UK NICE 2021 ME/CFS Guideline, published 29th October - post-publication discussion

[Simbindi]

It seems that there is confusion over what constitutes a 'fixed increment'. A personalised goal can still constitute a fixed increment if it has a time limit set for it to be achieved in, as the increase in activity would be set (hence 'fixed'). Setting fixed increments does not necessarily imply a linear increase in the amount of activity, a therapist can personalise increments yet they are still 'fixed' if they are not able to be adjusted by the patient themselves in response to their symptoms, including reducing activity as much as required.

I think this is where clinics offering activity management as a form of 'therapy' would be a warning sign. It's not a therapy, it's just a technique for new patients to learn to manage symptoms so as to not exacerbate them, which in turn may gradually increase a person's functional capacity.

I hope that the charities stay on top of monitoring the clinics and see what actually transpires in practice to check if this complete change in emphasis is being taught to patients.

 

[livinglighter]

This isn't quite correct. They can offer physical activity and exercise programs if patients want them within the constraint that patients stay within their activity limits. This should place strict limits on any advice to gradually increase activity for anyone who has ME/CFS as defined in the guideline, as it's made clear that if there's a flare up of symptoms or PEM, patients need to cut back activity until they have returned to their previous level.

Sorry I wasn't clear. That's what I meant by being flexible. The activity level is to be adjusted up or down while considering the patient's energy limits and relapses and flare-ups. But what I'm saying is clinics may still be able to advertise they offer GET as long as it's the NICE recommended approach.

 

[NelliePledge]

Any service including any element of exercise in what they promote to people with ME whether or not it is graded should be expected to demonstrate their protocol for informing the patient about the risks involved. If this can’t be shown how can they claim the patient’s consent was informed. This should be independently audited.

 

[Kitty]

Would quite like to send them all a T-shirt, saying My patients are already doing too much!

 

[Andy]

https://www.bmj.com/content/375/bmj.n2647

NICE understates role of exercise and CBT in managing ME/CFS, say medical leaders

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2647 (Published 29 October 2021)Cite this as: BMJ 2021;375:n2647

Medical leaders have questioned the updated guideline from the National Institute for Health and Care Excellence (NICE) on myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS) for downplaying the importance of activity and exercise in managing the condition.
They say that the guideline understates the connection between mental and physical health, does not reflect how exercise therapy is used in practice, and fails to represent the positive discussions that leaders have had with patient groups.
The guideline was finally published on 29 October,1 after NICE delayed its publication because three members of the committee overseeing its production resigned in August and royal colleges raised concerns about the recommendations and processes used in developing it.2
NICE said that graded exercise therapy (GET) should no longer be used to treat ME/CFS but that exercise programmes could still be offered, provided they were based on patients’ energy levels and led by them rather than by a graded plan. It also said that cognitive behavioural therapy (CBT)—which had in the past been seen as a cure for CME/CFS—should be offered only to help people manage their symptoms and reduce the distress associated with having a chronic illness.

Joint statement

In their joint statement seven heads of royal colleges and faculties said, “The published guideline contains some positive changes, but these do not go as far as we would have liked and understate the importance of activity and exercise in the management of ME/CFS and the connection between people’s mental and physical health. We also do not think the changes represent the positive discussions that have been had with patient groups.
“As in many chronic conditions, people’s mental and physical health are intrinsically linked. This guidance risks undermining the importance of these links by dismissing the potential of treatments such as CBT as of less value in alleviating symptoms than pharmacological interventions.”
The leaders, who include Andrew Goddard, president of the Royal College of Physicians, Martin Marshall, president of the Royal College of General Practitioners, and Adrian James, president of the Royal College of Psychiatrists, said that while there was disquiet among doctors and some patient groups about how the evidence for the guidelines was assessed, “the important thing now is that services are commissioned in a safe and effective way that does not disadvantage any patients being treated now or in the future.”
They pointed out to those commissioning services that “GET as defined in the guidance is not reflective of the personalised paced exercise programmes that are currently used in the NHS and termed GET. These have provided benefit to many patients and should not be discontinued. However, we recognise that the phrase GET is unhelpful and this terminology should be dropped to allow clinicians to work with their patients in a more productive way.”
They said that CBT remained a valuable treatment for alleviating symptoms in ME/CFS and that services should ensure that patients have access to this and other psychological therapies.
The statement also highlighted the role of specialist rehabilitation medicine services and exercise medicine services in looking after patients with ME/CFS—something that the NICE guidelines omitted to mention and which could mean patients lose out on care if these are not used.
The leaders emphasised that training must be made available for everyone involved in the care of people with ME/CFS and that GPs and other clinicians must be able to access these professionals.
“Many patients with ME/CFS have other conditions including chronic pain and fibromyalgia which are improved with exercise as recommended in other NICE guidance,” they said. “It is important that a holistic approach is taken to ensure that other conditions do not deteriorate.”
The signatories to the statement were:

Andrew Goddard, president of the Royal College of Physicians

Andrew Elder, president of the Royal College of Physicians of Edinburgh

Martin Marshall, president of the Royal College of General Practitioners

Adrian James, president of the Royal College of Psychiatrists

Helen Stokes-Lampard, chair of the Academy of Medical Royal Colleges

John Etherington, president of the Faculty of Sport and Exercise Medicine, and

Steve Nimmo, president of the Faculty of Occupational Medicine

Rapid Response to this by Peter Kemp.

"Medical leaders have raised concerns over the processes NICE used in developing their new guideline for ME/CFS, and for downplaying the importance of activity and exercise in managing the illness. [“NICE understates role of exercise and CBT in managing ME/CFS, say medical leaders.” https://www.bmj.com/content/375/bmj.n2647]

The research evidence provided below contradicts these views. It also calls into question whether the medical leaders and the Royal Colleges views, are based on scrupulous analysis of published research, rather than on misleading media reports."

https://www.bmj.com/content/375/bmj.n2647/rr-1

 

[Sly Saint]

https://www.bmj.com/content/375/bmj.n2647/rr-1

The PACE trial data shows that GET and CBT benefited around 15% of participants. Whereas 85% of participants derived no benefit that can be attributed to one of the therapies. These statistics which negate the use of GET and CBT for ‘CFS/ME’, do not even allow for factors such as lax participant selection, participation bias, dubious target thresholds, reliance on participant subjective measures or the trend for more than 50% of participants to spontaneously improve. Therefore, the PACE Trial has provided compelling statistical evidence that GET and CBT are useless as treatments for ME/CFS.

 

[Jonathan Edwards]

'The PACE trial data shows that GET and CBT benefited around 15% of participants.'

Not even that. 15% may have reported feeling better having been on those arms. That is no way the same as 'benefited'. The reasons why are given, but it is time to stop allowing this sort of language to slip through!

 

[Barry]

The PACE trial data shows that GET and CBT benefited around 15% of participants.

And even that 15% were nothing like true benefits, given based on subjective outcomes in unblinded trial.

Edit: X-posted with @Jonathan Edwards.

 

[Sean]

Thank you, @Peter Kemp.

 

[adambeyoncelowe]

Sorry I wasn't clear. That's what I meant by being flexible. The activity level is to be adjusted up or down while considering the patient's energy limits and relapses and flare-ups. But what I'm saying is clinics may still be able to advertise they offer GET as long as it's the NICE recommended approach.

They shouldn't be calling it GET in any case. The NICE GL defines what GET is and says not to offer it. It also says risks and benefits must be discussed. You can't give informed consent if your treatment is mislabelled (e.g., giving aspirin instead of paracetamol).

I see that charities and patient groups (I'm including DwME and PfME within this) are already on the case with logging cases of 'old wine in new bottles', so this may be enough to get the ball rolling. If BACME are now officially against GET, we can use them, the charities and CCGs to challenge clinics and ask them what they think they're up to.

I've been saying we needed an alternative to the Yellow Card system for non-pharma treatments for years, but I know a few of the charities are finally on this, and NICE seems receptive to helping.

I think the outlook is definitely better than it was even a year ago.

 

[Peter T]

They shouldn't be calling it GET in any case. The NICE GL defines what GET is and says not to offer it. It also says risks and benefits must be discussed. You can't give informed consent if your treatment is mislabelled (e.g., giving aspirin instead of paracetamol).

I see that charities and patient groups (I'm including DwME and PfME within this) are already on the case with logging cases of 'old wine in new bottles', so this may be enough to get the ball rolling. If BACME are now officially against GET, we can use them, the charities and CCGs to challenge clinics and ask them what they think they're up to.

