Trial reportCritical care (London, England)2011
The added value of ordinal analysis in clinical trials: an example in traumatic brain injury.
Trial report in Critical care (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 4 of them syntheses that pooled it.
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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.
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Who cites it
88 citing papers in PubMed, 4 syntheses or guidelines pooled it, 185 citations in OpenAlex.
- Evaluating whether the proportional odds models to analyse ordinal outcomes in COVID-19 clinical trials is providing clinically interpretable treatment effects: A systematic review.Clinical trials (London, England) · 2024Pooled it
- Long-term effects of lower versus higher oxygenation levels in adult ICU patients-A systematic review.Acta anaesthesiologica Scandinavica · 2022Pooled it
- Baseline results of a living systematic review for COVID-19 clinical trial registrations.Wellcome open research · 2020Pooled it
- Core Outcomes and Common Data Elements in Chronic Subdural Hematoma: A Systematic Review of the Literature Focusing on Reported Outcomes.Journal of neurotrauma · 2016Pooled it
- Effects of aspirin and omega-3 fatty acids on composite and subdomain scores from the NEI-VFQ-25 questionnaire: the ASCEND-Eye randomized controlled trial.BMC ophthalmology · 2024Trial
- Topical and subconjunctival anesthesia versus topical anesthesia alone in patients with senile cataracts undergoing phacoemulsification: a double-blind randomized controlled trial.BMC ophthalmology · 2024Trial
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- Effect of alteplase on the CT hyperdense artery sign and outcome after ischemic stroke.Neurology · 2016Trial
- Comparative study of outcome measures and analysis methods for traumatic brain injury trials.Journal of neurotrauma · 2015Trial
- Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.Trials · 2015Trial
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- Trial
- Autoantibodies targeting G protein-coupled receptors and clinical outcome after ischemic stroke (PROSCIS-B).Journal of neurology · 2026Observational
- 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
- Optimizing endpoints in early phase clinical trials of acute respiratory distress syndrome.American journal of respiratory and critical care medicine · 2026Article
- Observational and genetically-informed characterization of Gulf War Illness symptoms in 1990-1991 Gulf War deployed Veterans and non-deployed Gulf War Era Veterans.Environmental health : a global access science source · 2026Article
- Impact of sex on outcomes in critically ill patients with subarachnoid hemorrhage: a secondary analysis of a French prospective cohort study.Journal of anesthesia, analgesia and critical care · 2026Article
- Longitudinal Extension of the Win Odds for Ordinal Repeated Measurements.Statistics in medicine · 2026Article
- Statistical analysis of Likert-based ordinal scales: a guide for clinical trialists.BMC medical research methodology · 2026Article
28 more citing papers are in PubMed but not listed here.
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Authors and funding
10 authors at 5 institutions in 3 countries.
Funding
Abstract
introductionIn clinical trials, ordinal outcome measures are often dichotomized into two categories. In traumatic brain injury (TBI) the 5-point Glasgow outcome scale (GOS) is collapsed into unfavourable versus favourable outcome. Simulation studies have shown that exploiting the ordinal nature of the GOS increases chances of detecting treatment effects. The objective of this study is to quantify the benefits of ordinal analysis in the real-life situation of a large TBI trial.
methodsWe used data from the CRASH trial that investigated the efficacy of corticosteroids in TBI patients (n = 9,554). We applied two techniques for ordinal analysis: proportional odds analysis and the sliding dichotomy approach, where the GOS is dichotomized at different cut-offs according to baseline prognostic risk. These approaches were compared to dichotomous analysis. The information density in each analysis was indicated by a Wald statistic. All analyses were adjusted for baseline characteristics.
resultsDichotomous analysis of the six-month GOS showed a non-significant treatment effect (OR = 1.09, 95% CI 0.98 to 1.21, P = 0.096). Ordinal analysis with proportional odds regression or sliding dichotomy showed highly statistically significant treatment effects (OR 1.15, 95% CI 1.06 to 1.25, P = 0.0007 and 1.19, 95% CI 1.08 to 1.30, P = 0.0002), with 2.05-fold and 2.56-fold higher information density compared to the dichotomous approach respectively.
conclusionsAnalysis of the CRASH trial data confirmed that ordinal analysis of outcome substantially increases statistical power. We expect these results to hold for other fields of critical care medicine that use ordinal outcome measures and recommend that future trials adopt ordinal analyses. This will permit detection of smaller treatment effects.
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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.