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Erschienen in: Intensive Care Medicine 2/2005

01.02.2005 | Clinical Commentary

Why are physicians so skeptical about positive randomized controlled clinical trials in critical care medicine?

verfasst von: Jesús Villar, Lina Pérez-Méndez, Armando Aguirre-Jaime, Robert M. Kacmarek

Erschienen in: Intensive Care Medicine | Ausgabe 2/2005

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Excerpt

Scientific evidence is an essential part of good medical practice. However, expert opinion, derived from personal experience and understanding of mechanisms, rather than scientific evidence is commonly used as a foundation for many decisions in medicine [2]. Practicing evidence-based critical care medicine is a difficult task; it must take into consideration the effectiveness of specific treatments in the context of patients who have multiple problems, and who are often receiving many different therapies in a setting that is different from those tested in most clinical trials. Although much of our care is based on expert opinion, results from many randomized clinical trials (RCT) have changed the practice of most critical care physicians. RCTs, when designed and performed appropriately, should provide the most reliable evidence of treatment effectiveness, particularly when the effects are small or moderate. Without clinical trials critical care physicians could continue applying ineffective and even harmful therapeutic interventions [3]. Recent RCTs enrolling large numbers of patients in the field of critical care medicine [4, 5, 6, 7] have reported harmful outcomes for well known treatments and beneficial effects of novel therapies. However, many clinicians do not translate the results of RCTs into clinical practice [8]. Several obstacles experienced by physicians can create barriers to the acceptance of RCTs [9]: lack of access to relevant information, lack of resources at the institutional level, lack of specialized training, incorrect interpretation or application of the evidence, rejection of evidence, influence of the clinical behavior at their institution, low salary, lack of financial incentives, reluctance to develop practice guidelines, and concern over increasing cost. …
Literatur
1.
Zurück zum Zitat Brochard L, Mancebo J, Tobin M (2003) Searching for evidence: don’t forget the foundations. Intensive Care Med 29:2109–1111CrossRefPubMed Brochard L, Mancebo J, Tobin M (2003) Searching for evidence: don’t forget the foundations. Intensive Care Med 29:2109–1111CrossRefPubMed
2.
Zurück zum Zitat Buckley NA, Smith AJ (1996) Evidence-based medicine in toxicology: where is the evidence? Lancet 347:1167–1169CrossRefPubMed Buckley NA, Smith AJ (1996) Evidence-based medicine in toxicology: where is the evidence? Lancet 347:1167–1169CrossRefPubMed
3.
Zurück zum Zitat Simes RJ (2002) Clinical trials and “real-world” medicine. Med J Aust 177:407–408PubMed Simes RJ (2002) Clinical trials and “real-world” medicine. Med J Aust 177:407–408PubMed
4.
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
5.
Zurück zum Zitat Bernard GR, Vincent JL, Laterre PF, La Rosa SP, Dhainaut JF, López-Rodríguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fischer CJ Jr (2001) Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 344:699–709CrossRefPubMed Bernard GR, Vincent JL, Laterre PF, La Rosa SP, Dhainaut JF, López-Rodríguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fischer CJ Jr (2001) Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 344:699–709CrossRefPubMed
6.
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
7.
Zurück zum Zitat Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaut P, Bellissant E (2002) Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 288:862–871PubMed Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaut P, Bellissant E (2002) Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 288:862–871PubMed
8.
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
9.
Zurück zum Zitat Kalassian KG, Dremsizov T, Angus DC (2002) Translating research evidence into clinical practice: new challenges for critical care. Crit Care 6:11–14CrossRefPubMed Kalassian KG, Dremsizov T, Angus DC (2002) Translating research evidence into clinical practice: new challenges for critical care. Crit Care 6:11–14CrossRefPubMed
10.
Zurück zum Zitat Taubes G (1996) Looking for the evidence in medicine. Science 272:22–24PubMed Taubes G (1996) Looking for the evidence in medicine. Science 272:22–24PubMed
11.
