Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

中文翻译：

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心脏外科随机试验

与医学专业的随机对照试验 (RCT) 相比，心脏外科的 RCT 面临着特定的问题。个人和集体的平衡、手术技术的快速发展以及获得资金的困难以及外科界临床流行病学教育有限是试验设计阶段最重要的挑战。复杂干预措施和学习曲线效应的使用、个体操作者专业知识的差异、盲法困难和缓慢招募使成功完成心脏手术 RCT 尤其具有挑战性。事实上，在过去的 20 年中，心脏手术 RCT 的数量显着下降。在这篇综述中，一组外科医生、试验者、