@article{ref1,
title="A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial",
journal="Journal of evaluation in clinical practice",
year="2016",
author="Arundel, Catherine and Jefferson, Laura and Bailey, Matthew and Cockayne, Sarah and Hicks, Kate and Loughrey, Lorraine and Rodgers, Sara and Torgerson, David J.",
volume="23",
number="1",
pages="73-78",
abstract="OBJECTIVES: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). <br><br>METHODS: A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. <br><br>RESULTS: Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. <br><br>CONCLUSION: Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Rseults should, however, be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended.<br><br>© 2016 John Wiley & Sons, Ltd.<p /> <p>Language: en</p>",
language="en",
issn="1356-1294",
doi="10.1111/jep.12576",
url="http://dx.doi.org/10.1111/jep.12576"
}