PACE Trial and PACE Trial Protocol

[Esther12]

Just so I'm sure, did you mean arguments supporting PACE and/or challenging claims made by the critics?

Hmmm... challenging claims made by sensible critics? Or challenging widley made criticisms? (I'm sure that some poor criticisms will have been made and rebutted).

Equally, good defences of PACE which you think we would disagree with would be interesting, but defences which no-one here would dispute are probably less worthwhile. What do you think?

 

[Angela Kennedy]

Hmmm... challenging claims made by sensible critics? Or challenging widley made criticisms? (I'm sure that some poor criticisms will have been made and rebutted).

Equally, good defences of PACE which you think we would disagree with would be interesting, but defences which no-one here would dispute are probably less worthwhile. What do you think?

Well- as the only 'defences' I've seen of PACE are those attacking its critics, ignoring their criticisms, and appealing to authority, I'd be very interested to see a 'good' defense that refrains from those rhetorical strategies that are actually fallacies of reasoning. I've not seen one yet...

 

[Marco]

I did the test a few times, here is the last attempt:

I guess this makes me some sort of welfare-sympathizing pinko with a mild distrust for authority?

Good point Dolphin, I can just imagine those who gargle and swallow the PACE Trial results while dumping on anyone who doesn't will be more likely to appear on the other side of the spectrum.

OMG call the coppers and the UK news media, a possible sexual reference, better add "sexual harassment" to the list of "criminal activities" committed by "ME militants"!

They BS crew may trend towards the authoritarian pole biophile but you'll find that they also tend to be left wing.

I suspect their orientation on simple axes such as this depends very much on their prior opinions of the subject under discussion.

 

[Dolphin]

The Authoritarian/Libertarian axis may not be perfect measure to measure some people's willingness or otherwise to accept the mainstream or establishment view. But I do come across people who seem to not question that much - if an official body says something, it's seen as most likely true and one is obviously a wild radical to think otherwise (and almost certainly wrong) (that's the impression). And the main point I was making was that the PACE Trial results/authors have grabbed the mainstream/establishment/evidence-based ground (from getting MRC/other funding, GET and CBT being seen as evidence-based, published in the Lancet, lots of professors/etc (they had lots of names on the paper - many journals say one can have a maximum of 6), etc).

 

[Angela Kennedy]

The Authoritarian/Libertarian axis may not be perfect measure to measure some people's willingness or otherwise to accept the mainstream or establishment view. But I do come across people who seem to not question that much - if an official body says something, it's seen as most likely true and one is obviously a wild radical to think otherwise (and almost certainly wrong) (that's the impression). And the main point I was making was that the PACE Trial results/authors have grabbed the mainstream/establishment/evidence-based ground (from getting MRC/other funding, GET and CBT being seen as evidence-based, published in the Lancet, lots of professors/etc (they had lots of names on the paper - many journals say one can have a maximum of 6), etc).

And such unquestioning acceptance of claims to authority is a polar opposite of a rationalist 'scientific', even 'skeptical' approach as claimed by various parties

 

[Dolphin]

(Not exciting)

Just doing a Google search for something and came across this link so thought I'd post it even though it doesn't say anything much

http://www.mhrn.info/data/files/MHR...TERS/East_Anglia_Hub_Newsletter_40_May_11.pdf

The NIHR Mental Health Research Network is part of the National Institute for Health Research and the NIHR Clinical Research Network in England.

This is the East Anglia Hub

MHRN National Scientific Meeting 2011

PACE Trial results: How should we treat chronic fatigue syndrome?

Peter White, Professor of Psychological Medicine at Barts and the London Medical School presented the
results of the PACE trail. This large-scale trial is the first in the world to test and compare the effectiveness
of four of the main treatments currently available for people suffering from chronic fatigue syndrome
(CFS), also known as myalgic encephalomyelitis (ME).

These are adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and
standardised specialist medical care. All of the treatments offer ways for patients to deal with and improve
the symptoms of CFS/ME and its effects on disability. The participants in the trial are randomly allocated
to one of the treatments and then given a 12-month programme involving appointments with specialised
doctors and, for three of the four treatment groups, therapists.

641 participants were recruited and equally divided into the four groups, each participant followed their
allocated treatment arm using the specifically designed study treatment manual. Information was
gathered from participants in areas such as work and social adjustment, sleep disturbance, depression,
anxiety, fatigue, concentration and memory.

