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

Client feedback_Readability User Testing_Jan15User 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.

Luto’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).


The appropriate selection of participants is critical to obtaining robust results from interviews. Luto’s market leading database of participants includes patients, carers and healthcare professionals. We have built links with community and support groups which allow the efficient recruitment of specialist patient cohorts, where required.

In this video Professor Theo Raynor gives an overview of user involvement in patient information.


Luto has extensive experience in the field of User Testing and has conducted over 1,000 User Tests for clients throughout the EU. We have experience covering all types of submission procedures: Centralised, Mutual Recognition, Decentralised and National procedures.

We have conducted User Testing across all therapeutic groups from complex Package Leaflets for biotechnology products, to OTC ‘switch’ products. By using Luto, you will have direct access to over 30 years of expertise in Consumer Medicines Information built from a foundation in research.


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.

Our team

All User Tests involve directly employed and trained staff. Our experienced team are involved in every project, they include: information design specialists, graphic designers, psychologists, nurses, pharmacists and academics.

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.


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

Capacity and speed

As the largest User Testing company in the market, Luto has experience in handling large and complex portfolios for global pharmaceutical companies. We also have experience with biotechnology products and unlicensed medicines (‘specials’).

Our size means that Luto has the capacity to start work quickly and we have completed User Tests within four weeks.


Luto strives to understand its clients’ needs and deliver a service that reflects the best elements of price, quality, speed and expertise.

The User Testing marketplace is competitive and unregulated. Our experience in communications research with robust testing methodologies delivers excellent results readily accepted by Competent Authorities. Luto believes that the formula of experience, quality and speed delivers the best value in the marketplace. Luto’s returning clients are a testament to this.

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.

Contact us today to discuss your requirements for Readability Testing.