Zurück zum Zitat Davis D, O’Brien MA, Freemantle N, Wolf FM, Mazmanian P, Taylor-Vaisey A (1999) Impact of formal continuing medical education: do conferences, workshops, rounds, and other traditional continuing education activities change physician behaviour or health care outcomes? JAMA 282:867–874CrossRefPubMed Davis D, O’Brien MA, Freemantle N, Wolf FM, Mazmanian P, Taylor-Vaisey A (1999) Impact of formal continuing medical education: do conferences, workshops, rounds, and other traditional continuing education activities change physician behaviour or health care outcomes? JAMA 282:867–874CrossRefPubMed
12.
Zurück zum Zitat Marshall BJ, Warren JR (1984) Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet I:1311–1315CrossRef Marshall BJ, Warren JR (1984) Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet I:1311–1315CrossRef
13.
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
14.
Zurück zum Zitat Villar J, Kacmarek RM, Hedenstierna G (2004) From ventilator-induced lung injury to physician-induced lung injury: why the reluctance to use small tidal volumes? Acta Anaesthesiol Scand 48:267–271CrossRefPubMed Villar J, Kacmarek RM, Hedenstierna G (2004) From ventilator-induced lung injury to physician-induced lung injury: why the reluctance to use small tidal volumes? Acta Anaesthesiol Scand 48:267–271CrossRefPubMed
15.
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
16.
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
17.
Zurück zum Zitat Thompson B, Hayden D, Matthay MA, Brower R, Parson P (2001) Clinicians’ approach to mechanical ventilation in acute lung injury and ARDS. Chest 120:1622–1627CrossRefPubMed Thompson B, Hayden D, Matthay MA, Brower R, Parson P (2001) Clinicians’ approach to mechanical ventilation in acute lung injury and ARDS. Chest 120:1622–1627CrossRefPubMed
18.
Zurück zum Zitat Hayden D, Schoenfeld D, Bernard G, Brower R (2000) Outcome of participants vs. eligible participants in clinical trial of critically ill patients (abstract). Am J Respir Crit Care Med 161:A210 Hayden D, Schoenfeld D, Bernard G, Brower R (2000) Outcome of participants vs. eligible participants in clinical trial of critically ill patients (abstract). Am J Respir Crit Care Med 161:A210
19.
Zurück zum Zitat Villar J, Pérez-Méndez L, Kacmarek RM (1999) Current definitions of acute lung injury and the acute respiratory distress syndrome do not reflect their true severity and outcome. Intensive Care Med 25:930–935CrossRefPubMed Villar J, Pérez-Méndez L, Kacmarek RM (1999) Current definitions of acute lung injury and the acute respiratory distress syndrome do not reflect their true severity and outcome. Intensive Care Med 25:930–935CrossRefPubMed
20.
Zurück zum Zitat Ferguson ND, Kacmarek RM, Chiche JD, Singh JM, Hallett DC, Mehta S, Stewart TE (2004) Screening of ARDS patients using standardized ventilator settings: influence on enrolment in a clinical trial. Intensive Care Med 30:1111–1116CrossRefPubMed Ferguson ND, Kacmarek RM, Chiche JD, Singh JM, Hallett DC, Mehta S, Stewart TE (2004) Screening of ARDS patients using standardized ventilator settings: influence on enrolment in a clinical trial. Intensive Care Med 30:1111–1116CrossRefPubMed
21.
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
22.
Zurück zum Zitat Horrobin DF (2003) Are large clinical trials in rapidly lethal diseases usually unethical? Lancet 361:695–697CrossRefPubMed Horrobin DF (2003) Are large clinical trials in rapidly lethal diseases usually unethical? Lancet 361:695–697CrossRefPubMed
23.
Zurück zum Zitat Petrucci N (2003) Generalisability of randomised controlled trials: a matter of discussion. Intensive Care Med 29:858PubMed Petrucci N (2003) Generalisability of randomised controlled trials: a matter of discussion. Intensive Care Med 29:858PubMed
24.
Zurück zum Zitat Pronovost PJ, Berenholtz SM, Dorman T, Merritt WT, Martinez EA, Guyatt GH (2001) Evidence-based medicine in anesthesiology. Anesth Analg 92:787–794PubMed Pronovost PJ, Berenholtz SM, Dorman T, Merritt WT, Martinez EA, Guyatt GH (2001) Evidence-based medicine in anesthesiology. Anesth Analg 92:787–794PubMed
25.
Zurück zum Zitat MRC Streptomycin in Tuberculosis Trials Committee (1948) Streptomycin treatment of pulmonary tuberculosis. BMJ II:769–783 MRC Streptomycin in Tuberculosis Trials Committee (1948) Streptomycin treatment of pulmonary tuberculosis. BMJ II:769–783
26.
Zurück zum Zitat Hart PD (1999) A change in scientific approach: from alternation to randomised allocation in clinical trials in the 1940s. BMJ 319:572–573PubMed Hart PD (1999) A change in scientific approach: from alternation to randomised allocation in clinical trials in the 1940s. BMJ 319:572–573PubMed
27.
Zurück zum Zitat Altman DG (1998) Confidence intervals for the number needed to treat. BMJ 317:1309–1312PubMed Altman DG (1998) Confidence intervals for the number needed to treat. BMJ 317:1309–1312PubMed
