GENDER-Q Youth Patient-Reported Outcome Measure: Protocol for an International Cross-Sectional Field Test Study.

Background: The need for gender-affirming care (GAC) for young people has increased rapidly worldwide. GAC includes social, psychological, and medical interventions aimed at alleviating gender-related distress. Given that many outcomes of GAC relate to how young people function and feel, a rigorously developed patient-reported outcome measure (PROM) is needed. To address this need, GENDER-Q Youth was developed with extensive input from youth with lived experience. Concept elicitation interviews were performed with 47 youth from Canada and the United States. A conceptual framework and draft PROM were developed and refined with feedback from 33 experts and 17 youth, and were pilot tested with 406 older youth. The field test version of GENDER-Q Youth includes 16 independently functioning scales (248 items) that measure health-related quality of life, gender practices, voice, and experience of care. Objective: This paper outlines the protocol for an international cross-sectional study to field test GENDER-Q Youth in a sample of transgender and gender diverse (TGD) adolescents and young adults aged 12 to 25 years receiving GAC. Methods: This study follows international guidelines for PROM development and validation (eg, US Food and Drug Administration and Consensus-Based Standards for the Selection of Health Measurement Instruments [COSMIN]). GENDER-Q Youth was translated into Danish, Dutch, and German following the Professional Society for Health Economics and Outcomes Research (ISPOR) guidelines for the translation and cultural adaptation of PROMs. For the field test, TGD youth are being recruited using multiple strategies (eg, face-to-face, emails, and so on). A REDCap survey is used to collect sociodemographic and clinical data. Branching logic is used to ensure relevant GENDER-Q Youth scales are completed as some scales are gender-specific. For psychometric analysis, Rasch measurement theory (RMT) analysis will be used to examine fit of the observed data to the Rasch model. A series of tests and criteria will examine item fit and scale reliability and validity. Test-retest reliability will be examined with intraclass correlation coefficients. For construct validity, 147 predefined hypotheses of expected group differences and correlations between GENDER-Q Youth scales will be examined. Acceptance of at least 75% of hypotheses is considered sufficient evidence of construct validity per COSMIN criteria. Results: The research described in this protocol is funded by a Canadian Institutes of Health Research Sex and Gender Science Chair (April 2020) and supported by a Canada Research Chair in Patient-Reported Outcomes (April 2025). With the Danish, Dutch, and German translations now completed, the international field test is underway in Canada, Europe, Australia, and the United States. Data collection and analysis are expected to be completed by the end of 2026. Conclusions: This protocol describes the international GENDER-Q Youth field test study. Once developed, GENDER-Q Youth can be used to inform GAC, research, and quality improvement efforts.