An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial
Cockayne, Sarah Fairhurst, Caroline Adamson, Joy Hewitt, Catherine Hull, Robin Hicks, Kate Keenan, Anne-Maree Lamb, Sarah E. Green, Lorraine McIntosh, Caroline
Cockayne, Sarah
Fairhurst, Caroline
Adamson, Joy
Hewitt, Catherine
Hull, Robin
Hicks, Kate
Keenan, Anne-Maree
Lamb, Sarah E.
Green, Lorraine
McIntosh, Caroline
Identifiers
http://hdl.handle.net/10379/10825
https://doi.org/10.13025/28729
https://doi.org/10.13025/28729
Repository DOI
Publication Date
2017-03-28
Type
Article
Downloads
Citation
Cockayne, Sarah; Fairhurst, Caroline; Adamson, Joy; Hewitt, Catherine; Hull, Robin; Hicks, Kate; Keenan, Anne-Maree; Lamb, Sarah E. Green, Lorraine; McIntosh, Caroline; Menz, Hylton B.; Redmond, Anthony C.; Rodgers, Sara; Torgerson, David J.; Vernon, Wesley; Watson, Judith; Knapp, Peter; Rick, Jo; Bower, Peter; Eldridge, Sandra; Madurasinghe, Vichithranie W.; Graffy, Jonathan (2017). An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial. Trials 18 ,
Abstract
Background: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. Methods: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. Results: Six thousand and nine hundred patients were randomised 1: 1: 1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). Conclusions: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study.
Funder
Publisher
Springer Nature
Publisher DOI
Rights
Attribution-NonCommercial-NoDerivs 3.0 Ireland