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PACE Trial and PACE Trial Protocol

Discussion in 'Latest ME/CFS Research' started by Dolphin, May 12, 2010.

  1. Esther12

    Esther12 Senior Member

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    I see what you're saying but I'm just so used to people assuming that questionnaire results accurately reflect symptoms that I barely consider it a sin. It's a problem, but one which is so normal that neuroskeptic probably shouldn't be singled out for it (although obviously still fair to criticise)
    Valentijn likes this.
  2. Dolphin

    Dolphin Senior Member

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    biophile likes this.
  3. biophile

    biophile Places I'd rather be.

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    On the University of Maryland Medical Center's webpage for CFS:

    http://umm.edu/health/medical/reports/articles/chronic-fatigue-syndrome

    "Although CBT doesn't bring patients completely back to normal, research has found that people who use the therapy have higher mental health scores, and are able to walk faster and with less fatigue than those who do not use CBT."

    The reference for this statement is not entirely clear because there are a list of references at the end of the article but no inline citations. Is anyone aware of any CBT studies for CFS which demonstrated improved walking speed? Otherwise it appears to me to be referring to the PACE Trial, in which such a statement would be incorrect.
    Simon likes this.
  4. Dolphin

    Dolphin Senior Member

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    Can't think of anything.
    I imagine there is a good chance "physical functioning" was misinterpreted here and/or is regularly misinterpreted (when CBT is said to improve physical functioning in CFS studies what invariably is being referred to are questionnaire measurements, usually the SF-36 physical functioning subscale).
    biophile and Valentijn like this.
  5. biophile

    biophile Places I'd rather be.

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    I just came across this potentially interesting article. It is about the lack of adequate placebo control in the video-game-training research literature, but it touches upon the problem in general too. Many of the statements could also apply to CBT/GET and the PACE Trial:

    The Pervasive Problem With Placebos in Psychology: Why Active Control Groups Are Not Sufficient to Rule Out Placebo Effects.

    Walter R. Boot, Daniel J. Simons, Cary Stothart, Cassie Stutts

    Perspectives on Psychological Science

    July 2013 vol. 8 no. 4 445-454

    doi: 10.1177/1745691613491271

    http://pps.sagepub.com/content/8/4/445

    http://pps.sagepub.com/content/8/4/445.full

    http://pps.sagepub.com/content/8/4/445.full.pdf

    Abstract: To draw causal conclusions about the efficacy of a psychological intervention, researchers must compare the treatment condition with a control group that accounts for improvements caused by factors other than the treatment. Using an active control helps to control for the possibility that improvement by the experimental group resulted from a placebo
    effect. Although active control groups are superior to “no-contact” controls, only when the active control group has
    the same expectation of improvement as the experimental group can we attribute differential improvements to the
    potency of the treatment. Despite the need to match expectations between treatment and control groups, almost no
    psychological interventions do so. This failure to control for expectations is not a minor omission—it is a fundamental
    design flaw that potentially undermines any causal inference. We illustrate these principles with a detailed example
    from the video-game-training literature showing how the use of an active control group does not eliminate expectation
    differences. The problem permeates other interventions as well, including those targeting mental health, cognition,
    and educational achievement. Fortunately, measuring expectations and adopting alternative experimental designs
    makes it possible to control for placebo effects, thereby increasing confidence in the causal efficacy of psychological
    interventions.
    wdb, Dolphin and Sean like this.
  6. Graham

    Graham Senior Moment

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    Hi all

    Those of you who helped to produce the analysis of the PACE trial that we did on Phoenix Rising may be pleased to hear that I just got a very nice email from a member of the Hampshire ME support group. They decided to print the whole of our ten point conclusion / summary in their magazine (with attributes), and she wanted to thank us all for "taking an objective, careful, expert view". She had been a psychiatrist herself until the ME forced her to retire, and commented that psychiatrists are very divided over the "Wessely school" of thought.

