Readability testing required but you don’t know where to start?
We’ve been taking the time and guesswork out of readability and usability testing for 20 years.
We’ve been taking the time and guesswork out of readability and usability testing for 20 years.
Let’s say you’re in pharma or medical devices. Do you know how to read a patient leaflet from a patient’s perspective? Do you know how to edit it if patients don’t understand? Do you know where to recruit 25 lay participants of the right mix of age, gender and background?
Because if you’re a drug manufacturer, you must include a readability test report in your regulatory submission. And if you’re a medical device manufacturer, you must often include a patient section in your SSCP.
So what do you do?
Get MediLingua to do it for you.
We can perform a readability test of labels and package leaflets for drugs. We also test patient sections of SSCPs for medical devices. We pull in participants, draw up safety questions, conduct interviews, edit where necessary, and send you a fully traceable test report.
From there, you upload your readability test report to the regulatory authorities. Done!
We do usability testing, too. We check that IFUs are easy to follow and allow your end users to safely operate your product.
Typically, we perform usability testing for high-end hospital equipment, test kits and home-use medical devices.
We’ve helped pharma and medtech with their readability and usability testing since it became an EU requirement. That’s almost 20 years of testing package leaflets, IFUs and SSCPs.
With this many readability tests under our belts, we can smell a problem like a shark smells blood in water. Which is good, since this way you only have to pay and wait for your readability test once.
But we are not medical people. In other words, we can understand any medical document you throw at us. But we see it from the patient’s perspective. No jargon slips by our eagle eyes.
MediLingua is certified to ISO 9001 and ISO 17100. These certifications are the two stamps of approval that regulatory authorities look for, making our translations perfect for your regulatory submissions. Even so, we don’t believe in just meeting standards. We believe in surpassing them. That’s why we take our quality of translation even further.
Get it right first time with MediLingua.
The readability test is a small but crucial step in your MAA. You’re right to think carefully before choosing the right provider. Read on for further reassurance. If you’ve got questions, we’d love to hear them.
First, we take your label, package leaflet or SSCP and screen it for problems. We check you’ve followed the QRD template, MedDRA terminology and EDQM terminology. We also look for obvious problems that would cause the text to fail the test. If we find any, we come back to you with suggestions on how to fix them. These pre-test checks save you time and money. You don’t want to fail the test and have to do it again, do you?
Once your text is test-ready, we draw up a list of questions about the key safety aspects of your product. These are the parts of your patient text that lay readers must understand.
We enrol 20 to 25 lay participants if we’re performing a readability test of a package leaflet for a medicine. For other texts, we enrol around 10 to 15 participants. These participants must:
1. not have medical knowledge
2. include people over the age of 60
3. include men and women
4. have an average level of education
Next, we conduct and record one-to-one interviews with each lay participant. We interview them in a quiet, distraction-free environment. We ask each one the same questions. We closely observe how much time and effort it takes the lay participant to answer the questions. If they answer incorrectly, we ask them what the problem was. If they answer correctly, we ask them what could be made clearer.
Please note: If there is a clear problem with your text after the first 3 interviews, we stop. We suggest ways of making the text easier to read and validate them with you. Then we retest the new version of your text.
We follow EU guidelines on readability tests for labelling and package leaflets.
Once the test is complete, we provide a test report detailing the participants, test phases, and changes made to your text based on the test outcome.
Still unsure about some aspect of readability or usability testing? Tell us what it is.
When we do a readability test, we usually test patient information. This may be the package leaflet and labelling for a drug. It can also be the patient section of a SSCP for a medical device. In a readability test, we want to find out how easy it is for patients to answer questions they may have about their medicine or device. An example question is “Can I take this medicine if I’m pregnant?”
When we do a usability test, we check the manual or IFU of medical equipment or a medical device. Here, we test how easy it is for the user to operate the equipment or device using the instructions. This time, example questions are “How do you create a new patient profile?” and “What do you do if this error message appears?” If we are testing the IFU for high-end medical equipment, we test it on healthcare professionals. If we’re testing the IFU of a home-use medical device or a test kit, we test it on lay participants.
Yes, there are free tests like the Flesch Kincaid and Fry readability tests. These do basic calculations. For example, they count the number of words in each sentence. Then, they apply a formula to the result to give you a readability score. These free tests eliminate simple problems of long sentences and difficult words.
But free tests like these are not accepted by the regulatory authorities. Besides, can a statistical model recreate the real-life experience of a 62-year-old who’s not sure whether the medicine they’ve just been prescribed is safe to use with the anticoagulants they forgot to tell their doctor about? We don’t think so.
If possible, we can also do what is known as a “bridging analysis”. Here, we test your patient text or user manual against a previously validated text. This can save you certain costs compared to a full readability or usability test. Contact us for more information.