A general thread on the PACE trial!

Apologies if this blog post from 2013 has been posted already:

Abu Abioye,
Students 4 Best Evidence

Assessing the PACE trial using the CASP Tools for Randomised Controlled Trials

https://s4be.cochrane.org/blog/2013...-casp-tools-for-randomised-controlled-trials/

I realize that it's from 2013, but as it's still retrievable and stands unchallenged on the 'Students for Best Evidence' webiste....

Two points that seemed to me particularly weird:

Question 4: Were the patients, health workers and study personnel ‘blind’ to treatment?

"No, due to the nature of the interventions, only the statistician doing the analysis of the results could be blinded, therefore there is room for bias from the clinicians and patients. The authors performed various statistical analyses to assess if there was bias in the results from each clinician, however these analyses showed no bias.

"We still cannot discount the patients’ bias because most of the outcome measures were subjective and self-reported by the patients."

(Genuine question: Is it really possible to statistically analyze if there was bias in the results from each clinician?)

Question 9: Can the results be applied to the local population?

"If I were to use this trial to make evidence-based decisions about a patient, the results would be applicable to a 35-45 year old, white patient with CFS (as defined by the Oxford criteria), who has been ill for 1.5 – 6 years and who is slightly overweight. The results are not applicable to patients who cannot attend hospital."

Both the the author's statement about risk of "patients' bias" (Q 4) and the restrictions regarding the patient population (Q 9) are not reflected in his overall assessment of the trial. In the conclusion he states:

Conclusion

"The results show that CBT and GET, when added to SMC, are effective treatments for CFS. Their effect size is moderate. GET performed better than CBT in the objective test (metres walked in six minutes), however CBT was better at reducing depression. The results showed that adding APT to SMC was no better than SMC alone."

 

The patients who were involved in the trial were preselected by the people running the trial much the same way it was to be done in the LP trial that did not pass ethical review. What criteria they used to decide who was eligible to enter the trial has never been published.

It was implied that it was because of factors like being able to commit to the length of the trial and well enough to go but at the time the ME community felt that it was so that it was only patients who would get better with GET. Before the results came out I believed that the patients had been so cherrypicked that it would be a stunning success so even their doctored figures were shockingly low.

If I remember correctly it was something like over 3000 put forward for the trial but only 640 deemed suitable.

Then the results were claimed to prove that the treatment should be used on all ME patients.

 

Apparently some wikipedian has made a creative interpretation of the APT in PACE:

https://twitter.com/user/status/1407459119947124737


(General hint: something can't have been "popularized" if it only exists within the confines of a single experiment and is therefore neither popular nor even in use anywhere by anyone)

 

I think it is generally regarded that this 'variety' of pacing ie APT was adopted by BACME and AfME and the ME/CFS clinics that were set up and includes the idea of baseline, boom and bust, 'pacing-up' etc,
completely going against what most ME patients understood as pacing.
I wouldn't say it was 'popularised' tho', more like 'imposed'.

 

(Edit: I just like the quote, haven't read the article yet.)

Tweet by the AMA Journal of Ethics:

Code:

https://twitter.com/JournalofEthics/status/1412441212494229511

"The PACE study has since been roundly critiqued by patients, academics, and experts alike for serious methodological flaws."

-Dorothy Wall, MA

From: Wall, D: The Importance of Listening in Treating Invisible Illness and Long-Haul COVID-19, AMA J Ethics. 2021;23(7):E590-595. doi: 10.1001/amajethics.2021.590

Forum thread here

 

A certain somebody felt compelled to reply to that tweet:

https://twitter.com/user/status/1412806404046528513

 

All together now.

Oh yes it does...


I didn't like the results because they truncated the Y axis and there is only one reason to truncate a Y axis folks.

 

Of course he did!!

 

Oh noes, we certainly would not want to have an ideologically-driven commitment to force a population to accept a level of morality and disability, now would we? As long as that population can effectively fight back, anyway.

It would really be bad, wouldn't it? Not half as bad as the people objecting to it, clearly. Turns out that depends entirely on whatever opinion one has on the issue. Terrorists, freedom fighters, all depends on who you ask. How strange, and wholly arbitrary in exactly the way politics can be.

https://twitter.com/user/status/1413599090680770566

 

not sure if"morality "is a typo or deliberate i like it more if deliberate because morality and politics rarely seem to be on speaking terms .

 

My typo indeed. Morality is so much more flexible than mortality. Patient dead? Can't argue with that. Immoral negligence? Can be endlessly argued as "for our own good", or that actually it's all good, no complaints recorded, it's not allowed.

Frankly anything that requires this much individual judgment is doomed to fail. Even the very concept of harm is so ambiguous that it can be spun around completely, this makes for too easy moral relativism and endless cycles of cheap excuses for failure.

But at least judicial systems have the presumption of innocence, due process and burden of evidence. This places safeguards on the limits of individual judgment, "beyond any reasonable doubt". In medicine we have the exact opposite, process can be bypassed entirely and outcomes don't even have to be accounted for.

 

From:
The Lancet, China and the origins of coronavirus
https://www.spectator.co.uk/article/the-lancet-china-and-the-origins-of-coronavirus
https://twitter.com/user/status/1420048257460363264

 

I find this strangely arm's-length sentence intriguing:

This was a classic demonstration of the importance of transparency: critics of the study (of whom there are many) had to make a Freedom of Information request and wait years to see the data — at which point they argued that their re-analysis showed far less impressive results than the original.

Maybe it was designed to reduce the number of unsolicited emails from psychiatrists to be received by the author?

 

Can't remember seeing that name before: Nick Ross.


Thirty years of HealthwatchUK. Thirty years of ex-BBC Nick Ross deceiving patients?
https://drnmblog.wordpress.com/2021...years-of-ex-bbc-nick-ross-deceiving-patients/

One client was/is the Department of Work and Pensions. The DWP part-funded a highly controversial trial of psychosocial interventions for ME/CFS, the PACE trial, which was published in 2011. One of the lead investigators was, and remains, a Professor at Kings College London, and is a close associate of other supporters of PACE at KCL, who have a high public profile. The HealthwatchUK Chair is an honorary Professor at KCL.

After updated NICE guidelines on ME/CFS are published in August, it is likely that there will be further efforts by campaigners to obtain a formal ‘expression of concern’ about the PACE trial, or even its retraction. That will include my own call for the PACE trial to be retracted, primarily on ethical grounds.

Many ME/CFS campaigners have been concerned about the PACE trial being unfairly promoted in the media, and themselves being unfairly portrayed as ‘abusive activists’. The question arises, as a leading ex-journalist, did Mr Ross have any role in this?​

 

We would need to go back to the politicking in the early days of Healthwatch round about 1990. There is information about , but I will have to think about it. The controversy was originally around Caroline Richmond who appeared to be do the original legwork but then was ousted. Her views on ME were and are well known.

Healthwatch long been known to have been significant. Wessely was a member. Chalmers was a member. The information about the DWP being a client of Ross is certainly worth looking into.

EDIT there was also controversy about Richmond using an address for Wellcome Foundation in an early document and having to point out that that was merely her work address and that Wellcome was not otherwise associated.

 

I find Dr McFarlane's approach a bit scattershot and he obviously has his own agenda but I was having a conversation with Nick Ross on another forum couple of days ago and I find the connections suggested in this blog interesting!

 

the problem with that client list is that, so far as I can see, it does not provide information as to the nature of the work or the date. If there was a single corporate speech given in, say, 2015 it would not be too significant.

There are some other interesting clients. Allied Dunbar. AXA.

Even assuming that he merely gave a single corporate speech for the DWP that should present an image proble. Presumably he takes a fee of many thousand pounds. To those that have shall be given. To those that have not shall be taken away even that which they have.

 

Nick Ross is a very well known face in the UK, mainly because of a programme he used to present called Crimewatch. I didn't know until recently he was there at the beginning of HealthWatch.

Nicholas David Ross CBE is a British radio and television presenter. During the 1980s and 1990s he was one of the most ubiquitous of British broadcasters but is best known for hosting the BBC TV programme Crimewatch, which he left on 2 July 2007 after 23 years

 

I'm guessing that someone could ask a freedom of information request e.g. asking DWP whether they paid Mr Ross and if so what was he contracted to do --- probably a better way to ask that!