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PACE Trial and PACE Trial Protocol

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

  1. Dolphin

    Dolphin Senior Member

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    Newly-submitted FOI request:

    https://www.whatdotheyknow.com/request/6min_walking_test_results_for_re/new
  2. Graham

    Graham Senior Moment

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    Now that would be interesting. Call me suspicious if you like, but I think that if the results of the 6 minute walk reflected an improvement in the "recovered" group, they would have been included in the report.
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  3. Esther12

    Esther12 Senior Member

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    From that FOI, is it clear that they want results for patients before and after treatment? I'd expect that those classed as recovered' would have higher means than those not classed as recovered.

    It could still be interesting if those who did SMC alone and APT and were classed as recovered had better 6mwt results than those who were classed as recovered following CBT and GET, as this could indicate that the 'positive' psychosocial interventions led to 'positive' questionnaire scores which exaggerated improvement.
    Valentijn, Sean and biophile like this.
  4. Esther12

    Esther12 Senior Member

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    I was just reading a thread on this paper:

    Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale.

    Journal of Psychosomatic Research xx (2011) xxxxxx

    Matteo Cella, Michael Sharpe, and Trudie Chalder

    It makes an interesting read, now that we have the figures on employment from PACE. Sections like this stand out more:

    Also - noticed that biophile had already criticised this claim, regardless of the fact that they were sitting on data from their own trial which contradicted it:

    http://forums.phoenixrising.me/inde...-a-rct-burgess-et-al.14222/page-2#post-235243

    Also another comment from Dolphin on it:

    Their point that...

    ...seems important, although perhaps not in the way that they mean, given the poor results from CBT for objective measures of disability.

    As they said in their protocol:

    Side note: I'm not sure that I noticed that this paper was based on data from the 90s. I should go back and re-read that paper:

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  5. Andrew

    Andrew Senior Member

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    I think it was in this thread that someone uploaded a copy of the peer review comments for the pace trial publication. I downloaded it to my computer, but now I cannot find it. Can someone point me to this please?
  6. Esther12

    Esther12 Senior Member

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    I'm pretty sure that they've not been released. It would be very interesting to see them though. Anyone want to contradict me? I may have missed them. It would be great if they were available. I don't think any of the PACE stuff has been published in a journal which makes peer review comments public.
    Dolphin likes this.
  7. Andrew

    Andrew Senior Member

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    My mistake, the peer review comments seem to be in response to "A preliminary prospective study of nutritional, psychological and combined therapies for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in a private care setting."
  8. Bob

    Bob

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    Simon likes this.
  9. Dolphin

    Dolphin Senior Member

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    This might be worth a freedom of information act request. If they are going to publish the data, they can say that.

    I'm concerned this promise could easily be broken, given it isn't in the full protocol.

    I think freedom of information act requests are ideally done by people in the UK.
  10. Dolphin

    Dolphin Senior Member

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    Reposted from the thread on this paper:

    http://forums.phoenixrising.me/inde...ical-and-community-settings.7946/#post-348840
    --------
    This study was used to define normal fatigue for the PACE Trial paper in the Lancet (main one) and the recovery paper.
    They used a sample of people who had attended their GP in the last year:

    I happened to see the following on Twitter today:

    This would suggest the sample is likely not representative at all.
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  11. Esther12

    Esther12 Senior Member

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    Just a little point raised by someone else who was a participant in some research that invovled some psych questionnaires, and saying that they think that they filled them out really differently depending upon whether they were doing them at home, or at a medical appointment. Attending an appointment is often inconvenient/difficult, when it's just forms to be filled in at home, they can be left until you're feeling well enough to do them.

    I expect that these points have been mentioned before, but thought I would repeat it anyway as it was brought up by someone being researched upon.
    WillowJ, Sean and Dolphin like this.
  12. user9876

    user9876 Senior Member

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    I remember reading some research done on the SF36 scale comparing interviewer or self filled in surveys and I think they were finding differences but can't remember which way.

    I think the time window of when the survey is filled in could lead to a very important source of bias if people wait until they are well enough to fill the survey in.
    WillowJ, Sean and Dolphin like this.
  13. Dolphin

    Dolphin Senior Member

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  14. WillowJ

    WillowJ Senior Member

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  15. Mark

    Mark Acting CEO

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    There were a couple of superb quotes on the PACE trial in the FDA Workshop; Chris Snell's analysis was particularly noteworthy. Followers of this thread might like to look them up (the video's online now) and pull out the quotes to post here.
    Valentijn, ukxmrv, Sean and 2 others like this.
  16. Sean

    Sean Senior Member

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  17. ukxmrv

    ukxmrv Senior Member

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    Sean, I'm looking at panel 3 at the moment. Dr Snell is about to speak at 48:35.
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  18. Sean

    Sean Senior Member

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    Ta. :thumbsup:

    ETA: Just realised that the Snell video had not yet been posted when I made my first post above. They must have been in the process of adding them as I posted.
    ukxmrv likes this.
  19. Bob

    Bob

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  20. Bob

    Bob

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    Very brief summary of presentations:

    Prof Rowe points out that only 13% of patients responded to treatment, and that an average 3 point improvement on a 33 point scale (for fatigue) after a year of treatment, was unimpressive, and that he would expect to see more of an improvement in patients over a year (He was referring to his own work, and his expectations for the patients that he deals with.) He says that the 'modest improvements in the PACE Trial were 'significant' because of the large size of the study.
    He has a short discussion of the Chalder and SF-36 PF scales, but doesn't have too much to say about them.

    Dr Christopher Snell says that the 6MWDT was the only objective test used in the PACE Trial ("the only true objective measure that they had in the whole study"), and the final results for the 6MWDT indicate 'severe disability' (The reference given for this claim was: "Weber/NYHA")*.
    He also notes that a large proportion of participants did not complete the 6MWDT and asks why?
    He also discussed various reasons why the 6MWDT is not an appropriate or helpful test, especially for CFS patients. (This discussion might be a bit earlier, or later, in the video.)

    *(Weber/NYHA: Dr Snell didn't specify the exact paper. I think he was referring to a paper that discusses walking speeds rather than the 6MWDT specifically.)

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