A general thread on the PACE trial!

In 2011, it published a study, known as the pace trial, about chronic fatigue syndrome, now known as ME/CFS. The study concluded that cognitive behavioral therapy and exercise can be effective treatments for the condition. Many patients reacted furiously to that claim, which they found stigmatizing, and to the study’s recommendations, which they say do not reflect their experience with the illness; meanwhile, David Tuller, a journalist who teaches at the University of California, Berkeley, reported concerns about the pace trial’s methodology. (The US Centers for Disease Control and Prevention, whose guidance reflected the recommendations set forth in the pace study, revised it in 2017.)

Opponents of the pace trial say they found Horton to be dismissive when they raised concerns. (He didn’t provide an answer to a follow-up email about it.) “When you get pushback, even if it’s coming from people without big credentials, I think that needs to be taken seriously,” says Julie Rehmeyer, a science journalist and ME/CFS patient who has written about the pace trial. “A journal like The Lancet really needs to be aware of the power that they hold.”
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This sort of framing makes it so easy for people to dismiss us. I'm sure that the reporter didn't intend it, but that it can occur without it being a deliberate attempt to undermine our concerns is pretty disastrous. I guess that it's easier to briefly mention stigma and lived experience, rather than lay out the more substantial problems. I'm not sure what can be done to improve things there.

Interesting that Horton didn't respond to a follow-up e-mail about PACE.
 
Interesting to see it discussed but did not adequately portray the circumstances and impact. It is so much worse than this. At least people interested can read it in-depth from the link to Tuller's blog.

More of a slap on the wrist. I have no idea what Horton is still doing in his position. So many failures.
 
Esther12 said:
This sort of framing makes it so easy for people to dismiss us. I'm sure that the reporter didn't intend it, but that it can occur without it being a deliberate attempt to undermine our concerns is pretty disastrous. I guess that it's easier to briefly mention stigma and lived experience, rather than lay out the more substantial problems. I'm not sure what can be done to improve things there.
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I understand your point but I think you're over-focused on it. And I think there's a split in how people in the US and UK view this "psychological vs biomedical" issue. Anyway, most people won't notice that line. They'll read the passage in the context of Horton being a dick about a lot of things, and in context of the fact that CDC removed the recommendations, which is an implicit endorsement of the concerns raised. The story linked to my work and to a piece that Julie and I wrote about the CDC.
And yes, what happened is a lot worse that the language indicates. But even a couple of years ago PACE wouldn't have been mentioned as an issue at all.
 
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I will leave this here for no particular reason, other than that it's extremely relevant.



The quote in the tweet represents Sharpe, Wessely and their peers to a tit. I have no idea why they ever thought they have what it takes to attack this problem in a way that allows them to conclude that if they can't succeed, no one will. But here we are. Millions of destroyed lives later, they still haven't learned a damn thing out of being completely out of their depth.
 
Assessment of the PACE trial by the NICE guidelines committee:

[H] Appendices for the management of ME/CFS
https://www.nice.org.uk/guidance/GID-NG10091/documents/evidence-review-8

Appendix D–Effectiveness evidence: p. 31ff

PACE trial: ("White 2011") : p. 149f

'Nice' detail among "Further details":

"1. type of intervention: based on deconditioning and exercise intolerance theories of chronic fatigue syndrome;"

see also https://www.s4me.info/threads/no-more-mr-nice-guy…-by-prof-brian-hughes.17915/page-2#post-304021
 
The following links and quotes have been posted at diverse places on the forum before. Thought they might be worth reposting.

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.
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Science Media Centre: Expert reaction to letter from the HRA [Health Research Authority] to Norman Lamb regarding the S&T Committee’s inquiry on Research Integrity and the PACE trial

Reactions to a letter from the Health Research Authority (HRA) to Norman Lamb MP on an inquiry into the PACE trial.

