Agents intervening against delirium in the intensive care unit trial — Protocol for a secondary Bayesian analysis

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Background: Delirium is highly prevalent in the intensive care unit (ICU) and is associated with high morbidity and mortality. The antipsychotic haloperidol is the most frequently used agent to treat delirium although this is not supported by solid evidence. The agents intervening against delirium in the intensive care unit (AID-ICU) trial investigates the effects of haloperidol versus placebo for the treatment of delirium in adult ICU patients. Methods: This protocol describes the secondary, pre-planned Bayesian analyses of the primary and secondary outcomes up to day 90 of the AID-ICU trial. We will use Bayesian linear regression models for all count outcomes and Bayesian logistic regression models for all dichotomous outcomes. We will adjust for stratification variables (site and delirium subtype) and use weakly informative priors supplemented with sensitivity analyses using sceptical priors. We will present results as absolute differences (mean differences and risk differences) and relative differences (ratios of means and relative risks). Posteriors will be summarised using median values as point estimates and percentile-based 95% credibility intervals. Probabilities of any benefit/harm, clinically important benefit/harm and clinically unimportant differences will be presented for all outcomes. Discussion: The results of this secondary, pre-planned Bayesian analysis will complement the primary frequentist analysis of the AID-ICU trial and facilitate a nuanced and probabilistic interpretation of the trial results.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
Vol/bind66
Udgave nummer7
Sider (fra-til)898-903
ISSN0001-5172
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
This trial was funded by the Innovation Fund Denmark (4108‐00011B), the Regional Medicines Fund (R124‐2651), the Zealand Region Research Fund and Intensive care Symposium Hindsgavl and Foghts Foundation. The authors would like to thank patients and their relatives, all research staff, clinical staff and investigators at the participating sites, all regulatory authorities and all founding sources involved in the AID‐ICU trial. The Department of Intensive Care at Rigshospitalet has received funding for other projects from The Novo Nordisk Foundation, Pfizer, Fresenius Kabi and Sygeforsikringen “danmark”, and conducts contract research for AM‐Pharma. The Department of Anaesthesiology, Zealand University Hospital has received funding for other projects from The Novo Nordisk Foundation and Sygeforsikringen “danmark” and conducts contract research for AM‐Pharma.

Publisher Copyright:
© 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

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