Lightning Process study in Norway - Given Ethics Approval February 2022

Kalliope said:
Professor in psychology Leif Edward Ottesen Kennair will be the supervisor of this research project and promise to do everything he can for the treatment effect to be assessed in an independent, fair and scientific way. He has no qualms regarding Landmark being both a research fellow and LP coach.

Prof. Per Magnus from the Norwegian Directorate of Public Health will also be advisor in the project and says in an email that in this connection Landmark is a researcher and that she runs a risk if the project won't show any effect.
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I don't know where Leif Edward Ottesen Kennair and Per Magnus stand on the BPS scale but let's assume they're genuine in their wish to produce quality research. I'm still extremely concerned that the proposed use of CCC is giving false credibility to this study. The CCC stand and fall with the definition of PEM - and Wyller defines PEM as post-exertional fatigue. So we'll get another study enrolling people with who knows what but where the authors claim it's about ME because they used CCC.
 
Ravn said:
I don't know where Leif Edward Ottesen Kennair and Per Magnus stand on the BPS scale but let's assume they're genuine in their wish to produce quality research. I'm still extremely concerned that the proposed use of CCC is giving false credibility to this study. The CCC stand and fall with the definition of PEM - and Wyller defines PEM as post-exertional fatigue. So we'll get another study enrolling people with who knows what but where the authors claim it's about ME because they used CCC.
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In addition it seems the plan is that Live Landmark gets to individually choose participants who have not yet "identified" themselves with the diagnosis.

They say that the statistician who will analyse the data is independent and objective, but it is not without interest that the participants have been undergoing a considerable amount of manipulation before those forms are filled out.
 
Kalliope said:
In addition it seems the plan is that Live Landmark gets to individually choose participants who have not yet "identified" themselves with the diagnosis.

They say that the statistician who will analyse the data is independent and objective, but it is not without interest that the participants have been undergoing a considerable amount of manipulation before those forms are filled out.
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This. Is the statistician analyzing objective or subjective data? Why can't they talk a bit more about the outcomes they are interested in and how they will be collected..? An independent statistician won't help with bad data.
 
Kalliope said:
LP coach Live Landmark didn't wish to comment, as she in this connection is a doctoral research fellow.
Professor in psychology Leif Edward Ottesen Kennair will be the supervisor of this research project and promise to do everything he can for the treatment effect to be assessed in an independent, fair and scientific way. He has no qualms regarding Landmark being both a research fellow and LP coach
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Leif Kennair is an author of this book
https://norla.no/nb/books/1166-harmful-help-the-possible-negative-effects-of-psychotherapy
 
lycaena said:
The introduction does not really say what it is about. Maybe it's just about over-medicalisation?

Anti over-medicalisation advocats often seem not to take ME/CFS seriously.
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I guess one can say it is about over-medicalisation of psychotherapy, from what I read.
And that’s very good for us, we don’t need psychotherapy to cure us. Better do nothing. And that’s what the book is about, I believe. Contexts and others things that makes psychotherapy counterproductive.
 
I did an interview today with Dagbladet (Norwegian Newspaper), which will be doing a bit on the petition I did for wanted methodological changes to the LP-study. I am mainly focusing on the fact that subjective outcomes is worthless alone here due to the nature of the intervention (ignoring symptoms), and so the argument is that u due to this have to also have objective outcomes like studies/work and e.g sensewear armband like in the cyclo-study. If not, you can easily get the situation that the patients report being healthy, while they are still on benefits.

I also took up the issue of Live choosing "motivated" ME-patients for the study. This brings unnecessary bias, and i see no scientific reasons to do this.
Also her economic conflict of interest is huge here, and I seriously mean she should not have such an active role in the study.

Lastly i said that its not acceptable to only listen to the experiences of the few people that claim to be cured through LP in the "Recovery Norge"-group, when a survey from the Norwegian ME-association showed that over 50 % reported worsening from LP. The researchers have chosen to completely ignore this, and they dont respond when asked about it. This does not bode well for neutrality in their research

I told her that I dont want the study to not go forward, but that I want it changed so that the results actually can be used. At the present moment the study is "rigged for success".

Now, is there anything else central that I should tell the journalist? If anyone have something please reply today. I don't want to miss something important Thank u :)

Edit: I should add, when contacting the ethics committee I will obviously have to focus the arguments on the more ethical elements. But the petition is mainly to raise awareness of the general problems with the current methodology
 
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@Marky, this is perhaps less of an ethical no no than with the UK paediatric study, but still telling people with health issues to ignore medical symptoms and to lie about those symptoms is profoundly dangerous particularly with anyone who might be vulnerable for any reason.

