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Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials
  1. Louise Roper1,
  2. Mark D Lyttle2,3,
  3. Carrol Gamble4,
  4. Amy Humphreys4,
  5. Shrouk Messahel5,
  6. Elizabeth D Lee5,
  7. Joanne Noblet5,
  8. Helen Hickey4,
  9. Naomi Rainford4,
  10. Anand Iyer6,
  11. Richard Appleton6,
  12. Kerry Woolfall1
  1. 1 Institute of Population Health, University of Liverpool, Liverpool, UK
  2. 2 Emergency Department, Bristol Royal Children's Hospital, Bristol, UK
  3. 3 Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK
  4. 4 Clinical Trials Research Centre (CTRC), University of Liverpool, Liverpool, UK
  5. 5 Emergency Department, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK
  6. 6 Department of Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, Merseyside, UK
  1. Correspondence to Dr Kerry Woolfall, University of Liverpool, Liverpool L69 3BX, UK; k.woolfall{at}liverpool.ac.uk

Abstract

Background Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the ‘Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children’ (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC.

Methods Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner–parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe et al (2016) model for recruitment to trials.

Results We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC.

Conclusion This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.

  • paediatric emergency med
  • qualitative research
  • research, clinical
  • research, methods
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Footnotes

  • Handling editor Edward Carlton

  • Twitter @mdlyttle, @kerry_woolfall

  • Contributors KW conceived and led the consent study. KW and LR developed study materials and topic guide. LR conducted the interviews. LR and KW analysed the data. LR wrote the initial manuscript draft, which was reviewed and developed by KW and MDL. All authors reviewed and approved the final manuscript. KW took responsibility for the paper as a whole.

  • Funding National Institute for Health Research Health Technology Assessment programme (project grant 12/127/134). All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The researchers are independent from the funders. The funders had no role in role in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Ethics approval The Consent study was approved as part of the EcLiPSE trial by National Research Ethics Service Committee North West- Liverpool Central (15/NW/0090).

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

  • Data availability statement No data are available. Consent was not sought for open access to data.