Safety, quality & education

Cluster Versus Individual Randomization in Prehospital, Emergency and Critical Care Trials: A Meta-Epidemiological Study

Crit Care MedPublished meta-epidemiological study

Main finding · Mortality (absolute ln(OR))Result — go to the resultMD in absolute ln(OR) −0.110 95% CI −0.093 to 0.313

Authors' conclusion

A systematic difference between cRCTs and iRCTs in length-of-stay- or days-alive-type outcomes, but not mortality, was identified, with cRCTs reporting smaller effect size magnitudes than iRCTs. With under half of identified meta-analyses reporting on randomization modality, these results highlight the need for improved transparency and statistical consideration of randomization type in future meta-analyses in prehospital, emergency, and critical care.

Study context

Population
Meta-analyses in prehospital, emergency, or critical care within the last decade that included at least one cRCT and one iRCTn = 315,276 patients, 65 meta-analyses in quantitative analyses, 212 randomized clinical trials, cluster-randomized clinical trials (cRCTs) 39, individually randomized clinical trials (iRCTs) 173
Participants
39 vs 173
Comparison
Deviations in effect estimates between cRCTs and iRCTs
  • cRCTsn = 39
  • iRCTsn = 173
Outcome
Mortality (absolute ln(OR))
Methodological detailssystematic literature search in PubMed and Embase, data extracted in duplicate, mixed regression models
  • Systematic literature search in PubMed and Embase
  • Data extracted in duplicate
  • Mixed regression models

Main finding

As reported in the abstract

MD in absolute ln(OR)

−0.110

95% CI −0.093 to 0.313

Secondary outcomes

OutcomeMD in absolute Hedges' g (95% CI)
Length-of-stay- or days-alive-type outcomes (absolute Hedges' g; secondary outcome)−0.202 (−0.392 to −0.012)
  • Length-of-stay- or days-alive-type outcomes (absolute Hedges' g; secondary outcome): significant difference; cRCTs reporting smaller effect size magnitudes

Meta-analyses reporting on randomization type

Eligible meta-analyses identified
94
Reported on randomization type (cRCT or iRCT)
44.7%

Original publication

Cluster Versus Individual Randomization in Prehospital, Emergency and Critical Care Trials: A Meta-Epidemiological Study. Crit Care Med. Published 21 October 2026. doi:10.1097/ccm.0000000000007386

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