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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)

Waterfield, Thomas; Lyttle, Mark D.; Shields, Michael; Fairley, Derek; Roland, Damian; McKenna, James; Woolfall, Kerry

Parents' and clinicians' views on conducting paediatric diagnostic test accuracy studies without prior informed consent: Qualitative insight from the Petechiae in Children study (PiC) Thumbnail


Authors

Thomas Waterfield

Michael Shields

Derek Fairley

Damian Roland

James McKenna

Kerry Woolfall



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.

Citation

Waterfield, T., Lyttle, M. D., Shields, M., Fairley, D., Roland, D., McKenna, J., & Woolfall, K. (2019). Parents' and clinicians' views on conducting paediatric diagnostic test accuracy studies without prior informed consent: Qualitative insight from the Petechiae in Children study (PiC). Archives of Disease in Childhood, 104(10), 979-983. https://doi.org/10.1136/archdischild-2019-317117

Journal Article Type Article
Acceptance Date Apr 25, 2019
Online Publication Date Jun 7, 2019
Publication Date Sep 20, 2019
Deposit Date Jul 15, 2020
Publicly Available Date Mar 28, 2024
Journal Archives of Disease in Childhood
Print ISSN 0003-9888
Electronic ISSN 1468-2044
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 104
Issue 10
Pages 979-983
DOI https://doi.org/10.1136/archdischild-2019-317117
Keywords Pediatrics, Perinatology, and Child Health
Public URL https://uwe-repository.worktribe.com/output/6137434

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