Validating measures of pediatric health status, functional status, and health-related quality of life: Key methodological challenges and strategies

Objective.-To describe key methodological challenges in the validation of measures of pediatric health status, functional status, and health-related quality of life (HRQOL) and ways to address them. Methods.-Validation strategies of measures of pediatric health status, functional status, and HRQOL were reviewed. Results.-Three key challenges were identified: 1) clarifying and testing measurement models; 2) measuring responsiveness to clinically meaningful change; and 3) considering data from multiple respondents. Conclusions.-Research strategies to enhance validity of measures include specifying intended validity and measurement models, documenting sensitivity of measures to clinically meaningful change, and considering data from multiple informants.