ME/CFS patients and a carer made their voices heard on our January 2022 webinar. Patients Life of Pippa’s Pippa Stacey and Blue Sunday: the Tea Party For ME creator Anna Redshaw explained their roles talking to the online ME/CFS community about the study and encouraging people to register.
Claire Tripp, a carer and part of the study’s Patient and Public Involvement steering group, explained the important role ME/CFS patients and carers play in making the study as inclusive as possible. Scientist Chris Ponting gave an update on the recruitment process and the team answered your questions. Sonya Chowdhury from the study’s Management Group hosts.
Watch the recording:
Direct link: Watch the webinar recording on Youtube.
Listen to the audio:
Read the transcript:
Read the full transcript below, or the key parts are split across different web pages:
Sonya: Welcome everybody. This is another of our DecodeME webinars. I’m really delighted that we’ve got another opportunity to share updates with you and to answer questions. We’ve had lots of fantastic questions that have come in via email, but those of you joining the webinar can post them in chat and those of you joining us by Facebook Live can share your questions there too and those will be passed on to us.
Welcome to those of you on Facebook Live who have just joined. My name is Sonya Chowdhury. I’m Chief Executive of Action for M.E. and i’ve also got the absolute pleasure of working with the most amazing DecodeME partnership team to help set up and run the study. I’m also joined by some colleagues today and i’m going to ask them to introduce themselves but I also just wanted to let you know that Dani and Issy, also part of our team, are helping with all the tech in the background. They’re staying off camera but are there to help us if we have any issues. So thank you to both of those.
It’s a really exciting time. we’ve been so incredibly busy and we’re really looking forward to being able to talk you through some of the things that we’ve been doing, but we won’t possibly be able to give justice or do justice the amount of work that is taking place behind the scenes and I can honestly say if i had never been involved in this study I would have absolutely no idea the amount of work that goes in to running something like this and on such scale.
So I’m going to start off by asking Chris to introduce himself and then afterwards Claire will introduce herself and talk to you about her role within the study. We’ve also got a couple of films from two other colleagues that we’re working with, Pippa and Anna. And then we will have an opportunity for questions. So over to you Chris.
Chris: My name is Chris Ponting. I’m a human geneticist. I work at the University of Edinburgh and it is an absolute pleasure to work with such a wonderful team including Sonya and Claire, and Pippa and others that you’ll be hearing from today. You’ll be hearing more from me later. I’ll be available to take your questions and I’ll see how I do in answering them.
Sonya: Thank you. Claire.
Claire Tripp’s talk on Patient and Public Involvement:
Claire: Don’t forget to unmute myself! Hi, so hello everyone. As Sonya said, I’m Claire Tripp and I’m going to talk to you a little bit about what we’ve been doing behind the scenes in designing the study, getting ready to launch and how people with ME have shaped the study and been included in how we’ve decided to do things.
So I’m on the DecodeME PPI steering group, which is Patient and Public Involvement and we are a group of people that represent different needs within the study. We have different experiences. We have different insights into what it’s like to have ME or to look after someone with ME and we make sure that the study, the design of the study, recognizes what challenges people with ME might have when participating in the study and then what we can do to overcome those. I look after my daughter who has had ME since she was 14, so I bring the carer’s voice. I bring an understanding of the additional responsibility that carers might undertake when they’re trying to help a person with ME participate in the study and my daughter’s now 20. So I also understand how difficult it is to balance my need to support her and her need for independence, for confidentiality, and how we need to make sure that the study basically meets her needs, as well. So I bring that insight and point of view.
So the PPI steering group has oversight and input into every delivery team in the study and we have three three teams. We have the Genetic Delivery Team which covers the science side of things and hopefully, when we start to get some data in, someone from the Genetic Delivery Team will be able to come and talk to you about what they’re doing and what that means.
We have the Marketing and Communications Group which is around the study messaging, making sure the tone is appropriate that everything is transparent and that it’s made available in bite-sized pieces for you so that you find it accessible and inclusive. The majority of people in this group have ME themselves and I think you can probably see the impact that this has had on how good the communication has been about the study and how your needs as a person with ME has been taken into account.
Then we have the Cohort Delivery Team and this is all around delivering the cohort, which is the participants to the study, and it’s providing the data that the researchers will work with. As a PPI Steering group member I sit directly on two of those groups – the Marketing and Communications Group and the Cohort Delivery Team – and my role within those two teams is to make sure that all the decisions are made with people within ME in mind and to make sure that the whole Steering Group is involved in that process. So the Cohort Delivery Team is where the main bulk of work to date has taken place over the past two years, although obviously communications and publicity work has started to ramp up a bit now. Our task on the cohort delivery team is to design and develop processes that will get 20,000 to 25,000 of you all the way from registration right up to donating your DNA samples and we’ve been working on every aspect of this and PPI has been involved every step of the way.
