title: A systematic review of techniques and interventions for improving adherence to inclusion and exclusion criteria during enrolment into randomised controlled trials.
abstract: BACKGROUND
  Enrolment of patients into a randomised controlled trial (RCT) in violation of key inclusion or exclusion criteria, may lead to excess avoidable harm. The purpose of this paper was to systematically identify and review techniques and interventions proven to prevent or avoid inappropriate enrolment of patients into RCTs.
  
  
  METHODS
  EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Methodology Register, online abstract repositories, and conference websites were searched. Experts were contacted and bibliographies of retrieved papers hand-searched. The search cut-off date was 31 August 2009.
  
  
  RESULTS
  No primary publications were found. We identified one study in the grey literature (conference abstracts and presentations) reporting the results of an evaluation of the effectiveness of an intervention designed to prevent or avoid inappropriate enrolment of patients into an RCT. In the context of a multicentre trial, use of a dummy enrolment run-in phase was shown to reduce enrolment errors significantly (P < 0.001), from 16.1% during the run-in phase to < 1% after trial initiation.
  
  
  CONCLUSIONS
  Our systematic search yielded only one technique or intervention shown to improve adherence to eligibility criteria during enrolment into RCTs. Given the potential harm involved in recruiting patients into a clinical trial in violation of key eligibility criteria, future research is needed to better inform those conducting clinical trials of how best to prevent enrolment errors.
authors.affiliation: Department of Intensive Care, Northern Clinical School, University of Sydney, Sydney, NSW, Australia. fsimpson@nsccahs.health.nsw.gov.au
authors.forename: Fiona
authors.initials: F
authors.lastname: Simpson
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Sweetman
authors.forename: Gordon S
authors.initials: GS
authors.lastname: Doig
mesh_terms: D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015203:Reproducibility of Results; D016896:Treatment Outcome