Webinar recording and transcript – The DecodeME Questionnaire
DecodeME webinar from August 2022 on the DecodeME questionnaire.
Sonya Chowdhury, Chris Ponting and Sian Leary discuss the study launch and the process of taking part. Learn all about the questionnaire stage and the work that has been done with PPI to design it. The webinar also includes a Q&A session towards the end.
Watch the recording:
Direct link: Watch the webinar recording on YouTube
Listen to the Audio:
Read the transcript:
- Study launch update
- Taking part in DecodeME: the questionnaire
- The new DecodeME questionnaire: improvements made with PPI
- Q&A
Study launch update
(SONYA)
Hi, everybody. Welcome to another DecodeME webinar. My name is Sonya Chowdhury. I’m Chief Executive of Action for M.E., and I’m also part of the DecodeME team, so I’m going to be sort of chairing the webinar today.
I’m going to start off by giving you a bit of an update and then I’m going to hand over to Chris. He’s going to explain how you actually take part in this study, and then Sian is going to tell you about the work that we’ve done with patient-public involvement at the heart to develop our new DecodeME questionnaire. It’s an improved questionnaire and it’s been developed on the back of feedback that we’ve had from our first group of people that have helped us refine what we do and how we do it.
So we began our online testing phase in June and we randomly selected 500 people who’d registered their interest via the website, and if you haven’t done that already, please go and do that at DecodeME.org.uk -you’ll be first in line to hear when the full recruitment launches. So it’s really important that you do that if you want to get ahead.
So we had 500 people who were selected to take part in the Phase One testing and they signed up and completed the questionnaire and they were also asked to give us feedback to tell us what we could do better. This has been really useful. It was mostly positive and the majority of people told us that it was easy or very easy to use the questionnaire, and the questions were easy to understand, but we got some really interesting feedback, which we’ve been able to act on as well. Some of those participants were also sent spit kits (and Chris will tell you more about what that means in a minute), and they’ve been providing their DNA samples. It was really exciting for us as the DecodeME team and we’re a massive team. It’s really exciting to hear that the first spit kit and saliva samples had been received and were being processed. So they’re still coming back to us. People have taken a bit of time to complete all the steps that they need to, but those numbers are increasing day by day.
The other thing that we want to tell you is that we are going to launch in September. We have waited, you have waited a long time. You’ve been so patient in supporting us and giving us time to make sure that we get this as good as we possibly can with patient and public involvement right at the very heart. And I have to say, I think all of us would agree, and the scientists that we’ve been speaking to outside of the study, our scientific advisory panel have all said that the quality of science is so much better because of the patient and public involvement right from those that are working within the team to our social media ambassadors that are working to support us with recruitment and through to a large number of you that have contributed to questionnaires and surveys giving us feedback at various points over the last couple of years.
So before I hand over to Chris, I want to say we want to say a huge thank you to you, and we are really excited about launching in September. If you’ve signed up and registered your interest, you will get information a little bit ahead of everybody else, and we will confirm the date very soon. So I’m now going to hand over to Chris, who will introduce himself and tell you about how you can take part.
Taking part in DecodeME: the questionnaire
(CHRIS)
Hello, all. I’m just going to share my screen, and hopefully you’ll see my slides now. So my name is Chris Ponting. I’m a human genetics researcher at the University of Edinburgh, and I’m very excited because we’re now almost at the full launch of DecodeME and it feels as if we altogether have climbed several mountains to get to this exciting position.
So you may have followed previous webinars where we’ve talked about the DNA side of the decode in the project. So if you go to these other webinars, you’ll see how we have designed the project so that people who are selected to be part of that side of the project receive the sample collection kits and then donate the saliva sample, put it back in the regular post, and off it goes for the processing. And eventually, we in Edinburgh get the data and analyse them. We’ll be comparing people with M.E. and their DNA against control individuals whose data we already have from the UK BioBank.
So today I want to say something a bit different from that. I want to talk to you about three things. I want to talk about how taking part in DecodeME is more than donating DNA. That’s the first thing. Then the second thing I want to say is that your questionnaire answers are important to us and important beyond DecodeME. And finally, I want to say what a challenge it is to recruit the number of people – I’m going to say 50,000 people in the UK with M.E. – who we need to complete the new DecodeME questionnaire. So we’ll need everyone’s help, your help, please, to help us achieve this very difficult goal.
So let me start by talking about genetics and to say that we know already, we know that more than one gene is disrupted in people with M.E. There will be many genes, and each of those will contribute just a little to someone’s risk of being diagnosed with M.E.. This gives us a spectrum. We know that M.E. genetics, therefore, is not black or white. It’s a spectrum. And it gives us this scientific problem. Because it’s a spectrum, where does our study DecodeME draw the line? On one side will be people who are included in the study with respect to the DNA, and everyone is included in the study with respect to the questionnaire and questionnaire answers. We have to draw a line between those two, we have to draw a line somewhere. And the reason is that all scientific studies are based on criteria and we have to stick to the science.
So the obvious question is, well, what criteria? Well, this was decided a long time ago, November 2019 altogether in a room, scientists, people with M.E., carers, funders, we all met and decided to use the IOM and CCC criteria for people who have been clinically diagnosed. And that went off to peer review and peer reviewers said that that is exactly the right approach. So people with M.E. will be on one side of the line, we will be asking you for your DNA sample. What we never knew, given the criteria, was what fraction of people we would ask for their DNA. We didn’t know this until we started asking people questions through the new DecodeME questionnaire. So that fraction that we asked the DNA could be any number, it could be a small fraction or it could be a much larger fraction. We actually never knew. Turns out from the testing that Sonya was talking about, it’s about 60% and 60% of you who complete questionnaire and consent to participate will split the science spit for DecodeME and donate your saliva sample for DNA, that will be read out and we can then compare against healthy controlled DNA.
But my message really today is for everyone, everyone in this circle, not just for those who donate their DNA to DecodeME. We actually need about 50,000 people, and actually probably more. 50,000 people in the UK with M.E. to successfully complete DecodeME and its objectives. So by taking part, every single person who completes our questionnaire provides information that I think will be hugely valuable to science. Well, why? Well, it could reveal subgroups. As I said, it’s a spectrum. So it may be that there will be subgroups where there’ll be one group will have a particular genetic cause and another group will have another genetic cause or set of causes. And your answers to the questionnaire would enable us to do that analysis. And then also your answers are a powerful record of your symptoms and your life experience, which we don’t take for granted.
So if you provide consent, we then have a vast database with thousands of people’s life experience which will be available to researchers to better understand what your lives are, what living with M.E. means to you. When I say that, I have to say that you will perhaps always remember that we will always protect your data and provide your data to researchers in an anonymous way, and that’s very important to us and to you. So many people, researchers, clinicians, government, society, large friends, families; I’ve heard that they misunderstand what it means to live with M.E. Single anecdotes provide powerful testimonies. But it’s the big data, in my view, that counts. And it’s the transformative power of that data, the tens of thousands of people living with M.E. that together, I don’t think we should underestimate. So, for example, with this vast data set in hand, DecodeME can provide more precise evidence on the scale, the demographics, the comorbidities, the severity and the impact of living with M.E. for people in the UK, who will help us create the world’s biggest set of data on M.E., helping researchers and other researchers understand the disease better. It might help also to show politicians and doctors who often misunderstand the illness, how disabling the illness is. So my message is taking part in DecodeME is more than donating your DNA, and as I said, 60% of you will be asked to donate your DNA. But this is a large number. 50,000 people of people in the UK with M.E. is about one fifth of all people with M.E. in the UK. Now, one thing I’ve learned about you all, is how committed and tenacious you are, and without you, DecodeME will be nothing. So this is your study, it’s about you, with you, and we as scientists will deliver the best possible project to provide the best chance of providing new research directions leading to effective therapies.
When you take the questionnaire, on average, when you complete it, it will take you about twelve minutes to complete if you’re mildly affected, and 20 minutes if you’re severely affected, on average. It may take some people much longer than that so we also have people on standby to help with completion of the questionnaire. And it would help us enormously if you could try out the online questionnaire first. And if this doesn’t work for you, that’s fine. Please ask for a paper questionnaire or ask for someone from the 25% group to help you to complete the question. So when we launch fully in September, please do complete the questionnaire and tell everyone you know and ask them to do so too. We need a snowball effect where everyone from up and down the country know about DecodeME and participate, and know why it’s important to participate. Thank you very much.
(SONYA)
Thank you, Chris. I just want to remind everybody that you can ask us questions. We’ll try our very best to be able to answer them. We’ve got 200 participants here on Zoom and we’ve got others that have joined us on Facebook Live, and you’ll be able to share this or view this afterwards, particularly if an hour is too much for you to watch, all in one go.
So, before we go to Questions and Answers, I’m going to hand over to Sian, who’s going to tell you a bit more about the questionnaire.
The new DecodeME questionnaire: improvements made with PPI
(SIAN)
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.
Q&A
(SONYA)
Thank you, Sian. And thank you, Chris. We’ve got lots of questions coming in, which is fantastic. As always, we’ll try our best to answer as many of them. But just to remind you as well, we do have a Frequently Asked Questions on the DecodeME website, so if you want to, you can go and read more there. All of the responses have been developed with patient-public involvement and the scientists, so we’ve worked together as a team to pull those together. We’re not in a position to answer lots of individual questions outside of the webinars, but we do try and put responses into the Frequently Asked Questions and ensure that they’re kept up to date.
So we’ve got questions from Facebook through Zoom and also some that were sent through previously.
So I’m going to ask you a question first, Chris, because this has come up quite a lot in the chat as well.
Are you planning on including overseas patients as well for the study?
(CHRIS)
We are not, at the beginning, planning to recruit from overseas, so there is a good scientific reason for that, in that we could have spent hard earned tax-payers money on the data that comes from healthy people, because we need the data from healthy people to compare against people with M.E., but we chose not to. We chose to compare against the data from the half million-strong UK BioBank cohort that already exists. And a byproduct of that decision to spend our money only on people with M.E. is because UK BioBank people are people from the UK. We have to match against people of the UK. In other words, we have to ask first people with M.E. from the UK. Whereas I would absolutely love to widen the study to other countries, I think that would be difficult at this stage, but I’m not going to say it’s not going to happen. There would be challenges because of postal systems being different, et cetera, but we would wish to do that in the longer term. But at the beginning of the study, it will be for people with M.E. diagnosed with M.E., who live in the UK.
(SONYA)
Thank you, Chris. And just a reminder, we’re looking for people who are over the age of 16 and live in the UK, and if you want to register your interest, so you’re first in line when we do launch in September, you can do that on the DecodeME website.
So, another question for you, Chris. I’m having difficulty getting enough air into my lungs. Any research being done in this area? Sian chip in as well, if you want to.
(CHRIS)
Yeah, I read that about half the people with M.E. have shortness of breath and I know that people with long cover often report this too. And then I also read that there are theories that explain this, such as micro clots existing in blood vessels that are in the lungs and reduced oxygen exchange. And this could be true for people with people with long covid. The good thing about DecodeME and the genetics that we’re looking at is that it looks at everything, all of the genes, all of the DNA, and it does that blinded, really, to any prejudice that anyone might have. And that objective approach means that whatever is the strongest genetic signal that’s out there has the best chance of being found by the study. And it may be that it reveals something that is going wrong in the lungs, but it may also be that it’ll be something that’s going wrong elsewhere? We’ll find out.
(SONYA)
Thank you. Chris. We’ve got quite a few questions from people saying, have I already filled in the questionnaire? So just to let you know that if you preregistered your interest on our website, the DecodeME website, you’ve given us information to help us build the study. When we launch the recruitment in September, you will be sent a link and then you will follow that link and you’ll be able to complete the questionnaire.
We’ve got a question, Sian, about the questionnaire. Somebody has said that they’re actually going to be away in September and how long will they have to complete it. Maybe you’d like to answer that one for us.
(SIAN)
Sure. And I think that’s one of the great things about the questionnaire is that we’ve made it open ended. So you have as long as you need to complete it. Basically, if you’re not around in September, then do it in October or November. If you need to take a long time to do it, there is absolutely no pressure to do it quickly and you’ll still be involved. So, yeah, we’re pleased with the systems we have in place to allow you to save your progress and come back to it. You can come back the next day, next week, the next month. We understand it’s different for people with M.E., for many reasons and different circumstances, so take part in your own time, but please do take part.
(SONYA)
Thank you. Sian, we’ve got a number of questions around morbidities, first of all, I think probably Chris, and then, Sian, for you to add anything. Somebody has asked what a comorbidity is, and then we’ve got questions that are asking if you’ve received a diagnosis, say, with hypothyroidism or other diseases, can you participate? Are there any possible medications available?
So we can’t answer questions about medications we’re not qualified to do, so that’s something I’m afraid will have to redirect you to a health professional, but also, if you highly suspect you’ve got a comorbidity, say, for example, mast cell activation syndrome, that I as yet undiagnosed, can you participate?
(CHRIS)
So let’s start with comorbidity. What it means is that you may have a medical condition in addition to having M.E. So people might have hypothyroidism, which is what Sonya referred to, as well as M.E. And we’re wanting and hoping for everyone in the UK who have been diagnosed with M.E. by a medical professional, irrespective of what else you’ve been diagnosed with to participate in DecodeME. But the questionnaire has to ask questions about what else you’ve been diagnosed with, just in case your symptoms can be better explained by something else than it can be by M.E. And that’s really one of the major reasons why we have to employ the questionnaire and the criteria.
(SIAN)
I think I would jump in and out a bit about medication. Part of what this study is doing is looking at genes. It’s very unlikely that medication is going to impact that. So we don’t ask about the medications that you’re on in the questionnaire, and it’s not something you need to know at this stage. So if you’re concerned about whether that impacts you taking part, you don’t need to be right.
(SONYA)
Thank you. The question here, Chris, I wanted to ask about autism. Is autism burnout and any sensory overload are so similar. I’ve recently been diagnosed with autism, and it was a light bulb moment. How similar are they neurologically? I wondered if you’ll be looking at this.
(CHRIS)
Unfortunately, science knows very little about M.E. It knows a little bit more about autism spectrum disorder nowadays. It didn’t previously. And because we know so little about M.E., we don’t know about the overlap with autism, particularly neurologically. Genetically DecodeME provides the opportunity to look at the overlaps and the distinctions, actually, not just with autism. DecodeME will look at the overlap or the separation of M.E. with every type of disease. So it’s a study that not just says, what are the genetic risk factors for M.E., but what are the common risk factors common to M.E. and other things. And people will ask about long covid. We’ll ask whether there’s overlap with long covid or not an overlap, a distinction with long covid, are they different? My guess is they’re going to be overlapping and different, if you know what I mean, all through the genetics and all through the data that comes from the DNA that you provide, and all in a way that is completely objective and not prejudiced by previous studies and hypotheses.
(SONYA)
Thank you. And just to say that we will be analysing the data within two years in terms of once you’ve completed the questionnaire. Even though we are opening recruitment later than we had hoped, we’re still going to complete our study on time. We’re very confident that we will have completed this study within the timeframe we were awarded, four years, and that will be August 2024. Get my date is right there.
Chris, you mentioned about long covid and potential overlaps and potential differences. We’ve had a few questions here about whether you can link the results to any research to be done on Long Covet because of those similarities. And this individual said it would be a shame if it wouldn’t be possible in the future to utilize your results because of the anonymization of data.
(CHRIS)
Thank you for this question and every question, actually. We will not hold our data to our chests, right. We will make it available in an anonymous way to bona fide M.E. researchers everywhere. If we don’t do an analysis here in Edinburgh, we hope that others will. In order to ensure that progress is made in M.E. research and uncovered research or whatever, we don’t give out enough information for people to find out who each of the participants is, and that’s a key thing. We don’t provide personal, identifiable information, but we provide enough information on aggregate of you all, that questions can be asked about the commonalities and the differences with other diseases. And we will not put up barriers for any researcher to come to us who are wanting to use the data. Rather, we will be going out there seeking out people who will make use of the data. And that process has already started.
