There are considerable numbers of interventions which are undertaken at points of emergency; severe head injury, severe septic shock, myocardial infarction, admissions to intensive care units… In these situations it can be extremely tricky to get the critically ill, often unconscious, individual to agree to being randomised in a clinical trial. Yet without that, we won’t know what treatment to give. Or not give.
But surely we should just use common sense?
Or can we undertake “deferred consent” – a rather odd phrase which means seeking consent for the data collected after a patient has been, because of a critical care emergency, entered into a randomised trial.
I can hear the gasps of disbelief from here, despite not having any form of audio connection to your laptop. (No honestly, you don’t need to put the colander back on. I really really can’t hear anything. It’s a figure of speech.)
Not only can this be done, and is legal in the UK and many other places, but there’s some wonderful research been undertake on this looking at the views of parents whose children took part in such trials. The bottom line is, that while there is some individual variation, the large majority of parents were happy for their children to have been entered into such studies. And more than that, the @CONNECTstudy have gone even further and come up with guidelines for researchers: tinyurl.com/CONNECTguideline
The challenge, it seems, is working out how to get on the ground practitioners to believe in research and act on it. Surely it’s not that difficult? After all, mag-sulf antenatally protects neonatal brains and that’s widely used .. isn’t it?