAS. Although GAS patients scored higher on the quality of life, satisfaction, and gender dysphoria scales (higher scores mean less gender dysphoria), this did not reach significance. Conclusions:This protocol describes a method for developing and validating a short-form GAS PROM. Preliminary phase 2 results show that VMP-G has the potential to quantify the clinical benefit of GAS on health-related quality of life, gender dysphoria, other outcomes. By measuring transgender-specific aspects of health outcomes, the VMP-G will be used to support future transgender care and research. Additionally, this methodology can be applied to other areas to address the paucity of short-form PROMs.

Table 1. VMP-G Field Test Questionnaire
Scale: Quality of Life (physical and psychosocial)
1.How would you rate your overall quality of life?
2.How would you rate your physical function (e.g., mobility, strength, bladder, bowel, etc.)?
3.How often do you experience negative feelings about yourself?
4.How often are you misgendered?
5.How often do feelings of gender dysphoria disrupt daily life?
6.How safe do you feel in your daily life?
7.How comfortable are you in public settings?
Scale: Self-Concept
8.I accept my physical appearance.
9.I feel my body aligns with my gender identity.
Scale: Satisfaction
Please answer the following questions (10-14) based on your satisfaction level with:
10.Your overall health?
11.Your personal life?
12.Your professional life?
13.Your sex life?
14.The care you receive from your healthcare providers?
15.Based on my current knowledge and experiences, I would receive gender affirming surgery.
Scale: Gender Dysphoria
How often do you have feelings of gender dysphoria related to your:
16.Face/neck
17.Chest
18.Genitals
19.Hips/buttocks
20.Voice

Table 2. Phase Two Patient Characteristics and Preliminary VMP-G Scores
CharacteristicOverall (n=31)Pre-operative (n=6)Post-operative (n=25)p
Assigned sex 0.067
Male17 (45.9%)1 (16.7%)16 (64.0%)
Female14 (37.8%)5 (83.3%)9 (36.0%)
Intersex000
Gender identity0.162
Male9 (24.3%)3 (50.0%)6 (24.0%)
Female16 (43.2%)1 (16.7%)15 (60.0%)
Non-binary5 (13.5%)2 (33.3%)3 (12.0%)
Other1 (2.7%)01 (4.0%)
Race/ethnicity0.509
White or Caucasian26 (70.3%)5 (83.3%)21 (84.0%)
Black or African American2 (5.4%)02 (8.0%)
Asian or Pacific Islander1 (2.7%)01 (4.0%)
Hispanic or Latino1 (2.7%)1 (16.7%)1 (4.0%)
Multi-racial or Biracial1 (2.7%)01 (4.0%)
Age32±10.0328±15.9732±8.320.367
Scale scores
Quality of life26.65±4.1923.33±4.1827.44±3.860.290
Self-concept6.74±2.224.17±1.337.36±1.930.001*
Satisfaction24.19±3.7322.83±3.3724.52±3.800.328
Gender dysphoria16.45±4.6914.00±4.4317.04±4.640.157
Total score74.03±12.1864.33±11.0876.36±11.430.027*

NOTE: Continuous variables are given as mean ± SD. Each question is scored on a 5-point Likert Scale with a total possible questionnaire score of 100.*Statistically significant


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