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Báo cáo khoa học: "Lack of evidence for qualitative treatment by disease severity interactions in clinical studies of severe sepsis"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về ngành y học đề tài: Lack of evidence for qualitative treatment by disease severity interactions in clinical studies of severe sepsis. | Available online http ccforum.eom content 9 6 R607 Research Lack of evidence for qualitative treatment by disease severity interactions in clinical studies of severe sepsis William L Macias1 David R Nelson2 Mark Williams3 Rekha Garg4 Jonathan Janes4 and Andreas Sashegyi5 Senior Medical Director Lilly Research Laboratories Indianapolis Indiana USA 2Associate Senior Statistician Lilly Research Laboratories Indianapolis Indiana USA 3Associate Medical Director Lilly Research Laboratories Indianapolis Indiana USA 4Medical Fellow Lilly Research Laboratories Indianapolis Indiana USA 5Senior Statistician Lilly Research Laboratories Indianapolis Indiana USA Corresponding author William L Macias wlm@lilly.com Received 29 Mar 2005 Revisions requested 11 May 2005 Revisions received 14 Jul 2005 Accepted 18 Jul 2005 Published 22 Sep 2005 Critical Care 2005 9 R607-R622 DOI 10.11 86 cc3795 This article is online at http ccforum.com content 9 6 R607 2005 Macias et al. licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http creativecommons.org licenses by 2.0 which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Open Access Abstract Introduction The design of clinical trials of interventions aimed at reducing mortality in patients with severe sepsis assumes that the relative treatment effect of the intervention is independent of the patients risk for death. We reviewed published data from phase III clinical studies of severe sepsis to determine whether a relationship exists between risk for death and the relative benefit of the investigational agent. Such an interaction might warrant a change in the assumptions that underlie current trial designs. Methods We conducted a systematic review of published phase III randomized placebo-controlled trials in adult patients with sepsis severe sepsis or septic shock up to November 2004. All studies