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: “Randomized, double-blind, placebo-controlled, exploratory phase II study.”
Comment: Allocation sequence probably 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 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 outcomes: Mortality (D28). Mortality (D60 or more). Adverse events. Serious adverse events. |
Missing outcome data |
Low |
Comment: 17 participants randomized; 16 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: One participant withdrew due to dementia. Missingness could not depend on the true value of the outcome. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). 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 (D28). Mortality (D60 or more). Adverse events. Serious adverse events. |
Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan and prospective trial registry (dated 16 April 2020) were available.
Outcomes pre-specified. 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 (D28). Mortality (D60 or more). Adverse events. Serious adverse events. |
Overall risk of bias |
Some concerns |