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

Background: The 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). Methods: In 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. Results: The 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). Conclusions: The 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

Room temperature precipitation in quenched Al-Cu-Mg alloys: a model for the reaction kinetics and yield strength development

The microstructural evolution during low temperature ageing of two commercial purity alloys (Al-1.2Cu-1.2Mg-0.2Mn and Al-1.9Cu-1.6Mg-0.2Mn at.%) was investigated. The initial stage of hardening in these alloys is very rapid, with the alloys nearly doubling in hardness during 20 h ageing at room temperature. The microstructural evolution during this stage of hardening was investigated using differential scanning calorimetry (DSC), isothermal calorimetry and three-dimensional atom probe analysis (3DAP). It is found that during the hardening a substantial exothermic heat evolution occurs and that the only microstructural change involves the formation of Cu-Mg co-clusters. The kinetics of cluster formation is analysed and the magnitude of the hardening is discussed on the basis of a model incorporating solid solution hardening and modulus hardening originating from the difference in modulus between Al and clusters