Validity and comprehensibility of outcome measures in children with shoulder and elbow disorders: creation of a new Pediatric and Adolescent Shoulder and Elbow Survey (Pedi-ASES)

Background Valid patient-reported outcomes (PROs) for the shoulder and elbow do not exist for children. We assessed children's comprehension of the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire and the American Shoulder and Elbow Surgeons (ASES) standardized shoulder assessment form, identified response errors, and modified items to create a new pediatric shoulder and elbow PRO. Methods We recruited 50 children (aged 10-18 years) with shoulder or elbow disorders from a children's hospital–based orthopedic clinic for this qualitative study. A trained researcher conducted cognitive interviews to identify children's comprehension of PROs. In phase 1, 40 children were purposefully sampled on the basis of age and gender, interviewed, and audiotaped. A behavioral scientist analyzed transcripts, modified items, and created the Pediatric and Adolescent Shoulder and Elbow Survey (Pedi-ASES). In phase 2, 10 children were interviewed to gather feedback on and to refine the Pedi-ASES. Results The average interview time was 25 minutes (range, 17-44 minutes). There were 242 comments generated about the QuickDASH; 51% of children struggled with complex terminology, and 35% did not understand “tingling.” Children generated 309 comments about the ASES, primarily associated with narcotic medications (65%) and shoulder instability (42%). Time frame and format issues were noted. In phase 2, children found the new PRO easier to comprehend and answer. Conclusions Modifications were needed in general instruction, language, format, and response mapping in the original PROs. Children had few difficulties with the Pedi-ASES. Designing PROs that are specific to children will enable researchers and clinicians to more accurately assess health status and clinical outcomes.