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

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
 
Esther12 said:
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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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?
 
Barry said:
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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This is what Tuller said:

In fairness to Professor Crawley, she sought ethical approval for her unorthodox maneuver. She filed an application for a substantial amendment to her initial protocol in early August, 2012, and received approval not long after. To figure out what exactly had happened, I filed a freedom of information request with the regional ethical review board to obtain the application for this protocol amendment. This document outlined the request to extend the feasibility study into the full study and also to swap the primary and secondary outcomes.
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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.
 
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.
 
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."
 
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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.
 
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:
Professor Crawley promised to seek verification of self-reported school attendance by requesting official school attendance records. Although she mentioned this in the protocols for both the feasibility trial and the full trial, these school records are not mentioned anywhere in the full-trial report. Nor did she discuss the feasibility of accessing these records in the logical place–the feasibility trial report. One possible and very logical conclusion is that she obtained these objective data but decided not to mention them because they did not provide optimal results.
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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:
Does the SMC believe it is acceptable for researchers to promise in protocols that they will seek objective data—in this case, official school absence records—and then not mention these data in their published trial reports? What assumptions does the SMC think might be reasonable to draw about such an omission?
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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: )
 
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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?
JohnTheJack said: ↑
2. School attendance in the previous week, collected as a percentage (10, 20, 40, 60, 80 and 100%)
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Esther12 said:
Is that the data drawn from school records (and thus less prone to problems with reporting bias)? That should be useful for providing more reliable information on the impact of LP.
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Thanks for all your work regarding this ridiculous SMILE trial, @JohnTheJack and @dave30th , and all your work of digging into all that work, @Esther12!
 
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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:

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

Conclusions
The addition of the LP to SMC may be helpful to children with CFS/ME. However, this study needs to be replicated before the LP should be offered in the NHS.
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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?
 
Welcome to the forum @rainy

rainy said:
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?
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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.

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

rainy said:
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?
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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.

rainy said:
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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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.
 
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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