Below is the transcript for the next 15 minutes of the DecodeME Winter Webinar (available on YouTube) from 22nd December 2020. The first fifteen minutes can be found in Part 1, with minutes 15 to 30 in Part 2.
Is the study blinded?
Chris: There are two aspects to this. One is when people do the analysis, will they know who you are. The participants. Your names, addresses. The answer is no. That is not information that will be passed to the analysts. We’re not particularly interested, at that point, in that information. We’re just interested in if you pass the criteria as being someone with ME. The other aspect is, we’re not blinded to the fact that you will have a diagnosis of ME and pass the criteria, because that is exactly the information we need to know to compare with members of the general population. And we’re drawing the data for those people from a previously funded study of half a million people in the U.K. So we’re not spending any money whatsoever on that, but we are spending money on people with ME only. So in that respect, we’re not blinded to people with ME as being the cases. But the genetic analysis is so objective, and so analytical, the result is what it is. We are not blinded in terms of subjectivity and previous preconceptions as to what the causes are with ME. We will be looking at it all because it all can be coded into our genome. And so in that one very important respect it doesn’t matter that we’re not blinded to ME status because we’re looking at everything.
How do we get the app?
Sadie: As an individual for DecodeME you’ll be able to come in, enter some information, and either qualify for the study [or not] based on the information you enter. And at the end of that process, you’ll be given the opportunity to join the Registry. The Registry is where we have 2000 individuals already, where you can enter more information and track your symptoms over time using the app. The app is connected to participation in the Registry and that’s really to do with how the consent process works. You consent through the Registry process and then that allows you access to the app.
Sonya: We will be in contact with everybody who signed up for updates to let you know the first day we’re opening, and we will provide links so you can go immediately to participate. We’ll also have information on social media and on our website. If you want to be amongst the first people to be able to sign up and to take part, then do sign up for the updates.
Can we choose which other research studies our data is used?
Sadie: The process of how individuals will use the data is that we’ll get a request from a Researcher; we’ll get a proposal and an application from a Researcher for access to the blind anonymised data. So they won’t have any information about the individuals; it’ll be blinded data. And that proposal will be reviewed by a group of individuals, including individuals with ME, clinicians, and researchers, who will evaluate whether or not that research is valid and they believe [that research] is going to result in forward advancement of the science. If that proposal is approved then the individual will get access to either the data or the data with the bio-specimens that we have in the bio bank depending on what they’re looking for. And then the research will go from there. So in that regard, as an individual in the Registry you don’t get to say whether or not your particular data can be part of that data set. However we do have a part of the Registry that’s going to feature different research studies. So the research opportunities will be posted within the Registry and you can choose in that regard ‘Yes I want to be part of this study’. Then you’d click that, your information can be part of that study or you may be asked to provide additional information that might be specific to a study. For example, if someone wants to look at Post Exertional Malaise they might ask you to track something really closely for a period of time. And by clicking on that ‘Yes I want to be part of this study’ you would maybe do a few different pieces of data tracking.
Can researchers from all over the world apply for the data or is it limited to certain countries?
Sadie: Researchers from all over the world can apply and, as I mentioned before, currently the Registry is only open to US participants, but we have plans to open it globally in 2021.
Has Covid affected the study and will Long Covid take away any attention or funding from DecodeME?
Chris: We were very grateful to the funders for them granting us funding at Easter time [2020]. They’re not going to take the money away. That’s dedicated to the ME study over the next (up to) four years, from the beginning of September. That’s secure. There are other funding calls that are looking at Long Covid. Up to £20,000,000 has been set aside for studies on Long Covid. And I understand entirely why some people are saying “Why is it that that amount of money had not been previously dedicated to ME?” I understand that.
Has Covid affected this study? Only in small ways. It’s delayed it by a month or so. We’ve rejigged things so that we’re using a ‘mail out’ company for the ‘spit kits’, rather than being reliant on us being required to go into a particular Institute and mail them out from there. So we’re trying to make sure it’s Covid-robust. We think we can run this project from within the pandemic if it, as it probably will, rumbles on for quite a while yet.
Andy: One aspect of the question – Whether any attention will be taken away from DecodeME. Within the [ME] Community? I don’t think so. Because obviously we will continue to reach out to you all via these webinars, via social media, via our updates by email and suchlike. And obviously we will be looking to extend that reach even further once we open recruitment because us getting to the 20,000 participants is very important in order to ensure that the analysis is as valid as it can be. So in that way I don’t think any attention has been taken away from it. From my point of view it’s not taken away any of my attention from it and I’m equally reassured that all the other members of the team have their full attention on the study and are determined to progress it, even though we are having to change things and adapt to the current situation.
Sonya: It’s also worth mentioning that when we were successful with getting this funding, the funders (The Medical Research Council and the National Institute for Health Research) both said the research funding is for ME. So we would hope this isn’t an ‘Either Or’ – Long Covid or ME. Both are important. Both groups, both communities, need research. They need a focus. They need support. And we need to keep advocating for that. I can completely say that all three of us [Sonya, Chris, Andy] and the rest of the partnership team will be working with funders to say what’s the next step. The Research Collaborative will also be doing the same. And we also have funding that’s gone into the priority setting partnership which will help look at what the research priorities should be for clinical research going forward. So we’re all completely behind making sure this is a starting point, not the endpoint.
Will the data be reused after the DecodeME study, and if so how?
Chris: Absolutely. The data will be made available to bonafide researchers worldwide in academic settings from companies, etc. Why would we do this? Because it capitalises advances, progress. We’re not going to limit others to perform ground-breaking research. We’re going to make sure that we can help them as much as we can. So with your informed consent the data will be made available, in a completely anonymised manner, so that that future research can be done to the best of many peoples abilities. And I just want to say, because my answer is quite similar to Sadie’s, that one of the main reasons we have this webinar today is to try to make it clear that Solve ME is putting forward their vision, which is across the globe really. And we absolutely agree with it, and so with the instantiation of it in the United Kingdom and working with them, they will harbour a whole bunch of data, from people across the world. And we will collect a lot of data. But we will be harmonising the data and what questions are going to be used, to allow studies to be done across the whole world. And there’s no element of competition, and there is a element of working together in harmony. That’s really why we’re so grateful for Sadie joining us today to explain that.
Sonya: And Solve ME have also developed a partnership with Emerge in Australia so there’s active use of the app there, as well as rolling out more broadly. And we’ve been in discussion with Researchers in the United States and elsewhere to look at how we can work together. It’s such an important point – collaboration is fundamental. Collaboration between Researchers and the patient community but also with Researchers internationally. So that’s something that we’re all very much committed to.
M.E. myself and I 
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