UK Genome Wide Association Study (GWAS) project - draft website goes live, feedback sought on recruitment plan, and updates

[NelliePledge]

I would imagine most celebrities affected by ME are going to go to private places like Optimum and adopt the positive mental attitude think yourself better, steps to ‘recovery’ beliefs. Not helpful in explaining the reality.

 

[Sean]

I am wary of formal celebrity endorsements. Great, if it works out. Not so great if it doesn't, for both the celebrity and those they speak for.

(Nothing wrong with celebs talking about their own experiences, of course.)

Also with Esther12 about the SMC. We should have nothing to do with them, and in no way give them any credibility. They have proven beyond any doubt to be utterly untrustworthy, and will only shamelessly and ruthlessly distort the facts to serve their interests. Avoid them like the plague.

 

[Robert 1973]

IMO the only thing to be done at the SMC is to point out the appalling role they have played in promoting prejudice and misinformation.

They are so bad that anything good they do is likely to cause net harm by allowing them to point to that as an indication of how 'balanced' they are.

Also with Esther12 about the SMC. We should have nothing to do with them, and in no way give them any credibility. They have proven beyond any doubt to be utterly untrustworthy, and will only shamelessly and ruthlessly distort the facts to serve their interests. Avoid them like the plague.

I fully understand these sentiments, and I share your anger at the SMC’s treatment of ME/CFS. But I still think it is an issue which needs to be discussed, and a decision which needs to be made one way or another.

The fact is that if Chris Ponting et al give a press conference at the SMC, it will be covered in most UK national newspapers, and he will probably be interviewed on Today programme and other influential TV and radio programmes. And I’m not sure whether or not there any other practical ways of achieving that sort of coverage.

Also, if those behind the proposed GWAS study were to succeed in getting significant media coverage without the SMC, the SMC would probably then arrange its own press conference with its own ME/CFS “experts” to give their views, which would likely get far more coverage than anybody else’s.

I’m not particularly keen for the the SMC to be involved. I would much rather it was done without the SMC if that would be possible without jeopardising the project’s chances of success. But I do think that all the pros and cons need to be carefully considered – even if the conclusion is reached that it’s a bad idea – and I’m pleased to hear from that @Andy that the idea is “on the table.”

I’m also mindful of the fact that this is a joint venture with the CMRC which was itself launched by the SMC in 2013 (https://www.sciencemediacentre.org/chronic-fatigue-syndrome-unravelling-the-controversy/). And I quite like the idea of the new vice-chair of the CMRC sitting at an SMC press conference explaining to journalists that PACE is now widely accepted to be very bad science, that we have patients to thank for pointing out its multiple methodological flaws, and that that is one of the reasons why the decision has been made involve patients so closely with the design of this proposed study.

 

[Esther12]

The fact is that if Chris Ponting et al give a press conference at the SMC, it will be covered in most UK national newspapers, and he will probably be interviewed on Today programme and other influential TV and radio programmes. And I’m not sure whether or not there any other practical ways of achieving that sort of coverage.

I don't think that's a fact - especially if he's saying things that don't conform to the SMC's narrative. If the SMC are involved in setting up press promotion then the prejudices of those at the SMC is likely to shape how reporters view it.

eg: Did this briefing from Lipkin lead to any coverage at all? https://www.sciencemediacentre.org/expert-encounter-prof-ian-lipkin-columbia-university/

Also, if those behind the proposed GWAS study were to succeed in getting significant media coverage without the SMC, the SMC would probably then arrange its own press conference with its own ME/CFS “experts” to give their views, which would likely get far more coverage than anybody else’s.

I'm not sure if that's right either. The SMC setting up a conference for researchers not associated with this project to criticise it? Even for the SMC, that would seem odd imo.

