Log in | Register

Is it better to consent to an RCT or to care? : Μηδεν αγαν (“nothing in excess”)

Didier Dreyfuss
Clinical Commentary
Volume 31, Issue 3 / March , 2005

Pages 345 - 355

No abstract available.

References

  1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. United States Government Printing Office, Washington
  2. White RM (2000) Unraveling the Tuskegee study of untreated syphilis. Arch Intern Med 160:585–598
    • View reference on publisher's website
    • View reference on PubMed
  3. Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386
    • View reference on publisher's website
    • View reference on PubMed
  4. Grunberg SM, Cefalu WT (2003) The integral role of clinical research in clinical care. N Engl J Med 348:1386–1388
    • View reference on publisher's website
    • View reference on PubMed
  5. Truog RD, Robinson W, Randolph A, Morris A (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 340:804–807
    • View reference on publisher's website
    • View reference on PubMed
  6. Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711
    • View reference on publisher's website
    • View reference on PubMed
  7. Paasche-Orlow MK, Taylor HA, Brancati FL (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348:721–726
    • View reference on publisher's website
    • View reference on PubMed
  8. Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B (2001) Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med 29:1893–1897
    • View reference on publisher's website
    • View reference on PubMed
  9. King NM, Churchill LR (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 341:449–450
    • View reference on publisher's website
  10. Visser HK (2001) Non-therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818–819
    • View reference on publisher's website
    • View reference on PubMed
  11. Lemaire FJ (2003) A European Directive for clinical research. Intensive Care Med 29:18–20
  12. Singer EA, Mullner M (2002) Implications of the EU directive on clinical trials for emergency medicine. BMJ 324:1169–1170
    • View reference on publisher's website
    • View reference on PubMed
  13. European Parliament (2001) Directive 2001/20/EC of the European Parliament and of the Council. Official J Eur Communities L121:34–44
  14. Dreyfuss D (2004) To consent or not to consent, that is (not) the (sole) question. Intensive Care Med 30:180–182
  15. Evidence-Based Medicine Working Group (1992) Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 268:2420–2425
    • View reference on publisher's website
    • View reference on PubMed
  16. D’Arcy Hart P (1999) A change in scientific approach: from alternation to randomised allocation in clinical trials in the 1940s. BMJ 319:572–573
    • View reference on PubMed
  17. Meldrum M (1998) “A calculated risk”: the Salk polio vaccine field trials of 1954. BMJ 317:1233–1236
    • View reference on PubMed
  18. Löwy I (2004) Essai clinique. In: Lecourt D (ed) Dictionnaire de la pensée médicale. PUF, Paris, pp 441–446
  19. Beecher HK (1966) Ethics and clinical research. N Engl J Med 274:1354–1360
    • View reference on PubMed
  20. Vandenbroucke JP, de Craen AJ (2001) Alternative medicine: a “mirror image” for scientific reasoning in conventional medicine. Ann Intern Med 135:507–513
    • View reference on PubMed
  21. Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:1167–1170
    • View reference on publisher's website
    • View reference on PubMed
  22. Davidoff F, DeAngelis CD, Drazen JM, Nicholls MG, Hoey J, Hojgaard L, Horton R, Kotzin S, Nylenna M, Overbeke AJ, Sox HC, Van Der Weyden MB, Wilkes MS (2001) Sponsorship, authorship, and accountability. N Engl J Med 345:825–826–
    • View reference on publisher's website
    • View reference on PubMed
  23. Warren HS, Suffredini AF, Eichacker PQ, Munford RS (2002) Risks and benefits of activated protein C treatment for severe sepsis. N Engl J Med 347:1027–1030
    • View reference on publisher's website
    • View reference on PubMed
  24. Siegel JP (2002) Assessing the use of activated protein C in the treatment of severe sepsis. N Engl J Med 347:1030–1004
    • View reference on publisher's website
    • View reference on PubMed
  25. Angell M (2000) Is academic medicine for sale? N Engl J Med 342:1516–1518
    • View reference on publisher's website
    • View reference on PubMed
