Healthcare disparities in transgender patients are complex topics that warrant national attention. Transgender patients often experience unique healthcare concerns and systemic barriers that current medical practices are under-equipped to handle. These gaps include discrimination at healthcare facilities, lack of knowledgeable providers, lack of evidence-based medicine to guide care, and the challenges with laboratory information systems (LIS) and electronic medical record (EMR) representing transgender patients.

At Tuesday’s session “Breaking Down Gender from Cis to Trans,” Dina Greene, PhD, Gabrielle Winston-McPherson, PhD, and Martha Lyon, PhD, discussed how laboratories can contribute to improving the quality of care for transgender patients and address the gaps within laboratory medicine in serving this population. 

A fundamental standard of care that laboratories furnish with results is the corresponding reference interval for the patient population being tested. In transgender patients, laboratory parameters can be affected in those that undergo hormone replacement therapy to affirm gender identity. As such, the reference interval based on a cisgender population is not applicable. “Being able to integrate someone’s affirmed gender into their basic laboratory testing is what’s most important,” noted Greene.

Greene showed that hematology parameters for patients on stable hormone therapy are equivalent to their affirmed gender. In contrast, transgender patients need their own reference interval when it comes to hormones. “If you are a transgender man on hormone therapy for some amount of time, the estrogen reference interval for [a] cisgender man is going to be a little too idealistic for what you would expect to get for a transgender guy,” Green said, “whereas the estrogen reference interval for cisgender women is going to be completely different than anything you would expect. It’s about getting a realistic expectation for estrogen or testosterone for people that are on gender affirming hormone therapy.” 

Lyon remarked that the CALIPER study can teach us a lot about collaboratively establishing reference ranges in vulnerable patients, as it is often impractical for laboratories to establish their own ranges in these patients. Studies like these enable laboratories to adopt data-driven reference intervals for assays that are standardized or harmonized.

An additional challenge in delivering appropriate reference intervals lies in being able to represent transgender patients in the LIS/EMR. Lyon noted that the existing LIS/EMR systems have the functionality to better represent transgender patients but utilization requires additional updates by the vendors. To determine the readiness of LIS/EMR systems to represent transgender patients, Lyon’s group sent a survey to several vendors asking questions such as the ability to collect, retain and display assigned sex at birth, gender identity, patient preferred name, pronoun, and fields for transgender specific reference ranges. The answers to these questions were a mixed bag in which vendors are at different stages of preparedness. Vendors were also asked when they would be able to provide updates reflecting these changes to their systems, and most anticipate a 1-2 years’ time frame.

Discussing the lack of clinical studies on transgender health, Winston-McPherson delved into the microbiome changes in vaginal flora of transgender men and potential clinical implications. “There is increased alpha [intra-individual] diversity of vaginal flora in transgender men and transgender women receiving hormonal therapy,” she noted. “The vaginal microbiome of cisgender women is composed primarily of lactobacillus; however, this is not the case for transgender men. Vaginal flora is impacted by hormonal changes and this is reflected in the vaginal microbiota of transgender patients.”

While additional studies are needed to define clinical implications of changes in the microbiota, prior evidence indicates replacement of lactobacillus and microbial diversity have been associated with bacterial vaginosis (BV). BV also has been implicated in increased risk of HIV transmission. This type of pioneering research is critical to improving transgender healthcare.