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Title: Mortality in Multicenter Critical Care Trials: An Analysis of Interventions With a Significant Effect.
Austin Authors: Landoni, Giovanni;Comis, Marco;Conte, Massimiliano;Finco, Gabriele;Mucchetti, Marta;Paternoster, Gianluca;Pisano, Antonio;Ruggeri, Laura;Alvaro, Gabriele;Angelone, Manuela;Bergonzi, Pier C;Bocchino, Speranza;Borghi, Giovanni;Bove, Tiziana;Buscaglia, Giuseppe;Cabrini, Luca;Callegher, Lino;Caramelli, Fabio;Colombo, Sergio;Corno, Laura;Del Sarto, Paolo;Feltracco, Paolo;Forti, Alessandro;Ganzaroli, Marco;Greco, Massimiliano;Guarracino, Fabio;Lembo, Rosalba;Lobreglio, Rosetta;Meroni, Roberta;Monaco, Fabrizio;Musu, Mario;Pala, Giovanni;Pasin, Laura;Pieri, Marina;Pisarra, Stefania;Ponticelli, Giuseppe;Roasio, Agostino;Santini, Francesco;Silvetti, Simona;Székely, Andrea;Zambon, Massimo;Zucchetti, Maria Chiara;Zangrillo, Alberto;Bellomo, Rinaldo 
Affiliation: FTGM-"G. Pasquinucci" Heart Hospital, Massa, Italy
Anesthesia and Resuscitation, United Company Hospital Papardo-Piemonte, Messina, Italy
Department of Anesthesia and Intensive Care, University of Cagliari, Cagliari, Italy
Cardioanesthesia and Intensive Care, Civil Hospital "SS Annunziata," Sassari, Italy
Department of Intensive Care, Austin Health, Heidelberg, Victoria, Australia
The University of Melbourne, Melbourne, Victoria, Australia
Cardiovascular Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy
Division of Cardiac Anesthesia and Intensive Care, Azienda Ospedaliera Dei Colli, V Monaldi, Naples, Italy
A.O. Mater Domini Germaneto, Catanzaro, Italy.
Cardioanesthesia and Intensive Care, IRCCS University Hospital San Martino Ist, Genova, Italy.
Department of Anesthesia and Intensive Care, S. Maria dei Battuti Hospital ULSS 9, Treviso, Italy
Cardiothoracic and Vascular Anesthesia and Intensive Care, S. Orsola-Malpighi University Hospital, Bologna, Italy
Cardiac and Vascular Department, Casa di Cura Villa Verde, Taranto, Italy
Division of Cardiac Surgery, University of Genova Medical School, Genova, Italy
Department of Anesthesiology and Intensive Care, Semmelweis University, Budapest, Hungary
Department of Anesthesia, Intensive Care Medicine, Cardinal Massaia Hospital, Asti, Italy
Department of Anaesthesia and Critical care medicine, University Hospital of Pisa, Pisa, Italy
Anesthesia and Critical care medicine, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy
Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Cardiac and Vascular Department, Mauriziano Hospital, Turin, Italy.
Department of Medical Sciences "M. Aresu," University of Cagliari, Cagliari, Italy
Department of Anesthesia and Intensive Care, Maria Cecilia Hospital - GVM Care & Research, Cotignola (RA), Italy
Department of Pharmacology and Anesthesiology, University Hospital of Padova, Padova, Italy
Department of Anesthesia and Intensive Care, "S. Maria di Ca' Foncello," Treviso, Italy
Issue Date: 27-Mar-2015
Publication information: Critical Care Medicine, 2015-03-27
Abstract: We aimed to identify all treatments that affect mortality in adult critically ill patients in multicenter randomized controlled trials. We also evaluated the methodological aspects of these studies, and we surveyed clinicians' opinion and usual practice for the selected interventions.MEDLINE/PubMed, Scopus, and Embase were searched. Further articles were suggested for inclusion from experts and cross-check of references.We selected the articles that fulfilled the following criteria: publication in a peer-reviewed journal; multicenter randomized controlled trial design; dealing with nonsurgical interventions in adult critically ill patients; and statistically significant effect in unadjusted landmark mortality. A consensus conference assessed all interventions and excluded those with lack of reproducibility, lack of generalizability, high probability of type I error, major baseline imbalances between intervention and control groups, major design flaws, contradiction by subsequent larger higher quality trials, modified intention to treat analysis, effect found only after adjustments, and lack of biological plausibility.For all selected studies, we recorded the intervention and its comparator, the setting, the sample size, whether enrollment was completed or interrupted, the presence of blinding, the effect size, and the duration of follow-up.We found 15 interventions that affected mortality in 24 multicenter randomized controlled trials. Median sample size was small (199 patients) as was median centers number (10). Blinded trials enrolled significantly more patients and involved more centers. Multicenter randomized controlled trials showing harm also involved significantly more centers and more patients (p = 0.016 and p = 0.04, respectively). Five hundred fifty-five clinicians from 61 countries showed variable agreement on perceived validity of such interventions.We identified 15 treatments that decreased/increased mortality in critically ill patients in 24 multicenter randomized controlled trials. However, design affected trial size and larger trials were more likely to show harm. Finally, clinicians view of such trials and their translation into practice varied.
Gov't Doc #: 25821918
DOI: 10.1097/CCM.0000000000000974
Journal: Critical Care Medicine
Type: Journal Article
Appears in Collections:Journal articles

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