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Smile Trial - Crawley Lightning process trial

Discussion in 'PsychoSocial ME/CFS Research' started by Adrian, Oct 29, 2017.

  1. Adrian

    Adrian Senior Member (Voting Rights)

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    Full open paper http://adc.bmj.com/content/early/2017/09/20/archdischild-2017-313375
     
  2. Adrian

    Adrian Senior Member (Voting Rights)

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    I would describe the Smile trial as a bit like a magic trick. The basic methodology is one of ask people how they feel and how they function. Use the Lightning process to tell them they can think themselves better if they ignore symptoms. Then ask them how they feel and how they function. Maybe it just measures what techniques are most effective at getting patients to change questionnaire answers (CBT or lightning process)

    The lack of meaningful objective measures makes this trial meaningless in terms of any derived information. Perhaps the interesting thing is the more objective measure of (self reported school attendance) has the worst results.

    The statistical analysis plan said that:
    http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/statisicalanalysespdf.pdf
    But they failed to report the records as reported by the school. @JohnTheJack has put in an FoI request for the data and if this is released it will be interesting to see if there are differences.
     
  3. Adrian

    Adrian Senior Member (Voting Rights)

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    From the paper

    This looks dodgy and could bias results in that giving results over the phone could lead to additional response bias. Especially if the children had a perception that there is a 'right answer' that the researchers are after.
     
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  4. Adrian

    Adrian Senior Member (Voting Rights)

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    Could there be questions about ethical approval

    The timings for the trial were:
    1) Ethics committee approved something sept 2010
    2) Randomisation for feasibility study trial started sept 2010
    3) Ethic committee approved amended protocol May 2011
    4) Trial was registered July 2012 (but using original ethics approval)
    5) Trial recruitment started Sept 2012
    6) Trial should have finished March 2013 - but given the 1 year monitoring this is impossible so I assume that is end of randomisation. The paper says April 2013 was the last randomization.
    trial registration http://www.isrctn.com/ISRCTN81456207
    Full protocol http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/protocol1.pdf

    The ethical approval form
    http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/recfrmrfs.pdf

    Which seems to be for the original feasibility study saying
    But in the protocol they claim
    So it may be that they got ethical permission to convert to a full trial but this seems a bit underhand to me. I believe @JohnTheJack has asked for the amendments in a FoI so we will see.
     
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  5. Skippa

    Skippa Moderator Staff Member

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    Agree+++++, I would extend this description to more of "their" work too.
     
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  6. JohnTheJack

    JohnTheJack Established Member (Voting Rights)

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    Yes, I'll get their reasons why they won't provide me with it on Friday. At least, that's what I'm anticipating.
     
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  7. Adrian

    Adrian Senior Member (Voting Rights)

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    You could try the ethics committee as well as Bristol University. But if they don't release them it does suggest that they know something is wrong.
     
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  8. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Mike O’Brien MP, Minister of State for Health
    at
    All Party Parliamentary Group on M.E. held at 3.15-16.45 pm, Wednesday 2 December 2009 Committee Room 11, House of Commons

     

    Attached Files:

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  9. Esther12

    Esther12 Senior Member (Voting Rights)

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    Thanks - I remember cringing at this bit when I first read it years ago.

    I'd love to pick his brain on LP!
     
  10. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    He seems to be suggesting that the Lightning Process is a way of delivering CBT. I wonder if Dr Chalder would agree.

    David T has had some more thoughts on the trial - he summarised the sequence of events in SMILE very well when we last met for dinner. I think we will hear more.
     
  11. Adrian

    Adrian Senior Member (Voting Rights)

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    I only just realized that this comes from 2009. I think status of the arguments have moved on in terms of a better understanding of the failures in the evidence for CBT. I was going to say it sounds like he had a dodgy briefing but I wondered if the claims for CBT as a cure were pushed more openly in 2009.

    Worrying that his is assuming detail but not able to go into it.
     
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  12. Amw66

    Amw66 Established Member (Voting Rights)

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    Because if you tell anyone what' s involved it dosn' t work (!)
     
  13. large donner

    large donner Established Member (Voting Rights)

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    I'm so sick and tired of hearing crap like this, its so patronizing. The notion its automatic that some Evian drinking, bullshitting, state appointed psychologist who wouldn't be employed if it wasn't for government funding to supply bullshit, is any more useful at dealing with ones own psychology than that person themselves, and then that they have the audacity to proclaim this mind owning nonsense a treatment is just so tiring.
     
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  14. NelliePledge

    NelliePledge Senior Member (Voting Rights)

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    Mike O’Brien hasn’t been in Parliament since he lost his seat in 2010 so luckily hasn’t been imparting his understanding of Lightning Process since then
     
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  15. Amw66

    Amw66 Established Member (Voting Rights)

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    Perhaps he' s an LP coach ....
     
  16. Sbag

    Sbag Established Member (Voting Rights)

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  17. Barry

    Barry Senior Member (Voting Rights)

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    "... results of the feasibility study do not confer ...". Is there anything similar stated for the full study @Sbag?
     
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  18. Esther12

    Esther12 Senior Member (Voting Rights)

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    I think that's the key point.

    Although it is a bit complicated by the fact that it seems the feasibility study became the full study.
     
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  19. Barry

    Barry Senior Member (Voting Rights)

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    This letter, at the link provided by @Sbag, clearly shows what David Tuller just blogged about - see https://www.s4me.info/index.php?threads/tuller-trial-by-error-the-crawley-chronicles-resumed.1507/.

    Clearly states that EC had applied for and been approved, to feed the feasibility trial's data forward into the full study, whilst in the same breath (same letter anyway) confirming the outcome switching. Who could ever seriously believe that by this point, EC would not have already got a damned good idea of what outcome measures would best favour the feasibility data, and by extension the full trial, being as it used much of the same data. Even if the full trial had been fully independent, switching outcomes simply because the feasibility trial suggested results could be made to look better, is appalling. But doing it because you know your full trial is actually using much of the same data that underpins the reason for switching outcomes ... is just incredible. Not only is it not good science, I don't think it even counts as bad science ... it's simply not science at all! It's cheating, plain and simple.

    upload_2017-12-15_22-3-11.png
     
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  20. Sbag

    Sbag Established Member (Voting Rights)

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    I cant find any ethics documents for the full study apart from the forms that she fills in. I may have overlooked though so will check again tomorrow. There may have been another letter I suppose that is not posted on the site, but it looks like all of the documents there are the ones used for the main trial and are referenced in the forms that she fills in. So the ethics letter would probably be the only one otherwise there would be others posted there.
    If so and the promotional aspect only applies to the feasbility study then may be it is ok to use results from the full trial for his own advertising, as it wasn't specifically mentioned in the first letter etc
     

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