International ME/CFS and FM Awareness Day Is On May 12, 2018
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"Sammanställning av de metodologiska problemen i KBT/GET-studierna" (Swedish)

Discussion in 'General ME/CFS News' started by Dolphin, Nov 18, 2014.

  1. Dolphin

    Dolphin Senior Member

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    I heard this was good e.g.

    Full text at: http://www.rme.nu/sites/rme.nu/files/metodologiskaproblemcbtochget_ver1.pdf

    Somebody could put it through an online translator in the meantime I suppose.
     
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  2. Denise

    Denise Senior Member

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  3. Snow Leopard

    Snow Leopard Hibernating

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    Google translate:

     
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  4. mango

    mango Senior Member

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    yes, this is really well researched and well written! fantastic job by helmfrid, warmly appreciated.

    @Anne knows more about the english translation, don't you?
     
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  5. Anne

    Anne Senior Member

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    Oh dear, please don't use the Google translate... ;-)

    We have made a crude translation which we submitted as a comment to the AHRQ review, but we felt it necessary to do much more work on the English translation before we publish it.

    I will let Sten Helmfrid know it is eagerly awaited! He really has done an amazing job with the article - a short, succinct review of the methodological shortcomings in these studies.

    We will get back to you as soon as we have a decent English version of the text. It may take a while - but it will be quicker than your learning Swedish! ;-)
     
    Last edited: Nov 19, 2014
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  6. Helen

    Helen Senior Member

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    I agree @Anne and @mango , the google translation doesn´t reflect the great article that Sten Helmfrid has written. Should we mention that Helmfrid is a doctor of technology with good knowledge in research methodology? He
    shouldn´t be ignored of that reason at least.

    While waiting for the translation we can enjoy this statement from his article (thanks to @Dolphin and @Snow Leopard) :
    There are studies that claim positive treatment results, but they have serious methodological flaws. The lack of objective data and patient groups are unclearly defined. Negative physiological consequences is demonstrated in other studies and independent evaluations of patient organizations confirms the negative consequences. Patients with ME / CFS should be dissuaded from cognitive behavioral therapy and gradually increased training
    according to this model.
    (My bolding and minor changes)
     
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  7. Sean

    Sean Senior Member

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    From memory, the CBT group showed no statistically significant improvement on the 6 Minute Walk Test, only the GET group did and only a very modest improvement that failed to reach the more important practical standard of clinically significant, leaving patients (average age 40) with a functional capacity equal to somebody twice their age, and less than all but the worst end-stage cardio-pulmonary disorders.

    PACE also failed to show improvement on any other objective measure, like employment, welfare use, etc.

    So, for all practical purposes, PACE delivered no meaningful improvement on objective measures, and the 'improvements' on the subjective self-report measures were modest and within the general range of confounding effects like priming, and social desirability.
     
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  8. anciendaze

    anciendaze Senior Member

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    Every time something causes me to reexamine PACE I run into yet another absurdity. While answering a question for someone unfamiliar with ME/CFS, and checking for better translations of this paper, I discovered a letter to the journal "Psychological Medicine" by Dr. Charles Shepherd.

    He makes a point which had been lost in the hype and spin about results reported in the PACE trial: the cost of benefits to those patients included in the study actually increased. This nugget was buried in an economic analysis by McCrone, but is nowhere available in prior published material allegedly supporting the claim of effectiveness. For the government which paid for the study this would appear to be an indication of failure, since spending on treatment showed no corresponding decrease in ongoing cost of disability payments. So long as we are limited to composite figures like group means we have no way to tell if the study caused any patients to recover in the sense that they returned to work and/or left disability.

    I suspect this is a case of researchers being hoist on their own petard. As either a carrot or stick the lure of benefits, and the implicit or explicit threat of denial of benefits if patients did not cooperate with "sound medical advice" (in advance of study results showing this "soundness") was a major factor in getting patients to participate. We know researchers had trouble getting patients even so. Denying benefits for those who did participate would provoke a very negative response which might well reveal even more unsavory aspects of this study.

    The mention above of results on the six-minute walk test brings to mind another unsatisfactory aspect of reliance on published group means. If you take the values for group mean and standard deviation on that test, and you believe the distribution being studied is in fact normal (Gaussian), you can conclude that the probability any patients walked the full 600 meters typical of healthy people -- after a year of treatment -- is so low these might well be people without the illness included due to diagnostic error.

