How to Test Mandatory Text Templates: The European Patient Information Leaflet

The structure of patient information leaflets (PILs) supplied with medicines in the European Union is largely determined by a regulatory template, requiring a fixed sequence of pre-formulated headings and sub-headings. The template has been criticized on various occasions, but it has never been tested with users. This paper proposes an alternative template, informed by templates used in the USA and Australia, and by previous user testing.The main research question is whether the revision better enables users to find relevant information. Besides, the paper proposes a methodology for testing templates. Testing document templates is complex, as they are "empty". For both the current and the alternative template, we produced a document with bogus text and real headings (reflecting the empty template) and a real-life document with readable text (reflecting the "filled" template). The documents were tested both in Dutch and in English, with 64 British and 64 Dutch users. The test used a set of scenario questions that covers the full range of template (sub)topics; users needed to indicate the text locations where they expected each question to be answered. The revised template improved findability of information; this effect was strongest for the "filled" template with readable text. When participants were shown both filled templates, there was a clear preference for the revised template. A closer analysis of the findability data revealed question-specific effects of topic grouping, topic ordering, subtopic granularity and wording of headings. Most of these favoured the revised template, but our revision led to adverse effects as well, for instance in the new heading Check with your doctor. Language-specific effects showed that the wording of the headings is a delicate task. Generally, we conclude that document template designs can be analyzed in terms of the four parameters grouping, ordering, granularity and wording. Furthermore, they need to be tested on their effects on information findability, with template translations requiring separate testing. The methodology used in this study seems an appropriate one for such tests. More specifically, we find that the new patient information leaflet template proposed here provides better information findability.