The promise and pitfalls of composite endpoints in sepsis and COVID-19 clinical trials

Pharm Stat. 2021 Mar;20(2):413-417. doi: 10.1002/pst.2070. Epub 2020 Sep 7.


Composite endpoints reveal the tendency for statistical convention to arise locally within subfields. Composites are familiar in cardiovascular trials, yet almost unknown in sepsis. However, the VITAMINS trial in patients with septic shock adopted a composite of mortality and vasopressor-free days, and an ordinal scale describing patient status rapidly became standard in COVID studies. Aware that recent use could incite interest in such endpoints, we are motivated to flag their potential value and pitfalls for sepsis research and COVID studies.

Publication types

  • Review

MeSH terms

  • COVID-19 / epidemiology*
  • COVID-19 / therapy
  • Endpoint Determination / methods
  • Endpoint Determination / statistics & numerical data*
  • Humans
  • Randomized Controlled Trials as Topic / methods
  • Randomized Controlled Trials as Topic / statistics & numerical data*