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: “Masked randomisation was centralised and done electronically through an automated interactive web-response system (IWRS). Participants were randomly assigned (1:1) to either colchicine treatment or placebo, using an allocation sequence that was computer generated using a blocking schema with block sizes of six. Allocation sequence was not stratified.”
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
| Deviations from intervention |
Low |
Quote: “Randomized, double-blind trial”
Comment: Blinded study (participants, 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: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 4506 participants randomized; 4488 participants analyzed for efficacy; 4412 analyzed for safety.
Data available for all or nearly all participants. Risk assessed to be low for the outcomes: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Quote: "double-blind, placebo-controlled"
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: Hospitalization or death. Mortality (D28). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available (dated March 25th, 2020).
HOSPITALIZATION OR DEATH. MORTALITY Outcome pre-specified in the registry. 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: Hospitalization or death. Mortality (D28). ADVERSE AND SERIOUS ADVERSE EVENTS Safety outcomes were not pre-specified in the registry. No information on whether the results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcome: Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |