NICE ME/CFS draft guideline - publication dates and delays 2020

I seem to remember MS specifically stating that PACE and the like were not intended to provide guidance for treating pwME.

From this I would infer it was meant to provide guidance to those without PEM (a reach I know).

So presumably MS has effectively stated on the record that there is no data on PEM in PACE (the biggie, that virtually all of the BPS studies are 'based' on), as they didn't believe in it, so therefore didn't look/record, and as a result ignored any reports from their victims.

Seems pretty cut and dried to me - the BPS 'studies' cannot, practically by definition, contain any info on PEM.

ETA - correction - it was not MS, it was PW;

From MEpedia
https://me-pedia.org/wiki/Peter_White#The_PACE_trial
In a letter to Richard Horton, editor of the Lancet journal, Peter White et al stated: “The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME”;[59]
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InitialConditions said:
I decided to publish this blog post today, rather than add further details that probably aren't needed at this stage. This has been sort of rushed, so I'm open to any comments on the post and if it can be improved.

The blog is here: https://domsalisbury.github.io/mecfs/nice-mecfs-guideline-delay/
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Not had time to properly digest this, but is it creating an opening for NICE to reassess their evidence quality gradings of the various studies under analysis?
 
Andy said:
So my initial thoughts and assumptions, based on what is in the blog.

BPSers, in an attempt to reverse the downgrading of their junk research, are claiming that their research papers, which sought to emphasise the chronic fatigue aspects, do actually provide evidence of their cohorts suffering PEM, so that the results are more directly applicable to pwME, and should therefore receive a higher grading. Their claim is that this evidence of PEM is hidden away in supplementary documents. My guess would be that if it is there, it will be along the lines of patients agreeing that they feel tired after exerting themselves, so hardly a definition of PEM that we would agree with.

Will it be enough to reverse the recommendations against GET that we all welcomed? Perhaps, but NICE must have felt that they were on solid enough ground to make the interim recommendations that they did, and I would like to think that this won't be enough to get their pseudo-science rated highly enough to make a difference.

This is my opinion, from an initial read. Happy to acknowledge any error that I might have made.
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Your guess is right. From mail 57_Redacted, this will be the aim of the reanalysis:

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Barry said:
Not had time to properly digest this, but is it creating an opening for NICE to reassess their evidence quality gradings of the various studies under analysis?
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It appears so, yes.

It seems that those who submitted the comments about "proportions of study population hav[ing] PEM" want to see GRADE ratings of outcomes bumped up by one mark (e.g. from very low to low, or low to moderate). NICE had downgraded every outcome where indirectness related to PEM was a concern by one point.

ETA: I believe 'SH' means stakeholder in the mail above.
 
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Having thought about this some more, and at the risk of looking very stupid if I'm wrong, I don't think that this reanalysis will make a difference, at least in regard to the main message about GET in the guideline.

The only way that it could would be if the BPSers 'evidence' that they recorded PEM were taken as the truth, and that the regrading then meant that PACE et al then outscored all the other evidence for the potential of harm. I think that it will be found that their claims about recording PEM aren't true, and so any regrading will be minimal, if there is any change at all.

Additionally, this will then provide further evidence of how inappropriate their research is, so while this might be something that causes some concern at the moment, I think this will turn out to be a good thing in the long run.

But this is all opinion and guesswork, so take with as big a pinch of salt as you feel is necessary :)
 
So, are NICE going to review all the papers to check whether patient harm was adequately measured, recorded and followed up too (including long term), and then downgrade or reject the research accordingly? Pretty sure if they were to do this they would end up with very little research to assess....
 
I do continue to think that NICE are extremely unlikely to change the main points of their draft guideline, as they would call into question their own process.

I do believe that various parties do know this and are instead interested in buying time (or perhaps concessions around the margins insofar as possible). The longer the official guideline is not changed, the longer various parties have to set up GET/CBT practices targeting long covid patients (many are already being advised to do GET) without having to worry too much about the ME/CFS guideline. It may become more difficult after that as people start to understand the issue better. This helps them make inroads at a crucial time.
 
Surely behaving in such a manner would amount to malfeasance?

Deliberately trying to get around a coming rule change, that's being instituted to 'protect' patients from exactly the same 'therapies' as they practice.

It is certainly (IMO) unethical, and immoral.
 
I don't think NICE is going to change its advice. If anything I would suspect that the credibility of the BPS crowd wears thinner month by month and everyone on the NICE committee is aware of that whatever their standpoint.

I doubt there is any strategy on the part of the BOPS people here. It is just throwing more and more rattles out of the pram.
 
Andy said:
I think that it will be found that their claims about recording PEM aren't true, and so any regrading will be minimal, if there is any change at all.
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As far as I am aware, none of the UK and Benelux trials of behavioural and physical activity interventions for CFS, e.g. those included in the Cochrane reviews, recorded PEM. Many used the Oxford case definition of which PEM is not a criterion.

Arguably, even mentioning PEM in these studies would have been detrimental to BPS proponents: it would have lent weight to the idea that PEM is an important symptom of ME/CFS, i.e. that it is not (only) chronic fatigue, going against their attempts at portraying the disease as such.

Did any of the few trials that used Fukuda explicitly list the prevalence of each criterion/symptom among their cohort? PEM would have appeared then, but again I cannot recall that any such trial provided these details.

I can only think of Scandinavian trials, and notably Norwegian ones, where (some) patients would have been diagnosed with the Canadian consensus criteria. I'm not sure how many have been published, nor how many were included in NICE's evidence review.

Ariel said:
I do continue to think that NICE are extremely unlikely to change the main points of their draft guideline, as they would call into question their own process.

I do believe that various parties do know this and are instead interested in buying time (or perhaps concessions around the margins insofar as possible). The longer the official guideline is not changed, the longer various parties have to set up GET/CBT practices targeting long covid patients (many are already being advised to do GET) without having to worry too much about the ME/CFS guideline. It may become more difficult after that as people start to understand the issue better. This helps them make inroads at a crucial time.
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This would be a plausible explanation.

Additionally, I think NICE reviewers will not be very keen to be burdened further with searching for, as well as analyzing, swathes of supplementary material. Unlike the layout of a research article, documents with supporting data are unstructured so they can be time-consuming to review. I would also think that the reviewers don't expect this analysis to provide new tangible evidence.

Even in the case that some is found and that part of the evidence grades changes, grading and issuing recommendations are separate processes. The committee still has the final word. Given the stance it has already adopted and that it is aware of the many issues with BPS research, it seems unlikely that it would overhaul the recommendations compared to the draft guidance.
 
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Wonko said:
I seem to remember MS specifically stating that PACE and the like were not intended to provide guidance for treating pwME.

From this I would infer it was meant to provide guidance to those without PEM (a reach I know).

So presumably MS has effectively stated on the record that there is no data on PEM in PACE (the biggie, that virtually all of the BPS studies are 'based' on), as they didn't believe in it, so therefore didn't look/record, and as a result ignored any reports from their victims.

Seems pretty cut and dried to me - the BPS 'studies' cannot, practically by definition, contain any info on PEM.

ETA - correction - it was not MS, it was PW;

From MEpedia
https://me-pedia.org/wiki/Peter_White#The_PACE_trial
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That's because they don't believe there is such a thing as a disease called ME, just chronic fatigue of unexplained cause. Which should make it impossible for them to argue that they indirectly considered PEM, as far as I am aware none of the BPS papers have ever even used the term or any variation thereof. Everything is framed in terms of psychological setbacks or other vague but unrelated concepts.

So that would be one question for NICE: is there such a thing called ME? Or is it just tiredness? Which would then nullify any claims that they consider the actual symptoms, and therefore that their studies are representative of the population. And since none of the research even bothers with any symptom other than fatigue, that's clearly a very bad faith argument that likely hides the real political pressure happening behind the scenes.

Their written record makes it plain they only ever consider fatigue and everything else falls under a subset of fatigue. The matter then is whether words mean anything at all. Would they consider the broader context, which makes their claim of taking PEM into account farcical? Or only what's in the evidence, where neither the terms nor any coherent variation thereof is present, only ever fatigue and only ever all about anxiety, self-efficacy and whatnot, things that have nothing to do with the actual illness?

I'll say that's way too much to ask of an agency with such a specialist remit. What an incredible mess, that's for sure.
 
Jonathan Edwards said:
I don't think NICE is going to change its advice. If anything I would suspect that the credibility of the BPS crowd wears thinner month by month and everyone on the NICE committee is aware of that whatever their standpoint.

