17 Aug, 14 | by Iain Brassington
Guest Post by Ruth Stirton and Lindsay Stirton, University of Sheffield
One of us – Ruth – was on Newsnight on Wednesday the 13th August talking about the PARAMEDIC2 trial. The trial is a double blind, individually randomised, placebo controlled trial of adrenaline v. normal saline injections in cardiac arrest patients treated outside hospital. In simpler terms, if a person were to have a cardiac arrest and was treated by paramedics, they would usually get an injection of adrenaline prior to shocks to start the heart. If that same person was enrolled in this study they would still receive an injection but neither the person nor the paramedic giving the injection would know whether it was adrenaline or normal saline. The research team is proposing to consent only the survivors for the collection of additional information after recovery from the cardiac arrest. This study is responding to evidence coming from other jurisdictions that indicates that there might be some significant long term damage caused by adrenaline – specifically that adrenaline saves the heart at the expense of the brain. It is seeking to challenge the accepted practice of giving adrenaline to cardiac arrest patients.
Our starting position is that we do not disagree with the research team. These sorts of questions need to be asked and investigated. The development of healthcare depends on building an evidence base for accepted interventions, and where that evidence base is not forthcoming from the research, the treatment protocols need changing. This going to be tricky in the context of emergency healthcare, but that must not be a barrier to research.
There are two major ethical concerns that could bring this project to a grinding halt. One is the opt-out consent arrangements, and the other is the choice of methodology.
Consent, then. more…