The 12th Invest in ME Conference, Part 1
OverTheHills presents the first article in a series of three about the recent 12th Invest In ME international Conference (IIMEC12) in London.
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MEA response to the GETSET trial

Discussion in 'General ME/CFS Discussion' started by charles shepherd, Jun 28, 2017.

  1. charles shepherd

    charles shepherd Senior Member

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    The MEA has decided to produce a detailed critique of the GETSET trial - for reasons set out below

    It can be read in full here:

    http://www.meassociation.org.uk/201...antly-improve-physical-function-28-june-2017/

    Dr Charles Shepherd
    Hon Medical Adviser, MEA


    ME Association Review: GETSET fails to demonstrate GET can significantly improve physical function | 28 June 2017

    Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial


    In view of the fact that the results from this clinical trial are going to form part of the research evidence that NICE will be examining over the coming weeks in relation to making a decision as to whether the 2007 NICE guideline on ME/CFS needs to be revised, MEA trustees decided that the MEA should make a very careful and thorough response to the paper in The Lancet.

    This is set out below and is also available for DOWNLOAD.

    For the benefit of anyone who just requires a summary of the key points and concerns we are making, our main criticisms of the GETSET trial are:

    1. GES had little or no effect on physical function and did not result in participants claiming that GES had any significant overall effect on their ME/CFS

    2. The study design – i.e. addition of a new primary outcome measure – was altered after the trial had started

    3. Patients were recruited using the very broad NICE diagnostic criteria for ME/CFS – which meant a significant proportion did not meet Fukada and are unlikely to have met the Canadian diagnostic criteria for ME/CFS

    4. The trial recruited an unrepresentative number of people who were likely to have been in the mild category of illness severity, could exercise, and were enthusiastic about taking part. This is not representative of the overall ME/CFS population

    5. The trial relied on self-reported and subjective outcome measures rather than employing any form of objective outcome measure (e.g. use of an actometer) for measuring changes in physical activity levels

    6. Examining and reporting on the results after only 12 weeks of treatment is far too short to draw any meaningful conclusions about the efficacy and safety of GES

    7. The study was not blinded – for obvious reasons. However, we believe that this sort of approach to activity management, where there has to be considerable individual variation in approach, is not really suitable for assessment in randomised controlled trials that rely on subjective outcome measures

    Dr Charles Shepherd
    Hon Medical Adviser, ME Association
     
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  2. trishrhymes

    trishrhymes Senior Member

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    Thank you.
     
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  3. dangermouse

    dangermouse Senior Member

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    :thumbsup: Thanks.
     
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  4. Mark

    Mark Acting CEO

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    I find it interesting that (IIRC) the recent Klimas study, which seemed to demonstrate a placebo response amongst its results, seemed to show that placebo response affecting self-reported fatigue but not self-reported physical function. Perhaps there may be good evidence from a number of other sources along similar lines, which if pulled together might demonstrate that the effects in trials like these are typical of known placebo-like responses in ME/CFS self-reported measures?
     
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  5. Barry53

    Barry53 Senior Member

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    @charles shepherd: I notice in the above response:-
    But in the Participants section of the GETSET paper it says:-
    Given the MEA response, does this mean they although participants were assessed for CDC criteria, failing it did not constitute exclusion? If so then that is such a mealy-mouthed bit of wording in the GETSET paper.
     
  6. Barry53

    Barry53 Senior Member

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    Which is undoubtedly why CFQ "had" to be included. To me these people are digging their own professional graves.
     
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  7. Forbin

    Forbin Senior Member

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    I think that's right. They seem to distinguish between "patients" and "participants." I think once you're a "participant," you're in the trial.

    [Ooops! Sorry. Didn't mean to answer a question you had actually asked of Dr. Shepherd.]
     
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  8. Barry53

    Barry53 Senior Member

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    Ah yes! So why did they bother subsequently assessing participants for CDC criteria? Was it some perverse head-mangling so they could say they also used CDC? The "logic" seems to get increasingly bizarre, to the point of being irrational. Or are they lining up to avoid retribution on the grounds of diminished responsibility? (Which they seem to have exhibited for years anyway). :confused: Screwy.
     
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  9. Barry53

    Barry53 Senior Member

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    Your opinion still welcome anyway, thanks.
     
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  10. Barry53

    Barry53 Senior Member

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    What a very salient point that is! I suppose an alternative possibility might be that the selection process somehow favoured those most likely to respond? Would be interesting to know how these patients did not meet the NICE criteria.
     
    Last edited: Jul 1, 2017
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