title: Feasibility, limits and problems of clinical studies in Intensive Care Unit.
abstract: 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.
authors.affiliation: Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, University Milano Bicocca, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Grasselli
authors.forename: L
authors.initials: L
authors.lastname: Gattinoni
authors.forename: B
authors.initials: B
authors.lastname: Kavanagh
authors.forename: R
authors.initials: R
authors.lastname: Latini
authors.forename: A
authors.initials: A
authors.lastname: Laupacis
authors.forename: F
authors.initials: F
authors.lastname: Lemaire
authors.forename: A
authors.initials: A
authors.lastname: Pesenti
authors.forename: P
authors.initials: P
authors.lastname: Suter
authors.forename: A
authors.initials: A
authors.lastname: Slutsky
authors.forename: G
authors.initials: G
authors.lastname: Tognoni
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003422:Critical Care; D016638:Critical Illness; D019317:Evidence-Based Medicine; D006801:Humans; D007362:Intensive Care Units / Q000458:organization & administration* / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic