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"News" 8 Sep 2016: PACE trial team analyse main outcome measures according to the original protocol

Discussion in 'Latest ME/CFS Research' started by Simon, Sep 8, 2016.

  1. Yogi

    Yogi Senior Member

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    Can you not delete tweets below your original comment?

    Why can't we see the tweets now? Where have they gone on MS's original tweet ( they will be on the other person's twitter obviously).
     
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  2. Yogi

    Yogi Senior Member

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    Ahh...So he must have blocked lots of people. Thanks @Bob
     
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  3. Tom Kindlon

    Tom Kindlon Senior Member

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    I thought I would explain exactly what is being discussed as some people have said they are confused (elsewhere).

    The PACE Trial investigators published a protocol in which they described how they would report their results.

    See below for their primary outcome measures (the most important results of a trial). Note that the 3rd one is called "overall improvers".

    However when they came to publish the results, they decided to alter these and not publish the original results alongside so people could make their own decisions about whether the changes made a difference or not.

    They also decided to make up a new definition for improvement. They said this was a post-hoc analysis i.e. performed after they had seen the data.

    This led to them to say in the Lancet that 61% improved overall (i.e. on fatigue and self-reported physical functioning) with GET and 59% improved overall with CBT.

    Today they have now released the data showing that if one used the original definition for overall improvers that they commited to publish in the 2007 protocol paper, 21% were overall improvers with GET and 20% were overall improvers with CBT i.e. approximately one 3rd of the rate of improvement they reported in the Lancet.

    Note that today they never mentioned the 61%/59% improvement rates so readers won't see or be made aware of the stark difference.

    From:
    from

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    Last edited: Sep 8, 2016
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  4. Yogi

    Yogi Senior Member

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    Blocked David Tuller as well!!!

     
    Last edited: Sep 8, 2016
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  5. Kati

    Kati Patient in training

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  6. daisybell

    daisybell Senior Member

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    Yes - of course, you're right!
     
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  7. Research 1st

    Research 1st Severe ME, POTS & MCAS.

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    Good point, but that would still only be an alleged recovery from F48.0 Psychiatric criteria CFS as this criteria was used in PACE. (The established research in CFS science, does not use F48.0 criteria, as this is psychiatric, and CFS is not classified as psychiatric disorder). A very important when considering PACE data.

    This is where the ME denial lobby are screwed, by foolishly inventing their own criteria (Oxford CFS), in order to rig the game against patients with Myalgic Encephalomyelitis (Organic CFS in USA) believing the situation would never change as they called the shots.

    PACE was meant to keep UK patients with organic disease ME hostage for at least another 20 years, it's lasted about 7 though.

    Even if PACE had 'won' by denying ME (ME as psych CFS F48.0) this lie only remains, as long as biomedical ME research is blocked and psychiatry is massively over presented in research journals, health services, and in the eyes of the public who see ME patients as inferior. Time ran out for that. Science has moved on even if the politics hasn't.

    Bogus Science and Government are always joyously linked, but that doesn't consider Independent Honest Scientists, changing the Status Quo. This is happening, not just in America. Too many studies are now published to propose ME doesn't exist and CFS is psych F48.0.
     
  8. Research 1st

    Research 1st Severe ME, POTS & MCAS.

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    Thanks for that Kati.
    Peter Tatchell is an incredible guy, he always stands up for freedom and an end to Xenophobia for all people irrespective of sexuality.

    The treatment of ME CFS (via disease denial) is a form of Xenophobia.

    It's great to see Peter Tatchell can see this and is supporting us. Perhaps this heralds the first signs of equality?
     
  9. Daisymay

    Daisymay Senior Member

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    Just looking at some of the wording of this:

    http://www.wolfson.qmul.ac.uk/images/pdfs/pace/PACE_bimodal_CFQ_analysis_final_8_Sept_2016.pdf

    "PACE was a randomised controlled trial"

    No, it wasn't an RCT, as they know only too well, it was merely a randomised trial, as is clearly stated in the PACE title:

    "Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial"

    "Interpretation - The pattern of trial outcomes observed when the Chalder Fatigue scale was bimodally scored was very similar to that seen in the main PACE results paper (White et al 2011) for the Likert scored CFQ i.e. there was a greater improvement in fatigue in those allocated to CBT and GET groups compared with those allocated to APT and SMC with these differences being of moderate size."

    So have I got this right.....they're saying it's OK because whichever method they used they found "very similar" patterns????

    "In summary, these results support our initial interpretation that “CBT and GET can safely be added to
    SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective
    addition.”


