title: Alternative clinical trial design in neurocritical care.
abstract: Neurocritical care involves the care of highly complex patients with combinations of physiologic derangements in the brain and in extracranial organs. The level of evidence underpinning treatment recommendations remains low due to a multitude of reasons including an incomplete understanding of the involved physiology; lack of good quality, prospective, standardized data; and the limited success of conventional randomized controlled trials. Comparative effectiveness research can provide alternative perspectives and methods to enhance knowledge and evidence within the field of neurocritical care; these include large international collaborations for generation and maintenance of high quality data, statistical methods that incorporate heterogeneity and individualize outcome prediction, and finally advanced bioinformatics that integrate large amounts of variable-source data into patient-specific phenotypes and trajectories.
authors.affiliation: Division of Neurocritical Care and Vascular Neurology, Department of Neurology, Baylor College of Medicine, 6501 Fannin Street, MS: NB320, Houston, TX, 77030, USA, jisuarez@bcm.tmc.edu.
authors.forename: Christos
authors.initials: C
authors.lastname: Lazaridis
authors.forename: Andrew I R
authors.initials: AI
authors.lastname: Maas
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Souter
authors.forename: Renee H
authors.initials: RH
authors.lastname: Martin
authors.forename: Randal M
authors.initials: RM
authors.lastname: Chesnut
authors.forename: Stacia M
authors.initials: SM
authors.lastname: DeSantis
authors.forename: Gene
authors.initials: G
authors.lastname: Sung
authors.forename: Peter D
authors.initials: PD
authors.lastname: Leroux
authors.forename: Jose I
authors.initials: JI
authors.lastname: Suarez
mesh_terms: D002986:Clinical Trials as Topic; D003422:Critical Care / Q000379:methods*; D006801:Humans; D064926:Neurophysiological Monitoring / Q000379:methods*; D012107:Research Design