Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: Qualitative study of parents' and health professionals' views and experiences

Jenny McLeish, Fiona Alderdice, Helen Robberts, Christina Cole, Jon Dorling, Chris Gale

Research output: Contribution to journalReview articlepeer-review

8 Citations (Scopus)

Abstract

Background More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form. Objective To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials. Methods A qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis. Setting Eleven neonatal units in England. Participants Eleven parents and ten health professionals with experience of simplified consent. Results Five themes emerged: â € opt-out consent operationalised as verbal opt-in consent', â € opt-out consent normalises participation while preserving parental choice', â € opt-out consent as an ongoing process of informed choice', â € consent without a consent form' and â € choosing to opt out of a comparative effectiveness trial', with two subthemes: â € wanting "normal care"' and â € a belief that feeding is better'. Conclusion Introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as â € opt-out' can help to normalise participation and emphasise that parents can withdraw consent.

Original languageEnglish
Pages (from-to)F244-F250
JournalArchives of Disease in Childhood: Fetal and Neonatal Edition
Volume106
Issue number3
DOIs
Publication statusPublished - May 1 2021

Bibliographical note

Funding Information:
Funding This study was funded by the UK Medical Research Council: MR/ N008405/1.

Funding Information:
Competing interests CG reports grants from Medical Research Council and

Funding Information:
the National Institute for Health Research during the conduct of the study; grants from National Institute for Health Research, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports grants and personal fees from Chiesi Pharmaceuticals outside of the submitted work; the grant is for a research study and the personal fee was to support attendance at an educational meeting. He was an unremunerated member of the Neonatal Data Analysis Unit Board, which oversees the National Neonatal Research Database. Patient consent for publication Not required.

Publisher Copyright:
© 2021 Author(s) (or their employer(s). Re-use permitted under CC BY. Published by BMJ.

ASJC Scopus Subject Areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynaecology

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

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McLeish, J., Alderdice, F., Robberts, H., Cole, C., Dorling, J., & Gale, C. (2021). Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: Qualitative study of parents' and health professionals' views and experiences. Archives of Disease in Childhood: Fetal and Neonatal Edition, 106(3), F244-F250. https://doi.org/10.1136/archdischild-2020-319545