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Lessons from ME/CFS: Finding Meaning in the Suffering
If you're aware of my previous articles here at Phoenix Rising then it's pretty clear that I don't generally spend my time musing upon the philosophy of the disease. I find it better to spend my time reading research and trying my best to break it down to its core elements and write...
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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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    This journal takes letters to the editor, which is good.
    No word limit mentioned in instructions: http://assets.cambridge.org/PSM/PSM_ifc.pdf .
    However, my impression is that the standard of English will have to be reasonably good e.g. one or two big/fancy/"jargony" words would help, "tight letter" e.g. avoiding repeating words if possible, concise, etc.
  2. WillowJ

    WillowJ Senior Member

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    APT was supposed to be testing 'pacing' as 'championed' by the patients, so it was not really envisioned as a control (apologies if someone mentioned this already; I am kind of behind).

    However there are all kinds of problems with APT as traditional pacing. It supposedly used a model of 'undiscovered illness' causing symptoms (therefore pacing to ameliorate possible effects of said mystery illness, opaque to research), but patients were told that symptoms were caused by, for example, 'overbreathing' (disproved by research; CBT intrusion as hyperventilation would go along with anxiety/fear), poor sleep hygiene (CBT intrusion; this is an issue traditionally explored by CBT-type interventions and not solely caused by physiological disease) and, iirc, possibly by reconditioning (GET intrusion). Furthermore most patients' pacing doesn't involve extensive planning; this tends to wear us out. While we do have an idea of stopping activity before we wear ourselves out, the notion of 70% threshold in particular is novel AFAIK.

    I think the notion of 'create the best conditions for natural recovery' is a bit weak of a plan compared to the promises of CBT and GET (basically, we have done this before and this can truly cure you, wasn't it?).

    Also there is a lot of confusion in the APT module, between the official APT model and the intrusion of the preferred models of the manual authors. I think this confusion could have reduced efficacy. Plus the idea of an illness which nobody has any idea of any substantial physical pathology for, despite conducting research, is not exactly encouraging. It's too bad some researchers (and government agencies) do not seem to know how to read anything more complicated than the Daily Mail.
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  3. WillowJ

    WillowJ Senior Member

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  4. WillowJ

    WillowJ Senior Member

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    that's odd
  5. Dolphin

    Dolphin Senior Member

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    Not sure if this has been highlighted before. I know one of their studies was mentioned somewhere.

    In
    ----

    ----

    SF-36 physical functioning <=70 represented "patients with physical disabilities at baseline"

    plus, from the full text:


    Contrast that with:

    In the PACE Trial editorial, Knoop & Bleijenberg described a SF-36 physical functioning >=60 plus Chalder Fatigue Questionnaire score (Likert) <=18 as a "strict criterion (sic) for recovery"

    (Higher scores equal better functioning on this scale)
  6. Andrew

    Andrew Senior Member

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    I skimmed (not read) the PACE trial manual for patients. The instructions to patients didn't look like graded exercise to me. But I'd have to read more.
  7. Dolphin

    Dolphin Senior Member

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    There were different arms of the trial. I presume you were reading the graded exercise manual (apologies if this is a stupid question/point).
  8. Dolphin

    Dolphin Senior Member

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    Two more papers involving Gijs Bleijenberg somebody has drawn my attention to are:



    ---------------------------------------------------------------------------

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  9. Andrew

    Andrew Senior Member

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    Yes, I was reading the GET manual.
  10. Dolphin

    Dolphin Senior Member

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    The GET process is summarised on page 32 of this http://www.pacetrial.org/docs/get-participant-manual.pdf
  11. Dolphin

    Dolphin Senior Member

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    Somebody has just drawn my attention to the following:


    http://www.foundation.org.uk/events/audios/audiopdf.htm?e=440&s=1200

    There is sound to go along with the slides. Not sure when it is from but includes some slides on the PACE Trial i.e. from the Lancet paper so is from the last two years.
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  12. Valentijn

    Valentijn Activity Level: 3

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    Haven't listened to the audio yet, but will. Here's some excerpts from the slides:
    Edit: It looks like the audio and slides match up with an article from December 2011 in http://www.foundation.org.uk/journal/pdf/fst_20_07.pdf

    Edit #2: It looks like the articles are pretty much transcripts of the meetings for the Foundation for Science and Technology. The speaker immediately before Wessely was a "Richard", and the article preceding Wessely's is by a "Richard Leyard". Richard Leyard's article is introduced as being from "a meeting of the Foundation for Science and Technology on 4 May 2011." Thus it seems likely that's the date for the audio of Wessely's presentation.
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  13. Esther12

    Esther12 Senior Member

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    re PACE and recovery paper: I wonder if they will spin it in a different way than we are expecting.

    Maybe they'll come up with a very tight definition for 'recovery', but then go on to argue that it is unrealistic for patients to expect this, but that treatments can successfully lead to a remission of symptoms. With 'remission' not meaning anything like what most people would expect (eg: A remission is a temporary end to the medical signs and symptoms of an incurable disease), so it's definition would include patients still suffering from symptoms which seriously restrict them (I expect that 'remission' will be defined in a way which requires only a very minor change in questionnaire scores). This would allow them to spin the media and public perception of treatment in a way that is more easily defensible imo. "Oh they thought we meant 'remission' as in a temporary relief of abnormal symptoms?... what a misunderstanding. The media are bad at reporting on science, aren't they? They love to make it sound so dramatic and impressive."

    Just a thought. It's easy to assume that they'll go on making really exaggerated claims about recovery, but it is possible that they'll dramatically change tactics. I think that the data from PACE is so bad for them that they're going to have to come up with a new way of spinning it.
  14. Dolphin

    Dolphin Senior Member

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    Who knows. One of their previous comments suggested there would be various definitions reported on.

    However, I want to know the numbers for the secondary outcome measure, "recovery". Recovery has been mentioned in brochure for KCL clinic, Barts clinics and in some papers. Also, when the first PACE Trial paper came out, as you know, the 28%/30% figures were portrayed in some contexts as like recovery. So I want the figure for the definition they used which I expect will be low and suggests that the illness isn't simply due to factors that can be overcome by CBT or GET. It's the most useful in terms of proof-of-concept.
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  15. Graham

    Graham Senior Moment

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    I remember reading somewhere recently about a group of psychologists defining "recovery" as a process. So it may be that they take that approach. In which case it is the flattening out of the graphs which would be relevant.
  16. Dolphin

    Dolphin Senior Member

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    I hope they get quite a few letters. For the FITNET Trial, the Lancet published two and I heard from one other person whose letter wasn't published.
  17. Esther12

    Esther12 Senior Member

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    I somehow doubt they're going to come with the 'honest apology and correction' spin.

    I certainly think that they owe it to patients to provide access to data for this outcome as it was laid out in their protocol.

    Yeah. I saw someone defending a crazy re-definition of recovery on the grounds that it would help mental health staff feel as if they were achieving more! As if claims made about recovery were intended to act as motivational tools for manipulating people, rather than just providing access to information which will help people make decisions about what different treatments were worthwhile.

    Paternalism and pragmatism seem to be used to justify all sorts of disdainful quackery.
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  18. Simon

    Simon

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    Good point.

    I got the impression from one of their previous comments that 'Recovery' might have been redefined pre-unblinding, at the same time the primary outcome measures were redefined. That might explain why they still haven't released the Analyses Strategy [whatever], even though it must have been agreed and finalised prior to unblinding in spring 2010. I guess we will know soon enough.
  19. Dolphin

    Dolphin Senior Member

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    Thanks

    Why would that cause a delay in releasing the Analysis Strategy?
  20. Dolphin

    Dolphin Senior Member

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    At least there isn't the rush there was with the Lancet in terms of writing letters.

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