Asthma Awareness Questionnaire: Development, Psychometric Validation, and Extent

INTRODUCTION: Patient awareness extends beyond factual knowledge, encompassing emotional and cognitive engagement with the disease. As in other chronic diseases, it plays a critical role in asthma management. A comprehensive, validated tool for assessing this multifaceted construct in patients with asthma has been lacking. This study aimed to develop and validate the Asthma Awareness Questionnaire (AAQ) within the framework of the Mild/Moderate Asthma Network of Italy (MANI) study, a real-world, prospective, longitudinal cohort study involving adults diagnosed with mild-to-moderate asthma according to Global Initiative for Asthma (GINA) 2020 criteria. METHODS: The questionnaire was developed through a Delphi process involving clinicians and patients. Psychometric properties (scale dimensions, internal validity, construct validity, and reliability) were explored, as well as the total and domain level of awareness. RESULTS: Starting from an initial list of 39 items, the Delphi process led to a provisional 22-item version. A total of 149 participants completed the AAQ at baseline and 6-month follow-up visit. Exploratory and confirmatory factor analyses supported a three-factor structure-agency, knowledge, and acceptance-with the exclusion of four items. Internal consistency (Cronbach's α = 0.78), construct validity (assessed through correlations with established patient-reported outcome measures), and test-retest reliability (ICC = 0.723) were assessed. Awareness levels were suboptimal overall (mean total score ≈ 60/100), with knowledge scores nearing the 80/100 threshold, while agency and acceptance lagged. CONCLUSION: The AAQ is a psychometrically sound instrument that captures the multidimensional nature of asthma awareness. Its use may guide future interventions aimed at improving patient self-management. Further validation in broader clinical settings is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT12345678.