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PACE Trial team won't release data they've already published in graph form

Sean

Senior Member
Messages
7,378
This relates to this graph. CBT and GET had the lowest (i.e. worst) fitness scores at 52 weeks
View attachment 12005

Time points are baseline, 12 weeks, 24 weeks and 52 weeks.
Don't need fancy stats to know that graph says CBT & GET failed to make any difference on one of the two (reported) objective physical outcome measures.

The other reported physical outcome measure was the 6 Minute Walk Test, where CBT made no difference, and GET made a very small statistical difference that did not reach clinical significance and still left patients scoring equivalent to some of the sickest cardiopulmonary patients medicine has to deal with.

Then there is the whole failure to collect actometer outcome data saga... :mad:

Short version: No objective physical outcome measure in PACE showed a meaningful improvement for patients.
 
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A.B.

Senior Member
Messages
3,780
Does anyone know exactly what specialist medical care was? It could be almost anything. I'm curious what kind of specialist treatment is less effective than mere pacing.
 
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Hutan

Senior Member
Messages
1,099
Location
New Zealand
From the discussion section of the paper, which is masterful in its obfuscation:

This mediational analysis strengthens the validity of our theoretical model of CBT and supports the idea that a similar model is valid for GET by confirming the role of fearful beliefs and avoidance behaviour. The review of beliefs in chronic fatigue syndrome and fibromyalgia34 suggested that fear and avoidance of movement were related to poorer outcomes. Our results suggest that fearful beliefs can be changed by directly challenging
such beliefs (as in CBT) or by simple behaviour change with a graded approach to the avoided activity (as in GET).

Argh
 

A.B.

Senior Member
Messages
3,780
The review of beliefs in chronic fatigue syndrome and fibromyalgia34 suggested that fear and avoidance of movement were related to poorer outcomes.

Because everyone knows the only explanation for a correlation between beliefs and outcomes is that the beliefs are determining the outcome. It is like, totally impossible, that beliefs (or any other psychological measure) are an index of disease severity.
 
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MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Because everyone knows the only explanation for a correlation between beliefs and outcomes is that the beliefs are determining the outcome. It is like, totally impossible, that beliefs (or any other psychological measure) are an index of disease severity.

If it starts raining when I am out, I get wet, so I have come to believe that if I go out in the rain I will get wet. I'll have to try not believing that I will get wet - then presumably I won't. o_O
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Does anyone know exactly what specialist medical care was? It could be almost anything. I'm curious what kind of specialist treatment is less effective than mere pacing.
It wasn't really specialist medical care in the usual sense of the word 'specialist'. It consisted of some basic advice to avoid boom and bust, and prescribing of pain and sleep meds where needed. I'm going from memory but I think that was it in essence.
 

user9876

Senior Member
Messages
4,556
It wasn't really specialist medical care in the usual sense of the word 'specialist'. It consisted of some basic advice to avoid boom and bust, and prescribing of pain and sleep meds where needed. I'm going from memory but I think that was it in essence.

It did give the biggest gain of all which I suspect comes from people getting better pain and sleep meds
 

A.B.

Senior Member
Messages
3,780
It did give the biggest gain of all which I suspect comes from people getting better pain and sleep meds

The adaptive pacing therapy group had the biggest gain in the long term. It just started noticeably worse off and therefore the fact that it had the biggest gain isn't apparent in the tiny graph. Anyway, speaking of "big" gains is misleading, none of the interventions would qualify as effective.
 
