| Methods | n = 99, 7 centres Allocation concealment: sequentially numbered drug packs Baseline similarity: age (A), duration of ventilation (A), organ failures (A), sepsis Blinding: caregivers, investigating team Cointerventions: not described Withdrawals: none Losses to follow‐up: none |
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| Participants | Inclusions: Risk factor for ARDS; bilateral CXR infiltrates; PaO2 of 70 mmHg or less on FiO2 of at least 0.4, or PaO2/PAO2 of 0.3 or less; no LAH Exclusions: Hypotension; burns; some infections |
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| Interventions | IV methylprednisolone,30 mg/kg IV every 6 hours for 4 doses, or placebo | |
| Outcomes | 45 day mortality: RR 0.95 (95% CI 0.69 to 1.29) Adverse events leading to discontinuation of therapy not reported Other safety information: infectious complications (treatment: 8/50, control: 5/49) |
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| Notes | Mean duration of mechanical ventilation before study entry was 2.8 days (standard error 0.5 days) in the methylprednisolone group and 1.9 days (standard error 0.4 days) in the placebo group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |