Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Lykkebækvej 1, 4600, Køge, Denmark.
Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Intensive Care Med. 2023 Apr;49(4):411-420. doi: 10.1007/s00134-023-07024-9. Epub 2023 Mar 27.
The AID-ICU trial was a randomised, blinded, placebo-controlled trial investigating effects of haloperidol versus placebo in acutely admitted, adult patients admitted in intensive care unit (ICU) with delirium. This pre-planned Bayesian analysis facilitates probabilistic interpretation of the AID-ICU trial results.
We used adjusted Bayesian linear and logistic regression models with weakly informative priors to analyse all primary and secondary outcomes reported up to day 90, and with sensitivity analyses using other priors. The probabilities for any benefit/harm, clinically important benefit/harm, and no clinically important differences with haloperidol treatment according to pre-defined thresholds are presented for all outcomes.
The mean difference for days alive and out of hospital to day 90 (primary outcome) was 2.9 days (95% credible interval (CrI) - 1.1 to 6.9) with probabilities of 92% for any benefit and 82% for clinically important benefit. The risk difference for mortality was - 6.8 percentage points (95% CrI - 12.8 to - 0.8) with probabilities of 99% for any benefit and 94% for clinically important benefit. The adjusted risk difference for serious adverse reactions was 0.3 percentage points (95% CrI - 1.3 to 1.9) with 98% probability of no clinically important difference. Results were consistent across sensitivity analyses using different priors, with more than 83% probability of benefit and less than 17% probability of harm with haloperidol treatment.
We found high probabilities of benefits and low probabilities of harm with haloperidol treatment compared with placebo in acutely admitted, adult ICU patients with delirium for the primary and most secondary outcomes.
AID-ICU 试验是一项随机、双盲、安慰剂对照试验，旨在研究氟哌啶醇与安慰剂在因谵妄而急性入住重症监护病房（ICU）的成年患者中的作用。本预先计划的贝叶斯分析有助于对 AID-ICU 试验结果进行概率解释。
我们使用调整后的贝叶斯线性和逻辑回归模型，并使用弱信息先验进行分析，以分析报告的所有主要和次要结局，直至第 90 天，并使用其他先验进行敏感性分析。根据预先定义的阈值，针对所有结局，呈现氟哌啶醇治疗任何获益/危害、临床重要获益/危害以及无临床重要差异的概率。
存活天数和第 90 天（主要结局）的平均差异为 2.9 天（95%可信区间（CrI）-1.1 至 6.9），任何获益的概率为 92%，临床重要获益的概率为 82%。死亡率的风险差异为-6.8 个百分点（95% CrI-12.8 至-0.8），任何获益的概率为 99%，临床重要获益的概率为 94%。严重不良反应的调整风险差异为 0.3 个百分点（95% CrI-1.3 至 1.9），无临床重要差异的概率为 98%。使用不同先验进行敏感性分析的结果一致，氟哌啶醇治疗的获益概率超过 83%，危害概率低于 17%。
与安慰剂相比，我们发现氟哌啶醇治疗急性入住 ICU 的成年谵妄患者的主要和大多数次要结局具有较高的获益概率和较低的危害概率。
