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 |
Some concerns |
Quote: (registry)/(asbstract) "randomized study".
Comment: Allocation sequence probably random. Allocation sequence probably concealed. |
| Deviations from intervention |
Low |
Quote: “triple blinding”
Comment: Blinded study (participants and personnel/carers) Our analysis for the binary outcome is an 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 |
Some concerns |
Comment: 837 randomized, 595 analyzed
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: Reasons are unknown. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: 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. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The prospective registry was available and consulted up to version dated December 31, 2020.
Outcome pre-specified. 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 outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |