Clinical and cost-effectiveness of the Lightning Process for chronic fatigue syndrome

[user9876]

The letter about ethics approval from November 2016 talks only about a feasability study:

http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/15 SW 0124 Confirmation of favourable opinion 24.11.16 (1).pdf

That looks like ethical approval for the Magenta trial rather than Smile. Also from a different board. It was SW2 (in exeter) that approved Smile. This one is the Frenchay Committee in Bristol.

 

[Jonathan Edwards]

Do you have any idea how weird it is to use a 'pilot' study like this?

I think it is out of court completely if this is supposed to be a prospective controlled trial. As indicated above, it is fair to accumulate data if it is made clear that it is simply a practice report but not to analyse as if a prospective trial. In the past I do not think any editor would publish such a study, but things have changed dramatically in the last ten years.

 

[user9876]

I am amazed. We have Morse, Poirot, Holmes and Marple on the case and they are still 'wrestling with the question' and it's my bedtime! Ah well, maybe it takes little longer. Maybe we need one of those FOI jobs.

Only teasing. It does look seriously odd to me but I don't want to jump to conclusions and this sort of ferreting around dates is not something I am very good at personally.

It might be possible to make enquiries to the editor of Archives of Diseases of Childhood if we are clear what the questions should be.

I think we may need an FoI.

I'm assuming that it would not be normal for an ethics committee to approve an amendment to switch ethical approval from a feasibility study to a full trial?

 

[A.B.]

How about we just ignore LP. Phil Parker will destroy himself soon enough. He is now trying to peddle LP for POTS.

http://www.heartrhythmcongress.org/programme/02-10-2017/5

Phil Parker is, in the words of Coyne, a "raving quack" and that should be painfully obvious to most people that matter. Crawley will go down with him if she continues to hold onto LP.

 

[cyclamen]

How about we just ignore LP. Phil Parker will destroy himself soon enough. He is now trying to peddle LP for POTS.

http://www.heartrhythmcongress.org/programme/02-10-2017/5

Phil Parker is, in the words of Coyne, a "raving quack" and that should be painfully obvious to most people that matter. Crawley will go down with him if she continues to hold onto LP.

I hope the cardiologist don`t fall for it. My last encounter with a cardiologist regarding POTS ended with her upbeat goog bye: "Just enjoy life and forget about your symptoms, they will be gone sooner than you think!"

 

[Esther12]

That looks like ethical approval for the Magenta trial rather than Smile. Also from a different board. It was SW2 (in exeter) that approved Smile. This one is the Frenchay Committee in Bristol.

LOL - I'm such an idiot. I think that page must have been open from a while back, and I assumed it was a SMILE page. Will go back and edit. Luckily I hadn't thought this was a key piece of evidence!

 

[Sea]

I hope the cardiologist don`t fall for it. My last encounter with a cardiologist regarding POTS ended with her upbeat goog bye: "Just enjoy life and forget about your symptoms, they will be gone sooner than you think!"

 

[HowToEscape?]

I hope the cardiologist don`t fall for it. My last encounter with a cardiologist regarding POTS ended with her upbeat goog bye: "Just enjoy life and forget about your symptoms, they will be gone sooner than you think!"

What country was that in?

 

[cyclamen]

What country was that in?

Germany - und this was the rare cardiologist, who has known about POTS. This was the reason I went there.

 

[anni66]

Presenteeism aside, I think there's just a fundamental flaw with using school attendance as a supposed objective outcome that is worse than using employment outcomes for adults. After all, had the FINE long-term follow up found significantly better employment outcomes then I think it would have provided a decent argument for at least exploring CBT/GET further (patient selection issues aside). The difference compared to SMILE is that, in PACE/FINE, it was the patient who decides whether they are well enough to go to work. But for SMILE, we are talking about children and therefore the decision as to whether to go to school on a given day is, at best, a joint decision. School attendance cannot be considered a truly objective outcome because it is possible that a family that has received a 'treatment' materials that consists of telling them to ignore symptoms and avoid 'negative thinking' might well dispatch their child to school when a family in the control group wouldn't have.

School attendance ceases to be an objective outcome if the parents are aware of which treatment their child receives and therefore could be influenced as to whether they think their child is cured. It's as if the PACE trial had also sent information to the bosses of patients in the CBT/GET arms telling them that their employee was now cured and should get their arse back into work.

Remember also that this is the land of PRS and social services involvement for non attendance. Given whom the trial was run by, presenteeism is virtually guaranteed.

 

[trishrhymes]

I want to pass on to someone not on PR a link to information about the Lightning Process, particularly what it involves and patients stories of harms caused. I'm sure I've seen such a resource, but haven't found it. Can anyone help?

 

[AndyPR]

I want to pass on to someone not on PR a link to information about the Lightning Process, particularly what it involves and patients stories of harms caused. I'm sure I've seen such a resource, but haven't found it. Can anyone help?

Perhaps not what you are thinking of but is this of use? http://me-pedia.org/wiki/Lightning_Process

 

[trishrhymes]

Perhaps not what you are thinking of but is this of use? http://me-pedia.org/wiki/Lightning_Process

Thanks Andy, that looks helpful.

 

[JohntheJack]

Thanks @JohntheJack

Do you know if either of the ethics approval ammendments are publicly available? Do you have any idea how weird it is to use a 'pilot' study like this?

I don't. I have been digging around a little today but not found anything new. The protocol for the main study says:

'Ethical review A favourable ethical opinion was given on 8 September 2010 (reference 10/H0206/32) by South West 2 Local Research Ethics Committee.'

But the 08/09/2010 ethical approval states it is for the feasibility study:
https://web.archive.org/web/2012102...ue/correspondencewithethics/applet14sep10.pdf

There are, as you say, two later amendments:
'Two favourable opinions have been provided on 31 May 2011 and 6 September 2012 for amendments to study documents and protocol.'

These don't seem to be available.

In any case, the final paper states: 'Between September 2010 and April 2013, we recruited participants.' So the final study dates back to the start of the feasibility study, immediately after the 08/09/2010 approval.

One of the approvals was for a change in protocol. Could one have been to convert the feasibility study into the main study? Would that be an 'amendment to study documents'?

Think I'll do an FOI for those amendments.

 

[Esther12]

Thanks for letting me know.

In case of interest, the 2010 ethics submission is available here: http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/recfrmrfs.pdf

This says:

A57.
What is the primary outcome measure for the study?

The feasibility and acceptability of doing an RCT will be assessed using the percentage recruited of those eligible for
recruitment and the percentage who complete each intervention out of those randomised to each arm.

A58.
What are the secondary outcome measures? (if any)

1. The primary outcome from the interventions will be school attendance at 6 months
2. Secondary outcome measures for the interventions will be school attendance at 6 weeks, 3 months and 12 months;
the SF36 (physical function) at 6 weeks, 3 months, 6 months and 12 months and pain visual analogue scale at 6
months

 

[dreampop]

Pragmatic randomised controlled open trial.

I haven't read the whole thread so I'm sorry if this is already covered. If the control arm (SMC) is meant to incorporate at least some response bias but the patient knows they are receiving supplementary treatment (SMC +LP) won't they be more likely to respond positively? There is a least some probability that any additional treatment (LP) will provide additional benefit.

Seems like a particularly problem if the LP is attempting to modulate a person's response to illness (...a theory session with taught elements on the stress response, how the mind and body interact, and how thought processes can be either helpful or negative).

What I'm trying to say is there is no control for response bias towards the LP treatment specifically (desire to please, demand characteristics) for a treatment that modifies response bias towards the disease.

 

[Esther12]

[QUOTE="dreampop, post: 912147, member: 25677"If the control arm (SMC) is meant to incorporate at least some response bias but the patient knows they are receiving supplementary treatment (SMC +LP) won't they be more likely to respond positively? [/QUOTE]

Yup, you're right.

It's possible that in this SMC vs SMC+LP trial, those who received only SMC received more CBT & GET (as a part of SMC) than those who were in the +LP group, but we don't know if that's the case as data on this has not been released.

 

[Dolphin]

https://www.facebook.com/nancy.blake.9803/posts/10212755299070365

Nancy Blake
6 hrs ·
SMILE: LIGHTNING PROCESS INSTRUCTS CHILDREN TO LIE ABOUT OUTCOMES

A recent tweet quoted a part of the Lightning Process which instructs patients always to say that their symptoms are gone, that they are fine, no matter how they are actually feeling.

Results Based On Questionnaires

The trial results were based entirely on responses to questionnaires. The children in the trial had had a treatment which instructed them to say they were better even if they weren’t. How were they supposed to answer the questionnaire: honestly, or according to the instructions to say they were better no matter what?

The ‘Double-Bind’ and Schizophrenia

Bateson, in the 60’s, described a situation which in his view, produced psychosis:

The patient is being asked to do two opposite things at the same time, he cannot escape from the situation, and he cannot state that he is in the situation. (Father demands son is successful, but goes into a rage if son beats him at anything; he is not allowed to criticise father, and is expected to continue to achieve.)

SMILE Trial Subjects and the Double-Bind

Crawley notes that many of the children asked to participate in the trial didn’t want to do it. Of the ones who did participate, many had to be contacted several times before they answered the questionnaires.

Any children who had not recovered, or who had been made worse during the treatment had been required to lie about that as part of the treatment, and not to talk about the treatment. Now they are being asked to respond to questionnaires asking them about the results of treatment.

They are being asked to do two opposite things at the same time, have been told they must not talk about the situation, and are being pressed, in repeated phone calls, to give their responses.

Has anyone checked up on the effect this will have had on the children’s mental health?

And what scientific credence can be given to the results of a trial based on questionnaires answered by children who have been instructed to lie as part of their treatment?

 

[anni66]

https://www.facebook.com/nancy.blake.9803/posts/10212755299070365

This is the nub of the problem. There has been no elucidation of what constitutes the "Lightening Process" in the press. Did the REC committee know the details?

For those with ME ( again a mixed bag selection criteria), this is dangerous. Kids who have been isolated and feel different anyway may have any underlying issues compounded by this process.

It goes against all child protection principles

 

[Cfs2019]

Anyone want to see my notes from Mickel Therapy, that they ask you to write?