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.
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.
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.
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.
What is it about? Pediatric asthma is a common chronic condition that affects many children worldwide, causing symptoms like coughing and shortness of breath. This condition impacts patients’ daily lives and can lead to hospital visits. The study focuses on how asthma’s impact on a child’s life is reflected in scores from the Patient-Reported Outcomes Measurement Information System® Pediatric Asthma Impact Scale. For example, if a child’s score is 55, is that good or bad? If the score changes to 52, is the change meaningful to the child? This study addresses such questions by determining which asthma impact scale scores reflect better or worse asthma control and symptoms, and what changes in scores are meaningful for children with asthma. This information will enhance the use of the scale in clinical care and research to improve decision making.
How was the research conducted? The study is based on a secondary analysis of data from 106 children aged 8 to 17 years with asthma, who answered weekly surveys about their asthma over 4 weeks. Researchers used an anchor-based method that compares the asthma impact scale scores with other established patient-, caregiver-, or clinician-reported measures of asthma control and symptoms that have clear score interpretation. This method helps to identify scores or differences that are truly meaningful and useful to patients and families.
What were the results? The study found that improvements in Pediatric Asthma Impact Scale scores were meaningful to patients when decreases (ie, reduced impact) were over 2.3 to 2.5 points, while worsening asthma impact was meaningful with a 3.5 to 3.6 point increase or more. Additionally, specific cutoff scores were identified to differentiate asthma control levels and how good or bad symptoms felt. A notable finding was that it takes a larger change in scores to notice worsening asthma impact than improvement, suggesting different patient experiences.
Why are the results important? These results offer a clearer way to interpret asthma impact scale scores, which can help in real-life asthma management. Healthcare providers can better monitor asthma control and make informed treatment decisions using these guidelines. Children and families benefit by having a more understandable way to track asthma progress and communicate with healthcare providers. In the long term, these findings could help identify effective treatments and improve asthma management and quality of life for children with asthma.
What are the strengths and weaknesses of this study? A key strength is the study’s diverse sample and rigorous methods, which provide reliable results for interpreting asthma impact scale scores. The main limitation is the relatively small sample size, which may not fully capture the experiences of children with severe asthma. Future research could expand on these findings by including larger and more diverse samples.
This study contributes significantly by offering tools for interpreting the scale scores and better understanding the life impact of asthma. The study approach aligns with the US Food and Drug Administration’s guidance on patient-focused drug development, and it can serve as an example for improving the interpretation of health measures.
Note: This content was created with assistance from artificial intelligence (AI) and has been reviewed and edited by ISPOR staff. For more information or for inquiries on ISPOR’s AI policy, click here or contact us at info@ispor.org.