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SMILE - Lightening Process - Trial Feasibility Study Published

Messages
13,774
Thanks Wildcat,

Interesting that the primary outcome measure has now been changed. I wonder if that was out of these concerns and if the MEA and Tyme have anything further to add in light of this change? I doubt it will change their concern but I will ask.

This is the reasoning they gave:

Primary outcome
During the study, parents and participants commented that the school attendance primary outcome did not accurately reflect what they were able to do, particularly if they were recruited during, or had transitioned to, A levels during the study. This is because it was not clear what ‘100% of expected attendance’ was. In addition, we were aware of some
participants who had chosen not to increase school attendance despite increased activity.

I totally agree with @wdb 's citing of that thread.

School attendance was never a great outcome measure, but it's a lot better than SF36-PF and Chalder Fatigue Scale scores. Measuring the supposed efficacy of something like the Lightning Process with self-report questionnaires is just a joke. nIf they wanted a more comprehensive measure of activity, they should have used actometers.

This is from the paper:

The Phil Parker Lightning Process® (LP) is a trademarked intervention that is used for a variety of conditions including CFS/ME. It was developed from osteopathy, life coaching and neurolinguistic programming. The LP trains individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of
standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations (www.lightningprocess.com). The intervention includes three group sessions on consecutive days where participants are taught theories and skills, which are then practised through simple steps, posture and coaching.

Is there any evidence that these claims are true? Does LP train train individuals to recognise when they are stimulating or triggering unhelpful physiological responses, and avoiding them? Is it not unethical and repulsive to claim that it does without good supporting evidence?

Here's the info that was given to the kids (they avoid mentioning the obviously quacky NLP and osteopathy):

What is the Lightning Process?

The Lightning Process is based on the idea that the body and mind work together to affect
your health. It is a training programme, run as a course on three consecutive days (for 3
hours 45 minutes a day) in a group with up to five other young people aged between 12 and
18 years old. The course is run by a Lightning Process Practioner who is trained and licensed
to run the course. The courses will be held somewhere near you, either in a clinic or hospital,
or in a hotel or community hall. Where ever it is held, it will be suitable for the course and for
young people your age.

There are regular breaks throughout the course and a mixture of group and individual
discussions. Each day the course will include a theory session and a practical session. In the
theory session, teenagers learn about stress and its physical effects, how the mind-body
interacts and how thought processes can be helpful and unhelpful. In the practical session,
teenagers identify goals they wish to achieve (for example, standing for longer) and are given
different ways to think about and prepare for this. They then have the chance to practise this
on the course with the Lightning Process practitioner there to support them.
A parent can attend and a researcher may be present to watch the session. Teenagers are
given up to 30 minutes homework each day so they can continue

http://meagenda.wordpress.com/2010/09/16/smile-–-specialist-medical-intervention-and-lightning-evaluation-documents/

In these sessions, do the kids really learn about how the mind-body interacts and how thought processes can be helpful and unhelpful? Is there good evidence to support the claims that are made to them during these sessions? Or is it just misleading quackery? The Advertising Standards Authority seems to think that there's rather too much quackery in some of the claims made by Phil Parker and his followers.
 
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Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
RE FULL TRIAL UNDERWAY
Are you sure?
It says here SMILE is a feasibility study:
that was my take on this included in the full text abstract:
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.
 

Dolphin

Senior Member
Messages
17,567
that was my take on this included in the full text abstract:

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.
Thanks. I'd missed that. So it looks like maybe we won't get outcome data from the feasibility study.
 

Seven7

Seven
Messages
3,444
Location
USA
Here is what I understand of the psy studies. Now with the whole OIM things coming to life, what they do makes much sense, a paper is a paper, no matter how much we disagree or how controversial it is.

They know how to play the game (the phsy group), publish, confirm studies no matter how ludicrous it is. Then when fight comes to it, they are the only ones doing the things that at the end politically and bureaucratically will count.

While we participate we are our own enemies. WAKE UP PEOPLE.
 

barbc56

Senior Member
Messages
3,657
Phil Parker is a known scam artist. (mods. feel free to delete my strong language.):D

I used to have a file on him but can't find it, atm, but when/if I do, will post.

My question is if he is making any money for giving permission to use his so called protocal as I think it is patented/ copyrighted/licensed.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Phil Parker is a known scam artist. (mods. feel free to delete my strong language.):D

I used to have a file on him but can't find it, atm, but when/if I do, will post.

My question is if he is making any money for giving permission to use his so called protocal as I think it is patented/ copyrighted/licensed.

I think he wants "scientific" respectability, as a positive result will allow him to make claims of scientific evidence in a clinical RCT, which also gives him a claim to be evidence based.

I don't consider such subjective studies to be sufficiently valid to be considered an RCT without downgrading the evidence grade to the lowest available.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I think a trial of LP on children with CFS/ME is one of the most disgraceful and unethical things that I've seen in the field of ME. (And that's not an easy accolade to achieve!)

I'd like to see child developmental behavioural specialists carry out a safety audit on LP for children before this trial goes ahead.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I think he wants "scientific" respectability, as a positive result will allow him to make claims of scientific evidence in a clinical RCT, which also gives him a claim to be evidence based.

I don't consider such subjective studies to be sufficiently valid to be considered an RCT without downgrading the evidence grade to the lowest available.
Yes, it would be an enormous coup for Parker if this study achieved positive results. LP would then be (legally) widely promoted as a successful treatment for children with ME. It would perhaps also mean that the NHS would pay him to use LP as an NHS therapy.

And, as we know from PACE, it's very easy for an open-label trial to achieve subjective improvements, even where there are no objective improvements.

I'd like to see the trail of money for this trial. (i.e. who has received money from whom.)
 
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Dolphin

Senior Member
Messages
17,567
It would be good if one or more people posted comments on the journal's site re: http://www.trialsjournal.com/content/14/1/415/abstract
"We suggest that a full study uses other primary outcomes, such as the SF-36 or the Chalder Fatigue Scale and uses school attendance as a secondary outcome."

This doesn't seem very wise to me given that LP involves 3 days of hypnosis/similar where participants are trained not to "do M.E." i.e. they're trained to say they're well and have no problems doing things if people ask.

Objective outcome measures like motion-sensing devices would seem preferable for trials of such interventions.

All participants i.e. in both arms also receive an intervention involving encouraging graded activity

so again it would be good to have objective measures.
Saw a psychologist with ME post this elsewhere:

So made it easier to look like it was effective...... or is it just me being a cynic???

Substituting a hard measure that can be verified independently – not just patient report - for two softer ones that patients may complete with social desirability bias as they do not want to come away feeling that they have failed in some way....... and I bet they get that feeling of failure in spades from the LP......

I mean come on, if the kids are not back at school – they ain’t well. End of.
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
This isn't new, but I'd forgotten about it, so perhaps others have forgotten as well.
It's a letter published in the Church Times (of all places) in 2010, about the trial:

‘Children should not be used as guinea pigs’, Church Times, 8 Oct 2010
From the Church Times, 8 October 2010
Clinical trials of a training programme for ME, MS, and other conditions raise serious ethical questions, argues Robin Gill.

http://www.meassociation.org.uk/201...-used-as-guinea-pigs-church-times-8-oct-2010/


(BTW, it includes a reference to Esther Rantzen (a UK TV & radio presenter), who used to promote LP, as she claimed that her daughter, who was diagnosed with CFS, benefited from it. They found out years later that her daughter actually had ceoliac disease, and not CFS.)
 

barbc56

Senior Member
Messages
3,657
Big red flag here:

I did the LP 2 years ago, and straight away after beginning to use the process, I began to make changes- and quite dramatic ones at that. I was able to get out of my wheelchair and walk, take a shower, go to the park, drive my car, eat anything I wanted and many more things, all within the 3 days of the LP course. I had previously been unable to do any of these things. I am completely well and lead a completely normal life.

http://www.lightningprocesshelpedme.com/discussion/comment/185http://www.lightningprocesshelpedme.com/discussion/comment/185

I just had to post this. Now I will try to get back to the topic of ethical/science issues.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Saw a psychologist with ME post this elsewhere:

"I mean come on, if the kids are not back at school – they ain’t well. End of."

Yes, if not at school they are not well. However even if back at school they might not be well. So many of us can attend, but are we paying attention? Can we focus? Can we think? Can we get involved? Its more than just attendance. What happened to their grades?
 

Sean

Senior Member
Messages
7,378
Utter disgrace that this drivel gets a penny of precious research or clinical funds, especially to be inflicted upon children.

A shocking example of how far off the rails this area of medicine has gone.
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
"We suggest that a full study uses other primary outcomes, such as the SF-36 or the Chalder Fatigue Scale and uses school attendance as a secondary outcome."

This doesn't seem very wise to me given that LP involves 3 days of hypnosis/similar where participants are trained not to "do M.E." i.e. they're trained to say they're well and have no problems doing things if people ask.

Objective outcome measures like motion-sensing devices would seem preferable for trials of such interventions.

All participants i.e. in both arms also receive an intervention involving encouraging graded activity

so again it would be good to have objective measures.
Worth noting what the paper says about this:
During the study, parents and participants commented that the school attendance primary
outcome did not accurately reflect what they were able to do, particularly if they were
recruited during, or had transitioned to, A levels during the study
. This is because it was not
clear what ‘100% of expected attendance’ was. In addition, we were aware of some
participants who had chosen not to increase school attendance despite increased activity
.

...
Recommendations for a full study
This study suggests that trials involving 17 and 18 year olds need to consider alternative
primary outcome measures to school attendance. In addition to the difficulty measuring
change in school attendance for those transitioning from GCSEs to A levels, it may be a poor
outcome measure for those who do not consider school attendance their primary goal.
I think there is something in this, but also agree with you that an objective measure is needed too, such as actometers. I'd also like to see the outcome data for school attendance vs SF36 etc, in case this was a factor in the authors' plan to downgrade school attendance to a secondary outcome.

Here's an example of a motion-sensing device shown to accurately measure total energy expenditure in people in normal life (as opposed to rather meaningless studies showing actometers are good at measuring treadmill activity):

Evaluation of a portable device to measure daily energy expenditure in free-living adults
Results: Mean estimated daily EE measured with the armband was 117 kcal/d lower (2375 ± 366 kcal/d) than that measured with DLW (2492 ± 444 kcal/d; P < 0.01). Despite this group difference, individual comparisons between the armband and DLW were close, as evidenced by an intraclass correlation of 0.81 (P < 0.01).
Correlation of 0.81 is very high (0-1.0 scale), and the "DLW" method is the gold standard for measuring energy expenditure so this is a good study.
 
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user9876

Senior Member
Messages
4,556
Another thing that really worries me is that if this trial is claimed to be a 'success', parents may be forced to have their children subjected to it under threat of being charged with child abuse/neglect, diagnosed with Munchausen's Syndrome by Proxy and/or having their children taken away.

I doesn't even need to be a direct threat. Esther Crawley has quite a reputation. I did hear that her clinic was dropping 'non-complaint' patients from one of the therapists working there. This creates a situation where parents may feel have to take part or they will be dumped on unsympathetic GPs. I also hear rumors that Crawley is dropping the ME diagnosis for some of the more severe patients and suggesting PRS.

This adds to pressure not only to take part in the trial but to give better results (including feeling forced to increase school attendance) for the favored treatment.

If I was designing such a trial I would be careful to add in privacy preserving properties so that the doctors don't know which results apply to a given patient.