So I’m going to give you some examples of how we’ve done that and made sure that our study design has been designed to make sure that happens. So, for example, when you sign up, we’ll ask you to give us some information about yourself and complete a questionnaire so that we can determine if you meet the scientific criteria to take part in the [second part of the] study. Having PPI here has really mattered because we’ve made sure that every single question on that questionnaire has value we; don’t want you spending energy on giving answers that aren’t 100% necessary to the study. We’ve been through it with a fine tooth comb. We’ve made sure that the wording is clear, we know that many of you have brain fog or will find it exhausting trying to understand something if it’s not clear and we don’t want you to give up and not come back, so we need to make sure that it’s fit for purpose and it’s as simple as possible.
We’ve also developed the online portal in the Cohort Delivery Team, so this is what you’ll see when you register. We’ve been testing it behind the scenes, we’ve been trying to break it. What PPI has done is we’ve given considerations to how many questions you see on each page. We try to keep the balance between overwhelming you with all the questions at once, but also trying to minimize the number of clicks that you need to make to get through to the next set of questions. We made sure that your answers save automatically for you, so that when you have to take a break you can go away and come back to it later and you don’t need to re-input and restart the questionnaire.
Some of the other things we’ve been doing is we’ve been working with the suppliers making sure that they can deliver all the kits that meet the Royal Mail requirements for sending saliva through the post. Sending human specimens now obviously has been tightened up. Right down to choosing the color of the bags that you will send your spit kits back in so that they’re clearly identified at the lab as being part of DecodeME. We’ve, on PPI, we’ve made sure that the outer packaging of the kits doesn’t say anything about DecodeME to maintain your confidentiality. You might shout from the rooftops that you have ME or you might not want anyone to know. Confidentiality has been important and we understand that, so we’ve made sure that your postman doesn’t know that you’re participating in the study unless you want to tell them.
We’ve made sure that the boxes will fit through your letterbox so that you don’t get that dreaded red card and have to go down to the sorting office to pick your kit up. We’ve also made sure that you can send them back properly. That you’re not going to have any problems that you need to go to the post office. We’ve tested every single variety of post box. I’m pretty sure, hand on heart, i’m sure we have and who knew that there was so many different types of post boxes and different size slots? But your kits will go through. You do not need to go to the post office.
We’ve made sure that the kit instructions are clear. We don’t want your spit kit sitting on your table because you feel overwhelmed. PPI requested a video for those of you that find it easier than reading, and an audio file of all our documentation for those that find listening easier. Things that I think wouldn’t normally be thought about in a study design but PPI has made sure that this is prioritized because we understand we recognize those difficulties and we want to overcome them. This isn’t only important from an accessibility inclusivity point of view, of course, we want you all to take part. We don’t want anyone to feel excluded. We don’t want anyone to feel like they can’t can’t take part but we need, from a science point of view, a good sample [size] across the whole range of severities of M.E. in order to make this study a success. This is crucial for us in the study design to make sure that everybody that wants to take part can take part and it was during one of the meetings about the online portal that PPI raised the question around accessibility for those of you who don’t have access to a computer.
We know that computers and online access has been really important for many of our community in socialization, connecting with other people but there are lots of people out there that don’t have that access and there are people who don’t want to be supported by a carer. We know that confidentiality and independence is important. It’s all well and good if you have a close family member looking after you like my daughter does, but what if it’s an external carer that you don’t want to share your private medical information with? So we set up a process with the 25% (ME) Group, where those of you who cannot participate independently can be supported by someone who understands. This was very important to us on PPI that this service was made available to people who need it and we also set up a process where you can participate by paper, if for any reason you can’t get on a computer or you don’t want to do it that way.
So we’ve also been working with other delivery teams on the Cohort Delivery Team so we’ve been working with the Marketing and Communications Group and I’ve had both hats on to decide how often and when we will remind you that we are waiting for you to return your sample. We don’t just want to follow the standard timelines in other studies. We want to make sure that the tone and the wording is appropriate and that it recognizes that for many of you, despite all our efforts in the study team, participating is still going to be challenging for some of you and we want to try and get that balance right.
So PPI has been making sure that your needs have been anticipated and it’s as simple as can be and we want to make sure that you know and feel that people with ME have been kept at the heart of the study because it’s really important to us that everybody that is participating knows and feels that. So when we launch we’ll be monitoring and tweaking the processes as we go, if needed, making sure that everything is working as it should be. 20 to 25 000 people is a lot of people to get through this study and we don’t want any hiccups. We don’t want to ask you to do more than you have to do.
Every one of you is important to the study and we all know how important this study is to you and it is to everyone who is part of it. It’s our study and we need to make sure you are all included and this is how PPI have been doing it. We need to make sure that you feel you can sign up and get all the way to the end and I hope, I really hope, we’ve been able to do that. So I haven’t wanted to overwhelm you with the amount of work that we’ve been doing behind the scenes but I hope that that’s sort of touched a little bit on it and it’s been interesting. But I’m sure you can all appreciate how hard we’ve been working and how important this is to all of us. And I just want to finish and I’ve written this bit because I want to get this bit right.
I want to finish by saying that the support across the whole study for input and involvement that PPI has had has been excellent and I hope everybody has been reassured by that. It’s testament to how much everyone involved cares about this study and the tremendous respect that they have for you people with ME. It’s been really touching to see a really truly-shared desire to get this right at all levels and it has been our study and I’m really proud to be part of it and, along with all of you, I cannot wait till the green light comes on and we can go.
I hope that’s been interesting and if anyone has any questions about what we’ve been doing what PPI has been doing about study design or anything then please put them in the chat and then I’ll try and answer them later.
Sonya: Thank you. Thank you Claire. I know all the work that our Patient and Public Involvement members have been involved in and we’ve been alongside you and working together. But just sitting listening to all of that and I know that’s just a tiny little bit of how much work we’ve all been doing together. It’s quite remarkable, so thank you for sharing that and and know just on a really personal note I know this is shared by others in the team. It’s been absolutely fantastic working with you and colleagues have kept us in check, you’ve held us to account, you’ve slowed us down, you’ve sped us up, you’ve supported us when we’ve needed a bit of support and I think it’s worked the other way around. So I feel really proud too that we’ve got a study that is where we’re all pulling together in the right direction and that really is because of the Patient and Public Involvement at the heart.
Anna Redshaw and Pippa Stacey’s talks on their roles communicating about the study:
So we’re now going to hear from, we’ve got two short films that are just a minute long. Pippa and Anna have pre-recorded these because that’s easier for them in terms of managing their energy, so I’ll leave them to introduce themselves.
Anna: Hi. I’m Anna. I am a patient and I have had ME/CFS for 11 years now. I am on the DecodeME team in the Marketing and Communications Group and, essentially, my role is
checking that any communication that’s going out to potential participants is clear and easy to comprehend even for those of us who have quite severe cognitive dysfunction. I’ve never been a part of anything like this before. It’s incredibly exciting. And the biggest thing for me is how inclusive DecodeME is. How much patients
are being listened to and how much patients are actively being sought out for their input. It is just incredible. As someone who’s been ill over a decade and who has felt ignored and invisible for so long, this is just so refreshing and so exciting.
Pippa: Hello. My name is Pippa Stacey. I’m a writer and a blogger and I mostly work freelance in the charity sector and I’m part of the DecodeME Marketing and Communications team.
I myself have lived experience with ME. I’ve lived with the condition for about 12 years now and I know that as well as managing all of the physical elements of the condition and how utterly life-changing they can be, one of the most difficult things to deal with day-to-day is just hanging on to a level of hope and a belief that things might get better and I think that’s why DecodeME means so much to so many people. And, as somebody who can very much relate to that, it’s been so incredible to see just how dedicated the entire team is to making this project a success. So much input and so much attention to detail has been given to every little element of the project, so I hope this reassures you that everybody involved is absolutely committed to making this a success.
I think, ultimately, a project of this scale is a testament to the community and all of the people who are out there feeling somewhat invisible and like they aren’t being heard. So thank you so much in advance for any support you can offer as we move into the recruitment phase. Please keep spreading the word and you can rest assured that everybody on the team will be doing their best to deliver something that really could be a game changer and, for me, this is the most hope I’ve felt in years so it’s absolutely wonderful to be a part of this.
