Background: Research information for children is often presented in a manner that is difficult to understand. We designed this study, therefore, to examine the effect of improved readability and processability of written study information on children's understanding.
Methods: One-hundred-ninety children aged 7-17 yr who were hospitalized for a surgical procedure or medical treatment were randomized to receive study information using either a standard form or a modified form with improved readability and processability. Children were interviewed to determine their understanding of eight study elements, including the risks, benefits, protocol, etc., and their responses scored by two independent assessors.
Results: Children who were randomized to the modified form had significantly greater overall understanding of the information and greater understanding of the protocol and benefits (P < 0.05). The modified form was particularly effective in improving younger children's (7-10 yr) understanding of the material. Multivariate analysis identified several predictors of understanding, including the modified format, age, reading ability and the degree to which the child read the information. When shown both forms, 81.3% of children preferred the modified form stating that it was "friendlier" and "easier to read." The use of a larger font size and pictures were particularly popular.
Conclusions: Results of this study suggest that modification of study information to better fit the ages and meet the reading and cognitive abilities of children results in their improved understanding and acceptance of the material.