Lightning Process study in Norway - Given Ethics Approval February 2022

A deeply depressing decision!

 

This makes all the bleating about unapproved treatments especially dumb and hypocritical, especially given that BMJ published SMILE.

Can't criticize pseudoscience when the officially supported treatments are literally harmful pseudoscience of the worst kind. Even by the standards of political hypocrisy, this is excessive. It's actually hard to be this blatantly corrupt and unethical.

 

To summarize, the NEM committee granted ethical approval after asking that the following conditions be met:

• that Live Landmark (principal investigator & LP coach) won’t be involved in the recruitment of participants
  
  
• that the data analysis be done an independent statistician
  
  
• that Live Landmark’s financial conflict of interest be “clearly communicated in all writings and publications from the project, including in the information letter to NAV [Norwegian Department of Work and Pensions], GPs and specialist health services”

• that the anonymized trial data be made available following the FAIR guideline (go-fair.org) even if the results of the trial aren’t published
  
  
• that the trial registration be carefully detailed to “curb possible future objections associated with the choice of outcome measures and statistical analyzes”
  
  
• that a safety assessment be made, but since there is no agreement on whether the method can lead to injuries, this doesn’t seem to be possible (?); “there is a need for more knowledge on the problem”

A majority of the NEM committee (9 members out of 12) agreed that these measures sufficiently addressed the issues raised by the Norwegian ME Association in their appeal.

By contrast, a dissenting minority of 3 committee members, including the chair and the deputy chair of NEM, said:

“The primary endpoint of the study is based on a questionnaire with self-evaluation of symptoms and function. This is less suitable than an objective evaluation if there is real doubt about the researchers' independence, and the validity of the answers also becomes uncertain when a central part of the course consists of learning verbal reformulations of one's own experiences.

The minority further believes that the potential for physical side effects has not been sufficiently taken into account, as the participants may have unknown underlying diseases. One of the characteristics of CFS / ME, based on the criteria by which the project itself operates, is precisely effort-induced fatigue, and the risk for vulnerable participants therefore appears to be real.”

 

As far as I can see, NEM have not stated so.

 

I see that the University of Bristol are collaborating

this surely goes against the NICE guidelines (although I don't imagine they are bothered)

 

I assume those only apply to clinical advice, don't apply to research. Clearly "researching" pseudoscience is good and official.

Of course this is only because this particular type of pseudoscience is beloved, don't try that with any non-official pseudoscience or there would be consequences.

 

I think that responding with this study is the best reply to anyone whining about patients trying untested treatments. When medical institutions are openly supporting pseudoscience, and in fact the current official treatments are basically the same thing, any criticism of untested treatments must apply the same to this junk study, they must denounce this equally, and demand high quality research.

But of course none of this is happening, no one who criticizes the desperate patients for trying to get better, while the BS official treatments are essentially based on the opposite, wants high-quality research that will properly define Long Covid, almost no one actually supports that, they only criticize the patients for the fact that it's not happening.

Because there is an entire national healthcare system behind this study, openly supporting pseudoscience that essentially screams: there will never be any treatment for this, we are making damn sure of it. Medicine has to choose between science and pseudoscience, they are fully mutually exclusive.

 

Among the three dissenters out of the twelve NEM committee members were the chair and the deputy chair of NEM, respectively Kari Milch Agledahl and Anne Kjersti C. Befring. The third, Steven Blackman, is a lay member.

https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/nem/about-nem/

 

Uh. Courage, a rare sight at this level. RIP to their career.

 

How did the ethics committee ensure that participants in the "trial" would be given sufficient information to enable them to give "informed consent"?

 

Personally, I don't think anyone within the orbit of Pluto who is involved with LP should be involved in the recruitment of participants.

 

Presumably the Lighting Process organisation will still have someone selecting potential participants’ readiness for the ‘course’, somewhat defeating excluding any individual trainer, ie Live Landmark from the recruitment process. Also there is still plenty of opportunity for highly partisan ‘researchers’ to introduce bias at subsequent stages. In general when evaluating bias, even when researchers are completely unaware of their impact, if there is an opportunity to introduce bias it will be found.

Also presumably LP practitioners, including Live Landmark, will also be involved in undertaking the LP sessions and facilitating the evaluation. It strikes me, unless they have a meaningful control, allocate to the trial arms randomly, have evaluation facilitated independently by a neutral third party blinded to who was in which trial arm and have objective outcome measures there remains considerable scope for introducing bias.

 

This is being shared a lot in response to the study's approval, how they recruit participants and how obviously any such trial fails at randomization, you can't have a randomized cohort while also selecting for the people most open to being manipulated (or likely to recover on their own anyway, only the mildest of mild cases). Especially while people are whining about giving false hope when this is being hyped like Zeus on a cracker.

Is there an English version of this? It would make a bigger splash, could be shared in response to all the whining about unevidenced treatments while there is currently not a single ongoing clinical trial and the medical profession has clearly and openly made the decision to do nothing at all about this major disaster, for which medicine is itself responsible in the first place.

https://twitter.com/user/status/1547270670052106242

 

It's two pages from an application form. Don't know if it's still in use.

Here's a quick translation:

Application form
The Lightning Process seminar

Am I ready for the training program?
Fill out this application form and send it to us. Once we have received it, you will get a place on our waiting list. When time is near, we'll call you to find out if this process is right for you at this current time.

The Lightning Process (LP) is a training program. Our experience indicates that those who use the methods from the teaching of LP can start a change of old thought-and behavioural patterns that are influencing their health.

As in any training program, the instructor can only take responsibility for teaching and training to the best of his or her ability. Then the participant must acquire the knowledge and methods him or herself. If the participants don't follow the course plan and teaching, they'll obviously see little of the benefits. We recommend that you think carefully before enrolling in this course. Does it appeal to you and do you think it sounds sensible, something you can commit to?

If you feel insecure, skeptical or just want to try it out to see what happens, then this is probably not the right time for you. It's important that you are honest with yourself and this application. Wait until you feel certain, talk to others who have done the process, see what else is available, so you don't have to waste both time and money.

How the training takes place.
A lot will be required from you over the three days of the course, but if you take the challenge, the rewards could be formidable.

The course leader has a demanding role in assisting the participants as they go through this challenging process. There are some special ground rules and understandings that will make the training easier for you and them.

The course leader will do his or her best for you to get the result you want. As a result:
- They will not tolerate any behavior that prevents you from achieving the success you deserve
- They will give you honest and important feedback, do not misunderstand this as they not caring.
- They will not always say what you want to hear.
- If what you do will be at the expense of your success, they will tell you, even if they risk you getting annoyed with them.

-----------------------------

4. How ready are you.

How big do you think the possibility is that you can get back your life with the help of the Lightning Process? Use a scale from 1 to 10, where ten is the highest...____

Give a score on the following claims on a scale from 1 to 10, where 10 means that "I agree completely with this claim".

Claim 1.
I will solve all my challenges. ___

Claim 2
It's possible for me to solve all my challenges. ___

Claim 3.
I am capable of learning how to solve all my challenges. ___

Claim 4.
It is suitable for me to solve all my challenges and I am prepared to do what it takes to make these changes. ___

Claim 5.
I am willing to change negative life style patterns, thought processes and limiting beliefs. ___

Claim 6.
I am responsible of solving these challenges and have power to do so. ___

Claim 7.
I deserve and am worthy enough to solve the challenges. ___

Claim 8.
When it comes to my challenges and my abilities to follow instructions, I am similar enough to all the others who have used the process to get back their lives, so that I can achieve the same change-results as them. ___

I have decided to become the next success story YES/NO/MAYBE

5. X-factor
Write a few sentences about what you feel is needed from YOU through The Lightning Process to achieve the same changes others have made.

 

My aspiration: Hope no one falls for this BS.