| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Patients were randomly assigned to either the triple combination lopinavir–ritonavir, ribavirin, and interferon beta-1b group or the control group (lopinavir–ritonavir only), in the ratio of 2:1, by simple randomisation with no stratification. Randomised treatment was open-label. Patients were assigned to a serial number by the study coordinator. Each serial number was linked to a computer-generated randomisation list assigning the antiviral treatment regimens. The study medications were dispensed by the hospital pharmacy and then to the patients by the medical ward nurses." |
| Deviations from intervention |
Low |
Comment: Unblinded study. There is no evidence of deviation from the intended intervention that arose because of the trial context’ (i.e., no cross-over; co-interventions administered are balanced between arms). A higher proportion of participants in the treatment received glucocorticoids, compared to the control arm (69,7% vs 48,7%); however this difference is small in absolute values (i.e., number of participants that received glucocorticoids per arm: 6 vs 2). Outcome data were analyzed by using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 127 randomized/127 analyzed. Risk assessed to be low for the outcomes: Time to negative viral conversion. Mortality. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: the trial was not blinded. Outcomes are observer-measured and do not involve clinical decision-making except for adverse events which could be patient-reported or involve assessor judgment. Risk assessed to be "low" for the outcomes: Mortality. Time to viral negative conversion Risk assessed to be "some concerns" for the outcomes: Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: the protocol was available. The statistical analysis plan was not available. Risk assessed to be "low" for the outcomes: Mortality. Time to viral negative conversion. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |