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"News" 8 Sep 2016: PACE trial team analyse main outcome measures according to the original protocol

Dolphin

Senior Member
Messages
17,567
In summary, these results support our initial interpretation that “CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.” (White et al, 2011).
(I think this was mentioned before)
Improvement rates of 21% and 20% versus 10% for SMC don't seem like evidence that the therapies moderately improve outcomes
 

Dolphin

Senior Member
Messages
17,567
We have explained that, in common with many trials, the statistical analysis plan was developed after the trial had started but before any data were examined and was ratified by the trial steering committee.
This was an open label trial. Also these are self rated scores so it's not like say results from a blood test where one might have no idea whether levels have changed or not and to what degree.
 

Seven7

Seven
Messages
3,444
Location
USA
@Dolphin would be nice to know what is the rate of self improvement also.
Like every Fall I am down 50% from the level I am on Summer for example. So for me a 50% fluctuation in functionality is normal (I am remitting relapsing) so I know I am an extreme case.
But most CFSers I know a 10-20% improvement we get by just the nature of CFS on and off. So not sure how would this play a role.
 

Dolphin

Senior Member
Messages
17,567
In the main text file, there are 13 mentions of physical function/physical functioning in the text (along with others in the figures and tables) but no mention that this is a self rated scale rather than an objective measure of physical function. Does happen quite a bit. Frustrating.
 

BruceInOz

Senior Member
Messages
172
Location
Tasmania
Has anyone noticed that in the Lancet paper the percent improved uses the the number of survey responses at 52 weeks as the denominator in the percent calculation while in the latest offering they use the number randomised. I'm no statistician so I don't know which is more correct but the Lancet numbers are inflated by a few percent compared to using number randomised.
 

Sean

Senior Member
Messages
7,378
Subtracting the contribution of SMC from the CBT & GET results for the two different methods:

PACE 2011 (Lancet)
CBT - SMC = 59 - 45 = 14%
GET - SMC = 61 - 45 = 16%

PACE 2016 (Protocol)
CBT - SMC = 20 - 10 = 10%
GET - SMC = 21 - 10 = 11%

So the already marginal advantage of CBT & GET over SMC dropped by approximately a third when calculated by the more rigorous method.
 

Dolphin

Senior Member
Messages
17,567
One effect that comes to mind is that the medical textbook entry, I think written by Peter White, which said that around 60% improved in the PACE Trial with CBT or GET would need to be significantly altered.
One can read what trainee doctors are learning about Chronic Fatigue Syndrome in the 8th edition of the Kumar & Clark textbook, "Clinical Medicine":

Peter D. White and Julius Bourke was responsible for this chapter.

Sample extract:

----------------
"Prognosis

Prognosis is poor without treatment, with less than 10% of hospital attenders recovered after 1 year. Outcomes are worse with greater severity, increasing age, co-morbid mood disorders, and the conviction that the illness is entirely physical. A large trial showed that about 60% improve with active rehabilitative treatments, such as graded exercise therapy and cognitive behaviour therapy when added to specialist medical care."

Kumar.png

Kumar 2.png
 
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Dolphin

Senior Member
Messages
17,567
Peter White's service claims:

What outcomes can I expect from the Service?

We have found that approximately three-quarters of our patients with Chronic Fatigue significantly improve or recover with treatment in our clinic. Research has suggested that a quarter recover and half significantly improve. For some people, recovery may Not mean a return to previous lifestyles, if this contributed to them becoming ill in the first place.

https://www.elft.nhs.uk/service/308/Chronic-Fatique-Service/
 

Kati

Patient in training
Messages
5,497
One can read what trainee doctors are learning about Chronic Fatigue Syndrome in the 8th edition of the Kumar & Clark textbook, "Clinical Medicine":

Peter D. White and Julius Bourke was responsible for this chapter.

