1% recruited so far for the AWARE II study
Peter sent me an email, which I confess seemed a little gloomy and frustrated since he had looked at the latest status of the AWARE II study and learned that they had only recruited 1% of the patients that they intended to. He then asked me for my predictions for the outcome of this second version of the study.
Firstly, I have two reasons to not be quite so gloomy as Peter.
- From my own experience with clinicaltrials.gov, which is the US equivalent of the website that the AWARE study has its details, updates are usually very out of date. For instance studies will often be closed and collecting results before the website reflects that status. So it is entirely possible that more than 1% (which would be about 15 patients) have so far been recruited into the study.
- Even if it has taken 3 months to recruit 15 patients, I see that as a positive sign as it may mean that the investigators are being very narrow in their interpretation of the inclusion criteria. In my view they should only include patients who could possibly have had an NDE and who were in a room with the portable LCD monitor displaying random images.
As I have said before, in the first AWARE study, patients were included who were not even in rooms with the cards facing the ceiling. This defeats the purpose of the study in my view, so hopefully the reason that we are seeing them struggle with recruitment is that they are selecting patients in a more rational way.
My predictions for the outcome of this study are outlined in my book AWARE of AWARE, in which I discuss the original study, and predict only a couple of confirmed OBEs. I based this assumption (incorrectly), that only patients who survived a cardiac arrest, and were interviewed, and were in rooms with the cards, would be included in the analysis. If the AWARE II study follows this approach, and they recruit 1500 patients, all of whom had CAs and were resuscitated with the screen present AND were able to give an interview afterwards, then I would predict that only a couple would confirm their NDE by stating what was on the screen, this is based on the fact that only 10% of people who die and are resuscitated recall an NDE, of those maybe 25% have an OBE. Of those I would expect maybe 10% to notice the screen…that makes 3-4 patients. I must stress though, that this is only if the inclusion criteria are as strict as I outline and if they stick to this criteria.