A new tool for inhalers' use and adherence monitoring: the Amiko® validation trial
Abstract
The lack of adherence to treatment and misuse of inhaled medication are hot topics in asthma and COPD management. Novel electronic monitoring devices are regarded as promising in assessing medication use. The aim of this study was the experimental performance evaluation of an electronic monitoring device (Amiko® ) on Ellipta® (GlaxoSmithKline), Spiromax® (Teva Pharmaceutical Industries), and NEXThaler® (Chiesi Farmaceutici). Amiko® introduces a clinically negligible inspiratory flow resistance when added to the tested DPI. It was able to detect the performed inhalation in more than 99% of cases providing also an estimate of the patient’s inspiratory effort with a limited gap across the different devices. All the loading manoeuvres were recorded correctly for each DPI, independently of the orientation of the device, resulting in an accuracy of 100.0%. Similarly, the tool was able to detect the device orientation during the performed inhalation with a mean absolute error inferior than 3.53° for the three DPIs. All the above reported results suggest that Amiko® technology will allow to identify, store and communicate relevant data for adherence improvement and misuse correction. Usability test, efficacy and effectiveness in improving respiratory disease management, need to be explored in clinical research setting and in real life.
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Introduction
Asthma and COPD are the most common chronic respiratory diseases and represent a great burden for both patients and society (1). In real life, the outcomes of their management are often far from the results obtained in clinical research (2, 3). The reasons could be found both in the substantial differences in comorbidities between patients in traditional RCTs and routine clinical practice, and in the lack of adherence or misuse of the prescribed long-term treatment (6, 7). Suboptimal usage of inhaled medication is one of the main factors responsible for failure to achieve treatment-related goals, and carries a significant economic burden as a result of health care service utilization and overall health care costs. In fact, poor medication-taking behaviour has been associated with an increased risk of hospital admission, increased mortality rate, reduced quality of life, and increased healthcare expenditures (8-10). Interventions to improve medication-taking behaviour, and hence both clinical and economic outcomes, depend upon reliable information about the real-life usage of inhaled medication, and require a genuine understanding of the determinants of suboptimal adherence and poor administration technique (11). Novel electronic monitoring devices are regarded as promising in assessing medication use because of their objectivity and their ability to provide detailed information about actual patterns of medication use in both research and real life settings (12-16). Such information can be helpful for better understanding the use and the effectiveness of an inhaled drug therapy, and for the development and assessment of interventions promoting adherence and correct inhaler technique (17,18). Amiko® (Amiko, Milan, Italy), is an accessory device intended for single-patient use to assist patients and healthcare professionals in recording and monitoring inhaler usage. The device has been developed as an add-on to existing inhalers without any need of intervention on the functionality of the inhaler itself. Amiko® combines sensor technology with proprietary machine learning algorithms to record events such as the inhaler dose loading and the inhalation maneuver, and to capture data about the patient’s inspiratory effort and the inhaler orientation during the inhalation. The device stores the data and wirelessly exchanges it with a paired smartphone or a PC. Amiko® is compatible with the associated software application, Quantified Medicine, which provides reports on adherence patterns and inhaler technique.
Conclusion
The current paper provides the experimental performance evaluation of Amiko® as an electronic monitoring device, using a range of currently available dry powder inhalers (Ellipta® , Spiromax® and Nexthaler® ). Amiko combines sensor technology with proprietary machine learning algorithms to record events or features of the dispenser or the dispensing, including inhaler dose loading, inhalation maneuver, estimation of the patient’s inspiratory effort and evaluation of the inhaler orientation during the inhalation. Amiko does not affect the inspiratory flow resistance. In fact, the flow resistance introduced by the monitor (Resistance with Amiko® – Resistance without Amiko® ) was found to be smaller of four orders of magnitude compared to the intrinsic resistance of the inhalers. So the difference in resistance with Amiko® can be considered clinically negligible. Amiko® was found to be over 99% accurate in detecting the performed inhalation. Furthermore, it provided an estimate of the patient’s inspiratory effort, recording the inhalation duration with a mean absolute error smaller than 180ms (0,18 s) and the PIF with a mean absolute error smaller than 8.16 L/Min. All the loading manoeuvres were recorded correctly for each DPI, independently of the orientation of the device, resulting in an accuracy of 100%. Similarly, the tool was able to detect the device orientation during the performed inhalation with a mean absolute error inferior than 3.53° for the three DPIs. All the above reported results suggest that Amiko® technology will allow to identify, store and communicate relevant data for adherence improvement and misuse correction. Usability test, efficacy and effectiveness in improving respiratory disease management, need to be explored in clinical research setting and in real life.