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Peter White at it again - Now its a 'GETSET' Trial

Discussion in 'Latest ME/CFS Research' started by Wildcat, Apr 10, 2012.

  1. Wildcat

    Wildcat Senior Member

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    .
    Please read the Link for the Full Information on this Trial:
    http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12053

    .


    Graded Exercise Therapy guided SElf-help Treatment for CFS/ME

    Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with chronic fatigue syndrome/myalgic encephalomyelitis: a randomised controlled trial in secondary care

    .

    Topic
    Generic Relevance & Cross Cutting Themes

    Portfolio Eligibility
    Automatically eligible



    .
    Research Summary
    Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME) is a chronic disabling condition of no known cause and with no established cure. It affects about one in a hundred people. The National Institute for Health and Clinical Excellence (NICE) guidelines on the management of CFS/ME recommend graded exercise therapy (GET) as one of only two treatments for which there is research evidence of benefit. In contrast most ME charities believe that GET can be harmful, and they do not recommend it.

    This study will test the acceptability, effectiveness, costeffectiveness and safety of Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with CFS/ME attending hospital clinics. GETSET has been designed to incorporate the best elements of GET provided by current and previous research trials, paying particular attention to safety and acceptability.

    Patients will be randomly allocated to one of two treatments. The first is to implement GETSET described in a booklet. Patients will follow the six steps described in the GETSET booklet that will inform them how to use graded exercise or physical activity to feel less tired and reduce disability in a safe way. The alternative (control) treatment is for the patient to follow specialist medical advice alone.

    Those implementing GETSET will be given individual guidance either face-to-face or by telephone/Skype soon after being randomised and another 3 times in the following 8 weeks, by a physiotherapist experienced in treating people with CFS/ME, on how to use and implement GETSET.

    Those who feel the need may contact the physiotherapist thereafter. We will ask people to rate their own health and disability at the end of the treatment period and also measure how much consequent treatment they receive afterwards, to see if those who had the GETSET need less face-to-face treatment afterwards.
    .


    Main Inclusion Criteria
    Patients attending two CFS/ME specialist clinics in London and receiving a diagnosis of CFS/ME from a specialist doctor. Patients must be 18 years or over, speak and read English adequately to provide informed consent and read
    the therapy booklet

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    Main Exclusion Criteria
    Not receiving a diagnosis of CFS/ME. Having a comorbid
    condition that requires exercise to be performed only in the
    presence of a doctor. Being under the age of 18. Having active suicidal thoughts.

    .

    Chief Investigator(s)
    Prof PD White
  2. Wildcat

    Wildcat Senior Member

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  3. Esther12

    Esther12 Senior Member

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    *sigh*

    Thanks Wildcat.
    Wildcat likes this.
  4. Wildcat

    Wildcat Senior Member

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    Hi Esther!

    Yes, I *sigh* in unison!

    "Patients will follow the six steps described in the GETSET booklet that will inform them how to use graded exercise or physical activity to feel less tired and reduce disability in a safe way..."
    .

    .
    *Groan*
  5. Sean

    Sean Senior Member

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    Triple sigh.

    How about if Mr White, et al, were required to publish all the PACE data before they are allowed any more research funds to waste.
  6. Wildcat

    Wildcat Senior Member

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    This is a relatively small Trial when compared to PACE - and its obvious to us that it smacks of desperation on the part of PD White - but REALLY, when are they going to give up and concede that their Paradigms and Concepts re Exercise and Deconditioning have nothing to do with ME!
    Min, Bob, taniaaust1 and 3 others like this.
  7. Esther12

    Esther12 Senior Member

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    Yeah.

    We want the primary outcome measures, as laid out in the protocol.

    We want the figures on recovery, as laid out in the protocol.

    We want the figures on employment.

    What's the point of giving them more money to do studies, when they're unwilling to release their results? I thought White's excuse for not releasing more data is that he's been so busy... yet he's already spending time on getting a new study going? Release the results that have already been paid for.
    mango, Bob, WillowJ and 7 others like this.
  8. biophile

    biophile Places I'd rather be.

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    Anyone else notice how CBT/GET proponents are recently trending towards a minimalist approach with therapy based on booklets and the internet?
    mango, Bob, taniaaust1 and 3 others like this.
  9. SOC

    SOC Moderator and Senior Member

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    Yeah, that will really hide us from the public eye. Talk about being invisible! Hand 'em a pamphlet or an internet address and tell them to go away. Easy, cheap, and they quit bothering you. Nice "medical" treatment. :rolleyes:
    mango, Min, Googsta and 1 other person like this.
  10. Mark

    Mark Acting CEO

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    Quadruple sigh.

