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PACE Trial and PACE Trial Protocol

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

  1. Graham

    Graham Senior Moment

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    I think we have two problems here. One is, as you say, due to the poor definition of GET. It is likely that GET was applied with far more sensitivity in the PACE trial than most people experience it through ME centres and the like.

    The other is that CBT and GET would benefit a number of healthy people that I know, as it would a wide variety of people with different illnesses. My guess is that people with ME would show less improvement than a random sample of healthy people, simply because I do not believe that these therapies are relevant to ME, and can actually do harm. The problem with measuring the effect though is that many measurements are designed at measuring the ill, and healthy folk tend to clump at the top end. Effects on the 6 minute walking test would be interesting though. Would healthy folk show a greater improvement after a year of walking each day than people with ME? Is that an obvious question? Is it obviously an obvious question?
    Roy S, alex3619, Bob and 1 other person like this.
  2. Bob

    Bob

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  3. Bob

    Bob

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    This got me thinking that, like you say, AfME seem to be assuming that if GET is given sensitively, by an insightful and flexible therapist, that it will not be harmful. But we don't actually have the deterioration rates for the PACE trial yet, which might demonstrate that a significant minority of patients deteriorated when treated with GET, even in a clinical trial setting, and with an adaptive pacing-like approach to setting a baseline and responding to set backs etc.
  4. user9876

    user9876 Senior Member

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    I think AfME in their latest paper (which I've not yet finished reading) are assuming that RCTs provide unquestionable evidence and hence are looking for reasons why it doesn't work in practice. Here they look for what might be going wrong in practice and seem to be blaiming GPs and untrained analysts for failing to use a proper protocol. They imply that the NICE guidelines provide a clear protocol to follow (I've not checked yet) but they fail to test their assertion. There unjustifiable assumptions about the infalibility of RCTs and the clarity of the NICE guidelines lead them to blaim some of those implementing GET.

    Looking at their positive comments most seem to be about finally finding someone who understands their condition. I wonder if a large amount of the sucess relates to simply not having a doctor constantly dismiss all symptoms rather than any substantial improvement. The negative comments suggest a lack of sympathy from many therapists but they never question why and whether this is a function of the individuals or the media and other coverage of the RCTs.

    From the RCT perspective I would have two theories. Firstly that they are just measuring a placebo effect which is different for different types of therapies but doesn't lead to objective improvements. Secondly I wonder if they set off to not increase activity much with GET so that they minimised the chances of adverse reactions - given their desire to demonstrate the protocols safety. I don't think that they recorded how much patients were told to increase their activities and they didn't report any such figures. Hence we don't really know how their protocol was implemented.
    WillowJ, biophile and Valentijn like this.
  5. biophile

    biophile Places I'd rather be.

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    I just love this bold-faced "fact" [cough] in the GET participant manual (in bolded text too):

    "The evidence we have is in fact the opposite: there is no evidence to suggest that an increase in symptoms is causing you harm. It is certainly uncomfortable and unpleasant, but not harmful."

    Page 79.

    http://www.pacetrial.org/docs/get-participant-manual.pdf

    The PACE Trial manuals are short on references for any "evidence" mentioned. There is no objective evidence that patients can safety increase total activity levels anyway. As Valentijn pointed out earlier, the available evidence actually suggests no such increases occur. It is also quite cavalier to claim symptom exacerbations are safe per se.

    Later on in the advice for relatives, friends, carers, etc: "It is however vital that you do not encourage people to push themselves past their limits. Despite being tempted to increase what you are doing by a small amount, it can prove severely detrimental in patients with CFS/ME."

    So, severely detrimental AND not harmful?
  6. Bob

    Bob

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    "We need the full methods and results on all the trials that have been conducted on all of the treatments that we use today, to make informed decisions as doctors and patients."

    Nice to see Dr Ben Goldacre supporting our requests for trial data (I said without a hint of cynicism) (short BBC video clip):
    http://www.bbc.co.uk/news/uk-politics-22957195.

    Here's a further discussion, if you can access BBC programs from your location (watch @1.16.08):
    http://www.bbc.co.uk/iplayer/episode/b030l0ks/Daily_Politics_19_06_2013/
    Sean and Valentijn like this.
  7. Dolphin

    Dolphin Senior Member

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    http://www.meassociation.org.uk/?p=15790

    ETA: A thread has now been set up on this at: http://forums.phoenixrising.me/index.php?threads/pace-trial-and-press-complaints-commission.23921
  8. Dolphin

    Dolphin Senior Member

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    I'm just writing something I'd like to post today. Can anybody direct me to where it was said that the PACE Trial investigators had been shown the Bleijenberg & Knoop editorial before it was published?
  9. biophile

    biophile Places I'd rather be.

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    I vaguely recall Hooper first making that claim, but I did a quick search and the first thing I found was recent statements by the Countess of Mar writing to White, do a text search for "approve" on this thread to find it:

    http://forums.phoenixrising.me/inde...-and-prof-white-and-prof-sir-s-wessely.21545/

    Edit (emphasis mine):

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  10. Bob

    Bob

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    Am I right in thinking that we should get the long-term PACE trial data this year? I've forgotten - should it include the long-term follow-up improvement rates? If so, it should be interesting. Anyone want to hazard a guess what the long-term improvement rates will be for CBT and GET?
  11. Esther12

    Esther12 Senior Member

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    Anyone know if they're allowed on-going contact with participants, other than just sending out questionnaires?

    eg: What about the patient that they pull out to provide anecdotal evidence of how wonderful CBT is?

