Webinar recording and transcript – Taking part in DecodeME

Taking part in DecodeME - 16th November 2022 webinar.

With Sonya Chowdhury and Chris Ponting.

This webinar updates on the study's progress since recruitment was launched in September 2022, talks through every step to participating, and includes a Q&A session.

Watch the recording:

Direct link: Watch the recording on YouTube

Listen to the audio:

Read the transcript:

 

(SONYA)

 

Hi everybody and welcome. Welcome to those who joined us on zoom, but also those who have joined us on Facebook live. For those that don't know me, my name is Sonya Chowdhury, I'm Chief Executive of Action for ME, and I’m also one of the co-investigators on the DecodeME study.

 

I'm joined today by Chris who will introduce himself in a moment.

 

Today's focus is very much about taking part in the study. In a moment Chris is going to give us a presentation, and then we have a short film from Paul, who describes his experience of participating and also what he's done to help us recruit more people.

 

We know that there were over 800 people that registered for this webinar. I want to acknowledge that people who are joining may be at different stages of taking part. There may be some of you that aren't yet sure whether you want to, so we will have some questions and answers at the end of Paul's film.

 

You can send questions in the chat; you can post them on Facebook live and they'll hopefully be passed on to me; and I also have a really long list of questions that have been sent to us in advance. We may not get to all of the questions, but we'll certainly try our best to get through as many as possible.

 

But also, I just want to remind you that there is a frequently asked questions section on the website

www.decodeme.org.uk. You can find out more, and you can sign up to participate.

 

I also just want to thank everyone, everyone who's taken part, everyone who's helped to spread the word. This is your study - it's not our study, it's your study. We're doing this for the community, and you have helped us to make a significant impact so far in terms of our recruitment. And we were really pleased at the weekend to see the press coverage in the Mirror, and we've had various bits on the TV and in the press, and lots on social media.

 

But the study's not over, we still need tens of thousands more people to join us, and we need your help to help reach those people.

 

Chris is going to touch on that a little more after his presentation. Over to you Chris.

 

How To Take Part

(CHRIS)

 

Thank you, Sonya. So, I just want to let you know, what Sonya has just said, this isn't the University of Edinburgh’s project. It isn't Action for ME's project. It is the whole community's project, and every time we interact with anyone, we make it clear that this is a project that involves everyone directly and indirectly up and down the country.

 

So, today I'm going to be talking about 2 things: how to participate, and then secondly, feeding back to you what you told us about your lived experience, and I'll explain more later.

 

So, how to participate: the first step is to sign up and confirm your email address. And obviously you do that on decodeme.org.uk, and just press on the sign-up button, and then you put in your email address.

 

You might say how you found out about the study, but that's optional, and then you will receive an email, and then there'll be a link in blue asking you to confirm your email address.

 

There are times when you don't receive an email, so check whether your address is correct, but you must click on the link and answering the email does not count as confirmation. And there is an expiry date, so if that goes past the expiry date, then please just let us know and we’ll issue you with a new one.

So, then you create an account and this involves a password, and as with many passwords, you might have some difficulty with it. Apologies for that, but we need to have a very secure way in which to hold your data in the best way possible and the most secure way possible. So please do take your time over providing a very secure password, and we've provided help on that, on that page.

 

So, then you put in your email address and your password. You can reset your password and there is again some help. And make sure that if you can't seem to log in then you can retype and put in your email address correctly.

You can read the study information and if there's anything you want to contact us about there are ways in which you can contact us, and there are ways in which you can, at that point, change your password, update your details, etc.

 

So, there are times when this doesn't go so well and obviously then, you can scroll down, you can be in touch with us, and make sure you're happy with everything that you're being asked to do.

There are audio recordings on each page to help, so please do use that facility if you wish and use the scroll button to go up and down the page.

 

Now here's an important thing: to participate we need you to press that submit button there, because we think that there might be some people who have gone all the way through the whole process, have given their time and energies to get through the whole process without pressing the submit button.

 

So, if you think you're one of those people, then please go through and put in your email address, and you'll be able to navigate to this point in the process, and if you see this final message then you will have completed the questionnaire, the survey completion will be 100%, and you will receive an email with a result after completing the questionnaire.

 

But if you don't receive that email, if you don't reach this point and you haven't therefore pressed the submit button, we’d appreciate it if you could go back and find out and press the submit button if you can.

Postage and Logistics

So, here is the second part of the talk: I'm telling you what information we’ve received from you, and we've received a fantastic response over the last 2 months from everywhere up and down the country. We know through post codes where you come from, so we're able to put on this map the numbers of people who have participated thus far.