I've been saying we needed an alternative to the Yellow Card system for non-pharma treatments for years, but I know a few of the charities are finally on this, and NICE seems receptive to helping.

I think the outlook is definitely better than it was even a year ago.

In the short term there may be a few specialist services trying to offer a relabelled form of GET, but that should be relatively easy to address. On the whole I suspect the present ideological pro exercise advocacy is not at the level of service provision but from the ‘great and the good’ of the British BPS academics and the various Royal Colleges most of whom are fortunately not working on the coal face.

What I suspect will be a harder problem to combat long term will be from well intentioned clinicians slipping into pacing up. It may prove that with clinician and patient both desperate for improvement that an initial improvement from better activity management through pacing and more rest will be mistaken as part of an ongoing recovery process. Unfortunately any such improvement is likely for most to be within an activity level ceiling, but that ceiling may not be hit until after the end of the time limited specialist service involvement. So any service not undertaking long term follow up may have no idea of subsequent relapses resulting from misguided attempts at pacing up.

Certainly, my experience of pacing support from a specialist service OT was just this. My OT was very enthusiastic about the overall increases in my activity levels achieved by better activity management, but never once cautioned me against the risks of misinterpreting this as an ongoing recovery process, discharging me while things were going well, but also with dangerously unrealistic long term expectations. When things did fall apart I still interpreted it as me failing to get my pacing right, rather than having crashed into an activity ceiling. Whether intentional or not my OT had fostered my mistaken and potentially harmful belief that if I just managed my activity better I would eventually recover.

 

[livinglighter]

They shouldn't be calling it GET in any case. The NICE GL defines what GET is and says not to offer it. It also says risks and benefits must be discussed. You can't give informed consent if your treatment is mislabelled (e.g., giving aspirin instead of paracetamol).

That’s great to hear, but then it's disturbing to see NHS commissioned clinics overtly flouting the rules. Some websites may still require updating, but they've had long enough to prepare. The referral criteria I've seen also seems more stringent. All other possibilities, including psychiatric disorders, need to be first ruled out. That could be a good or bad thing, as it may help more symptoms being addressed. Still, I also hope it doesn't result in lots of PWME receiving a psychiatric evaluation, as there tends to be a lot of overlapping symptoms with conditions such as BDS/BDD.

I see that charities and patient groups (I'm including DwME and PfME within this) are already on the case with logging cases of 'old wine in new bottles', so this may be enough to get the ball rolling. If BACME are now officially against GET, we can use them, the charities and CCGs to challenge clinics and ask them what they think they're up to.

I've been saying we needed an alternative to the Yellow Card system for non-pharma treatments for years, but I know a few of the charities are finally on this, and NICE seems receptive to helping.

I think the outlook is definitely better than it was even a year ago.

Hopefully, NICE can help make it happen for everyone working on it. There really should be an alternative to the Yellow Card system for non-pharma treatments.

I'm still unsure of the functions of BACME. Does it serve to provide a benchmark of service for clinics with members part of it?

 

[CRG]

I'm still unsure of the functions of BACME. Does it serve to provide a benchmark of service for clinics with members part of it?

BACME is an Association of professionals working in the field of ME/CFS - this kind of Association is common amongst health professionals in the UK. It doesn't have any formal role within the NHS, but as with many such Associations it includes in its Objects [1], provision for education and training.

Benchmarking in the NHS is a formal process, which as far I understand it is managed through the in-house benchmarking service of the NHS [2], I don't know how health professional's Associations fit in with that, if at all.

When BACME was first set up there was suspicion on the part of patients that it was just a front for the BPS crowd (not unreasonable given who was involved) but none of the usual suspects now seem to be involved[3]

[1] https://www.bacme.info/sites/bacme.info/files/BACME CIO Constitution January 2021.pdf
[2] https://www.nhsbenchmarking.nhs.uk/
[3] https://www.bacme.info/sites/bacme.info/files/BACME Board Members Oct2021.pdf

 

[Keela Too]

What I suspect will be a harder problem to combat long term will be from well intentioned clinicians slipping into pacing up. It may prove that with clinician and patient both desperate for improvement that an initial improvement from better activity management through pacing and more rest will be mistaken as part of an ongoing recovery process.

