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Clinical and cost-effectiveness of the Lightning Process ... for paediatric chronic fatigue syndrome, 2018, Crawley et al (Smile Trial)

Discussion in 'Psychosomatic research - ME/CFS and Long Covid' started by Adrian, Oct 29, 2017.

  1. Barry

    Barry Senior Member (Voting Rights)

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    From what I can see, there are just three forms available that EC has filled in, all dating to May 2010. (Note that it looks like there are four of them, but two of the links, albeit named differently, are to the same document).

    All three relate to the feasibility trial, not just from the dates, but explicitly stated. I cannot see any forms filled out by EC that relate to when the feasibility trial morphed into the full trial.

    Signed by EC 24 May 2010:
    http://www.bristol.ac.uk/media-library/sites/ccah/documents/Ethics - NHS REC Form.pdf
    upload_2017-12-15_23-58-49.png ... etc.
    upload_2017-12-16_0-1-53.png

    Signed by EC 26 May 2010:
    (Note this is duplicated in two adjacent links to the same URL on the SMILE Documents page).
    http://www.bristol.ac.uk/media-library/sites/ccah/documents/Ethics - NHS SSI.pdf
    upload_2017-12-15_23-55-46.png

    Signed by EC 27 May 2010:
    http://www.bristol.ac.uk/media-library/sites/ccah/documents/Ethics - NHS R&D Form.pdf
    upload_2017-12-16_0-3-28.png ... etc.
    upload_2017-12-16_0-4-45.png
     
  2. Esther12

    Esther12 Senior Member (Voting Rights)

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    Tuller mentioned getting some via FOI in his blog, so they may not have been posted on the Bristol SMILE page.
     
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  3. Barry

    Barry Senior Member (Voting Rights)

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    I'd be interested to know what answer was given to question A5-2.
     
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  4. Esther12

    Esther12 Senior Member (Voting Rights)

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    I wonder if she had to answer all that stuff if all she was doing was getting an amendment to her earlier approval? It could be she evaded a lot of the oversight that would have occurred with an application for a new trial?
     
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  5. Barry

    Barry Senior Member (Voting Rights)

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    Yes, but the 'amendment' would have had to include stating that she was now doing the actual RCT she had previously being doing the "feasibility and acceptability" for, which would be one hell of an amendment to the 'same' trial. How did she slide that one past everybody?
     
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  6. Esther12

    Esther12 Senior Member (Voting Rights)

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    This is what Tuller said:

     
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  7. Sbag

    Sbag Senior Member (Voting Rights)

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    I had a look through and the protocol for the full study stated that for the ethical review:
    "A favourable ethical opinion was given on 8 September
    2010 (reference 10/H0206/32) by South West 2 Local Re-
    search Ethics Committee. Two favourable opinions have
    been provided on 31 May 2011 and 6 September 2012 for
    amendments to study documents and protocol."

    So they were using the original ethical review with the amendments. The amendments were around the way the study was performed and reported, so the part about not using any results to promote LP should still be valid.
     
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  8. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    I remember way back thinking that maybe one should not make too much fuss about the 'feasibility study' since it would not produce data that could be manipulated for inappropriate conclusions. I also remember being puzzled that I had never heard about a full study going ahead when the results came out, only a feasibility study. I was too asleep to twig that something really was badly wrong. Thanks to those who were slightly more awake.

    I am not quite sure what more to say at this stage other than that this looks like seriously bad scientific and ethical practice. Really bad. The Phil Parker advert makes it so much worse. The question is whether anyone in the establishment cares any more. Maybe they do.
     
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  9. Sbag

    Sbag Senior Member (Voting Rights)

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    Someone did write a letter to the ethics committee about it back in 2010, it's quute long so I will just put the link here https://frownatsmile.wordpress.com/2010/10/10/letter-to-ethics-service-re-smile-october-2010/

    I have looked a bit more on that site and there were some more letters. I havent read them all yet but one is about the fact that Phil Parker was usung the results to get more business! https://frownatsmile.wordpress.com/category/sw2-ethics-committee/

    I have now read the response from the ethics people to some of the concerns raised and this was their comment on the LP bit

    "7. Mr Parker has used the study to increase sales

    No evidence has been provided that Mr Parker has specifically used this study to increase sales. It was noted that the adjudication by the Advertising Standards
    Authority (ASA) had stated that “The ad [16 June 2010 Internet sponsored search] must not appear again in its current form. We [the ASA] told Withinspiration to ensure they held substantiation before making similar efficacy claims for the lightning process” and that all Lightning Practitioners had been advised of this. The protocol and application clearly state that practitioners had been informed that they must make NO therapeutic claims on the basis of this study."
     
    Last edited: Dec 16, 2017
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  10. Sbag

    Sbag Senior Member (Voting Rights)

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    There is a huge amount of detail on the Frown at SMILE site - they seem to have dissected everything that was available at that time. I can't process it mentally at the moment but if David Tuller is still looking at this then it might be worth passing the site link on so that he can see if there is anything useful. There is also an email contact so he may be able to contact them and see if they would be willing to start looking at it again now further papers have been published.
     
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  11. Esther12

    Esther12 Senior Member (Voting Rights)

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  12. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    I'm aware that @dave30th and others have written a lot about the SMILE trial. That this trial already has been debunked doesn't seem to have reached a wider, non-ME-informed audience, though.

    Just am thinking a *short* article addressing some non-ME-specific issues which could interest a wider audience could be a worthwhile task?

    The main point could be to highlight the most significant pseudoscientific aspects of the Lightning Process (LP), the role LP practioners played in the trial and the commercial gain for these practitioners. (Phil Parker posted the trial results on the LP website https://lightningprocess.com/research/ ).

