A randomised study of the impact of different styles of patient information leaflets for randomised controlled trials on children's understanding.

T his study explores how the format of written information presented to children affects their understanding of the concepts behind randomised controlled trials (RCTs). Its aim was to identify whether this understanding could be increased by altering the style of information forms. We hypothesised that focusing information in a question and answer format, or presenting concepts as a story, would lead to a greater understanding than is achieved by the traditional block text format. If this proved successful, researchers could have more confidence that a child’s consent was informed. The Department of Health upholds the concept of Gillick competence for research purposes and recommends that ‘‘appropriately designed information should be available for children involved in research’’. The aim is to allow children to develop competence in giving informed consent, which is necessary to protect children’s rights. Improved written patient information would mean research involving children could be undertaken with more confidence, leading to increased participation of children in RCTs.