[Webinar recording & transcript] Why patient involvement is crucial

We held our Winter Webinar in mid-November. Sonya Chowdhury, Chris Ponting and Sian Leary from the DecodeME team updated on study progress, explained why involving patients and carers is vital in this study, and answered your questions.

If you were unable to join live you can access the recording in your own time:
Read the transcript (below)

Watch the recording on YouTube (with captions).

Listen to the recording on SoundCloud:
(You can play this while reading the transcript below).

This transcript is a long read, but we’ve broken it down into sections and highlighted questions from attendees which were answered by the panel. There may be some typos left in the transcript – we will continue to correct these.

Welcome and Introduction from Sonya Chowdhury:

Welcome everybody to the DecodeME study webinar. We’ve had several webinars previously.

I’m delighted to say that today we’re joined by Sian Leary who’s one of our Patient and Public Involvement members. Sian will be talking about the work that she’s done, and is involved in, alongside Chris is going to give us some updates.

But first of all I want to just say thank you to our colleagues. We have a huge number of people that are working as part of the DecodeME study. So it would take me ages to read through everybody but I want to acknowledge that we’re a huge partnership. We have people with ME at the very heart of the work that we’re doing. Carers, scientists, charity members.

We have a number of partners that input as well. So Itineris and Hot Tin Roof are involved in PR and marketing. We have our Solve ME colleagues. We have people at the Bioresource Centre. who go to be processing samples. Gemini printer producing the the spit kits and sending those out. 

We have our funders. We have the community who have engaged in surveys. You’ve given us great suggestions. You’ve helped us promote the study. We have social media ambassadors that are working to help us in the background.

We have colleagues in Action For ME and the University of Edinburgh who are outside of the core project team that have given their time freely to make things happen.

We have our scientific advisory board led by Professor Stephen Holgate. We have Helen from the 25% ME group who is helping us ensure that people can be involved, where they have more severe ME, and a whole raft of other people that are supporting the work that we’re doing so I just want to acknowledge everyone that’s played a part, and to say a huge thank you to all of you. And those of you that are probably going to join the team at a later stage.

So I’m now going to hand over to Chris, who is going to give us an update on the work that we’ve done, and also outline the work that we’ve got ahead of us, and we’ll celebrate some of the successes that we’ve had so far.

Chris Ponting’s presentation: update and apology:
Thank you very much. So, as some of you know, DecodeME is seeking to recruit 25,000 people in the UK diagnosed with ME/CFS.

Because some people will not fit the exact criteria that will be used, we have to engage many thousands more. We always knew this was going to be a huge task but exactly how huge to me has only really become apparent over the last year.

So the first thing I want to say is sorry. There has been some impatience which is completely understandable, about the fact that we have not yet launched. Many people have waited decades for this kind of huge study.

And we don’t take this project, or the subject or people with ME, at all lightly. So I understand this viewpoint. I have been trying to get this study up and off the ground for two and a half years, and I cannot imagine how it is for people who have lived with ME for much longer.

So what have we been doing? Well, this is Diana, and she is the project manager, and she’s working with people from You and ME in the states, Solve, Thermo Fisher, Royal Mail, Biocentre, with people doing the putting together the spit kits. Well, she’s been making sure that there are all contracts that we have contractual arrangements with everyone that we have procurement, because there is different procurement law in Scotland, we have to make sure that all that procurement is done properly. And she has done all these things in difficult circumstances because of the pandemic.

And then we also have to ensure that when we share data with people. And I’ll talk about whether this data is personalized and almost always it is not. I’ll talk about that in a minute.

When we share data with people, again it’s under contract, so we know exactly what it is that we’re sharing with people. Why we need to do this is that, for example if a spit kit is lost, then we can find that out immediately and send one out.

So more recently we’ve been focusing on our computer systems, here at the University of Edinburgh. And these computer systems of course need to be robust and also are set up according to GDPR regulations. And I have realized, over the last few months, that I seriously underestimated the amount of work required for this in house computer system.

I initially planned for something which was much smaller. It’s as if I originally planned for a completely new plumbing in a townhouse. You know pipes going in and out, but don’t leak etc.

But what we actually need now for DecodeME is new plumbing for very large hotel, like a sort of busy airport hotel, much more complicated needs a lot more thought and planning, and we also needed to take our plumbing inside, outside to join up the Solve’s You and ME infrastructure.

And that was because we needed to use the Cure ME symptom assessment algorithm, this turned out to be far more complicated than we anticipated. Now in response, of course, we’ve roped in volunteers to help with all of this and put more people on the case. But I’m sorry I got that wrong.

Now, we’ve also got our control data. We’ve already got that from UK Biobank so that’s something we already done.