    In order to confine the article to at most three points that are easy to understand independent of any knowldege about ME: Are there any updates on the fact that the SMILE trial investigators reported school attendance as outcomes, but used only self-reported school attendance despite they previously stated they had also school documents as objective outcomes -- but failed to refer to a source for these data?

    (Did I understand this properly at all?)

    Furthermore: Did the authors first give the impression that the used school attendance data were objective outcomes?

    From @dave30th's virology blog article:
    http://www.virology.ws/2017/12/13/trial-by-error-the-smile-trials-undisclosed-outcomes/

    I think it's also worthwhile to recall the SMC's and especially M. Sharpe's role in praising and spreading the trial results.

    http://www.sciencemediacentre.org/expert-reaction-to-controversial-treatment-for-cfsme/

    Tried to edit for clarity.

    Edit 2: Found and re-read David's 2nd article with some questions directed at the SMC, also the question about the school attendance/ absence records:
    http://www.virology.ws/2017/12/18/trial-by-error-my-questions-for-the-science-media-centre/
    Apologies for my ignorance--but did the SMC respond in any way?

    Edit 3: https://www.s4me.info/threads/smile-trial-data-to-be-released.8548/page-3#post-150215

    (By accident I first posted this here: https://www.s4me.info/threads/assoc...erne-smile-etc-on-lack-of-blinding-prob.1235/
    Even if that thread also deserved a bump, I think it's time for resuming my forum break. :ill: )
     
    Last edited: Apr 13, 2019
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  13. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Just recalled @JohnTheJack's finally successful FOI request.

    So I guess I'll have to wait until the actual release of the requested data and whether these data will answer @Esther12's question?
    Thanks for all your work regarding this ridiculous SMILE trial, @JohnTheJack and @dave30th , and all your work of digging into all that work, @Esther12!
     
    Last edited: Apr 13, 2019
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  14. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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  15. rvallee

    rvallee Senior Member (Voting Rights)

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    The Wikipedia page on the LP is a huge mess, highly editorialized and not up to encyclopedia standards at all.

    At least it's listed in pseudoscience.
     
  16. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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  17. rainy

    rainy Senior Member (Voting Rights)

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    Hi. I’m wondering if someone can help me understand these questions I have about the trial.

    I’m confused why in the abstract the conclusion is:

    while at the end of the article, the conclusion is:

    Aren’t these two different conclusions? How can they say it is effective, but later say it may be helpful, but more research is needed? Is this a common practice in research?

    I also wonder, have Esther Crawley ever written something on what her theory of ME is?

    Because Phil Parker has, and as I understand it, his theory is that the Physical Emergency Response has become stuck, which causes an imbalance in the immunnesystem and hormones, which creates a downward spiral and further imbalance in the body. The purpose of the Lightning Process is to stop this downward spiral by creating new nerve pathways in the brain.

    What does Esther Crawley think of this theory? Is the theory behind the Lightning Process not relevant to her when conducting a trial on it? Why is it not mentioned in the study, or shouldn’t it be? Shouldn’t there be a mention of what the therapy consists of and what it’s therapeutic effect is supposed to be?

    And how does this fit in with GET or CBT as treatments? How would GET and the Lightning Process be a treatment for the same illness? To me it seems like they are based on different theories of what ME is?
     
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  18. Judee

    Judee Established Member

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    Perhaps they should call it the gaslightning process?
     
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  19. Andy

    Andy Committee Member

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    Welcome to the forum @rainy

    Yes, they are different conclusions. As I understand it, most researchers attempt to keep their paper logically consistent, why this one isn't I can't explain.

    There are other forum members who are well versed in Crawley's research output but, as far as I know, she hasn't ever sat down and explained her own theory, but her research output is very much focused on investigating the BPS side of things i.e. GET and CBT.

    I don't believe she has ever said in public. As I understand it, LP isn't explained in the paper because it is a copyrighted process. Of course, not knowing what exactly was done means that any attempt to replicate this study is impossible, as it can't be guaranteed that the same process is used.

    I'm not so sure that they are based on different theories. GET and CBT are based on the idea that we have false cognitions about the limitations of our bodies, which seems to be very much the same as the broad concept behind the LP.
     
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  20. Trish

    Trish Moderator Staff Member

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    Hi @rainy, welcome to the forum.

    I agree those are two very different conclusions.

    It seems, from my limited experience of reading these badly run studies on ME/CFS, like the PACE trial and the SMILE trial, that they are a bit more careful in the conclusion to the full paper to report what actually happened (on subjective measures). But in the abstract, they just say whatever they want to say with an eye to the fact that this is mostly what is read by doctors and organisations like NICE. They show their prejudices in the abstract and distort or overstate the findings in doing so.

    I seem to remember in the PACE long term follow up trial they played a similar trick. The study showed no significant between group differences at long term follow up, and that is what the abstract should have reported. Instead, they focused in both the abstract and in media publicity on the fact that the within group improvement in the GET/CBT groups were maintained at long term follow up. A completely irrelevant point when the long term effect was no better than doing nothing. This allowed them to pretend the long term trial showed the treatments worked, when in fact it showed they didn't.

    As to what theory of ME/CFS the different practices like LP, CBT and GET are based on, in a way that is irrelevant, since none of the theories have any biological evidence base. They just make up theories to justify their treatments and make them sound scientific.

    What they are testing in the trials is whether the treatments work, regardless of cause. And what they find is they seem to work a bit on subjective outcome measures, but they avoid using any objective measures because they know perfectly well it's just temporary placebo/therapist effect, or in some cases like LP, brainwashing.
     
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