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Trial by Error, Continued: More on Graded Exercise from Peter White and The Lancet

Discussion in 'General ME/CFS News' started by Kati, Jun 28, 2017.

  1. Kati

    Kati Patient in training

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    David (Tuller) posted a new blog post today regarding GETSET. He asked on twitter to leave comments on the blog:

    http://www.virology.ws/2017/06/28/t...ded-exercise-from-peter-white-and-the-lancet/

    He consulted with statistician Bruce Levin and quoted him (in his post)

    Exerpt:


    Much more at the link above.
     
    Last edited: Jun 29, 2017
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  2. Tom Kindlon

    Tom Kindlon Senior Member

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    I don`t think this comment is that significant.
    ---
    ---
    Peter White has used "causes" before (e.g. 10 years ago on a discussion list with me) to refer to what initially caused the illness e.g. an infection. He sees what perpetuates the condition as something else.
     
  3. Wolfiness

    Wolfiness Activity Level 0

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    Indeed PACE itself says
    This new caveat is more weaselly though.
     
  4. Sean

    Sean Senior Member

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    The lack of effectiveness of behavioural treatments does imply that the condition is not psychological in nature.
     
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  5. A.B.

    A.B. Senior Member

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    obscurantism
    1. opposition to the increase and spread of knowledge.
    2. deliberate obscurity or evasion of clarity.

    That the PACE authors continuously fail to mention important biomedical findings in their papers is a form of obscurantism.

    The PEM literature is highly relevant to any discussion about exercise. I'm fairly sure it has never been acknowledged in any paper by the CBT/GET proponents. One can only conclude that they wish to keep readers in the dark and shield their cherished therapy from highly inconvenient facts.
     
    Last edited: Jun 29, 2017
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  6. lilpink

    lilpink Senior Member

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    Surely Prof Levin's observation "Obviously they were looking at baseline data in order to notice that “too many” subjects had non-disabled physical functioning" is the most damning of all? Assuming I have understood the context correctly then the GET-SET PI's have by their own foolishness accidentally revealed that they did look at baseline data. It wasn't blinded? And their mid stream changes might amount to research fraud?
     
  7. dangermouse

    dangermouse Senior Member

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    I reckon GetSetJulie will be one of their biggest errors, it's so blatantly obvious that whoever dreamed up Julie's diary has not got a clue about the nature of ME and how it impacts the human body.

    Even prior to getting ME I'd have struggled to keep up with Julie's timetable of activities!

    The more exposure GetSetJulie gets the better! She's proof of how flawed the whole thing is.

    It's so ridiculous it's laughable.

    Ah, she likely claps hands and reminds herself not to "do" ME throughout the day, that'll be it.
     
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  8. slysaint

    slysaint Senior Member

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    Brightened my day a bit............David Tuller the Magnum PI of the ME world:heart:

    " The investigators mention patient surveys on reported harms from graded exercise, but they choose to ignore the growing peer-reviewed literature from leading medical research centers around the world. They also ignore the major 2015 report from the U.S. Institute of Medicine (now called the Academy of Medicine), which identified “post-exertional malaise” as the cardinal symptom, in the process renaming it “exertion intolerance.”

    One for the NICE guidelines I hope. (fingers crossed emoji)
     
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  9. Karen Kirke

    Karen Kirke

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    I posted this comment on David Tuller's blog, showing how the manuals clarify that the rationale for GES in GETSET is essentially the same as that for GET in PACE:

    Thank you Dr Tuller and Prof Levin. I don't think there is a shift in rationale or hypothesis between PACE and GETSET, there is just a shift in where that rationale or hypothesis is explicitly stated, from the published paper and trial manuals to trial manuals only. This shift could reduce readership of that rationale or hypothesis and therefore reduce criticism of the trial. The GETSET trial therapist manual and patient booklet make it very clear that the rationale and theoretical model for GES in GETSET is the same as that for GET in the PACE trial (see below).

    The therapist manual was authored by Clark, Tims and White and can be read here: http://www.wolfson.qmul.ac....

    The patient booklet was written by 9 NHS GET therapists, edited by Clark with thanks to White, Cunningham and Bavinton, and can be read here: http://www.wolfson.qmul.ac....

    The patient booklet sticks with the PACE rationale for graded exercise:
    “After a period of illness…we tend to avoid physical activity and rest more than usual. When we do less each day our body loses fitness and strength in a physical process called deconditioning…The inability to function as before leads to frustration and an eventual lack of motivation for any physical activity. This starts a vicious cycle of avoiding activity and increased fatigue which then results in further deconditioning. The aim of GET is to break this cycle.” (p.4)

    Patients are also reassured that no harm will come to them:
    “Will GET do me harm? You may be worried that any increase in exercise or physical activity could make your condition worse. Be reassured – research has shown that a guided, gradual exercise programme can help people who suffer from CFS/ME without causing ill effects.” (GETSET patient booklet p.2)

    Patient surveys famously contradict this claim of no harm – see figure 1 and table 1 of this article for an overview of UK survey data: http://journals.sagepub.com....

    A more nuanced explanation is given to the therapists. On p.7 of the GETSET therapist manual, Clark
    et al state:
    “It is not fully understood why GET helps many people with CFS/ME…One theory which can be used to explain GET, as outlined in the GET booklet is based on deconditioning…Another theory points to an altered perception of effort (this may be more significant than deconditioning) [NB Patient booklet does not refer to this more significant effort perception theory.] Participants are encouraged to see symptoms
    as temporary and reversible, as a result of their current physical inactivity, and not as signs of progressive pathology.”

    Mechanisms are discussed here:

    "Apart from the behavioural and perceptual effects of graded exposure to previously avoided physical activities, there may be other mechanisms involved in the success of GET such as reversing deconditioning, including elements of habituation, and positive effects of re-engagement with important activities" (p.7-8, GETSET therapist manual).

    "Preliminary research suggests that reduced symptoms (including fatigue) are related to simply participating in a GET programme, rather than necessarily getting fitter, whereas improved functioning is related to getting fitter and stronger" (p.7, GETSET therapist manual).

    Therapists are told that "It is important to explain that although [patients] have an increase in symptoms, ‘hurt does not equal harm’ (GETSET therapist manual p.26). Patients are told "Remember that although you may not feel like exercising during a CFS/ME related setback, by resting too much you can quickly lose the physical gains you have made" (GETSET patient booklet p.20).

    While Clark et al tell the GES therapists that the effort perception theory may be more significant, they tell therapists:
    “The rating of perceived exertion…is not discussed in the GET booklet [for patients] and therefore is not something you need to discuss with the participant unless they mention it.” (p.49)

    They go on to explain to the GES therapists that:
    “[rating of perceived exertion] is a concept that is important to the participant in their overall success with GES because it is usual for CFS/ME patients to have higher Rating of Perceived Exertion (RPE) than those who do not have CFS.”

    While some might think this is because the key feature of ME/CFS is exertion intolerance, to the extent that the Institute of Medicine suggested renaming it “Systemic Exertion Intolerance Disease” https://www.ncbi.nlm.nih.go..., Clark et al explain to the GES therapists in their manual that:

    “[CFS patients’ higher Ratings of Perceived Exertion] may be related to sleep disturbance, deconditioning, enhanced interoception (increased awareness of body sensations), or mood disturbance among other reasons.”

    They then clarify for the GES therapists that:
    “The RPE cannot therefore be used as an objective measure of intensity for this patient group…After an exercise programme, research has shown that the RPE in CFS patients is normalised, and can at that stage usually be reliable as a measure of intensity.”

    To be clear, they have stated that a rating of a patient’s perception of how effortful things are relative to other things is an objective measure in some patient groups, but is not objective in CFS, because CFS patients differ from other patient groups in that they have skewed perceptions, perceiving things to be more effortful than they actually are. This skewed perception is fixed, according to the authors, by exercise programmes.

    Perception rating scales are, objectively speaking, not objective; they are and will be subjective for every patient group that exists now and may exist in the future. All outcome measures in GETSET were subjective.

    Thankfully other researchers are seeking to understand what ongoing pathophysiological process might be behind exertion intolerance in ME/CFS, taking patients’ experience/perceptions as their starting point, and using objective as well as subjective outcome measures.
     
  10. TiredSam

    TiredSam The wise nematode hibernates

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    The date of the booklet's publication is 2009. In the light of research since then (obviously sufferers' testimonies before and since then have counted for nothing due to their "skewed perceptions") it should be withdrawn as a matter of urgency.
     
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  11. Karen Kirke

    Karen Kirke

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    I couldn't see a publication date - can you let me know where it is? And did you see one on the patient booklet too?
     
