title: SWAT-1: The effectiveness of a 'site visit' intervention on recruitment rates in a multi-centre randomised trial.
abstract: BACKGROUND
  Recruitment rates in multi-centre randomised trials often fall below target recruitment rates, causing problems for study outcomes. The Studies Within A Trial (SWAT) Programme, established by the All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Council Network of Hubs in the United Kingdom and others, is developing methods for evaluating aspects of trial methodology through the conduct of research within research. A recently published design for a SWAT-1 provides a protocol for evaluating the effect of a site visit by the principal investigator on recruitment in multi-centre trials.
  
  
  METHODS
  Using the SWAT-1 design, the effect of a site visit, with the sole purpose of discussing trial recruitment, on recruitment rates in a large multicentre trial in the Republic of Ireland was evaluated. A controlled before and after intervention comparison was used, where the date of the site visit provides the time point for the intervention, and for the comparison to control sites. Site A received the intervention. Site B and Site C acted as the controls. Z-scores for proportions were calculated to determine within site recruitment differences. Odds ratios and 95% confidence intervals were calculated to determine between site recruitment differences.
  
  
  RESULTS
  Recruitment rates were increased in Site A post-intervention (17% and 14% percentage point increases at 1 and 3 months, respectively). No differences in recruitment occurred in Site B or in Site C. Comparing between site differences, at 3 months post-intervention, a statistically significant difference was detected in favour of higher recruitment in Site A (34% versus 25%; odds ratio 1.57, 95% confidence interval 1.09 to 2.26).
  
  
  CONCLUSIONS
  This is the first reported example of a study in the SWAT programme.. It provides evidence that a site visit, combined with a scheduled meeting, increases recruitment in a clinical trial. Using this example, other researchers might be encouraged to consider conducting a similar study, allowing the findings of future SWAT-1s to be compared and combined, so that higher level evidence on the effect of a site visit by the principal investigator can be obtained.
  ISRCTN-96340041 ( www.controlled-trials.com ); date of registration: 25 March 2008.
authors.affiliation: School of Nursing and Midwifery, Trinity College Dublin, D'Olier Street, Dublin 2, Ireland. smithv1@tcd.ie.|School of Nursing and Midwifery, National University of Ireland, Galway, Ireland. smithv1@tcd.ie.
authors.forename: Valerie
authors.initials: V
authors.lastname: Smith
authors.affiliation: Northern Ireland Network for Trials Methodology Research, Queen's University Belfast, Grosvenor Road, Belfast, BT12 6BA, UK. m.clarke@qub.ac.uk.
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.affiliation: School of Nursing and Midwifery, Trinity College Dublin, D'Olier Street, Dublin 2, Ireland. cbegley@tcd.ie.
authors.forename: Cecily
authors.initials: C
authors.lastname: Begley
authors.affiliation: School of Nursing and Midwifery, National University of Ireland, Galway, Ireland. declan.devane@nuigalway.ie.
authors.forename: Declan
authors.initials: D
authors.lastname: Devane
mesh_terms: D015148:Cardiotocography; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D005260:Female; D006326:Heart Auscultation; D006340:Heart Rate, Fetal; D006801:Humans; D007494:Ireland; D007745:Labor Onset; D016017:Odds Ratio; D018579:Patient Selection; D011237:Predictive Value of Tests; D011247:Pregnancy; D012108:Research Personnel; D018401:Sample Size; D013997:Time Factors