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

Trial By Error: BMJ Responds to Appeals About Norway's CBT-Music Therapy Study
This morning, I received a message from BMJ’s “research integrity coordinator.” Hm. That seems like an important position at BMJ, given what appears to be a major lack of research integrity in some of the papers I have examined.

Anyway, the research integrity coordinator promises to have an answer in two weeks!

 

“research integrity coordinator” sounds a bit like duty scapegoat, or duty sacrificial lamb.

 

I'm actually confused about the idea of "coordinating" research integrity. What is there to coordinate, exactly?

 

Here's a presentation of Simone Ragavooloo, the Research Integrity Coordinator from BMJ:

With formal academic qualifications in biological sciences and extensive experience across both the production and editorial branches of Science, Technology, Engineering and Mathematics (STEM) publishing. Simone worked in similar roles at SpringerNature; Biomed Central.

Today, Simone resolves potential ethical or legal concerns in editorial and production procedures. Whilst she predominantly focuses on maintaining BMJ’s high research integrity standards, Simone also supports the upkeep of best practices within the wider publishing community.

https://www.bmj.com/company/researchintegrity/meet-the-team/

 

thanks, Kalliope--I guess that clarifies it. Let's see how she applies her well-developed integrity skill set to this problem.

 

Maybe their job is to ask the study authors questions such as "Did you switch outcomes to obtain a better result?"

The answer will of course be "No, we would never do this. We just liked these outcomes better."

 

The lack of it with the illusion that it is?

 

A Norwegian news site for research has written an article about the music therapy study. The journalist is Ingrid Spilde who has written several good articles about ME research before (including the PACE trial). It seems she's actually read the study and sees through the spin. Wyller is interviewed, so is another ME researcher, Rasmus Goll, whom I believe is involved in a current study on ME and fecal transplantation. Goll is sceptical to the study's conclusions.

The results generally showed little difference between the treatment group and the control group. None of the differences were clear enough to be statistically significant, ie above the threshold where the impact is so large that it can hardly be due to chance.

However, some measurements showed a tendency for differences between the groups.

With regard to the main objective of the study - the level of activity of the participants - the results showed that the treatment group actually did worse than the control group.
...

Goll writes that the way the figures are presented presents the result as very positive, because the participants who dropped out are taken out.

If the results for recovery were instead intended as so-called " intention-to-treat " - which everyone counts for - there would be no difference between the treatment group and the control group.

Norske forskere testet musikkterapi mot kronisk utmattelse
google translation: Norwegian researchers tested music therapy for chronic fatigue
(regarding the google translation - "kissing illness" is a name for mononucleosis)

 

When lying is normalized liars keep on lying.

It's the fact that it is normalized that is absurd. Liars lie, it's what they do. But to give those lies credibility, I have no idea how that became a good idea in a serious profession. When the ends justify the means, the means become the ends. They had to lie to get to the starting line and even though they're still stuck at the starting line the only way to remain in the race is to lie and lie again.

If only there were some process where lies and deceit were not acceptable. Oh well, can't imagine something like that but it sure would be swell, especially when the cost of those lies is literally millions of lives. Sadly a correct use of literally here...

 

The "effect" of colloidal silver can last for years too.

 

article in Science Norway

Norwegian researchers have tested music therapy for chronic fatigue

full article here
https://sciencenorway.no/chronic-fa...ted-music-therapy-for-chronic-fatigue/1706704

 

Wasn't it two weeks yesterday?

 

I guess perhaps they're might still trying to figure out if there's a way to get out of retracting it.

 

Great opportunity
Do comment in English!! Since forskning.no (to ScienceNordic.com) has translated their news article (from 19Jun2020) regarding Malik et al / Wyller Mental Therapy PI-EBV study - yes please

...they really deserves a proper response... don't u think

( I do think that u have to post comments here: https://forskning.no/me-medievitens...t-musikkterapi-mot-kronisk-utmattelse/1700265 )

with love, respect and regards (and some peace of mind dear friends)
Marit Hjelsvold

(yes I'm trying too, since April.... )

 

For best results, consider homeopathic music therapy:

[Video is kind of loud. Be sure to adjust volume to OFF position for full homeopathic effect.]

https://www.youtube.com/watch?v=HgO-jEh-i0Y

 

A month ago, several colleagues and I wrote to BMJ about the problematic Norwegian study of CBT-plus-music-therapy for treatment of adolescents with chronic fatigue post-mononucleosis. After I sent a nudge two weeks later, I received a response from a research integrity coordinator, promising an update within two more weeks. That two-week period ended yesterday. Today, I sent BMJ this follow-up:

Dear Ms Ragavooloo--

It has been more than two weeks since our previous exchange, so I wanted to reach out again and check in on the status of the cognitive behavior therapy/music therapy study conducted by Norwegian investigators and published earlier this year by BMJ Paediatrics Open. I have cc'd several colleagues from Berkeley, Columbia, and University College London; they also signed the initial letter to BMJ and are also eager to see this matter properly resolved.

As we indicated in that letter more than a month ago, a proper resolution would mean withdrawing the study pending a second review by someone who promises to read the paper--unlike the original second reviewer. The new reviewer should be asked to compare the published work with the trial protocol and statistical analysis plan. Should the reviewer and BMJ confirm the identified methodological and ethical lapses outlined in our letter and on Virology Blog, the study should be retracted.

In reality, it should take an experienced reviewer no more than an hour to scrutinize the trial materials and assess how the paper itself diverged from what was laid out in the trial protocol and statistical analysis plan. It might take longer to determine why the investigators made the decisions they did and where BMJ's peer review process fell apart.

In the meantime, you might have seen this excellent article in the Norwegian press about the BMJ Paediatrics Open study. The article mentions the unusual downgrading from full-scale trial to feasibility study, which the investigators themselves chose not to mention in the published paper. The article also highlights the negative results for daily steps taken--the primary and only objectively measured outcome--and the key fact that the intervention group did even worse on that measure than those who did not receive the intervention.

The Norwegian article does not mention that post-exertional malaise, an outcome highlighted in the paper, was not included in either the protocol or statistical analysis plan. Nor does it mention that one of the two BMJ Paediatrics Open reviewers acknowledged not having read the paper. Overall, however, the article raises troubling issues that remain unanswered. (I have also cc'd the journalist, Ingrid Spilde, on this message.)

Before touching base with BMJ about this study, I wrote directly to the senior investigator and invited him to respond to my concerns, offering to post his full comment on Virology Blog. He did not respond.

I also wrote to the first reviewer. Unlike the second reviewer, she apparently read the paper and raised smart, pertinent questions about whether the research was designed to be a full-scale trial or a feasibility study. I wanted to find out whether she realized that the investigators, in response to her request for clarity about the goal of the research, falsely presented it as having been designed as a feasibility study. I did not hear back from her either.

My colleagues and I look forward to learning what BMJ plans to do about this problematic paper, which unfortunately has the potential to influence the treatment of children with serious illness--a highly vulnerable group. Given the paper's multiple methodological and ethical anomalies and the fact that BMJ published it after a peer review process that clearly violated recognized standards, we urge you to reach an acceptable decision quickly.

Best--David

David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley