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To the Editor: Dr Ferrer and colleagues¹ reported the results of a study of a national educational program based on the Surviving Sepsis Campaign guidelines. The authors found that the educational intervention was associated with improved hospital mortality rates. However, I am interested in their statement that "[t]he need for informed consent was waived in view of the observational . . . nature of the study," which does not seem accurate.

There has been controversy over the evaluation of quality improvement efforts,² including issues such as whether a study actually constitutes research or quality improvement, the need for institutional review board evaluation, and the obligation of obtaining informed consent.³ A relevant question is therefore whether the before-after study designed by Ferrer et al represents clinical research. I believe that the answer is yes, because application of novel interventions by physicians who did not apply them previously was a modification of the care they deliver. . . . [Full Text of this Article]

François Lemaire, MD
francois.lemaire@hmn.aphp.fr
Paris 12 University
Créteil, France

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