Monash University, Melbourne, Australia; University of Warwick, Coventry, UK.
Int J Cardiol. 2013 Oct 3;168(3):1724-7. doi: 10.1016/j.ijcard.2013.05.045. Epub 2013 Jun 2.
The publication of the European Society of Cardiology (ESC) guidelines for the management of heart failure, in 2012 represented the latest and arguably the most comprehensive document to date summarising recommended treatment and diagnostic options for the care of heart failure patients. The impact of clinical practice guidelines is now so great that it is important to review the processes that underlie guideline development. The ESC guideline process is compared and contrasted to those of other guideline bodies. The ESC uses its own internal experts inclined to review source clinical trial data rather than published or commissioned meta-analyses and systematic reviews. Uncertainties exist in several areas, such as how are the scope of potential treatments to be reviewed chosen, if there is no call for proposals or external consultation?, Two illustrative discrepancies are highlighted i) the non-surgical MitraClip device for reducing mitral regurgitation is given the verbal equivalent of a Class IIb recommendation on the basis of 107 patients in an uncontrolled registry, whereas no drug is reviewed based on such data, and another device, the subject of 3 prospective randomised controlled trials, was not reviewed at all and ii) for Ivabradine the whole trial population was included in the recommendation, despite a subgroup not benefitting, whereas for CRT the sub-group not thought to benefit was excluded from the recommendation. We propose that more interaction is needed between ESC and stakeholders so each can better understand the processes for producing guidelines to improve some of these aspects.
2012 年,欧洲心脏病学会 (ESC) 心力衰竭管理指南的发布代表了迄今为止最新、也是最全面的文件,总结了心力衰竭患者治疗和诊断选择的建议。临床实践指南的影响现在如此之大,因此审查指南制定背后的过程非常重要。本文将 ESC 指南的制定过程与其他指南制定机构进行了比较和对比。ESC 使用自己内部倾向于审查原始临床试验数据的专家,而不是发表或委托的荟萃分析和系统评价。在几个领域存在不确定性,例如如何选择要审查的潜在治疗方法的范围,如果没有提案或外部咨询的要求呢?有两个说明性差异被强调:i)对于减少二尖瓣反流的非手术 MitraClip 装置,基于 107 名未经控制的注册患者,给予相当于 IIb 类的口头推荐,而没有基于此类数据审查任何药物,而另一种装置,即 3 项前瞻性随机对照试验的主题,根本没有被审查;ii)对于 Ivabradine,整个试验人群都被包括在推荐中,尽管亚组没有受益,而对于 CRT,不认为受益的亚组被排除在推荐之外。我们建议 ESC 与利益相关者之间需要更多的互动,以便双方都能更好地了解制定指南的过程,以改善其中的一些方面。