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Review
. 2021 Mar;20(2):413-417.
doi: 10.1002/pst.2070. Epub 2020 Sep 7.

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

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Review

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

P M Brown et al. Pharm Stat. 2021 Mar.

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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References

REFERENCES

    1. WHO R&D blueprint novel coronavirus (COVID-19) therapeutic trial synopsis. World Health Organization 2020 Web site. https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Trea... Published February 18, 2020. Accessed August 11, 2020.
    1. Matsouaka RA, Singhal AB, Betensky RA. Optimal weighted Wilcoxon-Mann-Whitney Test for prioritized outcomes. New Frontiers of Biostatistics and Bioinformatics. Switzerland: Springer; 2018:3-40.
    1. Mebazaa A, Laterre PF, Russell JA, et al. Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure. J Intensive Care. 2016;4:24-24.
    1. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999;18:1341-1354.
    1. Fujii T, Luethi N, Young PJ, et al. Effect of vitamin C, hydrocortisone, and thiamine vs hydrocortisone alone on time alive and free of vasopressor support among patients with septic shock: the VITAMINS randomized clinical trial. JAMA. 2020;323(5):423-431.

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