AWARE Study II methodology: If the mountain won’t come to Mohammed…
Firstly I would like to thank Peter for contacting me and alerting me to the fact that the design of the second phase of the AWARE study is now available on the UK clinical Research Network website.
This is obviously great news, and shows that this important research is going forward and that at some point in the future more data will emerge on attempts to capture an NDE using robust methods. This last point is certainly something that seems to have been addressed in the new design of the study. If you have read my previous posts, you will have noted that I pointed out the statistical problems facing the investigators, namely that due to the fact that only a small proportion of people survive a Cardiac Arrest (CA), and of those only 10% claim to have had any type of NDE, and of those only about 25% report an Out Of Body Experience, the numbers you would need to enroll into a study to validate an OBE would be huge. This problem is amplified by the fact that in the original AWARE study less than half the subjects actually had CAs in areas with validating images, so even if someone reported an NDE with an OBE, their chances of seeing the image were extremely low. I suggested that they either set up a huge study to insure enrolling enough patients to sufficiently power the research, or they increase the number of cards with images on, and choose areas where CAs are most likely.
The solution that has been arrived at is outlined in the design of AWARE II:
Emergency Department or Research staff will be alerted to cardiac arrest and will attend with portable brain oxygen monitoring devices and a tablet which will display visual images upwards above the patient as resuscitation is taking place. Measurements obtained during cardiac arrest will be used to compare data from all cardiac arrest patients independent of outcome [whether they live or die]. Survivors will then be followed up and with their consent will have in-depth, audio recorded interviews.
This is the Mohammed going to the mountain solution, and has real potential to overcome many of the problems encountered in the first study. This way, and I am making an assumption here, only CAs where this research team actually arrive and are able to get the tablet in place will be included in the study. This instantly erases the problem of having sufficient rooms with images to insure capturing an OBE. It does not however overcome the problem of whether or not the person experiences their OBE from the perspective of being directly above themselves. While this is common, it is not the universal “pop out position” that subjects report, therefore we may get a frustrating account of someone having an OBE standing in the corner and reporting someone holding a tablet above them. Also, I can imagine there will have to be a considerable amount of training involved for the researchers and also a great deal of co-operation from resuscitation teams whose immediate priority is reviving the patient. However, this new method does have significant advantages over those used in the first study, and therefore should have a higher chance of validating an OBE without recruiting tens of thousands of patients..
The study is aiming to enroll 900-1500 subjects by the end of MAY 2016 at the latest, and will be a multi-center international study like AWARE. I wish the investigators the best of luck in their endeavor to validate NDEs and OBEs, and I would like to commend Dr. Parnia and his co-investigators for their ingenuity and tenacity.
Finally, with regard to this blog, I will be starting a new project on these pages related to this subject area in the New Year, and will of course continue to add any emerging data or news on research in this field.