Clinical trial recruitment--a complex intervention?

AIMS AND
OBJECTIVES: To discuss the evidence of poor recruitment rates in randomised clinical trials and relate this to existing recruitment methodology before a novel approach to recruitment is suggested.
BACKGROUND: Recruitment is crucial to the success of research projects. Effective recruitment leads to effective retention, an increased pool of data and in-time completion of projects. Robust evidence indicates that recruitment remains a challenge in many clinical trials.
DESIGN: Discursive article.
METHODS: The complexity of recruitment is mandated based on the findings from a literature review that summarises common threats to successful recruitment. Nursing theories and models that incorporate recruitment are critically reviewed before recruiting, and its planning is related to existing complex intervention methodology.
CONCLUSION: Threats to sufficient recruitment are inherent in the planning of studies, the recruiting process and triadic relationships between institutions, recruiter and participants. Existing nursing theories and models address important recruitment issues but do not account for all aspects that jeopardise sufficient recruitment. Hence, available frameworks for complex intervention planning and evaluation are useful to guide recruitment and its planning as an umbrella methodology. RELEVANCE TO CLINICAL PRACTICE: Using complex intervention methodology for recruitment and its planning enhances a nurse researcher's awareness of the challenges and pitfalls recruitment poses and may translate to improved recruitment rates and overall success of clinical trials.