2024: Call for a Research Case Definition Consensus Statement for ME/CFS

Posts split from United Kingdom: News from #MEAction Network UK
Note: this is not an MEAction UK initiative. Rather it is the initiative of Adam Lowe, Caroline Kingdon and Leonard Jason

Open letter by MEAction UK asking for use of stricter criteria in research. (Basically asking to stop using Fukuda).

https://docs.google.com/forms/d/e/1FAIpQLSecBUYptb8h1PZJz3IMgjg0CfzI_9bYIMAtVUsT42KBjqJG9Q/viewform

 

Does this need its own thread in the Advocacy sub-forum? Seems important. Done

 

You’re welcome to create one, the way it was shared was ambiguous to me, and I wasn’t sure if it was a new initiative or something old resurfacing so I decided to share it here for now.

 

I don't know if this is a new initiative or not. They seem to have lots of signatures already. Anyone know?

 

@MBailey ?

 

The Fukuda criteria should obviously no longer be used as it has become accepted that PEM is a fundamental diagnostic criterion. In research there are all manner of reasons for choosing different cohorts - it very much is dependent on the research question being asked. Research criteria need not look like criteria used for clinical decision-making and that is often the case in medicine. I'm a little puzzled about some of this:

One of the major changes in NICE 2021 was the reduction from 6 months in adults to 3 months. Is the proposal that for research 6 months is ideal?

Also not sure what is meant by "IOM. . . when using the proposed exclusionary criteria" - who has proposed additional exclusionary criteria for IOM? Do they mean the ones in Table 2 of their Ref 5 (p9)? If so there are a number of conditions not on that list that should be, and some that are debatable.

 

Personally, I would not advocate for cognitive impairment to be required and I like the IOM criteria as-is. In studies looking at immune profiling, neurometabolic and neurovascular imaging etc, sub-group analyses on cog +/- might turn out to be very informative.

 

I and I think a lot of others would like to see ME/CFS looked at a lot more within long Covid research.

I have a concern that requiring the following of long Covid researchers could be quite burdensome and perhaps put off some looking at ME/CFS:

- A consistent approach to exclusionary conditions. This includes any previously diagnosed medical condition whose resolution has not been documented beyond reasonable clinical doubt and whose continued activity may explain the symptoms of ME.5**

● A consistent approach for evaluation of key criteria. This is done with structured questionnaires that evaluate both symptom severity and frequency as well as level of functional impairment. An example of a widely used method is the DePaul Symptom Questionnaire.6,7,8 Research publications should outline how criteria have been operationalized.

 

I am also not at all happy that this has been effectively sprung on the ME/CFS patient community, who are invited to add their signatures to this document, without having had any wider opportunity to consider or debate its contents beforehand.

Who invited Perrin to sign? He's not a legitimate researcher or scientist. What next, Parker?

Everything about us without us, over and over again...

 

I think we all need to start having a big discussion about this branding of me/cfs as ‘an illness of exclusions’

The logic on this no longer adds up.

And for the purposes of diagnosis and treatment I really don’t get it. PEM is PEM , it’s apparently unique. The laying flat thing is becoming another distinctive clue. I’d further add in the old school idea that was based on that wrong fatigue bucket that people were slow or tired all the time when many will seem ‘able’ and do things then collapse out almost cold flat on their back for four days with all sorts of symptoms is what the layperson actually might see until people get severe and their body is screwed all the time or they have to actually live with someone and see the reality.

These other conditions have treatments and experts in what those look like with and without other things etc.

it’s important in the old days fir ‘people who got persistent fatigue they didn’t have before’ to have the obvious things that could be fixed or were red flags checked out … and it still is. That all just tracks back to GP guidelines and whatever was going on there too

But these days it is PEM that makes the condition distinctive and certainly people not only could have something else too but those who have ended up really ill are more likely too.

there might be very very tiny niche specific research projects where excluding those with comorbidities or pwme who have other bits falling off might be needed but otherwise even for research it feels like niching the field and missing really important clues because whatever’s wrong likely makes many susceptible to other things or has downstream effects that do particularly when you include environment ie how much some of us have been hammered to trudge on for years in agony doing beyond the impossible

and some things might be actually parts of ‘types’ or progression so we aren’t getting the full picture as these are big clues if something shonky happens ‘uo a level’ and the clue is that when it combines with x in certain people you see y

to me that one feels like a hangover from the behavioural psychosomatic days.

someone not having another illness doesn’t make them more likely to be ‘true’ than something with other conditions. Just like with other medical conditions. It seems a ‘cfs’ old school thing.

 

There is a DSQ-PEM scale which doesn't really seem to me to capture PEM very well:

https://www.researchgate.net/public..._-_Post-Exertional_Malaise_short_form_DSQ-PEM

https://www.commondataelements.nind...FS/F2771_Guidance_for_Core_PEM_Assessment.pdf

The questions read to me as more of a metric of exertional intolerance than of of PEM.

