Lambrechts 2017.

Methods	Prospective, single‐centre, non‐blinded, randomised controlled trial to compare KD (classic KD and MCT KD) to a control group over a 4‐month period. Follow‐on studies then compared long‐term clinical outcomes at 16 months, cognitive and behavioural impacts and an economic evaluation. A 4‐week baseline period was completed.
Participants	57 participants aged 1 to 18 years with drug‐resistant epilepsy, seizures not adequately controlled by 2 or more AEDs and surgical remedial causes of epilepsy not viable. Study was conducted in the Netherlands
Interventions	Randomised into 1 of 2 groups; KD (classic KD and MCT KD) and control for a four‐month period
Outcomes	Seizure reduction Adverse events Attrition Quality of life Cost‐effectiveness Cognitive and behavioural changes
Notes	7 participants in the KD group dropped out by 4 months; 1 due to compliance, 1 due to ineffectiveness, 1 due to ineffectiveness combined with adverse events, 2 due to adverse events alone, 1 due to change in seizure pattern and 1 due to withdrawn consent. In the control group 9 participants dropped out, all 9 due to dissatisfaction with randomisation arm. By 16 months, a further 4 participants had discontinued KD; 2 due to compliance, 1 due to ineffectiveness and 1 due to ineffectiveness combined with adverse events. Data at 16 months for the control group is not presented as the control arm had no option to commence KD after the initial 4‐month control period was completed. Exclusion criteria: medical contraindications, behavioural or motivational problems that would preclude compliance. The study was supported financially by the Netherlands Organisation for Health Research and Development.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	ALEA, minimisation method of sequence generation
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding (performance bias and detection bias) All outcomes	High risk	Study did not report whether blinding was undertaken although it seems from the design of the study that blinding would not be possible.
Incomplete outcome data (attrition bias)	Low risk	Study attrition reported and ITT analysis carried out
Selective reporting (reporting bias)	Low risk	Protocol published. No evidence to suggest selective reporting bias
Other bias	High risk	Excluded participants with motivational or behavioural problems. Baseline differences in mood and behaviour scores, gender balance and seizure frequency (no significance value reported to fully assess extent). Gastrointestinal problems greater at baseline in KD group compared to control (P < 0.05). Under powered to assess QALYs and tool extrapolated from adult tariffs.