Asthma and Allergy Mobile Apps in 2018

Selecting an appropriate mHealth app depends upon who you are and what features one is seeking, as well as the app’s quality, price, and services. But every patient, physician, nurse, clinic administrator, insurer, payer, employer, and regulator has their own interests and points of view (Fig. 1). Beauty, like truth, exists in the mind of the beholder.

Surveys of patients and clinicians have revealed that patients are primarily interested in access to educational materials, telemedicine services, and being alerted when their disease is out of control. Caregivers prefer seeing symptom score test results, air pollution and pollen levels, and medication adherence data. Overall, caregivers view mobile health technology as enhancing the patient-centered medical home [9‐11]. Pulmonologists prefer obtaining mobile spirometry results between in-office visits, while pediatricians do not share this view. All caregivers, however, are concerned about the accuracy of data obtained and security of patient information.

In collaboration with the Allergy & Asthma Network [12], we surveyed allergy patients and members of the American College of Allergy, Asthma and Immunology (ACAAI) to determine which features they would use in a mobile asthma app. Patients preferred asthma apps that are free, easy to use, accurately monitor symptoms over time, and offer instructions on what to do during asthma exacerbations. Patients were also interested in replacing in-office visits with telemedicine services. Allergy specialists prefer mobile apps that record symptom scores, improve medication adherence, document lung functions, inform patients when to telephone their clinics for help, and alert caregivers when patients are using rescue inhalers more frequently than prescribed (Tables 1 and 2).

Life and health insurance corporations believe in the potential health benefits of mHealth and have established reward programs that offer annual insurance premium discounts for using wearable devices, including the Apple Watch and Fitbit [13].

Mobile asthma apps are also being used by health insurers to determine if prescribed treatments are cost-effective and to compete directly with hospitals, medical clinics, and private practitioners. Using an insurance corporation’s smartphone app, or Internet website portal, employees who receive health care benefits at work may choose to see an employer-paid physician via telemedicine often at no out-of-pocket cost, creating a potential conflict of interest, for such physicians are servants of the insurance company—not the patient [14].

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) play central roles in guiding the development and regulation of mobile medical devices [15‐20]. Entities interested in creating mHealth apps must become familiar with existing FDA rules, regulations, and guidance. As a consequence of the recently enacted amendment to the Twenty-First Century Cures Act, the Food, Drug and Cosmetic Act, some software functions are no longer considered medical devices [17] Therefore, the FDA is now using enforcement discretion for mobile medical apps that do not present risks to patients and consumers. Importantly, developers of mobile apps and medical software are not required to submit their products for premarket reviews nor register them with the FDA. Practical examples of mHealth apps that do not require FDA reviews can be found online [21].

To protect patients and consumers, the FDA is building a new regulatory model to assess the safety and effectiveness of software technologies without inhibiting consumer access to new technology. The FDA’s new Digital Health Software Precertification (Pre-Cert) Program is now reviewing feedback from app stakeholders as the FDA begins to form its consumer friendly, flexible, and adaptive regulatory framework [18]. The rapidly expanding mHealth marketplace will benefit from common sense regulations that can be modified and improved over time, as will software and mobile medical devices the FDA seeks to standardize.

The FDA is also working with Xcertia™, a stakeholder organization formed initially by the American Heart Association, American Medical Association, Health Information and Management System Society (HIMSS), the Digital Health Group (DHX), and others in the mHealth industry to establish guidelines regarding mobile app security, privacy, content quality, operability, clinical efficacy, and ease of use, as summarized online at xcertia.​org/​the-guidelines/​. Xcertia and the FDA hope to bring order in mHealth markets, where to date there has been inadequate oversight and standardization of mHealth products to guide consumers and caregivers.

Interactive asthma apps often employ symptom score tests to assess the status of a user’s disease, the results of which may inform patients how to respond to asthma exacerbations. To guarantee the quality of an app’s clinical assessments and possible recommendations, however, validated rhinitis and asthma outcomes measures are an absolute necessity.

mHealth apps that do not include validated outcomes measures offer nothing more than entertainment to patients and their clinicians; one cannot accurately monitor patients’ symptoms in real time without such proven instruments. The Asthma Control Test (ACT®) and Asthma Control Questionnaire (ACQ) are corporate-owned validated outcome measures employed by several mobile asthma apps [22‐23]. Their owners, however, may request payments from app developers and medical clinics for the use of their intellectual property at any time, causing experienced investigators to encourage development and validation of new asthma and rhinitis questionnaires to be placed in the public domain [24]. The Mobile Asthma Severity Test (MAST® test) was developed and validated to address this issue and was shown to be equivalent to the ACT in an adult asthma population (Fig. 2) [25].

For decades, clinicians depended upon patient-reported peak expiratory flow (PEF) results to diagnose and treat adult and pediatric asthma patients. Even today, many primary care physicians, professional medical organizations, and school nurses promote using peak flow measurements in their Asthma Action Plans—even though peer-reviewed, well-controlled scientific publications have proven that peak flows are effort dependent, inaccurate, and nearly useless in the diagnosis and treatment of asthma.

