Callans David J, Reynolds Matthew, Zimetbaum Peter J
Electrophysiology Section, Cardiovascular Division, Perelman School of Medicine, University of Pennsylvania. Philadelphia, PA, US.
Electrophysiology Section, Cardiovascular Division, Lahey Hospital and Medical Center, Burlington, MA, US.
Arrhythm Electrophysiol Rev. 2020 Jun 3;9(1):15-19. doi: 10.15420/aer.2019.21.
Although it has not always been this way, the impact of large, randomised clinical trials in electrophysiology is limited, at least compared with other disciplines in cardiology. This has been particularly true regarding procedural aspects of our field: successful randomised trials are rare and observational trials are small and typically without a proper active control group. In this article, the authors examine the reasons behind this circumstance, which include underinvestment from funding sources; lack of consensus on procedural endpoints; lack of consensus on techniques; and a therapeutic bias in favour of procedural intervention that stands in the way of investigator equipoise. Together, these factors have created a scientific culture dominated by small-scale, siloed, observational research and unwillingness to collaboratively advance the field with consensus and prospective trials. The authors feel that it is increasingly urgent to improve the scientific basis for clinical practice and explore strategies to accomplish this goal.
尽管情况并非一直如此,但与心脏病学的其他学科相比,大型随机临床试验在电生理学中的影响有限。在我们这个领域的程序方面尤其如此:成功的随机试验很少,观察性试验规模小,而且通常没有适当的活性对照组。在本文中,作者探讨了这种情况背后的原因,包括资金来源投资不足;对程序终点缺乏共识;对技术缺乏共识;以及有利于程序干预的治疗偏见,这阻碍了研究者的 equipoise(该词可能有特定专业含义,暂直译为“平衡”)。这些因素共同营造了一种由小规模、孤立的观察性研究主导的科学文化,并且不愿意通过共识性和前瞻性试验来协同推动该领域的发展。作者认为,改善临床实践的科学基础并探索实现这一目标的策略变得越来越紧迫。