Zena and Michael A. Wiener Cardiovascular Institute, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.
Bostick Heart Center, Department of Cardiovascular and Thoracic Surgery, Winter Haven Hospital, BayCare Health System, Clearwater, Florida.
Ann Thorac Surg. 2024 Dec;118(6):1327-1337. doi: 10.1016/j.athoracsur.2024.03.016. Epub 2024 Mar 24.
There is a recognized lack of diversity among patients enrolled in cardiovascular interventional and surgical trials. Diverse patient representation in clinical trials is necessary to enhance generalizability of findings, which may lead to better outcomes across broader populations. The Cardiothoracic Surgical Trials Network (CTSN) recently developed a plan of action to increase diversity among participating investigators and trial participants and is the focus of this review.
A review of literature and enrollment data from CTSN trials was conducted.
CTSN completed more than a dozen major clinical trials (2008-2022), enrolling >4000 patients, of whom 30% were women, 11% were non-White, and 5.6% were Hispanic. CTSN also completed trials of hospitalized patients with coronavirus disease 2019, wherein enrollment was more diverse, with 42% women, and 58% were Asian, Black, Hispanic, or from another underrepresented racial group. The discrepancy in diversity of enrollment between cardiac surgery trials and coronavirus disease trials highlights the need for a more comprehensive understanding of (1) the prevalence of underlying disease requiring cardiac interventions across broad populations, (2) differences in access to care and referral for cardiac surgery, and (3) barriers to enrollment in cardiac surgery trials.
Committed to diversity, CTSN's multifaceted action plan includes developing site-specific enrollment targets, collecting social determinants of health data, understanding reasons for nonparticipation, recruiting sites that serve diverse populations, emphasizing greater diversity among clinical trial teams, and implicit bias training. The CTSN will prospectively assess how these interventions influence enrollment as we work to ensure trial participants are more representative of the communities we serve.
心血管介入和外科试验纳入的患者存在明显的多样性缺乏。临床试验中患者的多样化代表对于增强研究结果的普遍性是必要的，这可能会导致更广泛人群的更好结果。心胸外科临床试验网络（CTSN）最近制定了一项行动计划，以增加参与研究人员和试验参与者的多样性，这是本综述的重点。
对 CTSN 试验的文献和入组数据进行了回顾。
CTSN 完成了十多项主要临床试验（2008-2022 年），入组了超过 4000 名患者，其中 30%为女性，11%为非白人，5.6%为西班牙裔。CTSN 还完成了 2019 年冠状病毒病住院患者的试验，入组更加多样化，女性占 42%，亚洲人、黑人、西班牙裔或来自其他代表性不足的种族群体占 58%。心脏外科试验和冠状病毒病试验在入组多样性方面的差异突出表明需要更全面地了解（1）广泛人群中需要心脏干预的基础疾病的流行情况，（2）心脏手术的获取和转诊方面的差异，以及（3）参与心脏外科试验的障碍。
致力于多样性，CTSN 的多方面行动计划包括制定特定于站点的入组目标，收集健康社会决定因素数据，了解不参与的原因，招募服务多样化人群的站点，强调临床试验团队之间更大的多样性，以及隐性偏见培训。CTSN 将前瞻性评估这些干预措施如何影响入组情况，因为我们努力确保试验参与者更能代表我们服务的社区。
