Core Outcome Measures in Effectiveness Trials

Development of outcome criteria to measure effectiveness of antiepileptic therapy in children

General Information

Purpose: Clinical trials of antiepileptic drugs frequently measure outcomes of seizure control,which demonstrate efficacy. Yet, functional status, quality of life, and long-termtreatment effects reflecting effectiveness are scarcely
assessed. Wesought to use a consensus method to help identifywhich outcome criteria key stakeholders consider should be used to measure effectiveness in trials of antiepileptic treatments for children.

Method: A two-round Delphi survey was used; parents of children with epilepsy and local, international experts comprising academics and clinicians participated in the survey. In the first round, 32 experts, 50 parents, and 15 children with epilepsy aged N13 years suggested outcomes that they considered important in determining effectiveness of antiepileptic therapy in children, separately for preschool and school age. In the second round, 29 experts and 42 parents scored the importance of outcomes from the list suggested by at least 10% of round 1 respondents and also proposed five most important outcomes.

Results: Complete seizure freedom (67%), seizure frequency (48%), ability to perform normal day-to-day activities (45%), and quality of life (40%) were identified as the most important outcomes of antiepileptic therapy in
children of both age groups. Additionally, effect on developmental milestones (47%) and child's compliance to treatment regimen (39%) were identified as most important in preschool age group and school performance (49%); adverse effects (39%) were identified as most important in school age group.

Conclusion: For the first time, this study has identified outcome priorities regarding antiepileptic treatment in children based on the key stakeholders' perspectives. It could be used as a provisional list of outcomes for inclusion in a core outcome set for children with epilepsy.

Murugupillai, Roshini Ranganathan, Shalini Sri Wanigasinghe, Jithangi Muniyandi, Ravi Arambepola, Carukshi


Epilepsy & Behavior
56 - 60
Further Study Information

Not stated
Funding source(s):
We acknowledge the World Bank for providing fund through HETC QIG W3 grant (Higher Education for Twenty first Century – Quality and Innovative Grant – Window 3)

Health Area

Disease Category

Disease Name

Target Population

Age Range
0 - 18


Nature / type of Intervention


Delphi process

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research

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