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PACE Trial and PACE Trial Protocol

Messages
5,238
Location
Sofa, UK
Actually they have released all the data. It was a hot, sunny day, so they opened up the doors and windows, and all the data went outside to play, and they haven't been able to round them all up and box them up again. The data clearly had got fed up of being mistreated.
Outstanding! :D
 
Messages
5,238
Location
Sofa, UK
Beliefs about damage and symptom focussing were more frequent in patients with anxiety disorders while embarrassment and behavioural avoidance were more common in patients with depressive disorder.

So as for their latest study, I've only seen the abstract, and of course we all know one should never just judge by the abstract, one should read the whole paper in order to get a proper sense of the full horror of it, but if anybody has yet done so, and recovered from any resulting anxiety or depression, is my interpretation of their findings correct? Or am I missing something earth-shatteringly useful?

- roughly half of the PACE trial participants were suffering from an anxiety disorder, a depressive disorder, or both (though whether they also had ME is, of course, another question).

- this is not unexpected, because previous research has shown that if you use the Oxford Criteria to define "CFS/ME", large numbers of patients have anxiety and depression.

- the patients with anxiety disorders tended to be more anxious about their health.

- the patients with depressive disorders tended to be more embarrassed and didn't do much.


This does not seem exactly ground-breaking news to set the ME research world alight, but I'm probably missing something - did they bury away their most exciting findings in the paper itself, and not mention them in the abstract?
 

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
Have you seen the latest "PACE" report? http://www.ncbi.nlm.nih.gov/pubmed/22571806

Be aware, that this is a tertiary care study and these sorts of figures are common in tertiary care of individuals with other chronic diseases as well.

Those who agree to take part in a study like PACE are more likely to have co-morbid disorders. It isn't rocket science.

Given these results, I wonder whether the 'measured' effect was related to a change in reporting behaviour due to a reduction in depressive/anxiety symptoms, rather than a reduction in CFS symptoms...
 
Messages
5,238
Location
Sofa, UK
It's all done? Great work people. Are we going to get a PR article on it?
Yes, hopefully that will be up later today...soonish, anyway. Didn't quite manage to get it all done in time for the target of a May 12 launch for both the new forums and the PACE report, but we were pretty close...
 
Messages
13,774
Seems like you've all put in heroic efforts Mark. I need to be better at getting things done... you're all an inspiration.
 

WillowJ

คภภเє ɠรค๓թєl
Messages
4,940
Location
WA, USA
#41 is clever (asterisks added): "The *effectiveness* of cognitive behaviour therapy (CBT) as a treatment for CFS does not make assumptions about the nature of the illness." Then they mention CBT for heart disease etc. Plenty of inferred and implied assumptions were made about CFS in the CBT manuals.

well said.

of course, the *ineffectiveness* of CBT, when designed to treat fears (and deconditioning; there was some overlap with APT despite their stated cautions, wasn't there?), might well lead to an inference about the nature of the illness.
 

oceanblue

Guest
Messages
1,383
Location
UK
How relevant are exercise capacity measures for evaluating treatment effects in chronic fatigue syndrome? Results from a prospective, multidisciplinary outcome study

Not sure if this (from 2006)had been posted before but looks relevant to PACE:

Results: The total group significantly improved on nearly all reported HRQoL/ psychosocial variables. Changes in exercise capacity measures were rather modest and did not correlate or only weakly correlated with HRQoL/psychosocial variables. Subgroup analyses indicated that less fit patients improved significantly more on exercise capacity measures than their more fit counterparts. Patients who were fitter at baseline scored better on pretreatment HRQoL/psychosocial variables, but both subgroups improved similarly on these variables


Conclusions: Health-related quality of life and psychosocial functioning in patients with chronic fatigue syndrome improves after a six-month cognitive behaviourally and graded exercise-based multidisciplinary treatment programme. Increase in exercise capacity measures is not a necessary condition for reported improvements, except for less fit patients.
Full text
Reported SF-36 PF scale means increased from baseline 18.07 to 19.06 post therapy, but those figures look too low to me on either traditional (0-100) or norm-based scoring.
 

Dolphin

Senior Member
Messages
17,567
How relevant are exercise capacity measures for evaluating treatment effects in chronic fatigue syndrome? Results from a prospective, multidisciplinary outcome study

Not sure if this (from 2006)had been posted before but looks relevant to PACE:


Full text
Reported SF-36 PF scale means increased from baseline 18.07 to 19.06 post therapy, but those figures look too low to me on either traditional (0-100) or norm-based scoring.
Scoring on sheets is 1-3 for the 10 questions i.e. 10-30. So presumably that's what they have done i.e. on traditional scoring, 40.35 (baselines) to 45.30 (post therapy).
 

