PACE Results Correction

Daisymay

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PACE Trial Results: an Update

Margaret Williams 9th June 2011

In the interests of transparency and openness, Professor Hooper thinks it important to put in the public domain the fact that The Lancet has agreed to correct the Comment by Bleijenberg and Knoop in which they asserted that 30% of PACE Trial participants recovered with CBT and GET (Chronic Fatigue Syndrome: where to PACE from here? G Bleijenberg and H Knoop: DOI:10.1016/S0140-6736(11)60172-4).

On 6th June 2011 an email was sent on behalf of Professor Hooper to Zoe Mullan, Senior Editor at The Lancet, and relevant points of the text are reproduced here:

There is a major problem with the Comment by Bleijenberg and Knoop which The Lancet editorial team has so far failed to address, namely their claim of a 30% recovery rate with CBT and GET for PACE participants.

It cannot be argued that this is merely a matter of semantics (Bleijenberg & Knoop state: The answer depends on ones definition of recovery): those authors have unequivocally misrepresented the findings of the published paper.

The PIs do not report the number of participants who recovered, only those who fell within their own much criticised definition of normal range for fatigue and physical function.

It cannot be acceptable for The Lancet to allow Bleijenberg and Knoop to claim that 30% of participants recovered after CBT or GET when the definition of recovered on which they rely has been set artificially low by White et al so low in fact that a participant described by them as recovered could still be sufficiently disabled to meet the trials entry criteria.

This surely represents a significant failure of both the peer review process and editorial oversight.

Anyone reading Bleijenberg and Knoops Comment will be left with a grossly incorrect understanding of the results of the PACE Trial.

As mentioned in his response to Peter White, Professor Hooper quoted medical statistician Professor Martin Bland: Potentially incorrect conclusions, based on faulty analysis, should not be allowed to remain in the literature to be cited uncritically by others (BMJ: 19th February 2000:320:515-516).

In view of this, Professor Hooper once again formally requests that The Lancet either retracts or corrects the Bleijenberg & Knoop Comment and he would appreciate being informed of your editorial decision about this important issue.

On 8th June 2011 Zoe Mullan replied in the following terms:

Thank you for your message and the attachments, which I will read. In the meantime, yes I do think we should correct the Bleijenberg and Knoop Comment, since White et al explicitly state that recovery will be reported in a separate report. I will let you know when we have done this.

Professor Hooper is most grateful to The Lancet for this clarification.
 

biophile

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About time

I wonder what changed their minds? A number of people including myself emailed them about this problem earlier. Horton never replied to me, maybe he was the wrong person to email, but before I sent it I did hear (private communication) that the Lancet editors were already aware of this problem months ago and decided it did not warrant a correction. I guess mere plebeians have no weight regardless of the argument, I am just glad Hooper got through to them and appreciate the mammoth effort he has put into critique of the PACE trial in general.
 

Bob

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A number of people including myself emailed them about this problem earlier. Horton never replied to me...
Horton says that we have targeted him as part of an orchestrated campaign, based on an emotional reaction to the PACE Trial, and without any objective or rational arguements. So he is unlikely to engage with us. He must also be of the opinion that we are all hysterical individuals with a psychiatric disorder, based on the fact that he believes the PACE Trial is solid and valid research.

Thanks to all those who made this happen. Hopefully this is just one of many corrections to come.

There has also been another correction relating to the SF-36 normal population data:
http://www.meactionuk.org.uk/whitereply.htm
 
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That sounds like good news, and well done Hooper.

But being cynical...

Can't they just say something fudging along the lines of... 'While the editorial accompanying White et al indicated a recovery rate among CFS patients of 30% using CBT/GET, White et al did not report recovery rates in the paper as they intend to do so in a second paper. They did, however, report that 30% of patients benefitted moderately from CBT/GET and returned to within the normal range (??)

I know that is still a 'changing the posts' admission, but for many readers, does it sound like just a technicality?

I am still concerned that more is to be published from PACE. Not so much the actual data, which we now know are fairly feeble, but how the data are written up and whether they get even more editorial accolades. Ugg!
 

Esther12

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I can only imagine the grovelling apology they'll feel the need to serve up. They know how damaging psychosocial factors can be, and being misled about the efficacy of treatments can have a really profound impact upon patients...

oh no, I forgot how they think of CFS patients - they won't give a toss.
 

Sasha

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Unbelievable, the whole situation. Well done to Prof Hooper for getting this done.
 

WillowJ

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That sounds like good news, and well done Hooper.

But being cynical...

Can't they just say something fudging along the lines of... 'While the editorial accompanying White et al indicated a recovery rate among CFS patients of 30% using CBT/GET, White et al did not report recovery rates in the paper as they intend to do so in a second paper. They did, however, report that 30% of patients benefitted moderately from CBT/GET and returned to within the normal range (??)