Sonya: Thank you to Pippa and Anna. I’m sure many of you will have appreciated hearing from them. As I mentioned earlier, we are quite a significant team in terms of numbers. We’ve got people not just working from the Patient and Public Involvement team, from the University of Edinburgh, from Action for M.E. but we’ve also got people in the organizations that are contributing. We’ve got a PR agency, social media marketing agency, we’ve got the people who’ll be receiving the samples, we’ve got the people who are posting out the kits so that you can complete samples, we’ve got the team Solve in the States, we’ve got lots of people working in the background contributing to this study. So I just really want to acknowledge the amazing work that they’re doing and to say thank you to everyone. Often it’s me, Chris and a few others that are involved in the webinars giving you the updates, but actually there is an army of people in the background contributing and making this study happen and I also want to acknowledge the 300 plus people that we’ve got who are signed up to be our social media ambassadors who will be helping keep you up to date once we launch, making sure that you’ve got information, helping direct you to the website where there are questions and answers. All of those things. Chris, can I hand over to you to give us a bit of an update on some of the other things that we’ve been doing that Claire hasn’t shared with us.
Chris Ponting’s update on study progress:
Chris: It’s a very complicated study, as has been said. So we have done a whole variety of things. We’ve got permission from the UK Biobank to use the data which we need for the comparison with the general population. So this is a UK-based study so we need people from the UK against whom we will compare the genetics of people with ME. So that’s now done.And what else have we done? We are testing and testing and testing and whenever we test we will find things that aren’t exactly right and we found that fixing those those issues has has taken a little bit of time more time than we would have wished and then we’ve obviously gone back into another round of testing, so I think we’re in a really good place.
We’re looking forward to recruiting our first participants on the last day of this month and just, if I may Sonya, just talk a little bit about our recruitment plan at the moment so we’re going to be starting quite slowly and that’s deliberate with tens of participants and we’ve chosen people to participate at the beginning, those who are severely affected by ME, and we’ve chosen these people because they’ll need more time to complete paper-based questionnaires and we’re processing these paper questionnaires by hand. Deliberately again, so that will allow us to iron out problems with the electronic data management system. So that’s the first bit, then we’ll go and ramp up with some hundreds of participant numbers. [It] will not be in the thousands because we’re still ironing out issues with the platform. We have been working with our partners every week Solve to adapt their existing platform which needed some additional functionality so it wasn’t something that we just took off the shelf and we’re still finding things that they need attention, so we stopped testing and then start again once the issue is resolved. As I said earlier, this has taken us longer than we’d anticipated and it’s still ongoing. So the speed at which we ramp up from the hundreds to the thousands is not entirely clear but i’ll say what I’ve said before in these webinars, that people such as yourselves who have waited for such a long time too long for a large study such as this, we owe it to you to launch in the most successful way possible and we won’t compromise.
We’ve always done things in the best possible way and we’re not going to change that. So that’s my update and I look forward to hearing from people later and with questions.
Question and answer session:
Sonya: We’re going to take some questions and answer, going to take some questions in a moment but I do just want to flag that we do have a frequently asked questions section on the website www.DecodeME.org.uk. You can go in your own time [and] you can listen to responses. As Claire highlighted, you can read those. You can ask people to read them for you. There’s lots of information and we’re continually updating. We’re not in a position to respond to every single question we get. We get a lot of questions as you might expect and Dani and the team do their best to engage and be responsive, but actually our focus has to be on getting ourselves ready to launch recruitment. So please bear with us if you don’t get a response, but do go to our website and remember if you’re over 16, you live in the UK, you have a diagnosis of ME (or CFS, or ME/CFS) then you can sign up for web for updates via our website or you can phone Action for M.E. and ask to receive those updates and you will be first in line when we launch recruitment.
We will do our best to keep you updated on recruitment news we will let you know when we’re about ready to launch, but – as Chris said – we have to be absolutely certain every single thing is in place so that it goes as smoothly as possible and that will take the time that it needs but we are still going to complete our study within the four-year time frame that we have committed to.
So I’m now going to kick off the questions by asking Chris a question. This one came in by email in advance:
Are you only looking for people who currently suffer from ME or will you also consider more who’ve suffered for years but have almost completely recovered?
Thank you Sonya. So we are looking for people with a clinical diagnosis of ME and those who pass two types of criteria: the Canadian Criteria and the IOM Criteria one or the other. That means that people who are fully recovered, who don’t have ME symptoms anymore, but you will not be eligible for this study but others should answer the question and see whether they come through what are scientifically quite strict criteria. I do recognize that relatively few people have fully recovered and so relatively few people will not be eligible for the criteria for DecodeME. Thank you chris.
Question for you Claire:
What have you learned about communicating about and talking to people with ME since joining DecodeME? I know you talked quite a lot earlier on and you’re hugely experienced given your caring role, but are there are a couple of things that you think you’ve learned in addition to that?
I think that’s been quite interesting because my daughter’s had it since she was 14, so I have always dealt with the communication. Anything has come through me and as part of the process what I’ve been doing is trialing some of our communications, some of our questions on her and really building up an understanding of what she isn’t able to understand. Working with the Marketing and Communications Group, I’ve really been able to see how how everything needs to be in bite-size pieces and how overwhelmed people are when they see a big bulk of text but I also want to just say as well that as a carer we are also overwhelmed by a lot of text. we’re not limited by brain fog but we are limited by headspace. We’re limited by time – we’re caring for our people with
ME and we’re often having to fight an awful lot, so it’s understanding that it is the people within the team have understood what it’s like to have ME but the people who are carers also understand what it’s like to care for people with ME and how we might not be limited in our executive function but we are also limited in time so we need to make the messaging clear and we need to make it necessary and also to make sure that it’s in small pieces. I think that’s the biggest takeaway. Great, thank you Claire.
Is there anything Chris that you’d like to add to that?
I think the thing that I have learned most is what a co-production is. We are, as scientists here, not leading this project, we’re using the lived experience to benefit the science and harnessing it in ways I’d never seen before and there are benefits on both sides and challenges on both sides. But it’s just been an amazing experience and a learning experience for me, which i’m very privileged to have been part of.
Thank you Chris. Chris, i’m going to stick with you for another question here and just a reminder to people on Facebook Live do post your questions. Dani’s passing those through and obviously you can use your question and answer function in the webinar.
Will you be dealing with co-morbidities like EDS – Ehlers-Danlos syndromes and hypermobility spectrum disorders? So we absolutely we recognize that people will have [been] diagnosed [with] multiple different conditions and we will be capturing as many of those as we can in the questionnaire but we haven’t put a full set out for the reasons that Claire’s already told us about.
But principally we’re interested in ME, people who have been diagnosed with ME and who are eligible according to the criteria. So, if the question does having fibromyalgia or other conditions mean that you cannot participate in DecodeME? The answer is no.
If you have a clinical diagnosis where ME and pass the criteria you’re in and we welcome you into the study.
Sonya: Great, thank you, and just to remind people that if you don’t get into the study, you don’t meet the eligibility criteria, [it] doesn’t mean that we’re saying you don’t have ME. [It] just means that you don’t meet the criteria for this specific study but you can still give information and, with your consent, that can be used for future research.
I’m going to flip and take a question from Facebook. Claire: I think probably you can answer this one?
Just to double check, is the diagnosis of CFS acceptable? As the NHS in Liverpool do not diagnose ME.
Yes, so the reason why we call the study in all our communications is about ME, CFS or ME CFS or CFS ME, because so many different people call it different things and, yes, if you have been diagnosed with Chronic Fatigue Syndrome then you meet the criteria in that sense, it – for us – it doesn’t matter what it’s called you still have to meet the criteria for the ICC and IOM or whatever they’re called that’s not my area of expertise, i’m afraid but as long as you meet that that scientific criteria and that somebody somewhere has told you ‘yes, you have Chronic Fatigue Syndrome/ME/ME CFS or CFS ME’ then you’re included.
Great, thank you Claire. Chris – one for you – there’s lots of people saying thank you and really appreciating the Patient Public Involvement input and the impact that that’s had, so please forgive me I’m not going to read all of those out, but we do love hearing them.
This one’s for you Chris:
I have a very dry mouth and find it hard to give samples. Is there any way around this please?
Yes, so, we do need a saliva sample – we thought of alternatives but through PPI. We came to realize that saliva was the best option, although it’s difficult for some people and we realized that.
So in our documents and our paperwork we’ll give you it will contain some suggestions as to how you will be aided in providing a saliva sample and you needn’t do this in one time slot. You can come back to it and and top up uh time and again and once your saliva sample is in that tube it’s stabilized and should be good for for quite a while. So, unfortunately, albeit that we recognize what the challenges are this is the way that we’ve had to choose to acquire your DNA for this study.
Thank you and i’m just going to…we’ve had quite a lot of questions around communication and kind of the eligibility and so I’m not going to kind of repeat those but…it’s a question here
Chris that asks about:
Whether the study will involve any clinical investigations such as blood tests and we’re not we’re using saliva in the questionnaire? So what does that mean in terms of being totally reliant on subjective answers of participants to the questionnaire?
So that’s a brilliant question and one answer that I’ve seen recently been discussed by scientists is that all symptoms are self-reported and we should not bend them just because it’s the lived experience of people. In fact we should celebrate people’s lived experience, rather than not believing individual self reports. In fact if you look at the evidence from genetics, the genetics tell you, tells me anyway, the self-reported observations made by people are at least as good as electronic health records. So we absolutely take on trust the self-reported clinical diagnosis of ME for good scientific reasons. I hope that’s clear.
