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

T

Three Chord Monty

Senior Member (Voting Rights)
Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis

Peter White, Susan Abbey, Brian Angus, Harriet A Ball, Dedra S Buchwald, Christine Burness, Alan J Carson, Trudie Chalder, Daniel J Clauw, Jan Coebergh, Anthony S David, Barbara A Dworetzky, Mark J Edwards, Alberto J Espay, John Etherington, Per Fink, Signe Flottorp, Béatrice Garcin, Paul Garner, Paul Glasziou, Willie Hamilton, Peter Henningsen, Ingrid Hoeritzauer, Mujtaba Husain, Anne-Catherine M L Huys, Hans Knoop, Kurt Kroenke, Alexander Lehn, James L Levenson, Paul Little, Andrew Lloyd, Ira Madan, Jos W M van der Meer, Alastair Miller, Maurice Murphy, Irwin Nazareth, David L Perez, Wendy Phillips, Markus Reuber, Winfried Rief, Alastair Santhouse, Tereza Serranova, Michael Sharpe, Biba Stanton, Donna E Stewart, Jon Stone, Michele Tinazzi, Derick T Wade, Simon C Wessely, Vegard Wyller, Adam Zeman

Abstract
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive–behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.

We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which ‘downgraded’ the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.

We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.


https://jnnp.bmj.com/content/early/2023/07/09/jnnp-2022-330463

Edit to add:
Free link posted here to the full paper provided on Twitter by Paul Glasziou
https://t.co/LgEphp9UxR
 
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BMJ, behind a paywall so far as I can tell. Interesting this wouldn't be deemed worthy of open publishing.

Mods--if anything needs to be reformatted, my apologies, by all means change/edit/reformat, if necessary.

I'm not copying the 'competing interests' section. It's so long it might break the forum. And my computer.

But then if I could read this I might break my computer anyway.
 
I note that this journal takes e-letters:
https://jnnp.bmj.com/content/early/2023/07/09/jnnp-2022-330463.responses

Such e-letters don't have to be perfect but best to do them in scientific format with numbered references underneath. Even just one or two references underneath might be sufficient. One easy one is
1. White P, Abbey S, Angus B, et al. Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitisJournal of Neurology, Neurosurgery & Psychiatry Published Online First: 10 July 2023. doi: 10.1136/jnnp-2022-330463


Not sure whether it publishes any letters formally: there is no mention here of any guidance on this topic:
https://jnnp.bmj.com/pages/authors/#submission_guidelines
 
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Was Peter White's ill health ever given as a reason not to respond to some issues e.g. freedom of information requests relating to the PACE Trial? I know we never got data for one of mine because it was supposedly going to be published. Because he has been able to publish a number of papers in recent years.

Some data from the PACE trial has never been published in papers that I can recall e.g. on predictors*.

*I know that Kim Goldsmith did publish some complicated papers which were more on the statistics than anything else but they hardly count.
 
The authors advise GET is collaborative, negotiated and symptom dependent.

My understanding about GET, at least as it is used for CFS and ME, is that symptoms are to be ignored. If symptoms worsen, just carry on with the GET.

Part of the belief system the BPS Movement has about ME/CFS is that pw this illness incorrectly believe they have a physiological disease. Since the BPS Movement holds the belief pw this disease are imagining their symptoms and illness, one aspect of GET in this situation is to encourage the person to ignore the symptoms, and push through.
 
Merged
The Guardian: Chronic fatigue guidance discouraging exercise is flawed, say researchers

New guidance for doctors discouraging them from recommending exercise and cognitive behavioural therapy for chronic fatigue patients is not evidence based, according to researchers.

A study questions the National Institute for Health and Care Excellence (Nice) review process for this guideline for clinicians dealing with chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) patients and its use of scientific standards in considering the evidence.

One of the study’s lead authors, Prof Trudie Chalder from the psychiatry department at King’s College London said: “The decision to change the guideline has had a direct effect on doctors’ and therapists’ ability to treat patients. Services are no longer able to provide a full range of evidence-based therapeutic interventions.

“This could have a devastating impact on people’s lives in that they will no longer be able to access the treatment that could help them the most.”​

Full article: https://web.archive.org/web/2023071...scouraging-exercise-is-flawed-say-researchers
 
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Three Chord Monty said:
Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis

Peter White, Susan Abbey, Brian Angus, Harriet A Ball, Dedra S Buchwald, Christine Burness, Alan J Carson, Trudie Chalder, Daniel J Clauw, Jan Coebergh, Anthony S David, Barbara A Dworetzky, Mark J Edwards, Alberto J Espay, John Etherington, Per Fink, Signe Flottorp, Béatrice Garcin, Paul Garner, Paul Glasziou, Willie Hamilton, Peter Henningsen, Ingrid Hoeritzauer, Mujtaba Husain, Anne-Catherine M L Huys, Hans Knoop, Kurt Kroenke, Alexander Lehn, James L Levenson, Paul Little, Andrew Lloyd, Ira Madan, Jos W M van der Meer, Alastair Miller, Maurice Murphy, Irwin Nazareth, David L Perez, Wendy Phillips, Markus Reuber, Winfried Rief, Alastair Santhouse, Tereza Serranova, Michael Sharpe, Biba Stanton, Donna E Stewart, Jon Stone, Michele Tinazzi, Derick T Wade, Simon C Wessely, Vegard Wyller, Adam Zeman

Abstract
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive–behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.

We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which ‘downgraded’ the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.

We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.


https://jnnp.bmj.com/content/early/2023/07/09/jnnp-2022-330463
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There needs to be a strong, clear, unanimous response to this paper from those on the NICE Committee and those that gave expert evidence, along with all of the ME charities. This is an attempt at an attack on science and the scientific method in favour of anti-science and belief.
 
Article mainly sourced to Chalder and Garner, so as one would expect. Annoying that it is so prominent online. It would be better if outraged patients didn’t click on it, and it was superseded by the latest twists and turns of silly-season scandals.

Pretty robust response from NICE, which is good. They promise a rebuttal to Chalder’s paper.
 
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Joan Crawford said:
There needs to be a strong, clear, unanimous response to this paper from those on the NICE Committee and those that gave expert evidence, along with all of the ME charities. This is an attempt at an attack on science and the scientific method in favour of anti-science and belief.
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NICE were pretty robust in responding to the Graun’s otherwise uncritical regurgitation:


A Nice spokesperson said: “We reject entirely the conclusions drawn by the authors of this analysis, and in particular their conclusion that Nice has not followed international standards for guideline development which has led to guidance that could harm rather than help patients. In developing our guideline, as well as bringing together the best available scientific evidence, we also listened to the real, lived experience and testimony of people with ME/CFS to produce a balanced guideline which has their wellbeing at its heart.

“We will provide a detailed response to this analysis and in the meantime we are confident that system partners and the ME/CFS community will continue to work together to make sure the important recommendations in our guideline are implemented.”
 
"CFS/ME" because of course.

So, what went wrong? In this article, we raise concerns regarding the evidence synthesis, appraisal and interpretation that appear to have underpinned the revised guidance.
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For full details of concerns over the review process, please refer to the responses to consultation of the draft guideline by four Royal Colleges of Medicine and the Association of British Neurologists, among others, which are available on the NICE Guideline website. There was a remarkable consistency in the criticisms made by these organisations.
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Remarkable consistency.

CFS/ME shows pathophysiological changes, but there are no diagnostic tests.
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People with CFS/ME may not have their illness taken sufficiently seriously by health and other professionals.
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Both things that the authors bear quite some responsibility for.

Postexertional malaise is a common and important symptom of the illness.
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No. It is the defining feature.

While there is strong evidence that PEM is an important and common symptom of CFS/ME, the new guideline made it mandatory for making the diagnosis. This is problematic as PEM is not a mandatory symptom in the Centers for Disease Control and Prevention (CDC) definition which, with over 6000 citations on Google Scholar, is far and away the most widely researched definition of the condition
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The CDC says: "You can read more about how ME/CFS is diagnosed in the 2015 Institute of Medicine report on ME/CFS". Oh you're talking about the old and long superseded 1994 Fukuda definition.

Any longer-term follow-up is purely naturalistic and outcomes, good or bad, are progressively less attributable to the original treatment to which the participants were randomised. However, the NICE committee only considered outcomes for each trial at the data point furthest away from randomisation. The justification for this decision was to allow examination of long-term outcomes, such as mortality; but since CFS/ME is not a fatal disease, this is unconvincing.
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It was pretty fatal for those poor patients that died of it. Perhaps you should read The Times. And of course, given that, you know, mind and body can't be separated, you seem to be ignoring all the ME/CFS and Long Covid suicides (refs 1, 2, 3, 4) for some reason.

Time Magazine in 2022 said:
“My wife didn’t kill herself because she was depressed,” Güthe says. “She killed herself because she was in excruciating physical pain.”
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Suggesting that CBT should only be used to manage symptoms and reduce distress associated with having a chronic illness implies that there is a ‘core illness’ that CBT cannot change. This assumption is puzzling given that CFS/ME is defined purely in terms of symptoms and impaired functioning.
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Like Parkinson's then: Mayo Clinic —

Currently, there isn't a specific test to diagnose Parkinson's disease. A diagnosis is made by a doctor trained in nervous system conditions, known as a neurologist. A diagnosis of Parkinson's is based on your medical history, a review of your symptoms, and a neurological and physical exam.
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The new guideline refers the reader to the NICE guideline on neuropathic pain. However, the pain of CFS/ME is not neuropathic pain, which is caused by a lesion or disease affecting the somatosensory nervous system. There is no evidence that this is the case in CFS/ME, and the International Association for the Study of Pain does not include CFS/ME as a cause of neuropathic pain.
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Good for them. Can I remind you and them that absence of evidence is not evidence of absence?
 
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Charles B. said:
Why are so many FND zealots on this author list? To my knowledge, they’ve contributed little to nothing in bolstering understanding of the disease. How familiar would they be with the evidence base and controversy? All strange
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Many of them are keen on labelling ME/CFS as a functional condition, and many are keen on using CBT and physiotherapy as 'treatments' for functional conditions, so to have NICE show that the evidence base for CBT and GET for ME/CFS is severely lacking undermines their position.
 
Shadrach Loom said:
NICE were pretty robust in responding to the Graun’s otherwise uncritical regurgitation:


A Nice spokesperson said: “We reject entirely the conclusions drawn by the authors of this analysis, and in particular their conclusion that Nice has not followed international standards for guideline development which has led to guidance that could harm rather than help patients. In developing our guideline, as well as bringing together the best available scientific evidence, we also listened to the real, lived experience and testimony of people with ME/CFS to produce a balanced guideline which has their wellbeing at its heart.

“We will provide a detailed response to this analysis and in the meantime we are confident that system partners and the ME/CFS community will continue to work together to make sure the important recommendations in our guideline are implemented.”
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Good to see.

Will NICE be likely to respond to the journal editor? For publication. Is there a precedent for this?
 
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