 

Hi and thanks @Sly Saint for tagging.

Just to give a bit more detail - this initiative is not being led by MEAction UK - it's a project from Caroline Kingdon, Adam Lowe ( @adambeyoncelowe ) and Leonard Jason.

Initially they developed the consensus statement and gathered a list of researchers and organisations (including MEAction UK) who have signed the statement as show here:


They see the next step as getting buy in from patients, rather than just professionals. As part of that they contacted us and The ME Association, asking if we could help with collating signatures and getting the message out as we're better placed to do this with access to suitable tools and we're registered with the ICO for data protection/GDPR etc.

I'm not sure there will ever be a consensus that everyone agrees on, so I can understand why they didn't open to a wider discussion from the start, but I do agree that a more standardised definition for research would be helpful and could certainly counter some of the BPS'ers crowing about what is frankly nonsense "science".

Otherwise yes, I think we could have probably communicated MEAction UK's role in this a little clearer - useful to know for next time!

 

I was certain that I'd seen a paper referencing some effort to bring something like this about earlier this year - searching my collection of papers I found it - it's this one from February. The paper is very interesting in itself but I think the ME Action announcement sounds like an outgrowth of the effort described in this quote:

 

My reading of the document is that you would have fitted the definition based on the fact that you had cognitive impairment when you were in PEM.

I also think it’s important to note that the statement does not specifying exactly what the inclusion criteria should be. It is just saying that the undersigned agree that there should be a “consistent set of required inclusion criteria” and gives an example.

I assume that this is not the end of the process of forming a consensus.

The URL where you can add your signature to the letter states [their bold]:

“The group leading this initiative, in consultation with others, comprises Caroline Kingdon and Adam Lowe (both of whom served on the NICE Guideline Committee) and Leonard Jason, an experienced ME/CFS researcher from de Paul University in the US.​

I have great respect for the 3 people named as leading this. I am confident that they will have consulted with knowledgeable people to date, and I’m sure they will listen to feedback going forwards.

I agree that it’s odd to have Perrin as a signatory. I wonder if he was invited or whether he just heard about it and offered to sign.


One part of the statement that I wouldn’t have written is this:

“The time has come to improve cross-study comparability and ensure study participants have ME.”
​

This is a sentiment which is often expressed but it doesn’t make logical sense to me. ME/CFS is defined by diagnostic criteria or case definitions. If a patient meets the criteria then they have ME/CFS according to that definition. It is legitimate to debate which criteria are most useful for diagnosis and research but it’s meaningless to refer to ME as though it can be identified independently of the criteria by which it is defined.

However, I don’t think that detracts from the substance of the statement, which I broadly agree with and am minded to sign.

I also agree that this should have its own thread if anyone would like to start one.

 

They didn't need to accept his signature - he is the worst kind of quack and his involvement in ME research would effectively be a form of harm.

Also, his is not the only name of considerable concern.

This is how this effort was introduced:

No request for comment, no discussion, no debate, not even a "we're considering this, and would welcome your suggestions". It is presented as a fait accompli; pwME are needed "to demonstrate support", but not to be consulted as to the scope of it or even whether it should occur at all. (That happens so often to pwME that it could be a meme.)

I have read the Ref 5 exclusions paper; there is plenty I do not agree with - when one of the authors has already written a paper stating what the exclusions should be, and this is referenced in the "consensus statement", I do wonder how open this process would actually be and whether significant decisions have already been made.

I haven't yet finished reading the paper from February but this definitely seems to be a continuation of the same effort.

Given the DePaul locus there will almost certainly be some effort to include the DSQ scales - used as examples and referenced in the "consensus statement" - as approved measures. I really do not want DSQ given the status of a pwME-approved consensus outcome measure. It is deeply flawed, and DSQ-PEM is dreadful.

I am not even sure that we really have enough of an evidence base for a research consensus definition. In research so much depends on the question you are asking (& research criteria need not look like clinical criteria). We also need far better metrics & outcome measures before trying to entrench particular ones by consensus.

 

I agree.

I wondered why my name was not on the list and then remembered that Caroline had asked me to sign and I politely said no thanks, for these reasons.

 

On reflection, I think @Nightsong and @Jonathan Edwards may be right.

It’s tricky as there have been many studies that would have been improved if they used more useful case definitions, so I can see the incentive.

On the flip side, although PACE was criticised for using Oxford, using that criteria had the unintended advantage of informing us that CBT and GET don’t help anybody diagnosed with CFS, however loosely it is defined, which we wouldn’t have known if they had used CCC or ICC.

On exclusion criteria, I seem to recall that DecodeME initially excluded a number of people who were later accepted. I don’t know if the details have been revealed but I assume that the criteria was loosened in order to ensure the study was adequately powered.

Reading the consensus statement and writing the above, I’m reminded of that Waldo quote about a foolish consistency!

 

Our explanatory blog, https://www.decodeme.org.uk/inviting-more-participants-to-donate-dna/