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Parents’ and clinicians’ views on conducting paediatric diagnostic test accuracy studies without prior informed consent: qualitative insight from the Petechiae in Children study (PiC)
  1. Thomas Waterfield1,
  2. Mark D Lyttle2,3,
  3. Michael Shields1,
  4. Derek Fairley4,
  5. Damian Roland5,
  6. James McKenna4,
  7. Kerry Woolfall6
  8. On behalf of Paediatric Emergency Research in the UK and Ireland (PERUKI)
  1. 1 Centre for Experimental Medicine, Wellcome Wolfson Institute of Experimental Medicine, Queen’s University Belfast, Belfast, UK
  2. 2 Emergency Department, Bristol Royal Hospital for Children, Bristol, UK
  3. 3 Faculty of Health and Applied Sciences, University of the West of England Bristol, Bristol, UK
  4. 4 Emergency Department, Royal Belfast Hospital for Sick Children, Belfast, UK
  5. 5 SAPPHIRE Group, University of Leicester, Leicester, UK
  6. 6 Institute of Population Health and Society, University of Liverpool, Liverpool, UK
  1. Correspondence to Dr Thomas Waterfield, Royal Belfast Hospital for Sick Children, Belfast BT12 6BE, UK; thomas.waterfield{at}googlemail.com

Abstract

Objective The Petechiae in Children (PiC) study assesses the utility of presenting features and rapid diagnostic tests in the diagnosis of serious bacterial infection in feverish children with non-blanching rashes. An embedded qualitative study explored parents’ and clinicians’ views on the acceptability of the PiC study, including the use of research without prior consent (RWPC) in studies of diagnostic test accuracy.

Design Semistructured qualitative interviews. Analysis was thematic and broadly interpretive, informed by the constant comparative approach.

Participants Fifteen parents were interviewed 55 (median) days since their child’s hospital attendance (range 13–95). Five clinicians involved in recruitment, and consent were interviewed.

Results Parents and clinicians supported RWPC for the PiC study and future emergency paediatric diagnostic test accuracy studies as long as there is no harm to the child and emergency care is not delayed. Parents and clinicians made recommendations around the timing and conduct of a consent discussion, which were in line with RWPC guidance. Parents enrolled in the PiC study preferred a design that included consent discussions with the research team over the alternative of ‘opt-out’ consent only.

Conclusions This embedded qualitative study demonstrates that RWPC is appropriate for use in paediatric emergency studies of diagnostic test accuracy and that the approach used in PiC was appropriate. Future diagnostic studies involving additional invasive procedures or an opt-out only approach to consent would benefit from exploring parent and clinician views on acceptability at the pretrial stage.

Trial registration number NCT03378258

  • qualitative research
  • general paediatrics
  • test accuracy
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Footnotes

  • Contributors All authors conceptualised and designed the study. TW and KW completed analysis and drafted the initial manuscript. All authors edited and approved the final manuscript as submitted. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

  • Funding This study was funded by the Public Health Agency of Northern Ireland (EAT/5313/16). The funder had no involvement in the design or conduct of the study.

  • Competing interests None declared.

  • Ethics approval The Northern Ireland Research Ethics Committee (REC) and the Belfast Trust IRB approved the PiC protocol, including the embedded qualitative research (REC Reference - 17/NI/0169)(IRB Reference 16201MS-SW).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

  • Collaborators On behalf of (PERUKI) Paediatric Emergency Research in the UK and Ireland.

  • Patient consent for publication Not required.

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