A general thread on the PACE trial!

[Jonathan Edwards]

Didn't they just sort of disprove their methods work for anything that could have been included by the selection criteria

I am not sure one can argue that. If the trial put people with true ME off for reasons not related to any criteria (i.e. anyone with ME for any length of time would not want to try GET) then the Oxford selection does not even produce a 'general' case from which to argue exceptions. The PARACHUTE trial is actually rather a nice metaphor for just how impossible it is to draw any conclusions from PACE.

 

[MeSci]

Just posting this again in case anyone hasn't seen it or has any remarks on it:

(from https://www.s4me.info/threads/rethi...l-of-graded-exercise-and-cbt.2282/#post-41444)

I wrote this to AfME on 14th March 2011 (please excuse errors):

"Dear AfME,

I am just skim-read your article about the PACE study on page 4 of the Spring issue of InterAction, and hope that your scientists will be producing a detailed critique of the study.

A very quick look at the main study paper reveals a number of areas which merit question. For example, an overwhelming proportion of people initially approached to participate were excluded, and the expectations of those who did participate appear highly atypical, but concur closely with outcomes. The study sample may have been an overly self-selected sub-group. It is likely, for example, to have excluded people who have previously tried GET and experienced adverse effects, as in your own studies.

Unfortunately I cannot spare the time to analyse the study thoroughly myself without remuneration, being a sufferer myself who is struggling to make ends meet and suffers severe adverse effects from over-exertion.

Regards,"

That was before my more-recent worsenings. I don't think there was any answer in the magazine; I certainly did not receive any answer myself.

 

[ME/CFS Skeptic]

If the trial put people with true ME off for reasons not related to any criteria (i.e. anyone with ME for any length of time would not want to try GET)

Do you think that was the case? Because the many patient surveys indicate that quite a lot of people with ME have tried GET and I know that some important ME advocates did as well. In the early stages of ME you do not know for sure what disease you have and how your body will respond. So if doctors propose a treatment that might help you without there being an alternative then it’s not easy to say no, especially if you’re desperate. So I’m not sure that most ME patients will refuse GET, especially in the years 2000 when knowledge about the harms of GET was less well known and criticism was less prominent.

There’s only one thing that makes me doubt. I think the results of the PACE trial are very much what anyone with knowledge of ME/CFS and no obvious bias would have expected. The only thing that surprised me is that there was no clear evidence of harm by GET or CBT. I’ve read Toms insightful articles on this and his arguments explain so much but my feeling is that there’s still something not quite right.

I think if ME patients were given instructions to increase activities for months on end they would fail to do so and would have gotten much worse trying. Inadequate reporting of harms, substituting normal activities with exercise and failure to comply with the treatment cannot fully explain why we did not see patients getting worse IMHO. So perhaps this indicates that selection bias was an important factor as well and that few patients in the trial had 'real ME'? Once again interested in what the veterans make of this...

 

[Barry]

I think if ME patients were given instructions to increase activities for months on end they would fail to do so and would have gotten much worse trying. Inadequate reporting of harms, substituting normal activities with exercise and failure to comply with the treatment cannot fully explain why we did not see patients getting worse IMHO. So perhaps this indicates that selection bias was an important factor as well and that few patients in the trial had 'real ME'? Once again interested in what the veterans make of this...

I also wonder if this is why the PACE authors so ardently refuse to release the rest of the PACE trial data. I think it is very possible that hidden amongst that might be more evidence of harms, and/or evidence of what we know to be harms but they likely dismissed as outside their definition of harms. I cannot recall where it was now, but in a reply to one of the online blog articles (possibly one of @dave30th's) somebody commented that they were a PACE participant, and that their heart rate reading went way off of normal, and the therapist refused to believe the reading was genuine, and blamed the instrument. I think the commenter managed to get them to record it, but it was done very reluctantly. Which illustrates the PACE team-culture, and how it would have been so easy (and maybe likely?) for harms to be hidden from view.

Edit: found it ...

 

[BruceInOz]

Edit: found it ...

Reading that quote from the TMG minutes again, I was struck by

It was noted that the Dutch study by Bleijenberg and colleagues reported that actigraphy was not a good outcome measure since the majority of patients are reasonably active and there is no change in this in spite of improvement in fatigue

If patients are reasonably active doesn't that suggest a theory of deconditioning may not be well founded? I guess that's what happens when you become so wedded to a belief that you just don't even see the evidence that contradicts it.

 

[Esther12]

I still think of myself as 'new' to PACE, but I'm probably not any more.

