Abstract

<b>Background:</b> The use of electronic monitoring devices (EMDs) in asthma has the potential to transform recognition and management of inhaler non-adherence. To translate readily into clinical practice, EMDs need to be reliable and easy to use. Supportive laboratory-based validation data exists for a major brand of EMDs, but investigator-led pre-trial checks are still required. <b>Aims and Objectives:</b> To assess reliability of an EMD brand in a real-world study using published validation methodology. <b>Methods:</b> Each device was registered with a test ID on an online platform and synchronisation with two versions of the mobile phone application (app) was checked. For each app version, time was recorded to the nearest second for the following procedures: -Inhaler insertion -Two actuations approximately 20 seconds apart, followed by a gap of around 15 minutes -Two more actuations approximately 20 seconds apart -Inhaler removal Battery function was assessed manually and also via the online platform record. Connection via universal serial bus to a local platform was also assessed. <b>Results:</b> 34 devices were tested. Of these, 24 passed and 10 failed (four with minor and six with major problems). The results were relayed to the manufacturer who promptly conducted a firmware update and replaced one device. All devices were retested to the same protocol. This time, 27 passed and seven failed (one with minor and six with major problems). <b>Conclusion:</b> Whilst bench validation studies are encouraging, our experience highlights the importance of pre-use testing for EMDs. This has resource implications in the clinical setting, where data collected may be used to inform treatment decisions.

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