PIL readability testing

The DOCLINX team provides services for conducting user testing of package leaflets.

What is the purpose of user testing for package leaflets?

A package leaflet (instructions for medical use) is an official document approved by the authorized body of an EAEU member state in accordance with current regulations. It contains important information for the consumer and is included with the packaging of the medicinal product.

User testing takes into account patients' opinions on the content, design, and layout of the package leaflet. This allows for the creation of a final document that is submitted as part of the registration dossier and helps most consumers of the medicinal product make safe and correct decisions about its use.

Technical requirements for the package leaflet

When conducting user testing, it is necessary to use a full-color mock-up of the package leaflet for the medicinal product intended for release. Using only a text version is not acceptable, as the design and layout significantly affect the patient's ability to find and understand key information about the safe use of the product.

The design and layout of the package leaflet are key aspects that influence how effectively patients receive important information about the safe use of the medicinal product. The main elements of design and layout include:

• font and its size;
• headings and subheadings, their uniform placement;
• dimensions of the package leaflet, page orientation (portrait or landscape), and number of columns;
• color scheme;
• writing style and wording;
• design of sections critical for safety;
• use of pictograms.

How is user testing of package leaflets conducted?

The authorized bodies of EAEU member states do not require the use of a specific testing method. Instead, they evaluate data confirming that potential users of the package leaflet are able to find the necessary information and apply it correctly.

The standard methodology for conducting user testing is described in the EEC Council Decision No. 78 "On approval of requirements for instructions for medical use of medicinal products and general characteristics of medicinal products for medical use", Appendix No. 14.

Testing of the package leaflet can be conducted by the marketing authorization holder or a specialized contract organization. It should be performed by an experienced specialist with interviewing skills, observational abilities, and the ability to listen carefully and understand the consumer.

The user testing process consists of the following stages.

Preparation stage for the study:

• Writing the text of the package leaflet
• Preparing the mock-up of the package leaflet

Conducting the study:

• Drafting the testing protocol
• Selecting test participants
• Pilot testing
• Main testing
• Analysis of results
• If required, making changes to the package leaflet and retesting
• Compiling a report on the results of the testing conducted

For successful testing, 20 participants are sufficient (not counting those who participated in trial tests).

For successful user testing, it is important to identify key information about the safe use of the specific medicinal product in advance. This information is unique to each product. The questionnaire should cover these key points and confirm that patients can find and understand them for safe use of the product.

Questions should be open-ended, allowing the participant to imagine themselves in a specific situation, and should not suggest the answer from the package leaflet. Each question should be carefully formulated. Accumulation of data or inability of participants to find or understand one or more key questions is unacceptable.

There is no need to test all patient groups in all possible situations. It is sufficient to include participants who can imagine themselves in the condition for which the product is used. To avoid misunderstanding, information intended for healthcare professionals and other specialists working with medicines should not be included. People who are very familiar with the tested product are usually not suitable for participation in testing. However, they can be a valuable source of recommendations at the stage of study design development.

What are the criteria for successful user testing?

The test result is considered acceptable if 90% of participants understand the information requested from the package leaflet. This means that 16 out of 20 participants were able to find the necessary information, answer each question, and act accordingly. Success criteria must be achieved for each question separately - results cannot be generalized across the entire study.

Is it necessary to conduct repeated user testing when making changes to the package leaflet?

When making significant changes to the design and layout of a previously tested package leaflet, it is often necessary to adjust the dimensions of the leaflet in accordance with new production capabilities. If the orientation and placement of information remain unchanged, additional testing or bridging studies are not required. However, changes in page orientation, text size, or the introduction of alternative formats (for example, switching to a booklet format) should be considered as grounds for conducting additional bridging studies, focus groups, or, in some cases, full-scale user testing.

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Regulatory acts

• EEC Council Decision No. 88 "On approval of requirements for instructions for medical use of medicinal products and general characteristics of medicinal products for medical use"