Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York.
Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands. Electronic address: https://twitter.com/AKappetein.
J Am Coll Cardiol. 2020 Apr 7;75(13):1593-1604. doi: 10.1016/j.jacc.2020.01.048.
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.
与医学专业的随机对照试验（RCT）相比，心脏外科的 RCT 面临着一些特殊的问题。个体和集体的均衡状态、手术技术的快速发展，以及在心脏外科领域获得资金的困难和临床流行病学教育的有限性，这些都是试验设计阶段最重要的挑战。复杂干预措施的使用和学习曲线效应、个体操作者专业技能的差异、盲法的困难以及招募速度缓慢，使得心脏外科 RCT 的成功完成变得极具挑战性。事实上，在过去的 20 年中，心脏外科 RCT 的数量显著减少。在这篇综述中，一组外科医生、试验者和流行病学家讨论了心脏外科 RCT 面临的最重要的挑战，并为心脏外科 RCT 的成功设计和完成提供了一系列建议。