    There was a patient mentioned in the physiotherapy puff-piece who talked about now running their own disability advice business. Could they be 'supported' in that by those involved with PACE?
  12. Bob

    Bob

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    Ten Top Tips For Reporting On Clinical Trials
    by Ruth Francis, Head of Communications for BioMed Central and Springer, UK.
    Credit for list also given to: @oh_henry @bengoldacre @senseaboutsci @PaulGThorne

    http://storify.com/NeuroWhoa/ten-top-tips-for-reporting-on-clinical-trials

    Items #2, #3, #8 seem particularly relevant...

    2/10 Is primary outcome reported in paper the same as primary outcome spec in protocol? If no report maybe deeply flawed

    3/10 Look for other trials by co or group, or on treatment, on registries to see if it represents cherry picked finding

    8/10 Be precise about people/patient who benefited – advanced disease, a particular form of a disease?
    Sean, WillowJ, biophile and 2 others like this.
  13. Firestormm

    Firestormm Content Team Lead

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    Simon and Esther12 like this.
  14. Valentijn

    Valentijn Activity Level: 3

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    Sounds like Neuroskeptic can't bother to read the actual recovery paper. Because it's clear in that one that all of the yardsticks are based entirely upon their perceptions - there were no objective outcomes.

    Edit: despite that lack of objective outcomes, he seems to take the statement that CBT/GET patients did "better" at face value.
  15. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    Zero or a minus figure?
    Roy S, peggy-sue and Valentijn like this.
  16. biophile

    biophile Places I'd rather be.

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    It appears that Neuroskeptic is questioning the dependence on subjective measures in general? In a world where it has basically become politically incorrect for some to significantly criticize the questionable methodology employed in CBT/GET research and claims of efficacy/safety, lest one risks being painted as an extremist for denying the evidence, after 3 years since the first paper was published, Neuroskeptic just barely manages to scratch the surface of the problems with PACE.

    Other less subjective "yardsticks" included walking test distance and data on employment and welfare. These outcomes did not match the subjective improvements either. CBT/GET proponents have generally downplayed the importance of objective measures, especially when there has been a null result (think of Nijmegen CBT school and actigraphy).

    Neuroskeptic does raise an interesting point, why is satisfaction higher in the (adjunctive) APT group than the SMC (alone) group despite no advantage? The APT group did receive more attention, about the same as the CBT and GET groups, which may have biased the satisfaction results for all 3 therapy groups irrespective of actual improvements?

    For some reason this issue reminded me somewhat of Nijmegen CBT school: "Our findings suggest that cognitive behavioral interventions for CFS need to change the illness perception and beliefs of their patients in order to be effective." http://www.ncbi.nlm.nih.gov/pubmed/22469284

    I did a quick search for Neuroskeptic and PACE CFS and found this Twitter message from 10th June 2012:

    "Last year the PACE trial of treatments for chronic fatigue syndrome/ME created controversy. Patient group critiques it: http://evaluatingpace.phoenixrising.me/summary.html"
    Valentijn and Esther12 like this.
  17. Esther12

    Esther12 Senior Member

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    I didn't think that there was anything really wrong with the Neuroskeptic piece, other than the fact that he clearly hadn't done much reading around the topic, so was just focusing on one little bit of data that they found interesting. It probably is a bit misleading to do this, but I didn't think it was 'shitty-to-CFS-patients' in the way that a lot of stuff is.

    edit: lol- Maybe my standards for science journalism around CFS are a bit low?
    urbantravels and Valentijn like this.
  18. Snow Leopard

    Snow Leopard Senior Member

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    He is, and it is both a good point and a positive step that people are actually talking about this...
    Firestormm and Valentijn like this.
  19. Valentijn

    Valentijn Activity Level: 3

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    He says "Two other conditions, CBT and GET, were associated with better symptom outcomes than the other two." He is taking this on face value, never questioning whether they actually had better symptom outcomes, and does not seem to recognize the problem with it being a subjective outcome itself.

    He's making an unfounded assumption that (CFS) patients' perceptions are wrong compared to the presumed trustworthy answers on a different questionnaire. It's nonsensical to see that two sets of answers on different questionnaires don't match up, and assume that patients' perceptions about one topic are correct, but the ones on a different topic are faulty.

    I suppose having my perceptions questioned based on crappy research is a bit of a sore spot for me :p And I'm REALLY tired of people not doing their homework before "analyzing" these sorts of things.
    Bob, peggy-sue and MeSci like this.
  20. Firestormm

    Firestormm Content Team Lead

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    Yes indeed. Methinks that the larger question is relating to judgement. Our own and other people's. What we base our own judgements on - does this help? if so in what way? - and what they use to interpret our responses and how they ask the questions I suppose:

    Fundamental questions that perhaps many patients especially don't ponder overly much. We think we 'know' when something helps and maybe don't need to know why. If we say 'it helps' the assessor ticks his box. If we say something and/or our behaviour indicates something to an assessor - upon what is he basing his interpretation?

    'Yardsticks' are our own internal ones as much as the assessors. The question of helpfulness is too simplistic. We should be trying to better explain how something helps or how we believe it has helped (or not); and their interpretations should better allow for the less-simple answers.

    Life isn't black and white and when dealing with matters pertaining to 'thought' and interpretation the questions and answers shouldn't be expected to fit neatly into a box. Focusing on 'helpfulness' is not the way to proceed.

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