I doubt there is any strategy on the part of the BOPS people here. It is just throwing more and more rattles out of the pram.
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I dearly hope you are right.
 
I am not surprised that the BPS cabal are jumping up and down at the dismissal of all their precious, yet meaningless research being disregarded.

However there is so much more that is wrong with all these papers, such as using dodgy questionnaires like the CFQ, and a long list of flaws in PACE
 
Ariel said:
I do continue to think that NICE are extremely unlikely to change the main points of their draft guideline, as they would call into question their own process.

I do believe that various parties do know this and are instead interested in buying time (or perhaps concessions around the margins insofar as possible). The longer the official guideline is not changed, the longer various parties have to set up GET/CBT practices targeting long covid patients (many are already being advised to do GET) without having to worry too much about the ME/CFS guideline. It may become more difficult after that as people start to understand the issue better. This helps them make inroads at a crucial time.
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Ironically, all this does is raise the stakes. Long haulers weren't really involved in this, or much aware of it. Now that many of them are receiving the same mistreatment, it will only bring more visibility and none of it will be in their favor.

But truth doesn't always win. The question over evidence is settled and clear: their stuff is uninterpretable junk. The real question is whether politics will overrule the evidence, which is how it happened in 2007 so they probably feel confident they can pull it off again.

But they have this pesky habit of pissing off as many patients as possible, and sure as sure is, they are doing it yet again. That used to be irrelevant because we were completely ignored. Not anymore. The political balance has changed significantly.
 
Andy said:
BPSers, in an attempt to reverse the downgrading of their junk research, are claiming that their research papers, which sought to emphasise the chronic fatigue aspects, do actually provide evidence of their cohorts suffering PEM, so that the results are more directly applicable to pwME, and should therefore receive a higher grading. Their claim is that this evidence of PEM is hidden away in supplementary documents. My guess would be that if it is there, it will be along the lines of patients agreeing that they feel tired after exerting themselves, so hardly a definition of PEM that we would agree with.
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From the sound of that it will just reinforce the indirectness, if they seek to rely on oblique suggestions, obscurely related documents etc. Surely if such information is not in the main trial reporting, then implicitly was was deemed unimportant to the investigators at the time. Seeking to ramp up the important of it years and decades after just shows how "post-hoc" obsessed they are.
 
Wonko said:
Surely behaving in such a manner would amount to malfeasance?

Deliberately trying to get around a coming rule change, that's being instituted to 'protect' patients from exactly the same 'therapies' as they practice.

It is certainly (IMO) unethical, and immoral.
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Oh yeah. Problem is unethical and immoral don't mean illegal. It's one of those things that aren't in rules because no one expects anyone to behave in such bad faith.

Which is exactly why it must be in the rules. Medicine has a loooooooong history of doing exactly this and it always ends up the same.
 
Thank you to @InitialConditions for your work on this, and also to the other commenters so far.

I am not with it today and am struggling to get my head around all the FIO information, so will return to the thread later.

My main concerns with the consultation draft were that it could be seen as still leaving a back door open for so called individualised CBT and GET-lite and leave the psychologisers in control of clinics; in effect with a little blurring at the edges allowing a path for the UK specialist services to remain much as they are.

This new information is reassuring in that it seems clearer NICE are not colluding with the BPSers to subvert the guideline process itself, but I still worry that with the delay there may be sufficient muddying of the water to help the BPS vested interests retain their hold on the UK clinics and, as already said, give them more time to get a toe hold in the new long Covid services currently being developed.
 
cassava7 said:
As far as I am aware, none of the UK and Benelux trials of behavioural and physical activity interventions for CFS, e.g. those included in the Cochrane reviews, recorded PEM. Many used the Oxford case definition of which PEM is not a criterion.

Arguably, even mentioning PEM in these studies would have been detrimental to BPS proponents: it would have lent weight to the idea that PEM is an important symptom of ME/CFS, i.e. that it is not (only) chronic fatigue, going against their attempts at portraying the disease as such.
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If I remember correctly PACE used the london criteria (although perhaps a strangely modified version) which has PEM as a requirement. There results showed no or little difference between those just meeting that criteria or the Oxford one. If they do represent two different sets of patents this suggests to me there is a high chance that improvements are reporting biases rather than any real change.
 
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