Readability User Tests (RUT)

PAINT-Consult is the leading provider of package insert readability user tests, with:  

  • readability user tests in English, German and all other official European Union languages
  • EU-wide acceptance and validation of our written readability test method
    - minimum 20 participants divided across 2 test rounds
    - final report in PDF version ready for submission in compliance with CTD module 1.3.4
  • completion of the readability user test in 4‑6 weeks including extensive optimisation of the package insert; test completion within 2 weeks is possible
  • flexible, tailored solutions for each package insert
  • tests of instructions and handling of application devices
  • high levels of pharmaceutical expertise and customer satisfaction  

 

PAINT-Consult's written readability test method is accepted by all European medicines agencies for all procedures - CP, DCP, MRP and national. Examples include:

  • CMDh - co-ordination group of European medicines agencies (PDF)
  • BfArM - German medicines agency (PDF)
  • AGES - Austrian medicines agency (PDF)
  • MHRA - United Kingdom medicines agency (PDF)
  • URPL - Polish medicines agency (PDF)

 

PAINT-Consult achieves the following package insert optimisations in readability user tests:

aspect


average

original
package inserts

(n)
optimised
package inserts

(n)
optimisation-
quota

(%)
difficult words8614*84
abbreviations17476
long sentences
(longer than 20 words)
29776
volume of text
(number of words)
2505200220

Drug Information Journal 2010 (PDF)
* All remaining difficult words were explained using our study results. 

The development of readability user tests

Research into the readability and comprehensibility of package inserts via readability user testing 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 questions the test participant 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 provides the requested information independently. The tester observes the participant carefully during the written readability test, however, influencing factors such as facial expressions, gestures or hearing problems, are irrelevant and a true-to-life test situation is provided. Once the questionnaire has been returned, the tester discusses any relevant test issues with the participant.

Due to its self-designed and validated written readability test method, PAINT-Consult has a unique position among providers of readability user tests within the European Union.
Both forms of readability user tests remain the only EU-wide officially accepted methods for readability user tests and are referred to in the CMDh position paper from February 2011 (PDF) as the “Australian method of user testing" and the "self-completion method".

Last update: 30.10.2018

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