Sample extract:

----------------


View attachment 17199
View attachment 17200
The PACE authors left their marks everywhere. It will take a long time and lots of willpower from the 'authorities' to make it right for millions of patients and to clean up this mess.

And we're still missing the data. There is no expression of concern with Lancet. There is still the MAGENTA trial recruiting children into a new PACE trial. Patients like Karina Hensen is still held captive in Denmark, and there are probably other families at risk, when british pediatrician Nigel Speight is prohibited to see ME pts or speak publicly.

These authors are still doing business as usual, making money out of their lies and cover ups.
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
This was an open label trial. Also these are self rated scores so it's not like say results from a blood test where one might have no idea whether levels have changed or not and to what degree.
The statistical analysis of "normal" is invalid. How anyone could ratify it, if it were included in the plan, is hard to see. Its a failure to sufficiently investigate the analysis.

We have explained that, in common with many trials, the statistical analysis plan was developed after the trial had started but before any data were examined and was ratified by the trial steering committee.
 

mfairma

Senior Member
Messages
205
@Kati, sometimes I wish I believed in heaven and hell, so I could least have the consolation that justice will one day be rendered. I suspect they'll all just sail off into cushy retirements and a new generation of doctors will ring their hands about how terrible it all was, while doing the same to some other set of patients.
 
Messages
15,786
This appears to be an appeasement to get people to back off, but as @JohnCB says, it's not what they were asked to do. It's a compromise, and it's weird that they believe a compromise to be in any way sufficient.
I don't think it's intended as a compromise, so much as an attempt to release their narrative (the changes didn't matter) before patients release a competing narrative (the changes had a large impact). Journals also often won't publish something if the authors have already made it public somewhere, so they might be hoping that they can persuade journals not to publish an outsider analysis of the same data.

They've not released the recovery data, and that's what will cause them the most trouble. If this was an attempt to get their presentation of pre-specified analyses out before others got the data they'd have included recovery outcomes imo. I think that this is an attempt to avoid some of the blow back from the scientific community that they're expecting when they appeal.
I think it's a sign that they won't appeal. A Tribunal appeal at this point could only be on the interpretation and application of the law. They would not be examining evidence, and the (lack of) publication of the data certainly is a matter of evidence, not law. It is completely impossible that they would be able to introduce new evidence at this point.

Their "publication" also won't work as a substitution for releasing the data as ordered by the court. The court order was clear regarding what QMUL must do if they don't appeal, and anything short of that would be in contempt of the court, and cause them extremely serious legal problems.

So I expect we'll be seeing the actual data within in a week or so.

So the already marginal advantage of CBT & GET over SMC dropped by approximately a third when calculated by the more rigorous method.
I think it's more accurate to say that their post-hoc changes to improvement criteria resulted in improvement figures being inappropriately inflated by nearly 50%. The numbers are more impressive that way as well :D
 

A.B.

Senior Member
Messages
3,780
I think it's more accurate to say that their post-hoc changes to improvement criteria resulted in improvement figures being inappropriately inflated by nearly 50%. It's more impressive that way as well :D

Nearly 50%? They were inflated by a factor of about 3 for CBT and GET.

PS: trying to translate math into language isn't always easy. It's probably best to simply cite the numbers. So CBT went from 20% improved to 59% improved due to protocol changes.
 
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Cheshire

Senior Member
Messages
1,129
Journals also often won't publish something if the authors have already made it public somewhere, so they might be hoping that they can persuade journals not to publish an outsider analysis of the same data.

Thanks for highlighting that @Valentijn
But as it hasn't been published through a peer-review process, do you think it has the potential to prevent any further publication?
 

Sean

Senior Member
Messages
7,378
Nearly 50%? They were inflated by a factor of about 3 for CBT and GET.
Defined as ratio of differences between SMC and CBT/GET: 10/14 for CBT, and 11/16 for GET. Equals nearly 50% reduction for each.

