Anomalies in the review process and interpretation of the evidence in the NICE guideline for (CFS & ME), 2023, White et al

It is possible to report the post, which I have done (in my mind for the first sentence). Sadly, it doesn't ask for any justification for reporting, so, don't hold out much hope of it being removed, but can only try.

 

The PACE Trial used the Oxford criteria. Yet 97% of the participants who didn't have a psychiatric disorder satisfied the definition of M.E. used (see post from 2011 below). This is not very credible. It either shows that the London ME criteria are not good or alternatively that they were operationalised in an unusual way.

======

https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1106A&L=CO-CURE&P=R2764

Title: PACE Trial - 97% of the participants who didn't have a psychiatric disorder satisfied the definition of M.E. used

[I and others have noted these percentages in discussions on the internet before; however, I thought the latest quote brings clarity to the wording in the Lancet paper. Tom]

In the Lancet paper on the PACE Trial (by White et al (2011)), it said: ---------- "Participants were also assessed by international criteria for chronic fatigue syndrome,12 requiring four or more accompanying symptoms, and the London criteria13 for myalgic encephalomyelitis (version 2), requiring postexertional fatigue, poor memory and concentration, symptoms that fluctuate, and no primary depressive or anxiety disorder (interpreted as an absence of any such disorder)." -----------

I was not 100% sure what "no primary depressive or anxiety disorder (interpreted as an absence of any such disorder)" meant in relation to the percentage we were given for "any psychiatric disorder" i.e. could there be an overlap.

The following is an extract of a letter that clarifies it (see asterisked bit) - the letter was written by PD White, KA Goldsmith, AL Johnson, R Walwyn, HL Baber, T Chalder, M Sharpe, on behalf of all the co-authors (of the PACE Trial)

--------- The trial did not study ME/CFS (pages 12-18)

The selection of patients was for CFS operationalised using the broadest criteria (the Oxford criteria). No sensible neurologist would apply the diagnosis of CFS (or indeed ME) to patients who had "proven organic brain disease", such as Parkinson's disease. For the purposes of this trial ME was not regarded as a "proven organic brain disease". In order to ensure balance between the trial arms in those participants who met alternative criteria for CFS and ME, randomisation was stratified by the International (Centers for Disease Control) criteria (which require additional symptoms) and by the London ME criteria (based on Melvin Ramsay's original description, and which excludes co-existing "primary" psychiatric disorders [****which we interpreted as any psychiatric disorder****] and emphasises post-exertional fatigue). We were provided with the second revised version of the London ME criteria; we did not invent our own. We considered use of the Canadian criteria for ME but we found it impossible to operationalise them adequately for research purposes; to our knowledge they have not been used in a major research trial. We studied the results for differently defined subgroups and they were similar to those in the entire group.

(source: http://www.meactionuk.org.uk/whitereply.htm )

------- The figures from the paper (Table 1) show that, of the 640 participants, 300 (46.9%) had "any psychiatric disorder" and 51.4% (329) satisfied the London criteria*.

This means that of the 340 patients in the trial (i.e. who satisfied the Oxford criteria**, with a principal symptom of fatigue, who did not have a psychiatric disorder), 329 (96.8%) satisfied the London criteria for M.E., the definition of M.E. used in the trial!

This is an amazingly high figure for a definition of M.E. given the "looseness" of the Oxford criteria e.g. unlike the Fukuda CFS criteria or Carruthers ME/CFS criteria, it doesn't require other symptoms apart from fatigue.

It seems to me the definition for M.E., at least as it was used in this trial, is very suspect. And hence it is questionable what can read from into how people with M.E. responded in the trial.

Tom

---------- *One can how the London Criteria were used at: http://bit.ly/lyqddJ i.e. http://s982.photobucket.com/albums/ae301/tkindlon/?action=view&current=London_Criteria_in_PACE_Trial.jpg

** One can how the Oxford Criteria were used at: http://bit.ly/kAh1cg i.e. http://s982.photobucket.com/albums/...iew&current=Oxford_Criteria_in_PACE_Trial.jpg

Annex 1: We already cannot be sure if the participants are representative of patients in the community based on who refused to take part, were excluded, etc.

 

Your treatment has been neglectful, and cruel. It is shameful!

You are so right about care and consideration. At least it would be something. Something that most citizens expect, or hope for. It's the lowest bar in medicine.

My experiences haven't been as physically cruel, but I have certainly experienced abandonment, ridicule, and downright nastiness. People going out of their way to poke a figurative stick in my eye.

I hope things get better for you.

 

well, that might have created problems for Lifelines' ZonMW grant, I suppose.

 

https://twitter.com/user/status/1679598546083803136

 

Because the PACE Trial had already been going a long time at that stage (it got funding in May 2003).

Also the trial cost in the region of £5 million.

 

I've been a bit slow.

(Non)Sense and Sensibility.


edit:
Apologies @Robert 1973. You were there on Wednesday.

"A comedy of anomalies?

Nonsense and Insensitivity?"

 

I think I’m in a minority but I don’t think the wording of the 2007 NICE GL makes it clear if PEM is a requirement or not. It is very badly written, and I suspect that may have been a deliberate fudge so that it could be interpreted in different ways.

Peter is right that “fatigue characterised by fatigue doesn’t make sense”. But that’s what it says. The words “typically” and “for example” are significant too.

I’ve not followed things very closely recently but I’m inclined to think it’s not particularly important now. Before I started following the research closely, I guessed that definitions of ME/CFS, and whether PEM was a requirement, must have been crucial in all these studies that were supposedly showing that CBT and GET were effective treatments. I wrongly assumed that they must be effective for some people who were diagnosed with CFS but didn’t have PEM. But then I read the literature and studied the data, and changed my mind. As far as I am aware there is no reliable evidence that CBT or GET help anyone with CFS, however broadly or badly it is defined, on any objective measures such as actigraphy, employment, benefits etc.

So, while I agree that it is important that PEM is a required symptom for a diagnosis of ME/CFS, and it is highly relevant when assessing the risk of harm from CBT/GET, I don’t think it’s particularly important when assessing the efficacy of CBT/GET as, to my surprise, the data suggests that they don’t seem to work for anyone diagnosed with CFS, even using criteria that don’t require PEM.

Although I take a slightly different view to Peter on this particular issue, I am exceedingly grateful to him for all the positive work he’s done for people with ME/CFS – particularly as, as far as I’m aware, he doesn’t have a personal stake in this.

[edit: typos]

 

That's really not in the spirit of free speech and to be honest I'd rather these clowns show their true colours so that we know what we're dealing with and have a record of what's been said, than have medical professionals and BPS researchers keep quiet due to political correctness but still treat us like trash.

 

I dont understand why the presence of any other condition would negate a diagnosis of ME given that PEM (so ewhat arguably?) is only found in ME. If PEM is present in someone with MS do they not also have ME?

 

I think this is misleading, these researchers think that ME is a mind/body disorder, something that they have no objective proof of.

 

I'm getting the suspicion that many people who support this paper do so because they have no idea about ME/CFS and have been fed misinformation by the PACE trial authors.

 

I don't think that's a safe assumption, and it's probably best avoided in debates. Until someone has studied it, we don't really know.

 

I saw a list of criteria that require postexertional malaise.
Another one is Rowe et al 2017 drawn up by an international panel of experts:

 

The Community Note twitter put on was helpful - is there an action where people on s4me and are on twitter can set up community note access? This can then be coordinated as a response

 

Dr Shepherd posted the following on Facebook yesterday:

NB: The first part of my letter, which was concentrating on the conflicts of interest by some of the clinicians and researchers who authored this paper, has not been published.

People with ME/CFS welcome the recommendations in the NICE guideline

Dear Editor

The NICE guideline committee (of which I was a member) spent an enormous amount of time over three years reviewing all the evidence on CBT and GET from both clinical trials and from people with ME/CFS.

They concluded that the clinical trial evidence for the use of CBT and GET was of very poor quality and acknowledged that people with ME/CFS have consistently reported that CBT was ineffective and that GET made their condition worse - some ending up in wheelchairs as a result. off receiving harmful advice on activity mansagement.

The ME Association is therefore pleased to see that NICE is robustly defending the new recommendations regarding the use of CBT and the removal of GET and the way in which these recommendations were reached.

These recommendations have been widely welcomed by the ME/CFS patient community here and abroad, and by the vast majority of health professionals who are actively involved in managing people with ME/CFS in both primary and secondary care.

Competing interests: No competing interests

 

The issue is more over the fact that the charlatans are trying to depict the change as complete and radical, when it was in fact relatively minor all things considered. They never called it PEM, but they have always used "boom and bust" and it was about the same thing, just their interpretation vs our actual reality.

As changes to definitions go, this is pretty much the smallest one that can happen as most definitions have at least included PEM and all the recent ones made it the defining feature, including the IOM/NAM one which formed the basis of the updated NICE.

They're pretending it's a complete 180 change when it's basically about a 20 at best. It just happens that they chose to ignore it throughout their entire body of work and now they're screwed by what is effectively a minor change in direction. They have no one else to blame but themselves for this, so of course they blame us DARVO style, as they always do.

 

The community note tagged onto the Guardian piece on Twitter has now disappeared. Anyone any idea how or why?