Asthma is the most common chronic disease in children. To date, there is no asthma symptom diary suitable for use in pediatric clinical trials of asthma therapy to support labeling claims in children. This study was to characterize the symptom experiences in children with asthma and their parents/caregivers (parents), to elicit concepts and language surrounding children’s asthma experiences directly from children (ages 4-11 years) and parents, to understand the age at which children can comprehend and report asthma symptoms.
Concept elicitation interviews were conducted, consistent with the FDA Guidance for Industry on Patient-Reported Outcomes. Child and parental perceptions of the asthma symptom experiences were elicited from child-parent dyads. Data from interviews were analyzed, using a content analysis approach with ATLAS.ti qualitative data analysis software.
A total of 27 child-parent dyads from sites in the US were interviewed. Children and parents were generally consistent in their reporting of daytime asthma symptoms; including coughing, wheezing, chest tightness/discomfort, and shortness of breath. Both children and parents reported that these symptoms may also occur at night and lead to nighttime awakenings. Children were more aware of chest tightness and discomfort; parents were more aware of wheezing, which may be easier to detect by an observer. Younger children were less able to accurately describe their symptoms over longer timeframes/recall periods than older children. Children and their parents described symptom severity in terms of intensity and frequency. Results supported a daily recall of symptoms as most appropriate.
The qualitative data support the development of an observer asthma symptom diary for parents of children 4 years and older with a daily recall period. In addition, children 8 years of age and older may also be able to accurately report their symptoms on a daily basis.
© 2014 Published by Elsevier Inc.