Meaningful Score Differences and Meaningful Score Regions of the Patient-Reported Outcomes Measurement Information System® Pediatric Asthma Impact Scale.

OBJECTIVES

To estimate meaningful score differences (MSDs) and meaningful score regions (MSRs) for the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric Asthma Impact Scale to enhance score interpretability.

METHODS

Secondary analysis included 106 children with asthma (8-17 years of age) who completed weekly surveys for 4 weeks. Repeated measures correlations examined the magnitude of association of the PROMIS Pediatric Asthma Impact Scale with other asthma measures. MSDs were calculated using mixed models with the Global Impact of Change (GIC) on Asthma and Health scores as anchors. MSRs were calculated using the receiver operating characteristics analysis with Self-Reported Asthma Symptom Rating (ASR), Global Initiative for Asthma (GINA) control criteria, and Asthma Control Test (ACT) or Childhood Asthma Control Test (cACT) as anchors.

RESULTS

Changes in PROMIS Pediatric Asthma Impact T-scores were correlated with GIC-Asthma (r = 0.45) and GIC-Health (r = 0.34). MSDs were 2.3 to 2.5 points for improvement and 3.5 to 3.6 points for deterioration. PROMIS Pediatric Asthma Impact T-scores were correlated with GINA (r = -0.22), ACT (r = -0.42), cACT (r = -0.41), and ASR (r = -0.47). The MSR cutoff T-scores for GINA were 38.7 and 49.2 between controlled, partly controlled, and uncontrolled asthma; for ACT/cACT, 45.6 between controlled and uncontrolled; and for ASR, 47.9, 50.1, and 55.8 between very good, good, a little good, and bad.

CONCLUSIONS

Following recommendations from the US Food and Drug Administration's patient-focused drug development guidance on clinical outcome assessments, estimated MSDs and MSRs aid the interpretation of scores and changes in scores observed in clinical research studies to reflect the meaningful impact of asthma on children.