Development of an Oral Health-related Quality of Life tool for children with Neurodevelopmental Disorders: A mixed methods approach

Aim: The aim of this study was to develop a tool for assessing oral health-related quality of life (OHRQoL) for children with neurodevelopmental disorders (NDDs) using a mixed methods approach. Settings and Design: This tool development was done among 304 parents of 6–12-year-old children with NDDs attending the Institute of Mental Health and Neurosciences, Kozhikode, Kerala, India. Methods: The tool development protocol in the initial stage includes a mixed qualitative–quantitative approach. Initial item generation was done using an extensive literature search and qualitative methods, such as in-depth interviews and focus group discussions. The development process followed the steps as enunciated by Streiner and Norman and also the COSMIN criteria. Statistical Analysis: Reliability statistics, such as test–retest reliability and internal consistency reliability, were assessed with the intraclass correlation coefficient (ICC) and Cronbach’s alpha, respectively. Content, construct, and convergent validity were tested with content validity ratio, exploratory factor analysis, and Spearman correlation coefficient, respectively. Results: An 18-item final tool was developed with 5 factors (OHRQL-NDD tool). The test–retest reliability of the instrument with ICC was 0.922. Internal consistency reliability assessed using Cronbach’s alpha measurement was 0.737. The five factors together explained a total variance of 58.20%. Convergent validity by Spearman correlation with another tool measuring similar construct was found to be 0.606. Conclusions: The proposed tool was deemed feasible for assessing the OHRQoL in children with NDDs. The final item pool had adequate test–retest reliability, face validity, content validity, construct validity, and internal consistency reliability.