Methods | Single‐centre, randomised, parallel‐group trial conducted in the UK 3 treatment arms: CBZ, PHT, VPS |
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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 |
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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 |
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Outcomes | Cognitive assessments Summary of withdrawals from randomised drug |
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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' |
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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 |