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  12. TiredSam

    TiredSam The wise nematode hibernates

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    The link to the therapist manual in your post didn't work for me, so I've only seen the patient booklet. Publication date is August 2009, on page 36, the last page.
     
  13. Valentijn

    Valentijn Senior Member

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    They really do brainwash the therapists just as intensely as the patients :meh:
     
  14. TiredSam

    TiredSam The wise nematode hibernates

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    From the patients' booklet:

    Absolutely insane. They just made it up.
     
  15. IThinkImTurningJapanese

    IThinkImTurningJapanese Moderator

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    Last edited: Jun 29, 2017
  16. Wolfiness

    Wolfiness Activity Level 0

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    Again? "We only realised halfway through the trial that the methods we've been using for decades to assess patients are inadequate." AGAIN?! Fascinated by their genuine stupidity.
     
    Last edited: Jun 29, 2017
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  17. Karen Kirke

    Karen Kirke

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    Thank you! I see it now. It's a while ago, eh? Yes I saw that the therapist manual link wasn't working so I replied to my own comment giving links again.

    Hopefully this will work:
    http://www.wolfson.qmul.ac.uk/images/pdfs/getset/GETSET therapists manual with appendices.pdf

    If not, navigate to both therapist manual and patient booklet from here http://www.wolfson.qmul.ac.uk/current-projects/getset-trial#links
    or here http://www.wolfson.qmul.ac.uk/current-projects/getset-trial#trial-information
     
  18. slysaint

    slysaint Senior Member

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    From the therapists manual, Re: Use of heart monitor:

    "Most people with CFS/ME have a higher RPE score than normal subjects for the same heart rate, so they cannot rely on their subjective RPE ratings to determine optimal exercise intensity. However, in the GET booklet heart rate is not used to measure exercise intensity, but distance covered. If a participant is particularly interested in using a heart rate monitor to determine their exercise intensity, you can provide advice within the time you have, but will need to inform the participant that you do not have much time to dwell on it.

    You could provide them with the following information: once participating in 30 minutes of physical activity or exercise on at least 5 days of the week, they should aim to be working between 60 and 75% of their predicted heart rate maximum.

    Participants may decide to use heart rates to measure the intensity of their exercise. So this information is for your general knowledge, but does not need to be used with participants unless they require this information so that they are exercising safely.

    The participant’s target HR zone is calculated from a universally accepted and understood method; a method used for normal, healthy people (220–age, X 0.6-0.75). Where 0.6 to 0.75 correspond to 60% and 75% of predicted maximum heart rate."

    So did the participants wear heart rate monitors?
     
  19. Karen Kirke

    Karen Kirke

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    The example of what to do during a setback is also interesting (p.21 of patient booklet http://www.wolfson.qmul.ac.uk/images/pdfs/getset/GET guide booklet version 1 22062010.pdf).

    Fictional "Joe" is supposed to be walking for 17 minutes 5 days a week, but he has a fictional ME/CFS "setback" so he follows his setback plan, doing one of the following (wording is mine - see p.21 for wording in booklet):

    1. Keep walking for 17 minutes 5 days a week "even though this will feel more difficult".
    2. Keep walking for 17 mins 5 days a week, just go slower.
    3. Keep walking for 17 mins 5 days a week, with a 5 min rest in the middle.
    4. Go for two walks 5 days a week: walk for 10 mins in the morning and 7 mins in the evening.
    5. Walk for 17 mins 4 days a week, splitting it or taking a rest if needed.
    6. For one or two days, reduce length of walk to last week's duration: 14 mins, then go right back to 17 mins.
    7. Reduce length of walk to last week's duration: 14 mins, and do it 5 days a week.

    In case Joe didn't get the message, his setback plan ends with "I should aim to return to the 17-minute, pre-setback walk as soon as possible."

    It might explain why only 42% of participants adhered to GET completely or very well, 30% moderately well, 29% slightly or not at all (p.8 of the GETSET paper).
     
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  20. BurnA

    BurnA Senior Member

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    OMG.

    I thought using a heart rate monitor for measuring distance covered would be the craziest thing I read today. But then i read how therapists shouldn't dwell on it.

    Imagine dwelling on an objective measurement of whether or not the exercise was suitable for the patient.
    Or dwelling on the fact the a participant may suffer heart problems during the trial, Noooo definitely not to be dwelled upon.


    Seriously isn't this negligence.?
     

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