Development of a Patient-Reported Outcome Measure for Youth Receiving Gender-Affirming Care: The GENDER-Q Youth Module.

Abstract

Purpose: This study aimed to develop and establish the content validity of a patient-reported outcome measure for youth receiving gender-affirming care (GENDER-Q Youth).

Methods: This mixed-methods study involved concept elicitation interviews with youth who were seeking/receiving gender-affirming care (February 2019-October 2023). Data were used to develop a conceptual framework and set of independent functioning scales. Scales were refined through clinical and research expert input and cognitive debriefing interviews with youth (December 2023-April 2024). A pilot test was conducted to examine scale psychometric performance, overall content validity, and acceptability (July 2024).

Results: The concept elicitation interview sample included 47 youth aged 12-19 years. A conceptual framework with four main domains was created and included: health-related quality of life, gender practices, voice, and experience of care. To measure aspects of the framework, 17 scales (292 items) were developed and refined with input from 33 experts and 17 youth. The pilot test sample included 406 youth aged 18-25 years. Most respondents agreed that GENDER-Q Youth was easy to understand, thorough, asked important questions in a respectful way, felt safe to complete, and made them feel that their voice would be heard. The field test version of GENDER-Q Youth includes 16 scales (248 items).

Conclusion: Evidence of content validity of GENDER-Q Youth was established based on extensive input from experts and youth.