VALIDATION OF THE PATIENT/PARENT-REPORTED OUTCOME MEASURE OF FRACTURE HEALING (PROOF-UE) QUESTIONNAIRE FOR UPPER EXTREMITY FRACTURES IN CHILDREN

Clinical trials of pediatric fracture treatments seldom show differences based on patient-reported outcome measures (PROMs), possibly because the PROMs used do not adequately capture patients/parents’ perspectives about all the outcomes that matter. The Patient Reported Outcomes of Fracture Healing (PROOF) questionnaires are a new set of PROMs designed specifically for children's fractures. Derived from parents and patients, the content of the PROOF includes 4 domains (Scores:0-100): “how it looks’; “how it feels”; “how it works”; “how it healed”, which captures the overall recovery experience. This project evaluates the reliability, validity and responsiveness of the PROOF-UE questionnaires for pediatric upper extremity fractures. Children (1–17 yrs) with upper extremity fractures were prospectively enrolled. Parents and children (>8 yrs) completed the parent & child versions of the PROOF-UE, respectively, at 4 time-points until full recovery. Test-retest reliability two weeks apart (intraclass correlation coefficient) and internal consistency (Crohnbach's alpha) were determined at final healing. Known-groups validity was assessed by comparing those fractures that were open, associated with vascular or neurologic injury or complications versus those that were not. Convergent validity was assessed by comparing the PROOF-UE to the QuickDASH and PODCI. Responsiveness (sensitivity to change) was evaluated over 3 time-points using standardized response means (SRM). Finally, parents’ scores were compared with their respective children's scores. 294 children's fractures (188 boys/106 girls, mean age 7.8 yrs) of the clavice, proximal humerus, humeral shaft, supracondylar, lateral condyle, medial epicondyle, other elbow, radius and ulna, carpal, metacarpals and phalanges were included. The PROOF-UE demonstrated excellent test-retest reliability for the Total and 4 domain scores for children (ICC:0.67–0.98) and parents (ICC:0.57–0.84); and high internal consistency for children (0.62–0.88) and parents (0.76–0.90), respectively. As hypothesized, fractures with vascular or nerve injuries, or associated with complications scored significantly worse on the Total and relevant domain scores than uncomplicated fractures (p<0.05). There was moderate correlation with the QuickDash (R=-0.58) and the PODCI (R=0.66/0.84). The PROOF-UE was highly responsive to change with SRMs exceeding 1. Children's scores correlated strongly with their parents’ (R=0.85) with parents’ Total scores an average of 1.5 points lower than children's. The PROOF-UE questionnaires are reliable, valid and responsive condition-specific PROMs to measure upper extremity fracture outcomes that matter to children and their parents. The PROOF-UE may be considered as the PROM of choice to track or compare outcomes of pediatric upper extremity fractures and their treatments. As it reports scores across four different domains and in total, the use of the PROOF-UE may also serve to distinguish the pros and cons of competing treatment options that may better inform decision-making about treatment choices.