PACE Trial and PACE Trial Protocol

Esther12

Esther12

Senior Member
Messages
13,774
Dolphin said:
Queen Mary, University of London turn down another freedom of information request
https://www.whatdotheyknow.com/request/cfs_a_small_of_the_objective_phy
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The 6 minute walking test measures are attached as these are already in
the public domain.

I am afraid that the rest of your request remains impossible to fulfil
without exceeding the appropriate limit as defined by the Freedom of
Information and Data Protection (Appropriate Limit) Regulations 2004. For
your information this is £450, calculated as the estimated cost of one
person spending 18 hours in determining whether the information is held,
then locating, retrieving and extracting the information.
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18 hours? That sounds difficult to justify.
 
B

Barry53

Senior Member
Messages
2,391
Location
UK
I am afraid that the rest of your request remains impossible to fulfil without exceeding the appropriate limit as defined by the Freedom of Information and Data Protection (Appropriate Limit) Regulations 2004. For your information this is £450, calculated as the estimated cost of one person spending 18 hours in determining whether the information is held, then locating, retrieving and extracting the information.
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How convenient. I guess it just illustrates the problems they have with data.
 
R

RogerBlack

Senior Member
Messages
902
Esther12 said:
18 hours? That sounds difficult to justify.
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Solstice said:
Considering they happily spent 500 times that amount of money to keep their data secret their whole argument seems a bit sketchy.
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450 pounds is (one) statutory limit, and this is rated at 25 pounds an hour. (I am unsure if this is statutory). This leads to 18 hours.
Having said that, I don't see how any other method of data retrieval other than a particularly slow person retyping it could hit 18 hours.
 
Esther12

Esther12

Senior Member
Messages
13,774
For some reason, I've just re-listened to the partial recording of the 2011 PACE press conference at the SMC which the Lancet put on their website. I was interested in their use of the term 'back to normal' so pulled out some quotes on that, and a couple of bits where they work to present APT as being the form of 'pacing' that patient groups want.

http://www.thelancet.com/pb/assets/raw/Lancet/stories/audio/lancet/2011/18february.mp3

1:50 - CFS: Fatigue "which is bad enough to prevent you from leading a normal life"

2:25 - [patient groups] "expressed a preference for Adaptive Pacing Therapy"

7:00 "CBT and GET are both trying to see if you can overcome the limits imposed by the illness by trying to do more"

7:45 Committees oversaw the handling of the data - "there was a lot of independent scrutiny of the procedures of the trial, which is important because in some areas this trial will be seen as very controversial."

11:43 "If you think about the number of people who get back to normal levels of functioning and fatigue, then you see twice as many people in the graded exercise therapy and cognitive behavioural therapy group improving and getting back to normal, compared to the other two groups."

13:45 "The effect that we see, in terms of the improvements, was similar across all of the outcomes that we measured." - What about the trial's objective outcomes?

14:47 - "We'd just like to acknowledge the funders.." no mention of DWP.
 
D

Dolphin

Senior Member
Messages
17,567
I could never get past the simple fact that in the PACE trial, the paper was published in a journal which guaranteed access to the data. This is the start and end of the story, the alpha and omega, the end of the matter. All the mendacity which started immediately afterwards is secondary to this: they did not comply with this extraordinarily simple and straightforward rule of publication.

“It’ll identify people!” Remove the identifying information. It is not hard to de-identify data.
“It will be used mendaciously!” Then identify the mendacity in the criticism after you’ve given people the chance to make it. You should be able to win an argument concerning *your own data* if it’s presented honestly.
“We don’t have ethical approval to give the data away!” Then you violated the publication conditions.

PACE, for me at least, was a good example of two cultures in academia — one for the powerful, where ‘requires’ means ‘does not necessarily requires’ and one for everyone else.
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https://medium.com/@jamesheathers/i...paper-was-published-in-a-journal-2f4f339b7ddd
 
D

Dolphin

Senior Member
Messages
17,567
Psychometric properties & factor structure of a shortened version of Cognitive Behavioural Responses Questionnaire (CBRQ)

DOI: 10.1097/PSY.0000000000000536

Ryan EG1, Vitoratou S, Goldsmith KA, Chalder T.

