The promise and pitfalls of composite endpoints in sepsis and COVID-19 clinical trials |
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| Authors: | P M Brown Tormod Rogne Erik Solligård |
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| Institution: | 1. Gemini Center for Sepsis Research, Clinic of Anesthesia and Intensive Care, St. Olav's hospital, Trondheim University Hospital, Trondheim, Norway;2. 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 |
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| 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. |
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