When added to standardised specialist medical care CBT and GET had greater success in reducing fatigue
and improving physical function than did APT or SMC alone. Professor White identified that findings
were much the same for participants meeting the different diagnostic criteria for Chronic Fatigue
Syndrome and ME and so could be applied across both groups.

Further information on the PACE trail is available at www.pacetrial.org

 

[WillowJ]

that's hilarious that they would bill that study as "the first in the world to comparatively test the main treatments" (revised the quotation). Then again, since they totally made up a new thing for "pacing" just for this study, maybe they were.

 

[Sean]

PACE is bad science, and even worse ethics, and its supporters have not rebutted a single one of the legitimate and serious criticisms of it or the model it is based on.

Not. Even. Close.

If anything, the results from PACE provides substantial evidence against a significant explanatory or therapeutic role for the psycho-social-behavioural causal model it is based on. And its authors know that.





I know which side of the fence I would rather be on at this point. Which, given the utter shit hole my life has turned out to be, is saying something.

 

[biophile]

Esther12 wrote: Hmmm... challenging claims made by sensible critics? Or challenging widley made criticisms? (I'm sure that some poor criticisms will have been made and rebutted). Equally, good defences of PACE which you think we would disagree with would be interesting, but defences which no-one here would dispute are probably less worthwhile. What do you think?

I'll see what details I can come up with later. From memory an overall "defence" I could argue would be two-fold: (1) the trial is not entirely "debunked" and still provides some evidence that adjunctive CBT and GET on average has a small effect on self-reported symptoms and can further help a slim minority of people meeting a modified application of the Oxford criteria CFS; (2) the main criticisms do seem legitimate in kind when investigated but the degree to which they cast doubt on the findings has the potential for overstatement, but as I've said before all these individual criticisms accumulate into shaky ground for PACE. I doubt most people on this thread would agree with what I just wrote though.

Angela Kennedy wrote: Well- as the only 'defences' I've seen of PACE are those attacking its critics, ignoring their criticisms, and appealing to authority, I'd be very interested to see a 'good' defense that refrains from those rhetorical strategies that are actually fallacies of reasoning. I've not seen one yet...

I agree on this as being descriptive of the usual defence of PACE. This tactic is not just coming from crotchety anons but also (somewhat toned down worded versions) coming from online news media and the medical profession.

Angela Kennedy wrote: And such unquestioning acceptance of claims to authority is a polar opposite of a rationalist 'scientific', even 'skeptical' approach as claimed by various parties

Oh, the irony!!! And "skeptical approaches" often seem to be more about better positioning onself in the hierarchy of authority or even a website forum's social order, rather than rational (scientific) skepticism.

Sean wrote: PACE is bad science, and even worse ethics, and its supporters have not rebutted a single one of the legitimate and serious criticisms of it or the model it is based on. Not. Even. Close. If anything, the results from PACE provides substantial evidence against a significant explanatory or therapeutic role for the psycho-social-behavioural causal model it is based on. And its authors know that. I know which side of the fence I would rather be on at this point. Which, given the utter shit hole my life has turned out to be, is saying something.

I make no apologies for being a PACE Trial critic taking a somewhat harsh tone about the situation. If that makes me a "fringe radical" then so be it! If I am "deluded" for wondering why researchers claim that ?80/100 is the threshold for a healthy physical function score and that ?65/100 indicates "severe disability" but then later claim for PACE that ?60/100 is "normal" or "healthy", then so be it. If <insert a dozen other examples> makes me <insert a dozen other insults>, then so f*cking be it.

Marco: They BS crew may trend towards the authoritarian pole biophile but you'll find that they also tend to be left wing. I suspect their orientation on simple axes such as this depends very much on their prior opinions of the subject under discussion.

Good point.

Dolphin wrote: The Authoritarian/Libertarian axis may not be perfect measure to measure some people's willingness or otherwise to accept the mainstream or establishment view. But I do come across people who seem to not question that much - if an official body says something, it's seen as most likely true and one is obviously a wild radical to think otherwise (and almost certainly wrong) (that's the impression). And the main point I was making was that the PACE Trial results/authors have grabbed the mainstream/establishment/evidence-based ground (from getting MRC/other funding, GET and CBT being seen as evidence-based, published in the Lancet, lots of professors/etc (they had lots of names on the paper - many journals say one can have a maximum of 6), etc).

Good point on the axis issue. As for the rest of the comment, that is exactly how the response to criticism of PACE has been like.

