Successful recruitment to trials: a phased approach to opening gates and building bridges

Background: The pragmatic randomised controlled trial is widely regarded as the gold standard method for evaluating the effectiveness of health care interventions. Successful conduct of trials and generalisation of findings depends upon efficient recruitment of representative samples, which often requires the collaboration of 'gatekeepers' who mediate access to potential participants. Effective negotiation of gatekeeping is thus vital to process and outcomes of trials and the quality of evidence. Whilst relevant literature contains discussion of the problems of recruitment and gatekeeping, little is known about how recruitment can be optimised and factors leading to successful recruitment. Discussion: As practised researchers with first-hand experience of gatekeeping, we were aware that some researchers recruit more effectively than others and curious about the ingredients of success. With the goal of developing practical guidance, we conducted a series of workshops with 19 expert researchers to investigate and map successful recruitment. Workshops were digitally recorded and transcribed. Analysis of discussion supported modelling of effective recruitment as a process involving three phases, each comprising two key tasks. Successful negotiation of set-up, alliance, and exchange require judicious deployment of interpersonal skills in an appropriately assertive manner. Researcher flexibility and credibility are vital for success, such that a foundation for rapprochement between the worlds of research and practice is established. Our model provides a framework to support design and implementation of recruitment activities and will enable trouble shooting and support recruitment, supervision and training of effective researchers. This, in turn will support delivery of trials on time and on budget, maximising return on investment in the production of evidence. Summary: Pragmatic trials are central to development of evidence based health care but often failure to recruit the necessary sample in a timely manner means many fail or require costly extensions. Gatekeeping is implicated in this. Drawing on the knowledge of 19 expert researchers, we argue that successful researchers are resourceful and personable, judiciously deploying interpersonal skills and expertise to engage with gatekeepers and establish a shared objective. We propose that understanding recruitment as a phased process can enhance design and conduct of trials, supporting completion on time, on budget