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.
- patient-reported outcome
- quality of life
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Contributors AFK, MK, NJ, GME, SM, MGM, MO, LP, WR, TS, KS, JSe, JSo, ALP conceived and designed the study. AFK, MK, NJ, BPCK, GME, SM, MGM, MO, LP, WR, TS, KS, JSe, JSo, TCvdG, MvdM-R, DY-A, ALP revised the article critically for important intellectual content and have approved the final version to be published.
Funding Phase I of this study is funded by research grants received from the Canadian Institutes for Health Research (CIHR), the Plastic Surgery Foundation and ZonMw (project number 636330001). The authors have no financial interest to declare in relation to the content of this article. The Article Processing Charge was paid from a CIHR grant.
Competing interests None declared.
Patient consent Not required.
Ethics approval This study has been approved by the Hamilton Integrated Research Ethics Board (HiREB). Institutional review board approval has also been obtained in the Netherlands by the Medical Ethical Committee at VUmc, and in the USA by Advarra for Brownstein & Crane Surgical Services and Align Surgical Associates.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
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