ELIA ND Athens: Readability Testing of Patient Information within EU

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ELIA, Language, Translation

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

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