BMJ Archives of Diseases in Childhood: ''Editor’s note on correction to Crawley et al. (2018)'', 2019, Nick Brown. (SMILE LP Trial)

Lucibee said:
They were clear that they didn't look at the data during the feasibility stage ["There was no analysis of any outcome data during or after the feasibility phase until the entire trial was completed"]
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This might or might not be true. But I see no reason to take their word for it that the change was based on the qualitative findings, especially given a history of not telling the truth about the conduct of the trial. They didn't need to analyze the data to know which way trends were heading and which outcomes were producing good results. It was an open-label trial and the outcomes were self-reported.
 
dave30th said:
This might or might not be true. But I see no reason to take their word for it that the change was based on the qualitative findings, especially given a history of not telling the truth about the conduct of the trial. They didn't need to analyze the data to know which way trends were heading and which outcomes were producing good results. It was an open-label trial and the outcomes were self-reported.
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At the very least they should have been told to present the results for their two trials separately.
 
dave30th said:
This might or might not be true. But I see no reason to take their word for it that the change was based on the qualitative findings, especially given a history of not telling the truth about the conduct of the trial. They didn't need to analyze the data to know which way trends were heading and which outcomes were producing good results. It was an open-label trial and the outcomes were self-reported.
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I agree. The norm in science is to subconsciously massage data whenever the opportunity arises. People cannot help themselves from doing it. They do not even know they are doing it. that is why the assurance is worthless.
 
"There was no analysis of any outcome data during or after the feasibility phase until the entire trial was completed".
Jonathan Edwards said:
I agree. The norm in science is to subconsciously massage data whenever the opportunity arises. People cannot help themselves from doing it. They do not even know they are doing it. that is why the assurance is worthless.
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Absolutely. And it is carefully worded it seems to me: "There was no analysis". Seems to carefully skirt the high probability that outcome trends would have been unavoidably evident during the feasibility phase, and impossible to not pick up on. To suggest this played no part seems crass. This is surely the whole point of pre-trial prospective registration, because even the best-intentioned people would be unable to detach such awareness from their actions.
 
In a late 2017 article in Buzzfeed, she gives participant dissatisfaction as the reason for changing the primary outcome:

In response, Crawley said "all the outcomes were collected as planned, but children didn’t like our recommended primary outcome, school attendance, so we used disability." She added that the primary outcome measure change was made, and reported, before results were collected.
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But this correction says:
‘We did not have capacity to check school attendance using school records, but this could have provided an objective outcome. Further unpublished work suggests this is highly correlated with the self report measure we used."
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Despite what further unpublished work might suggest, I somehow I doubt that the children would have underreported their attendance, compared to school attendance records - but I guess we'll just never know.
 
Blog by Steven Lubet
Do the Editors at BMJ Archives of Disease in Childhood Care about Conflicts of Interest?

Fate has compelled be to pay attention to medical studies and journal articles on Chronic Fatigue Syndrome (ME/CFS). I am usually most interested in an article's abstract, describing the results, as I am not easily able to closely follow the medical details. Sometimes, however, there are ethics issues regarding the studies themselves, which are squarely in my wheelhouse. So it was with a recent study, in the British journal Archives of Disease in Childhood, of the so-called “Lightning Process,” which seemed to validate the three-day training process – which uses “neuro-linguistic programming,” life coaching, and “emotional self-regulation” – as a potentially effective treatment for ME/CFS in children.
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www.thefacultylounge.org/2019/07/fate-has-compelled-be-to-pay-attention-to-medical-studies-and-journal-articles-on-chronic-fatigue-syndrome-mecfs-i-am-usu.html
 
Barring a minor typo at the beginning ('be' instead of 'me') that is an excellent focus on the absurdity of the authors' marking their own homework. Also really glad that he highlights this:
Presumably it was possible to sense early outcome trends even without analyzing any data, since it was an unblinded trial relying on subjective reports.
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Also this from Steve Lubet's same blog:
Readers familiar with judicial ethics will recall that recusal is mandatory in circumstances where "impartiality might reasonably be questioned."
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"Impartiality might reasonably be questioned" ... clearly the BMJ Archives of Disease in Childhood Care editorial staff have pretty crap powers of reasoning. I wonder if that could be due to their own conflicts of interest by any chance. The words that come to my mind: Corrupt as hell.
 
The wikipedia article sounds like an advertisement. :eek:

Maybe someone could also put in Edzard Ernst's statement? https://edzardernst.com/2020/06/the-lightning-process-implausible-unproven-hyped-and-expensive/

and this sentence is misleading and abbreviated:

"The approach has raised some controversy due to using psychological techniques to cure what people feel is a physical illness."

what the referenced article actually says about the controversy:
But detractors point out that the Lightning Process is scientifically unproven, have criticized its practitioners for making what they consider extravagant claims, and on occasion labeled the organization as fraudulent.
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But as anecdotal reports have fuelled hope in some, the Lightning Process has also generated controversy. It is scientifically unproven, and not endorsed by any medical authority. And to some CFS support groups, the claim that a verbal method could cure a physical ailment seems to imply that CFS is a psychological manifestation after all, a notion they find offensive.

John Greensmith, a CFS sufferer and campaigner with the British advocacy group ME Free For All, also questions the fact that people who train in the process frequently go on to become practitioners themselves.

"That seems to me like a pyramid scheme," he says, noting that at a cost of around $1,200, the training program doesn't come cheap.

"We think their claims are extravagant," Greensmith adds, pointing out that Lightning Process practitioners assert that the training program should work in all cases so long as patients properly follow instructions.

"If you use it properly you will get the results each and every time," asserts Henk-Bryce.

Greensmith isn't sold. "So if patients get better, they claim the success of the treatment — but if they don't, they say the patient is responsible."

Isobel Bennett, 49 years old from London, says it didn't work for her when she tried it last year. In fact, she says it made her worse.

"It encouraged me to push myself beyond my natural limits, and afterwards I crashed badly, becoming housebound. I'm just gradually beginning to pick up now," she says.

Others recount similar stories of relapses after going through the process.

"I think it is potentially a useful technique," says Bennett. "But I am bitter that they are not very open to recognizing that it doesn't work for some people. It needs to be tailored more to individual cases rather than just a 'one size fits all, so if it doesn't work for you then tough' attitude. CFS is so little understood — it's not the same illness in everybody. For some people, it potentially could be dangerous." https://www.cbc.ca/news2/background/health/lightning-process.html
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