Methods: The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges.
Results: Two key recruitment obstacles emerged: 1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and; 2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway, and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target.
Conclusions: Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a ‘head start’ in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in ‘real-time’ as recruitment proceeds.
- feasibility study
- randomised controlled trial
- surgical randomised controlled trial
- recruitment obstacles
- recruitment intervention
- informed consent