Related Experiment Video
Updated: Jan 11, 2026
Author Spotlight: Advancing Pediatric Epilepsy Surgery in Children Through Novel Biomarkers and Enhanced Localization
Published on: September 20, 2024
Development and Validation of a Caregiver-Reported Quality-of-Life Questionnaire for Pediatric Patients With
Soma Basu1, A J Hemamalini1, Ranjith Kumar Manokaran2
1Clinical Nutrition, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research, Chennai, IND.
Insights
The ketogenic diet (KD) significantly improves quality of life (QoL) in children with drug-resistant epilepsy (DRE). A new validated questionnaire confirms KD
Area of Science:
- Pediatric Neurology
- Dietary Interventions
- Quality of Life Research
Background:
- Drug-resistant epilepsy (DRE) in children presents significant developmental challenges.
- The ketogenic diet (KD) is a promising non-pharmacological treatment for DRE.
- Comprehensive assessment of KD's impact on pediatric DRE patients' quality of life (QoL) is lacking.
Purpose of the Study:
- To develop and validate a QoL assessment questionnaire for pediatric DRE patients on KD.
- To evaluate clinical outcomes and QoL using caregiver-reported measures.
Main Methods:
- A six-domain questionnaire was developed via literature review and expert consultation.
- Content validity and inter-rater reliability were assessed using established metrics (I-CVI, S-CVI, Fleiss' kappa, ICC).
- Thirty caregivers of children (<5 years) on KD for ≥6 months completed the questionnaire.
Main Results:
- The questionnaire demonstrated excellent content validity (I-CVI=1.00, S-CVI=1.00) and reliability (kappa=1.00, ICC=1.00).
- 100% of patients showed seizure improvement, with 33% achieving seizure freedom.
- Caregivers reported significant improvements in seizure severity, energy, cognition, mood, social interaction, and overall QoL.
Conclusions:
- The developed questionnaire is a valid and reliable tool for assessing QoL in pediatric DRE patients on KD.
- KD therapy is associated with substantial improvements in seizure control, physical health, cognitive-emotional function, and family well-being.
- This research supports SDG 3 by promoting healthy lives and well-being for children with DRE.
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.
More Related Videos
05:42Elevated Plus Maze Test Combined with Video Tracking Software to Investigate the Anxiolytic Effect of Exogenous Ketogenic Supplements
Published on: January 7, 2019
05:56Implementation of Non-invasive Point of Care Transient Elastography for Evaluation of Liver Disease in Pediatric Populations with Cystic Fibrosis
Published on: August 29, 2025
Related Concept Videos
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
01:22Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
01:15Bioavailability Study Design: Healthy Subjects Versus Patients