Reviewers asked authors to change their study design. It apparently didn’t go well.

In what the editor of a psychiatry journal says in an unusual case, the authors of a paper on treatments for depression have retracted it after being alerted to “inconsistencies” stemming from a change to their study design that the peer reviewers had requested. 

Here’s the retraction notice, in The Journal of Nervous and Mental Disease:

At the request of the authors, the Editors and Publisher of The Journal of Nervous and Mental Disease retract the article “Comparison of Clinical Significance of Cognitive-Behavioral Therapy and Psychodynamic Therapy for Major Depressive Disorder” by da Silva et al., (Vol. 206, pp. 686–693, September 2018). The authors notified the Editors that there are important inconsistencies in the paper after the study was changed to a noninferiority study following suggestions from reviewers. This change had unforeseen implications to data analysis.  

The International Committee of Medical Journal Editors requires that researchers register their trials — including their designs — before starting a study. The paper does not mention a registration number, so it is unclear how the study was originally designed.

For those unfamiliar with noninferiority studies, here’s a primer:

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials.

I’ve written about the issues with such trials.


The authors of the study did not respond to a request for comment. We asked John Talbott, the editor of the journal, how the authors were able to change the design of their trial after it had already been completed and submitted for peer review. He told Retraction Watch:

The change in the study design at the time of publishing did not appear to impact the validity of the research. However, after receipt of a letter to the editor challenging the study design, and no response from the authors in response to the challenge, the manuscript was retracted. Although the reason for the manuscript being retracted is unusual, the editorial office gave the authors every opportunity to respond. We are comfortable with the decision.

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