Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
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Clinical and cost-effectiveness of the Lightning Process for chronic fatigue syndrome

Discussion in 'Latest ME/CFS Research' started by Dolphin, Sep 20, 2017.

  1. Dolphin

    Dolphin Senior Member

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    I recall reading somewhere (not in the last week) that some of the Crawley team were going to sit in on the sessions. Given the hypnosis element of the sessions, this makes me believe they might be less rigourous/sceptical.

    I have the same thoughts with some parents who sit in such as Esther Rantzen.
     
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  2. IreneF

    IreneF Senior Member

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    CBT and LP both have their origins in a theory called "general semantics" developed by Alfred Korbyzski in the 1920s.
    https://en.m.wikipedia.org/wiki/General_semantics
     
  3. Esther12

    Esther12 Senior Member

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    How seperate were the pilot SMILE trial and the non-pilot SMILE trial? How seperate are they meant to be?

    Sorry if I'm asking stupid questions, but I don't know what's normal with this sort of thing.

    Was there seperate ethics approval for i) the pilot/feasability study ii) the non-pilot trial?

    Was funding gained for the pilot, and then new funding for the main trial?

    I hope @Dx Revision Watch will be able to fill me in on this stuff.

    My memory was that there was only really announcements on funding and ethics approval for the pilot. Was I just distracted by PACE after that? eg: I remember this getting attention, but I don't remember new of further funding after that: http://www.meassociation.org.uk/201...o-the-lightning-process-and-children-with-me/

    The non-pilot SMILE paper says:

    The only mention I could see of an approved grant from the Linbury trust website was in 2010 - presumably for the pilot:

    http://www.ashdentrust.org.uk/files/Ashden Trust Annual report - 5 April 2010.pdf

    This letter dated Nov 2009 does seem to fit with this being for a feasability study: https://meagenda.files.wordpress.com/2010/07/funding-linbury-trust-04-11-09.pdf

    It looks like this was then paid out over a number of years.

    In the non-pilot paper they say:

    In the feasability/pilot study paper they say:

    And then:

    In the non-pilot paper they say:

    What's going on? This seems rediculous to me, but I have no idea how this sort of thing is meant to work. It looks like this supposedly non-pilot trial includes data from loads of participants who were part of the pilot study that was used to justify changing the primary outcome away from school attendance at six-months (this outcome showing no signifcant difference between groups in the non-pilot paper, and not being reported in the paper on the pilot study) to more subjective self-report outcomes. That can't be okay can it? It looks a bit like, instead of trying to get funding for a proper follow-up to the pilot, they just botched it and chucked a few extra participants in at the end. Surely they wouldn't try to get away with something else while they're already getting so much attention over PACE?

    The only other mention of a protocol change in the non-pilot paper was this:

    Does anyone with some knowledge of how pilot studies are meant to work want to comment on this? @Jonathan Edwards ?
     
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  4. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    It does look very fishy, at least as you have presented it. And in this business when things start to look fishy they usually seem to end up looking decidedly cod-like.

    A pilot study is a separate study that would require a separate ethical approval and a separate protocol. The same funding can be used but funding applied for for a pilot study is unlikely to be adequate to cover a formal non-pilot study. So the question arises as to whether funding was not granted for a formal study but it went ahead all the same, maybe using some of the pilot material. If so then it cannot be treated as a formal trial and certainly not a controlled trial.

    I have myself been in a slightly similar situation. I did a pilot study and published it. I then did further pilot work, with a view to a formal study. I published the further pilot work, including a re-publication of the first pilot study as part of the total. However, I published this as a retrospective review of clinical experience and made no statistical analysis because I knew that no valid statistical analysis could be made. It was merely an exercise in reporting observations made for the record. I then undertook the formal study with entirely new ethical approval and new funding.