Now I’m a kind of half glass half full type of person but sometimes that isn’t realistic and it’s taken longer to do things than I had originally anticipated and again I’m very sorry for this added of course is covered in all its impact. You know, scarcity of cardboard, people coming down unwell and the difficulties of working from home. But everyone’s working full pelt and we’re getting there.

We’re getting there, ensuring that people on their computers can do the questionnaire, and people who are home, who perhaps need help, and through Helen Baxter in the 25% ME group can have that help to ensure that everyone possible can contribute.

And this was something that was one of our core values at the beginning was inclusivity, and that took time and it’s taking longer than I had ever thought. It’s well worth making sure that our web forms are accessible, that there is accessible language on our web pages and PPI made sure of that. PPI (Patient and Public Involvement) is, of course, at the heart of everything that we do.

So we’ve needed to slow down at times to ensure that people have had their say and could contribute to decisions, and the value from that I must say it’s been enormous. On many things that we’re not previously foreseen, including scientific value, which is interesting isn’t it?

So we’re going full pelt. And now we find that Christmas is on the horizon and if we were to launch it in the next month, in December, then people might be distracted, because of Christmas spit kits would get lost in the post, our media campaign would get drowned out by everything else. So we now have to think about January. Once everyone’s back from their well-earned holidays.

So that’s what’s next? We will recruit our first participants in January. We will gradually open up for more and more participants after that, once we are absolutely sure that our digital processes are working efficiently.

So there are dozens of people as Sonya said working on DecodeME. Almost all working in the background: PPI, lawyers, data security experts, digital marketing, PR companies. Each and every one has been working flat out on weekends and evenings, all of them to make their contributions.

They are doing this and they want to do this because of the importance of the project to you, not just to us, but to you to people with ME. So thank you. And thank you for your patience.

Sian Leary’s presentation on why involving patients and carers in the study is so important:

Sian, you’re now going to talk to us about Patient and Public Involvement and tell us a little bit more about how you’ve been involved in the project and what difference it’s made.

Yeah. So, it’s fantastic to be here. I’m Sian.  I have ME and I’ve been involved in DecodeME for the past year on the patient, well a bit over a year now, especially in the Patient and Public Involvement Steering Group.

So today I want to talk about the power of Patient and Public Involvement. With the first question being: what’s the point of involving patients and carers? It makes studies better.

And I think that’s been demonstrated time and again in the past but we’re now proving that to be absolutely true. Indeed, it showed me we are succeeding here in being a gold standard for Patient and Public Involvement.

And that’s amazing in terms of its impact on DecodeME, but also because it sets a high achievable standard for future research into ME and other diseases.

So I’ll say a bit about how we work on DecodeME, then I’ll tell you some of the specifics of what patient and public involvement has done. And finally, I want to talk about the power of that, as its own success story.

So firstly, how do we do it? We have a management team, a patient and public involvement steering group. And then we’ve got three delivery teams, the cohort delivery team that I’m on the marketing and communications team, and genetics delivery team, and they work on different areas of making DecodeME every single team has patients and carers on it. And I think it’s important to start by saying that this isn’t tokenistic.

The staff working on this project. Don’t go away, make the decisions come back and ask us briefly and then go off again. We, the patients and public representatives are there developing the framework and making the decisions, as we go along. This is so important for getting things right, as it means we’re ensuring the decisions will work for people with me from the stock.

The Steering Group has representatives with ME, carers and reps from various UK patient organizations. But we know that a small steering group can’t fully represent the breadth of experience of ME. That’s why we’ve brought on additional representatives into the different teams.

Our team is made up of people from all across the country, and we work collaboratively through things like Microsoft Teams zoom meetings, and more.

I know multiple of our team members come to meetings from their beds, and I know I’ve done that too, because that’s what works for us. And each team is working to make sure that they are doing what they can for their individual representatives.

That might mean having 30 minute meetings instead of one hour long meetings or scheduling them, the time of day that works best those specific individuals, and we accept and acknowledge that me as a fluctuating owners, things change over time, the amount of involvement, we can have – it changes over time. and that’s okay, that’s part of working with people with ME.

In particular, we’re aware as a whole team, whole group, that people with SevereME have often been excluded from research. That’s just entirely unacceptable.

I myself was severely ill for about four to five years. And if I, I could have taken part in research, if it had been funded, and made accessible to me. But it wasn’t.

We also have carers on our team, such as Claire, whose daughter is severely ill. And it’s this sort of lived experience, past and present, that helps us constantly keep in mind how we can ensure people will sit there and be supported to participate.

And it’s vital for the genetic analysis that we have people with different severities taking part. Without patient and public involvement I don’t believe this would be happening.

Living with ME, or caring for someone with ME is not a singular experience. Everyone has a different perspective. And that strength, and bringing on many people instead of just few shows through in the work that they’re producing.

This is particularly true for accessibility. One of the key areas that people with ME and carers are advising on. Two people with ME may have very different access needs. And by having many people advising on this, we are creating multiple routes and access options for participants of this study, and make it as open to all as possible. So let me share some of the specifics of what patient and public involvement in this study has changed.

