{
  "abstract": "Background In neonatal trials, verbal opt-out consent has been used to reduce burden on families and make recruitment more efficient and representative. It involves information provision through posters and leaflets before randomisation, and parents can verbally ‘opt out’ of their baby being randomised to the trial. There is limited understanding of how opt-out consent is operationalised in a multicentre neonatal trial, and its acceptability to staff and parents.Objective To explore views and experiences of verbal opt-out consent in neoGASTRIC, a neonatal randomised trial comparing routine and no routine measurements of gastric contents in preterm babies.Methods A mixed methods (questionnaires, interviews and focus groups) process evaluation within a trial.Setting Four UK neonatal units.Participants 253 participants: 167 staff (149 questionnaires; 18 across two focus groups), 86 parents (85 questionnaires; 15 interviews; 14 took part in both).Results Parents and staff supported opt-out consent in neoGASTRIC as interventions were viewed as low risk and non-invasive. Parents appreciated an appropriately timed research conversation; only 21% noticed study information banners/posters. Operationalisation of opt-out consent varied in terms of when information was provided and randomisation timing. Women approached during labour or within hours of birth reported feeling overwhelmed and lacking capacity to consider research. Some staff operationalised a modified opt-in approach.Conclusions An appropriately timed verbal opt-out approach to consent was seen acceptable as proportionate in the neonatal context in a low-risk trial comparing different accepted clinical, non-pharmaceutical, practices. Findings informed neoGASTRIC and will guide approaches to consent in this setting.",
  "authors": [
    {
      "affiliations": [
        "Public Health, Policy and Systems, University of Liverpool, Liverpool, UK"
      ],
      "name": "Tracy Mitchell"
    },
    {
      "affiliations": [
        "Chelsea and Westminster Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Izabela Andrzejewska"
    },
    {
      "affiliations": [
        "School of Public Health and Centre for Paediatrics and Child Health, Imperial College London, London, UK"
      ],
      "name": "Cheryl Battersby"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Christina Cole"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Zoe Daskalopoulou"
    },
    {
      "affiliations": [
        "Department of Neonatal Medicine, University Hospital Southampton NHS Foundation Trust, Southampton, UK"
      ],
      "name": "Jon Dorling"
    },
    {
      "affiliations": [
        "Academic Neonatal Medicine, Imperial College London, London, UK"
      ],
      "name": "Chris Gale"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Michaela Graham"
    },
    {
      "affiliations": [
        "Leicester Royal Infirmary, University Hospitals of Leicester, Leicester, UK"
      ],
      "name": "Marie Hubbard"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Pollyanna Hardy"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Madeleine Hurd"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Andrew Robert King"
    },
    {
      "affiliations": [
        "Department of Obstetrics, Gynaecology and Newborn Health, The University of Melbourne, Melbourne, Victoria, Australia",
        "The Royal Women’s Hospital, Melbourne, Victoria, Australia"
      ],
      "name": "Brett James Manley"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "David Murray"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Elizabeth Nuthall"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Heather O’Connor"
    },
    {
      "affiliations": [
        "School of Medicine, University of Nottingham, Derby, UK",
        "Neonatal Unit, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK"
      ],
      "name": "Shalini Ojha"
    },
    {
      "affiliations": [
        "Department of Paediatrics, Monash University Faculty of Medicine, Nursing and Health Sciences, Clayton, Victoria, Australia",
        "Monash Newborn, Monash Children’s Hospital, Clayton, Victoria, Australia"
      ],
      "name": "Calum T Roberts"
    },
    {
      "affiliations": [
        "Monash Newborn, Monash Health, Clayton, Victoria, Australia",
        "Nursing and Midwifery, La Trobe University, Bundoora, Victoria, Australia"
      ],
      "name": "Amy Rodriquez"
    },
    {
      "affiliations": [
        "Faculty of Health and Life Sciences, The University of Bristol, Bristol, UK"
      ],
      "name": "Charles Christoph Roehr"
    },
    {
      "affiliations": [
        "National Perinatal Epidemiology Unit, Nuffield Department of Population Health, Oxford, UK"
      ],
      "name": "Kayleigh Stanbury"
    },
    {
      "affiliations": [
        "Faculty of Health, Social Care & Medicine, Edge Hill University, Ormskirk, UK",
        "Alder Hey Children’s NHS Trust, Liverpool, UK"
      ],
      "name": "Lyvonne Tume"
    },
    {
      "affiliations": [
        "Patient and Public Involvement Partner, Support for the Sick Newborn and Their Parents (SSNAP), Oxford, UK"
      ],
      "name": "Lauren Young"
    },
    {
      "affiliations": [
        "Public Health, Policy and Systems, University of Liverpool, Liverpool, UK"
      ],
      "name": "Kerry Woolfall"
    }
  ],
  "title": "Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a trial",
  "uid": "c23d6d33-7d6c-5d67-b684-909dd7c4a09b"
}