    By a weird coincidence, her last job was in the town where Kathy and I met, married and had Ian, which was in my "had a hairstyle" days.

    Give yourselves a pat on the back!
    Sam Carter, peggy-sue, Simon and 8 others like this.
  7. Esther12

    Esther12 Senior Member

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    Good work Graham. I've seen a few people around the internet referring to your videos as a helpful way of understanding/explaining the problems around PACE.

    In case you're interested, I'd posted a thread on another article covering this here: http://forums.phoenixrising.me/inde...in-psych-trials-some-interesting-links.24145/
    Valentijn likes this.
  8. Shell

    Shell Senior Member

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    I haven't gone back over the thread, sorry. So if this is merely a repeat ignore me.

    It's not just patient responses on questionnaires that can be biased either to make the questioner feel better or because the patient wants to believe all that work was for something.
    The question design can be done to ensure a certain answer. A kind of pressure can be put on the answerer to say or tick the "right" answer that the questionnaire designer is pushing for.
    There's often not extra space on these things to clarify a point because it would mess up the desired stats.

    Not to mention the fact that during the mainly English fight with the Govt over home education, some stats were simply made up and others were lied about.

    And even where deliberate dishonesty isn't at play it seems massive gaps in stats can be given.
    Take Lupus for example. As I'm in the process of being tested and seen for this I've been doing some reading. (ignorance has not been bliss over the last ten years to I am, to use my dh term rectum-frying this)
    Lupus websites - showing medical evidence - report the following; 80% of Lupus patients have +ANA results. Another site; between 90 and 95% have +ANA another site 95% have +ANA and finally nearly all Lupus patients have +ANA.
    That's a massive discrepancy and almost every document admits that Lupus is complicated, difficult to dx and blah blah...

    I'm not good on stats. I have only ever written one essay on them and the poor tutor wrote at the bottom "You really didn't understand this at all did you?"
    Valentijn likes this.
  9. Sean

    Sean Senior Member

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    Thanks for that, Graham.

    ••••••••••••••••••••••••

    RE: The Pervasive Problem With Placebos in Psychology...

    [Highlighting mine. Sean]

    Compare and contrast with PACE, et al, which was blatantly biased in this regard. That methodological weakness could easily explain the very modest 'positive' result they got.

    The phrase

    Always properly control for placebo effect.

    should be tattooed on the forehead of every psych researcher in the world.
    wdb likes this.
  10. biophile

    biophile Places I'd rather be.

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    Re the framing issue, here are the questions and answers for fatigue and physical function as used in the PACE Trial:

    Chalder fatigue questionnaire, 11 questions and 4 choices of answer:

    • Do you have problems with tiredness?
    • Do you need to rest more?
    • Do you feel sleepy or drowsy?
    • Do you have problems starting things?
    • Do you lack energy?
    • Do you have less strength in your muscles?
    • Do you feel weak?
    • Do you have difficulty concentrating?
    • Do you make slips of the tongue when speaking?
    • Do you find it more difficult to find the correct word?
    • How is your memory?

    Less than usual (bimodal score is 0, Likert score is 0).

    No more than usual (bimodal score is 0, Likert score is 1).

    More than usual (bimodal score is 1, Likert score is 2).

    Much more than usual (bimodal score is 1, Likert score is 3).

    The total bimodal score (0,0,1,1) range is 0-11 and the total Likert score (0,1,2,3) range is 0-33 where 11 is neutral.

    Physical function subscale of the SF-36 health survey, 10 questions and 3 choices of answer:

    Does your health limit you doing activities that you might do during a typical day? If so, how much? ...

    • Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports;
    • Moderate activities such as moving a table, pushing a vacuum cleaner, bowling or playing golf;
    • Lifting or carrying groceries;
    • Climbing several flights of stairs;
    • Climbing one flight of stairs;
    • Bending, kneeling or stooping;
    • Walking more than a mile;
    • Walking several hundred yards;
    • Walking one hundred yards;
    • Bathing or dressing yourself;

    Yes, limited a lot (score 10/10).

