title: Increasing participation of cancer patients in randomised controlled trials: a systematic review.
abstract: BACKGROUND
  There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments.
  
  
  METHODS
  A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted.
  
  
  RESULTS
  Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work.
  
  
  CONCLUSIONS
  There is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials.
authors.affiliation: Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK. cm36@york.ac.uk
authors.forename: Catriona
authors.initials: C
authors.lastname: Mc Daid
authors.forename: Zoé
authors.initials: Z
authors.lastname: Hodges
authors.forename: Debra
authors.initials: D
authors.lastname: Fayter
authors.forename: Lisa
authors.initials: L
authors.lastname: Stirk
authors.forename: Alison
authors.initials: A
authors.lastname: Eastwood