Snippets from White P et al. "Eight major errors in the review process and interpretation of the evidence in the NICE guideline [...]" [for ME/CFS]

White P et al. - Eight major errors in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis

Snippets were posted on Twitter by a journalist:
https://twitter.com/user/status/1602583979038760963

"The article should appear soon in the Journal of Neurology, Neurosurgery, and Psychiatry, as far as I know."

The paper was also mentioned in a press statement of the German Society for Psychosomatic Medicine and Medical Psychotherapy (DGPM) in November:
"Members of the DGPM are also co-authors on an international publication with more than 50 co-authors outlining serious methodological flaws in the guideline on ME/ CFS published last year by the English guideline organization NICE, to which many advocates of the biological view refer."
https://www.dgpm.de/de/aktuelles/nachrichten/nachricht/long-covid-wo-bleibt-die-psychosomatik/

 

Interesting use of the word "scientists"

 

thats what a lot of the therapy manual (PACE) makes it out to be (but it makes it very clear throughout that the theory behind it is deconditioning) until you get to this bit:

 

My first takeaway from this is that these people are now organising internationally — specifically across northern Europe — and it's key that patient organisations do so too.

 

The authors appear to contradict themselves in saying these patients are not taken seriously enough with their condition.

And yet, they also say too much attention is paid to the reports from pwME.

On the one hand they seem to be saying reports from patients are very important, but on the other hand, these reports should not be taken seriously.

 

Does anyone feel they can offer speculation about the probability of NICE convening a new panel and conducting another review? I know it’s difficult with only these brief snippets, but I still felt inclined to ask

 

As per the statement in the PACE therapy manual, do the authors have sufficient scientific proof that boom and bust cycles disallow desensitization to increases in activity?

(For healthy people, there are methods of training that advise alternating between rest and exercise to avoid over-training and injuries.)

 

Some of the “errors” that the authors mention are outright misleading.

I am puzzled by this argument. The 2007 NICE guideline (CG53) already required post-exertional fatigue or malaise with the typical 24h delay and prolonged recovery (§1.2.1.2). It also states that the diagnosis of CFS/ME should be reconsidered in the absence of PEF/PEM (§1.3.1.3). Therefore, had the PACE trial been published earlier and reviewed by NICE for the 2007 guideline, it should have been downgraded for indirectness because the Oxford criteria do not require PEF/PEM.

It seems important to note that the authors who were stakeholders in the 2007 guideline, in particular the first author and PACE trial lead investigator Peter White (via the St Barts CFS clinic), did not reject the mandatory presence of PEF/PEM. They cannot turn on their heels 15 years later.

Further, NICE merely modified the IOM criteria, which were one of the reasons why NICE started the process of developing a new guideline as mentioned in their 10 year surveillance report of the CG53 guideline.

Also, in one of the snippet above, the authors say that the “most widely used” CDC definition (Fukuda) doesn’t require PEM, but they omit to mention that the CDC now endorse the IOM criteria.

Perhaps this refers to NICE’s decision to use the longest follow-up data available (144 weeks) that Simon Wessely lobbied against by sending text messages to the former head of NICE.

If they want to use this argument, then surely one should have the right to invoke objective endpoints, which the authors tried to bury under the carpet by publishing them separately from the main results because they were null?

First, how should one interpret trial data on harms when participants were instructed to ignore and push through their symptoms, which they were told were the result of “false illness beliefs” and related maladaptive behaviour?

Second, it is known that reporting of harms in trials is often incomplete and this issue can only be compounded when the investigators have a strong bias in favour of the intervention they are trialing.

Third, 2274 patients responded to the survey on GET/CBT that was analyzed by the Oxford Brookes University and submitted to NICE as evidence for the guideline development process. This is 3.5 times as many patients as the number of participants in the PACE trial (641). Why should such a strong signal be ignored even if it comes from non-RCT evidence? The ”First Do No Harm” report on harms from drugs and medical devices published in 2021 by the Independent Medicines and Medical Devices Safety Review was based on post-marketing (non-RCT) evidence, yet the harms were acknowledged.

Fourth, speaking of post-marketing evidence, there is no equivalent of the Yellow Card scheme for GET/CBT and ME/CFS clinics do not have a system to report harms. https://journals.sagepub.com/doi/10.1177/1359105319854532

Did they?

@MECFSSkeptic already responded to these allegations: https://www.bmj.com/content/371/bmj.m4774/rr-9

With regards to synthesis, the appendices for the evidence review contain hundreds of pages of GRADE tables.

This is a blatant lie. NICE reviewed the trials carefully and summarized its findings on the definitions of graded exercise therapy in Box 5.

One can look at the PACE GET manual for therapists. The “GET process” is summarized on pages 38 and detailed from pages 39 to 56. A fixed increment is mandated, first in duration (20%; p. 38, p. 49) then, once exercise can be sustained for 30 minutes, in heart rate by 10-20% (p. 49).

