Ruth Masterson Creber, Sarah Eslami, Mario Gaudino
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Improving diversity in cardiac surgery clinical trials with ROMA:Women as an exemplar.
Purpose of review: To describe methods to improve representation of women in cardiac surgery clinical trials.
Recent findings: Cardiovascular disease risk among women is high. Historically, women have been excluded from cardiac surgery trials, in part due to restrictive inclusion criteria. Surgical outcomes, specifically after coronary artery bypass grafting, are consistently worse among female patients, and these outcomes have not improved over the last decade. Addressing treatment effects and clinical benefit among women requires accurate representation in cardiovascular surgery trials. ROMA:Women, is the first cardiac surgery trial to focus solely on women, with the goal of addressing underrepresentation. Through utilizing specific strategies, ROMA:Women is a promising first step in advancing health equity.
Summary: Strategies to ensure effective recruitment and representation among women in cardiac surgery clinical trials, such as tailored eligibility criteria and comprehensive strategies to improve communication and increase trust, are two of many potential approaches to address the structural barriers to female representation in cardiac surgery clinical trials. To date, ROMA:Women is an example of a trial that has shown extraordinary preliminary success enrolling women. Designing trials exclusively for women is one strategy to improve the diversity of clinical trial participation.
期刊介绍:
Current Opinion in Cardiology is a bimonthly publication offering a unique and wide ranging perspective on the key developments in the field. Each issue features hand-picked review articles from our team of expert editors. With fourteen disciplines published across the year – including arrhythmias, molecular genetics, HDL cholesterol and clinical trials – every issue also contains annotated reference detailing the merits of the most important papers.