BMJ: Rapid response to 'Updated NICE guidance on CFS', 2021, Jason Busse et al, Co-chair and members of the GRADE working group

Looks like a comedy sketch!

If they had objective measures at the start and subjective measurements at the end (and we know that subjective outcome monitoring overestimates activity) then that's a pretty neat (apologies) way to cook the books. If they'd used subjective indicators pre-intervention and subjective indicators post-intervention then they wouldn't have got the same "benefit". I just internally questioned their parents marital status, but the PACE folks weren't stupid -- greedy, deceitful ---- but not stupid!

 

Sorry--I guess I was discussing that on another thread somewhere. Health Research Authority. they issued a report on PACE a couple of years ago that gives the impression it is giving PACE an ethical clean bill of health. but in reality the agency's remit was limited and they didn't look at most of what the problems were. but it provides a veneer of protection to PACE.

 

Larun made a brief reference to safety on the Cochrane exercise review implying that the issue had been addressed by the PACE trial
https://www.s4me.info/threads/indep...ed-by-hilda-bastian.13645/page-35#post-322739

 

Got this reply from my MP:
"Thanks for getting in touch to raise this. We can certainly ask a written question about the issue to the Secretary of State for Health, but perhaps you think it may be best raised via the Public Accounts Committee. They can be contacted via this email pubaccom@parliament.uk."

So I may be drafting a written question and emailing the public accounts committee

I may be looking for advice

@dave30th

 

Hi here's an initial attempt re question to the Secretary of State:
"The PACE trial set out to discover whether cognitive behaviour therapy [CBT] and graded exercise therapy [GET] are safe and effective forms of treatment for myalgic encephalomyelitis/chronic fatigue syndrome."
The original study protocol required objective measurement of activity [Accelerometers - did it - reference] to measure the outcome of the intervention [CBT & GET] this was then changed, mid-study, to [subjective] self-report activity diary. The initial measurement of activity [pre CBT & GET] used objective measurement [Accelerometers] [was it changed - reference] but the post intervention outcome assessment was based solely on [subjective] self-report activity diary [was it changed - reference]. Since [subjective] self-report activity diary consistently overestimates activity levels, i.e. compared to objective measurement [Accelerometers], then, even if there was no intervention [CBT & GET], the study would have shown a positive impact!
The study was paid for by the Government £5 million [correct? - which Department paid for it]. It was then used as the basis for NICE guidance [correct? - evidence] i.e. supporting CBT & GET even though there was no objective evidence that these worked.
In addition to the direct financial cost, there's also the cost to individuals who were forced to exercise [GET] while there was no evidence that they were well enough to do so/would benefit. Also, CBT is inevitably a label that "negative thoughts" perpetuate illness. There are no biomedical tests for Alzheimer's disease but no one would suggest CBT since, in the absence of an understood biological cause, it must be "psychological".
NICE guidance is now being revised and the revised guidance, in part, addresses the absence of evidence for CBT & GET [correct? - evidence].

What steps is the Minister taking to ensure that studies funded by his Department now use objective evaluation criteria?

Will the Minister inform the public accounts committee of concerns that the publicly funded PACE trial did not follow the original protocol i.e. that the use of objective assessment criteria was abandoned mid-trial [correct? - evidence]? Also, that the revised NICE guidance highlights that the PACE study should not have been used to provide CBT & GET at public expense [correct? - evidence]."[end]

I'd be inclined to ask my MP to copy the email to the Secretary of State for Health to the public accounts committee - might help to put the secretary of state on notice that this may not quietly disappear.

The above may be inaccurate - evidence may be required to substantiate some points - grateful for your assistance.

@dave30th

 

I'm not sure that is strictly accurate.

There were a series of small previous trials on GET & CBT. They were underpowered and all faced some criticism I believe. The NICE (2007?) guidelines predate PACE (2011?).

PACE was the trial that was supposed to finally settle the GET &CBT question once and for all and reinforce the evidence underpinning the NICE guidelines.

Edit - removed a rogue question mark

 

I don't know if you've deliberately left it out for fear of muddying the waters @FMMM1 but during the PACE trial participants were issued a newsletter that basically told.them the GET & CBT were effective treatments.

Given the trial ditched the only objective measurement and relied mainly in subjective responses this newsletter would potentially have the effect of amplify any subjectively positive reports by patients desperate to get well.

