Open this publication in new window or tab >>Karolinska Inst, Dept Med, Stockholm, Sweden.;Karolinska Univ Hosp, ANOVA, Stockholm, Sweden..
Lund Univ, Dept Clin Sci, Pediat, Lund, Sweden..
Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden..
Univ Hosp Umeå, Dept Speech Language Pathol, Umeå, Sweden.;Umeå Univ, Dept Clin Sci, Umeå, Sweden..
Karolinska Inst, Dept Med, Stockholm, Sweden..
Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden.;Reg Stockholm, Stockholm Hlth Care Serv, Stockholm, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Psychiatry.
Swedish Federat Lesbian Gay Bisexual Transgender Q, Stockholm, Sweden..
Linköping Univ, Dept Biomed & Clin Sci, Linköping, Sweden..
Karolinska Univ Hosp, Speech & Language Pathol, Stockholm, Sweden.;Karolinska Inst, Dept Clin Sci Intervent & Technol, Stockholm, Sweden..
Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Plast Surg,Sahlgrenska Univ Hosp, Gothenburg, Sweden..
Uppsala University, WoMHeR (Centre for Women’s Mental Health during the Reproductive Lifespan).
Transammans, Stockholm, Sweden..
Sahlgrens Univ Hosp, Dept Endocrinol, Gothenburg, Sweden.;Univ Gothenburg, Inst Med, Dept Mol & Clin Med, Wallenberg Lab Cardiovasc & Metab Res,Sahlgrenska, Gothenburg, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Psychiatry.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Psychiatry.
Show others...
2025 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 15, no 7, article id e098300Article in journal (Refereed) Published
Abstract [en]
Introduction: Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.
Methods: Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations' reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2-3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.
Analysis: The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.
Ethics and dissemination: The study has received ethical approval by the Swedish Ethical Review Authority (Ume & aring; medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria. Trial registration number COMET registration number 3223.
Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2025
Keywords
Health Services for Transgender Persons, Patient Reported Outcome Measures, Protocols & guidelines
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:uu:diva-564324 (URN)10.1136/bmjopen-2024-098300 (DOI)001528426900001 ()40633945 (PubMedID)2-s2.0-105010630750 (Scopus ID)
Funder
Swedish Research Council, 2023-06407
2025-08-042025-08-042025-08-04Bibliographically approved