I’m not particularly keen for the the SMC to be involved. I would much rather it was done without the SMC if that would be possible without jeopardising the project’s chances of success. But I do think that all the pros and cons need to be carefully considered – even if the conclusion is reached that it’s a bad idea – and I’m pleased to hear from that @Andy that the idea is “on the table.”

I’m also mindful of the fact that this is a joint venture with the CMRC which was itself launched by the SMC in 2013 (https://www.sciencemediacentre.org/chronic-fatigue-syndrome-unravelling-the-controversy/). And I quite like the idea of the new vice-chair of the CMRC sitting at an SMC press conference explaining to journalists that PACE is now widely accepted to be very bad science, that we have patients to thank for pointing out its multiple methodological flaws, and that that is one of the reasons why the decision has been made involve patients so closely with the design of this proposed study.

If Ponting fancies trying to use the SMC to dump on PACE (and thus inevitably the SMC too), that's one thing, but I'm not sure that's very likely though.

I think that using the SMC for any legitimate CFS story without dumping on PACE/SMC/etc would be a mistake though.[/QUOTE]

 

[Saz94]

Unfortunately from what Ive seen it's a real coin toss with celebrity endorsements. It can go rather badly if they start going off script and endorsing non science and if they have their own story to tell their narrative while valid may not be what works best for advocacy of a large illness group. Just my own POV.

Yeah like martine mccutcheon. Not helpful at all.

 

[Andy]

Here goes with another one of my daft ideas. I'll say it anyway, though, just in case anyone can come up with anything better!

What if one of the major ME charities or groups put up a very simple online survey, asking people with ME to click whether they would – or wouldn't – be willing to take part in a study investigating the genetics of ME? Just those two options, and for UK patients only.

It would need a paragraph explaining that it's to test how many PWME can be reached, and how many of them would be willing to send a spit-and-post sample if the study can be funded. Make it easy to share on social media platforms and by email, and ask for something simple like the respondent's postcode to help cut down on duplicate 'votes' *. Encourage people to share it as widely as possible.

My impression is that ME patients in the UK are desperate to take part in research, but 98% of them have never had the chance. However, we all know how easy it is to make assumptions about how many people are actually connected to ME networks – this might give us an idea, specially if it's left open for some time.


* People could be given the option to supply contact details if they want to receive news updates, of course, but then you get into all the data protection stuff.

Thanks for the suggestions Kitty.

Would you be willing to potentially take part in this research? Would you like us to keep in touch with updates? Please complete the form below. We are using Survey Monkey to manage this, and will store the information you share with us safely and securely, as detailed in our privacy policy.

https://mebiomed.org.uk/get-involved/

Note that this is, hopefully, an interim measure until we awarded the funding we will be applying for - with funding we will have a fully integrated mailing list and sign-up.

 

[Simon M]

From the website (for referennce):

Recruitment Plan for the ME/CFS Biomedical Partnership

We will need saliva samples from at least 20,000 people with ME/CFS for the genome wide association study to look at whether some of the reasons that people get ME/CFS are genetic. You can find out more information about the ME/CFS Biomedical Partnership and this work on our FAQ page, which is being updated.

Because not everyone will meet the study inclusion criteria (Canadian Consensus Criteria or Institutes of Medicine criteria), we will need to recruit a larger number than this. We would really like your thoughts and ideas on how we should go about this so that we get the greatest number of people with ME/CFS taking part. One suggestion was that we should aim to recruit every person with ME in the UK to the study (Science4ME Forum), knowing that not everyone will be suitable.

Recruiting 20,000 people won’t be easy. While no one is quite sure how many people have ME/CFS, if we say that it affects roughly one in 200 of people, there would be about 180,000 people with ME/CFS in the UK aged 16 – 80 years. Of these, it is possible that a doctor has never diagnosed a number of them. While these figures are only very rough, recruiting one in six (20,000 of 120,00) will be a huge challenge.

