Bias | Author's judgement | Support for judgement |
Randomization |
Some concerns |
Quote: “Simple randomization with sealed envelope. The coding is done by a project colleague and the physician, assessor and patient are blind.” Comment: Allocation sequence random. No enough information on allocation sequence. |
Deviations from intervention |
Some concerns |
Comment: Blinding is unclear.
No cross-over reported. No information on administration of co-interventions of interest: antivirals, corticosteroids and biologics were reported Data were analyzed using intention-to-treat analysis |
Missing outcome data |
Some concerns |
Comment: 60 patients randomized; 54 patients analyzed.
Missingness in > 5% of population. Reasons: No laboratory tests (n=4), changed doctor (n=1), other (n=1). Missingness could depend on the true value but was not considered likely to. Risk assessed to be some concerns for the outcome: Mortality. |
Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcome: Mortality. |
Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and utlized.
Mortality was neither registered as an outcome nor reported as such in the paper. Result was 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 |
Overall risk of bias |
Some concerns |