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Minerva Anestesiologica 2007 November;73(11):595-601


lingua: Inglese

Feasibility, limits and problems of clinical studies in Intensive Care Unit

Grasselli G. 1, Gattinoni L. 2, Kavanagh B. 3, Latini R. 4, Laupacis A. 5, Lemaire F. 6, Pesenti A. 2, Suter P. 7, Slutsky A. 8, Tognoni G. 9

1 Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, University Milano Bicocca, Milan, Italy; 2 Department of Anesthesia and Intensive Care, IRCCS Foundation, “ Maggiore Policlinico, Mangiagalli, Regina Elena” Hospital, University of Milan, Milan, Italy; 3 Department of Anesthesiology and Critical Care Medicine, Hospital for Sick Children, University of Toronto, Toronto Canada; 4 Department of Cardiovascular Research, Mario Negri Institute, Milan, Italy, 5 Li Ka Shing Knowledge Institute, Toronto, Canada; 6 Assistance Publique-Hôpitaux de Paris, H. Mondor Hospital, University Paris XII, Créteil, France; 7 University of Geneva, Geneva, Switzerland; 8 Division of Respiratory Medicine, St. Michael’s Hospital, University of Toronto, Toronto, Canada; 9 Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy


In critical care medicine there is still a paucity of evidence on how to manage most of the clinical problems commonly encountered in critically ill patients. Randomized controlled trials (RCTs) are the most powerful instruments to evaluate the efficacy of a therapeutic intervention and to generate evidence for clinical practice. Unfortunately, the design and conduct of RCTs in our field are particularly complicated, because of some intrinsic and structural problems (e.g. lack of reliable nosography, concomitant use of different therapies, problems in the definition of end-points besides mortality) that will be discussed in this review. Further challenges are represented by the lack of tradition of large ICU networks, difficulties in linking or integrating physiologic and therapeutic objectives in designing clinical protocols, scarcity of independent or non-profit funds. A particularly stimulating opportunity of development is represented also by the relationship of critical care to EBM. Because of the above problems, metanalyses could be less informative than in other areas of medicine, as they are based on few trials which are often contradictory and of unsatisfactory quality. Few suggestions are formulated which could help looking forwards.

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