Sonya: Great, thank you, we’ve had a number of questions from people saying that they need support in getting a diagnosis. They have many symptoms but they’re having difficulty in accessing doctors etc.
Action for M.E. hears that on a regular basis, as do some of the other charities, I know. Please do go to one of the patient support charities and come to Action for M.E. We have an advocacy service, you can get support through the ME Association and some of the other charities that exist, so if you are struggling with the diagnosis please do come and utilize the support available by the charities and we’ll do our best to support you through that process. Obviously, if you then go on and get a diagnosis, you will be eligible to take part in the study.
Chris – another lot of science questions this time around:
Will you be looking at mitochondrial DNA?
We’ll be looking at every part of your genome, every corner, every chromosome, in and also the mitochondrial DNA. Absolutely I know that people think that the mitochondrion is an important element in why people have ME. The interesting thing is that a lot of the function for mitochondria doesn’t actually come out of the DNA of the mitochondrial DNA, it comes out of your chromosomes and, so, if we find genetic signals that indicate mitochondria, ironically it might be that we find them on the chromosomes which is not in the mitochondrial DNA. So, a scientific answer to a scientific question but, in general, yes we’re looking at everything. Okay, great, thank you.
Claire – question for you:
How will we know when we’re going to be part of the study?
Well, technically, everyone is part of the study as soon as they register. Everyone is. We consider everyone to be part of it at that point. What will happen is you will register, you’ll receive a link to verify your email and then you get to go through and answer a questionnaire about your symptoms and it’s when you’ve been through all that the algorithm will tell you at the end of it if you can progress through to the next stage. So it’s a little bit like ‘X Factor’ and we’ve made sure, as much as we can, that tone around that is important because we we’re not saying that you don’t have ME, we’re just saying that we have a lot of scientific criteria and you need to meet that. So you will find out as soon as you’ve answered the questionnaire but once you’ve done that, even if you’re not eligible to progress to the next stage and be sent your spit kit, you will still have the option of staying involved – receiving updates and also becoming part of other research studies that the DecodeME team will be filtering through and if, with your consent, putting your details forward for it – so even if you don’t meet the criteria at that stage, it’s not at the end of the line and you can still help after. That’s great, thank you claire.
Questions around whether or not people receive their individual personal DNA results. We’re not providing those results for you. There are other studies and ways in which you can get DNA results but that’s not something we’re offering.
We’ve got several questions about Long Covid and Covid.
So what effect will the presence of Covid in society and Long Covid have on this study? Will the two diseases be able to be untangled?
So, Chris, I’m going to start with you and then Claire if there’s anything you want to add or comment on then we’ll come to you next.
Chris: This is occupying worlds at the moment, so yes we’re carefully monitoring the impact of Covid, in particular, on the Royal Mail because, you know, Royal Mail has slowed down in its ability to deliver. This has recently improved but it’s still a concern to us and so we’re paying attention to that. Now, closer to home, Covid has affected the DecodeME team with many team members needing to isolate, looking after family members, becoming quite unwell at times, so we’ve obviously adjusted our ways of working as best we can but it is challenging I must admit. Long Covid is something that we’re all very interested in from a scientific point of view i’m interested in answering the question whether the genetics for ME for people with ME who had ME before the Covid-19 pandemic overlaps or not with ME that are diagnosed because of Covid infection. Are they overlapping or are they different?
So we have approval from the funders to recruit 5000 extra people who have an ME diagnosis because they’ve had Covid infection and that’s above and beyond our initial plans and so we’ll have the power scientifically to ask that question and hopefully answer it and I wish in the future, just looking to the longer term, that there will be a similar type of study such as DecodeME but in the Long Covid arena and would be very happy to talk to anyone about such prospects.
Claire – is there anything you want to add?
Just that, I think they said, what was it – that 46% of people with Long Covid will have ME?
But if they have Long Covid and they haven’t been diagnosed with ME then they need the diagnosis of ME, not just the symptoms. And, as you said earlier, if people are experiencing the post-exertional malaise part of Long Covid until they have ME then they need to be looking for that diagnosis in order to be part of the study. Great, thank you both.
We’ve got some questions around when we’re going to be launching outside of the UK.
