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: "Block randomization method was used in this study. Ten blocks including six patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, three patients will be assigned to adalimumab group and three patients will be assigned to control group randomization]"(registry)
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Low |
Quote: “not blinded”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: biologics. Antivirals and corticosteroids were reported as distributed to all participants. Hence, deviations probably did not arise because of the trial context. 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 outcomes: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 68 participants randomized; 68 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: 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. Unblinded study (outcome assessor) MORTALITY Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The study registry seemed to be retrospective (dated 2020-11-10).
Mortality outcome was not pre-specified in the registry; however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably 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 |