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Extensive research published concerning the QRD template

Dr. Anna Wolf finalised her extensive work in February 2015 concerning the QRD template of the European Union, under PAINT-Consult’s supervision at the University of Bonn. 

This dissertation (PDF) contains the following main investigations:

  • development of the QRD template from 1996 up to the present day
    Main results: Many improvements as a result of version 8; however, extreme text increase over the years. See sections 4.1 and 4.2.
  • comparison of templates used in EU and non-EU countries
    Main result: Many similarities in structure and content between different countries. See sections 4.3 to 4.5.
  • implementation of the QRD template based on an analysis of package leaflets of all centrally approved medicines
    Main result: Quick implementation through the pharmaceutical companies; however, the QRD template is one of the main reasons for the ongoing text increase in package leaflets. See section 4.6.
  • readability tests with 241 participants in the United Kingdom and Germany of QRD templates 7.3.1, 8 and a model template containing only 200 words. The model template investigated was developed by PAINT-Consult and successfully investigated in another QRD template study published in the PharmInd journal (PDF)
    Results include:
    Version 8 is an improvement
    of version 7.3.1; however, the shorter model template has significant advantages compared to both QRD templates. Relevant disadvantages were not found. The current side effect frequency explanation shows significant comprehensibility problems - particularly overestimations - compared to the EMA version published 2007. Deletion of the MAH representative list is a key patient request. See sections 4.7 to 4.10.

     

Last update: 12.10.2020

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