Lightning Process study in Norway - Given Ethics Approval February 2022

Three Chord Monty said:
This is a relatively rare and welcome item--a rather scathing column about the whole brouhaha.

SIGMUND OLAFSEN
Worthless and unethical ME research
As a researcher, I am frightened that there are still some who want self-reported, subjective effect goals as an outcome of research, writes Sigmund Olafsen.

https://khrono.no/verdilos-og-uetisk-me-forskning/595007
https://translate.google.com/transl...etisk-me-forskning/595007&prev=search&pto=aue







Wow.
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It would more accurate to describe them as lobbyists but whatever the framing is fair and they are behaving exactly as they accuse of. Scathing and fair piece. It really is important to point out that this study was completely unable to inform anything and had nothing to do with science, it was far more a marketing campaign than anything. This deserves serious condemnation for having gotten this much support from high places. It makes a mockery of science and makes medicine frankly look like no different than the worst of alternative medicine.

I hope we see more of this. Sanity is badly needed.

Edit: typo
 
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Here we go again with yet another round.

Nina E. Steinkopf has written an article where she tells that this planned Lightning Process study has gotten a new ethical approval from one of the Regional Committees for Medical and Health Research Ethics. They are the same who approved the study in last round, until The National Committee for Research Ethics overruled and withdrew the approval.

It seems that the study design this round is very similar to the last one. It will still be LP coach Live Landmark who will perform the "treatment", but a research nurse "will have a semi structural conversation about motivation for change, in line with the trans-theoretical model where the participants are ready to actively participate in their own process of change" (my translation).

Nina E. Steinkopf: Kontroversiell studie får ny, etisk godkjenning
google translation: controversial study gets new, ethical approval

quote:
The candidate, Live Landmark, will still be a course instructor. It may seem that the conversation with the "research nurse" is in addition to - and not a replacement - for Landmark's involvement.
 
If the "semi structural conversation about motivation for change" is new then the study is even worse than the one before that got rejected in terms of bias. If not then nothing has changed substantially. Landmark proving the national ethics committee was right to reject this.
 
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Snowdrop said:
Could you provide a link to that statement?
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It's from the .pdf Noir linked to, where the region midt ethics committee writes what they think about this new application in light of the objections from the national ethics committee on the lack of objective outcome meaurements. Google translate of the part I'm referencing:

Region Midt Ethics Committee said:
Primary endpoints
We do not perceive that NEM demanded objective primary endpoints, but they write that «It would have strengthened the project if there had been more objective, primary endpoints in the evaluations ».

You have not changed the choice of primary endpoint, but elaborate on the reasons for the choice in revised protocol (v. 3.0). Validated questionnaires must be used. The Committee agrees your assessments of what will be scientifically appropriate, and accept that this the point remains unchanged.
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Here is a google translate of the application where this is discussed:
Application said:
CFS / ME is a subjectively reported condition without objective markers. We therefore measure improvement and possible deterioration with the help of established questionnaires, as well as objective improvement of work ability with register data from NAV.

We have not found other relevant objective outcome measures for which there is a scientific basis. The cost of experimental objective outcome measures are too high and without validity weighed against the potential benefit we have reason to expect. It is considered potential objective measures, such as actiometers and pedometers, but there is no basis in the literature to say that people with CFS / ME moves less than others who are on sick leave and out of school / work.
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And these are the listed questionnaires: SF-36 (RAND), Chalder Fatigue Questionnaire, Brief Pain Inventory, A Brief Questionnaire to Assess Postexertional Malaise, The Warwick-Ediburgh Mental Wellbeing Scale (WEMWBS), Patient Global Impression of Change (PGIC), Kvalitet på parforhold/dyadisk funksjon, En 10-punkts versjon av Big Five Inventory, Brief Illness Perception Questionnaire, Hospital Anxiety and Depression Scale, Insomnia Psychological assessment and management.
 
Snowdrop said:
Could you provide a link to that statement?
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There's more info in the application pdf I linked in my other post, but it's in Norwegian, and I don't think Google Translate translate whole PDFs.

But here's a relevant section from the application:

"The reason for the choice of data and method in the project
3.6 Explain the academic and scientific justification for the choice of data and method

There is anecdotal evidence for the good effect of a 3-day course for CFS / ME. Two qualitative studies indicate positive effect, but also that are different experiences. A randomized controlled trial in adolescents with CFS / ME showed a positive effect on all measured parameters, and none serious side effects. There is no randomized controlled trial in adults with CFS / ME, and there is disagreement about the effect of participation.

CFS / ME is a subjectively reported condition without objective markers. We therefore measure improvement and possible deterioration with the help of established questionnaires, as well as objective improvement of work ability with register data from NAV.

