Study evaluating NICE, Oxford, and Fukuda prevalence

Not really, I prefer that the diagnosis of ME/CFS is made by a specialist centre or expert clinicians, not by GP's. But they are the ones following up on ME/CFS patients, so they need to know what PEM is and that fatigue in ME/CFS is not just sleepiness and tiredness etc.

I mainly want the NICE guideline to provide some basic info about ME/CFS, especially PEM, as is relevant in the management and care of patients with ME/CFS.
This has to be no more than a few lines.

Next to a warning about graded activity programs, I think this is the most relevant information for the management of ME/CFS. Don't know what else should be in the guideline that is more important.

 

I agree that a bit more on PEM would not go amiss. Maybe the committee, including @adambeyoncelowe and @Keela Too could consider this.

But I still think you are asking for something that belongs in basic GP educational packages, not the index of recommended management options that is the NICE guidelines.

I also still have reservations about the idea that this relevant to management and care. It would seem to be but I am not sure. The assumption seems to be that PEM is a good predictor of possible long term harm from GET. We don't know that. It may be that early on in the illness a number of people with ME do not appreciate that they have PEM, but they may be just as susceptible to any long term harms.

This does not seem to me implausible. We have heard lots of stories of PWME engaging enthusiastically in GET early on, presumably initially being buoyed up by adrenaline and unaware of any adverse reactions. They then describe a crash later.

Moreover, in other diseases, like rheumatoid arthritis, pain and stiffness after activity in the short term is not correlated with harm in the long term. In the long term exercise is helpful, despite aggravating symptoms soon after.

The relevance of this is that we do not want GPs to ask patients if they have PEM and if they say no for the GP to say 'Oh that's OK then, you will do fine with GET.' In other words we do not know that recognising GET, in the real world of a busy GP surgery, is going to be 'relevant to management and care'.

Moreover, if GET remains an approved option for all those other people who can get bundled under 'medically unexplained symptoms' then a rapid backslide to the status quo would seem inevitable.

For me the priority is to focus entirely on what we have reliable evidence for. I think we have reliable evidence for a high probability that GET causes long term harm, even if I don't understand why. We have no reliable evidence for GET being effective in any situation. So GET should not be recommended. Any attempt to tease out who should or should not have GET just muddies the waters.

 

Thanks. I've been monitoring this discussion and will continue to do so. PEM is definitely on the list.

 

I think that in the patient community strict diagnostic criteria are seen as solution to various problems.

As solution to so much resources going into CBT/GET and as counter to its illness model. The thinking here is that CBT/GET helps some but not those with proper ME. I think it's more correct to say that it helps nobody, or at least that there is no good reason to believe they help.

As solution to disbelief over the severity of the illess. Strict criteria are a way of saying "look how sick we are". We have diagnostic criteria that apparently attempt to be educational material.

As solution to lack of medical care. The thinking here appears to be that effective treatments exist but are being witheld. I think this idea is a major mistake the patient community tends to make. It is understandable and right that patients feel like not enough is being done to help, but nobody knows what really works and treatments such as IVIG, antivirals, antibiotics etc can cause harm. There is no treatment, stop asking for one.

As solution to lack of scientific progress. The idea is that if only the right diagnostic criteria are used, progress would soon be made, and that bad diagnostic criteria never produce useful results. While there is some truth to this, there are also many problems with this idea. There is no objective abnormality that we can point to that could confirm the superiority of any diagnostic criteria over others. It also doesn't take long to find studies that used bad criteria yet produced useful results. The first 2-day CPET study used the Fukuda criteria for example. There are many plausible reasons for a lack of progress that are discussed much less.

 

I agree with Jonathan's point- GPs should know this is a hallmark feature/symptoms.
That's why we emphasised it in our stuff for GP education.

 

I’m here too & reading & taking note.
@saranbonser is also on S4ME

 

That's why we emphasised it in our stuff for GP education.