 

Over 21,500 people have started the questionnaire, and that's fantastic! Thank you so much. And over 16,500 people have completed the questionnaire, and as I said previously, some of those people of the 21,500 may not realise that they haven't quite completed the questionnaire, so please do go back and have a look.

 

We've received questions occasionally, and just to say, we're not selecting people for the second phase of the project on the basis of the length of time that the people have been ill, that's not the case.

 

We are recruiting from across the UK and probably we are recruiting at about 10% so far of all people with an ME diagnosis in the UK. 9 out of 10 people with a diagnosis we haven't yet reached, or people don't wish to participate and that's fine. So, one of the things I'm going to ask please, is if you know people who may wish to participate, if you could let them know that would be fabulous, because, as Sonya said we do need tens of thousands more people to get scientific power for our study.

 

How long does it take to complete the questionnaire? – Well, if you have mild symptoms it'll take you about 12 minutes, on average. Some of those will take a bit longer; moderate, it'll take you 14 or so minutes, and severe, maybe 15 minutes and then others of course in those categories, it may take you slightly longer. We tried to make sure at the beginning of designing the questionnaire that we wouldn't go past the 20-minute mark, and on average that is the case.

 

But there are some delays that are outside of our control. There are delays in delivering of the post, and there are strikes. Those both are impacting on our ability to send kits out, and for the Biosample Centre to receive them in. So please bear with us, these are out of our control, and we are trying to make the best of a difficult situation.

 

There are large numbers of kits being delivered, and thousands of kits being delivered in Milton Keynes in the UK Biosample Centre and we're sorting out with them which of those kits have been received, but we don't know all of them yet, and they're going to tell us that information in the next couple of days. So, there will be participants who are experiencing a delay in receiving confirmation emails, confirmation that the kits have been received, and apologies for that. So, if it's okay, we would appreciate your patience because we're trying to engage with both Royal Mail and the UK Biosample Centre to improve on the situation. So, if you’ve not had an email confirmation that your sample has reached us, please let us know, but only about 4 weeks after you've sent it out to us. That would be great, thanks very much.

 

Now Christmas is coming, we have a last posting day before Christmas. If you complete the questionnaire before the end of the month and you'll be sent out a spit kit, then this kit will only go out in the New Year. So, because of Christmas closures and reduced capacity among our team, we don't really want to collide with the holiday postal period.

 

Coverage And Responses

Sonya has said, we are continually getting great coverage. This from Miriam Stoppard in the Mirror over the weekend, which is fabulous. It would be great for the media message to keep on going out.

Thank you for everyone who sent us any message. So many lovely messages from people and people thanking us in a variety of ways. People are delighted to have taken part and thanking us again. It is giving people hope, and that's lovely to hear.

 

This person thanks us again, understanding it's a scientific study; and just walking through what we've taken great effort on actually, to provide audio, auto-save, so people can go away from recording their results on the questionnaire, and then come back again without any change. Also, people can fill in the questionnaire on behalf of others and there's only one field that just needs typing, the rest is just tapping so hopefully that helps people to complete the questionnaire.

Data Release Timeline

So, we've obviously been asked questions:

 

Is there a timeline or planned release date for the data?

 

There is a timeline and a release date for the results of the data - we're not releasing the data, obviously, but the results. We think that we'll get the first tranche of data back from the ThermoFisher labs in about April, and we're going to analyse that as quickly as we can. We've already started cleaning the control data, and so it's going to be around about summer next year, 2023, and kindly people are saying that we need to rest and unwind, yes, we are working at full pelt. It is the case, particularly over Covid, that people have been unwell. People with lived experience of ME have had very great difficulties going beyond energy levels. We've gone beyond our energy levels, but we are looking after ourselves as best we can.

So, here's one surprising result in that of all the participants that have completed their questionnaires thus far, we've only got very few severe and very severely affected individuals. Now the reason for this is that the criteria that we used for severity are from the NICE guidelines, the new ones, and they are basically reallocating some people with previously severely affected status into the moderate, and we chose this definition or set of definitions to be concordant with other studies going forward. So it isn't that we believe that those who are described as moderate, have a moderate degree of symptoms. Far from it. We understand how severe symptoms are in ME.

 

Your Lived Experiences

Now on the lived experience of 16,500 of you, you have self-reported what are really important findings:

 

Over 90% of you report brain fog; nearly 90% of you say that your symptoms are disabling; nearly 90% of you say that you have headache, eye pain or migraine; nearly half of you also report IBS; a third of you report fibromyalgia; and some auto-immune conditions appear very infrequently, which I was quite surprised by.

