Feedback from Stakeholder Engagement Workshop for the NICE guidelines on ME, Jan 2018

[It's M.E. Linda]

From what I have heard the orthostatic intolerance in ME/CFS is probably mostly not POTS.

That's interesting. What makes you think this? My sense is the opposite, that many pwME/CFS have POTS (diagnosed or undiagnosed). In terms of the previous point about doctors not being comfortable with not having anything they can do, managing POTS symptoms (heck, even diagnosing them using something simple like the NASA Lean Test) is a something tangible which doctors can focus on, and which would improve the quality of lives of patients. Plus, there are clinical trials for POTS treatments (though I'm not sure if there are any in ME/CFS), so NICE could at least draw on that evidence-base in its recommendations.

@Valentijn or others may know more about this. My understanding from the discussions we have had and studies quoted is that most orthostatic intolerance in ME/CFS when studied has not conformed to POTS but falls into other categories such as neurally mediated hypotension. The claim that POTS is common in ME/CFS is widespread but so many things like that in this field are not based on good data collection. In many cases myths are perpetuated by physicians without any real physiological training.

I think the disagreement here is largely semantics. NMH and similar are much more common in ME patients than POTS, according to the research, but patients use "POTS" to mean all orthostatic intolerance. POTS is a nice easy acronym, and more people have heard of it - but it's still wrong. Using the proper terminology is extremely relevant when dealing with practitioners or agencies, especially if nitpicking assholes are involved who'd love an excuse to dismiss and ridicule patients .

Tilt table testing for OI is a good move. Information on good stretching exercises will help as muscles can get really bad if not maintained in some small way.

Very interested in this topic of "OI in PwME" (from recent experience) but will take it away to another thread in Symptoms....... somehow .......may need techie help.......please?!

Edit - ohhh, managing the tech stuff, slowly......

 

[MeSci]

The crucial argument with NICE is going to be about removing CBT and GET. The only way to do that is to insist on rigorous evidence. Making other suggestions that are not based on rigorous evidence will destroy the case completely.

Rigorous evidence that they don't work, or that they cause harm, or both? (Apologies if this has already been asked/answered)

 

[Alice]

So would I. And if we were starting from scratch with a new illness where there had not been years of wrong treatment advice, I think it could simply be stated that there is no curative treatment, but that some symptoms can be helped with drugs, eg sleep, pain, etc.

However, we do have many years of bad advice so ingrained in the medical system that I think NICE should make a statement that there is no evidence that GET or CBT are effective. And make it clear that exercise that exacerbates symptoms is not beneficial.

I think NICE has a duty to re-educate, rather than just pretend the last 30 years didn't happen. But I guess that's not how they work.

Charles Shepherd's (ME Association) summary: http://www.meassociation.org.uk/201...eport-by-dr-charles-shepherd-17-january-2017/

Great to see that at least one table raised HR pacing. It is also necessary to get food/chemical/environmental intolerances into the guidelines and the ease of identifying them with HR monitoring - these are a nightmare especially for anyone needing care outside the home and/or medical/dental work done. Sleep- hopefully the unique sleep issues ie under sleeping or too much exertion = tired and wired. Only using the bed for sleep doesn't work when you live in bed. Rest = a set range within resting HR (nominally 110%) - surely there is some research somewhere on this? If not can some be done quickly?

 

[Skycloud]

Information on good stretching exercises will help as muscles can get really bad if not maintained in some small way.

This would be helpful. Welcome to the S4ME

 

[Andy]

ME Research UK's feedback

“This meeting was extremely encouraging. Professor Mark Baker (Director of the Centre for Guideline at NICE) is determined to ‘do the right thing’ – and he does listen. So, I am hopeful that the outcome will be more favourable in the upcoming guideline than the present version. I also think that I have got through to him over the last year on the principle of “First, do no harm” in regard to Graded Exercise Therapy [GET] and that they may take the unusual step of issuing an Interim Advisory Note before the next version of the guideline is published.

Quote above looks to be their opinion on the meeting, the rest seems to explain the processes involved http://www.meresearch.org.uk/news/nice-guideline-review-stakeholder-workshop-jan-2018/

 

[James]

“First, do no harm” from an ethical standpoint and acknowledging the exercise intolerance (SEID) that the IOM included in it's 2015 report. Removing criteria such as the Oxford criteria as the NIH Statement is unambiguous that the Oxford criteria are flawed and lack reliability, thereby confounding the ability to interpret results drawn from studies which used them to select cohorts and noting that use of the Oxford criteria may impair progress and cause harm, therefore no research using them can be considered rigorous or valid for the patients the guidelines are written for.
Service provision for the severe and very severe that cannot attend clinics or partake of the currently issued advice that fails roughly 25% of the patient community is another elephant in the room.

 

[Barry]

In terms of the mix of 'stakeholders', my impression was that about half were from patient organisations and of one mind about CBT and GET. There were some professionals, including the ones I mentioned, but my impression was that psychology was barely represented, with the exception of Dr Michael Sharpe. I don't know how things went on that table but Lady Mar was also there!

Nice .

All in all it seems to me that something important has been achieved but there is still more work to do.

Inevitably. This is just the beginning, but a very important beginning by the sound of it.

 

[Wonko]

Service provision for the severe and very severe that cannot attend clinics or partake of the currently issued advice that fails roughly 25% of the patient community is another elephant in the room.

