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Báo cáo y học: "Role of clinical evaluation committees in sepsis trials: from 'valid cohort' assessment to subgroup analysis"

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: Role of clinical evaluation committees in sepsis trials: from 'valid cohort' assessment to subgroup analysis. | Available online http ccforum.eom content 13 2 124 Commentary Role of clinical evaluation committees in sepsis trials from valid cohort assessment to subgroup analysis Jean-Franọois Dhainaut Open Access Université Paris Descartes Service de réanimation Médicale Hôpital Cochin 75014 Paris France Corresponding author Jean-Franọois Dhainaut dhainaut@aeres-evaluation.fr Published 18 Mar 2009 Critical Care 2009 13 124 doi 10.1186 cc7686 This article is online at http ccforum.com content 13 2 1 24 2009 BioMed Central Ltd See related research by Laterre et al. http ccforum.com content 13 2 R36 Abstract In this issue of Critical Care the study from Laterre and colleagues offers suggestions for the role of clinical evaluation committees CECs in future sepsis trials. Despite encouraging preliminary results all randomized controlled trials RCTs devoted to potential compounds in severe sepsis have failed to show survival benefit. One of the reasons might be related to RCT-related factors that inevitably occur within a heterogeneous septic patient population. A patient population free from confounding events would seem to provide the most suitable platform upon which to judge therapeutic effect. To solve this issue CECs have been introduced into RCTs in sepsis to ensure uniform data for analysis and to identify such optimal cohorts for which the therapy was initially designed to treat. More recently some RCTs have reported positive results in sepsis. The role of CECs has shifted to become a more integral part of the detailed analysis of drug safety and efficacy in large databases and to identify subgroups of patients in which a therapy might be less or more effective and or safe. As an example the retrospective analysis by Laterre and colleagues focuses on patients with severe community-acquired pneumonia sCAP within a large failed RCT on recombinant tissue factor pathway inhibitor rTFPI . However the results should be interpreted with great caution and should be viewed as .