I agree with people's points, but as the PACE authors were putting such a positive spin on their results it would be very difficult to have just cited their work as evidence CBT/GET weren't effective.

Articles like the recent Wilshire one do emphasise how poor their results are, but having access to the data released via Matthee's FOI would have been useful for being able to get a paper that could be published in a respectable journal. https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-018-0218-3

Also, I think that some of the more detailed criticisms around let us get past being a simple 'difference of opinions' over how the data is interpreted, and make clear that their are undeniable problems with the PACE author's work. When results were first released there was such a clear narrative of 'careful rigorous scientists vs unreasonable dangerous patients' that patient's opinions were being dismissed out of hand, and here was a need to show that patients had something to contribute to the discussion.

But then there is the danger that more detailed criticisms put people off looking at the details.

It's hard to know what the best tactics for moving forward from here are.

 

[dave30th]

If patients are reasonably active doesn't that suggest a theory of deconditioning may not be well founded?

I took that sentence to mean they reported being reasonably active after the "treatment."

 

[Jonathan Edwards]

I took that sentence to mean they reported being reasonably active after the "treatment."

It does not seem to be that. They say 'reasonably active and there was no change [with treatment] - so they must have been reasonably active before as well?

 

[Sly Saint]

as the PACE authors were putting such a positive spin on their results

Although there has been media coverage of 'the flaws in the PACE trial' it has been nothing compared to the headlines of '60% of pwME recover with CBT/GET' style reporting (even though the 60% was 'improvement')

The move from 60% to 21% should surely have been a big enough revelation, even without all the other ins and outs of the trial, to warrant equally sensational headlines(?)

 

[Lucibee]

The only Catch22 is that if they frightened off all the people with real ME and only studied people without ME then they did't even prove the treatments did not work in ME because they did not study it. It takes quite a stretch to see why they should work in real ME but there is a hint of cherry-picking about saying they nailed the disproof when the methodology was so bad it could not disprove anything much!

There is so much we still don't know about this trial because of the way it was done and what was and was not measured.

I've never thought it safe to make any assumptions about the participants though. We simply don't know how many of participants had "real" ME.
Bad criteria are more likely to include such patients than exclude them. (They should have excluded them if, as Sharpe is so keen to say, they weren't studying ME. But I'm not sure how they could have done that.)

The whole "if you showed improvement, you can't have had ME" thing is unfair to those who reported subjective improvement despite being in the trial - no-one benefits from pretending they had an improvement when they didn't, but that's what they were being asked to do.

And we *still* don't know how much daily exercise/activity anyone actually did, because they didn't record it. Not even the patient/clinician-set goals were recorded in the main dataset because it would have clearly shown which intervention they were receiving (which is another flaw of the trial).

For every flaw, there will be a whole gamut of contradictory statements given by the trial authors. According to White, GET is not harmful, because it was done really, really carefully, unlike in the usual fatigue clinic setting. Yet Wessely describes it as a "pragmatic trial".

As @Michiel Tack says, the only thing you can take away from all this is that CBT/GET don't work. Not in ME. Not in CFS. Not in any fatigue-related illness.

 

[Invisible Woman]

The whole "if you showed improvement, you can't have had ME" thing is unfair to those who reported subjective improvement despite being in the trial - no-one benefits from pretending they had an improvement when they didn't, but that's what they were being asked to do.

I'm not sure we can say anything at all about anyone who reported improvement because of the way the trial was designed and run, plus of course the as campaign newsletter mid trial.

All one can say is given the inherent built in bias the only surprise is that the results were so poor. Demonstrating that, regardless of the hypothesis as to causes, this treatment doesn't seem to work for anyone within the staggeringly broad criteria.

Whatever the questions are as to the cause, PACE proved this treatment is not the answer.

 

[NelliePledge]

The PACE papers can be used to good effect. In his report to my pension scheme the PACE paper on long term follow up by McCrone was referenced by my ME specialist (private). he pointed out there was no evidence that I would be well enough to return to my job before reaching my normal retirement age - of 641 participants in PACE none returned to their previous employment.

 

[Lucibee]

Like (not like)

 

[Dolphin]

of 641 participants in PACE none returned to their previous employment.

Is that true? I don’t remember seeing that.

 

[chrisb]

On the subject of return to previous employment this statement by Sharpe made me take notice:

As patients recover, chronic difficulties and obstacles to recovery may become apparent. In particular a conflict between patient's aspirations and their current lifestyle, as described by psychodynamic theorists (McCranie 1980), often becomes apparent. The task then becomes one of helping the patients to use more effective coping methods for resolving the difficulty. This often entails both a modification of unrealistic work standards and, not uncommonly, a change of occupation.

Michael Sharpe. Chronic fatigue in Science and Practice of Cognitive Behaviour Therapy 1997 eds David M Clarke and Christopher G Fairburn.

It would seem that it was known and acknowledged that "recovery" never was recovery in any normal use of the word.

EDIT @p403

 

[Hoopoe]

As patients recover, chronic difficulties and obstacles to recovery may become apparent

It becomes apparent that the recovery isn't actually recovery?

 

[Jonathan Edwards]

As patients recover, chronic difficulties and obstacles to recovery may become apparent. In particular a conflict between patient's aspirations and their current lifestyle, as described by psychodynamic theorists (McCranie 1980), often becomes apparent. The task then becomes one of helping the patients to use more effective coping methods for resolving the difficulty. This often entails both a modification of unrealistic work standards and, not uncommonly, a change of occupation.

That quote is quite revealing in terms of the cognitive dissonance it arose from. It makes no sense. If a person is recovering then a discrepancy between their aspirations and their lifestyle is not an obstacle - as it would have been before recovery. And why do you need a psychodynamic theorist to describe someone wanting to work but not being able to? I suspect the psychodynamic theorists talked about people secretly wanting to keep their lazy lifestyle.

 

[Invisible Woman]

I vaguely remember that the % of PACE trial participants in employment (or possibly % of hours worked) dropped while there was a slight increase in those on benefits.

I seem to recall that when this was raised the PACE trial authors claimed this wasn't an objective measure because of possible changes in the employment market.

 

[Dolphin]

On the subject of return to previous employment this statement by Sharpe made me take notice:

As patients recover, chronic difficulties and obstacles to recovery may become apparent. In particular a conflict between patient's aspirations and their current lifestyle, as described by psychodynamic theorists (McCranie 1980), often becomes apparent. The task then becomes one of helping the patients to use more effective coping methods for resolving the difficulty. This often entails both a modification of unrealistic work standards and, not uncommonly, a change of occupation.

Michael Sharpe. Chronic fatigue in Science and Practice of Cognitive Behaviour Therapy 1997 eds David M Clarke and Christopher G Fairburn.

It would seem that it was known and acknowledged that "recovery" never was recovery in any normal use of the word.

EDIT @p403

I saw it previously in a magazine for local group in England in the early- to mid-2000s from a patient of Peter Denton White. PDW having a weird view of recovery doesn't explain the big changes made in the recovery criteria - he had these views about recovery when the recovery criteria were set:

---

"What do you class as recovery?

Peter White would say I'm a success story.

I would like to know what level other people are at whom he classes as having recovered.

To me if I'm recovered, I'm able to come off benefits, work full time, do my house work and have a life.

But when I said this he asked me: "Do you want to go back to the life that gave you ME?"

That's a cop out.

I disagree with his definition of recovery.

If you've improved significantly, to him that is recovery.

I don't believe in what they say 100%.

I believe you get ME and you just have to overdo it and the symptoms come back.

I can manage to a certain extent but part of it you can't control.

I know if I do too much I feel worse but according to them I bring this on by expecting to feel worse.

According to them this is not founded and irrational.

My belief system is holding me back.

They do not believe in any physical basis for the illness like a virus.

At the end of the day it's all very well to talk about attitude but I have a real illness which is more deep rooted.

I take what I need and don't give myself a hard time.

I don't blame myself.

Last time I saw Dr White I could tell he still thought it was partly to do with me.

He said,'Do you think it's down to you?' On my report he has written: "[name] is making good progress. [Name]'s only remaining barriers are [name]'s illness beliefs"

 

[Hoopoe]

And why do you need a psychodynamic theorist to describe someone wanting to work but not being able to? I suspect the psychodynamic theorists talked about people secretly wanting to keep their lazy lifestyle.

McCranie 1980 is this article

Neurasthenic neurosis: Psychogenic weakness and fatigue

Neurasthenic neurosis may be physical—with weakness and fatigue stemming from chronic overwork brought on by attempts to compensate for low self-esteem and the lack of primary coping techniques; or symbolic—with the somatic symptoms serving as expressions of and excuses for functional helplessness rather than resulting from actual physical exertion. Since functional helplessness results from the lack of effective coping patterns and inhibitions motivated by low self-esteem, the underlying dynamics in both types of neurasthenic neurosis are similar. In either type, helping the patient come to better terms with himself and acquire more adaptive coping patterns provides a practical approach to treatment.

https://www.researchgate.net/public...nic_neurosis_Psychogenic_weakness_and_fatigue