Composite outcome measures in high-impact critical care randomised controlled trials: a systematic review
Authors' conclusion
COM are increasingly used in critical care trials; however effect estimates are frequently inconsistent across COM components confounding outcome interpretations. The use of COM was associated with smaller sample sizes, and no increased likelihood of statistically significant results.
Study context
- Population
- RCTs published 2012–2022 in 16 high-impact journals reporting a patient important outcome and involving critical care patientstrials included
- Participants
- 194 participants
- Comparison
- Trials using composite vs non-composite outcomes
- Outcome
- Use of COM in high-impact critical care trials and comparison of study parameters (sample size, statistical significance, consistency of effect estimates) in trials using composite vs non-composite outcomes
Methodological detailsmethodological review of 16 high-impact journals
- Methodological review of 16 high-impact journals
Pooled result
As reported in the abstract
- Trials using a composite outcome measures (COM) (increased over time)
- 39.1%
- COM trials explicitly describing the outcome as composite
- 52.6%
- Median number of components (IQR 2-3)
- 2
- COM trials with effect estimates consistent across all components
- 43.4%
- COM including components that were not patient important
- 93%
- Trials in which predicted effect sizes were not overestimated
- 6
Further pooled results
Rate of statistical significance
P = 0.380
| Outcome | COM | Non-composite | P value |
|---|---|---|---|
| Sample size (participants recruited) | 409 (range 198.8–851.5) | 584 (range 300–1566) | P = 0.004 |
Original publication
Composite outcome measures in high-impact critical care randomised controlled trials: a systematic review. Crit Care. Published 28 May 2024. doi:10.
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