The United Kingdom Paediatric Critical Care Society Study Group: The 20-Year Journey Toward Pragmatic, Randomized Clinical Trials.
Journal
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
ISSN: 1529-7535
Titre abrégé: Pediatr Crit Care Med
Pays: United States
ID NLM: 100954653
Informations de publication
Date de publication:
01 12 2022
01 12 2022
Historique:
pubmed:
8
11
2022
medline:
6
12
2022
entrez:
7
11
2022
Statut:
ppublish
Résumé
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. Paediatric Critical Care Society Study Group (PCCS-SG) has over a 20-year tradition of fostering collaborative research, leading to the design and successful conduct of randomized clinical trials (RCTs). To date, the PCCS-SG network has delivered 13 different multicenter RCTs, covering a spectrum of study designs, methodologies, and scale. Lessons from the early years have led PCCS-SG to now focus on the entire process needed for developing an RCT, starting from robust preparatory steps such as surveys, data analysis, and feasibility work through to a definitive RCT. Pilot RCTs have been an important part of this process as well. 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.
Identifiants
pubmed: 36343185
doi: 10.1097/PCC.0000000000003099
pii: 00130478-202212000-00014
doi:
Types de publication
Pragmatic Clinical Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1067-1075Informations de copyright
Copyright © 2022 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.
Déclaration de conflit d'intérêts
Dr. Peters’ institution received funding from the National Institute of Health Research Health Technology Assessment grants; he received support for article research from the U.K. National Institute of Health and Social Care Research. Dr. Ramnarayan received funding from Sanofi. Dr. Tasker received funding from Society of Critical Care Medicine as the Editor-in-Chief of Pediatric Critical Care Medicine and from Oxford University Press, Up-to-Date, and Walters Kluwer. Dr. Scholefield is supported on a National Institute of Health and Social Care Research Clinician Scientist Fellowship. Dr. Tume has disclosed that he does not have any potential conflicts of interest.
Références
Macrae D, Grieve R, Allen E, et al.: A randomized trial of hyperglycemic control in pediatric intensive care. N Engl J Med 2014; 370:107–118
Wolf A, McKay A, Spowart C, et al.: Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: The SLEEPS (safety profile, efficacy and equivalence in pediatric intensive care sedation) study. Health Technol Assess 2014; 18:1–212
Gilbert RE, Mok Q, Dwan K, et al.: Impregnated central venous catheters for prevention of bloodstream infection in children (the CATCH trial): A randomised controlled trial. Lancet 2016; 387:1732–1742
Peters MJ, Agbeko R, Davis P, et al.: Randomized study of early continuous positive airways pressure in acute respiratory failure in children with impaired immunity (SCARF) ISRCTN82853500. Pediatr Crit Care Med 2018; 19:939–948
Inwald D, Canter RR, Woolfall K, et al.: Restricted fluid bolus volume in early septic shock: results of the Fluids in Shock pilot trial. Arch Dis Child 2019; 104:426–431
Peters MJ, Woolfall K, Khan I, et al.: Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: A multicentre randomized clinical pilot trial. Crit Care 2019; 23:69
Tume LN, Woolfall K, Arch B, et al.: Routine gastric residual volume measurement to guide enteral feeding in mechanically ventilated infants and children: The GASTRIC feasibility study. Health Technol Assess 2020; 24:1–120
Blackwood B, Tume LN, Morris KP, et al.: Effect of a sedation and ventilator liberation protocol vs usual care on duration of invasive mechanical ventilation in pediatric intensive care units: A randomized clinical trial. JAMA 2021; 326:401–410
Ramnarayan P, Richards-Belle A, Drikite L, et al.: Effect of high-flow nasal cannula therapy vs continuous positive airway pressure following extubation on liberation from respiratory support in acutely ill children admitted to pediatric critical care units: A randomized clinical trial. JAMA 2022; 327:1555–1565
Ramnarayan P, Richards-Belle A, Drikite L, et al.: Effect of high-flow nasal cannula therapy vs continuous positive airway pressure therapy on liberation from respiratory support in acutely ill children admitted to pediatric critical care units: A randomized clinical trial. JAMA 2022; 328:162–172
