A general thread on the PACE trial!

Lucibee said:
Oh - I thought I had... I'll check other browsers...
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Sorry, have just checked and it's just on my phone that it's hard to distinguish the two. Much better on a real computer. Not something that you could do anything about I imagine.

Dr Norman Swan (the interviewer) is a much respected radio medical journalist on the ABC, our national Australian broadcaster. However, I lost a lot of respect for him after that broadcast with how he fawned all over Horton and Sharpe. They were telling him there was controversy but he was not interested in making any attempt to understand the other side. Does anyone know if he has ever done anything else on ME to reset the balance? If not, someone should point him to the PACE fiasco and ask why he hasn't covered it recently.
 
Norman Swan is the founder of the huge Tonic Health Media organization which aims to bring very basic health information to the masses. The leaflets and film clips played in doctors' surgeries and exercise programs in businesses are examples. Their reach is far and wide and is based on prevailing scientific evidence. Mental health features prominently in their advice.

This is the interview with Micheal Sharpe and then Richard Horton, April 2011, referred to by @BruceInOz above.
They discuss the common criticisms and Sharpe defends the trial. The role of AFME in the trial is discussed from 4:50 to 5:30.
http://mpegmedia.abc.net.au/rn/podcast/2011/04/hrt_20110418_0830.mp3

This is another Norman Swan interview with Dr. Samuel Harvey, Kings College London, from 2012, discussing mental illness and chronic fatigue syndrome and the characteristics and traits of PWME. It goes from 14:43 to 21:00.
http://www.abc.net.au/health/video/clips/3404256.htm

ETA: sorry if these have already been posted
 
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That 2011 program on PACE by Swan is a contemptible puff piece. Swan either didn't have a clue about the problems with PACE, or simply refused to address them and ask some genuinely hard questions of Horton and Sharpe. (I have not listened to the Harvey one, don't think my blood pressure would handle it.)

It was a very disappointing effort from somebody who otherwise has a very good track record, and has helped set a solid standard for health reporting in the media.

But when it comes to psychosocial stuff in general he seems to be a true believer, and considerably less critical than he should be.

Just goes to show that nobody is perfect.
 
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I just came upon QMUL's 2011 press release for PACE, and thought it was worth posting the headline given the way in which there now seems to be an attempt to pretend that the harmful headlines casually promoting 'exercise' are all the result of the media.

Exercise and CBT best treatments for chronic fatigue
Two effective treatments benefit up to 60 per cent of patients with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME), according to a collaborative trial funded by the Medical Research Council and UK government departments.
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https://www.qmul.ac.uk/media/news/items/smd/44140.html
 
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Somebody who got this reply sent it on to me.

Thank you for your correspondence of 20 February to Caroline Dinenage about chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). I have been asked to reply.


I am sorry to read of your illness.


I appreciate your concerns about the PACE trial and graded exercise therapy (GET).


As you may already be aware, CFS/ME has been highlighted as a priority for the Medical Research Council (MRC) for a number of years. The MRC is currently inviting funding applications for research on biological mechanisms underlying chronic changes related to CFS/ME. This is an ongoing highlight notice with no current deadline for receipt of applications. You may wish to visit the MRC website at www.mrc.ac.uk/funding/how-we-fund-research/highlight-notices/cfs-me-highlight-notice/.


The PACE trial undertaken by Queen Mary University of London was the largest ever trial of treatments for CFS/ME and was funded by the Medical Research Council, a non-departmental public body funded through the Government’s science and research budget. The first results from the trial were published in 2011 in The Lancet, and a number of other evaluations based on the trial have been published since.


The trial provided evidence that both cognitive behavioural therapy (CBT) and GET were moderately effective when provided alongside specialist medical care (SMC) and were better than adaptive pacing therapy or SMC alone in improving both symptoms and disability. All the treatments were found to be safe without any serious reactions to treatments in any of the treatment groups. Where patients deteriorated during the trial, this was as a result of a serious life event or infection that prompted a relapse. In 2013, a follow-up study, looking at recovery after one year, was published. This study supported the findings that CBT and GET were therapies most likely to lead to recovery.


The Government is aware that the use of CBT and GET in treating CFS/ME has long been a controversial issue for patient groups, charities and some clinicians. Since 2011, PACE trial data has been shared with many independent scientists as part of normal research collaboration, including the internationally respected research organisation Cochrane, which independently validated the findings.


Following a number of requests to the chief investigators of the PACE trial for the public release of data from the study, the Information Commissioner ruled that the Wolfson Institute at Queen Mary University of London should release this data.


The data has since been examined more widely and critics, including some clinical academics, have suggested that it shows that CBT and GET are not as effective as the trial results suggested.


