Spillover effects on mortality within randomized concurrent controlled trials of antimicrobial based infection prevention interventions among the mechanically ventilated patient population. A reappraisal of Cochrane review data.

IF 3.9 3区医学 Q1 INFECTIOUS DISEASES

Journal of Hospital Infection Pub Date : 2025-06-06 DOI:10.1016/j.jhin.2025.05.021

James C Hurley

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引用次数: 0

Abstract

Background: The ventilator associated pneumonia (VAP) and mortality prevention effects of topical chlorhexidine and topical antibiotic prophylaxis (TAP) have been widely studied in randomized concurrent controlled trials (RCCT's) among ICU patients receiving mechanical ventilation (MV). Do these interventions have spillover (population) effects on VAP and mortality incidences among these RCCT's additional to any direct (individual level) effects?

Methods: The per-protocol (PP) and intention-to-treat (ITT) VAP and mortality data within five recent Cochrane reviews of antimicrobial based VAP prevention interventions were reconciled. VAP and mortality prevention effect size (ES) risk ratio estimates were derived using random effects for RCCT's with control group VAP incidences above versus below the upper limit of the widely accepted VAP incidence range.

Results: The mortality prevention ES for RCCT's with control group VAP incidence >40% versus ≤40% was (Risk ratio & 95% confidence interval, 0.85; 0.76 - 0.96; n = 24) versus (1.0; 95% CI 0.91 - 1.1; n = 29), respectively. The corresponding summary control group mortality incidences were 29% (95% CI 24-35) versus 25% (95% CI 20-30), respectively, whereas the corresponding intervention group mortality incidences were 24% (95% CI 20-29) versus 23% (95% CI 19-28). Paradoxically, there was more dispersion amongst the control group mortality and VAP incidences than amongst the intervention group incidences.

Conclusions: The findings here implicate spillover increasing VAP and mortality incidences and dispersion within control groups of topical antimicrobial intervention RCCT's. Hence, any inference of prevention is spurious. Moreover, these topical antimicrobial interventions increase mortality and are unsafe for ICU populations.

查看原文本刊更多论文

机械通气患者群体中基于抗菌药物的感染预防干预的随机并发对照试验对死亡率的溢出效应。Cochrane综述资料的重新评价。

背景：在接受机械通气（MV）的ICU患者中，随机并行对照试验（RCCT’s）广泛研究了局部氯己定和局部抗生素预防（TAP）对呼吸机相关性肺炎（VAP）和死亡率的预防作用。除了直接（个体水平）的影响外，这些干预措施是否对这些RCCT中的VAP和死亡率发生率有溢出（群体）影响？方法：在最近的五篇Cochrane综述中，对基于抗菌药物的VAP预防干预措施的每方案（PP）和意向治疗（ITT） VAP和死亡率数据进行了协调。VAP和死亡预防效应大小（ES）风险比估计是使用随机效应得出的RCCT，对照组VAP发病率高于或低于广泛接受的VAP发病率范围的上限。结果：对照组VAP发生率≤40%与对照组VAP发生率≤40%的RCCT患者的死亡率预防ES为(风险比和95%置信区间，0.85；0.76 - 0.96；N = 24) vs (1.0；95% ci 0.91 - 1.1；N = 29)。相应的总对照组死亡率分别为29% （95% CI 24-35）和25% (95% CI 20-30)，而相应的干预组死亡率分别为24% （95% CI 20-29）和23% （95% CI 19-28）。矛盾的是，对照组的死亡率和VAP发病率比干预组的发病率更分散。结论：本研究结果提示外溢性增加了局部抗菌干预RCCT对照组的VAP和死亡率发生率和分散性。因此，任何关于预防的推论都是虚假的。此外，这些局部抗菌干预措施会增加死亡率，并且对ICU人群不安全。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Hospital Infection 医学-传染病学

CiteScore

12.70

自引率

5.80%

发文量

271

审稿时长

19 days

期刊介绍： The Journal of Hospital Infection is the editorially independent scientific publication of the Healthcare Infection Society. The aim of the Journal is to publish high quality research and information relating to infection prevention and control that is relevant to an international audience. The Journal welcomes submissions that relate to all aspects of infection prevention and control in healthcare settings. This includes submissions that: provide new insight into the epidemiology, surveillance, or prevention and control of healthcare-associated infections and antimicrobial resistance in healthcare settings; provide new insight into cleaning, disinfection and decontamination; provide new insight into the design of healthcare premises; describe novel aspects of outbreaks of infection; throw light on techniques for effective antimicrobial stewardship; describe novel techniques (laboratory-based or point of care) for the detection of infection or antimicrobial resistance in the healthcare setting, particularly if these can be used to facilitate infection prevention and control; improve understanding of the motivations of safe healthcare behaviour, or describe techniques for achieving behavioural and cultural change; improve understanding of the use of IT systems in infection surveillance and prevention and control.