CL1 DEFINING AND DEMONSTRATING A CHILD-CAREGIVER DYAD QUESTIONNAIRE ADMINISTRATION APPROACH TO THE ASSESSMENT OF PEDIATRIC HEALTH-RELATED QUALITY OF LIFE

Age and developmental factors may limit a child’s understanding and reliable self-report of health-related outcomes. Informant reports are possible; however, observer-reported outcomes are limited to concepts that are observable, and proxy reports often differ from children’s reports. While the FDA PRO Guidance indicates that ‘there is some support for a parent-child dyad approach to the assessment of the child’s HRQOL’, very few examples of...