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

The NICE Guidelines appear superficially reasonable but because they fail to mention either the seriousness of too much exertion and fail to offer any guidance on how to determine whether or not a person needs to rest more or has the physical functional capacity to be more active and or tolerate exposure to more exertional triggers they fail the ME/CFS community. The sad thing is that the research of Workwell et al has not been validated and extended. People are rightly concerned about harm caused by 2 day CPET tests. However, the key to improving health is not the 2 day CPET test, rather it is staying under anaerobic threshold and resting hard within 10% of morning resting heart rate. These 2 things are enabling people to improve. Limited research has been done regarding the limits of energy metabolism but Workwell et al have found an abnormally low anaerobic threshold and worldwide patients are observed to exceed their anaerobic threshold frequently. Athletes need to push themselves to reach the limits of their energy metabolism. However, people with ME/CFS reach and exceed these limits on a daily basis. All people with ME/CFS really need is for standard exercise physiological measures to be applied to them e.g. exercise/carry out daily activities at what is regarded as low intensity exercise e.g. 30% age predicted maximum..... Seriously - how many people with ME/CFS can get their HR's that low. Our problem appears to be that exercise physiology has NOT been applied to people with ME/CFS. Instead of experts in physiology looking at our heart rate abnormalities we have had mental health people tell us we are physically healthy and/or heart rate abnormalites are due to anxiety.
 
Jonathan Edwards said:
I do not know of any scientific studies that show a specific form of exercise causes harm in ME patients. Are there?

Do we know CBT based on stress is useful - as far as I know we know nothing about the benefits of CBT.
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Mark Van Ness has a paper showing symptom exacerbation after the CPET test. This paper may help: Neural consequences of post-exertion malaise in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Dane B. Cooka,b,⇑, Alan R. Lightc, Kathleen C. Lightc, Gordon Broderickd, Morgan R. Shieldsb, Ryan J. Doughertyb, Jacob D. Meyerb, Stephanie VanRiperb, Aaron J. Stegnerb, Laura D. Ellingsone, Suzanne D. Vernonf
 
Jonathan Edwards said:
I do not know of any scientific studies that show a specific form of exercise causes harm in ME patients. Are there?

Do we know CBT based on stress is useful - as far as I know we know nothing about the benefits of CBT.
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From memory the USA Agency for Healthcare Quality - quotes some CBT studies as being mildly beneficial. They also make the point that ME/CFS has not been studied.
 
Our big problem is the lack of appropriate research. Most of the studies appear to still being designed by researchers with a bias and not ones that are listening and believing patients e.g. Fred Friedberg of StoneyBrook University using HRV and heart rate monitoring in a study but NOT in the way that patients are using these tools to great effect. One aspect of NICE that would be a shame to lose is the reference to HR monitoring and the implied implication that people should exercise under 50% of their max predicted HR until they can do 30 min of exercise a day. (Impossible for most people with ME/CFS to keep their HR this low whilst carrying our ADLS).
 
Jonathan Edwards said:
However, I sense an attitude even amongst physicians and paediatricians that if CBT and GET are not available they will have nothing to offer. A lot of doctors find that uncomfortable. They should not but they do. So there will be a tendency for CBT and GET to remain in the guidelines even if watered down. That will depend to a degree on who is on the committee. That needs some thought. Applications are being taken in June and July.
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I agree with others on this thread that this is a huge issue.

It's so easy for 'The evidence for GET is weak' to become 'There's evidence for GET, although it's weak'.

And NICE may be embarrassed to say CBT/GET don't work after all the harm they'll have done by promoting it all these years, let alone the issue of doctors' natural discomfort in not being able to help patients by offering something.

There's already a petition to avoid the NICE committee being stuffed with CBT/GET proponents.

Very seriously, do we also need a 'Tell us honestly there's nothing?' campaign?
 
Alice said:
Our problem appears to be that exercise physiology has NOT been applied to people with ME/CFS.
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So we have no reliable evidence and NICE have no reason to be interested.

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.
 
Alice said:
rather it is staying under anaerobic threshold and resting hard within 10% of morning resting heart rate. These 2 things are enabling people to improve.
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I have not seen that claim before. Is there research on the 10% of morning resting heart rate. I would not be able to get out of bed if I had to stay that low.

Sadly, none of the useful stuff on HR monitoring can be insisted on by patients without the danger of the GET brigade insisting on their approach too. Neither has sufficient evidence, so neither can be included.

Perhaps we should ask for a guideline that simply says that there is no robust scientific evidence that any particular management strategy leads to improvement.

