A general thread on the PACE trial!

Sean said:
Didn't the HRA report explicitly say it was not commenting on technical aspects (i.e. methodology), only on required ethical and legal compliance?
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My recollection is that it made clear the parameters of the investigation and either implied or stated that other matters were outwith the remit of the enquiry. It is hard to know whether it would be more serious to fail to understand that, or to misrepresent it.
 
chrisb said:
My recollection is that it made clear the parameters of the investigation and either implied or stated that other matters were outwith the remit of the enquiry. It is hard to know whether it would be more serious to fail to understand that, or to misrepresent it.
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It also sites the Cochrane review as a 'seal of approval' for PACE; a lot hinges on Cochrane so whatever they decide in May is crucial. Would be good to have a 'joined up' response ready from all advocates for whichever way it goes. [ ie @dave30th @Brian Hughes @Carolyn Wilshire @Tom Kindlon @JohnTheJack ] and all others.
 
Kalliope said:
Forskning.no, a Norwegian news site about research, has had a couple of critical articles about the PACE trial, but today they have an article claiming the trial was let completely off the hook by Health Research Authority.

Professor Wyller is interviewed, so is Ingrid Helland, leader of the national competence center for ME/CFS, both known for their biospsychosocial approach to ME.

Only speculations from my side, but was this an important article to get published before Cochrane's final decision about the review on GET and ME which is due in May?

Forskning.no: Omstridt ME-studie undersøkt: Forskerne fant ingen metodefeil
google translation: Controversial ME study investigated: Researchers found no method error

HRA, which is a kind of watchdog for research, has concluded that the study was verifiable and met all the guidelines for studies that applied at that time.

There is no reason to consider the PACE study to be of poor quality, according to Jonathan Montgomery, head of the HRA, in a letter to the Research and Technology Committee.

....
Professor Vegard Bruun Bratholm Wyller believes the report from the British health authorities supports that the criticism of the PACE study has been unfounded. He is a senior consultant at the Children's and Youth Clinic at Ahus.

"This criticism seems to be scientific, but in reality it is marked by a campaign aimed at weakening the credibility of the PACE study. The report that is reproduced in BMJ is just about just ethical / legal aspects, but the researchers behind the PACE study have recently entered in depth - and very convincing - on the methodological objections, he writes in an email to forskning.no.

Read the relief here in BMC Psychology 2019.

- There is therefore no need to question the main conclusion of the PACE study: Many patients with ME may benefit from cognitive behavioral therapy and that there is no reason to be afraid of the harmful effects of such treatment. This is also consistent with several other studies, and also fits well with what we otherwise know about disease mechanisms at ME, he writes.
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Who has given Helland authority in this area? She's clearly not up to it. Is there anything that can be done to get her to debate her positions?
 
Esther12 said:
Who has given Helland authority in this area? She's clearly not up to it. Is there anything that can be done to get her to debate her positions?
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She used to work in prof. Wyller's team before becoming the leader of the competence center for ME/CFS.
There was recently a petition with over 7 000 signatures asking to remove the management at the competence center. The center also got a rather critical evaluation from the Norwegian Directorate of Health. But nothing has changed.
 
The use of the HRA report is perhaps not unexpected by these people. I was, however, interested, when Jerome Burne initially assumed it was authoritative on PACE quality. I explained to him that it was just an ethical review.

I don't think declarations like this from BPS people in Norway will alter the Cochrane decision. I think that will depend on internal politics and how the real scientific issues are to be viewed. Cochrane is fully informed of all the scientific problems, it is just a question of how they respond to them. David Tovey could see that the Larun review was not valid. My impression is that he did not want to fight against those who pointed out that Larun could refuse to withdraw. The new editor will have to show their ability to impose proper standards. If the goings on at the Board are anything to go by the result may not be exciting.
 
Didn't really know where to put this but it was too perfect.

And since I can imagine Sharpe tweeting this genuinely believing he is the left column, I guess a solid dose of Dunning-Kruger applies on top of that.


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Kalliope said:
Forskning.no, a Norwegian news site about research, has had a couple of critical articles about the PACE trial, but today they have an article claiming the trial was let completely off the hook by Health Research Authority.

Professor Wyller is interviewed, so is Ingrid Helland, leader of the national competence center for ME/CFS, both known for their biospsychosocial approach to ME.

Only speculations from my side, but was this an important article to get published before Cochrane's final decision about the review on GET and ME which is due in May?

