GRADEing the un-GRADE-able: a description of challenges in applying GRADE methods to the ethical and implementation questions of pediatric organ donation guidelines

Abstract

Good practice statements (GPSs) have been proposed by the GRADE working group as a way of avoiding the inappropriate characterization of evidence as low quality in support of strong recommendations justified by indirect evidence. This commentary examines how the GPS methodology was applied to the development of a recent guideline for pediatric deceased donation after circulatory determined death. This guideline was informed by a broad body of indirect literature and addressed a variety of social, legal, and ethical questions in addition to several implementation issues. While the resulting document contained a vast majority of GPS (63 as opposed to seven actionable GRADEd recommendations), we maintain that this application was appropriate to develop recommendations within the GRADE framework. This commentary explores how GPS may be applied in this context and explores whether a new classification of recommendations focused on these types of issues may be appropriate.

Keywords: Ethics; GRADE methodology; Good practice statements; Guideline development; Organ donation; Pediatrics.