Prevalence and representation of comorbidities and multimorbidity in randomised controlled trials in sepsis or septic shock: a systematic review
Authors' conclusion
Baseline comorbidity data are absent from most sepsis RCTs, and trials that report such information differ systematically from those that do not.
Study context
- Population
- Randomised controlled trials (RCTs) (January 1992–August 2025) enrolling adult ICU patients with sepsis or septic shock
- Participants
- 591 RCTs
- Comparison
- Trials reporting vs not reporting baseline comorbidity data
- Reporting comorbidityn = 209
- Outcome
- Reporting of baseline comorbidity data
Methodological detailsmethodological review of RCTs, Delphi-derived classification framework, Two reviewers independently screened and extracted data using a predefined protocol
- Methodological review of RCTs
- Delphi-derived classification framework
- Two reviewers independently screened and extracted data using a predefined protocol
Pooled result
As reported in the abstract
Reporting comorbidity
35.4%
209
- Patients enrolled in trials reporting comorbidity data
- 48,429
- Median patients per trial
- 91
Further pooled results
| Outcome | OR (95% CI) | |
|---|---|---|
| Trend in comorbidity reporting over time≈8% per year | 1.08 (1.06–1.11) | |
| 0.512Odds ratio (log scale) |
- Trend in comorbidity reporting over time — Correlation of reporting with time (ρ)
- 0.80
- Trend in comorbidity reporting over time: p < 0.001
Most frequently reported comorbidities (among reporting trials)
- DM
- 86.1%
- Hypertension
- 65.1%
- CKD
- 56%
- Cancer
- 53.1%
- % of trials
Multimorbidity reporting and structured frameworks
- Trials explicitly reporting multimorbidity
- 4 (1.9%)
- Trials using structured framework (e.g. Charlson Comorbidity Index)
- 12 (5.7%)
- Trials excluding participants based on ≥1 comorbidity
- Nearly 80%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Prevalence and representation of comorbidities and multimorbidity in randomised controlled trials in sepsis or septic shock: a systematic review. Crit Care. Published 6 May 2026. doi:10.
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