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

Abstract

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

Validating clinical practice guidelines for the management of children with non-blanching rashes in the UK (PiC): a prospective, multicentre cohort study

“…Due to the potentially life-threatening nature of invasive MD, research without prior consent (RWPC) was utlilised, and is described in full in the published study protocol (14,16,17).…”

Applying clinical decision aids for the assessment and management of febrile infants presenting to emergency care in the UK and Ireland: Febrile Infant Diagnostic Assessment and Outcome (FIDO) Study protocol

“…For this study, we will use research without prior consent (RWPC) methodology 17 18. This approach has been shown to be effective and acceptable to both parents and clinicians for diagnostic studies based on prior works such as the Petechiae in Children Study 19 20. RWPC has also been used in the EcLiPSE trial undertaken by PERUKI 21.…”

Insisting on prospective consent in paediatric critical care research may be throwing the baby out with the bathwater

“…The literature describes parental support for the concept of deferred consent in paediatric emergency and/or critical care research, depending on the nature of the trial 8,9,11,14,19 . One study surveyed the level of support for deferred consent and found 91% of parents were satisfied with the consent process 20 .…”