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PACE trial: Lancet Psychiatry paper on long term follow - correspondence

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
However, the outcomes reported by those who received these treatments in the trial and participated in the follow-up study had improved to the extent that, in a comparison of long-term outcomes by original trial treatment allocation, we found few differences. Although this finding might mean that all PACE treatments have similar long-term outcomes, we cannot draw this conclusion.
Huh? They managed to draw the opposite conclusion, that CBT/GET were superior, even though their own data (above, see graph and table) showed those who went on to have any CBT/GET after SMC/APT did no better than those that had no further treatment.

I guess this just highlights the limits of correspondence, with the authors having the last word, as opposed to debate. "A duel where your opponent has the last shot", as James Coyne has said before.
 

Sidereal

Senior Member
Messages
4,856
Which of course ignores the fact this gain was from baseline, not compared with the control groups. The advantage of CBT/GET was only around 8 points at the end of the trial (a self-report measure in an unblinded trial) and there was no advantage at long-term follow-up, which is actually what this correspondence is all about.

Maybe it's just me but I've noticed that in recent press releases and letters they just sort of ignore the follow-up study (even though the article/correspondence is supposed to be about the follow-up) and instead rehash the findings of the 2011 Lancet paper.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
Three good letters. Thank you authors.
Predictable reply, both on approach and content.
Job not done yet but it all helps to bring the details of PACE out into the light for proper scrutiny. I predict it will encourage more people to pay attention and start having doubts.
 

A.B.

Senior Member
Messages
3,780
Maybe it's just me but I've noticed that in recent press releases and letters they just sort of ignore the follow-up study (even though the article/correspondence is supposed to be about the follow-up) and instead rehash the findings of the 2011 Lancet paper.

Thoughts about negative studies are negative and must be replaced with positive thoughts.

And so they went from "no difference between interventions at follow up" to "CBT and GET maintained their benefits at follow up".

It's frustrating dealing with people that seem to have no interest in reality.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
charles shepherd said:
The only way to conclude if people on the PACE trial have recovered from ME/CFS is to re-interview them to confirm they are symptom free; have returned to normal health and functioning; have resumed any education or employment preceding the illness, and have ceased to claim any disability benefits.
That would be great if it could be done by people not involved in the PACE trialThat would be great if it could be done by people not involved in the PACE trial
Would there be any value at this point in doing actimeter/actometer tests and comparing them with baseline results?
 

charles shepherd

Senior Member
Messages
2,239
charles shepherd said:
The only way to conclude if people on the PACE trial have recovered from ME/CFS is to re-interview them to confirm they are symptom free; have returned to normal health and functioning; have resumed any education or employment preceding the illness, and have ceased to claim any disability benefits.

Would there be any value at this point in doing actimeter/actometer tests and comparing them with baseline results?

There would be if people really wanted to obtain some objective information about improvement/recovery- but it ain't going to happen!
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
Would there be any value at this point in doing actimeter/actometer tests and comparing them with baseline results?

Not in terms of comparing results across the four treatment arms, because the PACE authors have essentially destroyed the randomisation at this point by allowing further PACE treatments according to choice during the follow-up period. They acknowledge this in their response. It's no longer a randomised trial. All actimeter tests would do right now would be to show results as a big group of 640, and - usefully - to provide data on the subset who were considered "recovered" in the "recovery" paper.

But as Charles said:

There would be if people really wanted to obtain some objective information about improvement/recovery- but it ain't going to happen!
 

Gijs

Senior Member
Messages
690
Where are all those recovered ME/CFS patiënts? I never read anything from them on fora and internet. If i was better i would write about it and find out if i had really ME/CFS like other patiënts etc... The pace trial is scientific fraud. The researchers are not concerned about this disease and the patiënts. They are pure quacks. True scientists would share their data. It's supposed to be transparent. One day they will be unmasked.
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
One day they will be unmasked.
They have been unmasked, but until recently it was mostly patients who were looking, and a very few doctors and researchers. Now more and more are looking. As more scientists, doctors and psychiatrists look, they will see what is going on. The only question is will more hype and press releases overcome careful and scientific scrutiny.
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
Here is the data

They started with 3000 patients to select cohorts from, end up with subgroups of 7 patients, and we are supposed to take their conclusions seriously? I'm still trying to understand p values, so I'm wondering what we should conclude from p values like .88, .50, .57

So they are admitting that their follow up data is worthless?

Their own follow-up study has to be rejected, because it so clearly shows the original study conclusions are wrong. Perhaps when they published the followup study they didn't realize that someone influential might actually read it.
 
Messages
13,774
I wonder what they're doing with their 5-year follow up data?

It sounds like they don't think it's going to be hugely enlightening. I wonder if they applied to get funding for it after having the 2.5 year data, and realising that there was nothing there that would let them claim CBT/GET was associated with better scores? It would be interesting to see their applications for funding.
 

worldbackwards

Senior Member
Messages
2,051
White et al said:
As highlighted by Charles Shepherd, the findings of the PACE trial and follow-up study differ from those of a patient association membership survey,3 which reported that CBT and GET were unhelpful and even harmful. Although of interest, these survey findings do not negate the results of the trial.
There was a programme on the radio the other week about the differences between the way that Brits and Germans speak. One point that came up was that if someone said something was 'interesting' or 'of interest' in Germany, they generally wanted to hear more, whereas in the UK, it meant that they wanted you to go away because they didn't give a damn.

I think we can safely say which tradition this falls into.
 

Snowdrop

Rebel without a biscuit
Messages
2,933
They have been unmasked, but until recently it was mostly patients who were looking, and a very few doctors and researchers. Now more and more are looking. As more scientists, doctors and psychiatrists look, they will see what is going on. The only question is will more hype and press releases overcome careful and scientific scrutiny.

They have been unmasked by the fact that having been publicly called out they are now fighting a rearguard action and are prepared to fight dirty. some new tactics--go after Dr's like Dr Speight who actually help patients.

Take the fight to a new arena--don't mention the useless indefensible CBT/GET and diss all other biological treatments as flaky, poorly researched, unwise to pursue etc.

Deny what was previously stated that no longer is useful and always use words in a cagey ambiguous way so there is plenty of future deniability/wiggle room.

Continue to malign patients and their advocates. Smear them if possible. Insist that it is a biological illness but that anything worthy of the name treatment will come from helping patients to understand what they can do through sheer bloody minded strength of will/character to alleviate their suffering by recognising how they contribute to it.

Ignore all issues that are inconvenient to engage with and that might lead to experts suffering from having to deal with reality.

What kind of world do these vested interests and half-baked journalists want to inhabit? Why not just make stuff up as a matter of course? It's so much simpler and saves a whole lot of time and effort.

Will careful honest scientific scrutiny overcome? Let's hope. The alternative is not worth entertaining in a decent world.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK

Yogi

Senior Member
Messages
1,132
Pathetic response from the PACE authors. Huge thanks to Frank Twisk, James Coyne and Keith Laws and @charles shepherd for their letter.

"PDW has done voluntary and paid consultancy word for the UK Government and a reinsurance company. TC has received royalties from Sheldon Press and Constable and Robinson. MS has received royalties from Oxford University Press. KAG and JW declare no competing interests."

I see they are a bit sheepish about fully declaring their conflicts of interests.

"UK Government" could mean anything - Peter Denton White has been doing consultancy for the Department for Work and Pensions and Swiss RE and he should have made that clear.

Michael Sharpe has been doing consultancy throughout the PACE trial for Aegon UK.

Trudy Chalder also worked for insurers throughout the PACE trial.

Have they stopped those conflicts of interest temporarily given the spotlight on them or did they not just declare?

http://www.thelancet.com/lanpsy/information-for-authors/statements-permissions-signatures
 
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Messages
13,774
Do they have to declare COIs only if they're close to the time they published the paper, rather than from when they were doing the research?
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Do they have to declare COIs only if they're close to the time they published the paper, rather than from when they were doing the research?
Good question. There ought to be rules, similar to those (I hope they still exist) about former politicians taking consultancy work - which is very common and is known as the 'revolving door' effect/syndrome. In that example there is supposed to be a certain amount of time before the former politicians can do the consultancy work and vice versa, I think.
 
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Yogi

Senior Member
Messages
1,132
"A conflict can be actual or potential, and full disclosure to The Editor is the safest course"

"At the end of the text, under a subheading "Declaration of interests", all authors must disclose any financial and personal relationships with other people or organisations that could inappropriately influence (bias) their work. Examples of financial conflicts include employment, consultancies, stock ownership, honoraria, paid expert testimony, patents or patent applications, and travel grants, all within 3 years of beginning the work submitted. If there are no conflicts of interest, authors should state that none exist."


It maybe that it is 3 years of this particular work being submitted. However given these letters all relate to the MAIN topic of the very controversial PACE trial (and the conflicts with insurers which David Tuller and also wrote about) then the "safest course" should be to disclose all such conflicts of interests and not be so shy about them now. This is especially so as although the bulk of the PACE trial has been reported they themselves say that they will be doing 5 year follow up report and the PACE trial keeps dribbling out like a bad case of diarrhoea for years on end.

It is important to be vigilant given the downright lies these people can spout and especially as Peter Denton White FAILED to disclose his conflicts of interest here until reminded to do so by Dr James Coyne:

http://forums.phoenixrising.me/inde...ystematic-review-protocol-of-intervent.42231/