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: “We used a central allocation mechanism in which participating centers called a central randomization unit, and registered their eligible patients to receive the 4-digit unique code for assigned group identification.”
Comment: Allocation sequence random. Allocation sequence concealed |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. Biologics, antivirals and corticosteroids were reported and were balanced between groups. Hence, deviations did not arise because of the trial context. Data for the outcome were analyzed using modified 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 (D60 or more). |
| Missing outcome data |
Some concerns |
Comment: 424 participants randomized; 373 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 4 centers (44 participants) were excluded because of poor compliance with study data collection (which is not due to missing data and unrelated to the outcome); 3 vs 4 participants were lost to follow up. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (same reason and equal proportion of missingess between arms). Risk assessed to be some concerns for the outcome: Mortality (D60 or more). |
| 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). Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D60 or more). |
| Selection of the reported results |
Some concerns |
Comment: The prospective version (dated Aril 1st, 2020) of the trial registry was available.
Unclear information on timepoint for mortality; stated in the registry as "once". No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D60 or more). |
| Overall risk of bias |
Some concerns |