Development and validation of the iKETO-KNOW questionnaire: A tool for assessing knowledge of the ketogenic diet therapy

Objective: Ketogenic dietary therapies (KDTs) are effective and safe alternatives for patients with drug-resistant epilepsy who are not candidates for surgical intervention. The success of KDTs depends heavily on patients’ strict adherence to dietary guidelines, which is closely linked to their knowledge of the therapy. This study aimed to develop and validate the iKETO-KNOW Questionnaire in the Italian language—a tool designed for adult patients and caregivers to assess knowledge related to KDTs. Methods: The iKETO-KNOW Questionnaire was created by a panel of experts and validated using the Delphi method, which incorporated feedback from clinicians and patient representatives. The final version includes three introductory items and ten multiple-choice questions, organized into two main domains: “food knowledge” and “diet management.” Results: The questionnaire was administered to 107 patients and caregivers undergoing KDT treatment. It demonstrated strong test–retest reliability, confirming its consistency over time. Participants generally showed high levels of dietary knowledge. No significant correlations were found between knowledge scores and factors such as patient age, duration of KDT, or ketonemia levels. Furthermore, knowledge scores did not differ significantly across various diagnoses or types of KDT, indicating the tool's broad applicability. Significance: Evaluating dietary knowledge is essential to improve adherence to KDTs. The iKETO-KNOW Questionnaire fills a gap in standardized assessment tools and can help identify educational needs, allowing for targeted psychoeducational interventions. Enhancing dietary knowledge is likely to improve adherence and, consequently, clinical outcomes in patients following KDTs.