In 1999, Brand published evidence that should have brought an end to the use of peak flow determinations when writing, “During treatment with inhaled corticosteroids the changes in PEF variation over time show poor concordance with changes in other parameters of asthma severity. When only PEF is monitored, clinically relevant deteriorations in symptoms, FEV-1 and PD20 may be missed. This suggests that home recording of PEF alone may not be sufficient to monitor asthma severity reliably in children.” [26]

There is little to no role for using peak flow data in caring for asthma patients, as summarized by Kamps: “Current asthma guidelines focus on self-management by the patient, in which monitoring of peak flow plays an important role. To be able to participate in self-management, the patient must be educated rigorously on pathophysiological mechanisms of the disease, principles of treatment, correct inhalation technique, treatment goals and the action to take when symptoms or peak flow worsen. This is a time-consuming but important and worthwhile task. The pivotal role of home peak flow monitoring in asthma self-management is based on the assumptions that peak flow variation is a useful measure of disease activity and that peak flow diaries are kept reliably by patients. There is now evidence that neither of these assumptions are true. Self-management plans based on education alone are just as effective as those incorporating peak flow monitoring. Education, therefore, is the most important component of asthma self-management, and home peak flow monitoring is not needed in the majority of asthmatic children.” [27]

Brusasco similarly stated, “In conclusion, no evidence has so far been provided to justify the inclusion of PEF measurement in asthma management plans. This recommendation should therefore be removed unless it can be shown that improving the accuracy of peak flow meters also improves compliance and clinical outcomes.” [28]

Based on these and other findings, the use of peak flow information in asthma self-management programs and mobile applications is a disservice to patients, their families, and caregivers.

Controversy regarding the use of asthma action plans has existed since the concept of self-management of asthma was introduced, primarily because of reliance on inaccurate and untrustworthy patient-performed peak flow measurements. Not only are peak flow test results unreliable, they fail to correlate with clinical outcomes following asthma exacerbations [29, 30]. As Kamps and others have established, better outcomes are achieved by educating patients and their family members about a subject’s asthma triggers and patient-specific treatments, demonstrating proper inhaler techniques and monitoring patients using validated symptom score tests such as the ACT® and MAST® tests. Simply put, peak flow features do not belong in mobile asthma apps.

Some physicians, however, continue to encourage patients, school nurses, and teachers to rely on peak flow test information when creating asthma action plans, to determine when to administer a rescue inhaler or call for emergency assistance [31‐33]. Whatever treatment algorithm one chooses, asthma action plans should not be based on peak flow results alone, whether such plans are provided on paper handouts in the clinic or programmed into mobile asthma applications.

The most challenging issue regarding symptom scores is convincing patients to record them routinely. Patients are understandably less motivated to record their symptoms when asymptomatic, making it difficult for clinicians to document the effectiveness of specific treatments to insurers, employers, government agencies, and other sponsors.

Two techniques known to motivate non-compliant patients are reward and punishment. Rewards may include discount coupons for products or services in collaboration with other businesses, (e.g., a local shoe store) and reduced insurance premiums as noted above [13]. The easiest approach is to compel patients to record their symptom scores when they arrive in the clinic before their appointments. For patients who refuse these gentle techniques, their prescription refills can be delayed until clinicians see the patient’s test scores.

Failure to comply with asthma treatment plans has been a major cause of hospital readmissions, unfortunate asthma deaths, higher health care costs, and lower quality of life in both pediatric and adult asthma populations [34‐39]. This problem has been mitigated in part by the development of electronic sensing devices that attach to inhaled respiratory medications and communicate with prescribing clinicians when inhalers are actuated. After detecting an actuation, a signal is transmitted via a Bluetooth-connected smartphone to secure Cloud-based databases accessible in real time to patients and their caregivers, enabling clinicians to monitor individual patients and an entire clinic population simultaneously.

Actuation sensors are now available worldwide, and their use has been associated with lower overall costs for asthma care and better clinical outcomes [40‐56]. Three peer-reviewed sensor studies are summarized in Table 3. Sensors from Adherium (adherium.​com/​) and Propeller Health (www.​propellerhealth.​com) were assessed for their effectiveness on adherence in combination with patient education and daily delivery of app-based medication reminders to test subject’s smartphones.

Foster [53], Morton [55], and Merchant [56] conducted controlled studies in adult and pediatric asthma patients comparing sensor users with non-users. These studies demonstrated significant clinical and economic benefits associated with actuation sensor use, even though adherence in both sensor user and non-user groups declined over time. Interestingly, Foster found no difference in ACT scores between sensor users receiving feedback and sensor non-users. Use of actuation sensors, however, was associated with a significant decline in emergency room visits and asthma hospitalizations.

Until recently, app quality was difficult to determine objectively, primarily because reliable measures of app quality, content, and usability were non-existent. Progress has been made, however, with development of the Mobile App Rating Scale (MARS) created at Queensland University of Technology [57, 58]. The MARS uses a five-point Likert scale to score four well-defined app categories: user engagement, functionality, esthetics, and information accuracy. Scores from each category are then summed to arrive at overall objective and subjective quality scores. (See: MARS questionnaire online).

Baptista acknowledged the MARS is a positive step forward and suggested more work remains, for MARS validation studies regarding structure and content were composed of small numbers of patients with asthma, heart failure, and obesity [59]. Thus, the science of determining app quality is an evolving science.

It may be impossible to create a single measurement tool for app quality in all circumstances for several reasons. First, patients, caregivers, payers, sponsors, and regulators will have different opinions of quality, and second, digital health apps designed for one disease may not accurately reflect the quality of another mHealth app designed for a different illness. For example, allergic rhinitis and asthma require different validated outcomes measures.

With this limitation in mind, MARS scores for three leading interactive mobile asthma apps are presented in Table 4. While Hailie, Propeller Health, and KagenAir asthma apps are unique, their overall MARS quality scores are comparable in all four categories. Likewise, MARS scores for two popular standalone asthma apps, Asthma Storylines and AsthmaMD, are similar in overall quality, but the subjective quality of Asthma Storylines is superior to AsthmaMD. (See: MARS app quality scores online).