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"News" 8 Sep 2016: PACE trial team analyse main outcome measures according to the original protocol

Simon

Senior Member
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3,789
Location
Monmouth, UK
Hardly 'latest research' as over five years late:

http://www.wolfson.qmul.ac.uk/current-projects/pace-trial#news

These show CBT/GET had more improvers than SMC, but only 20% for CBT and 21% for GET, vs 10% for SMC.

I think they'd said in the protocol they expected CBT/GET to do 5-6x better than SMC, not c 2x. So the vast majority of patients did not improve in this analysis according to the protocol (most did in the 2011 Lancet paper where they had replaced the protocol analysis with a new one).

The other main objections raised by patients were not addressed by this new analysis:

1. Recovery criteria had been dramatically weakened from those included in the protocol (and, related, new post hoc normal range were introduced that overlapped with trial entry). It's not clear why they authors didn't provide this protocol analysis too.

2. Self-reported gains were not backed up by objective ones in a non-blinded trial with no appropriate control group (just a bit of a methodological issue, that one)
 
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JaimeS

Senior Member
Messages
3,408
Location
Silicon Valley, CA
We remain of the view that the pre-specified analysis we conducted for the main PACE paper was the best way of addressing the trial questions. However, to address the criticism we have redone the analysis using the bimodal scoring.

"We know we did the right thing, but since so many of you fools insist..." ;)

This appears to be an appeasement to get people to back off, but as @JohnCB says, it's not what they were asked to do. It's a compromise, and it's weird that they believe a compromise to be in any way sufficient.

This was a court ruling. It's like a judge saying, "six months in prison for X," and the defendant saying, "four of community service" in reply... and expecting the judge will nod thoughtfully, find that this will do in place of prison, proud and pleased that the defendant shows some degree of willingness to appease those who accused him of a crime.

(And before anyone jumps on this, I'm aware that the PACE ruling wasn't in criminal court: it's a metaphor. ;))

PACE trial authors still don't accept what's happened, and believe they can negotiate with the law, or 'show willingness' in some way and this will stop.

This will stop once they release the data, truly independent researchers have gone over it, and a good roasting of the data has occurred. Then it will really be over.

-J
 

Research 1st

Severe ME, POTS & MCAS.
Messages
768
Thank you for the update Simon.

I would like to add that it's important to serially remember (burn it into your synapses) the PACE trial study participants of the trial did not meet Fukuda CDC criteria CFS, which is the established criteria in use today.

They met psychiatric criteria F48.0 Chronic Fatigue.

F48.0
is a code used in the psychiatric industry, in contrast, ME & CFS, is G93.3.
(For example, Somatization disorder is also F48.0).

Even if 100% of the participants had recovered, the results of PACE would have been irrelevant to Fukuda CFS, CCC CFS, IOM SEID + ME-ICC as they are not F48.0.

How did this absurdity of PACE occur?

It should be noted the allies of the Wessely school are on record of admitting THEY THEMSELVES CREATED Oxford Criteria CFS, because they felt the criteria for 'CFS' in general use, were too broad and required too many symptoms, in other words, psych patients reporting fatigue, would not be included at as high rate, unless they used Oxford CFS!

PACE did just that.

Astonishingly, Fukuda Criteria CFS only required CF + 4 or more symptoms and the NHS's CFS/ME, only requires
CF + PEM + 2 or more symptoms. (British CFS/ME therefore a peculiar mixture of one hallmark feature of ME, but with less symptoms than CDC CFS).

The entire situation of PACE is a disgrace and puts the patients with organic disease (within ME, CFS) in great danger and always exposes them to abuse (via misdiagnosis of F48.0 Chronic Fatigue), a non organic disease.

If the PACE trial is on non organic disease F48.0 and ME and CFS are G93.3:

How was it legal to even propose it?
How was it legal to fund it?
How was it able to be published?
Why aren't Scientists and doctors reminding those responsible of this?
Why aren't patients suing the MRC for green lighting a dangerous medical trial?
Why aren't patients reporting the PACE trial doctors to the GMC and BMA for endangering their lives? (Imagine MS researchers, claiming MS was a psychological illness, and 'proving this', using MS criteria that filters research participants suffering from non organic Fatigue related MS, by designing and then utilizing their own criteria for Fatigue related MS - to prove this point that MS is psychological?).

The story of the PACE trial scandal, and the Teflon nature of how the researchers act with impunity, is insane, literally.
 
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A.B.

Senior Member
Messages
3,780
They're scared and trying to negotiate. Guess what. Nobody cares. QMUL must publish the data or face contempt of court.

Simon Gaskell has just resigned from QMUL by the way. It looks a lot like the letter from Tuller pushed him over the edge.
 
Messages
13,774
Edited as I'm an idiot:

Looks like they're right on the edge of their pre-specified criteria for clinical significance of 2-3 times that improvement rate of SMC only.

Overall improvers, pre-specified primary outcome:

SMC only: 16 (10%)
SMC+CBT: 32 (20%)
SMC+GET: 33 (21%)
SMC+APT: 15 (9%)
 
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Simon

Senior Member
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3,789
Location
Monmouth, UK
The results don't look nearly so good according to the protocol

PACE-protocol-data.png




Note the Lancet paper and the protocol use very different definitions of improver, but I guess that's the whole point.
 

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13,774
@Tom Kindlon @Simon - are those figures based on assuming percentage figures were participant numbers?

(I may be missing something here)

Edit: I'm an idiot. Ignore me.
 
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Messages
13,774
edit: I'm a complete idiot.... the PACE figures for improvement are around 20%, I just totally misunderstood them!

Those results are better than I expected considering how poor results for their post-hoc recovery criteria were. If I'd had to guess, I'd have thought that they would be around the 20% level.



So if you add in the changes made to recovery criteria which havn't been analysed yet it seems. That would drop improver stats even lower?

Yes, this is just data for 'improvers', the pre-specified recovery criteria was much tighter again, so we'd expect lower figures.
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
Does this analysis still not correct to original recovery criteria then?
No, strangely not - even though the protocol clearly specified how to calculate recovery.

But it's worth noting that fewer "improved" according to the protocol than "recovered" according to the authors' revised recovery criteria. And the gap with SMC was smaller. (2013 recovery paper claimed 22% for CBT/GET, 8% for SMC).