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 were randomized centrally, and separately for each participating hospital, utilizing an online-dedicated software (http://www.randomization.com)”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “Recruiters, patients, treating physicians, nursing staff, and the rest of the treating team, along with the follow-up evaluation monitors and the data-entry personnel, were blinded to group assignment.”
Comment: Blinded study (participants and personnel/carers) Data 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 outcomes: Mortality (D28). Time to death. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 214 participants randomized; 214 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available (prospective).
Results were probably selected from multiple outcome measurements or analyses of the data for mortality and adverse events (different timepoints). Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D28). Serious adverse events. Time to death was not pre-specified. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Time to death. |
| Overall risk of bias |
Some concerns |