An investigation of practice and practitioner factors that influence the recruitment of patients to primary care based randomised controlled trials: case study of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study

Background: Patient recruitment to trials is problematic; many fail to achieve targets, leaving them underpowered and unable to address their hypothesis. Few solutions have been identified in existing literature. This thesis aimed to: identify factors associated with recruitment; and understand clinicians’ experiences of recruiting patients to a primary care based randomised controlled trial (RCT). This was explored using The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) trial as a case study. Methods: Mixed methods were used: a systematic review to identify factors influencing recruitment to primary care based RCTs; quantitative analysis of BAFTA data to identify factors associated with recruitment; and qualitative interviews with General Practitioners involved with BAFTA, to understand their experience of participation. Results: Existing literature demonstrated that influences on recruitment include: study workload; study question; concerns about patients. Recommendations to address these issues are not based on strong empirical evidence. BAFTA identified factors associated with patient recruitment (practice size; GP age; recruitment year); and patterns over time. Interviews identified differences in attitude between high and low recruiters, including risk perception and motivation. Conclusions: This thesis demonstrates how practitioners can influence patient recruitment. Revised recruitment methods need testing in prospective trials