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

NelliePledge

Senior Member
Messages
807
so Im wondering is EC at risk of pissing off a lot of people in her field by her association with PP - is this going to backfire


proper professional psychologists within the NHS presumably not terribly impressed at an approach delivered by people from "phil parker university". Although I guess that has already happened with these private companies that do sausage machine CBT (I went to one of them :mad:) they just have people who have gone through internal training programme I believe rather than professionals. So maybe the professional psychologists arent interested in fatigue or dont have power to change the situation so dont bother saying anything about it.

and what do other private psych type approach people think about this trial - they must be fuming why EC picked out LP not Mickel or Reverse or Optimum Health. Mickel is trained as a GP, Reverse guy is a professional psychologist I think , OHC is owned by ex ME patient but employs professional psychologist and nutritionist so arguably much more credible than LP. Say the NHS decided to open up to private sector providers for this type of approach there would be a process of bidding for a contract. This trial seems potentially to be putting LP in poll position for any NHS contract that might be offered in future (please no) so I would be moaning like mad about it being anti competitive, why arent you trialling my approach - and maybe getting legal advice? Or am I fantasizing here?

edit just spotted that OHC are working with Surrey on research not read it http://www.theoptimumhealthclinic.com/research-overview/clinicaltrial/
suspect I may be demonstrating my lack of background in ME issues here so apologies if this is all Noddy
 
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Art Vandelay

Senior Member
Messages
470
Location
Australia
Exactly. We can criticise the biased methodology, lack of a control group and blinding etc until we're blue in the face, but experience has shown us that people (particularly journalists and doctors) simply don't care about those issues because they are scientifically illiterate.

We have to use ridicule to get them interested. T hen, we might have an opening to explain why the study claimed a positive result.

Could some very basic graphics that could easily be shared on twitter might help with the message? For example:

lp.png



(I know it's very rough as I'm still a bit too brainfogged to do anything elaborate. I don't really have the energy for engagement on social media, so I'm happy for people to use this or if they'd like to adapt it for themselves.)
 
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user9876

Senior Member
Messages
4,556
I've finally finished reading the paper. The big methodological flaw of using subjective measures was obvious without a read and I think made worse because I would see LP as a 'persuasive' therapy in making people act as if they were better.

It looks like most of the reports are self reported and not all reported stuff. Taking questionnaire results over the phone seems dodgy to me.

The idea that SMC is a control is rubbish as its not clear what happened to people in this group even down to contact hours. I think there has been a lot written about treatment as usual controls and the complexity of trying to interpret anything from them.

The more objective the measure (i.e. self reported school attendance) the lesser the result which tends to suggest there is reporting bias in the primary outcome. In there stats plan they were going to use school record but given the drop outs then I assume they failed to do this but the paper doesn't provide real clarity here.

We should be concerned about the treatment arm as not all in there got LP. The question that is not addressed is why but LP seem to have a screening process to check that patients are ready so I wonder if the ones who didn't receive LP were seen as 'not ready'. Normally I would think that having some in a treatment group who had no treatment would suppress results but it is not clear to me how an additional selection process and combining this with no information about how drop outs related to non-treatment then it is hard to say much.

In general I find the quoting of the mean results frustrating it doesn't say help in understanding what has happened. Median would be preferable but ideally scatter plots are nicer as it provides a view as to whether there are a few people improve or it is the entire group. At the start of the paper Crawley claims that some large proportion of children get better quite quickly and it becomes hard to see if this could just be an imbalance between the groups there coupled with an under powered study. One thing I thought would be interesting is to look for correlations in school attendance and the other measures and see how they change with treatments. I'm probably just reflecting my desire to look at data and form my own opinions here.
 

Chrisb

Senior Member
Messages
1,051
On the question of use of school attendance as a guide to improvement, I realise that aspects of the problem have already been discussed but I think a name for the problem has not yet been mentioned.

Is not the issue under discussion "presenteeism", which will be familiar to those who have suffered from mild ME and been hanging on to their jobs by their fingertips? The fact that someone is sitting behind their desk is no indicator of their state of health.
 

trishrhymes

Senior Member
Messages
2,158
I'm probably just reflecting my desire to look at data and form my own opinions here.

I think unless we can get the raw data, we are really in the dark about what was actually done in this trial.

Even then, we'd need information on what actual SMC treatment each person undertook, whether they actually attended all the LP sessions, which ones had their follow up done by phone, what diagnosis each had at the start, including anxiety, depression, how long they had been ill, viral onset, and so many other factors.

And we'd need long term follow up where participants were completely free to say how they were actually feeling rather than still being under the threat of not getting better if they admit negative symptoms and feeling bound by the rule of not admitting negative symptoms.

And of course we'd need actometer and other objective data.

As it is, it's a non starter scientifically - a dreadful mis-mash of uninterpretable results.

Has anyone made an FOI request for the raw data?

Edit to add: What would be really useful would be information on which participants had experienced PEM before the trial, and which were still experiencing it after.
 

user9876

Senior Member
Messages
4,556
Even then, we'd need information on what actual SMC treatment each person undertook, whether they actually attended all the LP sessions, which ones had their follow up done by phone, what diagnosis each had at the start, including anxiety, depression, how long they had been ill, viral onset, and so many other factors.

I don't think that SMC was measured but it may have been as a function of the economic analysis. I think also the prescription drugs costs are worth a look from this perspective. Figure 1 suggests that 3 children gave up with LP after 1 day (they say received a 1 day course!).

There are some interesting figures about baseline levels in the appendix but not how they relate to the different treatment groups. One thing I noticed was that two of the people who at base-line weren't attending school within the SMC group did not provide the sf36 figures at 6 months.
 

slysaint

Senior Member
Messages
2,125
Where Phil Parker 'qualified':
https://britishhypnosisresearch.com/past-students/

"Many of our graduates have now become authorities in the field and include many of the most respected names in hypnotherapy and NLP.

Igor Ledochowski called his approach ‘Conversational Hypnosis’ and created international courses, books and CDs, Hugh Willbourn became an author and co-wrote about self-help therapy with Paul McKenna,
Phil Parker created ‘The Lightening Process’, Joe Griffin created the influential ‘Human Givens’ approach, Adam Eason set up his own hypnosis school, Ian McDermott set up the ‘ITS’ NLP training company and became a best selling NLP author, Phyllis Alden became president of the British Society of Experimental and Clinical Hypnosis, Mark Tyrell set up ‘Uncommon Therapy’ running courses and selling therapy downloads, Peter and Mary Lawrence founded ‘The British Institute of Hypnotherapy’, Kerin Webb wrote the acclaimed ‘Language Pattern Bible’, Andrew Austin wrote ‘The Rainbow Machine’ NLP book and created ‘Integral Eye Movement Therapy’ – and there are many more success stories… and they all started their hypnosis training with Stephen Brooks – quite an achievement!"

Surprised no ones written a book 'How to make money out of other peoples misery'
 

Esther12

Senior Member
Messages
13,774
I was just looking through the protocol for:

Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) - pilot Randomised Controlled Trial.

http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/smprotv6final.pdf

They say that:

The primary outcome measure for the interventions will be school attendance/home tuition at 6 months.
Secondary outcome measures 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.

Were the results for this primary outcome ever released?

In this paper they say that they're going to change their primary outcome for SMILE:
The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235039/

I can't see where they released the results for this primary outcome measure though. [There was no significant difference between group for it in the recent paper, but I think that did not include those from this pilot?]

How dodgy is it to run a 'pilot' trial, and then use that to change your primary outcome for the proper trial? They're presenting it as if this change was patient led, but if they started with null results for their pilot, shouldn't that have been reported? This whole thing seems so weird that I don't know how to fairly complain about it (I feel like I should get all these papers out, and go through with a highlighter and biro... but don't want to!). Any views? I don't know what's seen as normal/acceptable/respectable for this sort of pilot trial.

Also, as Valentijn pointed out, in their original protocol it seemed that they were planning to check attendance rates with the school, rather than relying on potentially biased self-report:

School attendance
Children and young people are asked about school attendance and home tuition in a two item
inventory. We will ask for consent to check school attendance using school records and will do
this at assessment, 3 months 6 months and 12 months.

It seems that was changed but I couldn't find disucussion of it.
 
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user9876

Senior Member
Messages
4,556
I was just looking through the protocol for:



http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/smprotv6final.pdf

They say that:



Were the results for this primary outcome ever released?

In this paper they say that they're going to change their primary outcome for SMILE:


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4235039/

I can't see where they released the results for this primary outcome measure though. [There was no significant difference between group for it in the recent paper, but I think that did not include those from this pilot?]

How dodgy is it to run a 'pilot' trial, and then use that to change your primary outcome for the proper trial? They're presenting it as if this change was patient led, but if they started with null results for their pilot, shouldn't that have been reported? This whole thing seems so weird that I don't know how to fairly complain about it (I feel like I should get all these papers out, and go through with a highlighter and biro... but don't want to!). Any views? I don't know what's seen as normal/acceptable/respectable for this sort of pilot trial.

Also, as Valentijn pointed out, in their original protocol it seemed that they were planning to check attendance rates with the school, rather than relying on potentially biased self-report:



It seems that was changed but I couldn't find disucussion of it.

I think they changed it after an initial feasability study and if I remember correctly this was discussed in a paper that discussed the feasibility study but gave no results.

This page has links etc including to the stats plan
http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/smile.html
 

Esther12

Senior Member
Messages
13,774
I think they changed it after an initial feasability study and if I remember correctly this was discussed in a paper that discussed the feasibility study but gave no results.

This page has links etc including to the stats plan
http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/smile.html

Yes, the paper I linked to discussed changing it, but didn't provide the actual results. Surely that's a bit dodgy?

The statistical analysis play doesn't seem to include anything extra on one the primary outcome was changed or what the original results were, but does say:

2.10.2. Secondary outcomes
School attendance in the previous week, collected as a percentage (10, 20, 40, 60, 80 and 100 %), at 3 months, 6 months and 12 months; the SF-36 (physical function) at 3 and 12 months; Chalder Fatigue Scale score at 3, 6 and 12 months and pain visual analogue scale at 6 months.

We have obtained consent to check school attendance using school records at assessment, 3, 6 and 12 months.

http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/statisicalanalysespdf.pdf
 

user9876

Senior Member
Messages
4,556
Yes, the paper I linked to discussed changing it, but didn't provide the actual results. Surely that's a bit dodgy?

The statistical analysis play doesn't seem to include anything extra on one the primary outcome was changed or what the original results were, but does say:



http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/statisicalanalysespdf.pdf

I remember thinking at the time it was dodgy. There stats plan shows that it can't be due to the additional reporting (although I think they still used self reported attendance. So that would leave the 'too complex to understand' or not accurate excuses. But I suspect the results weren't good.
 

Dolphin

Senior Member
Messages
17,567
I recall reading somewhere (not in the last week) that some of the Crawley team were going to sit in on the sessions. Given the hypnosis element of the sessions, this makes me believe they might be less rigourous/sceptical.

I have the same thoughts with some parents who sit in such as Esther Rantzen.