Addressing the need for standardized assessments of asthma symptom severity
Published: December 07, 2021
One of the goals of asthma management is to reduce the frequency and severity of asthma symptoms. The experience of asthma symptom severity can only be known to patients themselves. Patient-reported outcome (PRO) measures (i.e., questionnaires) are therefore critical tools for use in clinical studies to evaluate the effectiveness of new treatments. However, the lack of standardized (i.e., consistent) PRO measures for use across clinical studies has been a hindrance to understanding and comparing patient responses to treatment. To fill this gap, two new PRO measures have been developed as part of a multi-stakeholder collaboration including representatives from numerous pharmaceutical firms, PRO measure development consultants, and clinical experts: the Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD).
In an original article in The Journal of Allergy and Clinical Immunology: In Practice, Gater et al. report findings from a study in which a demographically and clinically diverse sample of adults and adolescents (N=219) completed the ADSD and ASND for a period of 10 days alongside other PRO measures. Data collected from this study were used to evaluate the reliability and validity of the measures.
The study provided strong evidence for the reliability and validity of the ADSD and ANSD. Results demonstrated that all 6 items of the ADSD and ANSD assess related concepts. Consistency in scores (i.e., test-retest reliability) was also observed over time among participants reporting no change in the severity of their asthma symptoms. Exploration of relationships between ADSD/ANSD scores and scores from similar PRO measures, and of differences in ADSD/ANSD scores between groups of participants that differed according to various clinical characteristics, also supported the validity of the ADSD and ANSD. The ADSD and ANSD are currently being administered in several ongoing clinical trials investigating new treatments for asthma.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.