{
  "abstract": "Objectives Perioperative randomised controlled trials (RCTs) in liver transplantation are relatively infrequent. RCTs performed in this complex patient population need to be robustly conducted to maximise patient benefit and graft utility given the scarcity of donor organs. Recruitment challenges can compromise RCTs and studies in this population face unique challenges due to recipient illness severity, their comorbidities, demographics and the geographical constraints of specialist transplant centres. Emergency presentation and after-hours admission may further limit patients’ capacity or readiness to consider trial participation. This Study Within a Trial (SWAT) specifically explored motivators and barriers to recruitment in patients awaiting liver transplantation.Design An observational mixed-methods ‘Study within a Trial’, nested within a feasibility RCT.Setting This study was dual centred at two Tertiary National Health Service Hospitals; The Royal Free Hospital, a liver transplant centre in North London and University Hospital Birmingham, a liver transplant centre in Birmingham.Participants Adults who were eligible for liver transplantation and recruitment into the associated RCT were eligible for inclusion into the SWAT.Interventions Completion of an 18-question validated written questionnaire which explored motivation for accepting or declining participation in the RCT.Main outcome measures Through completion of the questionnaire, participants shared their perspectives on the RCT and their rationale for consenting or declining participation. Responses were analysed, providing feedback to the Trial Management Group (TMG) to refine recruitment strategies for future trials. An additional component, comprising interviews and audio recordings of recruitment consultations, was planned if the RCT recruitment rates fell below prespecified thresholds or concerns were raised by the RCT TMG, neither of which occurred.Results 84 completed questionnaires were received. Motivators included patients believing that the trial will benefit others, interest in helping with research, perception that benefits outweigh risks and belief that it offered the best treatment. Barriers included concerns about randomisation, feeling overburdened and a perception of lack of support from family or friends.Conclusion This is the first study exploring recruitment to a perioperative RCT involving patients undergoing liver transplantation. Key motivators were altruism and perceived safety, while barriers included concerns about randomisation and lack of family support. Future focus during recruitment should be on neutral patient-centred consultations, adequate information sharing, fostering of patient trust, improved explanation of randomisation and engagement of the patient’s support network.Trial registration number NCT04941911 (Health Research Authority) and SWAT 152 (the Study With A Trial Database).",
  "authors": [
    {
      "affiliations": [
        "North Central and East London Rotation, NHS Health Education England London School of Anaesthesia, London, England, UK"
      ],
      "name": "Katherine Elizabeth Sarah Coppack"
    },
    {
      "affiliations": [
        "North West London Rotation, NHS Health Education England London School of Anaesthesia, London, UK",
        "Anaesthesia, Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK"
      ],
      "name": "Ilya Kantsedikas"
    },
    {
      "affiliations": [
        "Department of Anaesthesia, Royal Free London NHS Foundation Trust, London, UK"
      ],
      "name": "Edgar Brodkin"
    },
    {
      "affiliations": [
        "Department of Anaesthesia, Royal Free London NHS Foundation Trust, London, UK"
      ],
      "name": "Ee Neng Loh"
    },
    {
      "affiliations": [
        "Department of Statistical Science and Joint Research Support Office, University College London, London, UK"
      ],
      "name": "Gareth Ambler"
    },
    {
      "affiliations": [
        "Centre for Perioperative Medicine, Division of Surgery and Targeted Intervention, University College London, London, UK",
        "Health Services Research Centre, Royal College of Anaesthetists, London, UK"
      ],
      "name": "Suneetha Ramani Moonesinghe"
    },
    {
      "affiliations": [
        "Department of Anaesthesia, Royal Free London NHS Foundation Trust, London, UK",
        "Faculty of Health, University of Plymouth, Plymouth, UK",
        "Department of Anaesthesia, University Hospitals Plymouth NHS Trust, Plymouth, UK"
      ],
      "name": "Jeremy Fabes"
    },
    {
      "affiliations": [
        "Department of Anaesthesia, Royal Free London NHS Foundation Trust, London, UK"
      ],
      "name": "Vivienne Hannon"
    },
    {
      "affiliations": [
        "Division of Surgical Biotechnology, University College London, London, England, UK",
        "Intensive Care and Anaesthesia, Royal Free Hospital, London, England, UK",
        "Health Technology Research Centre in Sustainable Innovation, Royal Devon University Healthcare NHS Foundation Trust, Exeter, England, UK"
      ],
      "name": "Michael Spiro"
    },
    {
      "affiliations": [
        "Centre for Perioperative Medicine, Division of Surgery and Targeted Intervention, University College London, London, UK"
      ],
      "name": "Duncan Wagstaff"
    }
  ],
  "title": "Understanding recruitment to a randomised controlled trial (RCT) during liver transplantation: an observational mixed-methods Study Within A Trial (SWAT)",
  "uid": "a53a69fa-3451-59c5-a15c-358267b61152"
}