    Yes, limited a little (score 5/10).

    No, not limited at (score 0/10).

    [Edit: In the PACE Trial, the score range was 0-100]. The total physical function score is usually out of 100 (technically it is out of 20 with each questioning scoring 0 or 1 or 2 rather than 0 or 5 or 10, but these are usually multiplied by 5). Sometimes the scores are "normalized" so that 50 is the average of the group with a standard deviation of 10, IIRC.
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  11. user9876

    user9876 Senior Member

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    Its slightly more complex in that if their are (upto 3?) answers missing then the remaining answers are scaled to a 0..100 scale. I'm not sure if this was done in PACE but it is certainly done with the Bowling paper which they use to define 'healthy'
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  12. Dolphin

    Dolphin Senior Member

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    Scaling would be the same thing: both are the percentages out of 100 of the questions answered.

    What was done in the PACE Trial wasn't normalised scoring. That's SF36v2.
    Valentijn likes this.
  13. Dolphin

    Dolphin Senior Member

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    This trial:

    contains:

    (one of the interventions was KCL-style CBT).

    I'm not sure whether this refers to data given in the paper or not.

    It may be the following:

    Anyone know how this RCI and age adjusted RCI might apply to the PACE Trial?

    *COG was an intervention that involved pacing plus some elements of non-CFS CBT (paper gives the details - this is a rough description from memory). CBT was the type of CBT in the PACE Trial
    biophile likes this.
  14. Dolphin

    Dolphin Senior Member

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    I wonder had he the PACE Trial in mind?

    From Co-Cure: https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1307c&L=co-cure&F=&S=&P=9540

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  15. Bob

    Bob

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    Here we see a conflict of interest in action, as Peter White provides advice to Swiss Re insurance about CFS/ME treatment and diagnosis. It covers the PACE Trial. Brace yourself, take a deep breath, and hold your nose, before reading (it's the usual nonsense)...

    Swiss Re: Managing claims for chronic fatigue the active way
    http://www.swissre.com/clients/newsletters/Managing_claims_for_chronic_fatigue_the_active_way.html

    I've started a separate thread to discuss the non-PACE aspects of the webpage. which seem quite revealing and interesting:
    http://forums.phoenixrising.me/inde...e-from-peter-white-diagnosis-treatment.24394/
    Sam Carter likes this.
  16. Dolphin

    Dolphin Senior Member

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    This was posted elsewhere.

    Thought I'd post although we don't have information on what exactly was said about the PACE Trial:


    Sean likes this.
  17. biophile

    biophile Places I'd rather be.

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    Why do I get the feeling that if we looked at these studies, direction of causation would not be shown?

    Re "Not duration of illness!" Yes, perhaps the placebo response is not susceptible to duration of illness.
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  18. Esther12

    Esther12 Senior Member

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    re moderators - that they've not released the data from PACE, or referenced it even though the above presentation released unpublished PACE data on 'remissions' (which was then sold as 'recovery'), makes me suspect that they're having trouble spinning it in a way which supports their conclusions.
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  19. Graham

    Graham Senior Moment

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    I see once again that membership of a self-help group is branded as a problem. With PACE the biggest subjective improvements came in the first few weeks, presumably as patients came to terms with their diagnosis and understanding of the illness, so why is it beyond their wit to understand that if people who are members of a self-help group show less improvement, it might be that the group has already helped that patient part-way along that route?
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  20. Firestormm

    Firestormm Senior Member

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    Do they amend these in say a Trial to take into account circumstance? For example, what is 'usual' in the Chalder fatigue questionnaire may be very relevant to circumstance and to whether a person is newly diagnosed or not. Unless this is specifically related to time and the individual then it's pretty weak when used across a cohort I would think unless there are specifics established.

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