Applying User Testing Methodology
User Testing examines how a piece of information – in this case the PIS – will perform when given to people for the first time.
Participants read through the document and are then asked to answer a series of factual questions, first by finding where the relevant information is located, and then by stating it in their own words.
EU legislation requires User Testing to ensure that Package Leaflets are understandable by patients. It has superseded readability formulae (such as the Fog or Flesch scales), since it looks at document performance and not just its content.
Whilst sharing some common methodology with legislated Package Leaflet testing, User Testing of PIS is applied using a more iterative, formative process, to highlight and where possible correct problems with patient information.
Participants read through the document and are then asked to answer a series of factual questions, first by finding where the relevant information is located, and then by stating it in their own words.
EU legislation requires User Testing to ensure that Package Leaflets are understandable by patients. It has superseded readability formulae (such as the Fog or Flesch scales), since it looks at document performance and not just its content.
Whilst sharing some common methodology with legislated Package Leaflet testing, User Testing of PIS is applied using a more iterative, formative process, to highlight and where possible correct problems with patient information.
