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. 2025 Apr 1;8(4):e254708.
doi: 10.1001/jamanetworkopen.2025.4708.

Development and Assessment of a Patient-Reported Outcome Instrument for Gender-Affirming Care

Manraj N Kaur  1 , Charlene Rae  2 , Shane D Morrison  3 , Alexis Laungani  4 , Pierre Brassard  4 , Margriet G Mullender  5 , Tim C van de Grift  5 , Danny A Young-Afat  5 , Jens Ahm Sørensen  6 , Lotte Poulsen  6 , Sylvie D Cornacchi  2 , Jack G Graesser  6 , Michelle Mistry Igbokwe  7 , Thomas Satterwhite  8 , John H Pang  8 , Arya A Akhavan  8 , Allison Hu  8 , Natasha Johnson  2 , Stefan J Cano  9 , Kinusan Savard  10 , Gerhard S Mundinger  11 , Fermín Capitán-Cañadas  12 , Daniel Simon  12 , Luis Capitán  12 , Devin Coon  13 , Hilliard T Brydges  14 , Rachel Bluebond-Langner  14 , Eduardo D Rodriguez  14 , Lee C Zhao  15 , Kathleen A Armstrong  16 , Nicola R Dean  17 , Tamara A Crittenden  17 , Zac A Cannell  18 , Megan Lane  19 , Caleb A Haley  19 , Jessica Hsu  19 , Geolani W Dy  20 , Blair R Peters  21 , Jens U Berli  21 , Christina E Milano  22 , Christian X Lava  23 , Kenneth L Fan  23 , Gabriel A Del Corral  24 , Christodoulos Kaoutzanis  25 , Nargis Kalia  25 , Ty Higuchi  26 , Oren Ganor  27 , Sangeeta Subedi  27 , Laura M Douglass  28 , Alireza Hamidian Jahromi  29 , Helia C Hosseini  30 , Jacqueline Ihnat  30 , Neil Parikh  30 , Kevin Hu  30 , Michael Alperovich  30 , Edward C Ray  31 , Youssef Aref  31 , Bashar A Hassan  32 , Fan Liang  32 , Lily Mundy  32 , Mang L Chen  33 , Andrea L Pusic  34 , Anne F Klassen  2
Affiliations

Development and Assessment of a Patient-Reported Outcome Instrument for Gender-Affirming Care

Manraj N Kaur et al. JAMA Netw Open. .

Abstract

Importance: There is an urgent need for a validated gender-affirming care-specific patient-reported outcome measure (PROM).

Objective: To field test the GENDER-Q, a new PROM for gender-affirming care, in a large, international sample of transgender and gender diverse (TGD) adults and evaluate its psychometric properties.

Design, setting, and participants: This international cross-sectional study was conducted among TGD adults aged 18 years and older who were seeking or had received gender-affirming care within the past 5 years at 21 clinical sites across Canada, the United States, the Netherlands, and Spain; participants were also recruited through community groups (eg, crowdsourcing platform, social media). The study was conducted between February 2022 and March 2024. Participants had to be capable of completing the instrument in English, Danish, Dutch, or French-Canadian. Eligible participants accessed an online REDCap survey to complete sociodemographic questions and questions about gender-affirming care they had received or sought (ie, to look, function, or feel masculine, feminine, gender fluid, or another way).

Main outcome and measures: Branching logic was used to assign relevant instrument scales. Rasch measurement theory (RMT) analysis was used to examine the fit of the observed data to the Rasch model for each scale. Test-retest reliability and hypothesis-based construct validity of instrument scales were examined. The hypothesis was that instrument scale scores would increase with better outcomes on corresponding categorical questions.

Results: A total of 5497 participants (mean [SD] age, 32.8 [12.3] years; 1837 [33.4%] men; 1307 [23.8%] nonbinary individuals; and 2036 [37.0%] women) completed the field test survey. Participants sought or had the following types of gender-affirming care: 2674 (48.6%) masculinizing, 2271 (41.3%) femininizing, and 552 (10.0%) other. RMT analysis led to the development of 54 unidimensional scales and 2 checklists covering domains of health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Test-retest reliability of the scales (intraclass correlation coefficient [average] >0.70) was demonstrated. Only 1 item (phalloplasty donor flap) had an ICC less than 0.70. As hypothesized, scores increased incrementally with better associated self-reported categorical responses. For example, among 661 participants who reported poor psychological well-being, the mean (SD) scale score was 45 (18) points; for those who reported excellent psychological well-being, the mean (SD) scale score was 85 (16) points (P < .001).

Conclusions and relevance: In this cross-sectional study of 5497 TGD adults, the instrument demonstrated reliability and validity. The instrument was validated in an international sample and is designed to collect and compare evidence-based outcome data for gender-affirming care from the patients' perspective.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs Kaur, Pusic, and Klassen reported being codevelopers of the GENDER-Q instrument, which is owned by McMaster University and Mass General Brigham, and receiving a share of license revenues as royalties for its use in for-profit research based on their institution’s inventor sharing policy. Dr Kaur reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr Rae reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr Igbokwe reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr Cano reported being president of Modus Outcomes outside the submitted work. Dr Dean reported being involved in an application to the Australian government about improving public funding for gender-affirming surgery outside the submitted work; this work has been unpaid. Dr Berli reported owning Jens Berli Consulting and providing expert legal counsel and educational consulting to Johnson & Johnson and other groups outside the submitted work. Dr Fan reported consulting for Integra outside the submitted work. Dr Alperovich reported consulting for Johnson & Johnson during the conduct of the study. Dr Pusic reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr Klassen reported receiving grants from Canadian Institutes of Health Research during the conduct of the study and consulting for Anne F Klassen Research through EVENTUM Research outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Overview of the Instrument’s Development and Field Test
aThe community sample included data from pilot field tests 1 and 2.
Figure 2.
Figure 2.. Conceptual Framework of the Patient-Reported Outcome Measure Instrument
See this image and copyright information in PMC

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