Risk of bias | ||
---|---|---|
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Consecutive cases from each clinical population were randomly assigned to treatment by FLEK or by PK. The randomization code was generated using a permuted block size of 2.” |
Allocation concealment (selection bias) | High risk | Allocation cannot be concealed with a block size of 2 |
Blinding of participants (performance bias) | Unclear risk | Not specified |
Blinding of outcome assessment
(detection bias) All outcomes |
Unclear risk | Not specified |
Incomplete outcome data (attrition
bias) All outcomes |
High risk | “In the FLEK group, four
patients did not receive the allocated treatment due to
significant preoperative events and were eventually excluded
from the study analysis. All patients in the PK group received
the allocated treatment.” The proportions lost to follow-up were not low: 29/40 in FLEK group and 39/40 in PKP group and the study investigators did not perform intention-to-treat analysis |
Selective reporting (reporting bias) | Unclear risk | Protocol not available |
Other bias | Low risk | No other source of bias identified |