This is probably the largest survey of lived experience of people with ME worldwide and I wanted to show you these results that came to me on Monday morning as soon as I could. This morning we had a meeting with the MRC and the NIHR, funders of DecodeME, to show case to them how important these results are. That information essentially now can go back into the funders, into the UK CRC, Department of Health and Social Care process, to make sure that informed decisions are taken going forward based on the evidence.

 

You describe your illness in these ways:

 

Mostly fluctuating, worsening, relapsing, and remitting. Very few, unfortunately improving. This is a very sobering set of data that's captured your lived experience and it is a message, as I said, that needs to go to the very highest level, how devastating ME is to most.

77% of people have completed their questionnaires, and half of those people will be allocated to a spit kit, and nearly all of those have been sent a kit, but not all. As you know, we always knew that we were going to try for 20,000 people with ME diagnosed pre-Covid, and we have a few hundred people post-Covid, and we're going to try and bump those numbers up in the New Year.

 

So, we always get this question, which is absolutely fine:

 

How on earth is the algorithm choosing people who are going to be sent the DNA spit kit?

 

When we started our journey, we all we decided, together with PPI, that we would apply the Canadian or the IOM criteria, and when we came to peer review for the grant, we were essentially obliged to add additional criteria at that point, otherwise we would not have been funded. And as you know, the population prevalence of ME is thought of as anything between 0.2% and 4%, and that's basically because people draw the line in different places.

 

And so the peer reviewers have drawn the line in a different place to where I would, and we've had to go with their line and their criteria, in addition to the core criteria, Canadian or IOM.

 

We don't explain to each individual person why they have or they have not been asked for a DNA sample. The reason is that we need to blind people to data recording for this stage. We will always, and I hope it's understood we will make everything that we do clear to everyone when our recruitment phase is over. But we can only do the best science by ensuring that the whole project is not biased.

 

If we told people exactly who was going through to the second phase, or who would not, then even subconsciously, that would influence people's responses, and unlike, for example, in the PACE Study, where people were told that their therapy option was going to improve their lived experience during the study, we don't want to make that mistake.

 

So, it's a reasonable question, why might you trust us, that we're doing the right thing? I understand if you may not trust us, but please do trust those with lived experience because they oversee everything that is done across the whole project. Nothing is held back; it is there in clear view of everyone who's part of the PPI team.

 

We've in a previous talk, talked about what genetic insights we will get. It hopefully will be similar to the insights that came from the genetics of acute Covid. I won't explain the data, but essentially if you see any of these towers that peek their head above the dashed red line, then that is a genetic signal; and there was one ringed here, TYK2, that told the investors that a good therapy for critical Covid would be this Baricitinib, and that indeed saved lives in the Covid pandemic and that came directly from the genetics insight.

An unpublished study on Lyme disease has found a particular skin protein, that there is a genetic signal there, and the skin protein inhibits bacterial cell growth - exactly what you might expect of the bacterial disease Lyme disease. So, there are genetic insights that have been made from these two studies.

 

What do we know about the genetics of ME?

 

Well, this is our latest unpublished result of 4,000 people with ME or CFS from the UK biobank (I apologise, it's very blurry). We don't see any of these data points poking ahead above the dotted line. So, there is no genetic signal in this analysis from the UK Biobank. This is the largest ME genetic analysis that's ever been performed.

This is a sobering number. We have captured your lived experience of 150,000 person years of ME, and yet you're only one tenth of the number of people with ME across the United Kingdom. Every year that we go forward, tens of thousands more person years are added to this. Our only aim is to get to a place where there is effective therapy for as many people as possible. Our only aim is to do that as rapidly as possible.

 

What can you do if you wish to help us? Well, please help us recruit to the project. Help us recruit, it's a numbers game - we need tens of thousands of more people. Please help us recruit. We're not doing so well in the non-white communities, and, as I said, only a few hundred people with post-Covid.

 

So, thank you to everyone. The tens of thousands of people who have already participated in DecodeME, and if you wish to sign up, it's at decodeme.org.uk.

 

Thank you so much.

 

(SONYA)

 

Thank you Chris. We're now going to hear from Paul, who's taken part in our study.

 

Participant Experience

 

(PAUL)

 

Hi my name's Paul. I was diagnosed with ME in 2017 after being ill at the start of 2016 with a virus from which I never really recovered. For the first 3 years or so, my symptoms were what would be classed as mild, which means that they were still hugely disruptive, but I was fortunate enough that I could still work full time through careful pacing and really prioritising all of my effort and energies around being able to work. For the last 3 and a half to 4 years, then my symptoms have been worse, I am now what would be classed as moderate, and for the large part I’m housebound.

