The Acute Respiratory Distress Syndrome Network controversy: Lessons and legacy

Current Opinion in Critical Care

Volumn 10, Issue 6, 2004, Pages 560-564

  Silverman, Henry J ^a,b  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b ARDS NIH Clinical Trial Network   (United States)

Author keywords

Acute Respiratory Disease Syndrome Network; Critical care; Human experimentation; Human subject protection; Research ethics

Indexed keywords

CLINICAL PRACTICE; CLINICAL RESEARCH; CONTROL GROUP; CRITICAL ILLNESS; HUMAN; INTENSIVE CARE; MEDICAL ETHICS; MEDICAL LITERATURE; METHODOLOGY; PROTECTION; PUBLICATION; RESPIRATORY DISTRESS SYNDROME; REVIEW; TIDAL VOLUME;

EID: 10244257540     PISSN: 10705295     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ccx.0000144766.73540.52     Document Type: Review

References (31)

1. Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 2000, 283:2701-2711.
2. The Acute Respiratory Distress Syndrome Network: Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000, 342:1301-1308.
3. Fluid and Catheters Treatment Trial (FACTT): Available at: http://www.ardsnet.org/ards05.php. Accessed August 9, 2004.
4. Hebert PC, Wells G, Blajchman MA, et al.: Transfusion requirements in critical care investigators, Canadian Critical Care Trials Group. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 1999, 340:409-417.
5. Askie LM, Henderson-Smart DJ, Irwig L, et al.: Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003, 349:959-967.
6. Eichacker PQ, Gerstenberger EP, Banks SM, et al.: Meta-analysis of acute lung injury and acute respiratory distress syndrome trials testing low tidal volumes. Am J Respir Crit Care Med 2002, 166:1510-1514.
7. Eichacker P, Banks S, Natanson C: Meta-analysis of tidal volumes in ARDS [letter]. Am J Respir Crit Care Med 2003, 167:798-800.
8. Parshuram C, Kavanagh B: Meta-analysis of tidal volumes in ARDS [letter]. Am J Respir Crit Care Med 2003, 167:798.
9. Brower RG, Mathay M, Schoenfeld D: Meta-analysis of acute lung injury and acute respiratory distress syndrome trials [letter]. Am J Respir Crit Care Med 2002, 166:1515-1517.
10. Brower RG, Rubenfeld G, Thompson BT: Meta-analysis of tidal volumes in ARDS. Am J Respir Crit Care Med 2003, 168:255-256.
11. Miller FG, Silverman HJ: The ethical relevance of the standard of care in the design of clinical trials. Am J Respir Crit Care Med 2004, 169:562-564. The authors describe the concept of the medical standard of care and its ethical relevance to clinical trial design. In brief, the standard of care is relevant, although not necessarily decisive, to two basic moral considerations regarding the design of clinical trials: (1) pursuing scientific knowledge and (2) protection human subjects.
12. Silverman HJ, Miller FG: Control group selection in critical care randomized controlled trials evaluating interventional strategies: an ethical assessment. Crit Care Med 2004, 32:852-857. These authors formulate an ethical framework for analyzing control group selection for critical care trials. Control group selection should be determined in light of four ethical objectives of trial design: (1) clinical value, (2) scientific validity, (3) efficiency and feasibility, and (4) protection of human subjects. Achieving the latter objective ought to be paramount.
13. Thompson BT, Hayden D, Schoenfeld D: Safety is not improved with the inclusion of a usual care arm in ICU trials. Am J Respir Crit Care Med 2004, 169:A256. Adding a routine care group to a two-arm study evaluating contrasting strategies will lead to an increase in sample size that might have adverse effects on safety.
14. Parshuram CS, Kavanagh BP: Positive clinical trials. Understand the control group before implementing the result. Am J Respir Crit Care Med 2004, 170:223-226. These authors emphasize the characteristics of the control group that will be determinant of the overall conclusion of the clinical trial. If entry into a control group leads to changes from usual care, then any positive results attributed to the experimental intervention might not have been caused by the beneficial effects of the intervention but rather by the adverse effects of the control strategy.
