MyAirCoach: The use of home-monitoring and mHealth systems to predict deterioration in asthma control and the occurrence of asthma exacerbations; Study protocol of an observational study

© Published by the BMJ Publishing Group Limited. Introduction Asthma is a variable lung condition whereby patients experience periods of controlled and uncontrolled asthma symptoms. Patients who experience prolonged periods of uncontrolled asthma have a higher incidence of exacerbations and increased morbidity and mortality rates. The ability to determine and to predict levels of asthma control and the occurrence of exacerbations is crucial in asthma management. Therefore, we aimed to determine to what extent physiological, behavioural and environmental data, obtained by mobile healthcare (mHealth) and home-monitoring sensors, as well as patient characteristics, can be used to predict episodes of uncontrolled asthma and the onset of asthma exacerbations. Methods and analysis In an 1-year observational study, patients will be provided with mHealth and home-monitoring systems to record daily measurements for the first-month (phase I) and weekly measurements during a follow-up period of 11 months (phase II). Our study population consists of 150 patients, aged ≥18 years, with a clinician's diagnosis of asthma, currently on controller medication, with uncontrolled asthma and/or minimally one exacerbation in the past 12 months. They will be enrolled over three participating centres, including Leiden, London and Manchester. Our main outcomes are the association between physiological, behavioural and environmental data and (1) the loss of asthma control and (2) the occurrence of asthma exacerbations. Ethics This study was approved by the Medical Ethics Committee of the Leiden University Medical Center in the Netherlands and by the NHS ethics service in the UK. Trial registration number NCT02774772

Domiciliary fractional exhaled nitric oxide and spirometry in monitoring asthma control and exacerbations

Background: Domiciliary measurements of airflow obstruction and inflammation may assist healthcare teams and patients in determining asthma control and facilitate self-management. Objective: To evaluate parameters derived from domiciliary spirometry and fractional exhaled nitric oxide (FENO) in monitoring asthma exacerbations and control. Methods: Patients with asthma were provided with hand-held spirometry and FENO devices in addition to their usual asthma care. Patients were instructed to perform twice-daily measurements for 1 month. Daily symptoms and medication change were reported through a mobile health system. The Asthma Control Questionnaire was completed at the end of the monitoring period. Results: One hundred patients had spirometry, of which 60 were given additional FENO devices. Compliance rates for twice-daily measurements were poor (median [interquartile range], 43% [25%-62%] for spirometry; 30% [3%-48%] for FENO); at least 15% of patients took little or no spirometry measurements and 40% rarely measured FENO. The coefficient of variation (CV) values in FEV1 and FENO were higher, and the mean % personal best FEV1 lower in those who had major exacerbations compared with those without (P < .05). FENO CV and FEV1 CV were associated with asthma exacerbation during the monitoring period (area under the receiver-operating characteristic curve, 0.79 and 0.74, respectively). Higher FENO CV also predicted poorer asthma control (area under the receiver-operating characteristic curve, 0.71) at the end of the monitoring period. Conclusions: Compliance with domiciliary spirometry and FENO varied widely among patients even in the setting of a research study. However, despite significant missing data, FENO and FEV1 were associated with asthma exacerbations and control, making these measurements potentially clinically valuable if used

SERIES:eHealth in primary care. Part 4: Addressing the challenges of implementation

Background The implementation of eHealth applications in primary care remains challenging. Enhancing knowledge and awareness of implementation determinants is critical to build evidence-based implementation strategies and optimise uptake and sustainability. Objectives We consider how evidence-based implementation strategies can be built to support eHealth implementation. Discussion What implementation strategies to consider depends on (potential) barriers and facilitators to eHealth implementation in a given situation. Therefore, we first discuss key barriers and facilitators following the five domains of the Consolidated Framework for Implementation Research (CFIR). Cost is identified as a critical barrier to eHealth implementation. Privacy, security problems, and a lack of recognised standards for eHealth applications also hinder implementation. Engagement of key stakeholders in the implementation process, planning the implementation of the intervention, and the availability of training and support are important facilitators. To support care professionals and researchers, we provide a stepwise approach to develop and apply evidence-based implementation strategies for eHealth in primary care. It includes the following steps: (1) specify the eHealth application, (2) define problem, (3) specify desired implementation behaviour, and (4) choose and (5) evaluate the implementation strategy. To improve the fit of the implementation strategy with the setting, the stepwise approach considers the phase of the implementation process and the specific context. Conclusion Applying an approach, as provided here, may help to improve the implementation of eHealth applications in primary care.Prevention, Population and Disease management (PrePoD)Public Health and primary car

