Readability User Tests (RUT)

Benefit from our many years of regulatory and pharmaceutical expertise!

 

What we test within our readability tests:

  • package inserts of all medicines and medical devices
  • handling instructions for application systems for medicines and medical devices
  • patient information for each type of study, including consent forms
  • any other medical information

 

Our readability tests include:

  • systematic review and optimisation, or preparation of package inserts, (text and layout) based on our regulatory and pharmaceutical competence and
    - our checklist of almost 200 validated quality criteria
    - the results of our studies with over 10,000 participants
    - our comprehensibility studies of over 2000 medical terms
    - findings from more than 1400 evaluated scientific and regulatory publications
  • generation of product-specific questionnaires
  • tests with at least 20 participants divided across 2 test rounds
  • final test report in each required official European Union language in a PDF version ready for submission in compliance with CTD module 1.3.4

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Phone: +49 3641 549396

The benefits of our test method are:

  • EU-wide, validated written readability test
  • readability tests in English, German and any other official European Union language
  • precise and reproducible evaluation during testing
  • completion of the readability user test in 4 to 6 weeks including extensive optimisation of the package insert; however, test completions within 2 weeks are also possible
  • flexible, customer tailored solutions for each package insert and other information to be tested
  • high levels of pharmaceutical expertise and customer satisfaction
  • inclusion of the option of bridging studies following the tests

 

Validated written readability test

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:

  • CMDh - Co-ordination group of national 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

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: 06.11.2019

  Contact
  +49 3641 549396