Persistent organ dysfunction plus death: A novel, composite outcome measure for critical care trials

Critical Care

Volumn 15, Issue 2, 2011, Pages

  Heyland, Daren K ^a,b   Muscedere, John ^a,b   Drover, John ^a   Jiang, Xuran ^b   Day, Andrew G ^b  

^a QUEEN S UNIVERSITY   (Canada)

^b KINGSTON GENERAL HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CANADA; CONVALESCENCE; CRITICALLY ILL PATIENT; DATA ANALYSIS; DEATH; DIET THERAPY; EUROPE; FEMALE; HUMAN; INTENSIVE CARE; ISCHEMIA; KIDNEY FAILURE; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; MORTALITY; MULTIPLE ORGAN FAILURE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY FAILURE; RISK REDUCTION; UNITED STATES; AGED; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FOLLOW UP; INTENSIVE CARE UNIT; METHODOLOGY; MIDDLE AGED; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; STATISTICS;

AGED; CANADA; CRITICAL CARE; EUROPE; FEMALE; FOLLOW-UP STUDIES; HOSPITAL MORTALITY; HUMANS; INTENSIVE CARE UNITS; MALE; MIDDLE AGED; MULTIPLE ORGAN FAILURE; OUTCOME ASSESSMENT (HEALTH CARE); PROSPECTIVE STUDIES; UNITED STATES;

EID: 79952705627     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc10110     Document Type: Article

References (24)

1. Heyland DK, Kutsogiannis DJ. Quality of life following critical care: moving beyond survival. Intensive Care Med 2000, 26:1172-1175. 10.1007/s001340000621, 11089738.
2. Cohen J, Guyatt G, Bernard GR, Calandra T, Cook D, Elbourne D, Marshall J, Nunn A, Opal S, . UK Medical Research Council International Working Party New strategies for clinical trials in patients with sepsis and septic shock. Crit Care Med 2001, 29:880-886. 10.1097/00003246-200104000-00039, 11373487, UK Medical Research Council International Working Party.
3. Vincent JL, Mendonca A, Cantraine F, Moreno R, Takala J, Suter P, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Crit Care Med 1998, 26:1793-1800.
4. Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med 1995, 23:1638-1652. 10.1097/00003246-199510000-00007, 7587228.
5. Le Gall JR, Klar J, Lemeshow S, Saulnier F, Alberti C, Artigas A, Teres D. The Logistic Organ Dysfunction system. A new way to assess organ dysfunction in the in the intensive care unit. JAMA 1996, 276:802-810. 10.1001/jama.276.10.802, 8769590.
6. Vincent JL, Angus DC, Artigas A, Kalil A, Basson BR, Jamal HH, Johnson G, Bernard GR. Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial. Crit Care Med 2003, 31:834-840. 10.1097/01.CCM.0000051515.56179.E1, 12626993.
7. Heyland DK, Dhaliwal R, Day A, Muscedere J, Drover J, Suchner U, Cook D, . the Canadian Critical Care Trials Group REducing Deaths due to OXidative Stress: The REDOXS© Study: Rationale and study design for a randomized trial of glutamine and antioxidant supplementation in critically ill patients. Proc Nutr Soc 2006, 65:250-263. 10.1079/PNS2006505, 16923310, the Canadian Critical Care Trials Group.
8. Ware JE. The SF-36 health survey. Quality of Life and Pharmacoeconomics in Clinical Trials 1996, 337-345. Philadelphia: Lippincott-Raven Publishers, Spilker B, 2.
9. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of diseases classification system. Crit Care Med 1985, 13:818-829. 10.1097/00003246-198510000-00009, 3928249.
10. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987, 40:373-383. 10.1016/0021-9681(87)90171-8, 3558716.
11. Groll DL, To T, Bombardier C, Wright JG. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol 2005, 58:595-602. 10.1016/j.jclinepi.2004.10.018, 15878473.
12. Schoenfeld DA, Bernard GR, . for the ARDS Network Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med 2002, 30:1772-1777. 10.1097/00003246-200208000-00016, 12163791, for the ARDS Network.
13. Freedman L. Tables of the number of patients required in clinical trials using the logrank test. Stat Med 1982, 1:121-129. 10.1002/sim.4780010204, 7187087.
14. Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research 2003, New York: Marcel Dekker.
15. Carson SS, Garrett J, Hanson LC, Lanier J, Govert J, Brake MC, Landucci DL, Cox CE, Carey TS. A prognostic model for one-year mortality in patients requiring prolonged mechanical ventilation. Crit Care Med 2008, 36:2061-2069. 10.1097/CCM.0b013e31817b8925, 2728216, 18552692.
16. Nathens AB, Neff MJ, Jurkovich GJ, Klotz P, Farver K, Ruzinski JT, Radella F, Garcia I, Maier RV. Randomized, prospective trial of antioxidant supplementation in critically ill surgical patients. Ann Surg 2002, 236:814-822. 10.1097/00000658-200212000-00014, 1422648, 12454520.
17. Sward K, Valsson F, Odencrants P, Samuelsson O, Ricksten S. Recombinant human atrial natriuretic peptide in ischemic acute renal failure: A randomized placebo-controlled trial. Crit Care Med 2004, 32:1310-1315. 10.1097/01.CCM.0000128560.57111.CD, 15187512.
18. Schweickert W, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook C, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomized controlled trial. Lancet 2009, 373:1874-1882. 10.1016/S0140-6736(09)60658-9, 19446324.
19. Schuster MG, Edwards JE, Sobel JD, Darouiche RO, Karchmer AW, Hadley S, Slotman G, Panzer H, Biswas P, Rex JH. Empirical fluconazole versus placebo for intensive care unit patients. A randomized trial. Ann Intern Med 2008, 149:83-90.
20. Montori VM, Permanyer-Miralda G, Ferreira-Gonzalez I, Busse JW, Pacheco-Huergo V, Bryant D, Alonso J, Akl EA, Domingo-Salvany A, Mills E, Wu P, Schünemann HJ, Jaeschke R, Guyatt GH. Validity of composite endpoints in clinical trials. BMJ 2005, 330:594-596. 10.1136/bmj.330.7491.594, 554039, 15761002.
21. Ferreira-Gonzalez I, Busse JQ, Heels-Ansdell D, Montori VM, Aki EA, Bryant D, Alonso-Coello P, Alonso J, Worster A, Upadhye S, Jaeschke R, Schünemann HJ, Pacheco-Huergo V, Wu P, Mills EJ, Guyatt GH. Problems with the use of composite endpoints in cardiovascular trials: A systematic review of randomized controlled trials. BMJ 2007, 334:786. 10.1136/bmj.39136.682083.AE, 1852019, 17403713.
22. Niewoehner D, Erbland M, Deupree R, Collins D, Gross N, Light R, Anderson P, Morgan NA. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med 1999, 340:1941-1947. 10.1056/NEJM199906243402502, 10379017.
23. Rice TW, Bernard GR. Acute lung injury and acute respiratory distress syndrome: challenges in trial design. Clin Chest Med 2006, 27:733-754. 10.1016/j.ccm.2006.06.006, 17085259.
24. The CAPRICORN Investigators Effects of carvedilol on outcome after myocardial infarction in patients with left ventricular dysfunction: the CAPRICORN randomized trial. Lancet 2001, 357:1385-1390. 10.1016/S0140-6736(00)04560-8, 11356434, The CAPRICORN Investigators.