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01-04-2006 | Correspondence

Conflict of opinion -- is PROWESS real progress?

Author: Alasdair F. Mackenzie

Published in: Intensive Care Medicine | Issue 4/2006

Excerpt

I note that all three correspondents who have objected to my article [1] have declared conflicts of interest on this issue – my interest is only in patient safety. Dr. Ridley misreads my article: I do not cite the Global ENHANCE trial [2], which was unpublished when I wrote my commentary. Consistency with the April 2005 revised EMEA recommendation [3] was restored with an update from NICE in October 2005 [4]. As this change introduced the term “high risk” to the indication in Europe there are still problems: the term is undefined, and the Summary of Product Characteristics does not include this alteration [5]. Dr. Ridley correctly states that ‘looking for survival differences’ in the follow-up data, as done by Dr. Macias, is ‘unsound’. My statement regarding the loss of statistical significance in PROWESS with a shift of seven deaths from one group to the other appears correct. …

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Title: Conflict of opinion -- is PROWESS real progress?
Author: Alasdair F. Mackenzie
Publication date: 01-04-2006
Publisher: Springer-Verlag
Published in: Intensive Care Medicine / Issue 4/2006
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-006-0090-0

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