Expert Consensus on SABA Use for Asthma Clinical Decision-Making: A Delphi Approach.

PURPOSE OF REVIEW: A modified Delphi process was undertaken to provide a US expert-led consensus to guide clinical action on short-acting beta2-agonist (SABA) use. This comprised an online survey (Phase 1), forum discussion and statement development (Phase 2), and statement adjudication (Phase 3). RECENT FINDINGS: In Phase 1 (n = 100 clinicians), 12% routinely provided patients with ≥4 SABA prescriptions/year, 73% solicited SABA use frequency at every patient visit, and 21% did not consult asthma guidelines/expert reports. Phase 3 experts (n = 8) reached consensus (median Likert score, interquartile range) that use of ≥3 SABA canisters/year is associated with increased risk of exacerbation and asthma-related death (5, 4.75-5); SABA use history should be solicited at every patient visit (5, 4.75-5); usage patterns over time, not absolute thresholds, should guide response to SABA overuse (5, 4.5-5). Future asthma guidelines should include clear recommendations regarding SABA usage, using expert-led thresholds for action.

A Predictive Machine Learning Tool for Asthma Exacerbations: Results from a 12-Week, Open-Label Study Using an Electronic Multi-Dose Dry Powder Inhaler with Integrated Sensors.

Purpose: Machine learning models informed by sensor data inputs have the potential to provide individualized predictions of asthma deterioration. This study aimed to determine if data from an integrated digital inhaler could be used to develop a machine learning model capable of predicting impending exacerbations. Patients and Methods: Adult patients with poorly controlled asthma were enrolled in a 12-week, open-label study using ProAir® Digihaler®, an electronic multi-dose dry powder inhaler (eMDPI) with integrated sensors, as reliever medication (albuterol, 90 µg/dose; 1-2 inhalations every 4 hours, as needed). Throughout the study, the eMDPI recorded inhaler use, peak inspiratory flow (PIF), inhalation volume, inhalation duration, and time to PIF. A model predictive of impending exacerbations was generated by applying machine learning techniques to data downloaded from the inhalers, together with clinical and demographic information. The generated model was evaluated by receiver operating characteristic area under curve (ROC AUC) analysis. Results: Of 360 patients included in the predictive analysis, 64 experienced a total of 78 exacerbations. Increased albuterol use preceded exacerbations; the mean number of inhalations in the 24-hours preceding an exacerbation was 7.3 (standard deviation 17.3). The machine learning model, using gradient-boosting trees with data from the eMDPI and baseline patient characteristics, predicted an impending exacerbation over the following 5 days with an ROC AUC of 0.83 (95% confidence interval: 0.77-0.90). The feature of the model with the highest weight was the mean number of daily inhalations during the 4 days prior to the day the prediction was made. Conclusion: A machine learning model to predict impending asthma exacerbations using data from the eMDPI was successfully developed. This approach may support a shift from reactive care to proactive, preventative, and personalized management of chronic respiratory diseases.

Integrating digital inhalers into clinical care of patients with asthma and chronic obstructive pulmonary disease.

Modernizing inhaled medications through digital technology can help address persistent problems of non-adherence and poor inhaler technique in patients with obstructive lung diseases. With a growing body of supportive clinical studies, advances in digital inhaler sensors and platforms, greater support from payers and healthcare organizations, significant growth with these technologies is expected. While all digital (smart) inhalers record adherence, these are distinguished by their compatibility with commercial inhalers, capabilities to guide inhaler technique, use of patient-reported outcomes, and user-friendliness for both the healthcare professional (HCP) and patient. Due to the complexity and novelty of employing digital inhalers, collaboration with multiple entities within health systems is necessary and a well-planned integration is needed. For HCPs and patients, cybersecurity and privacy are critical, it will require review by each healthcare organization. In the US, some payers reimburse for remote monitoring using digital inhalers, but reimbursement is currently unavailable in other countries. There are several models for remote patient care, as employing an active, ongoing digital interface between the HCP and patient or they may choose to only review data at clinical encounters. Personalization of therapies and feedback are key to success. While digital inhaler malfunction uncommonly occurs, patient attrition over a year is significant. Some patients will be challenged to use digital platforms or have the necessary technology. Additional research is needed to address cost-effectiveness, in vivo accuracy of inspiratory measurement capable devices, ability to teach inhaler technique, their application for monitoring lung function, and lastly real-world adoption and implementation in routine clinical practice.

Digital Inhalers and Remote Patient Monitoring for Asthma.

Digital inhaler systems, remote patient monitoring, and remote therapeutic monitoring offer great promise as diagnostic tools and therapeutic interventions to improve adherence and inhaler technique for patients with difficult-to-control asthma. In turn, improvements in adherence and inhaler technique may translate into decreasing the need for high side effect treatments such as oral corticosteroids and costly therapies including biologics. Although more clinical trials are needed, studies that use digital inhaler systems to collect objective real-time data on medication-taking behavior via electronic medication monitors and feed this data back to patients on their mobile asthma app, and to health care professionals on the clinician dashboard to counsel patients, show positive outcomes. This article addresses the use of these diagnostic and therapeutic tools in asthma care, how to choose a digital inhaler system, how to teach patients to use the system, strategies for the adoption of these technologies in large health care systems as well as smaller practices, coding and reimbursement, liability concerns, and research gaps.

Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective.

Impressive advances in inhalation therapy for patients with asthma and chronic obstructive pulmonary disease (COPD) have occurred in recent years. However, important gaps in care remain, particularly relating to poor adherence to inhaled therapies. Digital inhaler health platforms which incorporate digital inhalers to monitor time and date of dosing are an effective disease and medication management tool, promoting collaborative care between clinicians and patients, and providing more in-depth understanding of actual inhaler use. With advances in technology, nearly all inhalers can be digitalized with add-on or embedded sensors to record and transmit data quantitating inhaler actuations, and some have additional capabilities to evaluate inhaler technique. In addition to providing an objective and readily available measure of adherence, they allow patients to interact with the device directly or through their self-management smartphone application such as via alerts and recording of health status. Clinicians can access these data remotely and during patient encounters, to better inform them about disease status and medication adherence and inhaler technique. The ability for remote patient monitoring is accelerating interest in and the use of these devices in clinical practice and research settings. More than 20 clinical studies of digital inhalers in asthma or COPD collectively show improvement in medication adherence, exacerbation risk, and patient outcomes with digital inhalers. These studies support previous findings about patient inhaler use and behaviors, but with greater granularity, and reveal some new findings about patient medication-taking behaviors. Digital devices that record inspiratory flows with inhaler use can guide proper inhaler technique and may prove to be a clinically useful lung function measure. Adoption of digital inhalers into practice is still early, and additional research is needed to determine patient and clinician acceptability, the appropriate place of these devices in the therapeutic regimen, and their cost effectiveness. Video: Digital Inhalers for Asthma or Chronic Obstructive Pulmonary Disease: A Scientific Perspective (MP4 74535 kb).

Digital Health Technology in Asthma: A Comprehensive Scoping Review.

BACKGROUND: A variety of digital intervention approaches have been investigated for asthma therapy during the past decade, with different levels of interactivity and personalization and a range of impacts on different outcome measurements. OBJECTIVE: To assess the effectiveness of digital interventions in asthma with regard to acceptability and outcomes and evaluate the potential of digital initiatives for monitoring or treating patients with asthma. METHODS: We evaluated digital interventions using a scoping review methodology through a literature search and review. Of 871 articles identified, 121 were evaluated to explore intervention characteristics, the perception and acceptability of digital interventions to patients and physicians, and effects on asthma outcomes. Interventions were categorized by their level of interactivity with the patient. RESULTS: Interventions featuring non-individualized content sent to patients appeared capable of promoting improved adherence to inhaled corticosteroids, but with no identified improvement in asthma burden; and data-gathering interventions appeared to have little effect on adherence or asthma burden. Evidence of improvement in both adherence and patients' impairment due to asthma were seen only with interactive interventions involving two-way responsive patient communication. Digital interventions were generally positively perceived by patients and physicians. Implementation was considered feasible, with certain preferences for design and features important to drive use. CONCLUSIONS: Digital health interventions show substantial promise for asthma disease monitoring and personalization of treatment. To be successful, future interventions will need to include both inhaler device and software elements, combining accurate measurement of clinical parameters with careful consideration of ease of use, personalization, and patient engagement aspects.

Geospatial-temporal analysis of the impact of ozone on asthma rescue inhaler use.

RATIONALE: Asthma is one of the most common chronic respiratory diseases in the United States. Several outdoor air pollutants have been associated with asthma morbidity. Previous studies of the effects of short-term air pollution exposure have been limited by potential exposure misclassification and limited spatial and temporal resolution of asthma outcome measures. OBJECTIVES: We aimed to assess the association of short-term air pollutant exposure with the use of short-acting beta-2 agonists (SABA) for asthma by monitoring the time and place of occurrence with electronic medication monitors. METHODS: In a cohort of adults and children with asthma (n = 287; 60% female), we deployed electronic medication monitors fitted to metered-dose inhalers to monitor SABA use, capturing the date, time and location of use. We assigned pollutant exposures based on each actuation's time and location (4-h mean measures for ozone and particulate matter of 2.5 µm or smaller (PM2.5)), assessed associations using generalized linear models and explored age-specific effects. MEASUREMENTS AND MAIN RESULTS: Ambient ozone exposure was positively associated with SABA use (p = 0.01). Age-specific associations were identified (interaction p = 0.01), with a larger increase in SABA use for children (11.3%; 95% CI: 7.0%-18.2%) than adults (8.4%; 95% CI: 6.4%-11.0%) per IQR increase of ozone (16.8 ppb). CONCLUSIONS: These findings support existing evidence that short-term exposure to ozone can cause morbidity in individuals with asthma, and suggest that ozone exposures below the current U.S. EPA standard may be associated with increased SABA use.