 

I decided to take part in the DecodeME study, as I saw it as a rare opportunity as an ME patient, as an ME sufferer, to contribute to the biomedical knowledge base on ME. To me it's an exciting study, because it has the potential to indicate why it is some people get ME, and some people don’t, and perhaps point to pathways for prevention and even treatment.

 

The questionnaire itself was easy to fill out. I did the online questionnaire. I found it simple to work through. After having completed that, I was asked if I would provide a spit sample for DNA extraction. The equipment all arrived in the post, and everything nicely packaged up and the instructions were nice and clear, easy to follow. It’s a slightly weird experience, but it was easy to do. I sat on the sofa with the collection equipment to hand and topped it up, as and when I felt able to, whilst watching the telly. It took me about 15 or 20 minutes. Once I’d filled up the tube to the right level, then everything easily to hand for packaging it up, and it was very convenient that it could just be popped in a post box rather than it needing to be taken to the post office.

 

To anyone with ME who hasn't participated in the DecodeME study yet, then please do it. I don't think you'll find any other study that is so simple and easy to participate in that could have such a huge impact on the understanding of ME and the mechanisms behind it.

 

I would also say publicise the study as much as possible. It can be surprising how many people out there, either have ME or know somebody with ME, and that word-of-mouth element could really help in drumming up extra participants for the study. Me personally, before I was ill, one of my passions from my pastimes was motorcycling. For me that meant restoring motorbikes, going out and riding them, racing on the racetrack, taking my kids to Motocross, all sorts, it’s a very sort of social activity. The only bit of that I can do these days is participating in the online communities, so that's still a nice link back to something that I could do in the past, and something that ME has taken from me. And on those forums, in those communities, when I've mentioned the DecodeME study, it's surprised me how many people have said ‘Oh yes, my wife’s got ME’ or ‘my relative’s got ME’; ‘my friend’s got ME’, and that word-of-mouth element, in getting the awareness of the study out there, could really help in drumming up extra participants for the study.

 

(SONYA)

 

Thank you Paul for sharing your experience with everybody. As Paul said, we really want to stress the importance of getting more people to sign up. We still need tens of thousands of people to help us complete this study. The more people we have, the more data we have, the more power that we have statistically, and the more data that we have to be able to use to influence the government, research funders and others. So please do help us reach more people. Tell people with ME about the study. Tell people without ME about the study, they need to know how to spread the word even more for us.

 

You can go to the DecodeME website and there are some ways to share online - there's posters, there's leaflets; we've heard from people that have taken their posters and leaflets to their doctors who have also then gone on to tell others about the study.

 

So please do help us to reach more people. Most people signing up are undertaking the questionnaire online, but there is also the option to request a paper version, and you can contact the team for this. You can also get somebody to help you, a family member or a friend or carer, and we've also agreed to put in place telephone support available from the 25% ME group who are very, very experienced, with working with those who are the most severely affected, and they will help record the answers for you in as many sittings as you need to do.

 

So, as I said, please go to our website, look at the ways to share and help us reach as many people as possible. There's also, as I said, information there for clinicians.

 

Audience Questions

So, we're now going to some questions, I’ve been trying to answer some questions in the Zoom chat as we go along, and colleagues Issy and Charlotte will be sharing any questions from Facebook. We'll try and get through as many as possible.

 

The first question is:

 

My sample was taken 2 days before I managed to send it. Will this sample be okay, I still sent it off? Chris, it's absolutely fine - is that correct?

 

(CHRIS)

 

Yeah, absolutely fine.

 

(SONYA)

 

Brilliant. And if the DNA sample doesn't work for some reason, will people be sent another one, and how will we know it's worked?

 

(CHRIS)

 

Yeah, so you'll be receiving an email to say whether it's worked or not - most of the time it'll be absolutely fine. The odd cases where the quality control means that we will ask you for a second sample, and we'll send you another kit.

 

(SONYA)

 

Thank you Chris, and is there a plan in the future to collect DNA from family members?

This person, Sarah says she's got 3 children with ME, and only one is old enough to take part in the study.

 

(CHRIS)

 

One of the fabulous things about DNA is that just from analysing data, we can tell how people are related to one another. We won't do that for individuals, we'll do that for everyone that is in the study and so, by using the family relatedness that is seen in the DNA, we use that information to ensure that we get the best chance of finding the genetic signals. I know it's a complicated answer,

but basically, we'll work it out computationally, and so that means that we can do that even though we don't have your family member’s DNA.

