Ann: Positive Preliminary Results from SMARTCOUGH-C-2 Study, page-256

Dear Fellow Hot RAP Cobbers, 

Well Cobbers it seems likeit has turned out to be the first option – the half empty option. Well actually, I think theUS glass is only partially empty. Just not yet quite full up to the brim.  As I said previously, a little more fluidmight be necessary. 

It seems it was indeed thecomplexity of the test method that caused the delay. 

The inaccuracy of onesubjective clinician is bad enough to cope with, as the announcement makes onlyto clear, but when the test method follows up with a second subjectivedecision, itself based upon the level of accuracy of the first, we simplymultiply the level of inaccuracy. 

As I understand it, unlikethe Australian trial, using the WHO protocol the ultimate decision in the UStrial is made by a clinician, or to be more precise the majority view of a numberof clinicians, who have had no contact with the patient. Rather they arerelying upon a written report of some form from another clinician and wherethat clinician would not be indicating their diagnosis in that report – rather,simply “stating the facts” and allowing the panel to work it out. 

Whatever inaccuracies theremight be in any clinical diagnosis surely seeing the patient helps a bit withthe diagnosis. 

What would be of interest is to see how thedistanced/objective diagnosis compares with the subjective diagnosis of theperson who saw the patient and compare how accurately the RAP system compareswith that person on the spot’s diagnosis. That would also allow a directcomparison with the Australian results since both trials would then be on thesame basis. 

If you assume the US accuracy is in fact thesame as the Aus accuracy, and I have to say I certainly do, the differencebetween the two results is simply a measure of the level of inappropriatenessof the protocol. That is, what they have actually measured is the level ofinvalidity of the second layer of the WHO protocol for such a device/test –this being the difference in the two tests. 

Indeed what they might have measured is thelevel of literacy of the US medical profession in communicating the results inwriting or, probably more fairly at least, the extent to which the necessaryinformation required to make the decision can actually be communicated in sucha simple objective way. 

It seems that in trying to eliminate subjectivityyou might be able to become so objective that you become irrelevant. If this isthe protocol the FDA expects for such a device they might well look to therelevance of their choice. 

Well that’s my take on it Cobbers. Just a delaywhilst we wait for our friends in the land of the free and the brave to workout how to pour a good glass. In the mean time we know how to do that and we have lots of other fullglasses around here to keep us very busy for quite a while.

poorinvestor