Department of Dietetics, Erasmus MC-Sophia Children's Hospital, University Medical Center Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.
Department of Dietetics, Erasmus MC-Sophia Children's Hospital, University Medical Center Rotterdam, Wytemaweg 80, 3015 CN, Rotterdam, the Netherlands.
Eur J Paediatr Neurol. 2019 Sep;23(5):740-748. doi: 10.1016/j.ejpn.2019.06.001. Epub 2019 Jun 29.
Children with pharmacoresistant epilepsy usually receive ketogenic diet (KD) as an inpatient, which makes it an expensive treatment.
To compare the effectiveness, safety, and costs of outpatient versus inpatient initiated KD.
Retrospective observational non-inferiority study.
PATIENTS/SETTING: Patients (1-18 years of age) who started KD either inpatient or outpatient.
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.
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.
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 € 2901, as compared to € 8195 of inpatient initiation per patient (mean difference € 5294, 95% CI; -€ 7653 to -€ 2935).
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.
患有药物难治性癫痫的儿童通常需要住院接受生酮饮食（KD）治疗，这使得治疗费用昂贵。
比较门诊和住院起始 KD 的有效性、安全性和成本。
回顾性观察性非劣效性研究。
患者/设置：门诊或住院起始 KD 的患者（1-18 岁）。
有效性定义为≥50%的癫痫发作减少。安全性通过急诊就诊次数和并发症来衡量。通过计算治疗总费用来分析经济影响。
使用两组间有效性和安全性终点差异的 95%置信区间来检验门诊起始的非劣效性，非劣效性边界为 10%。使用非参数自举技术得出两组间总费用差异的 95%置信区间。
2001 年至 2017 年期间，105 例患者开始 KD 治疗：43 例为住院患者，62 例为门诊患者。在 3 个月时，门诊患者 KD 的有效率为 61%，住院患者为 63%。门诊患者 KD 被认为是安全的，占 36%，而住院患者为 29%。门诊起始 KD 在安全性方面不劣于住院起始 KD。门诊起始的总医疗保健费用为每位患者 2901 欧元，而住院起始为 8195 欧元（平均差异为 5294 欧元，95%CI；-7653 至-2935 欧元）。
我们的研究表明，门诊 KD 起始在有效性和安全性方面不劣于住院起始，同时降低了医疗保健成本。
