Discussion in 'PsychoSocial ME/CFS Research' started by Adrian, Oct 29, 2017.
Full open paper http://adc.bmj.com/content/early/2017/09/20/archdischild-2017-313375
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:
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.
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.
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
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.
Agree+++++, I would extend this description to more of "their" work too.
Yes, I'll get their reasons why they won't provide me with it on Friday. At least, that's what I'm anticipating.
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.
Mike O’Brien MP, Minister of State for Health
All Party Parliamentary Group on M.E. held at 3.15-16.45 pm, Wednesday 2 December 2009 Committee Room 11, House of Commons
Thanks - I remember cringing at this bit when I first read it years ago.
I'd love to pick his brain on LP!
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.
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.
Because if you tell anyone what' s involved it dosn' t work (!)
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.
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
Perhaps he' s an LP coach ....
I was looking through some of the trial documents (http://www.bristol.ac.uk/ccah/resea...bility/chronic-fatigue/smile/smile-documents/) and in the ethics review of trial approval letter it says:
Having had a quick look at his website it looks suspiciously like he is using the study results for conferring evidence of the efficacy of LP:
"... results of the feasibility study do not confer ...". Is there anything similar stated for the full study @Sbag?
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.
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.
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
Separate names with a comma.