Trial reportBMC medical research methodology2023
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.
Trial report in BMC medical research methodology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04509973 (Higher vs. Lower Doses of Dexamethasone in Patients With COVID-19 and Severe Hypoxia), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Higher vs. Lower Doses of Dexamethasone in Patients With COVID-19 and Severe Hypoxia
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.Critical care (London, England) · 2023Pooled it
- Haloperidol for Hypoactive and Hyperactive Delirium in ICU Patients-A Post Hoc Bayesian Analysis of the AID-ICU Trial.Acta anaesthesiologica Scandinavica · 2026Trial
- Empirical Meropenem Versus Piperacillin/Tazobactam for Critically Ill Adults With Sepsis: Feasibility of a Randomised Trial.Acta anaesthesiologica Scandinavica · 2026Trial
- Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Clinical Trial.Chest · 2025Trial
- What is the optimal approach to analyse ventilator-free days? A simulation study.Critical care (London, England) · 2025Trial
- Shifting From Event Rates to Time at Home After Hospitalization for Heart Failure With Reduced Ejection Fraction: Trends and Equity in Days Alive and Out of Hospital in Singapore.Circulation. Population health and outcomes · 2026Article
- Use of Prokinetic Agents in Adult ICU Patients: An International Inception Cohort Study (PATIENCE).Acta anaesthesiologica Scandinavica · 2026Article
- Article
- Albumin for Adult ICU Patients With Shock: Protocol for the INCEPT-Albumin Platform Trial Domain.Acta anaesthesiologica Scandinavica · 2026Article
- Glucose Management in the ICU: The Bi-Centre GEM-ICU Cohort Study.Acta anaesthesiologica Scandinavica · 2026Article
- Low-Molecular-Weight Heparin for Adult ICU Patients Who Require Thromboprophylaxis: Protocol for the INCEPT-Thromboprophylaxis Platform Trial Domain.Acta anaesthesiologica Scandinavica · 2026Article
- Evaluation of days alive out of hospital as an outcome after intensive care admission: a national retrospective cohort study.Critical care (London, England) · 2026Article
- Article
- Statistical modeling of days alive out-of-hospital: An illustration using the SSU trial.Journal of clinical and translational science · 2026Article
- INCEPT: The Intensive Care Platform Trial-Design and protocol.Acta anaesthesiologica Scandinavica · 2025Article
- Advancing patient-centered metrics for heart transplantation: The role of days alive and outside the hospital.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2025Article
- Article
- Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial.Critical care science · 2025Article
- Statistical Power and Performance of Strategies to Analyze Composites of Survival and Duration of Ventilation in Clinical Trials.Critical care explorations · 2024Article
- Recommendations for clinical trial design in acute kidney injury from the 31st acute disease quality initiative consensus conference. A consensus statement.Intensive care medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDays alive without life support (DAWOLS) and similar outcomes that seek to summarise mortality and non-mortality experiences are increasingly used in critical care research. The use of these outcomes is challenged by different definitions and non-normal outcome distributions that complicate statistical analysis decisions.
methodsWe scrutinized the central methodological considerations when using DAWOLS and similar outcomes and provide a description and overview of the pros and cons of various statistical methods for analysis supplemented with a comparison of these methods using data from the COVID STEROID 2 randomised clinical trial. We focused on readily available regression models of increasing complexity (linear, hurdle-negative binomial, zero-one-inflated beta, and cumulative logistic regression models) that allow comparison of multiple treatment arms, adjustment for covariates and interaction terms to assess treatment effect heterogeneity.
resultsIn general, the simpler models adequately estimated group means despite not fitting the data well enough to mimic the input data. The more complex models better fitted and thus better replicated the input data, although this came with increased complexity and uncertainty of estimates. While the more complex models can model separate components of the outcome distributions (i.e., the probability of having zero DAWOLS), this complexity means that the specification of interpretable priors in a Bayesian setting is difficult. Finally, we present multiple examples of how these outcomes may be visualised to aid assessment and interpretation.
conclusionsThis summary of central methodological considerations when using, defining, and analysing DAWOLS and similar outcomes may help researchers choose the definition and analysis method that best fits their planned studies.
trial registrationCOVID STEROID 2 trial, ClinicalTrials.gov: NCT04509973, ctri.nic.in: CTRI/2020/10/028731.
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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.