Eligibility Criteria of Randomized Clinical Trials in Critical Care Medicine
Authors' conclusion
Most exclusion criteria in critical care medicine RCTs were strongly justifiable. Across poorly justified criteria, the most common exclusions were pregnant or lactating persons, those with communication barriers, and individuals without health insurance.
Study context
- Population
- Parallel-group randomized clinical trials (RCTs) enrolling adults in intensive care units (ICUs) or critically ill patients requiring life-sustaining interventions, published in the top 5 general internal medicine journals, January 1, 2018 to February 23, 2023RCTs included of 225 identified
- Participants
- 75 participants
- Primary endpoint
- Justification of exclusion criteria (poorly, potentially or strongly justified)
Methodological detailsindependent duplicate categorisation
- Independent duplicate categorisation
Primary result
As reported in the abstract
Justification of exclusion criteria
Strongly justified exclusion criteria
1080 criteria
74.2%
Potentially justified exclusion criteria
297 criteria
20.4%
Poorly justified exclusion criteria
5.4%
78 criteria
Studies with ≥1 poorly justified exclusion criterion
45 of 75 studies
60.0%
Further findings
Number of exclusion criteria per trial
- Median (IQR) exclusion criteria per trial
- 19 (14-24)
- Total exclusion criteria
- 1455
Common exclusion criteria
- Risk of adverse reaction to interventions
- 302 criteria [20.8%]
- Inability to obtain consent
- 120 criteria [8.2%]
- Treatment limitation decisions
- 97 criteria [6.7%]
Most common poorly justified exclusion criteria (of 78)
- Pregnancy
- 19 criteria [24.4%]
- Communication barriers
- 11 criteria [14.1%]
- Lactation
- 10 criteria [12.8%]
- Lack of health insurance
- 10 criteria [12.8%]
Original publication
Eligibility Criteria of Randomized Clinical Trials in Critical Care Medicine. JAMA Netw Open. Published 2 January 2025. doi:10.
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