Lightning Process study in Norway - Given Ethics Approval February 2022

Midnattsol said:
This article may belong in the News from Scandinavia where I have collected a few others in the same series, but it was very relevant here. How to design your study to give a positive result, and I think most will recognize the study design of the LP study ;)

Recipe for study that will give good results
  • Let the study be carried out by researchers who have a lot to gain from good results for the form of treatment being tested. It tends to affect the interpretation of the results.
  • Carry out the treatment in the studies in a way that maximizes the hope and expectation of the participants, not necessarily the way the patients will receive the therapy in reality.
  • Not controlled for the placebo effect! Rather, set up the experiment so that you compare the treatment with something that might make the patients worse. This is how it looks like your treatment is having a great effect.
  • Bring a few participants. This increases the chance of incidental positive findings, even when the treatment does not really have an effect.
  • Measure many possible changes to the treatment. If the method doesn't seem to work on what you were supposed to investigate in the first place, some positive changes may appear on the other targets. And then you can just focus on them, while not talking so much about what didn't work.
  • And should everything still end in negative results, you can always put the study in the drawer, instead of making the bankruptcy public, write Cuijpers and Cristea.
The article also features a short discussion on the problems of wait list controls, with a link to a more in-depth article on the topic :thumbup:

Noe er galt i forskningen på psykologi
Something is wrong in psychology research
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Plus there seems to be the added thing of paywall ing and saying a different result in the abstract (only but available to most without paying) to what you had to admit in the results/conclusion?
 
Midnattsol said:
This article may belong in the News from Scandinavia where I have collected a few others in the same series, but it was very relevant here. How to design your study to give a positive result, and I think most will recognize the study design of the LP study ;)
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I don't recognize the LP study here. I recognize the entire biopsychosocial formula universal to psychosomatic medicine. They all do this. All of them.

Well, aside from the last point, where it's instead common to just make stuff up, even change outcomes to turn a null result into a false positive. Then go to court to hide data from reanalysis. Then when reanalysis shows the fraudulent change just escalate commitment to the fraud, since they can get away with it.

But if only this was just about psychology research. It may rely on psychology standards, but most of this is medical research. In fact it overrules better medical research, placing it above, lower standards actually erasing basic rights and the entire value of why science matters and what it's entirely about.
 
Sean said:
Not controlled for the placebo effect!

Nor any of the other known potential biases and confounders, that often get lumped together under 'placebo effect'.
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Everything else being equal is such an important factor that it's drilled into every economics class and textbook. It's sprinkled all over the place, in intro classes you'll hear or read it dozens of times. And it's economics, not exactly a hard science. It's also the basis of most statistical analysis. In addition to correlation being very different from causation.

Here instead it's basically nothing else is equal. They maximize ambiguity precisely so that it can't be determined what influenced the outcome.
 
Trial By Error: Norwegian Lightning Process Trial Ejects Questioning Participant

"The administrators of a controversial study of the Lightning Process currently being conducted in Norway have ejected a participant who expressed critical views about the biopsychosocial approach to ME, according to MELivet [MELife], Nina Steinkopf’s invaluable blog. This decision appears to be an acknowledgement that the intervention only works if you believe it will work."

https://virology.ws/2023/10/05/tria...process-trial-ejects-questioning-participant/
 
Midnattsol said:
Two opinion pieces in NTNUs own newspaper on the exclusion of a participant mentioned in post #999 in this thread. One by the patient herself, another by a carer of a pwME who is also an academic and has written about this study before.

Participant: - I got a chin drop when I received the exclusion letter

Other: Lightning process: - Exclusion of skeptical participants does not give confidence in the study
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The reasoning for dropping this participant from the study is that a skeptical patient is an Environment, Health and Safety issue for the PhD candidate LP coach Landmark. This is too absurd!
 
Midnattsol said:
Two opinion pieces in NTNUs own newspaper on the exclusion of a participant mentioned in post #999 in this thread. One by the patient herself, another by a carer of a pwME who is also an academic and has written about this study before.

Participant: - I got a chin drop when I received the exclusion letter

Other: Lightning process: - Exclusion of skeptical participants does not give confidence in the study
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Honestly this dropping of a participant is small potatoes compared to the screening process that requires people to believe in the treatment, and the direct involvement and supervision of someone with a huge financial stake.

This isn't about one participant, the whole thing is ridiculous biased and corrupt. If it's what makes some people clue in to this, fine, but the selection process is explicitly biased towards a favorable outcome, as otherwise it wouldn't be a fair evaluation of the treatment, which has always required to affirm belief in the treatment to be accepted. Which is all about as valid as a trial of the healing power of prayer from religion X, only accepting people who believe in religion X's healing power of prayer.

Bit absurd, even. This is part of the basis for why the project was controversial to begin with, and initially rejected. Then some fiddling behind the scenes, and likely lots of pressure, made it pass anyway. Because nothing is too corrupt or biased in so-called evidence-based medicine.