(SONYA)
We are really committed to being as transparent as possible. And that’s why we want to make sure that we have the Frequently Asked Questions on our website, the webinars we’re doing. And we want people to be able to utilize our learning, the things that we’ve developed through this study, because we all want to see science accelerated. We need to see the improvements and treatments and the understanding about me for the 250,000 people and possibly more in the UK and 30 million worldwide that are affected by this.
Chris, we’ve had a few questions about the relationships within families and whether any is hereditary. So there’s a couple of questions here – could M.E. be hereditary or and gut related? And then presumably the questionnaire is going to ask about whether there’s a family history of M.E. wondering if we’ve taken into account how frequently the condition is misdiagnosed both now and especially in the past.
(CHRIS)
Okay, I think there’s three different things there. There’s the gut question and yes, there’s been a hypothesis called the leaky gut hypothesis that says that people with M.E. tend to leak bacteria and toxins from the gut into the blood. Now, that is a hypothesis, but it really needs more evidence for it to be considered definitive. So the second thing was, is there evidence for an inheritance of risk for someone to be diagnosed with M.E.? Is it more likely that their relatives, their blood relatives are going to be diagnosed with M.E.? And the answer is yes. We know that already from previous studies. First degree, second degree, third degree relatives are more likely to have M.E.
Are we going to use that information in the questionnaire? Actually, we’re not asking you for that information. I’ll tell you why. The reason is that if you have the DNA of one person and another family member, you can tell their relationship just from analyzing the DNA variance. And so we do that across the whole population of people with M.E. looking at the relatedness of individuals. And we’ll use that relatedness to determine how much of the risk for M.E. diagnosis is inherited. But we also use that to find out which of the pieces of the DNA are different in people with M.E. versus healthy controls.
Did I miss a question? I can’t remember..
(SONYA)
I don’t think so. Got a question about what happens after M.E. is decoded? Is this when us who aren’t officially diagnosed yet, might be able to get tested? And what does the timeline look like for this?
(CHRIS)
So, unfortunately, because it’s a spectrum, there is not a single gene that is disrupted. There’s not an easy DNA test that says, yes, you have M.E. or no, you don’t have M.E., unfortunately. And it is exactly the same as as other diseases, lot of autumn immune diseases, for example. Multiple sclerosis is one. Rather we think of DecodeME as providing, first of all, evidence that it is biological in origin, secondly, that we know what’s going wrong in cells, thirdly, which cells and what might be going wrong in molecules in those cells. So that we can go to the experts who are researching those molecules in those cells to tell them that they should be researching why people with M.E. have changes in those molecules. And then the next stage beyond that is that drug targets can be developed that can then go to clinical testing. And it’s a sad fact, I wish it wasn’t the case, that this is a process that will take a long time, it’s estimated ten years and more perhaps, but we have to start somewhere and we have to keep going as fast as we can to ensure that we get to that finishing line as soon as we can. And geneticists are only at the beginning, the starting line of this whole process, but we are trying to turbocharge the process to ensure it happens as fast as possible.
(SONYA)
Thank you, Chris. Sian, I’m going to ask you a question about the questionnaire and the individual wants to know, will the questionnaire differentiate about symptoms when uncontrolled or when managed by pacing? They then go on to explain they’ve learned a lot about their own limits when pacing and sticking to baseline symptoms, subside drastically, reasonably switched on, etc for. But when they don’t pace, they’re 100% house band, 50% bed band. So clearly there’s that differential. And I know that fluctuation in symptoms is something that many people with M.E. experience. So the individual says they would fill in the questionnaire differently based on those two scenarios. So can you just tell us a little bit about how that’s going to be managed within the questionnaire?
(SIAN)
That’s something that’s a really good question and something we’ve had to think about a lot since January this year. I’ve talked to people within the patient and public involvement team about how to manage this issue because things do fluctuate usually. And throughout the questionnaire we’ve included a few little tool tips that help explain some of the questions when they could very easily be answered differently depending on whenever you’re pacing or not. And we try to ask people to think about what would happen if they weren’t pacing on the whole. So we’re aiming to give clarity and advice around how to answer those questions so that hopefully you can do it in a way that reflects your experience with me.
