Disparities between randomized clinical trial participants and sepsis patients in real-world
Authors' conclusion
On average, trial participants were younger than the general sepsis patient population. Commercial support influenced patient selection.
Study context
- Population
- Adult sepsis patients in large multicentre randomized controlled trials (RCTs) vs general sepsis population
- Participants
- 60,577 patients · 94 trials
- Comparison
- Sepsis RCT participants vs sepsis patients in MIMIC and EICU databases
- Trialn = 60,577
- Outcome
- Weighted mean age of trial participants
Methodological detailsrandom effects model, comparison with MIMIC and EICU databases, multiple linear regression
- Random effects model
- Comparison with MIMIC and EICU databases
- Multiple linear regression
Pooled result
As reported in the abstract
Mean age
Trial
62.28
weighted mean · years
MIMIC
64.47
mean · years
EICU
65.20
mean · years
Trial vs MIMIC: P < 0.001 · Trial vs EICU: P < 0.001
Further pooled results
Diabetes comorbidity — Trial vs MIMIC
P < 0.001
Weighted mortality rate — Trial vs MIMIC
P < 0.001
| Outcome | P value |
|---|---|
| Diabetes comorbidityTrial vs EICU | P < 0.001 |
| Weighted mortality rateTrial vs EICU | P < 0.001 |
Sensitivity analyses
- Differences in age, severity score and comorbidities remained statistically significant
Factors associated with disparities (multivariable regression)
- Commercially supported trials more likely to include patients with higher severity scores
- P = 0.002
- Commercial support not significantly associated with age after adjustment for study region and sepsis diagnosis
Original publication
Disparities between randomized clinical trial participants and sepsis patients in real-world. J Crit Care. Published 4 July 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →