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

Integrating Data Clustering and Visualization for the Analysis of 3D Gene Expression Data

The recent development of methods for extracting precise measurements of spatial gene expression patterns from three-dimensional (3D) image data opens the way for new analyses of the complex gene regulatory networks controlling animal development. We present an integrated visualization and analysis framework that supports user-guided data clustering to aid exploration of these new complex datasets. The interplay of data visualization and clustering-based data classification leads to improved visualization and enables a more detailed analysis than previously possible. We discuss (i) integration of data clustering and visualization into one framework; (ii) application of data clustering to 3D gene expression data; (iii) evaluation of the number of clusters k in the context of 3D gene expression clustering; and (iv) improvement of overall analysis quality via dedicated post-processing of clustering results based on visualization. We discuss the use of this framework to objectively define spatial pattern boundaries and temporal profiles of genes and to analyze how mRNA patterns are controlled by their regulatory transcription factors

Developing stories : an alternative view from the South; documentation

Accompanying video produced by the BBC in association with TVE and One World Group of BroadcastersProducers of video: Bruno Sorrentino and Ian PottsDocumentary on the Developing stories series

Rabi : Burkina Faso

Version anglaise dans la bibliothèque: RabiUne production Cinecom pour BBC Television en association avec Television Trust for the Environment et tous les diffuseurs de "Un Seul Monde" (One World)Un conte d'Afrique de l'Ouest parlant d'un jeune garçon et d'une tortue ou comment le respect de l'environnement est nécessairement lié à celui de sa culture et de sa collectivité

Rabi : Burkina Faso

French version available in IDRC Digital Library: RabiSeries producer: P. FirstbrookA Cinecom Production for BBC Television in association with Television Trust for the Environment and the One World Group of BroadcastersA West African fable about a boy and a tortoise and how concern for the environment is inextricably bound up with respect for culture and the community

Developing stories : an alternative view from the South

Produced by the BBC in association with TVE and One World Group of BroadcastersProducers: Bruno Sorrentino and Ian PottsDocumentary on the Developing stories series

Germes d'abondance, germes de chagrin : Inde

Producteur de la série: P. FirstbrookHôte: N.E. BorlaugVersion anglaise disponible dans la Bibliothèque numérique du CRDI : Seeds of plenty, seeds of sorrowUne production Media Workshop pour BBC Television en association avec Television Trust for the Environment et tous les diffuseurs de "Un Seul Monde" (One World)Une enquête sur les aspects moins reluisants de la Révolution verte

Suspended dreams : Beirut

Series producer: P. FirstbrookLibrary has French version: Rêves inachevésAn MTC (Beirut) production for BBC Television in association with Television Trust for the Environment and the One World Group of BroadcastersLibrary has another version of this video: Beirut : suspended dreams (North South series, no. 109)A Beirut community's struggle to rebuild their lives and their shattered environment after sixteen years of civil war (subtitled)

Seeds of plenty, seeds of sorrow : India

Series producer: P. FirstbrookHost: N.E. BorlaugFrench version available in IDRC Digital Library: Germes d'abondance, germes de chagrinA Media Workshop production for BBC Television in association with Television Trust for the Environment and the One World Group of BroadcastersAnother version of this video available in IDRC Digital Library: Seeds of plenty, seeds of despair (North South series, no. 112)An investigation of the darker side of the Green Revolution (subtitled)