Bias | Author's judgement | Support for judgement |
Randomization |
Some concerns |
Quote: “Block randomization method was used for randomization. Eight blocks, including ten patients, were generated by the Online Randomizer website (www.sealesenvelop.com/ simple randomizer).”
Comment: Allocation sequence random. Unclear allocation sequence concealment. |
Deviations from intervention |
Some concerns |
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: biologics and corticosteroids. Antiviral administration was reported. Data were analyzed appropriately; participants analyzed according to randomized assignment. |
Missing outcome data |
Low |
Comment: 84 patients randomized; 84 patients analyzed.
Data available for all partipants. Risk assessed to be low for the outcome: Mortality. |
Measurement of the outcome |
Low |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality. |
Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. The trial registry was available and utilized.
Trial analyzed as prespecified. Results were not selected from multiple outcome measurements or analyses of the data. Risk assessed to be low for the outcome: Mortality |
Overall risk of bias |
Some concerns |