 

(SONYA)

 

Thank you Chris. This person asked is there still value to the study if we can complete only the questionnaire but don't wish to send a sample? Absolutely, the data that Chris has already shared with you is giving us so much information, and we've already shared some of that with the funders. It is so important to help influence decisions that are made about future research.

 

(CHRIS)

 

There's a fundamental principle here about consent, if you don't want to do something, you don't do it.

 

(SONYA)

 

Great. So, this person asks a fully completed questionnaire, sample sent back, trying to find out about feedback and updating on results, both interim and final. Read the study protocol on the principle of patient public involvement but wants to know a little bit more about how you propose to sense-check articles with end users? i.e. carry through co-creation, right into dissemination and beyond. And whether you'll be sending out seminary reports to all who took part and links to pre-prints, final articles, etc?

 

So, I think this is very much a question about are you going to be kept updated on what's happening? And yes, absolutely, if you've consented for us to contact you. If you haven't, you can still go to the DecodeME website, and we will be publishing blogs and we will let you know when we have pre-prints etc. We're really keen to share all the results, to be as transparent as possible.

 

Several people have been asking questions online about being able to take part outside of the UK?

 

You need to be over 16 and live in the UK to be able to participate. We'd love to be able to recruit people internationally, but we aren't funded to do that at the moment. But, if you know researchers that are keen to replicate this study, then please let us know, because we will happily work with them.

 

We've got a question here from somebody on Facebook: Do you have any posters, fliers that can be printed to leave at doctors, etc.?

 

There are ways to share on the DecodeME website www.decodeme.org.uk/ways-to-share

So please do go and find them. Any issues, we're talking about it all the time on social media.

 

The next question says: my sister, (this lady's watching on her behalf), is signed up originally.

Should she try and log in now and see if she can fill in the questionnaire? It’s possible she may have missed update emails as it's harder for her to keep up with emails. Should she just give it a go?

 

Yes absolutely, as Chris said in the presentation, you should get that confirmation email, and you need to click. If you haven't received that, you can contact the team, and it may be that the time has lapsed and you can go back in and try. So any difficulties, do contact us, but we'd love your sister to participate.

 

Lots of questions about the fact that people haven't had confirmation that spit kits have arrived.

As we said, there are delays outside of our control. There's a question here completed my questionnaire on the 27th of October and had email confirmation that a spit kit would be sent, and I would get an email when it was sent. I haven't had that email yet, should I be concerned?

 

So Chris, that's sort of what, 2 and a half to 3 weeks ago?

 

(CHRIS)

 

Yeah, if you can wait a bit longer, that would be great. I think we have a backlog because of the postal issues, and also the backlog that the Biosample Centre has told us about.

 

(SONYA)

 

Couple of questions here about the rationale for deciding whether a sample was required, and why it wasn't required. That was covered in Chris's presentation. So if you missed that you can obviously catch up by watching the recording, we will make sure the recording is available.

 

We've got another question from Facebook: When will any early findings from DNA testing be released? Chris?

 

(CHRIS)

 

The earliest findings, once we are certain that the results are true or bona fide, will be next summer.

 

(SONYA)

 

Right, thank you Chris. And I’ve got a question here about any findings around gender or endocrine differences in the data thus far? Aside from the data we've shared with you, we don't have any further data. Chris, you look like you're about to say something.

 

(CHRIS)

 

I can't remember whether I showed you the female bias. 85% of you are female in participants, and we will analyse your DNA separately from males as well as together.

 

(SONYA)

 

Right. There's a comment here about GPs stop investigating you once they diagnose. Wonder whether this individual has mass cell activation syndrome, but not worth chasing the GP?

 

We as DecodeME, we're not able to comment about individual health. But charities like Action for ME have a range of resources and information, and information support services that can assist. And we would, as Action for ME, always say if things change, go back and speak to your doctor, and if they won't listen then try and find another one, and if you need help, then the charities can help you.

 

There’s somebody again, we've got more about completed spit kits. We're experiencing delays that we have no control over, so we really, really appreciate your patience.

 

There's a question here Chris, about the slide on how many people are worsening, fluctuating, etc. compared to improving? What plans are there to publish that data soon, and in particular make sure it gets to DWP and NHS, both of whom often seem to think that most people with ME improve and will recover, when we all know that that's not true?

