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Understanding recruitment to a randomised controlled trial (RCT) during liver transplantation: an observational
Katherine Elizabeth Sarah Coppack1, Ilya Kantsedikas2,3, Edgar Brodkin4
1North Central and East London Rotation, NHS Health Education England London School of Anaesthesia, London, England, UK katherine.coppack@nhs.net.
BMJ Open
|January 7, 2026
Summary
Patients awaiting liver transplantation are motivated by altruism and perceived safety for clinical trial participation. Barriers include concerns about randomisation and lack of family support, highlighting the need for improved communication and trust.
Area of Science:
- Transplantation Research
- Clinical Trial Recruitment
- Surgical Oncology
Background:
- Perioperative randomized controlled trials (RCTs) in liver transplantation are infrequent and face unique recruitment challenges.
- Patient illness severity, comorbidities, demographics, and geographical constraints of transplant centers impact trial participation.
- Emergency presentations and after-hours admissions further complicate patient readiness for trial enrollment.
Purpose of the Study:
- To explore patient motivators and barriers to recruitment in perioperative randomized controlled trials (RCTs) for liver transplantation.
- To gather insights into patient perspectives on trial participation to refine recruitment strategies.
- To enhance the understanding of factors influencing enrollment in complex surgical trials.
Main Methods:
- An observational mixed-methods 'Study within a Trial' (SWAT) nested within a feasibility RCT.
- Dual-center study conducted at two tertiary National Health Service Hospitals.
- Adults eligible for liver transplantation completed an 18-question validated questionnaire on trial participation motivations.
Main Results:
- 84 completed questionnaires identified key motivators for trial participation.
- Motivators included belief in benefiting others, interest in research, perceived benefit outweighing risks, and belief in optimal treatment.
- Barriers included concerns about randomisation, feeling overburdened, and perceived lack of family/friend support.
Conclusions:
- This is the first study to investigate recruitment motivators and barriers for perioperative RCTs in liver transplant patients.
- Altruism and perceived safety are primary motivators; concerns about randomisation and family support are significant barriers.
- Future recruitment strategies should focus on neutral, patient-centered consultations, clear information, trust-building, and engaging support networks.
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