Co-design of resources to support researchers to develop accessible and inclusive patient information leaflets for randomised controlled trials: the UK-based MAPLE project

BACKGROUND: Low English language literacy and diverse communication needs are widespread in the UK. Provision of lengthy and complex patient information leaflets (PILs) for clinical trials can impose a barrier to research participation. Inclusive research design incorporates providing clear and accessible written information, often in a layered approach. This project aimed to co-design resources to support researchers to create visual, inclusive, and accessible PILs for randomised controlled trials (RCTs). METHODS: Nineteen public and community involvement and engagement co-design workshops were held with nine groups, with a total of 150 attendees. Workshops were held with communities, patients, and charity representatives that are often marginalised in health research, including representation from racially marginalised communities, adults with learning disabilities and/or autism, adults with physical and mental health conditions, and the LGBTQIA+ community. A prototype modifiable accessible PIL was developed by the research team, designed using previously co-developed recommendations. During the first round of 10 workshops, a prototype accessible PIL was reviewed and discussed, and changes made to the phrasing, order, format, and layout. Additional feedback informed the development of guidance to researchers on the use of the accessible PIL. Suggestions for images for each section of the accessible PIL were collated and corresponding images sourced from online platforms. During the second round of nine co-design workshops, images were discussed and selected for inclusion, alongside recommendations for further edits and refinements to the accessible PIL and guidance to researchers. RESULTS: The co-design process resulted in substantial changes to the prototype accessible PIL. A suite of resources were developed, including an adaptable accessible PIL that can be downloaded and modified offline for each RCT, a selection of images from which researchers can choose images to purchase from platforms to include in their accessible PIL, and additional guidance on the use and modification of the accessible PIL. The resources are available at https://maple.bristol.ac.uk/. CONCLUSION: These co-designed practical resources aim to support researchers to create more accessible and inclusive written information to reduce English language literacy as a barrier to participation in RCTs, as part of a layered approach to information provision.