Forskning.no: Omstridt ME-studie undersøkt: Forskerne fant ingen metodefeil
google translation: Controversial ME study investigated: Researchers found no method error

HRA, which is a kind of watchdog for research, has concluded that the study was verifiable and met all the guidelines for studies that applied at that time.

There is no reason to consider the PACE study to be of poor quality, according to Jonathan Montgomery, head of the HRA, in a letter to the Research and Technology Committee.

....
Professor Vegard Bruun Bratholm Wyller believes the report from the British health authorities supports that the criticism of the PACE study has been unfounded. He is a senior consultant at the Children's and Youth Clinic at Ahus.

"This criticism seems to be scientific, but in reality it is marked by a campaign aimed at weakening the credibility of the PACE study. The report that is reproduced in BMJ is just about just ethical / legal aspects, but the researchers behind the PACE study have recently entered in depth - and very convincing - on the methodological objections, he writes in an email to forskning.no.

Read the relief here in BMC Psychology 2019.

- There is therefore no need to question the main conclusion of the PACE study: Many patients with ME may benefit from cognitive behavioral therapy and that there is no reason to be afraid of the harmful effects of such treatment. This is also consistent with several other studies, and also fits well with what we otherwise know about disease mechanisms at ME, he writes.
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:( A journal for physiotherapists has picked up this story and writes that the HRA-report concludes PACE was a thorough trial. The final decision from Cochrane on whether or not to retract the Larun review on graded exercise therapy as ME treatment is due now in May. It's bad in itself to give physiotherapists new reasons to push GET on ME patients, but also very convenient timing for the biopsychosocial crowd to have articles with this version of the HRA report in Norwegian media.

Fysioterapeuten: Omstridt ME-studie: Fant ingen metodefeil
google translation: Controversial ME-study: No method error found

HRA, which is a kind of watchdog for research, has concluded that the study was verifiable and met all the guidelines for studies that applied at that time.

"There is no reason to consider the PACE study to be of poor quality," said Jonathan Montgomery, head of the HRA, in a letter to the Research and Technology Committee.
 
Jonathan Edwards said:
Did Montgomery actually say that?
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He said these things:

"While the quality of the trial design has been challenged, it has not been discredited."

"It would not be appropriate for the HRA to seek to resolve these debates about the quality of the study."

"The main funder was the Medical Research Council whose peer review processes would be regarded as robust. It was appropriate for the REC to rely on that scrutiny as assurance of the scientific quality."

"The continuing debate about the design of the study is not an indication that it should not have been approved, but if there was a general and consistent view that it was of poor scientific quality then it would give us cause for concern. This is not the case in relation to PACE."

"The robustness of the PACE trial has been considered in a Cochrane review that classified it as high quality."
 
So none of those statements adds up to what was quoted in Norway. One might seem to :

if there was a general and consistent view that it was of poor scientific quality then it would give us cause for concern. This is not the case in relation to PACE

But they are not saying that it is not the case that PACE was of poor quality, simply that there was no general and consistent view that this is the case - which is probably true.

All these statements boil down to 'other people think it was OK. I am giving no opinion of my own.'
 
The more evidence that emerges proving ME is not due to deconditioning, the more it must (surely?) prove their trial claiming to prove it was had to have been flawed. The issue then will be to convince people that it was not a case they could not have been expected to know better due to lack of wider knowledge.
 
Kalliope said:
met all the guidelines for studies that applied at that time
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On style. Not substance. HRA doesn't deal with substance, just if paperwork and applicable rules were followed. Which of course people pushing this out of self-interest fully know, highlighting further how corrupt and incompetent they are.

Medicine should never be based on deceit, shouldn't even contain any. Ethical failure built on moral bankruptcy.
 
Just to note that I presented my thoughts about trials of therapist-delivered treatments for ME and MUS to the department of Medicine at UCLH today. The session seemed to go well and comments were positive. Nobody disagreed with my analysis. I do not expect any immediate spin off from this but it is a way to start getting colleagues aware of the issues. I think the audience found the topic interesting and thought provoking.
 
Daisymay said:
Were the audience shocked at what they heard re the standard of the "science" ? And the links with the whole MUS issue?
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I doubt they were shocked. I suspect most of them were not at all surprised that trials of therapist delivered treatments were poorly constructed. But I think a good proportion of them took the point that things did not look very good. Certainly nobody defended the methodology. There was quite a lot of laughter when I showed the data slides and mentioned the change in outcome threshold.
 
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