A general thread on the PACE trial!

Today's PACE-Trial-For-Beginners-Quiz

So, I skimmed the Cochrane thread, bookmarked some threads in Woolie's wonderful library, digged into this fabulous general thread on the PACE trial, and ended up with two surprise questions for today:

1) What does the acronym "PACE" stand for?

2) Why is the PACE trial called a "controlled" trial when in fact it had no control group but was a merely comparative trial?
 
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MSEsperanza said:
1) What does the acronym "PACE" stand for?
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Its very contrived:

Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation (PACE)

I know, right?

PACE had a "control group", but the trial can't technically be called controlled, because that implies everything was identical in the control and active conditions except for the active ingredient. Since the "control" condition received less face time, that's incorrect. Arguably, other things, such as patients' expectations, were also not equivalent across trial arms.
 
MSEsperanza said:
Why is the PACE trial called a "controlled" trial when in fact it had no control group but was a merely comparative trial?
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The original PACE paper does not call it a controlled trial I think. Cochrane included it in their analysis of controlled trials. It has been pointed out to them that this is no good. We will wait to see what happens next.

As I understand it the name PACE was used specifically to please patient charities who wanted pacing included, presumably to improve recruitment.

In fact there were pretty good controls for CBT and for GET : GET and CBT. And there was no difference. The authors seem to be too dumb to realise that they have a negative result there. If CBT or GET had come out significantly better than the other then we would have had something interesting. The authors claimed that of course pacing was a positive control but it wasn't because there was no brainwashing about getting better in that group.
 
Woolie said:
PACE had a "control group", but the trial can't technically be called controlled
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Thanks, @Woolie . I noticed that the trial protocol (2007/BMC) called PACE a "randomised controlled trial" (RCT), but in the title of the Lancet paper ("The Paper" 2011) PACE was downgraded to a "randomised trial".

(Links to the papers: https://www.s4me.info/threads/publications-from-the-pace-trial.60/)

Woolie said:
because that implies everything was identical in the control and active conditions except for the active ingredient. Since the "control" condition received less face time, that's incorrect. Arguably, other things, such as patients' expectations, were also not equivalent across trial arms.
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But why call a trial arm that does'nt fulfill the criteria of a control group a "control" group? Is there no clearer language?

Woolie said:
Its very contrived:

Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation (PACE)

I know, right?
Click to expand...

Right :) and very contrived indeed.

Fun fake on Wikipedia's acronym list for PACE:

PACE trial (for "progressively accelerating cardiopulmonary exertion"), a controversial study on the effectiveness of different therapies for chronic fatigue syndrome
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https://en.wikipedia.org/wiki/PACE

EDIT: sorry, @Jonathan Edwards -- crossposted
 
MSEzperanza beat me to it. But here's my post anyway,...

Jonathan Edwards said:
The original PACE paper does not call it a controlled trial I think.
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It was described as controlled in the protocol paper (2007), but not in the main paper (2011). The word control/controlled is only mentioned twice in the main paper, both times in reference to other literature.

I doubt they relinquished that higher epistemological status voluntarily. It was probably denied them by the reviewers/editors. If so, then it is one thing they did get right.
 
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MSEsperanza said:
But why call a trial arm that does'nt fulfill the criteria of a control group a "control" group? Is there no clearer language?
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The fact that PACE is not controlled set me thinking about this and I thin it is quite subtle. In most scientific experiments you do a series of controls, each one designed to exclude your test result being due to a non-specific contextual factor. In PACE standard medical care and adaptive pacing are both controls in the sense that they exclude the result being due to just being in a trial over a period of time or just having some form of apparently novel procedure to follow. But they do not form an adequate set of controls.

So a controlled trial is, if it is to mean anything scientifically useful, a trial with an adequate set of controls. I see it as a bit like a locked house being a house with an adequate set of locks operated, not just a house with a lock.
 
Is this really true? Does PACE show that GET reduses PEM? Sounds strange....as some of the other cfs_research says

<blockquote class="twitter-tweet"><p lang="en" dir="ltr">And yet PACE found that GET reduced PEM. The difference is between exercise that is benecifial to patients, and that which is harmful. The new CDC guidelines seem to have a fairly good idea.</p>&mdash; CFS Research (@cfs_research) <a href="">July 16, 2018</a></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
 
benji said:
Is this really true? Does PACE show that GET reduses PEM? Sounds strange....as some of the other cfs_research says
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Self reported PEM decreased more in the CBT and GET arms, as assessed by questionnaire.

This doesn't show that CBT/GET reduce PEM because of the subjective unblinded trial design. I am also curious how they defined PEM.
 
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