The research team, led by Cassandra Chu and Jiya Patel under the supervision of cardiologist Amgad N. Makaryus of the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Northwell Cardiovascular Institute, set out to measure just how visible the LGBTQIA+ community is in contemporary cardiovascular guidance. The stakes are not abstract. Roughly 7 percent of the United States population identified as LGBTQIA+ as of 2023, according to Pew Research Center data cited by the authors. Members of this community may carry a higher predisposition to cardiovascular disease driven by increased psychosocial stressors, higher rates of obesity and smoking, and, for some transgender and gender-diverse patients, the use of gender-affirming hormone therapy. Clinical studies have also linked certain LGBTQIA+ subgroups to higher body mass index and elevated HbA1c levels, both established predictors of cardiovascular events.

The methodology was deliberately systematic and broad. The authors searched GuidelineCentral, a platform providing free access to up-to-date international clinical guidelines, for cardiology guidelines published within the ten years preceding August 8, 2024. Their keyword list was built from credible LGBTQ+ health resources, including the UCSF LGBTQIA+ Glossary and the Human Rights Campaign Glossary of Terms, and spanned several semantic categories: sexual orientation terms such as lesbian, gay, bisexual, queer, pansexual, and asexual; gender identity terms including transgender, non-binary, gender fluid, and gender non-conforming; umbrella population labels such as LGBT, LGBTQ, LGBTQIA+, sexual minority, and gender minority; and clinically relevant phrases for gender-affirming healthcare, including gender-affirming care, hormone therapy, and gender reassignment surgery. Crucially, the team intentionally retained historical terminology such as homosexual and transsexual to avoid missing relevant content in older documents that may use outdated language.

The results were stark. Of the 313 guidelines analyzed, just six contained any of the searched terms. The 2023 ACC/AHA/ACCP/HRS Atrial Fibrillation Guideline offers a brief but meaningful statement that patients with atrial fibrillation, regardless of sex and gender diversity, should be equitably offered guideline-directed stroke risk reduction therapies. The 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Chronic Coronary Disease Guideline identifies sexual orientation as a social determinant of health that affects all stages of disease management and calls for future research into whether cardiovascular risk increases among hormone-treated transgender women with established coronary disease. The 2020 VA/DoD Obesity Guideline recommends further research into how individual differences, including transgender identity, might predict outcomes after bariatric procedures.

Perhaps the most substantive engagement came from an unexpected quarter. The 2024 KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease, a kidney-focused document that nonetheless intersects with cardiovascular care, acknowledges that a small but increasing proportion of the world’s population identifies as transgender, gender-diverse, or nonbinary and describes an urgent need to build transgender cultural safety within all aspects of kidney disease management. It further recognizes the importance of evaluating sex differences in kidney function across hormonal stages of life and considering the effects of exogenous hormone use, explicitly including gender-affirming hormone therapy, on measures of kidney health. By contrast, two International Society for Heart and Lung Transplantation guidelines, one covering heart transplant recipients and one addressing the use of hepatitis C virus-infected organ donors, referenced men who have sex with men only in the narrow context of donor screening and HIV transmission risk, rather than in service of equitable or tailored care.

The authors argue that this minimal acknowledgment constitutes a systemic oversight with real clinical consequences. There is a widening gap between emerging epidemiological data showing elevated smoking rates, higher BMI, and poorer glycemic control in LGBTQIA+ populations and the clinical protocols and prevention strategies that are supposed to act on such evidence. Gender-affirming hormone therapy illustrates the problem vividly: it is increasingly recognized as a potential modifier of cardiovascular risk, yet current cardiology guidelines rarely address its cardiovascular implications. The authors call for future guideline development to include dedicated sections evaluating the effects of estrogen- and testosterone-based therapies on cardiovascular outcomes and the downstream implications for management strategies, particularly for the transgender and gender-diverse populations most likely to receive these treatments.

A major barrier to progress, the researchers contend, is the absence of standardized terminology and data collection practices around sexual orientation and gender identity, often abbreviated SOGI. Inconsistent and outdated use of LGBTQIA+-related terms across studies impedes the synthesis of existing data and makes cross-population comparisons unreliable. Without a unified framework for identifying and categorizing subgroups within the community, designing inclusive research protocols or deriving conclusions that can meaningfully inform practice becomes exceedingly difficult. The limited inclusion of LGBTQIA+ individuals in clinical trials compounds the problem, reducing the generalizability of study findings and potentially masking subgroup-specific treatment responses or risk patterns. The authors argue that inclusive guidelines must therefore be preceded by intentional recruitment strategies and data disaggregation efforts that illuminate these populations’ unique health outcomes.

