SMILE trial data to be released

[Esther12]

Amazing. Great work. This process looks so nerve-racking to go through, and so much work too. So pleased it turned out well.

I don't think I've even read the older the ICO judgement related to this.

"School attendance in the previous week, collected as a percentage (10, 20, 40, 60, 80 and 100%)."

Is that the data drawn from school records (and thus less prone to problems with reporting bias)? That should be useful for providing more reliable information on the impact of LP.

I've been seeing a few FOI things that present the disputes around ME/CFS/PACE/SMILE/etc in these terms:

In brief and probably crude summary, he and his fellow campaigners believe that the condition’s aetiology is physiological rather than psychological; they dispute research findings which indicate the contrary. For example, they regard research at Queen Mary University of London (QMUL) known as PACE as methodologically flawed and its conclusions unwarranted . Mr Peters has made a number of FOIA requests in relation to that research, at least two of which have reached the Tribunal.

To me, the physiological vs psychological dispute is largely besides the point with regards to PACE/SMILE/etc. I was wondering if this is an area where the Judge's summary (self-described as "crude", making me like the Judge) has got the wrong end of the stick, or is if @JohnTheJack presented the dispute in those terms in his own submissions?

22.
The University submitted that there was likely to be a ‘determined person with a particular reason to want to identify the individual’ within the public at large who would be motivated and able to identify the children to whom the SMILE data relates; even a small risk of reidentification of a single child participant would be unacceptable.

I just don't understand this - why would anyone want to try to identify SMILE participants from this data? That sounds like a huge amount of work to do something that would not help anyone apart from those trying to make it more difficult to access trial data. There's no evidence anyone has tried to identify PACE participants from that data - and trying to do so would be completely stupid imo.

Thanks again for all your work John.

 

[dave30th]

2. School attendance in the previous week, collected as a percentage (10, 20, 40, 60, 80 and 100%)

Of course, they promised to vet the self-reported school attendance with actual records from the schools. The official records were not reported, although they reported benefits for self-reported school attendance at 12 months. They provided no explanation for the absence of the official records.

 

[Sean]

Fun fact: it's not a good idea to attempt to mislead a tribunal by making bad faith arguments.

Poor dears, they know no other way.

They have been so used to getting away with this crap for decades that they have no idea how to respond to compelling evidence-based arguments before an independent authority not under their spell.

 

[ScottTriGuy]

I just don't understand this - why would anyone want to try to identify SMILE participants from this data? That sounds like a huge amount of work to do something that would not help anyone apart from those trying to make it more difficult to access trial data. There's no evidence anyone has tried to identify PACE participants from that data

Fear mongering is effective.

 

[Snowdrop]

This FoI win is great news.

I have a small concern. Maybe I'm just always seeing the potential fall out but I fear this win will have the BPS group doubling down on lobbying to change the rules for FoI's so that they can win on their own terms next time or the time after.

They most definitely do not want their data out where it can be seen. And I do not think that they will just give up entirely so changing the rules so that they are exempt is really their only recourse.

Is there some way to monitor this?

 

[Peter T]

This FoI win is great news.

I have a small concern. Maybe I'm just always seeing the potential fall out but I fear this win will have the BPS group doubling down on lobbying to change the rules for FoI's so that they can win on their own terms next time or the time after.

They most definitely do not want their data out where it can be seen. And I do not think that they will just give up entirely so changing the rules so that they are exempt is really their only recourse.

Is there some way to monitor this?

Wouldn't it require an Act of Parliament to change the rules, and there is not much chance of getting a government to look at anything but Brexit for at least the near future.

 

[Snowdrop]

Wouldn't it require an Act of Parliament to change the rules, and there is not much chance of getting a government to look at anything but Brexit for at least the near future.

Well there is that. But they are well connected and IMO doing the bidding of political overlords.

 

[Robert 1973]

I forget where I read it, but didn't Crawley also say of a Lightening Process practioner involved in the study that she (Crawley) had worked with her (the practioner) over a number of years. Doesn't this potentionally contradict her (Crawley's) claims that she had no expectations in relation to the Lightening Process.

At a meeting in 2010 she told the REC that she had worked with Parker* and that he was good:

Q5: The practitioner of the lightning therapy has no other allied professional qualifications. The Committee suggested that it might be beneficial to the research if the practitioner had external qualifications other than in Lightning therapy and was covered by a code of conduct?

Dr Crawley replied there is a geographical limitation to who can be chosen and that she has worked before with the Bath practitioner who is good. In addition, the children will remain under her care. Prof Gunnell pointed out that children will continue to be under the specialist service in both arms. As the Chief Investigator for the study Dr Crawley accepted responsibility for the activities of the research team and pointed out that in this feasibility study, all Lightning intervention sessions will be recorded and some observed.

