Understanding Pragmatic Trials in Clinical Research

In this World Shared Practice Forum podcast, Dr. Mark Peters discusses the Oxy-PICU trial, published in The Lancet in January 2024, which compared conservative to liberal oxygenation targets in critically ill children. The study highlighted the importance of pragmatic trial design and the need for larger trials to confirm these findings. LEARNING OBJECTIVES -Discuss the background driving the investigation of oxygenation in critically ill children -Summarize the study design of the Oxy-PICU Trial -Present the outcomes and challenges of the Oxy-PICU Trial -Identify the key characteristics of pragmatic trial design and the implication of pragmatic trial results AUTHORS Mark Peters, MBChB, MRCP, FFICM, FRCPCH, PhD Professor of Paediatric Intensive Care NIHR Senior Investigator UCL Great Ormond St Institute of Child Health Hon. Consultant Paediatric Intensivist Paediatric Intensive Care Unit and Children’s Acute Transport Service Great Ormond St Hospital Jeffrey Burns, MD, MPH Emeritus Chief Division of Critical Care Medicine Department of Anesthesiology, Critical Care and Pain Medicine Boston Children's Hospital Professor of Anesthesia Harvard Medical School DATE Initial publication date: November 26, 2024. ARTICLES REFERENCED AND ADDITIONAL RESOURCES Peters MJ, Gould DW, Ray S, et al. Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open, parallel-group, randomised clinical trial [published correction appears in Lancet. 2024 Jan 27;403(10424):354. doi: 10.1016/S0140-6736(24)00100-4]. Lancet. 2024;403(10424):355-364. https://pubmed.ncbi.nlm.nih.gov/38048787/ Fan E, Del Sorbo L, Goligher EC, et al. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome [published correction appears in Am J Respir Crit Care Med. 2017 Jun 1;195(11):1540. doi: 10.1164/rccm.19511erratum]. Am J Respir Crit Care Med. 2017;195(9):1253-1263. https://pubmed.ncbi.nlm.nih.gov/28459336/ Peters MJ, Ramnarayan P. Randomized Trials to Reduce Clinical Uncertainty: Gold Standard or Fool's Gold? Pediatr Crit Care Med. 2024;25(8):775-777. https://pubmed.ncbi.nlm.nih.gov/39101806/ Darnell R, Brown A, Laing E, et al. Protocol for a Randomized Controlled Trial to Evaluate a Permissive Blood Pressure Target Versus Usual Care in Critically Ill Children with Hypotension (PRESSURE). Pediatr Crit Care Med. 2024;25(7):629-637. https://pubmed.ncbi.nlm.nih.gov/38629915/ Taccone FS, Rynkowski Bittencourt C, Møller K, et al. Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial. JAMA.Published online October 09, 2024. https://pubmed.ncbi.nlm.nih.gov/39382241/ Jones GAL, Eaton S, Orford M, et al. Randomization to a Liberal Versus Conservative Oxygenation Target: Redox Responses in Critically Ill Children. Pediatr Crit Care Med. 2023;24(3):e137-e146. https://pubmed.ncbi.nlm.nih.gov/36728001/ UK-ROX: https://www.icnarc.org/research-studies/uk-rox/ MegaROX: https://www.anzics.org/current-active-endorsed-research/mega-rox/ ICU-ROX: https://www.thebottomline.org.uk/summaries/icm/icu-rox/ TRANSCRIPT https://cdn.bfldr.com/D6LGWP8S/as/rq7kgwqkh4hk4nk67584pfj/202411_-_WSP_-_Less_is_more_Oxygenation_Targets_in_Critically_Ill_Children_-_Transcript?position=2 CITATION Peters MJ, Burns JP. Less is More: Oxygenation Targets in Critically Ill Children. 11/2024. OPENPediatrics. https://soundcloud.com/openpediatrics/less-is-more-oxygenation-targets-in-critically-ill-children-by-m-peters-openpediatrics.