New NICE guideline on chronic fatigue syndrome: more ideology than science? 2022, Flottorp et al

The Lancet New NICE guideline on chronic fatigue syndrome: more ideology than science?
Signe A. Flottorp, Kjetil Brurberg, Per Fink, Hans Knoop, Vegard B B Wyller

Article is paywalled other than this text (references removed):

The National Institute for Health and Care Excellence (NICE) in the UK published a new chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) guideline in October, 2021.
The previous NICE 2007 guideline recommended cognitive behavioural therapy (CBT) and graded exercise therapy (GET) for people with mild or moderate CFS/ME based on evidence from randomised trials.
Since then, more randomised trials and systematic reviews have provided additional evidence supporting these recommendations.
No new or more effective interventions have been identified. Although we applaud guideline efforts, it is remarkable that recommendations in the 2021 NICE guideline differ substantially from the previous one, and do not include CBT and GET as means to treat CFS/ME. The new guideline presents strengthened evidence, but a major shift in interpretation. How could this happen?

 

Yes please. Thank you!

 

I do hope they explain that someone noticed they were trying to assemble a squirrel, using the instruction manual for a lobster.

 

Yes please. Thanks!

 

Could I have a copy? Thanks.

 

The National Institute for Health and Care Excellence (NICE) in the UK published a new chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) guideline in October, 2021.The previous NICE 2007 guideline recommended cognitive behavioural therapy (CBT) and graded exercise therapy (GET) for people with mild or moderate CFS/ME based on evidence from randomised trials. Since then, more randomised trials and systematic reviews have provided additional evidence supporting these recommendations. No new or more effective interventions have been identified. Although we applaud guideline efforts, it is remarkable that recommendations in the 2021 NICE guideline differ substantially from the previous one, and do not include CBT and GET as means to treat CFS/ME. The new guideline presents strengthened evidence, but a major shift in interpretation. How could this happen?

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00183-0/fulltext

Reference 18 is a forum thread here: https://www.s4me.info/threads/nice-...deline-committee-has-now-been-published.6197/

Not currently available on sci-hub so I can't read it.

 

Presumably they mean "How could this have been allowed to happen?"

Some did try their best.

 

Amazing aren't they. Even if the evidence had been identical, a new interpretation can very easily change significantly, especially if the old interpretation was simply rubbish, based on prejudicial beliefs and bias, rather than on scientific competence. The fact they cannot see this (or at least want others to not see it) is egregious and incompetent in itself. They don't do self-awareness much do they.

 

((happy to share the text but don't think it's allowed on the forum))

"didn't respect GRADE" moans the GRADE member.
"didn't like Cochrane's review" moans the Cochrane lead.
"didn't recommend CBT" moans the HK who receives royalties for a treatment manual of CBT for CFS/ME.
"committee members and expert witnesses had negative opinions regarding the interventions considered"...too much basis on ideology say the authors, recommending the guideline committee ought to have explored preconceptions and competing interests.

The previous NICE 2007 guideline recommended cognitive behavioural therapy (CBT) and graded exercise therapy (GET) for people with mild or moderate CFS/ME based on evidence from randomised trials.2 Since then, more randomised trials and systematic reviews have provided additional evidence supporting these recommendations.3–8

well that's fact then I guess. PACE = evidence pro. No reference to the detailed debate over PACE that has ensued over...a decade?

"PEM is present among cancer survivors" they say, based on a single study of 18 people of which 33% fit their criteria for PEM.

...committee presented a new non-validated diagnostic definition of CFS/ME, making post-exertional malaise (PEM) a required criterion. This reliance on one subjective symptom for diagnostic purposes is inconsistent with the guideline committee’s downgrading of trials that use subjective symptoms as primary endpoints. This approach also overlooks research showing that changes in diagnostic criteria can lead to unintended consequences in the target population11 and that PEM is unspecific (eg, it is prevalent among cancer survivors).12 The guideline committee downgraded all studies not mandating PEM for indirectness, although data presented during the consultation process showed improvement of PEM and other symptoms in trials of CBT and GET, and also overlooked evidence that treatment effect is similar across different diagnostic criteria, including those with PEM.6,13...

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The guideline committee decided to consider trial outcomes at the furthest time away from recruitment, overlooking data on end of treatment and the trial primary endpoint in the largest trial of CBT and GET.6 This omission contributed to downgrading for imprecision and the questionable conclusion in the new guideline that there was insufficient evidence for the efficacy of CBT and GET. Here, NICE did not account for cross-over between the intervention and the control group during long-term follow-up. Trials of COVID-19 vaccination might be illustrative: given the guideline committee’s principle of using outcome measures “furthest time away”, a long-term follow-up vaccination trial would probably show no beneficial effect of the vaccine because the control group would presumably have been immunised as well.

so...wait..seriously?

 

I'm sure what the current situation is but at the end of 2021 there seemed to be a moratorium on new material on SH - connected I think to a law suit in India https://www.nature.com/articles/d41586-021-03659-0

 

First page can be read here:
https://www.sciencedirect.com/science/article/abs/pii/S0140673622001830

 

What does HK mean?

 

Statement on Twitter from the ME Association on the Lancet comment.

And a comment from prof. Kunst reminding that it's not an editorial

 

Hans Knoop, perhaps

 

It seems strange that they say During the guideline process three professional members of the guideline committee stepped down.

It is both true and false. The Guideline was yet to be signed off by the Executive Committee, but the work of the Guideline Committee was concluded, and so far as we can tell, no objections were raised. What is the Lancet doing, publishing such misinformation? Or perhaps they can correct the impression which we have.

 

What are they even trying to say here? I read this over and over again trying to understand their reasoning.

That certain illnesses don't have an objective diagnostic test doesn't mean that clinical trials of treatments for these illnesses don't suffer from reporting bias affecting the outcomes.

I haven't checked but believe that the "new diagnostic definition" is just the IOM definition from 2015 with the minimum duration of symptoms reduced from 6 to 3 months. According to the IOM's review, PEM is considered the symptom that best helps distinguish ME/CFS from other conditions. So NICE wants clinical trials to use more reliable diagnostic criteria, and more reliable outcomes. No inconsistency here.

People unfamiliar with the topic could be misled by "This reliance on one subjective symptom for diagnostic purposes". This is a misunderstanding by the authors who appear to erroneously believe that PEM is the only symptom required for diagnosis. Maybe this explains the strange (lack of) reasoning.

 

Comments by Keith Geraghty https://twitter.com/user/status/1492135842416058370

 

One can look at the references mentioned in it for free at the Lancet site:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00183-0/fulltext