In developing the website, one person with ME raised the importance of having a dark mode. That’s now there on the website, and together earlier this year we supported the redesign of the logo and colors themes, to ensure that they meet the highest accessibility standards.

There’s a whole load of important documents that come with a study like this, but two of the big ones for those participants are the participant information booklet and Ihave a paper version here. But most of it will be online but it’s very exciting, and also a privacy policy.

These all went through a major rewrite process earlier in the year to ensure that written in plain English gave all the information that was necessary, but didn’t give too much information, because we don’t want to ask participants of this study to read than they can. These were actually sent out some of these documents to a group who would register their interest in taking part earlier this year for additional feedback, and then make further edits based on.

Part of participating will be a questionnaire. And that will ascertain what symptoms you have and other things. And we’ve honed that and tried to be as streamlined as possible they’re making sure that every question that part of this participants are asked is vital to the study, and communicated effectively.

And we’ve tried to take into account the energy and cognitive processing that’s required for this process. We know firsthand how difficult it can be to fill in questionnaires. So we’ve made sure it’s simple to save and return to the same place on the online version. And we’re trying to do everything we can to allow people to take the time they need to pace their energy.

But we know that an online route is not accessible for everyone, so, because of our involvement, there will be a fully offline route to participate in this study too. Not everyone with ME has access to the internet and considering over 75% of people with ME are not in work, and many of them not for long periods. We know that not everyone will have had access to technological advancement advancements and on top of that the cost of internet access phones, tablets, laptops can be out of reach for some people on benefits.

And then there’s people who have severe brain fog, or sensory overload symptoms, we can’t manage online technology. So the offline paper based option will be there for those who need it, and we’re now developing additional support with the 25% ME group. So the people who need it can get that extra advice and input that they’re going through the questionnaire process.

Additionally, our input has enabled the spit kit process to be designed specifically with the ME community in mind. We’re striving to make the process, and that includes receiving the kit, providing the saliva sample, and returning the kit as straightforward as possible, and suitable for all severities and post codes.

And we’re currently testing the spit kits ourselves, so we’ll hopefully be getting a few in the post to our team in the next couple of weeks, so that we can try out each step ourselves.

I’m really excited about having something tangible to hold, and test, and knowing that that’s going to go out to thousands of people who want to participate in the study and who want to find out what’s going on with me.

And so, yeah, I’m definitely getting a real sense that that’s building excitement in the wider team too.

We’ve got a marketing and communications team, who are amazing, and do a hell of a lot of work and patient and public representatives. We are out there living in this community, and communicating with this community, all time.

And this is so helpful when it comes to deciding on what blog posts to put up and what online content and updates the community would like to see and need to see because it’s literally a community for our reps that are deciding this, and all of our online content, and messages are reviewed and approved by patients and public representatives, and often to be honest, they’re written by us as well.

So that’s some of the specifics, but I also wanted to say that. I’ve had ME for a while now, and I’ve been increasingly involved in the community over the years.

What is obvious to all, is that there is still far from enough research happening. And on top of that, some of the research that has been funded hasn’t exactly excelled in patient and public involvement, DecodeME is absolutely about genetics, and ultimately it’s about understanding the causes of this disease, and hopefully getting clues on how to treat, or cure it. That’s what’s going to make the biggest difference to those of us living with this illness.

But what we’re doing here for our involvement is a success story in its own right, and one that we should be shouting about. Involving people with ME and carers is not a burden, it’s an absolute advantage.

We now have a group of people, amazing people, and researchers who can share their knowledge and expertise in this area, and people like our project manager Diana, who has won an award for her work involving us in this study. We are setting a benchmark for future research. And we see future research, we should also demand it lives up to the ideals.

And over to Sonya for the rest of the webinar.

Thank you, Sian. It’s really helpful and I, I think all of us proud of what we’ve achieved as a partnership so far. Not, notwithstanding the frustration that we’ve shared about about not launching recruitment in the time scale we did initially hoped having to push that back, but as Andy said earlier, we had a whole group meeting, and he said this is groundbreaking .It’s setting the foundations for future research and I think what you’ve just outlined, why that is.

And I hope our shared hope and shared ambition is that we can learn from the delivery of this project, we can identify the strengths, but we can also identify what we do differently going forward, because we don’t want this to be the end, we’re going to have leads hopefully that we can follow from this research, but we also need to do more. And we want to see a DecodeME mark to mark three. So that actually we increase the numbers, we increase the statistical power and scientifically. I’m sure Chris will correct me if I’m wrong here. We will start to see more, and that’s where the real excitement comes, so it’s absolutely critical that we learn from what we’re doing now.

