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Randomized Controlled Trial
. 2017 Feb;23(1):73-78.
doi: 10.1111/jep.12576. Epub 2016 Jun 20.

A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial

Catherine Arundel  1 , Laura Jefferson  1 , Matthew Bailey  1 , Sarah Cockayne  1 , Kate Hicks  1 , Lorraine Loughrey  1 , Sara Rodgers  1 , David J Torgerson  1 ; REFORM study team  1
Affiliations
Randomized Controlled Trial

A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial

Catherine Arundel et al. J Eval Clin Pract. 2017 Feb.

Abstract

Objectives: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT).

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.

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.

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. Results 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.

Keywords: embedded trial; leaflet; pre-notification; randomization; randomized controlled trial; recruitment.

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