Article Text

Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents’ and health professionals’ views and experiences
  1. Jenny McLeish1,
  2. Fiona Alderdice1,
  3. Helen Robberts2,
  4. Christina Cole1,
  5. Jon Dorling3,
  6. Chris Gale4
  7. Members of the WHEAT trial development group
    1. 1 Nuffield Department of Population Health, National Perinatal Epidemiology Unit, Oxford, Oxfordshire, UK
    2. 2 Bliss, Maya House, London, UK
    3. 3 Division of Neonatal–Perinatal Medicine, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
    4. 4 Academic Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK
    1. Correspondence to Dr Chris Gale, Academic Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London SW10 9NH, UK; christopher.gale{at}imperial.ac.uk

    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: ‘opt-out consent operationalised as verbal opt-in consent’, ‘opt-out consent normalises participation while preserving parental choice’, ‘opt-out consent as an ongoing process of informed choice’, ‘consent without a consent form’ and ‘choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘wanting “normal care”’ and ‘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 ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent.

    • ethics
    • neonatology
    • qualitative research

    Data availability statement

    Data are available upon reasonable request. Following the consent process, the individual qualitative interview transcripts will not be made publicly available.

    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Data availability statement

    Data are available upon reasonable request. Following the consent process, the individual qualitative interview transcripts will not be made publicly available.

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    Footnotes

    • Twitter @DrCGale

    • Collaborators Members of the WHEAT trial development group: MJ (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), AF (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), RH (Parent of preterm twins, c/o Bliss – The National Charity for the Newborn, Chapter House, 18-20 Crucifix Lane, London, SE1 3JW), CC (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), DJ (Division of Neonatal-Perinatal Medicine, Faculty of Medicine, Dalhousie University, IWK Health Centre, 5850/5890 University Avenue, Halifax, Nova Scotia, B3K 6R8, Canada), GC (Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital campus, London, SW10 9NH), CL (Bliss – The National Charity for the Newborn, Maya House, 134-138 Borough High Street, London, SE1 1LB), Jawad S (Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital campus, London, SW10 9NH), Bowler U (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), Forster A, King A (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), Linsell L (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), Turner M (Women’s and Children’s Health, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3BX), Stanbury K (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford), van Staa T (Centre for Health Informatics, Division of Informatics, Imaging and Data Science, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom), Modi N, Juszczak E (National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford).

    • Contributors Authorship is on behalf of the WHEAT trial development group. The research question for this study was conceived by CG and developed by CG, HR, LC, CC, NM, UB, AF, AK, LL, KS, TvS, JD and ED. The study takes place within the WHEAT pilot trial, which was developed by CG, HR, LC, NM, UB, AF, AK, LL, MT, KS, TvS, JD and ED. JMcL undertook the data collection and JMcL and FA took part in data analysis. JMcL drafted the manuscript with input from CG and FA. All authors were involved in interpretation, review and revision of the draft manuscript and approval of the final version.

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

    • Competing interests CG reports grants from Medical Research Council and 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.

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

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