{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:56:10Z","timestamp":1791233770767,"version":"4.1.0"},"reference-count":42,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/100420","type":"journal-article","created":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:15:18Z","timestamp":1791231318000},"page":"e100420-e100420","source":"Crossref","is-referenced-by-count":0,"title":["GENDER-Q Youth Patient-Reported Outcome Measure: Protocol for an International Cross-Sectional Field Test Study"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4720-0096","authenticated-orcid":false,"given":"Anne F","family":"Klassen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4309-4636","authenticated-orcid":false,"given":"Charlene","family":"Rae","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3868-3532","authenticated-orcid":false,"given":"Shane D","family":"Morrison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5599-8013","authenticated-orcid":false,"given":"Natasha","family":"Johnson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6330-8772","authenticated-orcid":false,"given":"Karine","family":"Khatchadourian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-7172-7856","authenticated-orcid":false,"given":"Jack","family":"Graesser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1911-0395","authenticated-orcid":false,"given":"Manraj N","family":"Kaur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,10,5]]},"reference":[{"issue":"Suppl 2","key":"R1","doi-asserted-by":"publisher","first-page":"s3","DOI":"10.1136\/archdischild-2023-326681","article-title":"Characteristics of children and adolescents referred to specialist gender services: a systematic review","volume":"109","author":"Taylor","journal-title":"Arch Dis Child"},{"issue":"3","key":"R2","doi-asserted-by":"publisher","first-page":"240","DOI":"10.1056\/NEJMoa2206297","article-title":"Psychosocial functioning in transgender youth after 2 years of hormones","volume":"388","author":"Chen","journal-title":"N Engl J Med"},{"issue":"2","key":"R3","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.0978","article-title":"Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care","volume":"5","author":"Tordoff","journal-title":"JAMA Netw Open"},{"issue":"2","key":"R4","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2021-056082","article-title":"Gender identity 5 years after social transition","volume":"150","author":"Olson","journal-title":"Pediatrics"},{"issue":"12","key":"R5","doi-asserted-by":"publisher","first-page":"1354","DOI":"10.1001\/jamapediatrics.2024.4527","article-title":"Levels of satisfaction and regret with gender-affirming medical care in adolescence","volume":"178","author":"Olson","journal-title":"JAMA Pediatr"},{"issue":"8","key":"R6","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pgph.0001478","article-title":"A PRISMA systematic review of adolescent gender dysphoria literature: 3) treatment","volume":"3","author":"Thompson","journal-title":"PLOS Glob Public Health"},{"issue":"2","key":"R7","doi-asserted-by":"publisher","first-page":"2","DOI":"10.7249\/rhq-12-02-02","article-title":"Interventions for gender dysphoria and related health problems in transgender and gender-expansive youth: a systematic review of benefits and risks to inform practice, policy, and research","volume":"12","author":"Dopp","journal-title":"Rand Health Q"},{"issue":"Suppl 2","key":"R8","doi-asserted-by":"publisher","first-page":"s48","DOI":"10.1136\/archdischild-2023-326670","article-title":"Masculinising and feminising hormone interventions for adolescents experiencing gender dysphoria or incongruence: a systematic review","volume":"109","author":"Taylor","journal-title":"Arch Dis Child"},{"issue":"11","key":"R9","doi-asserted-by":"publisher","first-page":"2279","DOI":"10.1111\/apa.16791","article-title":"A systematic review of hormone treatment for children with gender dysphoria and recommendations for research","volume":"112","author":"Ludvigsson","journal-title":"Acta Paediatr"},{"issue":"6","key":"R10","doi-asserted-by":"publisher","first-page":"437","DOI":"10.1136\/archdischild-2024-327921","article-title":"Gender affirming hormone therapy for individuals with gender dysphoria aged <26 years: a systematic review and meta-analysis","volume":"110","author":"Miroshnychenko","journal-title":"Arch Dis Child"},{"issue":"Suppl 2","key":"R11","doi-asserted-by":"publisher","first-page":"s33","DOI":"10.1136\/archdischild-2023-326669","article-title":"Interventions to suppress puberty in adolescents experiencing gender dysphoria or incongruence: a systematic review","volume":"109","author":"Taylor","journal-title":"Arch Dis Child"},{"issue":"Suppl 2","key":"R12","doi-asserted-by":"publisher","first-page":"s19","DOI":"10.1136\/archdischild-2023-326347","article-title":"Psychosocial support interventions for children and adolescents experiencing gender dysphoria or incongruence: a systematic review","volume":"109","author":"Heathcote","journal-title":"Arch Dis Child"},{"issue":"1","key":"R13","doi-asserted-by":"publisher","first-page":"e52","DOI":"10.1097\/SLA.0000000000004728","article-title":"Gender affirming surgery: a comprehensive, systematic review of all peer-reviewed literature and methods of assessing patient-centered outcomes (part 1: breast\/chest, face, and voice)","volume":"275","author":"Oles","journal-title":"Ann Surg"},{"issue":"1","key":"R14","doi-asserted-by":"publisher","first-page":"e67","DOI":"10.1097\/SLA.0000000000004717","article-title":"Gender affirming surgery: a comprehensive, systematic review of all peer-reviewed literature and methods of assessing patient-centered outcomes (part 2: genital reconstruction)","volume":"275","author":"Oles","journal-title":"Ann Surg"},{"issue":"3","key":"R15","doi-asserted-by":"publisher","first-page":"228","DOI":"10.21037\/tau.2019.05.04","article-title":"Patient reported outcome measures and quality of life assessment in genital gender confirming surgery","volume":"8","author":"Dy","journal-title":"Transl Androl Urol"},{"issue":"4","key":"R16","doi-asserted-by":"publisher","first-page":"1026","DOI":"10.1097\/PRS.0000000000004254","article-title":"Patient-reported outcome measures used in gender confirmation surgery: a systematic review","volume":"141","author":"Andr\u00e9asson","journal-title":"Plast Reconstr Surg"},{"issue":"3","key":"R17","doi-asserted-by":"publisher","first-page":"700","DOI":"10.1007\/s00266-017-0812-4","article-title":"A systematic review of patient-reported outcome measures following transsexual surgery","volume":"41","author":"Barone","journal-title":"Aesthetic Plast Surg"},{"issue":"8","key":"R18","doi-asserted-by":"publisher","first-page":"514","DOI":"10.1093\/pch\/pxae019","article-title":"Patient-reported outcome measures for paediatric gender-affirming care: a systematic review","volume":"29","author":"Jackman","journal-title":"Paediatr Child Health"},{"issue":"5","key":"R19","doi-asserted-by":"publisher","first-page":"1159","DOI":"10.1007\/s11136-018-1829-0","article-title":"COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study","volume":"27","author":"Terwee","journal-title":"Qual Life Res"},{"issue":"3","key":"R20","doi-asserted-by":"publisher","DOI":"10.1111\/hex.70678","article-title":"Co-development and validation of a patient-reported experience measure for trans and gender diverse young people: a multi-stage participatory study protocol","volume":"29","author":"Bailey","journal-title":"Health Expect"},{"issue":"1","key":"R21","doi-asserted-by":"publisher","DOI":"10.1186\/s41687-024-00785-x","article-title":"International study to develop a patient-reported outcome measure to evaluate outcomes of gender-affirming care - the GENDER-Q","volume":"8","author":"Kaur","journal-title":"J Patient Rep Outcomes"},{"issue":"4","key":"R22","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.4708","article-title":"Development and assessment of a patient-reported outcome instrument for gender-affirming care","volume":"8","author":"Kaur","journal-title":"JAMA Netw Open"},{"key":"R23","unstructured":"Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. US Food and Drug Administration; 2009. URL: https:\/\/www.fda.gov\/media\/77832\/download [Accessed 17-09-2026]"},{"issue":"8","key":"R24","doi-asserted-by":"publisher","first-page":"1889","DOI":"10.1007\/s11136-012-0344-y","article-title":"ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research","volume":"22","author":"Reeve","journal-title":"Qual Life Res"},{"issue":"4","key":"R25","doi-asserted-by":"publisher","first-page":"461","DOI":"10.1016\/j.jval.2013.04.004","article-title":"Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force","volume":"16","author":"Matza","journal-title":"Value Health"},{"issue":"2","key":"R26","doi-asserted-by":"publisher","first-page":"94","DOI":"10.1111\/j.1524-4733.2005.04054.x","article-title":"Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation","volume":"8","author":"Wild","journal-title":"Value Health"},{"key":"R27","doi-asserted-by":"crossref","unstructured":"Mokkink LB Elsman E Terwee CB . COSMIN manual: conducting a systematic review of patient-reported outcome measures (PROMs), version 2.0. COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments); 