Patient information leaflets for medicines: using consumer testing to determine the most effective design.

Comprehensive medicine information leaflets for patients are now mandatory across the European Union. In 1997, the European Commission (EC) proposed a prescriptive 'model' for the leaflets and a method for consumer testing. This exploratory study compared consumers' ability to use a leaflet based on the EC model leaflet and an alternative leaflet based on best practice in information design (Mark II). The leaflets were tested in two matched groups of 20 consumers, who were required to find, and understand, 15 pieces of information in the leaflets. The target that each question should be answered correctly by 16 out of 20 consumers, was achieved for three of the 15 points in the EC leaflet, compared with eight in the Mark II leaflet. Open questioning confirmed the problems with the EC leaflet, including a failure to understand key concepts about medicine interactions and contraindications. This research demonstrates the benefits of consumer testing, ensuring that leaflets are patient-orientated. A rigid model leaflet would prevent these benefits from being utilised.