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

Reviewer:
I struggle to understand from the aims of the study and the way the study is described whether this was intended as a feasibility study – i.e. to look at feasibility (can this be done?), acceptability (how do participants experience it?) and to give some indication of potential effect sizes to power a future larger scale trial, or whether this was intended as a fully powered trial. Throughout, I think this needs to be clarified for the reader and interpretations/conclusions drawn in light of what the aim was.

Author's response:
Thank you. We agree – this study should be regarded a feasibility study, and the manuscript has been rephrased accordingly

Exactly. Their response is evidence of research misconduct. That was not an editorial oversight. If your authors lie, that's on them.
 
So who was this reviewer suggesting that the study should be viewed as 'feasibility' and what was the motivation? It sounds like someone with an agenda to sell the feasibility concept.
I'm not a native english speaker, but from the excerpt of her peer review I read it as she is clarifying what a feasability trial is to the authors, not saying this should be a feasability trial.
 
Yes, but the whole concept of 'feasibility trial' is crap (as David would say).
I'd be interested if you could clarify that please. In my world of engineering feasibility studies sometimes make sense when wanting to assess if an idea is worth further researching/developing, and if it is, helping convince the bean counters it is worth their while stumping up the cash to do so.

Why is that so different in the world of medical trials?
 
That was not an editorial oversight. If your authors lie, that's on them
Or maybe both are to blame?

The 1st version of the submitted manuscript's title was "... an exploratory randomized trial".
https://bmjpaedsopen.bmj.com/content/bmjpo/4/1/e000620.draft-revisions.pdf

But in the peer review history provided by the journal, they don't display the original title; the first submission is listed already with the title "....a feasiblity study"
https://bmjpaedsopen.bmj.com/content/bmjpo/4/1/e000620.reviewer-comments.pdf

It's odd in many ways: That a reviewer needs to explain to the authors what a feasibility study is -- when the title includes that it's an "exploratory randomized trial"; and that the part of the title indicating the nature of the research could just be changed etc.

edit: typo (exploratory)
& clarity (title "includes")
 
Last edited:
Or maybe both are to blame?

The 1st version of the submitted manuscript's title was "... an explanatory randomized trial".
https://bmjpaedsopen.bmj.com/content/bmjpo/4/1/e000620.draft-revisions.pdf

But in the peer review history provided by the journal, it appears already with the title "....a feasiblity study"
https://bmjpaedsopen.bmj.com/content/bmjpo/4/1/e000620.reviewer-comments.pdf

It's odd in many ways: That a reviewer needs to explain to the authors what a feasibility study is -- when the title implies that it's an "explanatory randomized trial" and that the part of the title indicating the nature of the research could just be changed etc.
And they changed parts of the aim of the study when they rewrote it. In the article with the qualitative interviews the study is listed as: "Malik S, Asprusten TT, Pedersen M, et al. Music therapy combined with cognitive behavior therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: An explorative randomized trial. BMC Research Notes. Submitted."

BMC Research Notes is another journal than Pediatrics Open, no? Maybe something changed when they sent it to PO?
 
I'd be interested if you could clarify that please. In my world of engineering feasibility studies sometimes make sense when wanting to assess if an idea is worth further researching/developing, and if it is, helping convince the bean counters it is worth their while stumping up the cash to do so.

Why is that so different in the world of medical trials?

It's longish story but to simplify.

Feasibility studies are part and parcel of all sorts of research, especially when dealing with inanimate matter.
But
The 'feasibilityfest' we have been seeing in Bristol, and a centre in London that majors in feasibility studies (maybe King's) consists of trials that ought to be properly powered and controlled and sent to ethics committees that manage to be few or none of these things because they are just 'feasibility' studies. And the policy is deliberate if covert. The one that comes to mind is the one that had 100 patients - which you cannot possibly need to judge whether you would get any patients - that was morphed into a so called prospective trial with a few gerrymandering to make sure it got the right result.

If you like in this case 'feasibility' is a term of art (or subterfuge). Another example is 'pragmatic trial' which again is not so much pragmatic as dodging quality control.
 
Exactly. Their response is evidence of research misconduct. That was not an editorial oversight. If your authors lie, that's on them.

Exactly. She was asking for clarification because what they wrote was a muddle. She wasn't asking them to lie.

Just thought I'd mention that it seems people in medical research bend over backwards to avoid using a word like 'lie'.

I see problems with this culture, but I thought I'd mention it in case any incaution here could be a problem.

I've forgotten some of the details with this paper, but generally it's best for people to avoid talking about lying in CFS research unless they've got really clear supporting evidence imo.
 
I agree. I see little point in being English and sticking to niceties when people are walking all over the rules.
I am in medical research and would once not have used the word lie but times have changed dramatically. People are lying here and maybe more than one lot.
They are also doing it rather badly.
 
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