Outpatient Initiation of the Ketogenic Diet in Children with Pharmacoresistant Epilepsy: An Effectiveness, Safety and Economic Perspective

Abstract Background Children with pharmacoresistant epilepsy usually receive ketogenic diet (KD) as an inpatient, which makes it an expensive treatment. Objective To compare the effectiveness, safety, and costs of outpatient versus inpatient initiated KD. Design Retrospective observational non-inferiority study. Patients/setting Patients (1-18 years of age) who started KD either inpatient or outpatient. Main outcome measures Effectiveness was defined as ≥50% seizure reduction. Safety was measured by the numbers of emergency visits and complications. Economic impact was analyzed by calculating total costs of treatment. Statistical analyses Non-inferiority of outpatient initiation was tested using 95% confidence intervals of the differences in effectiveness and safety endpoints between groups with non-inferiority margins of 10%. Nonparametric bootstrap techniques were used to derive a 95% confidence interval for the mean difference in total costs between the groups. Results Hundred and five patients started KD in the period 2001 to 2017: 43 inpatient and 62 outpatient. At three months, the KD was effective in 61% of outpatients versus 63% of inpatients. The KD was considered safe in 36% of the outpatients, as compared to 29% in the inpatients. Outpatient initiation was shown to be non-inferior to inpatient initiation in terms of safety. Total health care costs of outpatient initiation were € 2,901, as compared to € 8,195 of inpatient initiation per patient (mean difference € 5,294, 95% CI; -€ 7,653 to -€ 2,935). Conclusions Our study suggests that outpatient KD initiation is no worse than inpatient initiation in terms of effectiveness and safety, while carrying lower health care costs.