Abstract

BACKGROUND Digital inhalers can monitor and support adherence and inhalation technique. While essential for implementation of digital inhalers in daily clinical practice, real-world outcomes of asthma patients using digital inhalers are lacking.

OBJECTIVE To create a minimal variable set available in routine clinical care, to inform the development of the world?s first real-world data registry of asthma patients using digital inhalers.

METHODS A modified, 3-round Delphi method process was used to select core and optional variables to be included in AURORA. The Delphi Panel (N=15) included Dutch clinical asthma experts, researchers, regulators, payers, e-health experts and medication adherence experts. In the first two rounds, the Delphi panel members assessed, added or deleted variables using an electronic Delphi programme. Then, patients provided input. In the third round, consensus was reached about the final variable set during an online meeting. At least 66% consensus was needed to retain a variable.

RESULTS Out of the 92 round 1 variables, the final AURORA registry contains 18 core and 45 optional variables. Core variables included data on demographics (age, gender, smoking), asthma control (ACQ), medication used, digital inhaler type, medication adherence, inhaler technique, exacerbations and satisfaction.

CONCLUSION Using a Delphi process, a registry of asthma patients using digital inhalers was created to facilitate real-world research and implementation of digital inhalers in daily clinical practice. The AURORA registry can be used to standardize data collection in the Netherlands and elsewhere in the world.