It is true that therapists are to collaborate with patients: “ALWAYS ensure the process is collaborative and that every stage is jointly negotiated” (p. 32). Collaboration is described as such:

However, the extent of collaboration is very much limited by the GET model and process.

First, collaboration mostly revolves around negotiating goals before starting the therapy and a baseline of exercise (p. 38). But even then, it is stated that:

- “Goals for GET should have relevance to exercise, physical activity or physical functioning” (p. 45) and not be “a reduction or absence of symptoms” (p. 42), which may differ from the patients’ preferred goals (and also highlights that GET is not meant to be a cure for ME/CFS)

- “The baseline should be renegotiated if, after subjective assessment or review of the Physical activity/exercise diary, the therapist feels this level is inappropriate” (p. 48), so the therapist has the upper hand on deciding the baseline activity level.

Then, the process insists on maintaining activity during crashes, which are “normal, and likely” (p. 51), even when the patient is reluctant to do so, because it is presumed that “hurt does not equal harm” and, otherwise, “the boom/bust cycle continues, and the body is not able to desensitise to the increase in activity”:

Therefore, going back to the authors’ claims about GET not having fixed increments and being collaborative, negotiated and symptom dependent:

- The increments are fixed (10-20%), whether in duration or in exercise intensity;

- The GET process leaves little room for collaboration before starting the program and almost none when it is ongoing — the patient is expected to comply with their exercise regimen and to maintain it even when they are experiencing a flare;

- How negotiation during the program should be done and what it entails is not specified; in particular, there is no mention of negotiating increments;

- To say that GET is symptom dependent while encouraging the patient to continue exercising even while they are crashing is disingenuous.

Here, the authors contradict themselves with regards to error 5.

NICE followed the same methodology for reviewing the evidence for the chronic pain and ME/CFS guidelines, so they synthesized and graded the evidence the exact same way. It makes no sense to criticize NICE’s protocol for the ME/CFS guideline but not for the chronic pain one.

Also, NICE’s evidence review of non-pharmacological interventions for chronic pain rated many of them as low quality (some moderate), just as in the ME/CFS evidence review. The decision to recommend exercise and psychotherapy in the chronic pain guideline was based on the committee’s clinical experience, as is clearly stated in the “Rationale and impact” section.

GET was recommended in the 2007 guideline without definitive evidence of its efficacy. It should also be noted that this energy management approach can hardly be considered a treatment.

 

I think we have been through all this stuff many times before.

I don't see Peter Barry (the committee chair) wanted to shift position. He was very confident that the guideline was robust and has no conflict of interest himself. I assume all those complaining do. Ilora Finlay (vice-chair and a political heavyweight) would be extremely resistant to any suggestion of review I think.

NICE is only going to allow a further review if some new person in charge is leant on. That might happen but remember that the 2017 review cost a huge amount of money and it would be difficult to re-do it for less.

@adambeyoncelowe knows all the ins and outs - any thought, Adam?

 

And remember that the Presidents of the Royal Colleges of Physicians, Psychiatrists, Paediatricians and GPs sat around a round table with the committee officers to give them a chance to present their criticisms and they didn't make a peep. When the chips are down there is nothing to say - the evidence was not there and even if you labelled on the benefit of the doubt it was not cost effective.

 

Note that Peter Henningsen had something to do with a rehab program in the UK run by Dr Moss-Morris. There was a video in which he presented his use of a completely untested black magic psychotherapy of some sort. It's a bit like a black hole calling the kettle black.

Edit: I am fairly sure that Henningsen is into Body Psychotherapy, which is witch-doctoring of an elaborate German kind as far as I can see, based on all sorts of pseudoscience.

 

It would be worth thinking about putting the issue in its broader context, how it's clearly the process behind this that is flawed and arbitrary. This isn't reserved for us, we're just the easiest punching bag for this. It's the entire EBM paradigm mixed with the BPS ideology that is universally toxic. It plays out the exact same everywhere.

Then again that would probably require joining forces and we haven't been fully able to do that with ourselves. It's so easy to conquer a group of people who are already divided, and disabled, and hated.

Urk this is way too nauseating. I can't believe this is what goes on in medicine. It explains so much. But the myth of medicine being special is done and over with, clearly never had any basis to begin with.

This quote is something:

Who do they think is pushing for that evidence? Or made it in the first place? And has been marketing it for decades?

 

Yeah but they "teach" this stuff themselves. Energy management is all over BPS stuff, in the pamphlets, in the "clinics". As treatments. Without evidence. While we explicitly remind that it's not a treatment at every opportunity.

So they are basically mad at their own argument, either unaware of it or indifferent at bothering to making any sense. Just like they're mad at CBT being recommended as support, which is an argument they make themselves all the time when they say that it's also used in cancer... as support.

Zero coherence to those arguments. But these people are supposed to be the experts. So who will notice the incoherence? This is all so incredibly broken.