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

Status
Not open for further replies.
Esther12 said:
Does anyone know what happens to all of the documents related to the draft NICE guidelines once the full ones are released?

Are they still made available or do we need to archive them somehow? There was mention of NICE having done updated evidence reviews, so I wonder if that could change things, or if they'd be supplementary?

Someone just mentioned the way the Busse BMJ letter misrepresented some matters, and it would be good to continue to have evidence of that.

I also wondered the same about the 2007 guidelines (which don't include the draft): https://www.nice.org.uk/guidance/cg53/evidence

People refer to submissions from Barts etc on the draft 2007 guidelines as evidence of their views. Will all those documents disappear when the new ones are released?

Maybe @adambeyoncelowe would know?
Click to expand...
I would just download everything to be sure, but that's me!
 
Dx Revision Watch said:
All these documents have been available on the "History" tab page for the CG53 2007 guidance since publication of the final CG53:

https://www.nice.org.uk/guidance/cg53/history
Click to expand...
Interesting.

adambeyoncelowe said:
I would just download everything to be sure, but that's me!
Click to expand...
Yes, just in case any "filtering" occurs in the process of NICE's archiving. If we have something ourselves, if any issues in the future we would have the confidence of knowing what really was.
 
Esther12 said:
...People refer to submissions from Barts etc on the draft 2007 guidelines as evidence of their views. Will all those documents disappear when the new ones are released?
Click to expand...

I have PDFs of the stakeholder comments archived on my Dx Revision Watch site in this post:

NICE CFS/ME consultation draft 29 September – 24 November 2006 Comments from stakeholders
MARCH 8, 2019

https://dxrevisionwatch.com/2019/03...-24-november-2006-comments-from-stakeholders/

Post #347 Shortlink: https://wp.me/pKrrB-4KP

NICE CFS/ME consultation draft 29 September – 24 November 2006 Comments from stakeholders

Stakeholder List: Stakeholders_CFSME

Comments on NICE version (in alphabetical order of stakeholder 575 pp): nice-version-table-of-comments2

Comments on NICE version (in alphabetical order of stakeholder 220 pp): NICEversion-tableofcomments

General comments from stakeholders (in alphabetical order of stakeholder 224 pp): General-tableofcomments

Comments on Chapter 1 (in alphabetical order of stakeholder 152 pp): Chapter1-tableofcomments

Comments on Chapter 2 (in alphabetical order of stakeholder 34 pp): Chapter2-tableofcomments

Comments on Chapter 3 (in alphabetical order of stakeholder 18 pp): Chapter3-tableofcomments

Comments on Chapter 4 (in alphabetical order of stakeholder 28 pp): Chapter4-tableofcomments

Comments on Chapter 5 (in alphabetical order of stakeholder 103 pp): Chapter5-tableofcomments

Comments on Chapter 6 (in alphabetical order of stakeholder 171 pp): Chapter6-tableofcomments

Comments on Chapter 7 (in alphabetical order of stakeholder 25 pp): Chapter7-tableofcomments

Comments on the Appendices (in alphabetical order of stakeholder 13 pp): Appendices-tableofcomments


A selection of points the Barts CF Service made during the development of the NICE Guidelines for CFS/ME [CG53 2007] extracted by Tom Kindlon can be found in this September 2007 post on my ME agenda site:

https://meagenda.wordpress.com/2007...g-the-nice-guidelines-for-cfs-me-tom-kindlon/
 
Last edited:
Trial by Error by David Tuller Three CBT/GET Proponents Quit NICE ME/CFS Guidance Panel as Publication Date Nears

Quote:
These resignations immediately before publication should have been expected. Like former President Trump, members of the CBT/GET ideological brigades have shown themselves to be sore losers. They appear to believe that decisions not aligned with their beliefs and assertions are illegitimate for one or some other claimed reason—most often having to do with the purportedly sinister influence of anti-scientific patients.
 
It appears the "conflict of interest" regarding Dr. Shepherd's role in the NICE Committee and MEA is that he is correctly not in favor of GET and CBT as treatments for ME, as there is no scientific evidence GET and CBT cure ME.

Dr. Shepherd's sound scientific knowledge conflicts with that of the beliefs of the BPS crowd, which is where we all know the real issue or conflict of interest is.

This standing down of Dr. Shepherd for a mis-perceived conflict of interest is concerning.

In the interest of fairness and equity, those making money from using GET and CBT for ME should also have been stood down.

ETA: changed "if" to "of"
 
Last edited:
Wonko said:
IMO their conflict of interests should have been seen, before the start, and they should never have been stood up.

But then I'm not NICE.
Click to expand...

We had discussed this at the stage of the committee being established and it does appear that conflict of interest is defined by NICE differently for those involved in advocacy work and the charity sector than it is for those working within the British NHS or universities, much tighter restrictions being imposed on the former than the latter.

