Lightning Process study in Norway - Given Ethics Approval February 2022

Kalliope said:
The Research Ethics Committees for Medicine and Health Sciences (NEM) have ruled that the design of the Lightning Process study is NOT satisfactory and that the study should NOT take place. It is not possible to appeal this decision.
:party::party::party:

google translated:

NEM believes that the project's greatest weakness is the research fellow's active role in all stages of the project, and the conflict of interest that arises because the research fellow has strong business interests in the project giving positive results. The conflict of interest most clearly emerges in the selection of the participants, which primarily takes place on the basis of a conversation with the research fellow. There is a possibility that the method means that only those who initially have the greatest potential for improvement are included. Furthermore, NEM believes that it is a problem that the selection appears to be based on subjective assessments that the research fellow must make. Should the method and any effect have transfer value, the selection criteria must be objective enough to be performed by others.

If society is to listen and have confidence in research results, it is important that there is no doubt that the researcher is primarily guided by a desire to gain new knowledge in an objective and trustworthy way. Projects where justified and serious questions of conflict of interest can be asked will not be able to achieve the necessary trust. In a controversial field of research, as research on the Lightning process must be said to be, this is extremely relevant.

NEM believes that the measures implemented in the project are not good enough to reduce the conflict of interest and create confidence in the results of the research. In that case, the research will not have the necessary potential for societal benefit.

Regardless of the results of the research, NEM believes that due to the conflict of interest mentioned above, it will be difficult for the research fellow to front the results of this research. The institution responsible for research has a special responsibility to prevent research fellows being placed in such a situation.

The term "sound research" includes an assessment and weighing of both risk and benefit of a research project. In this project, risk and inconvenience have been satisfactorily managed in NEM's opinion. However, based on the combined assessment of the project's design and the conflict of interest related to the research fellow, NEM considers that the project is not to be regarded as justifiable and cannot be carried out in its current form.

source original version in Norwegian

Source google translated
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Invisible Woman said:
Fantastic news!

I actually had to reread that paragraph 3 times to make sure it did say what I thought and not what I thought it should!

Well done to everyone involved in making submissions, writing letters.etc. :thumbup:
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"Should not take place in its current form". It's still a win and I'll take it :laugh:

Their biggest issue seems to be that Landmark would choose the participants and that this would be done without using objective criteria (so that it cannot be generelizable to others pwME), I wonder how they will try to get around that. Also NEM wants more objective primary outcomes, and they nailed the "teaching participants to answer better on questionnaires" issue.
 
This is disappointing:
In this project, it has been chosen to use a waiting list design, where the control group reviews
same course ten weeks after the intervention group. Waiting list design is a widely used design within
therapy research, and NEM has no objections to the choice of such a design
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But this is more interesting:
One weakness of the project concerns the evaluation of the effects of the intervention that takes place with the help
of a questionnaire, and that the interventions partly deal with how to respond to
questions about one's own health. NEM believes that the method poses a risk that the intervention could have an effect
the responses from the participants, for reasons other than real improvement. As NEM has perceived
intervention, a key part of what participants learn will be to overlook negative symptoms and to
put the spotlight on positive experiences. They are also encouraged to use active language, avoid
think of your own limitations, and to reinforce your own progress. The change in the way of thinking will
could significantly color the answers given in the questionnaire immediately after the course. The questionnaire
also contains elements that in more indirect ways can indicate effects of the intervention.
Information will also be obtained from NAV for an objective comparison of
work participation before and after the intervention. NEM believes that it would strengthen the project if
there had been several objective, primary endpoints in the evaluation
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Midnattsol said:
they nailed the "teaching participants to answer better on questionnaires" issue.
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This could be a serious obstacle to any further LP studies. It's at the core of what is LP is and how it's supposed to work which seems to imply that LP studies are inevitably fatally flawed. Unless they use objective outcomes but I think Landmark is clever enough to avoid them. They're likely to show no benefit and this would risk showing that LP is ineffective which is contrary to her goals.

Modifying LP to avoid the "telling others you're recovered/improved" issue risks weakening the effect (probably quite substantially). Even if a hypothetical study obtains a positive effect with a modified LP, it could fail to give credibility to the unmodified LP. The "telling others you're recovered/improved" component of the unmodified LP is also important in promoting LP via testimonials so it is not desirable to actually use the modified LP even if achieved a positive study result.

She might just decide that it's not worth pursuing this further.
 
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Jonathan Edwards said:
Well I'll be darned.
It shows how important it is to keep voicing concerns.
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Im so fucking ecstatic Jonathan.