  26. Knottnerus JA, Dinant GJ (1997) Medicine based evidence, a prerequisite for evidence based medicine. BMJ 315:1109–1110
    • View reference on PubMed
  27. Poynard T, Munteanu M, Ratziu V, Benhamou Y, Di Martino V, Taieb J, Opolon P (2002) Truth survival in clinical research: an evidence-based requiem? Ann Intern Med 136:888–895
    • View reference on PubMed
  28. Acute Respiratory Distress Syndrome Network (2000) 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 342:1301–1308
    • View reference on publisher's website
    • View reference on PubMed
  29. Milberg J, Davis D, Steinberg K, Hudson L (1995) Improved survival of patients with acute respiratory distress syndrome (ARDS): 1983–1993. JAMA 273:306–309
    • View reference on publisher's website
    • View reference on PubMed
  30. Dreyfuss D, Saumon G (2002) Evidence-based medicine or fuzzy logic. What is best for ARDS management? Intensive Care Med 28:230–234
  31. Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ (2002) Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA 287:345–355
    • View reference on publisher's website
    • View reference on PubMed
  32. Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski K, Bion J, Romand JA, Villar J, Thorsteinsson A, Damas P, Armaganidis A, Lemaire F (2004) Epidemiology and outcome of acute lung injury in European intensive care units. Results from the ALIVE study. Intensive Care Med 30:51–61
  33. Weinert CR, Gross CR, Marinelli WA (2003) Impact of randomized trial results on acute lung injury ventilator therapy in teaching hospitals. Am J Respir Crit Care Med 167:1304–1309
    • View reference on publisher's website
    • View reference on PubMed
  34. Ricard JD (2003) Are we really reducing tidal volume-and should we? Am J Respir Crit Care Med 167:1297–1298
    • View reference on publisher's website
    • View reference on PubMed
  35. Rubenfeld GD, Cooper C, Carter G, Thompson BT, Hudson LD (2004) Barriers to providing lung-protective ventilation to patients with acute lung injury. Crit Care Med 32:1289–1293
    • View reference on publisher's website
    • View reference on PubMed
  36. Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, Schoenfeld D, Thompson BT; National Heart, Lung and Blood Institute ARDS Clinical Trials Network (2004) Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med 351:327–336
    • View reference on publisher's website
    • View reference on PubMed
  37. Gattinoni L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, Di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R (2001) Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med 345:568–573
    • View reference on publisher's website
    • View reference on PubMed
  38. Dreyfuss D, Basset G, Soler P, Saumon G (1985) Intermittent positive-pressure hyperventilation with high inflation pressures produces pulmonary microvascular injury in rats. Am Rev Respir Dis 132:880–884
    • View reference on PubMed
  39. Jardin F, Fellahi JL, Beauchet A, Vieillard-Baron A, Loubieres Y, Page B (1999) Improved prognosis of acute respiratory distress syndrome 15 years on. Intensive Care Med 25:936–941
  40. Brochard L, Mancebo J, Tobin M (2003) Searching for evidence: don’t forget the foundations. Intensive Care Med 29:2109–2111
  41. D’Amico R, Pifferi S, Leonetti C, Torri V, Tinazzi A, Liberati A (1998) Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials. BMJ 316:1275–1285
    • View reference on PubMed
  42. Vincent JL (2003) Selective digestive decontamination: for everyone, everywhere? Lancet 362:1006–1007
    • View reference on publisher's website
    • View reference on PubMed
  43. Bartlett JG (1995) Selective decontamination of the digestive tract and its effect on antimicrobial resistance. Crit Care Med 23:613–615
    • View reference on publisher's website
    • View reference on PubMed
  44. Kollef MH (2004) Prevention of hospital-associated pneumonia and ventilator-associated pneumonia. Crit Care Med 32:1396–1405
    • View reference on publisher's website
    • View reference on PubMed
  45. Messori A, Trippoli S, Vaiani M, Gorini M, Corrado A (2000) Bleeding and pneumonia in intensive care patients given ranitidine and sucralfate for prevention of stress ulcer: meta-analysis of randomised controlled trials. BMJ 321:1103–1106
    • View reference on publisher's website