    And the scientific world really can't see how utterly useless and unscientific this sort of research is?

    So they will get some kind of Hawthorne effect on a diluted cohort of Oxford-criteria patients, they'll claim that patients being so put off by dangerous treatment that they give up on the NHS completely is another measure of success, and they and their mates in the Science Manipulation Centre will tell the press that this means ME patients just need pamphlets telling them to get out and exercise and they can all be magically cured.

    And if by some miracle they fail to twist the figures into showing what they want them to, they'll conclude that GET needs to be delivered by trained psychs (ie them) after all, and the information alone is not enough...after all, it worked soooo well in PACE, didn't it? Heads I win...

    They'll carry on like this till doomsday unless somebody does the decent thing and stops giving them our money for their completely bogus research.
  11. alex3619

    alex3619 Senior Member

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    I think there is an obvious reason this might be the case. Too many studies with good data show their treatments don't really work. If they release too much data it might be used to demolish their theories. If this is the case, and can be substantiated, its potential scientific fraud requiring an investigation.

    Bringing the medical profession into disrepute is considered a bad thing. These theories have so tainted psychiatry and the general medical profession that millions of us may view them very unfavourably. When we have people who are too afraid to use doctors because of the abuse we receive, there is a major problem - and its not showing many signs of improving yet. Psychiatry has an appalling reputation not because its about the stigma of crazy headcases, which it isn't, but because too much psychiatry is unsubstantiated unprovable theory ... and they don't seem to care.

    Bye, Alex
    Enid likes this.
  12. Enid

    Enid Senior Member

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    Yes we are all sighing here too. Is the man desperate, thick skinned, short of ideas - GETSET - catchy phrase. Am sure the scientists here will see all the errors in this so-called study.
  13. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Very well said, Mark.
  14. Valentijn

    Valentijn Activity Level: 3

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    Quintuple sigh!

    And now they have practice at hiding the existence of adverse results, as demonstrated in PACE. If they actually cared about safety, they wouldn't have deliberately designed PACE to mask PEM, and just reported the adverse events properly in the first pace.

    But since they have already denied adverse events and don't really care about them, I do wonder if this latest study might be a response to Tom Kindlon's paper on the matter. In which case it's nice to see that we are forcing them to react to us for a change.
  15. Marco

    Marco Old blackguard

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    Pure speculation on my part but I wouldn't be surprised that they were somewhat shocked by the relative ineffectiveness of the combined CBT/GET protocol and the fact that on certain measures GET was superior to CBT which somewhat undermines the core illness belief model (after all 'deconditioning' was proposed to arise as a result of inactivity due to 'fear avoidance'). The combination of CBT and GET is bound to look expensive when any modest benefits are examined objectively.

    Secondly, while further analysis of PACE has yet to become public (or may never) I wouldn't bet against other stakeholders/co-funders already being in posession of the raw data and able to crunch the numbers for themselves.

    Furthermore the GET protocol used appears to have been of relatively low intensity. Despite this we don't know exactly what adverse events occurred but were judged to be non-serious. This new trial would appear to adopt a similarly cautious approach even to the extent that the programme is to be self administered.

    Finally, I do wonder if GP's are finding their patients starting to filter back post therapy with the same complaints?

    This approach plus the previous internet delivered version is starting to look a little cut-price or dare I suggest a 'fire sale'?
  16. Firestormm

    Firestormm Senior Member

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    We were discussing this on MEA FB the other day. It actually made me laugh to think that GET was worth all that money and can now be delivered by way of a six-step booklet!! So much for therapists. Britain can't even be bothered with the internet either. Bloody cheapskates.

    Here's my Guide to Exercise: One step. Do what you can when you can within your limits! Bingo. Easy-peasy. Where's my Master's Degree in Psychology? :D
  17. alex3619

    alex3619 Senior Member

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    Hmmm, just thought of something, GET SET, ready, go away.
    Min, Wildcat, taniaaust1 and 2 others like this.
  18. taniaaust1

    taniaaust1 Senior Member

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    That's exactly one thing I was thinking.

