ArticleAmerican journal of respiratory and critical care medicine2014
Outcomes and statistical power in adult critical care randomized trials.
Article in American journal of respiratory and critical care medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 10 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
92 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- Non-adrenergic vasopressors for vasodilatory shock or perioperative vasoplegia: a meta-analysis of randomized controlled trials.Critical care (London, England) · 2024Pooled it
- Composite outcome measures in high-impact critical care randomised controlled trials: a systematic review.Critical care (London, England) · 2024Pooled it
- Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.Critical care (London, England) · 2023Pooled it
- A systematic review and meta-analysis of enrollment into ARDS and sepsis trials published between 2009 and 2019 in major journals.Critical care (London, England) · 2021Pooled it
- Understanding and Enhancing Sepsis Survivorship. Priorities for Research and Practice.American journal of respiratory and critical care medicine · 2019Pooled it
- Measuring and Analyzing Length of Stay in Critical Care Trials.Medical care · 2019Pooled it
- Unexplained mortality differences between septic shock trials: a systematic analysis of population characteristics and control-group mortality rates.Intensive care medicine · 2018Pooled it
- Effect sizes in ongoing randomized controlled critical care trials.Critical care (London, England) · 2017Pooled it
- Primary Outcome Measures in Pediatric Septic Shock Trials: A Systematic Review.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2017Pooled it
- Variation in the Contents of Sepsis Bundles and Quality Measures. A Systematic Review.Annals of the American Thoracic Society · 2015Pooled it
- Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial.Chest · 2025Trial
- Use of days alive without life support and similar count outcomes in randomised clinical trials - an overview and comparison of methodological choices and analysis methods.BMC medical research methodology · 2023Trial
- Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation.The New England journal of medicine · 2022Trial
- A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.Annals of the American Thoracic Society · 2020Trial
- Center effect in intubation risk in critically ill immunocompromised patients with acute hypoxemic respiratory failure.Critical care (London, England) · 2019Trial
- States Worse Than Death Among Hospitalized Patients With Serious Illnesses.JAMA internal medicine · 2016Trial
- Integrated haemodynamic monitoring of fluid responsiveness and fluid tolerance in critical care: from physiology to bedside applications.Journal of clinical monitoring and computing · 2026Review
- AI-enabled clinical trials.Nature reviews bioengineering · 2026Article
- Computational tools for personalizing treatment of acute respiratory failure, from machine learning to digital twins: a narrative review.Critical care (London, England) · 2026Review
- Simulation study of frailty as a baseline confounder: the need to improve reporting intensive care trials.Critical care (London, England) · 2026Review
32 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
rationaleIntensive care unit (ICU)-based randomized clinical trials (RCTs) among adult critically ill patients commonly fail to detect treatment benefits.
objectivesAppraise the rates of success, outcomes used, statistical power, and design characteristics of published trials.
methodsOne hundred forty-six ICU-based RCTs of diagnostic, therapeutic, or process/systems interventions published from January 2007 to May 2013 in 16 high-impact general or critical care journals were studied. MEASUREMENT AND MAIN
resultsOf 146 RCTs, 54 (37%) were positive (i.e., the a priori hypothesis was found to be statistically significant). The most common primary outcomes were mortality (n = 40 trials), infection-related outcomes (n = 33), and ventilation-related outcomes (n = 30), with positive results found in 10, 58, and 43%, respectively. Statistical power was discussed in 135 RCTs (92%); 92 cited a rationale for their power parameters. Twenty trials failed to achieve at least 95% of their reported target sample size, including 11 that were stopped early due to insufficient accrual/logistical issues. Of 34 superiority RCTs comparing mortality between treatment arms, 13 (38%) accrued a sample size large enough to find an absolute mortality reduction of 10% or less. In 22 of these trials the observed control-arm mortality rate differed from the predicted rate by at least 7.5%.
conclusionsICU-based RCTs are commonly negative and powered to identify what appear to be unrealistic treatment effects, particularly when using mortality as the primary outcome. Additional concerns include a lack of standardized methods for assessing common outcomes, unclear justifications for statistical power calculations, insufficient patient accrual, and incorrect predictions of baseline event rates.
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Identifiers
What OpenQuestion holds
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.