Impact of a digital health intervention on asthma resource utilization.

Digital health interventions have been associated with reduced rescue inhaler use and improved controller medication adherence. This quality improvement project assessed the benefit of these interventions on asthma-related healthcare utilizations, including hospitalizations, emergency department (ED) utilization and outpatient visits. The intervention consisted of electronic medication monitors (EMMs) that tracked rescue and controller inhaler medication use, and a digital health platform that presented medication use information and asthma control status to patients and providers. In 224 study patients, the number of asthma-related ED visits and combined ED and hospitalization events 365 days pre- to 365 days post-enrollment to the intervention significantly decreased from 11.6 to 5.4 visits (p < 0.05) and 13.4 to 5.8 events (p < 0.05) per 100 patient-years, respectively. This digital health intervention was successfully incorporated into routine clinical practice and was associated with lower rates of asthma-related hospitalizations and ED visits.

Digital Health Intervention for Asthma: Patient-Reported Value and Usability.

BACKGROUND: Although digital health tools are increasingly recognized as effective in improving clinical outcomes such as asthma control and medication adherence, few studies have assessed patient experiences and perception of value. OBJECTIVE: The aim of this study was to evaluate patient satisfaction, perception of usability and value, and desire to continue after 12 months of using a digital health intervention to support asthma management. METHODS: Participants were enrolled in a randomized controlled study evaluating the impact of a digital health platform for asthma management. Participants used electronic inhaler sensors to track medication use and accessed their information in a digital health platform. Electronic surveys were administered to intervention arm participants aged 12 years and older after 12 months of use. The survey assessed asthma control, patient satisfaction with the sensor device, and perception of the usability and value of the digital health platform through closed-ended and open-ended questions. Logistic regression models were used to assess the impact of participants' characteristics on survey completion, satisfaction, and perception of value. RESULTS: Of the 207 intervention arm participants aged 12 years and older, 89 submitted survey responses (42.9% response rate). Of these 89 participants, 70 reported being very satisfied (79%, 70/89) or somewhat satisfied (20%, 18/89) with the inhaler sensor device. Moreover, 93% (83/89) expressed satisfaction with the reports, and 90% (80/89) found the information from the reports useful for learning about their asthma. In addition, 72% (64/89) of the participants reported that they were interested in continuing to use the sensor and platform beyond the study. There were no significant differences in satisfaction with the device or the platform across participants' characteristics, including device type, age, sex, insurance type, asthma control, or syncing history; however, participants with smartphones and longer participation were more likely to take the survey. CONCLUSIONS: Electronic sensors and a digital health platform were well received by participants who reported satisfaction and perceived value. These results were consistent across multiple participants' characteristics. These findings can add to a limited literature to keep improving digital health interventions and ensure the meaningful and enduring impact on patient outcomes.

Effectiveness of Population Health Management Using the Propeller Health Asthma Platform: A Randomized Clinical Trial.

BACKGROUND: Telehealth strategies for asthma have focused primarily on adherence to controller medications. Telemonitoring of short-acting ß-agonist (SABA) focuses on patterns of use and may allow more timely action to avert exacerbations. Studies assessing this approach are lacking. OBJECTIVE: This pragmatic controlled study was designed to measure real-world effectiveness of the Propeller Health Asthma Platform to reduce use of SABA and improve asthma control. METHODS: A total of 495 patients were enrolled in parallel arms (1:1) for 12 months of monitoring SABA use. Intervention group (IG) patients received access to and feedback from the Propeller Health system. Routine care (RC) patients were outfitted with sensors but did not receive feedback. Physicians were able to monitor the status of their patients in the IG and receive proactive notifications. RESULTS: The daily mean number of SABA uses per person decreased by 0.41 for the IG and by 0.31 for RC between the first week and the remainder of the study period (P < .001 for the difference between groups). Similarly, the proportion of SABA-free days increased 21% for the IG and 17% for RC (P < .01 for the difference between groups). Asthma Control Test (ACT) scores were not significantly different between arms in the entire study population, but adults with initially uncontrolled ACT scores showed a significantly larger improvement in the proportion with controlled asthma in IG versus RC (63% controlled in the study period vs 49%, respectively; P < .05 comparing the 2 improvements). CONCLUSIONS: Compared with RC, the study arm monitoring SABA use with the Propeller Health system significantly decreased SABA use, increased SABA-free days, and improved ACT scores (the latter among adults initially lacking asthma control).