"Got ME? Just SMILE!" - Media coverage of the SMILE trial…..

[Jonathan Edwards]

Oh come on!?
Prof. Wessely's book is currently on sale for 40p at Amazon. Maybe a few of us could get together and split the cost to check it out?
https://www.amazon.co.uk/gp/aw/d/0198526423/

I think you may be forgetting how irrational people are, very much including 'scientists'.

These people are familiar with the component arguments about why blinding is needed in trials with bias. We have discussed Wessell's book before and he says how important blinding is. But when joining various arguments together makes a trial they like look bad they turn round and say it does not apply. So although they are familiar with what is needed to understand, I would say they do not understand the point I was making because they refuse to accept it is valid logic. (that PACE is no good because it is unblinded and has subjective endpoints). In one case a reviewer simply said my statements should be removed from my paper. Another complained that if people believed it then nothing in psychiatry would be believed so it shouldn't be said.

The point I am trying to make, I think, is that although we agree that they refuse to accept the argument for political reasons, I think they do this because they are genuinely incapable of allowing logic to override their mantras of professional dogma within their own heads. To me that means they do not understand, and are unsuitable for doing scientific research.

 

[user9876]

Another complained that if people believed it then nothing in psychiatry would be believed so it shouldn't be said.

The reviewer may have said that but psychiatry does have quite a lot of drug trials I believe which would be double bind. The issue is with the groups who study CBT and other similar talking/lifestyle therapies.

The point I am trying to make, I think, is that although we agree that they refuse to accept the argument for political reasons, I think they do this because they are genuinely incapable of allowing logic to override their mantras of professional dogma within their own heads. To me that means they do not understand, and are unsuitable for doing scientific research.

There is a concept of cognitive dissonance where people have conflicting beliefs. I think too often belief out weights method in a lot of what people do.

 

[Woolie]

I think it makes the most sense to analyse SMILE data according to randomisation. It's not exactly ideal that participants deviated from the treatments they were randomised to, but the researchers can't physically stop that from happening in a trial like this, and I think they dealt with this reasonably. (Although it would be better to have more information about all this).

Yes, that would be adhering to the intention-to-treat principle. Which is seen as the gold standard.

Ideally, you'd present results both ways. You'd present the intent-to-treat results first (as explained above). Then you'd present the per protocol results. Per protocol looks at what people ended up having, regardless of what group they started out in.

 

[Wolfiness]

I think you may be forgetting how irrational people are, very much including 'scientists'.

These people are familiar with the component arguments about why blinding is needed in trials with bias. We have discussed Wessell's book before and he says how important blinding is. But when joining various arguments together makes a trial they like look bad they turn round and say it does not apply. So although they are familiar with what is needed to understand, I would say they do not understand the point I was making because they refuse to accept it is valid logic. (that PACE is no good because it is unblinded and has subjective endpoints). In one case a reviewer simply said my statements should be removed from my paper. Another complained that if people believed it then nothing in psychiatry would be believed so it shouldn't be said.

The point I am trying to make, I think, is that although we agree that they refuse to accept the argument for political reasons, I think they do this because they are genuinely incapable of allowing logic to override their mantras of professional dogma within their own heads. To me that means they do not understand, and are unsuitable for doing scientific research.

I know that these people are irrational ideologues - the study of the BPS ideology is a primer in fallacies - I'm just interested in exactly how they justify it. You seem to be saying it is mostly the "if you cannot work out how to do a reliable study then an unreliable study can be taken as reliable" fallacy ?

Something I find myself saying quite a lot with my health situation is "Well actually yeah normally this principle would apply but what you as an outsider simply don't understand is that this context is in fact an exception for X and Y reasons". Usually it's "because I as an end user have no other choice and otherwise nothing will get done". But I require more consistency from people who are actually making the rules I’m breaking.

I think we are suffering for Wessely's obsession with the 2nd class, "unreal" stigmatisation of psychiatry - he talks of the need to reunite psychiatry and neurology, but as @A.B. has said elsewhere, without acknowledging psychiatry's problems. He has yet again confused cause and effect and believes that reunification is all that is needed to repair the schism. But the sloppiness of psychological methodology seems to be both effect and perpetuating cause of its separation from more verifiable science.

 

[A.B.]

I think we are suffering for Wessely's obsession

They are also obsessed with the idea of finally proving that thoughts and emotions cause disease. They have been trying since Freud.

 

[Wolfiness]

I blame the hypothalamus.

 

[Woolie]

I think we are suffering for Wessely's obsession with the 2nd class, "unreal" stigmatisation of psychiatry - he talks of the need to reunite psychiatry and neurology, but as @A.B. has said elsewhere, without acknowledging psychiatry's problems. He has yet again confused cause and effect and believes that reunification is all that is needed to repair the schism. But the sloppiness of psychological methodology seems to be both effect and perpetuating cause of its separation from more verifiable science.

Some Neurology is good. But Neurology researchers happily call on psychoBS whenever it suits them, and without questioning it. Grab a Freudian term here, assign an awkward subclass of memory disorders to the psychogenic bin there.

 

[Large Donner]

I don't think it would flush very well

However it does come ready covered with number 2.

 

[Jonathan Edwards]

I know that these people are irrational ideologues

I think we in complete agreement.

I blame the hypothalamus.

So do I

The reviewer may have said that but psychiatry does have quite a lot of drug trials I believe which would be double blind.

Indeed, there has been some excellent research. But I guess that is not what the reviewers are interested in.

 

[Skycloud]

This probably isn't important in the context of the many, many things wrong with this trial, but it bugs me.

I've previously seen a couple of parents say that attending the Bath clinic was useful for getting the schools off their backs.

In a well-designed trial (ha!) with school attendance as an outcome measure, shouldn't the concessions and support sought from the schools be the same for every participant? Is there any mention of this? If the therapists and doctors involved in the trial are also in contact with the schools, this role strikes me as something that could be used to influence attendance figures, through securing either more helpful, or stricter arrangements for some children. This could even happen unintentionally if there's no rule about it. Although since the schools' own figures were not sought anyway, this might not be very important.

I'm sure the relationships between the law, schools, chronically sick non/low attending child and parents is a factor in the results. There's a power dynamic that has to influence things, but that's a study area in itself. It bugs me too.

 

[Hajnalka]

Review by MEA is online:

https://twitter.com/i/web/status/918467787076468736

 

[A.B.]

I blame the hypothalamus.

Do you mean damage to the hypothalamus is causing our symptoms?

 

[BurnA]

The point I am trying to make, I think, is that although we agree that they refuse to accept the argument for political reasons, I think they do this because they are genuinely incapable of allowing logic to override their mantras of professional dogma within their own heads. To me that means they do not understand, and are unsuitable for doing scientific research.

Do you think they may understand but dont want to admit it becasue as one reviewer said - nothing in psychiatry would be believed so it shouldn't be said.

 

[Wolfiness]

Do you mean damage to the hypothalamus is causing our symptoms?

No, I mean it is scapegoat and enabler of mind-body quackery, this magical mind-body hinge converting thought into biochemistry.

 

[Inara]

Another complained that if people believed it then nothing in psychiatry would be believed so it shouldn't be said.

This must never happen, where would all their power go??

And thanks for saying this about irrationality in scientists, too. It allows to look upon it critically. I met some of those - the higher the position the more irrational, it seemed (politics? Power?) - but I enjoyed working with most of them. Well, in my field. Don't how it is elsewhere.

 

[Inara]

They are also obsessed with the idea of finally proving that thoughts and emotions cause disease. They have been trying since Freud.

They have been trying for much longer than that. A unison with neurology would be "the top of it all" for them, most possibly leading to more and more power. Let's hope the anti-psychiatry movement will succeed, some day.

 

[JohntheJack]

In case anyone is wondering about the data: I should have received a response last week. I chased up Uni of Bristol and got no reply. I tried again today and said if I didn't get a response by end of office hours I'd refer to the ICO. I got a reply including this statement:

I apologise for the delay in providing our response. We are currently extremely short staffed and have a significant backlog, which we are working through as quickly as we can. We have contacted the Information Commissioner’s Office to explain the situation.

