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Article: A Hitch in its Step: PACE Trial Indicates CBT/GET No Cure For CFS, 60% of Patients Show No

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Feb 19, 2011.

  1. Dolphin

    Dolphin Senior Member

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  2. Sean

    Sean Senior Member

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    I think this is an important point about real world outcomes.
  3. Sean

    Sean Senior Member

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    Did they completely reverse deconditioning, or only reverse it as far as it is possible under the circumstances?

    I would be very surprised if there was not some degree of general deconditioning, especially in the sicker, longer term patients. The sheer physical limitations of the disease probably make that difficult to avoid, and will also make it difficult to reverse.
  4. anniekim

    anniekim Senior Member

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    Thanks Dolphin, very appreciate your reply. It's disgusting how they've presented the figures. Can I ask what does the following mean?

    'They said this was within 1 S.D. of the norm for the population'

    Also in the overview it said patients selected had a physical function score of >65, what does this mean? Is this a scale of 1-100? In layman's terms what is roughly a physical function score of >65? 65 doesn't sound severe, so am I right in thinking that only moderate to mild patients were selected?
  5. Dolphin

    Dolphin Senior Member

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    Scores are 0-100 with 0 being the worst.
    Possible scores are 0, 5, 10, 15, 20, ... 85, 90, 95, 100 (unless somebody doesn't fill in all the questions).

    Initially one had to score <=60 (less than or equal to 60); they then changed this to <=65 as they weren't getting as many people as they wanted. The more people they had, the greater the chance they could find statistically significant differences.

    These scores wouldn't exclude the severe affected.

    The scoring again is:
    ------------
    Basically for the following 10 questions, you score 10 points if one says:
    "No, Not Limited At All" to a question and 5 points if one says: "Yes, Limited A Little".

    So one could (say) put "Yes, Limited A Lot" to 2 of the questions and "Yes, Limited A Little" to 4 more and still satisfy their recovery-type definition (of a score of 60+).

  6. anniekim

    anniekim Senior Member

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    THanks Dolphin. As you can see, am none too clued up on this, bit beyond my brain power. Am getting really confused. I thought in the overview under cohort, it said people were selected who had a physical function of more than 65, not less than?

    Also I still don't understand what the following means, 'They said this was within 1 S.D. of the norm for the population'. What does 1S.D mean?

    Many thanks for your time and patience!
  7. Dolphin

    Dolphin Senior Member

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    S.D. = standard deviation. It's a measure of how "spread out" the data is. For the moment, assume data is normally distributed, like IQ scores. Let's assume for the moment that these IQ scores have a mean (average) and median of 100. These scores will be in a "bell shaped curve" - like a hill with the peak of the hill being above 100. It is symmetric so any score above 100 is the same height as the same score below 100. IQ scores often have a standard deviation of 15. Tables have been calculated for normal distributions. Something with a score of 1 S.D. above the mean in a normally distributed function will mean that 84% of the population will have lower scores than this and 16% will have higher scores. So a IQ score of 115 in such a distribution means 84% (approx.) of a population have a lower IQ and 16% have a higher IQ.

    Other things in nature are also normally distributed with distributions like this. But they can be spread out in different amounts. So take something else that it is normally distributed with mean 100 but this time a standard deviation of 30 (double the IQ score deviation). What does a score of 115 represent for such a function. In this case, this is 0.5SD above the mean. 0.5SD above the mean in a normally distributed function has 69% of the population with a lower score and 31% with a higher score.

    So one can see that if somebody tells one that something is normally distributed with a mean of 100, one can't tell much about a score of 115 unless one is also given the SD.

    They have assumed SF-36 physical functioning scores are normally distributed with a mean score of 84 and a SD of 24. And thus 15/16% of the population would have a score of 60 or less so if one scores 60 or more, one is in the "normal range" so one is healthy (the accompanying editorial describes anyone satisfying such criteria as recovered and some of the media coverage has done likewise). We're trying to explain why this is flawed logic.
  8. Dolphin

    Dolphin Senior Member

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    Cort got this wrong. Easy thing to do I suppose as he was trying to get on top of a difficult and complex topic in a short space of time. I did point this out but he's a busy man.
  9. Dolphin

    Dolphin Senior Member

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    Searchable full PACE Trial protocol (i.e. with questionnaires, etc.) now available

    I previously re-circulated a copy of the full PACE Trial protocol with questionnaires.


    Doogle has now sent me a searchable version of this which means one can search for words, etc. for which I am most grateful.


    One should also be able to copy text.


    I've put it up in two places as only 100 downloads are allowed for each:

    http://bit.ly/h3tdO8 i.e.
    https://www.yousendit.com/download/T2pGTXRZQTZPSHhjR0E9PQ

    and

    http://bit.ly/dLQjKy i.e.
    http://www.yousendit.com/download/T2pINnFFdVVubVh2Wmc9PQ

    Eventually (in just under a week) the facility to download the file will expire.


    To explain again the reason for this:

    There is a protocol in the public domain:
    White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group.
    Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007 Mar 8;7:6.
    http://www.biomedcentral.com/1471-2377/7/6


    However, it refers to lots of questionnaires people may not be familiar with and might have a hard time getting (for example, Work and Social Adjustment Scale which I don't believe I ever saw before despite it being used). These measures could also be useful when trying to read other studies.


    Best of luck to anybody trying to write letters to the Lancet. Remember the rules are letters of 250 words or less and no more than 5 references (which means 4 if one quotes the Lancet article, and 3 if one also quotes the protocol in BMC neurology!). Submissions are made through:
    http://ees.elsevier.com/thelancet/
  10. Cort

    Cort Phoenix Rising Founder

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    What does this scale have to do with being normal?.....I can do everything here except vigorous exercise, walking more than a mile every day.......day in and day out....(sorry if you're jealous but I can)...where is the work every day component? Where is the time component? I can move a heavy table across the room - I couldn't do it for a moderate period of time without repercussions.....

