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

Henk Pander Maat1, Leo Lentz1, David K Raynor2

  • 1Utrecht Institute of Linguistics OTS, Utrecht University, Utrecht, the Netherlands.

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A revised patient information leaflet template improves information findability compared to the current EU standard. User testing revealed a preference for the new design, highlighting the importance of template structure and wording for medicine information accessibility.

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Area of Science:

  • Health Sciences
  • Human-Computer Interaction
  • Regulatory Science

Background:

  • European Union patient information leaflets (PILs) follow a rigid regulatory template.
  • This template has faced criticism but lacked user testing.
  • Existing templates from the USA and Australia informed an alternative design.

Purpose of the Study:

  • To evaluate if a revised PIL template enhances users' ability to find information.
  • To propose and validate a methodology for testing document templates.
  • To compare the findability of information using the current EU template versus a revised template.

Main Methods:

  • Developed and tested both current and alternative PIL templates using 'empty' (headings only) and 'filled' (readable text) versions.
  • Conducted user testing with 128 participants (64 British, 64 Dutch) in both English and Dutch.
  • Utilized scenario-based questions to assess information findability across template topics.

Main Results:

  • The revised template significantly improved information findability, especially in the 'filled' version.
  • Users showed a clear preference for the revised template when presented with both filled versions.
  • Analysis identified specific impacts of topic grouping, ordering, granularity, and heading wording on findability.

Conclusions:

  • Document template design parameters (grouping, ordering, granularity, wording) critically affect information findability.
  • User testing is essential for validating PIL template effectiveness and translations.
  • The proposed revised template offers superior information findability for patients.