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Published in: Critical Care 1/2020

Open Access 01-12-2020 | Editorial

A manifesto for the future of ICU trials

Authors: Ewan C. Goligher, Fernando Zampieri, Carolyn S. Calfee, Christopher W. Seymour

Published in: Critical Care | Issue 1/2020

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Excerpt

The intensive care unit (ICU) is both a challenging and opportune environment for the conduct of clinical trials. On the one hand, competing determinants of patient outcome (including multi-morbidity and pre-ICU illness trajectory) and the heterogeneity of critical illness syndromes attenuate the population-average treatment effect [1, 2]. On the other hand, the ICU is a controlled environment that facilitates monitoring of protocol adherence and outcome ascertainment. ICU trials may be improperly powered because of overly optimistic assumptions about the baseline event rate in the control group and about the predicted effect of treatment on that event rate [3, 4]. The treatment effect required to demonstrate statistically significant benefit often substantially exceeds what might be considered the minimum clinically relevant benefit, and consequently, trials sometimes are interpreted to show “no evidence of benefit” even when clinically relevant benefits are observed. …
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Metadata
Title
A manifesto for the future of ICU trials
Authors
Ewan C. Goligher
Fernando Zampieri
Carolyn S. Calfee
Christopher W. Seymour
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2020
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-020-03393-5

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