Patient Information Leaflet User Testing
Patient information leaflets need to demonstrate a satisfactory performance in user testing. This ensures compliance with the Directive 2001/83/EC as amended by 2004/27/EC Articles 59 and 63 which states:
“The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professional.”
SimPILy Read adopts a three phase process in the user testing.
Phase 1:
- Writing a new leaflet from SPCs or reviewing the existing leaflet.
- Checking the PIL is compliant with current regulatory requirements
- Designing the user testing protocol
- Pilot testing the protocol and the leaflet
- Advising on amendments or improvements
SimPILy Read will work with the company to identify key areas for testing and appropriate responses that would denote a satisfactory level of understanding by the user.
The protocol will test the user’s ability to locate key safety information in the PIL, understand it and know how to act upon it.
Phase 2:
- Subject recruitment
- Interviewing
- Analysis and feedback
Interviews will be conducted in rounds of 10 subjects until a satisfactory performance is achieved. i.e. 90% of target users are able to find information in the leaflet and, of those, 90% can understand that information.
Recommendations and PIL modifications will be provided as necessary.
Phase 3:
- Compiling the submission report
All results will be pooled and a final report will be based on the cumulative results. Implementation of recommendations by the company during the process will also be discussed.