PMID: 29023262
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I'm not sure I will read this but I thought this was interesting:
PACE patients were also required to have an SF36 score ≤60, which was later increased to ≤65; 348/576 (60.4%) patients had SF36 ≤60 in the clinical dataset and 377/576 (65.5%) patients had SF36 ≤65.
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People will recall a score of 60+ was a recovery criterion in the PACE Trial in which Trudie Chalder was a principal investigator.
 
R

RogerBlack

Senior Member
Messages
902
I've done some searching, and not quite found a nice definition in their own words concisely that CBT/GET is a psychological intervention.
Is there a nice concise source for this that doesn't involve closely parsing the treatment guide, for example.
Not third parties, those directly involved in promoting CBT/GET - the PACE trialists or very close allies.
 
Daisymay

Daisymay

Senior Member
Messages
754
RogerBlack said:
I've done some searching, and not quite found a nice definition in their own words concisely that CBT/GET is a psychological intervention.
Is there a nice concise source for this that doesn't involve closely parsing the treatment guide, for example.
Not third parties, those directly involved in promoting CBT/GET - the PACE trialists or very close allies.
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Not sure if this will do, from the original PACE paper, p3 at this link:

http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(11)60096-2.pdf

Panel 1 - treatments provided

CBT was done on the basis of the fear avoidance theory of chronic fatigue syndrome. This theory regards chronic fatigue syndrome as being reversible and that cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity) are linked and interact with physiological processes to perpetuate fatigue.

The aim of treatment was to change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability. Therapeutic strategies guided participants to address unhelpful cognitions, including fears about symptoms or activity by testing them in behavioural experiments.

These experiments consisted of establishing a baseline of activity and rest and a regular sleep pattern, and then making collaboratively planned gradual increases in both physical and mental activity. Furthermore, participants were helped to address social and emotional obstacles to improvement through problem-solving. Therapy manuals were based on manuals used in previous trials.19–21 CBT was delivered mainly by clinical psychologists and nurse therapists (webappendix p 1).

Graded exercise therapy (GET) GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity.

These changes result in the deconditioning being maintained and an increased perception of eff ort, leading to further inactivity. The aim of treatment was to help the participant gradually return to appropriate physical activities, reverse the deconditioning, and thereby reduce fatigue and disability.

Therapeutic strategies consisted of establishment of a baseline of achievable exercise or physical activity, followed by a negotiated, incremental increase in the duration of time spent physically active. Target heart rate ranges were set when necessary to avoid overexertion, which eventually aimed at 30 min of light exercise five times a week.

When this rate was achieved, the intensity and aerobic nature of the exercise was gradually increased, with participant feedback and mutual planning. The most commonly chosen exercise was walking. The therapy manual was based on that used in previous trials.22,23 GET was delivered by physiotherapists and one exercise physiologist (webappendix p 1).
 
R

RogerBlack

Senior Member
Messages
902
Daisymay said:
Not sure if this will do, from the original PACE paper, p3 at this link:

http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(11)60096-2.pdf

Panel 1 - treatments provided

CBT was done on the basis of the fear avoidance theory of chronic fatigue syndrome. This theory regards chronic fatigue syndrome as being reversible and that cognitive responses (fear of engaging in activity) and behavioural responses (avoidance of activity) are linked and interact with physiological processes to perpetuate fatigue.<snip>

These changes result in the deconditioning being maintained and an increased perception of eff ort, leading to further inactivity. The aim of treatment was to help the participant gradually return to appropriate physical activities, reverse the deconditioning, and thereby reduce fatigue and disability.
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This is a good start, but the emphasis on deconditioning is unfortunate for those that won't stop to think about if exercise deconditioning actually works like that.
Thanks.
 
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