CBT combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study, 2020, Wyller et al

[ME/CFS Skeptic]

In rare instances we determine after careful consideration that we should not make certain portions of the prepublication record publicly available.

Thanks - hadn't seen this. Will try to reword my comment.

Why won't they share the peer review?

 

[MSEsperanza]

I worry that a word like "lie" carries implications around intent, and that we should avoid speculating on researchers' intent, and focus on the outcome. Think it is better to avoid that particularly word, with all it baggage, and say something closer to observable fact, like they "misrepresented" their study, and must have been aware they were doing so.

I tend to agree. But on the forum I think it's OK to say what we think. In this particular case I find it difficult to not use words that imply an intention like "lie" or "whitewash".

Genuine question: What's the correct term for a 'failed" trial like this one? Is it correct to still name it just a "randomised controlled trial" in the paper's title?

 

[MSEsperanza]

Agree, thanks for pointing this out.

Would this be better:

Yes -- happy you understood what I was meaning to say.

 

[MSEsperanza]

Thanks - hadn't seen this. Will try to reword my comment.

Why won't they share the peer review?

Yes. Whom do they think they need to protect and why? And why not even display the review without the reviewers' names?

I'm thinking about publishing the following comment on the republished version:

I very much hope they will accept your thorough response. Thanks again for your important work.

(Also, thanks again to @dave30th and @Jonathan Edwards for all you do - would be great if you put together an additional letter.)

 

[Hoopoe]

I'm sympathetic to @Esther12's position here. I worry that a word like "lie" carries implications around intent, and that we should avoid speculating on researchers' intent, and focus on the outcome. Think it is better to avoid that particularly word, with all it baggage, and say something closer to observable fact, like they "misrepresented" their study, and must have been aware they were doing so.

To say they misrepresented the study and must have been aware what they were doing is just a polite way to say lie.

 

[Trish]

I'm sympathetic to @Esther12's position here. I worry that a word like "lie" carries implications around intent, and that we should avoid speculating on researchers' intent, and focus on the outcome. Think it is better to avoid that particularly word, with all it baggage, and say something closer to observable fact, like they "misrepresented" their study, and must have been aware they were doing so.

To say they misrepresented the study and must have been aware what they were doing is just a polite way to say lie.

I dont understand the difference. Surely 'knowingly misrepresenting' is a definition of lying.

 

[Jonathan Edwards]

I dont understand the difference. Surely 'knowingly misrepresenting' is a definition of lying.

From what I remember 'misrepresentation' is the way it is defined in law. You can get convicted of it.

 

[Midnattsol]

I dont understand the difference. Surely 'knowingly misrepresenting' is a definition of lying.

From what I remember 'misrepresentation' is the way it is defined in law. You can get convicted of it.

Misrepresentation would also be against the research ethics guidelines in Norway, and is mentioned as an example of what could be a serious breach of ethics in the pre-works* of our research ethics law. As far as I know, we have no cases where this part of the law has actually been tested.

*I'm not sure what this is in english. A hearing..? Comments and ideas that were proposed before the law was finalized. The law itself states the normal about plagiarism, falsifications and fabrication, with an "also other serious offenses" at the end.

 

[Woolie]

Maybe you're right, @Trish, perhaps "misrepresentation" is just a euphemism for "lie". But to me it feels like "lie" is more loaded with baggage about presumed intention, whereas misrepresentation is the behaviour itself and leaves open whether it was intentionally misleading or just negligent.

 

[Trish]

I take your point, @Woolie, and if I were writing a paper or response for a scientific journal, I would use the word misrepresentation. I think in forum discussion it's fine to tell it like it is.

 

[Hoopoe]

A culture of treating these constant lies as possibly being honest mistakes that shouldn't be punished is maybe exactly what allows the authors to get away with them.

 

[ME/CFS Skeptic]

Made some changes to the letter (changes indicated in red)

 

[Hoopoe]

I don't know how much this study cost but it's probably not a small sum. Did we learn anything useful from it? No. To be honest this study is uninterpretable. Now the authors instead of admitting all the problems are spinning the results so they can have another go with a larger study and waste even more money. This money is supposed to help patients by finding out what works and what does not, not help advance the careers of researchers.

 

[ME/CFS Skeptic]

Thanks @Sly Saint

 

[Woolie]

I take your point, @Woolie, and if I were writing a paper or response for a scientific journal, I would use the word misrepresentation. I think in forum discussion it's fine to tell it like it is.

Of course!

 

[dave30th]

The intention-to-treat analysis of the Chalder Fatigue Scale ordinal scoring (range 0-33) was also reported, and this showed little difference between the two groups. A plausible explanation for what the authors describe as “a trend towards higher recovery rate in the intervention group” is the high drop-out rate. At follow-up, only 13 patients were in the intervention group. The analysis highlighted by the authors does not take into account the 8 persons who were in the intervention group but were lost to follow-up. There are little reasons to suggest that more patients in the intervention group recovered than in the control group. It is unfortunate that the authors have used this term in their manuscript.

I'm confused here. When you talk about the "analysis they highlight," you mean the per-protocol analysis rather than the intention-to-treat analysis, I think? Maybe you can make that clear.

 

[dave30th]

I take your point, @Woolie, and if I were writing a paper or response for a scientific journal, I would use the word misrepresentation. I think in forum discussion it's fine to tell it like it is.

I would say in a forum OR blog post I feel very comfortable saying they're lying. I agree that "misrepresent" or some other euphemistic phrase that is not explicitly accusing them of lying is better. People can misrepresent things inadvertently. You can't really lie inadvertently.

 

[ME/CFS Skeptic]

I'm confused here. When you talk about the "analysis they highlight," you mean the per-protocol analysis rather than the intention-to-treat analysis, I think? Maybe you can make that clear.

Thanks, I meant the recovery rates. Will change the text.

 

[Marit @memhj]

Important to remember that - in this particularly chosen patient-cohort:

The patient study screening for acute EBV canditates, here; n=895. The recrutment stopped at 200 eligibiled canditates. VBB Wyller is obsessed that fatigue and pain after initial infection is sustained cuz the patients thinking, feeling and making stronger connetctions in the brain.

So to break this (fantasy - make believe - illusions hypothesis) signal-connections for fatigue and pain he initiated a early treatment program at 6 months (yes, same arguments for the Lightning Process (LP)). (and... ironyfact Herpes is persistent, once infected - they stays)

Adherens/satisfy to The Oxford criteria is bimodal CFQ ≥ 4 (as they say; severe fatigue).

How did it go - the results:

Adherens to ME/CFS criteria in this patient-cohort - baseline:



Fig: 6mo PI-EBV. VBB Wyller obtain/acquire the diagnostic criteria for ME/CFS by derive / extract post hoc or retrospectively, based on the answers to the participants / patients symptom questionnaire (yes, a non-specific method).

BASELINE: At 6-month PI-EBV, n = 91 participants were still fatigued (chronic fatigue (CF+); bimodal fatigue score CFQ value bimodal CFQ ≥ 4, while n = 104 had recovered from chronic fatigue (CF-); Bimodal fatigue score CFQ value ≤3. Which means that 53% of the patient population recovered from acute mono vs 47% of the participants still reported fatigue.

Of the 91 participants, 65 or 71.4% of the patients met only the Oxford 1991 criteria. n = 26 or 28.6% satisfied CDC1994 Fakuda criteria and n = 7 satisfied only Fakuda.

---
Baseline - RCT
Of all n= 43 participants, n=27 or as many as 62.8% of patients met only Oxford criteria. n = 16 or 37.2% satisfied CDC1994 Fakuda criteria and n = 6 or 37.5% satisfied only Fakuda. As many as 10 out of 16 Fakuda patients met the CCC2003 Canada criteria (62.5%), which for the entire patient cohort is reported 23.3%.

For the n= 21 participants in the mental therapy group (MT), 16 or as much as 76.2% of the patients met only the Oxford 1991 criteria. n=5 or 23.8% satisfied CDC1994 Fakuda criteria and n = 2 or 40% satisfied only Fakuda. As many as 3 out of 5 Fakuda patients met the CCC2003 Canada criteria (60%), and as reported for the entire patient group, 14.3%.

For the control group of n=22 patients (follow-up by a general practitioner; GP), n=11 or as many as 50% of the patients met only Oxford criteria. n =11 or 50% satisfied CDC1994 Fakuda criteria and n=4 or 42.9% satisfied only Fakuda. As many as 7 out of 11 Fakuda patients met the CCC2003 Canada criteria (57.1%), and as reported for the entire patient group, 31.8%.

When comparing the two groups; (MT n=16, 76.2%) vs (GP n=11, 50%) for how many only met Oxford criteria, shows that there are 18.5% and n = 5 more participants in the mental therapy arm than in the participant arm with general practitioner GP that only satisfies Oxford 1991 diagnostic criteria (CFQ ≥ 4).

It is not reported in the publication adheres to diagnostic criteria after 10 weeks of therapy treatment at 3 months primary endpoint (9 months PI-EBV) or another year later (21 months PI-EBV).

Oxford ONLY at Baseline: mental therapy group MT-arm 76.2% vs controllgr GP-arm 50%.

In the conclusion, you assume correctly; more than 3/4 of the participants receiving CBT/Music - mental therapy treatment only suffered from fatigue with not even enough symptoms for stronger ME-criteria.
---
In the Katz et al study:

Katz et al. N=301 EBV; 6mo PI-EBV: n= 39 (12,9%), Female n= 35 (11,6%), Male n=4 (1,3%); 12mo PI-EBV: n= 22 (7,3%), F n=22 (7,3%), M n=0; 24 mo PI-EBV n= 13 (4,3%), F n=13 (4,3%), M n=0. ME-criteria; Jason

presentation Gordon Broderick. Only n=3 ME/CFS young girls showed a clinical immune signature compatible with ME.

Recovered from mono:


Malik et al_BMJ Paediatrics Open_utsnitt Tabell 4_Manuscript ID bmjpo-2019-000620

N=17 did NOT Recover from mono 21 months PI-EBV in Malik et al [PMC old][PMC new] but who the F**KK knows... only per-protocol data can answer that Q.

spontaneous or delayed recovery... vs treatmenteffect? per-protocol for MT arm at endpoint vs controlls has a statistical significance of p = 0.016 that mental therapy treatment makes patients activitylevels worse....

underpowered? well, find papers with CBT and GET arms...

 

[ME/CFS Skeptic]

Have submitted my comment today: