title: Clinical trial recruitment--a complex intervention?
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. ralph.tramm@monash.edu.au
authors.forename: Ralph
authors.initials: R
authors.lastname: Tramm
authors.forename: Karen
authors.initials: K
authors.lastname: Daws
authors.forename: Verena
authors.initials: V
authors.lastname: Schadewaldt
mesh_terms: D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic
keywords: complex intervention; methods; nursing research; patient selection