Or following Valentijn's example: The Lancet 2011 results were inflated above the 2016 protocol results by 14/10 (1.4 times) for CBT, and 16/11 (1.45 times) for GET.


PACE 2011 (Lancet)
CBT - SMC = 59 - 45 = 14%
GET - SMC = 61 - 45 = 16%

PACE 2016 (Protocol)
CBT - SMC = 20 - 10 = 10%
GET - SMC = 21 - 10 = 11%
 

Kalliope

Senior Member
Messages
367
Location
Norway
The PACE authors left their marks everywhere. It will take a long time and lots of willpower from the 'authorities' to make it right for millions of patients and to clean up this mess.

And we're still missing the data. There is no expression of concern with Lancet. There is still the MAGENTA trial recruiting children into a new PACE trial. Patients like Karina Hensen is still held captive in Denmark, and there aree probably other families at risk.

These authors are still doing business as usual, making money out of their lies and cover ups.
Just this Wednesday, the Danish psychiatrist Per Fink (Karina Hansen's previous doctor) said in one of the biggest newspapers in Denmark that "I don't know of a single scientifically trained expert who has criticised the PACE-trial. The criticism comes from patient-groups. The trial is well performed and published in one of the world's most prestigious journals. So I don't understand the criticism of the two often good treatments" (CBT & GET).

To be fair to the newspaper, this interview followed a couple of thorough articles on among other the criticism from international ME-experts on how ME is defined as a functional disorder in Denmark.
 
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Messages
15,786
But as it hasn't been published through a peer-review process, do you think it has the potential to prevent any further publication?
It certainly could prevent journals from publishing the same papers which they have now posted publicly. It's the reason data is often embargoed at conferences and such pending publication - a journal doesn't want to purchase or try to sell a product which is already available for free elsewhere.

But I think they would have trouble convincing journals not to publish an analysis of the same data by different groups or individuals. However, due to their, erm, persistent denial of reality, they might still try to use it to persuade journals not to publish those outsider analyses.

My bet is that White, Chalder, and Sharpe wanted to appeal to the bitter end, but QMUL is ready to cut its financial and reputational losses. And PACE can't appeal without QMUL, since QMUL holds the data and is responsible for it.
 
Messages
15,786
Nearly 50%? They were inflated by a factor of about 3 for CBT and GET.

PS: trying to translate math into language isn't always easy. It's probably best to simply cite the numbers. So CBT went from 20% improved to 59% improved due to protocol changes.
What @Sean said.

The 60% rates were never an appropriate representation, when they were claiming SMC was a control group. The impact of the treatment was always the CBT/GET improvement rates minus the SMC improvement rates.

However the 60% rates are good for showing what a big impact it had when they changed the scoring thresholds, and that they were not inconsequential.
 

Art Vandelay

Senior Member
Messages
470
Location
Australia
I see this as an attempt to control the narrative rather than a sign that they won't release the data. In fact, I think this indicates that they will release the data - and I think tomorrow was their last day to appeal.

Exactly. This is Damage Control 101. That is, you get your spin out there ahead of the release of any embarrassing information in order to try and control the narrative.

In this case, I'd guess that their narrative will be something like: "we had good reasons to change the recovery criteria (subtext: these were complex statistical reasons that these irrational, crazy and vexatious militant patients couldn't possibly understand) but we've acquiesced to their unreasonable demands and released our results assessed in line with the original criteria. The figures may not be as impressive as those results reported initially but they're still very positive. So shut up."

They will now rely on the media and the medical establishment to not ask any questions or look too closely at the real figures. Based on past behaviour, this seems like a rational assumption.

In the unlikely event that any difficult questions come from journalists or researchers in the future, they will bat them away by claiming that any issues with PACE have been dealt with in this "latest research" and rely on the fact that most won't take the time to examine it properly.

You see this happen all the time when politicians in particular get caught engaging in unethical behaviour.

Edit: I wonder if they've hired any damage control consultants? (most likely at taxpayers' expense)
 
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