Question and Answer section, lead by Sonya Chowdhury:

Introduction: So, thank you to everybody that’s joined but also to those people who are live on Facebook I just like to acknowledge that our colleagues Claire and Dani, working in the background on social media, feeding through questions, making sure the technology’s working, and to those of you that in the zoom webinar, you can type in questions through the q and a. I’ve got them on my screen so if I look slightly distracted it’s because I’m trying to find the questions on a small laptop screen as well as look at a list of questions that I’ve got here as well, and things that are coming through on social media so we’re trying to answer as many questions as possible.

But I just want to highlight that if you’re over 16, you live in the UK, you have a diagnosis of ME, then you are potentially eligible to participate in our DecodeME study. Please please please sign up on our website for updates because you will be first in line when we open recruitment.

We will contact you, or to let you know that we’ve opened before we go public, and therefore you will be first in line to do sign up to the website, www.DecodeME.org.uk

There’s also lots of information in the FAQ Frequently Asked Questions section, you can find out about all the other people that are working as part of our partnership team, and you can, we’ll be updating the FAQ with pictures of the spit kits.

Somebody asked what actually is a spit kit? So I’m going to hand over to Chris so that you can tell us what a spit kit is. So we want people to donate their DNA. And what we don’t want is to come and take blood, because that would be far too difficult for many, and would also be expensive, much easier to ask for your saliva.

And so what we have planned is for people who are eligible for the study to receive a kit through the regular post, into which they present their saliva sample.

It’s only a couple of mls to get into a tube. And then that can go back into the regular post, and will go to our partners in Milton Keynes who will extract DNA from it, and lots of things happen after that.

That’s why we need spit (saliva). And we need 10s of thousands of people to do that for us.

As Sian mentioned we’re at the point where we’re (team) going to be trialing, use of the spit kits so we will have some pictures that will be put out on social media and on the website for you to see.

We’ve got another question from Roslyn who says: what should I do if I’ve not been contacted to provide a spit sample to the study? We haven’t opened recruitment yet so nobody has been contacted or sent a spit kit. At this stage, 1000 people will be content will participate in the first phase of the study in January. And we will pick people randomly, so we will only be inviting that one thousand group and that’s for us to fully test the process. Then after that a few weeks later, we’ll be contacting everybody who signed up through the website. You’ll get an email and you’ll be invited to participate, you’ll complete the questionnaire.

And if you’re eligible and not everybody who has ME will be eligible because there are scientific requirements that we need to meet. It doesn’t mean you haven’t got ME, it just means that for this study, you’re not able to participate. And we understand that will be upsetting and frustrating for some but we will tell you who’s participating and who’s not eligible to participate, and what’s going to happen next. And for those that aren’t eligible to participate and receive a spit kit, you can still provide details that are going to be helpful for research, and you can give consent to be contacted about other research. So we urge lots of people to participate, so that that information can be collated, and you can still engage in future research.

Linda would like to say that she’s “got no question just to say how much she appreciates the efforts being made here.” “No need for any apologies, especially when delay is due to painstaking attention to detail, along with the unavoidable effect and impact of the pandemic.”

Thank you Linda. We’ve got a question from Jen, which I’m going to direct to Chris.

I’ve moved to Europe but still have a UK address. Can I still participate? We will be delighted to send a spit kit to a UK address for you to fill if you can. So, if that’s possible for you from the UK address that would be fabulous. Thankyou.

And we’ve had a question in advance, which is do I have to travel to a clinic to take part? I think just to remind people, Chris outlined that you will be able to send your saliva kit from home. We wanted to make sure this was accessible as possible. And for those with more severe ME and particularly very severe ME.

We appreciate that not everybody will be able to, to give us a saliva sample. We do understand that, but we have tried to make this as inclusive as possible, and Helen from the 25% ME group is helping us by supporting people to fill in the questionnaire offline, if they really can’t do it online and you have nobody in your immediate support network to help you do that.

We’ve got a question from Facebook. How are you going to ensure that those applying to take part actually have a firm diagnosis of strictly defined ME/CFS, considering that nearly 50% of those referred to the British Association for CFS ME, or known as BackME member NHS services, after thorough assessment turn out to have an alternative diagnosis. Chris. So, we will ensure that people are in accordance with the Canadian consensus criteria or the IOM NAM criteria. These are internationally, well understood and well used sets of criteria.

We also have exclusionary criteria, which are to essentially try and address this issue. But we do not expect to reduce the number of those who perhaps in other circumstances will be diagnosed with something else. We do not expect for those people to be reduced to zero.

What we do expect is that we will have a vast proportion of people who will have me according to the strict definition that I mentioned that are therefore a firm diagnosis by a health care professional. And that will provide us with the statistical power that we need to determine what are the genetics to distinguish people with ME as a group from others in the UK.