Hey, at least it's exposing how intellectually and ethically bankrupt this entire model is, but this is only going to matter in years. Meanwhile real people continue to be harmed. This is revolting.
 
The excluded patient have shared more information on this twitter thread (in Norwegian), including a copy of the letter she received telling her she could no longer participate, a letter sent by the research group to the regional ethics committee explaining why they have excluded her (short story: she is accused of having made "very critical" remarks of a biopsychosocial understanding of ME/CFS and professionals who have these views, having worked against the study in social media, and have been involved in an episode at a medical conference making serious accusations towards a doctor and researcher with BPS views in addition to another "similar episode), and lastly her rendition of the events mentioned in the letter to REC.

Nitter (site to view twitter without being logged in) link: https://nitter.net/LenaFoxfoot/status/1714648787895894316#m

The letter to the participant from the researcher has already been translated and can be read in post #999. But I am translating the letter from the research group to the ethics committee and the participants own telling of the events. Will do this in parts as I have already done a lot of cognitive work today.

Letter to the ethics committee from research group said:
Exclusion of registered participant in study

This is about the study "A three day course for CFS/ME in adults: A randomized controlled study", which is lead by NTNU. Project lead is professor Leif Edward Ottesen Kennair and project employee is ph.d. candidate Live Landmark. The person responsible for research ("Forskningsansvarlig") is head of the institute of psychology at NTNU Magne Arve Flaten. The study is approved by REK, application number 394844.

In the study a participant was recently included that over time have been active in social media with a very critical view of a biopsychosocial understand of ME and by professionals who hold these views. This person has worked against the study in social media. There has previously been an episode at a medical conference where this person came with serious accusations against a doctor and research that had a biopsychosocial view. There has also been another, similar, incident.

Inclusion of the participant in the study can careate a situation that challenged the quality of the ph.d. work, the working conditions of the ph.d. candidate, and the safety of the other participants. An important point is that the research participants are a very vulnerable group.

Due to possible unfortunate consequences for research, and health- environment and safety of the ph.d. candidate and other patients in this case, the person responsible for research have concluded that the person can not participate in the study. This has been communicated through letter the 13.09.2023 through the person responsible for including participants in the study.

With regards
Magne Arve Flaten
Head of institute, professor
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Participant's rendition of the events mentioned in the letter above:
Excluded participant said:
I have, as I write in the opinion piece, been openly sceptical to some parts of this study. In this explanation for exclusion, that NTNU sent to REK [regional ethics committee], it says that I in an episode at a medical conference have made "serious accusations towards a doctor and researcher that has a biopsychosocial view". Since I have only participated in one ME-conference, that was held by the ME-association and NKT [national competence center] for CFS/ME, I know this must be about a short conversation with Signe Flottorp from FHI [Norwegian Institute of Public Health] in a break. This is by the way the same Flottorp that through personal emails pressured members of the national research assication (NEM) to influence the decision to give the study ethical approval, while a complaint was under consideration.

In this break I heard first that Flottorp made critical comments about the research quality of a biomedical study to the person that had just presented the study. I then told Flottorp that I, personally, was not impressed by the meta-analyses by FHI around the effects of cognitive therapy and graduated exercise as treatments for ME. I also said ME doesn't have to be funded in psychology and that the one-sided psychologization of ME, that she fronts, have "taken peoples lives away". I am then thinking of both how publicity around this type of research in Norway have taken focus away from biomedical research and delayed effective treatments, and given patients and carers a one-sided representation that everyone with ME can fix themselves as long as they want to hard enough. So this is the "serious accusations". The other "similar incident" must have been that I wrote a comment on Twitter, on a tweet by Egil Fors, who is part of the study about Lightning Process and ME, after he came with what I would call poorly substantiated claims on the cause of "Long Covid". This is the comment I made: (screenshot)
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The letter says “A randomized controlled study”, however if subjects are preselected it is not randomised unless the control group undergo the same preselection and the randomisation only happens after the preselection, and even then it is only meaningfully controlled if the control arm undergoes an activity which is comparable in activity levels and contact with trainers/other participants.

But even then the study, without objective outcome measures is totally at risk of bias given it is open label.
 
The patient has written a new account of her experience in Khrono, after having been asked about her motivations for trying to participate in the study

That is why I wanted to take part in the ME study

I have been asked about my motivation for participating in the mentioned study. The motivation is that all stones must be turned over in the attempt to get better. Maybe I'll pick up some tools that might be useful down the road? After working in research environments for 35 years, I have probably developed a certain critical sense. I like to ask questions, and think that doubt is an important part of science. Both doubts about one's own understanding and hypotheses, and critical scrutiny of others'.
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After working in research environments for 35 years, I have probably developed a certain critical sense. I like to ask questions, and think that doubt is an important part of science. Both doubts about one's own understanding and hypotheses, and critical scrutiny of others
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That likely explains the reason for being excluded. Rational critical thinkers not welcome!
 
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