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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. Cort

    Cort Phoenix Rising Founder

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    I'm not up on the UK stuff but I'm more inclined to think this is a big blow to these types of efforts; its a big expensive study - they threw everything they had at it - they rigorously trained the nurses, they videotaped them and they brought in a more representative set of patients. This study demonstrates that its impossible to do this type of therapy effectively on a large scale on the broad swath of CFS patients - its basically stating in my view, since CBT done by therapists is so expensive, that that branch of the medical community has little to offer CFS patients.

    It can only hurt; now the government has to contemplate (a) spending massive amounts of money for trained therapists to do this type of work -something they probably would never do (b) going in a different direction (c) forgetting about the public health aspect of CFS. The possibility of treating CFS patients on a broad scale using these therapies just got a heck of a lot harder to do in the UK.
  2. Cort

    Cort Phoenix Rising Founder

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    I disagree. Yes those authors may get more work - its a big field but their big project failed and failure is typically rewarded with no further studies. Training nurses to deliver CBT-like courses is not going to happen in the UK. That's a big thing because the government presumably could have afforded something like that and that would have been the new 'answer' to CFS. Sure, they'll try other things but this big possibility - which UK officials must have dearly hoped for - is probably over.
  3. oceanblue

    oceanblue Senior Member

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    If this was just another small clinical trial, then that would probably be the case. But FINE was altogether different as the largest ever clinical trial, with nearly 300 participants, it was 7 years in the making and cost well over 1m. Failure on this scale is surely anything but a case for more funding?

    Authors' weak defence
    Two arguments have been used to explain why the trial didn't work but both are undermined by the trial itself.
    1. The therapy wasn't done correctly. The model itself and the detail of the therapy were designed by the trial authors so the only let out was that it wasn't applied correctly. However, as the paper spells out, training was rigorous, nurses were checked in 'live' therapy situations before the trial began and all sessions were recorded. Crucially, independent assessors were asked to listen to sessions and rate how well the nurses applied the therapy during the trial (another example of a well-designed trial). Assesors gave an average rating of 5.5 out of 7, equivalent to very good. So according to both the authors and the independent assessors, the therapy was carried out correctly. Sure, experienced therapists might have got slightly better results but not changed the overall result. Remember, the pilot study showed a huge different between the therapy group and the controls.

    2. The intervention was too little given the illness of the participants. Well, before the results came out the authors were pleased to point out that their study was based in primary care with patients treated at home and no exclusions because that's a better sample of the real world than a specialist hospital clinic. They knew what they were letting themselves in for, so it's a bit odd to now suggest that the protocol was wrong.

    More importantly, if it really was the case that illness severity was the issue, where is the analysis to back this up? It would be easy to divide patients into two groups based on how ill they were at the start of the study: say the most ill half versus the least ill half. No new research is needed. I suspect that the reason no such analysis was published was because it doesn't support their case.

    So neither of the excuses for the trial up to examination, and I think the authors know it. They have, unwittingly I suspect, provided good evidence to undermine their own theories, and it seems a shame to let this evidence go to waste.

    As I see it, the authors are currently wriggling on a hook. Dismissing the study risks letting them off this hook when it might be more in our interests to tell the world that they have had a truly impressive failure.

    Thanks for all the links to magical medicine, looks like quite a read.
  4. Marco

    Marco Old blackguard

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    Taking a slightly different tack on this, there's quite a bit of evidence that the CBT psychs have been busily empire building and have indeed received criticism from within their own ranks for pushing the 'therapy' beyond its original premise and onto unsuitable patient groups/illnesses. Meanwhile the NHS have been gleefuly ramping up the capacity to deliver CBT to more and more patients e.g. :

    http://www.psychminded.co.uk/news/news2008/feb08/depression004.htm

    I find it interesting that the PACE trial uses a VERY ill defined version of pacing as one of the control therapies (no guesses how succesful this will be compared to CBT and GET) and the nurse delivered CBT/GET has failed.

    My cynical take on this is that pacing, usual GP care (non-existent) and nurse delivered CBT/GET were set up to fail. In contrast, the psych led CBT and GET will be a roaring success leading to a further tranche of CBT trainees funded by the NHS.

    The usual suspects will probably be knighted for their contribution to medicine.
  5. Bob

    Bob

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    Cort, the PACE trial is the big one to watch out for in the UK... I think it's been running for years and I think it's had more funding than the FINE trial...
    It involves comparing: "adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and standardised specialist medical care."
    In other words, it's comparing CBT, GET, standard medical care, and a form of Pacing (Adaptive Pacing Therapy, which is a perverted form of pacing, adapted by psychologists, maybe to fit their own world view of ME - it's not pacing as we know it anyway).
    I would be very surprised if it was allowed to fail, as they have done everything in their power to set it up to 'succeed'. (It's using the unofficial, unpublished, Oxford criteria for starters! The Oxford criteria doesn't exclude psychiatric patients.)
  6. Bob

    Bob

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    This is an interesting observation Marco, and I wouldn't be entirely surprised if this was the case, but I can't quite bring myself to believe that the FINE trial was set up to fail... but I think that the FINE trial will quickly be brushed under the carpet and conveniently forgotten anyway, once the PACE trial is published with the biggest publicity and PR event that we've ever seen in the ME community.
  7. Cort

    Cort Phoenix Rising Founder

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    I doubt the originators of the study set their own study up to fail - particularly since it was predicated on the success of an earlier study they had engaged in. I agree PACE is more important - altho I think its a big deal that a nurse based intervention is out - since the UK clearly would have loved to go that route, and it would have been devastating to UK CFS patients.

    I see recruitment for PACE ended Nov of 2008, the one year followup ended in March 2010 and they're writing up the results.

    Call me naive but I believe the results will be reported accurately and then, as every researcher does, massaged as best as they can to support their beliefs. That's what happened with the FINE trial - which had terribly disappointing results. It also happened with a Belgian, I think it was, study that was reported at the Reno Conference last year.

    I would note that yes the study used Oxford Criteria but so did the FINE study and the PACE trial will be broken up into people meeting the CDC and other criteria. The FINE study indicated that many members had other co-occurring conditions ie researchers using that definition do not necessarily exclude people with other co-ocurring conditions from the studies - as is often reported here.

    In any case we'll be able to tell: PACE will give us full demographics and clinical information including the level of co-morbid diseases. If there aren't any we'll know!

    I didn't realize that this was present

  8. Bob

    Bob

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    It has been suggested that they may have already manipulated their data, by subtly manipulating the patients, as per Prof Hooper's 'Magical Medicine' report.
    http://www.meactionuk.org.uk/magical-medicine.pdf
  9. oceanblue

    oceanblue Senior Member

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    By chance, I was taught pacing by one of the Action for ME occupational therapists who was involved in producing the manuals for APT for the PACE trial. She's very good, knows her stuff and as far as I'm aware the APT approach was not adapted by pyschologists, as Bob suggests, since it's not their therapy and I don't think it will be a perverted form of pacing - though I haven't seen the APT manual so I don't know for sure.
  10. Bob

    Bob

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    I thought I'd read about their APT and it didn't look very healthy to me... but it was a long time ago, and now I can't remember exactly what I read... so I may well be mistaken... maybe I should look it up and post some info about it.
  11. V99

    V99 *****

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    Oceanblue.

    So did the therapist get you to increase what you were doing? How often?
  12. Marco

    Marco Old blackguard

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    The APT 'manual' was discussed extensively in Magical Medicine. The conclusion was that it was a hastily thrown together sop with pages being filled by banal repitition and full page cartoons. Hardly representative of a therapy given the same opportunity for success as the non control therapies.
  13. V99

    V99 *****

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    Here are some sections of magical medicine.

    page 239

    pages 264/5

    page 265
  14. V99

    V99 *****

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    This is from the section called, Quotations from the Therapists Manual on APT, page 359


    pages 370/1

    page 371

    pages 371/2
  15. V99

    V99 *****

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    I will leave you with one more gem from magical medicine, page 374

  16. Bob

    Bob

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    Ah yes, thanks V99... I remembered correctly... APT is indeed a perverted form of pacing... It seems to be more like GET than pacing.


    So it's not pacing, as we know it, that they are trialing in the PACE trials... but they will try to promote the results of the trial to us as though they used pacing... and if the APT is found to be ineffective in helping the patients, then they will declare that pacing is ineffective as a therapy approach for ME.
  17. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Causing confusion and muddying the science worked so well by perverting the meaning of ME with "CFS" and "CFS" with the oxford criteria, they're applying this verbal slight of hand to other areas like "pacing".
  18. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    I agree, Cort.
  19. Bob

    Bob

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    Just to let you know what's going on over here in England, in terms of health care, and the authorities' view of CBT... The authorities are already convinced that CBT and GET should be the first line of treatment for ME (psychologists like our Simon Wessely made sure of that)... CBT and GET are the only treatments offered officially on the NHS... and it is set in stone in the NICE guidelines (National Institute of Clinical Excellence)... each locality of England has it's own health authority which is supposed to implement the NICE guidelines, but due to a perpetual lack of resources in the NHS, and the low priority that ME takes, the services available range from inadequate to non-existent.

    A combination of CBT and GET is the standard approach to treatment by the NHS in England... (Scotland might be different.)
    Generally, the only treatment available to us is a 10 week symptom management course (1 or 2 hours per week) which is based on CBT and GET techniques.

    The authorities will not be dropping GET or CBT anytime soon, as much as we are trying to move them away from the psychological view of ME.
  20. Dolphin

    Dolphin Senior Member

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    BMJ Rapid Response

    Other people can post them also
    http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235156

    To be honest, I think the editorial:
    is more worthy of replies - the spin, etc. in it should be challenged.

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