The Wolfson Institute also provided trial data to a member of the public, and subsequently analysis of the data was published on a blog. The analysis has not been validated by publication in a peer-reviewed journal or other means.


The National Institute for Health and Care Excellence (NICE) is responsible for deciding whether guidance on CFS/ME should be updated.


NICE’s clinical guidelines relate to a whole pathway of care and can make a large number of recommendations spanning all stages of care from diagnosis to treatment of a condition. In view of their complexity, clinical guidelines are not subject to the same statutory funding direction as NICE’s technology appraisals. NICE clinical guidelines represent best practice. They are based on the available evidence and developed through consultation.


NICE last reviewed the guidance with its stakeholders, including CFS/ME charities, in 2013. The review found no update was required and at that time no major ongoing studies or research were identified as due to be published in the next three to five years.


Recently, NICE has been made aware of three US reports that have indicated there are likely to be changes in diagnostic criteria that could have an impact on the CFS/ME guideline recommendations and decided to start a check of whether the guideline needs updating. NICE has also been made aware of new information about the PACE trial.


The NICE guideline consultation on CFS/ME ended on 24 July and I hope you were able to contribute. Following the consultation, on 20 September, NICE announced that it would begin a review of its 2010 guideline on the diagnosis and management of CFS/ME. Further details of the review will be published shortly.


I hope this reply is helpful.


Yours sincerely,


Daniel Belmore

Ministerial Correspondence and Public Enquiries

Department of Health and Social Care
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“The Wolfson Institute also provided trial data to a member of the public, and subsequently analysis of the data was published on a blog. The analysis has not been validated by publication in a peer-reviewed journal or other means.”
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This is not true. A paper on recovery was published in a peer-reviewed journal.

Although they couldn't have referred to it here a paper is coming out soon which includes a reanalysis of the primary outcomes as well as the recovery measure.
 
Also, LOL at this mentality: "The analysis has not been validated by publication in a peer-reviewed journal or other means."

The data was provided in the blog post! You can check it yourself. That's a more legitimate form of 'validation' than publication in a peer-reviewed journal, never mind the fact that their has also been a peer reviewed paper reporting this analysis anyway.

The culture of the UK civil service terrifies me.

"In 2013, a follow-up study, looking at recovery after one year, was published. This study supported the findings that CBT and GET were therapies most likely to lead to recovery."

That paper was published in a peer reviewed journal, and included clear factual inaccuracies that anyone interested in checking the detail can recognise. But of course, no-one in the UK civil service would bother to check the details.

"Since 2011, PACE trial data has been shared with many independent scientists as part of normal research collaboration, including the internationally respected research organisation Cochrane, which independently validated the findings."

This is such spin and BS. Has Cochrane ever claimed that they have validated the PACE trial's purported findings?
 
Dolphin said:
Somebody who got this reply sent it on to me.
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At least it makes it clear that the Department of Health is actually aware of what has been said, even if they have not picked up on publication.

The text still looks like a partially regurgitated message dictated by QMUL and this paragraph is not right:

The data has since been examined more widely and critics, including some clinical academics, have suggested that it shows that CBT and GET are not as effective as the trial results suggested.

Apart from the use of the singular pronoun for data it should be more like:
...have suggested that they fail to provide usable evidence for CBT and GET being effective, of the sort suggested by the trial publications.

But maybe we can have reasonable confidence that by the time the NICE committee sits they will be aware of the re-assessment paper and the JHP volume etc.
 
In 2013, a follow-up study, looking at recovery after one year, was published. This study supported the findings that CBT and GET were therapies most likely to lead to recovery.
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If they were to read more than the spin abstract, they could reach this part of the text, written by the PACE authors themselves, admitting null results for their therapies: "There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up." https://www.ncbi.nlm.nih.gov/pubmed/26521770
 
We need to keep mentioning/citing the follow-up study. They would have known the 2-year results when they published the 2011 paper. I very much doubt that a complete 5-year or 10-year follow-up will ever see the light of day, unless there is a full inquiry.
 
Dolphin said:
Somebody who got this reply sent it on to me.
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It's got some bits similar or the same to those from my MP Scott Mann in his rather frustrating response to my email to him about the Carol Monaghan debate and EDM 271:

"Thank you for your email regarding the recent debate in Parliament on ME and the PACE trial. Unfortunately I was unable to attend the debate due to other commitments. The debate was also only 30 minutes long which restricts the ability of other MPs to take part.

Chronic fatigue syndrome is a debilitating and poorly understood condition which is estimated to affect more than 200,000 people in England. We still do not understand the underlying causes of it and there is no single test to identify it.

