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GETSET - Graded Exercise Therapy guided Self-hElp Treatment (GETSET)

Discussion in 'Latest ME/CFS Research' started by Bob, May 22, 2016.

  1. Bob

    Bob

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    Edit: New! See the trial protocol here:
    http://forums.phoenixrising.me/inde...-conference-abstract.44749/page-4#post-733501

    -------------------------------------------------------------------------------------------------------------------

    The GETSET trial has arrived.


    Edit: it seems that the full paper hasn't been published yet, but just the abstract (posted below) as part of a list of conference abstracts: The conference of the European Association for Psychosomatic Medicine (EAPM) is titled: "Transforming health through evidence and empathy."
    http://eapm2016.com/

    There is previous discussion about GETSET here (I'm not sure if I should have started a new thread):
    http://forums.phoenixrising.me/inde...ite-at-it-again-now-its-a-getset-trial.15619/

    -----------------------------------------------------------------------------------------------------------------

    Conference abstract.

    Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care
    Clark LV, McCrone P, Ridge D, Cheshire A, Vergara-Williamson M, Pesola F, White PD.
    Journal of Psychosomatic Research, June 2016, Volume 85, 59-60.
    http://www.jpsychores.com/article/S0022-3999(16)30233-1/abstract

     
    Last edited: Jun 10, 2016
  2. Bob

    Bob

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    Last edited: May 22, 2016
    Comet, Valentijn and Esther12 like this.
  3. TiredSam

    TiredSam The wise nematode hibernates

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    Do these people have no idea how to make an acronym? It should be GETSHT, I wonder why they didn't use that?
     
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  4. Bob

    Bob

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    :)
     
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  5. user9876

    user9876 Senior Member

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    I think we can expect a lot of bad publicity, wild claims from them as they release these papers. I suspect that the SMC will bring out the usual hate speech against patients with ME so that White and friends can avoid the difficult questions and gloss over the issues with PACE.

    It will be interesting to see whether they have stuck to the protocol.
     
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  6. Bob

    Bob

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    Last edited: May 22, 2016
  7. Denise

    Denise Senior Member

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    Apologies if this has been already been noted.
    It looks as though the paper will be discussed in Sweden on 17 June:


    E. Chronic fatigue syndrome
    Chairs: Bernd Löwe, Peter White


    Authors


    Title

    ML Joustra, I Minovic, KAM Janssens, SJL Bakker, JGM Rosmalen

    Vitamin and mineral status in chronic fatigue syndrome and fibromyalgia syndrome: a systematic review and meta-analysis

    TE Williams, L Pangiotopoulou, T Chalder, M Sharpe, PD White

    Is chronic fatigue syndrome heterogeneous? A review of the literature and new study of the lumping versus splitting debate for functional somatic syndromes

    LV Clark, P McCrone, D Ridge, A Cheshire, M Vergara-Williamson, F Pesola, et al.

    Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care

    Anna Cheshire, D Ridge, L Clark, P White

    Why patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis improve or deteriorate with graded exercise therapy

    http://eapm2016.com/sessions/



    There are several other sessions at this meeting that are of concern - among them....

    E. Chronic fatigue syndrome: an update on mechanisms and implications for treatment
    Chair: Simon Wessely


    Authors


    Title

    Megan Roerink

    Is postural orthostatic tachycardia a useful diagnostic marker in chronic fatigue syndrome patients?

    S Fischer, J Strahler, C Markert, MB Kappert, U Nater

    Psychoendocrine alterations in individuals with chronic fatigue syndrome

    R Strawbridge, M-L Sartor, AH Young, AJ Cleare

    Is chronic fatigue syndrome an inflammatory disorder?

    S Kempke

    Personality and chronic fatigue syndrome: a biopsychosocial perspective


    C. Physical symptom disorders / MUS: a roadmap for future research into primary care interventions
    Chairs: Chris Burton, Tim Olde Hartman


    Authors


    Title

    M Rosendal

    The classification of MUS from a primary care perspective

    C Burton, S Chowdhury

    Outcome measures for intervention trials in somatic symptom disorders

    M Wortman, TC olde Hartman, P Lucassen, WJJ Assendelft

    Lessons from a randomised pilot trial of a new intervention for MUS in primary care

    A Aamland, A Fosse, E. Ree, E Abildsnes, K Malterud

    General practitioners successful strategies in managing patients with medically unexplained symptoms (MUS). A focus-group study
     
  8. Valentijn

    Valentijn The Diabolic Logic

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    That has to be the briefest abstract I've ever seen. It literally says nothing that isn't already in the title.
     