Just to highlight that’s one of the many areas where people with ME and carers been involved who went out and consulted with a large number of individuals to help inform our application and then the study design, and lots of the ideas that we’re now building up through the Marketing and Comms group to help us increase the numbers of people participating have come from people in the community who responded to a survey and sent in their ideas and suggestions.

So question for you, Sian. How do we monitor and record how people with ME are being involved in the study and decisions that this impacts? Yeah, so that’s a great question, and we have a whole log system, so each of our groups keeps a log of everything that the PPI representatives are commenting on and making changes on. And I think that’ll be really helpful to be able to look back on in the future. It’s just an Excel spreadsheet but it kind of clearly shows – this decision was made and this alteration was made.

And I think it’s going to help future researchers and research studies as well to maybe not even have to ask those questions in the first place, but have, you know, a system that and there’s little things like we’re using white envelopes, because we know that the DWP use brown envelopes, and they create a level of fear of people with ME.

And there’s you know there’s loads of tiny things along the way that are just being changed and adapted because of our input. And, yeah, I’m excited to see how that can be used in the future as well.

Thank you, Sian and one of the another question that we’ve had in advance was around what we’ve learned by working with people with ME CFS and their carers?

And Sian you’ve given us lots of fantastic examples of that. And I think one of the things that we’ve learned as a management group so that’s myself Chris and Andy, is that at times, we’ve had to slow things down to make sure that people can be involved properly. And that’s balanced against the desire to push this project forward so that we can start recruiting, as quickly as possible.

And that balance is, it’s really tricky and times we’ve had to slow things down, and other times we’ve sped things up. But we are still committed, and still on track to deliver this study on time.

So despite the fact we’ve pushed back, the recruitment launch date. We are still planning to deliver this study on time.

So, along that vein Chris, what advice would you give other researchers for improving their research by working with people with lived experience? Listen. Is the first thing. Be open minded. Be prepared to have your mind changed, know that people with lived experience often are more expert than scientists are, by definition, plough their own field, right.

So, I think it’s more and more important to recognize that what scientists should not do only is engage, what they should do is involve. Which means that right from the beginning, right through to the very end. We work in partnership, and this is a co-production. And it sometimes, as you said, takes longer, but I would argue – from this experience that probably in almost all cases it will make the science better.

So I think we had another question around how there might be or what wider implications for research that might be and I think Chris has responded to that.

The next question is, have we asked patients and the public what other studies that should be into ME, other than the genetics work this study is doing? So I’m going to pick that one up because Action for M.E. was funded to deliver a priority setting partnership. And that has been set up through a partnership of people with ME, carers, ME charities and clinicians working in the field. And the purpose of that is to identify the top 10 research priorities, from a clinical medical perspective.

And we have gone out and asked people what priorities they have for ME. And now we have launched a second survey to say help us prioritize the top 10. You can find out more about that, through the PSP-ME.co.uk website and Sian, given your sat here, I’m going to say you’ve been heavily involved with that alongside a whole range of other people. So, patient public involvement is truly transforming research in ME, but it’s a start and we’ve got a long long way to go.

Another question that we’ve had is – is there a diagram showing where we are in the study process and how when will we know if we are participants in the study? So we’ve responded already to the participants in the study you will get a notification, after you’ve completed your questionnaire. Once we open recruitment will take away and think about whether having a diagram is possible on the website. There are lots of ideas, and the focus has been on getting everything in place to launch recruitment but I think it’s a fantastic idea so we will certainly add that to the list.

A comment from Mark – my 30th year since diagnosis so very much welcome the work being done to advance research.

How will it take before the information is analyzed and have you any practical application? The DNA will be extracted quickly. The DNA will be analyzed by Thermo Fisher, and that will be done in batches that will take some months. So, we should tell you that we’ll get our first data back by the end of 2022. Then, we will be having to make the analysis which is tricky. And it’s big data science. And that will take some months. So the first analysis will be, I don’t know. halfway through 2023. But what we will not do is be early in telling you what we think, as the result because it may be wrong. We have to be firm in our scientific opinion as to what the results are before we come forward and tell everyone, but we will do that, ahead of publishing in a scientific journal.

There wasn’t a question at the end I’ve missed about the application of findings and actually, I’m going to link it to another question with that Chris from Natalie who says will this study try and find a diagnostic test that definitely tell us a person whether they have ME CFS? Maybe you could just sort of give us sort of broader answer with with that. Right. I think it’s unlikely that this study is going to give a diagnostic test. And I’m sorry about that. But what it will do is say, we hope anyway that it will say, what is going wrong in people with with ME, what’s causing your symptoms. And that will then shine a light on what aspects need to be studied next. So we, I think it’s true to say we don’t know what’s going wrong. There are plenty of hypotheses, but how to rank those hypotheses as the most likely to be true.

