A patient information leaflet (PIL) may be complete, aligned with the SmPC and prepared using the current QRD template – and still not be fully ready for readability testing.
Readability testing should not be the first time anyone looks at the leaflet through the patient’s eyes. Its value lies in showing how real users interact with the information – not in uncovering issues that could have been identified earlier.
“The PIL is final” can mean different things
For Regulatory Affairs, a final PIL may mean that the document is complete, its content has been agreed, it is aligned with the SmPC and follows the appropriate QRD template.
That is an important milestone.
But it does not yet answer another question:
Is the document ready from the perspective of the person who will actually use it?
Patients are not familiar with the SmPC or the QRD template. They were not involved in developing the product information and do not know why a particular piece of information appears in a particular section of the leaflet.
What matters to them is whether, at the moment they need it, they can quickly find the relevant information, understand what it means and know what to do based on it.
A patient may also reach for the leaflet at a moment of uncertainty or stress – for example, to check how to take the medicine, because they are concerned about a possible side effect, or because they need to know what to do in a particular situation.
It is not enough for the information simply to be present in the leaflet. Patients need to be able to reach it quickly – precisely when they need it.
This is where the regulatory perspective meets readability.
Regulatory compliance does not guarantee readability
The QRD template provides the essential structure for the leaflet and organises how information is presented. The SmPC provides the core source of medical information.
Both are fundamental.
But a document can be regulatory-compliant and still be difficult for the user.
The information may be present in the leaflet, but the patient may not find it.
They may find it, but understand it differently from what was intended.
Or they may understand the message correctly, yet still be unsure what they should do.
Having the correct information in the leaflet is therefore essential – but it is not, by itself, enough to ensure effective communication with the patient.
Patients do not know the leaflet as well as its authors do
Someone who has worked on the document knows where a particular piece of information is located. They know its structure and terminology. They may have read the same text many times.
A patient sees the leaflet from a completely different perspective.
They may look for information in a different place, use different words to describe what they are looking for, or focus on different elements from those anticipated by the people who developed the document.
That is why asking:
“Is this information in the leaflet?”
is not the same as asking:
“Will the patient be able to find it?”
This is where the real assessment of readability begins.
FIND → UNDERSTAND → ACT
At PHARMBICON, we look at patient information through three consecutive dimensions:
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.
This becomes particularly important when the information is intended to guide the patient’s actions.
Medical accuracy is essential. But for the patient, it is equally important to understand what the information means for them and what they should do as a result.
Readability testing should not be the first review of the leaflet
User testing is particularly valuable because it reveals the behaviour and interpretation of real users.
It may identify something that neither the document’s author nor a Regulatory Affairs expert anticipated.
And it should have room to do exactly that.
An expert review before testing and a study involving participants serve two different purposes.
The first asks:
Is the document appropriately prepared for testing?
The second asks:
How does a real user actually interact with it?
They are not alternatives. One does not replace the other.
Even a well-prepared leaflet can still surprise you
An expert review before testing cannot guarantee a positive outcome.
Nor should it.
If we could fully predict how patients would use a leaflet without involving participants, there would be little reason to conduct user testing in the first place.
The value of readability testing lies precisely in the fact that a real user may behave differently from what we expected.
The purpose of reviewing the document beforehand is therefore not to eliminate every possibility of an issue emerging during the study.
It is to ensure that the document entering the study is ready not only from a regulatory perspective, but also for meaningful evaluation with real users.
Summary
A final PIL is not always ready for readability testing.
Before starting a project, it is worth looking at the document from two perspectives:
REGULATORY – is the leaflet current, complete and appropriately prepared?
and
PATIENT – can the information be found, understood and used appropriately?
Readability testing should not be the first review of the leaflet. It should show how a well-prepared document performs when it reaches a real user.
Contact PHARMBICON
Are you planning readability testing and would like to assess whether your leaflet is ready before the project begins?