改善心脏外科临床试验的多样性,以ROMA:女性为典范
Ruth Masterson Creber1, Sarah Eslami1, Mario Gaudino2
1Columbia University School of Nursing, Columbia University Irving Medical Center.
Current opinion in cardiology
|June 27, 2024
概括
改善女性在心脏手术试验中的代表性至关重要. 定制标准和ROMA:妇女试验等策略可以提高女性患者的健康平等.
科学领域:
- 心血管外科心血管外科
- 临床试验多样性 临床试验多样性
- 健康 公平 卫生 公平
背景情况:
- 女性面临高心血管疾病风险,历史上一直被排除在心脏手术试验之外.
- 女性患者经历了持续的更糟糕的外科治疗结果,特别是在冠状动脉旁路移植后,过去十年没有任何改善.
- 在试验中准确地代表女性对于了解治疗效果和临床益处至关重要.
研究的目的:
- 描述改善女性在心脏手术临床试验中的代表性的方法.
- 解决阻碍女性参与心血管研究的结构性障碍.
- 通过包容性试验设计,促进心脏外科手术中的健康公平.
主要方法:
- 审查有效招聘和代表妇女的战略.
- 审查量身定制的资格标准,以扩大参与范围.
- 实施全面的沟通和建立信任的倡议.
主要成果:
- 罗马:女性试验是第一个专注于女性的心脏手术试验.
- 这项试验展示了一种有希望的方法来解决现场代表性不足的问题.
- 在招募女性方面取得的初步成功表明了专门试验设计的潜力.
结论:
- 量身定制的资格标准和加强的沟通策略可以克服女性代表性的障碍.
- 设计专门针对女性的试验,如ROMA:Women,是改善临床试验多样性的可行策略.
- 解决代表性不足问题是推动心脏外科手术健康平等的关键一步.
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