That’s what genetics does. So once we’ve ranked those to say you know the top three. I don’t know mitochondria. In particular neurons, at a particular time in your life course, then we can do the experiments. But, it will also help prioritize and may say the other aspects are not supported by the evidence, and then we should, I would hope that my fellow scientists will stop working in those areas and re-prioritize their work towards other areas that have greater evidence for it. That will then take time for others in the pharmaceutical industry etc to pick up on those discoveries and run with them with new drug targets.

If we’re lucky as a field, then we can take drugs that have already been passed for human use and repurpose them, that will work as they have worked for example, in acute Covid 19 will work quite quickly in this area. So that’s what we’re looking for. But we never can make firm promises unfortunately.

[Can I take part if I have Long Covid? That giving us a given us a nice segue into a bit of a discussion around Covid-19 and non-Covid, because one of the successes that we’ve had within the study is that we’ve had agreement from the funders, to add in an extra 5000 people who’ve had a diagnosis with ME CFS following Covid. So we’re calling this our post covid ME CFS group.

And that’s really exciting. And can you tell us a little bit about why that is Chris just as a reminder to people. Yeah, absolutely. And also a reminder that this didn’t slow us down, this is what we did, alongside everything goes.

We never planned, of course, to have a post Covid with ME arm. But then the pandemic came along and we realised that there will be people who will be diagnosed with me because of the Covid-19 infection. And we said to ourselves well. This might be different, a different type of me from those who came down with ME, prior to the pandemic.

And so if we collected everyone together and they are different. Then, what would be actually doing is diluting our power, reducing our power to find something that is relevant to people who have had ME for a very long time.

So that was the first thing, and secondly, because we can now separate out people who have been diagnosed because of the Covid 19 infection. We can eventually, once we’ve got the genetics and both sides, ask how similar or different are the ME because of Covid 19 or ME because of triggers prior to the pandemic? Are they different, do they overlap, or not? And that I think is a question that many people want to be answered.

And there’s been lots of discussion in the papers and the media, and from various doctors and scientists around the potential for us to learn more, for post infectious diseases including ME from the money that’s going into long Covid research, and so we’ve had several questions around collaboration with the long Covid research teams and groups and charities and, absolutely. Many of us have been linking in with those individual groups with the hope that we can raise the profile and challenge the stigma that exists across different disease areas. And we do want to see that the funding that’s going into long Covid and absolutely rightly got into long Covid that there is equity for me, and I am going to I know this is a DecodeME webinar but I am going to plug the fact that we’ve had a question around this, that there is an Equity for ME petition that is taking place at the moment it closes in two weeks time.

It’s being supported through ForwardME but you can find out more details on the Action For M.E. website. And I think that responds to questions around whether or not there’ll be more funding provided imminently for, for me, research, we absolutely hope.

And we will continue to advocate for that to happen. We’ve got a comment here that says not a question but I just wanted to say how excited I am that this is happening and thank you so much for putting so much effort into inclusion.

Elizabeth has asked a question around long Covid, and fitting criteria and we’ve just talked about that, but she raises a very valid point that people might not be seeking diagnosis and also we know that doctors aren’t giving a diagnosis and will that impact on whether people can take part in the study, you do have to have a diagnosis of ME, whether it’s post Covid or whether you’ve had it pre Covid.

If you need support, getting a diagnosis and talk to the me charities: Action For ME have got an advocacy service, to ME Association, and 25% ME group. There are many of us that would be willing to support you around that. 

Got a question from Alan that says does ME develop after a person has had a viral condition? Chris – a quick answer on that one. Many studies that show between 70 or 80% of people have said that they had a viral or bacterial type infection prior to their first symptoms.

Question: My wife signed up, last year will she have to sign up again? She’s one of the 25% group and is looking forward to helping. You will get get an email, you’ll get a link, and that will take you to the questionnaire which you will need to go through before we determine whether or not you’re eligible for this particular study,  so we will tell you when recruitment opens and when you can take part. If you’ve signed up through the website you will be first in line so if you haven’t signed up through the website, go to decode me.org.uk so that you can do that.

Question from Pauline- will the DNA analysis indicate a treatment plan? Chris I’m going to come to you on that one. This does not tell why any individual has ME/ CFS. What it does say is, as a group – what are the genetics that are different to many other people in the UK?

And that’s the way that genetics works at this level. And there are other ways that we could look at this and say that individuals have any symptoms for a particular reason.

But that is not what is being done in this study, and why we’re doing it this study and not the other way. It’s because this way, is powerful and affects many more people. And it’s cheaper. And it’s the first step I hope, along the path of ME genetics.

I’ve had a comment from somebody on Facebook, it’s amazing that you’re listening to us – we’ve waited so long to be seen and heard.

We’ve also got a question from Kate: I was diagnosed with chronic fatigue syndrome, not ME. I’m hoping I’m still eligible to participate? Yes you are. You have to have had a diagnosis. If you haven’t had a diagnosis and you think you’ve got me speak to one of the charities that can help support you in gaining access to somebody that can help with a diagnosis.

