What has been happening behind the scenes of the MTX study?
The short answer is: quite a lot!
Over the past few months, the research team has been working through the approval process needed to start the MTX Study. We're delighted to share that we have now received the green light from the NHS Research Ethics Committee and from our study sponsor, the University of Manchester, so the study can now move forward!
Although these approvals are an exciting milestone, they are not just about paperwork. Their purpose is to make sure that research is safe, ethical, and conducted in a way that protects and supports everyone who takes part.
Getting to this stage has taken a lot of hard work, as by the time we submitted our final study documentation, we had developed almost 120 different documents.
Why so many study documents?
120 study documents might sound like a huge amount, but there is a good reason for it.
Our aim has always been to make things as simple, flexible and accessible as possible for the children, young people and parents who may take part… even if that means making things a little more complicated for the research team behind the scenes! We were told by our amazing advisory panel that the most important thing was to provide choice, but make sure there is not more information than is needed to make informed decisions.
For example, rather than creating a single information sheet for everyone, we developed different versions for different age groups and study activities. Younger children may want information presented differently from teenagers, and parents often need different information from their children. Creating separate materials allows everyone to receive information that is appropriate for them.
Offering different ways to take part
An important feature of the study is that children and young people can choose how they would like to share their experiences.
Not everybody enjoys taking part in research in the same way. We were told that some children prefer talking, whereas others find it easier to express themselves through activities, photographs, videos or drawings.
Following discussions with our advisory panels of children, young people and parents, we developed several different participation options, including:
Activity booklets with creative exercises
Interviews
Photo and/or video blog (vlog) activities
All of these approaches are designed to explore similar topics, but they provide different opportunities for children and young people to share their experiences in ways that feel comfortable for them.
Learning from families
One of the most rewarding parts of preparing for the study has been working with children, young people and parents through our Patient and Public Involvement (PPI) activities with our advisory panels!
Their feedback has influenced many aspects of the study, including the design of participant information, recruitment materials, activity booklets, photography guidance, interview activities and the different ways that families can take part.
Many of the resources have been through several rounds of review and revision. Sometimes the changes have been small, such as adjusting wording to make it clearer. Other times, they have led to entirely new ideas being incorporated into the study. So exciting to see how far we have come through these different versions!
What happens next?
Our next step is setting up the study at Manchester University NHS Foundation Trust and Alder Hey Children’s NHS Foundation Trust.
Once this is complete, we will begin inviting families to take part in Stage 1 of the study, where we will be exploring children's and parents' experiences of taking methotrexate and identifying what information and support families would find most helpful.
We are excited to be moving closer to recruitment and would like to thank everyone who has supported the study so far, particularly our parent and young person collaborators whose ideas and feedback have helped shape the study from the very beginning.
We'll continue sharing updates on our progress through the website and look forward to introducing you to more of the project over the coming months. Check out the update on the Study Roadmap tab!