(SONYA)
Right, thank you, Sian. And I’ve got a question here from somebody on Facebook. They want to know whether receiving chemotherapy for cancer would exclude them from participating?
(CHRIS)
That particular part of their medical care will not exclude them from participating.
(SONYA)
And what happens if we don’t get 50,000 participants? Will the study still go ahead?
(CHRIS)
We’ll work harder.
(SONYA)
We are absolutely committed to getting the numbers that we need to. We have worked really hard on our recruitment plans and this is where you can help us. Everybody watching can help play a part in ensuring that we get the number of people to fill in the questionnaire, the number of people that will then be invited to go on and provide the stickers and provide a saliva sample. And as Chris said, every bit of data you provide is helpful for science, regardless of what you end up providing. But the one thing you absolutely can do is help us recruit more people. So tell everybody about the DecodeME study. If you know people with M.E., encourage them to participate. With your help, we will reach that 50,000 people and potentially more. And as Chris said, this is the start. We will need more data. We want other scientists replicating this study and expanding this study and taking it into other countries because we need to gain a better understanding. So please do support us with that.
Chris, I’m going to ask you a question about the DNA samples. When they’re collected, what will be the time frame for the first past results or findings to be given into government into the government spearhead group that’s been mentioned?
(CHRIS)
Yes. So the first DNA results will probably come out in the first quarter of next year and then we’ll receive them. And if we have a really good response from the full launch in September, then that may be enough for us to do the first analysis. And that will definitely be within the time frame of the Department of Health and Social Care group that has been put together and that will feed into that process and we are involved in that process. And so we will be making sure that everything that people have funnelled through us and everything that we think as being important is front and centre in that process.
(SONYA)
Thank you. Had a few more questions around when the questionnaire is going to be available and have people filled it in? The questionnaire will be available in September. It’s very unlikely that you filled it in. The only people that will have filled it in with those that were invited as part of the Phase One study and you had a specific link to follow and a specific reference number to input. What you will have completed is our registering of interest through the decoder website. And if you haven’t done that, please go and fill that form in. We will keep you updated and we will let you know when the recruitment launches and you will be first in line. You need to be over 16 to participate and at this point, you need to be in the UK to take part. Chris?
(CHRIS)
if you’ve registered and you forget and that’s fine, we all do that and you try and register again, we’ll know, we’ll tell you it’s all fine. You might need to change your password or whatever, but please keep and persevere because the system is built to help you with that.
(SONYA)
And as Sian said in her presentation, we have worked really hard to try and make sure that we put things in place that will help you. Not just help any of us, but also in recognition of the differing fluctuating symptoms that people with M.E. experience.
So, question here if specific abnormalities do show up in the future, could healthy siblings of M.E. sufferers be asked to donate spit samples to help narrow down exactly what is going on in M.E.? Chris?
(CHRIS)
So we would need to do another piece of science first. The science that we’re doing here is trying to find common explanations for M.E., and that is not going to reveal common disruptions in single genesis suspects we talked about earlier. But we have made sure that we’ll keep half of every person’s DNA sample that you donate. And the reason is this, that we will do the next piece of science, which is to read out every single bit of your DNA, which may reveal the rare changes that might only be in your family that no one else has. And when we do that, there might be strong signals that individual genes are often disrupted differently in different people, but it’s the same gene. And if that is the case, then there could, yes, be a blood test, a DNA test that people would have to sit for science for, and test for that change and to see whether it’s there in family members, but not yet, not for this first stage of what we do.
(SONYA)
That’s great. Got a question here that somebody says, can I complete the form from abroad? I live in the UK, but be away for a few months. Yes, you can. So please do complete that. You need to be living in the UK. If that’s your permanent address that happened to be out of the country, you can complete that.
We’ve got quite a few questions about diagnosis, so I’m going to try and bulk them together and then Chris and Sian can answer them. The first one is I’ve been diagnosed with post-viral fatigue syndrome but believe I meet the CCC criteria. Can I sign up? The next one is my GP thinks I have M.E., a neurologist thought I had M.E., referred to a Rheumatologist who thought I couldn’t have M.E. because I would not be able to get out of bed, which we know is wrong. So does two out of three count as a diagnosis and allow me to participate?