I know that is still a 'changing the posts' admission, but for many readers, does it sound like just a technicality?

I am still concerned that more is to be published from PACE. Not so much the actual data, which we now know are fairly feeble, but how the data are written up and whether they get even more editorial accolades. Ugg!
I'm with Katyak.

Be that as it may, well done Hooper, and everyone who has been on the Lancet's case about this. and the tide will eventually turn, because it must and Hooper and Dolphin and we all are on the morally and factually right side of this struggle.
 

taniaaust1

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Thanks to everyone who is putting in time to help make all the CFS studies more factual. We need to all keep fighting to stop all the misleading which goes on.
 

biophile

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Horton doesn't know about orchestrated campaigns

Horton says that we have targeted him as part of an orchestrated campaign, based on an emotional reaction to the PACE Trial, and without any objective or rational arguments. So he is unlikely to engage with us. He must also be of the opinion that we are all hysterical individuals with a psychiatric disorder, based on the fact that he believes the PACE Trial is solid and valid research.
Indeed, I suspect it was an attempt on his behalf to smear the ME/CFS community, in order to downplay the criticisms against the PACE trial and his involvement in publishing it. Horton indignantly complained about "dozens of letters" as part of this supposed "orchestrated campaign". Meanwhile around the same time: "Psychology Today responds after more than 70,000 ColorOfChange.org members demand apology for piece claiming it to be scientific fact that black women are less physically attractive than women of other races." http://www.colorofchange.org/press/releases/2011/5/37/

Diddums @ "dozens of letters" for Horton in his cosy office and nice salary while ME/CFS patients have their lives destroyed, unable to work, and keep having to put up with flawed research which offer no real hope.
 
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Bob

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Indeed, I suspect it was an attempt on his behalf to smear the ME/CFS community, in order to downplay the criticisms against the PACE trial and his involvement in publishing it. Horton indignantly complained about "dozens of letters" as part of this supposed "orchestrated campaign". Meanwhile around the same time: "Psychology Today responds after more than 70,000 ColorOfChange.org members demand apology for piece claiming it to be scientific fact that black women are less physically attractive than women of other races." http://www.colorofchange.org/press/releases/2011/5/37/

So LOL @ "dozens of letters" for Horton in his cosy office and nice salary while ME/CFS patients have their lives destroyed and keep having to put up with flawed research. I'd like to see how Horton would respond to 70,000 angry ME/CFS patients, then he would know what a real "orchestrated campaign" is like. :)
Yes, orchestrating large scale patient campaigns isn't one of our community's strong points, unfortunately.
I think this is probably due to a lack of health, energy and resources.
 

Esther12

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I don't think it has Dolphin. It wasn't the last time I looked.

This is very unfortunate, as it means it's still on the record and can be quoted by anyone, including doctors etc.
I quite like it, as an example of the sort of stupid and obvious errors which determine the way CFS patients are treated by their doctors. I sometimes think that peer-review, corrections of these sorts, etc hurt us by making certain researchers seem more reasonable than they really are, while their patient critics have no similar process, so can seem relatively unreasonable.
 

Dolphin

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I quite like it, as an example of the sort of stupid and obvious errors which determine the way CFS patients are treated by their doctors. I sometimes think that peer-review, corrections of these sorts, etc hurt us by making certain researchers seem more reasonable than they really are, while their patient critics have no similar process, so can seem relatively unreasonable.
Yes, a lot of me is hoping it still stays as an example of hype/misinformation. There was no talk of the threshold of 60 in the main paper being changed which would be more useful, I think.
 

Daisymay

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No Dolphin it hasn't been corrrected yet, in spite of Zoe MUllen saying on 8th June:

Thank you for your message and the attachments, which I will read. In the meantime, yes I do think we should correct the Bleijenberg and Knoop Comment, since White et al explicitly state that recovery will be reported in a separate report. I will let you know when we have done this.
 

Bob

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For the record, this is still published online:

Graded exercise therapy and cognitive behaviour therapy might assume that recovery from chronic fatigue syndrome is possible, but have patients recovered after treatment? The answer depends on one's definition of recovery.3 PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person's score. In accordance with this criterion, the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30%although not very high, the rate is significantly higher than that with both other interventions.

Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, ...

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60172-4/fulltext

doi:10.1016/S0140-6736(11)60172-4
 

Esther12

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Then we had this in the BMJ:

Less than a third of patients were cured by either treatment (30% (44/148) after CBT and 28% (43/154) after graded exercise therapy).
http://www.bmj.com/content/342/bmj.d1168

Now a new Crawley paper which uses PACE to claim:

Evidence from a recent evidence trial of cognitive behavioural therapy and graded exercise therapy indicated a recovery rate of 30-40% one year after treatment.
http://www.biomedcentral.com/content/pdf/1472-6963-11-217.pdf