 

One thing I just noticed about your very helpful info sheet: the man overlaps the text on the right. Is there any way to fix that?

 

On my computer it is fine.

 

Is that from Hummingbird?
I would not recommend using that for NICE or maybe not even for GP awareness. Some of the things on there are not documented features of ME as far as I know. I don't like the term neuroimmune exhaustion because it has no immunological basis and may give an unrealistic idea of what is known about the illness.

 

Can you read the right-hand text in detail? It looks like the first few letters of some of the words are chopped off.

The man has been cut out and placed onto the sheet, so there's a white box around him that directly obscures the text. Since it's an image, I can't see that it would show up differently on different devices (maybe if it were a PDF it would) but I may be wrong.

 

I take the point but it was generated elsewhere and I did not want to rewrite or alter text without consent.
I like the basic concept but maybe we should use it as a model and write our own?

Use PEM for a start.
I have not sent it to NICE.
Happy to do a rejig and re draft which we/you could knock into shape?

 

Yes, we could have a go at that.

 

You are right

 

would be good to have symptoms, that cant be explained (away) by too much resting / being sedentary.

 

Very interesting discussion. I'm sorry I missed it. I wanted to add a few points...

To @Jonathan Edwards' point, I agree that if a doctor is faced with a seriously fatigued person, then ME/CFS should be part of the differential diagnosis just as any other condition that causes chronic fatigue should be.

But unless I am misunderstanding, there seems to be a suggestion that the ME/CFS guidelines should explicitly cover both ME/CFS with its hallmark PEM and other forms of chronic fatigue. That's different than saying chronic fatigue should be included in the differential diagnosis of ME/CFS since NICE guidelines do also discuss treatment approaches. IMO, we certainly know enough to know from literature and patient reports to say there's an impairment in energy metabolism, that ME/CFS patients have been harmed when pushed to overexert (whether GET or other forms of overexertion) and that guidelines should recommend pacing as that can help patients minimize PEM and potential long-term worsening.

But there are potentially many other causes of chronic fatigue and without further investigation, its hard to know what would be appropriate for those conditions. I agree that PACE-style CBT and GET should not be recommended for any condition. I also agree that people with other CF conditions also need to be cared for. But lumping them all together under one diagnosis and treatment guideline - or as one cohort in a research study - does not help, especially since such a CF bucket is inevitably a wastebin of medically unexplained chronic fatigue - what AnnaMarie Jutel referred to as a diagnosis of the undiagnosable. And using the ME/CFS guideline to be the single guideline to cover both inevitably harms people with ME/CFS

Beyond treatment, some tests might help with the diagnosis if ME/CFS is suspected but not be needed for other forms of CF. For instance, tilt table or related tests (standing or NASA Lean) to demonstrate the orthostatic intolerance which we know has a higher prevalence in ME/CFS. NICE currently recommends against tilt table as a routine test and appears to underrecognize OI in its list of symptoms. I'd think that NICE guidance for ME/CFS should include both OI diagnostic considerations and pharmacological and non-pharmacological treatment but these might not be appropriate for other conditions that cause CF.

I agree with you that PEM is not easy to get and it unfortunately ends up being shorthanded as fatigue. But IMO, the medical community's failure to "get" PEM makes it difficult for them to understand how to diagnose and treat ME/CFS or differentiate from other conditions with CF. To me, the first step is the clear definition that @Michiel Tack discussed above. But then it's also about teaching doctors the questions to ask during the medical history. For starters, the IOM produced a brief Clinician's Guide that provides some good questions to ask - see page 11-12. It also has some good questions about functional impairment and how that relates to pre-illness level of functioning. I know that CDC has also done some additional work in this area but its not published yet.

