Development of the BODY-Q Chest Module Evaluating Outcomes Following Chest Contouring Surgery

BACKGROUND: Plastic surgery to improve chest appearance is becoming increasingly popular. The BODY-Q is a patient-reported outcome (PRO) instrument designed for weight loss and/or body contouring. In this paper, we describe the development of a new module for masculinizing chest contouring surgery. METHODS: Qualitative methods were used to develop and refine the content of the BODY-Q Chest Module, which was subsequently field-tested in Canada, USA, Netherlands and Denmark between June 2016 and June 2017. Participants were men and trans men aged 16 years or older and seen for gynecomastia, weight loss or trans men chest surgery. Data were collected using either a web-based application or paper questionnaire. Rasch Measurement Theory (RMT) analysis was performed. RESULTS: The sample included 739 participants (i.e., 174 gynecomastia, 224 weight loss, 341 gender confirming). RMT analysis refined a 10-item chest and 5-item nipple scale. All items had ordered thresholds and good item fit, and scales evidenced reliability, i.e., Person Separation Index and Cronbach's alpha values were 0.95 and 0.98 (chest scale) and 0.87 and 0.94 (nipple scale). Scores for both scales correlated more strongly with similar (satisfaction with the body) versus dissimilar (psychological and social function) BODY-Q scales. The mean score for the chest and nipples scales was significantly higher (p<0.001 on independent samples t-tests) in participants who were post-operative compared with pre-operative at the time of assessment. CONCLUSION: This new BODY-Q Chest Module is a clinically meaningful and scientifically sound PRO instrument that can be used to measure outcomes for masculinizing chest contouring 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