Asthma control cost-utility randomized trial evaluation (ACCURATE): the goals of asthma treatment

Contains fulltext : 97659.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination) therapy should be used for long periods in an attempt to achieve complete control of all features of asthma. An additional question is whether patients and society value the potential incremental benefit, if any, sufficiently to concur with such a treatment approach. We assessed patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical control: 1. sufficiently controlled asthma 2. strictly controlled asthma 3. strictly controlled asthma based on exhaled nitric oxide as an additional disease marker DESIGN: 720 Patients with mild to moderate persistent asthma from general practices with a practice nurse, age 18-50 yr, daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year), will be identified via patient registries of general practices in the Leiden, Nijmegen, and Amsterdam areas in The Netherlands. The design is a 12-month cluster-randomised parallel trial with 40 general practices in each of the three arms. The patients will visit the general practice at baseline, 3, 6, 9, and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an internet-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months and at each unplanned visit. Differences in societal costs (medication, other (health) care and productivity) will be compared to differences in the number of limited activity days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS). This is the first study to assess patient preferences and cost-effectiveness of asthma treatment strategies driven by different target levels of asthma control. Trial registration: Netherlands Trial Registration NTR1756

Long-term cost-effectiveness of digital inhaler adherence technologies in difficult-to-treat asthma

BACKGROUND: Digital inhalers can monitor inhaler usage, support difficult-to-treat asthma management and inform step-up treatment decisions yet their economic value is unknown, hampering wide-scale implementation.OBJECTIVE: We aimed to assess the long-term cost-effectiveness of digital inhaler-based medication adherence management in difficult-to-treat asthma.METHODS: A model-based cost-utility analysis was performed. The Markov model structure was determined by biological and clinical understanding of asthma and was further informed by guideline-based assessment of model development. Internal and external validation was performed using the AdViSHE tool. The INCA Sun randomized clinical trial data were incorporated into the model to evaluate the cost-effectiveness of digital inhalers. Several long-term clinical case scenarios were assessed (reduced number of exacerbations, increased asthma control, introduction of biosimilars [25% price-cut on biologics]).RESULTS: The long-term modelled cost-effectiveness based on a societal perspective indicated 1-year per-patient costs for digital inhalers and usual care (i.e., regular inhalers) of €7,546 and €10,752, respectively, reflecting cost savings of €3,207 for digital inhalers. Using a 10-year intervention duration and time horizon resulted incost savings of €26,309 for digital inhalers. In the first year, add-on biologic therapies accounted for 69% of the total costs in the usual care group, and for 49% in the digital inhaler group. Scenario analyses indicated consistent cost savings ranging from €2,287 (introduction biosimilars) to €4,581 (increased control, decreased exacerbations).CONCLUSION: In patients with difficult-to-treat asthma, digital inhaler based interventions can be cost-saving on the long-term by optimizing medication adherence and inhaler technique and reducing add-on biologic prescriptions.</p

Long-term cost-effectiveness of digital inhaler adherence technologies in difficult-to-treat asthma

BACKGROUND: Digital inhalers can monitor inhaler usage, support difficult-to-treat asthma management and inform step-up treatment decisions yet their economic value is unknown, hampering wide-scale implementation.OBJECTIVE: We aimed to assess the long-term cost-effectiveness of digital inhaler-based medication adherence management in difficult-to-treat asthma.METHODS: A model-based cost-utility analysis was performed. The Markov model structure was determined by biological and clinical understanding of asthma and was further informed by guideline-based assessment of model development. Internal and external validation was performed using the AdViSHE tool. The INCA Sun randomized clinical trial data were incorporated into the model to evaluate the cost-effectiveness of digital inhalers. Several long-term clinical case scenarios were assessed (reduced number of exacerbations, increased asthma control, introduction of biosimilars [25% price-cut on biologics]).RESULTS: The long-term modelled cost-effectiveness based on a societal perspective indicated 1-year per-patient costs for digital inhalers and usual care (i.e., regular inhalers) of €7,546 and €10,752, respectively, reflecting cost savings of €3,207 for digital inhalers. Using a 10-year intervention duration and time horizon resulted incost savings of €26,309 for digital inhalers. In the first year, add-on biologic therapies accounted for 69% of the total costs in the usual care group, and for 49% in the digital inhaler group. Scenario analyses indicated consistent cost savings ranging from €2,287 (introduction biosimilars) to €4,581 (increased control, decreased exacerbations).CONCLUSION: In patients with difficult-to-treat asthma, digital inhaler based interventions can be cost-saving on the long-term by optimizing medication adherence and inhaler technique and reducing add-on biologic prescriptions.</p

Long-term cost-effectiveness of digital inhaler adherence technologies in difficult-to-treat asthma

BACKGROUND: Digital inhalers can monitor inhaler usage, support difficult-to-treat asthma management and inform step-up treatment decisions yet their economic value is unknown, hampering wide-scale implementation.OBJECTIVE: We aimed to assess the long-term cost-effectiveness of digital inhaler-based medication adherence management in difficult-to-treat asthma.METHODS: A model-based cost-utility analysis was performed. The Markov model structure was determined by biological and clinical understanding of asthma and was further informed by guideline-based assessment of model development. Internal and external validation was performed using the AdViSHE tool. The INCA Sun randomized clinical trial data were incorporated into the model to evaluate the cost-effectiveness of digital inhalers. Several long-term clinical case scenarios were assessed (reduced number of exacerbations, increased asthma control, introduction of biosimilars [25% price-cut on biologics]).RESULTS: The long-term modelled cost-effectiveness based on a societal perspective indicated 1-year per-patient costs for digital inhalers and usual care (i.e., regular inhalers) of €7,546 and €10,752, respectively, reflecting cost savings of €3,207 for digital inhalers. Using a 10-year intervention duration and time horizon resulted incost savings of €26,309 for digital inhalers. In the first year, add-on biologic therapies accounted for 69% of the total costs in the usual care group, and for 49% in the digital inhaler group. Scenario analyses indicated consistent cost savings ranging from €2,287 (introduction biosimilars) to €4,581 (increased control, decreased exacerbations).CONCLUSION: In patients with difficult-to-treat asthma, digital inhaler based interventions can be cost-saving on the long-term by optimizing medication adherence and inhaler technique and reducing add-on biologic prescriptions.</p

Long-term cost-effectiveness of digital inhaler adherence technologies in difficult-to-treat asthma

BACKGROUND: Digital inhalers can monitor inhaler usage, support difficult-to-treat asthma management and inform step-up treatment decisions yet their economic value is unknown, hampering wide-scale implementation.OBJECTIVE: We aimed to assess the long-term cost-effectiveness of digital inhaler-based medication adherence management in difficult-to-treat asthma.METHODS: A model-based cost-utility analysis was performed. The Markov model structure was determined by biological and clinical understanding of asthma and was further informed by guideline-based assessment of model development. Internal and external validation was performed using the AdViSHE tool. The INCA Sun randomized clinical trial data were incorporated into the model to evaluate the cost-effectiveness of digital inhalers. Several long-term clinical case scenarios were assessed (reduced number of exacerbations, increased asthma control, introduction of biosimilars [25% price-cut on biologics]).RESULTS: The long-term modelled cost-effectiveness based on a societal perspective indicated 1-year per-patient costs for digital inhalers and usual care (i.e., regular inhalers) of €7,546 and €10,752, respectively, reflecting cost savings of €3,207 for digital inhalers. Using a 10-year intervention duration and time horizon resulted incost savings of €26,309 for digital inhalers. In the first year, add-on biologic therapies accounted for 69% of the total costs in the usual care group, and for 49% in the digital inhaler group. Scenario analyses indicated consistent cost savings ranging from €2,287 (introduction biosimilars) to €4,581 (increased control, decreased exacerbations).CONCLUSION: In patients with difficult-to-treat asthma, digital inhaler based interventions can be cost-saving on the long-term by optimizing medication adherence and inhaler technique and reducing add-on biologic prescriptions.</p

