Buzzfeed News - A Controversial Therapy For ME Has Led To Claims Of Death Threats, Harassment, And Pseudoscience

[TiredSam]

Won't Elves be a problem? Apparently they live through magic circles, and don't generally speak English from what I've read, so wouldn't understand the clear command to stop.

That's why we still need the National Elf Service.

I find that arrogance and ignorance is a common, unbeatable and extremely annoying combination. You´re too arrogant to see you know nothing, and too dumb to see your own arrogance.

Demonstrating that when it comes down to it, all he's got is name-calling. Arrogance, ignorance, annoying, dumb, yeah yeah yeah. Returning to matters of substance, could you please explain ...

 

[Sbag]

ooh maybe you could post a reply to him which is just "STOP" written in a circle

 

[Snow Leopard]

Henrik Vogt sounds just like the usual "alternative medicine" quacks...

 

[Sean]

I am not displeased that Herr Vogt is diving ever more blindly and deeply into the magic thinking cesspit.

What a man does with his own reputation is his business.

 

[Forbin]

Since it is claimed that ME can be "cured" with these techniques of the mind, it seems reasonable to assume that a "mirror" version of these techniques could also be used to induce ME.

I suggest that its proponents can prove their claims by inducing CCC ME/CFS in themselves and then failing to repeat their performance on a 2-day CPET (which can't be faked).

It should then be an easy matter for them to return themselves to normal health.

 

[chrisb]

A thought has occurred to me. It may already have occurred to others. My attention is intermittent.

The trial no doubt has details of attendance of the 3 day courses.

It no doubt has answers to questions, and possibly access to records, which may or may not show improvement in some over a period of time.

How does it show individual compliance with the approved and prescribed therapy over the course of the trial? How would it be known whether those allegedly improving had followed the protocol assiduously, or not at all? Likewise with those showing no effect?

 

[Trish]

How does it show individual compliance with the approved and prescribed therapy over the course of the trial? How would it be known whether those allegedly improving had followed the protocol assiduously, or not at all? Likewise with those showing no effect?

I agree this is a massive gaping hole in the middle of SMILE. It is also a hole in PACE, FINE etc etc. None of them assess compliance, as far as I know. One of the many holes that should have sunk these trials before they started.

I guess it's possible they may have asked the children to fill in activity diaries. They certainly didn't get them to wear actometers. I guess they can claim they are assessing the effect of a patient being put in a trial group, and analyse by 'intention to treat', whether patients actually undertook any of the treatment or not.

 

[Alvin]

I agree this is a massive gaping hole in the middle of SMILE. It is also a hole in PACE, FINE etc etc. None of them assess compliance, as far as I know. One of the many holes that should have sunk these trials before they started.

I guess it's possible they may have asked the children to fill in activity diaries. They certainly didn't get them to wear actometers.

The point was not to get accurate data, it was to "confirm" their belief that people with ME/CFS are mentally ill. The truth would present a problem to their worldview. Subjective data is easier to massage then precise data.

 

[Esther12]

I just saw this on the article:

UPDATE
January 5, 2018, at 3:28 p.m.
This post has been updated to reflect clarification from Professor Crawley about the trial process used in SMILE.

The change was that this:

“And the other way around is fine: If you blind everything so they patients don’t know if they’ve had the treatment, then you can use a subjective measure. But you can’t have an unblinded trial and a subjective outcome.” But the SMILE trial was unblinded, and the outcomes – which initially were intended to include an objective measure, school attendance – were changed after the initial proposal to a questionnaire. Edwards said such self-reported measures are often prone to bias, as subjects give the answers they think they are expected to give. For that reason, he believes, the trial is “useless”.

Changed to this:

“And the other way around is fine: If you blind everything so they patients don’t know if they’ve had the treatment, then you can use a subjective measure. But you can’t have an unblinded trial and a subjective outcome.” But the SMILE trial was unblinded, and Edwards also pointed out that the primary outcome that was measured was changed from an objective measure, school attendance, to a questionnaire. Edwards said such self-reported measures are often prone to bias, as subjects give the answers they think they are expected to give. For that reason, he believes, the trial is “useless”.

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.

"the primary outcome measure change was made, and reported, before results were collected."

That sounds dodgy to me, given what we know about how SMILE was conducted, but we don't have that as an exact quote from Crawley. She could have misled Chivers with half-truths?

 

[Peter T]

"the primary outcome measure change was made, and reported, before results were collected

I am not sure what Crawley means here, as she conducted a feasability study but then included the feasability study in the main trail, meaning that at least half the subjects had been through the process before the design took its final form.

Doesn't this mean that the data from at least half the subjects had been collected and analysed before the change in outcome measures was made.

Also what does it mean to say that "the children didn't like our recommended primary outcome measure"? How was this ascertained, why was it not reported in the write up. Which children was this, just those in the feasibility study or all the children? What is meant by 'like'? Did the children think the subjective measures were more accurate or a more preferable experience? I like eating ice cream better than completing questionnaires or recording my activity levels, but does that make it a better measure of anything?

[In relation to nothing in particular it must be at least three years since I have had any icecream. Been largely housebound and just never thought to include icecream in my on line grocery orders. Perhaps I am missing it?]

Also given the confusion about how school attendence was recorded are the children responding to school attendence recorded by the school as a measure or their own subjective account of school attendence or their family's subjective account in this reported preference.

