Does the treatment effect on Delta SOFA reliably reflect between-group mortality differences in intensive care RCTs?
Delta SOFA is a more reliable surrogate endpoint for mortality than Fixed-day SOFA in intensive care RCTs.
BACKGROUND: The sequential organ failure assessment score (SOFA) is increasingly used as an endpoint in intensive care randomized controlled trials (RCTs). Although serially measured SOFA is independently associated with mortality in observational cohorts, the association between treatment effects on SOFA vs. effects on mortality has not yet been quantified in RCTs. The aim of this study was to quantify the relationship between SOFA and mortality in RCTs and to identify which SOFA derivative best reflects between-group mortality differences. METHODS: ). RESULTS: ). CONCLUSIONS: Treatment effects on Delta SOFA appear to be reliably and consistently associated with mortality in RCTs. Fixed-day SOFA was the most frequently reported outcome among the reviewed RCTs, but was not significantly associated with mortality. Based on this study, we recommend using Delta SOFA rather than Fixed-day SOFA as an endpoint in future RCTs.
Grooth et al. (Mon,) studied this question.