The Committee requested that the fact that the practitioner is not clinically qualified be added to the PIS.

The Committee suggested that consideration should be given to using “clinically qualified” Lightning Practitioners should the feasibility study proceed to a full study in the future.

Extract of Minutes from South West 2 REC meeting held on 2 December 2010: https://www.meassociation.org.uk/20...to-lightning-process-and-children-with-mecfs/

As has been pointed out before, Prof Crawley’s apparent experience of having worked with Parker* and her belief that he was “good” appears to be inconsistent her claim to have been surprised by the positive result she reported.

[Edit: *see correction by @Esther12 below]

 

[Esther12]

At a meeting in 2010 she told the REC that she had worked with Parker and that he was good:
Extract of Minutes from South West 2 REC meeting held on 2 December 2010: https://www.meassociation.org.uk/20...to-lightning-process-and-children-with-mecfs/

As has been pointed out before, Prof Crawley’s apparent experience of having worked with Parker and her belief that he was “good” appears to be inconsistent her claim to have been surprised by the positive result she reported.

She didn't say Parker, but "the Bath practitioner who is good". I didn't think that was Parker, who is based in London.

It's still true that this claim about a "good" LP practitioner rather undermines her attempt to present herself as a rigorous sceptic surprised by her own results.

 

[Peter T]

The SMILE trial write up says (https://adc.bmj.com/content/103/2/155) under method

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP. Following the diploma, LP practitioners undertake a further course to learn the tools and delivery required for the LP after which they must pass both a practical and written examination. Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge. They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

and under acknowledgements

We are grateful to Phil Parker and the LP central office who provided advice and information on costs.

The latter suggesting Crawley had some contact with Parker, but that he was not the/a practitioner who participated in the study.

Neither the final published study or the published trial protocol (see https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-444 ) seem to say anything about the Lightening Process practioner(s) participating in the trial other than how she/they were trained. However the trial protocol does present the idea that this is an independent arm's length investigation of the Lightening Process on the grounds that some 250 children a year participate in this intervention:

Even though over 250 children and young people a year use the LP as an intervention for their CFS/ME, there are currently no reported studies investigating the effectiveness or possible side effects (for example serious adverse events) of the LP.

We will test the null hypothesis that the addition of the LP to SMC has no additional benefit to SMC alone and is not cost-effective.

But the protocol acknowledgements say:

The authors would like to thank Fiona Finch, Research Director from the Lightning Process. Fiona Finch provided information about the Lightning Process but had no role in the design of the study and did not take part in drafting this manuscript.

suggesting as he is not mentioned at this stage that Phil Parker only became involved once the full trial was underway.

The report on the feasibility study (https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-415) says

Children and their families then had two follow-up phone calls with the LP practitioner within 2 weeks of and 6 to 8 weeks after the LP course.

suggesting at this stage at least there was only one practitioner involved.

(An aside, rereading the published papers it becomes very obvious that the fact that the feasibility subjects' results were rolled over into the full trial was not made explicit at all.)

[added - the narrative of Crawley having no preconceptions about the outcome is also repeated "I was surprised that the LP provided additional benefit to specialist medical care" in Bristol Uni's press release on the publication of the final write up, see http://www.bristol.ac.uk/media-library/sites/ccah/cfsme/study-docs/Press Release 20 Sep Esther Crawley SMILE study final draft.pdf ]

 

[Jonathan Edwards]

I think this quote is interesting in the way it illustrates the completely bogus nature of 'qualifications' for these therapist-delivered treatments:

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP. Following the diploma, LP practitioners undertake a further course to learn the tools and delivery required for the LP after which they must pass both a practical and written examination. Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge. They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

If you don't even know if the treatment works how can there be any sort of yardstick by which to measure competence? What is the point of written and practical examinations in knowing about something nobody knows has any validity?

 

[Sean]

LP practitioners have completed a diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical examinations and is accredited by the British Institute of Hypnotherapy and NLP. Following the diploma, LP practitioners undertake a further course to learn the tools and delivery required for the LP after which they must pass both a practical and written examination. Practitioners undertake supervision and continuous professional development in order to further develop their skills and knowledge. They are regulated by the register of LP practitioners, adhere to a code of conduct and there is a Professional Conduct Committee that oversees complaints and professional practice issues.

All the trappings of a science based profession, and none of the content.

 

[Sly Saint]

"the Bath practitioner who is good"

could be this Fiona Finch

Meet our Practitioners: Fiona Finch
Posted on February 12, 2018 by Phil Parker
This week, in our ‘meet the practitioners’ series, we are talking about Fiona Finch.

