ArticleCritical care medicine2020
Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness.
Article in Critical care medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06195475 (Impact of Tidal Volume Magnitude in Pressure Support Mode on Mortality in Adults Under Invasive Mechanical Ventilation. Multi-center Retrospective Cohort Study.), which is not on this map. Cited by 26 papers, 3 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.
Impact of Tidal Volume Magnitude in Pressure Support Mode on Mortality in Adults Under Invasive Mechanical Ventilation. Multi-center Retrospective Cohort Study.
Who cites it
26 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- ADJUNCTIVE VASOPRESSORS AND SHORT-TERM MORTALITY IN ADULTS WITH SEPTIC SHOCK: A SYSTEMATIC REVIEW AND META-ANALYSIS.Shock (Augusta, Ga.) · 2025Pooled it
- Composite outcome measures in high-impact critical care randomised controlled trials: a systematic review.Critical care (London, England) · 2024Pooled it
- The Single-Syringe Versus the Double-Syringe Techniques of Adenosine Administration for Supraventricular Tachycardia: A Systematic Review and Meta-Analysis.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023Pooled it
- A Bayesian reanalysis of the Standard versus Accelerated Initiation of Renal-Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial.Critical care (London, England) · 2022Trial
- Simulation study of frailty as a baseline confounder: the need to improve reporting intensive care trials.Critical care (London, England) · 2026Review
- Waveform data capture substantial variation in tidal volume and other respiratory parameters.Annals of the American Thoracic Society · 2026Article
- Interventions for treating tibial shaft fractures in children.The Cochrane database of systematic reviews · 2025Article
- Tolvaptan versus other interventions for hyponatraemia in people with cirrhosis.The Cochrane database of systematic reviews · 2025Article
- Effects of transcutaneous auricular vagus nerve stimulation on sepsis-induced coagulopathy: protocol for a randomised controlled trial.BMJ open · 2025Article
- INCEPT: The Intensive Care Platform Trial-Design and protocol.Acta anaesthesiologica Scandinavica · 2025Article
- Minimum and optimal combined variations in sleep, physical activity, and nutrition in relation to all-cause mortality risk.BMC medicine · 2025Article
- Randomized controlled trials in resuscitation.Resuscitation plus · 2024Review
- Achieving large-scale clinician adoption of AI-enabled decision support.BMJ health & care informatics · 2024Article
- A maturity model for the scientific review of clinical trial designs and their informativeness.Trials · 2024Article
- Adjunctive Vasopressors in Patients with Septic Shock: Protocol for a Systematic Review and Meta-Analysis.medRxiv : the preprint server for health sciences · 2023Article
- Elements of Statistical Power in Pediatric Critical Care Trials.Annals of the American Thoracic Society · 2023Article
- Causal inference for planning randomised critical care trials: Protocol for a scoping review.Acta anaesthesiologica Scandinavica · 2022Article
- Sepsis subphenotyping based on organ dysfunction trajectory.Critical care (London, England) · 2022Article
- Reverse Bayesian Implications of p-Values Reported in Critical Care Randomized Trials.Journal of intensive care medicine · 2022Article
- Randomised clinical trials in critical care: past, present and future.Intensive care medicine · 2022Review
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Authors and funding
8 authors.
Funding
Abstract
objectivesRecurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects. DESIGN, SETTING, AND PATIENTS: Secondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality risk difference at the study-specific follow-up interval.
interventionsNone. MEASUREMENTS AND MAIN
resultsOf 101 included trials, 12 met statistical significance for their main endpoint, five for increased intervention-associated mortality. Most trials (77.3%) overestimated control group mortality in power calculations (observed minus predicted difference, -6.7% ± 9.8%; p < 0.01). Due to this misestimation of control group mortality, in 14 trials, the intervention would have had to prevent at least half of all deaths to achieve the hypothesized treatment effect. Seven trials prespecified adaptive sample size strategies that might have mitigated this issue. The observed risk difference for mortality fell within 5% of predicted in 20 trials, of which 16 did not reach statistical significance. Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit. Most trials (67.3%) could not exclude clinically important treatment benefit or harm.
conclusionsThe design of most high-impact critical care trials biased results toward the null by overestimating control group mortality and powering for unrealistic treatment effects. Clinically important treatment effects often cannot be excluded.
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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.