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)
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.