I’m starting this with intent to have a good scrap/thread about how to interpret the ANDROMEDA-SHOCK trial:
We’ve seen this basic problem before: most likely for budget/logistical reasons, the study size was capped at something that was only likely to reject the null if there is a very large effect (power calculation was based on capillary refill time [vs lactate] reducing mortality from 45% to 30%).
Actual results: 28-day mortality was lower with CRT (34%) than lactate (43%) but the final Cox model shows HR=0.76, 95% CI 0.55-1.02, p=0.06. As is customary, the conclusion was forced to state something like “no significant difference” about this trial or that use of CRT “did not reduce” mortality versus lactate.
I’ll need some clinical input from critical care folks, but it’s my understanding that capillary refill time is an easier thing to do than lactate, which is going to be germane in this discussion as well. If that is true, it’s arguable that even a conclusion of non-inferiority would support use of CRT rather than routine lactate measurement, but the trial was not designed as non-inferiority.
I have plenty more to say but that ought to be enough that we can open the floor for discussion.