| Tardif 2021 |
Low risk of bias |
The allocation sequence was probably random and concealed and there were no differences between intervention groups suggesting a problem with the randomization process. |
Some concerns |
Participants and carers were blinded, but there was insufficient information to decide whether the analysis was appropriate, as according to the study flow diagram the safety set in the colchicine group should be 2192, but SAEs were reported for 2195 participants (in the placebo group, safety set should be 2218 participants, but SAEs reported for 2217). |
Some concerns |
It was unclear how many participants were analysed for this outcome. The outcome could have been influenced by the inadequate knowledge of the relatives who responded the outcome assessment via telephone. |
Low risk of bias |
Outcome measurement is insufficiently described, however we do not expect any differences in measurement between intervention groups, because of the double‐blinded design |
Some concerns |
The outcome was not prespecified in the trial registry. |
Some concerns |
For the outcome "diarrhea" in this study, there is a low risk of bias from the randomization process and measurement of the outcome. However, there are some concerns for bias due to selection of the reported result, deviations from intended interventions and missing outcome data. |
