DecodeME puts people with ME/CFS at the heart of all its decisions

By Claire Tripp and Sian Leary (patient and public involvement team members)

 

Believe it or not, there’s no minimum standard for patient and public involvement (PPI) in scientific research. But one of the most important things in a study for people with ME/CFS is making sure that they are considered in everything we do. We can’t have a study about people with ME/CFS without them at the heart of it.

That’s why DecodeME has strong involvement from PPI teams. The PPI steering group is represented by people with lived experience of ME/CFS: those with ME/CFS, people who care for those with ME/CFS, and representatives from ME charities. Together the PPI steering group oversees everything that happens within DecodeME; from how the study is designed to what data we collect and how. And we believe we are setting a new standard for PPI in biomedical research.

The PPI steering group meets at least every three months. A typical meeting includes an update from the different delivery teams – these are the teams that do the day-to-day work of making this study a reality. Each team in the project has at least one person from the PPI steering group in it.

As steering group members, we both sit on the Cohort Delivery Team and Claire is also on the Marketing and Communications Team. During PPI meetings, we make sure that the rest of the PPI steering group is up-to-date with what’s going on in both delivery teams, the decisions that have been taken and how these will impact on participants in the study. We make sure all members of the steering group have an opportunity to feed into the work of the delivery teams. Without fail, key decisions are made with feedback from this group.

Sometimes feedback to the delivery teams can take a little longer and it slows things down, but this means PPI are making the best possible decisions. In all workplaces, decisions are made by those who are present, and we are proud that DecodeME ensures people with ME/CFS and carers are there every step of the way.

In between our steering group meetings we keep discussions going, and if there are any major decisions that need involvement from PPI, we’ll hold an extra meeting so these can be properly considered.

Some of the things that have been robustly discussed include:

  • the questions in the questionnaire, including whether the wording is clear and whether it’s necessary to include them in the first place
  • making sure the study consent form is simple and clear
  • how to make the website and portal as accessible as possible for all study participants
  • being clear how the data we gather will be used in scientific publications
  • ensuring each participant’s privacy is protected
  • the feedback we’ve received from early participants

Recently there has been a major focus on the questionnaire that assesses whether participants meet the criteria to send us their saliva sample (their DNA). After the study’s initial test launch in January, we received some really informative feedback from the first set of test participants going through our process.

As part of the PPI Steering Group and the Cohort Delivery Team, we worked with other members of both groups to carefully consider all of this. Combining the test participants’ feedback with our knowledge and experience of ME/CFS, the questionnaire has been completely rewritten. This now makes it simpler, more streamlined, and more direct.

Our new DecodeME questionnaire gives us greater confidence that all eligible participants will meet our study criteria – improving the power of the final DNA analysis. (It’s worth noting that, as with everything else, the DecodeME criteria were chosen after careful consideration with a range of people with ME/CFS and carers, even before we applied for funding.)

Everyone in the PPI steering group is involved in making decisions and ensuring that the people we are conducting the study for are considered every step of the way. We are heard by the delivery teams and by the Management Group, which is testament to how important the needs and capabilities of people with ME/CFS are in this study.

DecodeME isn’t just a study for people with ME/CFS. It’s a study by people with ME/CFS.