Here is a summary of how people would take part in the study:

The study will be widely advertised. People with ME/CFS will be asked to go to a website with lots of information about the study and be encouraged to take part. Friends and relatives of people with ME/CFS will also be able to look at the website and tell them about the study. We will make it easy for people to take part by providing an app on the phone or computer. People who don’t use technology like this will be able to join using paper forms.

People with ME/CFS will begin taking part in this study by giving some basic details about themselves. There are then four steps:

They will be asked to give informed consent,

They will be asked to fill in a questionnaire about how ME/CFS has affected them using tick boxes,

The study team will be able to see from the questionnaire answers whether the person is suitable for this particular study,

The study team will ask them to send us a saliva sample, by collecting spit in a container that will be sent to them at home.

As with every study, not everyone will be able complete all four steps, but even if someone with ME/CFS only gets as far as filling in the questionnaire, we will be able to learn more about the condition.

We think that under half of all those interested in taking part in the study will actually send in a spit sample. We know that people with ME/CFS are very keen to get some answers about the disease and will do their best to take part. Of course, not everyone will meet the study criteria. This does not mean that you haven’t got ME/CFS, just that you are not suitable for this particular study.

[I'd thought there was a list of planned activity, but can't see it now]


Question

Do you have ideas that would help us recruit as many people with ME/CFS as possible? Please tell us all your ideas; we may not be able to use them all but it would be great to have lots to choose from! We also want to hear any concerns or questions you have. We will not be able to respond to them individually but we will use them to inform the development of the project.

 

[Hoopoe]

Ads on facebook, Google, etc.

Medical journals and magazines read by GP could also send the recruitment message and bring in more patients.

Allow people to print and spread the recruitment flyers on their own (making them available on the website) and encourage them to do so in their local communities.

 

[Dolphin]

I would like to see patients being more proactive in sharing such appeals to Facebook groups and the like.
I have noticed studies have often struggled to reach recruitment targets in the UK and around the world.
One easy thing people can do to support research that doesn't cost any money is share requests to groups and forums such as on Facebook.

There are some ME/CFS groups that have over 10,000 members.

 

[Hoopoe]

Importantly: share multiple times, not just once.

 

[Saz94]

If you work with the SMC to publicise this then many ME Patients will get suspicious and refuse to participate. Any perceived connection with psychological research, at all, will make people think it's a conspiracy to say that it's psychological.

 

[Sly Saint]

IMO ease of recruitment will largely depend on what happens with the NICE guidelines and if the changes that we want, materialise or not.

It's worth considering that the international MS community have been involved in similar gene projects for many years ( the MS DNA bank is in the US).

The International MS Genetics Consortium
The next generation of MS genetics began when the International MS Genetics Consortium (IMSGC) was launched with early seed funding from a National MS Society Collaborative MS Research Center Award. The IMSGC brings together MS genetics researchers from 15 countries who collaborate and share results openly to spur progress. In 2007, the IMSGC published a groundbreaking initial genome-wide study that clearly identified two new genes that predispose people to developing MS. Just seven years later, after studies involving over 100,000 people, the IMSGC has identified 200 genetic variations related to MS, and has begun to identify the specific immune cells and proteins involved. These teams could not have accomplished this massive task if not for this international collaboration.

https://www.nationalmssociety.org/R...ng-the-Disease-Forever/Searching-for-MS-Genes

 

[Dolphin]

I would like to see patients being more proactive in sharing such appeals to Facebook groups and the like.
I have noticed studies have often struggled to reach recruitment targets in the UK and around the world.
One easy thing people can do to support research that doesn't cost any money is share requests to groups and forums such as on Facebook.

There are some ME/CFS groups that have over 10,000 members.

Somebody sent me a question about this. In case it is of interest to anyone else, here is my reply:

Hi ,

I'm afraid I'm rusty about which are the big groups. Before I set up
my Facebook page, I often used to post messages of various sorts to
lots of groups but generally don't do that now.

I doubt you will find one or two groups that will do the job as:
(i) not everyone will see every message;
(ii) most groups are not specific to the UK.