Question: Can you give an idea of who will and won’t be eligible for the study? You need to be 16 or over, in the UK, and you have to have a diagnosis of ME or CFS. Chris – do you want to add a couple of other things in terms of eligibility? So diagnosed with ME or CFS or ME /CFS, and there are some exclusion criteria that are to do with people’s own circumstances, and that’s why we have the questionnaire.

It will take far too long for me to run through them all, but they match against the Canadian criteria and or the IOM criteria and that’s exactly why we’re using those two sets. To repeat chronic fatigue syndrome, ME, ME/CFS, CFS/ME – any of those names from a clinician that’s diagnosed you. And that’s what that’s what we’re looking for.

Okay, so we’ve got a question here from Jenny, a number of members of my extended family half or have had ME is the data from family groups of interest, including those members of the family who don’t have ME? When you go through the questionnaire we will be asking about symptoms, which will help inform eligibility for this particular study, we are using data from healthy controls that those that don’t know me, but we’re doing that through the UK biobank which is the biobank with a whole range of people’s data from that’s held by the University of Edinburgh.

And we’ve had lots of positive comments and responses which we really appreciate and it’s lovely to see those. I hope you don’t mind, I’m not going to read all of those out.

There’s a question from Facebook: what exactly are you looking for within the saliva samples? So the saliva samples have DNA in them. And that means that we can all this our partners can extract the DNA, and we will then, through Thermo Fisher, read out the DNA differences that people have. And the DNA differences, then will be analyzed to see whether they are more prevalent among people with ME/CFS versus the UK Biobank healthy controls. And that will tell us exactly where in our DNA are the genes that – when changed – contribute to people being more likely to have ME.

We’ve got several questions around co-morbidities. So those people with other illnesses – POTS, Sjogren’s, Fibromyalgia etc, as well as the diagnosis for ME. Chris, can you just say something around how we’re going to be looking at eligibility in terms of other illnesses / diseases. Yes, so absolutely people will not be excluded because they have those particular diagnoses. 

If you have a diagnosis of ME (or CFS), then you will be eligible for this project. If you pass the other exclusionary criteria. So, I absolutely recognize that people will have multiple diagnoses.

But with this is a DecodeME/ CFS study. And so if you have a diagnosis of ME, ME/CFS, CFS/ME by a health care professional, then please do participate.

I’ve got a question from Paul. He says he was diagnosed in 2000. Recovered pretty well after about five years. As a reasonably recovered sufferer, am I useful to the study? So just a reminder, we have got strict eligibility criteria. If you think that you might still qualify for the study, you can still take part in the questionnaire. And even if you are not taken forward as a participant in this study, you can give consent for your data to be available for other research.

Are the full scientific details of the research design and intended analytical processes going to be released in advance, following open science principles? One for you, Chris. Yes, yes. So, of course,that is the way we do things. The reason why we haven’t published our scientific protocol is that we’re just busy. I’ve got to my right here, I’ve got it on my list of things to do, up on a whiteboard. I just haven’t got around to it yet, we will do it as soon as we can, of course, and I know why you’re asking this question. We will do everything openly and transparently and to the best of our ability. We will hide nothing. And we’re also going to make sure that people can access the data. So as long as somebody is a bonafide researcher, then we will be following the open source principles, we want to get as much science and research out of the data that we’re collecting. We owe it to every single person with ME that that happens, and we absolutely will be doing that.

We’ve had a question from Mary – who just asked for clarifying what PPI is? It’s patient, and public involvement and that’s at the very heart of our study.

We’ve got a number of questions that sort of we’ve already covered.

So, a question from Gary he says will we need a letter from our doctor or consultant confirming diagnosis? No you won’t. But you can find out more information about that from the discussion previously, or on our website.

Another question from Facebook: will vaccination affect your results? Chris that’s you again, it will not affect your result, vaccination does not change your DNA. So, It matters not, it’s irrelevant to this.

And another question from facebook: how long roughly will this study take? It is a four year study. We have funding until August of 2024.

Here we got some really interesting questions around privacy data protection, DNA going astray. Chris if you can just give us a bit of a summary answer that assures people about how that details are kept securely and reassuring people about DNA going astray.  So, DNA will will not go astray. What we are going to do through our partners is batch 5000 samples together. And in a special process get those to deliver it to Thermo Fisher, all at once in a single batch, and they will process them all at once, without ever knowing who’s DNA, they are. That’s the key thing. They will deliver the data to us via an exceptionally secure line from them to us in Edinburgh.

These details about how securities, what the transfer sharing protocols are are exactly the kinds of things we’ve already dealt with in our contractual arrangements with individuals. The second thing to say is that we hold people’s personal data within the University of Edinburgh. Only identified individuals in the project in the University of Edinburgh will have access to them.