The USA bodies have definitely not stated that the non-ME CF patients should get CBT and GET. The 2016 Agency for Healthcare Research and Quality Addendum only examined the extent to which the efficacy of CBT and GET relied on Oxford studies. They were also asked to reevaluate the quality of PACE because of study conduct issues, bias, conflicts of interest, etc. but unfortunately, declined to do that. CDC has not made any statement about why CBT and GET were removed from its site, as noted in Dave Tuller's recent article and we need them to do so. IMO, getting Cochrane and other reviews to reevaluate the conduct of these studies will be pivotal in getting official recognition that PACE style CBT and GET are ineffective and poor quality.

 

A lot of good points and a lot of common ground @Medfeb.

My comment about USA bodies was intended to be a bit of a barb I guess, but I think it is fair until proved otherwise - which I think is what David has also implied.

If CBT and GET were considered unsuitable for ME/CFS purely because of the Oxford recruitment then that is tantamount to saying that they are still regarded as suitable for 'Oxford fatigue', because no other shortcoming of PACE has, as far as I know, been raised.

These bodies had no right to decline to evaluate the quality of PACE in other ways.
And why have they made no comment about the reason for removal and why does Dr Unger mutter something about people not understanding what they meant?

We have had some discussions about different styles of dealing with rotten apples across the Atlantic. I agree that the UK establishment has a peculiar method of coverings tracks that leaves very bad taste in the mouth. On the other hand I worry that the authorities in the USA may be playing a different but equally evasive game. It is easier to rub out CBT and GET in the US health care system I think because the reason for their persistence in the UK relates to a weird distortion of commercial/socialised system dynamics where these modalities are being used to exploit what is now a strange hybrid.

On the other hand I worry that the removal of CBT and GET from recommendations in the USA actually means very little in terms of movement of views of the medical establishment. I guess I worry that the advocates have been fobbed off.

If representatives of any establishment body have really queried the quality of the science as a whole maybe they are from Cochrane. Hilda Bastian has been clear, although she was speaking as an individual. David Tovey made a pretty clear statement and then seemed to row back a bit. I think it is going to be very interesting to see what the month of May brings - with the deadline for rewriting the exercise review and Tovey's departure. I wonder which is due to come first?

Unfortunately, I suspect that Cochrane will not bite the bullet on this properly. And with all the recent scandal I am not sure Cochrane carries weight any more. Whichever outcome, the decision might be seen as 'political'.

I think we need medical academics to stand up and be counted and say it as it is. The completion of the Kindlon/Wilshire dialogue has done a lot to make it very plain what 'as it is' is. Crucially we need disinterested academics with no connection to ME/CFS to do this. Brian Hughes is one. We need more on both sides of the Atlantic, the Pacific and wherever else.

 

CDC has not given any reason for disappearing the terms - only AHRQ did and then only because of Oxford. But that's not tantamount to saying that CBT and GET are suitable for chronic fatigue. GET is not recommended for any other disease here and the ME/CFS recommendations on the CDC website are specific to ME/CFS and not meant for other causes of chronic fatigue.

Just to be clear - AHRQ had conducted their initial evidence review in 2014 where they found CBT and GET were effective and PACE a good trial. The community asked them to do a reanalysis that evaluated the quality of PACE and also the evidence of effectiveness after excluding Oxford. AHRQ only agreed to do the second on Oxford which is what led to the 2016 addendum. AHRQ was clear about downgrading their recommendations based just on excluding Oxford. And honestly, that's been helpful in conjunction with the IOM report to get CBT and GET recommendations reevaluated. I totally appreciate this is not the entire issue and that PACE conduct is a huge concern. But nonetheless this finding on Oxford driving conclusions about CBT/GET has helped open up the dialog as noted further below.

Regarding CDC, I wish I could but I cant answer that question. I also want to see an explanation for the disappearance of CBT and GET and I want that explanation to include not only bad study conduct and risk of harm, but also inclusion of patients with other conditions and the claims being based on a bogus disease theory that was never supported and does not fit the evidence. But even once GET is dropped, I want to see much more careful recommendations for other forms of "exercise" because at least here, we have to deal with an "exercise is good for everybody" mantra that can leave patients at risk of harm even if its not GET.

