Shoumann 2021 |
Some concerns |
There was no information on randomisation or allocation concealment. There are no baseline differences that would suggest a problem with randomisation. |
Low risk of bias |
Both participants and those delivering the intervention were aware of the intervention received, there were no deviations from intended interventions and the analysis was appropriate. |
Some concerns |
About 10% of outcome data were missing (participants were lost to follow‐up). Missing data were balanced between groups. Reasons for loss of follow‐up were not described. It is unlikely that missingness depended on its true value. |
Low risk of bias |
Outcome assessors were aware of the intervention received. Knowledge of intervention received could not have affected outcome measurement. |
Some concerns |
The protocol was prospectively registered. The outcome was not prespecified. |
Some concerns |
Due to insufficient information on randomisation, allocation concealment, and missing outcome data. Due to lack of prospectively registering the outcome. |