Research without prior consent procedure and intervention effect on mortality in critical care: a meta-epidemiological study of randomized controlled trials
Primary resultResult — go to the resultPooled ROR 1.05 95% CI 0.83–1.34Authors' conclusion
In critical care RCTs, RWPC procedures were not associated with differences in intervention effect on mortality but were linked to shorter time to randomization and higher recruitment rates.
Study context
- Population
- Meta-analyses of randomized controlled trials (RCTs) of therapeutic interventions in critically ill adults reporting mortality42 meta-analyses
- Participants
- 103,011 participants · 323 RCTs
- Comparison
- RCTs using research without prior consent vs standard consent
- Research without prior consent (RWPC)n = 59
Methodological detailstwo-step approach, random-effects model, Trials using RWPC were more recent, larger, more often multicentre (80% vs. 43%) and had lower overall risk of bias
- Two-step approach
- Random-effects model
- Trials using RWPC were more recent, larger, more often multicentre (80% vs. 43%) and had lower overall risk of bias
Primary result
As reported in the abstract
Pooled ratio of odds ratios (ROR)
1.05
95% CI 0.83–1.34
Secondary outcomes
Time to randomization
P < 0.01
Recruitment rate
P = 0.01
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Research without prior consent procedure and intervention effect on mortality in critical care: a meta-epidemiological study of randomized controlled trials. Crit Care. Published 24 July 2025. doi:10.
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