Study Protocol: Long-term Effects of COVID-19 in Adolescents (LoTECA), Wyller

MSEsperanza

MSEsperanza

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The international collaborative on fatigue following infection (COFFI), 2018, Katz et al

Long-term Effects of COVID-19 in Adolescents (LoTECA)

Information provided by (Responsible Party):
Vegard Wyller, University Hospital, Akershus

Primary Outcome Measures:
Fatigue [ Time Frame: 6 months follow-up ]
Total sum score on the Chalder Fatigue Scale (range 0 - 33, lower scores means less fatigue, ie. better outcome)

Study protocol:
https://clinicaltrials.gov/ProvidedDocs/34/NCT04686734/Prot_000.pdf

"Recent neurobiological studies suggest that PICF/CFS is related to misguided automatic and unconscious predictions.26,54

"This alternative model is supported by evidence of psychosocial factors (such as negative life events and trait negative affectivity) being risk factors for long-lasting post-infectious conditions."

References:
26 = Kube T, et al. Clin Psychol Rev 2020;76:101829
54 = Van Den Berg O, et al. Neurosci Biobehav Rev 2017;74:185-203.

For the present project, an advisory board of users will formally established, consisting of a) One representative from the “Youth council” at Ahus, consisting of adolescents suffering from chronic disorders; and b) One representative from the organization Recovery Norway, consisting of individuals having recovered from post-infectious chronic fatigue and similar conditions.
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Posted on this thread because..

The present projectis hosted by the PAEDIA research group at Akershus University Hospital (Ahus)
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The PAEDIA research group is headed by Prof. Vegard Wyller, who is also the PI of the present project, and Chair of the COFFI collaboration.
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Prof. Wyller is the most published and cited PICF/CFS researcher in Norway.
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National collaborative network and the COFFI collaborative
Over the last decade, Prof. Wyller has established a multidisciplinary national scientific collaborative network, covering a large area of expertise. Several co-publications exist. For the present project, the collaboration with Profs. B. Fevang and T.E. Mollnes at Oslo University hospital provides expertise in basic and applied immunology, the collaboration with Prof. H.L. Nilsen provides expertise in molecular immunology.
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As of March 2019, the consortium is chaired by Prof. Wyller; basic infrastructure (data managing, biobanking, statistical support) has been established, and will be made available for the present project.
Important measures to ensure integration between all collaborators encompass a) Shared responsibility for PhD supervision, b) Regular meetings (video link for international partners) to discuss scientific and strategic challenges; c) Hosting of seminars; and d) Face-to-face meetings.
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Edit: Seems they have a new website: https://www.coffi-collaborative.com/participatingcohorts

:confused: :ill:

@dave30th

Edit 2: Perhaps someone should ask Retraction Watch to follow up the Wyller's music therapy story?
 
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The study actually looks interesting. Look forward to seeing the results.

IMHO: the more researchers doing prospective studies on COVID-19 cases, the better (even if they have published bad studies in the past). We have to use the occasion to get valuable data on this.
 
Michiel Tack said:
The study actually looks interesting. Look forward to seeing the results.

IMHO: the more researchers doing prospective studies on COVID-19 cases, the better (even if they have published bad studies in the past). We have to use the occasion to get valuable data on this.
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Even with the Chalder questionnaire as primary outcome? Maybe someone should send the researchers a critique of CFQ, and encourage them to at least add a different fatigue scale and objective activity measurement.
 
Trish said:
Even with the Chalder questionnaire as primary outcome? Maybe someone should send the researchers a critique of CFQ, and encourage them to at least add a different fatigue scale and objective activity measurement.
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Yes, but they will also test many other things including different ME/CFS criteria.

I think the CFQ biggest problems are with its use in treatment trials (because of the interpretation problems and ceiling effects).

In cases like this, I think it's not that bad that it would ruin an entire study. It will indicate if patients have a lot of fatigue-related symptoms or not.

What do you see as the biggest issue with it in this context?
 
Michiel Tack said:
What do you see as the biggest issue with it in this context?
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Wyller's history of misrepresenting his own results is enough of a problem for me.

IMO the biggest problem with PACE was the researchers, and that was a big problem.

Here we have Wyller working with Recovery Norway, as with his music CBT study. I don't think that this is likely to be great.
 
Michiel Tack said:
Yes, but they will also test many other things including different ME/CFS criteria.

I think the CFQ biggest problems are with its use in treatment trials (because of the interpretation problems and ceiling effects).

In cases like this, I think it's not that bad that it would ruin an entire study. It will indicate if patients have a lot of fatigue-related symptoms or not.

What do you see as the biggest issue with it in this context?
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Aside from lack of credibility and a useless primary outcome, the lab work is very basic and has already been done. This is not their strength, whatever their strength actually is. Like Wessely doing a few immunological tests and calling it a day. Many studies have already gone into far more depth analyzing metabolites, immunological profiles and the rest of what they are testing for, already published.

It's only better than usual because they are doing lab work instead of just psychometric questionnaires. That's a very low bar, especially in the wrong hands and whatever that hypothesis about "misguided predictions" is doing there. It's just a waste of resources, frankly, will have no useful impact.

But in a sense if this means taking up time away from usual BPS junk, that makes it a trivial positive.
 
Spotted this on Twitter shared by Billy Hanlon.

The Centre for Pandemics and One-health research has interviewed Vegard Bruun Bratholm Wyller on adolescents with Long Covid. He also talks about ME/CFS

quotes:

What we are seeing now eventually is a kind of long COVID pandemic in the aftermath of the acute pandemic, which of course is also part of the greater picture. So, I think it is pertinent for the One-Health initiative to be interested in these long-term effects as well. By this,I mean that in addition to being interested in the biological mechanisms pertaining to the infection and immunity, we should also be interested in, for instance, the mental, psychological and social phenomena that occur simultaneously.

In the study we published, we found that in the group that did not have COVID, there was also a large number of people with chronic fatigue and other chronic problems. We believe this was partly due to the more general pandemic effect on society. The anxiety related to the situation, the lockdowns, and the social isolation people experienced. All this has consequences for symptoms. This is therefore very complex and very interesting also from a societal perspective.

...


The theory says that what you experience is not so much dependent on what is coming to you of information, but more on your predictions, such as what you think you are seeing. It is therefore related to how the brain functions, which is probably more amenable in the youngest. This is at least our hypothesis.


https://www.med.uio.no/sustainit/en...d-events/news/2024/0212_vegard_interview.html
 
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