Gong 2015.
Methods |
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Participants |
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Interventions | Intervention A (number of children: 13): propranolol oral (regimen below) + timolol maleate topical (regimen below) Intervention B (number of children: 13): propranolol oral: 10 mg tablet, at a 1.0 mg/kg dose orally once a day with food Intervention C (number of children: 13): timolol maleate topical: 0.5% timolol maleate eye drops to the lesion twice daily (25 mg/5 mL) with medical cotton swabs |
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Outcomes | Outcome A: the improvement in size after treatment was graded on a 4‐point scale as proposed by Achauer and colleagues: class I (poor) ‐ reduction in size of < 25%; class II (moderate) ‐ reduction in size of 25% to 50%; class III (good) ‐ reduction in size of 50% to 75%; and class IV (excellent) ‐ reduction in size of 75% to 100%. Classes I and II were considered ineffective treatment, and classes III and IV effective treatment. | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a random sequence was generated using a computer program to assign patients in a 1:1:1 ratio to three groups of 13 patients each." Page 837 Comment: Authors reported information about adequate random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | There was insufficient information to classify this item as high or low. |
Blinding of participants (Performance bias) | Unclear risk | It is highly probable that participants were aware of intervention group assigned, but it is unclear whether this had an impact or not on the trial results. |
Blinding of personnel (performance bias) | Unclear risk | It is highly probable that researchers were aware of intervention group assigned, but 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: "A panel of three surgeons who were unaware of which treatment the infant had been given and the response rates, assessed the outcomes." Page 837 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 of data was not detected. |
Other bias | Low risk | No other biases were identified. |