    No, these new results give no information at all on the safety or otherwise of CBT/GET, the issue of safety shouldn't be mentioned here.

    How can they call 10% better than SMC alone moderate improvement?
     
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  10. Yogi

    Yogi Senior Member

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    Ooooohhhhh!

    Someone is very sensitive today.

    What has he got to worry about?. I thought all this spin and putting out this "scientific paper" on a website would have lessened the pressure. Perhaps not.

    With all the blocking going on he seems very thin skinned all of a sudden.

     
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  11. Research 1st

    Research 1st Severe ME, POTS & MCAS.

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    Exactly, CBT is a placebo effect as nothing has to exist for the 'effect' to alter the disease, as no test is used to verify that anything is wrong with the person with F48.0 CFS in the first place. With Oxford criteria CFS, existing or prior history of mental illness, is permitted in the CF patient (unlike Fukuda CFS/CCC-CFS/ME-ICC/IOM SEID).

    It wouldn't be hard to enroll people with 'perhaps' MS in a study (with active depression or prior mental illness) to walk 6 mins a day, for 3 months whilst giving them magic pills, convincing them there is a potential cure for MS if they take it.

    And then answering a questionnaire, do you feel less fatigue?

    The results would be irrelevant to Science and nothing to do with MS, as the criteria with MS weren't met in the first place, before the placebo effect was given!
     
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  12. user9876

    user9876 Senior Member

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    Its specialist medical care.

    The others include the named approach + SMC
     
  13. Hutan

    Hutan Senior Member

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    So pleased the PACE investigators were presumably able to scrape up a statistician to retrieve the data for this analysis - given one of their reasons for not releasing the raw data was that they would have to hire and train a statistician and that was all just too onerous.

    Interesting changes but frankly it is all just wobble on the way to a null result at 2.5 years for a group of people that may well not even have had ME/CFS.
     
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  14. Dolphin

    Dolphin Senior Member

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    One effect that comes to mind is that the medical textbook entry, I think written by Peter White, which said that around 60% improved in the PACE Trial with CBT or GET would need to be significantly altered.
     
    Last edited: Sep 8, 2016
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  15. lnester7

    lnester7 Seven

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    Ok so the data released was not the raw data we expected? But another reanalisys?
     
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  16. Esther12

    Esther12 Senior Member

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    Yes. This was the results for the primary outcomes laid out in the trial protocol.

    It's really good to have these. They provide more realistic information on efficacy for those patients who are unconcerned by things like response bias, and are happy to try poorly evidenced interventions like homeopathy, that may be no more than placebo. These figures also provide more realistic information to doctors, and is likely to reduce the danger them being misled with exaggerated claims about the likelihood of significant improvement.
     
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  17. alex3619

    alex3619 Senior Member

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    Yep.
     
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  18. Dolphin

    Dolphin Senior Member

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    Don't know if I'm being too picky or not, but after reading this last sentence one could be forgiven for thinking that the composite outcome was not one of the prespecified primary outcomes in the protocol and instead they had just come up with it now to be transparent.
     
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  19. eastcoast12

    eastcoast12 Senior Member

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    So just thinking about this from a different angle. They used the Oxford criteria for entry into the trial which is just 6 months of fatigue ( did they even describe the type of fatigue? Was the 6 months of fatigue even documented in medical records? I'm thinking the word fatigue wouldn't be the word we use to describe that no lifeblood feeling we feel).
    So if it's just fatigue then it's pretty safe to bet that some people who were entered may have just been experiencing life. You know, work, kids, family etc. Before I got sick when I was working and tutoring and going to the gym and cooking and cleaning and going out with friends/family a lot, I would have considered myself fatigued specially if it was near the holidays. That's why you see in comments sections people saying things like I'm tired too stop being lazy.

    Second, because of the Oxford criteria used for entrance, it's also a pretty safe assumption that a significant portion of those entered had/have another health issue (psych/bio) causing fatigue.

    Three, with this in mind it's not only safe to say but it's definitive that we have no idea how many people in this study actually had cfs/me.

    Ok. So taking those things into consideration what I'm taking away from PACE is not only does GET/CBT/BPS not work for people with cfs/me it barely works for anything that may have been wrong with people in this trial. To me the bigger picture is that this study provides little evidence that they're GET/CBT/BPS model has any scientific legitimacy at all.
    If I'm overlooking anything or misinterpreting anything please let me know.
     
  20. Dolphin

    Dolphin Senior Member

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    I don't find a 20% overall improvement for CBT and 21% overall improvement for GET to be very similar to the 59% overall improvement rate for CBT and 61% overall improvement rate for GET reported in the main PACE results paper.
     
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