Given that the clinics and the currently issued advice is harmful doesn't it fail 100% of pwME?

 

[Andy]

The UK Biobank have put out a brief statement

Statement from CureME Director and Principal Investigator Dr Luis Nacul, who represented CureME and the LSHTM at yesterday's National Institute for Health and Care Excellence initial engagement meeting on new guidelines for ME/CFS:

"The meeting was positive and NICE seems committed to fully engaging people with ME/CFS among a wide range of stakeholders. There seems to be consensus that the previous guideline should be abandoned, and that the new guidelines should fully consider the growing evidence coming from biomedical research, together with the views of a range of experts in the disease.

It will take time, but the importance of what is happening cannot be underestimated, and I look forward to seeing continuing and effective involvement of people with ME/CFS alongside experienced health professionals and researchers as part of the process."

 

[Esther12]

Very seriously, do we also need a 'Tell us honestly there's nothing?' campaign?

Probably... but I suspect it will be hard to get widespread excitement for a campaign like that, particularly in the face of other people promoting questionable but exciting 'science', and the prospect of rapid access to effective treatments.

I agree with Edwards & co that there's a real conflict between anyone 1) wanting to remove CBT/GET because there's no good evidence that they're useful and 2) wanting to insert some speculative treatment with no good evidence of efficacy.

If people do start trying to promote unfounded treatments, it gives Wessely/Sharpe/etc something to exploit.

 

[Sasha]

Probably... but I suspect it will be hard to get widespread excitement for a campaign like that, particularly in the face of other people promoting questionable but exciting 'science', and the prospect of rapid access to effective treatments.

I agree with Edwards & co that there's a real conflict between anyone 1) wanting to remove CBT/GET because there's no good evidence that they're useful and 2) wanting to insert some speculative treatment with no good evidence of efficacy.

If people do start trying to promote unfounded treatments, it gives Wessely/Sharpe/etc something to exploit.

I take your point but I think there could be a 'Tell us honestly there's nothing' when it comes to RCT-backed therapies.

 

[Barry]

I think one of the major failures of the system is that adverse reactions are not identified, reported, tracked, investigated, nor results published; be it normal doctor/patient interactions, trials, whatever. It's disgusting. In the aircraft industry, which has parallel safety responsibilities, an operator is legally bound to report any serious incident. The AAIB (Air Accident Investigation Board, which also covers serious incidents a.k.a. near misses) may then investigate that incident. If we had the equivalent in the medical world, people would be much better protected, and science might acquire crucial data currently denied them. It's probably why civil air transport is so safe, and I'm sure much more so than PwME at the hands of the medical experts.

 

[Keela Too]

Agree @Barry Also I think it is a concern that there is a yellow card system for pharmaceuticals, but not for psychological/psychiatric therapies. So how can GPs and patients officially report problems with GET/CBT?

 

[Jonathan Edwards]

Rigorous evidence that they don't work

Sorry, I was meaning insisting on no recommendation without rigorous evidence for efficacy (which we are without).

 

[Jonathan Edwards]

In the US, most healthy people have yearly physicals to screen for some nasty problems which can show up early on basic (cheap) blood tests. It would make sense to at least do that much for ME patients in the UK,

I think that one got through to the facilitators and I think we can be optimistic it will be allowed through on new guidelines - an emphasis on regular checks to ensure something important is not being missed.

 

[Daisymay]

ME Research UK's feedback

Quote above looks to be their opinion on the meeting, the rest seems to explain the processes involved http://www.meresearch.org.uk/news/nice-guideline-review-stakeholder-workshop-jan-2018/

I'm hopeful we'll end up getting much improved guidelines, but I think we have to be cautious and remember the past to be sure we do get these improved guidelines and not be taken in with NICE nice speak.

The MERUK report mentions how there will be patients advocates and all these noble things NICE sets out to do with their guidelines and the whole process, blah blah.

These were all in place in 2007 and it made not a jot of difference, they steam rolled their way through the whole process making sure their agenda was fulfilled.

So real hope but caution.

 

[Barry]

Agree @Barry Also I think it is a concern that there is a yellow card system for pharmaceuticals, but not for psychological/psychiatric therapies. So how can GPs and patients officially report problems with GET/CBT?

Never knew about this. So we can report adverse incidents regarding all kinds of medicines and medical devices, yet no mechanism whatsoever for reporting adverse incidents form psychiatric interventions? I would have thought there should be a reporting mechanism for all kinds of medical interventions, be they psychiatric, physiotherapy, whatever. To me that seems barmy. You did say you were looking forward to getting stuck in @Carolyn Wilshire ( ), so can ask for your thoughts on this?

 

[Barry]

I think that one got through to the facilitators and I think we can be optimistic it will be allowed through on new guidelines - an emphasis on regular checks to ensure something important is not being identified.

Absolutely. I tend to worry about this one re my wife.

 

[Keela Too]

Yellow card: https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
I "think" this implies that therapies are not part of the yellow card scheme.
@Barry (Does this maybe need a new thread?)

 

[Barry]

Yellow card: https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
I "think" this implies that therapies are not part of the yellow card scheme.
@Barry (Does this maybe need a new thread?)

Yes, that's what I understand ... my post maybe was a bit confusing. Yes, I agree. As we sort issues out here ( ) maybe that could be an area to focus on.