• Marie Qvist Jensen, Marie Warrer Munch, Anders Granholm, MøllerMorten HylanderMHDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark., Marina Bahrenkova, and Anders Perner.
• Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
• Acta Anaesthesiol Scand. 2024 Nov 1; 68 (10): 158115871581-1587.

BackgroundSerious adverse events (SAEs) are common in intensive care unit (ICU) patients. Reporting of SAEs in randomised clinical trials (RCTs) varies why underreporting is likely. We aim to describe the reporting of SAEs from 2020 onwards and to illustrate the recent reporting of SAEs published in major medical journals.MethodsWe will conduct a methodological study assessing pharmacological interventions in RCTs including adult ICU patients. We will search 10 general medical and critical care journals in PubMed. We will include all RCTs published from 2020 onwards. The primary research question is how many RCTs report SAEs in the primary publication. Secondary research questions include how SAEs are reported in the primary publication either as (1) proportion of patients experiencing one or more SAE, (2) all single events occurred, or (3) both strategies combined. We will assess the association between the proportion of patients with reported SAEs and the following trial characteristics: multicentred versus single-centre RCTs, industry-sponsored versus academic-sponsored, published trial protocol versus unpublished work, blinding, trials sample size, and RCTs focusing on COVID-19 patients versus other populations.DiscussionThe outlined methodological study will provide important information on the reporting of SAEs in recent drug trials in adult ICU patients.© 2024 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

12 keywords...

hide…