    They didnt mention it but Im seeing CBT there in that study (more on this below)

    What I want to know is where they get all the funding to run the same kinds of studies over and over.. wouldnt that money be better put to other aspects of ME/CFS then just is what is basically the same kind of studies again. Who's at fault of funding them?
    ..................................................

    Im curious about the control group... by specialist medical advice... what exactly do they mean? What advice is the ME/CFS specialist they have choosen, giving the control group? .. it could only be CBT? and nothing else.

    So that would mean that this actually a CBT study compared to a GET study? A wow.. Im so excited.. another CBT and GET study. (if anyone has got me wrong, just note Im being sarcastic)

    They may want to conclude from it that both CBT and GET are good but have a back plan (marks post) to go to if the GET turns out to be less successful. I cant see them wanting to conclude anything but these.. so yeah this study is a great one for them.

    It cant really go wrong for them.. in truth no control group at all there.. its just one therapy of theirs, verses another version of theirs with nothing to loose.

    I'd love to see them using as a control group, the patients of one of the ME/CFS specialists on the other side of the fence who treats ME/CFS patients with anti virals and other things. Sadly... I dont think they would risk the outcome of a study like that.

    I note too that they arent using pedometers or anything to actually properly measure activity level for this study. I want to ask why? hahaha I think I already know the answers to that.. possibly then not all that much improvement will be found.

    Well Peter White. Dont you realise that there are more symptoms in ME/CFS then just tiredness. Please educate yourself on the illness some time.
    It would be great if things like dizziness, headaches, fevers were fixed by your study too.
    Min and Enid like this.
  19. Esther12

    Esther12 Senior Member

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    I agree. I think that they must have been surprised by the poor results, and that then led them manipulating them in the way that they did. If they were expecting results to be so poor, and planned to spin them from the start, then I don't think that they would have set things up in the way that they did.
    Min and WillowJ like this.
  20. biophile

    biophile Places I'd rather be.

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    There is no way the PACE Trial wasn't a disappointment to White et al

    I've done a number of calculations during analysis of the PACE Trial and it seems to me that the results were only about 25-50% (depending on outcome) of what they conservatively expected in the 2007 protocol (the cognitive behavioural model is obviously inaccurate as a primary explanation of ME/CFS, although White et al could still choose to blame patients for their stubborn beliefs and behaviours). That estimate is for the bias-prone subjective measures, the limited objective measures available make the situation look even worse.

    The semi-objective 6 minute walking test distances were a major embarrassment to the deconditioning hypothesis, in line with actigraphy from other trials which shows no increases in physical activity after CBT.* Other objective measures taken during the trial, such as fitness levels and employment hours, have not yet been published but it would be safe to assume we would have heard about them already if they were impressive. The reason that dismal 6MWD scores were even included in the Lancet paper was probably because something objective sounding needed to go in there to help avoid criticism, even if it only showed a very minimal advantage for GET and none whatsoever for CBT.

    The PACE Trial was their big dream, to test their pet therapies CBT and GET with idealish circumstances in a large trial against the pacing competition. The results would have been a disappointment behind the scenes, and unless they were clinically delusional, how could White et al seriously believe events are panning out for them as good as anticipated? There is no way they can spin the 6MWD results as "promising", although I recall White et al saying something like "the absolute scores don't matter as much as the relative advantage", which is a cringeworthy response because either way it is very poor and the scores were on par with serious medical diseases and an increased risk of death.

    * FYI, regarding CBT not improving the low physical activity levels that is characteristic of CFS, I discovered recently that the Nijmegen school of thought (the Dutch equivalent of White et al) have found a way to spin this around back onto patients. They rarely state clearly that CBT does not generally lead to increases in physical activity, it is usually worded as "increases in physical activity do not mediate the effect of CBT" which makes it sound like increases are still happening anyway. They still like to state that CBT is effective at reducing disability, based on self-report, even when the same trial shows no objective increase in physical activity. This is how they have justified the contradiction:

    (1) patients are (hypothetically) increasing their physical activity levels in the early stages of therapy which helps them to challenge their pathological illness-related beliefs, but then ...
    (2) since patients were allowed to substitute physical activity for social engagements later in the course of CBT this increase is not detected during followup after therapy, and ...
    (3) most patients are "relatively active" anyway and don't need to increase their physical activity levels in order to improve or even recover from CFS, and ...
    (4) the discrepancy between subjective disability and objective measures of activity is evidence that patients perceptions' about reality were distorted and needed CBT.
    Min, WillowJ, ukxmrv and 1 other person like this.

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