Article type
Year
Abstract
Background:
There are many opportunities across tens of thousands of reviews and trials to resolve uncertainties about methodology through embedded research. The SWAR (Studies Within A Review) and SWAT (Studies Within A Trial) programme, established by the All-Ireland Hub for Trials Methodology Research working with the Medical Research Council (MRC) Network of Hubs in the UK and others, is developing methods for such research. SWAT-1, the first in the series of these studies, provides an initial example, evaluating the effects of site visits by the principal investigator on recruitment rates in multi-centre randomised trials.
Objectives:
To evaluate the effects of a site visit on recruitment rates in a multi-centre randomised trial (the ADCAR trial).
Methods:
Using SWAT-1 methodology, a before-and-after comparison used the date of the site visit as the time point for the intervention, and for the comparison with control sites. Site A received the intervention. Site B and Site C did not receive it and acted as the controls. The primary outcome measures were difference in recruitment in each site from 1 month and 3 months pre-intervention to 1 month and 3 months post-intervention.
Results:
Recruitment in Site A was significantly increased at 1 (risk ratio (RR) 2.25, 95% confidence interval (CI) 1.06-4.77, P = 0.03) and at 3 months (RR 1.69, 95% CI 1.19-2.42, P = 0.002) post-intervention. There was no significant difference in recruitment in Site B (RR 0.72, 95% CI 0.45-1.15, P = 0.17) or in Site C (RR 1.04, 95% CI 0.69-1.58, P = 0.85) at 1 month post-intervention. Comparing intervention (Site A) with controls (Site B+C); the change seen in Site A was significantly different to the change seen in B+C at 1 (P = 0.02) and 3 (P = 0.02) months post-intervention.
Conclusions:
This study is the first example of a study in the SWAT programme, using the SWAT-1 design. It shows how these simple low (or no) cost studies can be done and provides evidence that the site visit increased recruitment rates in a randomised trial. Further SWAT-1s are required to substantiate these findings and to examine the effects in different trials in different settings.
There are many opportunities across tens of thousands of reviews and trials to resolve uncertainties about methodology through embedded research. The SWAR (Studies Within A Review) and SWAT (Studies Within A Trial) programme, established by the All-Ireland Hub for Trials Methodology Research working with the Medical Research Council (MRC) Network of Hubs in the UK and others, is developing methods for such research. SWAT-1, the first in the series of these studies, provides an initial example, evaluating the effects of site visits by the principal investigator on recruitment rates in multi-centre randomised trials.
Objectives:
To evaluate the effects of a site visit on recruitment rates in a multi-centre randomised trial (the ADCAR trial).
Methods:
Using SWAT-1 methodology, a before-and-after comparison used the date of the site visit as the time point for the intervention, and for the comparison with control sites. Site A received the intervention. Site B and Site C did not receive it and acted as the controls. The primary outcome measures were difference in recruitment in each site from 1 month and 3 months pre-intervention to 1 month and 3 months post-intervention.
Results:
Recruitment in Site A was significantly increased at 1 (risk ratio (RR) 2.25, 95% confidence interval (CI) 1.06-4.77, P = 0.03) and at 3 months (RR 1.69, 95% CI 1.19-2.42, P = 0.002) post-intervention. There was no significant difference in recruitment in Site B (RR 0.72, 95% CI 0.45-1.15, P = 0.17) or in Site C (RR 1.04, 95% CI 0.69-1.58, P = 0.85) at 1 month post-intervention. Comparing intervention (Site A) with controls (Site B+C); the change seen in Site A was significantly different to the change seen in B+C at 1 (P = 0.02) and 3 (P = 0.02) months post-intervention.
Conclusions:
This study is the first example of a study in the SWAT programme, using the SWAT-1 design. It shows how these simple low (or no) cost studies can be done and provides evidence that the site visit increased recruitment rates in a randomised trial. Further SWAT-1s are required to substantiate these findings and to examine the effects in different trials in different settings.