Clinical and Biochemical Outcomes in Transgender Individuals Undergoing Hormone Therapy: Protocol for a Systematic Review.

Monitoring of various clinical outcomes and parameters is recommended in transgender individuals undergoing hormone therapies, but comprehensive data to inform these recommendations is scarce.

• The authors identify a gap in the literature regarding the effects of hormone therapy on outcomes such as lipid levels in transgender individuals.
• The systematic review is being conducted to address this evidence gap.
• The review is registered in PROSPERO (CRD42024483138).

The systematic review protocol specifies searching multiple electronic databases and including both prospective and retrospective observational studies with and without a control group.

• The study population includes transgender individuals undergoing hormone therapy with testosterone or estrogen.
• Comparisons will include age-matched cisgender individuals and changes from baseline.
• Both adolescents and adults are included in the study population.

The primary outcomes of the systematic review are changes in or the development of abnormal lipid parameters.

• Secondary outcomes include BMI, weight, height, and blood pressure for age.
• Additional secondary outcomes include serum testosterone or estrogen levels.
• Disease development outcomes include hypertension, diabetes, fatty liver disease, obesity, adverse cardiac events, and all-cause mortality.

The protocol specifies that meta-analysis will pool studies where applicable and meta-regressions will be conducted to evaluate effect modifiers.

• The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach will be used to evaluate the overall certainty of evidence.
• Results will be summarized using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart for study selection.
• Results will be presented in a table summarizing the evidence.

Data collection for the systematic review is ongoing at the time of publication of this protocol, with the full paper expected to be published in Spring 2025.

• The protocol was published in JMIR Research Protocols in 2024.
• The review is prospectively registered under PROSPERO CRD42024483138.
• The protocol paper carries the identifier PRR1-10.2196/57931.