David Tuller: Trial by Error: Open Letter to The Lancet, version 3.0

[TiredSam]

The Lancet's response might well be interpreted as, "well, what are you going to do about it then?"

At least they can't use "Oh yeah? You and whose army?" any more.

 

[dave30th]

@dave30th are you aware of this?

I've written about the statement to COPE on the school absence study. I've also seen the COPE statement on the registration issue, and it does sound similar to the LP study. But the dates are off. Maybe they did that to disguise it? It would be excellent to have more groups from poorly represented countries, as well as more experts.

 

[adambeyoncelowe]

How much would it cost to publish this in the the UK's most read newspaper?

I worked on an insert magazine that went into copies of The Sunday Telegraph and another in The Guardian. I think it was about £15k for 10,000 32-page A5 booklets to go inside, but I could have completely made that up!

 

[Kalliope]

 

[Esther12]

But the dates are off. Maybe they did that to disguise it?

Yeah, my guess is that his was to 'anonymise' it.

 

[Alvin]

I worked on an insert magazine that went into copies of The Sunday Telegraph and another in The Guardian. I think it was about £15k for 10,000 32-page A5 booklets to go inside, but I could have completely made that up!

Not a cheap price, but not completely insane.
It does not have to be a booklet, an advertisement or editorial might be good enough?
Would a paper include it if it was sent as a letter to the editor (do they still do that)?

 

[dave30th]

Yeah, my guess is that his was to 'anonymise' it.

But I don't get that. Is that standard in COPE submissions? Why bother moving dates around by months here or there? Doesn't make a lot of sense to me. I mean, it certainly sounds like a similar case. But why would they bother to submit it to COPE at all?

 

[Esther12]

But I don't get that. Is that standard in COPE submissions? Why bother moving dates around by months here or there?

If the dates were exactly those from SMILE then it would be 100% clear that the 'anonymised' text referred to SMILE. Also, you've previously written on a COPE case so maybe they'd be a bit extra cautious?

But why would they bother to submit it to COPE at all?

So that they can disperse responsibility for failing to follow their own rules?

 

[adambeyoncelowe]

Not a cheap price, but not completely insane.
It does not have to be a booklet, an advertisement or editorial might be good enough?
Would a paper include it if it was sent as a letter to the editor (do they still do that)?

Possibly. Depends how strict the ad department is. For a one-page ad that goes in every copy of a paper the price might actually be much higher, because it circulation is likely to be 100,000s rather than 10,000s.

 

[Alvin]

Possibly. Depends how strict the ad department is. For a one-page ad that goes in every copy of a paper the price might actually be much higher, because it circulation is likely to be 100,000s rather than 10,000s.

Does it need to be a whole page?

 

[adambeyoncelowe]

Not necessarily. It's not a bad idea. Someone should look into the costs.

 

[Inara]

Was just looking for that example of COPE being mislead by the BMJ re Crawley's 'service evaluation': https://publicationethics.org/case/service-evaluation-research-controversial-area-medicine

Found what looks like a page on Crawley's SMILE trial:

https://publicationethics.org/case/retrospective-registration-outcome-switching-and-ethical-approval

This really looks like high-quality oversight.

These were the issues raised:
"The authors have admitted honest error with full explanations."
"...this is an important educative role, but does not remedy that the trial data are in the public domain and are misleading."

So the journal seems to be facing serious problems regarding this paper. The authors admitted the errors.

This is the Forum's reply

ADVICE:
...
The Forum suggested publishing an editorial note on the paper or, if the institution agrees to undertake an investigation, publishing an expression of concern. As there seems to be no institutional oversight, perhaps the editor should give the authors the benefit of the doubt. This could be an important educational opportunity, to educate the authors regarding trial registration; although now an international standard, many authors do not know about prospective registration. Hence a lengthy corrigendum and an editorial highlighting the issues would be appropriate.
...
Some journals ask for the full protocol to be submitted to the journal along with the article. The journal then checks the protocol against the paper before the paper is peer-reviewed. The authors are asked to explain any deviations from the protocol. The editor may wish to consider this approach to avoid similar situations in the future.

This seems to be a very mild reaction to something that is called "misleading".

@Esther12, how do you know this is about SMILE?

 

[Esther12]

@Esther12, how do you know this is about SMILE?

It just sounds a lot like it. I could be wrong.

Maybe I did jump to conclusions a bit... it sounds a lot like it though. I feel like their BS recommendations made me think it was particularly likely to be Crawley!

 

[Inara]

It just sounds a lot like it. I could be wrong.

Ok, I see.