Who Are We Missing? Reporting of Transgender and Gender‐Expansive Populations in Clinical Trials

• Type of Material: Article
• Authors: Eli N. Rice, Stanford University; Roy H. Lan, Stanford University; Julio C. Nunes, Yale University; Rushil Shah, Stanford University; Kira Clark, Stanford University; Vyjeyanthi S. Periyakoil, Stanford University; Jonathan H. Chen, Stanford University; Bryant Lin, Stanford University; Melvin Echols, Morehouse School of Medicine; Christopher Awad, Emory University; Muhammed Y. Idris, Morehouse School of Medicine; Erin Rose Cruz, Stanford University; Peter D. Poullos, Stanford University; Eldrin F. Lewis, Stanford University; Cati Brown-Johnson, Stanford University; Joseph Igwe, Stanford University; Sa Shen, Stanford University; Latha Palaniappan, Stanford University; Marcia L. Stefanick, Stanford University; Victor Ritter, Stanford University; Priscilla Pemu, Morehouse School of Medicine; Fatima Rodriguez, Stanford University; Brototo Deb, Georgetown University; Krishna Pundi, Stanford University; Paul J. Wang, Stanford University
• Language: English
• Date: 2023-11-10
• Publisher: Wiley
• Publication Version: Final Published Version
• Copyright Statement: © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): https://doi.org/10.1161/JAHA.123.030209
• Title of Journal or Parent Work: Journal of the American Heart Association
• Volume: 12
• Issue: 22
• Start Page: e030209
• Grant/Funding Information: Support for this project is from the American Heart Association.
• Keywords: Transgender; patient population; myocardial infarction; venous thromboembolism
• Research Categories: Health Sciences, Public Health; Health Sciences, General

Abstract

Transgender and gender‐expansive individuals are a growing segment of the population and have elevated risks of certain cardiac conditions, such as myocardial infarction and venous thromboembolism. 1 However, few large cardiovascular clinical trials have studied or reported clinical outcome data explicitly regarding this patient population. In this research letter, we characterized the reporting and language used for transgender and gender‐expansive populations in cardiovascular randomized clinical trials. We did a systematic review of randomized clinical trials across 4 cardiovascular areas (coronary artery disease, hypertension, atrial fibrillation, and diabetes) using ClinicalTrials.gov, which included 79 recently completed (2018–2022) interventional studies in the United States with published results for each area. Our research was exempted from the Stanford University Institutional Review Board approval, and no informed consent was required. A total of 451 807 participants were included (Table). We collected reporting of populations for sex and gender descriptions, as well as the inclusion and exclusion criteria. Almost all studies reported sex or gender as a single outcome variable. We inferred this to denote sex unless it was specified otherwise. All studies reported sex, with women representing 42% of all participants. Women represented the minority of study participants in coronary artery disease (30%), atrial fibrillation (42%), and diabetes (48%) clinical trials, but the majority of participants in hypertension trials (67%). Gender identity, including the option other, was reported in only 1 trial (<1%). No studies reported data regarding transgender or gender‐expansive identification. Several trials included pregnant women and lactating women as exclusion criteria, as well as man and woman as inclusion criteria. Our complete findings are available from the corresponding author upon request.