I think any plan should be just to go with quantity: get as many
people sharing to as many groups as possible.

I am a member of lots of groups. Only X seemed to be publicly
visible at: X.
Links on that will be clickable.
I'm attaching screenshots of my list of groups, I couldn't see on a
quick look how to give the full title.

I have been added to a lot of groups, some of which aren't really of
much interest to me. I just tend to turn off notifications, so it
doesn't matter much.

Not sure whether this is going to be of any help.

Best of luck,

 

[Saz94]

@Andy

I have already seen on Facebook somebody saying that they won't take part if it doesn't use ICC criteria.

I'm not sure what criteria it is using?

Please be aware of the small number of ME patients that are very active online and have extreme views about ME. I wouldn't be surprised if they find something to take offence at in this study (E.g. The diagnostic criteria used, and the fact that you refer to "PEM" rather than "PENE") and then go round telling other ME patients online not to participate and telling people that the study is part of a conspiracy to cover up the real ME.

I am not necessarily suggesting that you should do things differently in order to pander to these people; but you need to be aware that you will probably have this to contend with.

And a lot of the not-scientifically-informed patients may easily believe the extremists if the extremists tell them that the GWAS is part of the evil conspiracy. Since in the UK, ME patients have received very little indication that they can trust anyone who works in medicine or medical science to actually be trying to help them.

So how are you going to convince patients that you are actually trying to help them and that they can trust you?

(Sorry if that sounds harsh. I'm playing devil's advocate here in the hope of helping you develop your strategy.)

Bear in mind that if you are advertising in doctors surgeries (and especially if you are getting doctors involved in recruitment) that may lead some people to think that you are in league with their doctor who thinks that their ME is psychological!

If you can get the ME Association to spread the word for you, that may help a good number of people to trust you. Although there are also a number of people who will be more likely to distrust the research if it is advertised by the MEA.

If you can get #MEAction to help spread the word for you, that will probably help a large number of people to trust you. There are a few people who think #MEAction are evil (these are the same people who think that anyone who says PEM rather than PENE is trying to cover up the "real ME"), but that's very few compared to how many trust MEAction.

The same can be said for OMF as what I said for MEAction.

I advise NOT getting AFME to spread the word about it. That'll lead people to distrust. But if #MEAction or OMF is spreading the word too then it may be okay to have AFME spreading the word too.

 

[Andy]

I'm not sure what criteria it is using?

From the FAQ, which can be found here, https://mebiomed.org.uk/classes/

CureME will apply its diagnostic algorithm (a very specific set of rules) to assess people according to well accepted diagnostic criteria: the Institute of Medicine 2015 or the 2003 Canadian Consensus or Fukuda (or CDC 1994), but not Oxford or NICE, criteria. Post-exertional malaise (PEM) will be a mandatory symptom. This is because patients, patients’ organisations, and ME/CFS biomedical researchers all regard it as a defining symptom of the disease. Using these definitions help to ensure that findings are compatible with those used in biomedical research around the world.

Note: it lists Fukuda, which was part of the early thinking on the project but which will not now be used, this will be revised in a future update to the FAQ.

Please be aware of the small number of ME patients that are very active online and have extreme views about ME. I wouldn't be surprised if they find something to take offence at in this study (E.g. The diagnostic criteria used, and the fact that you refer to "PEM" rather than "PENE") and then go round telling other ME patients online not to participate and telling people that the study is part of a conspiracy to cover up the real ME.

Yes, we are aware.

So how are you going to convince patients that you are actually trying to help them and that they can trust you?

Through continuing our outreach and engagement to and with the patient community.

All members of our PPI (Patient and Public Involvement) steering group, https://mebiomed.org.uk/ppi-group/, will be involved in spreading the word. These are:

• Sonya Chowdhury, founding charity member of the UK CFS/ME Research Collaborative (CMRC) and CEO, Action for M.E. Sonya chairs this group and is also a Co-Investigator (PPI) on the Management Group
• Andy Devereux-Cooke, representative from the CureME Biobank Steering Group and co-founder of Science for ME forum. Andy is also a Co-Investigator (PPI) on the Management Group
• Countess of Mar, on behalf of Forward M.E. and the people with ME and carers the member organisations represent
• Jim Wilson, representative of the CMRC Patient Advisory Group
• Charles Shepherd, founding charity member of the UK CFS/ME Research Collaborative (CMRC) and Honorary Medical Advisor, ME Association

Forward M.E. membership, http://www.forward-me.org.uk/LinkedOrganisations.htm, currently consists of:

• Countess of Mar (Chairman)
• Carol Monaghan (MP) Vice Chairman
• Dr Nigel Speight
• Dr William Weir
• Dr Nina Muirhead
• 
  
• ME Association
• ME Research UK
• Action for ME
• The Young ME Sufferers Trust
• reMemberCFS
• Blue Ribbon for awareness of ME
• Neurological Alliance
• ME Trust
• 25% ME Group
• #MEAction

so we have engaged with almost all the UK ME charities/groups already. Hopefully all of them will spread the word, otherwise why agree to be involved, and as we need to reach as much of the UK patient population as possible AfME will have to be involved as much as any of the other charities/groups. If there are patients who are willing to dismiss the study on the basis that AfME are just one of the patient groups promoting it then I, personally, think it's likely to be a smaller number than those who AfME reach and are willing to engage with it - in other words it's likely to be an unavoidable trade-off which we will have to accept.

We also plan to have direct engagement - members of the PPI team, which if funded will include somebody employed as a PPI coordinator, will be available to visit those patient groups who meet up off-line to talk to them about the study - and it is likely we will do some kind of video updates/Q&As.

So we will be working hard to engage with the community, and we will require the support and help of those in the community who do believe and trust in us to spread the word to enhance the chances of recruiting the number of patients that we will need.

In return I will ask, not just yourself but everyone else reading this, "how else might we convince patients that we are actually trying to help them and that they can trust us?".

 

[It's M.E. Linda]

@Andy

I have posted the FAQs to help explain a few queries raised on twitter.

Have seen a couple of questions about ages of volunteers (mainly whether children or young people would be eligible to register).
C
you clarify please and I am happy to pass on info (may be worth adding to the FAQs too?)

 

[Andy]

I have posted the FAQs to help explain a few queries raised on twitter.

Great, thank you.

Have seen a couple of questions about ages of volunteers (mainly whether children or young people would be eligible to register).
C
you clarify please and I am happy to pass on info (may be worth adding to the FAQs too?)

Definitely 18 yrs and older, possibly 16 yrs and older. Recruiting younger volunteers always brings greater ethical concerns, and while we do want to recruit as many patients as possible the extra issues mean that we are unlikely to be able to recruit children. As far as I'm aware, there will be no upper age limit.

And yes, I'll ask for this to be added to the FAQ.

 

[Saz94]

From the FAQ, which can be found here, https://mebiomed.org.uk/classes/

Note: it lists Fukuda, which was part of the early thinking on the project but which will not now be used, this will be revised in a future update to the FAQ.


Yes, we are aware.


Through continuing our outreach and engagement to and with the patient community.