28.
Zurück zum Zitat Roupie E, Lepage E, Wysocki M, Fagon JY, Chastre J, Dreyfuss D, Mentec H, Carlet J, Brun-Buisson C, Lemaire F, Brochard L (1999) Prevalence, etiologies and outcome of the acute respiratory distress syndrome among hypoxemic ventilated patients. Intensive Care Med 25:920–929CrossRefPubMed Roupie E, Lepage E, Wysocki M, Fagon JY, Chastre J, Dreyfuss D, Mentec H, Carlet J, Brun-Buisson C, Lemaire F, Brochard L (1999) Prevalence, etiologies and outcome of the acute respiratory distress syndrome among hypoxemic ventilated patients. Intensive Care Med 25:920–929CrossRefPubMed
29.
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
30.
Zurück zum Zitat Hebert PC, Wells G, Martin C, Tweeddale M, Marshall J, Blajchman M, Pagliarello G, Sandham D, Schweitzer II, Boisvert D, Calder L (1999) Variation in red cell transfusion practice in the intensive care unit: a multicentre cohort study. Crit Care 3:57–63CrossRefPubMed Hebert PC, Wells G, Martin C, Tweeddale M, Marshall J, Blajchman M, Pagliarello G, Sandham D, Schweitzer II, Boisvert D, Calder L (1999) Variation in red cell transfusion practice in the intensive care unit: a multicentre cohort study. Crit Care 3:57–63CrossRefPubMed
31.
Zurück zum Zitat Boraless H, Rao MP, Morgan C, Soni N, Goldhill DR, Brett SJ, Boralessi H, Contreras M (2002) A survey of physicians’ attitudes to transfusion practice in critically ill patients in the UK. Anaesthesia 57:584–588CrossRefPubMed Boraless H, Rao MP, Morgan C, Soni N, Goldhill DR, Brett SJ, Boralessi H, Contreras M (2002) A survey of physicians’ attitudes to transfusion practice in critically ill patients in the UK. Anaesthesia 57:584–588CrossRefPubMed
32.
Zurück zum Zitat Hotchkiss RS, Karl IE (2003) The pathophysiology and treatment of sepsis. N Engl J Med 348:138–150CrossRefPubMed Hotchkiss RS, Karl IE (2003) The pathophysiology and treatment of sepsis. N Engl J Med 348:138–150CrossRefPubMed
33.
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
34.
Zurück zum Zitat Ross SS (2004) From p values to Bayesian statistics, it’s all in the numbers. Scientist 18:24–25 Ross SS (2004) From p values to Bayesian statistics, it’s all in the numbers. Scientist 18:24–25
35.
Zurück zum Zitat Heyland DK, MacDonald S, Keefe L, Drover JW (1998) Total parenteral nutrition in the critically ill patient: a meta-analysis. JAMA 280:2013–2019CrossRefPubMed Heyland DK, MacDonald S, Keefe L, Drover JW (1998) Total parenteral nutrition in the critically ill patient: a meta-analysis. JAMA 280:2013–2019CrossRefPubMed
36.
Zurück zum Zitat Sadowski ZP, Alexander JH, Skrabucha B, Dyduszynski A, Kuch J, Nartowicz E, Swiatecka G, Kong DF, Granger CB (1999) Multicenter randomized trial and systematic overview of lidocaine in acute myocardial infarction. Am Heart J 137:792–798PubMed Sadowski ZP, Alexander JH, Skrabucha B, Dyduszynski A, Kuch J, Nartowicz E, Swiatecka G, Kong DF, Granger CB (1999) Multicenter randomized trial and systematic overview of lidocaine in acute myocardial infarction. Am Heart J 137:792–798PubMed
37.
Zurück zum Zitat Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systemic review. BMJ 326:1167–1170CrossRefPubMed Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: systemic review. BMJ 326:1167–1170CrossRefPubMed
38.
Zurück zum Zitat Executive Committee for the Asymptomatic Carotid Atherosclerosis Study (1995) Endarterectomy for asymptomatic carotid artery stenosis. JAMA 273:1421–1428PubMed Executive Committee for the Asymptomatic Carotid Atherosclerosis Study (1995) Endarterectomy for asymptomatic carotid artery stenosis. JAMA 273:1421–1428PubMed
39.
Zurück zum Zitat Wennberg DE, Lucas FL, Birkmeyer JD, Bredenberg CE, Fisher ES (1998) Variation in carotid endarterectomy mortality in the Medicare population. JAMA 279:1278–1281CrossRefPubMed Wennberg DE, Lucas FL, Birkmeyer JD, Bredenberg CE, Fisher ES (1998) Variation in carotid endarterectomy mortality in the Medicare population. JAMA 279:1278–1281CrossRefPubMed
40.
Zurück zum Zitat Holmberg L, Baum M (1995) Can results from clinical trials be generalized? Nat Med 1:734–736CrossRefPubMed Holmberg L, Baum M (1995) Can results from clinical trials be generalized? Nat Med 1:734–736CrossRefPubMed
Metadaten
Titel
Why are physicians so skeptical about positive randomized controlled clinical trials in critical care medicine?
verfasst von
Jesús Villar
Lina Pérez-Méndez
Armando Aguirre-Jaime
Robert M. Kacmarek
Publikationsdatum
01.02.2005
Verlag
Springer-Verlag
Erschienen in
Intensive Care Medicine / Ausgabe 2/2005
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-004-2519-7

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