2024. URL: https:\/\/www.cosmin.nl\/wp-content\/uploads\/COSMIN-manual-V2_final.pdf [Accessed 17-09-2026]","DOI":"10.1007\/s11136-024-03761-6"},{"issue":"11","key":"R28","doi-asserted-by":"publisher","first-page":"2929","DOI":"10.1007\/s11136-024-03761-6","article-title":"COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0","volume":"33","author":"Mokkink","journal-title":"Qual Life Res"},{"issue":"4","key":"R29","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1089\/trgh.2024.0203","article-title":"Development of a patient-reported outcome measure for youth receiving gender-affirming care: the GENDER-Q Youth Module","volume":"10","author":"Kennedy","journal-title":"Transgend Health"},{"key":"R30","unstructured":"Rasch G . Probabilistic Models for Some Intelligence and Attainment Tests. Danmarks Paedagogiske Institut; 1960. ISBN: 9780598554512"},{"issue":"12","key":"R31","doi-asserted-by":"publisher","DOI":"10.3310\/hta13120","article-title":"Improving the evaluation of therapeutic interventions in multiple sclerosis: the role of new psychometric methods","volume":"13","author":"Hobart","journal-title":"Health Technol Assess"},{"issue":"8","key":"R32","doi-asserted-by":"publisher","first-page":"1358","DOI":"10.1002\/art.23108","article-title":"The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper?","volume":"57","author":"Tennant","journal-title":"Arthritis Rheum"},{"issue":"Pt 1","key":"R33","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1348\/014466506x96931","article-title":"An introduction to the Rasch measurement model: an example using the Hospital Anxiety and Depression Scale (HADS)","volume":"46","author":"Pallant","journal-title":"Br J Clin Psychol"},{"issue":"4","key":"R34","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.11.006","article-title":"STROBE--a checklist to Strengthen the Reporting of Observational Studies in Epidemiology","volume":"61","author":"Knottnerus","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"R35","doi-asserted-by":"publisher","first-page":"178","DOI":"10.1177\/0146621616677520","article-title":"Critical values for Yen\u2019s Q: identification of local dependence in the Rasch model using residual correlations","volume":"41","author":"Christensen","journal-title":"Appl Psychol Meas"},{"issue":"3","key":"R36","doi-asserted-by":"publisher","first-page":"297","DOI":"10.1007\/BF02310555","article-title":"Coefficient alpha and the internal structure of tests","volume":"16","author":"Cronbach","journal-title":"Psychometrika"},{"issue":"2","key":"R37","first-page":"205","volume":"3","author":"Smith","journal-title":"J Appl Meas"},{"issue":"5","key":"R38","doi-asserted-by":"publisher","first-page":"1147","DOI":"10.1007\/s11136-018-1798-3","article-title":"COSMIN guideline for systematic reviews of patient-reported outcome measures","volume":"27","author":"Prinsen","journal-title":"Qual Life Res"},{"key":"R39","doi-asserted-by":"crossref","unstructured":"Cohen J . Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Routledge; 1988. [doi: 10.4324\/9780203771587]","DOI":"10.4324\/9780203771587"},{"issue":"1","key":"R40","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1007\/s40271-025-00770-6","article-title":"Using a timeline activity in virtual concept elicitation interviews with youth: methods and lessons learned from an interpretive descriptive study to develop a patient-reported outcome measure (GENDER-Q Youth)","volume":"19","author":"Kennedy","journal-title":"Patient"},{"issue":"6","key":"R41","doi-asserted-by":"publisher","first-page":"597","DOI":"10.1007\/s40271-025-00756-4","article-title":"Prioritizing participant and research team emotional safety during data generation and analysis in qualitative patient-reported outcome measure research: development of a framework informed by the GENDER-Q Youth study","volume":"18","author":"Kennedy","journal-title":"Patient"},{"issue":"11","key":"R42","doi-asserted-by":"publisher","first-page":"1159","DOI":"10.1001\/jamapediatrics.2021.2061","article-title":"Experiences and perspectives of transgender youths in accessing health care: a systematic review","volume":"175","author":"Chong","journal-title":"JAMA Pediatr"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","deposited":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:15:20Z","timestamp":1791231320000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e100420"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,5]]},"references-count":42,"URL":"https:\/\/doi.org\/10.2196\/100420","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,5]]},"article-number":"v15iSuppl 2e100420"}}