Long-term cost-effectiveness of digital inhaler adherence technologies in difficult-to-treat asthma

BACKGROUND: Digital inhalers can monitor inhaler usage, support difficult-to-treat asthma management and inform step-up treatment decisions yet their economic value is unknown, hampering wide-scale implementation.OBJECTIVE: We aimed to assess the long-term cost-effectiveness of digital inhaler-based medication adherence management in difficult-to-treat asthma.METHODS: A model-based cost-utility analysis was performed. The Markov model structure was determined by biological and clinical understanding of asthma and was further informed by guideline-based assessment of model development. Internal and external validation was performed using the AdViSHE tool. The INCA Sun randomized clinical trial data were incorporated into the model to evaluate the cost-effectiveness of digital inhalers. Several long-term clinical case scenarios were assessed (reduced number of exacerbations, increased asthma control, introduction of biosimilars [25% price-cut on biologics]).RESULTS: The long-term modelled cost-effectiveness based on a societal perspective indicated 1-year per-patient costs for digital inhalers and usual care (i.e., regular inhalers) of €7,546 and €10,752, respectively, reflecting cost savings of €3,207 for digital inhalers. Using a 10-year intervention duration and time horizon resulted incost savings of €26,309 for digital inhalers. In the first year, add-on biologic therapies accounted for 69% of the total costs in the usual care group, and for 49% in the digital inhaler group. Scenario analyses indicated consistent cost savings ranging from €2,287 (introduction biosimilars) to €4,581 (increased control, decreased exacerbations).CONCLUSION: In patients with difficult-to-treat asthma, digital inhaler based interventions can be cost-saving on the long-term by optimizing medication adherence and inhaler technique and reducing add-on biologic prescriptions.</p

Long-term cost-effectiveness of digital inhaler adherence technologies in difficult-to-treat asthma

BACKGROUND: Digital inhalers can monitor inhaler usage, support difficult-to-treat asthma management and inform step-up treatment decisions yet their economic value is unknown, hampering wide-scale implementation.OBJECTIVE: We aimed to assess the long-term cost-effectiveness of digital inhaler-based medication adherence management in difficult-to-treat asthma.METHODS: A model-based cost-utility analysis was performed. The Markov model structure was determined by biological and clinical understanding of asthma and was further informed by guideline-based assessment of model development. Internal and external validation was performed using the AdViSHE tool. The INCA Sun randomized clinical trial data were incorporated into the model to evaluate the cost-effectiveness of digital inhalers. Several long-term clinical case scenarios were assessed (reduced number of exacerbations, increased asthma control, introduction of biosimilars [25% price-cut on biologics]).RESULTS: The long-term modelled cost-effectiveness based on a societal perspective indicated 1-year per-patient costs for digital inhalers and usual care (i.e., regular inhalers) of €7,546 and €10,752, respectively, reflecting cost savings of €3,207 for digital inhalers. Using a 10-year intervention duration and time horizon resulted incost savings of €26,309 for digital inhalers. In the first year, add-on biologic therapies accounted for 69% of the total costs in the usual care group, and for 49% in the digital inhaler group. Scenario analyses indicated consistent cost savings ranging from €2,287 (introduction biosimilars) to €4,581 (increased control, decreased exacerbations).CONCLUSION: In patients with difficult-to-treat asthma, digital inhaler based interventions can be cost-saving on the long-term by optimizing medication adherence and inhaler technique and reducing add-on biologic prescriptions.</p