Readability testing of package leaflets

Revised European regulations (Directive 2004/27/EC) have been approved to increase the readability of package leaflets; package leaflets for new medicines must be submitted to consumer panels. This requirement applies to medicines that will be authorised for the first time since November 2005 or have been significantly altered. In testing the readability of a package leaflet, one must check that information is easy to find, understand and apply. This test can provide the impetus to improve the package leaflet even further. A readability test is a required part of the marketing authorisation procedure and the results form part of the authorisation file.

Procedure

Wilkens c.s. Medical Translations tests package leaflets using a method based on the guidelines from the European Commission. The procedure works as follows:

• Potential questions are prepared on the basis of the package leaflet text. The questions are placed into three groups: can the test subject find the right information, can the subject explain the leaflet text in his own words, and can the subject do what is written in the text. We ensure that questions are asked about potentially problematic passages; our questions will not be about the standard QRD text.
• We provide these draft questions to the client for approval.
• We will then define what the correct answers are and give a score to the possible answers for each question.
• In two rounds of testing with at least ten subjects, we will analyse the readability using approximately 15 questions. In selecting participants, we will take into account age, gender, educational level, and previous knowledge of an illness and/or use of a medicine, among other factors. In addition to testing how easy information is to find, understand and apply, we will test the technical readability of the package leaflet.
• After the first round of testing we provide a report to the client with the results, based on which the text of the package leaflet can potentially be amended.
• The results of this research will be presented in a final report in English. This will include, among other things, a summary, a description of the completed test procedure, the questions asked as well as their respective answers and scoring, the answers of the test subjects as well as their scores, a declaration of technical readability and a conclusion.