Objective: This study assesses the usability of three patient information leaflets and attempts to improve them while complying with the current EU regulations. Methods: Three original leaflets were tested among 154 potential users. Every participant answered 15 scenario questions for one of the leaflets. The leaflets were subsequently redesigned based on the test results and evidence-based Document Design principles. The revised texts were tested among 164 participants. Results: All three original leaflets suffered from usability problems, especially problems related to finding relevant information. On average, only 75% of the topics could be located. Comprehension of the information, once found, was around 90%. The revisions led to better performance. Information was found faster and more successful. Comprehension scores were higher as well. A follow-up study shows that these findings can be generalized over paper formats. Conclusion: Although the current EU regulations for patient information leaflets do not guarantee leaflet usability, the leaflets can be improved somewhat within the regulations. However, further research should evaluate the text structure currently imposed on leaflets. Practical implications: Information leaflets must be written, or rewritten, according to Document Design principles. Furthermore, they must be user tested in a rigorous way. (c) 2009 Elsevier Ireland Ltd. All rights reserved.
