Respiratory failure & ventilation
Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review
Study context
- Population
- RCTs in adults with ventilator-free days (VFDs) as the primary outcome, PubMed and Embase until December 2021, journals with 2021 impact factor >5
- Participants
- 26 clinical trials
Methodological detailsmethodological review, Cochrane risk-of-bias tool
- Methodological review
- Cochrane risk-of-bias tool
Pooled result
As reported in the abstract
Trials unable to consider the unique distribution of VFDs and death as a competitive risk
96%
Trials using simple models (eg Mann-Whitney-Wilcoxon rank-sum test) for sample size estimation
14
54%
Sample sizes recalculated with alternative approaches varied by a factor of
1.6 to 17.4
Further pooled results
Risk of bias and trial characteristics
- Trials with "some concerns" on risk of bias
- 19 (73%)
- Two-arm superiority trials
- 24 (92%)
- Multicentre trials
- 23 (89%)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review. Crit Care. Published 1 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →