Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Køge, Denmark.
Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Acta Anaesthesiol Scand. 2022 Aug;66(7):898-903. doi: 10.1111/aas.14091. Epub 2022 May 31.
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.
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.
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.
谵妄在重症监护病房（ICU）中非常普遍，与高发病率和死亡率相关。抗精神病药氟哌啶醇是最常被用于治疗谵妄的药物，尽管这并没有确凿的证据支持。干预 ICU 中谵妄的药物（AID-ICU）试验研究了氟哌啶醇与安慰剂治疗成人 ICU 患者谵妄的效果。
本方案描述了 AID-ICU 试验的主要和次要结局的次要、预先计划的贝叶斯分析，直至第 90 天。我们将对所有计数结果使用贝叶斯线性回归模型，对所有二项结果使用贝叶斯逻辑回归模型。我们将调整分层变量（地点和谵妄亚型），并使用敏感分析使用怀疑先验补充弱信息先验。我们将以绝对差异（平均差异和风险差异）和相对差异（均值比和相对风险）呈现结果。后验将使用中位数作为点估计，并使用基于百分位的 95%可信度区间进行总结。将为所有结局呈现任何获益/危害、临床重要获益/危害和临床不重要差异的概率。
本二次、预先计划的贝叶斯分析的结果将补充 AID-ICU 试验的主要频率分析，并促进对试验结果进行细致和概率解释。
