Equipoise: an important ethical consideration when contemplating participation in a randomised controlled trial of hyperbaric oxygen treatment in necrotising soft tissue infections.

Abstract

A proposal for a large, multi-centre, randomised controlled trial investigating the role of hyperbaric oxygen treatment (HBOT) in necrotising soft tissue infections (NSTI) has led to much discussion locally and internationally about whether participation is ethical for a centre where stakeholders already consider HBOT standard practice. This article systematically addresses the concept of clinical equipoise specific to the role of HBOT in NSTI, and presents a series of considerations to be taken into account by key stakeholders at potential participating sites.