# Development and Validation of a Caregiver-Reported Quality-of-Life Questionnaire for Pediatric Patients With Drug-Resistant Epilepsy on a Ketogenic Diet

## TL;DR

This paper introduces a new questionnaire to assess quality of life in children with drug-resistant epilepsy on a ketogenic diet, finding significant improvements in seizure control and overall well-being.

## Contribution

The paper introduces a novel, validated caregiver-reported QoL questionnaire specifically for pediatric drug-resistant epilepsy patients on a ketogenic diet.

## Key findings

- The questionnaire showed perfect content validity and excellent inter-rater reliability.
- Most children experienced significant seizure reduction or freedom, along with improved energy, cognition, and mood.
- 100% of caregivers reported significant improvement in their child’s quality of life.

## Abstract

Background: Drug-resistant epilepsy (DRE) in children can lead to considerable challenges, impacting cognitive, emotional, social, and physical development. The ketogenic diet (KD) has emerged as an effective non-pharmacological intervention; however, its comprehensive impact on quality of life (QoL) in this population remains under-investigated.​

Aim/objectives: To develop and validate a QoL assessment questionnaire tailored for pediatric DRE patients undergoing KD therapy and to evaluate clinical outcomes based on caregiver-reported measures.​

Methods: A six-domain questionnaire was constructed through literature review and expert consultation. Content validity was assessed by three subject-matter experts using item-level content validity index (I-CVI), scale-level content validity index (S-CVI), Fleiss' kappa, and intraclass correlation coefficient (ICC). Thirty caregivers of children (<5 years) on KD for ≥6 months completed the validated questionnaire. Descriptive statistics summarized domain-specific outcomes.

Results: The questionnaire demonstrated perfect content validity (I-CVI=1.00; S-CVI=1.00), and inter-rater reliability was excellent (Fleiss' kappa=1.00; ICC=1.00). Complete seizure freedom was reported in 33% (n=10), and significant seizure reduction in 67% (n=20) of cases. Improvement in seizure severity was reported by 100% (n=30). Weight gain was observed in 70% (n=21), stable weight in 20% (n=6), and weight loss in 10% (n=3). Enhanced energy, cognitive function, and mood were reported in 100% (n=30). Social interaction improved in 90% (n=27). Adherence to KD was rated as "very easy" by 60% (n=18) and "somewhat easy" by 40% (n=12). Overall, 100% (n=30) of caregivers reported significant improvement in their child’s QoL.

Conclusions: The developed questionnaire exhibits excellent validity and reliability for assessing QoL in pediatric DRE patients undergoing KD therapy. KD was associated with substantial improvements across seizure control, physical health, cognitive-emotional functioning, and family dynamics, underscoring its broader therapeutic value. This work also aligns with the United Nations Sustainable Development Goal (SDG) 3, which emphasizes ensuring healthy lives and promoting well-being for all at all ages.