 

[Esther12]

I'll see what details I can come up with later. From memory an overall "defence" I could argue would be two-fold: (1) the trial is not entirely "debunked" and still provides some evidence that adjunctive CBT and GET on average has a small effect on self-reported symptoms and can further help a slim minority of people meeting a modified application of the Oxford criteria CFS; (2) the main criticisms do seem legitimate in kind when investigated but the degree to which they cast doubt on the findings has the potential for overstatement, but as I've said before all these individual criticisms accumulate into shaky ground for PACE. I doubt most people on this thread would agree with what I just wrote though.

Thanks biophile.

From what you're saying, it sounds like they agree that the PACE trial produced pretty trivial results which undermine the claims made about CBT/GET to patients, but then the results were then spun to patients and the media to indicate these treatments were much more effective than they really are. Isn't that the sort of thing that Bad Science are meant to be opposed to?

I agree with what you've summarised as their position, so I'm not sure they're 'defending' any aspect of the PACE trial that I am 'attacking'. Don't they think that the way the data was been misrepresented is a terrible thing? To me, it sounds like they should be on our side in attacking the PACE researchers, but I'm not aware of them being so.

 

[biophile]

Esther12 wrote: From what you're saying, it sounds like they agree that the PACE trial produced pretty trivial results which undermine the claims made about CBT/GET to patients, but then the results were then spun to patients and the media to indicate these treatments were much more effective than they really are. Isn't that the sort of thing that Bad Science are meant to be opposed to? I agree with what you've summarised as their position, so I'm not sure they're 'defending' any aspect of the PACE trial that I am 'attacking'. Don't they think that the way the data was been misrepresented is a terrible thing? To me, it sounds like they should be on our side in attacking the PACE researchers, but I'm not aware of them being so.

I'm afraid the situation is worse than that.

The defence I wrote above is what I personally agree with. Difficult to generalize and obviously I can't speak on their behalf (detractors of the critics of the PACE Trial), but in my overall impression I doubt "they" would endorse how I worded it above or your usage of the word "trivial" - they realize that PACE was not highly effective but may still take issue with using "small" rather than "moderate" to describe the effect size, and accuse us of downplaying the results we don't like. They would disagree that claims made about CBT/GET to patients have been undermined and the notion of PACE being on any sort of shaky ground. I'd be surprised if they agree that the main criticisms had significant bearing on the trial. They don't seem concerned about how the results were presented and would definitely take issue with claiming that they were "spun".

As for Bad Science forums in particular, I just had a look to see if there were any recent activity on this issue: "jeff" (not me) posted an OK summary of the goalpost shifting in the PACE Trial (http://badscience.net/forum/viewtopic.php?f=3&t=15791&start=7125#p678828). Most of these issues have been posted and dismissed before, making the more mouthy or aggressive members a little touchy when seeing them again. But the response so far for jeff? ...

"Oh dear, you're actually serious aren't you? Anyone got any gin?" Followed by "read the thread, resurrecting zombie arguments is unhelpful". Followed by the assertion that all jeff has is zombie arguments. Followed by "Jeff -aren't there some crayons you should be eating somewhere?". Would it surprise you to learn that one of these posters, who claimed that jeff's arguments are dead and won't stay down regardless how often they're supposedly refuted, also claimed previously to have been personally involved in the PACE Trial?

Sooner or later I will get around to combing through that thread again to see if these arguments have actually been refuted adequately. As nearly everything jeff said is verifiable and relevant, somehow I doubt it. From memory, the rebuttal will be along the simplistic lines of "these don't change the main conclusions that adjunctive CBT and GET are safe and moderately effective compared to SMC alone". The slightest hint of questioning the authors conduct or methodology will usually shut down discussion on it and attract accusations of tin-foil hat conspiracy theories or hatred for the authors.

The term "equal opportunity skepticism" exists for good reason, the Doubting Thomas attitude so readily and feverishly applied to CAM etc or their proponents is simply not being applied to PACE, therefore I would describe them as PACE Trial "apologists" and "detractors" of the critics. In turn they would probably describe me as a "stupid angry c*nt". ;-) These people don't have exclusive rights on the label "skeptic" and our critical analysis of PACE also makes us skeptics.

