PACE Trial and PACE Trial Protocol

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Dolphin

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Sasha

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I'm sorry I haven't read all 2,543 posts on this thread so far :eek: but can I ask a basic question?

Has anyone documented/tabulated/counted the differences between the analyses specified in the protocol and those reported in the published papers?

That is, do we have numbers for:
  • the number of planned analyses;
  • the number that were changed;
  • the number that remain unreported.

Thanks!
 
Esther12

Esther12

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Sasha said:
I'm sorry I haven't read all 2,543 posts on this thread so far :eek: but can I ask a basic question?

Has anyone documented/tabulated/counted the differences between the analyses specified in the protocol and those reported in the published papers?

That is, do we have numbers for:
  • the number of planned analyses;
  • the number that were changed;
  • the number that remain unreported.

Thanks!
Click to expand...
Not that I've seen.

Things keep changing, and we're still waiting for some further data to be released. I don't think that those figures would look good for PACE though.
 
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Sasha

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Esther12 said:
Not that I've seen.

Things keep changing, and we're still waiting for some further data to be released. I don't think that those figures would look good for PACE though.
Click to expand...
I'm surprised this hasn't been done. I've been going through the protocol, the main paper and the "recovery" paper in some detail and I'm astonished by what I seen so far, especially in the "recovery" paper (three "recovery" criteria changed out of four).
 
Esther12

Esther12

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Sasha said:
I'm surprised this hasn't been done. I've been going through the protocol, the main paper and the "recovery" paper in some detail and I'm astonished by what I seen so far, especially in the "recovery" paper (three "recovery" criteria changed out of four).
Click to expand...
I think it's four out of four for their trial recovery criteria, which is the one they gave the most press!

With a lot of PACE stuff, it's hard to do an overview because things keep changing slightly. There were some really good overviews that I tend not to use now as they're a bit out of date. eg with the new mediation paper we finally got the fitness data (no improvement for CBT/GET/APT over SMC alone) and mediation results that seemed to differ from the analysis laid out in the protocol (one of the critical letters mentioned this, although there wasn't much detail in the protocol).
 
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user9876

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Sasha said:
I'm surprised this hasn't been done. I've been going through the protocol, the main paper and the "recovery" paper in some detail and I'm astonished by what I seen so far, especially in the "recovery" paper (three "recovery" criteria changed out of four).
Click to expand...
We, they and the journal know the reason given for changing the sf36 threshold is wrong. But they don't want to make corrections or withdraw their paper as they should.

Esther12 said:
Unless I'm wrong - is thatthe 'no longer fulfilling Oxford, London, CDC criteria? For the trial recovery results they just had to not fulfil Oxford.
Click to expand...
I think they made some subtle changes to how they interpreted the Oxford criteria as well. I seem to remember a lot of patients even those not meeting the minimal recovery thresholds did not meet the oxford criteria at the end.
 
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Sasha

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Esther12 said:
Unless I'm wrong - is thatthe 'no longer fulfilling Oxford, London, CDC criteria? For the trial recovery results they just had to not fulfil Oxford.
Click to expand...
Yes - in the protocol they've got to drop below the threshold criteria for all three of the questionnaires (Chalder SF-36, CGI) plus no longer being Oxford/London/CDC...

and in the "recovery" paper, all three qnrre thresholds were lowered (bigtime)...

and there were now two definitions of recovery:

(1) "Trial recovery": below all three new qnrre thresholds and not meeting Oxford criteria;

(2) "Clinical recovery": below all three new qnrre thresholds and not meeting Oxford/London/CDC criteria.

Have I got that right, Esther? I'm reading that paper through a migraine. o_O I think I might need to study the paper more carefully to see if they mucked about with the diagnostic criteria, while they were at it.
 
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Sasha

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user9876 said:
We, they and the journal know the reason given for changing the sf36 threshold is wrong. But they don't want to make corrections or withdraw their paper as they should.
Click to expand...
It's clearly bizarre - just an absolute nonsense. This is shameful for them, the journal and QMUL.