The exception is that there is a company that will be sending out the saliva sample kits, the spit kit. They need to know what people’s addresses and names are, but that under contract is already dealt with the data will be handled in a secure way, and will be destroyed thereafter.

So, we have covered all of these aspects to the satisfaction of the University of Edinburgh, and to the research ethics committee who have given us the green light now twice for this perfect. All of this information will be available in the privacy policy and patient information that has been through so many rounds of patient public involvement review now.

And we’ve tried to lay it out so that it’s really easy to read, really simple to understand what’s going to happen with all of your data, and it’s going to be multiple content options so that you can choose exactly how your data is used in the future.

We’ve got a number of questions I’m afraid that we can’t answer around ‘why does it take so long for diagnosis?’ and particular questions about people’s personal circumstances. So I do apologize that we’re not able to answer those if you need support or have questions, please do go to one of the ME charities if it’s about something personal and not DecodeME related.

I got a question here about the age cutoff for selection for the spit kit. I’m almost 75 and have had ME for around 43 years diagnosed around 10 years after onset. Quick answer Chris I can see already knows the answer, but you go for it. There’s no upper age limit whatsoever. And if you just under the 16 year old, lower age limit, wait a bit until your 16th and then please register. Thank you.

Sorry, there are a huge number of questions here. I’m trying to make sure that we get a broad enough kind of cover with these.

How can we trust that the outcome will be fair, honest, and not manipulated, as in the GET trials? Chris. That’s really good question. The only way is to be honest and transparent as to exactly what we’re intending to do throughout the whole project, what are the analyses that we’re going to do, and to hold ourselves to the highest standards, international standards. So that if we find nothing, we say that we found nothing. Doesn’t mean that ME it would not be genetic, it would just mean that in this study, there would just be insufficient numbers of people to find the genetic basis to ME. But if there is a null result will say so.

Okay, so we’ve had a question about asking for reassurance that private medicine has no involvement into DecodeME. I can absolutely say that that’s the case.

We’ve had a few questions around which are the countries involved. This is a UK study, only. You have to be living and have an address and be based in the UK. We are looking at how we can replicate this study, we have no money to do that 

We have identified potential partners that we want to speak to, but our focus at the moment is getting the recruitment launched for this study. We are committed to exploring how to make sure that we can grow the number of participants, but we haven’t had a chance to to really develop the work on that at the moment.

And there may be some confusion that we’re partnering with Solve, which is a US based charity. And the reason we’re doing that, is that in the future the same type of studies will be done across the world, at least I hope, and they have infrastructure that should be reused again and again and again. That’s why we’re partnering with them. It isn’t to say that we are expecting people in the US to participate. Now this is a UK based project. And I’m very conscious that time is running out. 

So, question from Kim – what has been done to ensure research isn’t duplicated to work already being done in the US and others?

I keep a close eye on what OMF is sending me through email and on their websites and I haven’t seen a study of this type, or size, being funded by them. And that’s a good thing. Right. I mean, doing different types of research, means that, hopefully, a breakthrough will be made by someone soon. Now if there were to be a study, somewhere, doing something like this, we would work alongside them. And with them, because we’re all in this for one reason, and that is to find, you know, the way forward to ensure that people with ME have as soon as possible a new therapy that works.

Thank you, Chris. I’m really sorry we’ve run out of time to be able to answer any more questions. Several of the questions that I’m just scrolling through at the moment.

You can find answers on the website, www.decode.me.org.uk, so please do have a look there were not able to answer.

Lots of questions on social media and through the website at the moment because all our effort is going on getting ready for the launch in January so please bear with us. If you just get a holding email or we say we will review the frequently asked questions as and when we can.

We really are trying hard to be as responsive, whilst also making sure that we do deliver everything that we need to so that we can hopefully launch phase one of the study in January.

I just want to say thank you to all of my DecodeME colleagues at the beginning of the webinar we showed an image on the screen and even as we’ve gone through I’ve realized we’ve probably missed a couple of people off.

I want to thank every single person watching for all your questions, your engagement, your words of encouragement for people on social media that have sent positive comments in as well as questions.

And we will continue to work with you to engage with you and to ensure effective involvement in every single aspect of this study. This study has people with me at the heart of it, but that runs through every single aspect of the work that we do. And if you joined us at the end of the study this webinar, at the end of the webinar recording will be available, so that you can access this afterwards you can watch it in bite size chunks if, if you need to, you can watch it with the screen off as a podcast, you can share it, and you can listen to some of the ways in which patient and public involvement has changed this study for the better.

And this study is about people with ME, it’s your study. It’s our study. And we hope you will continue to support us. And we hope we blow that 20,000 target very quickly after recruitment launch and the additional 5,000 of people who have had a diagnosis post Covid.

Thank you very much everybody.

DecodeME phase 1 opens in the new year. Register your interest in taking part in the study.