Health state utility values in patients undergoing chest masculinization surgery.

BACKGROUND: Chest masculinization surgery is the most common gender-affirming procedure performed in transgender and gender-diverse individuals. While evidence on the health-related quality of life (HRQL) impact of chest masculinization is starting to emerge, data on health state utility values (HSUVs) associated with the surgery is largely missing. The objectives of this study were to estimate the HSUVs using EQ-5D for patients seeking chest masculinization surgery and assess the determinants of EQ-5D score at 6 months postoperatively. METHODS: Patients seeking chest masculinization at a single community plastic surgery clinic by 2 surgeons completed 3 patient-reported outcome measures - EQ-5D-3L, Patient Health Questionnaire (PHQ)-9, and BODY-Q Chest module - preoperatively and postoperatively at 6 weeks and 6-months. Friedman test was used to assess the differences in PROM scores at the 3 timepoints. Simple and backward stepwise regression analyses of 6-month postoperative EQ-5D scores were performed. RESULTS: A total of 113 patients (mean [SD] age, 25.7 [6.9] years) were included. The mean [SD] EQ-5D scores at preoperative, postoperative 6 weeks and 6 months were 0.81 [0.15], 0.84 [0.15] and 0.87 [0.12], respectively. Postoperatively, problems were most frequently reported in the dimensions "pain/discomfort" and "anxiety/depression". Preoperative PHQ-9 score was a predictor of 6-month postoperative EQ-5D scores following simple (p < 0.01) and backward stepwise linear regression analysis (p < 0.01). CONCLUSION: Chest masculinization was associated with an improvement in overall HRL at 6 months postoperatively; however, this did not achieve statistical significance. Preoperative depression severity was a significant determinant of postoperative HRL. Consequently, additional support must be offered to patients who have a higher level of preoperative depression.

The BODY-Q Chest Module: Further Validation in a Canadian Chest Masculinization Surgery Sample.

BACKGROUND: The BODY-Q Chest module is a patient-reported outcome (PRO) instrument that measures satisfaction with how the chest (10 items) and nipples (5 items) look. This PRO instrument was previously field tested in an international sample of people seeking treatment for gynecomastia (n = 174), weight loss (n = 224), and chest masculinization (n = 341). OBJECTIVES: The aim of this study was to examine the psychometric performance of the BODY-Q Chest module in a new chest masculinization surgery sample. METHODS: Data were collected from patients attending a private plastic surgery outpatient clinic in Canada between January 2018 and June 2019. Rasch measurement theory analysis was used to examine how the scales performed psychometrically. RESULTS: The sample provided 266 assessments (115 preoperative, 151 postoperative). All items had ordered thresholds, providing evidence that the 4 response options for each scale worked as expected. Item fit was within ±2.5 for all items, with all Bonferroni adjusted chi-square values nonsignificant. The data for the chest (χ2(20) = 18.72, P = 0.54) and nipples (χ 2(10) = 12.28, P = 0.27) scales fit the requirements of the Rasch model. Reliability was high with person separation index and Cronbach's α values of ≥0.95 for the chest and ≥0.87 for the nipple scales, respectively. More depressive symptoms on the Patient Health Questionnaire-9 and lower health-related quality of life scales were weakly correlated with worse scores on the chest and nipple scales (P < 0.001). CONCLUSIONS: The BODY-Q Chest module was shown to be scientifically sound in an independent sample of patients seeking chest masculinization surgery.

International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q).

INTRODUCTION: A critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments. METHODS AND ANALYSIS: This phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study. ETHICS AND DISSEMINATION: This study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.