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Abstract:

Introduction: Recommendations on readability testing of Patient Information Leaflets (PILs) are described in European Commission (EC) guidelines, as well as in other (trans)national guidelines. However, these recommendations are not obligatory, allowing market authorization holders and service companies to experiment with different readability testing techniques. Objectives: - To investigate to which extent readability testing companies comply with the suggestions made by the available transnational guidelines, and with the Sless & Wiseman info design theory on which these are built. - To investigate to which extent the plethora of available guidelines leads to confusion, or to diverging interpretations of how readability testing should be done. Methodology: A digital survey consisting of 77 items 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 different guidelines and the Sless & Wiseman info design 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 type of questions to ask and how to ask them. Furthermore, respondents formulated some critical remarks on the existing legislation. The survey also revealed that several service companies occasionally 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 regarding PIL readability testing as suggested by the 2009 EC guideline. It further shows that other testing methods than face-to-face interview are in place and are being used. More in-depth research should assess how these methods function in the field.