I think they made some subtle changes to how they interpreted the Oxford criteria as well. I seem to remember a lot of patients even those not meeting the minimal recovery thresholds did not meet the oxford criteria at the end.
Click to expand...
We crossed - thanks - I need to reread this.
 
Esther12

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user9876 said:
I think they made some subtle changes to how they interpreted the Oxford criteria as well. I seem to remember a lot of patients even those not meeting the minimal recovery thresholds did not meet the oxford criteria at the end.
Click to expand...
Yeah, I was talking to someone else about this. I'm not sure if anyone has worked out exactly what was going on there.

Sasha said:
Have I got that right, Esther? I'm reading that paper through a migraine
Click to expand...
That sounds right to me. Best wishes with your migraine.
 
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Bob

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Sasha said:
I'm sorry I haven't read all 2,543 posts on this thread so far :eek: but can I ask a basic question?

Has anyone documented/tabulated/counted the differences between the analyses specified in the protocol and those reported in the published papers?

That is, do we have numbers for:
  • the number of planned analyses;
  • the number that were changed;
  • the number that remain unreported.

Thanks!
Click to expand...
We have discussed this a lot, and many of the changes have been highlighted in various published letters. But I'm not sure if it's been done systematically.

A problem is finding somewhere that would publish a breakdown of all the changes. I'm not sure if anyone has tried, but I can't imagine who'd want to publish a simple critique of irregularities in the PACE trial. It could still be worth trying though. PACE is an excellent example of how to manipulate the data from a medical trial, so something could perhaps be written and submitted for publication on that basis.
 
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Sasha

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Bob said:
We have discussed this a lot, and many of the changes have been highlighted in various published letters. But I'm not sure if it's been done systematically.

A problem is finding somewhere that would publish a breakdown of all the changes. I'm not sure if anyone has tried, but I can't imagine who'd want to publish a simple critique of irregularities in the PACE trial. It could still be worth trying though. PACE is an excellent example of how to manipulate the data from a medical trial, so something could perhaps be written and submitted for publication on that basis.
Click to expand...
I wasn't thinking of a journal publication - I was thinking for PWME advocacy purposes. I would be great to have that just documented online as something that could be referred to - for example, in letters to journals. So when the next piece of PACE nonsense gets published, people would be able to write in and say, "X% of the analyses that have been published so far in the PACE trial were different in the study protocol".

I think X could be really quite high. It seems to be 100% for the recovery paper - indeed, 200%, because there now seem to be two versions of what was orginally one composite criterion.
 
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Bob

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Sasha said:
I wasn't thinking of a journal publication - I was thinking for PWME advocacy purposes. I would be great to have that just documented online as something that could be referred to - for example, in letters to journals. So when the next piece of PACE nonsense gets published, people would be able to write in and say, "X% of the analyses that have been published so far in the PACE trial were different in the study protocol".

I think X could be really quite high. It seems to be 100% for the recovery paper - indeed, 200%, because there now seem to be two versions of what was orginally one composite criterion.
Click to expand...
Yes, it would be good to have it documented in one place. One problem is that there are so many complex issues to get to grips with, that we all forget what's been written, and where. And, as Esther has said, once we get on top of the issues, they publish another paper, so everything changes.
 
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Sasha

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Bob said:
Yes, it would be good to have it documented in one place. One problem is that there are so many complex issues to get to grips with, that we all forget what's been written, and where. And, as Esther has said, once we get on top of the issues, they publish another paper, so everything changes.
Click to expand...
But the new papers don't alter the changes to planned analyses in the previous papers. Though I know not whereof I speak, not having read the 2,556 messages.

Is there an up-to-date list of publications?
 
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Sasha said:
But the new papers don't alter the changes to planned analyses in the previous papers.
Click to expand...
I'm not sure what you mean exactly, but new papers can confuse issues: We thought some of the planned objective measures had been dropped but then they published the step test data recently, four or five years after the original paper. And the original 2011 Lancet commentary that was published alongside the main paper made erroneous claims about recovery, and it defined 'recovery', but that all changed when the recovery paper was published which used yet another (the third) definition of recovery. So there were two sets of recovery data published to analyse and question.
 
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