The Readability Test

Prior to the appropriate launch of a medicinal product, the patient information leaflet must successfully attain goals set out by the European authorities and the EMEA. These goals are measured by a readability test procedure designed to evaluate and monitor the quality and usability of patient information leaflets (PILs).

Readability tests have been performed in the EU since October 2005. Results have demonstrated a change in attitude on the part of test readers to this seemingly insignificant piece of paper. The value of the patient information leaflet appears to have increased significantly as has the importance of the information contained within it. These changes in attitude can be attributed to test readers’ participation in the writing and construction of the leaflet.

INITIAL SPECULATIONS

Prior to the first readability tests our design group contemplated test reader reactions, and we eagerly anticipated hearing their comments and suggestions. We ourselves had a lot of questions in mind prior to the first test rounds, including:

• Will the test reader be anxious and nervous?
• Would he/she be able to deliver useful critiques?
• Would he/she be able to understand the text and find the sections we were asking about?
• Would the critiques and proposals from the test readers improve the readability and understanding of the leaflets?

Following the first test rounds we knew we could completely relax as we realised that our worries were unsubstantiated. Test readers were dedicated, interested, eager and concentrated on the task at hand. The majority of the test groups cared about their function as test readers and wanted to perform their ‘job’ as accurately as possible. Some of the test readers even went so far as to prepare themselves beforehand by reading PILs they had at home; they even brought old leaflets along to show us examples of poorly-constructed information.