Suknaic 2008.
Methods | RCT n=50 | |
Participants | CAF adults and children | |
Interventions | Botox 10u vs LIS | |
Outcomes | Healing Minor incontinence |
|
Notes | AS inadequate, AC no, B no, SS not stated R ‐ no (first 30 patients in one arm, second 30 in second arm) ITT+ Drop‐outs 10 Follow‐up 6 months |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Inadequate randomisation process. |
Allocation concealment (selection bias) | High risk | not concealed |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded due to injection vs surgery |
Selective reporting (reporting bias) | Low risk | appropriate outcomes/side effects reported |
Other bias | High risk | >10% drop outs, |
Duration of Follow‐up 6 months or more | Low risk | 6 months |