I was one of the ones who sent appeals with the methodological concerns, and to see The Research Ethics Committees explicitly acknowledge what we wrote and agree has given me som belief in the system again. This was a HUGE decision for us. That study would have been a disaster, everyone could see it except REK-midt and the researchers. Lets go!
 
Marky said:
Im so fucking ecstatic Jonathan.

I was one of the ones who sent appeals with the methodological concerns, and to see The Research Ethics Committees explicitly acknowledge what we wrote and agree has given me som belief in the system again. This was a HUGE decision for us. That study would have been a disaster, everyone could see it except REK-midt and the researchers. Lets go!
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Well done :thumbup:
 
Midnattsol said:
Their biggest issue seems to be that Landmark would choose the participants and that this would be done without using objective criteria (so that it cannot be generelizable to others pwME), I wonder how they will try to get around that.
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The initial assessment is a fundamental part of the LP. Allegedly, it assesses if you are "ready" or "suitable" for treatment. As far as I know every LP participant has to undergo this first.

It makes a nonsense of objective research because it is an ideal opportunity to cherry pick people who are most likely to be compliant during the course and tell the course leader what they want to hear.
 
When Esther Crawley published her Lightening Process study in 2018 I thought great, the whole methodology of open label trails with subjective outcomes in ME will be seen for what it is, this study being the ‘reductio ad absurdum’ of this approach when it purportedly endorses such a patently nonsensical intervention. Unfortunately the reverse seemed to happen and apparently serious scientist had taken the author’s and the LP’s claims on face value.

So it is great news that Lightening Process empire building in Norway has received this set back, which hopefully is reported world wide. Well done to all who fought it.
 
The committee's view that wait list controls are adequate is odd. It's easy to find critiques of the wait list control groups in psychotherapy research. It has even been argued that they could be a nocebo.

This raises an interesting question about what control group would be ideal. Given the reports of deterioration following contact with the healthcare system as well as widespread dissatisfaction, care-as-usual for ME may also be a nocebo.

Things are so much easier with a placebo control group.
 
strategist said:
The committee's view that wait list controls are adequate is odd. It's easy to find critiques of the wait list control groups in psychotherapy research. It has even been argued that they could be a nocebo.
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I agree it's easy to criticise, but waiting list controls is acceptable in psychological research, as far as I understand..
 
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This come right after Live Landmark, the Ph D candidat and ovner of LP in Norway tweets this

and this (I deleted this as it came with tweet from a third person)
(I hope it is easy to translate from Norwegian in Twitter, it uses to be that.)

Quite convenient that those attitudes got negatively rewarded today!
 
Presumably they can alter this and resubmit... but still, that was part of the problem with the study, and I'm surprised by an ethics committee taking a serious concern about a study like this seriously. As a sign things aren't as bad as I expected, that's got to be good.

It's a bit grim that things are so bad that I can be unsure whether making improvements is useful or not: maybe it's better to have things being as transparently terrible as possible?
 
Kalliope said:
waiting list controls is acceptable in psychological research, as far as I understand..
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It may be used by some but I think there is no good justification for this. It is not hard to see why a waiting list control is highly problematic. A child could understand it.

So if the field finds this acceptable, then psychological research would simply be unacceptable.

Esther12 said:
It's a bit grim that things are so bad that I can be unsure whether making improvements is useful or not: maybe it's better to have things being as transparently terrible as possible?
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I really think things are getting better and I would take any improvement no matter how small.

That said, a couple of years ago I thought Norway was a leading example in ME/CFS research, so it has been sad to watch this whole episode about the Lightning Process and CBT + Music therapy, Larun accusing activist patients of attacking her review, and now the study by Gotaas.
 
One weakness of the project concerns the evaluation of the effects of the intervention that takes place with the help
of a questionnaire, and that the interventions partly deal with how to respond to
questions about one's own health. NEM believes that the method poses a risk that the intervention could have an effect
the responses from the participants, for reasons other than real improvement. As NEM has perceived
intervention, a key part of what participants learn will be to overlook negative symptoms and to
put the spotlight on positive experiences. They are also encouraged to use active language, avoid
think of your own limitations, and to reinforce your own progress. The change in the way of thinking will
could significantly color the answers given in the questionnaire immediately after the course.
Click to expand...
NEM's clear recognition of this must surely have implications beyond the LP, because ME/CFS trials for CBT and GET have been plagued with the same sort of bias.
 
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