 

(CHRIS)

 

Via the National Institute of Health Research, I have shown them this data, this morning. It's gone to the Department of Health and Social Care via the NIHR, and we will bang on doors as loudly as we can with data, with evidence and it’s evidence that you have provided and it's the largest study that's ever been undertaken, and so people will have to listen to your experience.

 

(SONYA)

 

Chris, we've got a few questions around the sort of selection process in terms of who's invited to give DNA. I'm just wondering whether you can just re-say what you said in your presentation, just so that people are clear. And this particular question says that Chris said that additional diagnostic criteria had to be added to receive funding. Is this addition the Fukuda Criteria, where post-exertional malaise is obligatory, or are we talking an even wider set of criteria, like the Oxford Criteria? So maybe you could just reassert what you said in your presentation.

 

(CHRIS)

 

It isn't about widening the criteria, it's about narrowing the criteria, and unfortunately that was just what we had to do to secure the funding. There might be a strong scientific argument, for knowing the criteria, my personal scientific view was different from that, but we had to go with the peer review response.

 

(SONYA)

 

Thank you, and a comment here, I wish you had connective tissue or hypermobility disorder on your questionnaire. I know so many people with ME who have hypermobility in the neck, including myself, and are being treated for it. Anything you want to comment on that Chris?

 

(CHRIS)

 

So this, for example, maybe where the genetics might help. If it were to be that we see a genetic signal in the collagen genes COL5a12, those genes that Ehlers-Danlos-Syndrome have been implicated, then we would know then for whom that genetic signal was most relevant.

 

(SONYA)

 

A comment here about really needing support in the interim because you're being discriminated against by employers in the system. Please do contact the charities. As I said, Action for ME provides an information support service, advocacy services, amongst other things, and other charities offer services too, so please do reach out if you need support.

 

A question here from Holly, who says if the previous study looking at DNA with patients with CFS didn't show any markers above the line, what is the reason for this second trial?

 

(CHRIS)

 

So numbers, is the first answer. We need far more than the 4,000 in that study. Also that study used the wider criteria, and not the narrower criteria that we use. And my anticipation is that our study will most quickly lead us to a positive result, than that more encompassing study. So this is why we are coming back to you often and saying please can you help us to recruit individuals, it’s to provide the sufficient scientific power to find the genetic discoveries that you deserve.

 

(SONYA)

 

Thank you Chris. You mentioned that the sample collection will end in April. If the target of 25,000 patients hasn't been reached by then, will analysis start anyway, or do you have the options to expand beyond the UK border before starting analysis? And is there a threshold of number of participants that will lead to either analysis or expansion?

 

(CHRIS)

 

Thank you for that question. We are funded to recruit up to 25,000 people. If we haven't got to that number for the DNA portion, then we will keep going beyond April, so my anticipation is we will still be recruiting beyond April. If we have more than that number, then we will go out and try and find funders to keep going, because the more people that we’re able to study in the DNA portion, the more power we’ll have to find genetic discoveries; the more impact and insight we will gain on this devastating disease; the more people who we will impact on their lives, and this matters. So if we have too few people we'll find nothing. If we have beyond our 25,000, the only problem that I will have is going out and trying to have extra funding to allow all of those people to participate. But again, you are all participating in providing us with the lived experience that we're now feeding through to the Department of Health and Social Care. So, whomever you are, please do participate.

 

(SONYA)

 

We need 25,000 DNA samples, but we are going to need tens of thousands more people than that. If everybody in the UK over the age of 16 took part, we would have such powerful information to influence the government and funders and others. So we would like every single person over the age of 16, living in the UK to take part if you can.

 

A comment here from Penelope says: please can you let people know or remind them that if you need it, Royal Mail can be organised to collect packages and parcels and letters for those of us based at home due to ME and avoiding Covid risks. So that's really helpful information, thank you.

 

Question here around health centres and GP surgeries allowed to advertise the study. Yes, they can put up the posters. We're not directly recruiting through the NHS, we don't have ethical approval for that, but doctors and GP surgeries can, like you, help us to recruit as many people as possible.

 

Can UK citizens not living in the UK undertake the questionnaire? I see living in the UK as one of the criteria. Chris?

 

(CHRIS)

 

Unfortunately, only those living in the UK can participate. There are many reasons for that, but one of them is to do with the costs of posting outside the borders of the United Kingdom, and the other reason is the scientific one, where we are using a control group of people to compare against, for whom we already have the data.

 

(SONYA)

 

This one's from Beth who says: I have difficulties producing saliva. Do you have any tips to help with this?