    An alternative interpretation, consistent with public statements about responders and non-responders, is that the distributions being studied were very far from normal (Gaussian), which implies the p values in the published study are meaningless. We are left with the opinions of the authors that they did in fact produce recovery (as defined in common parlance?) in some number of patients without any supporting evidence, in published data for groups, showing a return to normal function. If they continue to oppose release of data which would allow someone outside that group to see what happened to individuals during the course of the trial, we must conclude they do not wish to support their claims with facts.
     
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  9. user9876

    user9876 Senior Member

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    And don't forget White is claiming it is harassment to ask about any data other than that he agrees to publish. So it is harassment to ask what the distributions are, to ask about how the scores for the 6mwt vary for those who have been marked as recovered. In fact QMUL have said it would take them more than 18 hours to calculate the latter category so perhaps they aren't even interested in knowing the truth!.
     
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  10. anciendaze

    anciendaze Senior Member

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    Here are some numbers to back the statements I made above. If we assume the published mean (379 meters) and standard deviation (100 m.) for the GET group in the PACE study are valid, and the distribution is approximately normal (Gaussian), then about 98% of the group would be below 584 m. and 99% would take us all the way to 611 m. There is a fair chance in this case a group this large would have one such member, but less likely there are two. (I'm not computing numbers here which would give a spurious sense of precision.)

    Is this the whole story? Not at all. If we assume there are two distributions mixed together after treatment, responders and non-responders, then it is reasonable to assume the data on the responders alone would show a higher mean, something Dr. White has indicated he sees in data we have not seen. However, excluding the non-responders from the computation would reduce the SD. If I quite plausibly assume a mean of around 400 m and SD of 70 m. we are looking at almost 3 SD to healthy performance. This puts the 99th percentile around 563 m. and 600 m. beyond the 99th percentile. They didn't have enough patients in their group to safely bet on having even one this far above the mean. Furthermore, even if one such turns up, they didn't take enough care with diagnostic criteria to say this represents a cure of a real CFS patient rather than a simple diagnostic error.

    Should it turn out that only one or two patients actually reached a level considered typical for healthy people of similar age, or even for healthy septuagenarians, it would seem that the claims about the results of this trial were grossly inflated, and normal interpretation of "recovery" based on only those few patients would indicate this trial was a complete failure with no more than tenuous support from objective data.

    I am quite willing to drop the insistence on normal distributions, if we also drop the statistics and claims which depend on this assumption.
     
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  11. alex3619

    alex3619 Senior Member

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    The cost of benefits to patients has been commented on before. Nobody in power seems to care that the objective outcomes include increased benefits and cost, decreased work participation, and decreased functional capacity or unaltered functional capacity. So long as few patients tick a few boxes indicating that things appear improved its OK.
     
  12. Sean

    Sean Senior Member

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    Just for the PR record, the quote from McCrone (et al, 2012) that Dr Shepherd is referring to is:

     
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  13. anciendaze

    anciendaze Senior Member

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    Isn't it remarkable Sean, that a study which was said to have a special relevance to questions of public moneys spent on health and disability costs should only make this modest, non-quantitative statement in a derivative paper? What kind of accountant would accept this statement without digging much deeper? Is there any accountability at all here?
     
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  14. alex3619

    alex3619 Senior Member

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    Doubtful.
     
  15. Sean

    Sean Senior Member

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    I think it is pretty clear that we are dealing with behaviour that in any other context (even politics!) would be classified as blatant sociopathic fraud.

    The fact that it is happening via the mainstream peer-reviewed scientific process, in democracies, the world over, makes it a particularly disturbing example of how easily 'knowledge' can be corrupted and abused.

    Not that our situation would be unique in having to deal with that.
     
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  16. GracieJ

    GracieJ Senior Member

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    Hey, even the Google translation is a refreshing change. Thanks so much.
     
  17. adreno

    adreno PR activist

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    Because nothing is really about knowledge for itself. Knowledge is used as a coercive tool in power dynamics. That's never going to change, as long as we have DNA fighting for domination.
     
  18. Sean

    Sean Senior Member

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    adreno

    Basically true. But power itself can be used for good or ill. The choice is ours.
     
  19. adreno

    adreno PR activist

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    Power is not a means, it's an end. The purpose of power is power.
     
    Last edited: Nov 21, 2014
  20. Min

    Min Guest

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    The only objective measurement of outcome in tbe PACE trial, the actometer, was abandoned on the advice of the participating charity Action for ME.

    No one in tbe trial returned to work.
     
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