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

P M Brown, Tormod Rogne, Erik Solligård

Journal: Pharmaceutical statistics 2021;20(2):413-417

PMID: 32893957

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.

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

DOI: 10.1002/pst.2070

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https://doi.org/10.1002/pst.2070

MeSH Terms: COVID-19, Endpoint Determination, Humans, Randomized Controlled Trials as Topic