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

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 Semi-structured 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 to 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 which 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 utilisedin PiC was appropriate. Future diagnostic studies involving additional invasive procedures oran opt-out only approach to consent would benefit from exploring parent and clinician viewson acceptability at the pre-trial stage.Trial registration number
ClinicalTrials.gov Identifier: NCT03378258