A general thread on the PACE trial!

and other researchers still can't access the data inspite of it now supposedly being 'available'.

eta: I wonder if it might be worthwhile asking Todd Davenport to try, particularly as he is on the Cochrane independant exercise review committee.

 

This is in the very first minutes of the TSC from April 2004 at item 7:

“The outcome measures were discussed. It was noted that they may need to be an adjustment of the threshold needed for entry to ensure improvements were more than trivial. For instance a participant with a Chalder score of 4 would enter the trial and be judged improved with an outcome score of 3. The TSC suggested one solution would be that the entry criteria for the Chalder scale score should be 6 or above, so that a 50% reduction would be consistent with an outcome score of 3. A similar adjustment should be made for the SF-36 physical function sub-scale. …”

I’m pretty sure that’s not how science is supposed to be done, but hey, what do I know, I’m just a bundle of deconditioning and unhelpful illness beliefs after all, I’m not a *proper* scientist…

I also found this in the TSC minutes from Jan 2006 (page 3) where they get into more detail about the proposed changes to the eligibility and outcome criteria. I think they’d already started recruiting by this stage going by what’s been discussed in other parts of the minutes but I could be wrong. I’m not an expert on PACE, I just like reading stuff like this. I hope this is what you were looking for .

“Proposed changes to eligibility:

1. Increase the threshold for exclusion by SF36 physical function sub-scale from its current level of 60 by one incremental point to 65.

At present, there are two ways of assessing recovery for the trial:
i. To increase score on the SF-36 to a score of 70 or above, or
ii. To demonstrate a 50% improvement on SF-36 score from baseline.

The outcome score would therefore also be altered in the protocol from 70 to 75 to maintain a difference of two incremental points between entry criterion and a positive outcome on the SF-36 scale. An outcome score of 75 would be comparable with the FINE trial which uses a cut off score of 75 (the FINE trial eligibility cut off score for the SF-35 is 70).

Of patients excluded so far, at least six have been identified as having been excluded for an SF-36 score of 65 and it possible that several more for whom we do not have SF-36 scores recorded in the trial data, may also have met criteria.

The trial statisticians report that this change would have no impact on the analysis.

The TSC supported this change.

ACTION 1: Trial manager/PIs to submit the proposed change to the eligibility criteria from a score of 60 to 65 on the SF-36 to the MREC for approval.
Action 2: /PIs to submit a change from 70 to 75 on SF36 physical function subscale outcome criterion to the MREC for approval.”

ETA some clarification re recruitment timings.

 

I particularly like the bit where the minutes say that “the trial statisticians report that this change would have no impact on the analysis.”….

 

Basically: "real numbers, fake numbers, they're all numbers, we're in the business of analyzing numbers here, we'll even take imaginary ones."

And those "50%" improvement bits there show a massive problem with oversight. None of those numbers are real, the scales are not graduated or relate to any number in real life. Someone going from 45 to 90 is not twice improved, this is all mathemagics to the point of almost being numerology. Anyone who takes those numbers as meaning anything substantial need some serious reality check over being recklessly incompetent at their job and the impact this has onto real people they will never see or hear from.

The Thetans, they go over 9,000! Basically.

 

so it went from 75 to 60 to 65 (as entry criteria) as per @Sarah post
https://www.s4me.info/threads/a-general-thread-on-the-pace-trial.807/page-51#post-371584

 

The details can get fuzzy. They started recruiting at 60. Nine months in, recruitment was not great so they relaxed it and moved it up to 65 so they'd get more patients. That was "ok" at first because 75 was the protocol threshold for "improvement" on the SF-36 and 85 was the threshold for "recovery" on that scale. It was only post-hoc that they reduced that "normal range"/"recovery" threshold back down to 60. The SF-36 thresholds changed as often as Zsa Zsa Gabor got married.

 

I expect she likely had better justifications for her changes .

 

LOL. Perfect choice - Zsa Zsa Gabor also being famous for post-hoc number reductions and hiding data.

For the youngsters reading: she routinely lied about her age and tried to hide her driving license from court reporters. It listed her DOB as 1928, it was actually 1917.

 

Ha! I'd forgotten about that part.

 

Guy shown to be misguided and ignorant on issue decides to double down on his misguided ignorance. It's maddening that reality doesn't factor in at all. It's just all opinion and ignorance speculation.

https://twitter.com/user/status/1441517329221832706

https://twitter.com/user/status/1441821900552880128

 

I originally posted about this here ...

https://www.s4me.info/threads/paul-...les-and-other-media.15629/page-81#post-380139

I'm wondering if this could have much wider implications than I originally thought. Possibly even legal, if it ever came to that, especially with MUS and Long Covid now.

