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SMILE - Lightening Process - Trial Feasibility Study Published

Bob

Senior Member
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16,455
Location
England (south coast)
Not sure whether I've pointed this out or not, but this journal allows comments: http://www.trialsjournal.com/content/14/1/415/comments .

They wouldn't have to be referenced although having one or two references (the paper itself can be one) should decrease a lot the chances of a comment not getting through.
Do you know if trialsjournal.com is actually a journal, or just an aggregation website?

Edit: This has been answered, below.
 
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Bob

Senior Member
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16,455
Location
England (south coast)
I've just flicked through the feasibility paper, and have a few observations...

Firstly, like the PACE trial, there is not an adequate control, if it can be claimed that there is any control. There's no placebo control. I would argue that it shouldn't be labelled as a controlled trial, just as the Lancet didn't allow the PACE trial to be labelled as a controlled trial. (Was that the only thing the Lancet got right?) It's an open-label comparison trial, and the expectations in the LP group are not controlled for.

There are two treatment groups: The LP group and the LP+SMC group.

SMC will include graded activity, and/or CBT and/or GET. (This is interesting because it means that they are comparing LP with the investigators' favourite established NHS 'treatment' i.e. graded activity etc.)

Outcome questionnaires were mostly completed at home, without a third-party assessor present. This is helpful in reducing response bias, to some degree, because it means that responders won't feel pressurised into giving the expected answers, quite so much.

Of course, any of the above might be different in the final trial protocol.


Edit: Drat. I totally forgot that the trial protocol has already been made public, along with a load of other documentation!

Protocol:
http://www.bristol.ac.uk/ccah/resea...fatigue/smilestudydocuments/smprotv6final.pdf
Other documentation:
http://forums.phoenixrising.me/inde...ch-study-on-children.2695/page-33#post-298313
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Do you know if trialsjournal.com is actually a journal, or just an aggregation website?
The LP feasibility paper is not actually published in trialsjournal.com, is it?

I think the journal is Trials. They just blur that an journal together in the http. Click on the Trials logo or Home tab.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I think the journal is Trials. They just blur that an journal together in the http. Click on the Trials logo or Home tab.
Ah, I see. Thanks alex.
The feasibility study was published in 'Trials', which is a BioMed Central journal.
I didn't realise that 'Trials' was the name of the journal.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Wish there was a "bronx cheer" emoticon.

ETA: Oh wait:

That's revolting! I have to avoid looking at it as it is so repulsive. There is an icon :p for sticking out the tongue which is rather less vile.

I have been thinking about whether it would be good to have a duck icon to indicate quackery, but wondered about the risk of people using it inappropriately.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I think recruiting ill children for positive-thinking-hypnosis therapy is what is truly revolting.

Positive thinking is more a cult than a science. There is little or no science behind it that has not been debunked. Its modern day religion. Psychogenic medicine has a history of merging unproven ideas into it. I think CBT for ME and LP would get on famously.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
SMILE trial progress update:
"In October 2013, we will have finished recruitment for the SMILE trial."
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/

If you click on the link that relates to the quote, it takes you to the SMILE Feasibility Study, I had thought you were indicating recruitment for the full trial, but I'm not sure it demonstrates this there.

Indeed most if not all of the documents attached to that page are dated 2010, and I think two from 2011; so I would suggest this is an old link referring to the Feasibility Study that has just been published and the recruitment for that study, not any subsequent one.

Interesting to note from that page that whenever this was written they claim only 250 kids a year were undergoing LP treatment, it seems rather a lot of fuss about such a small thing.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
If you click on the link that relates to the quote, it takes you to the SMILE Feasibility Study, I had thought you were indicating recruitment for the full trial, but I'm not sure it demonstrates this there.

Indeed most if not all of the documents attached to that page are dated 2010, and I think two from 2011; so I would suggest this is an old link referring to the Feasibility Study that has just been published and the recruitment for that study, not any subsequent one.

Interesting to note from that page that whenever this was written they claim only 250 kids a year were undergoing LP treatment, it seems rather a lot of fuss about such a small thing.

What do you mean? I hope you don't mean that potentially harming up to 250 children a year is a 'small thing'?

The other issue that causes even more concern is the risk of much larger numbers of children being harmed in the future if spuriously 'positive' results are published from such a trial, as were from the PACE study, and the treatment ends up being approved by NICE.

I wonder how they came up with the 'SMILE' acronym for the studies. I cannot help suspecting that it was a deliberate ploy to put a positive early spin on it. "Children - would you like to participate in the SMILE study?"

I note on the page you link to above that they say

All participants will be carefully monitored and regularly reviewed in the specialist CFS/ME service. Young people taking part can opt out of the trial at any point.

Will the children be monitored after the study? After they drop out? It is all-too-common for people to think that they are recovered after psychoquackery, only to have serious relapses months later or even later.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Given the estimated prevalence, I think 250 is a small thing to have appeared on anyone's radar especially for a Trial and given all the other things people are prescribed and try.
 
Messages
13,774
Given the estimated prevalence, I think 250 is a small thing to have appeared on anyone's radar especially for a Trial and given all the other things people are prescribed and try.

Yeah - I bet there are lots of quack treatments being used by more. Seems crazy to put limited research funding in to poor trials for them all.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Yeah - I bet there are lots of quack treatments being used by more. Seems crazy to put limited research funding in to poor trials for them all.

I wonder how unusual it is to get funding for a treatment that has low usage. Maybe it isn't considered when funding is being decided. After all, drug trials are carried out when no one has used them yet.
 

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
It is generally unheard of to first test a therapy on children before adults, unless those children are suffering from life threatening conditions...

They justify it for LP because they say that the illness is different in children.
 

Purple

Bundle of purpliness
Messages
489
They justify it for LP because they say that the illness is different in children.

Hmmmm... so there have been hundreds of rigorous, well-designed, well-executed and replicated observational and comparative scientific studies costing millions that compare the biology, aetiology and epidemiology of ME in children vs ME in adults, to confidently come to this conclusion? So how is the biology of the illness different in children from adults?

[sarcasm... and rhetorical questions]
 

Dolphin

Senior Member
Messages
17,567
Bob said:
SMILE trial progress update:
"In October 2013, we will have finished recruitment for the SMILE trial."
http://www.bristol.ac.uk/ccah/research/childrencomplexhealthneeds/chronic-fatigue/

If you click on the link that relates to the quote, it takes you to the SMILE Feasibility Study, I had thought you were indicating recruitment for the full trial, but I'm not sure it demonstrates this there.

Indeed most if not all of the documents attached to that page are dated 2010, and I think two from 2011; so I would suggest this is an old link referring to the Feasibility Study that has just been published and the recruitment for that study, not any subsequent one.
Based on the following, there are two separate trials or trial parts:

Trial registration: Feasibility study first randomization: 29 September 2010.

Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).

Full trial first randomization: 19 September 2012

(from: http://www.trialsjournal.com/content/14/1/415/abstract )

What was reported in the latest paper was a period before September 2012:
e.g.

Figure 2 describes the flow of children through the study. Between 1 October 1 2010 and 17 June 2012, a total of 312 children attended clinic appointments.
.