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The FINE Trial. BMJ ARTICLE. Nurse led, home based self help treatment for patients in primary care

Discussion in 'Latest ME/CFS Research' started by pollycbr125, Apr 23, 2010.

  1. Dolphin

    Dolphin Senior Member

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  2. Orla

    Orla Senior Member

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  3. Gerwyn

    Gerwyn Guest

    do you think we could get more patient"testimonials" like this especially in view of the "excellent" pace trial on its way.Could we advertise for participants to put their views forward.This would help avoid "another fine mess"(sorry).

    CBT now stands for completely biased testimoney or completely bogus treatment.
     
  4. Dolphin

    Dolphin Senior Member

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    Yes, it would be very interesting. There was at least one PACE Trial participant (GET arm of trial) on another forum I'm on and I used to be very interested in what she said. She was counting her housework in her x minutes exercise for certain days (i.e. they don't have to do it every day) which was not the intention of the study.
     
  5. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Nice to see the editorial didn't even mention what definition (Oxford) was used in the concurrently published research (article in first post). Also nice to know they've wasted $2M on this harmful nonsense.

    Can anyone who knows enough (unlike me) write a nicely cited letter to the editor on this? I've seen great work on this front from Gerwyn, Tom K. and others here in the past.
     
  6. Dolphin

    Dolphin Senior Member

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    Thanks justinreilly.

    I was all set to write a letter if this study came out positive. However at 70 weeks there was no difference. So I don't have much to work on! I am thinking of writing the type of letter that I know they won't publish - just a series of technical points e.g. outcome measures they didn't mention. Perhaps I will make a few other points. But I don't really feel I have enough to write a letter with enough substance for the main journal. I find the editorial more annoying and that's the one I'd like to see a reply on if any. It also shows the editorial bias of the BMJ that they publish should an editorial with a study which had such a poor result.
     
  7. biophile

    biophile Places I'd rather be.

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    A sign of things to come

    The poor results of the FINE trial may even make things harder for some patients. It helps kill off the competition to the cognitive behavioural approach, "supportive listening" could be discouraged based on these results. In the editorial Moss-Morris suggests the results for "pragmatic rehabilitation" were limited and temporary because the patients were too ill to be aided by "generalist" input and the trial itself was not long enough. Her answer to this problem? Longer courses of psychotherapy, with more intensive "specialist" input for the more severely affected patients! Now cue the PACE trial, which is almost guaranteed to be more optimistic than the FINE trial, and the authors will promote the benefits of "specialist" intervention, despite the lack of severely affected patients in the cohort.
     
  8. Bob

    Bob

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    Thanks biopsychobabble... you've put it all into a context that makes it all start to make sense... I think that we can probably guarantee that the PACE trials will be 'successful' and will be published with great fanfare and enormous publicity about their success, telling us all how the money has been well spent, and that it's a great outcome for people with ME. Unfortunately, the results will be completely meaningless, and even harmful, to people with ME as the research is based on the Oxford definition criteria which does not officially define people with ME. The 'successful' results will, however, be used for many years to come to inappropriately subject people, seriously ill with ME, to psychological intervention as the primary treatment.
     
  9. Dolphin

    Dolphin Senior Member

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    Yes, I agree biopsychobabble and also Bob.

    There was no guarantee that these people actually got information on ME. If I wanted to have a proper comparison trial with pragmatic rehabilitation, I'd make more like the real world that we might like: a patient might have a consultation with a sympathetic consultant or at least would be given "good" self-help info. And then after receiving that, give them counselling to cope.

    Where else in medicine would you get counselling before getting any treatment or information, even if you weren't particularly distressed (and these people weren't necessarily newly diagnosed) - about the only place would be psychiatry/with psychiatric conditions (not even sure how often it would happen there).

    The patients in the counselling arm of the trial were possibly voicing their frustration - subjective outcome measures were used so we can not be sure they actually really worse than treatment as usual with GP group or pragmatic rehabilitation - the latter would have given people hope that they were trying something that could really make a big difference, even if it was false hope.
     
