DecodeME Questionnaire: The new DecodeME questionnaire – improvements made with PPI


Hello, everyone. Fantastic to be speaking to you all today and see so many people watching. My name is Sian Leary and I’ve lived with M.E. for over nine years now. I spent the first four to five years severely affected, but I’m fortunate to be in a better period at the moment, and I’ve been a member of the Patient and Public Involvement steering rope DecodeME since funding for the study started. And I just want to say that I continue to be impressed at the extent to which people of M.E. and carers are at the heart of decision-making. This has had a huge impact on the study overall, with decisions small and large, all being influenced by the lived experience of this disease. There’s national guidelines out there on how best to do patient and public involvement, but from my reading of them and understanding of other studies, we are truly setting a gold standard in DecodeME and I am hopeful that will be mirrored in future M.E. research.

As a member of DecodeME and a person with M.E., I’m now also joining the research subgroup of the Government’s delivery plan alongside Sonya and Chris, to ensure that what we have learned from DecodeME is shared. We will all push for the targets that are set, the commitments that are made and the research that is taken forward to reflect the severity and impact of this disease, as well as the historical lack of research funding that M.E. has received.

But I’m actually here to tell you about the DecodeME questionnaire and algorithm today. So Chris has gone into this a bit, but I hope you don’t mind if I repeat some of what he said by explaining why we even have a questionnaire. And the first reason is that we’re gathering a hugely rich data set about people with M.E. in the UK. This is going to be able to tell the story of symptom, severity, onset diagnosis and more. And all of this information is vital to fighting for people with M.E. approving beyond a shadow of a doubt, the impact of this disease and for changing hearts and minds, as well as giving us scientific clues to pinpoint pathology, hopefully find treatments and do more. It’s going to be an incredible advocacy tool. And the second reason we have a questionnaire is that we’re using it alongside our DecodeME algorithm to tell us who we will be asking for a DNA sample.

Back in January this year, we started recruiting a really small number of participants into our offline paper-based process. We did this because we wanted to target people with severe M.E. and those who might be harder to reach, and we asked them all to fill in a feedback form about their experience of going through the questionnaire in the general process. This was usually hugely enlightening to us and showed that we still need to do further work to improve the question. We still needed to do further work to improve the questionnaire. I’m not going to tell you it’s now 100% perfect, but I do think the work we’ve done has made a major difference and that the end result is inclusive to those of all severities and encompasses different experiences of M.E. The vast majority of those who sent in feedback said they were having to read question multiple times to understand them, while many also said they found the questionnaire easy or very easy to fill in. There were enough who were confused by specific questions that we felt we needed to go back and rethink them. Lots of simple changes have been made to ensure the questions were appropriate to as many participants as possible, like asking for city/town of birth instead of just saying city. And one of the big issues we’ve tackled, and one that I think is vitally important and I know many in the community do, is how we are assessing post-exertional malaise. We know this is a key area and it’s particularly important to differentiate between the global increase in symptoms and decrease in functioning that we see in post-exertional malaise in comparison to the tiredness and muscle soreness that we see in exertional intolerance. By having people with M.E. and carers as part of this process, we believe we have been better able to tease apart these two phenomena. We’ve had long discussions around how to assess post-exertional malaise in mild M.E. and very severe M.E. simultaneously, I believe our questionnaire now works better for everyone.

On expert advice, we’ve also decided to ask about a few additional co-morbidities in the question there. We took this decision because we know among our patient and public involvement team and the many people with M.E. that we personally know, that co-morbidities often have a huge impact on quality of life and can be difficult to get diagnoses for. This will again improve the data we are getting and help us understand more about the experience of a broad cohort of people with M.E. Past research suggests as many as 90% of people with M.E. are diagnosed with at least one other comorbid illness. We’ll be able to see if this is true of our cohort, and information like this could again help us working towards understanding treatment options and their impact.

As Chris said, we’re using the Institute of Medicine and Canadian Consensus criteria to help us decide whether we should also be asking a participant to send us their DNA on top of their questionnaire answers. But these criteria weren’t originally designed or operationalized into a questionnaire. Assessing some of their requirements is difficult, and we’ve had to work really hard to be sure that the questions we are asking and the DecodeME questionnaire are understood in the way intended in the IOM and CCC criteria. But all of this work means that we will have a better data set to use alongside our DNA analysis. For instance, we may find that certain symptom groupings are more likely to occur if a person has certain differences in their DNA. This could help us subgroup people with M.E. and understand more about whether there are different pathways causing the same or different symptoms from different people.

Another focus for us has been ensuring accessibility of the online system. We’ve insisted throughout that there must be a really easy function to save your answers part way through so that you can come back to it at a later date. And I’m really pleased to say that this is working really well now. And as Sonya was describing, we’ve had our first cohort of participants going through questionnaire online and while a few niggles have come up, we’ve been able to address these and we are overall really proud of this piece of work. The feedback we’re getting is mostly really positive and people are finding it easy to work their way through the participant information, the consent form and then the full questionnaire.

I want to also say that we’re proud to be making this questionnaire available to any other researchers who wish to use it, so that we can see the massive amount of input from people with M.E. and carers that has gone into this questionnaire put into use time and again in the future. We think this will be a fantastic resource for other researchers and help to improve future research so that we can be more certain that we are researching homogenous cohorts. And then on a personal note, I think the results from this questionnaire could have a real impact on how M.E. is viewed by health professionals and other people across the world. I’m really hopeful that charities and other advocacy organizations will use the results to create resources that educate health professionals about the true reality of living with M.E. and that the amount of data we collect will be hard to argue with.

So as soon as we open recruitment fully in September, please do take part in DecodeME, if you have a diagnosis of M.E., CFS or M.E./CFS, complete the questionnaire to help us create this amazing resource of data. And if we also need you to send us your DNA, please do post it back. The next stage of DecodeME has been a long time coming and I am so excited it is finally here and that we can be really confident that this will be a powerful and robust study.

So thank you for sticking with us, listening to me today, coming to these webinars and all that you will continue to do to support this fantastic project. I really appreciate it.