Skip to main content
Erschienen in: Intensive Care Medicine 3/2005

01.03.2005 | Clinical Commentary

Is it better to consent to an RCT or to care?

Μηδεν αγαν (“nothing in excess”)

verfasst von: Didier Dreyfuss

Erschienen in: Intensive Care Medicine | Ausgabe 3/2005

Einloggen, um Zugang zu erhalten

Excerpt

Twenty-five years ago the Belmont report [1] established a formal distinction between care and research in order to protect patients. The legitimate fear that research might be conducted under the pretence of medical care regardless of whether this increased the risk to patients drove this effort toward clarification. A sound ethical foundation to medical research was deemed essential after the heinous Nazi experiments and the abhorrent 40-year-long Tuskegee syphilis study [2]. At the time that the Belmont report was issued randomized clinical trials (RCTs) were coming into vogue. An RCT is not routine clinical care, even when the treatments in both study arms are consonant with standard practice. Thus both the ability of RCTs to produce high-quality medical knowledge and the distinction between care and research were considered of paramount importance at the time of the Belmont report [1]. Whether research should be incorporated into medical care remains controversial, however, as reflected by several recent and conflicting statements of opinion [3, 4, 5]. …
Literatur
1.
Zurück zum Zitat 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 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.
Zurück zum Zitat White RM (2000) Unraveling the Tuskegee study of untreated syphilis. Arch Intern Med 160:585–598CrossRefPubMed White RM (2000) Unraveling the Tuskegee study of untreated syphilis. Arch Intern Med 160:585–598CrossRefPubMed
3.
Zurück zum Zitat Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386CrossRefPubMed Miller FG, Rosenstein DL (2003) The therapeutic orientation to clinical trials. N Engl J Med 348:1383–1386CrossRefPubMed
4.
Zurück zum Zitat Grunberg SM, Cefalu WT (2003) The integral role of clinical research in clinical care. N Engl J Med 348:1386–1388CrossRefPubMed Grunberg SM, Cefalu WT (2003) The integral role of clinical research in clinical care. N Engl J Med 348:1386–1388CrossRefPubMed
5.
Zurück zum Zitat Truog RD, Robinson W, Randolph A, Morris A (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 340:804–807CrossRefPubMed Truog RD, Robinson W, Randolph A, Morris A (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 340:804–807CrossRefPubMed
6.
Zurück zum Zitat Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711CrossRefPubMed Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711CrossRefPubMed
7.
Zurück zum Zitat Paasche-Orlow MK, Taylor HA, Brancati FL (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348:721–726CrossRefPubMed Paasche-Orlow MK, Taylor HA, Brancati FL (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348:721–726CrossRefPubMed
8.
Zurück zum Zitat 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 29:1893–1897CrossRefPubMed 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 29:1893–1897CrossRefPubMed
9.
Zurück zum Zitat King NM, Churchill LR (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 341:449–450CrossRef King NM, Churchill LR (1999) Is informed consent always necessary for randomized, controlled trials? N Engl J Med 341:449–450CrossRef
10.
Zurück zum Zitat Visser HK (2001) Non-therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818–819CrossRefPubMed Visser HK (2001) Non-therapeutic research in the EU in adults incapable of giving consent? Lancet 357:818–819CrossRefPubMed
11.
Zurück zum Zitat Lemaire FJ (2003) A European Directive for clinical research. Intensive Care Med 29:18–20 Lemaire FJ (2003) A European Directive for clinical research. Intensive Care Med 29:18–20
12.
Zurück zum Zitat Singer EA, Mullner M (2002) Implications of the EU directive on clinical trials for emergency medicine. BMJ 324:1169–1170CrossRefPubMed Singer EA, Mullner M (2002) Implications of the EU directive on clinical trials for emergency medicine. BMJ 324:1169–1170CrossRefPubMed
13.
Zurück zum Zitat European Parliament (2001) Directive 2001/20/EC of the European Parliament and of the Council. Official J Eur Communities L121:34–44 European Parliament (2001) Directive 2001/20/EC of the European Parliament and of the Council. Official J Eur Communities L121:34–44
14.
Zurück zum Zitat Dreyfuss D (2004) To consent or not to consent, that is (not) the (sole) question. Intensive Care Med 30:180–182CrossRefPubMed Dreyfuss D (2004) To consent or not to consent, that is (not) the (sole) question. Intensive Care Med 30:180–182CrossRefPubMed
15.
Zurück zum Zitat Evidence-Based Medicine Working Group (1992) Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 268:2420–2425CrossRefPubMed Evidence-Based Medicine Working Group (1992) Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 268:2420–2425CrossRefPubMed
16.
Zurück zum Zitat D’Arcy Hart P (1999) A change in scientific approach: from alternation to randomised allocation in clinical trials in the 1940s. BMJ 319:572–573PubMed D’Arcy Hart P (1999) A change in scientific approach: from alternation to randomised allocation in clinical trials in the 1940s. BMJ 319:572–573PubMed
17.
Zurück zum Zitat Meldrum M (1998) “A calculated risk”: the Salk polio vaccine field trials of 1954. BMJ 317:1233–1236PubMed Meldrum M (1998) “A calculated risk”: the Salk polio vaccine field trials of 1954. BMJ 317:1233–1236PubMed
18.
Zurück zum Zitat Löwy I (2004) Essai clinique. In: Lecourt D (ed) Dictionnaire de la pensée médicale. PUF, Paris, pp 441–446 Löwy I (2004) Essai clinique. In: Lecourt D (ed) Dictionnaire de la pensée médicale. PUF, Paris, pp 441–446
19.
Zurück zum Zitat Beecher HK (1966) Ethics and clinical research. N Engl J Med 274:1354–1360PubMed Beecher HK (1966) Ethics and clinical research. N Engl J Med 274:1354–1360PubMed
20.
Zurück zum Zitat Vandenbroucke JP, de Craen AJ (2001) Alternative medicine: a “mirror image” for scientific reasoning in conventional medicine. Ann Intern Med 135:507–513PubMed Vandenbroucke JP, de Craen AJ (2001) Alternative medicine: a “mirror image” for scientific reasoning in conventional medicine. Ann Intern Med 135:507–513PubMed
21.
Zurück zum Zitat Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:1167–1170CrossRefPubMed Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:1167–1170CrossRefPubMed
22.
Zurück zum Zitat 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–CrossRefPubMed 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–CrossRefPubMed
23.
Zurück zum Zitat Warren HS, Suffredini AF, Eichacker PQ, Munford RS (2002) Risks and benefits of activated protein C treatment for severe sepsis. N Engl J Med 347:1027–1030CrossRefPubMed Warren HS, Suffredini AF, Eichacker PQ, Munford RS (2002) Risks and benefits of activated protein C treatment for severe sepsis. N Engl J Med 347:1027–1030CrossRefPubMed
24.
Zurück zum Zitat Siegel JP (2002) Assessing the use of activated protein C in the treatment of severe sepsis. N Engl J Med 347:1030–1004CrossRefPubMed Siegel JP (2002) Assessing the use of activated protein C in the treatment of severe sepsis. N Engl J Med 347:1030–1004CrossRefPubMed
26.
Zurück zum Zitat Knottnerus JA, Dinant GJ (1997) Medicine based evidence, a prerequisite for evidence based medicine. BMJ 315:1109–1110PubMed Knottnerus JA, Dinant GJ (1997) Medicine based evidence, a prerequisite for evidence based medicine. BMJ 315:1109–1110PubMed
27.
Zurück zum Zitat 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 136:888–895PubMed 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 136:888–895PubMed
28.
Zurück zum Zitat 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 342:1301–1308CrossRefPubMed 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 342:1301–1308CrossRefPubMed
29.
Zurück zum Zitat Milberg J, Davis D, Steinberg K, Hudson L (1995) Improved survival of patients with acute respiratory distress syndrome (ARDS): 1983–1993. JAMA 273:306–309CrossRefPubMed Milberg J, Davis D, Steinberg K, Hudson L (1995) Improved survival of patients with acute respiratory distress syndrome (ARDS): 1983–1993. JAMA 273:306–309CrossRefPubMed
30.
Zurück zum Zitat Dreyfuss D, Saumon G (2002) Evidence-based medicine or fuzzy logic. What is best for ARDS management? Intensive Care Med 28:230–234CrossRefPubMed Dreyfuss D, Saumon G (2002) Evidence-based medicine or fuzzy logic. What is best for ARDS management? Intensive Care Med 28:230–234CrossRefPubMed
31.
Zurück zum Zitat 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 287:345–355CrossRefPubMed 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 287:345–355CrossRefPubMed
32.
Zurück zum Zitat 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 30:51–61CrossRefPubMed 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 30:51–61CrossRefPubMed
