Abstract
BACKGROUND: Health related quality of life (HRQOL) is a patient-reported metric (PRM) that provides a holistic measure of health that is not addressed in traditional outcome measures. The acute responsiveness of HRQOL after pediatric/congenital cardiac catheterization procedures has not, to our knowledge, been studied. METHODS: A single-center prospective cohort study was performed, longitudinally evaluating HRQOL and other PRM in school-age children and adolescents (ages 8-18) undergoing diagnostic and interventional cardiac catheterization procedures prior to their scheduled procedure, and then 1 day, ∼1 month, and ∼3 months after the procedure. Differences between HRQOL at baseline and at 1- and 3-month follow-up were evaluated using paired Student's t-tests. RESULTS: A total of 70 patient-parent/guardian dyads were studied. The participating patients were 13±3 years old, 51% female, and 74% non-Hispanic white, with 54% undergoing a diagnostic procedure. The trajectory of cardiac-specific HRQOL as measured through Pediatric Cardiac Quality of Life Inventory differed for patients undergoing diagnostic and interventional procedures. Following diagnostic procedures, there was no significant change in cardiac-specific HRQOL (P > .05). After interventional procedures, patient-reported cardiac-specific HRQOL increased at both 1-month (4.3±11, P = .04) and 3-months (5.9±11.4, P = .02), though the same changes were not seen in parent/guardian-reported cardiac-specific HRQOL (P > .05). PROMIS measures of physical function, psychological symptoms, and social function were associated with baseline cardiac-specific HRQOL (all P < .05), but no associations were seen between other patient-reported outcomes and baseline HRQOL or change from baseline to 3-month follow-up. CONCLUSION: Across a range of transcatheter interventional procedures, patient-reported cardiac-specific HRQOL improved in short term follow up, though these changes were not seen in parent/guardian reported measures. Incorporating these patient-centered metrics into evaluation of transcatheter therapies may provide more accurate measures of comparative effectiveness.