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

Fasting parameters for estimation of stimulated beta cell function in islet transplant recipients with or without basal insulin treatment

In order to assess beta cell secretory capacity after islet transplantation, standardized mixed meal stimulation tests are often used. But these tests are cumbersome and the effect of exogenous insulin on the test results is unclear. The aim of our study was to determine to what extent fasting glycemic indices can estimate stimulated beta cell function in islet transplant recipients with and without basal insulin. In total 100 mixed meal stimulation tests, including 31 with concurrent basal insulin treatment, were performed in 36 islet transplant recipients. In a multivariate model, fasting C-peptide and fasting glucose together estimated peak C-peptide withR(2) = .87 and area under the curve (AUC) C-peptide with aR(2) = .93. There was a larger increase of glucose during tests in which exogenous insulin was used (+7.9 vs +5.3 mmol/L,P < .001) and exogenous insulin use was associated with a slightly lower estimated peak C-peptide (relative change: -15%,P = .02). In islet transplant recipients the combination of fasting C-peptide and glucose can be used to accurately estimate stimulated beta cell function after a mixed meal stimulation test, whether exogenous basal insulin is present or not. These data indicate that graft function can be reliably determined during exogenous insulin treatment and that regular islet graft stimulation tests can be minimized.Analysis and support of clinical decision makin

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

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.

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

Patients' and Health Care Providers' Perceptions on mHealth Use After High-Altitude Climate Therapy for Severe Asthma: Mixed Methods Study

Background: Asthma is a common chronic disease with various clinical presentations. Although most patients are able to reach good asthma control, some patients are not able to reach sufficient asthma control following the regular treatment guidelines and could be referred to high-altitude climate therapy (HACT). HACT includes environmental trigger avoidance in the alpine climate with multidisciplinary clinical treatment. Patients with severe and difficult-to-control asthma, who are unable to reach asthma control at sea level, can follow a 12-week lung rehabilitation program at 1600 m above sea level. Mobile health (mHealth) tools can be used to enhance self-management in these patients when they return home. For an mHealth system to be effective, it must meet the expectations of the end users. Objective: In this Davos@home study, we explored the attitudes toward mHealth aimed at supporting the self-management of patients with severe, difficult-to-control asthma who underwent HACT and asthma health care providers. Methods: In the first stage, interviews with referrers to HACT and focus groups with patients with asthma who participated in or completed HACT were conducted. The data were then analyzed thematically. On the basis of these results, a questionnaire was developed. In the second stage of the study, this questionnaire, combined with the Asthma Control Questionnaire and the Individual Innovativeness Questionnaire, was provided to patients who completed HACT. Results: In total, 11 interviews and 3 focus groups (n=18, age 47.6, SD 12.1 years, Asthma Control Questionnaire score 2.6, SD 1.0) were conducted. A total of 3 themes were identified: potential goals, useful measurements, and perceived barriers and facilitators. The questionnaire developed in stage 2 included items based on these results. The most agreed-upon goal among the 52 patients who completed the questionnaire was to increase their asthma control (45/52, 86% of the patients). Conclusions: Different patients reported that they would benefit the most from different functionalities. Therefore, it is important to tailor functionalities to individual (treatment) goals. When developing an mHealth intervention, it is important to allow personalization to avoid overwhelming the users

