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PACE Trial and PACE Trial Protocol

Discussion in 'Latest ME/CFS Research' started by Dolphin, May 12, 2010.

  1. Esther12

    Esther12 Senior Member

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    Given the harm that's been done to patients through the promotion the the psychosocial approach to CFS, they'd better come up with something damn near curative. Moderately alter questions for a fatigue questionnaire? I'd be pretty pissed.
  2. oceanblue

    oceanblue Senior Member

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    Doesn't sound like they've found the Holy Grail, I guess we'll have to see the paper for how much effect they've had - and how long it lasts. And now I really must log off and settle down...
  3. Snow Leopard

    Snow Leopard Senior Member

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    Yes, that's all such studies show. If you condition patients to complain less about their symptoms, the questionnaire scores improve.

    The problem is that the improvements of scores on fatigue questionnaires and the sf-36 have been demonstrated not to be well correlated with activity levels after non-pharmaceutical interventions (See Dr Jason etc).

    additional edit:
    So if you had 1% of the population meeting the Oxford Criteria and 0.4% meeting CCC. And then you find 4/10 not improving....
    Sorry, thinking out loud.

    The measures I am interested in (as per PACE protocol paper) are:

    EQ-5D (I want to see how the reported QOL compares to other diseases)
    The Client Service Receipt Inventory (CSRI) (apparently measuring hours worked etc).

    I don't really care much about improvements on the questionaires in general.

    Tom Kindlon's point about the lack of objective measures of activity are still very important.
  4. Bob

    Bob

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    Erm, I'm sorry, but why did a professor of psychological medicine lead a multi-thousand pound study into a neuro-immune disease? How is he qualified to do that? (Sorry, it's just a rhetorical question - I couldn't help saying it again!)
    It's interesting that he says that CBT is the best therapy available for a neuroimmune disease. If there had been an immunologist leading the study, then maybe the study wouldn't have failed 4 out of 10 patients. (Sorry, I know i'm just going over old ground! - Just warming up for the results!)
  5. Snow Leopard

    Snow Leopard Senior Member

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    Since when does direct qualifications matter? Anyone can lead a multi-million pound study. All you need is the right political affiliations to get funding. ;)
  6. Bob

    Bob

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    Oh OK, just call me old fashioned... and naive!!!
    Was it a multi-million pound study? That makes it even worse.
    I wonder how much of that went into Wessely's and White's bank accounts.
  7. Dolphin

    Dolphin Senior Member

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    Reference for 5.0m cost

    Reference for UK5.0m cost

    http://tinyurl.com/ydsv857
    i.e.
    http://www.rae.ac.uk/submissions/ra5a.aspx?id=176&type=hei&subid=3181

  8. Dolphin

    Dolphin Senior Member

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    Breakdown of where most of the money came from

    Breakdown of where most of the money came from (never saw a figure for DWP contribution but it's on the record):


  9. Esther12

    Esther12 Senior Member

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  10. Dolphin

    Dolphin Senior Member

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    Abstract

    Here's the abstract
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext
  11. Esther12

    Esther12 Senior Member

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  12. Snow Leopard

    Snow Leopard Senior Member

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    edit - reading it now.
  13. Dolphin

    Dolphin Senior Member

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  14. Dolphin

    Dolphin Senior Member

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    Data on some of the interesting secondary outcome measures wasn't published

    If one looks at the PACE Trial Protocol:

    White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; on behalf of the PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BioMed Cent Neurol 2007; 7: 6.
    http://www.biomedcentral.com/1471-2377/7/6
    one sees that some of the more interesting data wasn't published:
    e.g.
    Call me cynical but I think if the figures were good we would have seen them.

    It might be worth highlighting this/pushing for the data.
    Peter White has been claiming a full recovery rate of 25% but based on the data on the loser criteria used here, I don't think it was anything like it if the "recovery" definition had been used.
  15. Sean

    Sean Senior Member

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    ..., independent of improvement in objective scores.