Brown A, Ferrando P, Popa M, et al.: Use of selective gut decontamination in critically ill children: Protocol for the paediatric intensive care and infection control (PICnIC) study. BMJ Open 2022; 12:e061838
Chang I, Thomas K, O’Neill Gutierrez L, et al.: Protocol for a randomized multiple center trial of conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): Oxygen in paediatric intensive care. Pediatr Crit Care Med 2022; 23:736–744
Peters MJ, Jones GAL, Wiley D, et al.: Conservative versus liberal oxygenation targets in critically ill children: The randomised multiple-centre pilot Oxy-PICU trial. Intensive Care Med 2018; 44:1240–1248
Ramnarayan P, Lister P, Dominguez T, et al.: FIRST-line support for assistance in breathing in children (FIRST-ABC): A multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care. Crit Care 2018; 22:144
Parslow RC, Morris KP, Tasker RC, et al.: Epidemiology of traumatic brain injury in children receiving intensive care in the UK. Arch Dis Child 2005; 90:1182–1187
Forsyth RJ, Parslow RC, Tasker RC, et al.: Prediction of raised intracranial pressure complicating severe traumatic brain injury in children: Implications for trial design. Pediatr Crit Care Med 2008; 9:8–14
Bell MJ, Rosario BL, Kochanek PM, et al.: Comparative effectiveness of diversion of cerebrospinal fluid for children with severe traumatic brain injury. JAMA Netw Open 2022; 5:e2220969
Macrae D, Pappachan J, Grieve R, et al.: Control of hyperglycaemia in paediatric intensive care (CHiP): Study protocol. BMC Pediatr 2010; 10:5
Morris JV, Kapetanstrataki M, Parslow RC, et al.: Patterns of use of heated humidified high-flow nasal cannula therapy in PICUs in the United Kingdom and Republic of Ireland. Pediatr Crit Care Med 2019; 20:223–232
Maslove DM, Tang B, Shankar-Hari M, et al.: Redefining critical illness. Nat Med 2022; 28:1141–1148
Lacroix J, Hebert PC, Hutchison JS, et al.: Transfusion strategies for patients in pediatric intensive care units. N Engl J Med 2007; 356:1609–1619
Fivez T, Kerklaan D, Mesotten D, et al.: Early versus late parenteral nutrition in critically ill children. N Engl J Med 2016; 374:1111–1122
Woolfall K, O’Hara C, Deja E, et al.: Parents’ prioritised outcomes for trials investigating treatments for paediatric severe infection: A qualitative synthesis. Arch Dis Child 2019; 104:1077–1082
Tume LN, Menzies JC, Ray S, et al.: Research priorities for UK pediatric critical care in 2019: Healthcare professionals’ and parents’ perspectives. Pediatr Crit Care Med 2021; 22:e294–e301
Snowdon C, Brocklehurst P, Tasker R, et al.: Death, bereavement and randomised controlled trials (BRACELET): A methodological study of policy and practice in neonatal and paediatric intensive care trials. Health Technol Assess 2014; 18:1–410
Woolfall K and the CONNECT Advisory Group: Research Without Prior Consent (Deferred Consent) in Trials Investigating the Emergency Treatment of Critically Ill Children: CONNECT Guidance Version 2. 2015. Available at: https://www.researchgate.net/publication/281279500_Research_without_prior_consent_deferred_consent_in_trials_investigating_the_emergency_treatment_of_critically_ill_children_CONNECT_Guidance_Version_2?channel=doi&linkId=55dedc5208ae79830bb596af&showFulltext=true . Accessed July 28, 2022
Paediatric Intensive Care Audit Network: Annual Report 2021. 2022. University of Leeds and Leicester. Available at: https://www.picanet.org.uk/wp-content/uploads/sites/25/2022/04/PICANet-2021-Annual-Report_v1.1-22Apr2022.pdf . Accessed October 1, 2022
Paediatric Early Rehabilitation and Mobilisation During InTensive Care Feasibility Study: The PERMIT study. Available at: https://www.birmingham.ac.uk/research/inflammationageing/research/permit-study.aspx . Accessed July 28, 2022
Angus DC, Berry S, Lewis RL, et al.: The REMAP-CAP (randomized embedded multifactorial adaptive platform for community acquired pneumonia) study. Rationale and design. Ann Am Thorac Soc 2020; 17:879–891
Kamata K, Jindai K, Ichihara N, et al.: Why participation in an international clinical trial platform matters during a pandemic? Launching REMAP-CAP in Japan. J Intensive Care 2021; 9:34