  10. Bob

    Bob

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    I'm beginning to think that these might actually be the final results of the FINE trial...
    and that it has died a quiet (but spectacularly unsuccessful) death.
    Does anyone have any confirmation of this, or any other information about it?

    Here is some more info that I've come across...

    'Rapid Responses' published on BMJ website, in response to the published paper:
    http://www.bmj.com/cgi/eletters/340/apr22_3/c1777

    BMJ editorial:
    http://www.bmj.com/cgi/content/extract/340/apr22_3/c1799

    And a 'Rapid Response' to the BMJ editorial:
    http://www.bmj.com/cgi/eletters/340/apr22_3/c1799#234919
    Quote: "The FINE trail has so predictably and so clearly failed"

    ME Association - links to the BMJ paper, with comment: 'The ME Association will be commenting on these two items in due course':
    http://www.meassociation.org.uk/ind...-trial-23-april-2010&catid=30:news&Itemid=161


    Where is all the comment and analysis about this from ME organisations? Why is everyone so quiet? Maybe I am just being impatient, as it's early days yet?
     
  11. Min

    Min Senior Member

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    'Preposterous Thinking' from Greg Crowhurst

    This is from UK nurse Greg Crowhurst, carer to his severely affected wife:
    Preposterous Thinking
    A Response to : Weareden et al (2010) Research Nurse led, home based self-help treatment for patients in primary care with chronic fatigue syndrome:
    randomised controlled trial BMJ 2010;340:c1777*
    *
    Greg Crowhurst*


    (Permission to Repost) *


    "Alice Burchfield (2009) a participant in the recent FINE
    trial, was scathing that the data used about her was
    misleading; that the trial totally disregarded ME as a
    real illness; that the program expected her to live a
    strict pacing regime, yet undergo 3 hour long sessions with
    the therapists ; and that she crashed after the last session
    and ended up worse than when she began; that the therapists
    had selective hearing and were critical of her and that
    the whole thing was unethical presenting the
    deconditioning theory of ME as fact. This is a shocking
    way to perform a supposedly serious study on ME.

    The FINE trail has so predictably and so clearly failed .

    Before the trail began, exsting research warned that
    patients would be made worse by it and that the gains of CBT
    and GET were minimal (Kinlon 2009) : exactly the conclusion
    the FINE trial itself has now reached at a cost of over
    one million pounds. As Margaret Williams (2009) stated :
    There can be no doubt that, for patients with ME/CFS as
    distinct from those suffering from chronic fatigue,
    neither CBT nor GET is effective, otherwise everyone would
    by now be cured.

    I am a Registered Nurse and I am affronted by what has been
    presented as good nursing practice and purported to be a
    treatment for people with ME.

    Personally I have cared for my wife, who has very severe ME,
    for almost 17 years now. I cannot begin to describe the
    horror and the pain and the sheer physical daily torment she
    experiences.

    The FINE trial considered itself suitable to challenge the
    supposedly dysfunctional illness beliefs of severely
    ill patients, like my wife, on the basis of a single report
    in the scientific literature of two wheelchair bound
    patients, who had dramatic improvements in health following
    a pragmatic rehabilitation regime. Pragmatic meaning
    that treatment is given in people own homes , preceded
    by qualitative interviews to explore patient views on
    illness causation, beliefs about chronic fatigue,
    expectations of intervention, and previous experience of
    treatment and doctor-patient relationships.

    The preposterous thinking behind FINE, was that patients
    would begin to understand their symptoms and, jointly with
    the nurse, agree a programme of rehabilitation.Never mind
    that ME is a WHO classified neurological disease with
    devastating multi-system dysfunction and that no treatment
    has been elicited to aid patient recovery first. In what
    other disease would rehabilitation be offered as front line
    treatment without first testing for and treating the illness
    itself ?

    The 25% Severe ME group and the research charity, ME
    Research called, way back in 2004, for each severely-ill
    person on the FINE trial to be given a comprehensive medical
    assessment to identify physical symptoms and signs. They
    asked whether or not autonomic disturbances, seizures, frank
    muscle weakness, neuroendocrine disturbances (like sweating
    episodes), recurrent flu-like symptoms would be recorded
    over the course of the trial ? They also asked would
    symptoms like musculoskeletal pain, neurocognitive problems
    and sleep dysfunction be comprehensively assessed?

    Critically they asked : will patients receive treatment for
    any of this? Sadly this did not happen. Invaluable data has
    therefore been lost.

    What a much better use of the wasted 147 000 that would
    have been !! The question must also be asked how mu time and
    energy have genuine ME sufferers wasted and how many lives
    have been made worse and subjected to unnecessary suffering
    and abuse ?

    The tactic of the seemingly all-powerful psychiatric lobby
    in the UK , whose influence over the MRC seems absolute,
    is to : ignore neurological ME; to change its name to "CFS",
    which they consider primarily to be a problem of false
    perception,and then to reclassify CFS/ME as a somatoform
    disorder (Williams 2009) .

    What no one saw coming, though, was this announcement of
    failure , so little trust does the ME Community have in the
    MRC ...cont
     
  12. Min

    Min Senior Member

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    ...cont

    "Not surprising given the serious problems highlighted in
    the House of Commons Select Committee on Science and
    Technology ( HC 132) , which lambasted the MRC for wasting
    funds and misguided strategies for research. (Hooper 2010).

    Also not surprising given the MRCs total failure to engage
    with the vast body of significant biomedical evidence about
    the nature of ME/CFS contained in more that 4,000 published,
    peer-reviewed research papers, the misleading and
    contradictory content of the FINE/PACE Trial manuals
    demonstrating the apparent coercion, and exploitation of
    patients and the seriously flawed and inadequate science
    that underpins the Trials as outlined in detail in Professor
    Hooper's 442 page report Magical Medicine .(Hooper 2010)

    The failed FINE trial announcement brings into shocking
    clarity the dreadful misrepresentation of ME as a mental
    heaklh disorder. The FINE trial has so clearly failed to
    achieve anything except waste valuable time and precious
    funding .

    It is now time that the psychosocial model be discredited,
    that the psychiatric involvement and interpretation of ME be
    rejected and a new era of genuine scientific research into
    the biomedical causes underpinning this desolatating
    neurological disease be given centre stage ?

    Surely now the current practices of the ME clinics around
    the UK will be overhauled and CBT and GET finally removed
    to the annals of history , no longer to damage deny and
    negate the truly dreadful physical suffering of tens of
    thousands of ME patients throughout the UK.

    This is medical neglect at its worse; it is time to stop."

    References



    Burchfield A (2009) From Alice Birchfield
    http://www.investinme.org/Article-015A FINE Trials-
    Alice.htm

    Hooper M (2010) LETTER to Dr Morven Roberts, Clinical Trials
    Manager, UK MEDICAL RESEARCH
    COUNCIL http://www.investinme.org/Article400 Magical Med
    icine%20Letter%20to%20Roberts%20MRC.htm

    Hooper M Williams M(2010) Magical Medicine : How to Make a
    disease
    disappear http://www.investinme.org/Article400 Magical M
    edicine.htm

    Kinlon T(2009) Why is the 11-item bimodal Chalder Fatigue
    Scale being used as a primary outcome measure?
    http : //www.biomedcentral.com/1741-7015/4/9/comments#298590

    Kinlon T (2009) Further comments on the outcome measures
    being used and suggestions for other outcome measures that
    could be useful in such trials
    http://www.biomedcentral.com/1741-7015/4/9/comments#298590

    ME Research (2004) Severely Overlooked by
    Science http://www.meresearch.org.uk/information/publication
    s/severe1.html

    Williams M (2009) Can the MRC PACE Trial be justified?
    www.meactionuk.org.uk/Can-the-MRC-PACE-Trial-be-
    justified.htm



    -
    Greg Crowhurst
    www.stonebird.co.uk
    (The Lived Experience of Severe ME)

    (well said Greg!)
     
  13. oceanblue

    oceanblue Senior Member

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    Maybe a good trial?

    I wonder if this trial could prove to be a turning point in ME/CFS research, unlikely though that might seem? It is, by far, the largest clinical trial ever published with nearly 300 participants. In a lot of ways it's more rigorous than previous trials - they even had a statistician as a co-author.

    The result for this trial was negative, while the smaller, less rigorous pilot trial of the same approach claimed over 60% of patients 'recovered' versus under 10% for the waiting list control group.

    I think maybe the therapy was proved unsuccessful because it was a good, robust trial. Also, the therapy uses a model that assumes deconditioning is the main factor underlying this illness. The therapy failed: what does that say about the deconditioning model?

    And as the trial used the Oxford Criteria rather than one of the more tightly defined criteria eg CDC, the failure is even more striking.

    Negative results can sometimes be as telling as positive ones.

    The PACE trial is due to publish later this year and I'm optimistic that it will be a rigorous trial giving a reliable result. They've recruited 600 patients and the protocol alone runs to 13 pages. Many of the authors have suspect research records but I think the PACE trial will be in a different league. Time will tell.
     
  14. V99

    V99 *****

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    oceanblue
    I would normally think the same way, but because those that design the study always support CBT and GET, I wonder if they are being honest here in order to push the CBT/GET theory. Make it look as though CBT/GET are the only thing that make a difference. After all, they keep saying CBT/GET do not work as well if they are not done by a specially trained therapist, and a nurse with 4 months training, would not be one of them.

    Have you read Prof Malcome Hoppers Magical Medicine, it rips apart the PACE trial, and rightly so.
     
  15. IamME

    IamME Too sick for an identity

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    This study is a disaster for us. Why? Because it claims to say, graded exercise/CBT is safe for severely affected patients. The "temporary" positive results are naturally going to be treated as they would in morbidly obese patients who go on diet/exercise when pushed but then "let themselves go" when the pressure is off.

    And despite prior hopes that it would be definitive, they are now using it to say it simply didn't run long enough to find out, or wasn't "intensive" enough.

    We will be lucky to get something like this with PACE which if anything will be less uncertain as that excludes severely affected pts and uses no reliable objective measures of total exertion.
     
  16. bluebell

    bluebell Guest

    Yeah, cause those initial improvements couldn't be due to intimidation/false wellness beliefs of patients desperate to believe that they can think their way out of this nightmare:p. Once we are well, we need to start some sort of organization to prevent a repetition of this sad history. It's obscene and should never happen to another group of people in a civilized society.
     
  17. Bob

    Bob

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    Make no mistake... The PACE trial has been designed to succeed... and to do maximum damage to our community.


    Well, it might be a little bit paranoid of us, but I wouldn't be at all surprised!
     
  18. oceanblue

    oceanblue Senior Member

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    I can see the logic, but I'd have thought this result was a bit of a disaster for the authors, given the amount of effort they've put in over many years on the trial - especially compared with the blaze of glory they'd have enjoyed had they found a 'cure' for ME. And the trial failure is bad news for the deconditioning model that underpins CBT/GET as well as their own model.

    Is Prof Hopper's PACE rebuttal available online?
     
  19. V99

    V99 *****

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    The authors will get to now to do more studies because it was a failure. That's good for them, as it gives them a job, a salary. A cure would mean that people would be ticked off the list, eventually there would be no patients to treat, no job, no salary. The decondition theory will still hold up based on this, as they say you need to be a specially trained therapist not a nurse with four months training.

    Here a link where you can find magical medicine. It is long, about 400 pages, but you can skip around and get the idea. http://www.investinme.org/Article400%20Magical%20Medicine.htm
     
  20. Bob

    Bob

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