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

Barry said:
"Although we originally planned to use actigraphy as an outcome measure, as well as a baseline measure, we decided that a test that required participants to wear an actometer around their ankle for a week was too great a burden at the end of the trial."
I find this interesting. If it was not too great a burden at the beginning of the trial, why was it too great a burden at the end of the trial, when people were supposedly improved?

Moreover, if it was a burden, then the very act of removing that burden would have inevitably resulted in improved subjective impressions of how participants would have felt. If I went on a hike with a backpack, and then the backpack was removed, any subjective impressions I gave would be improved because I could not help but feel more positive, given the lightened burden.
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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!
 
FMMM1 said:
what "HRA" is
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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.
 
dave30th said:
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.
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Even when it says that the debate should continue.

HRA report said:
The range of views suggests that the debate needs to be continued, not constricted by regulatory action.
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To me that seems like a very simple thing a journalist (not referring to you @dave30th) could have asked anyone who uses it to end discussion, but I've never seen that happen in Norway at least. It's just taken at face value that the report gave the study a clean bill of health.
 
FMMM1 said:
Finally emailed my MP i.e. to try to raise the change in the methodology (outcome indicators - objective to subjective) in the PACE protocol. If there's revised NICE guidance, which (at least in part) undoes the mistake, then this may be an opportune time to remind Government of the need to learn lessons.
Probably a lot of flaws in this*!

*"My MP,
there's a Government funded study on the use of Graded Exercise Therapy [GET] and Cognitive Behavioural Thereapy (CBT) in Myalgic Encephalomyelitis (ME)
- the study is called PACE. PACE was used for the current NICE guidance for ME.

The original protocol for the PACE study used objective monitoring of activity levels - actmetry - think of a Fitbit type device. However, the study protocol was revised to use subjective outcome measures (questionnaires). The reasons given for the change to the study protocol differed and were not convincing. Subjective measurement of activity consistently overestimates activity levels [https://www.sciencedirect.com/science/article/abs/pii/S0022399921000623]. In this case the use of subjective outcomes led to a policy [NICE guidance] which caused harm to people with ME/CFS.

The NICE guidance is currently being revised, and the review panel have downgraded studies, like PACE, which used subjective outcome measures.

I think the change to the study protocol, i.e.to replace objective outcome measures with (biased) subjective outcome measures, should be raised through the relevant oversight committee in Westminster - the public accounts committee?

I would be grateful if you would advise how to raise the issue of the change to the PACE study protocol to subjective (biased) outcome measurements.

Thank you for your assistance & happy to discuss
Francis
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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
 
FMMM1 said:
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
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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
 
FMMM1 said:
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.
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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.
 
Invisible Woman said:
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.
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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.
 
Barry said:
From pages 81~82 of the PACE GET Participant Manual:

"Example of a setback plan: (your plan might have some differences)
  1. Setbacks are a normal part of recovery: it is the overall trend that is important
  2. Setbacks are likely to become less severe and last for less time than previously as I get stronger
  3. I should try to maintain as much physical activity as I can, even though this may feel more difficult than normal
  4. I need to remember that there is no evidence to suggest that my symptoms are causing me any harm, even though they feel very uncomfortable
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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.
 
dave30th said:
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.
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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.


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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?
 
Trish said:
I dont think activity diaries were used in PACE. I think the only activity related outcome measure was the SF-36 physical function questionnaire.
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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
 
FMMM1 said:
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].
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I don't think this is right. It's important to be completely factually accurate in a situation like this. Worth checking the documentation.

As I understand it, the primary outcome measure for improvement and recovery in the original protocol was based on a mix of subjective measures - CFQ, SF36-PF, and how much the patient and the doctor said they had improved.
There were 4 objective secondary outcome measures - actimeter (steps), step test, 6 minute walk test and employment.
Only the actimeter was scrapped out of the 4. The other objective measures were reported with as little emphasis as possible, mostly in later papers, and showed no significant benefit.
The changes to primary outcome measures were on the subjective ones, enabling the researchers to claim improments and recoveries that weren't shown on reanalysis using the original protocol levels.
 
FMMM1 said:
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.
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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

The PACE trial[2] was funded by the UK Medical Research Council, Department of Health and Social Care (UK) for England, Scottish Chief Scientist Office, and - apparently uniquely for a clinical trial - the Department for Work and Pensions - the government department for sickness, disability and pension benefits.
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Sly Saint said:
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
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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.
 
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