Your specialist for readability compliance and readability user tests
Why is a readability user test carried out?
The patient information leaflet is, along with the consultation with the doctor and pharmacist, the most important source of information for patients about their medicinal products. When designing patient information leaflets, the pharmaceutical manufacturer is subject to numerous legal provisions that are anchored in Directive 2001/83/EC or the national legislative specifications such as the German Drug Law.
The patient information leaflet must be legible, easy to understand and user friendly, which is of course in the interests of the pharmaceutical company. To ensure that these requirements are met, in addition to the ever growing number of amendments to Directive 2001/83/EC, there are a number of European but also national recommendations that have been published such as the Readability Guideline in 2009, the QRD template and the notification about the restructuring of patient information leaflets.
Previous experience in the implementation of the legally required readability test demonstrates that this improves the understandability of patient information leaflets while also providing additional qualitative information. A patient information leaflet with clearly formulated contents and a logical design can also increase trust in the product and its manufacturer.
Readability user test and bridgings by orangeglobal
orangeglobal is an expert in readability user tests and bridgings and analyses the readability of the patient information leaflets for your medicinal product using consultations with target patient groups. By carrying out a readability user test we checks whether the patient can locate the necessary key messages for safe use of the particular medicinal product in the patient information leaflet and can understand that information.
Subject to certain requirements, readability can be demonstrated using existing readability results for other patient information leaflets. Standard methods include an abbreviated focus test on any variation of the patient leaflet (10 users are tested) and bridging by comparing content and layout differences between patient leaflets.
As part of the readability compliance, orangeglobal helps you with all issues related to readability testing and assessment of patient information leaflets in accordance with European specifications.
After clarification of the individual requirements, we carry out a comprehensive assessment of your patient information leaflet considering the relevant readability quality criteria and make proposals for optimising the text in terms of patient friendliness and the specifications of the authorities (e.g. Quality Review of Documents, so-called QRD-template).
Of course, we also provide recommendations for improvement on the design and layout of the patient information leaflet and complete the preparation and printing of the mock-up.
Carrying out the readability user test
The readability user test is carried out in English, German and each of the other official EU languages in accordance with SLESS and WISEMAN (1997).
For this purpose
- we prepare the product-specific questionnaire required for the readability user test
- we recruit subjects based on the target group
- we carry out interviews with the subjects in the form of a pilot test
- if necessary, we optimise the patient information leaflet and carry out the main test with 20 subjects
- we analyse the readability user test both qualitatively and statistically and
- we prepare a final report in a submittable version for Module 1.3.4 of the CTD-Dossier in English.
David Sless and Rob Wiseman, 1997: Writing about medicines for people, Usability Guidelines for Consumer Medicine Information, 2nd Edition, Communication Research Institute of Australia.
Carrying out the focus test and bridging
If a readability user test is not required, we carry out an alternative, shorter procedure for you such as a focus test or bridging:
- evaluation of previously conducted readability user tests regarding their suitability as reference material
- detailed comparison of your patient information leaflets (content, layout) with previously tested potential reference texts
- analysis of the effect of differences in your patient information leaflets on the success rate of a bridging for each key safety message
- writing a bridging report according to the CMDh template for a Decentralised (DCP) or Mutual Recognition Proceudre (MRP) or EMA template for a Centralised Procedures (CP). In case of a National Procedure of marketing authorization application we apply our standard and approved report format.
- execution of cost-effective focussed readability user tests if the differences cannot be justified by a bridging study alone
- robust argumentation taking into account contents, structure, layout and linguistic quality of the patient information leaflets
- harmonisation of your patient information leaflets with your tested reference texts, also across language boundaries.
As the leading service provider in the area of readability user tests and bridging, you benefit from our excellent experience and strategic and cost planning competencies for your entire product portfolio. We ensure that the readability user tests, that we carry out for you can be used across all of Europe.
Since December 2005 we have successfully carried out more than 2.800 readability user tests and bridgings in various European member states (99% success rate). Thanks to our flexible and customer-focused solutions for every patient information leaflet all the requirements for the readability user test and the final reports are met, ensuring that all regulatory authorities accept our readability studies.
We are happy to send you a detailed quote based on the provided dossier information of your drug product(s) and your objectives.
Please feel free to contact:
Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de