Trial reportCritical care medicine2020
Alive and Ventilator Free: A Hierarchical, Composite Outcome for Clinical Trials in the Acute Respiratory Distress Syndrome.
Trial report in Critical care medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses 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
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.Critical care (London, England) · 2023Pooled it
- Heterogeneity in design and analysis of ICU delirium randomized trials: a systematic review.Trials · 2021Pooled it
- Effect of targeting normoxemia on supplemental oxygen-free days for adults with acute thermal burns: A stepped wedge cluster randomized clinical trial.The journal of trauma and acute care surgery · 2025Trial
- Two-part model for ventilator-free days in a cluster randomized cross-over clinical trial.BMC medical research methodology · 2025Trial
- What is the optimal approach to analyse ventilator-free days? A simulation study.Critical care (London, England) · 2025Trial
- Targeted Normoxemia and Supplemental Oxygen-Free Days in Critically Injured Adults: A Stepped-Wedge Cluster Randomized Clinical Trial.JAMA network open · 2025Trial
- Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial.Annals of the American Thoracic Society · 2023Trial
- Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial.The Lancet. Respiratory medicine · 2022Trial
- Long Run Non-Transitivity of Win Ratio and How to Rule It Out.Statistics in medicine · 2026Article
- Refining normoxemia targets in acute burn care: Reply.The journal of trauma and acute care surgery · 2026Article
- Optimizing endpoints in early phase clinical trials of acute respiratory distress syndrome.American journal of respiratory and critical care medicine · 2026Article
- A Research Agenda to Mitigate Racial and Ethnic Disparities in U.S. Critical Care Medicine: An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2025Article
- Beyond the ventilator-free days: review of several estimands.Critical care (London, England) · 2025Review
- Determining the association of hyperoxia while on extracorporeal life support with mortality in neonates following Norwood operation.The journal of extra-corporeal technology · 2024Article
- The times are changing: A primer on novel clinical trial designs and endpoints in critical care research.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024Article
- Nebulized Furosemide for Pulmonary Inflammation in Intubated Patients With COVID-19: A Phase 2 Randomized Controlled Double-Blind Study.Critical care explorations · 2024Article
- Challenges and limitations of using ventilator-free days as an outcome in critical care trials.Critical care science · 2024Article
- Article
- Mechanical power of ventilation and driving pressure: two undervalued parameters for pre extracorporeal membrane oxygenation ventilation and during daily management?Critical care (London, England) · 2023Review
- Review
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
Abstract
objectivesSurvival from acute respiratory distress syndrome is improving, and outcomes beyond mortality may be important for testing new treatments. The "ventilator-free days" score, is an established composite that equates ventilation on day 28 to death. A hierarchical outcome treating death as a worse than prolonged ventilation would enhance face validity, but performance characteristics and reporting of such an outcome are unknown. We therefore evaluated the performance of a novel hierarchical composite endpoint, the Alive and Ventilator Free score.
designUsing data from four Acute Respiratory Distress Syndrome Network clinical trials, we compared Alive and Ventilator Free to the ventilator-free days score. Alive and Ventilator Free compares each patient with every other patient in a win-lose-tie for each comparison. Duration of mechanical ventilation is only compared if both patients survived. We evaluated power of Alive and Ventilator Free versus ventilator-free days score under various circumstances.
settingICUs within the Acute Respiratory Distress Syndrome Network. PATIENTS: Individuals enrolled in four Acute Respiratory Distress Syndrome Network trials.
interventionsNone for this analysis. MEASUREMENTS AND MAIN
resultsWithin the four trials (n = 2,410 patients), Alive and Ventilator Free and ventilator-free days score had similar power, with Alive and Ventilator Free slightly more powerful when a mortality difference was present, and ventilator-free days score slightly more powerful with a difference in duration of mechanical ventilation. Alive and Ventilator Free less often found in favor of treatments that increased mortality and increased days free of ventilation among survivors.
conclusionsA hierarchical composite endpoint, Alive and Ventilator Free, preserves statistical power while improving face validity. Alive and Ventilator Free is less prone to favor a treatment with discordant effects on survival and days free of ventilation. This general approach can support complex outcome hierarchies with multiple constituent outcomes. Approaches to interpretation of differences in Alive and Ventilator Free are also presented.
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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.