3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 14 sources, which was discussed by the committee. The evidence included 3 randomised controlled trials (one of which resulted in 3 publications), 3 systematic reviews, 1 non-randomised comparative study, 1 case series and 4 case reports. It is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be reduction in seizure frequency and improvement in the epilepsy seizure outcome scale, quality of life, reduction in hospital admissions and reduction in concomitant medication use.
3.3 The professional experts and the committee considered the key safety outcomes to be device failure and off-target stimulation.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that most of the evidence reviewed by the committee came from patients aged 18 years to 70 years.
3.6 The evidence reviewed by the committee included participants aged under 18. However, the CE mark certificate for the device is only indicated for adults. Therefore, in line with processes in the interventional procedures programme manual, this guidance only relates to use of the procedure in adults.
3.7 The committee was informed that the efficacy of this procedure may vary by type of epilepsy.