Mayet 2021 |
High risk of bias |
Baseline characteristics were comparable between intervention groups, but the sequence to allocate the participants was generated by odd or even numbers. |
Some concerns |
The study was described as "unblinded study" in which study personnel and participants could not be masked due to the nature of intervention. Data analysis was restricted to children who were followed up for at least 24 weeks after the last procedure. |
High risk of bias |
The outcome data for one participant (1.8%) in the BNT arm and eight participants in the surgery arm (14.5%) were not included in the final analyses. The reasons of lost to follow‐up or exclusion were not fully described. |
Low risk of bias |
Although the article failed to describe if outcome assessors were masked, the outcome data should not be influenced by knowledge of intervention received. |
Some concerns |
Protocol, trial register, or prespecified analysis plan was not publicly available. |
High risk of bias |
See the descriptions shown above. |