Grants Funded

Abstract
There are 25 million transgender people in the world (1-2 per 100 people) and no patient-reported outcome instrument developed to measure the health concepts that matter the most to them. Transgender is a term used to describe people who experience incongruence (i.e., gender dysphoria) between their gender identity and the sex assigned to them at birth. Treatments include hormonal therapy and sex-reassignment surgeries performed by plastic surgeons. Since gender confirming treatments often require complex and individualized interventions, highly specific PRO scales are required. Our team recently developed 2scales to measure appearance of the chest and nipples as a supplement to the BODY-Q. The scales were field-tested in an international (Canada, USA, Denmark, Netherlands) heterogeneous sample that included 341 gender confirming chest surgery patients. These scales represents the first step in our team's program of research to develop a comprehensive transgender-specific PRO instrument. PRO scales are urgently needed to cover the full range transgender-specific treatments that aim to alter facial, breast/chest and genital appearance and function. To develop such scales, we will adapt existing BREAST-Q and FACE-Q scales that our team previously designed that we hypothesize have content validity for the transgender population. We will also develop new scales as needed (e.g., to evaluate outcomes following genital reconstruction). The chest and nipples scales, plus the adapted and new scales, will be collectively included in a PRO instrument called TRANS-Q. The specific AIM of the proposed one-year study is to conduct a Phase 1 qualitative study to develop a set of independently functioning PRO scales that can be used in research and clinical practice to evaluate gender confirming treatments. The qualitative sample will include 50 adolescent and adults aged 16 and older recruited from sites in Canada and the USA. Interviews will be audio-recorded, transcribed and analysed. Patient interviews and expert input will be used to review and refine scales and develop new ones as needed. At the end of this Phase, the TRANS-Q will be ready to field-test.

Biography
Klassen completed a doctorate in Health Services Research at the University of Oxford in 1997. She subsequently received a Killam postdoctoral fellowship, followed by consecutive awards from the Canadian Institute of Health Research (CIHR), i.e., postdoctoral fellowship, new investigator and mid-career. She is currently Professor of Pediatrics and Associate Member of the Department of Health Research Methodology, Evidence and Impact and Scientist in the CanChild Center for Childhood Disability Research. She is internationally known as an applied health services researcher with expertise in developing patient-reported outcome (PRO) instruments. She uses state-of-the-art methods based on Rasch Measurement Theory to maximize the clinical meaning and scientific quality of the PRO instruments produced. To address the lack of available PRO instruments for use in pediatric and adult plastic and reconstructive surgery, she co-developed the following instruments: BREAST-Q, FACE-Q, BODY-Q, SCAR-Q, WOUND-Q, CLEFT-Q and FACE-Q Kids. These measures are being used by governments, organizations, industry, academia, and clinicians, helping to transform healthcare delivery and patient outcomes.