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A critical commentary and preliminary re-analysis of the PACE trial

D

Dolphin

Senior Member
Messages
17,567
Swedish newsletter

Referentgranskad och publicerad analys bekräftar kritiken av den stora KBT-träning-studien

I tidigare nyhetsbrev har ni kunnat läsa om den starka kritiken mot studierna av KBT och träning vid ME/CFS, inte minst den brittiska så kallade ”PACE”-studien. Efter att ”PACE”-teamet dömts av domstol att lämna ut rådata är flera forskargrupper sysselsatta med att göra omanalyser, vilket kommer att resultera i ett antal artiklar framöver. Den första referentgranskade artikeln är nu publicerad. Dess slutsats är att ”PACE”-författarnas ändringar av kriterierna för tillfrisknande, vilka gjordes under studiens gång, inte var befogade och orsakade missvisande slutsatser. Utan dessa ändringar hade författarna inte kunnat påstå att de uppnått resultat; när tillfrisknande analyserades enligt det ursprungliga studieprotokollet fanns inga signifikanta skillnader mellan KBT- och träning-grupperna och kontrollgruppen.
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Peer-reviewed and published analysis confirms the criticism of the large CBT training study

Earlier newsletter you have been able to read about the strong criticism of the studies of CBT and training at the ME/CFS, not least the British so called "PACE" study. After the "PACE" team have been sentenced by a court to disclose the raw data is multiple research groups engaged in making repeat assays,which will result in a number of articles in the future. The first peer-reviewed article is now published. Its conclusion is that "PACE"-the authors 'changes to criteria for recovery, which was made during the course of the study,was not justified and caused misleading conclusions. Without these changes, the authors had not been able to say thatt hey achieved results; When recovery was analyzed according to the original study protocol, there were no significant differences between CBT and training groups and the control group.
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T

Tom Kindlon

Senior Member
Messages
1,734
https://twitter.com/i/web/status/845120107642707969

rftg_a_1259724_f0002_c.jpg


https://twitter.com/i/web/status/845120845269782529
 
Esther12

Esther12

Senior Member
Messages
13,774
Esther Crawley said:
2. The statement “Additional post-hoc analyses used disability and fatigue thresholds in which patients
could get worse during the trial and yet be classed as effectively treated. Together, these analyses were
the basis for the PACE authors’ claim that GET was “moderately effective" ” is not correct. Neither is it
“new information” as it relates to analyses published in 2011. The authors performed an additional secondary post hoc a
nalyses to give the proportions of participants in each treatment arm who were within the population normal range (mean +/-SD) for the primary outcomes of fatigue and SF36 physical function sub-scale: "
In another post-hoc analysis, we compared the proportions of participants who had scores of both primary outcomes within the normal range at 52 weeks." (White et al, 2011) Since these thresholds were entirely independent of trial
thresholds for eligibility, there were some (13%) participants who were within normal range of one or
both primary outcomes at baseline. However, White and colleagues never stated that being in the
normal range for primary outcomes was the same as being effectively treated. Their analyses was based
on improvement between baseline and follow up. For a clinically useful difference or effect, participants
had to improve by 8 or more points in SF36 and/or 2 points in fatigue. Please see page 831 of the White
paper.
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PACE did use those normal range cut offs to make claims about patients getting "back to normal":

How many patients improved and how many were back to normal? Around six out of ten patients made an improvement in both fatigue and physical ability after CBT or GET, compared to four out of ten patients who improved with APT or SMC. The number of pa-tients returning to normal levels of fatigue and physical function was about three out of ten after
CBT or GET; about twice as many as those who received APT or SMC.
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http://www.wolfson.qmul.ac.uk/images/pdfs/participantsnewsletter4.pdf

I can't be bothered to go through this in detail.

Anyone know what she was responding to? It's possible that the thing she was responding to failed to tie her down on the exact language?
 
C

char47

Senior Member
Messages
151
Tom Kindlon said:
https://twitter.com/i/web/status/846396658694938625

https://twitter.com/i/web/status/846397826301116416
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The two graphs you've posted on this page are the 'dog's privates' Tom:thumbsup:. Nice one.
The first one shows up just what a load of BS the obfuscation of bimodal/lickert differences/changes as a way to say critisisms arent valid, is. And the 2nd one shows both the posthoc changes AND why a score of 60 is so rubbish on the same graph! I know you know this, lol thats why you did it :D But i am just so thrilled to have access to it. Its so simply & clearly illustrated that even a person completely unfamiliar with the field would be staggered & understand the issue. It's ace.
Sorry to be dense but can i/where can I get access to a copy of the image that i can print out to show people? Really sorry if thats already been covered here or elsewhere, i am getting really confused with all the different PACE related articles & papers now.
 
A.B.

A.B.

Senior Member
Messages
3,780
Wolfiness said:
This "patient voice" argument makes me so angry. Desperate people with no other option who are told CBT/GET works. Of course they clamouring for it. They have no other options.
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Desperate mothers who don't want their kids to be disabled may want to believe that the illness can be overcome with LP, CBT/GET, etc. They might not have any awareness of risks, knowledge to recognize bad science, or realize that they're being used.
 
A

AndyPR

Senior Member
Messages
2,516
Location
Guiding the lifeboats to safer waters.
Wolfiness

Wolfiness

Activity Level 0
Messages
482
Location
UK
A.B. said:
Desperate mothers who don't want their kids to be disabled may want to believe that the illness can be overcome with LP, CBT/GET, etc. They might not have any awareness of risks, knowledge to recognize bad science, or realize that they're being used.
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Yep. Even easier mistake to make when it's not your own experience. My mum coerced me into totally unqualified CBT 15 years ago; it ended in severe deterioration. Tried to force Reverse Therapy on me. My parents have only just stopped pressuring me to do AM type rehabilitation and finally realised for themselves it's a load of meaningless jargon. And my dad is a doctor ffs.

It felt not dissimilar to if they were pressuring me to undertake gay conversion therapy (which they never would, I hasten to add), except they wouldn't have had medical authority supporting them and if I were merely gay I could have at least have left home.
 
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