Asthma is one of the most common chronic childhood medical condition and one that disproportionately affects children from lower socioeconomic and/or African American backgrounds. Asthma has widespread impact on patient's lives, and therefore evaluation of asthma interventions requires assessment of a variety of outcomes, many which are best obtained through patient or (parent) proxy report. However, there are no standard measures of patient reported outcomes (PROs) currently accepted for asthma research and care. The primary objective of this proposal is to address that gap by validating pediatric Patient Reported Outcome Meaurement Information System (PROMIS) measures in three well-characterized cohorts of children (ages 5- 17) with asthma (total N=645). We will demonstrate the validity, reliability and responsiveness of asthma- relevant pediatric PROs, including measures of asthma impact and common asthma-associated caregiver and child outcomes such as fatigue, depression, anxiety, pain interference, peer relationships, perceived stress, and global health. Our secondary objective is to determine whether the known stress-related changes in asthma severity and related health outcomes are measured by PROMIS tools. We will characterize how levels of perceived stress relate to children's asthma and related health outcomes, and evaluate the sensitivity of PROMIS measures to these known effects. We will accomplish these objectives by adding pediatric PROMIS measures to three existing asthma clinical trials: The Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) Trial (PCORI contract# AS 1307-05420; PI: Krishnan; AAD-PEPR Site PI: Kumar); The Asthma Symptom Based Adjustment of Inhaled Steroid Therapy In African American Children (ASIST; PI/AAD-PER Site PI: Sumino) and the School Inner-City Asthma intervention Study (NIAID U01 AI110397-01A1; SICAS-2; PI/AAD-PER Site PI: Phipatanakul). All of these trials are over-represented with minority or underserved children (the most vulnerable to asthma morbidity and stress-related adverse outcomes) and already collect clinical and physiological measures of asthma severity and control along with other PROs. This information will be used to validate pediatric PROMIS measures, examine their responsiveness to clinically significant change in disease status, estimate the minimally important differences for PROMIS measures, and evaluate whether perceived stress, as measured by PROMIS, is associated with altered asthma control and related health outcomes. These validated measures will be a valuable addition to pediatric asthma clinical and comparativeness effectiveness research and, ultimately, to clinical care.
|Phipatanakul, Wanda; Koutrakis, Petros; Coull, Brent A et al. (2017) The School Inner-City Asthma Intervention Study: Design, rationale, methods, and lessons learned. Contemp Clin Trials 60:14-23|