PACE explained

[jace (Staff)]

Jane Clout
The PACE trial - and a fun and thorough explanation of just how wrong it was:

http://evaluatingpace.phoenixrising.me/summary.html

Check out the graphics! Learn all about how to lie with statistics!

Quote:In March 2011, a study in the UK into possible treatments for patients with ME/CFS (Chronic Fatigue Syndrome) was published in The Lancet. Called the PACE trial, it was based on the hypothesis that therapies with a psychological basis would be highly effective in treating the condition and significantly improve the prospects of most patients to return to normal health and functioning.

Patients were split into four groups: one had approximately 5 sessions of Specialist Medical Care (SMC) and nothing more: the other three groups had 3 or 4 sessions of Specialist Medical Care and approximately 12 to 15 sessions of Cognitive Behaviour Therapy (CBT), Graded Exercise Therapy (GET), or Adaptive Pacing Therapy (APT). CBT was "based on the illness model of fear avoidance" (of activity); whilst GET was based on "the illness model of deconditioning and exercise avoidance". Under the NICE guidelines, CBT and GET are all that are available for ME/CFS under the NHS in the UK.

All but one of the assessments reported in the trial were subjective, and were carried out by means of questionnaires. Only one objective assessment was carried out and reported upon in the study: the six-minute walking test, which measured how far the patients could walk in 6 minutes. Patients were assessed both at the start and at the end of the trial.

Play the animation to see the results of the six-minute walking test: it has a soundtrack.

[Angela Kennedy (Staff)]

Who wrote this Jace? I can't see any names.

[Angela Kennedy (Staff)]

Also- not impressed that, once again, my point that the Oxford Criteria allowed EXCLUSION of the 38% of clinic attendees possibly BECAUSE they have Myalgic Encephalomyelitis (and neurological deficits associated with such), has been ignored.

I tried to get people to understand this issue on that thread on PACE on PR, and was for the most part just ignored (bar one honourable exception).

And here, we can see that they have - incorrectly - discussed FUKUDA, when in fact the PACE trial used REEVES et al 2003 (different to Reeves 2005), which is actually MORE EXPLICITLY EXCLUSIONARY than Fukuda, although it does look like White et al CHANGED their criteria to Reeves et al 2003 FROM Fukuda at some point in the trial. Though it should also be noted Fukuda and London were NOT EVEN INCLUDED in the PACE Trial Identifier leaked by ONE CLICK in 2004 (just Oxford), and appear to have been added in response to criticisms about ignoring the Canadian Criteria - which myself and Jane Bryant raised publicly:

http://www.theoneclickgroup.co.uk/docume...ISSUES.pdf

http://www.theoneclickgroup.co.uk/docume...REPORT.pdf

http://www.theoneclickgroup.co.uk/docume...IER%20.pdf

They have also NOT addressed the discrepancies about the LONDON criteria - or that White et all used a 'version' of 'London' of their own making, that excluded people with signs of neurological deficits. In fact they have not even discussed the discrepancies about the London criteria, period, even before White et al bastardized it to suit themselves.

On top of this, I cannot see a reference list. I do see now the various people who took part in this, with Graham McPhee as the main man. I note they have not acknowledged other key people who were active in making critical points about the PACE trial right at the beginning, like myself, for instance.

This is not me being huffy because I've been ignored. My ego is not bruised. But I am frustrated that the key issues I've raised, which are vital to an effective critique of PACE, have been ignored. One of the biggest problems this community faces is when people refuse to acknowledge or co-operate with knowledgable others in the community, for reasons of petty prickliness, pomposity, or whatever. Even when I've had disagreements with people, if there are areas we can work together, or if someone is being treated unfairly, I will still co-operate wherever possible, because cutting one's nose off to spite one's face is not conducive to good advocacy strategy. People should have been working together on this - and I was one of those whose concerns and knowledge (and indeed, even my own complaint to the Lancet) have been largely ignored by the bods on that 'uber-thread' on the Phoenix Rising forums.

So - I'm not impressed. This in no way can be considered a comprehensive overview of the issues around the PACE trial, and I'm worried it will be presented as such. This would be highly detrimental to the ME community, because it ignores many of the key issues, of which the criteria, that I have been currently focusing on, is just one. I think key issues raised by Hooper have been ignored as well.

I'm going to tell Graham McPhee so as well.

[jace (Staff)]

I think this version of the many critiques of PACE fills a valuable niche. Yes, it doesn't include all the points, but what it does do is show clearly how the statistics were manipulated, for a lay audience.

You can educate some of the people one way, that flies right over the head of others of the people who need things put another way. The graphics, particularly, clearly show how little good was done.

By understating the case, I think this will convince people who are boggled by a more full rebuttal.

[Angela Kennedy (Staff)]

I have written this to Graham McPhee this morning:

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

Dear Graham

I am writing because you did invite comments on the above document.

What I am about to write may discomfit you, and I would first like to say I am not intending to write in any hostility, although the points I make here will be necessarily critical.

