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The promise and pitfalls of composite endpoints in sepsis and COVID ‐19 clinical trials
Author(s) -
Brown P. M.,
Rogne Tormod,
Solligård Erik
Publication year - 2020
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.2070
Subject(s) - sepsis , covid-19 , clinical trial , septic shock , medicine , intensive care medicine , shock (circulatory) , clinical endpoint , convention , virology , outbreak , disease , social science , sociology , infectious disease (medical specialty)
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.