Messages
32
Time to start demanding a published retraction of their dubious conclusions?
Indeed. In this published paper (the mediation analysis) in which the fitness data was published, the authors quietly acknowledged that their deconditioning hypothesis for CFS was not supported by their data. But it's only a very brief and subtle acknowledgement in one line of text; Blink and you'd miss it. The deconditioning theory was central to the PACE trial, because GET was designed to address and reverse deconditioning, as its fundamental mechanism of action. The step test was used to measure fitness which was the trial's indicator of conditioning/deconditioning, so it's quite a big deal that fitness did not improve after GET because it means that GET failed to improve deconditioning. Strange how there's so much fanfare in relation to the PACE trial's trumped-up, misleading and flawed claims of success, but then only a single line of fairly ambiguous text about the failure of the PACE trial to support the hypothesis upon which GET was based. And the fitness data, showing that GET failed to improve this objective measure of physical capacity, was buried in an obscure secondary analysis in the seventh-ish PACE trial paper, almost four years after the main paper was published. To acknowledge that their deconditioning theory (upon which GET was based) was not supported by the data in the biggest trial of GET for CFS, is a huge admission. They're basically admitting that they may have been wrong all these years about the nature of CFS (i.e. that CFS is not actually perpetuated by deconditioning after all, despite decades of aggressively claiming that this is the case, and saying that the patient community is misguided and foolish for thinking otherwise.) It's huge. But I doubt if we'll ever hear them admit it again. To admit that CBT and GET failed to clinically improve any of the objective measures in the PACE trial is an embarrassment for those who have built their careers aggressively claiming that CFS is reversible with CBT or GET. Which is why we'll never hear the authors making such an admission.

This is their subtle, brief and buried acknowledgement that their deconditioning theory has come crashing down around their heads in the biggest trial ever of GET for CFS. (Note that 'fitness' indicates 'conditioning', so a lack of fitness equates to deconditioning):
Chalder et al. 2015 said:
There were no effects on HADS anxiety, physical fitness, or the adjusted perception of effort measure (Borg scale).
Chalder et al. 2015 said:
We found that fitness and perception of exertion did not appear to mediate treatment effects, but that timed walking distance, assessed for the first time in our study, mediated the effect of GET. This suggests that increasing tolerance of physical activity might produce benefit without improving physical fitness.
Note that GET did not result in a clinically useful effect in the timed walking distance test either, so their claim that "timed walking distance .. mediated the effect of GET" seems a bit flaky, to say the least.
 
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Sean

Senior Member
Messages
7,378
This suggests that increasing tolerance of physical activity might produce benefit without improving physical fitness.

A particularly bizarre proposition. Increasing tolerance of physical activity is the same as saying increasing capacity for physical activity, which is the same as saying improving physical fitness.

What a complete crock. :thumbdown:
 
Messages
32
Chalder et al. 2015 said:
..timed walking distance, assessed for the first time in our study, mediated the effect of GET. This suggests that increasing tolerance of physical activity might produce benefit without improving physical fitness.
A particularly bizarre proposition. Increasing tolerance of physical activity is the same as saying increasing capacity for physical activity, which is the same as saying improving physical fitness.
It's also an odd remark to make because CBT and GET didn't meaningfully improve average 'tolerance of physical activity' in the PACE trial, as assessed via the 6 minute walking distance test. If they're still seeking to improve 'tolerance of physical activity' with CBT and GET, then they clearly haven't learned the lessons from the PACE trial.
 

user9876

Senior Member
Messages
4,556
The adaptive pacing therapy group had the biggest gain in the long term. It just started noticeably worse off and therefore the fact that it had the biggest gain isn't apparent in the tiny graph. Anyway, speaking of "big" gains is misleading, none of the interventions would qualify as effective.

All the groups had SMC with three having an additional component. I believe in general (rather than for this particular graph) that the SMC on its own had bigger gains than the difference between SMC and the additional component.
 

anciendaze

Senior Member
Messages
1,841
All the groups had SMC with three having an additional component. I believe in general (rather than for this particular graph) that the SMC on its own had bigger gains than the difference between SMC and the additional component.
Yes, but the SMC alone cohort lacked the pixie dust available to the CBT and GET cohorts. :rolleyes:
 
Messages
32
It's worth noting that, for CBT, there were absolutely no objectively-measured improvements in the PACE trial:

Employment outcomes - no improvements.
Welfare benefit claims - no improvements.
Private insurance claims - no improvements.
Physical disability (6 minute walking test) - no improvements.
Fitness (step test) - no improvements.
 
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Mark

Senior Member
Messages
5,238
Location
Sofa, UK
It's worth noting that, for CBT, there were absolutely no objectively-measured improvements in the PACE trial:

Employment outcomes - no improvements.
Welfare benefit claims - no improvements.
Private insurance claims - no improvements.
Physical disability (6 minute walking test) - no improvements.
Fitness (step test) - no improvements.
It might be worth setting out the before and after numbers, from the relevant papers, on those particular stats. Someone might be able to make a good leaflet, or graphic, or something, out of that..."CBT: Before and after..."