    If this study really is a botched extension of a pilot because no further money was available it raises the possibility of very bad research practice indeed. At least the PACE trial went through the motions of getting approval for changes within a pre-defined structure. Looks like a job for Morse again.*

    (*Morse was a British detective series.)
     
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  5. user9876

    user9876 Senior Member

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    The pilot study didn't report results I think it just included interviews with participants around 'acceptability'. When it was published it did read like a list of reasons to update the protocol - I remember it sounding more like an 'official' version of outcome switching.

    @Esther12 I think patients from the pilot were included in the results as they talk about getting outcome results over the phone from Feb 2011. From the dates you give it looks like this was when they changed the protocol, finished the pilot and then started again sometime later for the full trial randomization.
     
  6. Londinium

    Londinium Senior Member

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    Presenteeism aside, I think there's just a fundamental flaw with using school attendance as a supposed objective outcome that is worse than using employment outcomes for adults. After all, had the FINE long-term follow up found significantly better employment outcomes then I think it would have provided a decent argument for at least exploring CBT/GET further (patient selection issues aside). The difference compared to SMILE is that, in PACE/FINE, it was the patient who decides whether they are well enough to go to work. But for SMILE, we are talking about children and therefore the decision as to whether to go to school on a given day is, at best, a joint decision. School attendance cannot be considered a truly objective outcome because it is possible that a family that has received a 'treatment' materials that consists of telling them to ignore symptoms and avoid 'negative thinking' might well dispatch their child to school when a family in the control group wouldn't have.

    School attendance ceases to be an objective outcome if the parents are aware of which treatment their child receives and therefore could be influenced as to whether they think their child is cured. It's as if the PACE trial had also sent information to the bosses of patients in the CBT/GET arms telling them that their employee was now cured and should get their arse back into work.
     
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  7. Esther12

    Esther12 Senior Member

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    School attendance, combined with attainment, could be better? But there are a lot of potential problems there too.

    Nothing is perfect, but I still think that school records on attendance would be a better outcome measure than the SF36-PF or Chalder Fatigue Scale.

    All of these things would be less useful if the intervention itself was targeted at improving the particular outcome, rather than the patient's health more broadly - eg it's easy to imagine how a programme designed to improve school attendance could do so, even if this did nothing the improve people's health, and actually served to make their lives worse.
     
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  8. Esther12

    Esther12 Senior Member

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    Thanks.

    [IGNORE - this is about MAGENTA]: The letter about ethics approval from November 2016 talks only about a feasability study:

    http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/15 SW 0124 Confirmation of favourable opinion 24.11.16 (1).pdf


    I think that there are already a couple of detectives on this: @Dx Revision Watch @JohntheJack - do either of you have any idea about how the feasability study and the full study relate to one another, and what approval was granted when for what?

    In the trial protocol (for the full trial, not the feasability study) they say:

    http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/protocol1.pdf

    But surely that relates to the feasability study? Could the 'amendment' of 6th September 2012 allow them to move on to a full trial? That's just before they said they were due to start randomization for the full trial.

    To me, using a feasability study to change outcomes from one with a null result to one with a positive result seems a bit dodgy already (although I can see how justifications could be made for it if it was done very openly), but if the full study included data that was from the feasability study used to justify switching outcomes that's getting pretty odd.

    Yes - that's what it read like to me to. As if being so in your face about it made it less of a problem.

    Surely it's dodgy that they say in their feasability study: "Full trial first randomization: 19 September 2012"

    ...then in their full trial paper: "Between September 2010 and April 2013, we recruited participants after clinical assessment by the Bath/Bristol paediatric CFS/ME service, a large regional and national NHS specialist service."

    Surely the fact that the Lightning Process itself is so transparantly quacky means that they'd try to do everything else as by the book and above board as possible? Why would they take risks with something so likely to blow up in their face.
     
    Last edited: Sep 25, 2017
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  9. Valentijn

    Valentijn Senior Member

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    My impression is that the feasibility study and the full study ended up being the same thing.
     
