1. A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial.
- Author
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Arundel, Catherine, Jefferson, Laura, Bailey, Matthew, Cockayne, Sarah, Hicks, Kate, Loughrey, Lorraine, Rodgers, Sara, and Torgerson, David J
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ACCIDENTAL fall prevention , *CONFIDENCE intervals , *COST effectiveness , *ETHNIC groups , *HEALTH status indicators , *LONGITUDINAL method , *PAMPHLETS , *PODIATRY , *READABILITY (Literary style) , *RESEARCH funding , *STATISTICAL sampling , *INFORMATION resources , *STATISTICAL power analysis , *SECONDARY analysis , *RANDOMIZED controlled trials , *RELATIVE medical risk , *HUMAN research subjects , *PROPORTIONAL hazards models , *PATIENT selection , *DATA analysis software , *DESCRIPTIVE statistics , *OLD age - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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