Prof Michael Sharpe, Professor of Psychological Medicine, University of Oxford, said:
“The PACE trial authors welcome the findings of the Health Research Authority (UK HRA) review of the ethics and transparency of the trial. Patients with chronic fatigue syndrome, and the healthcare professionals who look after them, can be reassured that the evidence provided by PACE that cognitive behaviour therapy and graded exercise therapy are helpful and safe treatments for Chronic Fatigue Syndrome (CFS) is based on sound science.”
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Prof Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:
“The detailed comments from the Health Research Authority show that the PACE trial was conducted to a high standard.

“No trial is perfect, and over time there are continual refinements in our expectations for study design, conduct, analysis and reporting. In 2009 Glasziou and Chalmers published a discussion of research waste, and in 2014 the Lancet series on Increasing Value and Reducing Waste in biomedical research went further, with more detailed recommendations; recruitment to the PACE trial began 4 years before the first of these publications.

It is important that we continue to seek improvements in the way we do research, but that ambition does not devalue or invalidate the findings of previous research such as the PACE trial.”
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Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine (LSHTM), said:

“No randomised trial is perfect. Carrying out very good randomised trials is difficult and has been made more complex by layers of governance requirements, many (but not all) of which do help the quality and conduct of a trial.

When people do not like the results of randomised trials, they are prone to attempt to find faults with them which would not be raised if they liked the results. The careful scrutiny by the Heath Research Authority of the processes and conduct of the PACE trial has essentially vindicated the investigators in terms of their conduct of that trial. Instead of falling below contemporary standards the findings indicate that “Our review suggests that the PACE trial exceeded expectations in its transparency when judged against contemporary expectations.”

“There are no doubt improvements that can be made, and some lessons can be learnt, but it is clear that politicians can be driven by stakeholders who do not like results and may make unfounded criticisms that can appear to have greater merit than exists in truth. This does not mean that there should be complacency, but it does suggest that current processes are protecting patients as both participants in a trial and as consumers of the results of trails, especially those conducted under the auspices of the Medical Research Council.”
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Declared interests

Prof Michael Sharpe: Prof Michael Sharpe was an author on the PACE trial.

Prof Malcolm Macleod: MRM was an author of the Lancet Waste in Research Series

Prof Stephen Evans: I have neither competing nor conflicting interests in relation to this trial. I am and have been involved in trials conducted by public bodies as member and chair of Independent Trial Steering Committees and Data Monitoring Committees, but not in the area covered by the PACE trial.
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https://www.sciencemediacentre.org/...iry-on-research-integrity-and-the-pace-trial/
 
The HRA letter to Norman Lamb MP, Science and Technology Committee ,
https://www.parliament.uk/globalass...Research-Authority-to-Chair-re-PACE-trial.pdf

From the introductory lines, p.2:

"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. A review of the reception of the study shows indications that the science is sound, as well as evidence of concern.

"The results of the trials were published in high impact journals with peer review processes that would generally be regarded as robust (though not infallible).

"The robustness of the PACE trial has been considered in a Cochrane review that classified it as high quality. This was also challenged by critics, and the author of the review responded to those criticisms.

"It would be as inappropriate for the regulator to disregard these indications that the trial was of high quality as to ignore the criticisms that have been expressed. The range of views suggests that the debate needs to be continued, not constricted by regulatory action."

Edited to add:
Wikipedia about the chair of the HRA, Jonathan Montgomery:

Sir Jonathan Robert Montgomery is a British legal scholar who specialises in health care law. He is Professor of Health Care Law at University College London.[1]

Professor Montgomery was chair of the[2] Nuffield Council on Bioethics, the leading UK bioethics committee, from 2012 to 2017.[3] He was appointed Chair of the Health Research Authority in 2012.[4]

In March 2017 he became a member of the European Group on Ethics (EGE), which is the leading European bioethics committee[5] He is a regular contributor to items in the media, including the BBC[6][7][8] and broadsheet newspapers,[9] and has given evidence to the UK Parliament.[10]

In December 2018, he was appointed Chair of the Oxford University Hospitals NHS Foundation Trust.

He was appointed a Knight Bachelor in the 2019 New Year Honours for services to Bioethics and to Healthcare Law.
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