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TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study

sarah darwins

sarah darwins

Senior Member
Messages
2,508
Location
Cornwall, UK
user9876 said:
Part 2 is up now

http://www.virology.ws/2015/10/22/trial-by-error-ii/
Click to expand...

Is there an error in the titling? It reads:

Screen Shot 2015-10-22 at 14.10.31.png


Think it should be PART TWO

I don't have time now to open an account and leave a comment. perhaps someone with an account could mention it.

On later edit: it seems that possibly PART THREE is the first part of the second instalment (!), in which case ignore this comment (though this numbering system, as Peter Cook put it, could confuse a stupid person ... )
 
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S

Sasha

Fine, thank you
Messages
17,863
Location
UK
Sasha said:
Thanks, Sarah - I've posted (though I think my comment might be held in moderation).
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There's more to come tomorrow - I think it may have originally been in four parts, with Parts 1 and 2 yesterday, so this is the correct instalment but just mislabelled.
 
aimossy

aimossy

Senior Member
Messages
1,106
Both instalments so far have been phenomenal reading. Some Jaw dropping things - also a lot of things I hadn't come across before in my reading travels. @Tom Kindlon and everybody who has fought so hard for us about this basically ethically criminal and dishwater research, I really wish I could give you a huge smile and sincere hug for your efforts to challenge this continuously. I wasn't part of the online community to see this unfold at the time, thank you so much for sticking like tar on the issues!
 
S

Sean

Senior Member
Messages
7,378
Of the key objective measures mentioned in the protocol, the Lancet paper only included the results of the six-minute walking test. Those in the exercise arm [GET] averaged a modest increase in distance walked of 67 meters, from 312 at baseline to 379 at one year, while those in the other three arms, including cognitive behavior therapy, made no significant improvements, from similar baseline values.

But the exercise arm’s performance was still evidence of serious disability, lagging far behind the mean performances of relatively healthy women from 70 to 79 years (490 meters), people with pacemakers (461 meters), patients with Class II heart failure (558 meters), and cystic fibrosis patients (626 meters). About three-quarters of the PACE participants were women; the average age was 38.
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Should also be pointed out that while the 6MWT result for the GET arm did reach statistical significance, it did not reach clinical significance, as defined independent of PACE for that measure, and that clinical significance is a more important and relevant standard to patient’s daily lives.

http://www.ncbi.nlm.nih.gov/pubmed/17136972

(Also, the average age of PACE participants was 38 at the start of the year long trial, and hence 39 at the end.)
 
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T

Tom Kindlon

Senior Member
Messages
1,734
Sean said:


Should also be pointed out that while the 6MWT results did reach statistical significance for the GET arm, they did not reliably reach clinical significance, as defined independent of PACE for that measure, and that clinical significance is a more important and relevant standard to patient’s daily lives.

http://www.ncbi.nlm.nih.gov/pubmed/17136972
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Also all the other groups increased from baseline, so the adjusted gap was 35.3 metres.
 
Y

Yogi

Senior Member
Messages
1,132
The best bits:

"But Kindlon and others also noticed something very peculiar about these “normal ranges”: They overlapped with the criteria for entering the trial. While a physical function score of 65 was considered evidence of sufficient disability to be a study participant, the researchers had now declared that a score of 60 and above was “within the normal range.” Someone could therefore enter the trial with a physical function score of 65, become more disabled, leave with a score of 60, and still be considered within the PACE trial’s “normal range.”

The same bizarre paradox bedeviled the fatigue measure, in which a lower score indicated less fatigue. Under the revised, continuous method of scoring the answers on the Chalder Fatigue Scale, the 6 out of 11 required to demonstrate sufficient fatigue for entry translated into a score ranging from 12 and higher. Yet the PACE trial’s “normal range” for fatigue included any score of 18 or below. A participant could have started the trial with a revised fatigue score of 12, become more fatigued to score 18 at the end, and yet still been considered within the “normal range.”