We are going to need to have a replication study. That means that we need to actually increase the numbers of people and go from 20, 25 000 to 50,000 and beyond and rest assured we are ambitious. We want to see DecodeME grow, (but) our focus right now is getting the recruitment launch open for everyone and we will continue working with others and internationally to see if we can get DecodeME replicated and open for those people outside of the UK. That’s going to be really important in terms of being able to get the numbers in so that we can validate any findings that we have, but also the more people that we have involved the more we’re likely to see the more detail we’re going to get the bigger the numbers. So we are ambitious. You know, wouldn’t it be great to actually be able to have a hundred thousand, two hundred thousand and really start to learn some more about this illness?
I understand this is the first genetic study into ME – which, I think might not be quite correct, I think there are other genetic studies, but this is certainly the largest – do you have any hypotheses that we may find that ME is a number of different diseases given that it is often triggered by various viral infections?
The great thing about genetics is that we’re looking into every corner of our DNA and so we’re not simply going to be asking all of the questions that people are asking today, but we’re going to be able to ask the questions we haven’t even thought about yet.
So it is comprehensive. It is objective. We’ll be looking at over 20,000 genes with over 20,000 people. It’s not the first study but it is indeed the largest and, therefore, it will be the most powerful to answer all of those questions. So, of course, we’re interested in what people think as to what are the genetic risk factors for ME today, but when we look next year we may have a completely new hypothesis and if that is the hypothesis that has the greatest evidence that’s the one that should be pursued vigorously.
Thank you Chris. Got quite a few questions around how people can register and the questionnaire Claire’s answered that already and the film will be available so you can watch that again and listen to it again but you can also go to our website www.DecodeME.org.uk, which has lots of information there and does just give some responses in terms of the process. And we’ve got lots of questions we’re not going to get through all of these.
[When will we get findings / results from the study?]
So people are asking about timeline in terms of findings for the study we’ll be concluding in 2024 and we will share information as soon as we’re able and we will make that accessible. We’ll avoid jargon. We’ve had requests around that. Somebody’s asked if anyone else is getting emotional I have to say I teared up as I was listening to Claire as a mum of the child with ME this study means a huge amount and I can’t tell you how privileged I feel to be part of this study and I’m sure that there are lots of others that feel the way. And, I have to say, the whole DecodeME team feel very emotionally committed whether they’ve got a personal connection to ME or not.
There are lots of questions around eligibility again please go to our website to find out more.
Somebody’s shared an address in the question and answer. We’ll make sure either Issy or Dani capture that for us. Please don’t share your personal information in the Q and A. Give us a call at Action for M.E. and we can captured for you and make sure that you get the questionnaire sent out if you have Severe ME. We just want to protect your data.
And on that note we’ve got lots of questions about data privacy selling people’s data, so Chris:
Can you tell us a bit about how we’re going to keep everybody’s data secure?
We have to hold ourselves quite rightly to very high standards. In this study and beyond, the University of Edinburgh has data protection authority and we meet regularly to discuss data security. So we will hold everyone’s data very securely inside our firewalls with only a few of the DecodeME team having access to personal data. The data will be anonymized after that and I think one important thing to say is that DecodeME wish for the data to have a long-lasting impact so we do wish to share data but that’s anonymized data to bona fide researchers elsewhere who have ethical approval for their studies. However, I need to say this really clearly. If participants do not wish us to share their data with anyone then there’s a little check box which says ‘No. I don’t want you to do that’ and that does not disallow that individual from participating in DecodeME.
It just means we won’t share your data and that’s your choice. And we support you as much as we support others who actually say ‘Yes. I do want my data to be shared anonymously without personal details being passed on as well.’ So I’ll stop there, there’s so much to say on that issue that we are covering on a day-to-day, weekly by week basis. But please be reassured that this is uppermost in our minds, particularly at the moment.
Thank you Chris.
A number of people have asked for the website address again so I’ve just shared that in the Q&A for those on the webinar. It’s www.DecodeME.org.uk. Also we’ve had a request to slow down our speech, which is totally understandable. I think we’ve got so many questions we’ve been trying to work through them as quickly as possible and one thing we might consider is hosting a webinar that actually where we slow everything right down and we take a few questions in advance and share those questions so you know whether it’s something that you want to use your energy to listen to.
We also produce a transcript of the webinars and we also produce the film, so you can watch it again afterwards and there are often short clips that are shared as well. So there are lots of different ways you can get information and apologies that we’re not able all in one go to meet everyone’s needs, but as Claire said we are trying really really hard and we will try and make sure that everything is as accessible as possible.
There are lots of people offering to share their experiences.
We’ve got a few questions about the criteria and what are the Canadian and IOM criteria?
Chris: the Canadian and the IOM criteria come from scientific publications which are quite dense, so it’d be very hard for me to summarize them to you today. My request to everyone is please answer the questionnaire as you would any other questionnaire truthfully and just give it a go and we’ll take your answers. And if you’re not eligible for the study as you’ve been told already today doesn’t mean to say you don’t have ME. It just means for this particular study we were not able to take you forward for it, which is why we’re aiming not simply to have interest from 25,000 or whatever people. We probably need double that number so that we can have 20 to 25,000 through the door for the study for the spit kit for the DNA. So I haven’t quite answered that question, because it’s really quite detailed. It sounds [like you mean] Chris there are several questions about what clinical diagnosis means if you have been told by a doctor, your GP or a doctor at the hospital that you have ME or CFS or chronic fatigue syndrome or MECFS or CFSME then complete the questionnaire. And our algorithm, as Claire outlined earlier, will work through whether or not you’re eligible for this study. It’s quite clever. I have to say in terms of I’ll ask you questions that will help work out whether you can participate. If you’re able to participate, then we will send you a spit kit. You will know immediately after you complete that questionnaire whether we’re going to be sending you a spit spit kit.
Sorry, just a reminder if you’re over 16, you live in the UK, you have a diagnosis, you’ve been told by your doctor that you have ME, ME CFS, CFS etc, please sign up to our website. You’ll receive updates about what we’re doing, how things are going, and you will be told when we’re about to launch the recruitment. You will be first in line, which means you will be told before we go public and therefore you’ll have an opportunity to sign up. I’m very conscious of time and that we have lots and lots of questions that have come through. I want to remind everybody that you can go to our website www.DecodeME.org.uk where we have lots of frequently asked questions. There are also some really great blogs that some of our Patient and Public Involvement members have written and contributed to. There are science ones. There are ones about being part of the study. How we’re involving lots of different people.
I’m going to finish with one last actually/ I’m going to finish with two questions. The first one is:
Would you be able to see if there is a link with EBV, which is Epstein-Barr Virus, particularly after the recent finding in MS – will this show in spit samples?
Chris: It could be. We learned so much about Multiple Sclerosis from genetics from this kind of study, genetics alone did not provide the answers that we’re hearing about so recently about Epstein-Barr Virus and Glandular Fever but it played its part and and I’m so pleased to see that such an advance has been made recently and this is the initial step that we need to take for ME and if there is an immune component to ME that plays through into the genetics. We will see it either initially with the 20,000 plus samples or in subsequent studies, but it’s the right direction of travel.
Thank you Chris.
Questions around whether or not you’ve registered and how you check, if you’re not sure you can always register again, but if you’re getting emails from the DecodeME team that means that you have registered for updates and we will tell you when you can register to participate in the study and start completing the questionnaire.
The last question I’m going to take, which I’ll respond to, is about the Priority Setting Partnership.
This is a partnership where people with ME, carers and clinicians have been identifying the top 10 research priorities and that’s been done through wide consultation with the community. We will have the outcome of that in probably around April-time and we’ve already started to whittle down the number of questions and priorities. So the top 10 will come out in April and we will continue working with the government, with the funders and others to ensure that we see research programs funded. Not just DecodeME, but others. We want to see treatments. We need to invest in genetics, but actually we need treatments. We need improved care and we need the understanding of this disease that underpins it.
I just want to say thank you very much to my colleagues here.
I’m going to finish with one last question that’s come through from Facebook.
Will you be selling the [DecodeME] t-shirt Chris has on his desk?
Sonya: I think it’s a brilliant question and, actually, that is something we’re going to look at. I’m guessing that was a secret Santa present, Chris?
Chris: I’ve got the University of Edinburgh members a t-shirt but I can’t afford to buy one for everyone in the team because the team is huge. So, I think we should add to our list of things to consider once we’ve got a little bit of space and we’re about ready to launch is to think about whether or not we can have DecodeME t-shirts. Not to make money but actually it’s a really good way to advertise our study and to encourage people to join.
Sonya: So thank you to everybody that’s taken their time and their energy to join us. Whether it’s through the webinar on Facebook Live or watching later, reading the transcript later. We really, really value your involvement. You are part of the study just by being here today with us and joining us afterwards and if you know somebody with ME that hasn’t yet signed up please encourage them to do so. We’ll go through all the questions and if we if we can we will update our frequently asked questions on our website. So we will try and get those questions answered and we’re looking to hold monthly webinars, so there will be an opportunity to pick up some of those questions later.
Thank you so much to everybody and thank you Claire. Thank you Pippa. Thank you Anna. Thank you Dani and Issy who are working in the background and, of course, thank you Chris.