Li 2016.
Methods |
|
|
Participants |
|
|
Interventions | Intervention A (number of children: 14): oral propranolol in combination with topical timolol maleate Intervention B (number of children: 17): oral propranolol treatment alone |
|
Outcomes |
Primary Outcome A: Changes of size and colour of the haemangioma were assessed by B‐ultrasound and photographs at the onset of treatment, between treatment intervals, and at the conclusion of treatment. Secondary Outcome B: The visual analogue scale was compared with the response to treatment. |
|
Notes |
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly divided into experimental and control groups using a randomised number table." Page 56 Comment: Authors reported information about adequate random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | There was insufficient information to assess this item as low or high. |
Blinding of participants (Performance bias) | Unclear risk | Despite participants being aware of intervention group assigned, it is unclear whether this had an impact or not on the trial results. |
Blinding of personnel (performance bias) | Unclear risk | Despite researchers being aware of intervention group assigned, it is unclear whether this had an impact or not on the trial results. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Three independent surgeons blind to the patients assessed the efficacy by analysing the clinical photograph at baseline and the end of the treatment." Page 57 Comment: Authors reported information about adequate blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No children were lost at follow‐up. |
Selective reporting (reporting bias) | Low risk | Selective reporting was not detected. |
Other bias | Low risk | No other biases were identified. |