Outcome measures for clinical trials in neurotrauma

MR Bullock, RE Merchant, SC Choi, CB Gilman… - Neurosurgical …, 2002 - thejns.org
Under the auspices of the American Brain Injury Consortium and the Joint Section of
Neurotrauma and Critical Care of the American Association of Neurological Surgeons, the …

Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review

AV Hernández, EW Steyerberg, GS Taylor… - …, 2005 - journals.lww.com
OBJECTIVE: Few randomized clinical trials (RCTs) in the field of traumatic brain injury (TBI)
have shown a significant treatment benefit. We critically reviewed the use of two types of …

Comparative study of outcome measures and analysis methods for traumatic brain injury trials

AS Alali, D Vavrek, J Barber, S Dikmen… - Journal of …, 2015 - liebertpub.com
Batteries of functional and cognitive measures have been proposed as alternatives to the
Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury …

Outcome measures for clinical trials involving traumatically brain-injured patients: report of a conference

GL Clifton, RL Hayes, HS Levin, ME Michel, SC Choi - 1992 - journals.lww.com
Abstract A CONFERENCE WAS held in Houston, Texas, on October 8–9, 1991, to develop
recommendations for outcome measures for clinical trials in traumatic brain injury …

Adjustment for strong predictors of outcome in traumatic brain injury trials: 25% reduction in sample size requirements in the IMPACT study

AV Hernández, EW Steyerberg, I Butcher… - Journal of …, 2006 - liebertpub.com
The aim of this study was to quantify the potential reduction in sample size that can be
achieved by adjustment for predictors of outcome in traumatic brain injury (TBI) trials. We …

[HTML][HTML] New considerations in the design of clinical trials for traumatic brain injury

B Roozenbeek, HF Lingsma, AIR Maas - Clinical investigation, 2012 - ncbi.nlm.nih.gov
Randomized controlled trials in traumatic brain injury (TBI) pose several complicated
methodological challenges related to the heterogeneity of the population. Several strategies …

Optimizing outcome assessment in multicenter TBI trials: perspectives from TRACK-TBI and the TBI Endpoints Development Initiative

YG Bodien, M McCrea, S Dikmen… - The Journal of head …, 2018 - journals.lww.com
Traumatic brain injury (TBI) is a global public health problem that affects the long-term
cognitive, physical, and psychological health of patients, while also having a major impact …

Prognosis and clinical trial design in traumatic brain injury: the IMPACT study

AIR Maas, A Marmarou, GD Murray… - Journal of …, 2007 - liebertpub.com
Traumatic brain injury (TBI) is a major health and socio-economic problem throughout the
world. Many randomized controlled trials (RCTs) have been performed to investigate the …

The influence of enrollment criteria on recruitment and outcome distribution in traumatic brain injury studies: results from the impact study

B Roozenbeek, AIR Maas, A Marmarou… - Journal of …, 2009 - liebertpub.com
Substantial heterogeneity exists among patients who suffer from traumatic brain injury (TBI).
Strict enrollment criteria may diminish heterogeneity in randomized controlled trials (RCTs) …

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

AIR Maas, EW Steyerberg, A Marmarou, GS McHugh… - …, 2010 - Springer
Clinical trials in traumatic brain injury (TBI) pose complex methodological challenges,
largely related to the heterogeneity of the population. The International Mission on …