Alem Matthees analyses on released PACE data blast "recovery" claims - huge damage to PACE

deleder2k

deleder2k

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Margaret Williams' remaks:
  1. There was no committee approval for the re-definition of “recovery”.

  2. “Recovery” rates for CBT and GET were not statistically significant.

  3. The PACE PIs originally reported “recovery” rates of 22% for CBT and GET.

  4. The published “recovery” rates were based on thresholds that deviated substantially from the published protocol and were inflated by an average of four-fold.

  5. In contrast to the published paper by the PIs, the recovery rates in the CBT and GET groups are not significantly higher than in the SMC (standard medical care) group alone.

  6. APT (adaptive pacing therapy) was a highly modified version of “pacing” (preferred by patients).

  7. 13% of participants at baseline simultaneously met the trial entry criteria for

    “significant disability” and the revised “recovery” criteria.
2

  1. The Investigators excluded drop-outs, which is not recommended practice in clinical trials.

  2. Logistic regression (used by the PIs) has been shown to be an inappropriate method of analysis in randomised trials.

  3. The figures originally given by the PIs for the four groups were:

    SMC 7% (but according to the protocol are 3%)
APT 8% (but according to the protocol are 2%) CBT 22% (but according to the protocol are 7%) GET 22% (but according to the protocol are 4%)

11. “Our findings therefore contradict the conclusion of White et al (2013) that CBT and GET were significantly more likely than the SMC group to be associated with ‘recovery’ at 52 weeks”.

12. “The multiple changes to the recovery criteria had inflated the estimates of recovery by approximately 2.3 to 5.1-fold, depending on the group, with an average inflation of 3.8-fold”.

13. When using the revised recovery criteria, 8% of the “recovered” participants still met trial eligibility criteria for “significant disability”.

14. “The changes made by the PACE investigators after the trial was well under way resulted in the recovery criteria becoming too lax to allow conclusions about the efficacy of CBT and GET as rehabilitative treatments for CFS”.

15. “This analysis, based on the published trial protocol, demonstrates that the major changes to the thresholds for recovery had inflated the estimates of recovery by an average of approximately four-fold”.

16. “It is clear from these results that the changes made to the protocol were not minor or insignificant, as they have produced major differences that warrant further consideration”.

17. “The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny”.

18. “It seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results”.
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Source: http://www.margaretwilliams.me/2016/key-points-from-raw-data.pdf
 
Research 1st

Research 1st

Severe ME, POTS & MCAS.
Messages
768
***Breaking news from the psychological profession***

Background:
F48.0 psychiatric criteria chairs (what mainstream doctors call dogs/chairs) but patients prefer to call 'dogs' (believing dogs are 'animals' not made from wood and need feeding) unfairly critique psychiatry and delay research into dogs/chairs syndrome by time wasting and vexatious FOIA requests for study data of a tax payer funded trial, no one should have but us A small group of powerful and influential extremists 'dogs', even claim dogs shouldn't be treated as furniture but living creatures. One chair (calling itself a chihuahua, even barked).

Study design:
With the aim of flawless peer review, double-blinded, placebo control trial we aimed to scientifically study this claim and carried out an $8 million review of chair maintenance.

We chose to use the word chair, and not dog/chair, as we felt the average chair cannot be taken for a walk on a lead without distress. Gradually feeding the chair furniture polish was considered a more ethical approach than daily exercise and 150g pedigree chum.

Unfortunately by feeding (what we call dogs) furniture polish, the alleged 'dog' (actually a chair) died of neglect by starving to death.

Lessons have been learnt, to next time, select a different breed of chair, preferably younger chairs less able to resist influence from adult co-coercion to change levels of unapproved and poorly absorbed wood preservative brands, which chairs commonly are influenced by, from using the Internet and joining a 'self polishing group'.

Conclusion:
Through changes to questionnaires responses pre and post treatment in chairs (who can't speak) and dogs (who can't speak either) we concluded with robust scientific evidence that:

1)Chairs are certainly dogs and dogs don't exist other than in the minds of conspiracy theorists who delay research for other chairs, and drive furniture polishers away from the field of upholstery maintenance.

2) Chair maintenance is safe for 'dogs' and can be safely and cost effectively rolled out to all veterinary centers worldwide.

Conflict of Interests:
No conflict of interests declared,although Professor potty does work for a chair insurance company that pays out to home owners whose furniture is damaged by over exuberant boisterous dogs.
 
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Research 1st

Research 1st

Severe ME, POTS & MCAS.
Messages
768
Maybe since this whole PACE thing, someone should get in writing from the UK National Blood Service, that if a CFS ME patient engages in GET CBT we can safely donate blood, umbilical tissue and bone marrow? After all they are officially recognized therapeutic interventions, and therapies are meant to resolve 'belief' in the somatizer about an chronic infection

So if ME CFS is indeed a belief in an infection that alters behaviors leading to deconditioning and chronic fatigue, we can now all safely donate various body fluids, tissues etc?
 
Large Donner

Large Donner

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866
Stewart said:
What a magnificently condescending - and unintentionally hilarious given the recurring Naked Gun joke, which he can't have been aware of - dismissive comment for him to make.
Click to expand...

I'm confused, is someone claiming that Wessely actually said...

move along folks nothing to see here
Click to expand...

and if he did is there a link to it?