Fiona has worked as part of Phil’s management team for the last 10 years and prior to that she was an occupational therapist.

Since Fiona trained to be a LP Practitioner she has worked with clients where she lives in Bath – you can find out more by searching ‘Fiona Finch’ here: https://lightningprocess.com/Find-a-Practitioner or by going to her own website here: https://fionafinchcoaching.com

eta: just noticed Peter has already mentioned her.

 

[Peter T]

could be this Fiona Finch

eta: just noticed Peter has already mentioned her.

I notice on Fiona Finch's website she is also a qualified OT with some thirty years experience (see https://fionafinchcoaching.com/about-fiona/ ). In the ethical committee's consideration of 'converting' the feasibility study to a full study for SMILE there was discussion that the LP practitioner was not a qualified clinician and that this should be considered when the full study was launched. I don't know if this change happened or not, but it does suggest that Fiona Finch was not the practioner in the feasibility study.

However this does not rule her out as "the Bath practioner who is good", indeed her position as an OT might explain how Crawley knows her professionally, rather than just, as I had previously assumed, as an LP practitioner who had worked with some of Crawley's patients. It still leaves in the air how much contact Crawley had had with LP and/or LP practitioners prior to setting up the study, despite her assertions of complete scepticism.

Fiona Finch is acknowledged as an advisor in the feasiability write up and the full trial protocol, but Phil Parker is acknowledged in this role in the final write up. One option is that a different practioner was involved in the feasibility study, but Fiona Finch took over for the full study.

 

[large donner]

Isn't Parker also an osteopath?

 

[Sean]

He's a man of many talents, that Phil. Mostly revolving around getting money from people.

 

[rvallee]

This FoI win is great news.

I have a small concern. Maybe I'm just always seeing the potential fall out but I fear this win will have the BPS group doubling down on lobbying to change the rules for FoI's so that they can win on their own terms next time or the time after.

They most definitely do not want their data out where it can be seen. And I do not think that they will just give up entirely so changing the rules so that they are exempt is really their only recourse.

Is there some way to monitor this?

They are drops in an ocean. Science is moving the other way with unstoppable momentum. No worries there, but their flailing and wailing should be emphasized in that regard. No credible scientist has valid reasons to prefer secrecy. It's a big tell that they have something to hide.

 

[JohnTheJack]

Amazing. Great work. This process looks so nerve-racking to go through, and so much work too. So pleased it turned out well.

I don't think I've even read the older the ICO judgement related to this.

"School attendance in the previous week, collected as a percentage (10, 20, 40, 60, 80 and 100%)."

Is that the data drawn from school records (and thus less prone to problems with reporting bias)? That should be useful for providing more reliable information on the impact of LP.

I've been seeing a few FOI things that present the disputes around ME/CFS/PACE/SMILE/etc in these terms:



To me, the physiological vs psychological dispute is largely besides the point with regards to PACE/SMILE/etc. I was wondering if this is an area where the Judge's summary (self-described as "crude", making me like the Judge) has got the wrong end of the stick, or is if @JohnTheJack presented the dispute in those terms in his own submissions?



I just don't understand this - why would anyone want to try to identify SMILE participants from this data? That sounds like a huge amount of work to do something that would not help anyone apart from those trying to make it more difficult to access trial data. There's no evidence anyone has tried to identify PACE participants from that data - and trying to do so would be completely stupid imo.

Thanks again for all your work John.

Sure.

I am a little disappointed by a couple of things in the decision. The first is that it says I have CFS, when the only time I mentioned that I was ill (in making the appeal I said I may need consideration at some point during the process because 'I have ME') and his characterization of the dispute about the illness, which I never made. At least he said 'crudely'.

I did indeed make the point that it would not benefit anyone involved in the dispute even to attempt to identify someone and I think the decision does seem to take that onboard and points out it the possible motivated intruder may not be a patient with ME.

 

[JohnTheJack]

This FoI win is great news.

I have a small concern. Maybe I'm just always seeing the potential fall out but I fear this win will have the BPS group doubling down on lobbying to change the rules for FoI's so that they can win on their own terms next time or the time after.

They most definitely do not want their data out where it can be seen. And I do not think that they will just give up entirely so changing the rules so that they are exempt is really their only recourse.

Is there some way to monitor this?

On this we have very good support including from the Campaign for FOI.
https://www.cfoi.org.uk/

I have had contact with Maurice Frankel there (who helped Alem, I understand).

 

[Esther12]

and his characterization of the dispute about the illness, which I never made. At least he said 'crudely'.

Thanks John. It is annoying that this view of the debate seems to so readily be accepted by so many in the UK. It's really unfair when we're being presented as engaging in a different debate to the one that we're actually working on. Amazing you managed to win despite this!