A general thread on the PACE trial!

Just a thought - it would be easier to read if the original transcript and your comments were in different fonts, say italic for transcript and normal for comments.

 

Oh - I thought I had... I'll check other browsers...

 

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

 

It's really time he did a piece interviewing a representative sample of the authors of the Journal of Health Psychology special edition. But I'm not holding my breath.

 

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.

https://www.qmul.ac.uk/media/news/items/smd/44140.html

 

Somebody who got this reply sent it on to me.

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?

 

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.

 

Well said @Esther12 It is typical, isn’t it.

 

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.

 

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."

 

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!

 

If anyone has received such a letter from their MP, they should let them know that this info is misleading and needs to be corrected.

 

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.

 

Not just in the UK!

 

I got part-way through a reply and then saw the later stuff about the revision, and decided not to send it. He knows it's being revised.