ELIA ND Athens: Readability Testing of Patient Information within EU

ELIA ND Athens: Readability Testing of Patient Information within EU

Simon Andriesen – Medilingua

• Medicines are not optimally used without adequate patient information
• Research suggests that 40-50% of all prescribed drugs are not used partly because of a poorly written/translated leaflet
• EC Directive 2004/27/EC: readability testing mandatory since 2005 (only for new or heavily changed leaflets)
• Purpose of readability test:

1. Identify problems
2. Solve problems
3. Keep testing until problem-free

• EC Readability Guideline 2009: guideline on the readability of the labeling and package leaflet of medical products for human use
• Australian Test Method is most commonly used; based on David Sless’s “Writing about medicines for people”; adopted in 1998 by European Medicines Agency (EMA) for drug registration dossiers; since testing became mandatory in 2005, it is the most commonly used readability text method for patient information leaflets; relatively costly (4-7 thousand Euros per leaflet)
• Testing is done in two groups of 10 ‘average’ participants
• The test includes the following:

1. Source text
2. Profile of test participants
3. Key safety aspects
4. Questionnaire
5. Mock-up
6. Pilot test
7. First test round
8. Second test round
9. Write test report

• The final report is submitted to regulatory authorities for evaluation