I've also come across the argument that the ME/CFS community does not apply the same effort to critiquing the biological research. I don't expect everyone to apply equal effort to everything. We focus our limited resources on issues that interest us most for whatever reason and/or what we are best at, whereas an equal opportunity skeptic is a title reserved for the more committed. I don't have an interest in critiquing dubious CAM etc because there are plenty of other people willing to examine it, whereas no one outside the ME/CFS community seems interested in thoroughly examining the PACE Trial, I doubt any of them have spent as much time or effort looking beneath the PACE Trial as people on this thread have, just reading the full text paper and deciding it is OK doesn't cut it.

However, it isn't like someone posted on issues with the PACE Trial without any response, there are hundreds of replies, so said selective interest doesn't explain why these people are still posting regularly on a thread dedicated to CFS treatments on a forum dedicated to bad science without casting a critical eye on PACE. You won't find me posting on CAM threads that I have no interest in, actively defending a large CAM study as essentially flawless and abusing people who disagree.

 

[jace]

Dolphin posted (my bolding)

This is the East Anglia Hub

MHRN National Scientific Meeting 2011


PACE Trial results: How should we treat chronic fatigue syndrome?

Peter White, Professor of Psychological Medicine at Barts and the London Medical School presented the
results of the PACE trail. ... Professor White identified that findings
were much the same for participants meeting the different diagnostic criteria for Chronic Fatigue
Syndrome and ME and so could be applied across both groups.

Further information on the PACE trail is available at www.pacetrial.org

How do these statements from White square with his reply to Professor Hooper?

The undated response to Professor Hoopers complaint by Professors White, Sharpe and Chalder that was sent to Dr Richard Horton (Editor-in-Chief of The Lancet) on behalf of all the co-authors will, in the interests of openness and transparency, be placed in the public domain and will be fully addressed in due course, as will Professor Hoopers concerns over what he believes is the failure of The Lancets editorial process in this instance, but there is one point in Professor Whites letter that is of particular importance, so it is addressed in this initial response.

In their letter, Peter White et al state: The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME.

The sentence continues by stating that the PACE Trial studied: CFS defined simply as a principal complaint of fatigue that is disabling, having lasted six months, with no alternative medical explanation (Oxford criteria).

http://www.meactionuk.org.uk/Hoopers-initial-response-to-PDW-letter.htm

Pardon me for pointing out once again another inconsistency of the PACE trial instigators.

 

[Esther12]

@ Jace: Have we got the full letter from Peter White? I've seen a few quotes from it before, but not seen the context for it. Out of context, it seems a strange statement from him. I'd be cautious of building any arguments off it.

biophile: What impressive arguments from BS. I get the impression that their are quite a lot of doctors who take a similarly thoughtless and condescending approach to CFS, and that's why we're in so much trouble.

 

[biophile]

Ass covering 101? It isn't strictly called "CFS/ME" in the Lancet paper, but usually referred to as CFS. The authors do note in the introduction that there are varied opinions on CFS vs ME. They also stratified their Oxford criteria CFS participants into "alternative" criteria for ME ie the London ME criteria, which was an odd choice. Elsewhere in their work isn't it clear that the authors believe CFS and ME are essentially synonymous?

In the abstract of a 2008 presentation on CFS by Peter White it states: "ME was originally defined on the basis of several epidemics, and was clearly a different illness to CFS, as originally proposed. ME is now generally used as a colloquialism for CFS. However, some still regard ME as an incurable 'organic' neurological disease, with a consequent negative effect on prognosis." (http://www.rsm.ac.uk/chronicfatigue08/abs.pdf)

However, White's supposed reply to Hooper is betrayed by the brute fact that they actually labeled it "CFS/ME" in the PACE therapy manuals! So perhaps an explanation is that White et al do think the results probably apply to both CFS and ME in general because they think it is the same disorder and they used what they believe is criteria for both, but they are not saying so with absolute certainty and/or they are factoring in White's view that ME as originally proposed is a different illness to CFS but now ME has since become a colloquialism for CFS.

[EDIT: Esther12, White's full letter is here http://www.meactionuk.org.uk/whitereply.htm and a later longer version of Hooper's reply is here http://www.meactionuk.org.uk/Comments-on-PDW-letter-re-PACE.htm.]

 

[Dolphin]

UK Dept of Work & Pensions site hype efficacy of GET & CBT based on *their PACE Trial

(Apologies if this page was discussed before)

My attention was recently drawn to the following page:
http://www.dwp.gov.uk/publications/...onditions/chronic-fatigue-syndrome/treatment/

People familiar with the PACE Trial will recognise the language.

I've started a thread on it: http://forums.phoenixrising.me/show...cacy-of-GET-amp-CBT-based-on-their-PACE-Trial .

