Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote:"Eligible patients fulfilling all inclusion criteria and no exclusion criteria are randomised 1:1 using a centralised web-based system according to a computer-generated allocation sequence list, the stratification variables (trial site, invasive mechanical ventilation [y/n], age <70 years [y/n]) using varying block sizes. The allocation sequence list and block sizes are only known by the data manager at the Copenhagen Trial Unit and remain concealed from the investigators until the trial database has been closed, the data analysed and the abstract for the trial report written in two versions."
Comment: Allocation sequence random. Allocation sequence concealed |
| Deviations from intervention |
Low |
Comment: Blinded study (participants and personnel/carers)
Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 39 participants randomized, 39 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Mortality (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, registry were available.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). |
| Overall risk of bias |
Low |