 

(CHRIS)

 

So apparently, if you gently rub the outside of your cheeks, that helps. If you make chewing motions with your mouth, that helps. If you smell sour foods like lemons, that helps. And if you have a favourite food, if you think about that, and that helps. But really, just take your time, you don't need to do it within 5 minutes. Paul, I think took quarter of an hour, if it takes longer than that, that's all good.

 

(SONYA)

 

Thank you. How long will it take to develop an effective treatment after the study is complete?

 

(CHRIS)

 

I gave you an example of Baricitinib for acute Covid, that was a drug that's already been produced. If we were able to find something like that, that would be fantastic because they're being on the shelf, there'd be a drug that could be used effectively, hopefully. A new drug unfortunately takes about 10 years or more to develop, and to ensure that it's safe to take.

 

(SONYA)

 

Comments about samples not arriving at the lab, requested another kit but not yet received it, as we said, there are delays outside of our control. Please do be patient, but if you waited more than 4 weeks please contact the team, and they'll be able to help you.

 

A comment here from Catherine who says: Paul said in the video there seem to be a lot of people with ME. She comes across people all the time, it's likely there are a lot more people with ME than the official figures.

 

Absolutely, and we expect that number to grow with those individuals who have Long-Covid and also then in a place to be diagnosed with ME. We are hoping to also recruit some people who have been diagnosed post Covid-19 infection.

 

This is from Douglas who said: I was once found by my Auntie giving her DNA to an ancestry database. I didn't want to be discovered and it's put me off giving DNA samples to anyone. Can this happen if I contribute to your study? I don't want people finding me and my relatives by my DNA donation.

 

(CHRIS)

 

Not possible, we're not giving that information. Personally identifiable information we are disallowed explicitly from providing. No, it won't be possible, but if you don't want to consent to that part of the project, then please don't.

 

(SONYA)

 

We've got questions about needing an official diagnosis. You do need a diagnosis of ME or CFS. If you're having difficulty getting a diagnosis, there are the resources on the Action for ME website. You can also speak to one of the team who will also give you some advice.

 

A lot of thanks coming through. A question here about the funders of the study. It's the Medical Research Council (the MRC) and the National Institute for Health Research (the NIHR), and they are jointly funding that equally.

 

Another question here: I haven't had confirmation email; it's now been 5 weeks. Contact the team, anything over 4 weeks, contact the team, it may take longer. So if you're happy to be patient and wait a little bit longer, then we would appreciate that. The team are getting lots of questions, and it is taking us a bit of time to get to everybody. So we really appreciate your patience.

 

Somebody's asking here for a comment on treatment that a Dr Hirsch offers. We're not in a position to comment on any treatments, potential treatments, supposed treatments. Our focus is on collecting the data through the questionnaires and undertaking analysis on that, and also the DNA. So apologies for that.

 

Questions about how many questionnaires are being completed? That was provided in Chris's presentation - that's 16,500 just over currently, and we've had over 21,000 people start the process of completing the questionnaire.

 

Somebody said: can we add information e.g. ME giving people gastroparesis, there seems to be a link in reduced motility in the oesophagus too and on waking paralysis? Chris?

 

(CHRIS)

 

Yeah, I learned so much from people and their lived experience and ME. I hear lots of different explanations and they're all fascinating and I'm storing them away in my mind so that when it’s the right time I'm going to be hopefully making the right connections, so that we understand as many people’s lived experiences of ME as possible. But I hadn't heard this particular one, so I'll follow up on that.

 

(SONYA)

 

Thank you, Chris. A question here about can you help raise funding for future studies?

We have the funding for this study, we are keen to do future studies. Several of the charities also fund research. So if you want to help raise funding for future studies, please do speak to charities like Action for ME; ME Research UK and the ME Association, all of whom fund research.

 

You shared some information on Covid-19 and genetic markers, can you explain how this was possible when Covid-19 is only a very recent illness, and ME/CFS has been around much longer?

And why, when ME/CFS has been around much longer, there hasn't been these?

 

(CHRIS)

 

Yeah, if the question is ‘how on earth could it be that such a recent disease has received far more attention than ME has, despite ME being around for decades and centuries, and millennia?’, I can't answer that. I got into ME research, thinking that I would be a bit player on the periphery of all of this, because better qualified people would be central to answering the questions that are so important to you. It is galling to know that someone like myself, who hasn't worked in ME, is required to help with this. We need everyone, particularly scientists, to step up and to take on the challenge for people like yourself.

 

I can't answer this question.

