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Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the

Elizabeth Deja1, Mark J Peters2,3, Imran Khan4

  • 1Public Health, Policy and Systems, University of Liverpool, Liverpool, UK e.deja@liverpool.ac.uk.

BMJ Open
|March 11, 2021
PubMed

Insights

Parents and staff found the FEVER trial investigating fever thresholds in critically ill children acceptable. Pre-trial feedback and pilot experiences improved trial acceptability, though some pain concerns remained.

Area of Science:

  • Pediatric critical care research
  • Clinical trial methodology
  • Fever management in children

Background:

  • Fever is common in critically ill children, necessitating effective management.
  • Investigating optimal temperature thresholds for antipyretic intervention is crucial.
  • The FEVER trial aimed to address these critical care questions.

Purpose of the Study:

  • To assess parent and staff views on the acceptability of the FEVER trial.
  • To explore perceptions of a randomized controlled trial on temperature thresholds for fever treatment.
  • To identify factors influencing trial acceptability in pediatric intensive care units.

Main Methods:

  • Mixed-methods study conducted in English pediatric intensive care units.
  • Data collected via focus groups and interviews with staff and parents at three time points (pre-pilot, during, post-pilot).
  • Utilized Sekhon et al.'s theoretical framework of acceptability for analysis.

Main Results:

  • Initial support for the trial existed, with some concerns regarding temperature thresholds and pain management.
  • Pre-trial findings led to protocol changes and improved training, enhancing acceptability.
  • Parents and staff ultimately found the trial acceptable, with residual concerns about pain during ventilation weaning.

Conclusions:

  • Pre-trial feedback and pilot experiences significantly influenced trial acceptability.
  • Insights gained can inform future trial feasibility and protocol development.
  • An adapted theoretical framework of acceptability is proposed for future studies.
Abstract

Keywords:
medical education & trainingpaediatric intensive & critical carepaediatricspain managementqualitative research

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