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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Single‐centre, randomised, parallel‐group trial conducted in the UK
3 treatment arms: CBZ, PHT, VPS
Participants Children with at least 3 newly diagnosed generalised or partial seizures within a period of 6 months
Number randomised: CBZ = 23, PHT = 20, VPS = 21
No information on epilepsy type or sex
Age range: 5‐14 years
Interventions Monotherapy with CBZ, PHT or VPS
Mean dose: CBZ = 17.9 mg/d, PHT = 6.1 mg/d, VPS: 25.3 mg/d
Trial duration: 12 months, range of follow‐up not stated
Outcomes Cognitive assessments
Summary of withdrawals from randomised drug
Notes Outcomes chosen for this review were not reported
IPD not available, but could be constructed from the publication for the outcome 'time to withdrawal of allocated drug'
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quota allocation by sex, age, seizure type and current treatment is an inadequate randomisation method
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes High risk Personnel and participants (and parents) unblinded
Blinding of outcome assessment (detection bias) All outcomes Low risk Outcome assessors single‐blinded for cognitive testing
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported, results reported and analysed for all participants randomised and all who completed various stages of follow‐up
Selective reporting (reporting bias) Unclear risk One of four outcomes for this review reported. Cognitive outcomes described in methods section well reported in results section. Adverse effects reported, no seizure outcomes reported and outcomes chosen for this review not reported. No protocol available so unclear if seizure outcomes were planned a priori
Other bias Low risk None identified