El‐Rashidy 2013.
Study characteristics | ||
Methods | Single‐centre randomised controlled trial to comparing two different dietary interventions (MAD and classic KD in form of 4:1 liquid diet) and a control group (AED polytherapy). | |
Participants |
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Interventions |
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Outcomes |
Data were collected at 3 and 6 months. |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Although the paper stated that participants were 'randomly assigned', there was no information regarding how the randomisation sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | There was no information suggesting whether allocation was concealed or not. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not discussed in this paper, but considering the design of the study, blinding of participants and study personnel does not seem possible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding was not discussed in this paper, but considering the design of the study, blinding of outcome assessors does not seem possible. |
Incomplete outcome data (attrition bias) | High risk | Study attrition was reported but ITT analysis was not carried out. Reasons for drop outs were likely to be related to interventions. |
Selective reporting (reporting bias) | Unclear risk | Emailed author regarding protocol, awaiting response from co‐authors. Protocol currently unavailable. |
Other bias | High risk | No measure of seizure frequency reported at baseline. 20% of participants in the classic KD group had infantile spasms. |