Objective cough frequency, airway inflammation, and disease control in asthma

Background Cough is recognized as an important troublesome symptom in the diagnosis and monitoring of asthma. Asthma control is thought to be determined by the degree of airway inflammation and hyperresponsiveness but how these factors relate to cough frequency is unclear. The goal of this study was to investigate the relationships between objective cough frequency, disease control, airflow obstruction, and airway inflammation in asthma. Methods Participants with asthma underwent 24-h ambulatory cough monitoring and assessment of exhaled nitric oxide, spirometry, methacholine challenge, and sputum induction (cell counts and inflammatory mediator levels). Asthma control was assessed by using the Global Initiative for Asthma (GINA) classification and the Asthma Control Questionnaire (ACQ). The number of cough sounds was manually counted and expressed as coughs per hour (c/h). Results Eighty-nine subjects with asthma (mean ± SD age, 57 ± 12 years; 57% female) were recruited. According to GINA criteria, 18 (20.2%) patients were classified as controlled, 39 (43.8%) partly controlled, and 32 (36%) uncontrolled; the median ACQ score was 1 (range, 0.0-4.4). The 6-item ACQ correlated with 24-h cough frequency (r = 0.40; P &#60; .001), and patients with uncontrolled asthma (per GINA criteria) had higher median 24-h cough frequency (4.2 c/h; range, 0.3-27.6) compared with partially controlled asthma (1.8 c/h; range, 0.2-25.3; P = .01) and controlled asthma (1.7 c/h; range, 0.3-6.7; P = .002). Measures of airway inflammation were not significantly different between GINA categories and were not correlated with ACQ. In multivariate analyses, increasing cough frequency and worsening FEV1 independently predicted measures of asthma control. Conclusions Ambulatory cough frequency monitoring provides an objective assessment of asthma symptoms that correlates with standard measures of asthma control but not airflow obstruction or airway inflammation. Moreover, cough frequency and airflow obstruction represent independent dimensions of asthma control

Automatic polyp detection using microwave endoscopy for colorectal cancer prevention and early detection: phantom validation

A system to integrate microwave imaging with optical colonoscopy is presented. The overarching goal is to improve the prevention and early diagnosis of one of the main health and economic burdens of an increasingly aging population, i.e., colorectal cancer. For a colonoscopy, the gold standard for colorectal cancer diagnosis, 22% of polyps are not detected, and the risk of cancer after a negative colonoscopy can be up to 7.9%. To remedy this, a microwave imaging system able to generate an alarm when a polyp is detected is designed, manufactured and validated with a colon phantom composed of tissue-mimicking oil-gelatin materials reproducing the anatomy and dielectric properties of a human colon with a polyp. The acquisition was performed by a miniaturized ring-shaped switched array of 16 antennas attachable at the tip of a conventional colonoscope. This has been conceived to satisfy endoscopy size restrictions, patient safety and intercompatibility with current clinical practice. A Modified Monofocusing imaging method preceded by a previous frame average subtraction as a calibration technique shows a perfect detection of a 10-mm polyp (100% sensitivity and specificity) in the eight analyzed trajectories. The phantom results demonstrate the feasibility of the system in future preclinical trials.The work of Alejandra Garrido was supported by DIN2019-010857. The work of Roberto Sont, Ignasi Belda, and Marta Guardiola was supported in part by the European Union’s Horizon 2020 Research and Innovation Programme under Grant 960251 and in part by the European Institute of Innovation and Technology (EIT). The work of Jordi Romeu was supported by PID2019-107885GB-C31/AEI/10.13039/501100011033.Peer ReviewedPostprint (published version

Cost-Effectiveness of Internet-Based Self-Management Compared with Usual Care in Asthma

BACKGROUND: Effectiveness of Internet-based self-management in patients with asthma has been shown, but its cost-effectiveness is unknown. We conducted a cost-effectiveness analysis of Internet-based asthma self-management compared with usual care. METHODOLOGY AND PRINCIPAL FINDINGS: Cost-effectiveness analysis alongside a randomized controlled trial, with 12 months follow-up. Patients were aged 18 to 50 year and had physician diagnosed asthma. The Internet-based self-management program involved weekly on-line monitoring of asthma control with self-treatment advice, remote Web communications, and Internet-based information. We determined quality adjusted life years (QALYs) as measured by the EuroQol-5D and costs for health care use and absenteeism. We performed a detailed cost price analysis for the primary intervention. QALYs did not statistically significantly differ between the Internet group and usual care: difference 0.024 (95% CI, -0.016 to 0.065). Costs of the Internet-based intervention were $254 (95$243 to $265) during the period of 1 year. From a societal perspective, the cost difference was$641 (95% CI, $-1957 to$3240). From a health care perspective, the cost difference was $37 (95$-874 to $950). At a willingness-to-pay of$50,000 per QALY, the probability that Internet-based self-management was cost-effective compared to usual care was 62% and 82% from a societal and health care perspective, respectively. CONCLUSIONS: Internet-based self-management of asthma can be as effective as current asthma care and costs are similar. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79864465