There had even been discussion of this in relation to Dr Shepherd’s role with the MEA which was why he was made a non voting committee member, so it is hard to see what has changed recently. His role has always included responding to social media posts/comments.

I expect this represents the slow adjustment of NICE to including patients and patient advocates in their attempt to move on from being just a dispenser of medical edicts.
 
Trial By Error: The Times Fact-Checks BMJ on NICE Committee; My Letter to BMJ’s Fiona Godlee

"It is not often that a major news organization fact-checks BMJ, a leading medical publisher, in real time. But that’s what happened last week when The Times pushed back against biased BMJ reporting about the committee charged by the UK’s National Institute for Health and Care Excellence (NICE) with developing a new clinical guidance for ME/CFS. This isn’t the first time The Times has seen through the propaganda campaign emanating from those with financial and reputational interests in maintaining the GET/CBT approach despite widespread rejection of its theoretical and scientific underpinnings.

As I noted previously, the BMJ article, published August 3rd, presented quite a stupid line of argumentation—namely, that the draft NICE guidance published last November was developed without sufficient reliance on the available evidence. Sean O’Neill, a Times reporter whose previous work has demonstrated a more nuanced appreciation of ME/CFS issues than is common among his peers, countered such claims in a piece published the next day. The final version of the guidance is scheduled to be released next week. Perhaps other members of the UK press will follow the Times‘ lead and stop believing everything they read about ME/CFS in major medical journals and in press releases from the likes of London’s Science Media Centre."

https://www.virology.ws/2021/08/10/...ice-committee-my-letter-to-bmjs-fiona-godlee/
 
Journalists covering ME/CFS: Don’t ask about the new NICE guideline, ask about the old one

"To fully understand the future, it is important to know the past.

Next week, we finally get to see that long awaited new NICE treatment guideline for ME/CFS. As regular readers will know, all indications so far suggest the new guideline will be dramatically different from the old one. Graded Exercise Therapy is set to be expunged entirely, while Cognitive Behavioural Therapy is no longer to be used as “treatment” for ME/CFS, but instead is to be recommended as psychological support for people’s mental health and well-being.

By extension, the so-called “science” of so-called “psychogenic illness” is on the verge of being discredited. The whole transition amounts to nothing less than a paradigm shift in what has long been a contentious area of medicine.

Of course, there has been pushback from some quarters. Recently I described a highly partisan news story that appeared in the BMJ. The BMJ journalist appeared genuinely confused as to why the old guidelines had to be changed at all. As they wrote:

In 2007, NICE recommended interventions such as cognitive behavioural therapy and graded exercise therapy for people with mild or moderate ME/CFS, whereas the draft update cites a “lack of evidence for the effectiveness of these interventions.” It is unclear, however, how the evidence became unsupportive.

I anticipate that this line — “it is unclear how the evidence became unsupportive” — will be the preferred narrative used by those who wish to discredit the new guideline when it is published next week.

For defenders of the status quo, it’s always about narrative. That is because when evidence and logic evaporate, narrative is all you have."

https://thesciencebit.net/2021/08/1...the-new-nice-guideline-ask-about-the-old-one/
 
Of course, the usual suspects will have an armada of eminent 'experts' who will try to defend their CBT-and-exercise-always-helps-especially-in-functional-illness-narrative, mixed with narratives along the lines of 'no trial is perfect' and 'if blinding is not possible in clinical trials, we have to turn a blind eye to the otherwise required standards of assessing evidence'.

I think it might be important to be able to factually argue in detail with respect to the evaluation of the quality of evidence: What are the weaknesses of GRADE and how can it be used to either sift non-robust evidence out or to let it pass?

References to Michiel Tack's and Jonthan Edwards' responses might be useful in this regard:

https://www.bmj.com/content/371/bmj.m4774/rr-9

https://www.bmj.com/content/371/bmj.m4774/rr-8

One thing that it seems hasn't been addressed in the criticism of Torjesen's recent 'exclusive' BMJ news article is that the author refers to the Busse et al critique of the NICE draft as "the architects" of GRADE, whereas in their response it was explicitly stated that "it is not an official communication from the GRADE Working Group" [1].

It's also interesting that two of the eleven authors of the response aren't members of the GRADE working group:
Signe Agnes Flottorp and Paul Garner.

Another point is that Torjesen in her recent article double-references an argument of Turner-Stokes/Wade response, and does that without making clear that this is a quote.

Turner-Stokes/ Wade in their BMJ editorial 16.12.2020:

"[...] the new draft emphasises the potential harms of exercise, based on qualitative evidence provided by a small number of service users, and the balance has shifted towards helping patients to adjust to the long term debilitating effects of CFS/ME." [2]

Torjesen turns that opinion into a fact, referencing to the source, but not putting the quote into quotation marks:

"The draft update also emphasises the potential harms
of exercise, based on qualitative evidence provided
by a small number of service users, and the
importance of helping patients to adjust to the long
term debilitating effects of ME/CFS".[3]

And then she goes on to reference Busse et al without making it clear that they criticized Turner/Stoke with the exception of the rejection of the draft guideline's conclusions and the one point about the "small number of service users" that still wasn't factual.

Busse et al:

"They have, however - with the exception of one sentence – made the wrong attribution of the source of the problem. The authors note, correctly that 'the new draft is based on qualitative evidence provided by a small number of service users'." [1]

And that's what Torjesen makes of it when she cites the quote again two paragraphs later, again without putting it in quotation marks:

"The NICE guideline development process uses the
GRADE system to assess the quality and strength of
evidence. The architects of this system have
suggested that there was 'a disastrous misapplication
of GRADE methodology,' with conclusions about the
potential harms of exercise overemphasising
qualitative evidence from a small number of service
users."[3]

[1] Busse et al, https://www.bmj.com/content/371/bmj.m4774/rr-7 ; S4ME thread here.

[2] Turner-Stokes/Wade, https://www.bmj.com/content/371/bmj.m4774

[3] Torjesen, https://www.bmj.com/content/374/bmj.n1937

Edited for clarity.
 
Last edited:
Andy said:
https://thesciencebit.net/2021/08/1...the-new-nice-guideline-ask-about-the-old-one/
Click to expand...

Trish said:
That is such a good article. I hope it will be widely circulated to journalists covering the new guideline.
Click to expand...
Indeed. I wasn't aware of that part of NICE's history.

Thank you @Brian Hughes .

I hope it's OK to quote a bit more from Brian Hughes' article.

About the old (2007) NICE guidelines' evaluation of the then small evidence base:
Focusing on randomised controlled trials (RCTs), the core evidence base spanned just four studies. The section on GET contained just five RCTs. There was a small number of other studies that examined modified versions of CBT, or interventions that combined GET with drug treatments, but by definition these trials did not test the effects of CBT and GET per se.
Click to expand...

What made this rather slim discussion especially intriguing was its provenance. The work was prepared by a group of researchers from University of York’s Centre for Reviews and Dissemination. The intriguing part is that back in 2001, these very same authors published a much more thorough review of exactly the same evidence base. This earlier review was not exactly obscure: it appeared JAMA, the flagship journal of the American Medical Association.
Click to expand...

Unlike in their Appendix for NICE, in JAMA the York Reviewers elaborated on several caveats to the so-called evidence base:

  • The York Reviewers noted that the studies had high dropout rates, raising the prospect of survivor bias — a tendency for apparent improvement effects to be artificially inflated by the fact that the analysed datasets were likely to contain only those participants who found CBT or GET beneficial.
  • The York Reviewers criticised the use of subjectively measured treatment outcomes. They explained that it was “unclear” whether improvements in such measures amounted to actual improvements in real life. They specified that any tangible record of life function — such as post-treatment employment status, school participation, or physical activity — would have offered much better insights as to whether the interventions were truly beneficial. They bemoaned the fact that the studies they reviewed had lacked such measures.
  • The York Reviewers specifically identified a problem with the use of “self-reported function” as a measure of illness improvement. They pointed out that a patient might rate themselves as able to function better simply because their expectations have declined, or even plummeted. In other words, their frame of reference might have shifted downwards. This is especially relevant because such shifting-of-the-frame-of-reference is exactly the target of CBT treatment. When patients say they improve after CBT, it might just be a sign that the CBT taught them to attach higher ratings to their own poor health. Once again, the York Reviewers bemoaned the fact that in the studies they had reviewed, precisely this type of problematic measure was used as standard.
To be fair, the York Reviewers were quite polite in their JAMA paper. They did not rebuke the researchers, they merely drew attention to the large number of damaging flaws in their studies.

However, their conclusion was pretty clear. Given the various caveats that characterised this research, they declared: “All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies.” The best they could say about CBT and GET was that the relevant studies showed “promise.”
Click to expand...

Edited for clarity.
 
Last edited:
Andy said:
“it is unclear how the evidence became unsupportive”
Click to expand...

There is an interesting answer to this, maybe - the evidence became unsupportive because in the intervening period there was the 'definitive' PACE trial - which was unsupportive.

In 2007 the 'evidence' was based on some small inconclusive studies. By 2020 we had seen a large multi-arm trial show that almost certainly CBT and GET had no useful effect and if there was any it was trivial and unsustained. The authors had to truncate the Y axis to make any apparent difference visible and that difference was well below what would be predicted on the basis of other studies (e.g. rituximab phase 2, antivirals) from expectation bias alone.
 
I had not come across the history of the difference between what the same reviewers published and what they told NICE about the same research back in 2007. Would it be possible to find out what brief NICE gave the reviewers for their review for the 2007 guideline? Could the NICE committee, which I understand was stacked with BPS people, have told them to leave out all their criticisms of trial methodology and just present results taken at face value in their report?
 
Status
Not open for further replies.
Back
Top Bottom