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Comment & Response
December 2017

Deviations From Clinical Trials Registration in the ED-SAFE Study—Reply

Author Affiliations
  • 1Department of Psychiatry and Human Behavior, Brown University, Providence, Rhode Island
  • 2Butler Hospital, Providence, Rhode Island
  • 3Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston
  • 4Department of Emergency Medicine, University of Massachusetts Medical School, Worcester
  • 5Department of Psychiatry, University of Massachusetts Medical School, Worcester
  • 6Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester
JAMA Psychiatry. 2017;74(12):1278-1279. doi:10.1001/jamapsychiatry.2017.2487

In Reply We appreciate the opportunity to respond to Amos’ comments about our study.1 Amos raised questions about the association between our study and the information contained in the clinical trials registration. Although we agree with Amos’ concern about the congruence of clinical trial registration and publications, we take issue with several of the points he raised about our study. First, contrary to Amos’ comments, we did report deaths by suicide separately in the Outcomes subsection of the study.1 Second, nowhere in our study do we “claim that the study contributes to evidence that lives can be saved.” In fact, we explicitly discuss in the Limitations subsection that “we did not have sufficient power to detect differences in actual deaths by suicide.”1 Third, in our registration on https://ClinicalTrials.gov, we did not specify individual comparisons or data analytic plans. Thus, there is no discrepancy between the analyses reported in the study and the clinical trials registration.

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