I should say immediately in the interests of transparency that I have done quite a lot of work over the years on the way psychiatrists have EXCLUDED people with neurological deficits (associated with the neurological illness myalgic encephalomyelitis) from their research cohorts. I have also been a vocal and analytical critic of the PACE trial since its inception. I did try and explain the issues about the criteria to others on the threads about the PACE trial that evolved on Phoenix Rising, but with the honourable exception of one person, was largely ignored.

I am highly concerned that this document may be promoted, especially on PR, as a comprehensive overview of the issues around the PACE trial, when it is nothing of the sort (I note with dismay you claim to have 'done the analysis' - my italics). This would be to the immense detriment to the ME community, and to those of us (even non-ME but supporters like myself) who have worked extremely hard on identifying key problems with PACE since before the trial started in 2004, and the issues we have rightly raised. By claiming or implying it is definitive, you have dismissed serious key issues around PACE that have enormous adverse implications for ME sufferers and their safety, a key point I have raised in my complaint to the Lancet, and which I publicised on the relevant threads on PR.

One major problem with this is the lack of references to the work of others on PACE. There are a number of references I can give you. Just three are here from myself and from Jane Bryant of the One Click Group (when I was working with her), but these are not exhaustive, either of our respective works or of other people:

http://www.theoneclickgroup.co.uk/docume...ISSUES.pdf

http://www.theoneclickgroup.co.uk/docume...REPORT.pdf

http://www.theoneclickgroup.co.uk/docume...IER%20.pdf

I also cannot see references either to my own complaint correspondence, nor Malcolm Hooper's extensive work in this area. At the very least you should have provided a bibliography of the work others have done, especially as your document implies this is a definitive analysis. Obviously this implication is not correct. If you acknowledge it is not then you need to publicise that, and a bibliography is the best way to do this.

One key area in which any implication this is a definitive analysis is particularly problematic is around the issue of the criteria used in PACE. Your document leaves out key issues and is discrepant in some places:

1. A key problem is that my frequently stated point that the Oxford Criteria allowed EXCLUSION of the 38% of clinic attendees possibly BECAUSE they have Myalgic Encephalomyelitis (and neurological deficits associated with such), has been ignored. I did try and explain this at some length to people on the PR threads, and show why this is a possibility that needs exploring by scientists (I'm presuming your document is intended to raise at least some scientific interest in the concerns raised by the ME community and its supporters?) but was largely ignored or dismissed.

2. You have also here - incorrectly - discussed FUKUDA, when in fact the PACE trial used REEVES et al 2003 (different to Reeves 2005), which is actually MORE EXPLICITLY EXCLUSIONARY than Fukuda, although it does look like White et al CHANGED their criteria to Reeves et al 2003 FROM Fukuda at some point in the trial. Though it should also be noted Fukuda and London were NOT EVEN INCLUDED in the PACE Trial Identifier leaked by ONE CLICK in 2004, and appear to have been added in response to criticisms about ignoring the Canadian Criteria - which myself and Jane Bryant raised publicly, as you will see from the above links.

3. You have also not addressed the discrepancies about the LONDON criteria - or that White et all used a 'version' of 'London' of their own making, that excluded people with signs of neurological deficits. In fact, you have not even discussed the discrepancies about the London criteria, period, even before White et al bastardized it to suit
themselves.

I should make it quite clear that this is not me being 'huffy' because I've been ignored. My ego is not bruised. But I am frustrated that the key issues I've raised, which are
vital to an effective critique of PACE, have been ignored, and the adverse effects that will have on advocacy on this issue and protection of the patient community from the adverse effects of PACE and its promotion. One of the biggest problems this community faces is when people refuse to acknowledge or co-operate with knowledgable others in the community, for reasons of petty prickliness, pomposity, sometimes sexism or classism, or whatever. Even when I've had disagreements with people, if there are areas we can work together, or if someone is being treated unfairly, I will still co-operate and support wherever possible, because cutting one's nose off to spite one's face is not conducive to good advocacy strategy. People should have been working together on this - and I was one of those whose concerns and knowledge (and indeed, even my own complaint to the Lancet) have been largely ignored on the Phoenix Rising forums. While the problems of internet interaction is one thing (and there are a lot of problems in this area on the Phoenix Rising forums), it does not excuse the lack of attention to these important issues that I have raised here.

I hope that you will take my honest and reasonable concerns here on board in the spirit they have been sent, refrain from shooting the messenger, and seek instead to present a bibliography of the work others have done in this area, and publicly acknowledge, in the document itself, that your own analysis in this document is inevitably not comprehensive or definitive, because of the work named others have done. I can provide you with a reasonably wide comprehensive bibliography with links (though even this may not be exhaustive). I would also suggest you remove the term 'the analysis' and replace it with 'an analysis'.

Please do not hesitate to contact me if you need any further clarification. I should let you know I am publicising this email. you have my permission to share this email with others, but I ask it be done so in its entirety, so any part of it is not at risk of being taken out of context.

Best wishes
Angela

[jace (Staff)]

Nicely put, Ange.