Benefit from our many years of regulatory and pharmaceutical expertise!
What we test within our readability tests:
Our readability tests include:
The benefits of our test method are:
In the late 1990s, Dr. Jörg Fuchs developed the written readability test with standardised questionnaire. The high level of validation and standardisation inherent in this process guarantees valid and reproducible results.
Thus, in its position paper dated February 2011, the CMDh group explicitly recommends PAINT-Consult’s written readability test as an alternative to the Australian interview method (PDF).
PAINT-Consult's written readability test method is accepted by all European Union medicines agencies of the European Union for all procedures - CP, DCP, MRP and national. Examples include:
PAINT-Consult achieves the following package insert optimisations in readability user tests:
(longer than 20 words)
|volume of text|
(number of words)
Drug Information Journal 2010 (PDF)
* All remaining difficult words were explained using our study results.
Testing the legibility and comprehensibility of package inserts medicines via readability user tests began in the 1990s.
Australian communication researchers played a leading role in this field and developed readability user tests in the form of verbal interviews. Using this method, the interviewer asks the test participant questions on the key messages of package inserts via a verbal "face-to-face" interview. This method of readability user tests was published in 1998 in the Readability Guideline (PDF), as an example for the implementation of readability user tests.
In parallel, PAINT-Consult developed the written readability test method, which has since been validated by various studies with several thousand participants. In contrast to the Australian verbal readability user test, the participant receives all instructions and questions via a questionnaire and independently provides the requested information on this. The tester observes the participant carefully during the written readability test. Influencing factors such as facial expressions, gestures or hearing problems, are irrelevant and a true-to-life test situation is created. Once the questionnaire has been returned, the tester discusses any relevant test issues with the participant.
Due to its self-developed and validated written readability test method, PAINT-Consult occupies a unique position among providers of readability user tests within the European Union.
Both forms of readability user tests are the only EU-wide officially accepted methods for readability user tests and are mentioned in the CMDh position paper from February 2011 (PDF) as the “Australian method of user testing" and the "self-completion method".
Last update: 09.04.2019