The proposed path forward is institutional as much as scientific. The authors call for interdisciplinary collaboration among clinicians, researchers, and LGBTQIA+ health advocates, supported by funding, ethical guidance, and community partnership. Integrating SOGI data collection into electronic health records, clinical trials, and large-scale epidemiologic studies is described as a crucial first step, but one that demands careful ethical handling. Because SOGI information is highly sensitive, patients may worry about privacy, discrimination, or unintended disclosure of their identity. The authors recommend voluntary disclosure, clear communication about the purpose and use of collected data, robust safeguards and secure storage to minimize the risk of unauthorized disclosure, and policies consistent with regional privacy requirements, noting that legal protections for sexual and gender minorities vary across jurisdictions. They further suggest that guideline-writing committees such as those of the ACC and AHA recruit diversity consultants with expertise in LGBTQIA+ health to strengthen the inclusivity and clinical relevance of future documents.

Notably, the authors acknowledge the limits of their own analysis. A keyword-based approach may underestimate implicit inclusivity or relevant content not captured by search terms, and the scarcity of studies specifically addressing LGBTQIA+ cardiovascular health reflects the broader research gap the paper seeks to close. They propose that future analyses employ artificial intelligence and natural language processing to broaden keyword coverage and identify semantically related language that standard searches overlook, and they call for comparative analyses of how multiple marginalized populations are represented across guidelines.

Ultimately, the paper’s conclusion reaches beyond the LGBTQIA+ community to a principle of guideline design: an effective clinical guideline should provide healthcare providers with accessible, inclusive, and actionable information regardless of their patients’ identities. The authors propose treating the inclusion of LGBTQIA+ data, terminology, and population-specific considerations as a standard quality metric during guideline development, analogous to how evidence levels are assessed in clinical recommendations, alongside attention to how race, socioeconomic status, and geography shape cardiovascular risk. History offers a precedent: women and racial and ethnic minority groups experienced similar underrepresentation in cardiovascular medicine, and the resulting delays in recognizing subgroup-specific disease presentations eventually prompted guideline revisions toward more equitable care. The authors argue that cardiology now faces the same inflection point, with an opportunity not only to improve outcomes for sexual and gender minority patients but to model inclusivity and justice in medicine more broadly.

Subject of Research: Representation of LGBTQIA+ patients in cardiovascular disease clinical practice guidelines

Article Title: Representation of the LGBTQIA+ Patient Community in Cardiovascular Disease Clinical Guidelines

Article References: Chu, C., Patel, J., Castillo, A., Zeltser, R., & Makaryus, A. N. (2026). Representation of the LGBTQIA+ Patient Community in Cardiovascular Disease Clinical Guidelines. Journal of General Internal Medicine. https://doi.org/10.1007/s11606-026-10857-x

Image Credits: AI Generated

DOI: 10.1007/s11606-026-10857-x

Keywords: LGBTQIA+ health, cardiovascular disease, clinical guidelines, health equity, gender-affirming therapy, sexual orientation and gender identity, cardiology, health disparities, Journal of General Internal Medicine, social determinants of health, clinical trials inclusion, guideline development

The study highlights a troubling pattern: around 75% of the analyzed trials specifically excluded pregnant women. This exclusion presents significant challenges for healthcare providers and patients who must navigate the uncertainties surrounding medication safety without the benefit of rigorous testing in this population. As Alyssa Bilinski, an assistant professor at Brown’s School of Public Health, aptly puts it, the absence of pregnant women in such trials complicates the determination of whether these medications pose any risk to either mothers or their unborn children.

Bilinski emphasized the real-world consequences of this exclusion. In the absence of concrete evidence, pregnant women may face a dilemma: some may choose to take medications that have not been thoroughly evaluated for safety during pregnancy, exposing themselves and their children to potential harmful effects. Conversely, others may forgo medications that could be beneficial due to a lack of confidence in their safety stemming from inadequate research data. This incongruence illustrates a pressing need for more inclusive research practices that adequately consider the unique physiological and psychological complexities of pregnant women.