The blurb of this book ...

... strongly suggests that psychiatry has been very consciously aware, for a long time, that they can wilfully and easily influence people's self reporting of their physical symptoms. And their trials strongly suggest that, far from striving their best to avoid such bias, they in fact design their trials - and indeed their treatments - to actively exploit that mechanism, by whatever means.

I fully appreciate, from what @Jonathan Edwards has said in the past, that there is no excuse for any scientist of any discipline to not know this, but my point here is that psychology's own literature makes it very clear, so there is even less credibility of them being unaware. They do know it!

Surely, if it can be demonstrated that these BPS 'investigators' have been fully cognisant of this, long before embarking on any of their trials, then it strongly suggests much more than mere incompetence on their parts, but much more like wilful deception, fraudulent science. No matter how fervently a scientist might believe in their pet theory (and they are fully at liberty to), to wilfully manipulate outcomes in such a way, which in this instance requires manipulating people, must be so close to criminal. Especially when such manipulations then lead to such appalling medical practices.

My point here is not simply a rehash of what has been said many times before - I don't think. I'm saying that:

• They must have known beforehand that they could easily manipulate people so as to manipulate their results.
• That cannot have been unaware of this, because it is in their own psychology literature. If they were unware - professional ignorance is not a defence!
• Therefore they must have run their trials in full knowledge of how they could manipulate the participants and therefore their outcomes.
• Manipulation of trial results like this, when scientists must be fully aware of what they are doing - that is deception surely, plus whatever else that implies.
• Given this was achieved by deliberately manipulating participants, does this have any Human Rights implications?

So is this worth digging a bit deeper into? The aforementioned book cannot be the only psychology literature identifying this. (I'm emphasising the psychology literature because that is what the BPS crew would have the hardest time denying awareness of). And with that awareness how can they defend their work with ME/CFS, MUS, Long Covid, etc. that exploits such manipulation!

For them to try and argue they did not do this (in court or an enquiry one day?) they would have to argue ignorance of their own domain knowledge, which they of all people would be required to be fully up to speed on; knowledge which their own trials then demonstrated full exploitation of.

@dave30th, @Brian Hughes, @Jonathan Edwards, @Tom Kindlon, @Caroline Struthers

 

As a psychology undergraduate in the late 1970s and then involved in clinical research in the early 1980s, we were very much taught that self reported outcome measures in unblinded studies were methodologically unsound. It was accepted that in some circumstances they were unavoidable in psychological research, but then it was vital to seek convergent evidence. So for example even if it was agreed that PACE had to rely on subjective outcomes, it would be imperative to seek other approaches supporting you conclusions, for example undertaking studies to show that ME patients were demonstrably unfit, that they had demonstrably false views, that they became fitter as a result of the supposedly successful intervention, etc.

It feels to me that the research used by the BPS proponents is far from what was known to be ideal some forty years ago. Interestingly the main figures in this field are not research psychologists, but have drifted into psychological research from other fields, which perhaps is a contributory factor in their monomania for an inappropriate experimental design.

 

Not related to previous post, but just came across this...

 

Whereas they instead cite other trials all exhibiting the same shortcomings.

 

Yes ‘convergent evidence’ does not mean lots of evidence from repeated use of the same experimental design, but rather evidence from very different sources or different research methods.

Repeating the same error over and over again, does not make the results any more reliable, but it may be that a range of radically different evidence sources may help compensate for problems in anyone approach.

 

Oh, they knew all along, and admitted it freely among friendly audiences.

These charlatans have openly been attributing to themselves the mere passage of time. They knew it and did it anyway. And as other studies, and LC has emphasized, "some people" is actually most people. Essentially recovery is the norm from onset and time is the main factor. It can be slow and there is no more explanation for someone recovering after 2 years, 6 months or 6 weeks, but they don't even need to do anything and a significant enough number will naturally recover for them to take credit for.

It really needs to be emphasized that many countries have not developed anything at all for chronic illness. And while some countries, like Germany, have built a generic set of institutions for "psychosomatic" stuff, as best as we can tell there is no difference in outcome. They know, they even admit it when they don't have a choice. So, yes, there will be a strong case to make that they knew. There are only two options: malice, or rank incompetence. Or both.