Digital inhaler data in routine asthma care: defining a minimal dataset for clinical decision support (AURORA): a...

Digital inhalers can assess and support medication adherence and inhalation technique and may predict exacerbations, yet real-world evidence on their use, implementation, and clinical impact remains limited. To date, no standardized registry exists to systematically capture digital inhaler use across the full spectrum of asthma severity. To reach an expert consensus on a minimal and feasible dataset for a registry (AURORA) of asthma patients using digital inhalers. A three-round modified Delphi process was conducted involving 15 Dutch experts in asthma care, medication adherence, digital health, regulatory science, and healthcare policy. In Rounds 1 and 2, candidate variables were evaluated via an online Delphi platform, with predefined consensus thresholds for inclusion and exclusion. Patient perspectives were incorporated through structured interviews. Final consensus was achieved during an online meeting in Round 3 (≥66% agreement required). Of 92 variables considered, 18 were classified as core and 45 as optional. Core variables covered key domains, including patient demographics, asthma control, medication type, digital inhaler characteristics, medication adherence, inhaler technique, and patient satisfaction. Optional variables provide flexibility to support implementation across different healthcare settings. This modified Delphi study established a consensus-based national registry framework specifically focused on digital inhaler use in asthma. The AURORA registry provides a standardized and feasible foundation for generating real-world evidence to support future research, personalized treatment decisions, and the optimization of escalation strategies in routine asthma care.