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

Yes I fully agree with this.

Severity levels are a broad brush description, but necessary. For many people and groups it is important to appreciate the full range of disability levels that ME/CFS can incur. They are only going to listen and digest if it is kept simple for them - a full run-down of individual symptoms' severity means they will rapidly turn off and we lose their interest. We must never allow ourselves, especially here in S4ME, to become locked into a bubble, and lose sight of the bigger picture.

 

https://twitter.com/user/status/1329684781450338304

 

Common co-morbidities have mostly been left off. Hell, primary morbidities like neurological symptoms have been left off. Because there hasn't been enough research, itself because they are always left off. So cases with primarily neurological symptoms will likely be missed out entirely. In a neurological disease. Ugh.

NICE can only work with existing evidence. If it hasn't been researched they can't use it, even if it hasn't been searched because organizations like NICE screwed up in the past. A very finely tuned chicken-and-egg machine...

 

That can be argued based on the recognition that we have been maligned and mistreated, as the guidance recognizes. People did that. ME patients were not gaslighted, insulted and generally treated like dirt by objects or ideas. It was people. These people obviously should not be involved after having done harm that is now recognized by the guidance.

It will not be explicitly stated but it's a direct corollary of there having been harm in the first place, which people had to do willfully.

 

I don't know if it's been pointed out in the evidence the outcome of the FOI analysis of CFS clinics, that they report doing no monitoring of any kind. Surely moving forward it should be explicit that actual monitoring of the disease (that 250K figure is pretty old by now) and outcomes should be explicit and non-negotiable moving forward.

 

At the risk of taking this thread off-topic, I've been thinking about what may occur after the new guidelines are released, assuming of course that the committee doesn't buckle under the inevitable fusillade from the psychosomaticians.

Most CCGs will surely expect their currently commissioned services to adapt to the new guidelines; others, given that it is explicitly stated that neither CBT nor GET are curative, may see a cost-saving opportunity for retrenchment to a diagnostic-only service and expect GPs to provide all other ongoing management; others still may choose to completely reconfigure the services they commission.

There may be a small window of opportunity to exert some influence here, so, a (modest!) proposal: we should ask the various ME patients' organisations and charities to prepare to lobby both MPs and the CCGs directly, immediately upon release of the new guidelines, to ensure that services are (re-)commissioned that are congruent with the updated recommendations. I'm sure that a survey of patients, if conducted in advance, would show overwhelming approval for services based on genuinely supportive care with a strong research focus.

Additionally, some CCGs, including my own, do not commission any service at present; anyone requiring such a referral has to have their GP submit an IFR for out-of-area treatment. These CCGs, without existing vested interests, may be amenable to implementing a service along the lines we'd all like to see. Similarly, although I haven't been to an NHS CFS clinic for around a decade, it's clear that there are still a small number of those operating in the current CFS clinics that are not entirely happy with the current situation of effectively being forced to recommend CBT and GET to everyone whom they diagnose, and might welcome the opportunity to deviate from that approach.

Apologies if this has been mentioned in the other threads - I don't have the energy to read them all at the moment - but I'd also like to see it stated explicitly in the guideline that it is inappropriate to commission a generic PPS/MUS service for ME patients that is expected to adopt an identical approach to everything that is presently not well understood - fibromyalgia, chronic primary pain, tension-type headache, irritable bowel syndrome, etc, etc, and that not only is there no hard evidence base for these conditions being interrelated or for them to be combined together under the MUS rubric, but that, as ME patients, we have (often very acute) needs specific to our condition and far greater levels of disability that cannot be accommodated in clinics designed around such a uniform approach.

 

I've been wondering about that. Anyone got ideas on how that would be most appropriately phrased for NICE guidelines?

 

I think it is quite hard to expect NICE tone this specific about commissioning. AsI understand itNICE does not deal with service provision as such. It can advise on what sort of service provision is justified but probably not on logistics. I am not sure that I see a cast iron basis for having a separate service, even if it might be nicer. I ran a rheumatology service and saw everyone from people with one painful finger to those who needed full time care and had no usable joints to do as much as feed themselves. It worked fine. I gave the relevant amount of time to each.

It might be worth pointing out that there may be a serious drawback to having isolated ME clinics. They are very likely to be run by physicians who have been sidelined into running them and who actually have no interest in the condition - a very common situation now. It might be better if PWME were seen in general clinics so that a wide range of physicians could get experience with the condition, one or two of whom might be fired up to do some useful research.

Worse still, dedicated clinics are much more likely to be delegated in toto to therapists with little or no medical supervision-again I suspect a common situation now.

The situation for ME is in stark contrast to that for rheumatoid arthritis where huge progress has been made. The vast majority of patients with RA have always been seen in general rheumatology clinics.

 

I wasn't arguing for an entirely separate ME service, @Jonathan Edwards, but against the uniform approach of the PPS/MUS clinics in particular. I'd be entirely happy for ME patients to be seen in general clinics - I was originally diagnosed in a general clinic by an endocrinologist.

Also, with respect (and I do have a great deal of respect for your opinion) you didn't assume that your patients with RA and ankylosing spondylitis and the crystal arthropathies were simply exhibiting differing expressions of an common unifying cause, much less one that was all in their heads. That is the fundamental assumption at the heart of the PPS/MUS model: that all of the conditions categorised as such have a common psychosomatic origin and so can be managed in an identical manner.

The fundamental assumptions on which a PPS/MUS clinic is founded are antithetical to the provision of good care.

If you take a look at the NHS Cumbria PPS service guide - that is a good example of the specific type of clinic to which I'm objecting.

I agree that it would be very difficult to have NICE get this far down into the weeds, as it were, which is why I was suggesting lobbying MPs and the CCGs directly for better services upon the release of the final guidelines, and that it might help such efforts if we had survey evidence as to what the ME patient community as a whole would like to see.

Agreed. That is always a danger.

 

Agree. "Peronsalised" is one of those words that makes everything sound okay, but means absolutely nothing unless you explain exactly how you will decide what personal factors are relevant and how your approach will vary depending on them.

If the main factor is the individual's "preference" (either overall approach, or the size of exercise increments, or whatever), that's going to be easy to manipulate in the case of new, distressed and confused patients who still have confidence in the advice of their professionals.

If it is something else, then what?

"Personalised" has got to go.

 

It's not my impression that anybody here at S4ME is suggesting that?

My own argument for accepting recommendations/suggestions based on committee/patient experience (where no other evidence exists) for 'do no harm' situations was precisely to ensure those suggestions stay in the guidelines.

I fully expect the validity of patient experience as evidence to be challenged by others though. There'll be those who argue that patients (and allies) have discredited those beautiful GET/CBT/LP trials as very low quality evidence that one shouldn't base recommendations on. In their SMC reactions to the guidelines they've already signalled they'll be pursuing the 'evidence-based' angle (evidence-based in their view). So they'll argue that either anecdotal patient evidence should also be discounted as very low quality evidence or that their own 'evidence' should be rated higher, allowing for reentry of GET/CBT/LP. We need to be able to counter that argument.

As I see it, broadly speaking the guideline recommendations for management of ME can be divided into three categories: recommendations around overexertion (in a broad sense), symptom & comorbidity treatment, and the special case of the formerly recommended treatments now being advised against.

We have plenty enough evidence of harm following overexertion. Sure, much of it is based on patient surveys with selection bias, and on anecdotal patient reports, but there are so many of them that the threshold of 'reasonable suspicion of harm' was crossed long ago and we're now firmly into 'very probably harmful' territory (and it would be unethical to try to establish 'certain harm'). This patient experience is corroborated by studies showing our bodies do strange physiological things after exertion as well as by Jason's Energy Envelope study that shows pwME who manage to live withing their energy envelope do better over 3 or 5(?) years on fatigue scores than those who can't stay within their envelope. None of those pieces of evidence by themselves is a smoking gun telling us exactly what's going on but they're all pointing in the same direction: overexertion is harmful for us. The only 'evidence' to the contrary is claims by BPS study authors and clinics that they've never seen any harm yet. But since they never asked about harm in any meaningful way they can hardly claim to have studied the matter.

So the guidelines recommend against overexertion (in a broad sense) based on the above evidence. They then make a number of suggestions how this can be achieved, often based on common patient experience for lack of other evidence. These suggestions based on patient experience fit into the 'do no harm' box by providing optional tools to help patients avoid harm from overexerting in various ways. This includes suggestions like using heart rate monitors. The guidelines don't say every suggestion will suit every patient, or that patients using other strategies will come to great harm, and the guidelines certainly don't say every patient must wear a heart rate monitor or risk their benefits (as was pretty much the case with GET/CBT in the past).

Other suggestions/recommendations relate to symptom management and comorbidities such as nausea, depression and OI. These are not specific to ME and are recommended to be treated much as they would be in any other condition so the general evidence base for those symptoms and comorbidities applies - and falls outside the remit of this review except where the general recommendations conflict with the ME recommendation to avoid overexertion (exercise prescriptions for depression spring to mind). IIRC there's a recommendation based on patient experience to start medication at extra low doses but that falls under the do no harm label.

Finally there are GET, CBT & LP which require special attention because they've been the recommended and supposedly evidence-based treatments for so long and will take significant effort to uproot now. They also, unlike treatments for individual symptoms, claim to affect the course of ME itself. Clearly they fall foul of the do no harm principle and should be scrapped based on that basis alone. But, unlike many of the other suggestions where patient experience is the only thing we have for now, for this trio of treatments we additionally do have plenty of studies investigating them. And all those studies point in the same direction: the treatments don't work (assuming you look at the actual data, not at wishful interpretations).