33.
Zurück zum Zitat 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 167:1304–1309CrossRefPubMed 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 167:1304–1309CrossRefPubMed
34.
Zurück zum Zitat Ricard JD (2003) Are we really reducing tidal volume-and should we? Am J Respir Crit Care Med 167:1297–1298CrossRefPubMed Ricard JD (2003) Are we really reducing tidal volume-and should we? Am J Respir Crit Care Med 167:1297–1298CrossRefPubMed
35.
Zurück zum Zitat 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 32:1289–1293CrossRefPubMed 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 32:1289–1293CrossRefPubMed
36.
Zurück zum Zitat 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 351:327–336CrossRefPubMed 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 351:327–336CrossRefPubMed
37.
Zurück zum Zitat 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 345:568–573CrossRefPubMed 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 345:568–573CrossRefPubMed
38.
Zurück zum Zitat 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 132:880–884PubMed 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 132:880–884PubMed
39.
Zurück zum Zitat 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 25:936–941CrossRefPubMed 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 25:936–941CrossRefPubMed
40.
Zurück zum Zitat Brochard L, Mancebo J, Tobin M (2003) Searching for evidence: don’t forget the foundations. Intensive Care Med 29:2109–2111CrossRefPubMed Brochard L, Mancebo J, Tobin M (2003) Searching for evidence: don’t forget the foundations. Intensive Care Med 29:2109–2111CrossRefPubMed
41.
Zurück zum Zitat 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 316:1275–1285PubMed 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 316:1275–1285PubMed
42.
Zurück zum Zitat Vincent JL (2003) Selective digestive decontamination: for everyone, everywhere? Lancet 362:1006–1007CrossRefPubMed Vincent JL (2003) Selective digestive decontamination: for everyone, everywhere? Lancet 362:1006–1007CrossRefPubMed
43.
Zurück zum Zitat Bartlett JG (1995) Selective decontamination of the digestive tract and its effect on antimicrobial resistance. Crit Care Med 23:613–615CrossRefPubMed Bartlett JG (1995) Selective decontamination of the digestive tract and its effect on antimicrobial resistance. Crit Care Med 23:613–615CrossRefPubMed
44.
Zurück zum Zitat Kollef MH (2004) Prevention of hospital-associated pneumonia and ventilator-associated pneumonia. Crit Care Med 32:1396–1405CrossRefPubMed Kollef MH (2004) Prevention of hospital-associated pneumonia and ventilator-associated pneumonia. Crit Care Med 32:1396–1405CrossRefPubMed
45.
Zurück zum Zitat 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 321:1103–1106CrossRefPubMed 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 321:1103–1106CrossRefPubMed
46.
Zurück zum Zitat 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 275:308–314CrossRefPubMed 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 275:308–314CrossRefPubMed
47.
Zurück zum Zitat 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 29:1306–1313CrossRefPubMed 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 29:1306–1313CrossRefPubMed
48.
Zurück zum Zitat Thompson BT, Hayden D, Matthay MA, Brower R, Parsons PE (2001) Clinicians’ approaches to mechanical ventilation in acute lung injury and ARDS. Chest 120:1622–1627CrossRefPubMed Thompson BT, Hayden D, Matthay MA, Brower R, Parsons PE (2001) Clinicians’ approaches to mechanical ventilation in acute lung injury and ARDS. Chest 120:1622–1627CrossRefPubMed
50.
Zurück zum Zitat Beauchamp TL, Childress JF (1994) Principles of medical ethics, 4th edn. Oxford University Press, New York Beauchamp TL, Childress JF (1994) Principles of medical ethics, 4th edn. Oxford University Press, New York
51.
Zurück zum Zitat Abraham E (1999) Why immunomodulatory therapies have not worked in sepsis. Intensive Care Med 25:556–566CrossRefPubMed Abraham E (1999) Why immunomodulatory therapies have not worked in sepsis. Intensive Care Med 25:556–566CrossRefPubMed
52.
Zurück zum Zitat Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192PubMed Freeman BD, Danner RL, Banks SM, Natanson C (2001) Safeguarding patients in clinical trials with high mortality rates. Am J Respir Crit Care Med 164:190–192PubMed
53.
Zurück zum Zitat Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153–S160CrossRefPubMed Luce JM (2003) Is the concept of informed consent applicable to clinical research involving critically ill patients? Crit Care Med 31:S153–S160CrossRefPubMed
54.
Zurück zum Zitat Bigatello LM, George E, Hurford WE (2003) Ethical considerations for research in critically ill patients. Crit Care Med 31:S178–S181CrossRefPubMed Bigatello LM, George E, Hurford WE (2003) Ethical considerations for research in critically ill patients. Crit Care Med 31:S178–S181CrossRefPubMed
55.
Zurück zum Zitat Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612CrossRefPubMed Coppolino M, Ackerson L (2001) Do surrogate decision makers provide accurate consent for intensive care research? Chest 119:603–612CrossRefPubMed
56.
Zurück zum Zitat Luce JM (2003) California’s new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. Intensive Care Med 29:1024–1025PubMed Luce JM (2003) California’s new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. Intensive Care Med 29:1024–1025PubMed
57.
Zurück zum Zitat Lemaire F (2003) Suspension of the NIH ARDS Network fluids and catheters treatment trial. Intensive Care Med 29:1361–1363CrossRefPubMed Lemaire F (2003) Suspension of the NIH ARDS Network fluids and catheters treatment trial. Intensive Care Med 29:1361–1363CrossRefPubMed
58.
Zurück zum Zitat Silverman HJ, Miller FG (2004) Control group selection in critical care randomized controlled trials evaluating interventional strategies: an ethical assessment. Crit Care Med 32:852–857CrossRefPubMed Silverman HJ, Miller FG (2004) Control group selection in critical care randomized controlled trials evaluating interventional strategies: an ethical assessment. Crit Care Med 32:852–857CrossRefPubMed
59.
Zurück zum Zitat Concato J, Horwitz RI (2004) Beyond randomised versus observational studies. Lancet 363:1660–1661CrossRefPubMed Concato J, Horwitz RI (2004) Beyond randomised versus observational studies. Lancet 363:1660–1661CrossRefPubMed
60.
Zurück zum Zitat Steinbrook R (2003) How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome. N Engl J Med 348:1393–1401CrossRefPubMed Steinbrook R (2003) How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome. N Engl J Med 348:1393–1401CrossRefPubMed
61.
Zurück zum Zitat Partridge AH, Winer EP (2002) Informing clinical trial participants about study results. JAMA 288:363–365CrossRefPubMed Partridge AH, Winer EP (2002) Informing clinical trial participants about study results. JAMA 288:363–365CrossRefPubMed
62.
Zurück zum Zitat Tobias JS (1997) BMJ’s present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 314:1111–1114PubMed Tobias JS (1997) BMJ’s present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 314:1111–1114PubMed
63.
Zurück zum Zitat Tobias JS, Souhami RL (1993) Fully informed consent can be needlessly cruel. BMJ 307:1199–1201PubMed Tobias JS, Souhami RL (1993) Fully informed consent can be needlessly cruel. BMJ 307:1199–1201PubMed
64.
65.
Zurück zum Zitat 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) 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.
Zurück zum Zitat Steinbrook R (2002) Improving protection for research subjects. N Engl J Med 346:1425–14230CrossRefPubMed Steinbrook R (2002) Improving protection for research subjects. N Engl J Med 346:1425–14230CrossRefPubMed
67.
Zurück zum Zitat 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 169:10–14CrossRefPubMed 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 169:10–14CrossRefPubMed
68.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 30:30CrossRef 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 30:30CrossRef
70.
Zurück zum Zitat Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321–324CrossRefPubMed Annane D, Outin H, Fisch C, Bellissant E (2004) The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med 30:321–324CrossRefPubMed
71.
Zurück zum Zitat 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 341:448–450CrossRefPubMed 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 341:448–450CrossRefPubMed
72.
Zurück zum Zitat Zelen M (1979) A new design for randomized clinical trials. N Engl J Med 300:1242–1245PubMed Zelen M (1979) A new design for randomized clinical trials. N Engl J Med 300:1242–1245PubMed
73.
Zurück zum Zitat Bartlett RH, Roloff DW, Cornell RG, Andrews AF, Dillon PW, Zwischenberger JB (1985) Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 76:479–487PubMed Bartlett RH, Roloff DW, Cornell RG, Andrews AF, Dillon PW, Zwischenberger JB (1985) Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 76:479–487PubMed
74.
Zurück zum Zitat 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 84:957–963PubMed 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 84:957–963PubMed
75.
Zurück zum Zitat Baum M (1998) Informed consent. Numbers inform the debate. BMJ 317:947 Baum M (1998) Informed consent. Numbers inform the debate. BMJ 317:947
76.
Zurück zum Zitat Snowdon C, Elbourne D, Garcia J (1999) Zelen randomization: attitudes of parents participating in a neonatal clinical trial. Control Clin Trials 20:149–171CrossRefPubMed Snowdon C, Elbourne D, Garcia J (1999) Zelen randomization: attitudes of parents participating in a neonatal clinical trial. Control Clin Trials 20:149–171CrossRefPubMed
77.
Zurück zum Zitat Allmark P (1999) Should Zelen pre-randomised consent designs be used in some neonatal trials? J Med Ethics 25:325–329PubMed Allmark P (1999) Should Zelen pre-randomised consent designs be used in some neonatal trials? J Med Ethics 25:325–329PubMed
78.
Zurück zum Zitat Benson K, Hartz AJ (2000) A comparison of observational studies and randomized, controlled trials. N Engl J Med 342:1878–1886CrossRefPubMed Benson K, Hartz AJ (2000) A comparison of observational studies and randomized, controlled trials. N Engl J Med 342:1878–1886CrossRefPubMed
79.
Zurück zum Zitat Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892CrossRefPubMed Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892CrossRefPubMed
80.
Zurück zum Zitat 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 340:409–417CrossRefPubMed 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 340:409–417CrossRefPubMed
81.
Zurück zum Zitat 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 333:1025–1032CrossRefPubMed 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 333:1025–1032CrossRefPubMed
82.
Zurück zum Zitat 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 345:1368–1377CrossRefPubMed 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 345:1368–1377CrossRefPubMed
83.
Zurück zum Zitat 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 345:1359–1367CrossRefPubMed 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 345:1359–1367CrossRefPubMed
84.
Zurück zum Zitat 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 289:1963–1968CrossRefPubMed 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 289:1963–1968CrossRefPubMed
85.
Zurück zum Zitat 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 326:373CrossRefPubMed 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 326:373CrossRefPubMed
86.
Zurück zum Zitat 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 357:1583–1585CrossRefPubMed 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 357:1583–1585CrossRefPubMed
87.
Zurück zum Zitat Koski G (2004) Ethics, science, and oversight of critical care research: the Office for Human Research Protections. Am J Respir Crit Care Med 169:982–986CrossRefPubMed Koski G (2004) Ethics, science, and oversight of critical care research: the Office for Human Research Protections. Am J Respir Crit Care Med 169:982–986CrossRefPubMed
88.
Zurück zum Zitat Yoshioka A (1998) Use of randomisation in the Medical Research Council’s clinical trial of streptomycin in pulmonary tuberculosis in the 1940s. BMJ 317:1220–1223PubMed Yoshioka A (1998) Use of randomisation in the Medical Research Council’s clinical trial of streptomycin in pulmonary tuberculosis in the 1940s. BMJ 317:1220–1223PubMed
89.
Zurück zum Zitat 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 166:1510–1514CrossRefPubMed 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 166:1510–1514CrossRefPubMed
90.
Zurück zum Zitat Mello MM, Studdert DM, Brennan TA (2003) The rise of litigation in human subjects research. Ann Intern Med 139:40–45PubMed Mello MM, Studdert DM, Brennan TA (2003) The rise of litigation in human subjects research. Ann Intern Med 139:40–45PubMed
Metadaten
Titel
Is it better to consent to an RCT or to care?
Μηδεν αγαν (“nothing in excess”)
verfasst von
Didier Dreyfuss
Publikationsdatum
01.03.2005
Verlag
Springer-Verlag
Erschienen in
Intensive Care Medicine / Ausgabe 3/2005
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-004-2493-0

Weitere Artikel der Ausgabe 3/2005

Intensive Care Medicine 3/2005 Zur Ausgabe

Update AINS

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.