With regard to your recent requests we require some more time and hope to provide you with a response by 3rd November.

I imagine they'll claim some reason not to provide them then.

 

[Benji]

Here is our smile-article, Google translate

The results from a new study, SMILE, suggest that the Lightning Process (LP) training program has a positive effect for young people with ME / CFS.
The CFS / ME Competition Director, Ingrid Helland, says she is very excited that the study is long-awaited - and it's great that so many had the effect of LP. She draws one weakness of the study, namely, that there were few of those who were invited to participate, as if yes.
MISCELLANEOUS TRANSFER. However, we see far more weaknesses in the study than Helland mentions.
In his criticism of the study, Nina Steinkopf pointed out that it is used for extensive diagnostic criteria in the recruitment of patients and that the sickest have been omitted.
Participants did not have to meet the criterion of (delayed) exercise-induced symptom worsening, which is considered to be the cardinal symptom of ME.
This raises doubts as to whether the results from the SMILE trial can be transmitted to children and adolescents with ME diagnosis in Norway.
POWER MEASUREMENT. What was the effect of?
One group received LP courses and so-called "standard medical treatment", while the other received only the latter treatment. Standard medical treatment was in practice an individual rehabilitation program that varied from person to person. One of the groups thus received an additional offer in a group of other ME patients, while the other received only individual follow-up. This raises the question of what one actually measures the effect of; the content of the Lightning Process - or to meet and experience unity with other patients?
As the control group did not receive any form of standardized group treatment, it is impossible to distinguish the effect of the content of LP from the effect of group treatment.
GREAT PLACEBO EFFECT. Furthermore, it was well known to the participants what kind of treatment they received, and they had expectations thereafter.
Expectations that a treatment should work may, as known, in itself help make you feel better. In addition, participants in LP courses will be trained to convince themselves that they are healthy and can do what they want. This causes the results to be exaggerated. The placebo effect may potentially represent the entire observed group difference in results.

Last part in next post

 

[Benji]

NO OBJECTIVE OBJECTIVES. The basis for the power measurement in the study is the participants' own reports in the questionnaire, on the level of functioning, pain, anxiety, depression and school attendance. All goals are self-reported, and in addition to school participation, they are based on subjective assessments and experiences. From previous studies on cognitive therapy of ME among adults, we know that outcomes on subjective goals are not always reflected in objective goals; Patients fail to go further or work more.
This can also be the case for children and adolescents in the SMILE attempt, not least because children reflect less on questions and have less thoughtful answers than adults. Using subjective goals becomes a further problem when evaluating the effect of LP, where the participants are trained to convince themselves that they are healthy.
Furthermore; Only half of the participants provided a fully completed questionnaire.
INSECURITY. For self-reported functional level, which is the primary outcome goal in the impact assessment, results are missing for 17 out of 99 participants. This helps to create uncertainty about measured impact as it is not necessarily coincidental which participants failed to answer these questions.
Self-reported school attendance was inadequate; Results are out of the question for as many as one third of the participants. SMILE researchers initially announced that school participation should be the primary outcome of the impact assessment and that self-reported school participation should be verified by collecting information about absence from schools (1).
This was never done as far as we can see. Thus, the effect on school attendance is also very uncertain.
PROTECTED EFFECT. Finally, it is worth mentioning that although the SMILE study concludes that LP has an effect on functional level, the effect must be said to be modest. Participants in both groups experienced improvement during the trial period, and the difference in recovery between the two groups is relatively small.
SMILE researchers predetermined that the minimum ten-point difference in functional level was considered to be "clinically important". The group difference was 12.5 points after six months. Among the girls, the group difference was nine points after six months, not to be considered clinically important, according to the researchers' own definition.
The modest group differences, combined with the major weaknesses of the study, give little reason to believe that LP will have significant significance for ME patients, as the Competition Service seems to take for granted.

 

[Benji]

If anybody gets a chance, it would be nice to have Ester Crawleys comment about the fact that SMILE trial shows us that LP works for boys, but not for girls.