International INtegrated Database for the Evaluation of severe sePsis and drotrecogin alfa (activated) THerapy: component trials and statistical methods for INDEPTH

References

• Flather MD, Farkouh ME, Pogue JM, et al. Strengths and limitations of meta-analysis: larger studies may be more reliable. Control Clin Trials 1997;18:568–79
   PubMedGoogle Scholar
• Eisele B, Lamy M, Thijs LG, et al. Antithrombin III in patients with severe sepsis. A randomized, placebo-controlled, double-blind multicenter trial plus a meta-analysis on all randomized, placebo-controlled, double-blind trials with antithrombin III in severe sepsis. Intensive Care Med 1998;24:663–72
   Google Scholar
• Abraham E, Reinhart K, Opal S, et al. OPTIMIST Trial Study Group. Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA 2003;290:238–47
   Google Scholar
• Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345:1368–77
   PubMed Web of Science ®Google Scholar
• Dhainaut JF, Tenaillon A, Le Tulzo Y, et al. Platelet-activating factor receptor antagonist BN 52021 in the treatment of severe sepsis: a randomized, double-blind, placebo-controlled, multi-center clinical trial. BN 52021 Sepsis Study Group. Crit Care Med 1994;22: 1720–8
   Google Scholar
• Fisher CJ Jr, Dhainaut JF, Opal SM, et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. Phase III rhIL-1ra Sepsis Syndrome Study Group. JAMA 1994;271: 1836–43
   Google Scholar
• Opal SM, Fisher CJ Jr, Dhainaut JF, et al. Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. The Interleukin-1 Receptor Antagonist Sepsis Investigator Group. Crit Care Med 1997;25: 1115–24
   Google Scholar
• Dhainaut JF, Tenaillon A, Hemmer M, et al. Confirmatory platelet-activating factor receptor antagonist trial in patients with severe gram-negative bacterial sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. BN 52021 Sepsis Investigator Group. Crit Care Med 1998;26: 1963–71
   Google Scholar
• Opal S, Laterre PF, Abraham E, et al. Controlled mortality trial of platelet-activating factor acetylhydrolase in severe sepsis investigators. Recombinant human platelet-activating factor acetylhydrolase for treatment of severe sepsis: results of a phase III, multicenter, randomized, double-blind, placebo-controlled, clinical trial. Crit Care Med 2004;32:332–41
   Google Scholar
• Warren BL, Eid A, Singer P, et al. KyberSept Trial Study Group. Caring for the critically ill patient. High-dose antithrombin III in severe sepsis: a randomized, controlled trial. JAMA 2001;286:1869–78
   Google Scholar
• Abraham E, Laterre PF, Garbino J, et al. Lenercept Study Group. Lenercept (p55 tumor necrosis factor receptor fusion protein) in severe sepsis and early septic shock: a randomized, double-blind, placebo-controlled, multicenter phase III trial with 1342 patients. Crit Care Med 2001;29: 503–10
   Google Scholar
• Angus DC, Birmingham MC, Balk RA, et al. E5 murine monoclonal antiendotoxin antibody in gram-negative sepsis: a randomized, controlled trial. E5 Study Investigators. JAMA 2000;283:1723–30
   Google Scholar
• Reinhart K, Menges T, Gardlund B, et al. Randomized, placebo-controlled trial of the anti-tumor necrosis factor antibody fragment afelimomab in hyperinflammatory response during severe sepsis: The RAMSES Study. Crit Care Med 2001;29: 765–9
   PubMed Web of Science ®Google Scholar
• Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001;344:699–709
   PubMed Web of Science ®Google Scholar
• Bernard GR, Ely EW, Wright TJ, et al. Safety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis. Crit Care Med 2001;29:2051–9
   PubMed Web of Science ®Google Scholar
• Macias WL, Dhainaut JF, Yan SC, et al. Pharmacokineticpharmacodynamic analysis of drotrecogin alfa (activated) in patients with severe sepsis. Clin Pharmacol Ther 2002;72: 391–402
   PubMed Web of Science ®Google Scholar
• Abraham E, Naum C, Bandi V, et al. Efficacy and safety of LY315920Na/S-5920, a selective inhibitor of 14 kDa group IIA secretory phospholipase A2, in patients with suspected sepsis and organ failure. Crit Care Med 2003;31:718–28
   PubMed Web of Science ®Google Scholar
• Zeiher BG, Steingrub J, Laterre PF, et al. LY315920NA/S-5920, a selective inhibitor of group IIA secretory phospholipase A2, fails to improve clinical outcome for patients with severe sepsis. Crit Care Med 2005;33:1741–48
   PubMed Web of Science ®Google Scholar
• Wheeler AP, Doig C, Wright T, et al. Baseline characteristics and survival of adult severe sepsis patients treated with drotrecogin alfa (activated) in a global, single-arm, open-label trial (ENHANCE). Chest 2003;124:91S–2
   Google Scholar
• Beale R, Wright TJ, Wong K, et al. Safety of drotrecogin alfa (activated) in adult patients with severe sepsis: comparison of global ENHANCE to PROWESS. Chest 2003;124: 102S–3
   Google Scholar
• Knaus WA, Draper EA, Wagner DP, et al. APACHE II: a severity of disease classification system. Crit Care Med 1985;13:818–29
   PubMed Web of Science ®Google Scholar
• Vincent JL, Moreno R, Takala J, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/ failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996;22:707–10
   PubMed Web of Science ®Google Scholar
• Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet 1974;2:81–4
   PubMed Web of Science ®Google Scholar
• Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika 1983;70:41–55
   Web of Science ®Google Scholar
• Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc 1984;79:516–24
   Web of Science ®Google Scholar
• Huang IC, Frangakis C, Dominici F, et al. Application of a propensity score approach for risk adjustment in profiling multiple physician groups on asthma care. Health Serv Res 2005;40:253–78
   PubMed Web of Science ®Google Scholar
• Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann Intern Med 1997;127:757–63
   PubMed Web of Science ®Google Scholar
• D’ Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 1998;17:2265–81
   Google Scholar
• Ely EW, Laterre PF, Angus DC, et al. PROWESS I. Drotrecogin alfa (activated) administration across clinically important subgroups of patients with severe sepsis. Crit Care Med 2003;31:12–9
   Google Scholar
• Clermont G, Angus DC, Linde-Zwirble WT, et al. Does acute organ dysfunction predict patient-centered outcomes? Chest 2002;121:1963–71
   Google Scholar
• Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001;29:1303–10
   PubMed Web of Science ®Google Scholar
• Joffe MM, Rosenbaum PR. Invited commentary: propensity scores. Am J Epidemiol 1999;150:327–33
   PubMed Web of Science ®Google Scholar