 

Thanks @Trish

 

Just to clarify--the investigators published a newsletter and posted it. It is unclear whether it was sent to participants or "issued" to them in any way beyond it being posted. It doesn't matter--publicly posting it was a complete violation. But better to be accurate in describing it.
Also, PACE was not the basis for NICE--the NICE guidance came out in 2007 based on smaller studies. When it came out, PACE was used to essentially affirm the accuracy of the 2007 guidance.

Also, they didn't "replace" the objective with subjective measures. They always had subjective primary outcomes. But they dropped the one actual objective measure that could measure how much activity people engaged in for bogus reasons while claiming it was ok because they had other objective measures. Then, of course, all their objective measure failed, so they discounted them as not really objective after all.

 

This is astonishing. I suppose if you a priori disregard the decades-long consistent pattern of patient reports that doing exactly what is being suggested here made them worse or even bedridden then yeah sure there is no evidence that it causes harm.

 

I would argue that employment data and benefits data is a pretty objective measure of actual activity.
Of course, even though this was STRONGLY negative, it was only in one table of the 'cost-effectiveness' followup paper, and almost ignored in favour of more carefully cooked measures. (entirely ignored in abstract).
Actiometer readings are arguably only as important at best than measures of usual functioning.

Both have issues. If you can do 10000 steps a day as a zombie, as part of a continuing exercise program, this is no more or less important than if you have 'recovered' and are exhausted after a day at work.

 

Surely if they were at all interested in helping people 'recover' then that data should have prompted a trail into anti CBT/GET?

Which I suppose would involve telling people that they are really quite ill and that they should do less, relax if possible, with graded being served/helped classes - as well as throwing welfare benefits, aids etc at them.

Exactly the opposite of what they have been doing and propagating as part of the BPS approach.

When is the evidence based study into this going to happen?

 

Thanks for the feedback. Here's a revised draft re a parliamentary question to the [Westminster Parliament] Secretary of State for Health:

"The PACE trial set out to discover whether cognitive behaviour therapy [CBT] and graded exercise therapy [GET] are safe and effective forms of treatment for myalgic encephalomyelitis/chronic fatigue syndrome."

The original study protocol required objective measurement of activity [actometers] to measure the outcome of the intervention [CBT & GET] this was then changed, mid-study, to subjective measurements [questionnaires]. Subjective measurement of activity [questionnaires] consistently overestimates activity levels, i.e. compared to objective measurement [actometers].

While those who received CBT, and GET, were not able to increase the number of hours employed, in education, etc. they were labelled as "improved"; i.e. due to the use of subjective measurement of activity [questionnaires].

The PACE study was paid for by the Government (£5 million). The study was then used to support NICE guidance, i.e. recommending the use of CBT & GET, even though there was no objective evidence that these worked.

In addition to the direct financial cost, there's also the cost to individuals who were forced to exercise [GET] while there was no evidence that they were well enough to do so/would benefit. Also, CBT is inevitably a label that "negative thoughts" perpetuate illness. There are no biomedical tests for Alzheimer's disease but no one would suggest CBT since, in the absence of an understood biological cause, it must be "psychological".

NICE guidance is now being revised and the draft revised guidance, in part, addresses the absence of evidence for CBT & GET.

What steps is the Minister taking to ensure that studies funded by his Department now use objective evaluation criteria?

Will the Minister inform the public accounts committee of concerns that the (publicly funded) PACE study protocol specified objective evaluation criteria (actometers) and that this was changed (mid-study) to subjective criteria (questionnaires). Also, that the PACE study was used to support NICE guidance, recommending the use of CBT & GET for ME/CFS, despite the fact that the study did not use objective evaluation criteria?"

I can ask the MP to copy to the public accounts committee!

Grateful for feedback.

@dave30th

 

I don't know if it accurate to day it was fully funded by the government. Some of the cash apparently came from.the MRC & I don't know if that could be considered as govt money? According to.ME-pedia -
https://me-pedia.org/wiki/PACE_trial

 

From the Alzheimers society
"
Adapting cognitive behavioural therapy for people with dementia
Read about a research project we funded into adapting cognitive behavioural therapy for people with dementia."
https://www.alzheimers.org.uk/resea...cognitive-behavioural-therapy-people-dementia

 

You wouldn't/couldn't make it up --- you're cognitively impaired, due to an underlying (biological) illness, and they suggest CBT --- as if the world wasn't already confusing enough --- try CBT!

Thanks I'll re-draft.