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.
“We think that these patients may have had better blood flow to the brain during cardiac arrest, leading to consciousness and activity of the mind.”
That line seems curious and somewhat contradictory to what I have heard Dr. Parnia say before. He has often made the point that the patients evaluated meet the pre-established clinical definition of death. When a patient reaches that point, a better blood flow *during* the event will make no difference. That is, unless the patient was constantly receiving a cardiac massage after clinical death, which seems unlikely since nowadays defibrillation usually takes priority.
What do you think?
P.S. I agree that the procedure has been effectively streamlined.
Good spot Eric, that does indeed appear to contradict what Parnia has stated so emphatically before. I do wonder if there is a certain amount of playing to the audience with regard to this. We (people who believe that NDEs are most likely to be a real phenomenon) are not the audience, in this instance it is ethics committees, research proposal review boards etc, and if there is not an element of trying to establish if there are physical explanations for NDEs, which if understood might help improve outcomes for patients who have CAs, then they may struggle to get this study running in all but a few hospitals.
I am having second thoughts about the methodology having had a night to mull it over. I will come back to this in a post later in the month. It’s hard to see how they could do things much better than they have proposed, given financial and logictical constraints, however, I do see significant limitations with this method.
I think the O2 monitoring aspect is more of a double checking method should any more veridical recalls arise. I thought there was an established relationship between lack of bloodflow and oxygen supply, and that minimal oxygen perfusion would not allow the level of brain functionality necessary for cognition or memory storage. i.e. a heart stopped for say 2 minutes could not possibly be getting useful oxygen to the brain. I don’t know. As I say I think it’s a cover ‘all bases’ approach. Not so much looking for the possibility of present level of O2, but ruling it out.
You may be right, but they aren’t describing it in those terms in the study description:
I suspect there is an element of both. This lends scientific credibility for those who think it is all entirely physiological in that the study has as one of its aims the linking of blood flow to the brain to improved outcomes. On the other heand, we know from previous studies that people who experience NDEs usually have no blood flow to the brain, so if this is what is observed in this study then they will indeed be able to show that any “experience” was not the result of physiological processes…as you suggest. But that is not the way it is worded.
Yeah, you’re right. They are wording as such as exploring the oxygen possibilities. Fair enough, that in itself is quite interesting still as it could reshape understanding of brain function potential with minimal bloodflow. It is a possible explanation for audio recollection, but I like the way they are still using imagary in hope of a visual hit.
I hope they have success this time. Using the tablet also has the potential to limit the ability for “cheating”, which I will discuss in my forthcoming post. All in all, it game on though, and I have nothing but admiration for Dr. Parnia for persisting with this line of research.
Please could you clarify what you mean or are asking in your comments…not sure I quite understand. Thank you and look forward to hearing more from you!
Hello, can anyone post a link to the update webpage of the Aware team? Is saw a webpage, but they changed it and I can’t find the direct link.
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Done. It’s on a blog post. Apologies for my rubbish responding time. Not very good at wordpress!