(CHRIS)
So I believe the question in the questionnaire asked whether health professional has diagnosed you with M.E., M.E./CFS or CFS? That’s the question. It doesn’t say whether seven out of eight or two out of six or whatever it says has a health professional. A health professional diagnosed you with M.E., CFS or M.E./CFS?
(SONYA)
And have you been diagnosed with postviral fatigue syndrome?
(CHRIS)
So that is not identical to M.E., M.E./CFS or CFS.
(SONYA)
Great.
(SIAN)
Doesn’t mean that you can’t take the questionnaire but yeah, they’ll give us information but you’ll answer the question, that specific question on diagnosis, you’ll say you won’t have a diagnosis of M.E., CFS or M.E./CFS.
(CHRIS)
there will be people who would deserve, because of their symptoms, a diagnosis, so haven’t yet received a diagnosis and who might go to a GP and then receive that diagnosis. And even if that is February next year, we would welcome you to complete the questionnaire at that point in time.
(SIAN)
And then one thing I want to add is that you don’t need to show us a letter from your GP confirming the diagnosis. We ask you to tell us and truthfully whether or not you have a diagnosis but we don’t ask you for that next level of information to confirm that diagnosis.
(SONYA)
Also, for those who are struggling to get access to healthcare, struggling to get a diagnosis, there are charities around that would support and there is advocacy support available through Action for M.E. we’ve got lots of resources and the 25% group also provide support. 25% group are working as part of our team. We have asked them to work alongside those people who are very severely affected, who do not have anybody in their support network to help them complete the form and where their symptoms prevent them doing that so that support is available. As Chris said, we do hope that most people will be able to complete online either themselves or with the support of somebody. But we’re really keen to ensure that those that are more severely affected can participate and indeed the science will be better if we get a range of people of ages, different diversities and different severities.
I’m going to ask another question about comorbidities. Are there any that could rule you out from taking part in this study?
(CHRIS)
So there are peer review made sure that we would include in the questionnaire and I think it is right for us not to detail those in particular what they are.
(SONYA)
Great, thank you.
(SIAN)
Can I just add that we still want you to fill in the questionnaire. That data set is still going to be massively important to us and it may mean that we don’t invite you to also send in a DNA sample. But it doesn’t mean that you don’t have M.E. and it doesn’t mean that your data isn’t incredibly useful to us and it’s going to have a huge impact on how M.E. is it understood and viewed forever.
(CHRIS)
And what we would love to do is to ensure that in the future we have a diagnostic tool that comes from DecodeME that does this job better of diagnosing people more accurately and this is the first step. So it may be imperfect, I appreciate that, but it is the first step and it’s the best step that we can make.
(SIAN)
Please do take part. You are still a valued participant to us.
(SONYA)
Thank you. There’s a comment from somebody who says they prefer the use of the word cooccurring, a psychotherapist who also has M.E. And we appreciate that language is very important, which is why we’re really keen to make sure that we tested this with people with severe M.E., people online and through our patient-public Involvement group.
Question here about the data. Will the data collected in this study be publicly available?
(CHRIS)
So the answer is no. Because it’s your data, we have no right whatsoever to publish your data. The data will be made available to bona fide researchers who have a good reputation and good reason for the data from anywhere in the world. But they won’t know that the data comes from individuals. We will have ensured that it’s properly anonymized. But no, we would not allow anyone to gain access to any person’s data.
(SIAN)
I would also like to add to that that our consent form specifically asks if you’re happy for us to share your data with other researchers. So you can tell us that you only want your data to be used in DecodeME and that’s fine, perfectly acceptable. Or you can tell us that you want us to be able to, through the systems we have in place, share that data anonymized with other bona fide researchers, but it’s really your choice.
