Making trials more accessible through better patient information leaflets

The participant information leaflets (PILs) used in clinical trials are often long, complicated and not written plainly enough. These impose a barrier to research participation, potentially preventing people with lower English language literacy from participating because the information provided is not useful to them. 

One approach to providing participant information in a more accessible way is to use a layered approach. Layering means that people can choose how much detail they are interested in. For example, layering information through links to webpages with more information or signposting to wider resources. This is an approach recommended by the UK’s Health Research Authority, especially when done together with patient and public contributors. 

There is a framework of recommendations for developing accessible participant information. The researchers who developed the framework, mainly based at the University of Bristol in the UK, knew that while useful, the framework would not be enough on its own to support changes in how PILs are put together.  To address this, the team created the MAPLE project and worked with patient and public contributors to create a suite of practical resources to support researchers to create accessible PILs for clinical trials.  

These resources were created through 19 workshops with communities, patients and charity representatives. Over 150 people attended these workshops, with representation from racially marginalised communities, adults with learning disabilities and/or autism, adults with physical and mental health conditions, and the LQBTQIA+ community. The resources developed are: 

• A modifiable accessible PIL which can be downloaded and adapted offline for each trial 
• A collection of guides to support the adaption of the accessible PIL 
• Example images and image guidance for each section of the accessible PIL 
  
  

The resources and more information about the project are available on the MAPLE website: https://maple.bristol.ac.uk/  

You can download the flyer shown above here.