Articles: critical-care-methods.
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Pediatr Crit Care Me · Dec 2022
Multicenter Study Pragmatic Clinical TrialThe United Kingdom Paediatric Critical Care Society Study Group: The 20-Year Journey Toward Pragmatic, Randomized Clinical Trials.
Over the past two decades, pediatric intensive care research networks have been formed across North America, Europe, Asia, and Australia/New Zealand. The U. K. ⋯ Facilitators of successful research have included the presence of a national registry to facilitate efficient data collection; close partnerships with established Clinical Trials Units to bring together clinicians, methodologists, statisticians, and trial managers; greater involvement of transport teams to recruit patients early in trials of time-sensitive interventions; and the funded infrastructure of clinical research staff within the National Health Service to integrate research within the clinical service. The informal nature of PCCS-SG has encouraged buy-in from clinicians. Greater international collaboration and development of embedded trial platforms to speed up the generation and dissemination of trial findings are two key future strategic goals for the PCCS-SG research network.
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Acta Anaesthesiol Scand · Nov 2022
Causal inference for planning randomised critical care trials: Protocol for a scoping review.
Randomised clinical trials in critical care are prone to inconclusiveness owing, in part, to undue optimism about effect sizes and suboptimal accounting for heterogeneous treatment effects. Planned predictive enrichment based on secondary critical care data (often very rich with respect to both data types and temporal granularity) and causal inference methods may help overcome these challenges, but no overview exists about their use to this end. ⋯ The outlined scoping review aims to assess the use of causal inference methods and secondary data for planned predictive enrichment in randomised critical care trials. This will help guide methodological improvements to increase the utility, and facilitate the use, of causal inference estimates when planning such trials in the future.
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Mortality historically has been the primary outcome of choice for acute and critical care clinical trials. However, undue reliance on mortality can limit the scope of trials that can be performed. Large sample sizes are usually needed for trials powered for a mortality outcome, and focusing solely on mortality fails to recognize the importance that reducing morbidity can have on patients' lives. ⋯ Power to detect differences in OFDs typically is greater than that for other clinical trial outcomes, such as mortality and ventilator-free days. OFDs is the primary outcome for the Fourth Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) Host Tissue platform, which evaluates novel therapies targeting the host response to COVID-19 among adults hospitalized with COVID-19 and new hypoxemia. This article outlines the rationale for use of OFDs as an outcome for clinical trials, proposes a standardized method for defining and analyzing OFDs, and provides a framework for sample size calculations using the OFD outcome.
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The American Journal of Critical Care's Junior Peer Reviewer program aims to mentor novice reviewers in the peer review process. To grow their critical appraisal skills, the participants take part in discussion sessions in which they review articles published in other journals. Here we summarize the articles reviewed during the second year of the program, which again focused on the care of critically ill patients with COVID-19. ⋯ Current methodology in crisis standards of care may result in inequity and further research is needed. The use of extracorporeal carbon dioxide removal to facilitate super low tidal volume ventilation does not improve 90-day mortality outcomes. Continued research to better understand the natural history of COVID-19 and interventions useful for improving outcomes is imperative.
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Nosocomial pneumonia, including hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), are the most common nosocomial infections occurring in critically ill patients requiring intensive care. However, challenges exist in making a timely and accurate diagnosis of HAP and VAP. Under diagnosis of HAP and VAP can result in greater mortality risk, especially if accompanied by delays in the administration of appropriate antimicrobial treatment. ⋯ Optimal diagnosis and management of HAP and VAP require a systematic approach that combines clinical and radiographic assessments along with proper microbiologic techniques. The use of more invasive sampling methods (bronchoalveolar lavage and protected specimen brush) may enhance specimen collection resulting in more specific diagnoses to limit unnecessary antibiotic exposure. Molecular techniques, currently in use and investigational technique, may improve the diagnosis of HAP and VAP by allowing more rapid identification of offending pathogens, if present, thus increasing both appropriate antibiotic treatment and avoiding unnecessary drug exposure.