Managing Treatment eXperience (MTX): Developing psychoeducational resources for children with rheumatic conditions who are taking methotrexate

Background: Methotrexate is the gold standard treatment in rheumatic conditions, it is an immunosuppressive agent for many childhood inflammatory diseases. Whilst it can be highly effective, over half of children experience a phenomenon called methotrexate intolerance due to severe side effects leading to non-adherence and discounting medication. Establishing optimal treatment early in the disease, through better understanding and shared decision making around methotrexate (improved health literacy) has positive long-term implications. However, there are currently no psychoeducational resources co-developed with children and young people (CYP) that improve health literacy around methotrexate. Aims and objectives: to co-develop psychoeducational resources with CYP to address their knowledge and understanding about methotrexate treatment, and improve their ability to join in consultations, make choices and decisions and co-management treatment. The study is underpinned by three objectives, firstly to understand CYP s experiences of taking methotrexate, secondly to co-develop resources and thirdly to optimise resources by examining the acceptability of the resources developed. Methods: The three objectives will be addressed across three stages. Stage one will recruit 40 CYP aged 6 – 16, using maximum variance sampling to ensure a variety of conditions, ages, genders, points of treatment, neurodivergence and bilingualism. Photo elicitation interviews and activity books will be used to elicit CYP s experiences and perceptions. Data will be analysed through reflexive thematic analysis. Stage two will involve four participatory workshops with CYP (n=30), parents/caregivers (n=20) and the Young People Advisory Panel to co-develop drafts of the resources. Data collected will be analysed through a team-based rapid qualitative analysis. Stage 3 will use think aloud interviews with 30 CYP (aged 6 to 16) and focus groups with parents/caregivers (n=10) to review the prototypes of the psychoeducational resources and decide on the final versions. Data will be analysed to create a table of changes relating to format and content. Timelines for delivery: The study will be delivered within 18 months. The first 3 months will involve set-up, gaining ethics approval, training for PPI and establishing the steering committee. Stage 1 will be completed by month 10. Stage 2 and the co-development of resources (e.g. animations/books) will be completed by month 14. Stage 3 will be completed by the end of month 17. Across the whole project we will carefully plan outputs. Anticipated impact and dissemination: The team will write blogs, infographics and lay summaries throughout the project and share these widely through a University of Manchester hosted webpage and social media. The team (including PPI members) will present findings of each stage at academic and practice-based conferences. We will provide evidence briefings to the paediatric rheumatology clinical studies group and specialist forums. Findings written with PPI members will be published in open-access peer-reviewed journals. We will work with impact managers to review our pathway to impact plan and host a multi-disciplinary workshop at the end of the study to gain consensus on the next steps for evaluation, implementation and dissemination of the psychoeducational resources.