Grant: Foundation Grant

Hormones and gender-affirming surgery provided to transgender and gender diverse people can dramatically change how the face, body and genitals look and function. However, a critical barrier to measuring outcomes for such gender-affirming healthcare is the lack of a patient-reported outcome measure (PRO). This Foundation award would be used to cover the development of a PRO for gender-affirming treatment (GENDER-Q) and its implementation into clinical practice. The GENDER-Q will provide a comprehensive set of independently functioning scales that cover concepts such as appearance, body image, physical, sexual and psychosocial function. Phase 1 (underway) is an international qualitative study. Trans men and women aged 16 years and older who are seeking or have had hormonal or surgical treatments are being invited to take part in an interview. Recruitment is taking place in Canada, USA, Denmark and the Netherlands. Interviews are recorded, transcribed and coded. From the analysis, a conceptual framework will be formally defined that covers outcomes of importance. We will also create a pool of items that will inform the development of scales. Scales will be refined through cognitive patient interviews and expert input. In Phase 2, preliminary scales will be administered to a large international sample of transgender people. The modern psychometric method of Rasch Measurement Theory analysis will be employed to shorten and define the measurement properties for each scale. At this stage the GENDER-Q will be ready for use. Phase 3 involves studies to examine responsiveness to change for a range of gender-affirming treatments. Phase 4 involves implementing the GENDER-Q into clinical practice for use in patient care. Once developed, the GENDER-Q will be made available to researchers, providers, administrators and payers around the world to collect meaningful, valid and reliable data on important transgender-specific patient-centered outcomes.