降低不朽时间偏倚的影响会影响苏沃雷生预防危重症患者谵妄的分析：一项回顾性队列研究。

Reducing the effect of immortal time bias affects the analysis of prevention of delirium by suvorexant in critically ill patients: A retrospective cohort study.

机构信息

Department Anesthesiology and Critical Care Medicine, Saitama Medical Center, Jichi Medical University, Omiya, Saitama, Japan.

Data Science Center, Jichi Medical University, Shimotsuke, Tochigi, Japan.

出版信息

PLoS One. 2022 Dec 1;17(12):e0277916. doi: 10.1371/journal.pone.0277916. eCollection 2022.

DOI:10.1371/journal.pone.0277916

PMID:36454811

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9714704/

Abstract

BACKGROUND

Studies assessing the effect of suvorexant on delirium prevention included patients treated before development of delirium, which can introduce immortal time bias. The objective of the present study was to evaluate the effect of suvorexant on delirium, comparing patients treated before the onset of delirium with patients treated within 72h of admission using the same dataset.

METHODS

Data from adult patients admitted to the ICU from August 2018 to July 2021 were retrospectively analyzed. In "any time before" analysis, the incidence of delirium was compared for patients who received suvorexant at any time during their ICU stay (suvorexant) (unless delirium developed before treatment) with patients who either did not receive suvorexant or received suvorexant after development of delirium (control). This design was used in previously published studies. In "within 72h" analysis, the incidence of delirium was compared for patients who received suvorexant within 72 hours of admission (suvorexant) and patients who did not receive suvorexant or received it more than 72 hours after admission (control). Patients who developed delirium during the initial 72 hours were excluded from "within 72h" analysis (N = 799).

RESULTS

"Within 72h" analysis included 1,255 patients, and "any time before" analysis included 2,054 patients (of 6599 admissions). The unadjusted hazard ratio of "any time before" analysis was 0.16 and the 95% confidence interval was 0.13-0.21 (p<0.01). The adjusted hazard ratio was 0.21, and the 95% confidence interval was 0.16-0.27 (p<0.01). "Within 72h" analysis had an unadjusted hazard ratio of 0.54 and the 95% confidence interval was 0.36-0.82 (p<0.01). However, this association lost statistical significance after adjustment for potential confounders (adjusted hazard ratio 1.02, 95% confidence interval 0.65-1.59, p = 0.93).

CONCLUSION

Reducing the effect of immortal time bias led to a significantly reduced effect of suvorexant for the prevention of delirium.

摘要

背景

评估苏沃雷生预防谵妄效果的研究纳入了在谵妄发生前接受治疗的患者，这可能引入了无事件时间偏倚。本研究的目的是使用相同的数据集，比较在谵妄发生前和入院后 72 小时内接受苏沃雷生治疗的患者，评估苏沃雷生对谵妄的影响。

方法

回顾性分析 2018 年 8 月至 2021 年 7 月期间入住 ICU 的成年患者的数据。在“任何时间前”分析中，比较 ICU 期间任何时间接受苏沃雷生治疗的患者（苏沃雷生）（除非在治疗前发生谵妄）与未接受苏沃雷生治疗或在发生谵妄后接受苏沃雷生治疗的患者（对照组）的谵妄发生率。此前的研究中使用了这种设计。在“72 小时内”分析中，比较入院后 72 小时内接受苏沃雷生治疗的患者（苏沃雷生）与未接受苏沃雷生治疗或入院后超过 72 小时接受苏沃雷生治疗的患者（对照组）的谵妄发生率。在“72 小时内”分析中排除了在最初 72 小时内发生谵妄的患者（N=799）。

结果

“72 小时内”分析纳入 1255 例患者，“任何时间前”分析纳入 2054 例患者（6599 例入院患者）。“任何时间前”分析的未调整风险比为 0.16，95%置信区间为 0.13-0.21（p<0.01）。调整后的风险比为 0.21，95%置信区间为 0.16-0.27（p<0.01）。“72 小时内”分析的未调整风险比为 0.54，95%置信区间为 0.36-0.82（p<0.01）。然而，在调整潜在混杂因素后，这种关联失去了统计学意义（调整后的风险比为 1.02，95%置信区间为 0.65-1.59，p=0.93）。