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

npj Primary Care Respiratory Medicine

Abstract

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.

Authors 13

1. Mechteld B. R. Wiertz

   University Medical Center Groningen · University of Groningen · Isala

   Affiliation as printed

   Isala Medical Centre, Department of Pulmonology, Zwolle, The Netherlands

   University of Groningen, University Medical Centre Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, The Netherlands

2. Amber A. Eikholt

   University Medical Center Groningen · University of Groningen

   Affiliation as printed

   Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands

   University of Groningen, University Medical Centre Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, The Netherlands

3. Anneke Ten Brinke

   Frisius MC

   Affiliation as printed

   Frisius Medical Centre, Department of Pulmonology, Leeuwarden, The Netherlands

4. Els J.M. Weersink

   Amsterdam University Medical Centers

   Affiliation as printed

   Amsterdam University Medical Centre, Department of Pulmonology, Amsterdam, the Netherlands

5. Irene Van Weerdt
   Affiliation as printed

   COPD and asthma general practitioners advise group (CAHAG), Utrecht, the Netherlands

6. Johannes C.C.M. in ’t Veen

   Erasmus MC · Sint Franciscus Gasthuis

   Affiliation as printed

   Erasmus MC, Department of Pulmonology, Rotterdam, the Netherlands

   Franciscus Hospital, Centre of Excellence for Asthma and COPD, Rotterdam, the Netherlands

7. Kornelis Wiebe Patberg

   Isala

   Affiliation as printed

   Isala Medical Centre, Department of Pulmonology, Zwolle, The Netherlands

8. Martijn Goosens

   Gelre Hospitals

   Affiliation as printed

   Gelre Hospital, Department of Pulmonology, Apeldoorn, the Netherlands

9. Niels Henrik Chavannes Aachen Department of Public Health and Primary Care Medicine National eHealth Living Lab

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Leiden University Medical Centre, Department of Public Health and Primary Care Medicine, National eHealth Living Lab, Leiden, the Netherlands

10. Sandra Been-Buck

    Martini Ziekenhuis

    Affiliation as printed

    Department of Pulmonology, Martini Hospital, Groningen, the Netherlands

11. Titia Klemmeier

    Martini Ziekenhuis

    Affiliation as printed

    Department of Pulmonology, Martini Hospital, Groningen, the Netherlands

12. Huib A.M. Kerstjens

    University Medical Center Groningen · University of Groningen

    Affiliation as printed

    Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands

    University of Groningen, University Medical Center Groningen, Department of Pulmonology and Tuberculosis, Groningen, the Netherlands

13. Job F. M. van Boven corresponding

    University Medical Center Groningen · University of Groningen

    Affiliation as printed

    Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands. j.f.m.van.boven@umcg.nl

    Medication Adherence Expertise Centre of the northern Netherlands (MAECON), Groningen, The Netherlands. j.f.m.van.boven@umcg.nl

    University of Groningen, University Medical Centre Groningen, Department of Clinical Pharmacy & Pharmacology, Groningen, The Netherlands. j.f.m.van.boven@umcg.nl