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: “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. Unclear allocation concealment (No information on sequentially numbered opaque envelopes). |
Deviations from intervention |
Low |
Comment: Unclear blinding (participants and personnel/carers)
Deviations from intended intervention arising because of the study context: No participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation arose 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 outcome: Mortality (D28). |
Missing outcome data |
Some concerns |
Comment: 60 participants randomized; 54 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: No laboratory tests (1 vs 3), changed doctor (0 vs 1), other (0 vs 1). Missingness could depend on the true value but was not considered likely to. Risk assessed to be some concerns 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. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). |
Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and retrospective (dated April 5th, 2020).
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 (D28). |
Overall risk of bias |
Some concerns |