Randomized-controlled trials are methodologically inappropriate in adolescent transgender healthcare.

Autor:	Ashley F; Faculty of Law & Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada., Tordoff DM; School of Medicine, Stanford University, Stanford, CA, USA., Olson-Kennedy J; The Center for Transyouth Health and Development, Division of Adolescent Medicine, Children's Hospital Los Angeles, Los Angeles, CA, USA.; Keck School of Medicine, University of Southern California, Los Angeles, CA, USA., Restar AJ; Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA.; Research Education Institute for Diverse Scholars (REIDS), School of Public Health, Yale University, New Haven, CT, USA.
Jazyk:	angličtina
Zdroj:	International journal of transgender health [Int J Transgend Health] 2023 Jun 24; Vol. 25 (3), pp. 407-418. Date of Electronic Publication: 2023 Jun 24 (Print Publication: 2024).
DOI:	10.1080/26895269.2023.2218357
Abstrakt:	Background: Despite multiple rigorous observational studies documenting the association between positive mental health outcomes and access to puberty blockers, hormone therapy, and transition-related surgeries among adolescents, some jurisdictions have banned or are attempting to ban gender-affirming medical interventions for minors due to an absence of randomized-controlled trials (RCTs) proving their mental health benefits. Methods: This article critically reviews whether RCTs are methodologically appropriate for studying the association between adolescent gender-affirming care and mental health outcomes. Results: The scientific value of RCTs is severely impeded when studying the impact of gender-affirming care on the mental health of trans adolescent. Gender-affirming interventions have physiologically evident effects and are highly desired by participants, giving rise to concerns over adherence, drop-out, response bias, and generalizability. Complementary and well-designed observational studies can instead be used to ground reliable recommendations for clinical practice and policymaking in adolescent trans healthcare, without the need for RCTs. Conclusion: The lack of RCTs on the mental health impacts of gender-affirming care for trans adolescents does not entail that gender-affirming interventions are based on insufficient evidence. Given the methodological limitations of RCTs, complementary and well-designed observational studies offer more reliable scientific evidence than RCTs and should be considered of sufficient quality to guide clinical practice and policymaking. Competing Interests: The authors have no conflicts of interest relevant to this article to disclose. (© 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.)
Databáze:	MEDLINE
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