Safety, quality & education

Serious adverse events reporting in recent randomised clinical trials in intensive care medicine – A methodological study protocol

Acta Anaesthesiol ScandPublished Methodological study protocol

Study context

Population
Randomised clinical trials (RCTs) of pharmacological interventions in adult intensive care unit (ICU) patients published from 2020 onwards in 10 general medical and critical care journals
Primary endpoint
Number of RCTs reporting SAEs in the primary publication
Methodological detailsSearch of 10 general medical and critical care journals in PubMed, Secondary questions: how serious adverse events (SAEs) are reported (proportion of patients with ≥1 SAE, all single events, or both)
  • Search of 10 general medical and critical care journals in PubMed
  • Secondary questions: how SAEs are reported (proportion of patients with ≥1 SAE, all single events, or both)

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Serious adverse events reporting in recent randomised clinical trials in intensive care medicine – A methodological study protocol. Acta Anaesthesiol Scand. Published 11 September 2024. doi:10.1111/aas.14512

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