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The reform patient information sheet sub study - an embedded trial evaluating the enhancement of patient information sheets to improve recruitment

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Trials201516 (Suppl 2) :P87

  • Published:


  • Logistic Regression Analysis
  • Randomise Control Trial
  • Retention Rate
  • User Testing
  • Trial Participant

During recruitment, potential trial participants are usually given a written study patient information sheet (PIS). These are often long, complex and visually unappealing documents, which may have a negative impact on recruitment. Improving their readability by employing user testing, and their presentation by using graphic designers may improve patient understanding and aid recruitment.

We undertook an embedded randomised controlled trial within the NIHR-funded REFORM study, as part of the MRC START initiative, to evaluate whether enhancing PIS improves trial recruitment and retention. 6,900 patients due to be mailed a REFORM recruitment pack were randomised in a 1:1:1 ratio to receive one of three types of PIS: the original based on the NHS ethics template (n=2,298); an enhanced, user tested PIS (n=2,301); or a ‘template’ PIS which was developed using an enhanced PIS from another trial in a similar population (n=2,301).

193 participants (2.8%) were randomised to the trial: 62 (2.7%) in the control group; 63 (2.7%) in the user tested group; and 68 (3.0%) in the template group (OR: template vs control 1.10 (95% CI 0.77-1.56, p=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)). Logistic regression analysis demonstrated that PIS allocation did not significantly predict recruitment (p= 0.33) or retention in the trial (p=0.83).

There was no evidence to suggest that enhanced PIS increased recruitment and retention rates to the REFORM trial. However, the number of patients randomised was low and we may be underpowered to detect a difference.

Authors’ Affiliations

University of York, York, UK
The University of Manchester, Manchester, UK
NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK
University of Oxford, Oxford, UK
NUI Galway, Galway, Ireland
La Trobe University, Bundoora, Australia
Sheffield Teaching Hospitals, Sheffield, UK


© Cockayne et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.


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