Neuman Mark D, Bosk Charles L, Fleisher Lee A
Department of Anesthesiology and Critical Care, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA The Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Anesthesiology and Critical Care, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA The Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA Department of Sociology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
BMJ Qual Saf. 2014 Nov;23(11):957-64. doi: 10.1136/bmjqs-2014-003114. Epub 2014 Aug 18.
For more than two decades, the role of beta-blockers in preventing cardiac complications after major surgery has been the subject of contentious scientific and policy debate. Based on two small but highly publicized randomized trials published in 1996 and 1999, prominent U.S. organizations embraced preoperative beta-blocker initiation as a “best practice” and an opportunity for widespread safety improvement. Yet only a few years later, expert recommendations regarding preoperative beta-blockers were revised and downgraded when subsequent research failed confirm promising early findings and called attention to potential harms associated with beta-blocker overuse. In this paper, we trace the history of preoperative beta-blocker recommendations as a case study in lessons to be learned from reversals of guideline recommendations based initially on evidence drawn from randomized, controlled trials. Ultimately, we find that the policy significance that stakeholders ascribed to early beta-blocker studies combined with the prestige that experts assigned to the randomized controlled trial as a form of evidence to short-circuit discourse on the risks of preoperative beta-blocker initiation and led it to be elevated prematurely as a best practice. As such, the story of preoperative beta-blockers illustrates threats to objectivity in guidelines that can emerge from policy imperatives that lend primacy to the rapid translation of research into practice and from perspectives that unduly emphasize the strengths of randomized trials.
二十多年来，β受体阻滞剂在预防大手术后心脏并发症方面的作用一直是科学和政策争论的焦点。基于1996年和1999年发表的两项规模虽小但备受关注的随机试验，美国一些知名机构将术前开始使用β受体阻滞剂视为一种“最佳实践”，以及一个广泛改善安全性的契机。然而，仅仅几年后，当后续研究未能证实早期令人鼓舞的发现，并提醒人们注意β受体阻滞剂过度使用带来的潜在危害时，关于术前使用β受体阻滞剂的专家建议被修订并下调。在本文中，我们追溯术前β受体阻滞剂推荐的历史，以此作为一个案例研究，从中吸取教训，这些教训来自于最初基于随机对照试验证据的指南推荐的逆转。最终，我们发现利益相关者赋予早期β受体阻滞剂研究的政策意义，加上专家赋予随机对照试验作为一种证据形式的威望，导致关于术前开始使用β受体阻滞剂风险的讨论短路，并使其过早地被提升为最佳实践。因此，术前β受体阻滞剂的故事说明了指南客观性可能受到的威胁，这些威胁可能源于将研究迅速转化为实践的政策要求，以及过度强调随机试验优势的观点。