It's possible some of the individual suggestions based on patient experience will eventually be shown to be ineffective, if anyone ever gets around to properly studying them, but for now they're the best we have. At least they're based on a premise there is some evidence for - that overexertion causes harm - and there are no reports of harm from people using them. So let's keep those suggestions in the guidelines.

Whereas the GET/CBT/LP type treatments have already been shown to not work and the postulated mechanisms of how they were supposed work have been debunked and there's no end of reports of harm from them. So let's get rid.

Edit: grammar

 

Trial By Error: The Science Media Centre and UK’s Coverage of New NICE Draft

https://www.virology.ws/2020/11/20/...ia-centre-and-uks-coverage-of-new-nice-draft/

 

Thorough article on a Norwegian news site about research about NICE's guideline draft. It's written by journalist Ingrid Spilde, who's written several articles about ME, research into ME and the PACE trial.

Forskning.no - Store endringer i anbefalinger for behandling av ME i Storbritannia
google translation: Major changes in recommendations for the treatment of ME in the UK

In the recommendations on treatment, the working group begins by stating that there is no treatment or cure for ME.

The guidelines recommend that healthcare professionals help patients regulate their activity so that they avoid worsening of symptoms.

The working group is aware that exercise should not be used as treatment:

- Do not offer people with ME any form of therapy based on physical activity or exercise as a treatment or cure for ME, they write.

This includes graded training, as well as therapies that stem from osteopathy, coaching or so-called neurolinguistic programming, such as the Lightning Process.

 

exactly this; TC has said as much fairly recently although not using MUS:
"
The term 'somatic symptom disorder' which is very controversial but I really like it.
I like it because the same model can be applied irrespective of the cause of the
symptom"
https://www.s4me.info/threads/cogni...20-goldstein-chalder.15251/page-4#post-273720

I know Keith Geraghty and others have written papers on the 'problems' with the whole MUS model but a clear, no holds barred (such as @Jonathan Edwards submission to NICE) piece would be very useful.

 

NICE and the RCP are in breach of Government Guidelines on Consultation"The Compact" see below, I would suggest!

Regarding Consultations,
I have dealt with this conundrum before, including when NICE issued their edict in 2017 and I made a formal complaint.

So suggest, we challenge the current process arrangement and demand more time!

Suggest all stakeholders put in a complaint.

“Where it is appropriate, and enables meaningful engagement, conduct 12-week formal written consultations, with clear explanations and rationale for shorter time-frames or a more informal approach.” The Compact (Cabinet Office 2010) para 2.4)

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/100807/file47158.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/255180/Consultation-Principles-Oct-2013.pdf

'Time frames for consultation should be proportionate and realistic to allow stakeholders sufficient time to provide a considered response and where the consultation spans all or part of a holiday period2policy makers should consider what if any impact there may be and take appropriate mitigating action.The amount of time required will depend on the nature and impact of the proposal (for example, the diversity of interested parties or the complexity of the issue, or even external events), and might typically vary between two and 12 weeks.The timing and length of a consultation should be decided on a case-by-case basis; there is no set formula for establishing the right length. In some cases there will be no requirement for consultation, depending on the issue and whether interested groups have already been engaged in the policy making process.For a new and contentious policy,12 weeks or more may still be appropriate. When deciding on the timescale for a given consultation the capacity of the groups being consulted to respond should be taken into consideration.
However, longer and more detailed consultation will be needed in situations where smaller, more vulnerable organisations such as small charities could be affected. The principles of the Compact between government and the voluntary and community sector must continue to be respected 1


1. Where it is appropriate, and enables meaningful engagement, conduct 12-week formal written consultations, with clear explanations and rationale for shorter time-frames or a more informal approach.” The Compact (Cabinet Office 2010) para 2.4)

 

FRom 2017, jane.gizber@nice.org.uk

Communications Director @ National Institute for Health and Care Excellence (NICE)

surveillance@nice.org.uk

To Surveillance Team,

Today as a registered stakeholder for NICE, in good faith, I have composed and prepared my response to your consultation.

Plus Disability Discrimination Act- Suitable arrangements needing to be made......

 

The Science Bit by Brian Hughes - No More Mr NICE Guy...

NICE’s verdict on psychosocial treatments for ME amounts to nothing less than an utter repudiation. That it comes from an authoritative agency and is based on a thorough empirical review is extremely significant.

This is not just a turning point for people with ME, CFS, and related conditions — it is a high-profile exposure of exactly how, for years, entire subfields of the psychological sciences have been willing to overlook, if not embrace, shoddy standards.

In all respects, this public shaming is long overdue.

It is richly deserved.

ETA: This article was a feast to read!

Discussion of this article has been moved to a new thread:
"No More Mr NICE Guy…" by Prof. Brian Hughes