Readability Testing of Patient Information Leaflets

Product – MediLingua Medical Translations B.V.
Readability Testing of Patient Information Leaflets

Contact Supplier: MediLingua Medical Translations B.V.
Supplier Product: Readability Testing of Patient Information Leaflets
Address: Poortgebouw – Rijnsburgerweg 10, 2333 AA Leiden, The Netherlands
Tel: +31 71 568 0862
Fax: +31 71 523 4660

Readability Testing of Patient Information Leaflets

MediLingua provides a specialist readability testing service to ensure compliance of patient information leaflets for drugs and other medicinal products, and recently completed test project number 300!

Since November 2005, all medicinal products in Europe are legally required to have patient information leaflets (PILs) readability-tested to ensure they comply with European Directive 2001/83/EC (as amended by Directive 2004/27/EC). These stipulate that leaflets should be “legible, clear and easy to use”, and that the manufacturer has to deliver a readability test report that confirms these qualities.

The (British) Medicines and Healthcare products Regulatory Agency (MHRA) defines the reason for testing as ‘to help produce a leaflet that most medicine users can use to take safe and accurate decisions about their medicines’.

Detailed requirements for leaflet compliance have been left largely undefined and most readability test services have simply extracted their own test method, based on ‘an example of a method for testing the readability of the leaflet’ that was published by the EC.

MediLingua obeys more rigorous criteria that ensure the leaflet will:

• Comply with the template published by the Quality Review of Documents (QRD) group of the European Medicines Agency (EMA) that defines what information has to be placed under various headings.
• Use the correct template for central procedure (CP), mutual recognition procedure (MRP), or decentralized procedure (DP).
• Pass validated readability tests for spelling, grammatical construction, non-ambiguity, specificity, clarity, and ease of understanding.
• Be correctly understood by at least 90 per cent of readers.

The MediLingua Method
We test leaflets using a rigorous seven-step method.

1. All our readability test projects begin with a preparation phase, during which the text of the leaflet is carefully edited and checked; spelling or grammatical errors are corrected and sentences are rephrased. This is an important step: approximately 70 per cent of all changes to the leaflet are made during the preparation phase, which aligns content to the appropriate EMA template.

2. We then draft a questionnaire with 12 to 15 questions that cover the most important details of the product and its use(especially safety aspects). These are the questions that must be answered correctly by any user to ensure they are using the product correctly.

3. We then conduct a pilot test with five readers who assess the prototype leaflet from the viewpoints of clarity, simplicity of language, safety, non-ambiguity, etc.

4. Results from the pilot test are used to revise the leaflet (text and/or design) and, if necessary, the questions. At this point, everything is ready for the actual test.

5. The full test is conducted using two test panels, each of 10 people who are balanced for age, gender and education and who are native speakers of the language of the leaflet. We ensure each test panel contains at least one young person (18- 22 years of age) and two or three over-60s. The testers on each panel are then interviewed on the 15 key questions about the product, and are allowed to refer to the leaflet where necessary. A readability test consists of at least two test rounds during which all testers should answer most questions correctly and no question should consistently cause problems. The criteria have to be met in one test round and the results should be confirmed during the next round.

6. After each test round, the results are scored for success in answering questions correctly and speed of response. A leaflet passes a test round when:
• At least 90 per cent of the questions lead to the right information being located
• The information is correctly understood in 90 per cent of responses

7. Where a leaflet has passed testing, a report is written that details test results. In the rare cases where a leaflet does not successfully pass the first test round, we re-examine any problem areas and carry out the process again.

For more information or to discuss the readability testing of patient information leaflets please contact MediLingua Medical Translations directly.

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