Background: Recent research aims to improve treatment for gender dysphoria, but a lack of consensus on essential outcomes results in inconsistent findings and hinders evidence-based guidelines.
Purpose: This study aims to develop a core outcome set for transgender healthcare in Sweden, covering endocrinology, surgery, voice and communication, and mental health and psychosocial well-being.
Results: The resulting core outcome set will standardize research, facilitate evidence-based guidelines, and improve healthcare quality for people with gender dysphoria in Sweden.
Other relevant COS: Other relevant COS that are being developed right now are one for genital gender- affirming surgery (GENDER-COS) in the Netherlands and one for facial gender-affirming surgery (fGAS-COS) in the US.
Rationale for our COS: National Specialized Medical Care Centers were introduced in Sweden in January 2024, which integrate various disciplines, such as psychiatry, endocrinology, speech therapy, and plastic surgery, to provide comprehensive care to patients with gender dysphoria. We aim to identify a core outcome set that is applicable for the Swedish context and, therefore, includes all these interventions. Surgery is only a part of our COS.
Principal investigator: Fotios Papadopoulos (Uppsala University)
Alkistis Skalkidou (Uppsala University)
Edward Summanen (Transammans)
Frank Berglund (Patientförening för transpersoner)
Genarro Selvaggi (University Gothenburg)
Gunnar Kratz (Linköping University)
Jenny Holmberg (Umeå University)
Levi Karvonen (RFSL - the Swedish Federation for Lesbian, Gay, Bisexual, Transgender, Queer and Intersex rights)
Louise Frisén (Karolinska Institutet)
Maria Elfving (Lund University)
Maria Södersten (Karolinska Institutet)
Åsa Tivesten (University Gothenburg)
Disease Category: Other
Disease Name: Gender dysphoria
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Communication, Hormone, Psychological & behavioural, Surgery
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Nominal group technique (NGT)
- Survey
We will address our aim in 4 phases.
During phase 1, an umbrella review combined with a review of guidelines in transgender healthcare and reports from patient and interest organisations will be conducted to compile a comprehensive list of outcomes typically assessed in clinical research for gender dysphoria. In Phase 2, we will conduct an anonymous survey, focus groups and interviews to solicit input from individuals with lived experience of gender dysphoria and thereby identify outcomes of personal significance. In Phase 3, using the Delphi method, 2- 3 rounds of assessment will be conducted where researchers, healthcare professionals, and individuals with lived experience of gender dysphoria will rate the identified outcomes by perceived importance. In Phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalize the core outcome set.