The study further revealed that 24% of the analyzed trials did not clearly specify whether pregnant participants were included. However, upon closer investigation, it became evident that pregnant women were systematically excluded from most of these studies. Notably, even trials that included pregnant participants primarily focused on pregnancy-related conditions, such as labor and the prevention of preterm labor. In stark contrast, chronic conditions commonly affecting pregnant women and their children, like asthma and diabetes, were largely disregarded in clinical research.

Bilinski pointed to a stark statistic: of the numerous trials assessed, only 19 focused on non-infectious chronic conditions—such as anxiety, depression, and asthma—that included pregnant participants. This limited inclusion only exacerbates the need for more comprehensive research that encompasses a wider array of health issues that can significantly impact pregnant women’s overall well-being and their offspring’s development. While the hesitation to include pregnant women in clinical trials may stem from concerns about potential risks, this hesitance only serves to perpetuate a cycle of misinformation and uncertainty regarding the safety of medications during pregnancy.

The historical context behind these practices is equally concerning. It wasn’t until the year 1962 that the United States Food and Drug Administration (FDA) mandated pharmaceutical companies to demonstrate the safety and efficacy of their products for public consumption. Even more alarmingly, it took until 1993 for guidelines to be established requiring the inclusion of women in clinical trials. As Bilinski notes, the relatively recent nature of these regulations serves to underscore how outdated the current practices of excluding pregnant women from clinical research have become.

Despite numerous calls for increased participation of pregnant individuals in clinical trials, the study’s findings indicate a stubborn stagnation in the rates of inclusion over the past fifteen years. This lack of progress underscores an urgent need for systemic reforms within the realm of clinical research to ensure that the complexities of pregnancy are adequately represented in the evaluation of drug safety.

The methodology utilized in randomized control trials, which represents the gold standard for assessing the safety and efficacy of medications, relies on a controlled environment where treatment is administered to a randomly selected cohort while withholding it from others. This method has consistently proven effective in demonstrating both a drug’s efficacy and its potential side effects. Yet, the persistent exclusion of a significant portion of the population, namely pregnant women, severely limits the applicability of these findings, creating a significant knowledge gap that calls for immediate attention.

The data analyzed in this study was collected from ClinicalTrials.gov, a comprehensive database of publicly and privately funded trials conducted worldwide. The researchers, led by Bilinski and colleague Natalia Emanuel, aimed to draw attention to the glaring lack of representation of pregnant women in clinical drug trials and advocate for their inclusion. It is essential to bridge this gap to improve the overall quality of maternal health care and to empower pregnant individuals with the information necessary to make informed decisions about their health and the health of their children.

As we progress into an era defined by rapid advancements in medical research and technology, it is imperative that efforts are made to dismantle the barriers preventing pregnant women from participating in clinical trials. By fostering a culture of inclusivity within research, we can contribute to the generation of high-quality evidence that will ensure the safety and well-being of both mothers and their children. Ultimately, addressing this critical issue within the medical research community will be paramount to achieving better health outcomes and fostering trust between healthcare providers and patients.

The researchers behind this study hope that, in thirty years’ time, the absence of high-quality evidence regarding medication safety during pregnancy will be viewed as antiquated and unacceptable. They envision a future where inclusivity in clinical trials is the standard, rather than the exception, thereby empowering pregnant women with informed choices while ensuring that the medications they use are not just effective but also safe.

In conclusion, the findings presented in this vital research underscore an urgent need for improved policies and practices surrounding the inclusion of pregnant women in clinical drug trials. Until meaningful reforms are implemented in the medical research community, the critical questions regarding drug safety for this population will remain unanswered, leaving both practitioners and patients navigating with incomplete information and uncertainty.

Subject of Research: Inclusion of Pregnant Women in Clinical Drug Trials
Article Title: Fewer than 1% of US Clinical Drug Trials Enroll Pregnant Participants
News Publication Date: 4-Jan-2025
Web References: Link to the study
References: Bilinski, Alyssa and Emanuel, Natalia. American Journal of Obstetrics and Gynecology.
Image Credits: Brown University, American Journal of Obstetrics and Gynecology

Keywords: Pregnancy, Drug Safety, Clinical Research, Drug Efficacy, Maternal Health, Chronic Conditions, Clinical Trials, Public Health.