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

Adrian

Adrian

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Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial

Abstract
Objective Investigate the effectiveness and cost-effectiveness of the Lightning Process (LP) in addition to specialist medical care (SMC) compared with SMC alone, for children with chronic fatigue syndrome (CFS)/myalgic encephalitis (ME).

Design Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.

Setting Specialist paediatric CFS/ME service.

Patients 12–18 year olds with mild/moderate CFS/ME.

Main outcome measures The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.

Results We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.

Conclusion The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.
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Full open paper http://adc.bmj.com/content/early/2017/09/20/archdischild-2017-313375

(Moderator note: see this post for an alternative link to the paper and links to related threads)
 
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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
School attendance in the previous week, collected as a percentage (10, 20, 40, 60, 80 and 100 %), at 3 months, 6 months and 12 months ; the SF-36 (physical function) at 3 and 12 months; Chalder Fatigue Scale score at 3, 6 and 12 months and pain visual analogue scale at 6 months. We have obtained consent to check school attendance using school records at assessment, 3, 6 and 12 months.
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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

From February 2011, non-responders were telephoned by a researcher and the SF-36-PFS and Chalder Fatigue Scale were completed over the phone to improve follow-up rates.
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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
http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/recfrmrfs.pdf

Which seems to be for the original feasibility study saying
A10.
What is the principal research question/objective?
To assess the feasibility and acceptability of conducting a randomised controlled trial to investigate the effectiveness and cost effectiveness of specialist medical care compared with specialist medical care plus the Lightning Process.
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But in the protocol they claim
A favourable ethical opinion was given on 8 September 2010 (reference 10/H0206/32) by South West 2 Local Research Ethics Committee. Two favourable opinions have been provided on 31 May 2011 and 6 September 2012 for amendments to study documents and protocol.
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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.
 
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

Mike O’Brien: There are also different views about how treatment best deals with the condition. Some people feel that things such as the lightning process, CBT or GET are the right response, while others feel that those are not the right approach at all.
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Mike O’Brien: I am aware that there is a lot of controversy around the lightning process. Some people feel that it is absolutely useless, and others think it is wonderful and a process that can help them to recover.
Janice Kent: If they’re not ill.
Mike O’Brien: Well, that is your view.
Janice Kent: That is Dr. Mike Broughton’s view.
Mike O’Brien: Well, I don’t happen to share it. It is a matter of controversy among people with ME. Clearly, it is not working for some, but it does appear to help others. Because it is basically about the way that people deal with a long-term condition, it might assist them in dealing with that condition. However, it is probably not a cure in itself—no one is arguing that.
Janice Kent: That is how it is presented.
Mike O’Brien: I don’t want to get into a detailed argument about the lightning process, which I do know a fair amount about. I would say that it seems to be a way in which CBT can be used to help people deal with a long-term condition that would otherwise be more debilitating than it is. Is it a cure? That depends on the extent to which you regard ME as a physical rather than a psychological condition. If people are ill for a long period with a physical condition, they’re also psychologically affected. My basic view about CBT and the lightning process in particular is that it can help people who have long-term illnesses, but that does not necessarily mean that it is the cure for anything. If the illness is caused by physical issues, a psychological response might help the individual to deal with it, but not cure them.
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Attachments

Esther12 said:
Thanks - I remember cringing at this bit when I first read it years ago.



I'd love to pick his brain on LP!
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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.
 
Esther12 said:
Thanks - I remember cringing at this bit when I first read it years ago.



I'd love to pick his brain on LP!
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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.
 
Adrian said:
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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Because if you tell anyone what' s involved it dosn' t work (!)
 
If the illness is caused by physical issues, a psychological response might help the individual to deal with it, but not cure them.
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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.
 
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
 
Esther12 said:
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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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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