I would like to see NICE go further and say that patient surveys suggest that pacing using activity diaries and/or HR monitoring is helpful in preventing worsening. But...
 
Jonathan Edwards said:
My thoughts about the NICE stakeholder meeting:

NICE are very clear that the great majority of patients believe that CBT and GET are worse than useless. They realise that a committee must not be made up entirely of psychiatrists. However, when the committee comes to look at the evidence the only evidence for treatments working they will find will be on CBT and GET.
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This is why the work that David Tuller, Keith Geraghty and others are doing, in demonstrating the flaws in the supposed evidence base in favour of recommending CBT & GET is vitally important.

There would be no argument with recommending these treatments if they were well-evidenced, but they clearly aren't.

The whole evidence base for behavioural interventions in ME /cfs stinks. So many of the papers published in this field have been shown to be unreliable, that until every one has been reanalysed and properly reviewed, non of them can realistically be trusted.

What seems certain to me, is that after the debunking of PACE, there is no reliable evidence remaining to support GET remaining as a recommended treatment in the new guideline.

Given his lamentable response to Invest in ME, Prof. Mark Baker seems to think otherwise, but it seems to me that the remaining evidence that he (and NICE) are relying on, has yet to be subjected to the same close scrutiny that has been applied to PACE.
Whilst I'm not too familiar with Tom Kindlon's work in this area, I believe that he has collated evidence of harm resulting from GET. More of this kind of evidence is needed - preferably published in a peer reviewed journal.

With regards to the use of CBT, there needs to be a clear distinction made between the kind of coercive brain-washing which has wrongly been labelled as CBT by the PACE crowd (and used to force ME patients comply with a GET regime), as opposed to the conventional kind of supportive talking therapy which the term CBT is generally understood to mean.

Nobody argues with use of the conventional kind of CBT as a supportive therapy for patients suffering with other serious illnesses.

If its delivery can be reliably cleansed of the impurities which the PACE crowd have contaminated it with (as far as it applies to M.E / cfs) and its relative ineffectiveness is properly acknowledged, then I wouldn't quibble with CBT remaining as an adjunct treatment recommendation in the new guideline.
 
Jonathan Edwards said:
My thoughts about the NICE stakeholder meeting:

@Keela Too has admirably summarised the format of the meeting and the main proposals I suspect put across on all six discussion tables.

My only personal quibble would be that I think ME/CFS or CFS/ME are sensible terms to retain, partly because I see ME on its own as likely to alienate even more potentially unsympathetic doctors. I don't think 'ME and CFS' is helpful because that either suggests that there are 'two diseases' which there are not, or that the guidelines are intended to include 'not ME' i.e. 'chronic fatigue' which is actually not what is wanted. Moreover, it is not a matter for NICE what doctors call illnesses, so any request to NICE for a change will be by definition window dressing, and I worry that obscures the important issues.

I agree that perhaps the key general point, which we also touched on, was that the guidelines should not imply that professionals should 'know what is needed' and present patients with certainties but rather be open about the fact that nobody is sure what the best thing to do is.

What intrigued me most was the elephant in the room - the reason why we were there at all, which was not mentioned once by the speakers from the floor and I suspect hardly at all even in the groups - the need to remove recommendations for CBT and GET. It nevertheless became clear that the NICE staff were absolutely clear that this was why we were there and that they had taken on board that this was not an issue for a few minority activists but essentially for all patients. At our table the facilitator said 'I presume everyone here is agreed on that' - despite the fact that a paediatrician and an occupational therapist were present who I suspect may not have realised this was why we were there and for whom these remained standard practice.

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!

I presume that knowing the guest list the organisers decided to make it impossible for any open debate to arise between stakeholders, on the assumption that it would lead to acrimony. Any reference to any sort of dissatisfaction with specific treatments was studiously ignored by floor speakers. That seemed disappointing. However I think the two outcomes one might have hoped for in this respect were both fulfilled. NICE heard a uniform opinion from all patient related groups that CBT and GET were not wanted. Moreover, whether in the pub or at the meeting patient advocates had a good opportunity to compare notes and get a sense of solidarity.

On the down side I think we may have spent too much time, at least at our table, asking for things that people should not expect NICE to help with. I think a lot of time was taken up with asking for a beefed up service. I am sure there should be a beefed up service - indeed just a service would be a start. But I do not think that is what NICE is about. Their job is to give guidance on what a service should provide if there is one. The real problem is probably with NHS England or Mr Hunt not finding funds. I personally think the old guidelines are actually pretty reasonable on most issues although there could be a greater sense of urgency.

Time was also taken up with suggestions based on doubtful 'science'. There was a request for doctors to be able to be more flexible in using treatments that might benefit individuals even if there was no firm evidence from trials. That seems to me the sort of thing not to ask for because it immediately allows the BPS side to argue the same. There is no good reason to think that antivirals and such like really do any good to anybody and it is going to be so easy for a committee to dismiss patient requests if they are seen as inconsistent. There was also a suggestion that there is scientific evidence for GET being bad for patients but the reality is that there is none. We simply have the experience of patients to go on. In normal healthy people certain types of exercise, like repeatedly stepping down on a treadmill, cause damage to muscle over a period of days. However, there is no reason to think this is bad in the long term and if you do a sport that requires such actions you need to work through the damage phase. So 2 day CPET results are interesting but they do not provide a reason not to use GET.

All in all it seems to me that something important has been achieved but there is still more work to do. NICE are very clear that the great majority of patients believe that CBT and GET are worse than useless. They realise that a committee must not be made up entirely of psychiatrists. However, when the committee comes to look at the evidence the only evidence for treatments working they will find will be on CBT and GET. It is going to be hard for them to not at least mention that there is supposed to be some evidence. Hopefully that will not be followed by a recommendation. However, I sense an attitude even amongst physicians and paediatricians that if CBT and GET are not available they will have nothing to offer. A lot of doctors find that uncomfortable. They should not but they do. So there will be a tendency for CBT and GET to remain in the guidelines even if watered down. That will depend to a degree on who is on the committee. That needs some thought. Applications are being taken in June and July.
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Jonathan Edwards, you say, 'There was also a suggestion that there is scientific evidence for GET being bad for patients but the reality is that there is none. We simply have the experience of patients to go on. '

Given that patients' reports of their experience of GET are not generally believed, what biomedical evidence do you think would satisfy the profession of a causal relationship of harm from GET? (eg, the equivalent of h. pylori) We find that even physical evidence of abnormalities following exercise is often interpreted to satisfy the bps concepts.
 
arewenearlythereyet said:
I think the new guideline should have some emphasis in it to encourage GPs to monitor ME symptoms and act upon any changes to retest for other conditions that may develop. My biggest fear is that they will miss something like cancer or heart disease because it's being masked by the regular shitty symptoms. I'm sure hypothyroidism, PA and a whole load of other conditions are going untreated unnecessarily as well for a whole load of ME patients for the same reason.
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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, especially since some risks are likely elevated due to either ME or general chronic illness: vitamin D deficiency, diabetes, cancer, etc.

Simone said:
My sense is the opposite, that many pwME/CFS have POTS (diagnosed or undiagnosed).
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Jonathan Edwards said:
y 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.
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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 :rolleyes:

Jonathan Edwards said:
I do not know of any scientific studies that show a specific form of exercise causes harm in ME patients. Are there?
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I'm not sure there's a smoking gun, but there is a large amount of compelling circumstantial evidence. If using legal thresholds, the evidence of exercise being more harmful than helpful is certainly "more likely than not", and I think it's even "beyond a reasonable doubt." It's not 100% proven, but then again I'd argue that nothing is, neither in the legal world nor in the medical world.
 
I think Jonathan Edwards is right here to focus on what we do not know. To demonstrate the harm of GET beyond patient reports would require carefully put together long term data. I also think some of the harm is psychological and not objectively measurable.

According to Geraghty's data, the most promising symptom management program is Pacing with aspects of CBT, which of course, with research and development can score even higher. Whether that's strong enough data to push for Pacing I'm not qualified to determine. But it definitely has patient approval.

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.
 
Valentijn said:
If using legal thresholds, the evidence of exercise being more harmful than helpful is certainly "more likely than not", and I think it's even "beyond a reasonable doubt." It's not 100% proven, but then again I'd argue that nothing is, neither in the legal world nor in the medical world.
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Yep
 
Alice said:
Mark Van Ness has a paper showing symptom exacerbation after the CPET test. This paper may help: Neural consequences of post-exertion malaise in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Dane B. Cooka,b,⇑, Alan R. Lightc, Kathleen C. Lightc, Gordon Broderickd, Morgan R. Shieldsb, Ryan J. Doughertyb, Jacob D. Meyerb, Stephanie VanRiperb, Aaron J. Stegnerb, Laura D. Ellingsone, Suzanne D. Vernonf
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Here it is: http://www.sciencedirect.com/science/article/pii/S088915911730051X?via=ihub
 
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