ABSTRACT
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.
