Developing online resources to create accessible patient information leaflets

The National Literacy Trust says that 7.1 million people (16 per cent of adults) in England have very poor literacy. Giving long and complex information to people who might want to take part in clinical trials is a well–known barrier to taking part.

Clinical trials are research projects that compare different treatments to see which one is best. People who are asked to take part in clinical trials are often given written information about the trial first. This information usually comes as a leaflet and should have everything people need to know to help them decide if they would like to take part.

Patient information leaflets are often long, complicated and difficult to read. This can stop people with low English language literacy taking part in trials because they aren’t being given the information in a way that is easy to understand. It can also make it challenging to translate them into different languages. Simplifying the information we provide in patient information leaflets could improve people’s understanding and help a wider range of people to take part in trials.

This project follows our previous work on the MAPLE project. The MAPLE project looked at how to make trials more accessible through better patient information leaflets. We looked at what has been written about making patient information leaflets easier to understand. We also worked with marginalised community groups, charities and patients to ask their advice. We put all this information together to make ‘best practice’ guidelines for creating accessible patient information leaflets.

Project aims

Our aim was to use guidelines from the MAPLE project and work together with members of the public, marginalised community groups, charities and IT experts to make online resources. These resources will help researchers make visual, inclusive and accessible patient information leaflets for clinical trials.

What we did

Through 19 workshops with over 150 attendees from underserved communities, patient groups and charities, we developed resources to support researchers to create accessible and inclusive patient information leaflets for clinical trials.

The resources are:

• A modifiable, accessible patient information leaflet which can be downloaded and adapted for each trial
• A collection of guides to help researchers adapt the accessible patient information leaflet
• Example images and image guidance for each section of the accessible patient information leaflet

These are available for anyone to access.

The resources and more information about the project are available on the MAPLE website. The accessible patient information leaflet is free to use in academic research, and a small fee applies for use in commercial research.

We are now publicising these resources so researchers can use them to create more accessible and inclusive recruitment information for clinical trials.

What we hope to achieve

By creating these resources to help researchers make better patient information leaflets, we hope to help make it easier for patients with low English literacy to take part in clinical trials, and get better diversity in those people who take part. This would mean that clinical trials of the future will better represent the people who live in the UK.

Partners

We involved community, patient and charity organisations and groups throughout the project, including:

• National Voices
• Dhek Bhal
• My Friday Coffee Morning – Barton Hill
• The Brandon Adventurers
• Patient Experience Partnership in Research (PEP-R) group
• Research Abilities Group, Lawnmowers Theatre Company
• The Misfits Theatre Company
• Chinese Community Wellbeing Society
• Eastern European PPI Group
• OUTpatients
• TransActual
• Roma Support Group
• Learning Disability England

We also involved people living with physical and mental health conditions.

More information about the people involved in this work is available on the MAPLE website.