Understanding recruitment to a randomised controlled trial (RCT) during liver transplantation: an observational mixed-methods Study Within A Trial (SWAT).

objectivesPerioperative 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.

designAn observational mixed-methods 'Study within a Trial', nested within a feasibility RCT.

settingThis 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.

participantsAdults who were eligible for liver transplantation and recruitment into the associated RCT were eligible for inclusion into the SWAT.

interventionsCompletion of an 18-question validated written questionnaire which explored motivation for accepting or declining participation in the RCT.

main outcome measuresThrough 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.

results84 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.

conclusionThis 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).