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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. Mark

    Mark Acting CEO

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    I'm not sure about that: the published letters didn't look like a good representative sample of the critique to me. From my scan of the letters, my impression was that the ones that were published were pretty much all along similar lines - mostly statistical and quite technical; relatively opaque to those not familiar with the SF scale issues. There seemed to be an awful lot of key points that didn't make it into print - some analysis of which criticisms were and weren't printed would be interesting.
    Adamskitutu likes this.
  2. Sean

    Sean Senior Member

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    Hear what you are saying, Mark, and I am certainly no fan of the way The Lancet has handled this.

    But there will never be agreement on the ideal combination of letters that should have been published. Point is they did publish some, and those letters did make a lot of good points, including stuff about actometers, shifting goal posts, etc. Their choices are at least defensible, if not optimal.
  3. Dolphin

    Dolphin Senior Member

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    Discussion on the Lancet page on Facebook

    If anyone is so inclined, they could post in the discussion "PACE Trial with particular reference to editorial and correspondence" on the Lancet page on Facebook:
    http://www.facebook.com/topic.php?uid=374651963469&topic=16694 - preferably to criticise the PACE Trial and the like (i.e. as opposed to the letters that were sent).
  4. Dolphin

    Dolphin Senior Member

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    I think the Lancet letters were probably largely chosen to avoid overlap/repetition of the same points. It would be interesting to collate points that didn't make it into print but I certainly don't have the time.
    (or of course, other lists of points could be used and then see how many of them were in the letters).
  5. Bob

    Bob

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    I noticed that a certain type of letter was being accepted, and a certain type rejected...
    I don't know if I'm correct about this because I haven't given it careful consideration...

    Accepted Letters:
    Raised discussions about how the authors' (supposedly legitimate) scientific assumptions and interpretations could be interpreted in another way based on different research papers. In other words, where there is an argument to be had about the interpretation of the data, but only when based on different scientific references to the ones that the authors used.

    Rejected Letters:
    Raised points about the implications of the study or the implications of the results of study.
    Raised points about the legitimacy of the results or the conclusions, based purely on the motives or competence of the authors, or the methodology of the Trial.
    Raised issues where the competence of the authors was at stake.
    Raised issues about the basis of the Trial.
  6. Dolphin

    Dolphin Senior Member

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    The authors being somewhat hypocritical

    Somebody sent me this in an E-mail and said I could quote it:

    For anyone who doesn't know, needs their memory jogged, the primary outcome measures in the published protocol said:

    http://www.biomedcentral.com/1471-2377/7/6

    which they claimed they dropped because they wanted continuous measures (but they presumably would have included in the paper the continous figures anyway).

    As well as introducing post-hoc definitions for normal functioning and normal fatigue, they also introduced post-hoc definitions for improvement. So their claim that they prefer continuous measures is very debatable; I think they just knew that the figures wouldn't look good if they used the primary outcome measures as they originally published them.
  7. Sean

    Sean Senior Member

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    The case for a re-analysis according to the original published protocol is overwhelming.
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  8. Bob

    Bob

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    Have you all seen this response from White to Malcolm Hooper?:

    I think this is a quote to keep handy at all times!
  9. Dolphin

    Dolphin Senior Member

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    I don't think that quote is that exciting. He says it doesn't apply to "CFS/ME" (as for example the Canadian criteria were not used) but in the paper he says it applies to both CFS (International (2003) - very similar to Fukuda) and M.E. (London criteria), albeit, that they have to have fatigue as their main symptom. I might post that on another thread as I don't particular want this thread clogged up on this point.

    ETA: I've re-posted the comment here: http://forums.phoenixrising.me/showthread.php?11744-Hooper-s-initial-response-to-White-re-PACE-Trial - please challenge it on that thread if you disagree.
  10. Angela Kennedy

    Angela Kennedy *****

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    Just to say I've commented briefly on that thread as to why that comment from White is extremely important, for those of us especially working on different issues to the outcome measures. Do not underestimate its importance people! ;)
  11. Dolphin

    Dolphin Senior Member

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  12. Dolphin

    Dolphin Senior Member

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    This issue was discussed on one or more other threads before but thought I'd highlight it here after their "correction". The population from which this figure derived included all the old people, all the sick people, etc. in society. Not a good way to calculate what might be a normal level of functioning for people of mean age 39 who have had other conditions excluded and are well enough at the start of treatment to attend clinics for exercise therapy, etc.
  13. Dolphin

    Dolphin Senior Member

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    This is one of the references in the authors' reply:
    It is interesting that they quote this as they basically didn't include any data on pain in their paper (unless one counts "post exertional malaise" where they just gave presence/absence at baseline and 52 weeks) despite the fact that pain is a very prominent symptom for a lot of people affected. I think they may run away from it as I think GET can make the pain worse for many people with ME/CFS.

    For what it's worth, I posted the bits I underlined from this paper and a few comments in a thread at: http://forums.phoenixrising.me/show...e-clinical-importance-of-group-differences-in
  14. oceanblue

    oceanblue Senior Member

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    A recent Journal of Internal Medicine editorial by van der Meer and Lloyd critiquing the new International Consensus Criteria makes an extraordinary claim that these letters represent "unscientific and sometimes personal attacks" on PACE and its authors. I imagine those who wrote these letters will want to respond.

    Firestormm has posted a thread on the ICC critique itself.
  15. Snow Leopard

    Snow Leopard Senior Member

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    Yes, criticising a study is de-facto unscientific. Nothing good has ever come from publishing letters to the editor.
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  16. Sean

    Sean Senior Member

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    Even just considering such an action clearly indicates major psychopathology, and probably moral and criminal deviance as well.
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  17. Dolphin

    Dolphin Senior Member

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    I've just noticed that decimal points have disappeared from the published letters. I think this may have happened with the forum software change. I can't edit the letters (written too long ago).
  18. Dolphin

    Dolphin Senior Member

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    An error was subsequently corrected for the PACE Trial authors' reply:
    http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673611611239.pdf

    i.e. Dworkin et al should be reference 2.
  19. biophile

    biophile Places I'd rather be.

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    So the Lancet have issued a correction for a reference in the PACE authors' reply, but not for content errors in the original paper and the accompanying editorial? WTF?

    I had the same problem with some of my earlier posts, certain symbols weren't carried over.
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  20. Dolphin

    Dolphin Senior Member

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    Yes, although just to be thorough, we did get this clarification published on February 18, 2012 (exactly a year after the online publication).

    These sorts of little clarifications/corrections could even make the authors look very scrupulous (i.e. if you are not aware of the things they're not correcting).

    The Lancet, Volume 379, Issue 9816, Page 616, 18 February 2012​

    doi:10.1016/S0140-6736(12)60267-0[​IMG]Cite or Link Using DOI

    PACE trial clarification

    T Chalder a[​IMG], M Sharpe a, PD White a
    In the PACE trial,1 we stated that we used the Chalder fatigue questionnaire.2 We would like to clarify that we used an updated version of the scale.3 The item “Do you have problems thinking clearly?” was replaced with “Do you find it more difficult to find the correct word?” This updated version has slightly better reliability than the original scale.2, 3 In practice, either item can be used without altering the interpretation of the scale.2
    TC has done consultancy work for insurance companies and has received royalties from Sheldon Press and Constable and Robinson. MS has done voluntary and paid consultancy work for government and for legal and insurance companies, and has received royalties from Oxford University Press. PDW has done voluntary and paid consultancy work for the UK Departments of Health and Work and Pensions and Swiss Re (a reinsurance company).

    References

    1 White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011; 377: 823-836.Summary | Full Text | PDF(309KB) | CrossRef | PubMed
    2 Chalder T, Berelowitz G, Hirsch S, et al. Development of a fatigue scale. J Psychosom Res 1993; 37: 147-153. CrossRef |PubMed
    3 Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res 2010; 69: 17-22. CrossRef | PubMed

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