Masterarbeit
Readability User Testing of package leaflets: Regulatory requirements, methodologies and assessment ***
Kirsten Martin (2007)
Language: English
The performing of "consultation with target patient groups" according to Article 59 (3) of Directive 2001/83/EC as amended in order to check legibility, comprehensibility and usability of a package leaflet (PL) is on of the requirements of the New Medicines Legislation (NML).
PLs are created to inform patients adequately about the risks and the benefit of the medicinal product. The information presented in a PL is often not well understood by patients which can cause inappropriate use of the medicinal product in question.
User testing is only a tool to check the readability of a PL. Before testing, all efforts should be made to improve the readability.
Beside other guidances, the Guideline on Readability of the label and package leaflet of medicinal products for human use is the most important document to assist writers of a PL to create a legible and comprehensible leaflet. Due to the introduction of the NML, this Guideline is under revision. The recommendations provided in the draft version are listed and analysed regarding their meaning for the readability.
The demand for performing consultation with target patient groups does not require a specific method. The best investigated and described method is Diagnostic User Testing which was developed in Australia. Many guidance documents exists, but none of them describes all important items in one. In this thesis all aspects which need to be taken into account in order to perform such a test successfully are described and analysed. Two other appropriate forms of consultation, the written readability test called PAINT and the
Psychological Analysis of Patient Information named P.A.P.I, are also introduced and described.
P.A.P.I has been developed in Austria. This method to check the readability of PLs until today is only used for national Austrian marketing authorisations.
In opposite, PAINT has already been used for testing PLs as part of a European marketing authorisation procedure. This makes it possible to investigate the effectiveness and usability of the PAINT method in comparison to the golden standard of User Testing.
In order to compare both methods effectively, tests have been chosen which were performed for similar medicinal products.
This thesis shows that both methods can be used to check the readability of PLs.
The conclusion of this comparison is that not the used method itself but the correct performance of testing and the draw up of the right conclusion from the test results is most important to improve the readability of a PL.
Additionally to the assessment of the test reports, the resulting PLs have been compared. Legibility and comprehensibility have been tested using known criteria for readability.
The discussion at the end of this thesis shows, how and if testing changes PLs and whether testing is a meaningful tool to improve PLs. Several measures are shown, which could improve and harmonise PLs. A future scenario should be the creation of comprehensible, well designed and structured PLs,
A PL of high quality in design, layout and wording might not experience any change by User Testing. So the future approach could be the creation of ideal and patient-orientated PLs which do not need to be tested anymore.
Pages: 69, 3 Annexes: 75 pages