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: “227 patients were randomly distributed into the three treatment groups, using a random list in blocks of three sequentially permuted numbers.”
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Low |
Quote: “Double-blind”
Comment: Blinded study (participants and personnel/carers). Our analysis for the binary outcomes 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). Hospitalization or death. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 139 participants randomized; 122 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 1 participant in the TDF-alone arm was excluded because they did not start the treatment; 8.5%, 15.5% and 12.8% were lost to follow up. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome because proportions missing vary only a little in a blinded study. Risk assessed to be some concerns for the outcomes: Mortality (D28). Hospitalization or death. Serious adverse events. |
| 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). Hospitalization or death. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The registry (15 Jan 2021) was retrospective.
HOSPITALIZATION OR DEATH. SERIOUS ADVERSE EVENTS. Outcome not prespecified. No information on whether other results were selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Hospitalization or death. Serious adverse events. MORTALITY Mortality outcome was not pre-specified, 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 |