“It was absurd that the criteria for ‘normal’ fatigue and physical functioning were lower than the entry criteria,” said Kindlon."

upload_2015-10-22_20-50-50.jpeg


Some PACE trial participants were unpleasantly surprised to learn only after the trial of the researchers’ financial and consulting ties to insurance companies. The researchers disclosed these links in the “conflicts of interest” section of the Lancet article. Yet the authors had promised to adhere to the Declaration of Helsinki, an international human research ethics code mandating that prospective trial participants be informed about “any possible conflicts of interest” and “institutional affiliations of the researcher.”

upload_2015-10-22_20-49-18.jpeg



Thank you again to Tom Kindlon and David Tuller for this.

And there is silence from Action for ME, the Lancet, MRC, DWP. What have they got to say to this. Is this harassment? If they don't respond voluntarily they need to be held to account and forced to respond to this.

These psychobabblers have wasted £5 million of limited UK taxpayers funds. Once the whole of this is exposed UK taxpayers should ensure that they should be forced to pay (and no that is not a threat or harassment) back all this money given the budget defecit and the austerity!!

Can't wait for the next part.
 
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Kati

Kati

Patient in training
Messages
5,497
Yogi said:
The best bits:

"But Kindlon and others also noticed something very peculiar about these “normal ranges”: They overlapped with the criteria for entering the trial. While a physical function score of 65 was considered evidence of sufficient disability to be a study participant, the researchers had now declared that a score of 60 and above was “within the normal range.” Someone could therefore enter the trial with a physical function score of 65, become more disabled, leave with a score of 60, and still be considered within the PACE trial’s “normal range.”

The same bizarre paradox bedeviled the fatigue measure, in which a lower score indicated less fatigue. Under the revised, continuous method of scoring the answers on the Chalder Fatigue Scale, the 6 out of 11 required to demonstrate sufficient fatigue for entry translated into a score ranging from 12 and higher. Yet the PACE trial’s “normal range” for fatigue included any score of 18 or below. A participant could have started the trial with a revised fatigue score of 12, become more fatigued to score 18 at the end, and yet still been considered within the “normal range.”

“It was absurd that the criteria for ‘normal’ fatigue and physical functioning were lower than the entry criteria,” said Kindlon."

View attachment 13163

Some PACE trial participants were unpleasantly surprised to learn only after the trial of the researchers’ financial and consulting ties to insurance companies. The researchers disclosed these links in the “conflicts of interest” section of the Lancet article. Yet the authors had promised to adhere to the Declaration of Helsinki, an international human research ethics code mandating that prospective trial participants be informed about “any possible conflicts of interest” and “institutional affiliations of the researcher.”

View attachment 13162


Thank you again to Tom Kindlon and David Tuller for this.

And there is silence from Action for ME, the Lancet, MRC, DWP. What have they got to say to this. Is this harassment? If they don't respond voluntarily they need to be held to account and forced to respond to this.

These psychobabblers have wasted £5 million of limited UK taxpayers funds. Once the whole of this is exposed UK taxpayers should ensure that they should be forced to pay (and no that is not a threat or harassment) back all this money given the budget defecit and the austerity!!

Can't wait for the next part.
Click to expand...
@Yogi, your graphics are detracting from what you are writing, sorry I ca't read.
 
Y

Yogi

Senior Member
Messages
1,132
Kati

Kati

Patient in training
Messages
5,497
Yogi said:
Sorry @Kati didn't realise it was making it difficult to read. Do you want me to delete them?

Some interesting tweets
https://twitter.com/davidtuller1/status/657217182313525248

"emperor's new clothes is exactly what it is. I hope everyone can now see that the dude is completely nude"

https://twitter.com/ColumbiaMSPH

"The troubling case of the PACE Chronic Fatigue Syndrome study in @TheLancet by @davidtuller1: http://ow.ly/TIPhA #mecfs (via @profvrr)"
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i would just suggest to keep that in mind for the future posts. I am sure that what you have to say matters, it's just that I couldn't read it. Sensory overload, you know?
 
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