Evidence Library

Title: Can user testing of a clinical trial patient information sheet make it fit-for-purpose? – a randomised controlled trial
Author: Knapp, P., Raynor, D., Silcock, J. and Parkinson, B
Date Published: 2011
Reference: BMC Medicine, 9, 89
Are service users or carers authors: No/Not Known

Abstract: Aim: To test whether involving the public in developing a patient information sheet (PIS) for a clinical trial for leukaemia, made the PIS easier to read and understand. Methods: A PIS written by the researchers was reviewed three times in a row by members of the general public (50 in total). The revised PIS was compared to the original version in a randomised controlled trial. A total of 123 participants were recruited to the leukaemia trial. They were randomly allocated one version of the PIS to read and then asked about their understanding of the trial. Findings/ recommendations: 66% of the trial participants who read the revised version of the PIS understood all aspects of the trial, compared to 15% of the participants reading the original version. When asked which version they preferred 87% preferred the revised version. The authors conclude that the original version of the PIS would not have supported genuinely informed consent and that testing out the information with the public led to significant improvements.

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Categories: health
Designing research
impact on research
impact on research ethics
impact of public involvement
journal article

Date Entered: 2015/07/06

Date Edited: 2015/07/06

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