Thanks for this. I agree that the scoring system is “non-traditional” and completely arbitrary. And to my knowledge it has not been used in any other study, so there’s minimal experience in correlating a 0.4 point difference to clinical relevance. That said, it seemed like a novel way to give different weights to the individual components of a composite endpoint, which is lacking in most studies. It’s a shame this model did not catch on, so we’re forever left with “improved composites driven by the softest endpoint” that we often see.
I’d also note that, while ACM was not an individual outcome, it was part of the composite primary outcome. So it actually gives me more confidence that the benefit seen was driven by the hardest endpoint (again in contradistinction to most studies where it’s the softest outcome that drives the boat).
Even today, the majority of studies are primarily of “middle aged white guys”. So to me it was welcome that there was a study addressing a specific (and different) cohort. And in the early aughts, imo the “self-identification” was less of an issue than our current woke identitarian era.
Thanks for this. I agree that the scoring system is “non-traditional” and completely arbitrary. And to my knowledge it has not been used in any other study, so there’s minimal experience in correlating a 0.4 point difference to clinical relevance. That said, it seemed like a novel way to give different weights to the individual components of a composite endpoint, which is lacking in most studies. It’s a shame this model did not catch on, so we’re forever left with “improved composites driven by the softest endpoint” that we often see.
I’d also note that, while ACM was not an individual outcome, it was part of the composite primary outcome. So it actually gives me more confidence that the benefit seen was driven by the hardest endpoint (again in contradistinction to most studies where it’s the softest outcome that drives the boat).
Even today, the majority of studies are primarily of “middle aged white guys”. So to me it was welcome that there was a study addressing a specific (and different) cohort. And in the early aughts, imo the “self-identification” was less of an issue than our current woke identitarian era.
Your points are well taken, Steve. We always appreciate your thoughtful insights and really enjoy reading your commentary on the reviews.