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Discrepancies in Control Group Mortality Rates Within Studies Assessing Topical Antibiotic Strategies to Prevent Ventilator-Associated Pneumonia: An Umbrella Review.

ABSTRACT: Objectives:To test the postulate that concurrent control patients within ICUs studying topical oropharyngeal antibiotics to prevent ventilator-associated pneumonia and mortality would experience spillover effects from the intervention. Data Sources:Studies cited in 15 systematic reviews of various topical antibiotic and other infection prevention interventions among ICU patients. Study Selection:Studies of topical antibiotics, stratified into concurrent control versus nonconcurrent control designs. Studies of nondecontamination-based infection prevention interventions provide additional points of reference. Studies with no infection prevention intervention provide the mortality benchmark. Data from additional studies and data reported as intention to treat were used within sensitivity tests. Data Extraction:Mortality incidence proportion data, mortality census, study characteristics, group mean age, ICU type, and study publication year. Data Synthesis:Two-hundred six studies were included. The summary effect sizes for ventilator-associated pneumonia and mortality prevention derived in the 15 systematic reviews were replicated. The mean ICU mortality incidence for concurrent control groups of topical antibiotic studies (28.5%; 95% CI, 25.0-32.3; n = 41) is higher versus the benchmark (23.7%; 19.2-28.5%; n = 34), versus nonconcurrent control groups (23.5%; 19.3-28.3; n = 14), and versus intervention groups (24.4%; 22.1-26.9; n = 62) of topical antibiotic studies. In meta-regression models adjusted for group-level characteristics such as group mean age and publication year, concurrent control group membership within a topical antibiotic study remains associated with higher mortality (p = 0.027), whereas other group memberships, including membership within an antiseptic study, are each neutral (p = not significant). Conclusions:Within topical antibiotic studies, the concurrent control group mortality incidence proportions are inexplicably high, whereas the intervention group mortality proportions are paradoxically similar to a literature-derived benchmark. The unexplained ventilator-associated pneumonia and mortality excess in the concurrent control groups implicates spillover effects within studies of topical antibiotics. The apparent ventilator-associated pneumonia and mortality prevention effects require cautious interpretation.

SUBMITTER: Hurley JC

PROVIDER: S-EPMC7063908 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Discrepancies in Control Group Mortality Rates Within Studies Assessing Topical Antibiotic Strategies to Prevent Ventilator-Associated Pneumonia: An Umbrella Review.

Hurley James C JC

Critical care explorations 20200129 1

<h4>Objectives</h4>To test the postulate that concurrent control patients within ICUs studying topical oropharyngeal antibiotics to prevent ventilator-associated pneumonia and mortality would experience spillover effects from the intervention.<h4>Data sources</h4>Studies cited in 15 systematic reviews of various topical antibiotic and other infection prevention interventions among ICU patients.<h4>Study selection</h4>Studies of topical antibiotics, stratified into concurrent control versus nonco ...[more]

PMID: 32166296

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Project description:Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns.We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial.This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP.A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n?=?77), and the remainder occurred out of hospital (n?=?25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices.A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).

Project description:IntroductionVentilator-associated pneumonias (VAPs) are a complication of mechanical ventilation in the intensive care unit (ICU) that increase length of stay, morbidity, and mortality. While identifying and treating infections early is paramount to improving patient outcomes, more and more data demonstrate limited courses of antibiotics improve outcomes. Prolonged (10-14 day) courses of antibiotics have remained the standard of care for pneumonia due to gram-negative bacilli (GNR). We aimed to review our GNR VAPs to assess risk factors for recurrent GNR infections.MethodsWe reviewed trauma patients who developed VAP from 02/2019 through 05/2022. Demographics, injury characteristics, and outcomes were reviewed with a focus on pneumonia details including the cultured pathogen(s), antibiotic(s) used, treatment duration, and presence of recurrent infections. We then compared single episode VAPs to multiple episode VAPs among patients infected by GNRs.ResultsEleven of the fifty trauma patients admitted to the ICU suffered a VAP caused by a GNR. Of these eleven patients, six experienced a recurrent infection, four of which were caused by Pseudomonas aeruginosa and two of which were caused by Enterobacter aerogenes. Among the patients who received ten days of antibiotic treatment, half suffered a recurrence. Although, there was no difference in the microbiology or antibiotic duration between the recurrences and single episodes.ConclusionDespite prolonged use of antibiotics, we found that the risk of recurrent or persistent infections was high among patients with VAP due to GNB. Further study is needed to determine optimal treatment to minimize the risk of these recurrences.Key messageVentilator-associated pneumonia due to gram-negative bacilli is a rare but high morbidity complication in intensive care units. Despite prolonged duration of therapy, these infections still appear to account for many recurrent infections and further study into optimal therapy is warranted.

Dataset Information

Discrepancies in Control Group Mortality Rates Within Studies Assessing Topical Antibiotic Strategies to Prevent Ventilator-Associated Pneumonia: An Umbrella Review.

Publications

Discrepancies in Control Group Mortality Rates Within Studies Assessing Topical Antibiotic Strategies to Prevent Ventilator-Associated Pneumonia: An Umbrella Review.

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