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

Summary 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‐fre...

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Veröffentlicht in:Pharmaceutical statistics : the journal of the pharmaceutical industry 2021-03, Vol.20 (2), p.413-417
Hauptverfasser: Brown, P. M., Rogne, Tormod, Solligård, Erik
Format: Artikel
Sprache:eng
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Zusammenfassung:Summary 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.
ISSN:1539-1604
1539-1612
DOI:10.1002/pst.2070