All members of our PPI (Patient and Public Involvement) steering group, https://mebiomed.org.uk/ppi-group/, will be involved in spreading the word. These are:

• Sonya Chowdhury, founding charity member of the UK CFS/ME Research Collaborative (CMRC) and CEO, Action for M.E. Sonya chairs this group and is also a Co-Investigator (PPI) on the Management Group
• Andy Devereux-Cooke, representative from the CureME Biobank Steering Group and co-founder of Science for ME forum. Andy is also a Co-Investigator (PPI) on the Management Group
• Countess of Mar, on behalf of Forward M.E. and the people with ME and carers the member organisations represent
• Jim Wilson, representative of the CMRC Patient Advisory Group
• Charles Shepherd, founding charity member of the UK CFS/ME Research Collaborative (CMRC) and Honorary Medical Advisor, ME Association

Forward M.E. membership, http://www.forward-me.org.uk/LinkedOrganisations.htm, currently consists of:

• Countess of Mar (Chairman)
• Carol Monaghan (MP) Vice Chairman
• Dr Nigel Speight
• Dr William Weir
• Dr Nina Muirhead
• 
  
• ME Association
• ME Research UK
• Action for ME
• The Young ME Sufferers Trust
• reMemberCFS
• Blue Ribbon for awareness of ME
• Neurological Alliance
• ME Trust
• 25% ME Group
• #MEAction

so we have engaged with almost all the UK ME charities/groups already. Hopefully all of them will spread the word, otherwise why agree to be involved, and as we need to reach as much of the UK patient population as possible AfME will have to be involved as much as any of the other charities/groups. If there are patients who are willing to dismiss the study on the basis that AfME are just one of the patient groups promoting it then I, personally, think it's likely to be a smaller number than those who AfME reach and are willing to engage with it - in other words it's likely to be an unavoidable trade-off which we will have to accept.

We also plan to have direct engagement - members of the PPI team, which if funded will include somebody employed as a PPI coordinator, will be available to visit those patient groups who meet up off-line to talk to them about the study - and it is likely we will do some kind of video updates/Q&As.

So we will be working hard to engage with the community, and we will require the support and help of those in the community who do believe and trust in us to spread the word to enhance the chances of recruiting the number of patients that we will need.

In return I will ask, not just yourself but everyone else reading this, "how else might we convince patients that we are actually trying to help them and that they can trust us?".

Sounds good. I'm sorry if my post came across as aggressive? I just meant it as throwing ideas out there. Am not good at tone in writing - I'm autistic so just speak directly and sometimes this comes across as rude? Sorry if so. Too much brain fog to think how to do differently. Only trying to be helpful.

 

[Kitty]

In return I will ask, not just yourself but everyone else reading this, "how else might we convince patients that we are actually trying to help them and that they can trust us?".

The fact that this is a genetics study might at least reassure people that it's nothing to do with the BPS brigade?

I agree that ME patients are factionalised (why wouldn't we be, given our history!), but we just have to keep explaining. No study will meet with everyone's approval, but I sense a real hunger for serious UK-based research that will hopefully overcome many reservations. The association with the UK Biobank, which seems to be well-respected, will help.

I also think we should embrace any arguments with the message 'Debate is a crucial part of good science.' Patients have to learn to discriminate between personal opinions, marketing, and respectable research – it's not obvious to most of us at the outset, and there's no reason it should be. It's a journey, it takes time, and we have to accept that it will never appeal to some people.

 

[Simon M]

Sounds good. I'm sorry if my post came across as aggressive? I just meant it as throwing ideas out there. Am not good at tone in writing - I'm autistic so just speak directly and sometimes this comes across as rude? Sorry if so. Too much brain fog to.think how to do differently. Only trying to be helpful.

You came across a smart and thoughtful, as usual. You raised important issues, and as you can see from Andy‘s reply, the project, particularly the PPI group, has spent time thinking about just these things.

I have tried to engage With ICC-only supporters but got absolutely nowhere. Still, I haven’t seen any published evidence that ICC detects patients with a different illness from CCC. Though I don’t intend to revisit the arguments here. I'm afraid t’s probably just not possible to please everyone.

But it is worth remembering that we are trying to engage with the whole community, most of whom won’t even have heard of either ICC or CCC.

As Andy says, the most important thing is to be open and transparent (not to mention this study has probably got far greater patient involvement than any large ME/CFS study so far, and also more than the vast majority of studies of any illnesses).