I suspected that you would have an opinion on the use of SOFA as a primary endpoint, Lawrence.
I fully admit that I am a bit perplexed by some of the objections I read about the use of an objective endpoint like all-cause mortality (linked in the PulmCrit post was another post stating the author’s opinion on why mortality is not a good endpoint: PulmCrit- Chasing mortality endpoints is a fool's errand). That particular PulmCrit post contains a lot of truth, but also some stuff that puzzles me a little bit as an objection to mortality as an endpoint. IMO, the best ‘objection’ to mortality as an endpoint is when mortality is a much rarer event or one that takes a relatively long time to occur, rendering the trial impractical unless they can enroll thousands of patients and follow them for 5 years. In the intensive care setting, neither of those is really true, I’m rather less convinced by “it’s hard to make difference in mortality” because, well, that seems kind of like the point. As a patient, I probably don’t care that much if my SOFA score improved, I care whether I walked out of the hospital alive.
In the post above, I also note above the vagaries of the NIH process, and it is possible that the trialists used this endpoint because they were told to use a “clinical endpoint” other than mortality, and this was most palatable to the field / study section.
It’s perfectly fair to point out the limitations of SOFA. Given that this is the trial data in front of us, I am (attempting) to start a discussion about the results that we do have in front of us, and what that means for now and for future trials. The mortality data are important, and they’re especially important in light of seeing people look at the “negative” primary endpoint (flawed though SOFA might be) given the bias that differential mortality would introduce to that endpoint.