Graham

Senior Moment
Messages
5,188
Location
Sussex, UK
I thought I had finished asking questions on this, but I haven't. When the trial patients were assessed for fatigue and physical functioning, did they get given the questionnaires to fill in, or were they led through it by an interviewer? Implicit in one person's response to me is the suggestion that it was the latter. If so, wouldn't that greatly increase the potential for bias?
 
Messages
13,774
I thought I had finished asking questions on this, but I haven't. When the trial patients were assessed for fatigue and physical functioning, did they get given the questionnaires to fill in, or were they led through it by an interviewer? Implicit in one person's response to me is the suggestion that it was the latter. If so, wouldn't that greatly increase the potential for bias?

I had assumed that they were given them to be filled in rather than being led through them... but that was just dangerous good faith on my part. I don't think that they said one way or the other. I can't see any legitimate reason for doing it that way though, and as you say, it just greatly increases the potential for bias.

I did read some things about the impact of different ways of taking tests affecting the scores... I think that some of it was in the Bowling paper that they cited for their SF36 PF norms. That paper also mentioned that people with chronic health problems tended to get higher SF36 scores if they had already filled out a questionnaire specifically about their health condition first, possibly making the order of when patients filled out CFQs and SF36 PF questionnaires important.

I could probably dig out a quote if you wanted... I've forgotten so much of this stuff already though!

PS: I just dug out the paper... and there was nothing really conclusive. It was more about reporting different concerns and possible recommendations. As this paper's now quite old, it could well be that more recent work supersedes it. This was all for population based stuff, and nothing about trials where researchers want to show the efficacy of particular treatments.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
The Countess of Mar has agreed to ask some parliamentary questions about the PACE Trial, based on original questions formulated by Malcolm Hooper.

There's some info about it all here:
http://www.meactionuk.org.uk/Further_Articles.htm

The questions to be asked are here:
http://www.meactionuk.org.uk/PACE-Questions-as-tabled.htm

Malcolm Hooper's original questions are here:
http://www.meactionuk.org.uk/Questions-re-PACE-Trial.htm

Here are the useless responses (just re-posting them in this thread, in case anyone missed them):
http://forums.phoenixrising.me/index.php?threads/responses-to-pace-questions.17587/
http://www.meactionuk.org.uk/Responses-to-PACE-questions-CoM.htm
 

Dolphin

Senior Member
Messages
17,567
I thought I had finished asking questions on this, but I haven't. When the trial patients were assessed for fatigue and physical functioning, did they get given the questionnaires to fill in, or were they led through it by an interviewer? Implicit in one person's response to me is the suggestion that it was the latter. If so, wouldn't that greatly increase the potential for bias?
Do you have the 226-page protocol file: http://www.mediafire.com/view/?w9whdn7hh112b7y ? It is useful to answer similar questions.
Unfortunately, I don't think it's clear in this case. My guess is they were written answers for those questionnaires.
 

Dolphin

Senior Member
Messages
17,567
Correlation between 6MWT and actometer readings

The 6MWT and it's meaningulness has been discussed on another thread. Thought this would be useful info re PACE:

Correlates of Physical Activity in Chronic Obstructive Pulmonary Disease

Abstract

Background: Physical activity is a key dimension of functional status in people with chronic obstructive pulmonary disease (COPD), and the central target of interventions in this group.

Objectives: To determine the relationships among functional performance measured as physical activity, functional capacity, symptom experiences, and health-related quality of life in people with COPD.

Method: Cross-sectional, descriptive study. Convenience sample of 63 outpatients with COPD studied prior to entry into a pulmonary rehabilitation program.

Results: Daily physical activity, as measured by an accelerometer, was strongly associated with maximal distance walked during a 6-minute walk test (r = .60, p < .00), level of airway obstruction (r = .37, p < .01), walking self-efficacy (r = .27, p < .05), and physical health status (r = .40, p < .01). Physical activity was not correlated with self-report of functional status. The only predictor of physical activity was the 6-minute walk test.

Conclusions: Accelerometer measurement of functional performance was most significantly related to walking abilities. This methodology represents a novel approach to measuring an important dimension of functional status not previously well quantified.
Thanks. Interesting.
I think this level of correlation would likely hold for the initial assessment, before therapy.

The question is whether the correlation would be quite as strong for future assessments. I think it is possible that the individual therapies could have different correlations, as I've said before e.g. some groups, such as CBT or particularly GET, might push themselves a bit harder, for one reason or another, while a group like APT, might push themselves a little less.

Also, as many people will know from running a middle or long-distance race, it can help to have done it before a few times, so as not to go either too slow or too fast initially. The same person can get different times/do different speeds, depending on how well they work this out. I know this is a walking rather than a running test, but one can walk at quite different speeds. The training effect.