15. McMahon AD: Study control, violators, inclusion criteria and defining explanatory and pragmatic trials. Stat Med 2002, 21:1365-1376.
16. Hebert PC, Cook DJ, Wells G, et al.: The design of randomized clinical trials in critically ill patients. Chest 2002, 121:1290-1300.
17. Rubenfeld G, Caldwell E, Hudson L: Publication of study results does not increase use of lung protective ventilation in patients with acute lung injury. Am J Respir Crit Care Med 2001, 163:A295.
18. Weinert CR, Gross CR, Marinelli WA: Impact of randomized trial results on acute lung injury ventilator therapy in teaching hospitals. Am J Respir Crit Care Med 2003, 167:1304-1309.
19. Young MP, Manning HL, Wilson DL, et al.: Ventilation of patients with acute lung injury and acute respiratory distress syndrome: has new evidence changed clinical practice? Crit Care Med 2004, 32:1260-1265. This retrospective study evaluates the impact of the ARDSNet tidal volume trial in the three largest hospitals in northern New England. The authors compare the selection of tidal volumes between two study periods, 1998-1999 and 2000-2001, and show that although there were significant reductions in tidal volumes, practice was highly variable and the proportion of patients receiving less than 8 mL/kg remains modest.
20. Brower RG, Thompson BT, Ancukiewicz M: Clinical trial of mechanical ventilation with traditional versus lower tidal volumes in acute lung injury and acute respiratory distress syndrome: effects on physicians' practices. Am J Respir Crit Care Med 2004, 169:A256. This study shows modest increases in the use of a tidal volume of 6 mL/kg PBW in hospitals that participated in the ARDSNet trials.
21. Rubenfeld GD, Cooper C, Carter G, et al.: Barriers to providing lung-protective ventilation to patients with acute lung injury. Crit Care Med 2004, 32:1289-1293. Using a survey of nurses and respiratory therapists, the authors perform a content analysis of open-ended responses to determine the barriers to implementing a lung-protective ventilatory strategy.
22. Ricard J-D: Are we really reducing tidal volume - and should we? Am J Respir Crit Care Med 2003, 167:1297-1298.
23. Sandham JD, Hull RD, Brant RF, et al. for the Canadian Critical Care Clinical Trials Group: A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med 2003, 348:5-14.
24. Richard C, Warszawski J, Anguel N, et al. for the French Pulmonary Artery Catheter Study Group.: Early use of the pulmonary artery catheter and outcomes in patients with shock and acute respiratory distress syndrome. A randomized controlled trial. JAMA 2003, 290:2713-2720.
25. Intensive Care National Audit and Research Centre: Pulmonary artery catheters in patient management. Available at: http://www.icnarc.org/PACMan.htm. Accessed August 8, 2004.
26. Wood KA, Huang D, Angus DC: Improving clinical trial design in acute lung injury. Crit Care Med 2003, 31 (suppl):S305-S311.
27. Dreyfuss D, Saumon G: Evidence-based medicine or fuzzy logic: what is best for ARDS management? Intensive Care Med 2002, 28:230-234.
28. Tobin MJ: The role of a journal in a scientific controversy. Am J Respir Crit Care Med 2003, 168:511-515. Using the ARDSNet controversy as a springboard for discussion, the author examines the concept of the "truth" as applied to the results of clinical trials. Commenting on the fragile foundation and nature of randomized, controlled clinical trials, the author emphasizes a dialectical path to the truth that involves open discussion of opposing thoughts.
29. Poynard T, Munteanu M, Ratziu V, et al.: Truth survival in clinical research: an evidence-based requiem? Ann Intern Med 2002, 136:888-895.
30. Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000, 342:1887-1892.
31. Benson K, Hartz AJ: A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000, 342:1878-1886.