 

[Dolphin]

It was Graham who originally made this observation. I suggested he post it here but he's probably too busy:

http://www.biomedcentral.com/1471-2377/7/6
(Original protocol)

Primary outcome measures Primary efficacy measures

..

The 11 item Chalder Fatigue Questionnaire measures the severity of symptomatic fatigue [27], and has been the most frequently used measure of fatigue in most previous trials of these interventions. We will use the 0,0,1,1 item scores to allow a possible score of between 0 and 11. A positive outcome will be a 50% reduction in fatigue score, or a score of 3 or less, this threshold having been previously shown to indicate normal fatigue [27].

The bit about the threshold of 3 or less adds nothing as:

Inclusion criteria
[..]
4. The participant's Chalder Fatigue Questionnaire score is 6 or more [27].

That is to say, there will be no occasion when somebody hasn't gone down by 50% but they will reach the criteria by having a score of 3 or less.

I'm guessing they put it in to make it look like they didn't pick criteria out of the air. If they wanted to use a validated definition, they should have used the threshold of 3 or less. My bet is that very few of the patients would have reached such a score.

Anyway, this isn't that important as they didn't use these criteria in the end. Just thought I'd post it somewhere.

 

[Esther12]

Especially if a lot of CBT is about encouraging patients to view their fatigue as being within the (very big) normal range.

I just noticed this on page two, from before the results came out and we saw that the defined 'back to normal' in a way that included people who were more ill than was required to be classed as suffering from severe and disabling fatigue at the start of the trial.

I thought they were only going to be manipulating patients, not the Lancet too! Looks like they managed it.

 

[Graham]

From the pattern in the improvements from bad to good patches in the survey we did, I'm pretty confident that, had they stuck to the original requirement of halving the bimodal score, the results would have been very very poor (as opposed to just pretty poor). Had they stuck with the target of a score of 3 or less, I don't think they would have had more than a handful get through.

Of course this is speculation, but the survey results do give us a measure of how the two measurement systems compare (Likert and bimodal). What we really need is access to the raw data. A few years ago my son bought me a pink pig with wings to attach to my study ceiling, as a comment on the likelihood of me keeping it tidy. Perhaps I should attach a photo of it to my request for the raw data.

 

[WillowJ]

A letter came through on Co-Cure that I thought was pertinent. It's an English excerpt from a Swedish ME physician's letter. (I was hoping he'd written a letter to a journal, but via Google translate, it appears to be a letter to the author of the Swedish blog). Compares PACE to exercise therapy in MS, saying exercise is more successful in MS and PACE therapies could not be considered curative. Cites the Nunez study and two MS studies, one with free full text.
https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1111d&L=co-cure&T=0&P=5783

 

[Marco]

A letter came through on Co-Cure that I thought was pertinent. It's an English excerpt from a Swedish ME physician's letter. (I was hoping he'd written a letter to a journal, but via Google translate, it appears to be a letter to the author of the Swedish blog). Compares PACE to exercise therapy in MS, saying exercise is more successful in MS and PACE therapies could not be considered curative. Cites the Nunez study and two MS studies, one with free full text.
https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1111d&L=co-cure&T=0&P=5783

We are all aware of how the PACE results were spun and reported in the press yet the response of ME/CFS charities/advocates has been either to report the results as presented and then appeal to patient surveys to counter the over inflated claims or to get into arcance arguments over case definitions and scoring systems which would mean little to the casual observer (I'm as guilty as anyone of the latter).

This may have been discussed before in this thread and this letter may not be the only exception but there is ample scope to use the PACE results to make some very simple points that suggest a very different interpretation to what has been reported.

Assuming charities/advocacy organisations firmly believe that ME/CFS has an organic etiology, why didn't they just state something along the lines of :

Thanks for showing that the modest results of CBT and GET for some ME/CFS patients are smaller than those found with similar approaches with MS (plus many other diseases I've previously referenced) thereby confirming that neither faulty illness beliefs nor deconditioning play any major or specific role in ME/CFS:

Thanks also for showing that following a year of therapy, ME/CFS patients were still functioning physically at a similar level to 85 year olds (6MWT) and below or close to the lowest 16% of the population (SF36 - PF mean minus 1SD, a level which the PACE authors defined as 'normal').

Clearly, this illness model contributes little to our understanding of ME/CFS and the associated therapies offer only marginal benefits to this very disabled population.



I know the flaws go much deeper than this but these are stark and easily understood.