    • View reference on PubMed
  46. Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, Tryba M (1996) Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA 275:308–314
    • View reference on publisher's website
    • View reference on PubMed
  47. Faisy C, Guerot E, Diehl JL, Iftimovici E, Fagon JY (2003) Clinically significant gastrointestinal bleeding in critically ill patients with and without stress-ulcer prophylaxis. Intensive Care Med 29:1306–1313
  48. Thompson BT, Hayden D, Matthay MA, Brower R, Parsons PE (2001) Clinicians’ approaches to mechanical ventilation in acute lung injury and ARDS. Chest 120:1622–1627
    • View reference on publisher's website
    • View reference on PubMed
  49. Baum M, Vaidya JS (1999) The price of autonomy. Health Expect 2:78–81
    • View reference on publisher's website
    • View reference on PubMed
  50. Beauchamp TL, Childress JF (1994) Principles of medical ethics, 4th edn. Oxford University Press, New York
  51. Abraham E (1999) Why immunomodulatory therapies have not worked in sepsis. Intensive Care Med 25:556–566
  52. Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192
    • View reference on PubMed
  53. Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153–S160
    • View reference on publisher's website
    • View reference on PubMed
  54. Bigatello LM, George E, Hurford WE (2003) Ethical considerations for research in critically ill patients. Crit Care Med 31:S178–S181
    • View reference on publisher's website
    • View reference on PubMed
  55. Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612
    • View reference on publisher's website
    • View reference on PubMed
  56. Luce JM (2003) California’s new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. Intensive Care Med 29:1024–1025
    • View reference on PubMed
  57. Lemaire F (2003) Suspension of the NIH ARDS Network fluids and catheters treatment trial. Intensive Care Med 29:1361–1363
  58. Silverman HJ, Miller FG (2004) Control group selection in critical care randomized controlled trials evaluating interventional strategies: an ethical assessment. Crit Care Med 32:852–857
    • View reference on publisher's website
    • View reference on PubMed
  59. Concato J, Horwitz RI (2004) Beyond randomised versus observational studies. Lancet 363:1660–1661
    • View reference on publisher's website
    • View reference on PubMed
  60. Steinbrook R (2003) How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome. N Engl J Med 348:1393–1401
    • View reference on publisher's website
    • View reference on PubMed
  61. Partridge AH, Winer EP (2002) Informing clinical trial participants about study results. JAMA 288:363–365
    • View reference on publisher's website
    • View reference on PubMed
  62. Tobias JS (1997) BMJ’s present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 314:1111–1114
    • View reference on PubMed
  63. Tobias JS, Souhami RL (1993) Fully informed consent can be needlessly cruel. BMJ 307:1199–1201
    • View reference on PubMed
  64. Mazur DJ (2003) Influence of the law on risk and informed consent. BMJ 327:731–734
    • View reference on publisher's website
    • View reference on PubMed
  65. Silverman HJ, Luce JM, Lanken PN, Morris AH, Oldmixon CF, Thompson BT, Bernard GR (2004) Recommendations for informed consent forms for critical care trials. Abstracts, ATS 100th International Conference)
  66. Steinbrook R (2002) Improving protection for research subjects. N Engl J Med 346:1425–14230
    • View reference on publisher's website
    • View reference on PubMed
  67. Silverman HJ, Luce JM, Schwartz J (2004) Protecting subjects with decisional impairment in research: the need for a multifaceted approach. Am J Respir Crit Care Med 169:10–14
    • View reference on publisher's website
    • View reference on PubMed
  68. Department of Health and Human Services, Food and Drug Adminsitration (1996) Protection of human subjects: informed consent and waives of informed consent requirements in certain emergency research. Final rules. Title 21, Code of federal regulations. Part 50:24. Fed Regist 61:51528–51533
  69. Silverman HJ, Druml C, Lemaire F, Nelson R (2004) The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis. Intensive Care Med 30:30
  70. Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321–324