    (And the conditioning used is sometimes pretty unpleasant, dishonest, and unethical stuff too. Any fool with a bit of power can get somebody else in a less powerful position to change their immediate external behaviour by making threats of some sort, explicit or implicit. Doesn't mean the superficial behaviour change is real or sustainable, or even desirable.)

    That pretty well sums up the 'evidence' for CBT in ME/CFS.


    Although this paper and the furious spin that will accompany it will be a serious PITA to deal with, the other side of that coin is that this is their best shot, but all they could manage was a "moderate" improvement in a limited number of subjective measures. (And let's wait and see the actual numbers say. I think it is reasonable to assume that the available abstract gives the most favourable possible spin on it they can get away with. If they are only able to claim a moderate improvement, and if their spin (and methodology) is their usual standard, then I will bet a closer look at the numbers shows the actual outcomes to be less than even merely moderate.)

    They almost totally dominate the politics and public relations in the field, get the lion's share of the funding, had almost total control over the study, and had first crack at spinning the results, at framing the debate. It is the most favourable possible set of conditions for them and their model, and so presumably this is the best they can do with it. But they have not delivered any substantial real-world outcome. And that is before we factor in the serious methodological problems with this study and its underlying model. Frankly, it is pathetic, especially given how extravagant and assertive the claims about the effectiveness of this approach has been over the years.

    Definitely no killer blow in there for them.

    I would suggest that this is their high point. They will not be able to do any better than this. It is all down hill from here.

    (No, I don't think it will suddenly change policy or life on the ground for patients, it will take time to filter through. But they have simply failed to deliver their promised land, and that will not go unnoticed among the more hard nosed policy makers and purse string holders.)

    I also think that the issue of lack of objective measures, especially when they were originally in the study protocol but were later removed (on very dubious grounds), will not sit well with real scientists. This issue will come back to haunt them.
  16. Sean

    Sean Senior Member

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    I have no doubt if those numbers had been good for their model then they would have been loudly proclaiming them at every possible opportunity. It would be the ultimate vindication for them (from their perspective). But... crickets (thus far, at least).

    This was supposed to be their big moment, the definitive proof of their explanatory and therapeutic model, and of course the coup de grace to their critics, and, well, they blew it.

    Like I said, I strongly suspect that when we get to look at the actual data (and all of it, not just selectively released bits of it), it will clearly fail to provide solid support for even for a "moderate" success.
  17. Snow Leopard

    Snow Leopard Senior Member

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    Reminds me of the Nijmegen research - they didn't publish the unimpressive actometer data until much later.

    Note, the appendix states one case of "Deterioration in mobility and self-care". Guess which treatment this was associated with? (yes, GET!)

    The amount of patients ruled out after basline screeing (over 2,200) is staggering. Apparently there were 745 that had been clinically diagnosed, but did not meet the Oxford criteria?

    Is this a result of bad recruitment, or do three times as many people claim to have CFS than actually meet Oxford criteria?
    I wish I knew the exact reasons why they were ruled out.

    40% were taking antidepressants at baseline. Is this normal?

    Note they also keep stressing 'postexertional malaise' improvements, as if their questionnaires can actually measure this objectively.
  18. Angela Kennedy

    Angela Kennedy *****

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    Hi Sean

    Thank you. I think these are very wise words.
  19. Cort

    Cort Phoenix Rising Founder

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    A quick look at this suggests that the news overall is good. This was their best shot - right? I think we'll look and say....this where CBT/GET peaked as a therapy for CFS.......now.there MUST be a recognition that the research establishment must look elsewhere.

    http://www.nytimes.com/2011/02/18/health/research/18fatigue.html?ref=science


    To repeat

    Notice that in Table Five from 60-70% of all patients did reported only minimum or negative change. Only 41% at the most reported positive change - and that doesn't mean cure.

    The idea of CBT/GET curing CFS is OVER! Let them have their 'moderate effect' in their 40% of the patients and lets get on with the real research...
  20. Cort

    Cort Phoenix Rising Founder

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    I thought Tuller blew it in his rather small article. These were my comments to the NYTimes

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