I think this & the one about problems coming after the patient leaves the clinic are very good points.

 

[MEMarge]

When BACME was first set up there was suspicion on the part of patients that it was just a front for the BPS crowd (not unreasonable given who was involved) but none of the usual suspects now seem to be involved[3]

Anna Gregorowski is fully BPS and a Crawley follower. She ran the CFS paediatric clinic at Gt Ormond St. It is now based at UCLH.

Further discussion of this has been moved to this thread
https://www.s4me.info/threads/me-cfs-services-in-the-united-kingdom.5625/page-18#post-391887

 

[Peter T]

I'm still unsure of the functions of BACME. Does it serve to provide a benchmark of service for clinics with members part of it?

Such associations have no official role in relation to the NHS or to specific services, but rather serve as a voluntary specialist group for clinicians working in a particular field. They tend to be aimed at information sharing, networking and perhaps training or even creating voluntary standards. Participating in such groups may however be part of the job descriptions for clinical specialists, though it is often written as a general principle of participating in regional or national clinical special interest groups rather than naming individual organisations.

The group I used to be involved with in relation to alternative and augmentative communication enables individuals working single handed to establish informal links with the large established specialist services, to provide a channel of communication to specialist government advisors, etc, to share information on perceived good practice, to communicate about ongoing research projects, to interact with equipment suppliers, hold conferences, etc.

Often such groups depend on the enthusiasm or interests of its current active membership, and so can change significantly over time.

 

[Midnattsol]

Tronstad has also written on the new guideline (or, a bit more about what might be going on in pwME cells with the guideline as a backdrop):

Hva er årsaken til at trening gjør ME-pasienter sykere?
What is the reason why exercise makes ME patients sicker?

On GET:
"The goal of the GET method is for the ME patient to train for improvement by means of an escalation plan with gradually increasing training doses. This may at first glance look good, but the problem is that the GET method was established with a basic idea that the disease is due to reversible physiological changes as a result of lack of physical activity.

The US and British health authorities have thus found that this understanding of the disease is incompatible with recent research that points to chronic disease mechanisms."

Pure and simple

 

[adambeyoncelowe]

That’s great to hear, but then it's disturbing to see NHS commissioned clinics overtly flouting the rules. Some websites may still require updating, but they've had long enough to prepare.

They probably thought they'd win in the end. But it's clinically risky for them to keep this out of date info on their websites, because it makes it easier for us to argue they aren't fit for purpose.

I think it will help us identify the intractable positions, so we can better engage with them (or the people above them who hold the purse strings) to get better services.

The referral criteria I've seen also seems more stringent. All other possibilities, including psychiatric disorders, need to be first ruled out. That could be a good or bad thing, as it may help more symptoms being addressed. Still, I also hope it doesn't result in lots of PWME receiving a psychiatric evaluation, as there tends to be a lot of overlapping symptoms with conditions such as BDS/BDD.

Evidence suggests about 40% of those referred to ME clinics don't have ME, so it is important that differential diagnosis is made. But you can get a referral earlier on (though there will still be a wait for any appointment).

There's always the risk malicious doctors will misdiagnose people. That's not unique to ME. But we have to write the guidelines assuming some degree of good faith.

Stakeholders were also very keen that we have a list of tests and exclusions. Even patient groups asked for this, so it wasn't just the clinics.

I think it would be untenable to argue that people shouldn't have a mental health assessment if they need it. The GL does suggest that testing and referral should be based on clinical history and presentation.

You wouldn't send someone for a test for which there are no indications that it's relevant. Especially not on the NHS, where there are pressures to keep costs down.

 

[Barry]

Evidence suggests about 40% of those referred to ME clinics don't have ME, so it is important that differential diagnosis is made. But you can get a referral earlier on (though there will still be a wait for any appointment).

Are you saying that that 40% still remain diagnosed with ME/CFS? Or that the clinics then recognise this and rediagnose?

 

[adambeyoncelowe]

Are you saying that that 40% still remain diagnosed with ME/CFS? Or that the clinics then recognise this and rediagnose?

I think we've asked that very question on here before, and it wasn't clear. But I think they meant people referred to the clinic who ended up with an alternative diagnosis.