Trial reportJournal of neurotrauma2015
Comparative study of outcome measures and analysis methods for traumatic brain injury trials.
Trial report in Journal of neurotrauma, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Progesterone for acute traumatic brain injury.The Cochrane database of systematic reviews · 2016Pooled it
- Glasgow Outcome Scale Measures and Impact on Analysis and Results of a Randomized Clinical Trial of Severe Traumatic Brain Injury.Journal of neurotrauma · 2019Trial
- Hypertonic saline maintains coagulofibrinolytic homeostasis following moderate‑to‑severe traumatic brain injury by regulating monocyte phenotype via expression of lncRNAs.Molecular medicine reports · 2019Trial
- A Meta-epidemiologic Analysis of Differences in Treatment-Effect Estimates According to Outcome Scale (GOS vs. GOSE) in Moderate-to-Severe Traumatic Brain Injury Trials.Neurocritical care · 2026Article
- Association Between Disability and Life Satisfaction, Participation, and Psychological Health: A Traumatic Brain Injury Model Systems Study.Neurology · 2025Article
- Exploration of simultaneous transients between cerebral hemodynamics and the autonomic nervous system using windowed time-lagged cross-correlation matrices: a CENTER-TBI study.Acta neurochirurgica · 2024Article
- Contusion expansion, low platelet count and bifrontal contusions are associated with worse patient outcome following traumatic brain injury-a retrospective single-center study.Acta neurochirurgica · 2024Observational
- Research considerations for prospective studies of patients with coma and disorders of consciousness.Brain communications · 2024Review
- Selection of a statistical analysis method for the Glasgow Outcome Scale-Extended endpoint for estimating the probability of favorable outcome in future severe TBI clinical trials.Statistics in medicine · 2023Article
- Comparison of the predictive value of the Helsinki, Rotterdam, and Stockholm CT scores in predicting 6-month outcomes in patients with blunt traumatic brain injuries.Chinese journal of traumatology = Zhonghua chuang shang za zhi · 2023Article
- Using metabolomics to predict severe traumatic brain injury outcome (GOSE) at 3 and 12 months.Critical care (London, England) · 2023Article
- Brain Tissue Oxygen Levels as a Perspective Therapeutic Target in Traumatic Brain Injury. Retrospective Cohort Study.Journal of critical care medicine (Universitatea de Medicina si Farmacie din Targu-Mures) · 2023Article
- Prognostic value of day-of-injury plasma GFAP and UCH-L1 concentrations for predicting functional recovery after traumatic brain injury in patients from the US TRACK-TBI cohort: an observational cohort study.The Lancet. Neurology · 2022Observational
- Predicting Clinical Outcomes 7-10 Years after Severe Traumatic Brain Injury: Exploring the Prognostic Utility of the IMPACT Lab Model and Cerebrospinal Fluid UCH-L1 and MAP-2.Neurocritical care · 2022Observational
- Moderate and severe TBI in children and adolescents: The effects of age, sex, and injury severity on patient outcome 6 months after injury.Frontiers in neurology · 2022Article
- A Manual for the Glasgow Outcome Scale-Extended Interview.Journal of neurotrauma · 2021Article
- Sliding Scoring of the Glasgow Outcome Scale-Extended as Primary Outcome in Traumatic Brain Injury Trials.Journal of neurotrauma · 2020Article
- Functional Status Examination Yields Higher Measurement Precision of Functional Limitations after Traumatic Injury than the Glasgow Outcome Scale-Extended: A Preliminary Study.Journal of neurotrauma · 2020Article
- The Spectrum of Long-Term Behavioral Disturbances and Provided Care After Traumatic Brain Injury.Frontiers in neurology · 2020Article
- Testing a Multivariate Proteomic Panel for Traumatic Brain Injury Biomarker Discovery: A TRACK-TBI Pilot Study.Journal of neurotrauma · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
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 (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.