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 allocated in an equal ratio, using computer randomization procedures. There were two separate allocation lists. The first was the global list, in which the allocation sequence was prepared by an independent statistician appointed by the international steering group. The second was a national list prepared as a back-up if allocation according to the global list was not available." Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "The trial was open-label without a placebo control"
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. Information on the administration of co-interventions of interest: corticosteroids and biologics were reported and balanced between arms. Hence, deviations did not arise because of the trial context. 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). Mortality (D60 or more). |
| Missing outcome data |
Low |
Comment: 101 participants randomized; 99 participants analyzed.
Data available for all or nearly all participants randomized (1 patient in the control group, 3 in the intervention group were lost to follow-up). Risk assessed to be low for the outcome: Mortality (D28). 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 (D28). Mortality (D60 or more). |
| Selection of the reported results |
Low |
Comment: The protocol and 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 outcome: Mortality (D28). Mortality (D60 or more). |
| Overall risk of bias |
Low |