Readability Testing Patient Information Leaflets (PILs) and Instructions for Use (IFUs) across the EU and US

User Testing as a method of Readability Testing was developed in the 1990s in Australia. It has been widely applied to diverse types of consumer information and its application has been extensively researched.

Readability Testing itself does not improve the quality of the information. It should be employed in a formative, iterative way to identify and rectify readability problems within Package Leaflets (also known as Patient Information Leaflets or PILs), Instructions for Use (IFUs) and other patient information.

It is possible for badly written leaflets to pass testing where the methodology has been poorly applied. Competent authorities are increasingly aware of this and are looking for the correct application of the methodology and importantly that improvements are reflected in the final leaflet.

Client feedback_Readability User Testing_Jan15Luto’s methodology

Luto’s unique methodology recognises both the formative and iterative nature of User Testing. Before conducting a study, we are happy to advise on the readability of the material being tested and, if appropriate, offer a full review of the leaflet, incorporating our unique ‘Audience Design Step’ (ADS).

Reporting

As part of our service, we supply a comprehensive report detailing the process of User Testing and a full analysis of study results. The reports are written in line with regulatory requirements and are reviewed and signed off by an expert in the field of consumer communications. Our reports have been submitted to Competent Authorities throughout the EU and US.

Portfolio bridging

Competent Authorities do not expect every product’s Package Leaflet to be readability tested. Luto has successfully applied its bridging expertise to many large client portfolios. This expertise can greatly reduce the cost of Readability Testing for clients.

Quality

Luto is one of the very few ISO 9001 accredited User Testing companies. The benefits for clients are:

  • Fully documented procedures
  • Audited operations, including electronic recording of all interviews, which can be made available to clients
  • Luto welcomes client visits to oversee or audit operations

Requests for information

Luto’s service does not stop when the User Testing report is delivered to clients.

Luto looks to provide clients with support in dealing with information requests that may arise post submission from the diversity of Competent Authorities throughout the EU or US. Luto’s quality processes and audit trail throughout the User Testing process are particularly relevant in supporting clients’ feedback.

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