A positive readability test outcome matters. But it should not be the only measure of the quality of a patient information leaflet.
Readability testing is not an exam that a PIL needs to “pass”. Its purpose is to show whether real users can effectively use the information they have been given.
That distinction changes how we think about readability.
The test outcome matters. The patient matters more
In the regulatory process, it is easy to look at readability in terms of deliverables: the study has been completed, the required criteria have been met and the final report is ready for inclusion in the regulatory dossier.
From a regulatory perspective, all of this matters.
But the patient does not use the readability test report.
The patient uses the leaflet.
And they may reach for it when they need a specific answer – sometimes quickly, sometimes at a moment of uncertainty or stress.
So the real question is not only:
“Did the leaflet achieve a positive test outcome?”
It is also:
“Can the patient use it when they really need it?”
Readability does not end when the information has been found
A patient may find the relevant part of the leaflet, but that alone does not mean the information has fulfilled its purpose.
They still need to understand it correctly.
And in many situations, they also need to know what to do based on that information.
This is why, at PHARMBICON, we look at readability through three consecutive stages:
FIND → UNDERSTAND → ACT
FIND – can the patient find the information they need?
UNDERSTAND – do they correctly understand what it means?
ACT – do they know how to act on that information?
Finding the information is only the beginning.
The goal is a good leaflet. Not just a positive test outcome
This distinction is particularly important when preparing a document for user testing.
The aim should not be to tailor the leaflet to the testing process itself.
The aim is to provide information that patients can actually use.
Readability testing should show how users interact with the document – and it may reveal something that was not anticipated beforehand.
That is precisely where its value lies.
If readability is viewed only in terms of achieving the expected test outcome, it is easy to lose sight of the more important question:
Does the information actually work for the patient?
A positive outcome should not be the end of thinking about PIL quality
Readability is part of a bigger picture.
The leaflet needs to be medically and regulatory correct. It needs to contain the required information. And patients need to be able to find and understand that information.
These objectives do not compete with one another.
A good PIL brings regulatory requirements and the patient perspective together.
A positive readability test outcome is therefore important – but it should never replace thinking about the person the document was created for.
Summary
A positive readability test outcome matters.
But the ultimate user is not the report, the procedure or the regulatory dossier.
It is the patient.
That is why readability ultimately comes back to three simple questions:
Can they FIND it?
Can they UNDERSTAND it?
Do they know how to ACT?
The goal is a good leaflet. Not just a positive test outcome.