A general thread on the PACE trial!

Sly Saint said:
the PACE protocol said


I'm sure that someone must have looked at the outcome measures of these 'successful' trials, but if they then used the same ones in the PACE trial, why did they then feel that they had to change them?

Presumably they were not considered 'too extreme' when they were 'successful'.
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Amazing, isn't it? They use their history of running many identical, though smaller, trials to justify why they are experts at this, but also the fact that everything was unpredictable so they had to massively change course during the trial to match the expected effectiveness they promised firmly, based on their experience with prior trials, enough that the 2007 NICE guidelines were published basically certain that it would confirm the baseless claims they relied on.

It would be great to have a small library of their blatant contradictions, such as this nonsense about unhelpful beliefs being a strawman even though those are their literal words going back decades. It's going to be so damning once we can do that, though. Just how much they lied, but also how no one but us cared that they did. Journalists could easily care to check before writing, most don't even care to correct when presented with contradictions to what they wrote.
 
I cant believe that Sharpe just said 'illness beliefs' was a straw man.

I just cannot believe what i'm reading. I know i shouldnt be shocked, but i am.

If they dont think beliefs about the illness underpin anything why are they targeting said beliefs in CBT. I'm staggered by that comment. I hope someone is responding to him, just for the sake of those he will take in.
 
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@JemPD i suspect he is playing games around ‘false illness beliefs’ again because his lot have used ‘unhelpful’ illness beliefs so whenever people use the word false he feels able to deny it. Splitting hairs of course but it makes it seem to casual observers that they have never claimed anything about illness beliefs at all.
 
None of this would work if fellow physicians and journalists called them out on it, or literally anyone for that matter. They almost never do. Those who do, like Tuller, they just never talk to on record. It takes people to overlook those lies for them to be able to continue spewing them. That's the main consequence of "de-medicalizing" a disease: no one has to give a damn, there is no professional responsibility in medicine for something that isn't medical, it makes it someone else's job. Well technically it doesn't but it works out the same, gives implausible deniability.

It takes a lot of people to accept blatant lies for liars to succeed. There is huge demand for those specific lies, the medical profession buys every last one of them. And as for journalists fact-checking, they turn to medical experts for that, so it's not possible to fact-check most details, so it seems most never bother at all.
 
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NelliePledge said:
@JemPD i suspect he is playing games around ‘false illness beliefs’ again because his lot have used ‘unhelpful’ illness beliefs so whenever people use the word false he feels able to deny it. Splitting hairs of course but it makes it seem to casual observers that they have never claimed anything about illness beliefs at all.
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Ah yes... i'm not sure how often i read the word 'false' in the lit, just aberrant & then unhelpful, but since the premise of the CBT for ME is that we beleiev we have organic illness when we dont, 'false' describes that. So regardless of how many times he has said the actual word 'false', to believe something that is not true, is the same as to believe something that is false... ergo...
 
Sly Saint said:
found myself drawn back into reading the protocol

"Assumptions
: At one year we assume that 60% will improve with CBT, 50% with GET, 25% with APT and
10% with UMC.
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These figures are interesting in that they may illustrate just how prevalent it may be for physicians like Andrew Goddard to 'see the efficacy of the treatments', and how wrong this impression actually is.

It looks as if these figures were derived from previous trials but we know that the authors have a preference for results that fit with their experience in the clinic.

In fact it makes it rather ironic that the justification for changing the outcome measure in PACE was that it gave results more consistent with experience. It didn't it seems. Experience had led them to expect quite different results?

Controlled trials can give disappointing results for a variety of reasons - the effect of blinding may show that preliminary studies had subjective bias. But PACE was not blinded. Large trials may recruit patients who in reality would not be chosen as suitable for the treatment. But the PACE authors insist that they recruited the right population.
 
Jonathan Edwards said:
but it seems they changed the outcome thresholds because the results weren't consistent with their previous experience! Assuming course we are talking of experience of outcomes rather than experience of having your trials come out the way you want.
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Exactly. They justified it on the basis of their clinical experience, and also on the basis that the results with the changed outcomes were more consistent with the earlier trila results. In other words, they based PACE on the early trials and then changed PACE outcomes so the results would reflect the earlier trials that PACE was supposed to be testing. It's a circular argument.
 
3.6 What are the planned inclusion/exclusion criteria?
Inclusion criteria: Subjects will be required to meet operationalised Oxford criteria for CFS.2 This means 6 months or more of medically unexplained, severe, disabling fatigue affecting physical and mental functions.2
We will operationalise CFS in terms of fatigue severity and disability as follows: a Chalder fatigue score 23 of four or more and an SF36 physical function score 24 of less than 75 (see section 3.9).

We chose these broad criteria in order to enhance generalisability and recruitment. The more narrowly defined CDC criteria are about to be revised and then superseded by an empirically derived definition (PDW is a member of this CDC led group). Those subjects who also meet the criteria for "fibromyalgia" (chronic widespread pain) will be identified but included,25 because CFS and "fibromyalgia" commonly coexist.26
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https://web.archive.org/web/20040715194646/http://www.bryantpr.plus.com/THE PACE TRIAL IDENTIFIER .pdf

eta: so the inclusion criteria for the SF-36 was even higher to begin with(?)
 
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Sly Saint said:
anyone know when they changed the official entry criteria for SF-36 from 75 to 65?

eta: presumably it was before they started recruiting(?)
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The official protocol is here:
https://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6

It uses 65 or less.

I think it one stage it was 60 and then it was moved (I'm a bit rusty). It definitely wasn't 75 when they started recruiting.

The interesting thing about their proposing 75, is it shows how ridiculous the threshold of sixty is for normal physical functioning and also as one of the revised criteria for recovery (the protocol used 85).
 
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From page 154 of the GET therapists' manual:

upload_2021-9-4_15-29-29.png

That is all there is on the subject. The same is on page 55 of the GET participants' manual.

And if you look at the previous section for each manual, relating to normal reactions to exercise, it becomes abundantly clear they had no acknowledgement of the possibility that the exacerbation of symptoms might, itself, be a form of harm attributable to the treatment itself.

ETA: There seems a rather bitter irony that it also says "If you feel anything else that is making you feel uncomfortable during exercise be sure to discuss this with your physiotherapist or doctor". Were they 'aving a larf or what! And no mention of after exercise.
 
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Sly Saint said:
anyone know when they changed the official entry criteria for SF-36 from 75 to 65?

eta: presumably it was before they started recruiting(?)
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Dolphin said:
It uses 65 or less.

I think it one stage it was 60 and then it was moved (I'm a bit rusty). It definitely wasn't 75 when they started recruiting.
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According to Vink in JHP commentary, PACE trial authors continue to ignore their own null effect, at trial registration in 2003 it was less than 75, before the trial started it was changed to 60 or less and then, during the trial, it was changed to 65 or less.
 
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