  71. Carome MA, Grodin MA, Dresser R, Johnson JR, Silverman H, King NMP, Churchill LR, Tenery RM, Truog RD, Robinson W, Morris AH (1999) Is informed consent always necessary for randomized controlled trials? N Engl J Med 341:448–450
    • View reference on publisher's website
    • View reference on PubMed
  72. Zelen M (1979) A new design for randomized clinical trials. N Engl J Med 300:1242–1245
    • View reference on PubMed
  73. Bartlett RH, Roloff DW, Cornell RG, Andrews AF, Dillon PW, Zwischenberger JB (1985) Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 76:479–487
    • View reference on PubMed
  74. O’Rourke PP, Crone RK, Vacanti JP, Ware JH, Lillehei CW, Parad RB, Epstein MF (1989) Extracorporeal membrane oxygenation and conventional medical therapy in neonates with persistent pulmonary hypertension of the newborn: a prospective randomized study. Pediatrics 84:957–963
    • View reference on PubMed
  75. Baum M (1998) Informed consent. Numbers inform the debate. BMJ 317:947
  76. Snowdon C, Elbourne D, Garcia J (1999) Zelen randomization: attitudes of parents participating in a neonatal clinical trial. Control Clin Trials 20:149–171
    • View reference on publisher's website
    • View reference on PubMed
  77. Allmark P (1999) Should Zelen pre-randomised consent designs be used in some neonatal trials? J Med Ethics 25:325–329
    • View reference on PubMed
  78. Benson K, Hartz AJ (2000) A comparison of observational studies and randomized, controlled trials. N Engl J Med 342:1878–1886
    • View reference on publisher's website
    • View reference on PubMed
  79. Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892
    • View reference on publisher's website
    • View reference on PubMed
  80. Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E (1999) A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med 340:409–417
    • View reference on publisher's website
    • View reference on PubMed
  81. Gattinoni L, Brazzi L, Pelosi P, Latini R, Tognoni G, Pesenti A, Fumagalli R (1995) A trial of goal-oriented hemodynamic therapy in critically ill patients. SvO2 Collaborative Group. N Engl J Med 333:1025–1032
    • View reference on publisher's website
    • View reference on PubMed
  82. Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M (2001) Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 345:1368–1377
    • View reference on publisher's website
    • View reference on PubMed
  83. Berghe G van den, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R (2001) Intensive insulin therapy in the critically ill patients. N Engl J Med 345:1359–1367
    • View reference on publisher's website
    • View reference on PubMed
  84. Davis N, Pohlman A, Gehlbach B, Kress JP, McAtee J, Herlitz J, Hall J (2003) Improving the process of informed consent in the critically ill. JAMA 289:1963–1968
    • View reference on publisher's website
    • View reference on PubMed
  85. Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM (2003) Patients’ consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ 326:373
    • View reference on publisher's website
    • View reference on PubMed
  86. Bottiger BW, Bode C, Kern S, Gries A, Gust R, Glatzer R, Bauer H, Motsch J, Martin E (2001) Efficacy and safety of thrombolytic therapy after initially unsuccessful cardiopulmonary resuscitation: a prospective clinical trial. Lancet 357:1583–1585
    • View reference on publisher's website
    • View reference on PubMed
  87. Koski G (2004) Ethics, science, and oversight of critical care research: the Office for Human Research Protections. Am J Respir Crit Care Med 169:982–986
    • View reference on publisher's website
    • View reference on PubMed
  88. Yoshioka A (1998) Use of randomisation in the Medical Research Council’s clinical trial of streptomycin in pulmonary tuberculosis in the 1940s. BMJ 317:1220–1223
    • View reference on PubMed
  89. Eichacker PQ, Gerstenberger EP, Banks SM, Cui X, Natanson C (2002) Meta-analysis of acute lung injury and acute respiratory distress syndrome trials testing low tidal volumes. Am J Respir Crit Care Med 166:1510–1514
    • View reference on publisher's website
    • View reference on PubMed
  90. Mello MM, Studdert DM, Brennan TA (2003) The rise of litigation in human subjects research. Ann Intern Med 139:40–45
    • View reference on PubMed

Sign In

Connect with ICM

Top 5 Articles Editors Picks Supplement