British journal of anaesthesia
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Multicentre RCTs are widely used by critical care researchers to answer important clinical questions. However, few trials evaluating mortality outcomes report statistically significant results. We hypothesised that the low proportion of trials reporting statistically significant differences for mortality outcomes is plausibly explained by lower-than-expected effect sizes combined with a low proportion of participants who could realistically benefit from studied interventions. ⋯ When designing clinical trials, researchers most likely overestimate true population effect sizes for critical care interventions. Bayesian modelling demonstrates that that it is not necessarily the case that most studied interventions lack efficacy. In fact, it is plausible that many studied interventions have clinically important effects that are missed.
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Multicenter Study
Pharmacokinetic properties of remimazolam in subjects with hepatic or renal impairment.
Remimazolam is a new benzodiazepine for procedural sedation and general anaesthesia. The aim of this study was to characterise its pharmacokinetic properties and safety in renally and hepatically impaired subjects. ⋯ Hepatic impairment trial: ClinicalTrials.gov, NCT01790607 (https://clinicaltrials.gov/ct2/show/NCT01790607). Renal impairment trial: EudraCT Number: 2014-004575-23.
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European Society of Cardiology/European Society of Anaesthesiology (ESC/ESA) guidelines inform cardiac workup before noncardiac surgery based on an algorithm. Our primary hypotheses were that there would be associations between (i) the groups stratified according to the algorithms and major adverse cardiac events (MACE), and (ii) over- and underuse of cardiac testing and MACE. ⋯ NCT02573532.