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 |
Low |
Quote: "Using an interactive Web-based response technology system, we randomly assigned trial participants" Comment: Allocation sequence random. Allocation sequence concealed. Risk assessed as low. |
Deviations from intervention |
Low |
Quote: “study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded. All other study and site personnel, including the investigator, investigator staff, and participants, will be blinded to study intervention assignments”
Comment: Some study staff were not blinded; patients and investigators were blinded. No participant cross-over. Unlikely to have been deviations from intended intervention. Data were analyzed using intention-to-treat analysis; As we are assessing the effect of assignment to intervention, the analysis method performed on these safety outcomes, was considered appropriate. Risk assessed to be low for the outcomes: Mortality. Local adverse events. Systemic adverse events. Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 195 randomized/195 analyzed for safety and mortality
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality. Local adverse events. Systemic adverse events. Adverse events. 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. Local adverse events. Systemic adverse events. Adverse events. Serious adverse events. |
Selection of the reported results |
Low |
Comment: The prospective protocol and statistical analysis plan were available (15 April 2020).
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. Local adverse events. Systemic adverse events. Adverse events. Serious adverse events. |
Overall risk of bias |
Low |