Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?

Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level.