Validity and responsiveness of the pediatric quality of life inventory (PedsQL) 4.0 generic core scales in the pediatric inpatient setting.
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IMPORTANCE: Validated patient-reported outcomes responsive to clinical change are needed to evaluate the effectiveness of quality improvement interventions. OBJECTIVES: To evaluate responsiveness, construct validity, and predictive validity of the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales in the pediatric inpatient setting. DESIGN, SETTING, AND PARTICIPANTS: Prospective, cohort study of parents and caregivers of patients 1 month to 18 years old (n=4637) and patients 13 to 18 years old (n=359) admitted to Seattle Children's Hospital between October 1, 2011, and December 31, 2013. Of 7184 eligible participants invited to complete the survey, 4637 (64.5%) completed the PedsQL on admission, and of these 2694 (58.1%) completed the follow-up survey 2 to 8 weeks after discharge. MAIN OUTCOMES AND MEASURES: Responsiveness was assessed by calculating improvement scores (difference between follow-up and admission scores). Construct validity was examined by comparing the mean improvement scores for known groups differing by medical complexity. Predictive validity was assessed using Poisson regression to examine associations among admission scores, prolonged length of stay (3 days), and 30-day readmissions or emergency department (ED) return visits. Similar models examined the association between improvement scores and risk for 30-day readmissions or ED return visits. RESULTS: The mean (SD) PedsQL improvement scores (scale, 0-100) were 22.1 (22.7) for total, 29.4 (32.4) for physical, and 17.1 (21.0) for psychosocial. The mean PedsQL total improvement scores were lower for patients with medically complex conditions compared with patients without chronic conditions (13.7 [95% CI, 11.6-15.8] vs. 24.1 [95% CI, 22.4-25.7], P<.001). A 10-point decrement in the PedsQL total admission score below the established community-based mean was associated with an increase in risk for prolonged length of stay (15% [95% CI, 13%-17%]), 30-day readmissions (8% [95% CI, 3%-14%]), and ED return visits (13% [95% CI, 6%-20%]). A 5-point decrement in the PedsQL total improvement score below the study sample mean improvement score was associated with an increase in risk for 30-day readmissions or ED return visits (9% [95% CI, -1% to 19%]). CONCLUSIONS AND RELEVANCE: The PedsQL demonstrated responsiveness, construct validity, and predictive validity in hospitalized pediatric patients. The PedsQL may be a useful patient-reported outcome for hospital-based clinical effectiveness research.