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

PW:
“It is also remarkable that the committee use the symptom of post-exertional fatigue as a reason for not providing GET"

surely they (NICE) used PEM ie post exertional malaise not fatigue?

again nervous about the use of 'cause'; echos of the BACME statement.

Does this also extend to the CBT that 'encourages' patients to incrementally increase activity?
'pacing-up'?

eta:
from DTs blog

hopefully the penny will finally drop for journalists.
Time to retract the PACE trial.

 

In many ways I see us coming back to the discussions I had with a number of people now here about damage limitation for ME services. There is a strong argument for disbanding all the multidisciplinary teams providing management with no evidence base but then there would be little chance of rebuilding a service or getting any blood samples for research.

As indicated in my witness statement I do see an argument for continuing to have teams with nurse specialists and occupational therapists, and yes for children physiotherapists to help with things like preventing achilles tendon contractors in severe cases. Amongst these people there will be sensible folk who have seen does of people with ME and come to understand how to provide support. The difficulty is how you justify such a team with no evidence base. You have to do what the draft does - a bit of hand waving.

My instinct at this point is to recognise that people on the committee have worked hard to get what is in general a very good recommendation out. There will be backsliding but I am not sure that quibbles about the guidelines will change that. I see it as perhaps more useful to focus on the scientific achievement of getting the evidence record straight.

But these are just first thoughts. No doubt there will some issues of detail worth raising that may add usefully to the final product.

 

If you go to the first post in this thread where all the sections are listed and linked, you can see that the last section linked to is something like comments from experts. JE's is the first one.

 

I also thought the following passage on the theorethical grounding of CBT and GET was very solid

"Patients recruited to studies are likely to be relatively well disposed to the trial therapies.
Patients may have seen a CBT trial as a way to get NHS CBT that otherwise they would have had to wait for–less likely for ‘adaptive pacing’ since pacing is normally self-managed.
Patients who had experienced intolerance of exercise (characteristic of ME) would be likely to be put off trials involving GET.
These difficulties are not easy to solve, but they need solving. As indicated below, methodology for trials of these treatments may need to be significantly different from the standard format.
In the context of these problems, the best we can probably expect from such studies is to glean a negative result, despite confounding effects of positive bias towards test treatments.
Maybe we can.

Follow-up results from PACE showed no advantage of CBT and GET over comparators.
Objective measures retained in the final PACE analysis showed no convincing evidence of reduction in disability.
The trial appears to refute the model that beliefs about health status perpetuate disability.
At least in terms of subjective reports,beliefs appeared to change but without any significant change in disability, suggesting that beliefs are not the cause of disability.

A final point; the true gold standard for clinical trials is a combination of randomised, adequately controlled/blindedstudies showing efficacy,plus corroboration from things like a dose response relation or a consistent time profile of response (kinetics). Dosing and kinetic studies are typically done first, and large controlled trials not set up until a minimum effective dose, dose response relation and kinetic profile have been documented, even if not with full statistical power. Without establishment of these initial data it is always difficult to be sure that a specific active modality has been identifiedand can be delivered in a reproducible fashion. For trials of therapist-delivered treatments there are few, if any, such data available.In summary, trials in ME/CFS, in particular those using therapist-delivered treatments, suffer from several fundamental flaws.

The PACE trial was intended to be definitive for CBT and GET but suffers from the same flaws. In their most recent response to criticism the PACE authors fail to address these issues (see Kindlon and Wilshire, 2019.) Difficulties Associated with Theoretical Grounding Strength of theoretical grounding is not usually a key factor inclinical trial quality but poses difficulties for CBT and GET trials because theory intrudes into treatment delivery. Both appear to be delivered in a framework of assuming that patients have unhelpful beliefs about their activity capacity that can be overcome by a therapist. As far as I can see there is no evidence to indicate this assumption is more than popular prejudice. The only argument I have seen used is that strong belief in being organically ill is associated with lower chance of recovery. However, the alternative hypothesis –that the patients’ beliefs are accurate -predicts the same finding.

The only further evidence I am aware of comes from the results of trials. PACE, if anything, refutes the hypothesis because apparent changes in beliefs were not associated with objective evidence of lesser disability. There is also a built-in problem with the theoretical model in terms of drawing useful conclusions from trial results. The unhelpful belief model on which CBT is based assumes the patient’s self-reported assessment of their health status does not reliably reflect functional potential, which is what patients want to improve (even if it reflects current limitations).It is no good then to take final self-assessments as a reliable index of functional potential. There has to be consistency in the interpretation for it to be valid."

I would like to thank @Jonathan Edwards for an excellent piece of expert commentary. It should be required reading for researchers in the field of ME/Cfs, as it is that good and important.

 

I thought the same thing, I was almost moved by how good these guidelines are in a wide array of different scenarios related to the disease.. Specific advice for the severely ill..Children.. Hospital visits.. flare management.. To name a few. Just wonderful. Patients, parents and caretakers have been crying out for something as thorough for the general practitioner to see, and usually had to provide it themselves.

 

No I agree it could be more clear why they disregard GET, thought the same thing. That being said im so happy to see it disregarded quite clearly earlier in the draft, that I didnt mind much.

 

Many thanks for posting these excellent and well argued points. Whereabouts in the document is it? Thanks. I'm popping in and out of reading between clinics

 

My pleasure! Se Thrish`s comment, and heres the list with all the draft documents: https://www.nice.org.uk/.../consultation/html-content-2

 

Ah , the infrastructure to maintain ...

 

A point I have not seen raised in this thread (or not understood if it has been made).
It is important for any mention of CBT in the document to make clear it is not CBT based on the fear avoidance, or 'deny your symptoms' model.

CBT for how you feel about the illness might in principle have a role (I have doubts).
Any CBT that denies symptoms or possible worsening is actively dangerous.
Also ALL services for patients must have a yellow card system.

 

Hahaha... it's so good to see LP being recommended against.

Phil Parker has said nothing so far. He recently tweeted on how LP allegedly improves fatigue in long covid. Lessons have clearly not been learned.

 

Yes these guidelines are an improvement but there are areas of serious concern for children.

School guidelines are poor and non specific and will not protect children from all the misconduct, abuse, reporting for attendance issues.

A lot of work and detail is needed to protect children. The guidelines appear to have been written with those more familiar with adult ME and need a lot of work in the area of safeguarding, Fii that large numbers of ME parents are being accused of.

The clause that a psychological well being assessment is needed in order to get an ME diagnosis is nonsense and very dangerous. It will push all kids in particular into Camhs who will run the show and there will be no biomedical care . This is very dangerous and needs to be removed.

The definition of moderate ME states not at school, when children with moderate ME can manage a few hours per week in some cases. This needs to be changed.

No tests are recommended. How did we do two years of review and have no tests? This helps to continue the narrative that it’s not a biomedical illness. Ferritin and vit D are low in most ME children, amino acids , malabsorption issues. Dietary advice is very poor and lacking yet cbt is 3 times the length.

 

superb piece.
@Jonathan Edwards
I don't know what the rules are re copyright but your commentary deserves to be published as it is not only relevant to ME/CFS research.

 

Does anyone know if NICE are able to post out paper copies of the Guidelines? I do not have access to a printer, and staring at a laptop screen for hours on end is not an option for me.

 

The science media centre website has now included another testimony, surprisingly not a CBT or GET advocate: https://www.sciencemediacentre.org/...deline-on-diagnosis-and-management-of-me-cfs/

---------------------------

Prof Simon Carding, Group Leader in gut microbes in health and disease, Quadram Institute Bioscience, said:

“Patients will welcome the acknowledgement from NICE that deleterious therapies that may harm patients, such as GET, are the wrong path to take and that high quality biomedical research is required to overcome the lack of treatments for this devastating disease. At Quadram Institute we are pursuing a strategy of gaining scientific evidence/data and trialling possible treatment for a subgroup of ME patients. Working with European UK and collaborators and patients we hope we can provide more evidence for the next NICE review.”

-------------------------

Did they realize how biased they come across?

This is the old article: https://web.archive.org/web/2020111...deline-on-diagnosis-and-management-of-me-cfs/

 

https://twitter.com/user/status/1326113193098420228

 

More important points from Jonathan:

"Recent comments by three PACE authors in a published response to critique indicate how little the difficulties of expectation bias are understood. The authors say that they prefer the altered outcome criteria that they introduced post-hoc because they gave results more consistent with previous studies and their clinical experience. They do not seem to realise that outcome measures need to be predefined in order to avoid exactly this sort of interference from expectation bias (see Kindlon and Wilshire, 2019).

A major reason for poor quality control in terms of conducting trials may be the anomaly that therapist-delivered treatments have not been subject to the licensing requirements for drug treatments. The lack of regulation for therapist-delivered treatments may reflect a perception that these treatments do not cause harm. However, there are good reasons to think that both psychotherapy and exercise therapy can do harm, particularly if they involve misrepresentation of knowledge about an illness."

 

Report in Guardian: https://www.theguardian.com/society...me-exercise-therapy-loses-nice-recommendation :

I hope someone might be persuaded to write a letter to the Editor about harms (ie evidence from surveys and the lack of a system for reporting harms). Unfortunately, it’s too late to get a letter published in tomorrow’s paper but still a chance for Thursday. (I’ve already sent a letter making a different point.)

If anyone does write, please remember to keep it as short and concise as possible (certainly no more than 250 words) to maximise chance of publication. Send email to: guardian.letters@theguardian.com and remember to include full name, address and tel no.