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

P M Brown; Tormod Rogne; Erik Solligård

doi:10.1002/pst.2070

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.

Authors

P M Brown^{1

2}, Tormod Rogne^{1

3}, Erik Solligård^{1

3}

Affiliations

¹ Gemini Center for Sepsis Research, Clinic of Anesthesia and Intensive Care, St. Olav's hospital, Trondheim University Hospital, Trondheim, Norway.
² Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
³ Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.

PMID: 32893957
DOI: 10.1002/pst.2070

Abstract

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*