 

(SONYA)

 

Thank you Chris. Questions here about GP surgeries, hospital specialists, counsellors, psychotherapists, etc. being told the study exists with a link to share with patients. We've done as much as we can through speaking at the BACME conference, to getting things in the press and out on social media. Many of you have shared things with your GP surgeries and others. We need your help. Please do help us to reach as many people as possible.

 

Somebody's asked for a 1-hour email reminder to the zoom meetings. We'll look into that and see if that's possible.

 

Lots of people thanking us for the important work.

 

A question here: my symptoms may be related to the menopause, and I have reduced my symptoms with testosterone. Will this be taken into account?

 

(CHRIS)

 

We do some research out with ME, and that includes research on hormones and their effect in the middle of the cells, the nucleus. So, when the time comes I will remember that question, and in particular, because we know ME is so strongly biased towards women, the likelihood that there are important findings to be made, discoveries to be made in the future that are more relevant to women over men, that likelihood is high.

 

(SONYA)

 

Thank you. comment here: the name chronic fatigue doesn't help, downplays. Absolutely, couldn't agree more with you on that one.

 

Somebody who's made a comment about the GP service from Action for ME being amazing. Lots are adding thanks; lots of people saying how encouraging this is.

A question about data available on the age of participants taking part? Is that in your presentation Chris?

 

(CHRIS)

 

It wasn't, I tried to slim it down. Quite happy to provide it. We are clearly hitting across the whole life course from 16 years upwards, and every time I see a graph like that I know that underlying the data are individuals with single life histories, and it is horrifying to know that people have experienced ME symptoms for the majority of their lives.

 

(SONYA)

 

Thank you. A question here. When you say over 16, does 16 count?  Yes, absolutely, if you've had your sixteenth birthday, then you are able to take part.

 

Another question: Do you mean that family members who do not have ME may participate? You have to have a diagnosis.

 

(CHRIS)

 

I think Sonya has gone - just froze for a bit. So yes, you have to have a diagnosis of ME. I think that's what you're saying Sonya.

 

(SONYA)

 

Yeah, thank you. Are you concerned that we will not find any insights, as the results from the biobank didn't show anything?

 

(CHRIS)

 

Of course, but the science will tell us the answer. I'm not going to change any criteria from what we have already decided, to fit the data. No, the data will tell us, and if we don't find any genetic signals that go above the line - we will recruit more people. With more people, we have greater power, with greater power, we will have more genetic findings, with more genetic findings, we will have the ability to affect new therapies and new research directions.

 

(SONYA)

 

If you need so many thousands of participants, will you approach those of us who were turned down from taking part? Chris has just answered that one. I just want to say, if you've completed the questionnaire, you have taken part. You are part of our study, or part of your study. So every bit of information you give us will be helpful and will be used.

 

Many people with ME have POTS or other dysautonomia. This wasn't included on the questionnaire, or the data Chris shared. I'm wondering why not?

(CHRIS)

 

There’re related questions on the questionnaire - we had to take out a fair few questions that we would have loved to have made and ask, and that was to ensure that people would not go beyond, most people would not go beyond the 20 min mark. We didn't want to place you as participants under a huge burden. That wouldn't have been fair, but I take your point. There may yet be plenty of things that we could have done better. But the important thing was to accelerate the research and get on with it. So at some point we just drew a line and moved on. So our apologies, my apologies for that.

 

(SONYA)

 

Chris, can people who have recovered participate?

 

(CHRIS)

 

Please do fill in the questionnaire. Some of the questions may not be entirely relevant, you may not think. It would be lovely to hear from you and your responses to those questions. Because of the criteria that we set up initially, then you would not be sent a DNA sample kit.

 

(SONYA)

 

I'm just reading through - we have got through 78 questions. There are still 17 questions open, and I have 2 sheets of A4 questions, several of which we have answered. So I'm really sorry if we haven't got to your question, please do go to the DecodeME website, there's a frequently asked questions section there. There is also a section with lots of resources and ways that you can share information about the study. We need your help to recruit tens of thousands more people with ME living in the UK with a diagnosis of ME or CFS, and over the age of 16.

 

We're already gathering huge amounts of data but we've got so much more to gather. We've got the largest data set of ME in the entire world, and as Chris said earlier, we have already started sharing that with funders who make important decisions about what research happens and what research gets funded. But we still need your help.

 

Thank you so much to you for joining us; those of you that joined on zoom; those of you who joined us on Facebook; those of you that have joined just for a bit because that was all you could manage, and those of you who are watching the recording afterwards.

 

Thank you for everything that you are doing to help us make this study a success.