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:"Double blind randomization was achieved by on-site physician choosing identically loaded syringes with saline or reconstituted BCG"
Comment: Allocation sequence probably random. No information on allocation concealment. Method of randomization unconventional, with no information on who prepared the syringes |
| Deviations from intervention |
Some concerns |
Quote: “Double blind randomization was achieved by on-site physician choosing identically loaded syringes with saline or reconstituted BCG”
Comment: There was no clear information on whether participants and providers were aware or unaware of the assigned intervention. Unclear blinding (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. Hence, no information on whether deviations arose because of the trial context. Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcomes: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 60 participants randomized; 59 participants analyzed.
4 patients only partially included in analyses because they withdrew or were lost to follow up. Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: 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. Unclear blinding (outcome assessor). Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). |
| Selection of the reported results |
Some concerns |
Comment: The study registry and protocol were available, but no statistical analysis plan.
Timepoint for the outcome Mortality in the registry and protocol is described as "Time From enrollment" while there is no clear timepoint reported in the manuscript. No information on whether the result was 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: Mortality (D28). |
| Overall risk of bias |
Some concerns |