The PREDIMED study's primary results still held after re-analysis despite randomization issues.

“to the best of my knowledge even when you take into account those changes or those inconsistencies or those methodologic I don't believe it changed the results or the outcome of predamond”

“it it turned out in the case of predomen the results still held um but it will always kind of be a cloud that hangs over it”

“they did a re-analysis that was published in 2018. I think it came from this this fellow named John Carlisle who had this way this this way of looking and I think this was that we have a we've got a email on this with David Allison it's a great statistician he talks about this in his article too um as well where he he looked at this but um this fellow named John Carlisle did this analysis where he looked at thousands of studies and he could flag the studies and see does this does this truly look like randomization based on some particular statistics and the predimate study was flagged looking like this doesn't look like proper randomization it might be something going on here”

“it turns out that um some of the villages or the the clinics I forget how many clinics in total there there were in the study but at 11 of the clinics they one of the uh investigators were randomizing the entire clinics um to one group and that this is what I think is really interesting about just looking at like if you really want to dig into a study sometimes you really have to get the story which is and and why you think it I think oftentimes you look at randomization oh that's really simple you just randomize people to different groups and you know blinded or unblinded it's very it's very hard to Blind uh the fact that you you see your you see your neighbor get a delivery every week of all of a jug of olive oil or a or a sack of uh mixed nuts which were the two Mediterranean groups and I think what happened was people started complaining in the in the in the Villages they're like what do I get and they're like you got your you got your low-fat diet pamphlet remember like we give it to you every year um so that happened in that study and that that's typically referred to as a so you can do that in a study and that's typically referred to as a as a cluster a cluster randomization where you might you might randomize one classroom to another classroom which might be convenient but it it requires different statistical methods”