ArticleTrials2022
Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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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.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2025: post-resuscitation care.Intensive care medicine · 2025Guideline
- Hemodynamic Effects of Anesthetics, Sedatives, and Analgesics in the CICU: Clinical Decision Guidance.JACC. Advances · 2026Review
- Article
- Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial.Acta anaesthesiologica Scandinavica · 2025Article
- Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial.Acta anaesthesiologica Scandinavica · 2025Article
- Sedation, temperature and pressure after cardiac arrest and resuscitation-The STEPCARE trial: A statistical analysis plan.Acta anaesthesiologica Scandinavica · 2025Article
- Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial.Acta anaesthesiologica Scandinavica · 2025Article
- Psychological and behavioral dimensions in cardiac arrest survivors and their families: A state-of-the-art review.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025Review
- Deep learning for EEG-based prognostication after cardiac arrest: from current research to future clinical applications.Frontiers in neurology · 2023Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions have no interactions on outcomes. Here, we present a protocol for a simulation study investigating the consequences of different levels of interactions between the trial interventions on outcomes for the future 2×2×2 factorial designed randomised clinical Sedation, TEmperature, and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial in comatose patients after out-of-hospital cardiac arrest.
methodsBy simulating a multisite trial with 50 sites and 3278 participants, and a presumed six-month all-cause mortality of 60% in the control population, we will investigate the validity of the trial results with different levels of interaction effects on the outcome. The primary simulation outcome of the study is the risks of type-1 and type-2 errors in the simulated scenarios, i.e. at what level of interaction is the desired alpha and beta level exceeded. When keeping the overall risk of type-1 errors ≤ 5% and the risk of type-2 errors ≤ 10%, we will quantify the maximum interaction effect we can accept if the planned sample size is increased by 5% to take into account possible interaction between the trial interventions. Secondly, we will assess how interaction effects influence the minimal detectable difference we may confirm or reject to take into account 5% (small interaction effect), 10% (moderate), or 15% (large) positive interactions in simulations with no 'true' intervention effect (type-1 errors) and small (5%), moderate (10%), or large negative interactions (15%) in simulations with 'true' intervention effects (type-2 errors). Moreover, we will investigate how much the sample size must be increased to account for a small, moderate, or large interaction effects. DISCUSSION: This protocol for a simulation study will inform the design of a 2×2×2 factorial randomised clinical trial of how potential interactions between the assessed interventions might affect conclusions. Protocolising this simulation study is important to ensure valid and unbiased results.
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