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Published in: Critical Care 6/2002

01-12-2002 | Letter

The limitations of observational studies on the treatment of severe sepsis

Author: Christian J Wiedermann

Published in: Critical Care | Issue 6/2002

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Abstract

Observational studies usually agree with randomised, controlled trials. It is a logical fallacy, however, to suggest that agreement in one direction implies prediction in the other direction. Observational studies are not scientifically capable of proving or disproving hypotheses such as the efficacy and safety of the treatment of severe sepsis with antithrombin. Observational studies are difficult to analyse and interpret because of the heterogeneity of real-life patient populations, the lack of standardised treatment regimens, the lack of standardised indications for treatment, and the lack of predefined endpoints.
Literature
1.
go back to reference Messori A, Vacca F, Vaiani M, Trippoli S: Antithrombin III in patients admitted to intensive care units: a multicentre observational study. Crit Care 2002, 6: 447-451. 10.1186/cc1540PubMedCentralCrossRefPubMed Messori A, Vacca F, Vaiani M, Trippoli S: Antithrombin III in patients admitted to intensive care units: a multicentre observational study. Crit Care 2002, 6: 447-451. 10.1186/cc1540PubMedCentralCrossRefPubMed
2.
go back to reference Pocock SJ, Elbourne DR: Randomized trials of observational tribulations. N Engl J Med 2000, 342: 1907-1909. 10.1056/NEJM200006223422511CrossRefPubMed Pocock SJ, Elbourne DR: Randomized trials of observational tribulations. N Engl J Med 2000, 342: 1907-1909. 10.1056/NEJM200006223422511CrossRefPubMed
3.
go back to reference Benson K, Hartz AJ: A comparison of observational studies and randomised, controlled trials. N Engl J Med 2000, 342: 1878-1886. 10.1056/NEJM200006223422506CrossRefPubMed Benson K, Hartz AJ: A comparison of observational studies and randomised, controlled trials. N Engl J Med 2000, 342: 1878-1886. 10.1056/NEJM200006223422506CrossRefPubMed
4.
go back to reference Concato J, Sha N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000, 342: 1887-1892. 10.1056/NEJM200006223422507PubMedCentralCrossRefPubMed Concato J, Sha N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000, 342: 1887-1892. 10.1056/NEJM200006223422507PubMedCentralCrossRefPubMed
5.
go back to reference Warren BL, Eid A, Singer P, Pillay SS, Carl P, Novak I, Chalupa P, Atherstone A, Pénzes I, Kübler A, Knaub S, Keinecke HO, Heinrichs H, Schindel F, Juers M, Bone RC, Opal SM: High-dose antithrombin III in severe sepsis – a randomized controlled trial. JAMA 2001, 286: 1869-1878. 10.1001/jama.286.15.1869CrossRefPubMed Warren BL, Eid A, Singer P, Pillay SS, Carl P, Novak I, Chalupa P, Atherstone A, Pénzes I, Kübler A, Knaub S, Keinecke HO, Heinrichs H, Schindel F, Juers M, Bone RC, Opal SM: High-dose antithrombin III in severe sepsis – a randomized controlled trial. JAMA 2001, 286: 1869-1878. 10.1001/jama.286.15.1869CrossRefPubMed
6.
go back to reference Fourrier F, Chopin C, Huart J-J: Double-blind, placebo-controlled trial of antithrombin III concentrate in septic shock with disseminated intravascular coagulation. Chest 1993, 104: 882-888.CrossRefPubMed Fourrier F, Chopin C, Huart J-J: Double-blind, placebo-controlled trial of antithrombin III concentrate in septic shock with disseminated intravascular coagulation. Chest 1993, 104: 882-888.CrossRefPubMed
7.
go back to reference Eisele B, Lamy M, Thijs LG, Keinecke HO, Schuster HP, Matthias FR, Fourrier F, Heinrichs H, Delvos U: Antithrombin III in patients with severe sepsis. Intensive Care Med 1998, 24: 663-672. 10.1007/s001340050642CrossRefPubMed Eisele B, Lamy M, Thijs LG, Keinecke HO, Schuster HP, Matthias FR, Fourrier F, Heinrichs H, Delvos U: Antithrombin III in patients with severe sepsis. Intensive Care Med 1998, 24: 663-672. 10.1007/s001340050642CrossRefPubMed
8.
go back to reference Baudo F, Caimi TM, deCataldo F, Ravizza A, Arlati A, Casella G, Carugo D, Palareti G, Legnani C, Ridolfi L, Rossi R, D'Angelo A, Crippa L, Giudici D, Gallioli G, Wolfler A, Calori G: Antithrombin III replacement therapy in patients with sepsis and/or post surgical complications: a double-blind, randomized multicenter study. Intensive Care Med 1998, 24: 336-342. 10.1007/s001340050576CrossRefPubMed Baudo F, Caimi TM, deCataldo F, Ravizza A, Arlati A, Casella G, Carugo D, Palareti G, Legnani C, Ridolfi L, Rossi R, D'Angelo A, Crippa L, Giudici D, Gallioli G, Wolfler A, Calori G: Antithrombin III replacement therapy in patients with sepsis and/or post surgical complications: a double-blind, randomized multicenter study. Intensive Care Med 1998, 24: 336-342. 10.1007/s001340050576CrossRefPubMed
10.
go back to reference Villar J, Carroll G, Belizan JM: Predictive ability of meta-analyses of randomised controlled trials. Lancet 1995, 345: 772-776. 10.1016/S0140-6736(95)90646-0CrossRefPubMed Villar J, Carroll G, Belizan JM: Predictive ability of meta-analyses of randomised controlled trials. Lancet 1995, 345: 772-776. 10.1016/S0140-6736(95)90646-0CrossRefPubMed
11.
go back to reference LeLorier J, Gregorier G, Benhaddad A, Lapierre J, Derderian F: Discrepancies between meta-analyses and subsequent larger randomised controlled trials. N Engl J Med 1997, 337: 536-542. 10.1056/NEJM199708213370806CrossRefPubMed LeLorier J, Gregorier G, Benhaddad A, Lapierre J, Derderian F: Discrepancies between meta-analyses and subsequent larger randomised controlled trials. N Engl J Med 1997, 337: 536-542. 10.1056/NEJM199708213370806CrossRefPubMed
Metadata
Title
The limitations of observational studies on the treatment of severe sepsis
Author
Christian J Wiedermann
Publication date
01-12-2002
Publisher
BioMed Central
Published in
Critical Care / Issue 6/2002
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/cc1838

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