Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

Brian Parkinson,Peter Knapp,Jonathan Silcock,David K Raynor

doi:10.1186/1741-7015-9-89

Brian Parkinson, Peter Knapp + Show 2 more

Open Access

https://doi.org/10.1186/1741-7015-9-89

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Abstract

BackgroundThe participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16).MethodsIn the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts.ResultsThe first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p < .001). When asked to state a preference, 87.1% participants chose the revised PIS (Sign test p < .001).ConclusionsThe original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in trial information, and Research Ethics Committees and Institutional Review Boards should consider requesting such testing, to ensure that PIS are fit-for-purpose.

Highlights

The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent
Based on data from the developmental phase, we estimated that the revised PIS would result in twice as many participants having a clear round - a difference we considered meaningful in terms of valid consent
Time taken in interviews was much shorter, illustrating the difficulty faced in finding answers by those in the original version group, and almost two-thirds of participants were able to find and show understanding of all aspects of the AML16 trial

Summary

Introduction

The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. There is long-standing concern that these lengthy and complex documents are not fit-for-purpose This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. Studies looking at patients’ understanding at the end of a trial have found sub-optimal comprehension, such as one in five participants not knowing the name of the medicine being tested [7] and similar proportions not knowing that they could withdraw at any time [8,9] These findings are confirmed by a systematic review of communication and informed consent in cancer trials [10] in which aspects such as treatment risks and benefits and the right to withdraw consent were found to be not well understood. In two observational studies of patients being recruited to trials key aspects were missing from spoken information provided by clinicians and participants’ understanding of the trial (which was sometimes erroneous) was not checked or corrected [11,12]

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