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PACE Trial - letters that were published and authors' response (and editorial)

Discussion in 'Latest ME/CFS Research' started by Dolphin, May 16, 2011.

  1. Dolphin

    Dolphin Senior Member

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    PACE Trial - letters that were published and authors' response

    The correspondence on the PACE Trial has just been published at various links found at: http://bit.ly/j9cEoD or http://www.thelancet.com/search/res...Name=AllFields&journalFromWhichSearchStarted= .

    I'll post the letters and replies here.

    N.B.: I've given the editorial accompanying the correspondence its own thread: http://forums.phoenixrising.me/show...torial-accompanying-PACE-Trial-correspondence) . I can't seem to change the mention in the title - maybe a moderator can remove it?
  2. Dolphin

    Dolphin Senior Member

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    Jane Giakoumakis' letter

    Jane Giakoumakis' letter

  3. Dolphin

    Dolphin Senior Member

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    John T Mitchell's letter

    John T Mitchell's letter

  4. Dolphin

    Dolphin Senior Member

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    Sarah M Feehan's letter

    Sarah M Feehan's letter

  5. Dolphin

    Dolphin Senior Member

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    Andrew James Kewley's letter

    Andrew James Kewley's letter

  6. Dolphin

    Dolphin Senior Member

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    Letter from Bart Stouten, Ellen M Goudsmit & Neil Riley

    Letter from Bart Stouten, Ellen M Goudsmit & Neil Riley

  7. Dolphin

    Dolphin Senior Member

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    Tom Kindlon's letter

    Tom Kindlon's letter

  8. Dolphin

    Dolphin Senior Member

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    Mieko Shinohara's letter

    Mieko Shinohara's letter

  9. Dolphin

    Dolphin Senior Member

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    Letter from Vlaeyen JWS, Karsdorp P, Gatzounis R, Ranson S & Schrooten Martien

    Letter from Johan WS Vlaeyen, Petra Karsdorp, Rena Gatzounis, Saskia Ranson & Martien Schrooten

  10. Dolphin

    Dolphin Senior Member

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    The PACE trial in chronic fatigue syndrome Authors' reply

    The PACE trial in chronic fatigue syndrome Authors' reply

  11. Dolphin

    Dolphin Senior Member

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  12. Sean

    Sean Senior Member

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    STRAWMAN

    It makes no difference what disorder or therapeutic model they are testing, they still have to use objective measures to find if the therapy produced real world changes, which is the whole aim of the exercise. Shifting scores on self report measures by very modest amounts, with no objective confirmation, is nothing more than games with words.

    No substantial and sustained objective changes simply means that the therapy is ineffective. There is no way around that. Their excuse above, as with their excuse for failing to collect actometer outcome data, is just nonsense. If there are no (or only inadequate) objective measures used then it is not science.

    Their persistent unwillingness to properly use (relevant) objective measures is a serious methodological and ethical problem.
  13. Snow Leopard

    Snow Leopard Senior Member

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    The reply seems merely to be a rehash of the paper and does not really address the specific concerns. If there were changes to the protocol based on 'Statistical Analysis Strategy', they should have mentioned this in the original paper.

    This is invalid for the SF-36 PF score as the CFS sample systematically excluded people with other chronic diseases. The true mean minus 1 SD value should be that given by the figures in the letter by Andrew Kewley: 927 - 131 = 79.6. This is the true 'normal' figure according to the cited data.
  14. oceanblue

    oceanblue Senior Member

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    First, thanks to Dolphin for compiling this, and to all the successful letter writers who made important points and made them well.

    Agreed. Will be very interesting to see the Statistical Analysis Strategy, esp if it explain the rationale for changes from protocol. But nb they did say this in the paper:
    So, they've now admitted they used the all-adult population instead of the working-age population which was broadly aged-matched to their cohort - without mentioning this drops with mean-1SD by 10-15 points. As snow leopard points out, they should be using healthy working age adults as the reference group.

    They have also increased their claim for the study:
    In the original paper they somewhat sneakily said:
    The claim of CBT/GET+SMC was defensible (though meaningless since there was then no control/comparison group), the claim of moderate effectiveness vs SMC in their letter is not. As I endlessly point out, they needed to treat 7-8 patients with CBT/GET for just one to improve modestly and this does not equate to a moderate effect. Will post more fully on effect size using Cohen's d, but this won't happen for a while.
    I have to admit that this is a point well made! It sounds so convincing, even though it neglects the crucial issue of whether or not these self-rated improvements equate to real world changes - as Sean noted.

    ETA: The authors point out they didn't report on recovery, but didn't explain why they chose to omit recovery status from a paper that assessed the effectiveness of therapies. It's bonkers.
  15. Esther12

    Esther12 Senior Member

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    Good point about them dropping reference to SMC oceanblue. Sadly, not a surprise. Has anyone had access to SMC? I've never had it offered to me.

    Thanks to all those who managed to get their letters through - great work.

    I thought their reply was appallingly weak... but the Lancet editorial is entirely condemning of patients' concerns, and supportive of White et al. There seems to be no concern about how their results were mis-sold to the media, or how this might effect patients.
  16. Snow Leopard

    Snow Leopard Senior Member

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    It is also sad that Mieko Shinohara's point was not addressed at all. It seems they weren't much concerned with the specific details in the letters, but merely saving face.
  17. Dolphin

    Dolphin Senior Member

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    From Tom Kindlon's letter:
    Authors' reply:
    I'm not familiar with this directive. However any directive on medicinal products would presumably require manufacturers to define what dosages were used, something they didn't do with regard to dosages of activity/increases in the PACE Trial.
  18. oceanblue

    oceanblue Senior Member

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    Not quite. The headline grabbing yet nonsesical definition of normal which attracted so much attention in the letters, was dreamt up after they'd got their hands on the data:
    The 'improvers' outcome was used to support their claim of moderate effectiveness for the therapy, as was the 'within the normal range', while the 'within the normal range' data generated winning though misleading headlines.
  19. Bob

    Bob

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    As oceanblue says, this is an inaccurate statement. The changes recorded for SMC were far higher than the additional changes that were recorded for CBT and GET. It is not possible to know what changes CBT and GET were solely responsible for because of the methodology of the study.

    The additional changes recorded for both CBT and GET were minimal (not 'moderate' in my opinion), and were only just above the threshold of clinical significance in 3 cases, for 3 of the 4 measurements in the primary outcomes, and did not reach clinical significance in one case.

    Also, we don't know who might benefit from the 'treatments' because they used unofficial diagnostic criteria for the selection of patients such that any results cannot be used for the UK's CFS/ME patient population, as diagnosed using NICE guidelines.
  20. Sean

    Sean Senior Member

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    Oops, forgot to say congrats to those who got published.


    Also 8/44 letters is not a bad yield.

    I think we need to acknowledge that, whatever their serious failings might be, The Lancet did publish a good number of patient letters, and the ones they chose were a reasonable selection.

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