title: Inconsistencies in the development of the ESC Clinical Practice Guidelines for Heart Failure.
abstract: 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.
authors.affiliation: Monash University, Melbourne, Australia; University of Warwick, Coventry, UK. Electronic address: ajscoats@aol.com.
authors.forename: Andrew J Stewart
authors.initials: AJ
authors.lastname: Coats
authors.forename: Louise G
authors.initials: LG
authors.lastname: Shewan
mesh_terms: D002309:Cardiology / Q000592:standards*; D019468:Disease Management; D019317:Evidence-Based Medicine / Q000592:standards*; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*
keywords: Clinical trials; Evidence based medicine; Guidelines; Heart failure