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  9. Esther12

    Esther12 Senior Member

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    I wonder if anything will have changed post-Tuller. Will be interesting to see.
     
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  10. Bob

    Bob

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  11. Bob

    Bob

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    NOTE that Chalder fatigue is a post-hoc primary outcome...
    https://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=13898&query=%7B%22query%22%3A%22Graded%20Exercise%20Therapy%20guided%20SElf-help%20Treatment%20for%20CFS%2FME%22%2C%22facetDef%22%3A%7B%7D%2C%22rows%22%3A%2225%22%2C%22offset%22%3A50%2C%22openurl%22%3A%22yes%22%7D
     
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  12. Valentijn

    Valentijn The Diabolic Logic

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    Full abstract is at http://www.sciencedirect.com.sci-hub.cc/science/article/pii/S0022399916302331

    They used NICE criteria, but recruited from secondary care (their clinics presumably). They used the Chalder Fatigue Scale and SF36 physical function subscale. It only lasted 12 weeks, probably because PACE taught them that brainwashing doesn't hold up long-term :oops:

    These are tiny "improvements", especially for the SF-36. A 6.3 point improvement means that patients marked one question one step better than at baseline. They don't say if Chalder Fatigue scoring was bimodel, likert, or their preferred mishmash of both. They also only list "adjusted" scores, so unadjusted scores probably show no improvement.

    Of course they stay far away from anything where PEM is mandatory.

    No indication of what qualifies as a serious adverse event. Probably death or being bedbound for 6+ months (during a 3 month trial) :rolleyes:
     
    Last edited: May 22, 2016
  13. Bob

    Bob

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    SF-36 physical function (the pre-specified primary outcome) had a small effect size (0.2), which is acknowledged in the abstract. So no surprise that they added the post-hoc Chalder fatigue primary outcome which had a moderate effect size (0.5).
     
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  14. user9876

    user9876 Senior Member

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    Note that they have already changed the protocol:

    So my guess is that they were not having success with the sf36 scale or thinking they wouldn't. I assume it is another open label trial.

    The initial end of the trial was end March 2014 then on the 21 July 2015 they extend it to include more patients and extend the end date to 01/12/2015. But then the recruitment end date is now set at 1st Dec 2014 and no recordings of changes. So something odd is happening with end dates. My suspicion is that the change is wrongly recorded and that the original end date was the 31st March 2015 as this would be 3 months after the recruitment end date.

    So the extended the end of trial. This could be because the added a new primary outcome of the CFQ at 12 weeks and 1 year which would fit with the timing changes,

    It is not clear how/when they added additional patients to raise the number from 178 to 218 but I think they need to explain this and show the figures for the original 178 so that people can tell if they extended the numbers with the hope of getting better results. (I bet they won't do this).


    The also added in an additional primary outcome. So it will be interesting to see if the sf36 results are poor. In the trial registration they don't say how they will judge success.

    It is interesting how they extended the judgement time period and using an additional primary outcome after the original end of the trial.
     
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  15. user9876

    user9876 Senior Member

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    Its interesting that this appears to have been allowed after the end of the open label trial. If an ethics committee has approved this we should be calling for their resignation.
     
  16. user9876

    user9876 Senior Member

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    Given they seem to be engaging in yet more outcome switching I suspect they will be very aggressive in trying to dismiss anyone who may question their results.
     
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  17. Esther12

    Esther12 Senior Member

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    It looks like these are just abstracts from a conference, not full papers. The full papers will be coming out elsewhere.
     
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  18. Bob

    Bob

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    We know from the abstract that the SF-36 physical function outcome is poor. I wonder if the outcome wasn't statistically significant with the lower number of patients which is why they decided to increase the numbers.

    The trial registry says that a positive result will be statistical significance for physical function: "GETSET will be more effective at improving physical disability than usual specialist medical care alone as shown by a statistically significant difference between the two arms of the trial three months after randomisation."
     
  19. Bob

    Bob

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    What makes you say that, Esther?
     
  20. user9876

    user9876 Senior Member

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    That is an interesting one. If there is a statistical difference between the two arms but SMC were better then they could declare success! It is a very weak outcome. They also talk about recruitment outcomes there. The don't transfer that into the primary outcome piece but I guess that is about as weak as they could possibly make success of a trial.
     
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