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January 1, 2003

Corticosteroids for Patients With Septic Shock

JAMA. 2003;289(1):41-44. doi:10.1001/jama.289.1.41-a

To the Editor: We have several concerns about the study of Dr Annane and colleagues.1 First, the sample size calculations were based on a prior study involving 32 patients with septic shock, of whom 13 patients (100%) with a poor response died.2 The power of the current study was dependent on the consideration that mortality in nonresponders is really 100%, or 95% as used in the study. It would have been better to determine the sample size after the first interim analysis; at that time mortality rates and treatment effects were more clear and offered the opportunity of a sequential study design.

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