The removal of CBT and GET recommendations by CDC and the statement from last year's Clinician Summit have actually led to removal of these recommendations in other medical education sources and that's a start. But you are right that changing the medical establishment views is more challenging. As you correctly note, the issues we face are more complicated than simply removing recommendations for CBT and GET.

One challenge is the attitudes of medical doctors toward this disease, an attitude that's been fostered by 2-3 decades of the biopsychosocial view being hoisted onto this disease. The IOM said that the biggest barrier to getting patients the care they need is not lack of medical knowledge but the negative attitudes of providers and I agree with that.

Another is the medical community reliance on evidence-based guidance and the challenges that creates when the evidence for this disease is polluted by the things we all know - bad study conduct, unreported harms, conflicts of interest, bad disease theories, small study sizes, the conflation of a bunch of definitions, some overly broad, as though they are interchangeable, etc

Another is that the terms CBT and GET are sometimes/too often used to mean something different - perhaps that's a bigger challenge here than in the UK. For instance, CBT is sometimes used to mean helping patients cope with a chronic disease and GET to mean slow increases in activity for ME patients to the extent that a given patient is able to tolerate activity and always done in a way that never results in PEM. Both of those are very different than PACE style CBT and GET but the difference is muddied if the terms are used interchangeably by providers. For this disease, the terms have been branded in a certain way and we need to tease apart the different meanings and push to not allow them to be sometimes used to mean something different.

Then as above, we are also having to deal with the "exercise is good for everybody" mantra in a medical community that doesnt get PEM and the systemic intolerance to exertion that is characteristic of ME. IMO, even once "GET" has disappeared, we are going to have to teach the medical community about what PEM is and its implications in both diagnosis and management

I'm sure there are others but you get the idea.

Bastian was brilliant as is Hughes and the Kindlon/Wilshire work is critical. But we really need Cochrane or a body like that to step up. However, I suspect you are correct about them and that's very disturbing because the evidence is so clear. I also agree that we need disinterested academics to stand up and call this out. But that alone is going to take forever to eventually influence the medical community's attitudes and in the meantime, patients are being harmed, whether by GET or some other misguided recommendations "to go out and get a gym membership." In the meantime, we are just doing what we can, using every current tool at our disposal, to push out the best available guidance

Edited to add the obvious - While to my knowledge, CDC does not have recommendations specific to chronic fatigue, CF and CFS are also treated interchangeably in common use, the medical community, and even by some ME experts. Another challenge to tease apart

 

Does that mean that, in your view, the explanation of the CDC for removing the recommendation for GET and CBT (confusion about what the terms mean) makes sense?

 

CDC's statement is completely inadequate, especially since their previous recommendations for CBT and GET were explicitly supported with PACE and other studies as references and used language that could have reinforced the biopsychosocial view of the disease.

For instance, CDC had a CME in 2012 called “Diagnosis and Management of Chronic Fatigue Syndrome” which used the references listed in the attachment. That stated that "the goal of CBT is to help the patient understand their illness and to change perceptions, beliefs, and behaviors that can contribute to the impact of the symptoms. It also said that CBT "is associated with significant improvement and possible full recovery from some symptoms of the syndrome. Acceptance of both the illness and particular modes of therapy positively impacted the outcome." The reference for that last statement was the Deale study.

This CME expired in 2016, about one year before CDC's website was updated. CDC's website itself did not list references but the CDC Toolkit which as online til the website was updated referenced material from St. Barts which was BPS in nature.

So CDC was clearly using BPS studies to frame treatment recommendations. At the same time, this CME also talked about PEM and exercise intolerance as key symptoms and the use of pacing so what CDC was saying was a muddle to begin with that left it open to all kinds of different interpretations. Given the medical confusion, the CDC's position and their influence in the medical community, they need to be explicit about the problems with the original recommendations, the issues with the supporting studies, and the fact that the premise behind the BPS studies to begin with is completely wrong. And we also need our experts to be clear on all of these