ICU sedation, delirium & recovery
Mortality As a Measure of Treatment Effect in Clinical Trials Recruiting Critically Ill Patients*
Authors' conclusion
Differential mortality effects persist for 60 to 90 days following recruitment. Location-based measures approximate time-based measures for trials conducted outside the United States. The documentation of a mortality reduction has had a modest impact on practice.
Study context
- Population
- Adult ICU-based randomized clinical trials (RCTs) (≥100 randomised, high-impact general medical or critical care journals, mortality at ≥2 time points), 1990–2018
- Participants
- 228,784 participants · 343 RCTs
- Outcome
- Performance characteristics of all-cause mortality endpoint: temporal course, responsiveness to differential treatment effects, impact on practice
Methodological detailsmethodological review, adult ICU-based RCTs, ≥100 patients randomised
- Methodological review
- Adult ICU-based RCTs
- ≥100 patients randomised
Pooled result
As reported in the abstract
- Deaths by 180 days that had occurred by day 7
- one third
- Risk difference between arms continued to increase until day 60
- p = 0.01
- Risk difference possibly increased until day 90, stable thereafter
- p = 0.07
- Deaths at ICU discharge relative to deaths at 28-30 days
- 95% [interquartile range [IQR], 86-106%]
- Deaths at hospital discharge relative to deaths at 60 days
- 99% [IQR, 94-104%]
- Interventions showing mortality benefit adopted into widespread clinical practice
- 13 of 43 interventions (30.2%)
Original publication
Mortality As a Measure of Treatment Effect in Clinical Trials Recruiting Critically Ill Patients*. Crit Care Med. Published 20 January 2023. doi:10. 1097/ ccm. 0000000000005721
Composed by AI from the published abstract and checked against it. How Briefs are made →