My understanding is that this comment was someone paraphrasing over his general attitude to PACE not a direct quote.
 
PennyIA

PennyIA

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Location
Iowa
Large Donner said:
My understanding is that this comment was someone paraphrasing over his general attitude to PACE not a direct quote.
Click to expand...

That's how I read it as well. Though I can understand how brainfog can contribute towards a misinterpretation.

He didn't say those exact words... but his response was lacking everything we could have hoped it to be. Like an apology, or gee, maybe I need to re-evaluate my stance, or anything indicating that this was new news to him even.

The 'lack of' response to me is quite telling even - that they knew. They aren't shocked by the new numbers. They aren't arguing that the new numbers are wrong. (even more fuel for the belief that there was a conscious decision to mis-represent).
 
Countrygirl

Countrygirl

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What is all this about? I have read it but am none the wiser. What is White up to? Can anyone translate please?

It is dated 19th September 2016.

http://www.ncbi.nlm.nih.gov/pubmed/27647810
Measurement error, time lag, unmeasured confounding: Considerations for longitudinal estimation of the effect of a mediator in randomised clinical trials.
Goldsmith KA1, Chalder T2, White PD3, Sharpe M4, Pickles A5.
Author information

Abstract
Clinical trials are expensive and time-consuming and so should also be used to study how treatments work, allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments. These treatment processes can be studied using mediation analysis. Randomised treatment makes some of the assumptions of mediation models plausible, but the mediator-outcome relationship could remain subject to bias. In addition, mediation is assumed to be a temporally ordered longitudinal process, but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption. This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) to address these issues. In particular, autoregressive and simplex models were used to study measurement error in the mediator, different time lags in the mediator-outcome relationship, unmeasured confounding of the mediator and outcome, and the assumption of a constant mediator-outcome relationship over time. Results showed that allowing for measurement error and unmeasured confounding were important. Contemporaneous rather than lagged mediator-outcome effects were more consistent with the data, possibly due to the wide spacing of measurements. Assuming a constant mediator-outcome relationship over time increased precision.

© The Author(s) 2016.

KEYWORDS:
Mediation; chronic fatigue syndrome; clinical trials; longitudinal mediation models; measurement error; structural equation models

PMID:
Click to expand...

27647810

DOI:

10.1177/0962280216666111
 
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Stewart

Stewart

Senior Member
Messages
291
Large Donner said:
I'm confused, is someone claiming that Wessely actually said...



and if he did is there a link to it?

My understanding is that this comment was someone paraphrasing over his general attitude to PACE not a direct quote.
Click to expand...

PennyIA said:
That's how I read it as well. Though I can understand how brainfog can contribute towards a misinterpretation.

He didn't say those exact words... but his response was lacking everything we could have hoped it to be. Like an apology, or gee, maybe I need to re-evaluate my stance, or anything indicating that this was new news to him even.

The 'lack of' response to me is quite telling even - that they knew. They aren't shocked by the new numbers. They aren't arguing that the new numbers are wrong. (even more fuel for the belief that there was a conscious decision to mis-represent).
Click to expand...


The exact quote (from Julie Rehmeyer's statnews article) is:
"Wessely declined to comment on the lack of recovery. He summarized his overall reaction to the new analysis this way: “OK folks, nothing to see here, move along please.”

https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/
(It's near the bottom of the article, just above the section titled "A classic bad study")
 
PennyIA

PennyIA

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Location
Iowa
Stewart said:
He summarized his overall reaction to the new analysis this way: “OK folks, nothing to see here, move along please.”
Click to expand...
hmmmm...
OK, so who is "he" here...

I was thinking this read as "SOMEONE other than Wessely" summarized "Wessely's" overall reaction
 
Large Donner

Large Donner

Senior Member
Messages
866
Isn't it the author of the piece paraphrasing over Wesselys general attitude to the reanalysis?

The PACE researchers, the editor of the Lancet, and the editors of Psychological Medicine (which published the follow-up study on recovery) all declined to comment for this article.

Simon Wessely, president of the UK Royal College of Psychiatrists, defended the trial in an email exchange with me. He argued that some patients did improve with the help of cognitive behavior therapy or exercise, and noted that the improvement data, unlike the recovery data, was statistically significant. “The message remains unchanged,” he wrote, calling both treatments “modestly effective.”

Wessely declined to comment on the lack of recovery. He summarized his overall reaction to the new analysis this way: “OK folks, nothing to see here, move along please.” https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/
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Also I note he is now calling the favoured treatments Modestly effective whilst it was previously claimed that they were moderately effective. Also he states that....

the improvement data, unlike the recovery data, was statistically significant.
Click to expand...

so two admitted drastically different messages whilst he claims in the same breath that

“The message remains unchanged"
Click to expand...

So just to clarify, I am going to paraphrase him for the purpose of avoiding confusion. His new message is......

my paraphrasing
the message is the same except that the message is that the recovery data has changed and it shows zero recovery proof which is different to the original message and that the improvement reanalysis carries the same message as the published fanfare..... and that is that the message is that it is modestly effective and not moderately effective which means that the message has significantly changed except that the message remains the same.
Click to expand...


All this and we still have FOI and other data information requests to be fulfilled. On top of that they didn't use any available objectives measures to make their conclusions and match them to their subjective statistically insignificant results.

You couldn't make this shit up!!
 
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