Results Summary and Professional Abstract
Final Research Report
View this project's final research report.
Related PCORI-funded Supplemental Research Project
|Article Highlight: This study examined the largest cohort of transgender people in research to date. The researchers reported in Annals of Internal Medicine that transgender women who receive estrogen treatments may face a higher risk for stroke and dangerous blood clots than previously thought. In a guest blog post, the project lead and a stakeholder partner discuss the findings and what additional research could help transgender people make informed decisions about their health.|
New Evidence about Transgender Women Receiving Hormone Therapy
In this guest blog post, the principal investigator and a stakeholder partner discuss the findings of the study, which they reported in an Annals of Internal Medicine August 2018 article, and what additional research could help transgender people make informed decisions about their health.
Evidence for Decisions
Estrogen Use and the Risk for Blood Clots and Strokes Among Transgender Women
Many transgender women pursue medical transition with hormone therapy to help align their bodies with their female gender identity. Findings from a PCORI-funded study, which showed increased cardiovascular risks from estrogen use in transgender women, may help transgender women and their clinicians plan for ongoing health care.
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, the PI made changes including
- Specifying in the abstract that although there was increased risk of venous thromboembolism (VTE) and ischemic stroke (IS) after 6 years of estrogen therapy for transgender females compared to cisgender males, the overall rate of these events was relatively low, with a wide distribution in the risk estimates.
- Expanding the description of the difficulties that the researchers experienced in completing the portion of the study within the Veterans’ Administration (VA) system. Reviewers gave varied advice about how to deal with this part of the study, and the researchers felt it was important, especially since this was part of the original protocol, to present the VA findings and their insights into dealing with difficulties of data collection.
- Removing the presentation of analyses and results associated with a within-group analysis among transgender females based on when they started hormone therapy. The researchers found that using the hormone therapy as a basis for inclusion in the analysis, and then also differentiating within the group by when patients received the therapy, led to concerns about the complexity and the validity of those analyses.
- Acknowledging in the Discussion that the transgender population captured in the insured cohort used in this study may not reflect the transgender population of the United States, particularly in relation to income and insurance access. This limited the generalizability of the findings.
Finally, reviewers acknowledged that a key strength of this study was the incorporation of both risks and benefits of gender affirmation care in their study. Per reviewers’ request, the researchers expanded the discussion of the benefits of such care in the report.
Conflict of Interest Disclosures
View the COI disclosure form.