(SONYA)
Thank you. Question here about whether we’re asking synthetic celebrities to share the recruitment page. Yes, we are. We have got a whole recruitment campaign strategy that’s been pulled together. We’ve got a PR agency working with us, we’ve got a digital marketing agency working with us, but we still need your help. We have over several hundred social media ambassadors working with us, so we are taking it very seriously because we are going to hit the numbers that we need to. But if you have any contacts and you know, people that would be willing to support us, whether it’s on TikTok – some us don’t really do TikTok but other people do – and we do want people of all ages and backgrounds. So if you know anybody’s, social media influencers, celebrities that would be willing to work with us, then please do let us know.
We’ve had questions about different what’s known in the research about heart involvement, tachycardia, et cetera. I’m afraid we’re not going to have time to answer those today because today’s webinar is specifically about the DecodeME studies. So I apologize if we don’t take those questions. We’ve still got over 30 questions to get through, which we’re not going to achieve because we’ve got a few minutes.
But I’m just going to ask, is there any sorry, question for Sonya – I believe it’s possible to get a diagnosis of any confirmed by a GP if you develop the symptoms after having had covid. Is this my belief, too. Yes, it is. We would expect the GP to diagnose people with M.E. using the NICE guideline, the revised NICE guideline that was launched last year. You can still have a medical assessment and a diagnosis if you meet the criteria for M.E.
Another question. Let me try to find some different questions here. Will we be checking the level of the immune system? Chris, my understanding is that’s not part of what we’re doing within the DecodeME.
(CHRIS)
We’re studying DNA, and the DNA is the DNA that you were born with. And the risk, if you have it, for M.E., was hard coded into your DNA at that point. And that’s actually a benefit of what we do in genetics, because it may be that a study of the immune system may not reveal the cause of a disease. It may actually be a consequence. And so we want to get back to the cause because that’s where interventions drug therapies will work the best.
(SONYA)
We’ve had a question about how many people have registered their intent to participate in DecodeME? We’ve got around 30,000 people that are over 16 in the UK that have registered their intent. So we do encourage you, once you get that link, to go in and sign up, but also to help us recruit more people.
And several questions around whether it will be testing for anything else in the saliva? So, as Chris just said, we’re looking at DNA in this study.
Somebody said, I was born abroad due to my father being in the army, but I’m a British citizen, live in the UK is my permanent address. Yes, you can still take part.
Several questions about diagnosis. If you’ve been diagnosed by a health care professional, then yes, you will be able to participate.
Could this lead to renaming the disease? Fed up with people saying, I’m fatigued too. So I think we’re going to finish on that. One last comment from Sian and then Chris, before we wrap up.
(SIAN)
Just really grateful for your watching today and really excited for the next steps and for the long-term outcomes of this project, which I think could change my life and hopefully the lives of many of you watching.
(CHRIS)
Thank you very much for watching. People tell me various things, but mostly they say that this is a disease that they wish to be called M.E., that’s what I call it.
(SONYA)
Thank you. So, just a couple of reminders. You can sign up, you can register your interest and get updates for the DecodeME website, www.decodeME.org.uk. If you do that, we’ll keep in touch with you, we’ll let you know what’s happening and we will also tell you before we go public about the date and when you can participate and you can get ahead of the game and be first in line. If you register your interest through the DecodeME website, you won’t have received the questionnaire already. What you will have probably filled in is just the registering your interest and giving us some data to help inform development of the study. So please don’t worry. If you think you’ve already done it and want to do it again, you will get the link and you will be able to go in. If by any chance you’re one of our 500 participants, early on you will be told and if you start and you forget and you go back in, we are going to make it as easy as possible for you to participate.
So some of those questions were answered earlier and if you missed those, then you can also watch the webinar again. We’ll put it out through the website and on YouTube so that you can watch it in installments.
The last thing to say is that we need your help. You are part of our study. You’re part of our study. If you provide information through the questionnaire, you’re part of our study. If you provide DNA, you are part of our study. If you help us recruit more people, you are part of our study. If you just tell one person about how to participate. This is our study. It’s the M.E. community study and you are part of that. And we really value the input and the support that you’re giving and all the amazing messages that are coming through on Facebook and elsewhere telling us that this study is giving you hope. We are doing everything we can to get this launched as soon as possible. We will launch in September and we will still finish on time.
So thank you very much for all your support and we look forward to speaking with you again at our next webinar. Thank you, bye.