• Arch. Dis. Child. · Oct 2019

    Observational Study

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

    • Thomas Waterfield, Mark D Lyttle, Michael Shields, Derek Fairley, Damian Roland, James McKenna, Kerry Woolfall, and Paediatric Emergency Research in the UK and Ireland (PERUKI).
    • Centre for Experimental Medicine, Wellcome Wolfson Institute of Experimental Medicine, Queen's University Belfast, Belfast, UK.
    • Arch. Dis. Child. 2019 Oct 1; 104 (10): 979-983.

    ObjectiveThe 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.DesignSemistructured qualitative interviews. Analysis was thematic and broadly interpretive, informed by the constant comparative approach.ParticipantsFifteen parents were interviewed 55 (median) days since their child's hospital attendance (range 13-95). Five clinicians involved in recruitment, and consent were interviewed.ResultsParents 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.ConclusionsThis 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 NumberNCT03378258.© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…