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  10. NelliePledge

    NelliePledge plodder

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    excessive self confidence and belief that with SMC on side they are unassailable
     
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  11. TiredSam

    TiredSam The wise nematode hibernates

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    If a parent asks a child "How are you feeling today, do you think you can manage school?" And the child has recently been brainwashed into ignoring or not admitting their symptoms to themselves or anyone else under threat of being labelled at fault for not trying hard enough, what's the child more likely to reply? Not wanting to let their parents, therapist or self down, they may well say "yep, just let me step out of this circle" and try to do school instead of doing M.E, as they've been instructed by all around them. It's either that or disappoint everyone by not trying hard enough.

    I really don't think it would be going too far for Esther Crawley to be arrested and charged with child abuse and to be put on some kind of registry. Her manipulation of sick children and their parents to further her own career is sickening.
     
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  12. Wonko

    Wonko Senior Member

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    The other side.
    I'd say it depends on the aims of the study/protocol/etc.

    If the aim is simply to increase school attendance in children then increased attendance is a valid, and objective, outcome measure.

    If the aim is to achieve something meaningful, such as increase grades, or, heaven forbid, actually cure people, then it's not.

    If you take the view/accept that the people commissioning, performing, and reporting on this study are number driven morons with no understanding of the actual problem(s), then it all makes sense.

    It's still utter tosh, it's still mumbo jumbo ritualised brainwashing that should result in criminal charges, but you can sort of see.........
     
  13. user9876

    user9876 Senior Member

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    Something seems strange. The Feasibility study paper
    https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-415
    I take that as saying the feasibility study was not registered since it started in 2010 and the registration is in 2012.

    The trial registraion
    http://www.isrctn.com/ISRCTN81456207

    Has
    And also
    So it looks very unclear. The trial registration is badly filled in (including saying its adults in one place). Its also confusing but it looks like
    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.

    I've not looked at the ethics approval yet
     
  14. user9876

    user9876 Senior Member

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

    has it down as
    At this point in 2010 it wasn't a registered trial
    The aim here in the application form is clearly to test whether a trial is feasible

     
  15. Esther12

    Esther12 Senior Member

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  16. Esther12

    Esther12 Senior Member

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    Just pulling out the bits from the protocol that refer to the feasibility study:

    Yeah - or at least, they just added some extra participants. And surely that makes the way they changed their primary outcome extra dodgy?
     
  17. user9876

    user9876 Senior Member

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    I note that in the latest paper they don't reference an ethics committee approval number just
    But the trial registration references the ethics approval for the feasibility study with the application mentioned here
    http://forums.phoenixrising.me/inde...nic-fatigue-syndrome.54507/page-6#post-911369
    seeming clear that this is a feasibility study not a full trial.

    There appear to have been two amendments
    But I can't find information on these. It would seem to me unreasonable to turn an ethics approval for a feasibility into a full trial and if the ethics committee did that it brings into question whether a full trial was given full consideration and for the full committee.

    I'm starting to think that Bristol University may not have had ethics permission for the trial.
     
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  18. Esther12

    Esther12 Senior Member

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    It will be interesting to see what those two ammendments were for, and what exactly they say.
     
  19. JohntheJack

    JohntheJack Senior Member

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    I wrestled with this question myself and then like you decided that the feasibility study became the first part of the full study, ie the participants and results of the feasibility study were added to the new participants to make the complete trial.

    I noticed the acceptance rate is about the same (30%). I wonder whether that may be why they used the feasibility study in that way: despite doing the trial 'because of demand from patients and parents', they were just not getting enough to even claim significance. There may have been time and financial constraints, so easier for them just to fold the feasibility study into the full study.
     
  20. Esther12

    Esther12 Senior Member

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    Thanks @JohntheJack

    Do you know if either of the ethics approval ammendments are publicly available? Do you have any idea how weird it is to use a 'pilot' study like this?
     

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