We have not found other relevant objective outcome measures for which there is a scientific basis. The cost of experimental objective outcome measures are too high and without validity weighed against the potential benefit we have reason to expect. It is considered potential objective measures, such as actiometers and pedometers, but there is no basis in the literature to say that people with CFS / ME moves less than others who are on sick leave and out of school / work. There are no parts of the teaching that indicate that they should / must increase their physical activity"

It might not be the best translation, but you get the idiocy of it.
 
Thank-you @Midnattsol and @Noir

The reason I asked was because we do have some threads here on the various questionnaires often used by this group. The word 'validated' may be true but not surprisingly implies validity. The Q / measures may be 'validated' by those who use them but are not necessarily valid in terms of what they really measure or how they are interpreted (as we all well know).

So just for resource and for anyone new who comes upon this -- here are threads on two of the questionnaire's mentioned:

Chalder Fatigue Q S4ME discussion:

https://www.s4me.info/threads/explo...ic-fatigue-syndrome-1998-morriss-et-al.11065/

HADS:

https://www.s4me.info/threads/the-hospital-anxiety-and-depression-scale-hads-a-discussion.10160/

There are links in the science library to other questionnaires mentioned but no discussion threads as of yet. It could be useful to critique some of those as well (but I'm not volunteering as it's not in my ability).
 
Kalliope said:
Here we go again with yet another round.

Nina E. Steinkopf has written an article where she tells that this planned Lightning Process study has gotten a new ethical approval from one of the Regional Committees for Medical and Health Research Ethics. They are the same who approved the study in last round, until The National Committee for Research Ethics overruled and withdrew the approval.

It seems that the study design this round is very similar to the last one. It will still be LP coach Live Landmark who will perform the "treatment", but a research nurse "will have a semi structural conversation about motivation for change, in line with the trans-theoretical model where the participants are ready to actively participate in their own process of change" (my translation).

Nina E. Steinkopf: Kontroversiell studie får ny, etisk godkjenning
google translation: controversial study gets new, ethical approval

quote:
The candidate, Live Landmark, will still be a course instructor. It may seem that the conversation with the "research nurse" is in addition to - and not a replacement - for Landmark's involvement.
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Literally going with "same but with a fake mustache". And here the joke is not the clowns, but those who give assent to the clowns, making themselves the bigger clowns.

Why even have committees for ethics? Just dispense with the theater. Not even pretending to be serious here:
The cost of experimental objective outcome measures are too high and without validity weighed against the potential benefit we have reason to expect.
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This is like telling your teacher in advance that your dog will eat your homework and your teacher pretending it's a real excuse. Incredible. As in literally no credibility.
 
Nina E. Steinkopf is sharing more from the study application. It's not possible to google translate the text, so here's a hasty translation by me:

"It's important to be aware of the existence of the "ME-society", an internet based society, which among other has been described by Olaug Lian "United we stand" (2015). They followed 14 ME fora over three years and unraveled a virtual society with strong unity and feeling of togetherness.

The members of the ME-society view CFS/ME as a pure "physiological disease" and are negative to treatments that don't support their view. The attitude is that one must "save energy" and "adapt the activities", even if there is no scientific documentation supporting this. The norm in the internet societies is strong when it comes to what is allowed to say and what is not allowed to say, and there is no room for other voices. The researchers found no examples of positive experiences with the health care services.

The members share knowledge in line with their reality, and warn about the "danger of psychological treatment".
"The ME-society" create doubt regarding the effect of the 3-day course in general, and the candidate's motivation in particular. We don't think that is any reason to not go through with a study in a controversial field as CFS/ME.
Even if the study won't convince "the ME-society", we believe it's ethically problematic to not perform a study on a potentially useful measure for a substantial group of people which basically have no offers of documented measures".

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Snowdrop said:
The Q / measures may be 'validated' by those who use them but are not necessarily valid in terms of what they really measure or how they are interpreted (as we all well know).
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I wonder what validated means. From what I remember the CFQ was validated in terms of detecting ill people vs healthy people (I remember a paper with a RoC curve). But I don't think I have ever seen any work to validate that it measures change well which is how it is being used in a trial - and both marking schemes can't be valid as they can contradict each other (in practice as well as in theory - we've seen that in both the PACE and FINE trial data).

I wonder if validation of questionnaires used in terms of their ability to measure differences would be something worth tackling in the context of these trials.
 
Doesn't that letter from Crawley (pre NICE 2021) now raise a problem for this LP study ? If Crawley's work and the role of the Bath Clinic (largest in the world !?!) are inherently contributants to the position in England that led NICE to downgrade CBT and remove GET, then surely Crawley's support for the LP study is now both paradoxical and a negation of the standing of the proposed research ?
 
Adrian said:
I wonder if validation of questionnaires used in terms of their ability to measure differences would be something worth tackling in the context of these trials.
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Especially since data from other CBT/GET trials suggest a negative correlation between subjective scoring and actual measured activity!
 
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