NDLI: IMPACT recommendations for improving the design and analysis of clinical trials in moderate to severe traumatic brain injury

Content Provider	Springer Nature Link
Author	Maas, Andrew I. R. Steyerberg, Ewout W. Marmarou, Anthony McHugh, Gillian S. Lingsma, Hester F. Butcher, Isabella Lu, Juan Weir, James Roozenbeek, Bob Murray, Gordon D.
Copyright Year	2010
Abstract	Clinical trials in traumatic brain injury (TBI) pose complex methodological challenges, largely related to the heterogeneity of the population. The International Mission on Prognosis and Clinical Trial Design in TBI study group has explored approaches for dealing with this heterogeneity with the aim to optimize clinical trials in TBI. Extensive prognostic analyses and simulation studies were conducted on individual patient data from eight trials and three observational studies. Here, we integrate the results of these studies into the International Mission on Prognosis and Clinical Trial Design in TBI recommendations for design and analysis of trials in TBI:• Details of the major baseline prognostic characteristics should be provided in every report on a TBI study; in trials they should be differentiated per treatment group. We also advocate the reporting of the baseline prognostic risk as determined by validated prognostic models.• Inclusion criteria should be as broad as is compatible with the current understanding of the mechanisms of action of the intervention being evaluated. This will maximize recruitment rates and enhance the generalizability of the results.• The statistical analysis should incorporate prespecified covariate adjustment to mitigate the effects of the heterogeneity.• The statistical analysis should use an ordinal approach, based on either sliding dichotomy or proportional odds methodology. Broad inclusion criteria, prespecified covariate adjustment, and an ordinal analysis will promote an efficient trial, yielding gains in statistical efficiency of more than 40%. This corresponds to being able to detect a 7% treatment effect with the same number of patients needed to demonstrate a 10% difference with an unadjusted analysis based on the dichotomized Glasgow outcome scale.
Starting Page	127
Ending Page	134
Page Count	8
File Format	PDF
ISSN	19337213
Journal	NeuroRX
Volume Number	7
Issue Number	1
e-ISSN	18787479
Language	English
Publisher	Springer-Verlag
Publisher Date	2010-01-01
Publisher Institution	American Society for Experimental NeuroTherapeutics
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Traumatic brain injury clinical trials study design sliding dichotomy covariate adjustment prognosis Neurosciences Neurology Neurosurgery Neurobiology
Content Type	Text
Resource Type	Article
Subject	Neurology (clinical) Pharmacology Pharmacology (medical)

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