    This is how they determine normal??? blah!!
  11. Cort

    Cort Phoenix Rising Founder

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    I actually liked this CNN by Raison - he is a mind/body guy who stated the trial was not very effective - the first time I've seen this. He works with the CDC on CFS. I had no idea he meets with them every week. He probably has more influence than White on the program. One of the things he studies are interferon's effects on fatigue, etc.

    I wouldn't say the CBT people got much better. I would say they improved more and neither improved very much.

    He basically agrees that if you look at what is needed - the trial was a flop....it only helped a third of the patients...

    He even kind of suggests that CBT would probably help anyone...

    Coming from this guy in his position - this is an excellent article.

  12. Dolphin

    Dolphin Senior Member

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    Exactly.
    Two problems:
    (i) hard to define what normal is.
    (ii) questionnaires are relatively inexact.

    Actometers would have been better.
    Also hours worked.
    Also, as I pointed out, it's a lot easier for people with ME/CFS to score a reasonable amount on this if they're not trying to work full-time - which is basically the sort of people they should be compared to. If somebody can walk a few blocks every day once (and so they might say they are "not limited at all"), that doesn't mean they are able to do a normal amount of functioning if they do very little else. Part of what GET and CBT based on GET involves is to get people to go for these walks - but they may drop other activities to do this (the Wiborg et al. (2010) data shows this happens); but according to the score, they may show up as improved.
  13. Dolphin

    Dolphin Senior Member

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    (May be re-posted)

    Here's a relative newbie talking about the PACE Trials, etc. They gave me permission to repost what they said. Not news to a lot/most of you of course. She's referring to a letter I sent in to a newspaper.

  14. Dolphin

    Dolphin Senior Member

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    RE: Charles Raison article.
    This is the summary:
    So while he might not think it's the whole answer, that's what he took from it. That's not a message that I want to be told or to be thought generally out there. He was at least partly "conned" like lots of people, in my opinion.

    i.e. if you don't improve or get worse, it's your fault, not the program's fault. You did it wrong.

    It's helped re-invigorate me to work on the issue. Hopefully we can get some letters published.

    This discussion could be taken over discussing the Raison piece. People can post comments at:
    http://pagingdrgupta.blogs.cnn.com/2011/02/23/mind-body-inside-chronic-fatigue/?hpt=Sbin
  15. Dolphin

    Dolphin Senior Member

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  16. CBS

    CBS Senior Member

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    Coming from a guy in my position, Raison's position is self-serving, short-sighted and dangerous self-stimulation:

    Patients did not get "much better" on CFS and GET. Whoever they were (they sure don't look like ME patients to me), they had marginal improvement but the p values were supposedly impressive because of the number of depressed participants, not because of the size of the treatment effect.

    Go ahead, push yourself. Sometimes you need to do something besides sitting around waiting for the researchers and advocacy groups to do something meaningful. A decade from now when you can't think straight EVER, you can thank Raison, the CDC and everyone else who thought they knew so much about this disease.

    I've come to the conclusion that the real danger in ME is that is develops so slowly (yet relentlessly) that small temporary improvements have shaped everyone's perspectives but few, if any, of these "scientists" will follow someone who took their advice over the course of decades. My guess is that the PACE trial participants who weren't simply depressed will be spending their last decade drooling all over themselves, being spoon fed and having their own assess wiped by that cute nurse who's name they'll never be able to remember.
  17. Bob

    Bob

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    There a helpful letter in today's Guardian by Jane Colby, executive director of the 'The Young ME Sufferers Trust' (aka the 'Tymes Trust')...

  18. anciendaze

    anciendaze Senior Member

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    Today, I had a chance to explain the PACE trial to an old high-school classmate without special medical training who has stayed away from recent news because of time pressure from other activities. Aside from some problems with the arithmetic of converting miles per hour or kilometers per hour to a distance she could grasp, she had no trouble figuring out that the line of results for the 6 minute walk showed a thorough failure. She was able to do this quickly without being a journalist or medical expert.

    Maybe that is cheating.
  19. alex3619

    alex3619 Senior Member

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    Hi cort, how do the PACE assessments handle stairs fairly, as just one example of major problems. I can walk up a flight a stairs, no problem. On a good day. On a bad day I have to rest part way up one single flight. On a bad day I pass out on even three steps (orthostatic intolerance). If I pace myself (the real kind, not psychobabble) I don't have many bad days. If I was in the PACE trial, every day would be a bad day I suspect. They want to treat this as an independent measure, but it is directly tied to what I do. Bye, Alex
  20. Dolphin

    Dolphin Senior Member

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    (Pretty obvious in one way)
    We know that the authors moved the goals posts from when they published the trial protocol. This can be criticised for being done to suit the results.

    But another point about this is that when a trial is first approved, it has to go through peer-review to be accepted for funding by the MRC. Would those peer reviewers have been happy for example that a Physical Functioniong (questionnaire) score of 60 would be seen as acceptable for normal functioning, when the participants could have that score entering. Similarly for the fatigue criteria? And for lots of the other measures used? i.e. would it have been approved for taxpayers' money!? Maybe that's a different angle to bring up in advocacy for anybody so inclined.

    I also think there is a reasonable chance that when it was approved by peer review for funding first that actometers were outcome measures.

    i.e. at the start, would it have been considered a good use of 5m of taxpayers' money to get the data everyone has been presented with including with goalposts that were moved.

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