Recruitment to surgical randomised controlled trials (RCTs) can be challenging. The Sunflower Study is a large scale multi-centre RCT that seeks to establish the clinical and cost effectiveness of pre-operative imaging versus expectant management in patients with symptomatic gallstones undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones. Trials such as Sunflower, with a large recruitment target rely on teamworking. Recruitment can be optimised by embedding a Quintet Recruitment Intervention (QRI). Additionally, engaging surgical trainees can contribute to successful recruitment, and the NIHR Associate Principal Investigator (API) scheme provides a framework to acknowledge their contributions.
This was a mixed-methods study, that formed a component part of an embedded QRI for the Sunflower RCT. The aim of this study was to understand factors that supported and hindered participation of surgical trainees in a large scale RCT and their participation in the API scheme. It comprised semi-structured telephone interviews with consultant surgeons and surgical trainees involved in screening and recruitment of patients, and descriptive analysis of screening and recruitment data. Interviews were analysed thematically to explore the perspectives of - and roles undertaken by – surgical trainees.
Interviews were undertaken with 34 clinicians (17 consultant surgeons, 17 surgical trainees) from 22 UK hospital trusts. Surgical trainees contributed to patient screening, approaches and randomisation, with a major contribution to the randomisation of patients from acute admissions. They were often encouraged to participate in the study by their centre principal investigator, and career development was a typical motivating factor for their participation in the study. The study was registered with the API scheme, and a majority of the trainees interviewed (n=14) were participating in the scheme.
Surgical trainees can contribute substantial activity to a large-scale multi-centre RCT. Benefits of trainee engagement were identified for trainees themselves, for local sites and for the study as a whole. The API scheme provided a formal framework to acknowledge engagement. Ensuring that training and support for trainees is provided by the trial team is key to optimise success for all stakeholders
The study is also supported by the Royal College of Surgeons Surgical Trials Centre in Bristol. NB and JB are supported by the NIHR Bristol and Weston Biomedical Research Centre. JB is an NIHR senior investigator. The study sponsor is Leeds Teaching Hospitals NHS Trust (Research Governance Manager Anne Gowing, anne. gowing@ nhs. net), and the study is managed by the Bristol Trials Centre, Clinical Trials and Evaluation Unit. This study was designed and is being delivered in collaboration with the Bristol Trials Centre, Clinical Trials and Evaluation Unit, a UK Clinical Research Collaboration registered clinical trials unit, which is in receipt of NIHR clinical trials unit support funding. The research team acknowledges the support of the NIHR Clinical Research Network. The Sunflower Study is overseen by an independent SSC and DMSC. The study has been designed with input from public and patient groups. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care
© 2021, The Author(s).
- Centre for Surgical Research
- The Sunflower Study
- QuinteT Recruitment Intervention (QRI)
- QUALITATIVE RESEARCH
- Trainee doctors
- Optimising RCT recruitment
- Associate PI scheme