Also given the failure of the Lightening Process organisation to previously respond Publicly to any of the reported adverse effects for people with ME, how is the study intending to address recording any adverse effects in a way that is independent of the LP coaches, who can be assumed to believe that no adverse effects are possible, just signs that the participants are not believing hard enough.
 
Peter Trewhitt said:
@Marky, this is perhaps less of an ethical no no than with the UK paediatric study, but still telling people with health issues to ignore medical symptoms and to lie about those symptoms is profoundly dangerous particularly with anyone who might be vulnerable for any reason.

Also given the failure of the Lightening Process organisation to previously respond Publicly to any of the reported adverse effects for people with ME, how is the study intending to address recording any adverse effects in a way that is independent of the LP coaches, who can be assumed to believe that no adverse effects are possible, just signs that the participants are not believing hard enough.
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Very good points! Thank u, will include :thumbup:
 
A couple of thoughts @Marky

1). If the "control" also go on to have LP later this makes long term follow up meaningless.

Given ME is a fluctuating condition and patients can have relapses that last months, plus some are lucky enough to go through less severe patches (though still ill), to get a true picture of whether any effect is down to LP or not there should be several follow up points - I would suggest maybe 3 or 6 months, then a year, then maybe 18 months.


2). LP is a proprietary therapy and participants are have to agree not to discuss the therapy with others. This being the case there is no reason why there couldn't be a control arm, given a treatment similar to LP but with vital differences, as being honest about symptoms.

Again several follow up points should be included.
 
Invisible Woman said:
A couple of thoughts @Marky

1). If the "control" also go on to have LP later this makes long term follow up meaningless.

Given ME is a fluctuating condition and patients can have relapses that last months, plus some are lucky enough to go through less severe patches (though still ill), to get a true picture of whether any effect is down to LP or not there should be several follow up points - I would suggest maybe 3 or 6 months, then a year, then maybe 18 months.


2). LP is a proprietary therapy and participants are have to agree not to discuss the therapy with others. This being the case there is no reason why there couldn't be a control arm, given a treatment similar to LP but with vital differences, as being honest about symptoms.

Again several follow up points should be included.
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I knew i forgot something! I have your first point as one of my main complaints. The trial is literally designed to get placebo effects, so without follow up its pretty meaningless

With regards to ur point 2, thats very true! Ill mention that in the context of point 1

Thank u! :thumbup::emoji_clap:
 
Another point, sort of covered already:

LP is a commercial and secretive training method that only those who are trained by the LP organisation are allowed to practice, and neither patients nor practitioners are allowed to reveal the details of the therapy.

This makes it impossible for ethics committees to give valid ethical approval since they don't have access to the details of the therapy.

It also makes it impossible for independent researchers to try to replicate the research, making it scientifically invalid.
 
Marky said:
Lastly i said that its not acceptable to only listen to the experiences of the few people that claim to be cured through LP in the "Recovery Norge"-group, when a survey from the Norwegian ME-association showed that over 50 % reported worsening from LP. The researchers have chosen to completely ignore this, and they dont respond when asked about it. This does not bode well for neutrality in their research.
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Great point :)
 
Marky said:
I agree!

Although the journalist said it would be a short article, so I don't wanna waste anyone's time in case it does not get included.
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The problem with this would be the difference between different scientific fields, and a difference of opinion about what is important to research. For example, blinding will be hard/impossible in some fields due to the nature of the interventions used. And how the control group should be treated (or not ;) ) would depend on the goal of the study. I don't think dismissing "stepped wedge" as a bad design is useful for us, but explaining why it's not a good design for ME/CFS (the fluctuating symptoms like @Invisible Woman brought up) might work.
 
Trish said:
Another point, sort of covered already:

LP is a commercial and secretive training method that only those who are trained by the LP organisation are allowed to practice, and neither patients nor practitioners are allowed to reveal the details of the therapy.

This makes it impossible for ethics committees to give valid ethical approval since they don't have access to the details of the therapy.

It also makes it impossible for independent researchers to try to replicate the research, making it scientifically invalid.
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Ahh yess I forgot to think about the replication problem. Thats actually a really crucial issue! Thanks Trish :thumbup:
 
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