NICE ME/CFS guideline - draft published for consultation - 10th November 2020

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Peter Trewhitt said:
Thought once I wrote this that I would be asked, and am not sure how reliable my memory is.

I thought I had seen a couple of submitted comments, but on reconsideration this may be confabulation. On reflection I suspect what I have read was the various published letters, ‘editorials’ and social media comments that have been discussed here rather than the actual comments submitted to NICE. So I was probably being unfair not comparing like with like, even though the published BSP view points were badly argued and inadequately evidenced.
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InitialConditions said:
Yeah, I think the responses are under wraps until they are published with the guideline. I think we might have seen one or two, though I can't remember who from.
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The response from the Norwegian ME/CFS Competence Center was shared here some time ago.

Edit, found it:
Kalliope said:
The national competence service for CFS/ME in Norway (known for a BPS approach) submitted a commentary to the draft NICE guidelines. It's available under the headline "news" (Nyheter) at their website.

Here is direct link to their commentary
https://oslo-universitetssykehus.no...te-for-cfsme/Documents/NICEcomments-MECFS.pdf

This is their first comment:

The committee has produced consultation documents consisting of 2634 pages. In our opinion, the committee has done a biased review of the evidence, and a biased assessment of patient. The committee has discarded Cochrane reviews on exercise and CBT, and has suggested radical changes in recommendations compared with previous NICE guidance, without a balanced review of why. Lillebeth Larun and other colleagues at NIPH revised their Cochrane review on exercise for patients with CFS/ME based on critical comments in 2019, in dialogue with Cochrane chief editors.

The primary studies on the different interventions are presented in tables over hundreds of pages, with standardized assessments regarding downgrading for indirectness, risk of bias etc.
The evidence is downgraded for indirectness when inappropriate diagnostic criteria not including PEM are used, without providing evidence to support the hypothesis that effect should be mediated by type of criteria (on the contrary there is evidence that the effect is similar across different criteria). It is strange to see how evidence from well conducted trials is reduced whereas undue weight is given to evidence from qualitative studies (even for questions on effectiveness/harm).
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This is such a heartsink situation. I really hope it isn't the start of a cycle of continual delays for a few more months, then a few more months, and so on, for 'reasons'. Meanwhile, the harmful guidelines still stay put. It did seem to be too good to be true that the new guidelines were such an improvement; hope all that good work won't have been for nothing.
 
Thinking about this again...(and trying to reassure myself)

When S4ME were putting together their submission, I did think at the time, that there is so much that is being said - and so much for the committee to do - how are they going to get it all done in 4 months time? The guidelines had being rewritten completely (compared to the old guidelines), and now on top of it the submissions have so much in them. The S4ME one alone is so big, let alone all the others.. Each of them needs to be discussed, the consequences considered, how that ties into care. Even just the physical maintenance section for example and the CBT section, there would be so many long submissions on that.

It may just be the case, as NICE have said, that they need more time to reply (and to get the guidelines right). It is very upsetting for lots of people (including me), so close to the date, and it’s also upsetting that people will end up with GET during that time. I think as well there should be an interim guidance published (I think people already asked for that before). But on this, given what was already in the draft guidelines and the huge changes (esp for severe / very severe), which has been done over a period of many years, I don’t see how it can be backtracked on?

And thinking about it, realistically, how can BPS people change it? It’s not like Simon Wesseley and Peter White are on the committee. Some BPS people are, but they can’t single handedly change the guidelines either.
 
The ME Association have put a positive spin on the news:
The ME Association was expecting NICE (The National Institute for Health and Care Excellence) to push back the publication date for the new ME/CFS clinical guideline.

The announcement we received yesterday comes as no surprise but we had hoped the new guideline might have been published in early May so that we could have highlighted it during ME Awareness Week.

Publication was originally expected by 21 April and this decision reflects the massive workload that the voluntary clinical guideline committee has had to tackle following the stakeholder consultation at the end of last year.

There are over 230 stakeholders in the consultation process and while not all of them will have submitted feedback, a significant number have, and each response must be reviewed by the committee before final recommendations are made to NICE.

The April publication date was always optimistic. The committee is comprised of clinical experts and patient representatives who contribute their time on a voluntary basis and the deadline was restrictive. This new deadline will allow the committee to properly review and to consider the feedback and make informed recommendations to NICE.
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more at link:
https://meassociation.org.uk/2021/0...cation-date-for-the-mecfs-clinical-guideline/
 
Personally, gutted at the announcement, but professionally it was to be expected and cautiously welcomed. The guideline committee have an awful lot of ground to cover and this is all done voluntarily for many if not most of them.

I understand of course the concerns being expressed here and elsewhere, but while the committee might have realised just how much work had to be done to properly consider all the stakeholder comments before making final recommendations, I don't think the same can be said for NICE.

The original deadline for publication was unrealistic but I guess it took the initial processing of feedback and for NICE to hear the committee express concern before it was truly appreciated. Earlier I counted there are over 230 stakeholders and while not all of them will have responded to the November - December 2020 call for feedback, I suspect many of them would.

The committee should I think be applauded for continuing their work and for trying to undertake such a challenge. I don't know what this might mean for GET etc., but I do believe it was workload that has extended the guideline in this way and not anything untoward on the part of the committee or NICE.

https://meassociation.org.uk/2021/0...cation-date-for-the-mecfs-clinical-guideline/
 
I agree it's good that the committee take the extra time they need. We even suggested it in our submission. And I'm grateful to those on the committee for their work. What I find completely unacceptable is NICE dragging it's feet on informing stakeholders of the delay, and not taking down the old guideline in the 4 months delay period. This will undoubtedly lead to more harm to patients.
 
Sly Saint said:
when it comes to 'comments' is any more 'weight' given to stakeholders than 'public' comments?
and ditto comments from UK sources?
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My understanding is that all comments would be equally considered, but that only stakeholders’ comments would be published in full, other comments would only be summarised in the final document, which may mean some will feel they were not given the same weight if they are dissatisfied with the published summary.

Though we perhaps are naturally wary given past experience, so far we have no evidence that NICE are being in any way disingenuous in the current process, other than the publication delay coming very late in the day. Indeed so far with the process overall and specifically with the evidence reviews NICE has bent over backwards to be fair and open.
 
InitialConditions said:
Yep, four months seemed totally optimistic given the volume and detail of the comments. But why wait until 90% through those four months to decide a 100% extension (another four months) is needed!
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Sounds like the sort of thing I would do if I were in charge lol, I'm always in denial when I'm running behind with something (and I am talking about my past life as Healthy Sarah, here)
 
Trish said:
I agree it's good that the committee take the extra time they need. We even suggested it in our submission. And I'm grateful to those on the committee for their work. What I find completely unacceptable is NICE dragging it's feet on informing stakeholders of the delay, and not taking down the old guideline in the 4 months delay period. This will undoubtedly lead to more harm to patients.
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I am a lot more comfortable about NICE re keeping their old flawed guideline live than I am for Cochrane keeping its flawed reviews up. From memory, the old NICE guideline covers a lot more than GET and CBT, and some of it might be useful. And NICE has made a statement saying that GET should not be used as a treatment.

I don't think NICE could really say 'assume the new draft guideline is the guideline while we finish it up'. For one thing, it would send a message that the stakeholder feedback is irrelevant. And for another, you can't really be telling clinicians and the NIH in general 'Now follow this unfinished, unapproved guideline for four months. Review all of your processes and change them to be compliant. And, in four months' time, do it all over again, because the guideline might well be different then'. I don't think a bureaucracy, with all of its responsibilities and legal requirements, could do that.

I think, so long as the statement against GET has been made and it continues to be supported by NICE, that's the main thing. And there's nothing stopping individuals and advocates using the draft guideline to push for better care in the meantime e.g. for highlighting the particular care people with sensory sensitivities need in hospital.
 
Hutan said:
Ah, in that case I have been confused, and there should be an interim statement specifically on GET.
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And the thing is a statement on the NICE webpage is simply not enough, the info has to be sent out to all medical personnel otherwise it's pointless, all medics and professional bodies need to be informed by NICE. This shouldn't be a difficult task, there must be email systems in place to inform NHS staff of things like this, use that. Patient safety should be paramount.
 
There is now a mention on the 2007 GDL page: https://www.nice.org.uk/guidance/cg53

"NICE is aware of concerns about graded exercise therapy (GET) and is updating the current recommendations. Please see the guideline in development page for information on our update (including draft recommendations on GET) which we expect to publish in April 2021. We are also developing guidance on the management of the long-term effects of COVID-19."
(Starts with a warning sign :emoji_warning:, smaller and not yellow, but that didn't copy over)

As Daisymay says, won't be much use as most heathcare workers won't know about it.

However it did take a lot of pressure from many organisations to get it put on there at all.
 
I'm not sure if it's just me, but, in the current guidelines, on the interactive flow chart, I can't actually access the sections on CBT and GET. They're there and clickable, but it goes back to an index page of management. If it's not just me, I don't know if anything should be read by this.
 
I've been listening to the video of the Michael Sharpe Swiss Re presentation on Long COVID, and there's a highly disconcerting exchange at the end (transcript and bolding mine):

MODERATOR: One last question before we move on to our next speaker is regarding the change in the NICE guidelines, and I'm wondering whether that has any impact on our ability to manage this patient group?

SHARPE: Gosh, well that's an interesting highly political moving target there. The NICE guidance - existing NICE guidance for chronic fatigue syndrome - ME - advocated rehabilitation in the form of CBT, graded exercise. The revision of the guidance, which has been very driven by, by patient groups who feel strongly about this, is - was going to be very different. That's been out to consultation. I know several Royal Colleges have pushed back very hard indeed on that, and it's being considered and that will come out in March. On the positive side, the [inaudible] post COVID NICE guidance is very sensible, very pragmatic and advocates rehabilitation. So I think there's lots to play out there. What will happen with the chronic fatigue - ME ones, what will happen with the NICE ones, but I think we just have to, have to have this rehabilitation because it's the only thing we've got apart from time.
 
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