Title: Readability testing of Patient Information Leaflets in practice: compliance with legislation and use of existing test methods
Authors: Foulon, Veerle ×
Rombouts, Dries
Franck, Maarten
Van Vaerenbergh, Leona #
Issue Date: Aug-2010
Host Document: Pharmacy Practice vol:8 issue:Supplement 1 pages:118-118
Conference: International Social Pharmacy Workshop edition:16 location:Lisbon date:23-26 August 2010
Abstract: Objective: Recommendations on readability testing of Patient Information Leaflets (PILs) are described in European Commission (EC) as well as national guidelines. However, these recommendations are not obligatory, thus leaving the door open for market authorization holders and service companies to experiment with different readability testing methods. The aim of this study was to investigate to which extent readability testing companies comply with the EC (1) and UK (2) guidelines and with the Sless & Wiseman info design theory (3) on which the recommendations are built.
Methods: A digital survey consisting of 77 items and investigating current practice in readability testing was presented to the representatives of 45 service companies all over Europe. The results were examined against the criteria as presented in the EC and UK guidelines and the Sless & Wiseman theory.
Results: Results were obtained from 12 service companies. Generally, we found that all respondents mostly comply with legislative recommendations, as well as with the Sless & Wiseman principles. However, service companies seem to interpret guidelines in different ways with regard to the number and background of test persons and the number of test rounds. Furthermore, respondents formulated some critical remarks on the existing legislation. The survey also revealed that several service companies also use other testing methods than recommended, such as eye tracking, thinking aloud, focus groups and written surveys.
Conclusion: The findings of this survey show that service companies are well on their way to meet the criteria of the EC and UK legislations regarding readability testing. It further shows that other testing methods than the face-to-face interview are in place and being used. More in-depth research should assess how these methods function in the field.
[1] European Commission: A guideline on the readability of the labelling and package leaflet of medicinal products for human use. [], March 2010
[2] Medicines and Healthcare products Regulatory Agency (MHRA): Guidance on the user testing of Patient Information Leaflets. [], March 2010

[3] Sless, D, Wiseman, R (1997). Writing About Medicines for People: Usability Guidelines for Consumer Medicines Information, second edition, Canberra: Australian Government Publishing Service.
ISSN: 1885-642X
Publication status: published
KU Leuven publication type: IMa
Appears in Collections:Research Centre for Pharmaceutical Care and Pharmaco-economics (-)
× corresponding author
# (joint) last author

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