So here's my problem with this fun example ...
So here's my problem with this fun example ...
But would the New England Journal of Medicine, one of the world's most selective and prestigious journals, have published the Mediterranean diet paper from Martínez González if the randomization issues and softened conclusion had been included in the first place?
"It is difficult to answer hypothetical questions," New England Journal of Medicine spokeswoman Jennifer Zeis says. "We believe the evidence [in favor of the diet is still strong, but not as strong as a randomized study in which the randomization was executed flawlessly."
In other words, NO. Which is a problem, because the study is obviously strong enough that it is simply being republished with a downgrade on the causation versus association front in the one part of a paper that is creative/improvised - the discussion where authors offer their interpretation of all the technical data driven stuff.
As an aside, from what I can tell, they missed the kind of rigorous study site control and oversight that is always a challenge. It's supposed to catch the kind of stuff that happened with the one site lying about randomization. But you have to have the money and the people to do this, and the people have to be exceptional at a boring, pedantic job while still playing people skills games. That kind of violation is when you close a study site and strip everything that came from there out of your data. So this is a good catch and it's right and proper that the study be allowed to republish with corrections.
Nevertheless, it leaves me wondering about the reviewers and editors. Why haven't we universally adopted some sort of protocol, maybe this Carlisle approach or something else, that helps to raise flags and questions? Is that equivocation by NEJM because with revision to the study, somebody didn't get a P less than or equal to 0.05? How many studies are executed "flawlessly", really?
Carlisle praised the journal's response. "I think that the NEJM editorial team responded very maturely to my paper," he says. "They took the possibility of a problem seriously and acted quickly and thoroughly."
i mean, ok, I guess? Mostly, I would give them a "mature" rating for acknowledging the authors' willingness to be mature and re-evaluate themselves. Thus, allowing them to re-publish with corrections. A truly "mature" response would be a documented quality review of the editorial and review process that resulted in improvements in said process to prevent this while still trying to publish appropriate studies.
https://www.npr.org/sections/health-shots/2018/06/13/619619302/errors-trigger-retraction-of-study-on-mediterranean-diets-heart-benefits
https://www.npr.org/sections/health-shots/2018/06/13/619619302/errors-trigger-retraction-of-study-on-mediterranean-diets-heart-benefits
But would the New England Journal of Medicine, one of the world's most selective and prestigious journals, have published the Mediterranean diet paper from Martínez González if the randomization issues and softened conclusion had been included in the first place?
"It is difficult to answer hypothetical questions," New England Journal of Medicine spokeswoman Jennifer Zeis says. "We believe the evidence [in favor of the diet is still strong, but not as strong as a randomized study in which the randomization was executed flawlessly."
In other words, NO. Which is a problem, because the study is obviously strong enough that it is simply being republished with a downgrade on the causation versus association front in the one part of a paper that is creative/improvised - the discussion where authors offer their interpretation of all the technical data driven stuff.
As an aside, from what I can tell, they missed the kind of rigorous study site control and oversight that is always a challenge. It's supposed to catch the kind of stuff that happened with the one site lying about randomization. But you have to have the money and the people to do this, and the people have to be exceptional at a boring, pedantic job while still playing people skills games. That kind of violation is when you close a study site and strip everything that came from there out of your data. So this is a good catch and it's right and proper that the study be allowed to republish with corrections.
Nevertheless, it leaves me wondering about the reviewers and editors. Why haven't we universally adopted some sort of protocol, maybe this Carlisle approach or something else, that helps to raise flags and questions? Is that equivocation by NEJM because with revision to the study, somebody didn't get a P less than or equal to 0.05? How many studies are executed "flawlessly", really?
Carlisle praised the journal's response. "I think that the NEJM editorial team responded very maturely to my paper," he says. "They took the possibility of a problem seriously and acted quickly and thoroughly."
i mean, ok, I guess? Mostly, I would give them a "mature" rating for acknowledging the authors' willingness to be mature and re-evaluate themselves. Thus, allowing them to re-publish with corrections. A truly "mature" response would be a documented quality review of the editorial and review process that resulted in improvements in said process to prevent this while still trying to publish appropriate studies.
https://www.npr.org/sections/health-shots/2018/06/13/619619302/errors-trigger-retraction-of-study-on-mediterranean-diets-heart-benefits
https://www.npr.org/sections/health-shots/2018/06/13/619619302/errors-trigger-retraction-of-study-on-mediterranean-diets-heart-benefits
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