Definitions of the ratings of recommendations (A, B, C, U), translation of evidence to recommendations (A-C), and rating of therapeutic articles (Class I-IV) are provided at the end of the "Major Recommendations" field.
Recommendations
The decision as to whether or not to treat with antiepileptic drugs (AED) following a first unprovoked seizure in a child or adolescent must be based on a risk-benefit assessment that weighs the risk of another seizure (both the statistical risk of recurrence and the potential consequences of a recurrence) against the risk (cognitive, behavioral, and physical as well as psychosocial) of chronic AED therapy. This decision must be individualized and take into account both medical issues and patient and family preference. Therefore, the following recommendations are made for children and adolescents who have experienced a first seizure:
- Treatment with AED is not indicated for the prevention of the development of epilepsy (Level B).
- Treatment with AED may be considered in circumstances where the benefits of reducing the risk of a second seizure outweigh the risks of pharmacologic and psychosocial side effects (Level B).
Definitions:
Rating of Recommendation
A = established as effective, ineffective, or harmful for the given condition in the specified population.
B = probably effective, ineffective, or harmful for the given condition in the specified population.
C = possibly effective, ineffective, or harmful for the given condition in the specified population.
U = data inadequate or conflicting. Given current knowledge, treatment is unproven.
Translation of Evidence to Recommendations
Level A rating requires at least one convincing Class I study or at least two consistent, convincing Class II studies.
Level B rating requires at least one convincing Class II study or overwhelming Class III evidence.
Level C rating requires at least two convincing Class III studies.
Rating of Therapeutic Article
Class I: Prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population. The following are required:
- Primary outcome(s) is/are clearly defined.
- Exclusion/inclusion criteria are clearly defined.
- Adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias
- Relevant baseline characteristics are presented and substantially equivalent among treatment groups, or there is appropriate statistical adjustment for differences.
Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets a–d above or a randomized, controlled trial in a representative population that lacks one criterion a–d.
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome assessment is independent of patient treatment.
Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion.