Randomised controlled trials in critical care: Caveat emptor

Journal of the Royal College of Physicians of Edinburgh

Volumn 41, Issue 2, 2011, Pages 126-129

  Boylan, J F ^a   Kavanagh, B P ^b  

^a ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^b HOSPITAL FOR SICK CHILDREN   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ERITORAN; TRANEXAMIC ACID;

ARTICLE; BAYES THEOREM; BLEEDING; BLOOD TRANSFUSION; CRITICAL ILLNESS; DIAGNOSTIC TEST; DISEASE SEVERITY; FALSE POSITIVE RESULT; HUMAN; INSULIN TREATMENT; INTENSIVE CARE; MORTALITY; OVERALL SURVIVAL; PROBABILITY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVAL RATE; TRUE NEGATIVE RESULT; CLINICAL PRACTICE; HEALTH CARE DELIVERY; NOTE; PATIENT CARE; PHYSICIAN; PRACTICE GUIDELINE;

EID: 80052720947     PISSN: 14782715     EISSN: None     Source Type: Journal    
DOI: 10.4997/JRCPE.2011.216     Document Type: Article

References (26)

1. Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med 1984; 3:409-20. doi:10.1002/ sim.4780030421
2. Hirsh J, Guyatt G. Clinical experts or methodologists to write clinical guidelines? Lancet 2009; 374:273-5. doi:10.1016/S0140-6736(09)60787-X
3. Browner WS, Newman TB. Are all significant P values created equal? The analogy between diagnostic tests and clinical research. JAMA 1987; 257:2459-63. doi:10.1001/jama.257.18.2459
4. Kumar A, Soares H, Wells R et al. Are experimental treatments for cancer in children superior to established treatments? Observational study of randomized controlled trials by the Children's Oncology Group. BMJ 2005; 331:1295. doi:10.1136/bmj.38628.561123.7C
5. Ospina-Tascon GA, Büchele GL, Vincent J-L. Multicenter, randomized, controlled trials evaluating mortality in intensive care: Doomed to fail? Crit Care Med 2008; 36:1311-22. doi:10.1097/ CCM.0b013e318168ea3e
6. Ioannidis JP. Why most published research findings are false. PLoS Med 2005; 2:e124. doi:10.1371/journal.pmed.0020124
7. Van den Berghe G, Wouters P, Weekers F et al. Intensive insulin therapy in the critically ill patients. N Engl J Med 2001; 345:1359-67. doi:10.1056/NEJMoa011300
8. The NICE-SUGAR Study Investigators. Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009; 360:1283-97. doi:10.1056/NEJMoa0810625
9. Jadad AR, Moore RA, Carroll D et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17:1-12. doi:10.1016/0197-2456(95)00134-4
10. Griesdale DEG, de Souza RJ, van Dam RM et al. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ 2009; 180:821-7. doi:10.1503/cmaj.090206
11. Berger VW, Exner DE. Detecting selection bias in randomized clinical trials. Control Clin Trials 1999; 20:319-27. doi:10.1016/ S0197-2456(99)00014-8
12. Kahn JM, Kramer AA, Rubenfeld GD. Transferring critically ill patients out of hospital improves the standardized mortality ratio. Chest 2007; 131:68-75. doi:10.1378/chest.06-0741
13. Spiegelhalter DJ, Myles JP, Jones DR et al. An introduction to bayesian methods in health technology assessment. BMJ 1999; 319:508-12.
14. Wijeysundera DN, Austin PC, Hux JE et al. Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials. J Clin Epidemiol 2009; 62:13-21. e5
15. Kalil AC, Sun J. Why are clinicians not embracing the results from pivotal clinical trials in severe sepsis? A bayesian analysis. PLoS One 2008; 3:e2291. doi:10.1371/journal.pone.0002291
16. Peto R. Statistical aspects of cancer trials. In: Halnan KE, editor. Treatment of cancer. London: Chapman and Hall; 1982. p.867-71.
17. Peto R, Baigent C. Trials: the next 50 years. Large scale randomised evidence of moderate benefits. BMJ 1998; 317:1170-1.
18. CRASH-2 trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebocontrolled trial. Lancet 2010; 376:23-32. doi:10.1016/S0140-6736(10)60835-5
19. Hayward RA, Kent DM, Vijan S et al. Multivariable risk prediction can greatly enhance the statistical power of clinical trial subgroup analysis. BMC Med Res Methodol 2006; 6:18. doi:10.1186/1471-2288-6-18
20. Kent DM, Hayward RA. Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification. JAMA 2007; 298:1209-12. doi:10.1001/jama.298.10.1209
21. Ioannidis JPA, Lau J. The impact of high-risk patients on the results of clinical trials. J Clin Epidemiol 1997; 50:1089-98. doi:10.1016/ S0895-4356(97)00149-2
22. Tidswell M, Tillis W, LaRosa SP et al: Phase 2 trial of eritoran tetrasodium (E5564), a Toll-like receptor 4 antagonist, in patients with severe sepsis. Crit Care Med 2010; 38:72-83. doi:10.1097/ CCM.0b013e3181b07b78
23. Barochia A, Cui X, Natanson C et al. Risk of death and the efficacy of eritoran tetrasodium (E5564): design considerations for clinical trials of anti-inflammatory agents in sepsis. Crit Care Med 2010; 38:306-8. doi:10.1097/CCM.0b013e3181b77fe3
24. Kent DM, Rothwell PM, Ioannidis JPA et al. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2010; 11:85. doi:10.1186/1745-6215-11-85
25. Kett DH, Cano E, Quartin AA et al. Implementation of guidelines for management of possible multidrug-resistant pneumonia in intensive care: an observational, multicentre cohort study. Lancet Infect Dis 2011; 11:181-9. doi:10.1016/S1473-3099(10)70314-5
26. Yu J. Guidelines for hospital-acquired pneumonia and healthcareassociated pneumonia: a vulnerability, a pitfall, and a fatal flaw. Lancet Infect Dis 2011; 11:248-52. doi:10.1016/S1473-3099(11)70005-6