 

[Esther12]

How was this ascertained, why was it not reported in the write up. Which children was this, just those in the feasibility study or all the children? What is meant by 'like'? Did the children think the subjective measures were more accurate or a more preferable experience? I like eating ice cream better than completing questionnaires or recording my activity levels, but does that make it a better measure of anything?

In the paper on their feasibility study they talked about the participants' concerns about school attendance as an outcome. I don't recall anything to indicate that there was any discussion about how problems with bias might makes an outcome like the SF36-PF less reliable as an outcome.

 

[Peter T]

In the paper on their feasibility study

Thank you @Esther12 I had not realised there was a seperate paper on the feasibility study.

This surely reinforces the question mark over Crawley's claims that outcome measures were changed before results were collected. As the final study subjects included the feasibility study subjects surely results for more than half the subjects had already been collected before the change in outcome measures. As others have eloquently stated already this including the feasibility study results in the final study makes the final results very questionable.

 

[ladycatlover]

including the feasibility study results in the final study makes the final results very questionable.

She must have been desperate to get enough subjects! Low take up of her trawling for kids to experiment on?

 

[TiredSam]

but children didn’t like our recommended primary outcome, school attendance, so we used disability

Really wierd how she keeps referring to what children like and don't like as an excuse for her disgraceful methods. How can anyone she says this to not scream "What the fuck are you talking about?" at her? Kids designing trials? What?

EDIT: And then offer her a leg and say "Pull the other one, it's got bells on, go on ..."

 

[Alvin]

Really wierd how she keeps referring to what children like and don't like as an excuse for her disgraceful methods. How can anyone she says this to not scream "What the fuck are you talking about?" at her? Kids designing trials? What?

I didn't get that either, i just thought i'm mentally fried so i'm just gonna ignore that part (we already know she is full of it). I wonder if she is carrying the British be polite and defer to authority and exploiting it so she doesn't even have to make sense

 

[Jonathan Edwards]

"the primary outcome measure change was made, and reported, before results were collected."

That sounds dodgy to me, given what we know about how SMILE was conducted, but we don't have that as an exact quote from Crawley. She could have misled Chivers with half-truths?

The statement is obviously perfectly true. The primary outcome measure change was made, and reported, and then some results were collected. Some had already been collected - they must have been if there was a change in measure because the children did not like the first one. Doctors become highly skilled at saying things that appear to mean something they don't. I got very good at it over the years. We need to know exactly what happened in this trial. Experience so far suggests that the truth tends to come out when people are under oath in a legal setting (as in the FOI tribunal) but not before. In the legal situation you suddenly realise that you are being encouraged to say misleading things so that you can be forced into admitting you are contradicting yourself. It clarifies the mind no end to have a charge of perjury hanging over your head.

 

[Alvin]

Experience so far suggests that the truth tends to come out when people are under oath in a legal setting (as in the FOI tribunal) but not before. In the legal situation you suddenly realise that you are being encouraged to say misleading things so that you can be forced into admitting you are contradicting yourself. It clarifies the mind no end to have a charge of perjury hanging over your head.

So perhaps thats what we need to do if things get much worse.

 

[Barry]

Really wierd how she keeps referring to what children like and don't like as an excuse for her disgraceful methods. How can anyone she says this to not scream "What the fuck are you talking about?" at her? Kids designing trials? What?

EDIT: And then offer her a leg and say "Pull the other one, it's got bells on, go on ..."

Quite so. If I didn't know better I'd think she was struggling to find more excuses ... .

 

[Barry]

Thank you @Esther12 I had not realised there was a seperate paper on the feasibility study.

This surely reinforces the question mark over Crawley's claims that outcome measures were changed before results were collected. As the final study subjects included the feasibility study subjects surely results for more than half the subjects had already been collected before the change in outcome measures. As others have eloquently stated already this including the feasibility study results in the final study makes the final results very questionable.

Is that definitely so? A feasibilty study paper published before it morphed into the main trial? Even if there was not one actually published, the way the results had trended would have been known, especially as EC was so closely involved, as has been reported elsewhere - DT?

 

[Esther12]

Thank you @Esther12 I had not realised there was a seperate paper on the feasibility study.

This surely reinforces the question mark over Crawley's claims that outcome measures were changed before results were collected. As the final study subjects included the feasibility study subjects surely results for more than half the subjects had already been collected before the change in outcome measures. As others have eloquently stated already this including the feasibility study results in the final study makes the final results very questionable.

Yeah - in case of interest, here's the feasibility paper: https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-415

The statement is obviously perfectly true. The primary outcome measure change was made, and reported, and then some results were collected. Some had already been collected - they must have been if there was a change in measure because the children did not like the first one. Doctors become highly skilled at saying things that appear to mean something they don't. I got very good at it over the years. We need to know exactly what happened in this trial. Experience so far suggests that the truth tends to come out when people are under oath in a legal setting (as in the FOI tribunal) but not before. In the legal situation you suddenly realise that you are being encouraged to say misleading things so that you can be forced into admitting you are contradicting yourself. It clarifies the mind no end to have a charge of perjury hanging over your head.

"the primary outcome measure change was made, and reported, before results were collected."

Results had been collected, just not all of them. I think that falls rather short of 'perfectly true'!