The recommended treatments for CFS/ME, namely cognitive behavioural therapy and graded exercise therapy, were first recommended for patients with mild or moderate CFS/ME in 2007 in the NICE guidance which is in line with the best available evidence.

The guidance sets out that there is no one form of treatment to suit every patient and that the personal needs and preferences of patients should be taken into account. Th Government says that doctors should explain to patients that no single strategy will be successful; that in common with all people receiving NHS care, CFS/ME patients have the right to refuse or withdraw from any part of their treatment; and that those with severe symptoms may require access to a wider range of support managed by a CFS/ME specialist.

The results of the PACE trial were published four years after the NICE guidance. This was undertaken by the Queen Mary University of London and it was the largest ever trial for CFS/ME which included more than 600 participants in England and Scotland. It sought to assess and compare the effectiveness of the four main treatments for CFS/ME - adaptive pacing therapy, CBT, GET and standardised specialist medical care.

The peer-reviewed trial results published in The Lancet found that 60% of patients with CFS/ME benefited from CBT and GET when provided alongside specialist medical care. CBT and GET were found to be better than pacing therapy or specialist medical care alone in improving both symptoms and disability, and a follow-up study looking at recovery after one year further supported the benefits of interventions.

The trial had ethical approval from the NHS research ethics committee and had ongoing oversight from an independent trial steering committee, which included patient representatives. NICE considered the PACE results in 2011 and concluded that they supported its existing recommendations on both CBT and GET as described above.

The Government are aware that the use of CBT and GET in treating CFS/ME has long been a controversial issue for patient groups, charities and some clinicians. Since 2011, PACE trial data has been shared with many independent scientists as part of normal research collaboration, including the internationally respected research organisation Cochrane, which independently validated the findings.

However, in the last 18 months, the attention on the trial has increased substantially following a tribunal ruling in August 2016 which ordered the release of the trial data to a member of the public. The data has since been examined more widely, and critics, including some clinical academics, have suggested that it shows that CBT and GET are not as effective as the trial results suggested.

The controversy around the trial is problematic for researchers, but it is most of all distressing for patients with CFS/ME who deserve the most appropriate treatment from the NHS and to have confidence in the treatment that is being provided. That is why the Government welcomes the NICE decision to undertake a full review of the guidance which will examine the concerns around the PACE trial and any implications for its current recommendations.

NICE develops its guidance independently to support NHS organisations and clinicians to deliver services in line with the best available evidence. NICE welcomes the input of stakeholders, and more than 10 CFS/ME charities and organisations are already registered to support the guideline development process. All other parties who are interested can comment on the draft scope and draft guidelines at the appropriate time during the development process. Final guidance is expected in October 2020.

I hope this is helpful, and thank you again for contacting me."
 
MeSci said:
The peer-reviewed trial results published in The Lancet found that 60% of patients with CFS/ME benefited from CBT and GET when provided alongside specialist medical care. CBT and GET were found to be better than pacing therapy or specialist medical care alone in improving both symptoms and disability, and a follow-up study looking at recovery after one year further supported the benefits of interventions.
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Errr... they quoteth BS.

They *assumed* a 60% improvement in working out the sample size. This was based on the much smaller (and biased) Liverpool study. A 60% improvement was never mentioned in the trial report itself.

The "follow-up study" mentioned is the PACE trial itself, and not the 2-year follow-up study from 2015 that showed *no difference* between the interventions.

PACE authors have relied entirely on MPs and civil servants being unable to read primary medical articles. Shocking!
 
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Lucibee said:
The peer-reviewed trial results published in The Lancet found that 60% of patients with CFS/ME benefited from CBT and GET when provided alongside specialist medical care. CBT and GET were found to be better than pacing therapy or specialist medical care alone in improving both symptoms and disability, and a follow-up study looking at recovery after one year further supported the benefits of interventions.
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Errr... they quoteth BS.

They *assumed* a 60% improvement in working out the sample size. This was based on the much smaller (and biased) Liverpool study. A 60% improvement was never mentioned in the trial report itself.
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I'm not sure whether I am misreading what you said but improvement rates of 59% and 61% were reported in the Lancet using their revised, very lax, definitions of improvement.
 
Sorry, yes, you're right.

But... it was not a primary outcome measure. It wasn't reported in the abstract, and, as you say, their definitions were very lax and subject to regression to the mean given that both measures were used as selection criteria:
"at least 2 points for fatigue and at least 8 points for physical function at 52 weeks"

An "improvement" of 2 points for fatigue could also indicate a worsening, depending on how the CFQ is interpreted (which I've discussed elsewhere). 8 pts for PF is less than 2 pts on the scale itself.
 
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