A Master Protocol Template for Pediatric ARDS Studies.

Autor:	Miller AG; Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina; and Respiratory Care Services, Duke University Medical Center, Durham, North Carolina. Andrew.g.miller@duke.edu., Curley MA; Department of Family and Community Health, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania., Destrampe C; International Children's Advisory Network., Flori H; Pediatric Critical Care Medicine, Pediatrics, University of Michigan School Medicine, Ann Arbor, Michigan., Khemani R; Clinical Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California., Ohmer A; International Children's Advisory Network., Thomas NJ; Penn State College of Medicine, Hershey, Pennsylvania; and Pediatric Acute Lung Injury and Sepsis Investigators Network., Yehya N; Division of Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania., Ward S; Department of Pediatrics, University of California, San Francisco, San Francisco, California., West L; International Children's Advisory Network., Zimmerman KO; Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina; and Duke Clinical Research Institute, Durham, North Carolina., Venkatachalam S; Duke Clinical Research Institute, Durham, North Carolina., Sutton S; Duke Clinical Research Institute, Durham, North Carolina., Hornik CP; Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina; and Duke Clinical Research Institute, Durham, North Carolina.
Jazyk:	angličtina
Zdroj:	Respiratory care [Respir Care] 2024 Sep 26; Vol. 69 (10), pp. 1284-1293. Date of Electronic Publication: 2024 Sep 26.
DOI:	10.4187/respcare.11839
Abstrakt:	Background: Pediatric ARDS is associated with significant morbidity and mortality. High-quality data from clinical trials in children are limited due to numerous barriers to their design and execution. Here we describe the collaborative development of a master protocol as a tool to address some of these barriers and support the conduct of pediatric ARDS studies. Methods: Using PubMed, we performed a literature search of randomized controlled trials (RCTs) in pediatric ARDS to characterize the current state and evaluate potential benefit of harmonized master protocols. We used a multi-stakeholder, collaborative, and team science-oriented process to develop a master protocol template with links to common data elements (CDEs) for pediatric ARDS trials. Results: We identified 11 RCTs that enrolled between 14-200 total subjects per trial. Interventions included mechanical ventilation, prone positioning, corticosteroids, and surfactant. Studies displayed significant heterogeneity in ARDS definition, design, inclusion and exclusion criteria, and reported outcomes. Mortality was reported in 91% of trials and ventilator-free days in 73%. The trial heterogeneity made pooled analysis unfeasible. These findings underscore the need for a method to facilitate combined analysis of future trials through standardization of trial elements. As a potential solution, we developed a master protocol, iteratively revised with input from a multidisciplinary panel of experts and organized into 3 categories: instructions and general information, templated language, and a series of text options of common pediatric ARDS trial scenarios. Finally, we linked master protocol sections to relevant CDEs previously defined for pediatric ARDS and captured in a series of electronic case report forms. Conclusions: The majority of pediatric ARDS trials identified were small and heterogeneous in study design and outcome reporting. Using a master protocol template for pediatric ARDS trials with CDEs would support combining and comparing pediatric ARDS trial findings and increase the knowledge base. Competing Interests: Mr Miller discloses a relationship with Fisher and Paykel, S2N Health, MedEx Research, and Aerogen. Mr Miller is a section editor for Respiratory Care. The remaining authors have disclosed no conflicts of interest. (Copyright © 2024 by Daedalus Enterprises.)
Databáze:	MEDLINE
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