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事后分析结果表明,结局排序和抗生素风险调整后的可接受性(DOOR/RADAR)支持 ICU 获得性肺炎抗生素起始策略的均衡性。

Desirability of Outcome Ranking and Response Adjusted for Antibiotic Risk (DOOR/RADAR) Post Hoc Analysis Supports Equipoise for Antibiotic Initiation Strategies in Intensive Care Unit-Acquired Pneumonia.

机构信息

Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas, USA.

Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, Kansas, USA.

出版信息

Surg Infect (Larchmt). 2024 Apr;25(3):221-224. doi: 10.1089/sur.2023.367. Epub 2024 Mar 7.

DOI:10.1089/sur.2023.367
PMID:38466941
Abstract

Pneumonia is the most common intensive care unit (ICU)-acquired infection and source of potential sepsis in ICU populations but can be difficult to diagnose in real-time. Despite limited data, rapid initiation of antibiotic agents is endorsed by society guidelines. We hypothesized that a post hoc analysis of a recent randomized pilot study would show no difference between two antibiotic initiation strategies. The recent Trial of Antibiotic Restraint in Presumed Pneumonia (TARPP) was a pragmatic cluster-randomized pilot of antibiotic initiation strategies for patients with suspected ICU-acquired pneumonia. Participating ICUs were cluster-randomized to either an immediate initiation protocol or a specimen-initiated protocol where a gram stain was required for initiation of antibiotics. Patients in the study were divided into one of seven mutually exclusive outcome rankings (desirability of outcome ranking; DOOR): (1) Survival, No Pneumonia, No adverse events; (2) Survival, Pneumonia, No adverse events; (3) Survival, No Pneumonia, ventilator-free-alive days ≤14; (4) Survival, Pneumonia, ventilator-free-alive days ≤14; (5) Survival, No Pneumonia, Subsequent episode of suspected pneumonia; (6) Survival, Pneumonia, Subsequent episode of suspected pneumonia; and (7) Death. These rankings were further refined using the duration of antibiotics prescribed for pneumonia (response adjusted for antibiotic risk; RADAR). There were 186 patients enrolled in the study. After applying the DOOR analysis, a randomly selected patient was equally likely to have a better outcome in specimen-initiated arm as in the immediate initiation arm (DOOR probability: 50.8%; 95% confidence interval [CI], 42.7%-58.9%). Outcome probabilities were similar after applying the RADAR analysis (52.5%; 95% CI, 44.2%-60.6%; p = 0.31). We found that patients for whom antibiotic agents were withheld until there was objective evidence (specimen-initiated group) had similar outcome rankings to patients for whom antibiotic agents were started immediately. This supports the findings of the TARPP pilot trial and provides further evidence for equipoise between these two treatment strategies.

摘要

肺炎是重症监护病房(ICU)最常见的获得性感染,也是 ICU 人群中潜在脓毒症的来源,但在实时诊断中可能很困难。尽管数据有限,但社会指南仍支持快速启动抗生素治疗。我们假设对最近一项随机试点研究的事后分析将显示两种抗生素启动策略之间没有差异。最近的抗生素抑制治疗疑似肺炎试验(TARPP)是一项针对疑似 ICU 获得性肺炎患者的抗生素启动策略的实用集群随机试点研究。参与的 ICU 被集群随机分配到立即启动方案或标本启动方案,其中需要革兰氏染色才能启动抗生素治疗。研究中的患者被分为七个相互排斥的结果排名之一(结果排名的可取性;DOOR):(1)存活,无肺炎,无不良事件;(2)存活,肺炎,无不良事件;(3)存活,无肺炎,无呼吸机存活天数≤14;(4)存活,肺炎,无呼吸机存活天数≤14;(5)存活,无肺炎,随后出现疑似肺炎;(6)存活,肺炎,随后出现疑似肺炎;和(7)死亡。这些排名进一步通过为肺炎开的抗生素持续时间进行细化(调整抗生素风险后的反应;RADAR)。该研究共纳入 186 例患者。在应用 DOOR 分析后,随机选择的患者在标本启动组和立即启动组的结果排名同样有可能更好(DOOR 概率:50.8%;95%置信区间[CI],42.7%-58.9%)。应用 RADAR 分析后,结果概率相似(52.5%;95% CI,44.2%-60.6%;p=0.31)。我们发现,直到有客观证据(标本启动组)才停用抗生素的患者与立即开始使用抗生素的患者的结果排名相似。这支持了 TARPP 试点试验的结果,并为这两种治疗策略之间的均衡提供了进一步证据。

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