DecodeME Questionnaire Webinar: 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 300 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.